reasonably necessary for [[Organization A:Organization]] to Conduct and complete such Development activities. In the event [[Organization A:Organization]] elects to take over Development activities under the RA Phase 3 Development Plan pursuant to [subsection (y)], [[Organization A:Organization]] shall assume all costs related to the RA Phase 3 Development Plan that [[Party:Organization]] has irrevocably committed to (as substantiated by written documentation) prior to the RA Election. For purposes of clarity, after [[Organization A:Organization]] proceeds with the In-Licensing in respect of SLE, but has not yet proceeded with Development for RA, [[Party:Organization]] shall have the right to continue Development pursuant to the RA Phase 3 Development Plan until all requirements of the RA Election have been fulfilled.
RA Development Prior to In-Licensing. In the event [[Organization A:Organization]] does not proceed with the In-Licensing in respect of RA after delivery of the RA Complete Data Package, then [[Party:Organization]], in its sole discretion, shall have the option, at its sole cost and expense, to further Develop the Licensed Compound for RA; provided, that [[Party:Organization]] provides to [[Organization A:Organization]] and the Parties mutually agree upon # a final budget incorporating all costs associated for such Development, # the final protocol and a detailed synopsis for each Clinical Study for RA, # the relevant success criteria for such Clinical Studies, and # the tentative timelines to complete such Clinical Studies (collectively, the RA Phase 3 Development Plan). In the event the Parties are unable to agree despite good faith discussions upon the RA Phase 3 Development Plan, neither Party shall have the right to resolve the dispute unilaterally or through ADR and the proposed RA Phase 3 Development Plan shall be deemed rejected. Following initiation of the RA Phase 3 Development Plan # as part of the JDC meetings, [[Party:Organization]] shall keep [[Organization A:Organization]] regularly updated regarding the status, progress, timelines and clinically validated results for each Clinical Study for RA, and # any amendment to the RA Phase 3 Development Plan shall be discussed in good faith between the Parties, with [[Party:Organization]] having the right to make the final determination with respect to such amendment, unless the amendment would affect or could reasonably be expected to affect [[Organization A:Organization]]s interests in the Initial Indications pursuant to this Agreement. If the Parties are unable to agree on whether an amendment to the RA Phase 3 Development Plan would affect or could reasonably be expected to affect [[Organization A:Organization]]s interests in the Initial Indications pursuant to this Agreement, then such amendment shall be referred to the JDC for further discussion. In the event the JDC is unable to agree upon a resolution for such amendment, then the dispute shall be resolved pursuant to Section 13.8. In the event [[Organization A:Organization]] # proceeds with the In-Licensing following the receipt of the SLE Complete Data Package, and # subject to [Section 6.2.1(iii)(c)], moves forward with the Development of the Licensed Compound for RA ([subsections (1) and (2)])], collectively, the RA Election), then, in addition to the milestone and royalty payment obligations set forth in Article 6 related to RA, [[Organization A:Organization]] shall be required to pay [[Party:Organization]] the RA Phase 3 Payment pursuant to Section 6.2.3. Upon [[Organization A:Organization]]s RA Election, [[Organization A:Organization]] shall have the option to either # permit [[Party:Organization]] to continue the Development activities pursuant to the RA Phase 3 Development Plan; provided, that the Parties shall negotiate in good faith the financial consideration to be provided to [[Party:Organization]] for such services in accordance with the budget set forth in the RA Phase 3 Development Plan, or # take over the Development activities under the RA Phase 3 Development Plan and [[Party:Organization]] shall effectuate and coordinate a smooth and efficient transition of relevant obligations and rights to [[Organization A:Organization]] as CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [......]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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