FACILITIES AND MANUFACTURING. Except as set forth on Schedule 4.01(k) attached hereto, and only to the extent it could have a material adverse effect on the Assets or GW's performance hereunder or under any of the Collateral Agreements, during the period commencing on June 30, ]996, and ending on the date hereof, with respect only to the Products, neither GW nor its Affiliates have received or been subject to: (i) any FDA Form 483's relative to the Products; (ii) any FDA Notices of Adverse Findings relative to the Products; or (iii) warning letters or other correspondence from the FDA or any other governmental officials or agencies concerning the Products in which the FDA or other such governmental officials or agencies asserted that the operations of GW were not in compliance with applicable law, regulations, rules, or guidelines.
FACILITIES AND MANUFACTURING. Except as set forth on Schedule 4.01(k) attached hereto, and only to the extent it could have a material adverse effect on the Assets or KING's performance hereunder or under any of the Collateral Agreements, during the period commencing on January 1, 2000, and ending on the date hereof, with respect only to the Products, neither KING nor its Affiliates have received or been subject to: (i) any FDA Form 483's relative to the Products; (ii) any FDA Notices of Adverse Findings relative to the Products; or (iii) warning letters or other correspondence from the FDA or any other governmental officials or agencies concerning the Products in which the FDA or other such governmental officials or agencies asserted that or questioned whether the operations of KING were not in compliance with applicable law, regulations, rules, or guidelines.
FACILITIES AND MANUFACTURING. Except as set forth on Schedule 3.9, and only to the extent it could have a Material Adverse Effect on the Purchased Assets or AHPC's performance hereunder or under any of the Transaction Agreements, during the period commencing on January 1, 1998, and ending on the date hereof, with respect only to the Products, neither AHPC nor its Affiliates have received or been subject to: (i) any FDA form 483's relative to the Products; (ii) any FDA Notices of Adverse Findings relative to the Products; or (iii) warning letters or other correspondence from the FDA or any other governmental officials or agencies concerning the Products in which the FDA or other such governmental officials or agencies asserted that the operations of AHPC were not in compliance with applicable law, regulations, rules or guidelines.
FACILITIES AND MANUFACTURING. Except as set forth on Schedule 4.01(k) attached hereto, and only to the extent it could have a material adverse effect on the Assets or NOVAVAX’s or FIELDING’s performance hereunder or under any of the Transaction Documents to which it is a party, during the period commencing on January 1, 2005 and ending on the date hereof, with respect only to the Products, neither NOVAVAX nor FIELDING has received or been subject to: (i) any FDA Form 483’s relative to the Products; (ii) any FDA Notices of Adverse Findings relative to the Products; or (iii) warning letters or other correspondence from the FDA or any other governmental officials or agencies concerning the Products in which the FDA or other such governmental officials or agencies asserted that, or questioned whether, the operations of NOVAVAX or FIELDING were not in compliance with applicable law, regulations, rules, or guidelines.
