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.
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 [***]
