Manufacturing Standards and Quality Assurance Sample Clauses
Manufacturing Standards and Quality Assurance. 3.1 Each Product will be Manufactured, controlled, tested, and released in accordance with the executed Quality Agreement as set forth on Schedule B. If there is any inconsistency between this Agreement and the Quality Agreement, the terms of the Quality Agreement shall control with respect to quality issues, and this Agreement shall control with respect to all other issues.
3.2 AZ warrants that, as of the date of each delivery hereunder to ABBI, and until its date of expiration, each Product shall comply with the provisions of the FFDCA, and such Product shall not, when delivered to ABBI, be adulterated or misbranded within the meaning of the FFDCA. A material default by either Party of the Quality Agreement shall be deemed a default under this Agreement.
Manufacturing Standards and Quality Assurance a. Prior to commencement of manufacture of a New Product or a Modified Toymax Product, JI shall provide a sample or prototype of each Product for approval by JAKKS, the Toymax Company, or JAKKS' other Affiliate ordering such Product, and the entity ordering the Product shall notify JI of its approval, or the reasons for its disapproval, within a reasonable period of time after delivery of the sample or prototype. Prior to any initial shipment of a Product by JI, or as otherwise requested by JAKKS or the Product Vendee, JI shall provide the Product Vendee with samples of such Product for inspection and approval. In addition, JI shall have each of the Products tested in accordance with the testing procedures described in the applicable Specifications and shall provide JAKKS or the Product Vendee, at JAKKS or the Product Vendee's expense, with a certificate of compliance from an independent certified testing laboratory approved by JAKKS or the Product Vendee.
b. JAKKS or the Product Vendee shall provide to JI written notice of rejection of any shipment of Products if the subject Products do not meet the Specifications. In order to permit a timely and accurate investigation by JI, JAKKS or the Product Vendee shall provide supporting evidence in its possession on which JAKKS or the Product Vendee has based such belief.
c. If the Parties disagree with respect to whether a shipment of Product does not conform to the Specifications (a "Non-Conforming Product"), the Parties agree that the Product in question shall be submitted for testing to an independent testing laboratory acceptable to JI and JAKKS or the Product Vendee. The determination of such independent laboratory as to whether such Product meets and will continue to meet all Specifications will be binding on both parties with respect to the Product Vendee's right to return the shipment hereunder and refusal to pay the applicable Purchase Price. The cost related to such testing will be paid by the party who was in error with respect to whether the Product was a Non-Conforming Product.
d. Within a reasonable period of time after a determination that a Product is a Non-Conforming Product by (i) the mutual consent of the Parties, or (ii) an independent testing laboratory as provided above, JI shall issue a credit to the Product Vendee in an amount equal to the sum of (x) the amount invoiced to and paid by the Product Vendee for the manufacturing and processing of such Non-Conforming Product, unless such Produc...
Manufacturing Standards and Quality Assurance. 4.1Manufacturing Standards. Pfizer shall manufacture and supply the Product in material accordance with the Specifications and cGMP. Such Specifications may be revised through written notification by Pfizer to Purchaser to conform to the Authorization or changes to the manufacturing or distribution of the Product.
Manufacturing Standards and Quality Assurance. 3.1 Each Product will be Manufactured, controlled, tested, and released in accordance with the Quality Agreement. If there is any inconsistency between this Agreement and the Quality Agreement, the terms of the Quality Agreement shall control with respect to quality issues, and this Agreement shall control with respect to all other issues.
3.2 AZ warrants that, as of the date of each delivery hereunder to Dentsply, and until its date of expiration, each Product, whether for intended sale in the United States or elsewhere, shall comply with the provisions of the FFDCA, and such Product shall not, when delivered to Dentsply, be adulterated or misbranded within the meaning of the FFDCA. A material default by either Party of the Quality Agreement shall be deemed a default under this Agreement.
3.3 Dentsply warrants that each Product shall have all necessary and appropriate Government and Regulatory Approval for commercial sale by Dentsply in the Territory and further warrants such Product after delivery to Dentsply will not be adulterated or misbranded within the meaning of the FFDCA.
Manufacturing Standards and Quality Assurance. 10.1 Commercial Quality Agreement – Upon request by RADIUS, 3M and RADIUS will negotiate in good faith a form of Quality Agreement to be entered into with a CMO. 3M, a CMO and RADIUS will negotiate in good faith and enter into a Quality Agreement. In the event of a conflict between any provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any other matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.
Manufacturing Standards and Quality Assurance. 14 Section 5.01. Product Warranties...................................... 14 Section 5.02. Manufacturing Standards; Release of Product............. 15 Section 5.03. Specifications.......................................... 15
Manufacturing Standards and Quality Assurance. 7.1 SPECIFICATIONS. Sudormed will manufacture Product for Customer in accordance with the manufacturing specifications set forth in the attached Exhibit A, and any further specifications as shall be furnished by Customer and agreed to in writing by Sudormed which will not be unreasonably withheld (the "Specifications"), subject to reimbursement for costs and adjustments in price, as set forth in Section 4.1.
Manufacturing Standards and Quality Assurance. Section 5.01. Product Warranties. Manufacturer hereby covenants and agrees that:
(a) Manufacturer will Manufacture and deliver to Principal the Product in accordance with, and the Product will conform with, the Specifications for such product and all requirements set forth in the Product NDA, including specifications and requirements relating to composition, purity, appearance and stability, and the Product shall be capable of maintaining such until the applicable expiration date for such Product;
(b) Manufacturer will comply with all Applicable Laws relating to the Manufacture of such Product, including all then current GMPs applicable to the Manufacture of the Product which are in force or hereafter adopted by the FDA or any successor agency thereto, and it will ship the Product in accordance with DEA requirements and Applicable Law;
(c) the Product shall not be misbranded, adulterated, manufactured, packaged or transported in violation of Articles 501, 502, 505 or 506A of the FDC Act, as amended from time to time; and
(d) all Product supplied by Manufacturer hereunder shall be transferred to Principal free and clear of all liens, title claims, encumbrances, security interests and other third party claims. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.
Manufacturing Standards and Quality Assurance. 10.1 Commercial Quality Agreement – Upon request by RADIUS, 3M and RADIUS will negotiate in good faith a form of Quality Agreement to be entered into with a CMO. 3M, a CMO and RADIUS will negotiate in good faith and enter into a Quality Agreement. In the event of a conflict between any provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any other matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.
10.2 3M shall Manufacture or have Manufactured the Product and Applicator according to all Applicable Law, cGMP, the approved Specifications and the requirements of the Regulatory Approval for the Product and Applicator. 3M shall send electronically to RADIUS all Batch Documentation for all Product and Applicator as early as possible following receipt from CMO and determination that it is in compliance with the foregoing sentence. 3M shall ensure that the CMO completes release testing and sends such Batch Documentation to RADIUS within [*] days of the Manufacturing date of such Product. The Parties shall work together to establish a process to enable RADIUS to use Commercially Reasonable Efforts to review Batch Documentation and to communicate its decision to release for shipment to RADIUS or refusal to release the Product or Applicator or other request for correction or clarification of the executed Batch Record, as applicable, for shipment to RADIUS within [*] Business Days of receipt of the Batch
Manufacturing Standards and Quality Assurance