Development and Regulatory Diligence. Licensee will use and will cause its Affiliates and Sublicensees to use Commercially Reasonable Efforts to # Develop Licensed Products (consistent with [Section 3.3]) for use in the Territory, # to the extent additional indications or uses, or additional Licensed Products, are Developed, to seek Regulatory Approvals therefore, and # to maintain in good standing and effect all Regulatory Approvals in the Territory for Licensed Products, including both those Regulatory Approvals transferred to Licensee pursuant to this Agreement and new Regulatory Approvals obtained by Licensee during the Term.
Diligence. The Continuing Party will use Commercially Reasonable Efforts to Develop and Commercialize such Reversion Product in the Territory in a timely and effective manner and in compliance in all material respects with Applicable Law and applicable codes of conduct; provided that, for purposes of this [Section 3.3(c)] only, the definition of Commercially Reasonable Efforts will apply to the Reversion Product (in place of Product thereunder) and the clause in the pharmaceutical industry by a company will be replaced by the applicable Continuing Party and, in addition, the Continuing Party will at all times have the sole discretion to cease permanently to Research, Develop and Commercialize such Reversion Product as provided above.
Diligence. During the Term of this Agreement, Zai Lab shall use Commercially Reasonable Efforts to implement the Development Plan to Develop at least one (1) Product. Without limiting the generality of the foregoing, Zai Lab will use, and will cause its Affiliates, licensees and/or sublicensees to use Commercially Reasonable Efforts to Develop, Manufacture, seek Regulatory Approval and Marketing Authorization for, and following Regulatory Approval or Marketing Authorization to Commercialize FUGAN in China. Zai Lab will also use, and will cause its Affiliates, licensees and/or sublicensees to use, Commercially Reasonable Efforts to assess the feasibility to Develop, Manufacture, seek Regulatory Approval or Marketing Authorization for, and following Regulatory Approval or Marketing Authorization, to Commercialize GRAPE in the Territory and FUGAN in countries and regions other than China, provided that the foregoing shall not be construed as requiring ZAI to conduct any Development program with respect to GRAPE. .
Diligence. Following the successful completion by of the Initial Development Activities in accordance with the Initial Development Plan and Budget and [[Organization A:Organization]] proceeding with the In-Licensing, [[Organization A:Organization]] shall use Commercially Reasonable Efforts to obtain all Regulatory Approvals for the initial Licensed Product containing or comprising the Lead Compound for the Initial Indications in accordance with the applicable Development Plan.
Diligence. Allena, with or through its Affiliates and Sublicensees, as applicable, shall use Commercially Reasonable Efforts to Develop and, after receipt of Regulatory Approval, Commercialize a Licensed Product for the treatment of hyperoxaluria.
Diligence. Allergan shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the United States and Countries.
“Licensee Diligence Obligations” means Licensee’s Development and Regulatory Approval diligence obligations under [Section 3.2.1] and Licensee’s Commercialization diligence obligations under [Section 3.2.2].
During the Early Clinical Development Term, SGI will reimburse Unum for of all Development Costs for all Development Candidates actually incurred for the Territory pursuant to the Early Clinical Development Plan, in accordance with [Section 11.5], subject to the following sentence. Notwithstanding the amounts allocated to Development activities in the Shared Territory in the applicable Early Clinical Development Plan budget, for any calendar year, Unum will only be permitted to recover Development Costs with respect to Development activities that have been INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
Development Plan. An initial development plan is attached hereto as [Exhibit A] (such plan, as may be amended by time to time pursuant to this Agreement, the Development Plan). The Development Plan is a high-level summary of the Development activities Allergan anticipates being necessary to obtain Regulatory Approval for Licensed Products for the First Indication in the U.S. and Countries for which Allergan is using Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the First Indication. For as long as Development activities under this Agreement are ongoing, on or before each anniversary of the Effective Date, Allergan shall prepare an amendment, as appropriate, to the then-current Development Plan to reflect material changes or additions to the Development of Licensed Products for the First Indication in the U.S. and Countries. Allergan shall submit all amendments to the Development Plan to UroGen and, upon such submission, the amended Development Plan will become effective and supersede the previous Development Plan.
Development Records. Allergan shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Development activities hereunder, which books and records shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such books and records shall be retained by Allergan for at least years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.
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