Clinical Development Plan. The Project Team shall prepare and oversee the implementation of an overall development plan (the "CLINICAL DEVELOPMENT PLAN") for the Drug Product which shall describe fully the proposed preclinical studies, toxicology, clinical trials, regulatory plans and any other key elements of obtaining Regulatory Approval in each country of the world where Lilly elects to market the Drug Product.
Clinical Development Plan. The Parties shall undertake the Development of the Products in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Products relating to the Territory under this Agreement shall be governed by a written clinical development plan, as revised from time to time in accordance with this Section 5.2 (the “Clinical Development Plan”). The Clinical Development Plan shall include (a) an outline of Clinical Trials to be conducted by Zai in the Territory, including the Local Studies and Joint Global Studies; and (b) the material activities to be performed by the Parties to obtain the Regulatory Approvals for the Products in the Territory and to support the Joint Global Studies. The Clinical Development Plan shall contain in reasonable detail the major Development activities and the projected timelines for conducting such activities, including activities designed to achieve Regulatory Approvals for the Products in the Territory. As of the Effective Date, the Parties have agreed to an initial Clinical Development Plan, which is attached hereto as Schedule 5.2. From time to time, […***…] Zai shall propose updates or amendments, if any, to the Clinical Development Plan in consultation with TPTX and submit such proposed updated or amended plan to the JDC for review, discussion and approval. In accordance with Section 3.3(b), the JDC shall review, discuss and approve any updates or amendments to the Clinical Development Plan; provided […***…].
Clinical Development Plan. Within [***], the JSC will propose and agree on a high-level clinical development plan and regulatory strategy for any potential Development Candidate through completion of the first Pivotal Study, which plan may include activities related to the identification of biomarkers, natural history studies and endpoint development, if determined by the JSC (such plan the “Clinical Development Plan”). Praxis will propose the initial draft of such Clinical Development Plan to the JSC for review, comment and approval. Any such initial draft of the Clinical Development Plan will include the information set forth on SCHEDULE 3.7. If the JSC cannot agree upon the Clinical Development Plan, the matter will be referred to the Senior Representatives for resolution. Subject to Section 4.1.4(b) (but only with respect to [***]), if the Senior Representatives cannot agree on the Clinical Development Plan within [***] after the matter is so referred, Praxis will have final decision-making authority with respect to the [***].
Clinical Development Plan. Licensee’s initial plan for the clinical development of Recro Products is enclosed hereto as Schedule 8.2. Within one hundred twenty (120) days after the Effective Date, Licensee shall provide Orion with an updated clinical development plan for the Recro Products in the Recro Territory, which plan shall replace the aforementioned initial plan and describe in further detail the clinical study program for the Recro Products and projected timetable (such initial plan, as well as the updated plan furnished to Orion in accordance with this Section 8.2, the “Clinical Development Plan”).
Clinical Development Plan. The Parties shall ensure at all times that the Clinical Development Plan (a) is consistent with the terms and conditions of this Agreement, (b) is focused on efficiently obtaining Regulatory Approval for Licensed Products (whether as a monotherapy or as part of a Combination Therapy) in each Initial Indication and Additional Indication (other than a Rejected Additional Indication) in the Territory, (c) does not include activities that could reasonably be expected to have a material adverse effect on the Development, Manufacture or Commercialization of Licensed Compound or Licensed Products outside of the Territory; and (d) does not include activities that constitute or potentially constitute a violation of the requirements set out in Applicable Law in the Territory. The Clinical Development Plan shall provide a summary of each bridging study, Local Trial, Joint Global Trial, investigator sponsored trial and registry study to be conducted any Hutchmed Entity in the Territory, including in reasonable detail (i) all material Development activities reasonably anticipated to be undertaken by the Hutchmed Entities or Hutchmed Entities and Epizyme Entities, (ii) the endpoints for all clinical trials contemplated by such plan, (iii) identification of the clinical trials that are intended to be a Pivotal Trials, (iv) all material regulatory activities and Regulatory Authority interactions anticipated to be conducted by the Hutchmed Entities in support of Regulatory Approval of the Licensed Products in the Field in the Territory, including all planned material Regulatory Filings to be submitted in connection with such approvals, and (v) the budget for Hutchmed’s share of costs associated with participation in Joint Global Trials in accordance with Section 9.3(c)(iii). Each Party shall be responsible for determining the budget for its activities in its respective territory for Joint Global Trials.
Clinical Development Plan. The Clinical Development Plan shall contain key Development activities (other than CMC Development Activities) necessary to complete Development of the Initial Product for an IBD Indication through the end of Phase 3, and may also include Development activities with respect to other Compounds and Products mutually agreed upon by the Parties. For clarity, the Parties shall not conduct Development activities with respect to a Compound or Product during the Development Term unless such activities are agreed by the JSC and set forth in the Clinical Development Plan. The Clinical Development Plan shall include a reasonably detailed description of such activities, a timeline for completion of such activities and the deliverables for such activities. Without limiting the foregoing, the Clinical Development Plan shall include:
Clinical Development Plan. (a) Attached hereto as Schedule 1.19 is the initial Development Plan, setting forth [* * *].
Clinical Development Plan. Licensee has developed a technique to quantify reverse cholesterol transport (RCT) in both animals and humans through the use of stable isotopes and isotope-ratio mass spectrometry. Quantification of peripheral cholesterol mobilization from tissues into plasma, referred to as efflux, and elimination of plasma-derived cholesterol as fecal sterols, referred to as excretion, is made in a single procedure. Although the cardioprotective effects of HDL on RCT in both humans and experimental animals are well documented in the literature, the functional significance of RCT in atherosclerosis remains controversial. This uncertainty can be attributed, in large part, to the previous inability to measure RCT fluxes in vivo, particularly in humans, and thereby test hypotheses experimentally. It is clear that the concentration of HDL particles in blood does not accurately reflect efflux rate of cholesterol or global flux through the RCT pathway. This was most recently illustrated in the outcome of the Torcetrapib trial where, despite dramatically increased HDL concentration, no benefit on atherosclerosis was observed. Accordingly, it is critical to evaluate in humans the effect of HDL targeted therapies on cholesterol flux prior to commencing large and costly clinical outcome trials. Licensee intends to use its proprietary ability to directly measure RCT to direct and expedite the clinical development of 5A. Licensee has already assessed 5A with this proprietary technology in animals and has shown (see above) 5A's ability to increase RCT in a relevant animal model. As the only company with access to this patented method, Licensee intends to symmetrically apply its technology to demonstrate human Proof-of-concept in early Phase I studies of 5A. Licensee then intends to maximize the chances of successful development of SA by using its technology to optimize the dose-response of SA against RCT activity in phase Ib and Phase II studies. The most important element of the development plan is to establish clinical proof-of-principle in patients as quickly and efficiently as possible. Early assessment of clinical efficacy in healthy volunteers will be performed in Phase Ia and Ib through the use of Licensee's stable-isotope based kinetic measurement of RCT. This method, in contrast to either IMT or IVUS imaging metrics or traditional clinical outcomes, provides for rapid evaluation of drug efficacy on one of the primary targets of mimetic therapies, modulation of cholesterol fl...
Clinical Development Plan. (a) Initial Clinical Development Plan. Within ninety (90) days of the Effective Date, OV shall develop and document an initial comprehensive plan for a clinical development Program for conducting the Phase 2 Clinical Trial for the Primary Indication in accordance with the terms of this Agreement, with the long term goal of obtaining Regulatory Approval for the Product in the relevant jurisdictions of the Territory as decided by the JDC (the “Initial Clinical Development Plan”). The Initial Clinical Development Plan, which shall include a budget and timeline for activities, shall be attached hereto as Exhibit A and is incorporated herein and made a part hereof by reference. OV shall introduce the Initial Clinical Development Plan at the first meeting of the JDC following the above ninety (90) day period. Any existing or future studies conducted with the National Cancer Institute (“NCI”) or any investigator-sponsored trials (“ISTs”) shall be part of the Clinical Development Plan.
Clinical Development Plan. The Clinical Development Plan (as the same may be modified from time to time pursuant to the terms of this Agreement) shall specify (i) to the extent applicable, all technical, nonclinical, drug supply and clinical development activities, consistent with requirements for Regulatory Approval, that will be conducted by the Parties in Developing the Licensed Compounds and Licensed Products, and the Party responsible for each such activity; (ii) protocols for all Clinical Studies to be conducted under the Clinical Development Plan; (iii) clinical study reports (“CSRs”), summary activity reports, and budgetary reports to be provided by the Parties, as well as timelines of dates for such reports to be provided; (iv) scheduled budgets for the activities to be undertaken by OGX (including for activities to be conducted by Third Parties on behalf of OGX); and (v) Development activities to be conducted by Third Parties on behalf of either Party or the Parties jointly. The JSC shall review, amend and supplement the Clinical Development Plan on a [***] basis or more often as the Parties mutually deem appropriate, subject to the decision-making provisions under Section 3.5(d). As of the Effective Date, the Parties have agreed to protocols for the Phase III Clinical Studies for first-line CRPC and second-line CRPC as set forth on Exhibit A. On a [***] for the first-line non-small cell lung cancer Phase III Clinical Study to be conducted under the Clinical Development Plan, which protocol shall be consistent with the patient population, number of patients, and primary endpoint as summarized in Exhibit A.
