Performance of Development Activities Sample Clauses

Performance of Development Activities. (a) Each Party shall undertake its development activities and other obligations under the applicable Statement of Work (such activities and obligations with respect to a Party as expressly identified in a Statement of Work, such Party’s “Services” and any resulting products or deliverables with respect to a Party as expressly identified in a Statement of Work, such Party’s “Deliverables”) in accordance with and subject to the terms and conditions of this Agreement and the applicable Statement of Work. Each Party will use commercially reasonable efforts to meet, or cause its Subcontractors to meet, the timelines and budgets set forth in this Agreement and the Statements of Work in such Party’s (or its Subcontractors’) performance of its Services. (b) From time to time after the OA Effective Date, BH may propose changes to the Statements of Work (including Services, specifications, delivery, performance schedules, gate reviews and Deliverables) and it will consult with Company regarding such changes before affecting them. After taking into consideration Company’s input, BH will make, in good faith, all final decisions with respect to the scope of work and timelines under the Statements of Work.
Sample 1
AutoNDA by SimpleDocs
Performance of Development Activities. Each Party will perform the Development Activities for which such Party is responsible under the Study Plan and will use Commercially Reasonable Efforts to perform such activities in accordance with the timelines set forth therein; provided that Fortis’s performance of its Development Activities will be subject to FibroGen’s compliance with its funding obligations with respect to the Development Fees. Each Party will use Commercially Reasonable Efforts to cooperate with the other Party in carrying out the Development Activities in accordance with the Study Plan. Each Party will, and will require its Affiliates and Subcontractors to, comply with all Applicable Laws in its and their conduct of the Development Activities under the Study Plan, including where appropriate GMP, GCP and GLP (or similar standards). Notwithstanding anything to the contrary, FibroGen may not initiate, and no Study Plan will include, any Phase 3 Clinical Trial or any Clinical Trial other than a FibroGen Clinical Study or Fortis Clinical Study, with respect to any of the Products or Modified Products unless with the prior written consent of Fortis [*]. [*].
Sample 1
Performance of Development Activities. Each Party will perform the Development Activities for which such Party is responsible under the Study Plan and will use Commercially Reasonable Efforts to perform such activities in accordance with the timelines set forth therein; provided that Fortis’s performance of its Development Activities will be subject to FibroGen’s compliance with its funding obligations with respect to the Development Fees. Each Party will use Commercially Reasonable Efforts to cooperate with the other Party in carrying out the Development Activities in accordance with the Study Plan. Each Party will, and will require its Affiliates and Subcontractors to, comply with all Applicable Laws in its and their conduct of the Development Activities under the Study Plan, including where appropriate GMP, GCP and GLP (or similar standards). [*]. [*].
Sample 1
Performance of Development Activities. Each Party shall, with respect to all Development activities for which such Party is responsible under this Agreement, provide, directly or indirectly through its Affiliates, sub/licensees, Sublicensees, or Subcontractors, all materials, facilities, and resources necessary for it to perform such Development activities with reasonable care and skill, consistent with sound and ethical business and scientific practices, in compliance with all Applicable Laws, including GCP, GVP, GMP and GLP, and otherwise in accordance with the terms of this Agreement. Each Party shall devote the efforts of suitably qualified and trained employees and personnel capable of carrying out the Development activities for which such Party is responsible to a professional workmanlike standard. Without prejudice to any other remedies either Party may have, if a Party notifies the other Party that it has reasonable grounds to suspect that a breach of the other Party’s obligations under this Section 4.2 (Performance of Development Activities) has occurred or is reasonably likely to occur, the other Party shall (i) consider in good faith any comments or concerns provided by such Party in such notice with respect to such breach or potential breach and (ii) take commercially reasonable steps to remedy, in all material respects, any actual breach and to avoid any potential breach as soon as reasonably practicable.
Sample 1
Performance of Development Activities. Participant acknowledges and agrees that the development of the Project Well(s) shall be performed in consultation with the officially designated operator of the Leases (the “Operator”) and other oil and gas professionals, in the event any Project Well(s) are lost at any time at any depth for any reason, including without limitation, the encounter of any impenetrable formations or substances, the loss of circulation, or any other conditions are encountered rendering further development activities impracticable, the Company may plug and abandon any Project Well(s) in its sole discretion, that any phase of development activities shall be attempted and conducted only if and to the extent the Company should deem such activities to be necessary or appropriate, in its sole discretion, and that all of the obligations of the Company under this Agreement with respect to the development or operation of the Project Well(s) may and shall be assigned or subcontracted by the Company in whole or in part without any additional consent of the Participant.
Sample 1
Performance of Development Activities. Each Party shall perform any and all of its Development activities with respect to the Programs in accordance with the applicable Development Plan, in good scientific manner and in compliance with all Applicable Law, including applicable national and international (e.g., ICH, GCP, GLP, and GMP guidelines), informed consent and institutional review board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects.
Sample 1
Performance of Development Activities. (a) Appendix A sets forth a development plan (the "Development Plan"), ---------- including a series of milestones for conducting the activities described in this Section 3 (collectively, the "Development Activities"). Details regarding Phase 3 of the Development Plan shall be developed by the Steering Committee and set forth in an amendment to the Development Plan approved in accordance with Section 3.3(b). LifeSensors will undertake only those Development Activities that are set forth in the Development Plan, as it may be amended from time to time by the Steering Committee in accordance with Section 2.2. Each of Embrex and LifeSensors will devote not less than the resources specified in the Development Plan, as amended from time to time in accordance with this Section 3.3, to conducting its respective Development Activities, allocating such resources and conducting such activities substantially on the schedule set forth in and otherwise in accordance with the Development Plan, except to the extent otherwise provided on Appendix A. In particular, during Phase 2 of the ---------- Development Plan, LifeSensors agrees that no fewer than **** of its full-time employees will be dedicated to the project. (b) The Development Plan may be amended from time to time during the Term upon the mutual written agreement of at least a majority of the members of the Steering Committee and with the approval of the parties, whereupon Appendix -------- A shall be revised to reflect the amendment. - (c) Each party undertakes to diligently carry out its respective Development Activities under this Agreement, and such Development Activities shall be deemed a material obligation of such party under this Agreement. The parties shall cooperate with each other and make a good faith effort to carry out the Development Plan successfully. No party shall be liable to the other party in the event that the Development Plan is not ultimately completed, except for liability of one party determined in a final judgment by a court of competent jurisdiction to have resulted solely from actions taken or omitted due to such party's willful misconduct, gross negligence or knowing violation of law.
Sample 1
AutoNDA by SimpleDocs
Performance of Development Activities 
Sample 1

Related to Performance of 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.

  • 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).

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.

  • 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.

  • 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;

  • 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.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • 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.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!