Diligence Obligations. (a) Subject to Section 2.5(b) below, Proprius agrees to use commercially reasonable efforts (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the Term. Without limiting the generality of the foregoing (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to Proprius.
(b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval process.
Diligence Obligations. Licensee shall use Commercially Reasonable Efforts to (a) develop and commercialize the Licensed Product in the entire Territory in accordance with the terms and conditions of this Agreement; (b) obtain Regulatory Approval(s) with respect to the Licensed Product in the Territory; and (c) thereafter diligently and aggressively Exploit the Licensed Product in the Territory to maximize sales. Licensee shall ensure that any Sublicense be terminable at the option of the Licensee in the event that a Sublicensee fails to maintain active, diligent marketing efforts for Licensed Product.
Diligence Obligations. Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products in the Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****.
Diligence Obligations. Following the exercise of a Commercial Option, Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products for each of the Licensed Indications within the Field. Commercially reasonable efforts means efforts equivalent to those utilized by […***…] […***…].
Diligence Obligations. NN shall use commercially --------------------- reasonable efforts to achieve each of the following diligence obligations, for at least one Zid Embodiment in the ZSS, no later than the applicable deadline. The standard diligence time periods that ZGI and NN intend to be included in a Pre-Negotiated License under SECTION 7.8 in the situation where a Xxx Xxxx, Zid Protein or a Soluble Embodiment is the Product are recited below. However, both ZGI and NN recognize that specific circumstances surrounding a particular Zid Embodiment may lead the parties to negotiate one or more different diligence time period(s) within a particular Pre-Negotiated License. Under the standard diligence time periods, NN must:
(a) obtain approval by NN's review board to make such Zid Embodiment an NN project which is reasonably resourced and funded in accordance with NN practice and taking into consideration the stage of development of the Zid Embodiment, no later than sixty (60) days after NN exercises the BC Option under this ARTICLE 7;
(b) initiate a Phase III clinical trial no later [*] from IND approval;
(c) file a PLA or pay the [*] Milestone Fees under SUBSECTION 7.8.2 no later than [*] after fulfillment of diligence obligation (b) above.
Diligence Obligations. Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products in each of the disease indications within the Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****.
Diligence Obligations. Distributor shall use diligent efforts to obtain regulatory approval of the Product in the Territory. In fulfilling this diligence obligation, Distributor shall use at least the same level of effort to obtain regulatory approval as Distributor uses to obtain regulatory approvals for other products Distributor distributes, including those manufactured by its Affiliate. Supplier’s sole remedy for such a breach shall be to terminate this Agreement under Section 10(b).
Diligence Obligations. SIIPL will perform all activities set forth in the Development Plan and use its [***] to perform all such activities in accordance with the applicable timeframes set forth in the Development Plan. In addition, SIIPL will use [***] to Develop and obtain Regulatory Approval for the Product in all countries in the SIIPL Territory.
Diligence Obligations. (a) Purchaser shall act in good faith and shall use commercially reasonable efforts, and shall cause its Affiliates and Licensees to act in good faith and use commercially reasonable efforts, to (i) cause each of the Milestones to be achieved, including, as applicable, [***] with [***] and [***] discussions and negotiations to attempt to agree upon mutually satisfactory agreements relating to the [***] Commercial Program and the [***] Commercial Program, timely preparing and filing all documents necessary and diligently pursuing all filings necessary to achieve each Milestone, and developing, commercializing and selling CB-CAPS Products, (ii) develop, commercialize and sell Products subject to the Royalty Transactions, and (iii) collect, or cause to be collected, the Acquired Xifin Accounts Receivable. In addition, Purchaser [***]
Diligence Obligations. OSI will use its COMMERCIALLY REASONABLE EFFORTS to seek approval of NDAs (or its equivalent) in the MAJOR MARKETS, and to develop, commercialize and market, and achieve FIRST COMMERCIAL SALE of the PRODUCT in the first MAJOR MARKET country on or before [**]. If OSI reasonably and in good faith believes that it cannot, within the exercise of reasonable business judgment, commercialize the PRODUCT in one or more MAJOR MARKET countries in the TERRITORY by [**], then, provided OSI has exercised COMMERCIALLY REASONABLE EFFORTS as required in this Section 3.7, OSI may request from NEKTAR AL an extension of time, and the PARTIES shall negotiate in good faith to determine a time extension that is mutually acceptable. If OSI does not use COMMERCIALLY REASONABLE EFFORTS in this regard, then, NEKTAR AL may, at its sole option and by giving written notice to OSI, either convert the LICENSE to be non-exclusive in the country or countries of the MAJOR MARKETS in the TERRITORY in which such default occurs or terminate this AGREEMENT with respect to the country or countries of the MAJOR MARKETS in the TERRITORY in which such default occurs (in which latter case the TERRITORY shall no longer include such country or countries). If the LICENSE becomes non-exclusive in one or more countries of the TERRITORY as provided for in the immediately preceding sentence, OSI’s obligations to pay milestones and royalties to NEKTAR AL, as provided for in this AGREEMENT, shall continue. Notwithstanding the preceding provisions of this Section 3.7, if OSI does not (a) use at least COMMERCIALLY REASONABLE EFFORTS to develop the PRODUCT file and seek approval of NDAs, on a schedule permitting achievement of the following clause (b), (b) make the FIRST COMMERCIAL SALE of the PRODUCT in [**] or more MAJOR MARKET countries on or before [**], and (c) thereafter use at least COMMERCIALLY REASONABLE EFFORTS to continue to commercialize and market the PRODUCT in such MAJOR MARKET COUNTRIES, it shall be deemed a material breach of this AGREEMENT by OSI, and NEKTAR AL may terminate this AGREEMENT under Section 11.4 as its sole and exclusive remedy with respect to such breach of this Section 3.7.
