Commercial Quality Agreement definition

Commercial Quality Agreement has the meaning set forth in Section 6.3(b).
Sample 1Sample 2Sample 3
Commercial Quality Agreement. (QAg)” the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services; “Commercially Reasonable Efforts” with respect to CMC, such level of efforts and resources required to carry out an obligation under this Agreement in a sustained manner consistent with the efforts normally used by companies that provide manufacturing and related services in the biopharmaceutical industry, as applicable, of comparable size and resources to CMC, for a similar activity with respect to the scope of Services to be provided under this Agreement;
Sample 1
Commercial Quality Agreement means the commercial quality agreement, including all Appendices, attached hereto as Annex 4, which Xxxxxx International shall cause Xxxxxx Pharma to enter into with respect to the quality of the Product.
Sample 1

Examples of Commercial Quality Agreement in a sentence

  • Even though we have listed all the physical quantities in the previous section, further approximations have to be made in order to construct numerical models.

  • Within [***] of the Effective Date, the Parties shall agree in writing to a revised Clinical Quality Agreement and within [***] of the Effective Date, the Parties shall agree in writing to a Commercial Quality Agreement.

  • If any term of this Agreement conflicts with any term of the Commercial Quality Agreement, the conflicting term of this Agreement shall prevail.

  • Any references in this K[NO.] SOW to the Quality Agreement, will be deemed to be references to the Commercial Quality Agreement, as adopted for the K6 Campaign.

  • Each Party will perform its obligations under the Commercial Quality Agreement to be negotiated in good faith and entered into by and among the Parties on or [***].

  • No later than [***] prior to the agreed Delivery Date, Xxxxxx International shall send samples to third parties for analysis, as designated by Ascendis and further detailed in the Commercial Quality Agreement.

  • With respect to any change to be made in accordance with the Commercial Quality Agreement, Xxxxxx International and Ascendis shall also mutually agree on any necessary or desired amendments to this Agreement, including, without limitation, price adjustments and compensation for any additional costs, efforts and/or expenses.

  • For clarity, Incyte will be entitled, in its sole discretion, to [***] of Licensed Product for [***]; provided, that, to the extent Incyte releases [***], such Batches will be subject to the terms of the Commercial Quality Agreement.

  • Ascendis shall inspect the Product according to the provisions of the Commercial Quality Agreement, and review the batch documentation without delay, but in no event later than [***] after submission to Ascendis.

  • She urged that now is the time for positive input as we move forward to providing the employees at the Center with a worthwhile program.✓ Travis Martin inquired about the timeframes for employee group activities✓ R.


More Definitions of Commercial Quality Agreement

Commercial Quality Agreement is defined in Section 7.1.
Sample 1
Commercial Quality Agreement means the written agreement entered into by the Parties on or within [***] after the Effective Date defining pharmaceutical and certain operational responsibilities of the Parties with respect to the quality that is applicable to the Manufacture and Supply of the Licensed Compound Bulk Drug Substance under GMP.
Sample 1
Commercial Quality Agreement the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services, as further described in Clause 2.3; “[***]” [***] of an experienced contract manufacturing organization engaged in the cGMP manufacture of biological products that are similar to the Product;
Sample 1
Commercial Quality Agreement. (QAg) the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services;
Sample 1

Related to Commercial Quality Agreement

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • commercial air transport means an aircraft operation involving the transport of passengers, cargo, or mail for remuneration or hire.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Commercial Supply Agreement has the meaning set forth in Section 5.2.

  • Commercial Agreement means an agreement, other than an agency agreement, made between carriers and relating to the provision of their joint services for carriage of passengers by air;

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Supply Agreement has the meaning set forth in Section 7.1.

  • PJM Reliability Assurance Agreement means that certain Reliability Assurance Agreement Among Load Serving Entities in the PJM Region, on file with FERC as PJM Interconnection L.L.C. Rate Schedule FERC No. 44, and as amended from time to time thereafter.

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • Collaborative pharmacy practice agreement means a written and signed

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Technical Agreement means any technical or quality agreements signed by You (or Your Affiliate) and RB (or RB’s Affiliates) specifying technical and quality responsibilities in respect of the Output entered into prior to the date of the Order.

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Technical Guidance Letter or “TGL” means an instruction, clarification, or interpretation of the requirements of the Contract, issued by the System Agency to the Grantee.

  • Development Agreement has the meaning set forth in the Recitals.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • Commercial Agreements means all or any Agreement or Agreements with any third party including but not limited to broadcasting, media, sponsorship, marketing, merchandising, licensing and advertising, for the general promotion of each or any of the Clubs in the Competition and the Company, and which have the object of promoting the welfare and general commercial interest and increasing the financial resources of each of the Clubs, the Company and the Competition.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • Tax Compliance Agreement means the Federal Tax Certificate, Tax Compliance Agreement, Arbitrage Agreement, or other written certification or agreement of the Issuer setting out representations and covenants for satisfying the post-issuance tax compliance requirements for the Tax-Exempt Bonds.