Rights of Reference to Regulatory Materials. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials, including any data relied on in support of such Regulatory Materials, solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for the Products, consistent with the roles of the Parties set forth in this Agreement.
Rights of Reference to Regulatory Materials. Piramal hereby grants to AC Immune a right of reference to all Regulatory Materials filed by Piramal for Product, and AC Immune hereby grants to Piramal a right of reference to all materials filed by AC Immune with Regulatory Authorities for AC Immune Therapeutic Agent. Such rights of reference are granted by each Party solely for the purpose of the other Party obtaining approval on its respective product.
Rights of Reference to Regulatory Materials. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party for Product as follows: The right of reference granted to Affymax herein shall be solely for the purpose of Affymax obtaining Regulatory Approval for the Product in the U.S. The right of reference granted to Takeda herein shall be solely for the purpose of obtaining Regulatory Approval for the Product in the Field in the Royalty Territory, and/or, if necessary or applicable, for the purpose of fulfilling its responsibility in relation to the Regulatory Approval for the Product for the Oncology Indications in U.S. Each Party shall refer the Regulatory Materials filed by the other Party for Product as feasible (e.g., for avoiding redundancy of work as far as possible). Takeda also shall have a right to use, without any additional consideration, any and all data and information generated or obtained from either Party hereunder, for the purpose of Takeda's Development and Commercialization of the Product in Japan under the Japan Agreement.
Rights of Reference to Regulatory Materials. Allos hereby grants to Mundipharma a right of reference to all Regulatory Materials filed by or on behalf of Allos, which right of reference Mundipharma may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing and Commercializing the Product in the Field in the Licensed Territory. Mundipharma hereby grants to Allos and Allos’ licensees in the Allos Territory a right of reference to all Regulatory Materials filed by or on behalf of Mundipharma, which right of reference Allos may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing and Commercializing the Product in the Field in the Allos Territory. Each Party shall support the other Party, as reasonably requested by such other Party, in obtaining Regulatory Approvals in such other Party’s territory, including providing necessary documents or other materials required by applicable Laws to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.
Rights of Reference to Regulatory Materials. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party pursuant to this Agreement and/or the Global Agreement for Product as follows: The right of reference granted to Affymax herein shall be solely for the purpose of Affymax or its Affiliates obtaining Regulatory Approval in U.S. for the Product pursuant to the Global Agreement. The right of reference granted to Collaborator herein shall be solely for the purpose of obtaining Regulatory Approval for the Products in and outside the Licensed Territory pursuant to this Agreement and/or the Global Agreement. For the avoidance of doubt, Collaborator shall have a right of reference, for the purpose of obtaining the Regulatory Approval for the Products in the Licensed Territory pursuant hereto, to all Regulatory Materials filed by Collaborator pursuant to the Global Agreement, and vice versa.
Rights of Reference to Regulatory Materials. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party in its respective Territory for Product as follows: The right of reference granted to Affymax herein shall be solely for the purpose of Affymax, its Affiliates or any Third Party Partners of Affymax obtaining Regulatory Approval in the Affymax Territory for the Product. The right of reference [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. granted to Collaborator herein shall be solely for the purpose of obtaining Regulatory Approval for the Products in the Licensed Territory, subject to Section 4.1(a)(iii).
Rights of Reference to Regulatory Materials. Spectrum hereby grants to Purchaser and Purchaser’s Affiliates and licensees in the Licensed Territory a right of reference to all regulatory materials filed by or on behalf of Spectrum (including by its Affiliates and licensees), which right of reference Purchaser (and its Affiliates and licensees) may use for the sole purpose of seeking, obtaining and maintaining regulatory approvals and developing and commercializing the Licensed Product in the Licensed Territory. Purchaser hereby grants to Spectrum and Spectrum’s Affiliates and licensees in the Spectrum Territory a right of reference to all regulatory materials filed by or on behalf of Purchaser, which right of reference Spectrum [***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. 57 may use for the sole purpose of seeking, obtaining and maintaining regulatory approvals and developing and commercializing the Licensed Products in the Spectrum Territory. Each party shall support the other party, as reasonably requested by such other party, in obtaining regulatory approvals in such other party’s territory, including providing necessary documents or other materials required by applicable laws to obtain regulatory approval in such territory, all in accordance with the terms and conditions of this Agreement.
Rights of Reference to Regulatory Materials. (a) Onconova hereby grants to HanX a right of reference to all Regulatory Materials filed by Onconova for Development, Manufacture or Commercialization of the Product solely for the purposes of Manufacturing and Development Activities to obtain Regulatory Approval and Commercialization in the Field in the Territory.
Rights of Reference to Regulatory Materials. Subject to the provisions of Sections 4.4 and 4.9, Chroma hereby grants to CTI a right of reference to all Regulatory Materials filed by or for Chroma for the Product solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Products in the Licensed Territory, consistent with the roles of the Parties set forth in this Agreement. Subject to the provisions of Sections 4.4 and 4.9, CTI hereby grants to Chroma a right of reference to all Regulatory Materials filed by or for CTI for the Product solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Products in the ROW Territory, consistent with the roles of the Parties set forth in this Agreement.
Rights of Reference to Regulatory Materials. Novavax hereby grants to Takeda and its Affiliates a right of reference to all Regulatory Materials filed by Novavax or its Affiliates or its other licensees (to the extent Novavax has been granted the right to grant such right of reference to Regulatory Materials filed by its other licensees) for the Vaccine solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Vaccine in the Takeda Territory, consistent with the roles of the Parties set forth in this Agreement. Takeda hereby grants to Novavax, its Affiliates and its other licensees for the Vaccine a right of reference to all Regulatory Materials filed by Takeda and its Affiliates for the Vaccine solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Vaccine in the Novavax Territory. For the avoidance of doubt, Novavax or its Affiliates intends to directly submit all Regulatory Filings in the U.S., United Kingdom, Canada, Germany and France (collectively, the “Reference Countries”) and therefore, the foregoing right of reference of Takeda shall include a right of reference to all Regulatory Filings submitted to the Reference Countries. To the extent Novavax allows a Third Party to submit any Regulatory Filings in any of the Reference Countries, Novavax shall ensure that such Third Party expressly grant to Takeda a right of reference to all Regulatory Filings submitted by such Third Party to any Reference Country.
