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. 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. 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 [***] [***] *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. 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 or this Agreement, subject to Section 5.7(b)(ii), each 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 Parties shall initially collaborate to Develop and Commercialize the Initial Product in accordance with the terms and conditions of this Agreement, the Initial Development Plan and the Commercialization Plan for the Initial 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. Licensor shall manufacture and supply to Licensee the Initial Product, as and to the extent set forth in this Article 6. With respect to the Initial Product, the Parties will collaborate to agree and implement within one hundred and twenty (120) days following the Execution Date, a separate agreement relating to technical requirements including without limitation supply organization, quality assurance, specifications, complaints and batch recall, control of material, analytical testing and validation of the Initial Product (the “Technical [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Agreement”). Licensee understands and acknowledges that as of the Execution Date, Licensor does not manufacture itself the Initial Product, but rather relies upon certain third party contract manufacturers to supply bulk active and finished product. In that regard, Licensor has entered into that certain Manufacturing Services Agreement, as of December 20, 2002, with Cambrex Bio Science Baltimore, Inc. as amended (the “Cambrex Agreement”) for the manufacture and supply of IGF-1 bulk drug substance. In addition, Licensor has entered into that certain Drug Product Development and Clinical Supply Agreement with Xxxxxx Pharmaceutical Solutions LLC for finished dosage form of the Initial Product (the “Baxter Existing Agreement”) for development or clinical purposes, and is, as of the Execution Date in negotiations with alternative commercial manufacturers with respect to a commercial supply arrangement for finished dosage form of the Initial Product (once executed, or to the extent another commercial supply agreement is entered into with a party other than Baxter, the “Drug Product Commercial Agreement”). To the extent the terms in this Article 6 are inconsistent with those in the Technical Agreement, the terms in the Technical Agreement shall control.
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. 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.
