Ongoing Trials. If there are any ongoing clinical trials with respect to Products being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after the effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent). In such event, Cephalon shall be responsible for the costs of such transition.
Ongoing Trials. If any Licensed Product clinical trial(s) are ongoing at the time of termination, which clinical trials are solely sponsored by MorphoSys, then Xencor shall notify MorphoSys in writing within […***…] after the effection date of the termination which of the following Xencor elects and MorphoSys shall comply with and carry out Xencor’s election:
(1) MorphoSys shall continue such ongoing trial and/or transfer sponsorship of such ongoing Licensed Product clinical trial(s) to Xencor on a reasonable timeline. Xencor shall be responsible for (i) the costs of the continued conduct of the trial by MorphoSys and/or transfer (as applicable), which shall include that Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened cost, determined in accordance with GAAP , and (ii) for the costs of the trial as sponsored by Xencor (as applicable). -OR-
(2) MorphoSys shall wind down the trial and shall be fully and solely responsible for all costs associated such wind-down, and shall continue to comply with all remaining obligations and commitments made to Regulatory Authorities by MorphoSys (including if applicable, patient registries), to the extent the compliance with such obligations and commitments is required by law, at MorphoSys’s sole cost. Such costs shall be subject to reimbursement by Xencor to MorphoSys in accordance with Section 10.6 (e).
Ongoing Trials. If there are any ongoing clinical trials with respect to Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) applicable only to the Excluded Region at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after the effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent). In such event, Cephalon shall be responsible for the costs of such transition.
Ongoing Trials. Once TOBIRA commences any non-clinical or clinical trial of the Compound and/or the Product hereunder, then TOBIRA shall conduct such trial to its completion, unless TOBIRA’s decision to cease any such trial prior to its completion is due to one of the following causes: (i) if, in TOBIRA’s reasonable judgment, there are scientific or other technical problems, including any problems which relate to the safety, efficacy or toxicology of the Compound or Product; (ii) there are any significant, unexpected change in the regulatory requirements in a country concerning the development of the Compound or Product which comes into existence after the Effective Date, for example a new requirement for studies in specific patient sub-groups; or (iii) if, in TOBIRA’s reasonable judgment, there are significant, unexpected changes in the market that provide business justification for such cessation which comes into existence after the Effective Date, for example competitive products enter the market , provided, however, that in the case of subsections (ii) and (iii), TOBIRA shall complete the studies for the patient(s) already commenced (i.e., TOBIRA may decide not to conduct the newly required and/or additional studies, but TOBIRA shall conduct the portion of trials originally planned before such change of regulatory requirements or market change). In case of such cessation for any reason, TOBIRA shall be responsible for any and all winding-ups, including without limitation answering to the requests and/or questions from patients, including continuing to provide patients with the Product, if appropriate or required.
Ongoing Trials. Provided that the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if there are any ongoing clinical trials with respect to Collaboration Products being conducted by or under authority of Galderma at the time of notice of termination, Galderma agrees, at NovaBay’s request, to (i) promptly transition to NovaBay or its designee some or all of such clinical trials and the activities related to or supporting such trials at Galderma’s expense, (ii) continue to conduct such clinical trials for a period requested by NovaBay up to a maximum of six (6) months after the effective date of such termination, for which NovaBay would reimburse Galderma for its out-of-pocket expenses incurred with respect thereto, or (iii) terminate such clinical trials; in each case as requested by NovaBay, but without limiting Section 12.6.9, in no event shall Galderma be required to continue clinical trials if it reasonably believes such continuation might adversely affect the health of patients participating in the clinical trials.
Ongoing Trials. Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, if there are any ongoing clinical trials with respect to Licensed Products being conducted by or on behalf of Alcon (or its Affiliate or Marketing Partner) at the time of notice of termination, Alcon agrees, at NovaCal’s request, to (i) promptly transition to NovaCal or its designee some or all of such clinical trials and the activities related to or supporting such trials at Alcon’s expense, (ii) continue to conduct such clinical trials for a period requested by NovaCal up to a maximum of six (6) months after the effective date of such termination, for which NovaCal would reimburse Alcon for its out-of-pocket expenses incurred with respect thereto, or (iii) terminate such clinical trials; in each case as requested by NovaCal, but in no event shall Alcon be required to continue clinical trials if it reasonably believes such continuation might adversely affect the health of patients participating in the clinical study.
Ongoing Trials. If there are any ongoing clinical trials with respect to Licensed Products in such Sub-Field being conducted by or on behalf of Alcon (or its Affiliate or Marketing Partner) at the time of notice of termination, Alcon agrees, at NovaCal’s request, to (i) promptly transition to NovaCal or its designee some or all of such clinical trials and the activities related to or supporting such trials at Alcon’s expense, (ii) continue to conduct such clinical trials for a period requested by NovaCal up to a maximum of six (6) months after the effective date of such termination, for which NovaCal would reimburse Alcon for its out-of-pocket expenses incurred with respect thereto, or (iii) terminate such clinical trials; in each case as requested by NovaCal, but in no event shall Alcon be required to continue clinical trials if it reasonably believes such continuation might adversely affect the health of the patients participating in the study.
Ongoing Trials. Other than where this Agreement is terminated by [***], if there are any ongoing clinical trials with respect to the Product being conducted [***]. If this Agreement is terminated by [***] shall be responsible for the costs of such transition; in all other events, [***] shall be responsible for the costs of such transition and any ongoing activities.
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 tr...
Ongoing Trials. If there are any ongoing clinical trials with respect to such Terminated Compound(s) (or corresponding Product(s)) being conducted by or on behalf of Penwest (or its Affiliate or Sublicensee) at the time of the Termination Notice, Penwest agrees to (i) promptly transition to Edison or its designee some or all of such clinical trials and the activities related to or supporting such trials, or (ii) terminate such clinical trials; in each case as requested by Edison. In such event, Edison shall be responsible for the costs of such transition.