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. With respect to any clinical Development activities that are in progress at the time of notice of termination, (i) EPIZYME may elect, in its sole discretion, to complete such clinical Development activities, in which event EISAI shall transfer to EPIZYME all such clinical Development activities as part of the transition plan to be mutually agreed by the Parties under clause (c) above, at EPIZYME’s expense, or (ii) if EPIZYME does not elect to complete such clinical Development activities, EISAI shall promptly discontinue or wind-down, at EISAI’s cost, any such clinical Development activities, and forward all interim and final reports and underlying data from such activities to EPIZYME.
Clinical Development Activities. With respect to any clinical Development activities in the EISAI Territory that are in progress at the time of notice of termination, (i) EPIZYME may elect, in its sole discretion, to complete such clinical Development activities, in which event EISAI shall transfer to EPIZYME (or its designee) all such clinical Development activities as part of the transition plan to be mutually agreed by the Parties under clause (c) above, at EPIZYME’s expense, or (ii) if EPIZYME does not elect to complete such clinical Development activities, EISAI shall promptly discontinue or wind-down, at EISAI’s cost, any such clinical Development activities, and forward all interim and final reports and underlying data from such activities to EPIZYME (or its designee).
Clinical Development Activities. With respect to any clinical Development activities of Novartis directed to the Products with respect to the terminated countries that are in progress at the time of notice of termination, at XOMA’s election prior to the effective date of termination, Novartis shall to the extent not prohibited by applicable Law or any Regulatory -35- Certain confidential portions of this exhibit have been omitted and replaced with “[***]”. such identified information has been excluded from this exhibit because it is (i) not material and (ii) would likely cause competitive harm to the company if disclosed. Authority transfer to XOMA any such clinical Development activities, including responsibility for payment of all fees, costs and expenses associated with such clinical Development activities, and forward all interim and final reports and underlying data from such activities to XOMA to enable such clinical Development activities to be transferred to XOMA without interruption. Such transfer shall [*] in accordance with Section [*], unless [*] in accordance with Section [*], in which case [*].
Clinical Development Activities. Subject to Section 3.1, Novo shall use Commercially Reasonable Efforts to conduct all Development activities from IND Approval through Commercialization on at least [* * *] Development Candidates, provided that at least [* * *] Development Candidates are selected for Development Candidate nomination. If more than [* * *] Development Candidates are selected, then Novo shall, subject to the immediately preceding sentence, have the right to prioritize its Development efforts among such Development Candidates.
Clinical Development Activities. With respect to any clinical Development activities of Novartis directed to the terminated Product or Products with respect to the terminated countries that are in progress at the time of notice of termination, (a) Novartis shall [*]; or (b) at XOMA’s election prior to the effective date of termination, Novartis shall to the extent not prohibited by applicable Law or any Regulatory Authority[*] transfer to XOMA any such clinical Development activities and forward all interim and final reports and underlying data from such activities to XOMA to enable such clinical Development activities to be transferred to XOMA without interruption; [*]
Clinical Development Activities. (a) The Parties shall, at any time, cooperate in good faith and use all their Commercially Reasonable Efforts to pursue and complete their roles in the clinical Development activities of Licensed Products as assigned to each Party in the Clinical Development Plan with the goal of obtaining regulatory approvals in jurisdictions within the Licensed Territory (including, without limitation, EMA, Swissmedic, MHRA) as reasonably required to successfully exploit the License.
(b) Annex 3.1(b) sets forth in more detail the clinical development plan for the Existing Product as agreed upon execution of this Agreement, which includes the goals and timelines as well as the Parties' roles, responsibilities and financing of all clinical Development activities for the Existing Product and the intended cooperation with the regulatory authorities in the EU, Switzerland and United Kingdom (EMA, Swissmedic and MHRA) to get approvals for the Existing Product in due course (the Clinical Development Plan).
(c) Under the Clinical Development Plan and Technical Development Plan, it shall be the role and responsibility of LICENSOR, with the due support of LICENSEE for the conduct of clinical trials and regulatory matters at its cost, to use Commercially Reasonable Efforts to perform the clinical and non-clinical Development of the Existing Product until obtaining regulatory approvals for the Existing Product in the EU (EMA), Switzerland (Swissmedic) and United Kingdom (MHRA). LICENSEE shall be informed about the progress on such clinical and non-clinical Development activities performed by LICENSOR on a regular basis, and at least once per Calendar Quarter. The costs for such clinical and non-clinical Development activities for the Existing Product prior to regulatory approval (including trials required to achieve compliance to the agreed EU PIP for the Existing Product) shall be borne by LICENSOR, subject to anything stated to the contrary in the Clinical Development Plan. The costs for any post-approval Development activities, including any confirmatory clinical trial formally required as a post-approval commitment, and any additional Development activities as outlined in the Clinical Development Plan shall be borne in the following proportion by each Party: [***]% by LICENSOR and [***]% by LICENSEE. Any and all clinical studies with the Existing Product to be undertaken shall be jointly developed and discussed between the Parties in the JDC and ultimately approved by the JSC, a...
Clinical Development Activities. Hengrui shall be responsible for all Development Activities associated with clinical Development and Regulatory Approval of the Licensed Antibodies and Licensed Products in the Hengrui Territory. Subject to Section 4.1.6, Incyte shall be responsible for all Development Activities associated with clinical Development and Regulatory Approval of the Licensed Antibodies and Licensed Products in the Incyte Territory.
Clinical Development Activities. With respect to any clinical Development activities of Novo Nordisk directed to the Licensed Antibodies and Licensed Products that are in progress at the time of notice of termination, at XOMA’s request prior to the effective date of termination, Novo Nordisk shall to the extent not prohibited by applicable Law or any Regulatory Authority, [*] any then on-going clinical trials of Licensed Antibodies and Licensed Products, [*], and transfer to XOMA any other such clinical Development activities, including responsibility for payment of all fees, costs and expenses associated with such clinical Development activities, and forward all reports and underlying data from such activities to XOMA which are reasonably necessary to enable such clinical Development activities to be [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. transferred to XOMA without interruption. Novo Nordisk may [*] from the materials transferred pursuant to this subsection (iv), provided that, to the extent [*] is reasonably necessary for the orderly and efficient transfer, completion, wind-down or closeout of such clinical Development activities, Novo Nordisk shall work reasonably with XOMA and its designees to support such transfer, completion, wind-down or closeout in a manner that will [*].
Clinical Development Activities. (a) The Parties shall, at any time, cooperate in good faith and use all their Commercially Reasonable Efforts to pursue and complete their roles in the clinical Development activities of Licensed Products as assigned to the Parties in the Clinical Development Plan with the goal of obtaining regulatory approvals in each of the Major Markets as well as any other jurisdiction within the Licensed Territory as mutually agreed by the Parties and is reasonably required to successfully exploit the License for the commercial benefit of both Parties.
