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 8 <Page> 3.2. CHANGES IN SPECIFICATIONS OR MANUFACTURING PROCEDURES. (a) CUBIST CHANGES. Cubist shall notify Chiron in writing of any changes that it proposes to make to the Specifications, or the manufacturing procedures, for API or Filled Product. (i) In the event that a change to the Specifications, or the established manufacturing procedures, for API or Filled Product is being proposed by Cubist at any time prior to obtaining Regulatory Approval in (A) the European Union if Chiron is pursuing a centralized filing strategy for Regulatory Approval in the European Union, or (B) the reference member state if Chiron is pursuing a mutual recognition filing strategy for obtaining Regulatory Approval in the European Union (such Regulatory Approval pursuant to either clause (A) or clause (B) being hereinafter referred to as the [*], then Cubist will [*]. (ii) Cubist shall deliver with the notice required pursuant to Section 3.2(a) adequate documentation to enable Chiron to determine whether such change requires Regulatory Approval. As soon as reasonably practicable but in no event later than [*] after delivery of such notice, Chiron shall notify Cubist if such proposed change would require Regulatory Approval in any country in th...
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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.

  • 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 Over approximately the past eight years, the Parties have been supplying select Products to one another for use in the operation of their respective businesses within the United States of America, Canada and Mexico. The Parties developed and been following certain standard operating procedures in connecting with, among other topics, forecasting, production planning, ordering, delivering and resolving claims on the Products supplied to one another (the “Current SOPs”). The Parties will be updating their respective business systems over the next six months, and the updates to these business systems will require the Parties to modify the Current SOPs. Once the Parties have completed the updates to the business systems and agreed on the necessary modifications to the Current SOPs, the Parties will sign a written amendment to this Agreement appending the updated standard operating procedures (the “Updated SOPs”). Until the Parties have signed a written amendment appending the Updated SOPs, the parties will continue to follow the Current SOPs. The Parties will comply with the applicable SOPs in connection with the purchase and sale of products identified in a Purchase Schedule. The Parties may add terms and conditions to, and amend the terms and conditions of, the SOP in a Purchase Schedule, but any additional and amended terms and conditions in a Purchase Schedule supplementing and modifying the SOP will only apply the specific products identified in that Purchase Schedule for its duration.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • 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.

  • Quality Control Procedures The Seller must have an internal quality control program that verifies, on a regular basis, the existence and accuracy of the legal documents, credit documents, property appraisals, and underwriting decisions. The program must be capable of evaluating and monitoring the overall quality of its loan production and servicing activities. The program is to ensure that the Mortgage Loans are originated and serviced in accordance with prudent mortgage banking practices and accounting principles; guard against dishonest, fraudulent, or negligent acts; and guard against errors and omissions by officers, employees, or other authorized persons.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Billing Procedures (a) PROVIDER agrees all claims shall be submitted to OHCA in a format acceptable to OHCA and in accordance with the OHCA Provider Manual.

  • Transition Procedures Upon the expiration or termination of the Term of this Lease, for whatever reason (other than a purchase of the Leased Property by Lessee), Lessor and Lessee shall do the following (and the provisions of this Section 2.3 shall survive the expiration or termination of this Lease until they have been fully performed) and, in general, shall cooperate in good faith to effect an orderly transition of the management and/or lease of the Hotel:

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

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