Global Trials Sample Clauses

Global Trials. If the Parties agree to conduct a Global Trial, then the Parties and, if applicable, the relevant Neurocrine Collaborators shall discuss in good faith and determine the terms under which the Parties will conduct such Global Trial, including the allocation between the Parties of costs and expenses, decision-making process and authority for trial design and protocols, management of budget overages, allocation of Development activities and responsibilities and data sharing procedures. Neurocrine shall determine, in its sole discretion, whether and to what extent it participates in any cost-sharing or other activities related to Global Trials. Upon agreement, the Parties shall enter into a written agreement setting forth all such agreed terms.

Global Trials. If the Parties agree to conduct a Global Trial, then the Parties and, if applicable, the relevant ARS Collaborators shall discuss in good faith and determine the terms under which the Parties will conduct such Global Trial, including the allocation between the Parties of costs and expenses, decision-making process and authority for trial design and protocols, management of budget overages, allocation of Development activities and responsibilities and data sharing procedures. ALFRESA shall determine, in its sole discretion, whether and to what extent it participates in any cost-sharing or other activities related to Global Trials. ARS shall also determine, in its sole discretion, whether and to what extent it participates, and any of its ARS Collaborators participate, in any cost-sharing or other activities related to Global Trials. Upon agreement to conduct a Global Trial, the Parties shall enter into a written agreement setting forth all such agreed terms.

Global Trials. (a) Subject to Section 3.3.1(c), 3.7.2(b) and Section 3.7.2(c), Licensor will be responsible for all costs and expenses incurred by Licensor in connection with a Global Trial. (b) Licensee will be responsible for all costs and expenses incurred by Licensee in connection with a Global Trial in the Territory in accordance with the Development Plan, including all costs and expenses for recruiting, enrolling, dosing, treating, and providing follow-up support to, the human subjects to be enrolled by Licensee as part of such Global Trial in the Territory in accordance with the Development Plan; provided, however, that for each Global Trial, unless the Parties agree otherwise, a maximum of [***] of the total number of human subjects participating in such Global Trial worldwide will be allocated to the Territory. (c) If Licensee fails to enroll the number of human subjects to be enrolled by Licensee in the Territory as part of a Global Trial as set forth in the Development Plan for such Global Trial or otherwise agreed upon by the Parties in good faith, before the ‘last patient in’ for such Global Trial (excluding patients to be enrolled by Licensee), and such failure or shortfall is not attributable to Licensor’s breach of this Agreement, Licensor’s breach of the applicable clinical supply agreement between the Parties or any material delay caused by any actions or inactions of Licensor, Licensee shall [***]. In the event Licensee enrolls more than the number of human subjects originally agreed upon by the Parties to be enrolled by Licensee in the Territory as part of a Global Trial, Licensee shall [***].

Global Trials. 4.5.1 With respect to all Global Trials (other than any Global Trial for an Opt-Out Indication, but including for purposes of this Section 4.5.1 any AKP Local Studies contemplated under a properly issued AKP Local Study Notice), the Parties shall cooperate in good faith to conduct such Global Trials for the Product in accordance with this Section 4.5, and unless AKP properly issues an Opt-Out Notice to VectivBio in accordance with Section 4.5.2 in relation to a particular Opt-Out Indication, VectivBio shall update the Global Development Plan, and, if such Global Trials are Global Trials (with AKP) or AKP Local Studies contemplated under a properly issued AKP Local Study Notice, AKP shall update AKP Development Plan, to incorporate the relevant activities and responsibilities with respect to such Global Trials (with AKP). AKP shall participate in the Global Trial SBS Adult by way of bearing associated costs as set forth in Section 4.6.4. For sake of clarity, VectivBio shall be the sponsor of each Global Trial (with AKP), and in the conduct of each such Global Trial (with AKP), AKP shall use only the systems and databases (whether its own or VectivBio’s systems and databases) that have been appropriately reviewed and approved by VectivBio in accordance with the Co-Development Agreement (as defined below). In the conduct of each AKP Local Study contemplated under a properly issued AKP Local Study Notice, AKP may use its own systems and databases for such AKP Local Study (if AKP reasonably determines that the use of its own systems and databases would be desirable for a particular AKP Local Study contemplated under a properly issued AKP Local Study Notice) or VectivBio’s systems and databases (if AKP reasonably determines that the use of VectivBio’s systems and databases would be desirable for a particular AKP Local Study contemplated under a properly issued AKP Local Study Notice), in either case to the extent such systems and databases have been agreed between the Parties. Upon AKP’s request with respect to Global Trial (with AKP), VectivBio shall provide a copy of any agreement between VectivBio and a contract research organization or other Third Party vendor with whom AKP may be required to interact in the course of the Global Trial (with AKP) (to the extent that such agreement permits its disclosure to AKP); provided that VectivBio may redact proprietary and confidential information not directly relevant to the Global Trials (with AKP) in the Territory, a...

Global Trials. (a) ZLAB shall conduct the Global Trial for the Product in the Territory that is set forth in Schedule 5.3 as of the Effective Date. Throughout the Term, Regeneron may, through the JDC, request in writing that ZLAB perform a portion of an additional Global Trial in the Territory. If Regeneron makes such a request, it shall promptly provide ZLAB with a copy of the protocol (or, if the protocol is not then available, clinical trial design) for such Global Trial and Regeneron’s proposed percentage of global patients to be enrolled by ZLAB in the Territory for such Global Trial (or, if applicable, for each cohort of such Global Trial that ZLAB will participate in) (the “ZLAB Enrollment Percentage(s)”), Regeneron’s estimated total Global Trial Costs for the applicable Global Trial ([…***…]) and any other information that ZLAB reasonably requests to evaluate the conduct of such Global Trial in the Territory. Within […***…] of receipt of such a request, ZLAB shall inform Regeneron in writing if it wishes to perform such Global Trial in the Territory and provide ZLAB’s desired ZLAB Enrollment Percentage(s) for such Global Trial or such cohorts of such Global Trial, as applicable. If ZLAB’s desired ZLAB Enrollment Percentage(s) differ from Regeneron’s proposal, within […***…] of ZLAB providing such notice, the JDC shall meet, discuss and endeavor to agree on the ZLAB Enrollment Percentage(s) for such Global Trial or such cohorts of such Global Trial, as applicable; provided that, unless otherwise agreed by the Parties or the JDC, each initial ZLAB Enrollment Percentage shall […***…] of total global patients for such Global Trial or such cohort of such Global Trial, as applicable. (b) For any Global Trial included in the GT Operational Plan, Regeneron shall, in accordance with this Section 5.3.2(b), provide to the JDC for review (but not approval) a budget for its overall Global Trial Costs for the applicable Global Trial, which shall include a reasonably detailed budget for the remaining duration of the applicable Global Trial (broken down by Quarter for the first Calendar Year of such estimated budget and annually thereafter) (each, a “GTC Budget”). The initial GTC Budget for the Global Trial set forth in Schedule 5.3 shall be provided to the JDC […***…] promptly after the Effective Date. The initial GTC Budget for any other Global Trial that is included in the GT Operational Plan shall be provided to ZLAB promptly after the Parties agree to the ZLAB Enrollment Pe...

Related to Global Trials

Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.
Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.
Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.
Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

Global Trials Sample Clauses

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