Specifications and Terms of Supply; Multiple Sources Sample Clauses

Specifications and Terms of Supply; Multiple Sources. New River, in consultation with the JSC, shall establish the specifications, including any necessary documentation, certificates of analysis and test results, for the bulk Compound to be Manufactured under this Article 5, in each case subject to the prior written approval of Shire, such approval not be unreasonably withheld, conditioned or delayed. If a Governmental Authority in a country of the ROW Territory has promulgated any Laws or guidance documents that relate or will relate to the Manufacture of the Compound or a Collaboration Product that are different from those promulgated in the US Territory or the European Union, Shire shall notify New River of such Laws or guidance documents. The Parties shall endeavor to maintain compatible specifications for bulk Compound on a worldwide basis, and to minimize the number of distinct specifications in different countries. New River shall establish at least [*] sources of supply for bulk Compound to be Manufactured under this Article 5.
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Specifications and Terms of Supply; Multiple Sources. New River, in consultation with the JSC, shall establish the specifications, including any necessary documentation, certificates of analysis and test results, for the bulk Compound and bulk and finished Collaboration Products to be Manufactured under this Article 6, in each case subject to the prior written approval of Shire, such approval not be unreasonably withheld, conditioned or delayed. The Parties shall endeavor to maintain compatible specifications for bulk Compound on a worldwide basis, and to minimize the number of distinct specifications in different countries. New River shall establish at least [*] sources of supply for each of Compound and Collaboration Product to be Manufactured under this Article 6.
Sample 1Sample 2
Specifications and Terms of Supply; Multiple Sources. New River, in consultation with the JSC, shall establish the specifications, including any necessary documentation, certificates of analysis and test results, for the bulk Compound and bulk and finished Collaboration Products to be Manufactured under this Article 6, in each case subject to the prior written approval of Shire, such approval not be unreasonably withheld, conditioned or delayed. If a Governmental Authority in a country of the ROW Territory has promulgated any Laws or guidance documents that relate or will relate to the Manufacture of the Compound or a Collaboration Product that are different from those promulgated in the US Territory or the European Union, Shire shall notify New River of such Laws or guidance documents. The Parties shall endeavor to maintain compatible specifications for bulk Compound on a worldwide basis, and to minimize the number of distinct specifications in different countries. New River shall establish at least [*] sources of supply for each of Compound and Collaboration Product to be Manufactured under this Article 6.
Sample 1

Related to Specifications and Terms of Supply; Multiple Sources

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • 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.

  • Certain Calculations and Tests (a) Notwithstanding anything in this Agreement or any Loan Document to the contrary, when calculating any applicable ratio or determining other compliance with this Agreement (including the determination of compliance with any provision of this Agreement which requires that no Default or Event of Default has occurred, is continuing or would result therefrom) in connection with a Specified Transaction undertaken in connection with the consummation of a Limited Condition Acquisition, the date of determination of such ratio and determination of whether any Default or Event of Default has occurred, is continuing or would result therefrom or other applicable covenant shall, at the option of the Borrower (the Borrower’s election to exercise such option in connection with any Limited Condition Acquisition, an “LCA Election”), be deemed to be the date the definitive agreements for such Limited Condition Acquisition are entered into (the “LCA Test Date”) and if, after such ratios and other provisions are measured on a Pro Forma Basis after giving effect to such Limited Condition Acquisition and the other Specified Transactions to be entered into in connection therewith (including any incurrence of Indebtedness and the use of proceeds thereof) as if they occurred at the beginning of the four consecutive fiscal quarter period being used to calculate such financial ratio ending prior to the LCA Test Date, the Borrower could have taken such action on the relevant LCA Test Date in compliance with such ratios and provisions, such provisions shall be deemed to have been complied with. For the avoidance of doubt, (x) if any of such ratios are exceeded as a result of fluctuations in such ratio (including due to fluctuations in Consolidated EBITDA of the Borrower) at or prior to the consummation of the relevant Limited Condition Acquisition, such ratios and other provisions will not be deemed to have been exceeded as a result of such fluctuations solely for purposes of determining whether the Limited Condition Acquisition is permitted hereunder and (y) such ratios and other provisions shall not be tested at the time of consummation of such Limited Condition Acquisition or related Specified Transactions. If the Borrower has made an LCA Election for any Limited Condition Acquisition, then in connection with any subsequent calculation of any ratio or basket availability with respect to any other Specified Transaction on or following the relevant LCA Test Date and prior to the earlier of the date on which such Limited Condition Acquisition is consummated or the date that the definitive agreement for such Limited Condition Acquisition is terminated or expires without consummation of such Limited Condition Acquisition, any such ratio or basket shall be calculated on a Pro Forma Basis assuming such Limited Condition Acquisition and other transactions in connection therewith (including any incurrence of Indebtedness and the use of proceeds thereof) have been consummated; provided, that (other than solely with respect to the incurrence test under which such Limited Condition Acquisition is being made) Consolidated EBITDA, Consolidated Total Assets or assets and Consolidated Net Income of any target of such Limited Condition Acquisition can only be used in the determination of the relevant ratio and baskets if and when such Limited Condition Acquisition has closed.

  • Effective Date and Term of Agreement This Agreement is effective and binding on the Company and Employee as of the date hereof; provided, however, that, subject to Section 2(d), the provisions of Sections 3 and 4 shall become operative only upon the Change in Control Date.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Definitions and Terms Section 1.1

  • Statement of Work Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

  • Quality of Work No Advance or any portion thereof shall be made with respect to defective work or to any contractor that has performed work that is defective and that has not been cured, as confirmed by the report of the Construction Consultant, but Lender may disburse all or part of any Advance before the sum shall become due if Lender believes it advisable to do so, and all such Advances or parts thereof shall be deemed to have been made pursuant to this Agreement.

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