Common use of INDs Clause in Contracts

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. 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 CELGENE’s exercise of Proof of Concept for the applicable Phase 1 Option relating to 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 . In furtherance of the foregoing, (i) EPIZYME shall transfer and assign to CELGENE all INDs in the CELGENE Territory that relate to Licensed Compounds and Licensed Products upon Achievement directed to Selected Targets following such exercise of Proof of Concept of such Licensed Compounds and Licensed Products the applicable Phase 1 Option in accordance with Section 2.7.3(a)(ii)(1) or Section 3.3.1 the CELGENE Territory; 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 6.66.4, 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)(iii2.12.3(a)(iv) 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 6.66.4, 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.