Right of Reference. Section 1: If the two Parties fail to agree upon an interpretation of the Agreement, either Party shall have the right to refer the matter to the Joint Industry Committee, hereinafter provided, and if either party does make such reference, the other Party must accept the reference.
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...
Right of Reference. Company shall have the right to reference the DMF solely in connection Company’s regulatory filings submitted in connection with obtaining Marketing Approval for the Licensed Product.
Right of Reference. Neoprobe shall permit AstraZeneca to cross-refer to any Regulatory Documentation assigned under Section 3.3, at no additional cost to AstraZeneca, for the purposes of Exploiting the Licensed Products outside the Field and for use under AstraZeneca’s retained rights as set forth in Section 3.1.2. Neoprobe hereby agrees to provide AstraZeneca with a letter of consent to permit such cross-referencing, which letter may be provided by AstraZeneca to Health Authorities for purposes of performing its obligations and exercising its retained rights hereunder. Neoprobe shall submit to appropriate Health Authorities on a timely basis and maintain a Drug Master File or a similar dossier which may reasonably be required by such appropriate Health Authorities. Neoprobe shall make available to AstraZeneca the Drug Master File, if applicable, or any other relevant supporting documentation, on a timely basis as so requested by AstraZeneca, for each country of the Territory and at such times and in accordance with a mutually agreed schedule as requested by AstraZeneca. Neoprobe acknowledges that (a) the Licensed Know-How is secret and substantial and that without Licensed Know-How Neoprobe would not be able to obtain and maintain Health Registration Approvals, (b) such Health Registration Approvals together with the Health Registration Approvals assigned or licensed to Neoprobe hereunder give, or will allow Neoprobe to obtain and maintain, Data Exclusivity with respect to the Compounds and Licensed Products, (c) access to the Licensed Know-How and such Health Registration Approvals have provided Neoprobe with a competitive advantage in the marketplace beyond the exclusivity afforded by the Licensed Patents and the Data Exclusivity, and (d) the milestone payments and royalties set forth in Sections 6.1 and 6.2 are, in part, intended to compensate AstraZeneca for such exclusivity and such competitive advantage. Confidential Treatment – Asterisked material has been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.
Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party. Zai may use such right of reference to Paratek’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Licensed Products in Field in the Territory. Paratek may use the right of reference to Zai’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining regulatory approval of the Licensed Products outside the Territory.
Right of Reference. Each Party hereby grants the other a "Right of Reference," as that term is defined in 21 C.F.R. (S) 314.3(b), to any data developed under this Agreement, and a Party shall provide a signed statement to this effect, if requested by the other, in accordance with 21 C.F.R. (S) 314.50(g)(3).
Right of Reference. CytomX hereby grants to Pfizer a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by CytomX or its Affiliates (a) to the extent that it specifically pertains to a Probody contained in the Agreement PDCs, the Licensed Products or preclinical studies with respect to the Licensed Products and (b) that Pfizer reasonably believes may be necessary or useful to the Development, Manufacturing or Commercialization of any Agreement PDC or any Licensed Product pursuant to this Agreement, and CytomX will provide a signed statement to the foregoing effect, if so requested by Pfizer in accordance with 21 C.F.R. § 314.50(g)(3).
Right of Reference. The Licensor hereby grants to Alzheon and its Affiliates and sublicensees an exclusive Right of Reference to, and a royalty-bearing, irrevocable (except as set forth herein), exclusive (even as to the Licensor) license or sublicense (as applicable) to access and use, the Licensed Data (and any regulatory submissions, clinical dossiers and regulatory approvals that include such Licensed Data) for any and all purposes, other than developing, commercializing and/or seeking regulatory approval for the Vivimind Product in the Vivimind Field. The Licensor shall, at Alzheon’s request, provide a signed statement in accordance with 21 C.F.R. 314.50(g)(3) (or any analogous Law outside the United States), or otherwise provide appropriate notification of such right to the applicable Regulatory Authority, to the extent necessary for Alzheon and its Affiliates and sublicensees to exercise the Right of Reference granted hereunder.
Right of Reference. Biogen hereby grants to Bioverativ a fully-transferable and fully sub-licensable (in each case, in whole or in part) perpetual and irrevocable right of reference to all Regulatory Submissions (including all data and information contained therein) made, prior to or on or after the Separation, by or on behalf of Bioverativ or Biogen (or any Affiliate or permitted successor in interest or sub-licensee of Bioverativ or Biogen) in connection with Regulatory Submissions for the Bioverativ Field.
Right of Reference. Surface hereby grants to Novartis, and at the request of Novartis will grant to Novartis’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 early access/named patient programs for the T1 Licensed Products) included in or used in support of any drug master file maintained by or on behalf of Surface (including its Related Parties) that relates to any T1 Licensed Product to the extent necessary or useful to Research, Develop, Manufacture or Commercialize T1 Licensed Products in the Novartis Territory. Notwithstanding anything to the contrary in this Agreement, Surface will not withdraw or inactivate any regulatory filing that Novartis or its Related Parties reference or otherwise use pursuant to this Section 7.1.3.
