Clinical Development Costs Sample Clauses

Clinical Development Costs. All Clinical Development Costs incurred in accordance with the corresponding Clinical Development Plan budget shall be borne by Athersys and Angiotech in the following proportions: (a) Clinical Development Costs associated with the execution of any Phase I Study or Phase II Study pursuant to any Clinical Development Plan shall be shared fifty percent (50%) by Athersys and fifty percent (50%) by Angiotech; (b) Clinical Development Costs associated with the execution of the first Phase III Study conducted pursuant to this Strategic Alliance Agreement shall be shared thirty-three percent (33%) by Athersys and sixty-seven percent (67%) by Angiotech; and (c) Clinical Development Costs associated with the execution of any Phase III Study that is subsequent to the first Phase III Study trial described in clause (b) above shall be shared twenty-five percent (25%) by Athersys and seventy-five percent (75%) by Angiotech.
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Clinical Development Costs. HLBLS shall be responsible for all costs associated with clinical development of Licensed Products undertaken solely in the Licensed Territory. The Parties may agree to collaborate on clinical development under MFDS and other Regulatory Authorities, and costs of such clinical development will be shared on a pro-rata basis calculated by future market share projections.
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Clinical Development Costs. Except as set forth below or otherwise determined by the Project Team, Lilly shall pay all costs incurred in the Clinical Development Program (including those relating to Regulatory Approvals) after the Effective Date pursuant to the Clinical Development Plan, except those costs involved in conducting those immunology tests described in Exhibit E, which shall be borne by Ophidian. Ophidian shall be responsible for its own costs in providing advice to Lilly.
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Clinical Development Costs. Except as set forth below or otherwise determined by the Project Team, [*].
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Clinical Development Costs. Xxxxxxx will be responsible for one hundred percent (100%) of all Clinical Development Costs for each Clinical IRD Product; provided, however, that in no event will any Clinical Development Costs for any Calendar Quarter exceed the applicable Clinical Development Budget for such Calendar Quarter, except as otherwise provided in Section 10.3(b). Notwithstanding anything herein to the contrary, in no event [***].
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Clinical Development Costs. Within [***] after receipt of such invoice and report, Xxxxxxx will pay to MeiraGTx all the Clinical Development Costs set forth in each such invoice; provided, however, that if the total Clinical Development Costs for such Calendar Quarter exceeds the Clinical Development Budget for such Calendar Quarter, then MeiraGTx will provide written notice to Xxxxxxx as far in advance as reasonably possible of such cost overrun along with a reasonably detailed explanation of such cost overrun. Xxxxxxx shall pay for such excess only if: (i) the JSC approves of such excess; or (ii) such excess exceeds the Clinical Development Budget for such Calendar Quarter by [***] percent ([***]%) or less and is attributable to (A) a change in Applicable Law, (B) a variation in actual patient enrollment from projected patient enrollment or (C) a change to a clinical trial protocol required or requested by any Regulatory Authority; Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. provided, however, that in no event will total Clinical Development Costs in any given Calendar Year exceed the Clinical Development Budget for such Calendar Year by more than [***] percent ([***]%), which excess may only be approved by the Parties in writing. Xxxxxxx shall not be obligated to pay for any Clinical Development Costs in excess of the Clinical Development Budget except as otherwise set forth in this Section 10.3(b). All such payments of MeiraGTx’s Clinical Development Costs shall be non-creditable and non-refundable. In addition, subject to the terms and conditions herein, if any Clinical Development Plan Activities will exceed the respective portion of the applicable Clinical Development Budget or extend beyond the applicable Clinical Development Plan Term, then (x) MeiraGTx shall provide written notice to Xxxxxxx, as far in advance as reasonably possible, that MeiraGTx intends to not perform such Clinical Development Plan Activities (with reasonable detail regarding such Clinical Development Plan Activities and Clinical Development Costs), (y) MeiraGTx shall afford the JSC or the Parties, as applicable, a reasonable opportunity to approve additional funding or reimburse such Clinical Development Plan Activities as permitted in this Section 10.3(b), and (z) MeiraGTx shall not be obligated to undertake such Clinical Development Plan Activities unl...
Sample 1
Clinical Development Costs. Except as set forth below or otherwise determined by the Project Team, ************************************** ***************************************************************************.
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Clinical Development Costs 
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Related to Clinical Development Costs

  • Development Costs Licensee shall be responsible for all of its costs and expenses in connection with the Development of, and obtaining and maintaining Regulatory Approvals for, the Licensed Products in the Field in the Territory.

  • 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.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • 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.

  • 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.

  • Research Project The findings of any research project, which would change the provisions of this Agreement will not be implemented until such changes are negotiated and agreed to by the parties.

  • Design Development Phase INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE 1.1.6.1. The ARCHITECT/ENGINEER shall prepare from the approved Schematic Design Studies, the Design Development Documents consisting of drawings (including at least architectural, landscaping, civil, structural, mechanical and electrical plans, building sections; and finish schedule), outline specifications following the Construction Specification Institute "CSI" Format and other necessary documents to fix and describe the size and character of the entire Project as to its site, structural, mechanical, and electrical systems, materials and other such essentials as may be appropriate, for and until approved by the State. 1.1.6.2. The ARCHITECT/ENGINEER shall conduct meetings with the State, Efficiency Vermont, and relevant members of the design team, to review the Design Development Documents for the purposes of furthering the energy efficiency objectives of the Project. 1.1.6.3. The ARCHITECT/ENGINEER shall prepare for the State a revised accounting of how the Project is responding to LEED criteria. 1.1.6.4. The ARCHITECT/ENGINEER shall submit to the State a revised Statement of Probable Construction Cost based thereon for and until approved by the State.

  • 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).

  • 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.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

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