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Development Plan
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Business Development. Biose remains free to conduct any business development activities, during the term of this Agreement for the manufacture and supply of non-genetically modified single Strain Product intended for oral delivery, as long as performance of such manufacturing and/or supply activities begins after the termination of this Agreement.

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

During the Early Clinical Development Term Unum will keep the JDC fully informed regarding the progress and results of Development activities for Development Candidates in the Territory, including an annual review of results versus goals (as such goals are set forth in the Early Clinical Development Plan(s)).

Development Records. Each Party will maintain complete and accurate records (in the form of electronic files where appropriate) of all work conducted by it under the Early Clinical Development Plan or Late Clinical Development Plan for each Development Candidate. Such records ​ INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED

Development Candidates. Subject to the terms and conditions of this Agreement, on a Development Candidate-by-Development Candidate basis, effective as of the date on which the Collaboration Antigen of such Development Candidate becomes a “Collaboration Antigen” under this Agreement, Unum hereby grants to SGI a co-exclusive (with Unum), sublicensable (solely as permitted in accordance with Section 10.4), worldwide license, under the Unum Background Technology and Unum Program IP, to clinically Develop Development Candidates, all in accordance with the Late Clinical Development Plan provided that such license will automatically terminate, and be of no further force or effect, with respect to any Development Candidate and associated Product for which SGI has exercised its Opt-Out Right.

Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter “Development Reports”). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.

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.

Development Costs Relating to Initial Development Activities. […​…]

“Early Clinical Development Program” means, as to each Development Candidate, the program of Development activities for such Development Candidate in accordance with the associated Early Clinical Development Plan during the Early Clinical Development Term. For clarity, the Early Clinical Development Program will not include activities conducted under the Research Plan or Late Clinical Development Program or relating to Manufacturing.

Development Plan means a plan for the development of Hydrocarbons from an Exploitation Area.

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