Manufacturing Process Development Sample Clauses
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Manufacturing Process Development. Notwithstanding anything to the contrary herein or otherwise, to the extent the Manufacturing Process is not complete and specified in the applicable Specifications and/or SOW as of the Effective Date or a change in the Manufacturing Process is required under Applicable Law or a Regulatory Approval or for Regulatory Approval, the Parties shall develop and agree upon such Manufacturing Process for inclusion in such Specifications and/or SOW as follows: (i) upon Corden’s reasonable request, Viking shall provide additional specifications or functional requirements that are not already included in the Specifications and that are necessary for developing the Manufacturing Process; (ii) Corden shall develop, test and validate the Manufacturing Process as required for Regulatory Approvals, in accordance with Applicable Laws and in accordance with any protocol(s) and timeline(s) set forth in the applicable Specifications and/or SOW, Quality Agreement or otherwise mutually agreed in writing by the Parties; and (iii) upon Regulatory Approval of the Manufacturing Process and subject to Viking’s prior written approval (not to be unreasonably withheld), and without limitation of any of Corden’s other obligations and liabilities and any of Viking’s rights and remedies under this Agreement or otherwise, Corden shall strictly adhere to the Manufacturing Process and the applicable Specifications and/or SOW shall be promptly amended to include such Manufacturing Process. Notwithstanding anything to the contrary herein or otherwise, Corden shall be solely responsible and liable for the Manufacturing Process.
Manufacturing Process Development. Seller shall complete the Development of the Finished Product for commercial Manufacture in accordance with the Manufacturing process development schedule attached hereto and incorporated herein as Schedule D, as the same may be amended in accordance with this Section 2.15, except to the extent any actions of Purchaser or its affiliates (including the exercise of review and approval rights pursuant to this Section 2.15) prevent such Development and compliance with such schedule (as may be amended). The Manufacturing process development schedule attached as Schedule D shall be automatically amended to the extent reasonably necessary to reflect changes in the Development timeline for API, including due to changes in the Development plan for the API or the protocols for the Ongoing Trials implemented or directed by Purchaser or any of its affiliates (with amendments to Schedule D to be made on a commensurate basis with the changes in the Development timeline for the API). Any other amendments to the Manufacturing process development schedule attached as Schedule D shall be made only by mutual agreement of Seller and Purchaser. Seller shall permit Purchaser, upon reasonable advanced notice from Purchaser to Seller, to review Manufacturing process validation documents with respect to the Finished Product, and all such validation documents shall be subject to Purchaser’s approval (such approval not to be unreasonably withheld, conditioned or delayed); provided, that Purchaser shall reimburse Seller for all reasonable, documented out-of-pocket costs incurred by Seller in connection with such review and approval.
Manufacturing Process Development