Required Specification Changes. Allos will maintain a system (consistent with standard industry practice) to control and implement changes to API Specifications and Bulk Product Specifications, manufacturing processes and qualification procedures, in accordance with GMPs and other applicable Laws in the United States, the European Countries or under ICH Guidelines. Each Party will provide written notice in a timely manner to the other Party of any other applicable Laws in their respective territories that require any such changes. Any costs associated with changes to the Specifications required by Regulatory Authorities in the Licensed Territory that are not also required in the U.S. or Canada will be [***]. Any costs associated with changes to the API Specifications and Bulk Product Specifications procured by Allos for its own use required by Regulatory Authorities in the U.S. or Canada will be [***] unless such changes are also required by Regulatory Authorities in the Licensed Territory, in which case [***].
Required Specification Changes. For changes to the Specifications that are required by Laws (collectively “Required Specification Changes”), EUSA and Innocoll shall cooperate in making such changes and use Commercially Reasonable Efforts to implement such changes in compliance with such Laws and as promptly as practicable.
Required Specification Changes. 2.4.2.1 If a Required Specification Change is necessary, the Parties will confer immediately and in good faith to determine the most cost-effective and efficient means to implement or to otherwise provide for the Required Specification Change.
2.4.2.2 Subject to Sections 2.4.2.3 and 2.4.2.4 below (but notwithstanding anything to the contrary in Section 2.4.1 above), Pacira shall implement such Required Specification Change as quickly as reasonably possible.
2.4.2.3 The Parties shall itemize in good faith best estimates of the respective costs and impacts, including capital expenses and potential impacts that such Required Specification Changes will have on each Party. PACIRA & EKR CONFIDENTIAL
2.4.2.4 The Parties shall use reasonable commercial endeavours to agree the costs and expenses and how such costs and expenses should be allocated between them. In the event that the Parties cannot agree the costs and expenses or how such costs and expenses should be allocated between them either Party may refer the matter to Dispute Resolution in accordance with the terms of Schedule VIII of the License Agreement.
Required Specification Changes. For changes to the Specifications that are required by a Governmental Authority, the Marketing Authorization or applicable Laws (collectively “Required Specification Changes”), Adolor and Supplier shall cooperate in making such changes and Supplier shall implement such changes in compliance with such applicable Laws and as promptly as practicable.
Required Specification Changes. Spectrum will maintain a system (consistent with standard industry practice) to control and implement changes to Specifications, manufacturing processes and qualification procedures, in accordance with GMPs and other applicable Laws in the United States, the European Countries or under ICH Guidelines. Each Party will provide written notice in a timely manner to the other Party of any other applicable Laws in their respective territories that require any such changes. Any costs associated with changes to the Specifications required by Regulatory Authorities in the Licensed Territory that are not also required in the Spectrum Territory will be paid by MMCO. Any costs associated with changes to the Specifications procured by Spectrum for its own use required by Regulatory Authorities in the Spectrum Territory will be paid by Spectrum unless such changes are also required by Regulatory Authorities in the Licensed Territory, in which case they will be equally shared by the Parties.
Required Specification Changes. If a Governmental Authority in the Territory requires a change to the Product Specifications (a “Required Specification Change”), Incyte will promptly notify MacroGenics of such change. MacroGenics will use reasonable efforts to implement such Required Specification Change as promptly as possible within the time frame requested by the Governmental Authority at Incyte’s sole cost and expense.
Required Specification Changes. 2.3.2.1 If a Required Specification Change is necessary, the Parties will confer immediately and in good faith to determine the most cost-effective and efficient means to implement or to otherwise provide for the Required Specification Change.
2.3.2.2 Subject to Sections 2.3.2.3 and 2.3.2.4 below, Pacira shall implement such Required Specification Change as quickly as reasonably possible.
2.3.2.3 The Parties shall itemize in good faith best estimates of the respective costs and impacts, including capital expenses and potential impacts that such Required Specification Changes will have on each Party.
2.3.2.4 The Parties shall use reasonable commercial endeavours to agree the costs and expenses and how such costs and expenses should be allocated between them. In the event that the Parties cannot agree the costs and expenses or how such costs and expenses should be allocated between them either Party may refer the matter to Dispute Resolution in accordance with the terms of Schedule VI of the Marketing Agreement.
