Product Test Methods Sample Clauses

Product Test Methods. In consultation with and subject to the written approval of Cempra, no later than [*] days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the Commercially Reasonable procedures, methods and protocols by which the Product will be tested and released, as specified in Section 7.1 of the Agreement, and which will be consistent with and sufficient to satisfy, and shall, upon written notice to Cempra, and subject to Cempra’s written approval, in the future be modified as necessary to be consistent with and sufficient to satisfy the requirements of, cGMP, Applicable Law, and any Regulatory Approval(s). Upon completion and approval by Cempra, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. EXHIBIT 7.2 Form of Quality Agreement Cempra and Hospira agree to consult and use all reasonable efforts to prepare and complete the Quality & Technical Agreement in a form reasonably consistent with the form of such agreement under negotiation by the parties as of the Effective Date no later than [*]days after the Effective Date. Upon completion, the Quality & Technical Agreement shall be attached to this Exhibit 7.2 and shall be made an integral part of this Agreement. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. EXHIBIT 12.4 Alternative Dispute Resolution [*]
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Product Test Methods. In consultation with Hologic, no later than [***] days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Products will be tested and released, as specified in Section 7.1 of the Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Exhibit 7.2 Form of Quality Agreement [Omitted.] [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Exhibit 12.4
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Product Test Methods. In consultation with Durata, no later than [**] days after the Effective Date, Hospira will use reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Product will be tested and released, as specified in Section 7.1. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. PROCEDURAL MONOGRAPH TITLE: Determination of Dalbavancin and Impurities by HPLC in Dalbavancin for Injection MONOGRAPH #: PR-1623-B EFFECTIVE DATE: SUPERCEDES DATE: March 2, 2011 (Signature) (Print Signature) (Date) Prepared By/R&D Approval: /s/ D. Stegnor D. Stegnor 1-26-12 CQ Approval: /s/ Xxxxx Xxxxxxx Xxxxx Xxxxxxx 01-27-12 Durata Approval: /s/ Xxxxxx Xxxxxxxx Xxxxxx Xxxxxxxx 2-8-12
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Product Test Methods. In consultation with Genzyme, no later than forty-five (45) days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Products will be tested and released, as specified in Section 7.1 of the Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. Exhibit 7.2
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Product Test Methods. The parties will adopt and implement appropriate Product testing and release methods in accordance with the Quality Agreement to be attached to this Agreement as Exhibit 7.2. Upon adoption and implementation, such testing and release methods will be appended to this Exhibit 7.1 and will be made an integral part of this Agreement. Certain information in this exhibit, marked by brackets and asterisks [***], has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Exhibit 7.2 Form of Quality Agreement [***]
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Product Test Methods. In consultation with AMAG, no later than […***…] after the Effective Date, Pfizer will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Product will be tested and released, as specified in Section 7.1 of this Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. EXHIBIT 12.4
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Product Test Methods. In consultation with Kythera, no later than [*] days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Product will be tested and released, as specified in Section 7.2 of the Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.2 and shall be made an integral part of this Agreement. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXHIBIT 7.3 Technical & Quality Agreement Kythera and Hospira agree to consult and use all reasonable efforts to prepare and complete the Technical & Quality Agreement no later than [*] days after the Effective Date. Upon completion, the Technical & Quality Agreement shall be attached to this Exhibit 7.3 and shall be made an integral part of this Agreement. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXHIBIT 12.4
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Product Test Methods. In consultation with OBI, no later than ninety (90) days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Products will be tested and released, as specified in Section 7.1 of the Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement. Hospira – Oxygen Biotherapeutics Agreement Exhibit 7.2 Form of Quality Agreement OBI and Hospira agree to consult and use all reasonable efforts to prepare and complete the Quality Agreement no later than one hundred and twenty (120) days after the Effective Date. Upon completion, the Quality Agreement shall be attached to this Exhibit 7.2 and shall be made an integral part of this Agreement. Hospira – Oxygen Biotherapeutics Agreement Exhibit 12.4
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Related to Product Test Methods

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • 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.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

  • Product The term “

  • Supplier Selection If Customer selects a seat or galley supplier that is not on the Boeing recommended list, such seat or galley will become BFE and the provisions of Exhibit A, Buyer Furnished Equipment Provisions Document, of the AGTA will apply.

  • Combination Product The term “

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Acceptance Testing The MCP must have the capability to report all elements in the Minimum Data Set as set forth in the ODJFS Encounter Data Specifications and must submit a test file in the ODJFS-specified medium in the required formats prior to contracting or prior to an information systems replacement or update. Acceptance testing of encounter data is required as specified in Section 29(a)(v) of this Appendix.

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