At-Risk Launch Sample Clauses

At-Risk Launch. In the event that Purchaser receives an At-Risk Launch Notice, Purchaser shall notify Seller in writing within 10 days of Purchaser’s receipt thereof whether or not Purchaser agrees to launch the commercial sale of the Product to Purchaser Customers in the Territory as contemplated herein based on such At-Risk Launch Notice (an “At-Risk Launch”). In the event that Purchaser notifies Seller that it has determined to engage in an At-Risk Launch, Purchaser shall proceed according to the provisions of Section 2.3.3 below. In the event that Purchaser notifies Seller that it has determined to not engage in an At-Risk Launch, Seller shall have 10 days from receipt of Purchaser’s notice to notify Purchaser in writing whether or not Seller has determined to engage in an At-Risk Launch without Purchaser acting as Seller’s distributor of the Product to the Purchaser Customers in the Territory (a “Seller Launch”). In the event that Seller notifies Purchaser that it has determined to so engage in a Seller Launch, subject to Sections 2.3.4 and 2.3.5 below, this Agreement (including any rights of Purchaser to sell and distribute the Product in the Territory) shall automatically and immediately terminate as of the date of such Seller’s notice to Purchaser. In the event that Seller notifies Purchaser that it has determined to not engage in a Seller Launch, this Agreement shall continue in full force and effect and Seller may at any time thereafter submit a new Launch Notice, at which time the parties shall, among other things, again proceed in accordance with the provisions of this Section 2.3. Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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At-Risk Launch. Subject to Section 4(g) below, [**] after a third party launches an unauthorized generic to FENTORA® (“At Risk Launch”) Cephalon and its Affiliates would grant to Xxxx and its Affiliates a non-exclusive, temporary and contingent license to the Cephalon Patents to make, have made, use, import, market, sell or offer to sell in the Territory generic FENTORA® product (“At Risk License”). During the At Risk License period, Xxxx would have the option to sell either Xxxx Products under a contingent At-Risk launch license (“ANDA Contingent At-Risk Launch License”) or an authorized (Cephalon to Xxxx) generic (“Xxxx XX Products”) under a contingent At-Risk launch license (“AG Contingent At Risk Launch License”). [**], Xxxx would inform Cephalon whether it intends to exercise its option for the AG Contingent At Risk Launch License. For the avoidance of doubt, subject to applicable further limitations under Section 4(g) below, any temporary license under this Section would be available only in the event of and during the period of third party At-Risk Launch generic sales.
Sample 1
At-Risk Launch. 7.1 In the event that a Third Party commences sale of a Generic Equivalent in the Territory without a license or other written authorization from Vivus (an “At Risk Launch”) Actavis shall *** by the *** or (ii) the Launch Date (the “Actavis ***”), but only if either (a) *** after such At Risk Launch; or (b) Vivus ***.
Sample 1
At-Risk Launch. (a) In the event that a Third Party commences sale in the Territory of a Generic Equivalent or an Authorized Generic is sold in the Territory in each case before the occurrence of the ANDA License Start Date (such commencement of sales is an “At Risk Launch”), Defendants may, subject to Section 5.3(b), sell and offer to sell in the Territory the AG Product supplied to Defendants pursuant to the Supply Agreement Terms or, if then applicable, the Supply Agreement, during the period commencing on the At Risk Launch Start Date and ending upon the earlier of (i) three (3) days after the date when Plaintiff notifies Defendants that Plaintiff has obtained a court order requiring the relevant Third Party to stop its sale of the unauthorized Generic Equivalent or other relief sufficient to stop further sales of the unauthorized Generic Equivalent or (ii) the occurrence of the ANDA License Start Date (an “At Risk Period”), but only if at least one of the conditions listed below is met: either (1) the Third Party engaging in the At Risk Launch obtains a district court decision adverse to all then-asserted claims of all of the Patents-in-Suit on infringement and/or validity issues prior to the ANDA License Start Date, whether following a preliminary injunction motion, summary judgment motion or after trial, or (2) upon the At-Risk Launch, if both (A) Plaintiff fails to move for a preliminary injunction or to seek other equitable relief to stop such At Risk Launch within ten (10) days after such At-Risk Launch, and (B) Plaintiff fails to obtain a preliminary injunction or other equitable relief to stop such At Risk Launch within thirty (30) days after such At-Risk Launch. The “
Sample 1

Related to At-Risk Launch

  • Launch Customer shall use commercially reasonable efforts to begin distribution of the Google Desktop Applications promptly following the launch of the Desktop Portal.

  • Country Risk Country Risk shall mean, with respect to the acquisition, ownership, settlement or custody of Investments in a jurisdiction, all risks relating to, or arising in consequence of, systemic and markets factors affecting the acquisition, payment for or ownership of Investments including (a) the prevalence of crime and corruption, (b) the inaccuracy or unreliability of business and financial information, (c) the instability or volatility of banking and financial systems, or the absence or inadequacy of an infrastructure to support such systems, (d) custody and settlement infrastructure of the market in which such Investments are transacted and held, (e) the acts, omissions and operation of any Securities Depository, (f) the risk of the bankruptcy or insolvency of banking agents, counterparties to cash and securities transactions, registrars or transfer agents, and (g) the existence of market conditions which prevent the orderly execution or settlement of transactions or which affect the value of assets.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Commercial Milestone Payments Green Cross shall pay to MacroGenics the Net Sales milestone payments set forth below, which shall be due and payable within *** after the end of the first Calendar Year during which such milestone is triggered.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

  • Customer Notification By executing this Agreement, the Advisor acknowledges that as required by the Advisers Act the Sub-Advisor has supplied to the Advisor and the Trust copies of the Sub-Advisor’s Form ADV with all exhibits and attachments (including the Sub-Advisor’s statement of financial condition) and will promptly supply to the Advisor copies of all amendments or restatements of such document. Otherwise, the Advisor’s rights under federal law allow termination of this contract without penalty within five business days after entering into this contract. U.S. law also requires the Sub-Advisor to obtain, verify, and record information that identifies each person or entity that opens an account. The Sub-Advisor will ask for the Trust’s legal name, principal place of business address, and Taxpayer Identification or other identification number, and may ask for other identifying information.

  • Data Loss Prevention Transfer Agent shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving Transfer Agent’s control without authorization in place.

  • Sales Milestones As to each of the sales milestone events set forth below, GSK shall pay EPIZYME the non-refundable, non-creditable sales milestone payments indicated below upon the first achievement by GSK, its Affiliates or Sublicensees of the success milestone events set forth below with respect to each Selected Target, on a Selected Target-by-Selected Target basis. Sales Milestone Event (For Licensed Products directed to a Selected Target) Milestone Payment (in $ [**]) First Calendar Year in which aggregate world-wide Net Sales of Licensed Product(s) directed to such Selected Target are greater than or equal to $[**] [** ] First Calendar Year in which aggregate world-wide Net Sales of Licensed Product(s) directed to such Selected Target are greater than or equal to $[**] [** ] First Calendar Year in which aggregate world-wide Net Sales of Licensed Product(s) directed to such Selected Target are greater than or equal to $[**] [** ] Upon achievement by or on behalf of GSK, its Affiliates or Sublicensees of a sales milestone event set forth in this Section 6.7, GSK shall promptly (but in no event later than the date on which the royalty report for the Calendar Quarter in which such achievement occurs is due pursuant to Section 6.10.1) notify EPIZYME of such achievement, and GSK shall pay EPIZYME the corresponding sales milestone payment within [**] days after receipt of an invoice for the milestone payment from EPIZYME. Such invoice shall be sent to GSK’s Alliance Manager and [**] with a copy to [**] (or such other email address(es) as may be notified to EPIZYME by GSK). For the avoidance of doubt, more than one of the foregoing sales milestone payments may be earned and become payable with respect to Licensed Products directed to any given Selected Target in the same Calendar Year based on aggregate world-wide Net Sales of Licensed Product(s) directed to such Selected Target during such Calendar Year.

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