Production of Industrial Scale Batches Sample Clauses

Production of Industrial Scale Batches. Upon receipt by KRYPTON of GENTA JAGO's notice referred to in Section 7.1 above, the Parties shall initiate the production of three (3) industrial scale batches (hereinafter "Bio-Batches") on such equipment as shall eventually be used KRYPTON or a third party to commercially manufacture the Final Product, based on the Prototype Formulation (the size of each Bio-Batch to be not less than the greater of (i) 10% (ten percent) of the anticipated initial commercial batch size, or (ii) 100,000 tablets), according to Current Good Manufacturing Practices, such Bio-Batches to be subsequently used for stability testing and pivotal clinical studies; provided however, that GENTA JAGO shall have the ultimate responsibility with respect of any and all technical aspects of such production of batches related to the technology transfer and the implementation of such technology in the manufacturing site.
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Related to Production of Industrial Scale Batches

  • TECHNICAL EVALUATION (a) Detailed technical evaluation shall be carried out by Purchase Committee pursuant to conditions in the tender document to determine the substantial responsiveness of each tender. For this clause, the substantially responsive bid is one that conforms to all the eligibility and terms and condition of the tender without any material deviation. The Institute’s determination of bid’s responsiveness is to be based on the contents of the bid itself without recourse to extrinsic evidence. The Institute shall evaluate the technical bids also to determine whether they are complete, whether required sureties have been furnished, whether the documents have been properly signed and whether the bids are in order.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Particular Methods of Procurement of Goods and Works International Competitive Bidding. Goods and works shall be procured under contracts awarded on the basis of International Competitive Bidding.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Design Development Phase INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE

  • Other Methods of Procurement of Goods and Works The following table specifies the methods of procurement, other than International Competitive Bidding, which may be used for goods and works. The Procurement Plan shall specify the circumstances under which such methods may be used: Procurement Method

  • Commercial Driver’s License As a result of recent Federal statutory requirements, the State of Michigan enacted Act 346 of 1988. The parties agree that as a result of these statutory requirements some employees within the Technical Bargaining Unit may be required to obtain and retain a Commercial Drivers License (CDL) to continue to perform certain duties for the State. Whenever a CDL is referred to in this Section, it is understood to mean the CDL and any required endorsements. In order to implement this provision, the parties agree to the following:

  • Production Phase contract period in which the Development and the Production are to be performed.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Contractor Licensing, etc. Notwithstanding Section 14.c, District may terminate this Contract immediately by written notice to Contractor upon denial, suspension, revocation, or non-renewal of any license, permit, or certificate that Contractor must hold to provide services under this Contract.

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