Development of Licensed Products. (i) On or before execution of this Agreement, Company shall furnish University with a written business plan under which Company intends as of the Effective Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change.
(ii) Within sixty (60) days after the start of each calendar year, beginning on January 1, 2008, Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year.
(iii) Within five (5) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an IND or its equivalent with the FDA covering at least one (1) Licensed Product.
(iv) Within twelve (12) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product.
(v) Within three (3) months after receiving FDA approval of the NDA or BLA for any Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States.
(vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product.
Development of Licensed Products. Licensee, upon execution of this Agreement, will use Commercially Reasonable Efforts to (a) diligently proceed with the development and manufacture (directly or through a contracted third party) of Licensed Products and (b) after obtaining applicable regulatory approval, market and sell the Licensed Products in quantities sufficient to meet the market demands therefor. Licensee or a Sublicensee will use Commercially Reasonable Efforts to obtain all necessary governmental approvals in each country where Licensed Products are manufactured, used, sold, offered for sale or imported.
Development of Licensed Products. This LPA grants Publisher the right to publish, have manufactured, market, distribute and sell Licensed Products, and does not authorize Publisher to develop Licensed Products or to lease or license Development Tools from SCEA to assist in such development. In order for Publisher to have Licensed Products developed for the Player or to lease or license Development Tools from SCEA to assist in such development, it must either (i) enter into a Licensed Developer Agreement directly with SCEA or with an Affiliate of SCEA; or (ii) enter into an agreement with a Licensed Developer for the development of Licensed Products. Publisher may also publish, have manufactured, market, distribute and/or sell Licensed Products for a Licensed Developer or another Licensed Publisher pursuant to the terms of this Agreement. Publisher shall notify SCEA in writing of the identity of any third party or Licensed Developer with whom it has contracted to develop, publish, have manufactured, market, distribute and/or sell Licensed Products within thirty (30) days of entering into an agreement or other arrangement with the third party. Publisher shall have the responsibility for determining that any developers or other third parties meet the criteria set forth herein. It shall be considered a material breach of this LPA for Publisher to provide Development Tools or other Sony Materials to an unlicensed developer or other third party.
Development of Licensed Products. 3.1.1. ViroPharma shall use its Commercially Reasonable Efforts on a continuous basis to Develop a Licensed Product for an Orphan Indication in *** and *** of *** in ***. As of the Effective Date, ViroPharma acknowledges that its current intent is to use its Commercially Reasonable Efforts to Develop a Licensed Product for the treatment of Friedreich’s Ataxia, which intent may change from time to time. Without limiting the foregoing, ViroPharma shall (a) Initiate a Phase II Clinical Trial *** of the Effective Date; provided, however, that *** to *** the *** of *** to Initiate the Phase II Clinical Trial *** shall *** a *** of this provision; and (b) *** to *** the *** and the *** to *** for *** from the *** in *** and from the ***; and *** and ***, to ***; provided, however, that the provisions of this Section 3.1.1(b) are subject, ***, in the *** of *** under this Agreement, to *** of a *** to *** for a *** in *** and/or in ***.
3.1.2. ViroPharma shall not be liable to INS for the failure to successfully develop Licensed Products and/or obtain Regulatory Authorizations for Licensed Products in the Territory.
Development of Licensed Products. Subject to the terms of this Agreement, the Parties shall undertake Development activities with respect to Licensed Products in the Field pursuant to the Global Development Plans under the general direction and oversight of the JDC. Each Party shall use Commercially Reasonable Efforts to Develop Licensed Products in the Field, carry out the Development activities assigned to it in Development Plans in a timely manner and conduct all such activities in compliance with applicable Laws, including, without limitation, Good Practices.
Development of Licensed Products. (i) Within [***], Company shall furnish University with a written research and development plan under which Company intends as of the Effective Date to develop Licensed Products.
(ii) Within [***], beginning on January 1, 2015 Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year.
(iii) Within [***] after the Effective Date, Company, its Affiliate or Sublicensee shall [***].
(iv) Within ten (10) years after the Effective Date, Company, its Affiliate or Sublicensee shall [***].
Development of Licensed Products. Urohealth shall assume and pay all Licensed Product development costs incurred by Urohealth from and after the Effective Date and throughout the term of this Agreement.
Development of Licensed Products. 17 4.1. ARDS DEVELOPMENT PROGRAM .......................... 17 4.1.1. TRANSCEND RESPONSIBILITIES ............... 17 4.1.2. BI RESPONSIBILITIES ...................... 17 4.1.3.
Development of Licensed Products. 4.1. ARDS Development Program ------------------------
Development of Licensed Products. (a) Subject to Section 3.5 below, the Parties shall conduct collaborative development projects (i) to control or conduct any then on-going or future clinical trials with respect to Licensed Products, and (ii) to identify and develop Improvements to the Deflux Product and Solesta Product and additional Licensed Products, including additional clinical uses and new formulations or product design in the Licensed Field (each such development project in (i) and (ii) above shall be referred to as a “Project”). Q-Med will participate in assisting QMS in performing clinical studies as agreed between the parties in each case at QMS’ cost, unless otherwise agreed. For clarity, any pre-clinical and clinical activities associated with the first Solesta Product in the U.S., including the Solesta PMA Approval Clinical Trial, shall not be a Project.
(b) Notwithstanding the foregoing or anything else to the contrary in this Article III, Article IV or otherwise, (i) the Parties shall not develop a Project or Licensed Product if Q-Med upon written notice and explanation to QMS, reasonably determines that such development may adversely affect the Commercialization of Q-Med’s other products containing polymerized and cross-linked hyaluronic acid and with or without dextranomer microspheres, wherein the hyaluronic acid is derived from non-animal sources; and (ii) subject to Section 2.5, Q-Med may undertake any preclinical development of such Improvements and other Licensed Products on its own if it so chooses; provided, however, that upon the determination by Q-Med in its reasonable discretion that such development may have commercial application in the Licensed Field, Q-Med will in good faith discuss further development of such Improvement or Licensed Product with the JSC (as defined in Section 3.2 below).