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. [**] Xxxxxxx 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, Xxxxxxx 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, Xxxxxxx shall not be required to provide directly to Customer any Xxxxxxx 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. CONFIDENTIAL
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. 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.
Right of Cross-Reference. Puma hereby grants to Pint, its Affiliates and sublicensees the right to cross reference, in connection with any Regulatory Filing regarding Product in the Territory during the Term, any Regulatory Filing or Regulatory Approval regarding Product outside the Territory. Pint hereby grants Puma, its Affiliates and sublicensees the right to cross reference any Regulatory Filing or Regulatory Approval filed by Pint regarding Product to Develop and Commercialize Products outside the Territory and to Manufacture Products. The foregoing rights include without limitation the right for each Party and, to the extent permitted under this Agreement, its Affiliates and sublicensees, to access and make copies of and reproduce such documentation and information for the purposes set forth in this Section 4.2. Upon termination of this Agreement by Puma for cause pursuant to Section 11.3 (cause) or 11.4 (bankruptcy) or by Pint pursuant to Section 11.2 (at will), Puma’s rights under this Section 4.2 shall apply on a worldwide basis.
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. Novan, its Affiliates and Novan Licensees shall have the right to cross-reference, for purposes of developing Licensed Products outside of the Licensed Territory or in the Licensed Territory outside the Licensed Field, all Drug Approval Applications and other filings with Regulatory Authorities made by Sato for Licensed Products, subject to Section 2.3 (for clarity, for [***], this Section 6.5 applies, as to [***]). Sato shall have the right to cross-reference, for purposes of developing Licensed Products in the Licensed Field in the Licensed Territory all Drug Approval Applications and other filings with Regulatory Authorities made by Novan or, to the extent Controlled by Novan and as long as Novan would not incur costs to grant such a right to cross-reference to Sato, the Novan Licensees.
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.
