ESTABLISHMENT OF SPECIFICATIONS AND MANUFACTURING PROCEDURES Sample Clauses

ESTABLISHMENT OF SPECIFICATIONS AND MANUFACTURING PROCEDURES. The Parties shall mutually agree in writing (such agreement not to be unreasonably delayed or withheld), on a timely basis, on applicable API Specifications, Filled Product Specifications and Packaging Specifications that meet the requirements of the Regulatory Authorities and the Applicable Laws of each country in which Finished Products are to be sold. The Parties shall work expeditiously to agree upon such Specifications so as to permit Chiron to have adequate stocks of Conforming Product on hand in advance of the anticipated Commercial Launch in the Territory. The Parties acknowledge and agree that the API Specifications, the Filled Product Specifications, the Packaging Specifications and the manufacturing procedures for API and Filled Product shall be based substantially on Cubist's US FDA approved specifications and manufacturing procedures, but with all such modifications and additional procedures as may be required for the API and Filled Product to comply with cGMPs and the requirements under Applicable Laws. Any and all such modifications and additional procedures shall be adopted in accordance with the provisions of Section 3.2 hereof. * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION
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Related to ESTABLISHMENT OF SPECIFICATIONS AND MANUFACTURING PROCEDURES

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.

  • Testing Procedures Testing will be conducted by an outside certified Agency in such a way to ensure maximum accuracy and reliability by using the techniques, chain of custody procedures, equipment and laboratory facilities which have been approved by the U.S. Department of Health and Human Services. All employees notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative the Employer will reimburse the employee for the cost of the split sample test.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Standard Operating Procedures Standard Operating Procedures shall not contravene the Canada Labour Code, the Canadian Human Rights Code, or the Collective Agreement, and an allegation of such contravention is subject to the grievance procedure.

  • ORDERING PROCEDURES All task orders under OASIS SB must: 1. Be awarded by an OCO with a Delegation of Procurement Authority (DPA) or by a Contractor authorized to use the OASIS SB Contracts as a Government Source of Supply 2. Be within the scope of Section C and all other terms and conditions of the OASIS SBcontract 3. Be solicited and awarded under the proper NAICS Code and corresponding OASIS SB MA-IDIQ Contract Number (See Section H.4.) 4. Identify the proper Product Service Code (See Section H.5.) and, 5. Comply with the OASIS SB Contract, OASIS SB DPA Training, OASIS SB Ordering Guide, the Ordering Procedures in FAR Subpart 16.505, Ordering, and other applicable agency specific regulatorysupplements

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service xxxx, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Hiring Procedures Nothing contained in this Article 4 shall impair any of the rights of the Employer to hire new or additional employees to meet the employment needs of the Employer, in accordance with the terms and provisions of this collective bargaining Agreement or to meet the obligations of the Employer under Article 2, Section H of this Agreement or to take affirmative steps to comply with any requirements under any applicable Federal or State law prohibiting discrimination in employment.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

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