Conformity; Specifications; Quality Control Sample Clauses

Conformity; Specifications; Quality Control. (a) All quantities of API supplied by the Company pursuant to this Section 8 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunder. (b) Changes to the Specifications shall be made only by the JMC. (c) The Company shall conduct, or cause to be conducted, quality control testing of API prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "Testing Methods"). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company shall undertake all such tests. The Company shall retain records pertaining to such testing. Each shipment of API hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS shall have the right, at reasonable times and upon reasonable notice, to inspect all facilities at which API is manufactured pursuant to this Section 8 for compliance with cGMP, subject to existing agreements with Third Party Manufacturers. (e) All units of Finished Product manufactured pursuant to this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC f...
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Conformity; Specifications; Quality Control. All Finished Product manufactured, supplied, distributed and sold by or on behalf of Valera shall (i) be manufactured, packaged and labeled in accordance with cGMPs and with applicable laws; (ii) not be adulterated or misbranded; and (iii) meet and comply with VANTAS Specifications contained in the NDA for VANTAS. Valera shall conduct, or cause to be conducted, quality control testing of VANTAS, in accordance with such specifications, prior to shipment and prepare and retain records pertaining to such testing in accordance with the NDA, applicable laws and Valera’s internal standard operating procedures.
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Conformity; Specifications; Quality Control. (a) All quantities of Compound supplied by Inspire pursuant to this Section 8 will comply with the Compound Specifications and applicable Manufacturing Standards and shall adhere to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of Compound at the time it is shipped by Inspire hereunder. (b) Santen shall have the right to change the Compound Specifications, from time to time, to accommodate the demands or requests of any Regulatory Authority in the Territory at any time during the term of this Agreement on not less than 12 months' prior written notice to Inspire. Inspire shall use reasonable commercial efforts to meet such changes. In addition, other changes to the Compound Specifications shall be made only upon the mutual consent of the Parties. Any costs or expenses incurred by Inspire in connection with such changes shall be borne by Santen, and Inspire shall be entitled to include such costs and expenses in invoices submitted to Santen pursuant to Section 7.1(a), from time to time. (c) Inspire shall conduct, or cause to be conducted, quality control testing of Compound prior to shipment, in accordance with the Compound Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures agreed to by the Parties from time to time (collectively, the "Testing Methods"
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Conformity; Specifications; Quality Control. 5.8.1. All quantities of the Product supplied by Kamada pursuant to this Agreement will comply in all material respects with the Manufacturing Specifications and shall adhere in all material respects to all Applicable Laws relating to the manufacture, packaging, sale, storage, and shipment of each shipment of the Product at the time such shipment is delivered to Kedrion's Facility. 5.8.2. Kamada shall, at its sole cost and expense, conduct, or cause to be conducted, quality control testing of the Product prior to shipment, in accordance with the Manufacturing Specifications and such other quality control testing procedures adopted by Kamada from time to time (collectively, the “Testing Methods”). The Testing Methods shall include all FDA required release testing. Kamada shall retain records pertaining to such testing. Each shipment of the Product hereunder shall be accompanied by a certificate of analysis for each Lot of the Product therein. Kamada shall provide the Products to Kedrion as soon as possible following internal release process of sample Product and prior to FDA release of the sample Product. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
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Conformity; Specifications; Quality Control. (a) All quantities of Finished Product supplied pursuant to this Article 14 will conform in all material respects to the Specifications. Changes to the Specifications shall be made only by Indevus. Indevus shall provide Odyssey with notice of any such changes as soon as practicable. (b) Indevus shall conduct, or cause to be conducted, quality control testing of Finished Product prior to shipment, in accordance with the Specifications as are in effect from time to time and such other quality control testing procedures adopted by Indevus from time to time. Each shipment of Finished Product hereunder shall be accompanied by a certificate of analysis for each lot of Finished Product therein as well as such other documentation as is necessary or appropriate. (c) Each Party shall have the right, at reasonable times and upon reasonable notice, to inspect and audit all facilities at which Finished Product is manufactured and quality control tested pursuant to this Article 14 for compliance with cGMP, subject to Indevus’s existing agreements with Third Party Manufacturers. (d) The Parties agree to negotiate in good faith to enter into a mutually agreeable quality control agreement relating to the supply by Indevus to Odyssey under this Agreement of Finished Product.
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Conformity; Specifications; Quality Control. (a) All quantities of Product supplied by SANQUIN pursuant to this Section 4 will comply in all material respects with the Specifications and Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, packaging, sale, storage, and shipment of each shipment of Product at the time it is shipped by SANQUIN hereunder. (b) SANQUIN shall conduct, or cause to be conducted, quality control testing of Product prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted either by SANQUIN or LEVPHARMA from time to time (collectively, the "Testing Methods"
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Conformity; Specifications; Quality Control a. All quantities of the Product supplied by Omrix pursuant to this Agreement will comply in all material respects with the Specifications and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, packaging, sale, storage, and shipment of each shipment of the Product at the time it is shipped by Omrix hereunder. b. Omrix shall conduct, or cause to be conducted, quality control testing of the Product prior to shipment, in accordance with the Specifications as are in effect and such other quality control testing procedures adopted by Omrix from time to time (collectively, the "TESTING METHODS"). The Testing Methods shall include all FDA required release testing and Omrix shall undertake all such tests. Omrix shall retain records pertaining to such testing. Each shipment of the Product hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each Batch of the Product therein as well as such customs and other documentation as is necessary or appropriate.
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Conformity; Specifications; Quality Control. All Finished Product and Product Samples supplied, distributed and sold by or on behalf of CRTX in the Territory during the Term shall (i) be manufactured, packaged and labeled in accordance with cGMPs and with Applicable Laws; (ii) not be adulterated or misbranded; and (iii) meet and comply with each Product's Specifications contained in the applicable NDA. CRTX shall conduct, or cause to be conducted, quality control testing of Product, in accordance with such specifications, prior to shipment and prepare and retain records pertaining to such testing in accordance with the NDA, Applicable Laws and CRTX's internal standard operating procedures. In the event of any failure to comply with this Section 10.5 (other than a failure due to CRTX's gross negligence or intentional misconduct), CRTX's sole and exclusive liability under this Agreement, and DEY's sole and exclusive remedy, shall be that CRTX shall replace the non-conforming Product.
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Related to Conformity; Specifications; Quality Control

  • 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.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • DAF Specifications Developer shall submit initial specifications for the DAF, including System Protection Facilities, to Connecting Transmission Owner and NYISO at least one hundred eighty (180) Calendar Days prior to the Initial Synchronization Date; and final specifications for review and comment at least ninety (90) Calendar Days prior to the Initial Synchronization Date. Connecting Transmission Owner and NYISO shall review such specifications to ensure that the DAF are compatible with the technical specifications, operational control, and safety requirements of the Connecting Transmission Owner and NYISO and comment on such specifications within thirty (30) Calendar Days of Developer’s submission. All specifications provided hereunder shall be deemed to be Confidential Information.

  • 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.

  • Use; Quality Control a. Neither party may alter the other party’s trademarks from the form provided and must comply with removal requests as to specific uses of its trademarks or logos. b. Each party agrees to use, and to cause its Permitted Sublicensees to use, the other party’s trademarks only in good faith and in a dignified manner consistent with such party’s use of the trademarks. Upon written notice to the breaching party, the breaching party has 30 days of the date of the written notice to cure the breach or the license will be terminated.

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time. B. Controlled Affiliate agrees to comply with all applicable federal, state and local laws. C. Controlled Affiliate agrees that it will provide on an annual basis (or more often if reasonably required by Plan or by BCBSA) a report or reports to Plan and BCBSA demonstrating Controlled Affiliate’s compliance with the requirements of this Agreement including but not limited to the quality control provisions of this paragraph and the attached Exhibit A. D. Controlled Affiliate agrees that Plan and/or BCBSA may, from time-to-time, upon reasonable notice, review and inspect the manner and method of Controlled Affiliate’s rendering of service and use of the Licensed Marks and Name. E. As used herein, a Controlled Affiliate is defined as an entity organized and operated in such a manner, that it meets the following requirements: (1) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), must have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having not less than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate at least equal to that exercised by persons or entities (jointly or individually) other than the Controlling Plan(s); and Notwithstanding anything to the contrary in (a) through (b) hereof, the Controlled Affiliate’s establishing or governing documents must also require written approval by the Controlling Plan(s) before the Controlled Affiliate can: (i) change its legal and/or trade names; (ii) change the geographic area in which it operates; (iii) change any of the type(s) of businesses in which it engages; (iv) create, or become liable for by way of guarantee, any indebtedness, other than indebtedness arising in the ordinary course of business; (v) sell any assets, except for sales in the ordinary course of business or sales of equipment no longer useful or being replaced; (vi) make any loans or advances except in the ordinary course of business; (vii) enter into any arrangement or agreement with any party directly or indirectly affiliated with any of the owners or persons or entities with the authority to select or appoint members or board members of the Controlled Affiliate, other than the Plan or Plans (excluding owners of stock holdings of under 5% in a publicly traded Controlled Affiliate); (viii) conduct any business other than under the Licensed Marks and Name; (ix) take any action that any Controlling Plan or BCBSA reasonably believes will adversely affect the Licensed Marks and Name. In addition, a Plan or Plans directly or indirectly through wholly owned subsidiaries shall own at least 50% of any for-profit Controlled Affiliate. (2) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having more than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate. In addition, a Plan or Plans directly or indirectly through wholly-owned subsidiaries shall own more than 50% of any for-profit Controlled Affiliate.

  • Quality Control Program Engineer shall have a quality control program in place that ensures that all deliverable work is of high quality. Engineer shall submit a plan detailing its program to the Inspection Branch of the TxDOT Bridge Division for review and approval prior to beginning work. State may review or audit the programs.

  • The Specifications The Specifications are that portion of the Contract Documents consisting of the written requirements for materials, equipment, systems, standards and workmanship for the Work, and performance of related services.

  • Quality control system (i) The Contractor shall establish a quality control mechanism to ensure compliance with the provisions of this Agreement (the “Quality Assurance Plan” or “QAP”). (ii) The Contractor shall, within 30 (thirty) days of the Appointed Date, submit to the Authority’s Engineer its Quality Assurance Plan which shall include the following: (a) organisation, duties and responsibilities, procedures, inspections and documentation; (b) quality control mechanism including sampling and testing of Materials, test frequencies, standards, acceptance criteria, testing facilities, reporting, recording and interpretation of test results, approvals, check list for site activities, and proforma for testing and calibration in accordance with the Specifications for Road and Bridge Works issued by MORTH, relevant IRC specifications and Good Industry Practice; and (c) internal quality audit system. The Authority’s Engineer shall convey its approval to the Contractor within a period of 21 (twenty-one) days of receipt of the QAP stating the modifications, if any, required, and the Contractor shall incorporate those in the QAP to the extent required for conforming with the provisions of this Clause 11.2. (iii) The Contractor shall procure all documents, apparatus and instruments, fuel, consumables, water, electricity, labour, Materials, samples, and qualified personnel as are necessary for examining and testing the Project Assets and workmanship in accordance with the Quality Assurance Plan. (iv) The cost of testing of Construction, Materials and workmanship under this Article 11 shall be borne by the Contractor.

  • General specifications For the purpose of this Regulation, the vehicle shall fulfil the following requirements:

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