Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions

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Normalized: nelson labs portal essf frozen tissue samples additional questions
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2026-02-24 04:31:44.535234+00:00
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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Moderate — a somewhat similar entity exists
97%
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Strong source linkage

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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s). Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required) Section 351 P
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) 1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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1960 CASE PARKWAY SOUTH TWINSBURG , OHIO 44087 February 12, 2026 Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions Dear Mitch: MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products. Background Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission -critical services to the medical device, pharmaceutical, tissue, and food industries. As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261 ). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort. Project Scope and Approach Project Scope Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026). Enhancements include: eSSF and CRM Enhancements 1. New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s) o Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s). 1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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