Common use of Clinical Development Activities Clause in Contracts

Clinical Development Activities. (i) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has not notified CELGENE prior to the effective date of termination that it wishes to assume responsibility, CELGENE shall, at CELGENE’s cost and expense, complete such Clinical Trials, subject to Section 2.7.1, only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such Clinical Trials; and (ii) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has notified CELGENE 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 EPIZYME of the conduct of such Clinical Trials as soon as reasonably practicable after the effective date of termination, (B) until such time as the conduct of such Clinical Trials has been successfully transferred to EPIZYME, CELGENE shall continue to conduct such Clinical Trials, subject to Section 2.7.1, (C) between the effective date of termination and the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be responsible for, and shall reimburse CELGENE with respect to, all costs and expenses reasonably incurred by CELGENE in the conduct of such Clinical Trials during the foregoing transition period, and (D) following the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be solely responsible for all costs and expenses of such ongoing Clinical Trials.

Clinical Development Activities. (i) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) clinical trials of Terminated Products for which EPIZYME has not notified CELGENE GSK prior to the effective date of termination that it wishes to assume responsibility, CELGENE GSK shall, at CELGENEGSK’s cost and expense, complete such Clinical Trials, subject to Section 2.7.1, clinical trials only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such Clinical Trialsclinical trials. Notwithstanding the foregoing, GSK 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 GSK or the Data and Safety Monitoring Board with respect to any Terminated Product that present an unacceptable risk to patients participating in such trials; and (ii) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) clinical trials of Terminated Products for which EPIZYME has notified CELGENE GSK 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 EPIZYME of the conduct of such Clinical Trials clinical trials as soon as reasonably practicable after the effective date of termination, (B) until such time as the conduct of such Clinical Trials clinical trials has been successfully transferred to EPIZYME, CELGENE GSK shall continue to conduct such Clinical Trials, subject to Section 2.7.1clinical trials, (C) between the effective date of termination and the date on which the conduct of such Clinical Trials clinical trials has been successfully transferred to EPIZYME, EPIZYME shall be responsible for, and shall reimburse CELGENE GSK with respect to, all costs and expenses reasonably incurred by CELGENE GSK in the conduct of such Clinical Trials clinical trials during the foregoing transition period, and (D) following the date on which the conduct of such Clinical Trials clinical trials has been successfully transferred to EPIZYME, EPIZYME shall be solely responsible for all costs and expenses of such ongoing Clinical Trialsclinical trials.

Clinical Development Activities. (a) Lilly will use Commercially Reasonable Efforts to complete the Ongoing Lilly Trials, and any follow-on analysis and reporting and filing results with the FDA with respect thereto. (b) Subject to Sections 5.2(a), 5.2(c), 5.2(d), 5.2(e) and 5.2(f), United Therapeutics’ Development Activities shall include conducting (or having conducted) all clinical trials (including Phase IV studies) for the Product in the Field in the Territory other than the Ongoing Lilly Trials. Each Party agrees and acknowledges that the other Party shall not be in breach of this Agreement solely as a result of the failure of the Product in any clinical trial. (c) If the Parties agree in advance in writing that Lilly shall conduct any clinical development activities on behalf of United Therapeutics in United Therapeutics’ Domain, other than with respect either to the Ongoing Lilly Trials or as otherwise set forth in Section 5.2(e), then the Parties, acting reasonably, shall agree upon a protocol for each such activity. (d) In the event that the FDA requires any additional clinical study to be performed for the Product prior to obtaining Regulatory Approval of the Product in PAH in the Territory, United Therapeutics shall be responsible for conducting such study; provided that, prior to initiation of any such study, United Therapeutics shall notify Lilly, and submit to Lilly the protocol for such study, including any and all quality plans with respect thereto, including a plan for monitoring and auditing such study, and shall implement any and all of Lilly’s comments and suggestions regarding such study protocol and quality plans, which comments and suggestions shall be made to United Therapeutics as soon as reasonably possible, and in any event within sixty (60) days after Lilly’s receipt of the protocol and quality plans. For clarity, United Therapeutics shall not conduct any such study prior to obtaining Lilly’s approval, not to be unreasonably withheld, with respect to such study and such study protocol and quality plans. If the FDA requires any additional non-clinical study to be performed for the Product prior to obtaining Regulatory Approval of the Product in PAH in the Territory, the Parties will confer to determine what actions should be taken. (e) In the event that the FDA conditions initial Regulatory Approval for Product in PAH in the Territory upon a commitment to conduct following Regulatory Approval any additional non-clinical study or any additional clinical study for the Product, Lilly and United Therapeutics will use Commercially Reasonable Efforts to conduct such study. Lilly, acting reasonably, shall establish the protocol for such study, including any and all quality plans with respect thereto, including a plan for monitoring and auditing such study. (f) The Parties acknowledge that United Therapeutics intends to conduct certain Phase IV studies for the Product, as further described on Exhibit 5.2(f); provided, however, that all such studies shall be limited to PAH, and in the event that United Therapeutics pursues any Secondary Indication with the approval of Lilly as described in Section 5.2(i), such Secondary Indication. United Therapeutics, prior to initiating any such Phase IV study, will provide the protocol for such Phase IV study to Lilly, together with other information related to such Phase IV study requested by Lilly, for review and approval, such approval not to be unreasonably withheld. (g) United Therapeutics will not support, either directly or indirectly, any investigator initiated trial (“IIT”) with the Product unless, prior to the initiation of such an IIT, United Therapeutics provides the protocol for such IIT to Lilly, together with other information related to such IIT requested by Lilly, for review and approval, such approval not to be unreasonably withheld. The Parties will establish, as soon as practicable after the Effective Date, a standard procedure for the review and, where appropriate, approval by Lilly of the protocol, and other related information, for an IIT. (h) In the event that United Therapeutics desires to conduct any label enhancement study for the Product for PAH (other than a study required by FDA as described in Section 5.2(e) or for a Secondary Indication as described in Section 5.2(i)) after obtaining Regulatory Approval for the Product in PAH in the Territory, United Therapeutics shall provide the protocol for such study to Lilly, together with other information related to such study requested by Lilly, for review and approval, such approval not to be unreasonably withheld. (i) With The Parties acknowledge and agree that, under the terms of this Agreement, Lilly has granted rights to United Therapeutics in the Field, which includes Secondary Indications, but that United Therapeutics will not conduct any Development or Commercialization activities with respect to any ongoing Clinical Trials Secondary Indication without the prior consent of Lilly which may be given in Lilly’s sole discretion. In the event that United Therapeutics desires to conduct any Development activities, including any clinical study, with respect to the Terminated Country(ies) Product in a Secondary Indication in the Territory, United Therapeutics will notify Lilly and submit to Lilly the plan for such Development, and shall not conduct any such Development without the prior written consent of Terminated Products Lilly, which may be withheld in Lilly’s sole discretion. If Lilly consents to the conduct of such Development, United Therapeutics shall submit to Lilly the protocol for which EPIZYME has any study that United Therapeutics intends to conduct in connection with such Development, including for example any and all quality plans with respect thereto and a plan for monitoring and auditing such study. United Therapeutics shall not notified CELGENE conduct any such study prior to obtaining Lilly’s approval, which may be withheld in Lilly’s sole discretion. In the effective date event that Lilly approves such a plan for Development for a Secondary Indication, and studies conducted under such plan for Development achieve pre-specified primary endpoints, Lilly will not thereafter object to the pursuit of termination Regulatory Approval for such Secondary Indication, except based on valid safety, quality, or material regulatory concerns. (j) United Therapeutics shall from time to time provide a list of Third Party contractors used in the conduct of Development activities under this Agreement, and Lilly may object to the use of same by providing notice of such objection to United Therapeutics. United Therapeutics will not use such contractors without the prior written consent of Lilly. United Therapeutics shall disclose any data to any Third Party only as necessary for such Third Party to conduct the Development activities assigned to such Third Party and under obligations of confidentiality and non-use applicable to the Confidential Information of each Party that it wishes are at least as stringent as those set forth in ARTICLE 11; provided that the term of such obligations may be reduced so as to assume responsibilitybe commercially reasonable based on the circumstances. United Therapeutics shall provide a full audit report and any requested supporting documentation with respect to any and all audits performed by United Therapeutics of any Third Party contractors and/or clinical trial sites used by United Therapeutics to conduct Development activities under this Agreement. Lilly shall have the right to audit together with United Therapeutics, CELGENE shallany and all source data produced by United Therapeutics and/or any Third Party contractors, at CELGENE’s cost particularly those Third Party contractors whose activities would be material to the conduct of a study with specific reference to the quality of data to be obtained from such study, and/or clinical trial sites used by United Therapeutics to conduct Development activities. United Therapeutics shall notify the JSC of any serious and/or persistent site non-compliance issues, with respect to clinical trials conducted by United Therapeutics under this Agreement, along with a plan for correcting such issues. United Therapeutics shall provide confirmation to the JSC upon completion of any such corrective measures. (k) Each Party will have the responsibility for publication plans surrounding all studies, including authorship, abstract, poster, slide, and expensemanuscript content and submission plans, complete conducted by such Clinical TrialsParty, subject to Section 2.7.1, only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such Clinical Trials; and (ii) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has notified CELGENE 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 EPIZYME of the conduct of such Clinical Trials as soon as reasonably practicable after the effective date of termination, (B) until such time as the conduct of such Clinical Trials has been successfully transferred to EPIZYME, CELGENE shall continue to conduct such Clinical Trials, subject to Section 2.7.1, (C) between the effective date of termination and the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be responsible for, and shall reimburse CELGENE with respect to, all costs and expenses reasonably incurred by CELGENE in the conduct of such Clinical Trials during the foregoing transition period, and (D) following the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be solely responsible for all costs and expenses of such ongoing Clinical Trials11.6.

Clinical Development Activities. (i) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has not notified CELGENE prior to the effective date of termination that it wishes to assume responsibility, CELGENE shall, at CELGENE’s cost and expense, complete such Clinical Trials, subject to Section 2.7.12.12.1, only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such Clinical Trials; and (ii) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has notified CELGENE 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 EPIZYME of the conduct of such Clinical Trials as soon as reasonably practicable after the effective date of termination, (B) until such time as the conduct of such Clinical Trials has been successfully transferred to EPIZYME, CELGENE shall continue to conduct such Clinical Trials, subject to Section 2.7.12.12.1, (C) between the effective date of termination and the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be responsible for, and shall reimburse CELGENE with respect to, all costs and expenses reasonably incurred by CELGENE in the conduct of such Clinical Trials during the foregoing transition period, and (D) following the date on which the conduct of such Clinical Trials has been successfully transferred to EPIZYME, EPIZYME shall be solely responsible for all costs and expenses of such ongoing Clinical Trials.