Manufacturing Issues Sample Clauses
The 'Manufacturing Issues' clause defines how problems or delays in the production process are addressed within a contract. It typically outlines the responsibilities of the manufacturer and the buyer if defects, shortages, or other production setbacks occur, and may specify notification requirements, remedies, or timelines for resolving such issues. This clause ensures that both parties have a clear understanding of their obligations and the steps to take if manufacturing problems arise, thereby minimizing disputes and providing a structured approach to managing production risks.
Manufacturing Issues. 3.10.1 If during Manufacturing BN realises that it is generally unable to Manufacture Releasable Batches due to unforeseen events, the Parties will enter into good faith negotiation to a) resolve potential technical or Manufacturing problems and/or b) discuss the possibilities of manufacturing other drug substances using MVA-BN® instead of BDS and/or c) how to best limit financial losses. These issues should also be discussed by the JSC in accordance with Article 3 of the Collaboration Agreement.
Manufacturing Issues. 4.12.1. If it is necessary for the purposes of compliance with any applicable laws for Pharmacare to make any change to the manufacturing process, procedures or facilities including changes in or replacement of equipment it shall so notify Medtech and Medtech shall as soon as possible make all such changes to the marketing authorisation, through application to the relevant governmental or regulatory authority and Pharmacare shall, at Medtech's cost and expense (which costs and expenses shall be paid for by Medtech and/or reimbursed to Pharmacare by Medtech against demand), supply data which Medtech reasonably requires for such purpose.
4.12.2. Pharmacare warrants to Medtech that it will manufacture each product in compliance with the specifications for such product and in accordance with good manufacturing practices, the marketing authorisations and the provisions of the technical agreement.
4.12.3. Pharmacare will, at its cost and expense, maintain all necessary manufacturing authorisations to manufacture the products.
4.12.4. Pharmacare will be responsible for creating and retaining all records relating to the manufacture of the product as required by the applicable laws and confirmed in the quality agreement.
4.12.5. Pharmacare shall, at its cost and expense, conduct all necessary validation and routine maintenance stability studies in respect of the products.
4.12.6. Pharmacare shall be responsible for procuring all inventory for each product. All inventory procured by Pharmacare and used in the products shall be tested (by Pharmacare or the supplier thereof) to assure that they meet the specifications and quality standards. In addition, Pharmacare will maintain records and information of the inventory to support the Product and to assist with activities relating to the registration, maintenance and approval of inventory of existing Products. The aforegoing will include interactions with suppliers of the inventory to resolve Medtech's technical queries and obtaining documentation to support the CMC section of the Common Technical Documents ("CTD").
4.12.7. Pharmacare shall supply products bearing the trademarks and Medtech's marketing authorisation number and Medtech shall be responsible for determining the contents and appearance of the product containers labels, inserts and packaging materials in relation to the primary packaging.
4.12.8. Pharmacare shall make changes to the appearance of the primary packaging as requested by Medtech from time to tim...
Manufacturing Issues. In the event that Pfizer experiences quality issues, manufacturing problems or other related circumstances that (i) arise in the course of manufacturing the Product for AMAG, (ii) are beyond Pfizer’s reasonable ability to control in the current configuration of the […***…] Facility (including cross-contamination of other lines or products, EHS-related problems; etc.), and (iii) adversely affect Pfizer’s ability to manufacture at the […***…] manufacturing plant the Product […***…].
Manufacturing Issues. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay or other issue that is likely to adversely affect supply of its products for use in the Parties’ performance of the Research Program Activities. Thereafter, the Parties will promptly discuss such delay or issue, and the Party experiencing such delay or issue shall use Commercially Reasonable Efforts to: (a) remedy the situation giving rise to such shortage; and (b) take action to minimize the impact of the shortage on the Research Program Activities. Immatics, as the sponsor of the Combination Therapy Trial shall have the right to engage an independent Third Party reasonably acceptable to Moderna and subject to appropriate confidentiality agreements, to conduct a qualification audit of Moderna’s quality systems, manufacturing facility, and testing facility, as will be further set forth in the Quality Agreement; provided, that any report from such Third Party audit shall be limited to either the conformation of Moderna’s compliance with its requirements under the Quality Agreement or any specific deficiencies identified.