Common use of Diligence Requirements Clause in Contracts

Diligence Requirements. If, in any calendar year, COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has performed any one of the following with respect to a LICENSED PRODUCT, then COMPANY shall be deemed to have complied with COMPANY’S obligations under this Section 3.2 with respect to a LICENSED PRODUCT: (i) has expended a minimum of [***] for research, development, manufacture or commercialization of a LICENSED PRODUCT annually; (ii) is actively conducting a PHASE I TRIAL, Phase II trial, and/or PHASE III TRIAL with respect to a LICENSED PRODUCT; (iii) is preparing or has prepared documents for filing an NDA with respect to a LICENSED PRODUCT within [***] years of completion of a PHASE III TRIAL; (iv) has filed or is pursuing an NDA for MARKETING APPROVAL for a LICENSED PRODUCT; (v) has received MARKETING APPROVAL for a LICENSED PRODUCT; or (vi) a LICENSED PRODUCT is launched or is being sold. In the event that COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has not performed at least one of Sections 3.2(i) through (vi) during such calendar year with respect to a LICENSED PRODUCT, then, subject to COMPANY’S rights in the second paragraph of Section 3.1, XXXXXXXXX may treat such failure as a material breach in accordance with Section 13.3(b).

Diligence Requirements. If, in any calendar year, COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has performed any one of the following with respect to a LICENSED PRODUCT, then COMPANY shall be deemed to have complied with COMPANY’S obligations under this Section 3.2 with respect to a LICENSED PRODUCT: (i) has expended a minimum of [***] for research, development, manufacture or commercialization of a LICENSED PRODUCT annually; (ii) is actively conducting a PHASE I TRIAL, Phase II trial, and/or PHASE III TRIAL with respect to a LICENSED PRODUCT; (iii) is preparing or has prepared documents for filing an NDA with respect to a LICENSED PRODUCT within [***] years of completion of a PHASE III TRIAL; (iv) has filed or is pursuing an NDA for MARKETING APPROVAL for a LICENSED PRODUCT; (v) has received MARKETING APPROVAL for a LICENSED PRODUCT; or (vi) a LICENSED PRODUCT is launched or is being sold. In the event that COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has not performed at least one of Sections 3.2(i) through (vi) during such calendar year with respect to a LICENSED PRODUCT, then, subject to COMPANY’S rights in the second paragraph of Section 3.1, XXXXXXXXX may treat such failure as a material breach in accordance with Section 13.3(b).. ***Confidential Treatment Requested*** ***Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under