Right to Cross-Reference Sample Clauses

Right to Cross-Reference. Each Party shall have the right to cross-reference and make any other use of the other Party’s NDAs/XXXx and INDs/CTAs for the Product that it would have if it were the owner [***] including without limitation access to all data Controlled by the other Party and contained or referenced in such NDAs/XXXx and INDs/CTAs, in each case as may be reasonably necessary to enable such Party to Develop, Manufacture or Commercialize Products as permitted under this Agreement. In addition, each Party shall have the right to cross-reference the other Party’s drug master file (“DMF”) in connection with the performance of its obligations under this Agreement.
Sample 1Sample 2
AutoNDA by SimpleDocs
Right to Cross-Reference. Brammer hereby grants to Customer, its Affiliates and its sublicensees, with respect to the Product, a perpetual, irrevocable, sublicensable right to cross-reference Xxxxxxx’x regulatory submissions and Facility approvals for the purpose of obtaining and maintaining Regulatory Approvals with respect to the Product anywhere in the world. Within [**] after Customer’s written request, Brammer shall deliver to Customer for filing with the FDA or any foreign Regulatory Authority designated by Customer such authorization letters as Customer reasonably deems necessary for the foregoing purpose, which shall be substantially in the form attached hereto as Appendix B, subject to such modifications as may be required by Applicable Laws; provided, however, that if Customer proposes any material modifications to such form, Brammer shall be entitled to an additional [**] for review and approval of the modified form; and provided, further, that [**] associated with its request for such cross-reference, and for obtaining any notarization, legalization or apostille that may be required for filing any authorization letter with any foreign Regulatory Authority. For the avoidance of doubt, Brammer shall not be required to provide directly to Customer any Brammer documents that are general to Xxxxxxx’x business, such as Facility and equipment SOPs unless such documents are necessary to obtain any Regulatory Approvals with respect to the Product.
Sample 1
Right to Cross-Reference. Subject to obligations of confidentiality in Article 11, each Party may consult with the other Party and each Party shall share its expertise and Know-How relating to or useful for Regulatory Filings to facilitate the preparation of any Regulatory Filings related to the Product. As holder of the Marketing Authorisation under license from Thera, SA hereby grants to Thera the right to access, cross-reference or use any portion of the Regulatory Filings or Marketing Authorisation of the Product. SA shall provide Thera, if requested by Thera and within a reasonable period of time as of such request, with all documentation relating to any variation to the Regulatory Filings approved by the Regulatory Authorities.
Sample 1
Right to Cross-Reference. Each Party shall have the right to cross-reference and make any other use of the other Party’s Regulatory Documentation for the Product that it would have if it were the owner, including without limitation access to all data contained or referenced in such Regulatory Documentation, in each case as may be reasonably necessary to enable such Party to develop, Manufacture or commercialize the Product; except that such right of cross-reference and use shall not apply to trials pursued independently by one Party pursuant to Sections 5.4 or 5.5.
Sample 1
Right to Cross-Reference. Brammer hereby grants to Customer, its Affiliates and its sublicensees, with respect to a Product, a perpetual, irrevocable right to cross-reference Xxxxxxx’x regulatory submissions and Facility approvals for the purpose of obtaining and maintaining regulatory approvals (including Regulatory Approvals) with respect to each Product anywhere in the world. Within [**] after Customer’s written request, Brammer shall deliver to Customer for filing with the FDA or any foreign Regulatory Authority designated by Customer such authorization letters as Customer reasonably deems necessary for the foregoing purpose, which shall be substantially in the form attached hereto as Appendix B, subject to such modifications as may be required by Applicable Laws; provided, however, that if Customer proposes any material modifications ActiveUS 170335185 EXECUTION VERSION to such form, Brammer shall be entitled to an additional [**] for review and approval of the modified form; and provided, further, that Customer shall be responsible for all costs and expenses associated with its request for such cross-reference, and for obtaining any notarization, legalization or apostille that may be required for filing any authorization letter with any foreign Regulatory Authority. For the avoidance of doubt, Brammer shall not be required to provide directly to Customer any Brammer documents that are general to Xxxxxxx’x business, such as a Facility and equipment SOPs unless such documents are expressly requested by a relevant Regulatory Authority or are required by Applicable Laws. Additionally, if required, at Customer’s request and cost, Brammer shall promptly provide Customer with copies of all granted Regulatory Approvals and any other permits related to the manufacture of any Product. Customer will have the right to use any and all information contained in such approvals in connection with its own applications for Regulatory Approval and/or commercial development of the Products.
Sample 1
Right to Cross-Reference. In connection with the rights granted pursuant to this Article 3, King agrees that Core may cross-reference the NDA as may be required by Law or as necessary for Core to Manufacture or Commercialize Authorized Generic Product in accordance with customary industry practice. Core may reference the trademark “Skelaxin®” in its advertising to the limited extent of identifying Authorized Generic Product as a generic version of the Branded Product, and shall at all such times that it so uses the trademark “Skelaxin®” identify “Skelaxin®” as a trademark owned by King.
Sample 1
Right to Cross-Reference. Subject to obligations of confidentiality in ARTICLE 10, each of Xxxxxx and Thera Europe may consult with each other and each of them shall share its expertise and Know-How relating to or useful for Regulatory Filings to facilitate the preparation of any Regulatory Filing related to the Initial Product, each Elected Additional Product and any New Presentation. Xxxxxx hereby grants to Theratechnologies and Thera Europe (and, in the event of MA Transfer, the Thera Transferee) the right to access, cross-reference or use any portion of the Regulatory Filings or Marketing Authorisations for the Initial Product (a) to Commercialize, either themselves or through their Affiliates or any Third Party, (i) the Initial Product outside the Territory, and (ii) any Additional Product within or outside the Territory; (b) to conduct any Development activities within or outside the Territory, related to (i) any Product (including Clinical Trials, Phase IV Trials and New Presentations) and/or (ii) any Additional Product, and (c) to make and have made the Initial Product, any Elected Additional Product, and/or New Presentation in each case within or outside the Territory.
Sample 1
AutoNDA by SimpleDocs
Right to Cross-Reference. Each Party shall have the right to reference Regulatory Materials of any product comprising the Compound to the extent that such Regulatory Materials are Controlled by the other Party for purposes relating to obtaining Regulatory Approval for a product comprising the Compound. This covenant shall extend to Affiliates and Sublicensees of a Party.
Sample 1

Related to Right to Cross-Reference

  • Cross-References Unless otherwise specified, references in this Agreement and in each other Loan Document to any Article or Section are references to such Article or Section of this Agreement or such other Loan Document, as the case may be, and, unless otherwise specified, references in any Article, Section or definition to any clause are references to such clause of such Article, Section or definition.

  • Captions and Cross References The various captions (including, without limitation, the table of contents) in this Agreement are provided solely for convenience of reference and shall not affect the meaning or interpretation of any provision of this Agreement. Unless otherwise indicated, references in this Agreement to any Section, Appendix, Schedule or Exhibit are to such Section of or Appendix, Schedule or Exhibit to this Agreement, as the case may be, and references in any Section, subsection, or clause to any subsection, clause or subclause are to such subsection, clause or subclause of such Section, subsection or clause.

  • Headings and Cross-References The various headings in this Agreement are included for convenience only and shall not affect the meaning or interpretation of any provision of this Agreement. References in this Agreement to Section names or numbers are to such Sections of this Agreement.

  • General References All references in this Supplemental Indenture to Articles and Sections, unless otherwise specified, refer to the corresponding Articles and Sections of this Supplemental Indenture; and the term “herein”, “hereof”, “hereunder” and any other word of similar import refers to this Supplemental Indenture.

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • Right of Reference Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this 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. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]

  • CROSS-REFERENCE TABLE Trust Indenture Act Section Indenture Section 310 (a)(1) 7.10 (a)(2) 7.10 (a)(3) N.A.

  • Titles and References All references in this Deposit Agreement to exhibits, articles, sections, subsections, and other subdivisions refer to the exhibits, articles, sections, subsections and other subdivisions of this Deposit Agreement unless expressly provided otherwise. The words "this Deposit Agreement", "herein", "hereof", "hereby", "hereunder", and words of similar import refer to the Deposit Agreement as a whole as in effect between the Company, the Depositary and the Holders and Beneficial Owners of ADSs and not to any particular subdivision unless expressly so limited. Pronouns in masculine, feminine and neuter gender shall be construed to include any other gender, and words in the singular form shall be construed to include the plural and vice versa unless the context otherwise requires. Titles to sections of this Deposit Agreement are included for convenience only and shall be disregarded in construing the language contained in this Deposit Agreement. References to "applicable laws and regulations" shall refer to laws and regulations applicable to ADRs, ADSs or Deposited Securities as in effect at the relevant time of determination, unless otherwise required by law or regulation.

  • Definitions and References Capitalized terms not otherwise defined herein have the meanings assigned in the Credit Agreement. All references to the Credit Agreement contained in the Collateral Documents and the other Loan Documents, as amended or amended and restated, shall, upon the execution of this Amendment, mean the Credit Agreement as amended by this Amendment.

  • Headings; References The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. All references herein to "Articles" or "Sections" shall be deemed to be references to Articles or Sections hereof unless otherwise indicated.

Time is Money Join Law Insider Premium to draft better contracts faster.