SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT Sample Clauses

SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT. Section 2.1 The purpose of this Quality Assurance Agreement is to define and to establish the obligations and responsibilities of Bachem and Xeris relating to the quality assurance requirements of the manufacture, release and supply of the Product pursuant to the Agreement by Bachem in accordance with GMP guidelines tor active pharmaceutical ingredients (APIs), namely the US Code of Federal Regulation, Parts 11, 210, 211, applicable FDA guidance documents and ICH 07 GMP Guide for APIs as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the Pharmaceutical inspection Convention (PIC) scheme.
Sample 1Sample 2
AutoNDA by SimpleDocs
SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT. Section 2.1 The purpose of this Quality Assurance Agreement is to define and to establish the obligations and responsibilities of Bachem and Biodel relating to the quality assurance requirements of the manufacture, release and supply of the Product pursuant to the Commercial Agreement by Bachem in accordance with GMP guidelines for active pharmaceutical ingredients (APIs), namely the US Code of Federal Regulations, FDA guidance documents and ICH Q7 GMP Guide for APIs as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member states of the PIC scheme.
Sample 1
SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT. Section 2.1 The purpose of this Quality Assurance Agreement is to define and to establish the obligations and responsibilities of Bachem and Xeris relating to the quality assurance requirements of the manufacture, release and supply of the Product pursuant to the Agreement by Bachem in accordance with GMP guidelines tor active pharmaceutical ingredients (APIs), namely the US Code of Federal Regulation, Parts 11, 210, 211, applicable [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED FDA guidance documents and ICH 07 GMP Guide for APIs as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the Pharmaceutical inspection Convention (PIC) scheme.
Sample 1

Related to SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT

  • SCOPE OF THIS AGREEMENT 2.1. This Agreement, including Parts A through L, Tables One and Two and exhibits, specifies the rights and obligations of each Party with respect to the establishment, purchase, and sale of Local Interconnection, Collocation, resale of Telecommunications Services and Unbundled Network Elements. Certain terms used in this Agreement shall have the meanings defined in PART A – DEFINITIONS, or as otherwise elsewhere defined throughout this Agreement. Other terms used but not defined in this Agreement will have the meanings ascribed to them in the Act and in the FCC’s and the Commission’s rules, regulations and orders. PART B sets forth the general terms and conditions governing this Agreement. The remaining Parts set forth, among other things, descriptions of the services, pricing, technical and business requirements, and physical and network security requirements.

  • Amendment of this Agreement No provision of this Agreement may be changed, waived, discharged or terminated orally, but only by an instrument in writing signed by the party against whom enforcement of the change, waiver, discharge or termination is sought, and no amendment of this Agreement shall be effective until approved in a manner consistent with the 1940 Act and rules and regulations thereunder and any applicable SEC exemptive order therefrom.

  • Operation of this Agreement This Agreement shall take effect on and from the date of this Agreement. The parties must execute and enter into this Agreement as soon as possible after the Development Consent is granted and prior to the issue of any Construction Certificate that relates to any building work, other than demolition, excavation, piling, shoring and ancillary work for construction purposes including site hoardings and temporary site sheds that relates to works contained in DA-152/2021/B.

  • Effect of this Agreement Subject to the Corporation’s right to terminate the Option pursuant to Section 7.4 of the Plan, this Option Agreement shall be assumed by, be binding upon and inure to the benefit of any successor or successors to the Corporation.

  • Execution of this Agreement In lieu of an original signature to this agreement, Landlord will accept a valid and legitimate electronic and/or facsimile signature of the Resident. In so doing, Resident hereby acknowledges his or her endorsement and acceptance of this agreement, and he or she waives any challenge to validity of this agreement based on Resident’s endorsement by electronic and/or facsimile signature. THE RESIDENT HEREBY EXPRESSLY AGREES TO THE USE OF ELECTRONIC SIGNATURES FOR THIS LEASE.

  • Examination of this Agreement A copy of this Agreement shall be available at all reasonable times at the office of the Right Agent in the Borough of Manhattan, City and State of New York, for inspection by the registered holder of any Right. The Right Agent may require any such holder to submit his, her or its Right for inspection by it.

  • Terms of this Agreement The Parties acknowledge that this Agreement and all of the respective terms of this Agreement shall be treated as Confidential Information of both Parties.

  • Review of Agreement Each party acknowledges that it has had time to review this agreement and, as desired, consult with counsel. In the interpretation of this agreement, no adverse presumption shall be made against any party on the basis that it has prepared, or participated in the preparation of, this agreement.

  • Files Management and Record Retention relating to Grantee and Administration of this Agreement a. The Grantee shall maintain books, records, and documents in accordance with generally accepted accounting procedures and practices which sufficiently and properly reflect all expenditures of funds provided by Florida Housing under this Agreement. b. Contents of the Files: Grantee must maintain files containing documentation to verify all funds awarded to Grantee in connection with this Agreement, as well as reports, records, documents, papers, letters, computer files, or other material received, generated, maintained or filed by Grantee in connection with this Agreement. Grantee must also keep files, records, computer files, and reports that reflect any compensation it receives or will receive in connection with this Agreement.

  • Performance of this Agreement Buyer shall have duly performed or complied with all of the obligations to be performed or complied with by it under the terms of this Agreement on or prior to the Closing Date.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!