Discontinuation of Clinical Studies. Neither Party may discontinue any Clinical Study for a Product Candidate conducted pursuant to a Joint Plan without the consent of the other Party; provided that the Party holding the IND for such Product Candidate shall have the right to discontinue any Clinical Study in the event such Party reasonably determines in good faith that such Clinical Study presents a Safety Risk. In the event that the Party that does not hold the IND for a Product Candidate reasonably determines in good faith that a Clinical Study for such Product Candidate conducted pursuant to a Joint Plan presents a Safety Risk and therefore should be discontinued, such Party shall notify the Party that holds such IND. If the Party that holds such IND does not discontinue such Clinical Study within [***] days after receipt of such notice, the Party that does not hold such IND shall have the right to withdraw from participation in Development activities with respect to such Product Candidate immediately upon written notice to the IND holder, in which event the withdrawing Party shall have no further obligation to perform or fund Development activities for such Product Candidate, and the IND holder shall have the right to continue, unilaterally, Development activities for such Product Candidate under a Unilateral Plan in accordance with Section 5.6; provided that the withdrawing Party shall retain and may exercise in accordance with the terms hereof its Pre-Phase IIb Opt-In, Pre-Phase III Opt-In and EOP3 Opt-In, as applicable, with respect to such Product Candidate.
Appears in 3 contracts
Samples: Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc)
Discontinuation of Clinical Studies. Neither Party may discontinue any Clinical Study for a Product Development Candidate (including any Indication Survey Study) conducted pursuant to a the Joint Exploratory Development Plan without the consent of the other Party; provided that the Party holding the IND for such Product Development Candidate shall have the right to discontinue any Clinical Study for such Development Candidate in the event such Party reasonably determines in good faith that such Clinical Study presents a Safety Risk. In the event that the Party that does not hold the IND for a Product Development Candidate reasonably determines in good faith that a Clinical Study for such Product Development Candidate conducted pursuant to a the Joint Exploratory Development Plan presents a Safety Risk and therefore should be discontinued, such Party shall notify the Party that holds such IND. If the Party that holds such IND does not discontinue such Clinical Study within [***] days after receipt of such notice, the Party that does not hold such IND shall have the right to withdraw from participation in Joint Exploratory Development activities with respect to such Product Development Candidate immediately upon written notice to the IND holder, in which event the withdrawing Party shall have no further obligation to perform or fund Exploratory Development activities Activities for such Product Development Candidate, and the IND holder shall have the right to continue, unilaterally, Exploratory Development activities Activities for such Product Development Candidate under a Unilateral Exploratory Development Plan in accordance with Section 5.64.4; provided that that, in the event such Development Candidate is designated as a Product Candidate, the withdrawing Party shall retain nonetheless have the right to participate in the joint funding and may exercise in accordance with the terms hereof its Pre-Phase IIb Opt-In, Pre-Phase III Opt-In and EOP3 Opt-In, as applicable, with respect to Development of such Product CandidateCandidate as provided in Article 5.
Appears in 2 contracts
Samples: Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc)
Discontinuation of Clinical Studies. Neither Party may discontinue any Clinical Study for a Product Development Candidate (including any Indication Survey Study) conducted pursuant to a the Joint Exploratory Development Plan without the consent of the other Party; provided that the Party holding the IND for such Product Development Candidate shall have the right to discontinue any Clinical Study for such Development Candidate in the event such Party reasonably determines in good faith that such Clinical Study presents a Safety Risk. In the event that the Party that does not hold the IND for a Product Development Candidate reasonably determines in good faith that a Clinical Study for such Product Development Candidate conducted pursuant to a the Joint Exploratory Development Plan presents a Safety Risk and therefore should be discontinued, such Party shall notify the Party that holds such IND. If the Party that holds such IND does not Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. discontinue such Clinical Study within [***] days after receipt of such notice, the Party that does not hold such IND shall have the right to withdraw from participation in Joint Exploratory Development activities with respect to such Product Development Candidate immediately upon written notice to the IND holder, in which event the withdrawing Party shall have no further obligation to perform or fund Exploratory Development activities Activities for such Product Development Candidate, and the IND holder shall have the right to continue, unilaterally, Exploratory Development activities Activities for such Product Development Candidate under a Unilateral Exploratory Development Plan in accordance with Section 5.64.4; provided that that, in the event such Development Candidate is designated as a Product Candidate, the withdrawing Party shall retain nonetheless have the right to participate in the joint funding and may exercise in accordance with the terms hereof its Pre-Phase IIb Opt-In, Pre-Phase III Opt-In and EOP3 Opt-In, as applicable, with respect to Development of such Product CandidateCandidate as provided in Article 5.
Appears in 1 contract
Samples: Collaboration Agreement (Reata Pharmaceuticals Inc)