Initial Product. Within thirty (30) days following the first occurrence of each of the events set forth below for the first Initial Product (and, as applicable pursuant to Section 4.2(b) and (c), Alternate Product), Santen shall pay to Tracon each of the non-refundable, non-creditable milestone payments set forth below when such milestone is achieved by Santen or any of its Affiliates or Sublicensees: Milestone Event Milestone Payment […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] ***Confidential Treatment Requested 22. […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] […***…] U.S.$[…***…] Total Potential Milestone Payments U.S.$155,000,000 * If Santen […***…], Santen will notify Tracon in writing no later than sixty (60) days after the date of the […***…] whether Santen (a) will […***…] or (b) will […***…]. If such notice indicates that Santen will […***…], then such notice shall be deemed as an achievement of milestone for […***…] for the purpose of this Section 4.2(a).
Initial Product. Within 6 months of the Effective Date of this Agreement, the Development Committee will provide DTI with an Initial Product Development Plan setting forth Xxxxxxx'x anticipated development program for the Initial Product in the Territory, including target dates for key clinical and regulatory events in the Major Countries. Such plan shall specify the dates by which Xxxxxxx shall enroll the first patient in a pivotal Phase III study and file for regulatory approval in the first Major Country (these two dates are hereafter referred to as the Critical Target Dates). Such plan shall be finalized by the Development Committee and approved by DTI not later than 7 months after the Effective Date. Exhibit F contains a reasonable preliminary plan which has been reviewed by both parties.
Initial Product. The Parties will collaborate to develop a floor --------------- standing FCHA with an output of approximately [***] and an approximately {***] for use in Europe (the "Initial Product").
Initial Product. With respect to Net Sales of the Initial Product in each country in the Territory during the applicable Royalty Term for the Initial Product in such country, excluding Net Sales of the Initial Product in the Northern American Territory, royalties at the following royalty rates: Annual Net Sales of the Initial Product Royalty Rate On the portion of worldwide annual Net Sales of the Initial Product (excluding Net Sales of the Initial Product in the Northern American Territory) less than or equal to [***] [***] On the portion of worldwide annual Net Sales of the Initial Product (excluding Net Sales of the Initial Product in the Northern American Territory) greater than [***] and less than or equal to [***] [***] On the portion of worldwide annual Net Sales of the Initial Product (excluding Net Sales of the Initial Product in the Northern American Territory) greater than [***] [***] For the avoidance of doubt, the aggregate annual Net Sales of the Initial Product in the Northern American Territory during the Co-Funding Term shall be excluded from the calculation of the royalty thresholds set forth above and on royalties payable to MacroGenics pursuant to this Section 9.4(b)(i).
Initial Product. Unless otherwise specified in the applicable Development Plan, this Agreement or the LLC Agreement, subject to Section 5.7(b)(ii), each Operating Party shall bear ************ costs and expenses incurred in connection with its respective Development Activities with respect to the Initial Product, as such costs are incurred. Notwithstanding the foregoing, LFB Biotech shall purchase from GTC quantities of the Initial Product for the conduct of the LFB Biotech Development Activities in the European Territory and the Co-Exclusive Territory pursuant to the applicable Development Plans, as set forth in Article 7.
Initial Product. The term "Initial Product" means the fibrin sealant product currently approved by the FDA and known under the trade name Hemaseel APR(TM) which is fibrinogen, thrombin and diluent; the product circular and specifications for which are attached to this Agreement as Exhibit A and as may be amended prior to FDA approval of the BLA for such product.
Initial Product. InterMune will grant to Lilly a non-exclusive, world-wide, [*] license, with a right to sublicense, under InterMune Technology to the extent that it relates to Lilly's ability to make, have made, use, offer to sell, sell and import the Initial Product solely in, and for use in, the country or countries in which InterMune's rights to the Initial Product were so terminated. In addition to the license granted under this [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Section, InterMune also agrees to provide Lilly, at Lilly's expense, reasonable access and reference to, copies of, and use of InterMune Technology, [*] and if Lilly so requests, the [*] to the extent [*] to make, use, offer to sell, sell and import the Initial Product in, and for use in, such country or countries.
Initial Product. ANX-514 manufactured from anhydrous docetaxel will be the initial Product for which a New Drug Application for Regulatory Approval in the United States is submitted.
Initial Product. DURECT’s formulated product known, as of the Effective Date, as POSIMIR® and described NDA No. 204803. EXHIBIT 5.1 MATERIALS PURCHASE AND REIMBURSED EXPENSES Descriptions Amount [***] [***] [***] [***] [***] [***] Total amount [***]: [***] (see details below) EXHIBIT 5.2
Initial Product. Notwithstanding anything to the contrary in this Agreement, in no event will Product Purchase Price for any Initial Product sold by Roivant, or its Sub-distributors or its or their Affiliates, and included in Net Sales, after applying the applicable purchase price calculations under this Agreement (including any applicable deductions), be less on a per tablet basis than US$0.50 (the “Initial Product Minimum Product Purchase Price”), which amount shall be (A) reasonably adjusted to account for any packaging specifications or packaging requirements different than standard (as of the Effective Date) packaging, labels (including package inserts), bottles and closures, and (B) annually adjusted to account for any increased costs (i) of raw materials and components (to the extent that such increase exceeds the CPI Adjustment made pursuant to Section 7.3(d)(iii)), packaging or regulatory compliance activities, or (ii) resulting from changes to the Specifications requested by Roivant.
