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. 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. 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. Oakwood shall Manufacture such Product as is necessary to perform the Services called for in the Project Plans. Oakwood shall Manufacture the Products in accordance with all Applicable Laws, rules and regulations, as then in effect.
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.
(b) Supplier shall be responsible for procuring all materials (including raw materials and the ordering of Granules as set forth in Section 2.05(e)) used in the manufacture of Product at the Facility and shall be the importer of record for any such materials. Except as otherwise set forth herein, Supplier shall bear all costs and expenses associated with or resulting from such manufacture and Delivery of Product to Purchaser (including procurement of all necessary materials other than the Granules).
(c) Supplier may not make any changes (including technical, manual or analytical changes) to the Product or the manufacturing or Delivery process of Product (as such processes existed immediately prior to the Effective Date) without Purchaser’s prior written consent (such consent to be granted or withheld in Purchaser’s sole discretion) unless any such change: (i) is required under the Compliance Requirements (including applicable Law); or (ii) is the result of a non-discriminatory, universal change with respect to the Facility or the Animal Health Business that does not affect the manufacture or Delivery of the Product (including its production or quality). Except as otherwise set forth herein, Supplier shall bear all costs and expenses associated with or resulting from any such change.
(d) The cost and expenses of consumables required to maintain compliance with the Compliance Requirements shall be borne by Supplier.
(e) Any capital expenditure required to maintain compliance with the Compliance Requirements shall be borne by Supplier if such capital expenditure relates to manufacturing of products other than or in addition to the Product or the amount of such capital expenditure is below a U.S. Dollar amount that the Parties mutually agree in writing is a de minimis expense. If such capital expenditure relates exclusively to ...
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 — 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 — approved by X X — prepared by X — maintained by X — approved by X — prepared by X — approved by X X DESTRUCTION OF HANDLING OF PROCESS WASTE GENERATED AT SUPPLIER X — protocol & report prepared by X — protocol & report signed off by X — protocol & report approved by X X — protocol executed by X — protocol &report prepared by X — protocol & report signed off by X — protocol & report approved by X — protocol executed by X Stability protocol for SUPPLIER packing sites — prepared by X — approved by X X Stability testing for PACKED PRODUCT — performance of testing X — review of stability results X — communication of stability performance to EAGLE X Collection of complaints X X Investigation of complaints X — follow-up manufacturing records X — Testing X — report to EAGLE X — action and documentation X X — Response to Customer X — Collection of Adverse Drug Event (ADE) Information X X — Investigation of manufacturing records X — Reporting of Event to Regulatory Authorities X — Action, documentation and filing X
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.
5.3.2 Luitpold's quality control procedures and in-plant quality control checks on the production of Product for Iomed shall be applied in the same manner as those procedures and checks are applied to products manufactured for sale directly by American Regent Inc. as American Regent Inc. products. Luitpold shall provide a certificate of analysis with each shipment of Product.
5.3.3 Iomed shall have a period of ************* days from the date of receipt to inspect and reject any shipment of Product on the grounds that it does not conform with the Product Specifications. Iomed shall have the right to return any Product which does not conform. All or part of any shipment may be held for Luitpold's disposition if found to be not in conformance with the Product Specifications, provided Luitpold confirms 4 such nonconformance through generally accepted quality control procedures. Luitpold shall have ********** days from the effective date of rejection (written notice) by Iomed in which to confirm nonconformance. Failure to confirm within such ********** day period shall constitute agreement with Iomed's rejection of Product. Luitpold may, at its discretion, send Product to an independent third party for analysis of conformance. After Luitpold confirms nonconformance, Luitpold shall have a period of ********** days to replace such nonconforming Product. Replacement with conforming Product shall be Iomed's sole and exclusive remedy for any nonconforming Product delivered hereunder. Shipment of rejected Product to American Regent Inc. and shipment of replacement Product to Iomed shall be at American Regent Inc.'s expense and by the carrier designated by American Regent Inc.
5.3.4 American Regent Inc. hereby approves placement of a descriptive private label with Iomed's trademark and/or Iomed's trademark on the Product. Any material changes to the descriptive label must be approved by American Regent Inc. prior to implementing such changes.
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.
6.3.2 Abboxx'x xxxlity control procedures and in-plant quality control checks on the production of Product for Iomed shall be applied in the same manner as those procedures and checks are applied to products manufactured for sale directly by Abbott as Abbott products. Abbott shall provide a certificate of analysis with each shipment of Product.
6.3.3 Iomed shall have a period of ****days from the date of receipt to inspect and reject any shipment of Product on the grounds that it does not conform with the Product Specifications. Iomed shall have the right to return any Product which does not conform. All of part of any shipment may be held for Abboxx'x xxxposition if found to be not in conformance with the Product Specifications, provided Abbott confirms such nonconformance through generally accepted quality control procedures. Abbott shall have **** days from the effective date of rejection (written notice) by Iomed in which to confirm 5 6 nonconformance. Failure to confirm within such **** day period shall constitute agreement with Iomed's rejection of Product. After Abbott confirms nonconformance, Abbott shall have a period of **** days to replace such nonconforming Product. Replacement of Product with conforming Product shall be Iomed's sole and exclusive remedy for any nonconforming Product delivered hereunder. Any Product not rejected by Iomed pursuant to this subparagraph 6.3.3 shall be deemed accepted for all purposes and all claims with respect to such Product waived by Iomed. Shipment of rejected Product to Abboxx xxx shipment of replacement Product to Iomed shall be at Abboxx'x xxxense and by the carrier designated by Abboxx.
6.3.4 Abboxx xxxeby approves placement of a descriptive private label with Iomed's tradename and/or Iomed's trademark on the Product. Any material changes to the descriptive label must be approved by Abbott prior to implementing such changes.
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 third parties 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 ALZA's fully allocated Manufacturing Costs plus 25% of such Costs as determined in accordance with Exhibit G **Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
