Pharmaceutical Audit Rights of Sepracor Sample Clauses

Pharmaceutical Audit Rights of Sepracor. Sepracor shall be entitled to ascertain in accordance with this Article 10 that Nycomed is manufacturing and testing Product properly and in accordance with the instructions on manufacture and testing. Nycomed agrees to ensure that Nycomed's suppliers will be periodically audited by Nycomed in order to (i) keep their cGMP or, where not applicable, other appropriate qualification status current, and (ii) maintain compliance with the Product(s)' approved labeling. To the extent permitted to do so pursuant to its agreements with its suppliers, Nycomed will provide to Sepracor summaries of the audit reports and, when requested by Sepracor and required under the circumstances, the full audit reports, regarding its suppliers to Sepracor in order to keep Sepracor informed. If Sepracor should not be satisfied with the provided audit information and upon Sepracor's reasonable written request, Sepracor may audit Nycomed's relevant manufacturing and quality control facilities, upon reasonable prior notice and during normal business hours, [**], accompanied by Nycomed representatives as may be appointed by Nycomed. Such audit right shall include the right of Sepracor to audit suppliers of Product, together with representatives of Nycomed and representatives of such suppliers, always provided, however, that any audit rights of Sepracor regarding suppliers shall be limited by pre-existing bona fide agreements with any such suppliers and/or confidentiality obligations undertaken by Nycomed towards such suppliers; provided, however, that Nycomed shall use its reasonable efforts to (i) obtain audit rights for Sepracor under such pre-existing agreements and (ii) obtain, in any future agreements with suppliers, audit rights to the same extent as to which Nycomed has audit rights. The costs and expenses of Sepracor associated with any such audits shall be borne by [**]. In case Sepracor should wish to conduct audits more frequently than foreseen pursuant to this Section 10.2.4.2, Sepracor shall promptly [**], unless the applicable audit has been caused by the failure of Nycomed and/or the relevant supplier to properly manufacture, perform quality control and package Product in accordance with this Article 10.
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Related to Pharmaceutical Audit Rights of Sepracor

  • 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:

  • 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.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than [***].

  • Review of Materials During the term of this Agreement, Client shall ensure that all prospectuses, statements of additional information, registration statements, proxy statements, reports to shareholders, advertising and sales literature or other materials prepared for distribution to Fund shareholders or the public, which refer to the Subadviser in any way, prepared by employees or agents of Client or its affiliates are consistent with information previously provided by Subadviser. Subadviser shall promptly notify the Client of any changes to information pertaining to the Subadviser and stated in the materials described in this Section 6(g).

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

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  • Notice of Material Developments Each Party shall give prompt written notice to the other Parties of: (a) any material variances in any of its representations or warranties contained in Articles 2 or 3 above, as the case may be (the Disclosure Schedule); (b) any breach of any covenant or agreement hereunder by such Party; and (c) any other material development which adversely affects the ability of such Party to consummate the transactions contemplated by this Agreement.

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  • Complete Copies of Materials The Company has delivered or made available true and complete copies of each document (or summaries of same) that has been requested by Parent or its counsel.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

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