Company Development Activities Sample Clauses

Company Development Activities. Company shall be responsible for completing the Existing Study, subject to the Parties entering into a mutually agreeable clinical management agreement with customary terms (“Clinical Agreement”), including compensation to Company on an FTE basis at the FTE Rate, plus Company’s cost of materials, requirements that all Development activities are conducted in accordance with GCP, GMP and other applicable standards in the industry and Applicable Law, and other customary terms for agreements of this sort. Notwithstanding the foregoing, Company will not amend the protocol or enroll in any expansion or phase 2 cohorts other than ***or transition to *** for any *** for any Existing Study, without a decision of the JSC. To ensure timely submission of data to regulatory authorities, JSC may elect to have Licensee assume some or all of the operational aspects of the Existing Study, including but not limited to ***. Company may elect, subject to JSC approval and the Parties entering into a Clinical Agreement, to assume responsibility to perform up to two (2) additional *** on *** in ***. The Licensee shall not unreasonably withhold the approval of its JSC members for such additional ***. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposed election relating to a Terminated Indication. Following JSC approval of any additional *** to be conducted by Company, the Parties will work together, via the JSC, to incorporate such *** into the then-current Development Plan. Company’s conduct of the Existing Study and any such additional activities approved by the JSC are referred to herein, collectively, as the “Company Development Activities.” Company shall use Commercially Reasonable Efforts to perform the Company Development Activities. For clarity, JSC may not assign a Company Development Activity to Company in the Development Plan without the prior written consent of Company. The activities of Company’s Affiliates and its permitted Sublicensees shall be attributed to Company for the purposes of evaluating Company’s fulfillment of the obligations set forth in this Section 5.4. Except for Company Development Activities, neither Company nor its Affiliates shall perform any Development of IMMU-132.
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Company Development Activities. Except for Development activities to be undertaken prior to the Development Transition Date by MacroGenics pursuant to Section 4.1, Company shall be solely responsible for and have sole authority with respect to, at its own expense (subject to MacroGenics’ exercise of the Co-Funding Option), all Development of the Compounds and the Products. Company shall use Commercially Reasonable Efforts to Develop, and to seek Regulatory Approval for, [***]. In addition, Company shall use Commercially Reasonable Efforts to [***].
Sample 1
Company Development Activities. Except as expressly provided in this Agreement, Company shall be solely responsible for and have sole authority with respect to, at its own expense, all Development of the Compounds, Single Agent Products and Combination Products in the Company Field in the Company Territory, including Development for Monotherapy Use or Combination Use in the Company Field in the Company Territory. Company shall conduct such Development in accordance with the Company Development Plan, which may be updated from time to time by Company in accordance with Section 4.2(c).
Sample 1
Company Development Activities. (a) Company shall use Commercially Reasonable Efforts to conduct all Development activities assigned to Company under the Development Plan (the “Company Development Activities”), in accordance with the Development Plan and the direction of the JDC and JSC. Company shall conduct all Company Development Activities in accordance with the Development Plan and under the direction of the JDC and JSC. (b) The status, progress and results of Company’s Development Activities shall be discussed in reasonable detail at meetings of the JDC, and Company shall provide the JDC with a written report on the status and progress of such Company Development Activities on a [***] basis. In addition, Company shall make available to MDACC such information about Company Development Activities as may be reasonably requested by MDACC from time to time.
Sample 1
Company Development Activities. As between the Parties, Company will be responsible for all costs and expenses of any Development activities conducted by Company, its Affiliates, its Sublicensees or its subcontractors hereunder with respect to the Territory.
Sample 1

Related to Company 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;

  • Professional Development Fund Article 20

  • Professional Development Funds 23.1.1 Two Professional Development Funds, a Professional Development Support Fund and an Education Leave Fund, shall be established to support professional development activities as defined in 23.2. On April 1st of each year, the College will allocate an amount equal to no less than 0.9% of total faculty salary (exclusive of severance payments) to the Professional Development Support Fund, and an amount equal to no less than 0.6% of total faculty salary to the Educational Leave Fund. Any unused balances in these funds shall carry over to the next budget year. 23.1.2 The College agrees to provide the Association with the authority to administer the program on behalf of the College for those activities approved by the College in accordance with 23.2, 23.4 and 23.5. 23.1.3 Nothing in this Agreement prevents the College from funding professional development activities in addition to those activities supported through the Professional Development Funds (23.1.1) in accordance with the procedures described in this Article.

  • 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 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.

  • 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 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.

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