Purpose of the Quality Agreement Sample Clauses

Purpose of the Quality Agreement. This Agreement outlines the responsibilities of Tercica and CBSB with respect to the quality assurance of the Drug Substance. CBSB agrees not to subcontract or change the site of any of the manufacturing, packaging, labeling, testing, and/or handling of Drug Substance unless prior written authorization is obtained from Tercica. A matrix of responsibilities included at the end of this document delineates the primary responsible Party for the various aspects of this Agreement.
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Purpose of the Quality Agreement. AtheroGenics, Inc., a Georgia corporation with offices at 8000 Xxxxxxxx Xxxxxxx, Xxxxxxxxxx, XX 00000 (“AGIX”) and ISP Pharma Systems LLC, a Delaware limited liability company with offices at 9000 Xxx Xxxxxx Xxxx, Xxxxx X, Xxxxxxxx, Xxxxxxxx 00000 (“ISP”), have entered into a Manufacturing and Supply Agreement for the Manufacture and supply of AGI-1067 active pharmaceutical ingredient (“API”) and spray-dried dispersion (“SDD”)(API and SDD collectively referred to as “Product”). This Quality Agreement constitutes an agreement between the Quality Assurance functions of AGIX and ISP and is a support document to the Manufacturing and Supply Agreement. Capitalized terms in this Quality Agreement shall have the same meaning as defined in the Manufacturing and Supply Agreement. The purpose of this Quality Agreement between AGIX and ISP is as follows: i) To ensure that the respective Quality Assurance and joint and individual responsibilities of AGIX and ISP under current Good Manufacturing Practices (cGMP) are defined, understood and agreed upon in advance by both parties. ii) To define how the Quality functions (Quality Assurance (QA) and Quality Control (QC)) at ISP and AGIX will interact with each other. iii) To ensure that any lot or batch of Product Manufactured, packaged, labeled or tested for AGIX at a Facility, is done so in accordance with the cGMP requirements as set forth by the Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs) issued by the US Food and Drug Administration (FDA) in August 2001 (Q7A), and the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301, et. seq., and the regulations promulgated there under, as may be amended from time to time. iv) To help establish a strong co-operative partnership and working relationship between the personnel in the Quality functions at AGIX and ISP.
Purpose of the Quality Agreement. This Quality Agreement outlines the responsibilities of EDDI and MAP with respect to the quality assurance of the Product Intermediate as referenced in the Services Agreement.

Related to Purpose of the Quality Agreement

  • Second Amendment to Exhibit A to Services Agreement Exhibit A to the Services Agreement shall be, and here by is, supplemented with the following:

  • Amendment to Exhibit A to Services Agreement Solely with respect to Accounts that are not investment companies registered under the 1940 Act, the section of Exhibit A to the Services Agreement entitled “Administration and Risk Management” shall be, and hereby is, deleted in its entirety and replaced with the following:

  • Term of Agreement; Amendment; Assignment A. This Agreement shall become effective with respect to each Fund listed on Exhibit A hereof as of the date hereof and, with respect to each Fund not in existence on that date, on the date an amendment to Exhibit A to this Agreement relating to that Fund is executed. Unless sooner terminated as provided herein, this Agreement shall continue in effect for two years from the date hereof. Thereafter, if not terminated, this Agreement shall continue in effect automatically as to each Fund for successive one-year periods, provided such continuance is specifically approved at least annually by: (i) the Trust’s Board, or (ii) the vote of a “majority of the outstanding voting securities” of a Fund, and provided that in either event, the continuance is also approved by a majority of the Trust’s Board who are not “interested persons” of any party to this Agreement, by a vote cast in person at a meeting called for the purpose of voting on such approval. B. Notwithstanding the foregoing, this Agreement may be terminated, without the payment of any penalty, with respect to a particular Fund: (i) through a failure to renew this Agreement at the end of a term, (ii) upon mutual consent of the parties, or (iii) upon not less than 60 days’ written notice, by either the Trust upon the vote of a majority of the members of its Board who are not “interested persons” of the Trust and have no direct or indirect financial interest in the operation of this Agreement, or by vote of a “majority of the outstanding voting securities” of a Fund, or by the Distributor. The terms of this Agreement shall not be waived, altered, modified, amended or supplemented in any manner whatsoever except by a written instrument signed by the Distributor and the Trust. If required under the 1940 Act, any such amendment must be approved by the Trust’s Board, including a majority of the Trust’s Board who are not “interested persons” of any party to this Agreement, by a vote cast in person at a meeting for the purpose of voting on such amendment. In the event that such amendment affects the Advisor, the written instrument shall also be signed by the Advisor. This Agreement will automatically terminate in the event of its “assignment.” C. As used in this Section, the terms “majority of the outstanding voting securities,” “interested person,” and “assignment” shall have the same meaning as such terms have in the 1940 Act. D. Sections 7 and 8 shall survive termination of this Agreement.

  • Amendment of Schedule A Schedule A to the Agreement is hereby amended by deleting it in its entirety and inserting in lieu therefor the Schedule A attached hereto.

  • Certification Regarding Termination of Contract for Non-Compliance (Tex Gov. Code 552.374)

  • CERTIFICATION REGARDING BOYCOTTING CERTAIN ENERGY COMPANIES (Texas law as of September 1, 2021) By submitting a proposal to this Solicitation, you certify that you agree, when it is applicable, to the following required by Texas law as of September 1, 2021: If (a) company is not a sole proprietorship; (b) company has ten (10) or more full-time employees; and (c) this contract has a value of $100,000 or more that is to be paid wholly or partly from public funds, the following certification shall apply; otherwise, this certification is not required. Pursuant to Tex. Gov’t Code Ch. 2274 of SB 13 (87th session), the company hereby certifies and verifies that the company, or any wholly owned subsidiary, majority-owned subsidiary, parent company, or affiliate of these entities or business associations, if any, does not boycott energy companies and will not boycott energy companies during the term of the contract. For purposes of this contract, the term “company” shall mean an organization, association, corporation, partnership, joint venture, limited partnership, limited liability partnership, or limited liability company, that exists to make a profit. The term “boycott energy company” shall mean “without an ordinary business purpose, refusing to deal with, terminating business activities with, or otherwise taking any action intended to penalize, inflict economic harm on, or limit commercial relations with a company because the company (a) engages in the exploration, production, utilization, transportation, sale, or manufacturing of fossil fuel-based energy and does not commit or pledge to meet environmental standards beyond applicable federal and state law, or (b) does business with a company described by paragraph (a).” See Tex. Gov’t Code § 809.001(1).

  • CFR Part 200 or Federal Provision - Xxxx Anti-Lobbying Amendment - Continued If you answered "No, Vendor does not certify - Lobbying to Report" to the above attribute question, you must download, read, execute, and upload the attachment entitled "Disclosure of Lobbying Activities - Standard Form - LLL", as instructed, to report the lobbying activities you performed or paid others to perform. Compliance with all applicable standards, orders, or requirements issued under section 306 of the Clean Air Act (42 U.S.C. 1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive Order 11738, and Environmental Protection Agency regulations (40 CFR part 15). (Contracts, subcontracts, and subgrants of amounts in excess of $100,000) Pursuant to the above, when federal funds are expended by ESC Region 8 and TIPS Members, ESC Region 8 and TIPS Members requires the proposer certify that in performance of the contracts, subcontracts, and subgrants of amounts in excess of $250,000, the vendor will be in compliance with all applicable standards, orders, or requirements issued under section 306 of the Clean Air Act (42 U.S.C. 1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive Order 11738, and Environmental Protection Agency regulations (40 CFR part 15). Does vendor certify compliance? Yes

  • Reference to Supplemental Agreements Certificates authenticated, executed on behalf of the Holders and delivered after the execution of any supplemental agreement pursuant to this Article may, and shall if required by the Purchase Contract Agent, bear a notation in form approved by the Purchase Contract Agent as to any matter provided for in such supplemental agreement. If the Company shall so determine, new Certificates so modified as to conform, in the opinion of the Purchase Contract Agent and the Company, to any such supplemental agreement may be prepared and executed by the Company and authenticated, executed on behalf of the Holders and delivered by the Purchase Contract Agent in exchange for outstanding Certificates.

  • Amendment of Exhibit A Upon the admission of a Substituted Limited Partner, the General Partner shall amend Exhibit A to reflect the name, address, number of Partnership Units, and Percentage Interest of such Substituted Limited Partner and to eliminate or adjust, if necessary, the name, address and interest of the predecessor of such Substituted Limited Partner.

  • Binding Nature of Agreement; Assignment This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.

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