Hospira’s Review Sample Clauses

Hospira’s Review. For any relevant Project, at Genzyme’s request, Hospira shall review and consult with Genzyme on those portions of Genzyme’s proposed regulatory submissions relating to Hospira’s packaging or Manufacturing procedures before the submissions are filed with the appropriate Regulatory Authorities in the Territory. Hospira shall [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. complete its review of the submissions within [**] days for submissions in English, or within [**] days for submissions not in English, following receipt of a proposed regulatory submission. Genzyme shall be the sole owner of any regulatory submission filed pursuant to this Master Agreement. In the event that a Regulatory Authority requires additional review and consultation from Hospira (for example, for technical responses to a Regulatory Authority finding of deficiency, should one arise), Hospira shall provide Genzyme with cost estimates for any additional work to be done. If Genzyme approves such costs in writing, Genzyme shall reimburse Hospira for such additional work based on a rate of [**] per hour. Hospira shall provide Genzyme with an executed copy of its comments.
Sample 1
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Related to Hospira’s Review

  • Sub-Adviser Review of Materials Upon the Adviser’s request, the Sub-Adviser shall review and comment upon selected portions, relating to the Sub-Adviser and/or Strategy (including the Allocated Portion), of the Registration Statement, other offering documents and ancillary sales and marketing materials prepared by the Adviser for the Fund, and participate, at the reasonable request of the Adviser and as agreed to by the Sub-Adviser, in educational meetings with placement agents and other intermediaries about portfolio management and investment-related matters of the Fund. The Sub-Adviser will promptly inform the Fund and the Adviser if any information in the Registration Statement is (or will become) inaccurate or incomplete.

  • Asset Representations Review Process Section 3.01 Asset Representations Review Notices and Identification of Review Receivables. On receipt of an Asset Representations Review Notice from the Seller according to Section 5.7 of the Receivables Purchase Agreement, the Asset Representations Reviewer will start an Asset Representations Review. The Servicer will provide the list of Review Receivables to the Asset Representations Reviewer promptly upon receipt of the Asset Representations Review Notice. The Asset Representations Reviewer will not be obligated to start, and will not start, an Asset Representations Review until an Asset Representations Review Notice and the related list of Review Receivables is received. The Asset Representations Reviewer is not obligated to verify (i) whether the conditions to the initiation of the Asset Representations Review and the issuance of an Asset Representations Review Notice described in Section 7.6 of the Indenture were satisfied or (ii) the accuracy or completeness of the list of Review Receivables provided by the Servicer.

  • Independent Review Each of the parties hereto has reviewed this Release with its own counsel and advisors.

  • 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.

  • Quality Assurance Licensee agrees that all use of the Licensed Subject Matter shall be only upon the Products manufactured by or for Licensee in accordance with quality standards approved by Licensor prior to the commencement of manufacturing of the Products. Licensee shall submit for Licensor's sole and absolute approval the type of cereal, the name of cereal, the packaging design, advertising material, and all other materials to be used in connection with the Products subject to the sole and absolute approval of Licensor which shall not be unreasonably delayed or withheld.

  • 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 [***].

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Documents Reviewed We have reviewed originals, copies, drafts or conformed copies of the following documents:

  • Asset Representations Review The Seller shall (i) at all times while any Public Notes remain Outstanding, ensure that an Asset Representations Reviewer is appointed, (ii) provide the Asset Representations Reviewer with the Asset Representations Review Notice (to the extent a copy is received by the Seller) to the notices address set forth in the Asset Representations Review Agreement, and (iii) provide the Asset Representations Reviewer with reasonable access to the Seller’s offices and information databases upon the initiation of an Asset Representations Review as set forth in Section 7.6 of the Indenture.

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