Collaborative Development of Products Sample Clauses

Collaborative Development of Products. The Parties will each diligently collaborate in the Pre-Clinical Development and Development and use commercially reasonable efforts to develop and bring Products to the market as soon as reasonably practicable. The role of each Party in the Development process will be determined by the JDC, with the Parties intending that each Party will provide advisory and supporting services with respect to each phase of the process in which such Party is not actively or primarily involved. [ * ] shall supply [ * ] for each Product to be promoted or co-promoted by the Parties in the Territory in the aggregate, as determined by the JDC. A Party's required Development effort is hereinafter referred to as its ("Required Development Effort"). The JDC will determine appropriate written standards for measuring Required Development Efforts and accounting procedures to confirm and document each Party's performance of its Required Development Effort for any Product before the Parties commence Development thereof. No clinical trials involving any Product shall be commenced by or on behalf of either Party without the prior approval of the JDC. Nothing contained in this Section 3(d) shall be deemed to preclude either Party from terminating its participation in the collaborative Development, pursuant to Section 3(l), at such time. Any decision by a Party not to participate in development pursuant to Section 3(b) or to terminate participation in the collaborative Development pursuant to Section 3(l) shall not be deemed a breach of this Agreement.
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Collaborative Development of Products. The Parties will each diligently collaborate in the Pre-Clinical Development and Development and use commercially reasonable efforts to develop and bring Products to the market as [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Collaborative Development of Products. The Parties will each diligently collaborate in the Development of Products in the Co-Promotion Territory and use commercially reasonable efforts to develop and commercialize Products as soon as reasonably practicable. The role of each Party in the Development process will be determined by the JDC, with the Parties intending that each Party will provide advisory and supporting services with respect to any phase [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.
Collaborative Development of Products. Upon approval by the JSC of the applicable Collaborative Development Plan and associated Budget, each Party shall commence and conduct Collaborative Development activities assigned to it under, and in accordance with, such Collaborative Development Plan in good scientific manner and in accordance with all applicable Laws. For clarity, Ultragenyx shall have the right to generate modified products or derivatives incorporating the Compound identified by Arcturus under the Collaborative Development Plan, provided that (i) Ultragenyx shall promptly identify in writing all such modified products and derivatives to Arcturus and (ii) such modified products and derivatives shall be deemed as Products under this Agreement. Ultragenyx shall be solely responsible, at its discretion, for the development, manufacture and, if successful, commercialization of any and all Products after their respective PCC Designation.” (b) Section 4.5.3 of the License Agreement is hereby deleted in its entirety and replaced with the following:
Collaborative Development of Products. Upon approval by the JSC of the applicable Collaborative Development Plan and associated Budget, each Party shall commence and conduct Collaborative Development activities assigned to it under, and in accordance with, such Collaborative Development Plan in good scientific manner and in accordance with all applicable Laws. It is the Parties’ intent for Arcturus to be primarily responsible for identification and optimization of Compounds with respect to each Development Target for potential Product candidates in accordance with the Collaborative Development Plan, and for Ultragenyx to be primarily responsible for carrying out the in vitro and in vivo efficacy and proof-of-concept studies, including in animal disease models, with respect to each such Product candidate. For clarity, Ultragenyx shall have the right to generate modified products or derivatives incorporating the Compound identified by Arcturus under the Collaborative Development Plan, provided that (i) Ultragenyx shall promptly identify in writing all such modified products and derivatives to Arcturus and (ii) such modified products and derivatives shall be deemed as Products under this Agreement. Ultragenyx shall be solely responsible, at its discretion, for the development, manufacture and, if successful, commercialization of any and all Products after their respective PCC Designation.

Related to Collaborative Development of Products

  • Collaboration 31.1 If the Buyer has specified in the Order Form that it requires the Supplier to enter into a Collaboration Agreement, the Supplier must give the Buyer an executed Collaboration Agreement before the Start date. 31.2 In addition to any obligations under the Collaboration Agreement, the Supplier must: 31.2.1 work proactively and in good faith with each of the Buyer’s contractors 31.2.2 co-operate and share information with the Buyer’s contractors to enable the efficient operation of the Buyer’s ICT services and G-Cloud Services

  • 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).

  • 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.

  • 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.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • 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 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 Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Research Project The findings of any research project, which would change the provisions of this Agreement will not be implemented until such changes are negotiated and agreed to by the parties.

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