Co-Promotion. Upon ROCHE’s decision to file an application for Regulatory Approval in the United States of a Licensed Product for any Indication other than rheumatoid arthritis (which decision is expected to occur at least [***] ([***]) [***] prior to filing any such application) (such decision, the “Commercialization Decision”), ROCHE shall notify SYNTA in writing within twenty (20) Business Days thereof. For clarity, such obligation of ROCHE to notify SYNTA of any Commercialization Decision shall apply to all Licensed Products with respect to which the Commercialization Decision is made. On a Licensed Product-by-Licensed Product basis, SYNTA shall have the right to participate in the Co-promotion of any Licensed Product in the United States for the applicable Indication (the “Co-promotion Option”). SYNTA may exercise its Co-promotion Option by providing written notice to ROCHE within [***] ([***]) [***] after receipt of ROCHE’s Commercialization Decision notice, in which event the minimum terms set forth on Schedule 5.3 shall apply. If SYNTA does not exercise its Co-promotion Option within such [***] ([***]) [***] period, then SYNTA shall have no further right to elect to participate in the Co-promotion of such Licensed Product in the United States for the applicable Indication; provided, however, that the Co-promotion Option shall continue to apply to any and all subsequent Licensed Products, and the failure of SYNTA to exercise its Co-promotion Option with respect to any Licensed Product for any Indication shall not prevent or waive SYNTA’s right to exercise its Co-promotion Option with respect to such Licensed Product for any other Indication or with respect to any other Licensed Product. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Synta Pharmaceuticals Corp), Collaboration and License Agreement (Synta Pharmaceuticals Corp)
Co-Promotion. Upon ROCHE’s decision to file In the Shared Territory, Medivation shall have an application for Regulatory Approval in the United States of a Licensed Product for any Indication other than rheumatoid arthritis option (which decision is expected to occur at least [***] ([***]) [***] prior to filing any such application) (such decision, the “Commercialization DecisionCo-Promotion Option”)) to participate with Astellas in detailing and promoting (but not selling) each Product to Prescribers, ROCHE shall notify SYNTA on the terms and conditions set forth in writing within twenty (20) Business Days thereofthis Section 6.9. For claritySuch Co-Promotion Option may be exercised by Medivation, such obligation of ROCHE to notify SYNTA of any Commercialization Decision shall apply to all Licensed Products with respect to which the Commercialization Decision is made. On on a Licensed Product-by-Licensed Product basis, SYNTA [*] in the Shared Territory. If Medivation exercises such option, Medivation shall have the right to participate provide up to [*], and the obligation to provide at least [*], of the Promotion Effort for each Product in the Shared Territory, with the exact percentage within such range (the “Medivation Promotional Share”) to be determined by Medivation in accordance with the remainder of this Section 6.9(a). Medivation shall initially specify the level of Medivation Promotional Share (which level shall be in accordance with the previous sentence) when it exercises the Co-promotion Promotion Option. Unless otherwise approved by the JCC, such level of any Licensed Medivation Promotional Share shall remain in effect for the balance of the calendar year in which the First Commercial Sale of the Product in the United States for Shared Territory occurs, and the applicable Indication (first full calendar year thereafter. Commencing with the “Co-promotion Option”). SYNTA may exercise its Co-promotion Option by providing written notice to ROCHE within [***] ([***]) [***] after receipt second full calendar year following the First Commercial Sale of ROCHE’s Commercialization Decision notice, in which event the minimum terms set forth on Schedule 5.3 shall apply. If SYNTA does not exercise its Co-promotion Option within such [***] ([***]) [***] period, then SYNTA shall have no further right to elect to participate in the Co-promotion of such Licensed Product in the United States for the applicable Indication; provided, however, that the Co-promotion Option shall continue to apply to any and all subsequent Licensed ProductsShared Territory, and annually thereafter, Medivation may change the failure level of SYNTA to exercise its Co-promotion Option with respect to any Licensed Product for any Indication shall not prevent or waive SYNTA’s right to exercise its Co-promotion Option Medivation Promotional Share with respect to such Licensed Product Product, upon no less than [*] notice to the JCC, provided that the Medivation Promotional Share for any other Indication or with respect to calendar year may not vary by more than [*] from the Medivation Promotional Share from the prior year and must remain within the range set forth above. Changes in the level of Medivation Promotional Share may also occur at any other Licensed Product. Portions of this Exhibit were omitted time, and have been filed separately in any other amount, with the Secretary prior approval of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amendedJCC.
Appears in 2 contracts
Samples: Collaboration Agreement (Medivation, Inc.), Collaboration Agreement (Medivation, Inc.)
Co-Promotion. Upon ROCHE’s decision to file an application for Regulatory Approval in the United States of a Licensed Product for any Indication other than rheumatoid arthritis (which decision is expected to occur at least [***] ([***]) [***] prior to filing any such application) (such decision, the “Commercialization Decision”), ROCHE shall notify SYNTA in writing within twenty (20) Business Days thereof. For clarity, such obligation of ROCHE to notify SYNTA of any Commercialization Decision shall apply to all Licensed Products with respect to which the Commercialization Decision is made. On a Licensed Product-by-Licensed Product basis, SYNTA NewLink shall have the right to participate elect to Co-Promote each Licensed Product or Subsequent Product in each Indication in the Co-promotion of any Licensed Product in the United States for the applicable Indication Promotion Territory (the “Co-promotion Promotion Option”) as set forth in this Section 6.4.
(a) Approximately [*] for a Licensed Product or Subsequent Product in a particular Indication with the FDA, Genentech will notify NewLink of [*]”). SYNTA NewLink may exercise its option to Co-Promote such Licensed Product or Subsequent Product for such Indication in the Co-Promotion Territory by written notice to Genentech no later than [*] after the receipt of the Genentech Estimate for such Licensed Product or Subsequent Product and Indication. For clarity, NewLink shall have [*] under the Co-Promotion Option of this Section 6.4, for [*] for a [*].
(b) If NewLink exercises its Co-Promotion Option for a Licensed Product or Subsequent Product and Indication, unless NewLink terminates the Co-Promotion in accordance with Section 6.4(c) below, NewLink shall have the right to provide [*] percent ([*]%) of the total sales representatives, with [*] of [*] sales representatives in the Co-Promotion Territory as its Co-Promotion efforts for such Licensed Product or Subsequent Product and Indication (the “NewLink Co-Promotion Effort”). NewLink shall inform Genentech of its desired initial NewLink Co-Promotion Efforts concurrent with its written notification to exercise its Co-promotion Promotion Option by providing for such Licensed Product or Subsequent Product and Indication. Following [*] of NewLink Co-Promotion Effort, NewLink [*] the NewLink Co-Promotion Efforts from [*] set forth above upon [*] written notification to Genentech.
(c) Subject to the remainder of this Section 6.4, if NewLink exercises its Co-Promotion Option for a Licensed Product or Subsequent Product and Indication, it shall have the right to continue to Co-Promote such Licensed Product or Subsequent Product and Indication for as long as the Licensed Product or Subsequent Product is being marketed in the Co-Promotion Territory for such Indication. NewLink shall have the right to relinquish its Co-Promotion rights for such Licensed Product or Subsequent Product and Indication with [*] written notice to ROCHE within [***] ([***]) [***] after receipt of ROCHE’s Commercialization Decision noticeGenentech, in which event case the minimum terms set forth on Schedule 5.3 Parties shall applyreasonably cooperate to transition to Genentech, upon the effectiveness of such relinquishment all of NewLink’s Co-Promotion activities with respect to such Licensed Product or Subsequent Product and Indication so as to minimize disruption to sales activity. Upon such effective date, NewLink shall withdraw its sales representatives from such Co-Promotion activities in a professional manner. If SYNTA NewLink does not exercise its Co-promotion Promotion Option within such for a Licensed Product or Subsequent Product [***] ([***]) [***] period, then SYNTA shall have no further right to elect to participate in the Co-promotion of such Licensed Product in the United States for the applicable Indication; provided, however, that the Co-promotion Option shall continue to apply to any and all subsequent Licensed Products, and the failure of SYNTA to exercise its Co-promotion Option with respect to any Licensed Product for any Indication shall not prevent or waive SYNTA’s right to exercise its Co-promotion Promotion Option with respect to such [*] for which [*].
(d) Promptly after NewLink exercises its Co-Promotion Option for a Licensed Product or Subsequent Product and Indication, the Parties shall commence negotiations in good faith and enter into a separate co-promotion agreement (the “Co-Promotion Agreement”) in accordance with the terms and conditions set forth in Exhibit D attached hereto. The Parties shall use commercially reasonable efforts to enter into and execute the Co-Promotion Agreement within [*] following NewLink’s exercise of its Co-Promotion Option.
(e) Within [*] after NewLink exercises its first Co-Promotion Option for a Licensed Product or Subsequent Product and Indication under this Section 6.4, the Parties shall establish a joint commercialization committee (“JCC”) to [*]. The JCC shall be composed of two (2) to three (3) representatives of each Party that have knowledge and expertise in the Commercialization of compounds similar to the Compounds, [*]. Notwithstanding the foregoing, [*] related to the Licensed Product or Subsequent Product.
(f) NewLink sales representatives that are Co-Promoting a Licensed Product or Subsequent Product and Indication in the Co-Promotion Territory shall [*].
(g) In the event of [*] for any other Indication Licensed Product or with respect to Subsequent Product in the Co-Promotion Territory, [*]. In the event of [*] for any other Licensed Product or Subsequent Product in the Co-Promotion Territory, [*]; provided that [*].
(h) In the event that [*], then [*], in which case [*]. If NewLink [*] for a Licensed Product or Subsequent Product. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amendedthen [*]; provided that [*].
Appears in 1 contract
Samples: License and Collaboration Agreement (Newlink Genetics Corp)