Specific Development Diligence Clause Samples

Specific Development Diligence. With respect to the Product for the GBM Indication, Licensee shall (i) assuming the Regulatory Materials to be provided by VBL hereunder are sufficient for submitting a CTA in Japan, submit a CTA in Japan in accordance with the timeline set forth in Schedule 4.3.2, (ii) subject to VBL’s timely supply of required quantities of clinical samples, initiate clinical testing in Japan within [***] after obtaining CTA approval therefor, (iii) complete such trial within [***] after it is initiated, and (iv) file an Approval Application within [***] after completion of such trial. With respect to the Product for the ovarian cancer indication, the Parties shall meet with key opinion leaders, contract research organizations and other experts in such indication in order to generate a new Development Plan for such indication within [***] after the Effective Date. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.
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Specific Development Diligence. [***], Licensee shall (i) assuming the Regulatory Materials to be provided by Amarin hereunder are sufficient for submitting a CTA in the PRC, submit a CTA in the PRC [***], (ii) subject to Amarin’s timely supply of required quantities of clinical samples and placebo, initiate clinical testing in the PRC within [***] after obtaining CTA approval therefor, and (iii) file for IDL approval within [***] after finalizing clinical testing in the PRC. [***] the Parties shall meet with key opinion leaders, contract research organizations and other experts in such indication in order to generate a Development Plan [***]
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Related to Specific Development Diligence

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for one Product in the Field in [***]. Pfizer will have no other diligence obligations with respect to the Development or Regulatory Approval of Products under this Agreement.

  • 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.

  • 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 ▇▇▇▇▇, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • 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 ▇▇▇▇▇; 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 OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK