Performance; Diligence Clause Samples
Performance; Diligence. Licensee will use Diligent Efforts to Commercialize a POZEN Product in the Territory. The foregoing Diligent Efforts requirement will apply only to one POZEN Product in the Territory, irrespective of the number of POZEN Products Licensee elects to Develop and Commercialize, and Licensee may elect to fulfill its Diligent Efforts obligation in the Territory in respect to any POZEN Product of its choice in the exercise of its reasonable and good faith judgment. Licensee will have the right to Develop and Commercialize Products during the Term in the Territory, for so long as Licensee is using Diligent Efforts to Commercialize at least one POZEN Product in accordance with this Section 5.3, it being understood that the Parties intend for Licensee to focus its initial efforts on the Commercialization of the Initial POZEN Product in the Territory.
Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the U.S. Development of the Product for the Initial Indications and for any Joint Additional Indication in the U.S. consistent with the then-current U.S. Development Plan and in accordance with this Agreement.
(b) Takeda shall devote Diligent Efforts to the ROW Development of the Product for the Initial Indications and for any Joint Additional Indications for all the Level 1 Markets, and such other countries of the Royalty Territory wherein Takeda at its discretion elects to Develop the Product (as described in further detail in this Section 3.5 below), in accordance with its plan of ROW Development, the overall plan and updates of which shall be submitted to the JSC for such countries pursuant to Section 3.2.
(c) Without limiting the generality of Section 3.5(b), Takeda shall (i) devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in the Level 1 Markets, and (ii) file for Regulatory Approval of the Product with the EMEA promptly after, but in no event more than nine (9) months after, the submission for Regulatory Approval of the Product for such indication in the U.S., unless Takeda is required to conduct any additional Development activities to comply with the EMEA's requirements. Any failure by Takeda to comply with the terms of this Section 3.5(c) shall be deemed a material breach of this Agreement by Takeda in any applicable country or countries of the Level 1 Markets, and Affymax shall have the right to terminate this Agreement with respect to the applicable country(ies) of the Level 1 Markets pursuant to the terms of Section 13.2(b)(i).
(d) Without limiting the generality of Section 3.5(b), at any time after the date of the first approval of NDA for the Product in the U.S. (for [*]) of the Level 2 Markets) or the date of the first Regulatory Approval from the EMEA (for the other countries of the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇), ▇▇▇▇▇▇▇ may request Takeda, with regard to one or more countries of the Level 2 Markets where Takeda has not yet determined or initiated efforts to Develop and Commercialize the Product, to inform Affymax of its decision on whether or not it shall devote the Diligent Efforts to Develop and Commercialize the Product for the Initial Indication and the Joint Additional Indication, if any, in such country(ies).
(i) If Takeda informs Affymax of its decision to devote the Diligent Efforts in such country(ies), the...
Performance; Diligence. ITI shall use Commercially Reasonably Efforts to conduct the Research Program in accordance with the then-current Research Plan and in a timely and effective manner using its competent researchers and technicians. ITI shall be solely responsible (using a portion of the upfront payment made by Takeda under Section 8.1) for all costs and expenses incurred by ITI to conduct items 1-5 (excluding 5a), 6, 7 and 8 (excluding 8a and 8b) as described on Figure 1 of the Initial Research Plan. If Takeda either (i) requests an amendment to the Research Plan that would increase the costs to ITI to conduct the Research Program, and if the Research Plan is so amended in accordance with the decision making procedures of Article 3, or (ii) requests that ITI perform any activity described on the Initial Research Plan other than noted in the immediately prior sentence), then Takeda shall be solely responsible for all reasonable additional costs and expenses of ITI resulting from such amendment or request and the performance by ITI of such activities. Takeda shall pay such costs as it does ITI’s Development costs pursuant to Sections 4.5 and 8.2.
Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the Development of the Product consistent with the then-current Development Plan and in accordance with this Agreement.
(b) Without limiting the generality of Section 3.4(a), TGTX shall devote Diligent Efforts to obtaining Regulatory Approval of the Product in the Territory.
(c) TGTX shall conduct its Development activities under this Agreement in a good scientific manner and in compliance with all applicable Laws, including without limitation applicable GCP, GLP, and GMP.
Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the Development of the Product consistent with the then-current Development Plan and in accordance with this Agreement.
(b) Without limiting the generality of Section 3.5(a), TGTX shall devote Diligent Efforts to obtaining Regulatory Approval of the Product in the Territory. * Confidential material redacted and filed separately with the Commission.
(c) Rhizen shall use Diligent Efforts to ensure their Development and Commercialization activities in India are not detrimental in any way, or negatively impact Development and Commercialization of the Product outside India. Each Party shall conduct its Development activities under this Agreement in good scientific manner and in compliance with all applicable Laws, including without limitation applicable GCP, GLP, and GMP.
Performance; Diligence