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.
Manufacture of Product. ORDER PROCESS; DELIVERIES
Manufacture of Product. Oculus shall Manufacture (and not appoint any Third Party to Manufacture) and supply to Ruthigen as and when reasonably requested, Products in accordance with the relevant Specifications, and subject to the terms of this Article VI.
Manufacture of Product. In-process controls X — Full analytical testing (Including OOS investigation) X — Review of testing X — Checking of compliance with SPECIFICATION and Suitability of documentation X X — Retention of batch manufacturing and control records for PRODUCT X — Labeling of storage or shipping containers for PRODUCT X — Retention of record for filling PRODUCT into containers for storage or shipping X — Approval of PRODUCT for filling X — Generation of CERTIFICATE OF ANALYSIS X — Retention of reference samples of PRODUCT X — Inspection, testing and release of containers X — Secure storage and handling of PRODUCT X Responsibility for: Cipla Eagle FILLING, PACKING, INSPECTION AND RELEASE OF PRODUCT — Filling of PRODUCT solution including in-process controls X — Approval of filled PRODUCT for packing X — Packing and labeling of PRODUCT including in-process controls X — Full analytical testing (Including OOS Investigation) X — Review of Full testing (Including OOS Investigation) X X — Checking of compliance with SPECIFICATION and suitability of documentation X — Retention of BATCH DOCUMENTATION for PACKED PRODUCT X — Generation of CERTIFICATE OF ANALYSIS X — Retention of reference sample of PACKED PRODUCT X — Approval of PACKED PRODUCT X X — Handling of PRODUCT up to delivery to Eagle X — Audit of all BATCH DOCUMENTATION as requested X — Final Release of PRODUCT from DC X LABEL DESIGN AND CHANGE CONTROL FOR CONTAINERS OF BULK PRODUCT — prepared by X X [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. — approved by X X CORE PACKAGING TEXT — prepared by X — maintained by X — approved by X PACKAGE COMPONENT COPY DESIGN AND CHANGE CONTROL FOR PACKED PRODUCT — prepared by X — approved by X X DESTRUCTION OF HANDLING OF PROCESS WASTE GENERATED AT SUPPLIER X Responsibility for: Cipla Eagle PROCESS & PACKING VALIDATION — protocol & report prepared by X — protocol & report signed off by X — protocol & report approved by X X — protocol executed by X COMPUTER AND OTHER VALIDATION — protocol &report prepared by X — protocol & report signed off by X — protocol & report approved by X — protocol executed by X POST-MARKETING STABILITY CONFORMANCE Stability protocol for SUPPLIER packing sites — prepared by X — approved by X X Stability testing for PACKED PRODUCT — performance of testing X — review of stabili...
Manufacture of Product. AFP shall reserve sufficient production capacity and inventory of Product in order to be able to supply to MannKind pursuant to the terms of this Agreement. AFP shall manufacture Product in accordance with § 2.1, § 2.5, and United States and European Union regulations applicable to the transportation, storage, use, handling and disposal of hazardous materials. Each Party shall promptly notify the other of any new instructions or specifications with respect to the Product required under any applicable laws and shall confer with each other with respect to the best means to comply with such requirements. AFP represents and warrants to MannKind that it has, and shall maintain during the term of this Agreement, all government permits, including without limitation health, safety and environmental permits, necessary for the conduct of the actions and procedures that it undertakes pursuant to this Agreement.
Manufacture of Product. (a) Supplier shall manufacture the Product at the Facility and shall Deliver the Product to Purchaser in accordance with the Compliance Requirements (including the Anti-Bribery Commitments for Lilly Procurement Contracts, as revised by Purchaser or its Affiliate from time to time and published at xxxxx://xxx.xxxxx.xxx/suppliers/new-and-existing-suppliers/supplier-notifications or otherwise made available to Supplier). Supplier shall also obtain and maintain in force during the Term all licenses, permissions, authorizations, consents and permits needed to manufacture and Deliver the Product in accordance with the terms of this Agreement.
Manufacture of Product. 5.3.1 Luitpold shall manufacture Product in accordance with the Product Specifications for American Regent Inc., Product Number 4930-25. Such Product Number may be modified from time to time by Luitpold. The Product shall be labeled by American Regent Inc. in accordance with FDA approved label copy and as mutually approved by the Parties.
Manufacture of Product. 6.3.1 Abbott shall manufacture Product in accordance with the Product Specifications for ****, as modified from time to time by Abbott. Product shall be labeled by Abbott in accordance with FDA approved lable copy and as mutually approved by the parties.
Manufacture of Product. 3.1 Changes in the manufacturing site or the materials, equipment, process, or procedures used to manufacture the Products shall be handled by the parties as stated in the Quality Agreement. Bachem shall obtain Amylin’s prior written approval before it implements any such change. Amylin shall have the right to raise with Bachem any perceived deficiencies regarding any aspect of Bachem’s manufacture of Product. In the event that Amylin raises with Bachem any such deficiency both parties will engage in negotiations regarding remedial action. Upon mutual agreement, (A) Bachem shall, at its sole cost, promptly submit to Amylin a written plan to correct any such deficiency and promptly correct any such deficiency to Amylin’s satisfaction, (B) Amylin shall reimburse Bachem for any reasonable incremental one-time costs associated with such changes while any ongoing costs associated with such changes shall be reviewed by the parties and allocated between Amylin and Bachem as mutually agreed upon by the parties at such time. If such corrections are required to bring the Facility into compliance with Applicable Laws, then Bachem shall bear all associated costs.
Manufacture of Product. (a) Subject to the terms and conditions of this Agreement, including those set forth in this Section 5.6: (i) Durect shall have the exclusive right, in the Territory, to manufacture, assemble and finish commercial and clinical supplies of Products, including the right to make Systems and fill Systems solely and specifically for incorporation into Products and not for any other purpose (collectively "Manufacture"); (ii) on a Product-by-Product basis, Durect shall have the right to appoint such Affiliates for which Durect possesses, directly or indirectly, the power to direct or cause the direction of the management or policies of such Affiliates to Manufacture Products in [ * * * ] and such other countries as shall be agreed upon by the parties from time to time; and (iii) on a Product-by-Product basis, Durect shall also have the right to subcontract out to third parties who normally engage in such subcontract assembly work for others the manufacture of production and process equipment, System components, the filling of Systems, and sterilization and final assembly of Product for commercial and clinical supplies of Products, provided that System subassembly may not be subcontracted to any third party other than [ * * * ] without ALZA's written approval. Other than subcontracting as specifically set forth in Section 5.6(a)(ii)-(iii) above, the Manufacture of Product shall be performed only by Durect and may not be subcontracted to any parties other than ALZA without the prior written consent of ALZA. Unless agreed to in writing by ALZA, the rights granted to Durect pursuant to this Section 5.6 or manufacturing rights granted elsewhere in this Agreement shall terminate upon a change in control of Durect in which Durect becomes controlled by a third party company, in which event, ALZA shall have the right to elect to supply all of Durect's and its Affiliates and Subcontractor's clinical and commercial requirements for Product (excluding any Catheter or other components as agreed upon by the parties which are external to the System), at [ * * * ]; provided however, that the price charged by ALZA shall not exceed [ * * * ]. ALZA and Durect shall enter into a written supply agreement for such manufacture and supply to Durect, its Affiliates and Subcontractors which shall include such provisions for interim supply to ensure uninterrupted supply of Products [ * * * ] provided that the price charged by ALZA shall not exceed [ * * * ] until ALZA is able to fully meet...
