Quality Document Maintenance Sample Clauses

Quality Document Maintenance. CMH shall maintain and keep documentations and records related to all products impacted by this Agreement in accordance with FDA GMP quality guidelines and regulatory requirements. CMH must offer the records to Cytonics at the end of their record retention time. CMH will own and control the Regulatory Approval for the APIC System and will be listed as the manufacture of record, provided that this agreement is in effect, and CMH or its affiliates will be listed as the agent or distributor, if and when required. In the event that this agreement terminates pursuant to Article 16, CMH will inform the FDA that it is no longer the manufacturer of record and name Cytonics as the new manufacturer of record, and provide Cytonics with all quality documentation.
Sample 1
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Quality Document Maintenance. A2Mcyte shall maintain and keep documentations and records related to all products impacted by this Agreement in accordance with FDA GMP quality guidelines and regulatory requirements. A2Mcyte must offer the records to the Cytonics at the end of their record retention time. In all cases, Cytonics will own and control the Regulatory Approval for the APIC System and will be listed as the manufacture of record, and A2Mcyte or its affiliates will be listed as the agent or distributor, if and when required.
Sample 1
Quality Document Maintenance. Astaria shall maintain and keep documentations and records related to all products impacted by this Agreement in accordance with FDA GMP quality guidelines and regulatory requirements. Astaria must offer the records to Cytonics at the end of their record retention time. In all cases, Astaria will own and control the Regulatory Approval for the APIC System in the veterinary markets for the duration of this agreement. Should this agreement terminate for any reason, the quality documentation will be provided by Astaria to Cytonics within 30 days of the termination date.
Sample 1

Related to Quality Document Maintenance

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Transition Services Agreement Seller shall have executed and delivered the Transition Services Agreement.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

  • Statement of Work Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract.

  • Service Level Agreement Subject to the terms and conditions of this Agreement, Bank agrees to perform the custody services provided for under this Agreement in a manner that meets or exceeds any service levels as may be agreed upon by the parties from time to time in a written document that is executed by both parties on or after the date of this Agreement, unless that written document specifically states that it is not contractually binding. For the avoidance of doubt, Bank’s Service Directory shall not be deemed to be such a written document.

  • Master Services Agreement This Agreement is a master agreement governing the relationship between the Parties solely with regard to State Street’s provision of Services to each BTC Recipient under the applicable Service Modules.

  • Maintenance and Support Services Distributor shall provide Maintenance and Support Services to all of its Customers of Licensed Software as set forth in Sections 3.4(a) and 3.4(b) below. Distributor may require Customers to provide the own First-Line Support: however, in no event shall Siebel be responsible for First-Line or Second-Line Support. Subject to Distributor's payment of the Maintenance Fees set forth in EXHIBIT A Siebel shall provide Third-Line Support to Distributor in accordance with Siebel's then current Maintenance and Support Services Policy. Distributor shall be responsible for all support related to the Value Added Offering.

  • Services Agreement The Company has entered into the Services Agreement with the Sponsor pursuant to which the Sponsor will make available to the Company general and administrative services including office space, utilities and secretarial support for the Company’s use for $10,000 per month, subject to adjustment as provided for in the Services Agreement. Prior to the consummation of a Business Combination, the Company shall not enter into any other arrangement for the provision of such services with any Insider that will require the Company to pay in excess of $10,000 per month for such services.

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