Specification, Quality Control, Warranty Sample Clauses

Specification, Quality Control, Warranty. 8.1 All Product delivered by PharmaForm shall be in conformance with the Quality Assurance Agreement, the Specifications and any Applicable Laws. 8.2 PharmaForm shall be responsible for release testing of each Batch of Product. PharmaForm will provide a Certificate of Analysis (“CoA”) with each batch or lot of Product. The CoA will include a Product batch or lot number, the Specification and associated result of each analytical test performed on the Product and other information required under the Applicable Laws. 8.3 Corcept shall have [***] days from the receipt of Product to inspect the Product and/or perform or have performed any or all of the quality control procedures outlined in the relevant Specifications or the Quality Assurance Agreement to determine if the Product meets the Specifications. If Corcept has evidence to indicate that Product does not meet the Product Specifications, the Quality Assurance Agreement or Applicable Law and therefore contains a Nonconformity (such product being a “Defective Product”), Corcept shall promptly notify PharmaForm in writing and PharmaForm shall retest retained samples of such Product. Any Defective Product shall, at PharmaForm’s sole discretion and expense, either (i) be returned to PharmaForm within a reasonable period of time, or (ii) destroyed in accordance with Applicable Law. If the results of such retesting confirm that such Defective Product does not meet Product Specifications, the Quality Assurance Agreement or Applicable Law, and provided Corcept can certify in writing that the Defective Product was at all times during shipment and after receipt by Corcept, or its designated agent, handled and stored in accordance with cGMP and the recommended storage conditions, PharmaForm shall promptly [***]. The cost to Corcept for any Replacement Product shall be as set forth in Section 4.1. 8.4 In the case of Product with a Latent Defect, Corcept shall promptly, and in no event more than [***] business days after discovery or notification of such Latent Defect, notify PharmaForm of such Latent Defect. After the delivery of the Product, PharmaForm shall have no responsibility for Product with Latent Defects discovered after the expiration of the known shelf life of the Product which has been established by stability studies and agreed by the applicable regulatory agency. The replacement of Product with a Latent Defect and the cost incurred with such replacement shall be as set forth in Section 8.3 of this Agree...
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Specification, Quality Control, Warranty. 7.1 Upon receipt of Product, CORCEPT will have a period of sixty (60) days in which to notify PAS of its rejection of a delivered Product due to failure in whole or in part to conform to the Specifications; provided that in the case of latent defects written notice must be given to PCAS within sixty (60) days after discovery [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Specification, Quality Control, Warranty. 7.1. PCAS Changes to Manufacturing Process. Except as required by applicable federal, state, provincial or local law and/or respective regulations as established by the FDA and/or other regulatory authority (collectively, “Applicable Law(s)”), including without limitation GMP, PCAS shall not change the manufacturing process of a Product or change the facility or equipment used to manufacture a Product in a manner that requires a change to a Marketing Authorization without the prior written consent of Corcept. PCAS shall notify Corcept of all changes, including Material Changes, as soon as practicable after PCAS learns of such change. A “Material Change” is one that either Party deems in its sole discretion requires a submission to the FDA or other regulatory authority or that impacts or potentially impacts the manufacture of Product pursuant to this Agreement.

Related to Specification, Quality Control, Warranty

  • 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.

  • 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 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 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.

  • 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.

  • Attachment  C_ CONTRACT AFFIRMATIONS For purposes of these Contract Affirmations, HHS includes both the Health and Human Services Commission (HHSC) and the Department of State Health Services (DSHS). System Agency refers to HHSC, DSHS, or both, that will be a party to this Contract. These Contract Affirmations apply to all Contractors and Grantees (referred to as “Contractor”) regardless of their business form (e.g., individual, partnership, corporation). By entering into this Contract, Contractor affirms, without exception, understands, and agrees to comply with the following items through the life of the Contract:

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Service Specification The Parties have agreed upon the scope and specification of the Services provided under this Service Agreement in the Service Specification.

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