02-75A50126R00001_RFP Att 1 Prod Handling Guidance Don Nat.pdf

Ver20250818

Attachment 1

Product Handling Guidance for Donee Nations

1. PRODUCT HANDLING

1.1. Upon delivery of Product to the Donee Nation, the Donee Nation should:

1.1.1. store and handle the Product in the manner set forth in the instructions in Annex 1 (as such instructions may be amended, supplemented, or otherwise modified upon written notice to the Donee Nation) and any instructions as may be provided by <CONTRACTOR> in writing to ensure stability and integrity of the Product;

1.1.2. bear all expenses for distribution of the Product following delivery, including, but not limited to those relating to shipping to and distribution of the Product in their country;

1.1.3. be solely responsible and liable for the proper storage, handling, distribution, transportation, administration, use and disposal of the Product in their country following delivery of the Product;

1.1.4. ensure that any return and disposal of Products complies with Laws regarding pharmaceutical waste, medical waste, or hazardous waste, as appropriate; and

1.1.5. ensure that it has the requisite expertise to develop and implement appropriate procedures to enable proper handling of the Product in a safe and lawful manner.

2. RESERVED

3. REJECTION OF PRODUCT; DISPOSAL OF REJECTED SHIPMENTS

3.1. Where the Donee Nation wishes to reject any Product that does not materially conform to Specifications or cGMP (“Non-Complying Product”), Donee Nation should provide written notice of rejection to <CONTRACTOR> and USG, setting out detailed reasons for such rejection: (i) within and in no event more than five (5) business days of delivery of such Non-Complying Product in accordance with this Attachment; or (ii) within and in no event more than 5 business days of its first knowledge of a Latent Defect. The Donee Nation will not be entitled to reject any Product supplied based on service complaints unless a Product does not materially conform to Specifications or cGMP.

3.2. The Donee Nation should store and maintain the relevant Non-Complying Product in appropriately secure locations and in accordance with <CONTRACTOR>’s reasonable specifications

4. MAINTENANCE AND RETENTION OF RECORDS

4.1. Donee Nation should maintain detailed records with respect to its activities relating to receipt of Product as required by Laws.

4.2. The Donee Nation should maintain a quality system for receipt, inspection, storage, traceability to further delivery points, and recall activities.

5. DIVERSION ISSUES

5.1. The Donee Nation should ensure that the Product will be: (a) stored securely; and (b) distributed by the Donee Nation only in its territory in a secure manner appropriate to the transportation route and destination, in each case (a) and (b) to guard against and deter theft, diversion, tampering, substitution (with, for example, counterfeits) or unauthorized resale or export out of the Donee Nation’s territory, and to protect and preserve the integrity and e icacy of the Product. The Donee Nation should promptly notify <CONTRACTOR> and USG by email within five (5) business days (with follow up in writing (and in any event within five (5) business days)) of receiving information if at any time Donee Nation believes or becomes aware that any of the Product has been stolen, diverted, tampered with, substituted, or otherwise subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use contrary to any instructions issued by <CONTRACTOR>. The notice should provide all information relating to the Product diversion, including, but not limited to, detailed information including the date, time, location, number, batch number(s), expiration date, circumstances, and contact person(s) information. The Donee Nation should cooperate in good faith with <CONTRACTOR> or its designee, upon <CONTRACTOR>’s request in connection with such Product diversion. The Donee Nation shall not directly or indirectly resell, export, transfer, donate, or otherwise distribute Product.

6. DEFINITIONS

6.1. “Current Good Manufacturing Practices” or “cGMP” means the applicable current good manufacturing, distribution and storage practices set out in the United States Code of Federal Regulations, the United Kingdom Human Medicines Regulations 2012 or EU Directive 2001/83/EC (as amended by Directive 2004/27/EC), Directive 2017/1572, Directive 2003/94/EC and EudraLex - Volume 4 of the Rules Governing Medicinal Products in the EU, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

6.2. “Latent Defect” means a defect causing the Product to not conform to the applicable Specifications that the Donee Nation can show was present at the time of delivery (whether detected within any period of time after that) and which could not have been detected by the Donee Nation, its designee, or their Personnel at delivery through diligent inspection.

6.3. “Law/s” means, collectively, all applicable national and local laws, common laws, statutes, ordinances, codes, rules, regulations, orders, decrees, or other pronouncements of any government, administrative or judicial authority having the e ect of law.

6.4. “Person/s” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department, or agency of a government.

6.5. “Product/s” means <CONTRACTOR>’s <PRODUCT_DESCRIPTION>.

6.6. “Representatives” means the Donee Nation’s A iliates and its and their respective directors, o icers and employees, agents, contractors, consultants, advisors, and representatives who (a) are subject to an obligation of confidentiality protecting the Confidential Information on terms no less restrictive than those contained in this Attachment; and (b) have a need to know the Confidential Information in connection with the supply of Product.

Annex 1 - Product Delivery, Storage, Handling, & Re-Distribution Specifications

The Product is to be stored at a temperature-controlled warehouse between <NUMBER>°C to <NUMBER>°C (<NUMBER>°F to <NUMBER>°F). It can be transported in transportation control vehicles maintaining <NUMBER>°C to <NUMBER>°C (<NUMBER>°F to <NUMBER>°F).