Quality Control Samples and Methods Sample Clauses

Quality Control Samples and Methods. (a) Gilead shall retain samples of bulk drug and finally formulated Product for each Lot of Product for at least a period of one (1) year after the expiration date of Product from such Lot. The sample size shall be twice the size necessary to conduct quality control testing. Upon OSI's written request, Gilead shall provide OSI with up to one-half (1/2) the original amount of the retained samples. (b) In order to facilitate the prompt and efficient generation and exchange between the Parties of quality control data pertaining to Products to be supplied hereunder to OSI, Gilead will, at OSI's request, send to OSI test samples selected according to a sampling plan agreed between Gilead and OSI, before Gilead has finished all of its testing for a particular Lot. (c) To the extent requested by OSI, Gilead shall, pursuant to a Work Plan and Budget agreed by the applicable Development Team, perform technology transfer activities to transfer to an independent, Third Party laboratory the ability to conduct Gilead's validated QC methods for testing the Products for their conformity to the applicable Specifications. Gilead shall grant such Third Party a license under Patents and Information Controlled by Gilead, to perform such activities; provided that such Third Party shall enter into a written agreement with Gilead providing (i) for obligations of confidentiality and non-use of confidential information disclosed by Gilead to such independent laboratory (which shall specifically include information as to the validated methods taught the Third Party by Gilead) that are no less stringent than those set forth in Article 14 and that are perpetual (to reflect the fact that information disclosed to the Third Party will include trade secret information relating to liposomal technology methods), and (ii) for the grant by such Third Party to Gilead of a non-exclusive, perpetual license under all Liposomal Inventions conceived, reduced to practice or otherwise made by such Third Party in the course of its receipt of such technology transfer
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Quality Control Samples and Methods 
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Related to Quality Control Samples and Methods

  • 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.

  • 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.

  • Quality Control Procedures The Seller shall have an internal quality control program that verifies, on a regular basis, the existence and accuracy of the legal documents, credit documents, property appraisals, and underwriting decisions. The program shall include evaluating and monitoring the overall quality of the Seller's loan production and the servicing activities of the Seller. The program is to ensure that the Mortgage Loans are originated and serviced in accordance with Accepted Servicing Standards and the Underwriting Guidelines; guard against dishonest, fraudulent, or negligent acts; and guard against errors and omissions by officers, employees, or other authorized persons.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Benchmarks for Measuring Accessibility For the purposes of this Agreement, the accessibility of online content and functionality will be measured according to the W3C’s Web Content Accessibility Guidelines (WCAG) 2.0 Level AA and the Web Accessibility Initiative Accessible Rich Internet Applications Suite (WAI-ARIA) 1.0 for web content, which are incorporated by reference.

  • 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.

  • 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.

  • Substance Abuse Testing The Parties agree that it is in the best interest of all concerned to promote a safe working environment. The Union has no objection to pre-employment substance abuse testing when required by the Employer and further, the Union has no objection to voluntary substance abuse testing to qualify for employment on projects when required by a project owner. The cost and scheduling of such testing shall be paid for and arranged by the Employer. The Union agrees to reimburse the Employer for any failed pre-access Alcohol and Drug test costs.

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