Right of Cross-Reference Sample Clauses
The Right of Cross-Reference clause allows parties to refer to other sections, documents, or provisions within a contract or related agreements. In practice, this means that obligations, definitions, or procedures outlined elsewhere can be incorporated by reference, streamlining the contract and avoiding unnecessary repetition. This clause ensures consistency and clarity by making it clear that referenced materials are considered part of the agreement, reducing ambiguity and the risk of conflicting terms.
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Right of Cross-Reference. MITSUBISHI hereby grants VERTEX and its Affiliates or VERTEX Licensees the right to cross reference, in their regulatory filings made in the VERTEX Territory or in the Territory, if any, covering Bulk Drug Substance, a Compound or Drug Product, all regulatory filings, and information contained therein, made in the Territory by MITSUBISHI or its Affiliates or sublicensees relative to such Bulk Drug Substance, Compounds or Drug Products. VERTEX hereby grants MITSUBISHI and its Affiliates or sublicensees the right to cross reference, in their regulatory filings made in the Territory covering a Compound or Drug Product, all regulatory filings, and information contained therein, made in the VERTEX Territory or in the Territory, if any, by VERTEX or its Affiliates or VERTEX Licensees relative to such Compounds or Drug Products.
Right of Cross-Reference. (a) EQRx will authorize applicable Regulatory Authorities to cross-reference the appropriate EQRx Study Drug [***] to provide data access to TPT sufficient to support conduct of the Combined Therapy Clinical Trial. In the event that TPT decides to expand the Combined Therapy Clinical Trial in countries outside of the United States, TPT will notify EQRx and, within [***] business days of TPT’s notification, EQRx will notify TPT in writing of its election to, and EQRx shall either:
(i) timely provide its chemistry, manufacturing and controls data (the “CMC Data”) in its existing format to a Third Party vendor to support TPT’s regulatory filings in such countries, using best efforts to provide support required for such filings, and promptly responding to inquiries from such Third Party vendor or Regulatory Authority regarding such CMC Data[***]; or
(ii) timely provide its CMC Data in its existing format to TPT to support TPT’s regulatory filings in such countries, and will use best efforts to provide support required for such filings, promptly responding to inquiries from such Third Party vendor, any TPT appointed QP or Regulatory Authority regarding such CMC Data[***].
(b) Each Party grants to the other Party a non-exclusive, non-transferable (except in connection with a permitted assignment, sublicense or subcontract) Right of Cross-Reference with respect to Study Data and results related to its Compound and respective Regulatory Documentation, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions of the Combined Therapy Clinical Trial related to the other Party’s Compound and Regulatory Documentation. In all other cases, where a Right of Cross-Reference is not possible, the Parties will promptly discuss in good faith how to provide the required Regulatory Documentation for the Combined Therapy Clinical Trial. Further, each Party will provide to the other Party a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such Right of Cross-Reference on a need-to-know basis with respect to the confidential portion of the drug master files of both Parties. Notwithstanding anything to the contrary in this Agreement, neither Party will have any right to access the other Party’s chemistry, manufacturing and control data with respect to such other Party’s Compound. In the event of a regulatory filing by TPT for the Combined Therapy, the foregoing provisions will apply with respect...
Right of Cross-Reference. Vertex shall have a right of reference to all or any part of submissions made in connection with obtaining Regulatory Approvals if the Assistance Rights become effective under Section 3.7 hereof or as otherwise required by Regulatory Authorities for any reason.
Right of Cross-Reference. Takeda hereby grants Amylin the right to access and cross-reference all filings with and submissions to the Regulatory Authorities with respect to Products in the Field in the Territory as may be necessary or useful for Amylin to obtain Regulatory Approval with respect to Excluded Products. Amylin hereby grants Takeda the right to access and cross-reference all filings with and submissions to the Regulatory Authorities with respect to Excluded Products as may be necessary or useful for Takeda to obtain Regulatory Approval with respect to Products in the Field in the Territory.
Right of Cross-Reference. Ipsen hereby grants, and shall cause its Affiliates to Grant, to BMS a Right of Cross-Reference to the relevant Regulatory Documentation Controlled by Ipsen and its Affiliates for the Exelixis Compound and the Combined Therapy (i) for the conduct of any Combined Therapy Trial, and (ii) with respect to regulatory filings and approvals, solely to the extent required to submit regulatory filings and seek approvals for the BMS Compound(s) as part of a Combined Therapy or if required by the relevant Regulatory Authority (which right shall survive any expiration or termination of this Supplement and the Agreement). In such case, Ipsen shall reasonably cooperate with Exelixis and BMS and make written authorizations and other filings with the applicable Regulatory Authority reasonably required to effect such Right of Cross-Reference.
Right of Cross-Reference. BN grants ▇▇▇▇▇▇▇ (or its Affiliate or Sublicensee as appropriate) the right to cross-reference Regulatory Filings Controlled by BN as would be reasonably necessary or useful for Regulatory Filings of Licensed Components or Licensed Products Developed or Commercialized hereunder. BN shall, at its cost, provide ▇▇▇▇▇▇▇ with all the necessary paperwork to use this right of cross-reference in any country in the Territory.
Right of Cross-Reference. [**] Brammer shall deliver to Customer for filing with the FDA or any foreign Regulatory Authority designated by Customer such authorization letters as Customer deems necessary for the foregoing purpose, which shall be in substantially the form attached hereto as Exhibit F, subject to such modifications as may be required by Applicable Law; provided, however, that if Customer proposes any material modifications to such form, Brammer shall be entitled to [**] 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 ▇▇▇▇▇▇▇’▇ business, such as a Facility and equipment SOPs unless such documents are expressly requested by a relevant Regulatory Authority or are required by Applicable Law. CONFIDENTIAL
Right of Cross-Reference. Each Party shall provide a Right of Cross-Reference to its existing Regulatory Documentation for its Compound to the extent necessary for the conduct of the Combined Therapy Study, provided that, except as provided in Sections 3.1(b) and 3.2(b), such Right of Cross-Reference shall terminate upon the earlier of (1) the completion or termination of the Combined Therapy Study, and (2) the expiration or termination of this Agreement; provided that if the Combined Therapy Study is terminated for a Material Safety Issue pursuant to Section 11.3, then such Right of Cross-Reference shall remain in effect solely to the extent necessary to permit the Company to comply with any outstanding obligations required by a Regulatory Authority or Applicable Law, or as necessary to permit the Company to continue to dose subjects enrolled in the Combined Therapy Study through completion of the Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws.
Right of Cross-Reference. Vertex shall have a right of reference to all or any part of submissions made in connection with obtaining Regulatory Approvals if the Assistance Rights become effective under Section 3.7 hereof or as otherwise required by Regulatory Authorities for any reason. * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
Right of Cross-Reference. At ▇▇▇▇▇▇▇’▇ request, and to the extent required by a Regulatory Authority or pursuant to a requirement of a Regulatory Authority, F-star shall provide ▇▇▇▇▇▇▇ with a right of cross reference to relevant preclinical data in IND filings Controlled by F-star to the extent that these relate to the Fcab Platform Technology, for the purposes of ▇▇▇▇▇▇▇ and its Affiliates making their own Regulatory Filings in relation to relevant Products.