Pre-Validation Batches Sample Clauses

Pre-Validation Batches. [***] shall order by written request to Xxxxxxx, and Xxxxxxx shall Manufacture, any pre-validation Batches [***]. [***] shall be responsible for the cost of each pre-validation Batch produced under this Agreement and requested in writing by [***], and any Batch Manufactured following: [***]; provided, that the foregoing shall not apply to the extent [***]. Xxxxxxx and Sol-Gel shall cooperate in good faith to determine and resolve any problems [***].
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Pre-Validation Batches. Client shall be responsible for the full cost of each Batch produced under this Agreement at the theoretical quantities when priced on a per-unit basis (including Clinical Stage Batches and Batches necessary to support the validation portion of Client’s submissions for Product approvals by Regulatory Authorities and any Batch manufactured following (a) a change in Specifications or (b) a scale-up in the manufacturing process to produce greater quantities of Product), even if the Batch fails to meet the Specifications (and in such case, Client shall also be responsible for the cost of destroying the out-of-Specification Batch and its components), until all manufacturing, testing and storage methods and processes have been validated in accordance with industry standards (including production of at least three (3) consecutive cGMP Batches of each strength and packaging configuration that meet the then-applicable Specifications); provided, that the foregoing shall not apply to the extent such failure to meet the Specifications would not have occurred but for Cambrex’s Fault, in which case Cambrex will be responsible for such costs. Cambrex and Client shall cooperate in good faith to determine and resolve any problems causing the out-of-Specification Batch. 86274635_42
Pre-Validation Batches. Client shall be responsible for the cost of each Batch produced under this Agreement (including Batches necessary to support the validation portion of Client’s submissions for Product approvals by Regulatory Authorities and any Batch manufactured following (a) a change in Specifications or (b) a scale-up in the manufacturing process to produce greater quantities of Product), even if the Batch fails to meet the Specifications, until all manufacturing, testing and storage methods and processes have been validated in accordance with industry standards (including production of at least [***] Batches of each strength that meet the then-applicable Specifications); provided, that the foregoing shall not apply to the extent Halo was grossly negligent, engaged in willful misconduct, or violated cGMPs (to the extent applicable) in the manufacturing of the out-of-Specification Batch. In cases where Halo is responsible for an out-of-Specification Batch pursuant to the foregoing proviso, Halo will also be responsible for the cost of destroying the out-of-Specification Batch and its components. In all other cases, Client will be responsible for the cost of destroying the out-of-Specification Batch and its components. Halo and Client shall cooperate in good faith to determine and resolve any problems causing the out-of-Specification Batch.

Related to Pre-Validation Batches

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code. 11.2 Further Supplier hereby agrees, unless directed otherwise by the Buyer, to procure components through franchised distributors or direct component Suppliers. Supplier agrees to indemnify and hold the Buyer harmless from and against all costs and expenses for the removal, repair or replacement and reinstallation of counterfeit components incorporated into a Product sold by Supplier to the Buyer where the counterfeit component was procured by Supplier from a person or entity other than a franchised distributor or direct component Supplier or other person or entity pre-approved by the Buyer in writing.

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain : a. Name of the item as approved b. CMS Cat. No. c. Manufacturing date/Import date for the imported items. d. Expiry Date. (where applicable) e. Name & address of Registered Office of Manufacturers and place of manufacture. f. Manufacturing License Number. (where applicable for Manufactures) g. Batch Number (where applicable) h. Month and Year of supply. i. The label & Carton must invariably marked “W B. GOVT SUPPLY : NOT FOR SALE”. j. All Surgical items quoted/supplied by the tenderer must conform to IS /BIS /CE/USFDA. Pacemker must conform to CE & US FDA norms. In case of Drugs items quoted /supplied by tenderer MUST CONFORM TO IP, BP, or USP norms and N.F.I. –III specification as noted against the item(s) in catalogue as applicable. k. The MRP and Trade Name will not be allowed to be printed in any pack. This will lead to cancellation of candidature straightaway. However, for excisable products, insertion of writing of Govt MRP is allowed as per provision laid down in the order of the Central Excise dept. However, for imported item(s), MRP and Trade name may be allowed in addition to Generic name.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Validation Mechanism To be eligible for articulation, the student must show evidence of their CompTIA A+ certification and it must have been issued within three (3) years prior to their enrollment in the program.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Inspection and Tests 3.8.1 The Procuring entity or its representative shall have the right to inspect and/or to test the goods to confirm their conformity to the Contract specifications. The Procuring entity shall notify the tenderer in writing in a timely manner, of the identity of any representatives retained for these purposes. 3.8.2 The inspections and tests may be conducted in the premises of the tenderer or its subcontractor(s), at point of delivery, and/or at the Goods’ final destination If conducted on the premises of the tenderer or its subcontractor(s), all reasonable facilities and assistance, including access to drawings and production data, shall be furnished to the inspectors at no charge to the Procuring entity. 3.8.3 Should any inspected or tested goods fail to conform to the Specifications, the Procuring entity may reject the equipment, and the tenderer shall either replace the rejected equipment or make alterations necessary to make specification requirements free of costs to the Procuring entity. 3.8.4 The Procuring entity’s right to inspect, test and where necessary, reject the goods after the Goods’ arrival shall in no way be limited or waived by reason of the equipment having previously been inspected, tested and passed by the Procuring entity or its representative prior to the equipment delivery. 3.8.5 Nothing in paragraph 3.8 shall in any way release the tenderer from any warranty or other obligations under this Contract.

  • Quality- and Cost-Based Selection Except as ADB may otherwise agree, the Borrower shall apply quality- and cost-based selection for selecting and engaging consulting services.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

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