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. Licensor hereby grants to Licensee a right of reference to all Regulatory Materials filed by or on behalf of Licensor, which right of reference Licensee may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing, manufacturing, and Commercializing Products in the Field in the Licensed Territory. Licensee hereby grants to Licensor and Licensor’s licensees in the Licensor Territory a right of reference to all Regulatory Materials filed by or on behalf of Licensee, which right of reference Licensor may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and developing, manufacturing and commercializing Products in the Licensor 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 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. 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. 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.
15. Amendment to Section 4.2(c)(iv). The Parties hereby agree to amend and restate Section 4.2(c)(iv) of the Japan Agreement by replacing such Section, in its entirety, with the following:
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 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 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. Use of Clinical Data. Transcept hereby grants to Purdue an exclusive right of reference to all Regulatory Materials (including the IND) and Regulatory Approvals owned or Controlled by Transcept solely for the purpose of obtaining Regulatory Approval for Product in the U.S. Territory during the Term. Purdue hereby grants to Transcept an exclusive right of reference to all Regulatory Materials and Regulatory Approvals owned or Controlled by Purdue solely for the purpose of obtaining Regulatory Approval for Product in the Transcept Territory during the Term. Notwithstanding the terms of Article 2, each Party shall have the right, without any additional payment, to use any clinical data developed by the other Party and its Affiliates relating to the Product solely (a) to support the Regulatory Approval of Products in such Party’s territory and (b) for Promotional, marketing, and medical education purposes in support of the Commercialization of Product in such Party’s territory, which right may be sublicensed by such Party (with the consent of the other Party, not to be unreasonably withheld, conditioned or delayed) to any Third Party collaborator or licensee that agrees to allow any Product-related clinical data developed by such collaborator to be used by the other Party for such purposes in a reciprocal manner in such other Party’s territory. For clarity, the rights of reference and use granted by this Section 4.3 shall be in addition to the licenses and other rights granted under this Agreement and shall be independent of the ownership of the Regulatory Materials and Regulatory Approvals as allocated or transferred by 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.
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.
