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. 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 Xxxxxxx (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 Xxxxxxx 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 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 Law. Certain confidential information contained in this document, marked by [**], has been omitted because the information (i) is not material and (ii) would likely cause competitive harm to the Company if publicly disclosed. CONFIDENTIAL
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:
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. Section 4.2(b)(v) of the Agreement is replaced in its entirety by the following: “(v) to the extent necessary for the conduct of any Collaboration Study or Independent Study or BMS’s filing of a BLA or supplemental BLA as set forth in Section 10.1(b), providing BMS a Right of Cross-Reference to the relevant Regulatory Documentation, provided that, such Right of Cross-Reference shall terminate upon the expiration or termination of this Agreement for purposes of conducting any new Clinical Trials, except that in the case of termination for a Material Safety Issue pursuant to Section 16.4, such Right of Cross-Reference shall remain in effect solely (A) to the extent necessary to permit BMS to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (B) as necessary to permit BMS to continue to dose subjects enrolled in each Collaboration Study or Independent Study through completion of the applicable Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws;” 2.6 Reimbursement for Opt-Out Development Costs. Section 7.4 of the Agreement is replaced in its entirety by the following: “7.4 Reimbursement for Opt-Out Development Costs. If a Monotherapy Independent Study or Combined Therapy Independent Study results in Regulatory Approval or a Label expansion of a BMS Asset or Nektar Asset (including the Nektar Compound), the non-funding Party shall reimburse the funding Party for the non-funding Party’s allocated share of Opt-Out Development Costs incurred by the funding Party for the applicable Monotherapy Independent Study or Combined Therapy Independent Study (using the principles set forth in Sections 5.3(c)(i), 6.2 and 6.3) for which the non-funding Party would have been responsible had such Independent Study been a Collaboration Study, plus an amount equal to either (i) [***] of such reimbursement in the event that the applicable Combined Therapy Independent Study studies the Combined Therapy of a Product and the BMS Compound (whether or not other compounds are included in such study), or (ii) [***] of such reimbursement in all other cases. Such reimbursed Opt-Out Development Costs (and the [***] or [***], as applicable, additional reimbursement for such Independent Study) shall be subject to the reconciliation procedures set forth in Section 9.7 but shall not be subject to the Development Cost Cap.” 2.7
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. At Xxxxxxx’x request, and to the extent required by a Regulatory Authority or pursuant to a requirement of a Regulatory Authority, F-star shall provide Xxxxxxx 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 Xxxxxxx and its Affiliates making their own Regulatory Filings in relation to relevant Products.
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 each particular Combined Therapy Study, provided that, except as provided in Section 3.1 and Section 3.2, such Right of Cross-Reference shall terminate upon the earlier of the completion or termination of such Combined Therapy Study, and the expiration or termination of this Agreement. If a Combined Therapy Study is terminated for a Material Safety Issue pursuant to Section 11.3, 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 Sponsoring Party 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.
