Frontline therapy Sample Clauses

Frontline therapy. A pivotal Phase 2/3 study with ON 00000.Xx in previously untreated patients with metastatic pancreatic cancer has been initiated. Patients are randomized in a 2:1 ratio to the combination of gemcitabine plus ON 00000.Xx. vs. gemcitabine alone. The primary endpoint of this trial is overall survival. There will be a formal enrollment pause after 150 patients are entered in the trial. After 100 deaths have occurred in these patients, the DSMC will review overall safety and efficacy findings and make a recommendation regarding moving to Phase 3 (Q4, 2012). Assuming a positive recommendation, the DSMC will also perform a sample size re-estimation at this time. Phase 3 enrollment is planned to be completed by June, 2014 with survival data available in Q4 2014. The NDA submission is planned for Q1 2015 with approval later that year.
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Related to Frontline therapy

  • Marketing Services The Manager shall provide advice and assistance in the marketing of the Vessels, including the identification of potential customers, identification of Vessels available for charter opportunities and preparation of bids.

  • Development Services Licensee may from time to time wish to augment the RMSS product with additional functionality or utility, or to integrate it with Licensee systems from other sources, and for such purposes may request the provision of development services from RMSS.

  • Internet Services Transfer Agent shall make available to Fund and Shareholders, through its web sites, including but not limited to xxx.xxxxxxxxxxxxx.xxx (collectively, “Web Site”), online access to certain Account and Shareholder information and certain transaction capabilities (“Internet Services”), subject to Transfer Agent’s security procedures and the terms and conditions set forth herein and on the Web Site. Transfer Agent provides Internet Services “as is,” on an “as available” basis, and hereby specifically disclaims any and all representations or warranties, express or implied, regarding such Internet Services, including any implied warranty of merchantability or fitness for a particular purpose and implied warranties arising from course of dealing or course of performance. Transfer Agent shall at all times use reasonable care in performing Internet Services under this Agreement.

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Acquisition Services (i) Serve as the Company’s investment and financial advisor and provide relevant market research and economic and statistical data in connection with the Company’s assets and investment objectives and policies;

  • Transportation Management Tenant shall fully comply with all present or future programs intended to manage parking, transportation or traffic in and around the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Program Management (WBS 1.1) All components of the Project Management Plan as implemented for the Base Contract and Options 1-4 will be reviewed and amended to reflect specific needs for Option 5 and the outcome of continuous process improvement evaluations.

  • ELECTRICAL SERVICES A. Landlord shall provide electric power for a combined load of 3.0 xxxxx per square foot of useable area for lighting and for office machines through standard receptacles for the typical office space.

  • Asset Management Services (i) Real Estate and Related Services:

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