Commencing on First Commercial Sale of Contrave in the Initial Indication and ending Sample Clauses

Commencing on First Commercial Sale of Contrave in the Initial Indication and ending on the later of the [***] ([***]) anniversary of such date or [***] (the “PDE Term”), Takeda shall, in accordance with the Commercialization Plan and this Section 3.2.1, provide at least the following Primary Detail Equivalents for such Product; (i) during the first consecutive [***] ([***])[***] period following the First Commercial Sale, [***] ([***]) Primary Detail Equivalents, of which at least [***] ([***]) shall be [***] Details; (ii) during each of the following [***] periods thereafter, [***] ([***]) Primary Detail Equivalents, of which at least [***] ([***]) shall be [***] Details (pro-rated for any partial [***]). Takeda shall provide its PDE requirements with the goal of achieving the call plan described in Section 3.2.2, and in accordance with the following: (a) during each [***], at least [***] percent ([***]%) of its PDE requirement under the call plan; and (b) during each [***], at least [***] percent ([***]%) of its PDE requirement under the call plan. If Takeda fails to achieve [***] percent ([***]%) of its PDE requirement under the call plan in a [***], it must exceed [***] percent ([***]%) of its PDE requirement under such call plan in the following [***] by the number of PDEs that Takeda failed to achieve in the prior [***] (i.e., that caused it to achieve less than [***] percent ([***]%) of its PDE requirement). If Takeda fails to achieve [***] percent ([***]%) of its PDE requirement under the call plan in any [***], it must exceed [***] percent ([***]%) of its PDE requirement under the call plan in the following [***] by the number of PDEs that Takeda failed to achieve under the call plan in the prior [***] (i.e., that caused it to achieve less then [***] percent ([***]%) of its PDE requirement under the call plan). Any failure by Takeda to correct a PDE shortfall (i.e., achieving less than [***] percent ([***]%) of its PDE requirement under the call plan in a [***] or [***] percent ([***]%) of its PDE requirement under the call plan in a [***]) in the timeframe specified above shall be a material breach of this Agreement; provided, however, for the avoidance of doubt, (1) if Takeda achieves the PDE requirements as set forth above, including through the correction of any shortfall, it may not be held in material breach for failure to achieve [***] percent ([***]%) of the PDE requirements under the call plan and (2) details that are not [***] shall have no Primary Detail Equivalent value. Upon expiration of the PDE Term, (x) the JCC sh...
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Related to Commencing on First Commercial Sale of Contrave in the Initial Indication and ending

  • First Commercial Sale The term “

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • The First Closing Date Delivery of certificates for the Firm Shares to be purchased by the Underwriters and payment therefor shall be made at the offices of Xxxxxxxxx & Xxxxxxx LLP (or such other place as may be agreed to by the Company and the Representatives) at 9:00 a.m. New York City time, on [•], or such other time and date not later than 1:30 p.m. New York City time, on [•] as the Representatives shall designate by notice to the Company (the time and date of such closing are called the “First Closing Date”). The Company hereby acknowledges that circumstances under which the Representatives may provide notice to postpone the First Closing Date as originally scheduled include, but are not limited to, any determination by the Company or the Representatives to recirculate to the public copies of an amended or supplemented Prospectus or a delay as contemplated by the provisions of Section 11.

  • Tax Periods Ending on or Before the Closing Date Buyer shall prepare or cause to be prepared and file or cause to be filed all Tax Returns for the Company and the Company Subsidiary for all periods ending on or prior to the Closing Date which are required to be filed (taking into account all extensions properly obtained) after the Closing Date.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Initial Advance to Each Designated Subsidiary The obligation of each Lender to make an initial Advance to each Designated Subsidiary is subject to the receipt by the Agent on or before the date of such initial Advance of each of the following, in form and substance reasonably satisfactory to the Agent and dated such date:

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Preparation for Each Auction; Maintenance of Registry of Existing Holders (a) As of the date hereof, the Company shall provide the Auction Agent with a list of the Broker-Dealers and shall cause to be delivered to the Auction Agent for execution by the Auction Agent a Broker-Dealer Agreement signed by each such Broker-Dealer. The Auction Agent shall keep a list of Broker-Dealers with whom it has signed such Broker-Dealer Agreements, and shall endeavor to keep such list current and accurate and shall indicate thereon, or on a separate list, the identity of each Existing Holder, if any, whose most recent Order was submitted by a Broker-Dealer on such list and resulted in such Existing Holder continuing to hold or purchasing shares of AMPS. Not later than five Business Days prior to any Auction Date for which any change in such list of Broker-Dealers is to be effective, the Company shall notify the Auction Agent in writing of such change and, if any such change is the addition of a Broker-Dealer to such list, the Company shall cause to be delivered to the Auction Agent for execution by the Auction Agent a Broker-Dealer Agreement signed by such Broker-Dealer. The Auction Agent shall have entered into a Broker-Dealer Agreement with each Broker-Dealer prior to the participation of any such Broker-Dealer in any Auction.

  • Tax Periods Beginning Before and Ending After the Closing Date The Company or the Purchaser shall prepare or cause to be prepared and file or cause to be filed any Returns of the Company for Tax periods that begin before the Closing Date and end after the Closing Date. To the extent such Taxes are not fully reserved for in the Company’s financial statements, the Sellers shall pay to the Company an amount equal to the unreserved portion of such Taxes that relates to the portion of the Tax period ending on the Closing Date. Such payment, if any, shall be paid by the Sellers within fifteen (15) days after receipt of written notice from the Company or the Purchaser that such Taxes were paid by the Company or the Purchaser for a period beginning prior to the Closing Date. For purposes of this Section, in the case of any Taxes that are imposed on a periodic basis and are payable for a Taxable period that includes (but does not end on) the Closing Date, the portion of such Tax that relates to the portion of such Tax period ending on the Closing Date shall (i) in the case of any Taxes other than Taxes based upon or related to income or receipts, be deemed to be the amount of such Tax for the entire Tax period multiplied by a fraction the numerator of which is the number of days in the Tax period ending on the Closing Date and the denominator of which is the number of days in the entire Tax period (the “Pro Rata Amount”), and (ii) in the case of any Tax based upon or related to income or receipts, be deemed equal to the amount that would be payable if the relevant Tax period ended on the Closing Date. The Sellers shall pay to the Company with the payment of any taxes due hereunder, the Sellers’ Pro Rata Amount of the costs and expenses incurred by the Purchaser or the Company in the preparation and filing of the Tax Returns. Any net operating losses or credits relating to a Tax period that begins before and ends after the Closing Date shall be taken into account as though the relevant Tax period ended on the Closing Date. All determinations necessary to give effect to the foregoing allocations shall be made in a reasonable manner as agreed to by the parties.

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