New Indications. 7.1 Within:
New Indications. Provided that: (i) Voyager is not in default of any material term of this Agreement, (ii) DURECT is reasonably satisfied that Voyager has the resources to develop such products and (iii) Voyager and DURECT have agreed to provisions that ensure the diligent Exploitation of such products, DURECT shall agree to grant to Voyager a license under the SBS Technology and/or the SBS Improvements to Exploit a biodegradable polymeric implant (single, solid, preformed macroscopic device) for the treatment of cancers in humans, which cancers are to be specified and mutually agreed to by the parties and based upon experimental data that supports use in such cancers, that utilizes the SBS Technology or the SBS Improvement and contains the Active Agent on the same terms as applicable to the Product under the Agreement.
New Indications. 7.6.1. In the event that InterMune receives approval in the TERRITORY to commercially sell PRODUCT for indications other than Chronic Granulomatous Disease, and provided that InterMune has the right to grant a license to BII in the BI TERRITORY to make, use and sell PRODUCT for such additional indications (a "NEW INDICATIONS LICENSE"), InterMune shall provide BII written notice thereof.
New Indications. If SPI develops any New Indication(s) for the Products in the Initial Territory, Takeda shall be given the right of first refusal to obtain a license to develop and commercialize the Products for such New Indication(s) in the Initial Territory. SPI shall provide Takeda with notice of any such New Indication(s) once SPI enters into a proof of concept studies or Phase II studies for a New Indication(s) together with all such material information with regard to such New Indication(s) as enables Takeda to evaluate the New Indication(s) and its potential marketability, and if Takeda desires to obtain a license to the New Indication(s) stated in such notice for the Initial Territory pursuant to a separate written license agreement, the Parties shall then negotiate in good faith for a period of [**] after Takeda’s receipt of such notice. If basic terms and conditions of such license agreement have not been agreed upon by the Parties within the foregoing period, SPI shall be entitled to develop and commercialize the Product for such New Indication(s), and Takeda shall have no further rights with respect to such New Indication(s).
New Indications. 7.6.1 In the event that VIDARA receives approval in the TERRITORY to commercially sell PRODUCT for indications other than Chronic Granulomatous Disease and severe, malignant Osteopetrosis, and provided that VIDARA has the right to grant a license to BII in the BI *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. TERRITORY to make, use and sell PRODUCT for such additional indications (a “NEW INDICATIONS LICENSE”), VIDARA shall provide BII written notice thereof.
New Indications. Company shall have the right, in its sole discretion, to pursue a New Indication for the Product in the Territory (and to engage in development work and clinical trials outside the Territory for such purpose pursuant to the provisions of Section 2(a)), subject to and in accordance with the terms and conditions of this Agreement. If Company decides to pursue any such New Indication, Company shall be solely responsible at its own expense for accomplishing all Product development and commercialization, including without limitation (1) any pre-clinical, clinical and regulatory work, additional clinical testing or other studies and manufacturing requirements relating to the Product for such New Indication; (2) all FDA and other regulatory obligations post approval for such New Indication; and (3) any other Product and medical requirements relating to the sale or marketing of the Product for such New Indication.
New Indications. If, from time to time during the term of this --------------- Agreement, ORTHOVITA files with respect to a Product(s) for a dental indication other than the Indications, then ORTHOVITA shall promptly notify 3i in writing of such filing as provided by Section 10.4 below.
New Indications. (a) As provided in the Ex-US Agreement, Protalix shall notify the Steering Committee, at least every six (6) months during the Term, of any material updates with respect to any material Development activities, with respect to the Licensed Product for a New Indication (a “New Use”).
New Indications. Company shall have the right, in its sole discretion, to conduct development and commercialization of the Product for any New Indication in the Territory, subject to and in accordance with the terms and conditions of this Agreement. If Company decides to pursue any such New Indication, Company shall be solely responsible at its sole cost and expense for accomplishing all Product development and commercialization, including without limitation (1) any pre-clinical, clinical and regulatory work, additional clinical testing or other studies and manufacturing requirements relating to the Product for such New Indication; (2) all FDA and other regulatory obligations post approval for such New Indication; and (3) any other Product and medical requirements relating to the sale or marketing of the Product for such New Indication. Subject to Section 5(f), Company agrees to provide BPA with copies of all correspondence and documents to and from FDA and all notices received from FDA regarding such New Indication and to also provide BPA with regular updates as BPA may reasonably request.
New Indications. The JPC shall decide whether the Parties will file INDs or NDAs in connection with any indication for the Product other than SLE. Genelabs and Watsxx xxxll jointly conduct all studies associated with such INDs and NDAs designed to support the approval of such indication and shall be jointly responsible for the costs associated therewith.
