Current Development Status. Prior to the Effective Date, Novartis AG (“Novartis”) and/or Array have independently initiated the following Clinical Studies of the Products: (i) a Phase III clinical trial in NRAS Melanoma (“NEMO Clinical Study”), (ii) a Phase III clinical trial in BRAF Melanoma (“COLUMBUS Clinical Study”), (iii) a Phase III clinical trial in BRAF Colorectal Cancer (“BEACON Clinical Study”), and (iv) those additional Phase 1 and Phase 2 Clinical Studies and Investigator Sponsored Clinical Studies set forth in Exhibit 4.1 (collectively, the “Existing Clinical Studies”). Array shall use Diligent Efforts to complete, at its expense, the Existing Clinical Studies (including all pharmacovigilance aspects), including contracting and managing any contract research organization(s) that may be involved in such Existing Clinical Studies, and Array shall keep the JDRC informed of the status thereof and Ono [ * ] = 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 Exchange Act of 1934, as amended. shall have the opportunity to comment on the progress of the BEACON study through the JDRC. As between the Parties: (and subject to applicable agreements and consent requirements) Array shall have the right to implement modifications to any Existing Clinical Study(ies), provided that Array shall not implement any modification to any Existing Clinical Study(ies) that would prejudice Ono as regards safety or reputational issues, or the intended objectives for such Clinical Studies, or cause a material delay in such Existing Clinical Study(ies), and provided further that Array shall use Diligent Efforts to keep Ono informed through the JDRC of any material modification to any Existing Clinical Study(ies) being conducted in the Ono Territory.
Current Development Status. Prior to the Effective Date, the Company received Notice from the FDA that it completed its review of the Company’s IND application and that the Company could, accordingly, initiate the contemplated Phase 2 Clinical Trial entitled, “A Randomized, Double-Blind, Multicenter, Xxxxxxx-Xxxxxxxxxx, Xxxxx 0 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis” (the “Phase 2 ABPA Study”).
Current Development Status. Prior to the Execution Date, Nogra has independently initiated Clinical Studies of the Licensed Product as further described in Exhibit E. The Parties have agreed that Licensee will exercise Commercially Reasonable Efforts to continue the Development of the Licensed Products in the Field in the Territory in accordance with the Global Development Plan, at Licensee’s sole cost and expense.
Current Development Status. Prior to the Effective Date, Genmab has independently initiated Clinical Studies of the Licensed Products in the Field. The Parties have agreed to continue the Development of the Licensed Products in the Field in accordance with the GDPs and the terms of this Agreement.
Current Development Status. Prior to the Effective Date, Pharmacyclics has independently initiated Clinical Studies of the Product for various Hematological Cancers. The Parties have agreed to continue the Development of the Product in the Field in accordance with the GDP.
Current Development Status. (a) Ongoing Clinical Studies. [***] shall remain responsible for and shall complete [***] all ongoing Clinical Studies as of the Effective Date that are listed in EXHIBIT 3, including all analysis and reports that are reasonably necessary to obtain, extend or update the Marketing Authorization of the Product with the EMA, and shall remain responsible for contracting with and managing any Third Party that may be involved with such Clinical Studies (each, an “Ongoing Clinical Study”).
