Common use of Wind-Down of Regulatory Activities Clause in Contracts

Wind-Down of Regulatory Activities. In the case of any termination of this Celgene Lead Co-Co Agreement, if any Clinical Trials (including any Celgene Co-Co Additional Studies) are then being conducted at the time of such termination with respect to any Co-Co Product, the Parties hereby agree (i) to reasonably cooperate in the completion of any such Clinical Trials (including any Celgene Co-Co Additional Studies), and (ii) notwithstanding anything to the contrary contained herein, to grant to the Party that retains global Commercialization rights to such Co-Co Product following such termination (A) free of charge, copies of and rights of reference to and use of all Co-Co Product Data that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Co-Co Additional Studies) that are relevant to or necessary to address issues relating to: (1) the safety of such Co-Co Product in the Territory, including data that is related to adverse effects experienced with such Co-Co Product and/or (2) all activities relating to CMC regarding such Co-Co Product and in each of (1) and (2), that are required to be reported or made available to Regulatory Authorities in the Territory, when and as such data become available, and (B) copies of and rights of reference to and use of all Co-Co Product Data (other than the Co-Co Product Data referred to in subclause (A) above) that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Co-Co Additional Studies) that are relevant to or necessary to address the Development and Commercialization of such Co-Co Product promptly following the generation of such Co-Co Product Data if, but only if, as to such Co-Co Product Data described in this subclause (B), such Party that retains global Commercialization rights to such Co-Co Product following such termination promptly pays for all Development Costs incurred following any such termination of this Celgene Lead Co-Co Agreement with respect to such Clinical Trials (including any Celgene Co-Co Additional Studies).

Wind-Down of Regulatory Activities. In the case of any termination of this Celgene Lead Co-Co PD-1 License Agreement, if any Clinical Trials (including any Celgene Co-Co Additional Studies) are then being conducted at the time of such termination with respect to any Co-Co Licensed Product, the Parties hereby agree (i) to reasonably cooperate in the completion of any such Clinical Trials (including any Celgene Co-Co Additional Studies), and (ii) notwithstanding anything to the contrary contained herein, to grant to the Party that retains global Commercialization rights to such Co-Co Licensed Product following such termination (A) free of charge, copies of and rights of reference to and use of all Co-Co Licensed Product Data that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Co-Co Additional Studies) that are relevant to or necessary to address issues relating to: (1) the safety of such Co-Co Licensed Product in the Territory, including data that is related to adverse effects experienced with such Co-Co Licensed Product and/or (2) all activities relating to CMC regarding such Co-Co Licensed Product and in each of (1) and (2), that are required to be reported or made available to Regulatory Authorities in the Territory, when and as such data become available, and (B) copies of and rights of reference to and use of all Co-Co Licensed Product Data (other than the Co-Co Licensed Product Data referred to in subclause (A) above) that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Co-Co Additional Studies) that are relevant to or necessary to address the Development and Commercialization of such Co-Co Licensed Product promptly following the generation of such Co-Co Licensed Product Data if, but only if, as to such Co-Co Licensed Product Data described in this subclause (B), such Party that retains global Commercialization rights to such Co-Co Licensed Product following such termination promptly pays for all Development Costs incurred following any such termination of this Celgene Lead Co-Co PD-1 License Agreement with respect to such Clinical Trials (including any Celgene Co-Co Additional Studies).

Wind-Down of Regulatory Activities. In the case of any termination of this Celgene Jounce Lead Co-Co Agreement, if any Clinical Trials (including any Celgene Jounce Co-Co Additional Studies) are then being conducted at the time of such termination with respect to any Co-Co Product, the Parties hereby agree (i) to reasonably cooperate in the completion of any such Clinical Trials (including any Celgene Jounce Co-Co Additional Studies), and (ii) notwithstanding anything to the contrary contained herein, to grant to the Party that retains global Commercialization rights to such Co-Co Product following such termination (A) free of charge, copies of and rights of reference to and use of all Co-Co Product Data that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Jounce Co-Co Additional Studies) that are relevant to or necessary to address issues relating to: (1) the safety of such Co-Co Product in the Territory, including data that is related to adverse effects experienced with such Co-Co Product and/or (2) all activities relating to CMC regarding such Co-Co Product and in each of (1) and (2), that are required to be reported or made available to Regulatory Authorities in the Territory, when and as such data become available, and (B) copies of and rights of reference to and use of all Co-Co Product Data (other than the Co-Co Product Data referred to in subclause (A) above) that is Controlled by such Party and generated pursuant to such Clinical Trials (including any Celgene Jounce Co-Co Additional Studies) that are relevant to or CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. necessary to address the Development and Commercialization of such Co-Co Product promptly following the generation of such Co-Co Product Data if, but only if, as to such Co-Co Product Data described in this subclause (B), such Party that retains global Commercialization rights to such Co-Co Product following such termination promptly pays for all Development Costs incurred following any such termination of this Celgene Jounce Lead Co-Co Agreement with respect to such Clinical Trials (including any Celgene Jounce Co-Co Additional Studies).