Common use of Reagents Clause in Contracts

Reagents. (a) Buyer hereby covenants that it and each of its Affiliates will not (a) transfer to the United States or sell within the United States any (i) Products or (ii) other goods that (1) contain or are derivate of cell lines subject to paragraph 4 of the Consent Decree or (2) contain any Reagents supplied by Seller and its Affiliates that have not been created within the United States or (3) contain the Reagent 84165 S Pan-1; Hollow Fiber Harvest (“Prohibited Goods”) and (b) will use best efforts to prevent its representatives, agents, successors and assigns from transferring Prohibited Goods to or selling Prohibited Goods in the United States (including by the immediate termination or expiration of sales to distributors to the extent necessary to comply herewith); provided, however, that solely in the case of Products or other goods that contain any Reagents supplied by Seller and its Affiliates that have been created within the United States (other than Reagent 84165 S Pan-1; Hollow Fiber Harvest) this covenant shall not prohibit the transfer to or sale of such Products or other goods if (A) the FDA has first provided confirmation reasonably satisfactory to Seller that transfer or sale in the United States is acceptable to the FDA or (B) the restrictions imposed upon Seller with respect to a particular Prohibited Good under the Consent Decree has expired, lapsed or otherwise terminated. Buyer further acknowledges that because a breach, or failure to comply with, this Section 6.5(a) will cause irreparable injury to Seller for which there is no adequate remedy by Law and the exact amount of which will be difficult to ascertain, if Buyer, or any Affiliate, representative, agent successor or assign thereof, should in any way breach, or fail to comply with, the terms of this Section 6.5(a), Seller shall be immediately entitled to an injunction restraining such Person(s) from any such breach or failure, without the necessity of proving injury or damages or engaging in the alternative dispute resolution process set forth in the Asset Purchase Agreement. Resort of any such remedy provided for by Law shall not preclude or bar the concurrent or subsequent employment of any other appropriate remedy or remedies, or preclude the recover by Seller of monetary damages and compensation. (b) Buyer acknowledges and agrees that (i) those Reagents manufactured by Seller and its Affiliates outside of the United States are not manufactured in accordance with FDA standards and Seller and its Affiliates shall have no obligation to modify their manufacturing processes in order for them to comply with FDA standards, and (ii) Seller and its Affiliates have the right to move the manufacturing location of the Reagents without obtaining Buyer’s consent. If Seller or its Affiliates move the manufacturing location of the Reagents, Seller and its Affiliates shall perform and provide to Buyer, at Buyer’s request, internal equivalency studies which evidence that such relocation does not impact the performance of the Products, which Buyer agrees and acknowledges shall be Seller and its Affiliates’ sole responsibility with respect to such relocation of the manufacturing of the Reagents. Seller acknowledges and agrees that nothing in this Section 6.5 will limit Seller’s obligation to supply the Reagents under this Agreement.

Reagents. (a) Buyer hereby herby covenants that it and each of its Affiliates will not (a) transfer to the United States or sell within the United States any (i) Products or (ii) other goods that (1) contain or are derivate of cell lines subject to paragraph 4 of the Consent Decree or (2) contain any Reagents supplied by Seller and its Affiliates that have not been created within the United States or (3) contain the Reagent 84165 S Pan-1; Hollow Fiber Harvest (“Prohibited Goods”) and (b) will use best efforts to prevent its representatives, agents, successors and assigns from transferring Prohibited Goods to or selling Prohibited Goods in the United States (including by the immediate termination or expiration of sales to distributors to the extent necessary to comply herewith); provided, however, that solely in the case of Products or other goods that contain any Reagents supplied by Seller and its Affiliates that have been created within the United States (other than Reagent 84165 S Pan-1; Hollow Fiber Harvest) this covenant shall not prohibit the transfer to or sale of such Products or other goods if (A) the FDA has first provided confirmation reasonably satisfactory to Seller that transfer or sale in the United States is acceptable to the FDA or (B) the restrictions imposed upon Seller with respect to a particular Prohibited Good under the Consent Decree has expired, lapsed or otherwise terminated. Buyer further acknowledges that because a breach, or failure to comply with, this Section 6.5(a5.7(a) will cause irreparable injury to Seller for which there is no adequate remedy by Law and the exact amount of which will be difficult to ascertain, if Buyer, or any Affiliate, representative, agent successor or assign thereof, should in any way breach, or fail to comply with, the terms of this Section 6.5(a5.7(a), Seller shall be immediately entitled to an injunction restraining such Person(s) from any such breach or failure, without the necessity of proving injury or damages or engaging in the alternative dispute resolution process set forth in the Asset Purchase Agreement. Resort of any such remedy provided for by Law shall not preclude or bar the concurrent or subsequent employment of any other appropriate remedy or remedies, or preclude the recover by Seller of monetary damages and compensation. (b) Buyer acknowledges and agrees that (i) those Reagents manufactured by Seller and its Affiliates outside of the United States are not manufactured in accordance with FDA standards and Seller and its Affiliates shall have no obligation to modify their manufacturing processes in order for them to comply with FDA standards, and (ii) Seller and its Affiliates have the right to move the manufacturing location of the Reagents without obtaining Buyer’s consent. If Seller or its Affiliates move the manufacturing location of the Reagents, Seller and its Affiliates shall perform and provide to Buyer, at Buyer’s request, internal equivalency studies which evidence that such relocation does not impact the performance of the Products, which Buyer agrees and acknowledges shall be Seller and its Affiliates’ sole responsibility with respect to such relocation of the manufacturing of the Reagents. Seller acknowledges and agrees that nothing in this Section 6.5 5.7(b) will limit Seller’s obligation to supply the Reagents under this Agreement.