Upstream Development Activities Clause Samples
Upstream Development Activities. On the terms and conditions of this Agreement, Upstream shall be responsible for and control the development of the Product on a global basis including Japan, and shall consider in good faith the interests of Maruho in so doing. Upstream shall perform a Phase II(a) Clinical Trial for Orphan Drug Designation as part of Upstream’s global development strategy and shall aim to obtain the regulatory approval of FDA for the Product in that Orphan Drug Designation within [***] following the commencement of such global development; provided, however, that such obligation shall terminate immediately upon the effectiveness of a registration statement filed by Upstream pursuant to the Securities Act of 1933, as amended, for any equity securities of Upstream or Upstream becoming subject to the reporting requirements of the Securities Exchange Act of 1934. Upstream shall develop the Product for use in Japan as part of Upstream’s global development strategy and in accordance with industry practices for development of biological products for use in Japan as part of a global development, and as much as possible on a similar schedule it develops the Product for its initial territory/territories; provided that Upstream’s development of the Product for use in Japan shall be made in accordance with Section 6.1 below.
Upstream Development Activities. On the terms and conditions of this Agreement, Upstream shall be responsible for and control the development of the Product on a global basis including Japan, and shall consider in good faith the interests of Maruho in so doing. Upstream shall make commercially reasonable efforts to perform clinical development as part of Upstream’s global development strategy and shall aim to obtain the regulatory approval for the Products from FDA as quickly as possible in accordance with such strategy. For reference, the current Upstream global development strategy and its estimated schedule are attached in Exhibit C. Upstream shall develop the Product for use in Japan as part of Upstream’s global development strategy and in accordance with industry practices for development of biological products for use in Japan as part of a global development, and as much as possible on a similar schedule it develops the Product for its initial territory/territories; provided that Upstream’s development of the Product for use in Japan shall be made in accordance with Section 6.1 below.”