Technical Development Activities Sample Clauses

Technical Development Activities. Subject to Section 10.1, during the Technical Development Term Denali may conduct the Technical Development activities. Denali shall keep the JSC informed of such activities and the Parties shall discuss the same at each JSC meeting. Denali shall promptly provide to F-star Ltd a copy (in the form of a glycerol stock) of each Denali Library on its creation. Neither Licensor, nor F-star Ltd or F-star GmbH shall use any Denali Library to screen or identify Fcabs against any Accepted Fcab Targets.
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Technical Development Activities. (a) Subject to anything stated to the contrary, it shall be the role and responsibility of LICENSOR, with the due support of LICENSEE at its cost, to use Commercially Reasonable Efforts to perform and complete the drug substance and drug product CMC Development of the Existing Product and Licensed Compound for use in the Existing Product until obtaining regulatory approvals for the Existing Product in the EU (EMA), Switzerland (Swissmedic) and United Kingdom (MHRA). LICENSOR shall inform LICENSEE on a regular basis, and at least once per Calendar Quarter and as soon as reasonably practicable upon LICENSEE's request, about the progress of such CMC activities. The costs for such CMC Development activities accruing prior to regulatory approval (including, but not limited to, any CMC Development activities required as a post-approval commitment to support conditional approval as well as CMC Development activities required to achieve full compliance to the agreed EU PIP for the Existing Product) shall be borne by LICENSOR, subject to anything stated to the contrary in the Technical Development Plan. The costs for any post-approval Development activities and any additional Development activities as outlined in the Technical Development Plan, shall be borne in the following proportion by each Party: [***]% by LICENSOR and [***]% by LICENSEE. (b) Annex 3.2(b) sets forth the obligations of LICENSOR and LICENSEE with respect to the Development of the drug substance and drug product for the Existing Product and Licensed Compound for use in the Existing Product up to production scale and in compliance with the regulatory requirements and quality specifications required by the official standards agencies and competent authorities of the Licensed Territory, with EMA, Swissmedic and MHRA to obtain regulatory approvals in due course (the Technical Development Plan). For clarity, LICENSOR shall have no obligations hereunder with respect to Development other than those set forth in the Technical Development Plan. Each Party shall use Commercially Reasonable Efforts to perform and complete its obligations as detailed in the Technical Development Plan.
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Technical Development Activities. (a) In each case to the extent set forth in the Development Plan (as discussed by the JSC): (i) Spark shall undertake Technical Development activities related to obtaining or maintaining Regulatory Approvals; (ii) Spark shall undertake Technical Development activities related to [**]; and (iii) the Parties shall undertake Technical Development activities in respect of [**]. Acknowledging that Spark Controls the Spark Manufacturing IP (and that Novartis does not have access to or rights to exercise the Spark Manufacturing IP except as specifically ActiveUS 166647742v.1 provided in Section 3.1.1), Spark shall provide reasonable assistance and support to Novartis with respect to Novartis’ Technical Development activities. (b) Each Party shall use commercially reasonable efforts to perform its obligations pursuant to this Section 4.1.2, and shall conduct all such Technical Development activities in accordance with applicable Laws. (c) Novartis shall bear the costs of all Technical Development activities (except as otherwise expressly stated in Section 4.4.2), provided, however, that if Spark decides to use any developments or improvements resulting from such Technical Development within the Spark Territory, it shall [**]. For clarity, nothing in this Section 4.1.2(c) shall prejudice or otherwise override any cost sharing provisions of the Supply Agreement [**]. (d) For clarity, Spark shall not have an obligation to perform Technical Development included in any Development Plan or amendment to any Development Plan unless and until Spark has agreed to undertake such obligation.
Sample 1

Related to Technical 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.

  • 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 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 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.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • 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.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • 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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