Avecia Sample Clauses

Avecia. Dr. Xxxxxxx Xxxx Senior Vice President, Research and Development Dr Xxxxx Xxx, Senior Vice-President, Avecia Biotechnology Schedule 6 The Equipment Liquid Nitrogen Dewars (x2) and Data Logger Depth Filtration System 1000L jacketed bag holder Delipid filter skid 2x1000mm chromatography columns, hydraulic skid and spares 2 x Freezers (-30°C & - 70°C) Schedule 7 The Confidentiality Agreement See attached Schedule 1 Work Programme B2422 Work Programme Scope Statement Program to carry out technology transfer of the alfimeprase Process, Process characterization and validation of in-process and bulk API assays by Avecia and manufacture of two (2) cGMP Development Batches, one (1) Engineering Batch and up to five (5) Validation Batches of alfimeprase in Avecia’s ABC 5000 facility. Contents Stage 1. Data Acquisition and Assessment Stage 2. Process Transfer & Fit Stage 3. Capital Equipment Specification and Procurement Stage 4. 15L Fermentation Runs Stage 5. Laboratory Scale Purification Runs Stage 6. Assay Transfer of Validated Methods Stage 7. Assay Transfer Stage 8. Assay Validation Stage 9. Laboratory Process Characterisation (LPC) Stage 10. Fermentation Scale-Up and Centrifuge Trials at 3000L scale Stage 11. cGMP Preparation at 3000L scale Stage 12. Two (2) cGMP Development Batches at 3000L scale Stage 13. Validation Documentation Stage 14. One (1) Engineering Batch at 3000L scale Stage 15. Up to Five (5) Validation Batches at 3000L scale Appendix 1 Process Assumptions Appendix 2 B2422 Work Programme Timeline (see attachment) Detailed Work Programme Stage 1. Data Acquisition and Assessment
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Avecia will notify Nuvelo of any critical or major investigations and Out of Specification (OOS), Out of Trend (OOT) results related to the In process testing and final testing of the API within 72 hours or next working day (Monday-Friday). Nuvelo approval of such documentation is required and will be shown by sign-off on the back-page of the copy of the original investigation/OOS/OOT form faxed by Avecia QA to Nuvelo QA. Notification will be provided for minor investigations, OOS and OOT results on a weekly basis and no approval by Nuvelo QA is required.
Avecia is a corporation validly existing and in good standing under the laws of the State of Delaware with the power to own all of its properties and assets and to carry on its business as it is currently being conducted.
Avecia has the power to execute and deliver this Agreement and to perform its obligations under this Agreement.
Avecia has obtained all necessary consents and authorizations to execute and deliver this Agreement and to perform its obligations under this Agreement, and no other corporate proceedings of Avecia are necessary with respect thereto.
Avecia. ICI and the Purchaser shall, between the date of this Agreement and First Completion, use all reasonable endeavours (not including any expenditure of money) to develop and document (by way of amendment to or replacement of Clauses 11.1(b) and (c) and to the relevant provisions of Clause 11.2(b) of the Environmental Deed of Indemnity) an alternative approach with respect to any Avecia Claims (as defined in the Back to Contents Environmental Deed of Indemnity) which is acceptable to both of them, with the aim of ensuring so far as possible that:

Related to Avecia

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Baxter and Nexell shall cooperate in any action taken by a third party solely involving a nullity action, opposition, reexamination or any other action taken by such third party alleging the invalidity or unenforceability of any Licensed Intellectual Property. Both parties agree to share equally in the cost of the defense of such Licensed Intellectual Property.

  • Distributor The Distributor represents and warrants that: (i) the Distributor is a limited partnership duly organized and in good standing under New York law; (ii) the Distributor is registered as a broker-dealer under federal and applicable state securities laws and is a member of the NASD; and (iii) the Distributor is registered as an investment adviser under federal securities laws.

  • AMD to the Fixed Interest Account, beginning with the date of such transfer, shall be credited with the Current Rate of Interest under this contract which was in effect on the date the transferred contribution was originally deposited into the Fixed Interest Account under the previous AUL contract.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • WHEXXXX xs xxxx of a plan of reorganization, RESTART PARTNERS, L.P., a Delaware Limited Partnership ("Restart"), may acquire an ownership interest in Elsinore Corporation ("Elsinore") or the Four Queens, Inc. ("FQI");

  • Comverge Comverge hereby represents and warrants the following:

  • Supplier shall exercise reasonable care in carrying out the provisions of this Agreement, but shall be kept indemnified by, and shall be without liability to CMA and/or any Fund for any action taken or omitted by it in good faith without negligence including, without limitation, acting in accordance with any Proper Instruction. Supplier shall be entitled to rely on and may act upon the advice of counsel (who may be counsel for CMA or any Fund) on all matters arising in connection with the Services. At any time, Supplier may apply to any officer of CMA or a Fund for instructions and may consult with outside counsel for CMA or the applicable Fund or the independent auditors for the Fund at the expense of the Fund, or other individuals designated in writing by CMA or the Fund, for advice with respect to any matter arising in connection with the Services. Supplier shall not be liable, and shall be indemnified by each Fund or CMA, as applicable, for any action taken or omitted by it in good faith in reliance upon any such instructions or advice or upon any paper or document believed by it to be genuine and to have been signed by such officers or individuals. Supplier shall not be held to have notice of any change of authority of any officer or individual until receipt of written notice thereof from the Fund or CMA. Nothing in this Section shall be construed as imposing upon Supplier any obligation to seek such instructions or advice. Without in any way limiting the generality of the foregoing, Supplier shall in no event be liable for any loss or damage arising from causes beyond its control including, without limitation, delay or cessation of services hereunder or any damages to CMA or a Fund resulting therefrom as a result of work stoppage, power or other mechanical failure, natural disaster, governmental action, communication disruption or other impossibility of performance.

  • 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.

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