Ongoing Development Activities Sample Clauses

Ongoing Development Activities. Except as set forth below, Xxxxxxx shall have no further obligation to conduct Development activities with respect to a Compound or Product after the date of notice of termination. After the Opt-In Date, if Xxxxxxx is conducting any Development activity with respect to a Compound or Product on the date of notice of termination, then Theravance shall notify Xxxxxxx within [***] after the notice of termination: (i) with regard to any Clinical Trial, whether Theravance elects to have Xxxxxxx (A) complete such Clinical Trial on behalf of Theravance (unless Xxxxxxx reasonably believes there is a Material Safety Issue that should prevent the continuation of such Clinical Trial), (B) wind down such Clinical Trial as soon as practicable, subject to compliance with ethical and legal requirements or (C) transfer such Clinical Trial to Theravance as soon as practicable; and (ii) with regard to any other Development activity, whether Theravance elects to have Xxxxxxx wind down or transfer such activity to Theravance. Notwithstanding the foregoing, if Xxxxxxx terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5, then this Section 11.6(b) shall not apply and Xxxxxxx shall wind down any ongoing Development activities as soon as practicable after the date of notice of termination, subject to compliance with ethical and legal requirements; and each Party shall bear its own expenses incurred pursuant to such wind down. After the Opt-In Date: (i) If Theravance notifies Xxxxxxx of its election to have Xxxxxxx complete a Clinical Trial on behalf of Theravance, Xxxxxxx and Theravance will, as necessary, negotiate in good faith a separate agreement pursuant to which Xxxxxxx would complete such Clinical Trial. If the Parties fail to reach agreement within [***] after Theravance makes such election, Xxxxxxx may wind down such Clinical Trial, subject to compliance with ethical and legal requirements or, if requested by Theravance, transfer such Clinical Trial to Theravance. (ii) If Theravance notifies Xxxxxxx of its election to have Xxxxxxx wind down such Clinical Trial or other Development activity (or fails to provide notice within such [***] period), then Xxxxxxx shall wind-down such Clinical Trial or Development activity as soon as practicable, subject to compliance with ethical and legal requirements. (iii) If Theravance notifies Xxxxxxx of its election to have Xxxxxxx transfer such Clinical Trial or other Development activity to Theravance, then Xxxxxxx shall use ...
Sample 1
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Ongoing Development Activities. Notwithstanding anything in this Agreement to the contrary, including Section 2.8 and this Section 4.1, (i) G1 shall continue until completion, as the Clinical Trial sponsor, the Clinical Trials [***], and (ii) G1 shall use [***] to wind down any pre-clinical studies in respect of the Licensed Compound or Licensed Product that are ongoing as of the Effective Date, [***] in each case ((i) and (ii)) which activities shall not be deemed to be a breach of G1’s obligations under Section 2.8. At Licensee’s request, G1 shall permit [***] representative of Licensee to join as an observer at any of G1’s or its Affiliate’s external meetings, teleconference calls or other material activities directly related to such Clinical Trials, including all meetings or teleconference calls with Regulatory Authorities directly related to such Clinical Trials, in all cases subject to the terms and conditions of all applicable agreements with the applicable Clinical Trial sites (including confidentiality obligations therein). Further, on a [***] basis (or such other frequency as the Parties may mutually agree) until the completion of such Clinical Trials, such Licensee representative shall meet with members of G1’s clinical operations team to discuss the progress of such Clinical Trials. [***] in connection with the Clinical Trials described in clause (i) above. Within [***] after the end of each [***] during which such Clinical Trials are ongoing, G1 will provide an invoice to Licensee setting forth in reasonable detail the Out-of-Pocket Costs incurred in connection with such Clinical Trials during such [***]. Such [***] invoices will be accompanied by available supporting documentation, receipts or related information to the extent necessary to verify such incurred Out-of-Pocket Costs for a particular [***]. Within [***] after its receipt of such [***] invoice, [***] the undisputed amounts set forth in such [***] invoice. For purposes of this Section 4.1(b), “Out-of-Pocket Costs” means, with respect to activities performed by or on behalf of G1 after the Effective Date in connection with the Clinical Trials described in clause (i) above, specifically identifiable direct expenses paid or payable by G1 or its Affiliates to Third Parties and incurred to conduct such activities, including payments to contract personnel (including contractors, consultants and subcontractors).
Sample 1

Related to Ongoing Development Activities

  • 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.

  • PROJECT ACTIVITIES This Grant Agreement is for the Foundational Year only. Subsection 1. Continuous SIA Plan Implementation (a) Increasing instructional time, which may include: (A) More hours or days of instructional time; (B) Summer programs; (C) Before-school or after-school programs; or (D) Technological investments that minimize class time used for assessments administered to students. (b) Addressing students’ health or safety needs, which may include: (A) Social-emotional learning and development; (B) Student mental and behavioral health; (C) Improvements to teaching and learning practices or organizational structures that lead to better interpersonal relationships at the school; (D) Student health and wellness; (E) Trauma-informed practices; (F) School health professionals and assistants; or (G) Facility improvements directly related to improving student health or safety. (c) Reducing class sizes, which may include increasing the use of instructional assistants, by using evidence-based criteria to ensure appropriate student-teacher ratios or staff caseloads. (d) Expanding availability of and student participation in well-rounded learning experiences, which may include: (A) Developmentally appropriate and culturally responsive early literacy practices and programs in prekindergarten through third grade; (B) Culturally responsive practices and programs in grades six through eight, including learning, counseling and student support that is connected to colleges and careers; (C) Broadened curricular options at all grade levels, including access to: (i) Art, music and physical education classes; (ii) Science, technology, engineering and mathematics education;

  • 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 Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • 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 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.

  • 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.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

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