INDs. BMS will use its Commercially Reasonable Efforts to assign and transfer within [***] days after Company’s request (which request by Company shall come within [***] days after the Effective Date) all of its rights, title and interests in and to any INDs for the Licensed Compounds. Company will cooperate in connection therewith and shall perform all duties under such INDs from and after such assignment. Subject to the foregoing, the Parties will reasonably cooperate to ensure an orderly transition of duties under such INDs and to fulfill applicable filing obligations with regulatory authorities.
INDs. Subject to the terms and conditions of this Agreement, Aerpio hereby grants to Licensee a non-transferable (except in accordance with Section 11.1), exclusive (even as to Aerpio), royalty- and milestone-bearing right of reference, with the right to grant further rights of reference only to those person or entities that have been granted a sublicense by Licensee under the license grant in Section 5.1(a) in compliance with Section 5.2, to the INDs listed on Exhibit D, solely for the Licensed Compound and Licensed Products, for use in the Territory and in the Field.
INDs. Unless otherwise agreed by the Parties or as may be required by applicable Regulatory Authorities, on a Licensed Product-by-Licensed Product basis, following Achievement of Proof of Concept for the applicable Licensed Compound, each Party shall own all INDs filed by it for purposes of performing its Development responsibilities with respect to Licensed Products; provided that (i) EPIZYME shall transfer and assign to CELGENE all INDs in the CELGENE Territory that relate to Licensed Compounds and Licensed Products upon Achievement of Proof of Concept of such Licensed Compounds and Licensed Products in accordance with Section 2.7.3(a)(ii)(1) or Section 3.3.1 and (ii) CELGENE shall have the right to review and comment on any and all INDs filed in the CELGENE Territory by EPIZYME at least [**] days prior to such filing, which comments shall be considered in good faith by EPIZYME. Subject to Section 6.6, each Party shall have the right to cross-reference and make any other use of the other Party’s INDs and the data referred to in Section 2.7.3(a)(iii) for the Licensed Products that it would have if it were the owner, including access to all data contained or referenced in such INDs, in each case as may be reasonably necessary to enable EPIZYME or CELGENE to research, Develop, Manufacture or Commercialize the Licensed Products in the EPIZYME Territory or the CELGENE Territory, respectively. In addition, subject to Section 6.6, each Party shall have the right to cross-reference the other Party’s Drug Master File(s) (if any) in connection with the performance of its obligations under this Agreement.
INDs. 5.1.1 Each Party shall have the right to file INDs and make other filings with the Regulatory Authorities anywhere in the world in connection with the performance with its Development activities hereunder and to conduct correspondence and communication with Regulatory Authorities as they relate to such IND, including (to the extent consistent with Section 5.6 and the Pharmacovigilance Agreement, which shall govern with respect to required safety reports to Regulatory Authorities) to report adverse events to the applicable Regulatory Authorities if and to the extent required by such INDs. Each Party will allow the other Party a reasonable opportunity to review and comment on all INDs and other filings in the United States, Canada, China, Russia and the Major Market Countries in connection with the performance of Development activities hereunder in advance of submission of any such IND or filing by such Party or any of its Affiliates, licensees or Sublicensees, and such Party will, and will cause its Affiliates, licensees or Sublicensees to, reasonably consider all comments timely provided by such other Party in connection therewith.
5.1.2 To the extent permitted by the applicable Regulatory Authority, in connection with any IND or other filings in the United States, Canada, China, Russia and the Major Market Countries in connection with the performance of Development activities hereunder, each Party shall provide prior written notice reasonably in advance of, and the other Party shall have the right to have a designee participate in, meetings with such Regulatory Authorities being conducted by or on behalf of such Party or its Affiliates, licensees or Sublicensees, and the other Party shall have the right to participate in internal meetings or discussions of such Party or its Affiliates, licensees or Sublicensees (or the applicable portions thereof) occurring before or after, and related to, such meetings, and shall be provided with advance access to such Party’s materials prepared for such meetings.
5.1.3 Each Party, in connection with any IND or other filings in the United States, Canada, China, Russia and the Major Market Countries in connection with the performance of Development activities hereunder, shall also have the right to review and comment upon any material correspondence between the other Party or its Affiliates, licensees or Sublicensees and the Regulatory Authorities or their agents.
5.1.4 Each Party, in connection with any IND or other fili...
INDs. Except for any INDs filed by Array in the Ono Territory (i) with respect to an Approved Clinical Study for which the Parties agree in the applicable Joint Development Plan that the applicable Regulatory Filing will be owned by Array, and/or (ii) with respect to Clinical Studies conducted by Array in one or more countries of the Ono Territory pursuant to Section 4.5 above, which Regulatory Filings, the “Array Regulatory Filings”, shall be owned by Array, Ono shall be responsible, at its expense, for filing, obtaining and maintaining, and shall own, all INDs for the Product in the Ono Territory.
INDs. Licensee shall be responsible for obtaining and maintaining any IND or comparable regulatory filing in other jurisdictions required for the Clinical Trial.
INDs. Unless otherwise agreed in writing, Anesta shall have sole responsibility, by itself or through its Affiliates or Anesta Sub-Licensees, for applying for, updating and maintaining all INDs within the Territory and for ensuring that all requirements and conditions imposed upon the holder of such INDs are fully complied with at all times. However, upon the reasonable request of Anesta, ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. ImmuPharma shall provide reasonable assistance and cooperation in connection with such activities in relation to providing Technical Information requested by Anesta which is in ImmuPharma’s possession and Controlled by ImmuPharma and procuring that its staff, where necessary, attend regulatory hearings and are reasonably available to discuss matters specific to the Licensed Product. Anesta shall reimburse to ImmuPharma all reasonable costs and expenses, including without limitation all costs of materials, active ingredients and excipients, package, delivery and transport and the fair and proportional allocation of overhead costs of ImmuPharma’s personnel consistent with applicable IFRS.
INDs. Subject to this Section 4.1.1, INFI shall own and be responsible for preparing, filing and maintaining all INDs for the IPI-145 Compound and IPI-145 Product in the Field in the Territory as of the Effective Date and Licensee shall reimburse INFI’s reasonable and documented Internal Personnel Expenses and Out-of-Pocket Expenses related thereto. Promptly after the Effective Date and in any event no later than the end of the Transition Period, INFI and Licensee, as applicable, shall make the necessary filings with the Regulatory Authorities in the Territory necessary to transfer the INDs for the IPI-145 Compound and IPI-145 Product to Licensee, and following the approval of such transfer by the applicable Regulatory Authorities (if applicable) or other effectuated transfer, Licensee shall own all such INDs and be the IND holder for the IPI-145 Compound and IPI-145 Product in the Territory.
(a) Until such time as the INDs have been transferred to Licensee, INFI shall act as Licensee’s agent to maintain the INDs and communicate with Regulatory Authorities in the Territory relating to the IPI-145 Compound and IPI-145 Product and Licensee shall reimburse INFI’s reasonable and documented Internal Personnel Expenses and Out-of-Pocket Expenses related thereto. Except with respect to non-substantive administrative correspondence with Regulatory Authorities, (i) INFI shall act on Licensee’s behalf as instructed by Licensee with respect to submissions related to the INDs for the IPI-145 Compound and IPI-145 Product and receiving and submitting correspondence with Regulatory Authorities in the Territory related thereto and (ii) INFI will provide to Licensee copies of all correspondence received from Regulatory Authorities within [**] Business Days of receipt or such earlier date as required by applicable Law or the relevant Regulatory Authority or if necessary given the circumstances of the correspondence, and INFI shall not respond to such correspondences or otherwise interact with the Regulatory Authorities except as instructed by Licensee.
(b) With respect to the INDs for the IPI-145 Compound and IPI-145 Product, Licensee will provide INFI with copies of all submissions in advance of filing so that INFI may submit such submissions on behalf of Licensee. INFI will provide to Licensee copies of any material written communications to or from Regulatory Authorities related to the IPI-145 Compound and the IPI-145 Product within [**] Business Days of receipt or delivery of...
INDs. It is understood that, prior to the Effective Date, Array has been proceeding with development activities with respect to ARRY-142886, including activities directed to the preparation and filing of an IND (the “Initial IND”). To facilitate the development of ARRY-142886 in the Field, Array shall complete preparation of and file the Initial IND to cover the agreed Phase I clinical trial activities as set out in Exhibit 3.1.2, subject to AZ prior written approval of the study design and study protocol for such trial. Array shall be responsible, at its own cost, for the agreed Phase I clinical trial activities. In addition:
(a) Array shall only be entitled to use a clinical research organization for such Phase I clinical trial activities which has been assessed by and approved in advance in writing by AZ;
(b) during the preparation and filing of the Initial IND Array shall inform AZ of and involve AZ in any interactions between Array and the FDA with respect to the Initial IND;
(c) during the Phase I clinical trial Array shall provide AZ with all safety data arising from the Phase I clinical trial at the same time as it is provided to the FDA;
(d) during the Phase I clinical trial Array shall provide AZ with all pharmacokinetic and pharmacodynamic data arising from the Phase I trial as soon as reasonably practicable; and
(e) during the Phase I clinical trial Array shall inform AZ of and involve AZ in any interactions between Array and the FDA with respect to the Phase I clinical trial activities. At the completion of the Phase I clinical trial Array shall close or inactivate the Initial IND, shall complete all relevant clinical trial and Initial IND administrative activities and shall share all clinical trial data with AZ. AZ shall be responsible for the preparation and filing of all subsequent INDs with respect to any subsequent clinical development for ARRY-142886 and all INDs with respect to any clinical development of any other Candidate Drugs. Array shall also provide to AZ in support of any AZ IND filings all relevant ARRY-142886 non-clinical data, including CMC, pharmacology and toxicology generated by Array.
INDs. EQRx shall assign transfer, convey or otherwise grant to Hansoh all rights, title and interest in all [***] with respect to the Licensed Compounds or Licensed Products (in each case, as applicable), including any [***] solely with respect thereto in the EQRx Territory.
