As requested in your letter of September 25, 1976, I have executed and am enclosing herewith four copies of Modification No. 1 to the above letter contract. We have made two changes in Article IX - Payment; the price for Bivalent Vaccine was changed from $24.38 to $24.37 and the exact insurance premium amount for Wyeth should be $2,176,693.25. We will look forward to your return of one copy of the modification upon execution by the Government. The contractor shall manufacture and distribute influenza vaccine in accordance with the specifications set forth below during the contract period to the points and in the quantities specified on Delivery Orders issued by the Center for Disease Control. The only obligations or responsibilities of the Contractor in connection with the National Swine Flu Immunization Program of 1976 are contained in this contract (with exception that the contractor agrees to enter into good faith negotiations to definitize the contract.) ARTICLE II - SPECIFICATIONS: A. Type of Vaccine: B. C. The vaccine shall be Influenza Monovalent A/New Jersey/76 (Swine) and/or Bivalent A/New Jersey/76 (Swine) A/Victoria/3/75 manufactured under a current establishment and product license as set forth below. Formulation, standards, specifications and applicable tests of the vaccine shall be as set forth in the approved product license or as otherwise directed by the Food and Drug Administration. Product Licensure: The vaccine supplied under this contract shall be produced under U. S. Establishment License No. 3 and Amendment to the product license for influenza vaccine issued by the Bureau of Biologics. If, during the contract period of performance, the product or establishment license is suspended or revoked for any reason, production of the vaccine shall be discontinued until such time as the license is renewed. In the event production is suspended for the above reason, the Government shall not be held liable for failure to procure the vaccine contained in this contract nor shall the contractor be liable for failure to supply vaccine. Shelf Life: Delivered vaccine shall have an expiration date through August 1, 1977. The Government agrees to take all appropriate steps to see to it that all persons who are responsible for administering vaccine are notified that the vaccine must not be administered after, August 1, 1977. D. Containers: E. Vaccine shall be contained in vials of 50-dose capacity, with 2ml overfill. Fifty-dose rubber: Labeling: Labeling of vials shall be in accordance with 21 CFR 610.60. In addition, the color of label for the monovalent vaccine shall be red with black or white markings, and the color of the bivalent vaccine shall be blue with black or white markings. Lot number shall be specified on each vial label. Text of the labels shall be supplied by the Government. Each package shall be labeled in accordance with Paragraph 85.2.2.2 Intermediate Containers of Federal Standard 123D. In addition to the requirements of the referenced Federal Standard, the following is required: A. Labeling shall show applicable lot numbers. B. C. A paste-on label shall be attached to each package. Label shall conform to the sample supplied with RFP. Package inserts shall′ be placed in each intermediate package, a total of 10 Preservation, packaging, and packing shall furnish a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., and shall conform to applicable carrier rules and regulations, including carriers handling overseas shipments. Vaccine shall be shipped under refrigeration at a temperature between 2° and 15°C (34® to 60°F). Packing and packaging shall be such that this temperature is maintained during shipment for a period of up to 72 hours and that shipments shall arrive at destination in undamaged condition. H. Marking Provisions: Shipping containers: Containers shall be marked in accordance with Federal Number 123D, January 22, 1975, and shall contain as a minimum the following: ́ The number of doses, by vial sizes, to be furnished under the contract is: Monovalent Vaccine 50-dose vials 5 million doses · Variation in Quantity: A variation in the total quantity supplied hereunder will be accepted, provided that such variation is not in excess of 15% of the contract quantity specified above, and is available for delivery prior to the final delivery date January 15, 1977). The contractor shall notify the Government of availability of midi tional quantities as soon as this status becomes known to the contractor. The contractor shall deliver the vaccine F.O.B. Destination Within Consignee's Promises, Freight Charges Added, as directed on Delivery Orders, to approximately 200 points in the 50 states and Trust Territories. B. Delivery Schedule: C. Deliveries shall begin on or before October 1, 1976, with the total amount of bivalent and monovalent vaccine to be delivered in accordance with the attached Availability Schedule. All deliveries shall be completed on or before January 15, 1977. The Government agrees that the vaccine delivered by the Contractor shall not be administered prior to October 1, 1976. Overseas Delivery Requirements: Overseas shipping and delivery methods shall be utilized for delivery to those points located outside the Continental United States. D. Time of Delivery: Contractor shall deliver vaccine to consignees specified in the Government's Delivery Orders within 15 business days after receipt of such Delivery Orders provided the Government's Delivery Orders shall not exceed quantities of vaccine which have been released for marketing by the Government's Bureau of Biologice and which have been filled into final dosage form and packaged by the Contractor prior to the Contractor's receipt of Delivery Orders. E. Shipments shall be made in increments of 8,000 doses. ARTICLE V - DELIVERY TERMS: Delivery shall be made F.0.B. DESTINATION, WITHIN CONSIGNEE'S PREMISES, FREIGHT CHAI as defined below: The term, ".0.B. Destination, Within Consignee's Premises, Freight Charges Added,” to this contract is subject, means: (a) The Contractor shall deliver to within the doors of the Consignee's promises specifist in the contract or delivery instructions. The Government shall bear all transportation expenses necessary to effect such delivery and the Contractor shall include such charges on pertinent invoices to the Government. Supportive documents of Freight Charges in excess of $50 shall be supplied with the invoices. (b) That it shall be the responsibility of the contractor to do the following: (1) Pack and mark in such manner as to afford adequate protection against normal transportation hazards and secure prompt delivery to the consignee, and comply with all packing and marking specifications of the contract; (2) Properly prepare and distribute commercial bills of lading; (3) Make delivery laid down within the doors of the consignee's promises specified in the contract or delivery instructions; |