Ongoing Trials. If there are any ongoing clinical trials with respect to Excluded 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. 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. 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. It is understood that the Ongoing Clinical Trials are currently underway, and that Aventis has entered into the Clinical Trial Agreements with Third Parties with respect to the 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 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 indemnity reasonably satisfactory to the Aventis Parties is provided by Introgen Therapeutics.
(b) 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 the conduct of the Ongoing Clinical Trials, to the extent such 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 of this Agreement). Any requested reimbursement not made by Introgen Therapeutics within 30 days of notification by the Aventis Parties of such 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 Introgen Therapeutics any or all of the Clinical Trial Agreements. To effect any such transfer, Introgen Therapeutics will execute and deliver to the Aventis Parties, and the Aventis Par...
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. If there are any ongoing clinical trials with respect to Product being conducted by or on behalf of Impax (or its Affiliate or, subject to Section 10.6.5, its Sublicensee) at the time of notice of termination, Impax agrees to (i) promptly transition to Durect 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 (subject to any medically appropriate wind-down); in each case as reasonably requested by Durect. [* * *]. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
