Request for Proposals Attachment 1 Prod Handling Guidance Don Nat

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