Discretionary Manufacturing Changes. For changes to the Specifications or manufacturing process that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), Aventis and Purchaser must each agree to any Discretionary Manufacturing Changes and shall, to the extent commercially reasonable under the circumstances, cooperate in making such changes, and each agrees that it shall not unreasonably withhold its consent to such Discretionary Manufacturing Changes. Notwithstanding the foregoing, Aventis’ standard change control procedures shall be utilized in reviewing such changes.
Discretionary Manufacturing Changes. For changes to the Specifications that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), Adolor shall submit a request to PII for any such Discretionary Manufacturing Changes. Upon receipt of such request from Adolor, PII shall determine (a) one-time and/or ongoing costs that would be incurred resulting from the Discretionary Manufacturing Changes, (b) any resulting planned changes in timing for the delivery of the Drug Product and (c) the estimated time of implementing any such Discretionary Manufacturing Changes (the “Cost and Time Statement”). PII shall provide the Cost and Time Statement to Adolor setting forth the terms on which PII would be willing to make the Discretionary Manufacturing Changes. Upon Adolor’s written approval of the Cost and Time Statement, the parties shall cooperate in making such Discretionary Manufacturing Changes and PII shall implement such Discretionary Manufacturing Changes.
Discretionary Manufacturing Changes. Vericel may propose changes to the Specifications or Manufacturing process for the supply of Product to Vericel for the Territory that are not Regulatory Changes (any such change, a “Discretionary Manufacturing Change”). If agreed to by MediWound, MediWound or its Suppliers will use commercially reasonable efforts to make such proposed changes, and Vericel will bear [***] of the costs associated with such changes. MediWound may propose changes to the Specifications or Manufacturing process for the supply of Product for the Territory that are not Regulatory Changes. MediWound shall propose any such Discretionary Manufacturing Change in accordance with the applicable 9012190/26 Change Notification Period prior to the proposed implementation. [***]. Vericel shall, within [***] of receipt of MediWound’s notice, notify MediWound in writing whether Vericel accepts or rejects the proposed change, such consent not to be unreasonably withheld, conditioned or delayed unless consultations with regulatory authorities are required to assess the impact of such proposed change.
Discretionary Manufacturing Changes. With respect to changes to the Specifications or the manufacturing process for Supplied Products which are not Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”), the Parties shall, to the extent commercially reasonable under the circumstances, cooperate in making such changes and the party initiating such change(s) shall bear all the costs associated with and resulting from any such changes. If the proposed change is judged to require a prospective process validation or regulatory submission, then the costs to execute and resource such validation or submission shall be the responsibility of the initiating party. All regulatory submissions will be filed by Allendale.
Discretionary Manufacturing Changes. For changes to the specifications that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), Client shall submit a request to CRL for any such Discretionary Manufacturing Changes. Upon receipt of such request from Client, CRL shall reasonably and in good faith determine (i) one time and/or ongoing costs that would be incurred resulting from the Discretionary Manufacturing Changes, (ii) any resulting planned changes in timing for the delivery of the Drug Product and (iii) the estimated time of implementing any such Discretionary Manufacturing Changes (the “Cost and Time Statement”). CRL shall provide the Cost and Time Statement to Client setting forth the terms on which CRL would be willing to make the Discretionary Manufacturing Changes and the Parties shall promptly discuss such Cost and Time Statement in good faith. Upon Client’s written approval of the Cost and Time Statement (or any amended version thereof based upon the discussion between the Parties), the Parties shall cooperate in making such Discretionary Manufacturing Changes and CRL shall implement such Discretionary Manufacturing Changes. [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Discretionary Manufacturing Changes. Seller may, upon reasonable advanced notice to Buyer [REDACTED] make changes to the process of Manufacturing of Supplied Product other that Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”) [REDACTED] Buyer may request Discretionary Manufacturing Changes and if Seller agrees (in its reasonable discretion) to make any such Discretionary Manufacturing Changes, Seller will provide the estimated cost and time of implementing any such Discretionary Manufacturing Changes to Buyer along with the terms on which Seller would be willing to make such Discretionary Manufacturing Changes. Upon Buyer’s written acceptance of such cost and time estimate, the Parties shall cooperate in making such Discretionary Manufacturing Changes and Seller shall use commercially reasonable efforts to implement such Discretionary Manufacturing Changes as requested by Buyer.
Discretionary Manufacturing Changes. (a) If, as part of a general change program at its Manufacturing site(s) which will not disadvantage the Supplied Products as compared with other products Manufactured or supplied by Seller or its relevant Affiliate(s) at such site(s), Seller desires to make a Discretionary Manufacturing Change, Seller shall notify Buyer, providing reasonable details and the Parties shall promptly meet and discuss in good faith the reasonable concerns of Buyer relating thereto, with Seller providing such information to Buyer as Buyer may reasonably request. Provided that Seller follows the foregoing process and uses reasonable efforts to make such accommodations as Buyer may reasonably request to minimize the impact of such Discretionary Manufacturing Changes on the Product Business, Seller may make reasonable Discretionary Manufacturing Changes at Seller’s sole cost and expense (for the avoidance of doubt including any cost or expense incurred by Buyer reasonably and directly as a result of any such Discretionary Manufacturing Change), but Seller shall not implement any change prior to receipt of approval, if required, of any such variations to any Regulatory Approvals for the Product in the Territory.
Discretionary Manufacturing Changes. With respect to changes to the Specifications or the manufacturing process for Supplied Products which are not Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”), the Parties shall, to the extent commercially reasonable under the circumstances, cooperate in making such changes and the party initiating such change(s) shall bear all the costs associated with and resulting from any such changes. No manufacturing changes shall be made without the express written authorization of Allendale. If the proposed change is judged to require a prospective process validation or regulatory submission, then the costs to execute and resource such validation or submission shall be the responsibility of the initiating party. All regulatory submissions will be filed by Allendale.
Discretionary Manufacturing Changes. With respect to changes to the Specifications or the manufacturing process for Products which are not Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”), the Parties shall, to the extent commercially reasonable under the circumstances, cooperate in making such changes and the party initiating such change(s) shall bear all the costs associated with and resulting from any such changes. In no event shall NPI implement a Discretionary Manufacturing Change without providing JDS with six (6) months written notice of the change and, where appropriate, providing JDS with all documentation necessary to support a regulatory submission for the change. If the proposed change is judged to require a prospective process validation or regulatory submission, then the costs to execute and resource such validation or submission shall be the responsibility of the initiating party. All regulatory submissions will be filed by JDS.
Discretionary Manufacturing Changes. With respect to changes to the manufacturing process for the Product which are not Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”), the Parties shall, to the extent commercially reasonable under the circumstances, cooperate in making such changes and the Party initiating such change(s) shall bear all the costs associated with and resulting from any such changes. Unless waived by DARA, ONXEO shall not implement a Discretionary Manufacturing Change without providing DARA with six (6) months written notice of such proposed change and, where appropriate, providing DARA with all documentation necessary to support a regulatory submission for such proposed change. If the proposed change is judged by DARA to require a prospective process validation or regulatory submission, then the costs to seek and execute such validation or submission shall be the responsibility of the initiating Party. All regulatory submissions will be filed by DARA.
