Development and Regulatory Milestone Payments Sample Clauses
The Development and Regulatory Milestone Payments clause defines the terms under which one party will make payments to another upon the achievement of specific development or regulatory milestones in a project, typically in the context of pharmaceutical or biotechnology agreements. These milestones might include successful completion of clinical trials, regulatory submissions, or receipt of marketing approval from authorities such as the FDA. By clearly outlining when and how payments are triggered, this clause ensures both parties understand the financial incentives tied to project progress and helps allocate risk and reward throughout the development process.
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Development and Regulatory Milestone Payments. Buyer shall also pay the following development and regulatory milestone payments:
(a) With respect to Non-ALS or Stroke Orphazyme Products and subject to the terms set forth in subsection (b) below, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: Milestone Event First Non-ALS or Stroke Orphazyme Product Milestone Payment Second Non-ALS or Stroke Orphazyme Product Milestone Payment [*] [*] [*] [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
(b) Buyer shall pay to Seller the amounts set forth under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” when the first Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. Buyer shall pay to Seller the amounts set forth under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” when the second Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. A Non-ALS or Stroke Orphazyme Product will not be considered the second Non-ALS or Stroke Orphazyme Product for purposes of the preceding sentence unless it contains a different Compound than the first Non-ALS or Stroke Orphazyme Product. The amounts payable under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. The amounts payable under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party.
(c) With respect to each ALS or Stroke Orphazyme Product, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: [*] [*] Each milestone payment shall be payable only once for each ALS or Stroke Orphazyme Product irrespective of the number of times the milestone events shall have been achieved by such ALS or S...
Development and Regulatory Milestone Payments. With respect to each Arcus Program for which TAIHO exercised the Option and has been granted the License, TAIHO shall, subject to the terms of this Section 5.2, pay to Arcus the corresponding (depending on regulatory pathway and indication) one-time, non-refundable, non-creditable milestone payment within [***] days after TAIHO’s receipt of an invoice from Arcus following the first achievement, by TAIHO or any of TAIHO’s Sublicensees, of each of the milestone events set forth in the applicable table below by a Licensed Product in such Arcus Program (“Development and Regulatory Milestones;” and such payments “Development and Regulatory Milestone Payments”). For the sake of clarity and as an example only, if TAIHO exercises the Option with respect to six (6) Arcus Programs, then TAIHO may owe to Arcus a particular milestone payment up to six (6) times. TAIHO shall notify Arcus in writing within [***] days after the Achievement of any Development and Regulatory Milestones.
Development and Regulatory Milestone Payments. Subject to Section 10.7.4, on a Licensed Target-by-Licensed Target basis, Novartis will make one-time milestone payments to Surface (each, a “Developmental Milestone Payment”) upon the first achievement of the development and regulatory milestone events set forth in this Section 10.7 (each, a “Developmental Milestone Event”) with respect to a Licensed Target as set forth in the applicable table below for T1 Licensed Products, Global Licensed Products or Regional Licensed Products, as applicable. For clarity, and without limitation, references to Licensed Product include a Combination. Notwithstanding any other provision of this Agreement, each series of Development Milestone Payments will be payable only once with respect to the specified Licensed Target, notwithstanding the number of Licensed Products (or the number of times a Licensed Product) may achieve the applicable Development 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.
Development and Regulatory Milestone Payments. In the event BI achieves a Development or regulatory milestone specified below with respect to a Collaboration Compound or BI Compound, BI shall promptly, but in no event more than ten (10) days after the achievement of each such milestone, notify Vitae in writing of the achievement of such milestone. BI shall pay to Vitae the non-refundable, non-creditable milestone payments as specified below within thirty (30) days of receipt of a written invoice to be provide by Vitae as soon as practicable following achievement of the particular milestone. Notwithstanding the foregoing, if one or more Development milestones with respect to a particular Product does not occur, but a later Development milestone for the same Product is achieved, then all previous ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
Development and Regulatory Milestone Payments. In addition to the payments under Sections 10.1, to 10.4 inclusive, in further consideration for the exclusive licenses granted hereunder, and subject to the terms and conditions set forth in this Agreement, Genmab shall make the following non-refundable and non-creditable Development and regulatory milestone payments to CureVac:
Development and Regulatory Milestone Payments. In consideration for the exclusive licenses granted to GSK under the CureVac Technology, on a Product-by-Product basis, GSK shall pay to CureVac the one-time, non-refundable, non-creditable development milestone payments set forth in this Section 8.3 (each a "Development & Regulatory Milestone Payment") upon the first occurrence of the applicable milestone event with respect to any Product, provided that each such milestone payment shall be due only once for each Product (each a "Development & Regulatory Milestone Event"). On a Product-by-Product basis, if any one of the Development & Regulatory Milestone Events is not required for the Development of a Product, such Development & Regulatory Milestone Payment shall become payable upon achieving the Development & Regulatory Milestone Event following the Development & Regulatory Milestone Event which was not required, i.e., upon the achievement of such following Development & Regulatory Milestone Event two Development & Regulatory Milestone Payments become payable hereunder.
Development and Regulatory Milestone Payments. (i) Subject to the terms and conditions herein, within [***] after the first achievement of each milestone event below in connection with an Initial Licensed Product containing SAL200 by or on behalf of Lysovant or any of its Affiliates or Sublicensees (each, an “SAL200 Milestone Event”), Lysovant shall notify iNtRON of the achievement of such milestone event. iNtRON shall invoice Lysovant for the applicable non-refundable, non-creditable milestone payment corresponding to such SAL200 Milestone Event as shown below. Lysovant shall remit payment to iNtRON within [***] of the receipt of such invoice. [***] [*** ] [***] [*** ] [***] [*** ] [***] [*** ]
(ii) The milestone payments set forth in Section 7.2(a)(i) (Development and Regulatory Milestone Payments) shall be payable only once, upon the first achievement of the applicable milestone event by any Licensed Product containing SAL200, even if the same milestone event is later achieved by another Licensed Product. If a Combination Product containing SAL200 is the first Licensed Product to achieve a SAL200 Milestone Event then the corresponding milestone payment under Section 7.2(a)(i) (Development and Regulatory Milestone Payments) will be due for such Combination Product, but no additional payment under Section 7.2(a)(iii) (Development and Regulatory Milestone Payments) shall be due for the use of any other Licensed Endolysins in such Combination Product. For clarity,
(A) if a New Endolysin Milestone Event is achieved by a Licensed Product containing an Initial Endolysin other than SAL200 and the corresponding milestone payment made under 7.2(a)(iii) (Development and Regulatory Milestone Payments) and a SAL200 Milestone Event corresponding to such New Endolysin Milestone Event is subsequently achieved by a Licensed Product containing SAL200, then Lysovant will only have to pay to iNtRON the difference between the milestone payment previously paid for the achievement of such New Endolysin Milestone Event and the milestone payment due for achievement of such SAL200 Milestone Event under Section 7.2(a)(i) (Development and Regulatory Milestone Payments).
(B) If a Combination Product containing SAL200 and one or more different Licensed Endolysins achieves a SAL200 Milestone Event and such SAL200 Milestone Event has not previously been achieved by an Initial Licensed Product containing SAL200 or a Combination Product containing SAL200, then only the payment set forth under Section 7.2(a)(i) (Development and Regul...
Development and Regulatory Milestone Payments. The development and regulatory milestone payments shall be provided to Elion in 2 forms: Milestone Restricted Shares which shall be identical to the shares of Common Stock which constitute the Satisfactory Public Offering Securities (“MRSs”) or cash. The MRSs shall be issued within five (5) Business Days following satisfaction of the applicable Milestone Event and shall be subject to a six month Lock-up following the date of satisfaction of such applicable Milestone Event. All MRSs shall contain a customary restrictive legend that specifies that such shares of Common Stock have not been registered with the SEC until such time as Processa shall receive a satisfactory opinion of legal counsel (which may be Processa’s legal counsel) that specifies that such restrictive legend is no longer required by law; it being understood and agreed that Processa shall reimburse Elion for the reasonable costs associated with such opinion if not delivered by Processa’s legal counsel. Each milestone cash payment owed by Processa to Elion pursuant to this Section 6.4 shall be payable by Processa within thirty (30) days following the first achievement of the corresponding milestone event. For the avoidance of doubt each milestone payment, whether it be MRSs or cash, is only payable once, regardless of the number of times such milestone may be achieved by Processa, its Affiliates, and Sublicensees. For purposes of this Section 6.4, if the Initiation of a clinical trial of a Licensed Product satisfies more than one of the clinical milestone events below (e.g., if the first clinical trial of a Licensed Product is a Pivotal Trial), then the milestone payments corresponding to both of such clinical milestone events shall be made simultaneously upon the dosing of the first patient of such clinical trial. In addition, if a given milestone event is achieved by a Licensed Product without one or more preceding milestone events having been achieved by such Licensed Product, then the milestone payments corresponding to such skipped milestone events shall be made simultaneously upon achievement of such milestone event by such Licensed Product.
Development and Regulatory Milestone Payments. (a) On a Product-by-Product basis, SGI will make one-time only milestone payments to Unum based on the first achievement of the development and regulatory milestone events as set forth in this Section 11.7 for each Product. [***] or other [***] for each Product [***] First [***]in the [***] [***] For each[***], the earlier of (i) the [***] of such [***] through the [***] process, whereupon the full $[***] (or any amount not already paid pursuant to the following clause (ii)) will then be due and payable, or (ii) [***] in the first [***], whereupon [***] will then be due and payable upon [***] in each of such [***] (and for clarity, such [***] payments under this clause (ii) will be payable upon [***] in each of such [***], and will not be deferred until all [***] such [***] have been achieved). Total of up to [***], payable as provided in the column to the immediate left
Development and Regulatory Milestone Payments. On a Program-by-Program basis, Zai shall pay to MacroGenics the non-creditable, non-refundable milestone payments listed set forth in the table below within [***] after the first achievement of the applicable milestone events by the first Product in such Program, whether by or on behalf of Zai, its Affiliate or any Sublicensee. For clarity, each of the following milestone payments shall be payable only once per Program, regardless of the number of times such milestone is achieved.