Change of Manufacturer Sample Clauses

Change of Manufacturer. Provided it has no negative impact on the Regulatory Approval in the Territory, Vyrix has the right to subcontract manufacturing by providing Endo with no less than six (6) months advance notice of any change in manufacturer not listed in the regulatory dossier for the Product as of the Effective Date.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Change of Manufacturer. If at any time during the term of this Agreement, XXX decides to outsource the Manufacture of the Product, XXX will notify Pharmion promptly and in any event at least twelve (12) months before such transfer of Manufacture is expected to be completed, and the Parties will negotiate in good faith any necessary changes to Sections 9 and 12 of this Agreement, and any procedures developed thereunder. XXX shall only select a Manufacturer that holds cGMP certification from the FDA. XXX will use Commercially Reasonable Efforts to ensure that the change of Manufacturer will not affect the safety or efficacy of the Product. The necessary steps for the change of the Manufacturer will be handled within the scope of an NDA supplement submitted to the FDA. XXX will cooperate with Pharmion by providing the available Manufacturing and other data required to support any required supplement to the NDA. Any such change of Manufacturer may also require changes to the forecasting and ordering procedures set forth in this Agreement, and the Parties agree to make any reasonable changes to such procedures resulting from any such change of Manufacturer. Costs associated with any such change of Manufacturer will be borne by XXX except where such costs are associated with changes requested by Pharmion or where additional work is required only in order to comply with new regulatory or other requirements in the Territory, in which case such costs will be reimbursed by Pharmion.
Sample 1
Change of Manufacturer. Pharmion is aware that Schering intends, on or before July 27, 2009 to transfer Manufacture of the Product from Aventis to another Manufacturer. Schering shall only select a Manufacturer that holds current Manufacturing authorisation with, or holds an internationally recognized equivalent certificate to, the standards detailed in European Community Directive 91/356/EEC. Schering will notify Pharmion promptly and in any event at least twelve (12) months before such transfer of Manufacture is expected to be completed and the Parties will negotiate in good faith any necessary changes to Sections 9 and 12 of this Agreement, and any procedures developed thereunder. Pharmion acknowledges that the transfer of Manufacture from Aventis to another Manufacturer is likely to result in changes to the Manufacturing process and specifications of the Product, some of which may require variations to the Marketing Authorizations. Such variations to the Marketing Authorizations will be made by Pharmion at its own expense. However, Schering will use Commercially Reasonable Efforts to ensure that the change of Manufacturer will not affect the safety or efficacy of the Product. The necessary steps for the improvement of the Manufacturing process and the change of the Manufacturer will be handled within the scope of variation reports submitted to the EMEA. Schering will cooperate with Pharmion by providing the available Manufacturing and other data required to support any required application for variation of Marketing Authorizations. Pharmion is obliged to submit the variations related to changes of the Manufacturing process/Manufacturer without delay to the Agencies in the countries within the Territory in which it holds a Marketing Authorization and in which it is marketing and selling the Product. Such change of Manufacturer may also require changes to the forecasting and ordering procedures listed in this Agreement, and the Parties agree to make any reasonable changes to such procedures resulting from such change of Manufacturer. Costs associated with such change of Manufacturer will be borne by Schering except where such costs are associated with changes requested by Pharmion or where additional work is required only in order to comply with new regulatory or other requirements in the Territory, in which case such costs will be reimbursed by Pharmion.
Sample 1

Related to Change of Manufacturer

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Product The term “

  • Non-Conforming Product If Reliant notifies Cardinal Health during the Review Period that the Manufacturing Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Manufacturing Sample. The results of the independent review shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION OBLIGATIONS UNDER SECTION 14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

Time is Money Join Law Insider Premium to draft better contracts faster.