Common use of Milestone Payments Clause in Contracts

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “Notwithstanding the foregoing, if the milestone event of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***].

Appears in 2 contracts

Sources: Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc), Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Alnylam will pay MIT the amounts set forth below upon achievement by Alnylam or any of the Original Agreement is hereby amended by adding the following to the end its Affiliates or Sublicensees of the section: “Notwithstanding the foregoing, if the certain milestone event events as set forth below. Payments will be due in respect of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestonesmilestone events for each first Licensed Product containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards a specific Target or a specific combination of Targets; provided, however, that if in the course of development a given Licensed Product is discontinued and replaced with a different Licensed Product for the same therapeutic indication containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the Original Agreement is hereby amended by adding discontinued Licensed Product, milestone payments already paid for the following to the end discontinued Licensed Product will not be due for achievement of the section: “The Parties agree that same milestone event(s) by the maximum amount substituted Licensed Product. Milestone Event Payment Filing of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $an Investigational New Drug Application (or equivalent) $ [...***]. Notwithstanding the foregoing, ...] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [...***...] shall be added to Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [...***...] First Commercial Sale $ [...***...] • In the Sales Milestone Payments event of an assignment as described in order Article 10 of the sales MIT Agreement, the milestone payments set forth above that have not yet come due, will instead be replaced with the milestone events and payments set forth below. Milestone Event Payment Filing of Investigational New Drug Application (or equivalent) $ [...***...] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [...***...] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [...***...] First Commercial Sale $ [...***...] • The milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; providedtwo tables above are intended to be successive. In addition and notwithstanding the foregoing, however, that the addition of if any Unpaid Regulatory Milestone Payment for [***] to milestone is reached without achieving a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspreceding milestone, then the amount of such Submission Milestone Payment shall be deducted, in reverse order which would have been payable on achievement of the sales preceding milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount will be payable upon achievement of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Paymentnext successive milestone. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Alnylam will notify MIT within ten (10) days of the achievement of any of the above milestones by Alnylam or any of its Affiliates or Sublicensees.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Regulus Therapeutics Inc.), License and Collaboration Agreement (Regulus Therapeutics Inc.)

Milestone Payments. 1.1 Subject to the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly set forth below in this Section 7.2.1 5.4) milestone payments (Regulatory Milestones) whether such milestone is achieved by Merck or a Related Party): Milestone 1 [***] upon approval for entry into formal Good Laboratory Practices safety assessment studies of a Collaboration Compound; provided that such [***]. If no such [***], this milestone will be deemed to have been triggered. Milestone 2 [***] upon administration of Collaboration Compound or Product to the first human in Phase I Clinical Trial. Milestone 3 [***] upon administration of Collaboration Compound or Product to the first human in Phase II Clinical Trial. Milestone 4 [***] upon administration of Collaboration Compound or Product to the first human in Phase III Clinical Trial. Milestone 5 [***] upon NDA approval for Product in United States. Milestone 6 [***] upon NDA approval for Product in Japan. Milestone 7 [***] upon NDA approval for Product in the first European Market. Each of the Original Agreement is hereby amended by adding milestone payments described above in this Section 5.4 shall be payable [***], as the following case may be, to the end of the section: “Notwithstanding the foregoing, if the milestone event of reach such milestone; provided that [***] shall [***] Collaboration Compounds, or Products containing such Collaboration Compounds, as the case may be, to reach each such milestone. Each milestone payment shall be payable only upon the initial achievement of such milestone and no amounts shall be due hereunder for subsequent or repeated achievement of such milestone by the same Collaboration Compound or Product. Merck shall notify Metabasis in writing within thirty (30) days upon the achievement of each milestone, and shall make the appropriate milestone payment within thirty (30) days of the achievement of such milestone. If, for any reason, a Collaboration Compound or Product reaches a particular milestone specified above without having achieved one or more preceding milestones above, then, except as set forth in the preceding paragraph, upon the achievement of such milestone, both the milestone payment applicable to such milestone and the milestone payment(s) applicable to such preceding unachieved milestone(s) shall be due and payable within thirty (30) days of the achievement of such milestone. In the event that Merck has exercised its option for continued Exclusive Efforts in accordance with Section 2.10, the amount payable by Merck for achievement of each of the foregoing milestones 1 through 7 shall be adjusted as follows: i) Milestone 1: [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***].

Appears in 2 contracts

Sources: Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc), Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) As further consideration for the sale and transfer of the Original Agreement is hereby amended by adding Acquired Assets, BII shall pay to MabVax Therapeutics Holdings Inc. the following one-time, milestone payments (each a “Milestone Payment”) set forth below upon the first occurrence of the applicable milestone event with respect to the end of the section: “Notwithstanding the foregoingfirst BII Product, if the milestone event of provided that each such Milestone Payment shall be due only once. Each Milestone Payment shall be due and payable to MabVax Therapeutics Holdings Inc. within [***] Business Days after receipt of an Invoice from MabVax Therapeutics Holdings Inc., which shall be provided to BII as follows: i) soon as practicable after BII has notified MabVax Therapeutics Holdings Inc. that the particular milestone event has been achieved (whether achieved by or on behalf of BII or any of its Affiliates or Sublicensees). BII will notify MabVax Therapeutics Holdings Inc. within [***] Business Days after it becomes aware of the achievement of any milestone event for which a payment to MabVax Therapeutics Holdings Inc. is required under this Section 5.3. It is hereby understood that each Milestone Payment shall be paid [***] ii) . Start of Development of the first BII Product [***] Initiation of first Phase I Clinical Trial [***] [***] Initiation of first Phase III Clinical Trial [***] [***] First Commercial Sale [***] iii) in a Major Market [***] The Milestone Payment for the First Commercial Sale [***] in a Major Market shall be payable [***] iv) [***] For , for the avoidance of doubt, first Calendar Year in which the First Commercial Sale milestone event is achieved [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission First Commercial Sale Milestone Payment shall be deducted, in reverse order paid together with the Earn-Out-Payment of the sales Calendar Quarter during which the First Commercial Sale milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]event has been achieved.

Appears in 2 contracts

Sources: Asset Purchase and License Agreement (Mabvax Therapeutics Holdings, Inc.), Asset Purchase and License Agreement (Mabvax Therapeutics Holdings, Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestonesa) Enzon shall pay Santaris a milestone payment (each, an “Event Milestone Payment”) in respect of each of the Original Agreement is hereby amended following events (each, an “Event Milestone”) in the amounts set forth below no later than thirty (30) days after the occurrence of each Event Milestone: Event Milestone Event Milestone Payment (i) Determination by adding the following n/a n/a US[**Redacted**] Enzon to the end of the section: “Notwithstanding the foregoing, if the milestone event of per Additional [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [*Redacted**] For the avoidance Target (ii) Filing of doubt, [***]. [***]. Additionally, notwithstanding anything an IND in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [*US[**Redacted**] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [*US[**Redacted**] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [*US[**Redacted**] to a Sales the Enzon Territory for per Additional the first Product Target Event Milestone Payment shall not cause the amount Event Milestone Payment (iii) Completion of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [*US[**Redacted**] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [*US[**Redacted**] previously added to such Sales Milestone Payment. [***] $[*US[**Redacted**] [***] $[*Redacted**] [*per Additional (iv) Acceptance of filing US[**Redacted**] $[*US[**Redacted**] [*US[**Redacted**] $[*of a MAA for the first per Additional Product in the Enzon Target Territory (v) Launch of the first US[**Redacted**] [***]: [*US[**Redacted**] $[*US[**Redacted**] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Product for each Target per Additional in the Enzon Territory Target (b) Regardless of the number of Selected LNA Compounds or Products developed by Enzon with respect to each Enzon Target, each of the Event Milestone Payments set forth above shall be paid only one (1) time for each Enzon Target. (c) If the Event Milestone Payment set forth in Section 7.4(a)(ii), (iii) or (iv) is achieved without triggering one or more of the preceding Event Milestone Payments, then Enzon shall pay to Santaris the preceding Event Milestone Payments that were not paid on the date that such later Event Milestone Payment is due. (d) If Enzon has given Santaris any notice of termination of this Agreement in its entirety under Section 10.2, Enzon shall not be liable for the Event Milestone Payments that first accrue after the date of such notice.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Evivrus, Inc.), License and Collaboration Agreement (Enzon Pharmaceuticals Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Within 30 days following the achievement by ReN or by an Affiliate or sub-licensee hereunder of ReN of each of the Original Agreement following events, on a Product by Product basis, ReN shall give written notice thereof to SCI and shall pay to SCI the corresponding payments described below. *** upon initiation of the first human Phase I Clinical Trial of each ReN Product *** in the ReN Transplantation Field; *** upon completion of the first human Phase II Clinical Trial of each ReN Product *** in the ReN Transplantation Field; *** upon submission of the first BLA or its foreign counterpart for each ReN Product *** in the ReN Transplantation Field; *** upon approval of a BLA or its foreign counterpart for each ReN Product *** in the ReN Transplantation Field in the first of the United States, the European Union or Japan; *** upon initiation of the first human Phase II Clinical Trial of a ReN NCT; and *** upon the First Commercial Sale of a ReN NCT. For purposes of determining whether a milestone payment is hereby amended by adding due pursuant to this subsection (a) with respect to a given label Indication, a Product (the following “Follow-on Product”) shall not be considered as distinct from a Product as to which a milestone payment was previously made for the same label Indication (the “Initial Product”) if the clinical development of the Follow-on Product was lawfully conducted without the requirement that a new (as distinguished from an amended) IND be filed with respect to the end clinical testing of such Follow-on Product, i.e. that clinical development of the section: “Notwithstanding Follow-on Product occurred pursuant to the foregoingsame IND (whether or not amended) as that applicable to the Initial Product. Accordingly, if a Follow-on-Product developed pursuant to the same IND as the Initial Product shall not trigger (or accrue a payment obligation for) the milestone payments already paid for such Initial Product with respect to a given label Indication. In addition, the Parties acknowledge that a single development program intended to yield a single commercial Product for a specific Indication or set of Indications may involve the simultaneous development of multiple Product for that Indication or set of Indications, each based on a different Cell Line or combination of Cell Lines, and that the Product as to which one milestone event occurs (e.g. that due on the completion of [a Phase II Clinical Trial) may subsequently be abandoned and replaced by a back-up Product developed in the course of such development plan, for the same Indication or set of Indications, as to which the same milestone event occurs. In such event, the Parties intend that each milestone payment shall be paid only one time for each Indication regardless of whether such milestone payment is achieved by more than one Product developed for such Indication or set of Indications in the course of the same development program. Subject to the clarifications in the preceding two paragraphs, the Parties intend that achievement of each “Milestone Event” (defined as the initiation of a given Phase I Clinical Trial, completion of a given Phase II Clinical Trial, submission of a given BLA or approval of a BLA, to the extent triggering a milestone payment above) shall result in an obligation to make the corresponding payment obligation every time such Milestone Event occurs unless the subsequent occurrence of the Milestone Event involves both the same Product *** as a previous Milestone Event for which milestones were already paid. *** Furthermore, it is understood and agreed that no more than one milestone payment (in the applicable amount specified above, and not multiples thereof) shall be made with respect to a given Milestone Event, without limiting any milestones due for a subsequent occurrence of the same Milestone Event for a different Indication or Product. Thus, for example completion of a given Phase II Clinical Trial for a given Product within the applicable Field will trigger only one payment of ***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For , regardless of whether the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan such trial was a combination product containing two biological compounds from two different Cell Lines and Sales Milestone Payments shall regardless of whether the Indication targeted in such trial could potentially cover different patient populations or be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]subdivided into subtypes or subgroups.

Appears in 2 contracts

Sources: License Agreement (Stemcells Inc), License Agreement (Stemcells Inc)

Milestone Payments. 1.1 Section 7.2.1 Within five (Regulatory Milestones5) Business Days of EyeTech and/or its Affiliates or sublicensees achieving the first occurrence of each of the Original Agreement is hereby amended by adding milestone events listed below with respect to any Therapeutic Product, Diagnostic Product or Other Product, EyeTech shall notify CMI of such achievement and the following to the end date thereof, and within thirty (30) days of the section: “Notwithstanding the foregoing, if the milestone event of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement date of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of achievement, pay the Original Agreement is hereby amended one-time non-refundable fees specified below to CMI by adding the following Federal Reserve electronic wire transfer in immediately available funds to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2an account designated by CMI; provided, however, that in no event shall the addition following fees be payable more than once with respect to any given Product for any particular geographical area or Milestone: THERAPEUTIC PRODUCTS: MURINE FORMS: Milestone Fee --------- --- Initiation of any Unpaid Regulatory Milestone Payment for Phase I Clinical Trials [***] to a Sales Milestone Payment shall not cause the amount Initiation of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for Phase II Clinical Trials [***] has been added to the Sales Milestone Payments, then the amount Initiation of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for Phase III Clinical Trials [***] previously added to such Sales Milestone Payment. First Filing of NDA in the United States [***] $Regulatory Approval in the United States [***] First Regulatory Approval in the EU [***] $Regulatory Approval In Japan [***] Annual U.S. Sales Exceed $300 Million [***] $HUMANIZED FORMS: Milestone Fee --------- --- First IND Submission [***] Initiation of Phase I Clinical Trials [***] $Initiation of Phase II Clinical Trials [***] [***]: Initiation of Phase III Clinical Trials [***] $First Filing of NDA in the United States [***] $Regulatory Approval in the United States [***] $First Regulatory Approval in the EU [***] Regulatory Approval In Japan [***] Annual U.S. Sales Exceed $300 Million [***] $DIAGNOSTIC PRODUCTS: MURINE FORMS: Milestone Fee --------- --- Initiation of Clinical Trials [***] $Initial of Pivotal Trials [***] First Regulatory Approval in the U.S. [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Appears in 2 contracts

Sources: Development and Sublicensing Agreement (Cancervax Corp), Development and Sublicensing Agreement (Cancervax Corp)

Milestone Payments. 1.1 Section 7.2.1 LICENSEE shall also pay BCM the following one-time milestone payments set forth below following the first achievement of such milestone by LICENSEE, its Affiliate or Sublicensee: (Regulatory Milestonesi) Upon the first dosing of the Original Agreement is hereby amended by adding first patient in the following first phase III clinical trial (or foreign equivalent) for the first (1st) Distinct Product, LICENSEE shall make a [***REDACTED***] dollar($[***REDACTED***]) payment to BCM; (ii) Upon the end first dosing of the section: “Notwithstanding first patient in the foregoingfirst phase III clinical trial (or foreign equivalent) for the second (2nd) Distinct Product, if the milestone event of LICENSEE shall make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; Portions herein identified by [***] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (iii) Upon receipt of final FDA approval of the first Marketing Authorization for the first (1st) Distinct Product, LICENSEE shall be as follows: i) make a [***REDACTED***] dollar($[***REDACTED***]) payment to BCM; ii(iv) Upon receipt of final FDA approval of the first Marketing Authorization for the second (2nd) Distinct Product, LICENSEE shall make a [***] iii) REDACTED***] dollar ($[***REDACTED***]) payment to BCM; and iv(v) Upon first attainment of annual Net Sales of greater than five hundred million ($500,000,000) for the first (1st) Distinct Product, LICENSEE will make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; (vi) Upon first attainment of annual Net Sales of greater than five hundred million ($500,000,000) for the second (2nd) Distinct Product, LICENSEE will make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; (vii) Upon first attainment of annual Net Sales of greater than one billion ($1,000,000,000) for the first (1st) Distinct Product, LICENSEE will make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; (viii) Upon first attainment of annual Net Sales of greater than one billion ($1,000,000,000) for the second (2nd) Distinct Product, LICENSEE will make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; (ix) Upon first attainment of annual Net Sales of greater than two billion ($2,000,000,000) for any of the Distinct Products, LICENSEE will make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM. For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to payment is a one-time payment that will be paid for the contrary, a Regulatory Milestone Payment first Licensed Product that attains annual Net Sales of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] greater than $2,000,000,000; and (x) LICENSEE shall be discussed in good faith and determined by the Parties notify BCM in writing prior to within thirty (30) days following the achievement of each milestone. The annual Net Sales for Distinct Products subject to the Net Sales level-dependent milestone payments shall be calculated on a calendar year basis, beginning January 1st and ending December 31st. BCM will then invoice LICENSEE for payment of such Regulatory Milestone Events. 1.2 Section 7.2.2 milestone and LICENSEE shall pay the invoice within fifteen (Sales Milestones15) days upon receipt of the Original Agreement is hereby amended by adding the following invoice. Milestones are to the end be paid regardless of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoingwhether LICENSEE, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of its Affiliate or LICENSEE’s Sublicensee attains such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]milestone.

Appears in 1 contract

Sources: Exclusive License Agreement (Marker Therapeutics, Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Subject to the terms and conditions contained in this Agreement, in further consideration of the Original Agreement is hereby amended rights granted by adding MPC hereunder, MN shall pay MPC the following to the end milestone payments, contingent upon occurrence of the section: “Notwithstanding the foregoingspecified event, if the with each milestone event of [***] shall payment to be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior made no more than once with respect to the achievement of such Regulatory Milestone Events.milestone and no amounts shall be due hereunder for any subsequent or repeated achievement of such milestones, regardless of the number of Products for which such milestone may be achieved (but payable on the first achievement of such milestone): 1.2 Section 7.2.2 (Sales Milestonesa) [**] upon first IND submission in the MN Territory; (b) [**] upon initiation (dosing of the first patient) of the Original Agreement is hereby amended by adding first Phase 2 Clinical Trial in the following to the end MN Territory; (c) [**] upon initiation (dosing of the section: “The Parties agree that first patient) of the maximum amount of Regulatory Milestone Payments for Licensed Product first Phase 3 Clinical Trial in Japan and Sales Milestone Payments shall be US $the MN Territory; ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. (d) [**] upon the EMEA’s first acceptance for filing of an MAA; (e) [**] upon the FDA’s first acceptance for filing of an NDA; (f) [**] upon receipt in writing of the first Regulatory Approval in the United States by MN, its Affiliates or its sublicensees; (g) [**] upon receipt in writing of the first Regulatory Approval from the EMEA by MN, its Affiliates or its sublicensees together with Regulatory Approval in at least two (2) of the Major European Countries; and (h) [**] upon the achievement of cumulative Net Sales in the MN Territory of [**]. Notwithstanding MN shall notify MPC in writing within thirty (30) days after the foregoing, [***] achievement of the milestones specified in Sections 4.2 (a) through (g) and each such notice shall be added to accompanied by the Sales Milestone Payments appropriate milestone payment. MN shall notify MPC in order writing within ninety (90) days after the achievement of the sales milestone events set forth specified in the Sales Milestone Payment table in this Sections 4.2 (h) and any such milestone payment required to be made by MN under such Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment 4.2 (h) shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, paid together with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment royalty payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Calendar Quarter.

Appears in 1 contract

Sources: License Agreement

Milestone Payments. 1.1 Section 7.2.1 CureVac will make milestone payments (Regulatory Milestoneseach, a “Milestone Payment”) to Acuitas upon the first occurrence of each of the Original Agreement is hereby amended milestone events (each, a “Milestone Event”) by adding the following to the end Licensed Product as set forth below in this Section 4.1. CureVac will notify Acuitas of the section: “Notwithstanding the foregoing, if the milestone event achievement of each Milestone Event within [*****] shall business days of such achievement. Each Milestone Payment will be as follows: i) payable to Acuitas by CureVac within [***] ii) **] days of the achievement of the specified Milestone Event and receipt of a respective invoice from Acuitas, and such payments when owed or paid will be non-refundable and non-creditable. If one or more of the Milestone Events set forth below are not achieved or not required for any reason, the payment for such skipped Milestone Event will be due [*****] iii) . The maximum total of all Milestone Payments for all Licensed Products payable under this License Agreement is [***] iv) **] [*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****] *[*****] payments are payable for the [*****] for the [*****] For the avoidance of doubt, only license agreements concluded on the basis of the Development and Option Agreement will count towards the number of Active Agreements for the applicable [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by payments. Provided a Licensed Product under this License Agreement is the first product comprised of Lipid Nanoparticles (LNP) containing one or more mRNA Constructs intended to express a protein that is a licensed product under this or any other exclusive license agreement entered into between the Parties in writing prior to on the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) basis of the Original Development and Option Agreement is hereby amended by adding to reach a ▇▇▇▇▇ ▇, ▇▇▇▇▇ 2 or Phase 3 milestone, the following to the end of the section: “The Parties agree that the maximum amount of Regulatory first three clinical Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing(i.e., [*****] shall be added to If a Licensed Product under this License Agreement is not the Sales Milestone Payments in order first product under any exclusive license agreement entered into between the Parties on the basis of the sales milestone events set forth in Development and Option Agreement, but the Sales Milestone Payment table in first (and any subsequent) exclusive license agreement is terminated and the Licensed Product under this Section 7.2.2; providedLicense Agreement therefore becomes the “first product” (i.e., howeverno other exclusive license agreement under the Development and Option Agreement takes such place), that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added in clinical development milestones will be applied to the Sales Milestone Payments, then Licensed Product under this License Agreement for any clinical milestones not achieved under the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]first or any subsequent exclusive license agreements.

Appears in 1 contract

Sources: Development and Option Agreement (CureVac B.V.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) of the Original Agreement is hereby amended by adding Bayer shall make the following non-refundable, non-creditable Milestone Payments (the “Milestone Payments”) to Nektar, with respect to the end of the section: “Notwithstanding the foregoingProduct, if the milestone event of within [***] shall days after achievement of the relevant milestone for the Product. The milestones in this Section 8.3 are cumulative, such that under no circumstances is any single Milestone Payment to be as follows:deemed in lieu of, or to be substituted for, another Milestone Payment. For clarity, each milestone in this Section 8.3 is payable by Bayer to Nektar only once with respect to the achievement of any milestone under this Agreement. (i) Effective Date (reimbursement by Bayer [***]) $ 50 * (ii) [***]] $ 10 ** (iii) [***] $ [ ***] (iv) [***] For $ [ ***] (v) [***] $ [ ***] (vi) [***] $ [ ***] (vii) [***] $ [ ***] (viii) [***] $ [ ***] * $10 million of this payment shall be repaid to Bayer if Bayer terminates this Agreement within thirty (30) days following delivery by Nektar to Bayer of the avoidance of doubt, final report for the [***]. [***]* This milestone payment shall be used by Nektar to reimburse Bayer’s Development Costs of conducting any Phase III Clinical Trial in the Territory. Additionally, notwithstanding anything in this Agreement Bayer shall invoice Nektar quarterly for such Development Costs as such costs are incurred pursuant to the contraryDevelopment Budget commencing with the calendar quarter immediately following the calendar quarter in which the first Phase III Clinical Trial Commences. Bayer shall provide to Nektar with such invoice documentation reasonably acceptable to Nektar evidencing such Development Costs, a Regulatory Milestone Payment of [***]and Nektar shall have the right to verify any such Development Costs. The Parties agree that an amount of Regulatory Milestone Payments Nektar shall pay such invoiced amounts within [***] days after its receipt of an invoice. If Bayer terminates this Agreement before such milestone payment is fully applied to reimburse such costs, Nektar shall be discussed in good faith and determined by have the Parties in writing prior right to the achievement retain any remaining portion of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) milestone payment not applied to reimburse such costs as of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount effective date of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]termination.

Appears in 1 contract

Sources: Co Development, License and Co Promotion Agreement (Nektar Therapeutics)

Milestone Payments. 1.1 Purchaser shall pay to the Shareholders, in accordance with this Section 7.2.1 2.6, the following payments (Regulatory Milestoneseach, a “Milestone Payment”) upon achievement of the Original Agreement is hereby amended by adding following milestones (each, a “Milestone”): (i) an amount equal to |||||||||||| |||||||||||| (the following “First Milestone Payment”) upon the Company receiving notification from the FDA of the designation of the GLyPharma Product as an orphan drug as documented under 21 C.F.R. §316.24(c) (the “First Milestone”); provided, however, that if the FDA does not deliver a designation of the GLyPharma Product as an orphan drug as provided above prior to the end first patient dosing with the GLyPharma Product in a Pivotal Trial as set forth in Section 2.6(a)(iii), the First Milestone Payment shall be forfeited; (ii) an amount equal to ||||||||||||| ||||||||||||| (the “Second Milestone Payment”) upon the Therachon Board’s decision to proceed to a Pivotal Trial of the section: “Notwithstanding the foregoingGLyPharma Product, if the milestone event irrespective of [***] indication. Such decision shall be made as follows:early as practicable on a diligent and timely basis by the Therachon Board following the completion of the planned phase 2a clinical trial of the GLyPharma Product in short bowel syndrome patients dependent on total parenteral nutrition and short bowel syndrome intestinal insufficiency patients and shall depend on the acceptable safety/tolerability/efficacy results of such trials and must be corroborated by no regulatory objections from either the FDA or EMA (the “Second Milestone”); and i) [***] ii) [***] (iii) [***] ivan amount equal to ||||||||||||| ||||||||||||| (the “Third Milestone Payment” and together with the Second Milestone Payment, each an “Additional Milestone Payment”) [***] upon the first patient dosing with the GLyPharma Product in a Pivotal Trial, even if deferred pending other studies (the “Third Milestone” and together with the Second Milestone, each an “Additional Milestone”). For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory each Milestone may only be achieved one time and each Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall may only be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Eventspaid one time, if at all. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***].

Appears in 1 contract

Sources: Share Purchase Agreement (VectivBio Holding AG)

Milestone Payments. 1.1 Section 7.2.1 COMPANY shall pay to WH▇▇▇▇▇▇▇ ▇he amounts below upon achievement by COMPANY or its AFFILIATE of certain milestone events as set forth in the table below. (Regulatory Milestonesi) Payments will be due in respect of the Original Agreement is hereby amended by adding the following to the end achievement of the sectionmilestone events in the table below for the first LICENSED PRODUCT or LICENSED PROCESS or POLYPEPTIDE in the first indication to reach a given milestone below: “Notwithstanding the foregoing, if the milestone event of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $]: [***] [***]: [***] (ii) Payments will be due in respect of the achievement of the milestone events in the table below for each DISCOVERED PRODUCT to reach the milestone below (payable for the first three occurrences only): [***]: [***] [***]: [***] COMPANY shall make such non-refundable, non-creditable milestone payments within [***] after achievement of each of the milestones. For the convenience of the parties, in recognition of the value of the PATENT RIGHTS, LICENSED PRODUCTS, POLYPEPTIDES, and LICENSED PROCESSES in identifying DISCOVERED PRODUCTS, and in the time it takes to bring DISCOVERED PRODUCTS to market, COMPANY agrees to pay Milestone Payments under this Section. If the first LICENSED PRODUCT, POLYPEPTIDE, LICENSED PROCESS or DISCOVERED PRODUCT does not meet all milestones, any paid milestone will be considered fulfillment of that milestone obligation, which shall not be paid again on the next product to reach that milestone. Only milestones that have not been paid previously will be paid. The obligation to pay Milestone Payments on each DISCOVERED PRODUCT shall survive termination of this agreement as specified in section 12.5(a). (iii) The milestone events set forth in Section 4.1(c) above are intended to be successive. In the event that any Phase I clinical trial is combined with a Phase II clinical trial (i.e., a Phase I/II clinical trial), the milestone payment for the enrollment of the first patient in a Phase I clinical trial shall be due upon the enrollment of the first patient in the Phase I/II clinical trial; and in the event that any Phase II clinical trial is combined with a Phase III clinical trial (i.e., a Phase II/III clinical trial), the milestone payment for the enrollment of the first patient in a Phase III clinical trial shall be due upon the enrollment of the first patient in the Phase II/III clinical trial. In addition and notwithstanding the foregoing, if any milestone is reached without achieving a preceding milestone, then the amount which would have been payable on achievement of the preceding milestone shall be payable upon achievement of the following milestone.

Appears in 1 contract

Sources: Exclusive Patent License Agreement (Immunome Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestonesa) Effective commencing on the Effective Date, as further partial consideration for the grant of the Original Agreement is hereby amended rights and licenses hereunder, on a Product-by-Product basis, Company shall pay, or cause to be paid, to MRKDG the non-refundable milestone payments set forth below (each, a “Regulatory Milestone Payment”) for the first Product containing or comprising Pimasertib, as well as for the first Product containing or comprising 103B (in each case whether a monotherapy or in the form of a Combination Product or for concomitant or sequential use with other therapeutics) to achieve the corresponding Regulatory Milestone Event, provided that for the second Product (containing the respective other Compound) to achieve the corresponding Regulatory Milestone Event, such Regulatory Milestone Payments shall be reduced by adding the following to the end [*] 1 [*] [*] 2 [*] [*] 3 [*] [*] 4 [*] [*] 5 [*] [*] Each of the section: “Notwithstanding the foregoing, if the milestone event foregoing Regulatory Milestone Payments in this Section 6.2(a) shall be payable a maximum of [***] per Compound regardless of the number of times the applicable Regulatory Milestone Event was achieved by a Product containing or comprising the respective Compound, and no Regulatory Milestone Payment shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] due hereunder for any subsequent or repeated achievement of such Regulatory Milestone Event by a Product containing or comprising such Compound. For the avoidance of doubt, the maximum amount payable by Company to MRKDG pursuant to this Section 6.2(a) [***]] assuming in each case that each of the Regulatory milestone events in this Section 6.2(a) were achieved. (b) Company shall pay to MRKDG the applicable non-refundable milestone payments set forth below (each, a “Commercial Milestone Payment”) when cumulative Net Sales within the Territory for all Products reach each of the thresholds set forth below. [*] [ *] [*]] [ *] [*] [ *] [*] [ *] The achievement of a higher Commercial Milestone Event shall also trigger the payment of a lower Commercial Milestone Event in the event such lower Commercial Milestone Event had not been triggered prior to achievement of the higher Commercial Milestone Event. AdditionallyFor clarity, notwithstanding anything in such case both the payment of lower milestone and the higher milestone shall be triggered. Each of the foregoing Commercial Milestone Payments in this Agreement to the contrary, Section 6.2(b) shall be payable a Regulatory Milestone Payment maximum of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events as set forth in the Sales foregoing chart regardless of the number of times the applicable Commercial Milestone Payment table in this Section 7.2.2; providedEvent was achieved, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission and no Commercial Milestone Payment shall be deducteddue hereunder for any subsequent or repeated achievement of such Commercial Milestone Event. For the avoidance of doubt, in reverse order the maximum amount payable by Company to MRKDG pursuant to this Section 6.2(b) is [*] assuming that each of the sales milestone events set forth in the Sales this Section 6.2(b) were achieved. (c) Company shall notify MRKDG in writing [*] after a Regulatory Milestone Event or Commercial Milestone Event has occurred. (d) Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid any Regulatory Milestone Payment for or Commercial Milestone Payment by Company to MRKDG shall be due within [***] previously added upon receipt of a corresponding invoice from MRKDG for the applicable Milestone Payment notified by Company to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]MRKDG pursuant to Section 6.2(c).

Appears in 1 contract

Sources: License Agreement (Day One Biopharmaceuticals Holding Co LLC)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Alnylam will pay MIT the amounts set forth below upon achievement by Alnylam or any of its Affiliates or Sublicensees of certain milestone events as set forth below. Payments will be due in respect of the Original Agreement achievement of such milestone events for each first Licensed Product containing an m▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards a specific Target or a specific combination of Targets; provided, however, that if in the course of development a given Licensed Product is hereby amended by adding discontinued and replaced with a different Licensed Product for the following to the end same therapeutic indication containing an m▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the section: “Notwithstanding discontinued Licensed Product, milestone payments already paid for the foregoing, if discontinued Licensed Product will not be due for achievement of the same milestone event event(s) by the substituted Licensed Product. Filing of an Investigational New Drug Application (or equivalent) $[***] shall be as follows: iDosing of first patient in a Phase 2 clinical trial (or equivalent) [***] ii) [***] iii) [***] iv) $[***] For the avoidance Dosing of doubt, [***]. [***]. Additionally, notwithstanding anything first patient in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments Phase 3 clinical trial (or equivalent) $[***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US First Commercial Sale $[***]] • In the event of an assignment as described in Article 10 of the MIT Agreement, the milestone payments set forth above that have not yet come due, will instead be replaced with the milestone events and payments set forth below. Notwithstanding the foregoing, Filing of Investigational New Drug Application (or equivalent) $[***] shall be added to the Sales Milestone Payments Dosing of first patient in order a Phase 2 clinical trial (or equivalent) $[***] Dosing of the sales first patient in a Phase 3 clinical trial (or equivalent) $[***] First Commercial Sale $[***] • The milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; providedtwo tables above are intended to be successive. In addition and notwithstanding the foregoing, however, that the addition of if any Unpaid Regulatory Milestone Payment for [***] to milestone is reached without achieving a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspreceding milestone, then the amount of such Submission Milestone Payment shall be deducted, in reverse order which would have been payable on achievement of the sales preceding milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount will be payable upon achievement of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Paymentnext successive milestone. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Alnylam will notify MIT within ten (10) days of the achievement of any of the above milestones by Alnylam or any of its Affiliates or Sublicensees.

Appears in 1 contract

Sources: License and Collaboration Agreement (Isis Pharmaceuticals Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) BMPI will provide Luitpold written notice of the Original Agreement is hereby amended by adding the following to the end of the section: “Notwithstanding the foregoing, if the milestone event of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) each of the Original Agreement is hereby amended by adding milestone events (a) and (b) set forth below and Luitpold shall pay the following to the end relevant milestone amounts within thirty (30) days of such notice. Luitpold shall provide BMPI written notice within thirty (30) days of the section: “The Parties agree that the maximum amount achievement of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order each of the sales milestone events (c)-(h) set forth in below and Luitpold shall pay the Sales Milestone Payment table in this Section 7.2.2relevant amounts to BMPI as milestone payments with such notice; provided, however, that Luitpold shall be required to pay such amounts if, and only if, its achievement of the addition applicable milestone obligates BMPI to make a milestone payment to any Licensor: (a) within thirty (30) days after the date on which regulatory approval is first received in the United States to market the Licensed Products in the Field of Use, of which ** shall be payable for the rights granted under the Licensed Patents identified with an asterisk (*) on Exhibit A and ** shall be payable for the rights granted under the Licensed Patents not identified with an asterisk (*) on Exhibit A; ** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) on the second anniversary of the Approval Date of which ** shall be payable for the rights granted under the Licensed Patents identified with an asterisk (*) on Exhibit A and ** shall be payable for the rights granted under the Licensed Patents not identified with an asterisk (*) on Exhibit A; (c) upon filing an Investigational New Drug Application or an equivalent foreign filing for regulatory approval of a Licensed Product in the Field of Extended Use; (d) upon initiation of a Phase III or pivotal clinical trial, as "Phase III" is defined by Title 21: chapter 1 - Food and Drug Administration, Department of Health and Human Services for a Licensed Product in the Field of Extended Use; (e) upon filing a Biologies License Application or an equivalent foreign filing for a Licensed Product in the Field of Extended Use; (f) upon receipt of FDA approval to market a Licensed Product in the Field of Extended Use; (g) on the first anniversary of receipt of FDA approval to market a Licensed Product in the Field of Extended Use; and (h) on the second anniversary of receipt of FDA approval to market a Licensed Product in the Field of Extended Use. Luitpold shall provide BMPI with written notice of the achievement of any Unpaid Regulatory Milestone Payment milestone, accompanied by the applicable milestone payment, within thirty (30) days after the achievement of such milestone. Milestones (c) through (h) shall be deemed achieved by Luitpold if achieved by Luitpold, an Affiliate of Luitpold, a Distributor, or an agent or contractor of Luitpold, an Affiliate or a Distributor. In the event Luitpold pays for [***] any milestone payment described in (c) through (e) above, BMPI will be obligated to refund such individual milestone payment(s) to Luitpold if BMPI subsequently achieves any or all of the same milestones that, but for Luitpold's previous payment of the same milestone, would have triggered a milestone payment obligation from BMPI to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Licensor.

Appears in 1 contract

Sources: Exclusive Sublicense Agreement (Biomimetic Therapeutics, Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Within 14 days following the occurrence of each and any of the Original Agreement is hereby amended by adding milestone events listed below, Company shall provide written notice to CyDex of the following achievement of such milestone event, and within 21 days of the occurrence of such milestone event, pay to CyDex the applicable non-refundable milestone fee listed next to such event in further consideration of the rights granted Company hereunder. If for any respective Licensed Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the end omitted portions. Family, milestone (iv), (vi) or (viii) is achieved before any or all of milestones (i), (ii) and (iii) have been actually achieved, then any and all of milestones (i), (ii) and (iii) which were not previously actually achieved for such Licensed Product Family shall be deemed to have thereby been achieved for such Licensed Product Family, and the milestone payments for such deemed-achieved milestones shall also be payable within such 21 days. MILESTONE MILESTONE PAYMENT (i) Upon dosing of the section: “Notwithstanding first patient in the foregoing, if the milestone event of first [***] shall be as follows: i) [Clinical Trial by Company or under rights from Company for a Licensed Product in a Licensed Product Family* [ ***] (ii) Upon dosing of the first patient in the first [***] Clinical Trial by Company or under rights from Company for a Licensed Product in a Licensed Product Family* [ ***] (iii) [Upon submission of a NDA to the FDA for a Licensed Product in a Licensed Product Family* [ ***] (iv) [Upon receipt of Marketing Approval from the FDA for the first indication of a Licensed Product in a Licensed Product Family* [ ***] (v) Upon receipt of Marketing Approval from the FDA for each additional indication of a Licensed Product in a Licensed Product Family [ ***] (vi) Upon receipt of Marketing Approval in the EU for the first indication of a Licensed Product in a Licensed Product Family* [ ***] (vii) Upon receipt of Marketing Approval in the EU for each additional indication of a Licensed Product in a Licensed Product Family [ ***] (viii) Upon receipt of Marketing Approval in Japan for the first indication of a Licensed Product in a Licensed Product Family* [ ***] (ix) Upon receipt of Marketing Approval in Japan for each additional indication of a Licensed Product in a Licensed Product Family [ ***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] * such milestone shall only be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for payable once per Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Family.

Appears in 1 contract

Sources: License Agreement (MEI Pharma, Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Alnylam will pay MIT the amounts set forth below upon achievement by Alnylam or any of the Original Agreement is hereby amended by adding the following to the end its Affiliates or Sublicensees of the section: “Notwithstanding the foregoing, if the certain milestone event events as set forth below. Payments will be due in respect of [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestonesmilestone events for each first Licensed Product containing an m▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards a specific Target or a specific combination of Targets; provided, however, that if in the course of development a given Licensed Product is discontinued and replaced with a different Licensed Product for the same therapeutic indication containing an m▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the Original Agreement is hereby amended by adding discontinued Licensed Product, milestone payments already paid for the following to the end discontinued Licensed Product will not be due for achievement of the section: “The Parties agree that same milestone event(s) by the maximum amount substituted Licensed Product. Milestone Event Payment Filing of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $an Investigational New Drug Application (or equivalent) $ [***]. Notwithstanding the foregoing, ] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [**] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [**] shall be added to First Commercial Sale $ [**] • In the Sales Milestone Payments event of an assignment as described in order Article 10 of the sales MIT Agreement, the milestone payments set forth above that have not yet come due, will instead be replaced with the milestone events and payments set forth below. Milestone Event Payment Filing of Investigational New Drug Application (or equivalent) $ [**] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [**] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [**] First Commercial Sale $ [**] • The milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; providedtwo tables above are intended to be successive. In addition and notwithstanding the foregoing, however, that the addition of if any Unpaid Regulatory Milestone Payment for [***] to milestone is reached without achieving a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspreceding milestone, then the amount of such Submission Milestone Payment shall be deducted, in reverse order which would have been payable on achievement of the sales preceding milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount will be payable upon achievement of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Paymentnext successive milestone. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Alnylam will notify MIT within ten (10) days of the achievement of any of the above milestones by Alnylam or any of its Affiliates or Sublicensees.

Appears in 1 contract

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) of the Original Agreement is hereby amended by adding GPC shall make the following milestone payments to MORPHOSYS once for each GPC Target, upon the end first achievement of the section: “Notwithstanding the foregoing, if the such milestone event of [by a Licensed Product directed to such GPC Target: (a) Deutschmarks (DM ***] shall be as follows:) within thirty (30) days of confirmation by GPC that an ScFv antibody delivered by MORPHOSYS meets the Success Criteria for the relevant GPC Target; i(b) [Deutschmarks (DM ***]) within thirty (30) days of confirmation by GPC that an IgG antibody delivered by MORPHOSYS meets the Success Criteria for the relevant GPC Target; ii(c) [Deutschmarks (DM ***]) within thirty (30) days following the date GPC or an Affiliate commences a Phase I clinical trial in any country for the Licensed Product; iii(d) [Deutschmarks (DM ***]) within thirty (30) days following the date GPC or an Affiliate commences a Phase III clinical trial or other clinical trial designed to generate data sufficient for the filing of an NDA (e.g., a Phase II/III clinical trial) in any country for the Licensed Product; and iv(e) [Deutschmarks (DM ***] For ) within thirty (30) days following the avoidance date GPC or an Affiliate receives an FDA (or equivalent foreign regulatory agency) approval of doubtthe Licensed Product for commercial sale. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. In addition, [solely in the event that the non-exclusive license provided in Section 3.1(b) is granted to GPC by specific amendment of this Agreement, GPC shall make the following milestone payments to MORPHOSYS upon each occurrence of the listed event: (f) Deutschmarks (DM ***]. [) per Licensed Product within thirty (30) days of execution of an amendment granting any license for use of such specified Licensed Product in a clinical setting for patient screening to support the development of a non-Licensed Product; (g) Deutschmarks (DM ***]. Additionally, notwithstanding anything in this Agreement ) within thirty (30) days of the date of commencement of each clinical trial using a Licensed Product for patient screening to support the contrary, development of a Regulatory Milestone Payment of [non-Licensed Product; and (h) Deutschmarks (DM ***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 ) within thirty (Sales Milestones30) days of the Original Agreement is hereby amended by adding the following date GPC or an Affiliate first receives regulatory approval to the end commence sales of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for any non-Licensed Product developed using Licensed Products in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment a clinical setting for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]patient screening.

Appears in 1 contract

Sources: Collaboration and License Agreement (GPC Biotech Ag)

Milestone Payments. 1.1 Section 7.2.1 Upon first successful Phase 2 Clinical Trial safety/efficacy results in MM, as set forth in the Development Plan $ * * Upon first successful completion of Phase 3 Clinical Trial in MM, as set forth in the Development Plan (measured by FDA acceptance to file NDA for MM) $ * * Upon first Regulatory Milestones) Approval by the FDA of an NDA in r/r MM $ * * Upon first Regulatory Approval by the Original Agreement is hereby amended by adding FDA of an NDA in First Line MM $ * * ** Indicates that certain information contained herein has been omitted and filed separately with the following Securities and Exchange Commission. Confidential treatment has been requested with respect to the end of the section: “Notwithstanding the foregoing, if the milestone event of [omitted portions. ***] shall be * Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. $5,000,000 Upon first successful randomized Phase 2 Clinical Trial safety/efficacy results for solid tumors, as follows: iset forth in the Development Plan $ * * Upon first successful completion of Phase 3 Clinical Trial for solid tumors, as set forth in the Development Plan (measured by FDA acceptance to file NDA for the relevant solid tumor indication) [***] ii) [***] iii) [***] iv) [***] $ * * First Regulatory Approval by the FDA of an NDA in r/r solid tumors affecting <10,000 pts/yr, as per the FDA approved label indication $ * * First Regulatory Approval by the FDA of an NDA in First Line solid tumors affecting > 10,000 <50,000 pts/yr, as per the per FDA approved label indication $ * * First Regulatory Approval by the FDA of an NDA in First Line solid tumors affecting > 50,000 pts/yr, as per the per FDA approved label indication $ * * For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to “acceptance” as used above shall mean acceptance for review of the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined applicable regulatory filing by the Parties in writing prior to FDA, and “successful safety/efficacy results” means meeting the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestonesprimary endpoint(s) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events applicable protocol as set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that final analysis plan submitted to the addition applicable Regulatory Authority. If upon achievement of any Unpaid Regulatory Milestone Payment development milestone for [***] to each indication described above, a Sales Milestone Payment shall previous development milestone for that indication has not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspaid, then each such previous development milestone for that indication shall be payable along with the amount payment for the milestone then achieved for such indication. CTI will provide written notice to Chroma of the achievement of any milestone above within thirty (30) calendar days of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]achievement.

Appears in 1 contract

Sources: Co Development and License Agreement (Cell Therapeutics Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Subject to the terms and conditions of this Agreement, upon the first instance of attainment of the Original Agreement is hereby amended milestones as set forth below (unless otherwise provided therein), Oragenics has agreed to make certain milestone payments (each a “Milestone Payment” and together “Milestone Payments”) as set forth in this Section 5.2(b). Oragenics shall immediately advise Inspirevax of the attainment of milestone set forth below and Inspirevax shall thereafter issue an invoice to Oragenics for the applicable Milestone Payment, and the Milestone Payments are each payable in cash by adding the following wire transfer to the end account specified by Inspirevax within thirty (30) days of the section: “Notwithstanding the foregoing, if the applicable invoice. The Milestone Payments payable by Oragenics to Inspirevax upon achievement of each milestone event of [***] shall be are as follows: (i) [***] ii) [***] iii) [***] iv) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything in this Agreement to the contrary, a Regulatory one-time Milestone Payment of [***]. The Parties agree that ] upon Oragenics’ positive decision on an amount appropriate nasal-spray device, based on compatibility and characterization of Regulatory the device for use in the first clinical trial; (ii) one-time Milestone Payments Payment of [***] shall be discussed upon the first patient dosed in good faith and determined by the Parties in writing prior to the achievement first Phase 2a clinical trial under this Agreement; (iii) a one-time Milestone Payment of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to upon the Sales Milestone Payments in order of the sales milestone events set forth first patient dosed in the Sales first Phase 2b/3 clinical trial under this Agreement; (iv) a one-time Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] upon a Biologics License Application (BLA) submission for the Combination Product to the United States FDA; (v) a Sales one-time Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to upon the Sales Milestone Payments, then first filing for marketing authorization for the amount of such Submission Milestone Payment shall be deducted, in reverse order Combination Product outside of the sales milestone events set forth in the Sales United States; (vi) additional Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount Payments of the Unpaid Regulatory Milestone Payment for [***] previously added upon each additional filing for marketing authorization for the Combination Product outside of the United States, which is capped at five additional filings (i.e., not to such Sales Milestone Payment. exceed [***] $in the aggregate); (vii) a one-time Milestone Payment of [***] upon the first commercial sale of the Combination Product in the United States; (viii) a one-time Milestone Payment of [***] $upon the first commercial sale of the Combination Product in Europe; (ix) a one-time Milestone Payment of [***] upon the first commercial sale of the Combination Product outside of the United States and Europe; and (x) additional Milestone Payments of [***] $upon each commercial sale of the Combination Product outside of the United States and Europe, which is capped at five additional countries/regions (i.e., not to exceed [***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]in the aggregate).

Appears in 1 contract

Sources: Commercial License Agreement (Oragenics Inc)

Milestone Payments. 1.1 The milestone payments set forth in this Section 7.2.1 (Regulatory Milestones) 9.2 shall be paid only once, upon the first achievement of the Original Agreement is hereby amended applicable milestone event in the applicable listed geographic area. For purposes of determining whether a milestone event set forth in Sections 9.2.2 and 9.2.3 has occurred (and without creating an obligation to pay the milestone more than once as set forth in the preceding sentence), Net Sales for each fiscal year shall be aggregated for all Products sold in the Territory during the relevant fiscal year. 9.2.1 Within thirty (30) calendar days following the occurrence of each of the events set forth below for the Product, DSP shall pay to Intercept each of the non-refundable, non-creditable milestone payments set forth below: Milestone Event Development Milestones Milestone Payment PBC-Commencement of Phase III Clinical Trial US$ [***] PBC-Marketing Approval US$ [***] NA▇▇-▇nd indication-Marketing Approval US$ [***] Additional Indications-Marketing Approval US$ [***] PBC-Commencement of Phase III Clinical Trial US$ [***] PBC-Marketing Approval US$ [***] NA▇▇-▇nd indication-Commencement of Phase III Clinical Trial US$ [***] NA▇▇-▇arketing Approval US$ [***] Additional Indications-Commencement of Phase III Clinical Trial US$ [***] Additional Indications-Marketing Approval US$ [***] Portions of this Exhibit, indicated by adding the following ma▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the end Registrant’s application requesting confidential treatment pursuant to Rule 406 of the section: “Notwithstanding Securities Act of 1933, as amended. PBC-Marketing Approval US$ [***] * NA▇▇ ▇uccessful NIH Clinical Trial US$ [***] ** NA▇▇-▇arketing Approval US$ [***] *** PBC-Initiation of clinical trial US$ [***] PBC-Marketing Approval US$ [***] Additional Indications-Initiation of clinical trial US$ [***] Additional Indications-Marketing Approval US$ [***] *In the foregoingevent that the WAC exceeds US$[***] per day before approval in Japan, if the milestone event then an amount of US$[***] shall be paid as follows: i) an additional milestone payment (i.e., a total of US$[***] ii) ). **The milestone payment for the NA▇▇ ▇IH clinical trial is conditioned on the results being available no later than [***] iii) [, and supporting a decision by the JSC to continue Development of the Product for the NA▇▇ ▇ndication. ***] ivIn the event that (i) [***] For the avoidance of doubt, [***]. [***]. Additionally, notwithstanding anything NA▇▇ ▇arketing Approval in this Agreement the U.S. occurs prior to the contraryend of 2017 (i.e., based on a Regulatory Milestone Payment sNDA submission of [***]. The Parties agree that an the NIH clinical trial data) and DSP is able to use these data in support of a NDA submission in Japan, then the additional amount of Regulatory Milestone Payments US$[***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement paid (i.e., a total of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $US$[***]. Notwithstanding ); but (ii) if the foregoingNA▇▇ ▇arketing Approval in the U.S. occurs after the Marketing Approval in Japan, then no milestone payment of US$[***] shall be added to the Sales Milestone Payments in order of the sales milestone events as set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment chart above shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]due.

Appears in 1 contract

Sources: License Agreement (Intercept Pharmaceuticals Inc)

Milestone Payments. 1.1 Licensee shall make a non-refundable, non-creditable (except as permitted under Section 7.2.1 11.9) payment to Inhibrx within thirty (Regulatory Milestones30) days of the first achievement of each of the milestone events identified in Table 1 and Table 2: Table 1: Clinical Milestones Milestone Number Milestone Event Milestone Payment 1 Initiation (i.e., first patient dosed) of the Original Agreement first Phase II Clinical Trial by Licensee, its Affiliates and/or Sublicensees for Licensed Product. For clarity, this milestone is hereby amended by adding the following to the end of the section: “Notwithstanding the foregoing, if the milestone event of payable no more than once. $[***] shall be as follows: i2 Initiation (i.e., first patient dosed) of the first Phase III Clinical Trial by Licensee, its Affiliates and/or Sublicensees for Licensed Product for each of the first two indications of such Licensed Product will trigger the milestone payment. For clarity, this milestone is payable no more than twice. $[***] Table 2: Approval Milestones The following milestones are payable for the first [***] ([***] ii) Approved Indications (aggregated for all Licensed Products), and are not payable for any subsequent Approved Indications: Milestone Number Milestone Event Milestone Payment 3 Regulatory Approval in the US granted to Licensee, its Affiliates and/or Sublicensees for each Approved Indication for each Licensed Product. $[***] iii* 4 Regulatory Approval by EMA or in the first Major Market Country (whichever occurs first) granted to Licensee, its Affiliates and/or Sublicensees for each Approved Indication for each Licensed Product. $[***] iv) * *In Table 2, for each Approved Indication of a Licensed Product that is subsequent to the first Approved Indication, on an Approved Indication-by-Approved Indication basis, the payment for milestone 3 and the payment for milestone 4 with respect to such Approved Indication shall be [***] For the avoidance of doubt, percent ([***]%) of the corresponding milestone payment for the immediately preceding Approved Indication. For example, for the second Approved Indication of a Licensed Product, payment for milestone 3 is $[***]. Additionally, notwithstanding anything in this Agreement to and for the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement third Approved Indication of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement Licensed Product, payment for milestone 3 is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding With respect to milestone 1 and 2 in Table 1 above, if Licensee achieves any given milestone without first achieving the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales immediately preceding milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to (a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments“Skipped Milestone”), then Licensee shall make the amount of milestone payment for the Skipped Milestone when Licensee pays the milestone payment for such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]next-occurring milestone.

Appears in 1 contract

Sources: Licensing Agreement

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Alnylam will pay MIT the amounts set forth below upon achievement by Alnylam or any of its Affiliates or Sublicensees of certain milestone events as set forth below. Payments will be due in respect of the Original Agreement achievement of such milestone events for each first Licensed Product containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards a specific Target or a specific combination of Targets; provided, however, that if in the course of development a given Licensed Product is hereby amended by adding discontinued and replaced with a different Licensed Product for the following to the end same therapeutic indication containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the section: “Notwithstanding discontinued Licensed Product, milestone payments already paid for the foregoing, if discontinued Licensed Product will not be due for achievement of the same milestone event event(s) by the substituted Licensed Product. Filing of an Investigational New Drug Application (or equivalent) $ [***] shall be as follows: iDosing of first patient in a Phase 2 clinical trial (or equivalent) [***] ii) [***] iii) [***] iv) $ [***] For the avoidance Dosing of doubt, [***]. [***]. Additionally, notwithstanding anything first patient in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments Phase 3 clinical trial (or equivalent) $ [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, First Commercial Sale $ [***] shall be added to · In the Sales Milestone Payments event of an assignment as described in order Article 10 of the sales MIT Agreement, the milestone payments set forth above that have not yet come due, will instead be replaced with the milestone events and payments set forth below. Filing of Investigational New Drug Application (or equivalent) $ [***] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [***] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [***] First Commercial Sale $ [***] · The milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; providedtwo tables above are intended to be successive. In addition and notwithstanding the foregoing, however, that the addition of if any Unpaid Regulatory Milestone Payment for [***] to milestone is reached without achieving a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspreceding milestone, then the amount of such Submission Milestone Payment shall be deducted, in reverse order which would have been payable on achievement of the sales preceding milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount will be payable upon achievement of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Paymentnext successive milestone. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Alnylam will notify MIT within ten (10) days of the achievement of any of the above milestones by Alnylam or any of its Affiliates or Sublicensees.

Appears in 1 contract

Sources: License and Collaboration Agreement (Isis Pharmaceuticals Inc)

Milestone Payments. 1.1 Section 7.2.1 (Regulatory Milestones) Alnylam will pay MIT the amounts set forth below upon achievement by Alnylam or any of its Affiliates or Sublicensees of certain milestone events as set forth below. Payments will be due in respect of the Original Agreement achievement of such milestone events for each first Licensed Product containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards a specific Target or a specific combination of Targets; provided, however, that if in the course of development a given Licensed Product is hereby amended by adding discontinued and replaced with a different Licensed Product for the following to the end same therapeutic indication containing an ▇▇▇▇▇ Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the section: “Notwithstanding discontinued Licensed Product, milestone payments already paid for the foregoing, if discontinued Licensed Product will not be due for achievement of the same milestone event event(s) by the substituted Licensed Product. Milestone Event Payment Filing of an Investigational New Drug Application (or equivalent) $ [***] shall be as follows: iDosing of first patient in a Phase 2 clinical trial (or equivalent) [***] ii) [***] iii) [***] iv) $ [***] For the avoidance Dosing of doubt, [***]. [***]. Additionally, notwithstanding anything first patient in this Agreement to the contrary, a Regulatory Milestone Payment of [***]. The Parties agree that an amount of Regulatory Milestone Payments Phase 3 clinical trial (or equivalent) $ [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, First Commercial Sale $ [***] shall be added to • In the Sales Milestone Payments event of an assignment as described in order Article 10 of the sales MIT Agreement, the milestone payments set forth above that have not yet come due, will instead be replaced with the milestone events and payments set forth below. Milestone Event Payment Filing of Investigational New Drug Application (or equivalent) $ [***] Dosing of first patient in a Phase 2 clinical trial (or equivalent) $ [***] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [***] First Commercial Sale $ [***] • The milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; providedtwo tables above are intended to be successive. In addition and notwithstanding the foregoing, however, that the addition of if any Unpaid Regulatory Milestone Payment for [***] to milestone is reached without achieving a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Paymentspreceding milestone, then the amount of such Submission Milestone Payment shall be deducted, in reverse order which would have been payable on achievement of the sales preceding milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount will be payable upon achievement of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Paymentnext successive milestone. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]Alnylam will notify MIT within ten (10) days of the achievement of any of the above milestones by Alnylam or any of its Affiliates or Sublicensees.

Appears in 1 contract

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Milestone Payments. 1.1 Provided ▇▇▇▇▇▇ has exercised the option set forth in Section 7.2.1 (Regulatory Milestones) 2.3 above, ▇▇▇▇▇▇ shall make the MILESTONE PAYMENTS to LIPOXEN in accordance with the occurrence of the Original Agreement is hereby amended by adding MILSTONE EVENTS provided in Schedule III hereto for POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS, as the following case may be (subject to the end deductions set out in Section 8.2). The MILESTONE PAYMENTS shall be in addition to any royalty or other payments due under this AGREEMENT. Once a MILESTONE EVENT has been reached LIPOXEN shall submit an invoice to ▇▇▇▇▇▇ for the relevant MILESTONE PAYMENT (unless previously been paid under Schedule IV). 8.1.1 There shall be no multiple MILESTONE PAYMENTS for multiple products or multiple indications except that ▇▇▇▇▇▇ shall be required to make an additional [***] MILESTONE PAYMENT in the event: (i) ▇▇▇▇▇▇ has entered into clinical trials for the development of a POTENTIAL PRODUCT for a specific label indication, and (ii) ▇▇▇▇▇▇ terminates such clinical trials and elects to pursue the development of this or a different POTENTIAL PRODUCT with a different label indication within the FIELD, and (iii) the termination of the section: development of the POTENTIAL PRODUCT in clinical trials is not due to the failure to meet satisfactory clinical endpoints (a Notwithstanding CLINICAL FAILURE”). In such event, the foregoing[***] on the selection of one or more lead candidates to be developed for the new label indication. Any label indication in the same disease area shall be considered the same label indication. For example, if an indication for the milestone event of [***] and an indication for [***] shall be as follows: i) [***] ii) [***] iii) [***] iv) considered the same label indication. For clarity, in the event ▇▇▇▇▇▇ develops multiple POTENTIAL PRODUCTS with the same label indication, whether simultaneously or sequentially, whether in preclinical or clinical trials or launches multiple COMMERCIAL PRODUCTS with the same label indication, then no additional MILESTONE PAYMENTS are due. In the event ▇▇▇▇▇▇ launches multiple POTENTIAL PRODUCTS with different label indications, whether simultaneously or sequentially, whether in preclinical or clinical trials or launches multiple COMMERCIAL PRODUCTS with different label indications, then then no additional MILESTONE PAYMENTS are due. In the event ▇▇▇▇▇▇ cancels the development of a POTENTIAL PRODUCT due to a CLINICAL FAILURE and develops another POTENTIAL PRODUCT, whether in the same or different label indication(s), then no additional MILESTONE PAYMENTS are due. For example, if ▇▇▇▇▇▇ terminates the development of a POTENTIAL PRODUCT with a targeted indication [***] For the avoidance of doubt, prior to initiating clinical trials and elects to develop a different POTENTIAL PRODUCT with a targeted indication [***]] then no additional MILESTONE PAYMENT shall be due. For example, if ▇▇▇▇▇▇ terminates the development of a POTENTIAL PRODUCT with a targeted indication [***]. Additionally] after initiating clinical trials, notwithstanding anything in this Agreement and there has been no CLINICAL FAILURE, and elects to the contrary, develop a Regulatory Milestone Payment different POTENTIAL PRODUCT with a targeted indication of [***]. The Parties agree that ] then an amount of Regulatory Milestone Payments additional [***] MILESTONE PAYMENT shall be discussed in good faith and determined by due upon the Parties in writing prior to the achievement of such Regulatory Milestone Events. 1.2 Section 7.2.2 (Sales Milestones) selection of the Original Agreement is hereby amended by adding the following to the end of the section: “The Parties agree that the maximum amount of Regulatory Milestone Payments for Licensed Product in Japan and Sales Milestone Payments shall be US $[***]. Notwithstanding the foregoing, [***] shall be added to the Sales Milestone Payments in order of the sales milestone events set forth in the Sales Milestone Payment table in this Section 7.2.2; provided, however, that the addition of any Unpaid Regulatory Milestone Payment for [***] to a Sales Milestone Payment shall not cause the amount of a Sales Milestone Payment to exceed the amount set forth in the following table. If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***]: [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***] $[***] $[***] $[***] [***]lead candidate.

Appears in 1 contract

Sources: Exclusive Research, Development and License Agreement (Xenetic Biosciences, Inc.)