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. 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 CONFIDENTIAL 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.
INDs. Licensee shall be responsible for obtaining and maintaining any IND or comparable regulatory filing in other jurisdictions required for the Clinical Trial.
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:
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.
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. [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
INDs. EQRx shall assign transfer, convey or otherwise grant to Hansoh all [***] in the Field in the EQRx Territory with respect to the Licensed Compounds or Licensed Products (in each case, as applicable), including any [***] maintained by EQRx solely with respect thereto in the EQRx Territory.
INDs. Generally the needs of both DCTD and Collaborator are best served when each sponsors an IND. It is expected, therefore, that either DCTD or Collaborator will submit an IND which may cross-reference an IND or Drug Master File held by the other. All information in IND(s) will be fully shared between DCTD and Collaborator. However, certain information pertaining to manufacturing processes may be held in confidence by Collaborator (see Article 9 below).
