Common use of Research and Development Activities Clause in Contracts

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED ]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2.

Appears in 3 contracts

Samples: Stock Purchase Agreement (Icn Pharmaceuticals Inc), Stock Purchase Agreement (Icn Pharmaceuticals Inc), Stock Purchase Agreement (Icn Pharmaceuticals Inc)

AutoNDA by SimpleDocs

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED [REDACTED]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2.

Appears in 2 contracts

Samples: Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Ribapharm Inc)

AutoNDA by SimpleDocs

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED ]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days [REDACTED ] after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2.

Appears in 1 contract

Samples: Stock Purchase Agreement (Icn Pharmaceuticals Inc)

Time is Money Join Law Insider Premium to draft better contracts faster.