Manufacturing Change definition
Examples of Manufacturing Change in a sentence
In such event, the Parties shall discuss in good faith potential options with respect to such Major Manufacturing Change and agree on any such Major Manufacturing Change before it is implemented.
If Supplier wishes to make a Manufacturing Change with respect to any Drug Product, it shall provide Purchaser with prompt written notice of such determination and description of such proposed Manufacturing Change, including expected timelines for implementation (a “Change Notice”).
If Purchaser does not obtain approval of the Major Manufacturing Change from the applicable Regulatory Authority in a country in the Territory, or if Purchaser becomes aware of a potential failure to timely receive such approval, Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier thereof.
Supplier shall have the final say with respect to any Supplier Manufacturing Change.
If Supplier reasonably believes that implementation of a proposed Manufacturing Change may be required by a Regulatory Authority on a shorter time period than the time periods set out in this Clause 2.3.2, then Supplier shall include such timelines in the applicable Change Notice.
Within [***] Business Days of Supplier’s receipt of Purchaser’s request to meet, or such shorter time period as may be required by such Regulatory Authority, the Parties shall meet and determine if such Manufacturing Change would (i) impact Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (ii) require notice to or approval of a Regulatory Authority in the Territory or (iii) require approval of Purchaser under the terms of the Quality Agreement.
If Purchaser believes such proposed Manufacturing Change (x) impacts Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (y) requires notice to or approval of a Regulatory Authority in the Territory or (z) requires approval of Purchaser under the terms of the Quality Agreement, then Purchaser shall include in the Change Response a request to meet with Supplier to determine if such proposed Manufacturing Change meets subclauses (x) through (z) above.
Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier upon receipt of any required approval from the applicable Regulatory Authority or the filing of any required notification in order to enable Supplier to implement or procure the implementation of the Major Manufacturing Change.
Any Major Manufacturing Change that impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization or requires the approval of a Regulatory Authority in the Territory or approval of Purchaser under the terms of the Quality Agreement shall require the mutual agreement of the Parties and the approval of the Regulatory Authority (as applicable) prior to implementation.
The costs of any Supplier Manufacturing Change will be borne by [***].