Common use of Ongoing Trials Clause in Contracts

Ongoing Trials. In the event of: (x) a termination of this Agreement in its entirety, with respect to ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates; or (y) in the event of a termination of this Agreement in part by Pfizer pursuant to Section 9.3, with respect to those ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates that relate only to a country or countries that are located in the *** so terminated; the Parties will, with respect to such trials: (i) Within *** days of the date of the notice of termination, Pfizer will provide OPKO with a list of ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates. The trial listing shall include material details of the trials such as protocol summary, dates, sites, budget expended and estimated budget remaining, number of patients, current enrollment and safety issues. Pfizer shall promptly answer any questions of OPKO as to the status or details of any such trial. Prior to the date of termination, OPKO will notify Pfizer as to any trial for which OPKO wishes to assume responsibility and, Pfizer shall, at OPKO’s cost and expense for activities after termination, complete such Trial. Notwithstanding the foregoing, Pfizer may prematurely suspend or terminate any such Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy or (B) unacceptable safety signals are observed by Pfizer or a data and safety monitoring board with respect to the Licensed Product that present an unacceptable risk to patients participating in such trials. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. (ii) With respect to any ongoing Trials involving a Licensed Product for which OPKO has notified Pfizer prior to the effective date of termination that it wishes to assume responsibility, (A) each Party shall cooperate with the other Party to facilitate the orderly transfer to OPKO of the conduct of such Trials as soon as reasonably practicable after the effective date of termination, (B) until such time as the conduct of such Trials has been successfully transferred to OPKO, Pfizer shall continue such Trials, (C) between the effective date of termination and the date on which the conduct of such Trials has been successfully transferred to OPKO, OPKO shall be responsible for, and shall reimburse Pfizer with respect to, all costs and expenses reasonably incurred by Pfizer in the conduct of such Trials, and (D) following the date on which the conduct of such Trials has been successfully transferred to OPKO, OPKO shall be solely responsible for all costs and expenses of such ongoing Trials.

Ongoing Trials. In It is understood that the event of: (x) a termination of this Agreement in its entiretyOngoing Clinical Trials are currently underway, and that Aventis has entered into the Clinical Trial Agreements with respect to ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates; or (y) in the event of a termination of this Agreement in part by Pfizer pursuant to Section 9.3, with respect to those ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates that relate only to a country or countries that are located in the *** so terminated; the Third Parties will, with respect to such trials: (i) Within *** days of the date of the notice of termination, Pfizer will provide OPKO with a list of ongoing clinical trials and investigator-initiated trials involving a Licensed Product or related Device supported, directly or indirectly, by Pfizer or its Affiliates. The trial listing shall include material details of the trials such as protocol summary, dates, sites, budget expended and estimated budget remaining, number of patients, current enrollment and safety issues. Pfizer shall promptly answer any questions of OPKO as to the status or details of any such trial. Prior to the date of termination, OPKO will notify Pfizer as to any trial for which OPKO wishes to assume responsibility and, Pfizer shall, at OPKO’s cost and expense for activities after termination, complete such Trial. Notwithstanding the foregoing, Pfizer may prematurely suspend or terminate any such Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy or (B) unacceptable safety signals are observed by Pfizer or a data and safety monitoring board with respect to the Licensed Product performance of the Ongoing Clinical Trials. The performance of the Clinical Trial Agreements shall be continued through the Transition Period, or discontinued, at the direction of Introgen Therapeutics, as follows: (a) Introgen Therapeutics will have the right to control all aspects of the Ongoing Clinical Trials. To that present end, the Aventis Parties will exercise such rights as they have, and will cause any of their Affiliates, as appropriate, to do so under the Clinical Trial Agreements, as directed by Introgen Therapeutics, including by requesting the other Party or Parties to the Clinical Trial Agreements to take such actions, or to not take such actions, as are permitted or required under the Clinical Trial Agreements and under applicable laws, regulations and regulatory requirements, all as Introgen Therapeutics may so direct. However, neither Aventis Party shall have any duty to take such actions or fail to take such action unless an unacceptable risk indemnity reasonably satisfactory to patients participating in such trials. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the CommissionAventis Parties is provided by Introgen Therapeutics. (iib) With Introgen Therapeutics shall promptly reimburse the Aventis Parties for any amounts actually paid or accrued to any other Party or Parties to a Clinical Trial Agreement with respect to any ongoing Trials involving a Licensed Product for which OPKO has notified Pfizer prior to the effective date of termination that it wishes to assume responsibility, (A) each Party shall cooperate with the other Party to facilitate the orderly transfer to OPKO of the conduct of the Ongoing Clinical Trials, to the extent such Trials as soon as reasonably practicable payments are for the costs of performing activities under the Clinical Trial Agreements during the Transition Period and such Party is not an Affiliate or such Parties are not Affiliates of the Aventis Parties; provided that Introgen Therapeutics has approved such costs, which it may do or not do in its sole discretion, in writing (including costs that Introgen Therapeutics approved in writing or that were approved by the Joint Project Team before or after the effective date Effective Date of termination, (B) until such time as this Agreement). Any requested reimbursement not made by Introgen Therapeutics within 30 days of notification by the conduct Aventis Parties of such Trials has been successfully requested reimbursement shall be deemed late for purposes of Section 8.3. (c) Upon request by Introgen Therapeutics from time to time during the Transition Period, the Aventis Parties will cause to be transferred to OPKOIntrogen Therapeutics any or all of the Clinical Trial Agreements. To effect any such transfer, Pfizer shall continue such TrialsIntrogen Therapeutics will execute and deliver to the Aventis Parties, (C) between the effective date of termination and the date on which Aventis Parties will cause to be executed and delivered to Introgen Therapeutics, an Assignment and Assumption Agreement substantially in the conduct form of Exhibit 2.2.1(c). If any Clinical Trial Agreement is not transferable to Introgen Therapeutics or a Party promptly designated by Introgen Therapeutics, the Aventis Parties will, if possible, terminate such Trials has been successfully transferred Clinical Trial Agreements by or before the end of the Transition Period. Introgen Therapeutics shall remain free to OPKOenter into its own agreements in place of those terminated. In addition, OPKO after the Effective Date, the Aventis Parties will terminate any or all such Clinical Trial Agreements as Introgen Therapeutics may so request. Any reasonable costs incurred by Aventis in compliance with this Section 2.2.1(c) shall be responsible forreimbursed by Introgen Therapeutics with the exception of costs associated with the termination of Study [*], which costs shall be borne by Aventis. (d) The Aventis Parties agree to cooperate, and shall reimburse Pfizer to take such actions as Introgen Therapeutics may reasonably request, to enable Introgen Therapeutics to exercise full control of the Ongoing Clinical Trials and to obtain the benefits that were due to Aventis with respect toto the Clinical Trial Agreements and the Ongoing Clinical Trials. However, all costs and expenses the Aventis Parties shall have no duty to take such actions unless an indemnity reasonably incurred satisfactory to the Aventis Parties is provided by Pfizer in the conduct of such Trials, and (D) following the date on which the conduct of such Trials has been successfully transferred to OPKO, OPKO shall be solely responsible for all costs and expenses of such ongoing TrialsIntrogen Therapeutics.