Additional Milestone Payments. In addition to any payments made under Section 4.1 above, RELIANT will pay to PRONOVA additional milestone payments as follows:
(a) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of “IgA nephropathy” as an additional indication for the Product (provided that RELIANT owns the Registration for the Product at such time); and
(b) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of a label change for the Product containing the plaque stabilization data (Southampton Study) (provided that RELIANT owns the Registration for the Product at such time). RELIANT shall only be responsible for those costs directly related to the preparation and filing of the supplemental NDAs and similar documents required to be filed with the applicable Regulatory Authorities for the Regulatory Approvals related to the matters described in clauses (a) and (b) above, and RELIANT shall not be responsible for any other costs and expenses associated therewith, including any costs associated with clinical studies or data.
Additional Milestone Payments. EXHIBIT 10.1 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(B)(4) and 230.406
13.2.1 During the Term, if Success Milestones 7 and 8 have both been achieved (irrespective of whether UCLB has received payments with respect to either or both of Success Milestones 7 and 8), should any subsequent Logic Gate Product achieve [***] (being any Logic Gate Product that [***]), Autolus shall, in accordance with Clause 16, pay to UCLB a one-off milestone payment of GBP £[***] upon [***] of such subsequent Logic Gate Product (“Additional LG Milestone Payment”) provided that at the time of [***]. A “Milestone Logic Gate Product” is any Logic Gate Product in respect of which a Success Milestone Payment or Additional LG Milestone Payment has been paid or is payable. For the avoidance of doubt, subject to the requirement of [***], there shall be no limit on the number of Additional LG Milestone Payments that may be payable under this Clause 13.2.1. Upon there ceasing to be [***], this Clause 13.2.1 shall cease to apply.
Additional Milestone Payments. Santarus shall make the following one-time payments to the University for the first time each of the following Net Sales milestones for *** Licensed Products is achieved in a calendar year:
(c) Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(e) For the avoidance of doubt, in no event shall Santarus be required to make more than one payment pursuant to each of a, b, c, d and e of this Section 4.3.
Additional Milestone Payments. 3.4.1 In case the Company obtains EMA marketing authorisation or the equivalent FDA approval (“Market Approval”) for the first product/indication based on AlloCSCs in AMI (the “First Product”) and if at such time the Company has not licensed out to a third party (i.e., a party which is not part of the TiGenix Group) the rights to develop and commercialize the First Product, Genetrix shall be entitled to the following milestone payments on the terms and conditions set out below:
(i) EUR 20 million upon Market Approval for the First Product;
(ii) EUR 15 million when Net Sales of the First Product reach EUR 150 million in one calendar year for the first time;
(iii) EUR 30 million when Net Sales of the First Product reach EUR 300 million in one calendar year for the first time;
(iv) EUR 45 million when Net Sales of the First Product reach EUR 450 million in one calendar year for the first time;
(v) EUR 60 million when Net Sales of the First Product reach EUR 600 million in one calendar year for the first time;
(vi) EUR 75 million when Net Sales of the First Product reach EUR 750 million in one calendar year for the first time (each of the above, an “Additional Milestone Payment”), provided that the First Product is commercialised by an entity of the TiGenix Group and such Net Sales are realised during the relevant calendar year. For the avoidance of doubt, the Parties agree that if during a single calendar year the Net Sales meet two (or more) of the aforementioned thresholds, Genetrix shall be entitled to the aggregate of all the relevant Additional Milestone Payments. Taking into account the corporate interests of the TiGenix Group and except if the Company would decide to stop the AlloCSCs Programmes, TiGenix shall use its best efforts and shall procure that the Company shall use its best efforts to allocate sufficient financial and human resources to obtain the Market Approval for the First Product in the ordinary course. Within sixty (60) Business Days following the end of the calendar year during which Market Approval for the First Product occurs and each subsequent calendar year during which Net Sales of the First Product have been realised by the TiGenix Group, TiGenix shall provide Genetrix with the details of the computation of the Net Sales of the First Product for the relevant calendar year together with documents evidencing the determination of the Net Sales. As the case may be, Genetrix has fifteen (15) days to notify its disapproval to TiGenix (...
Additional Milestone Payments. 11 Section 4.05. Reports..........................................................................................12
Additional Milestone Payments. Should the Parties agree to develop the Six Month Product, Sanofi-Synthelabo shall pay to Atrix, as licensing fees, the following milestone payments within thirty (30) days after Atrix gives notice to Sanofi-Synthelabo of the occurrence of the specified milestone event:
(i) [**]
(ii) [**] provided however, [**] shall be credited against [**] and [**], if any, shall be credited against amounts owed by Sanofi-Synthelabo to Atrix as set forth in Section 4.04(ii).
Additional Milestone Payments. Should Novartis decide not to exercise its Call-Back Option as set forth in Article 6, the following additional milestone payments shall be due to Novartis:
a) An additional ** once MIP annual Net Sales amount of ** is achieved, payable in two equal installments, the first payment due by January 31st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.
b) An additional ** once MIP annual Net Sales of ** is achieved, payable in two equal installments, the first payment due by January 31st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.
c) An additional ** once MIP annual Net Sales amount to ** is achieved, payable in two equal installments, the first payment by January 31st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.
Additional Milestone Payments. The following milestone payments shall be in addition to those specified in Section 5.2, and shall be payable to MIP in the Calendar Quarter following that in which the milestone is achieved pursuant to article 5.10. The following additional milestones under this article 5.3 shall be cumulative. These additional milestone payments shall not be credited against any royalty or other payments to be made pursuant to this Agreement, and shall not be refundable. The payment shall be received by MIP 60 days after the occurrence of such milestone.
5.3.1 shall be due upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******;
5.3.2 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******; *Confidential Treatment Requested*
5.3.3 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******; and
5.3.4 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******.
Additional Milestone Payments. With respect to the Amgen Optioned Target, if any, Amgen shall pay to Kite the following additional milestone payments to those set forth in Section 8.1.4 (Milestone Payments) with respect to Amgen Optioned Products directed against such Amgen Optioned Target (“Additional Milestone Payments”) following the first occurrence of the corresponding milestone events set forth in the following table (the “Additional Milestone Events”): […***…] […***…] […***…] […***…] Amgen shall pay to Kite the applicable Additional Milestone Payment in the manner described below after the first occurrence of such applicable Additional Milestone Event with respect to an Amgen Optioned Product directed against the Amgen Optioned Target. For clarity, each Additional Milestone Payment is payable only once; no Additional Milestone Payment shall be payable for subsequent or repeated achievements of such Additional Milestone Event with one or more of the same or different Amgen Optioned Products directed against such Amgen Optioned Target. Each of the Additional Milestone Payments shall be non-refundable and non-creditable. Amgen shall report to Kite its achievement of each Additional Milestone Event for which payment to Kite is due, within […***…] after Amgen determines such achievement has occurred, and Kite shall invoice Amgen for the applicable Additional Milestone Payment. Amgen will pay each such invoice within […***…] of its receipt thereof.
Additional Milestone Payments i.. During the Term, if Success Milestones 7 and 8 have both been achieved (irrespective of whether UCLB has received payments with respect to either or both of Success Milestones 7 and 8), should any subsequent Logic Gate Product achieve [***] (being any Logic Gate Product that [***]), Autolus shall, in accordance with Clause 16, pay to UCLB a one-off milestone payment of GBP £[***] upon the [***] of such subsequent Logic Gate Product (“Additional LG Milestone Payment”) provided that at the time of [***]. A “Milestone Logic Gate Product” is any Logic Gate Product in respect of which a Success Milestone Payment or Additional LG Milestone Payment has been paid or is payable. For the avoidance of doubt, subject to the requirement of [***], there shall be no limit on the number of Additional LG Milestone Payments that may be payable under this Clause 13.2.
