Product Release Criteria Sample Clauses

Product Release Criteria. StemCell will inspect and test the Product (in accordance with Part IV of Schedule “C”, the “Acceptance Test”) prior to shipment to Oxford according to the quality control specifications (the “Product Release Criteria”) set out in Part V Schedule “C”. The Product supplied to Oxford by StemCell shall be in compliance with the Product Release Criteria and Oxford will accept Product that meets the Product Release Criteria. Oxford will have [***] ([***]) business days to conduct the Acceptance Test and confirm whether the Product as received by StemCell meets the Product Release Criteria (tested in accordance with Part IV of Schedule “C”). In the event that, based on its own performance of the Acceptance Test, Oxford determines that the Product does not meet the Product Release Criteria then Oxford and StemCell will repeat the Acceptance Test together at Oxford’s facilities, with all of StemCell’s associated costs to conduct such joint Acceptance Test at Oxford’s facilities to be borne solely by Oxford. The results of this joint Acceptance Test will be binding on both Oxford and StemCell. Notwithstanding anything to the contrary herein, in no event shall StemCell be responsible for the non-performance of a T-SPOT product used in association with the Product.
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Product Release Criteria. Corgenix shall perform all agreed upon procedures as documented in the manufacturing and quality release documents as further set forth in the Specifications for each Pilot Lot to ensure that each Pilot Lot is in compliance with all applicable Specifications. In addition, Corgenix shall provide to BG Medicine kits from each Pilot Lot in a quantity sufficient, in BG Medicine’s sole good faith discretion, for BG Medicine to validate the Products independently. Corgenix shall not provide Products made from the Pilot Lots to any Third Party, unless and until BG Medicine has determined, in its sole discretion, that such Products comply with any and all applicable Specifications. For each Lot after the Pilot Lots, Corgenix shall use its best efforts to, within ten (10) days after such Lot is ready for testing, test each such Lot for compliance with any and all applicable Specifications. Corgenix shall promptly provide BG Medicine a Certificate of Analysis and upon BG Medicine’s request any and all such test results and data (the “Test Results”) and kits from such Lot shall be provided to BG Medicine for the purpose of verifying such Test Results. The cost of the kits supplied to BG Medicine for such verification shall be borne by BG Medicine. Notwithstanding anything in this Agreement to the contrary, Corgenix shall not provide any Product from any Lot to any Third Party unless and until Corgenix: (i) has supplied any and all Test Results for such Lot to BG Medicine; and (ii) has received from BG Medicine written authorization to supply Products to Third Parties from such Lot (the “Release Criteria”). When BG Medicine has provided written acceptance to Corgenix for each Lot verifying performance to the Specifications listed in the Certificate of Analysis, invoicing will occur per Section 2.12 and BG Medicine assumes ownership of the Lot at that time.
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Product Release Criteria. At the sole discretion of diaDexus, within ten (10) days after a Lot is ready for testing, Denka Seiken shall either (i) test each such Lot for compliance with any and all applicable Specifications or (ii) provide to diaDexus Tests from each Lot in a quantity sufficient, in diaDexus’ sole good faith discretion, for diaDexus to test and qualify the Products. If Denka Seiken is the Party testing a Lot, (A) the cost of the Products used by Denka Seiken for its testing shall be borne by Denka Seiken and (B) Denka Seiken shall promptly provide diaDexus in writing any and all such test results and data (the “Test Results”) and, at diaDexus’ request, Products from such Lot shall be provided to diaDexus for the purpose of verifying such Test Results.
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Related to Product Release Criteria

  • Acceptance Criteria 6.7.2.1. During the test there shall be no evidence of:

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Milestones Subject to the provisions of the SGIP, the Parties shall agree on milestones for which each Party is responsible and list them in Attachment 4 of this Agreement. A Party’s obligations under this provision may be extended by agreement. If a Party anticipates that it will be unable to meet a milestone for any reason other than a Force Majeure event, it shall immediately notify the other Parties of the reason(s) for not meeting the milestone and (1) propose the earliest reasonable alternate date by which it can attain this and future milestones, and (2) requesting appropriate amendments to Attachment 4. The Party affected by the failure to meet a milestone shall not unreasonably withhold agreement to such an amendment unless it will suffer significant uncompensated economic or operational harm from the delay, (1) attainment of the same milestone has previously been delayed, or (2) it has reason to believe that the delay in meeting the milestone is intentional or unwarranted notwithstanding the circumstances explained by the Party proposing the amendment.

  • Sales Milestones Subject to the terms and conditions set forth in the Agreement, in the event that the Annual Net Sales made by or on behalf of a Selling Entity for all Licensed Products in a given calendar year first exceeds a threshold set forth in the table immediately below, Pyxis shall pay to LCB the following one-time, non-refundable, non-creditable milestone payments. Annual Net Sales Milestone Threshold Payment (US Dollars) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] In the event that in a given calendar year more than one (1) Annual Net Sales milestone threshold is achieved, Pyxis shall pay to LCB each separate Annual Net Sales milestone payment with respect to each Annual Net Sales milestone threshold that is achieved in such calendar year. Pyxis shall notify LCB in writing upon the first achievement, in respect of a Licensed Product, by or on behalf of Pyxis or its Affiliate or Sublicensee, of each of the Milestones set forth in Section 5.2 (Development Milestones), Section 5.3 (Regulatory Milestones) and Section 5.4 (Sales Milestones) no later than [***] of Pyxis’s knowledge of achievement thereof, and in any event, each of the Milestones set forth in Section 5.4 (Sales Milestones) no later than [***] after the end of the applicable calendar year in which such Milestone is achieved. No later than [***] of receipt of an appropriate invoice from LCB, Pyxis shall pay the applicable payment due upon achievement of the corresponding Milestone Event. Each Milestone Event shall be deemed to be achieved once for all Licensed Products and shall be payable only once.

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