Copies and Provision of Information. 6.3.1. KI PHARMA and GRELAN will keep BIONUMERIK regularly and fully informed of the preclinical and clinical process regarding the Venture Products. KI PHARMA and GRELAN also shall keep BIONUMERIK regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BIONUMERIK, upon BIONUMERIK's reasonable request, with English version copies of all important documents, data and other information supplied to or received from the Japanese Government or other approval authority in connection with the applications for the Government Regulatory Approvals. Upon receipt of each Government Regulatory Approval, KI PHARMA and GRELAN shall promptly furnish BIONUMERIK English version copies or other satisfactory evidence thereof. 6.3.2. BIONUMERIK shall provide KI PHARMA and GRELAN with copies of all information generated or controlled by it in the course of satisfying regulatory requirements in the United States and/or Europe related to any Venture Products BN that may be useful or necessary in obtaining Government Regulatory Approvals in the Territory, such as IND applications, annual reports, protocol amendments, IND amendments, and related documents ("IND and Related Information"). If BIONUMERIK grants a license for commercial distribution of any Venture Products BN in areas outside the Territory, BIONUMERIK agrees to use its best efforts to provide in any agreement hereinafter signed with respect to such license that the licensee under such license shall provide KI PHARMA and GRELAN with all data and information generated by such licensee with respect to such products for supporting the development of such products in the Territory. GRELAN shall provide KI PHARMA and BIONUMERIK with copies of all information generated or controlled by it in the course of satisfying regulatory requirements in the United States and/or Europe related to Venture Products GR that may be useful or necessary in obtaining Governmental Regulatory Approvals in the Territory, such as IND and Related Information. If GRELAN grants a license for commercial distribution of any Venture Products GR in areas outside the Territory, GRELAN agrees to use its best efforts to provide in any agreement hereinafter signed with respect to such license that the licensee under such license shall provide KI PHARMA and BIONUMERIK with all data and information generated by such licensee with respect to such products for supporting the development of such products in the Territory. In the event a prospective licensee for the commercial distribution of Venture Products in areas outside the Territory will not agree to the sharing of all data and information as provided above, each of BIONUMERIK and GRELAN will consult with KI PHARMA prior to signing any license agreement with such party and each of BIONUMERIK and GRELAN will use its best efforts to facilitate and provide an opportunity for discussion among GRELAN, BIONUMERIK and such prospective licensee with respect to a mutually satisfactory arrangement for the sharing of data and information. For purposes of this provision, "best efforts" shall mean those reasonable commercial efforts that would be used by reasonable business persons in a similar situation.
Appears in 3 contracts
Samples: Joint Venture Agreement (BioNumerik Pharmaceuticals, Inc.), Joint Venture Agreement (Bionumerik Pharmaceuticals Inc), Joint Venture Agreement (Bionumerik Pharmaceuticals Inc)
Copies and Provision of Information. 6.3.1. KI PHARMA and GRELAN will keep BIONUMERIK regularly and fully informed of the preclinical and clinical process regarding the Venture Products. KI PHARMA and GRELAN also shall keep BIONUMERIK regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BIONUMERIK, upon BIONUMERIK's reasonable request, with English version copies of all important documents, data and other information supplied to or received from the Japanese Government or other approval authority in connection with the applications for the Government Regulatory Approvals. Upon receipt of each Government Regulatory Approval, KI PHARMA and GRELAN shall promptly furnish BIONUMERIK English version copies or other satisfactory evidence thereof.
6.3.2. BIONUMERIK shall provide KI PHARMA and GRELAN with copies of all information generated or controlled by it in the course of satisfying regulatory requirements in the United States and/or Europe related to any Venture Products BN that may be useful or necessary in obtaining Government Regulatory Approvals in the Territory, such as IND applications, annual reports, protocol amendments, IND amendments, and related documents ("IND and Related Information"). If BIONUMERIK grants a license for commercial distribution of any Venture Products BN in areas outside the Territory, BIONUMERIK agrees to use its best efforts to provide in any agreement hereinafter signed with respect to such license that the licensee under such license shall provide KI PHARMA and GRELAN with all data and information generated by such licensee with respect to such products for supporting the development of such products in the Territory. GRELAN shall provide KI PHARMA and BIONUMERIK with copies of all information generated or controlled by it in the course of satisfying regulatory requirements in the United States and/or Europe related to Venture Products GR that may be useful or necessary in obtaining Governmental Regulatory Approvals in the Territory, such as IND and Related Information. If GRELAN grants a license for commercial distribution of any Venture Products GR in areas outside the Territory, GRELAN agrees to use its best efforts to provide in any agreement hereinafter signed with respect to such license that the licensee under such license shall provide KI PHARMA and BIONUMERIK with all data and information generated by such licensee with respect to such products for supporting the development of such products in the Territory. In the event a prospective licensee for the commercial distribution of Venture Products in areas outside the Territory will not agree to the sharing of all data and information as provided above, each of BIONUMERIK and GRELAN will consult with KI PHARMA prior to signing any license agreement with such party and each of BIONUMERIK and GRELAN will use its best efforts to facilitate and provide an opportunity for discussion among GRELAN, BIONUMERIK and such prospective licensee with respect to a mutually satisfactory arrangement for the sharing of data and information. For purposes of this provision, "best efforts" shall mean those reasonable commercial efforts that would be used by reasonable business persons in a similar situation.and
Appears in 1 contract
Samples: Joint Venture Agreement (Bionumerik Pharmaceuticals Inc)