Manufacturer’s Documentation for Regulatory Purposes Sample Clauses

Manufacturer’s Documentation for Regulatory Purposes. (“DMF”). Notwithstanding anything contained in this Agreement to the contrary, Orion shall at its expense have secured as of the Date of Agreement and shall maintain for so long as USL has the right to sell Product in the Territory under this Agreement, an authorization permitting USL to cross-refer to the DMF related to Compound used by Orion for manufacture of Product for reference by the Product NDAs. Such DMF shall contain all information related to the manufacture of Compound and the manufacturing facility used to produce Compound that is reasonably necessary to facilitate obtaining Regulatory Approvals for the Product in the Territory. Such authorization shall include the right of reference to such DMFs by all of the INDs and Product NDAs submitted under this Section 8.
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Related to Manufacturer’s Documentation for Regulatory Purposes

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.

  • Product Documentation Supplier shall produce and deliver to Sony Ericsson Product Documentation fulfilling the requirements set out in templates included in Enclosure 2.3.

  • 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:

  • Technical Documentation Subject to the terms of this Agreement, BROCADE hereby grants to McDATA a nonexclusive, nontransferable, worldwide license to reproduce and use BROCADE's technical documentation provided to McDATA by BROCADE hereunder, solely for McDATA's internal purposes in connection with the manufacture, marketing and support of the McDATA Products into which the Products are incorporated as set forth herein. Modifications to such technical documentation by McDATA shall require BROCADE's prior written authorization, which authorization will not be unreasonably withheld.

  • Responsibility for documentation Neither the Agent nor the Arranger:

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

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  • Timeliness of Instructions In giving an Instruction, the Fund shall take into consideration delays which may occur due to the involvement of a Subcustodian or agent, differences in time zones, and other factors particular to a given market, exchange or issuer. When the Custodian has established specific timing requirements or deadlines with respect to particular classes of Instruction, or when an Instruction is received by the Custodian at such a time that it could not reasonably be expected to have acted on such instruction due to time zone differences or other factors beyond its reasonable control, the execution of any Instruction received by the Custodian after such deadline or at such time (including any modification or revocation of a previous Instruction) shall be at the risk of the Fund.

  • MARKETING MATERIALS AND REPRESENTATIONS (a) The Participant represents and warrants that it will not make any representations concerning a Fund, Creation Units or Shares, other than those consistent with the Prospectus or any Marketing Materials (as defined below) furnished to the Participant by the Distributor.

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