Commercial Launch. LifeScan intends to [*], provided ENACT meets ----------------- its responsibilities set forth in Sections 2.2 and 5.
Commercial Launch. (a) Subject to subsections (b), (c) and (d) of this Section 4.02, Endo shall Launch the Licensed Product within the territory within thirty (30) days of Regulatory Approval of the Licensed Product.
(b) Endo's obligation to Launch shall be suspended until such time as it has received all launch supplies of Licensed Product properly ordered from Noven pursuant to the Supply Agreement; provided that any delays or non-delivery of Licensed Product under the Supply Agreement are not a result of a breach of the Supply Agreement by Endo.
(c) Endo's obligation to Launch and to sell Licensed Product shall be suspended ***
(d) Endo's obligation to Launch and sell Licensed Product shall be suspended for such time as it is prevented from selling Licensed Product by a court order in the relevant territory that Licensed Product infringes a valid claim of a patent of a Third Party or Endo is prohibited from marketing the Licensed Product by any judgment, order, injunction, decree or award of any court, administrative agency, or arbitrator or government body.
(e) Except as otherwise set forth in this Article IV and Section 14.14, if Endo fails to commence to market any Licensed Product in accordance with the requirements of this Article IV, and such failure continues for a period of fifteen (15) business days after written notice from Noven to Endo, then this Agreement shall immediately terminate upon notice to Endo by Noven. Thereafter, Noven shall be free to use and sell Licensed Product in the territory as it may see fit. If Noven determines to terminate this Agreement with respect to the Licensed Product, Endo shall promptly take such actions as Noven may reasonably request, in order to transfer to Noven or its designee, for no additional consideration, all of Endo's right, title, and interest in and to any Regulatory Approvals relating to the Licensed Product in such country, and all information relating to any Regulatory Approvals not previously supplied to Noven.
Commercial Launch. 2 1.10 Controlt...................................................................................... 2 1.11
Commercial Launch. Licensee shall give Schering prior written notice of at least sixty (60) days of its intent to file an NDA for the Licensed Product and at that time shall further provide Schering with the anticipated date of First Commercial Sale for the Licensed Product in the country of filing. Licensee shall promptly provide Schering with notice of any Regulatory Approval of Licensed Product.
Commercial Launch. “Commercial Launch” shall mean, with respect to a P2Y12 Receptor Antagonist Product and a given country, the first sale of such P2Y12 Receptor Antagonist Product to a third party in such country once regulatory approval therefor and therein has been obtained.
Commercial Launch. On or before [*], MDCO shall deliver to Eagle a Purchase Order for the Launch Quantities, which Purchase Order shall set forth the delivery dates for such quantities (the first of which delivery date shall not be earlier than one hundred eighty (180) days after the date of such Purchase Order), and Eagle shall use Commercially Reasonable Efforts, or shall use Commercially Reasonable Efforts to cause its Third Party Manufacturer to, deliver the Launch Quantities of Finished Product on the delivery dates specified in MDCO’s Purchase Order. If [*] Batches of the Launch Quantities do not have sufficient shelf-life for introduction into commerce due to a delay in obtaining Regulatory Approval, then, on a Batch-by-Batch basis, the Supply Cost for such Batches of Product shall be [*], it being understood that the Parties shall, during the first month of each Calendar Quarter during the Term, assess the applicable shelf-life of such Batches and conduct a “true-up” of the Supply Cost for such Batches for the immediately preceding Calendar Quarter, so that, on or before the last day of the first month of each Calendar Quarter during the Term, (i) if MDCO has paid more than [*] share of such Supply Costs for such Calendar Quarter, then Eagle will pay MDCO an amount equal to the difference between the Supply Cost actually paid by MDCO for such Batches and [*] share of such Supply Costs, or (ii) if Eagle has paid [*] of such Supply Costs for such Calendar Quarter, then MDCO will pay Eagle (subject to Section 7.2.2), an amount equal to the difference between the Supply Cost actually paid by Eagle for such Batches and [*] of such Supply Costs.
Commercial Launch. The commencement of the general availability of the N2K Areas to AOL Members (by means other than unadvertised keyword access).
Commercial Launch. Partner shall notify Optimer approximately […***…] in advance of the anticipated First Commercial Sale of any Product. Such notification shall include a preliminary estimate of the quantity of Supplied Product needed for the commercial launch. Partner may change the estimated date of the First Commercial Sale and the estimated quantity of Supplied Product needed for such commercial launch at any time by notifying Optimer; provided, however, that Partner will provide Optimer with an estimate of the minimum amount of Supplied Product that will be necessary for commercial launch at least […***…] prior to such launch (the “Launch Quantities”).
Commercial Launch. Par's management, and its board of directors, shall have the ultimate decision-making authority with respect to the scale and timing of the Commercial Launch of the Product.
(a) Subject to Section 4.3(b), Par agrees to Commercially Launch the Product before the later of June 1, 2005 or six (6) months after Regulatory Approval.
(b) Par's obligations to Commercially Launch the Product shall be suspended during the existence of any one or more of the following:
(i) Par is engaged in litigation with respect to Intellectual Property Rights of a Third Party that concern Product or Par is in good faith negotiations with a Third Party to obtain a license to Intellectual Property Rights that affect the ability to market Product; or
(ii) there is a court order that, in the United States, Product infringes a valid claim of a patent of a Third Party or Advancis is prohibited from marketing the product by any judgment, order, injunction, decree or award of any court, administrative agency, or arbitrator or government body; or
(iii) Subject to 4.3(c), Par is acting in a commercially reasonable fashion in consideration of reasonable threats of patent infringement. Par agrees to keep Advancis informed regarding such potential patent issues.
(c) In the event that Par has not yet launched the product pursuant to Section 4.3(b)(iii) above and Advancis desires to nevertheless launch the Product Advancis will so notify Par. Following such notice, Advancis may if it so chooses seek in good faith an opinion of counsel, which counsel is reasonably acceptable to Par, that such patents that Par is considering pursuant to Section 4.3(b)(iii) are not infringed and/or invalid and/or unenforceable. If Advancis receives such an opinion, Advancis will notify Par and provide a copy of the opinion to Par for its review. If after 45 days ("Par's review period") Par has not notified Advancis that it intends to launch the Product and otherwise comply with the requirements of this Section 4.3 Advancis shall have the right to seek to have a Third Party launch and market the Product or launch and market the Product itself and this Agreement shall automatically terminate as of either (1) the date that Advancis has entered into such an agreement with the Third Party or (2) the date that Advancis launches the Product. With respect to the foregoing item (2), Par hereby agrees that following Par's forty-five (45) day review period Advancis shall be free to enter into such arrangements as necessary to...
Commercial Launch. Sanofi shall notify MannKind approximately […***…] months in advance of the anticipated First Commercial Sale of Product in the Field in the Territory. Such notification shall include a preliminary estimate of the quantity of Product needed for the commercial launch. Sanofi may change the estimated date of the First Commercial Sale and the estimated quantity of Product needed for such commercial launch at any time by notifying MannKind; provided, however, that Sanofi will provide MannKind with its binding forecast for the amount of Product that will be necessary for commercial launch upon achievement of the [...***...] Milestone, and in any event, at least […***…] months prior to such launch (the “Launch Quantities”).
