Early Stage Development Program Sample Clauses

Early Stage Development Program. Subject to the terms and conditions set forth herein, RPRP and Introgen shall cooperate with respect to the Early Stage Development of Collaboration Products in accordance with an "Early Stage Development Program" for North America which shall be carried out in accordance with a Program Plan and Budget prepared and approved on an annual basis in accordance with Article 3.4
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Early Stage Development Program. Introgen will be responsible for conducting, directly or through third parties, all development of each new project and each Collaboration Product in North America through the completion of Early Stage Development in accordance with the Program Plan and Budget in effect from time to time. As soon as possible after completion of the necessary preclinical studies required by the applicable Product Plan and Budget for a Collaboration Product, Introgen shall be responsible for preparing, with the cooperation of RPRP, a data package for each Collaboration Product sufficient to meet IND requirements of the FDA. (a) In addition to the Early Stage Development Program, RPRP and Introgen will cooperate in the Later Stage Clinical Development of each Collaboration Product; provided, RPRP will be primarily responsible for conducting all such Later Stage Clinical Development, at RPRP's expense. Introgen shall be consulted and fully informed with respect to such Later Stage Clinical Development at all times through its representatives on the Development Committee. All Later Stage Clinical Development shall be monitored and managed by the Development Committee; [*]. (b) It is anticipated that RPRP will establish a committee of independent experts (the "External Review Committee") to provide advice with respect to Later Stage Clinical Development. The Chief Scientific Officer of Introgen, or other designee of Introgen, if a clinician of recognized stature, shall serve on and chair the External Review Committee; otherwise, RPRP and Introgen shall agree on the chair of such External Review Committee. In any event, Introgen shall have a representative on such External Review Committee. (c) It is understood that additional preclinical studies may be required following the completion of Early Stage Development with respect to a Collaboration Product. The parties anticipate that, where appropriate, such work will be performed by Introgen and reimbursed by RPRP, as agreed from time to time by the Development Committee.
Sample 1Sample 2
Early Stage Development Program. Introgen will be responsible for conducting, directly or through third parties, all development of each new project and each Collaboration Product in North America through the completion of Early Stage Development in accordance with the Program Plan and Budget in effect from time to time. As soon as possible after completion of the necessary preclinical studies required by the applicable Product Plan and Budget for a Collaboration Product, Introgen shall be responsible for preparing, with the cooperation of RPRP, a data package for each Collaboration Product sufficient to meet IND requirements of the FDA.
Sample 1Sample 2

Related to Early Stage 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.

  • 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.

  • 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.

  • Research Term The term “

  • 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.

  • 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.

  • 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 Period The Contractor may commence pre-construction activities like utility shifting, boundary wall construction or any other activity assigned to the Contractor by the Authority to enable construction of the Project Highway immediately after signing of the Agreement, to the extent that such work is ready for execution. The Parties agree that these works may be taken up and completed to the extent feasible by the Contractor, before declaration of the Appointed Date, but no claim against the Authority for delay shall survive during this period and that the undertaking of these works by the Contractor shall not count towards the Scheduled Construction Period of the project which starts counting only from the Appointed Date. No construction activity of the Project Highway shall be undertaken during the development period.

  • 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.

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