Milestone Payments. 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 5.4) milestone payments (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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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: Milestone 1: [***]
Appears in 2 contracts
Samples: Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc), Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc)
Milestone Payments. Within 30 days following the achievement by ReN or by an Affiliate or sub-licensee hereunder of ReN of each of the 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 due pursuant to this subsection (a) with respect to a given label Indication, a Product (the “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 clinical testing of such Follow-on Product, i.e. that clinical development of the Follow-on Product occurred pursuant to the same IND (whether or not amended) as that applicable to the Initial Product. Accordingly, 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 terms and conditions clarifications in this Agreementthe preceding two paragraphs, Merck shall pay to Metabasis the following non-refundable, non-creditable Parties intend that achievement of each “Milestone Event” (except defined as expressly set forth below in this Section 5.4) milestone payments (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 the initiation 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 given Phase I Clinical Trial. Milestone 3 [***] upon administration , completion of Collaboration Compound or Product to the first human in 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 4 [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 ***] upon administration , regardless of Collaboration Compound or Product to whether 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 such trial was a combination product containing two biological compounds from two different Cell Lines and regardless of whether the Indication targeted in Japan. Milestone 7 [***] upon NDA approval for Product in the first European Market. Each of the milestone payments described above in this Section 5.4 shall such trial could potentially cover different patient populations or be payable [***], as the case may be, to reach such milestone; provided that [***] shall [***] Collaboration Compounds, subdivided into subtypes 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:
Milestone 1: [***]subgroups.
Appears in 2 contracts
Samples: License Agreement (Stemcells Inc), License Agreement (Stemcells Inc)
Milestone Payments. Subject to Alnylam will pay MIT the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly amounts set forth below in this Section 5.4) upon achievement by Alnylam or any of its Affiliates or Sublicensees of certain milestone payments (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 [***]events as set forth below. If no such [***], this milestone Payments will be deemed to have been triggered. Milestone 2 [***] upon administration of Collaboration Compound or Product to the first human due 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 respect of the milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 events for each first Licensed Product containing an xxXXX 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 no amounts shall replaced with a different Licensed Product for the same therapeutic indication containing an xxXXX Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the discontinued Licensed Product, milestone payments already paid for the discontinued Licensed Product will not be due hereunder for subsequent or repeated achievement of such the same milestone event(s) by the same Collaboration Compound or substituted Licensed Product. Merck shall notify Metabasis Milestone Event Payment Filing of an Investigational New Drug Application (or equivalent) $ [...***...] Dosing of first patient in writing within thirty a Phase 2 clinical trial (30or equivalent) days upon $ [...***...] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [...***...] 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. 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 two tables above are intended to be successive. 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 each the preceding milestone will be payable upon achievement of the next successive milestone, and shall make the appropriate milestone payment . Alnylam will notify MIT within thirty ten (3010) 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 above milestones by Alnylam or any 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:
Milestone 1: [***]Affiliates or Sublicensees.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Regulus Therapeutics Inc.), License and Collaboration Agreement (Regulus Therapeutics Inc.)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable Within five (except as expressly set forth below in this Section 5.45) milestone payments (whether such milestone is achieved by Merck Business Days of EyeTech and/or its Affiliates 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 sublicensees achieving the first human in Phase I Clinical Trial. Milestone 3 [***] upon administration occurrence 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 each of the milestone payments described above in this Section 5.4 events listed below with respect to any Therapeutic Product, Diagnostic Product or Other Product, EyeTech shall be payable [***], as the case may be, to 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 notify CMI of such milestone achievement 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 milestonedate thereof, and shall make the appropriate milestone payment within thirty (30) days of the achievement date of such milestone. Ifachievement, pay the one-time non-refundable fees specified below to CMI by Federal Reserve electronic wire transfer in immediately available funds to an account designated by CMI; provided, however, that in no event shall the following fees be payable more than once with respect to any given Product for any reason, a Collaboration Compound particular geographical area 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 Milestone: THERAPEUTIC PRODUCTS: MURINE FORMS: Milestone Fee --------- --- Initiation 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:
Milestone 1: 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 [***] 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
Samples: Development and Sublicensing Agreement (Cancervax Corp), Development and Sublicensing Agreement (Cancervax Corp)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck Bayer shall pay to Metabasis make the following non-refundable, non-creditable Milestone Payments (except as expressly set forth below in this Section 5.4the “Milestone Payments”) milestone payments (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 to Nektar, with respect to the Product, within [***] upon approval days after achievement of the relevant milestone for entry into formal Good Laboratory Practices safety assessment studies the Product. The milestones in this Section 8.3 are cumulative, such that under no circumstances is any single Milestone Payment to be 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 a Collaboration Compound; provided that such any milestone under this Agreement.
(i) Effective Date (reimbursement by Bayer [***]) $ 50 *
(ii) [***] $ 10 **
(iii) [***] $ [ ***]
(iv) [***] $ [ ***]
(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 final report for the [***]. If no ** This milestone payment shall be used by Nektar to reimburse Bayer’s Development Costs of conducting any Phase III Clinical Trial in the Territory. Bayer shall invoice Nektar quarterly for such [***]Development Costs as such costs are incurred pursuant to the Development 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, this milestone will be deemed and Nektar shall have the right to have been triggeredverify any such Development Costs. Milestone 2 Nektar shall pay such invoiced amounts within [***] upon administration days after its receipt of Collaboration Compound or Product to the first human in Phase I Clinical Trialan invoice. 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 milestone payments described above in If Bayer terminates this Section 5.4 shall be payable [***], as the case may be, to reach Agreement before 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 is fully applied to reimburse such costs, Nektar shall be payable only upon have the initial achievement right to retain any remaining portion of such milestone and no amounts shall be due hereunder for subsequent or repeated achievement payment not applied to reimburse such costs as of the effective date 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:
Milestone 1: [***]termination.
Appears in 1 contract
Samples: Co Development, License and Co Promotion Agreement (Nektar Therapeutics)
Milestone Payments. Subject to Alnylam will pay MIT the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly amounts set forth below in this Section 5.4) upon achievement by Alnylam or any of its Affiliates or Sublicensees of certain milestone payments (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 [***]events as set forth below. If no such [***], this milestone Payments will be deemed to have been triggered. Milestone 2 [***] upon administration of Collaboration Compound or Product to the first human due 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 respect of the milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 events for each first Licensed Product containing an mxXXX 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 no amounts shall replaced with a different Licensed Product for the same therapeutic indication containing an mxXXX Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the discontinued Licensed Product, milestone payments already paid for the discontinued Licensed Product will not be due hereunder for subsequent or repeated achievement of such the same milestone event(s) by the same Collaboration Compound or substituted Licensed Product. Merck shall notify Metabasis Milestone Event Payment Filing of an Investigational New Drug Application (or equivalent) $ [**] Dosing of first patient in writing within thirty a Phase 2 clinical trial (30or equivalent) days upon $ [**] Dosing of first patient in a Phase 3 clinical trial (or equivalent) $ [**] 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. 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 two tables above are intended to be successive. 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 each the preceding milestone will be payable upon achievement of the next successive milestone, and shall make the appropriate milestone payment . Alnylam will notify MIT within thirty ten (3010) 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 above milestones by Alnylam or any 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:
Milestone 1: [***]Affiliates or Sublicensees.
Appears in 1 contract
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck Licensee shall pay to Metabasis the following make a non-refundable, non-creditable (except as expressly set forth below in this permitted under Section 5.411.9) milestone payments (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 payment 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 Inhibrx 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 first achievement of each of the foregoing milestones milestone events identified in Table 1 through 7 shall be adjusted as follows:
Milestone and Table 2: Table 1: Clinical Milestones Milestone Number Milestone Event Milestone Payment 1 Initiation (i.e., first patient dosed) of the first Phase II Clinical Trial by Licensee, its Affiliates and/or Sublicensees for Licensed Product. For clarity, this milestone is payable no more than once. $[***] 2 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 [***] ([***]) 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. $[***]* 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. $[***]* *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 [***] 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 $[***], and for the third Approved Indication of such Licensed Product, payment for milestone 3 is $[***]. With respect to milestone 1 and 2 in Table 1 above, if Licensee achieves any given milestone without first achieving the immediately preceding milestone (a “Skipped Milestone”), then Licensee shall make the milestone payment for the Skipped Milestone when Licensee pays the milestone payment for such next-occurring milestone.
Appears in 1 contract
Samples: Licensing Agreement
Milestone Payments. Subject to the terms and conditions contained in this Agreement, Merck in further consideration of the rights granted by MPC hereunder, MN shall pay to Metabasis MPC the following non-refundablemilestone payments, non-creditable (except as expressly set forth below in this Section 5.4) contingent upon occurrence of the specified event, with each milestone payments (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 payment to be made no such [***], this milestone will be deemed to have been triggered. Milestone 2 [***] upon administration of Collaboration Compound or Product more than once with respect 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 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):
(a) [**] upon first IND submission in the MN Territory;
(b) [**] upon initiation (dosing of the first patient) of the first Phase 2 Clinical Trial in the MN Territory;
(c) [**] upon initiation (dosing of the first patient) of the first Phase 3 Clinical Trial in 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 same Collaboration Compound first Regulatory Approval from the EMEA by MN, its Affiliates or Productits 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 [**]. Merck MN shall notify Metabasis MPC in writing within thirty (30) days upon after the achievement of the milestones specified in Sections 4.2 (a) through (g) and each milestone, and such notice shall make be accompanied by the appropriate milestone payment payment. MN shall notify MPC in writing within thirty ninety (3090) days of after the achievement of such milestone. If, for any reason, a Collaboration Compound or Product reaches a particular the 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 Sections 4.2 (h) and any such milestone, both the milestone payment applicable required to be made by MN under such milestone and the milestone payment(s) applicable to such preceding unachieved milestone(sSection 4.2 (h) shall be due and payable within thirty (30) days of paid together with the achievement of royalty payment for 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:
Milestone 1: [***]Calendar Quarter.
Appears in 1 contract
Samples: License Agreement
Milestone Payments. Subject to Alnylam will pay MIT the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly 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 this Section 5.4respect of the achievement of such milestone events for each first Licensed Product containing an xxXXX 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 xxXXX Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the discontinued Licensed Product, milestone payments already paid for the discontinued Licensed Product will not be due for achievement of the same milestone event(s) by the substituted Licensed Product. Milestone Event Payment Filing of an Investigational New Drug Application (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 equivalent) $ [***] upon approval for entry into formal Good Laboratory Practices safety assessment studies Dosing of first patient in a Collaboration Compound; provided that such [***]. If no such [***], this milestone will be deemed to have been triggered. Milestone Phase 2 clinical trial (or equivalent) $ [***] upon administration Dosing of Collaboration Compound first patient in a Phase 3 clinical trial (or Product to the first human in Phase I Clinical Trial. Milestone 3 equivalent) $ [***] upon administration of Collaboration Compound or Product to the first human in Phase II Clinical Trial. Milestone 4 First Commercial Sale $ [***] upon administration • In the event of Collaboration Compound or Product to an assignment as described in Article 10 of the first human in Phase III Clinical TrialMIT 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 5 Event Payment Filing of Investigational New Drug Application (or equivalent) $ [***] upon NDA approval for Product Dosing of first patient in United States. Milestone 6 a Phase 2 clinical trial (or equivalent) $ [***] upon NDA approval for Product Dosing of first patient in Japan. Milestone 7 a Phase 3 clinical trial (or equivalent) $ [***] upon NDA approval for Product in the first European Market. Each of the milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to reach such milestone; provided that First Commercial Sale $ [***] shall [***] Collaboration Compounds• The milestone events set forth in the two tables above are intended to be successive. In addition and notwithstanding the foregoing, or Products containing such Collaboration Compoundsif any milestone is reached without achieving a preceding milestone, as then the case may be, to reach each such amount which would have been payable on achievement of the preceding milestone will be payable upon achievement of the next successive 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 Alnylam will notify Metabasis in writing MIT within thirty ten (30) days upon the achievement of each milestone, and shall make the appropriate milestone payment within thirty (3010) 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 above milestones by Alnylam or any 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:
Milestone 1: [***]Affiliates or Sublicensees.
Appears in 1 contract
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Milestone Payments. Subject to the terms and conditions in of this Agreement, Merck shall pay to Metabasis upon the following non-refundable, non-creditable (except first instance of attainment of the milestones as expressly 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 5.4) 5.2(b). Oragenics shall immediately advise Inspirevax of the attainment of milestone payments (whether such milestone is achieved 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 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 wire transfer 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 account specified 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 Inspirevax within thirty (30) days of the achievement of such milestoneapplicable invoice. 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 The Milestone Payments payable by Merck for Oragenics to Inspirevax upon achievement of each of the foregoing milestones 1 through 7 shall be adjusted milestone event are as follows:
(i) a one-time Milestone 1: Payment of [***]] upon Oragenics’ positive decision on an appropriate nasal-spray device, based on compatibility and characterization of the device for use in the first clinical trial;
(ii) one-time Milestone Payment of [***] upon the first patient dosed in the first Phase 2a clinical trial under this Agreement;
(iii) a one-time Milestone Payment of [***] upon the first patient dosed in the first Phase 2b/3 clinical trial under this Agreement;
(iv) a one-time Milestone Payment of [***] upon a Biologics License Application (BLA) submission for the Combination Product to the United States FDA;
(v) a one-time Milestone Payment of [***] upon the first filing for marketing authorization for the Combination Product outside of the United States;
(vi) additional Milestone Payments of [***] 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 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
Milestone Payments. Subject to Alnylam will pay MIT the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly 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 this Section 5.4respect of the achievement of such milestone events for each first Licensed Product containing an mxXXX 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 mxXXX Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the discontinued Licensed Product, milestone payments already paid for the discontinued Licensed Product will not be due for achievement of the same milestone event(s) by the substituted Licensed Product. Filing of an Investigational New Drug Application (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 equivalent) $[***] upon approval for entry into formal Good Laboratory Practices safety assessment studies Dosing of first patient in a Collaboration Compound; provided that such [***]. If no such [***], this milestone will be deemed to have been triggered. Milestone Phase 2 clinical trial (or equivalent) $[***] upon administration Dosing of Collaboration Compound first patient in a Phase 3 clinical trial (or Product to the first human in Phase I Clinical Trial. Milestone 3 equivalent) $[***] upon administration of Collaboration Compound or Product to the first human in Phase II Clinical Trial. Milestone 4 First Commercial Sale $[***] upon administration • In the event of Collaboration Compound 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. Filing of Investigational New Drug Application (or Product to the first human in Phase III Clinical Trial. Milestone 5 equivalent) $[***] upon NDA approval for Product Dosing of first patient in United States. Milestone 6 a Phase 2 clinical trial (or equivalent) $[***] upon NDA approval for Product Dosing of first patient in Japan. Milestone 7 a Phase 3 clinical trial (or equivalent) $[***] upon NDA approval for Product in the first European Market. Each of the milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to reach such milestone; provided that First Commercial Sale $[***] shall [***] Collaboration Compounds• The milestone events set forth in the two tables above are intended to be successive. In addition and notwithstanding the foregoing, or Products containing such Collaboration Compoundsif any milestone is reached without achieving a preceding milestone, as then the case may be, to reach each such amount which would have been payable on achievement of the preceding milestone will be payable upon achievement of the next successive 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 Alnylam will notify Metabasis in writing MIT within thirty ten (30) days upon the achievement of each milestone, and shall make the appropriate milestone payment within thirty (3010) 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 above milestones by Alnylam or any 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:
Milestone 1: [***]Affiliates or Sublicensees.
Appears in 1 contract
Samples: License and Collaboration Agreement (Isis Pharmaceuticals Inc)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck LICENSEE shall also pay to Metabasis BCM the following nonone-refundable, non-creditable (except as expressly time milestone payments set forth below in this Section 5.4) milestone payments (whether following the first achievement of such milestone is achieved by Merck LICENSEE, its Affiliate or Sublicensee:
(i) Upon the first dosing of the first patient in the first phase III clinical trial (or foreign equivalent) for the first (1st) Distinct Product, LICENSEE shall make a Related Party):[***REDACTED***] dollar($[***REDACTED***]) payment to BCM;
Milestone 1 (ii) Upon the first dosing of the first patient in the first phase III clinical trial (or foreign equivalent) for the second (2nd) Distinct Product, LICENSEE shall make a [***REDACTED***] dollar ($[***REDACTED***]) payment to BCM; Portions herein identified by [***] upon have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
(iii) Upon receipt of final FDA approval of the first Marketing Authorization for entry into formal Good Laboratory Practices safety assessment studies of the first (1st) Distinct Product, LICENSEE shall make a Collaboration Compound; provided that such [***REDACTED***] dollar($[***REDACTED***]. If no such ) payment to BCM;
(iv) Upon receipt of final FDA approval of the first Marketing Authorization for the second (2nd) Distinct Product, LICENSEE shall make a [***], this milestone will be deemed to have been triggered. Milestone 2 REDACTED***] dollar ($[***] upon administration REDACTED***]) payment to BCM; and
(v) Upon first attainment of Collaboration Compound or Product to annual Net Sales of greater than five hundred million ($500,000,000) for the first human in Phase I Clinical Trial. Milestone 3 (1st) Distinct Product, LICENSEE will make a [***REDACTED***] upon administration of Collaboration Compound or Product to the first human in Phase II Clinical Trial. Milestone 4 dollar ($[***] upon administration REDACTED***]) payment to BCM;
(vi) Upon first attainment of Collaboration Compound or Product to annual Net Sales of greater than five hundred million ($500,000,000) for the first human in Phase III Clinical Trial. Milestone 5 second (2nd) Distinct Product, LICENSEE will make a [***REDACTED***] upon NDA approval for Product in United States. Milestone 6 dollar ($[***] upon NDA approval REDACTED***]) payment to BCM;
(vii) Upon first attainment of annual Net Sales of greater than one billion ($1,000,000,000) for Product in Japan. Milestone 7 the first (1st) Distinct Product, LICENSEE will make a [***REDACTED***] upon NDA approval for Product in the first European Market. Each of the milestone payments described above in this Section 5.4 shall be payable dollar ($[***REDACTED***]) payment to BCM;
(viii) Upon first attainment of annual Net Sales of greater than one billion ($1,000,000,000) for the second (2nd) Distinct Product, as the case may be, to reach such milestone; provided that LICENSEE will make a [***REDACTED***] shall dollar ($[***REDACTED***]) payment to BCM;
(ix) Upon first attainment of annual Net Sales of greater than two billion ($2,000,000,000) for any of the Distinct Products, LICENSEE will make a [***REDACTED***] Collaboration Compoundsdollar ($[***REDACTED***]) payment to BCM. For the avoidance of doubt, or Products containing such Collaboration Compounds, as this payment is a one-time payment that will be paid for the case may be, to reach each such milestone. Each milestone payment shall be payable only upon the initial achievement first Licensed Product that attains annual Net Sales 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 greater than $2,000,000,000; and
(x) LICENSEE shall notify Metabasis BCM in writing within thirty (30) days upon 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 shall make the appropriate milestone ending December 31st. BCM will then invoice LICENSEE for 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 LICENSEE shall pay the milestone payment(s) applicable to such preceding unachieved milestone(s) shall be due and payable invoice within thirty fifteen (3015) days upon receipt of the achievement invoice. Milestones are to be paid regardless of whether LICENSEE, its Affiliate or LICENSEE’s Sublicensee attains 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:
Milestone 1: [***].
Appears in 1 contract
Samples: Exclusive License Agreement (Marker Therapeutics, Inc.)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck GPC shall pay to Metabasis make the following non-refundable, non-creditable (except as expressly set forth below in this Section 5.4) milestone payments (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 [***] to MORPHOSYS once for each GPC Target, 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to 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 a Licensed Product directed to such GPC Target:
(a) Deutschmarks (DM ***) within thirty (30) days upon of confirmation by GPC that an ScFv antibody delivered by MORPHOSYS meets the achievement Success Criteria for the relevant GPC Target;
(b) Deutschmarks (DM ***) within thirty (30) days of each milestoneconfirmation by GPC that an IgG antibody delivered by MORPHOSYS meets the Success Criteria for the relevant GPC Target;
(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;
(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
(e) Deutschmarks (DM ***) within thirty (30) days following the date GPC or an Affiliate receives an FDA (or equivalent foreign regulatory agency) approval of the 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 appropriate following milestone payment 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 ***) within thirty (30) days of the achievement date of such milestone. If, commencement of each clinical trial using a Licensed Product for any reason, patient screening to support the development of 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(snon-Licensed Product; and
(h) applicable to such preceding unachieved milestone(sDeutschmarks (DM ***) shall be due and payable within thirty (30) days of the achievement date GPC or an Affiliate first receives regulatory approval to commence sales of such milestone. In the event that Merck has exercised its option any non-Licensed Product developed using Licensed Products in a clinical setting 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:
Milestone 1: [***]patient screening.
Appears in 1 contract
Samples: Collaboration and License Agreement (GPC Biotech Ag)
Milestone Payments. Subject Within 14 days following the occurrence of each and any of the milestone events listed below, Company shall provide written notice to CyDex of the 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 terms omitted portions. Family, milestone (iv), (vi) or (viii) is achieved before any or all of milestones (i), (ii) and conditions in this Agreement(iii) have been actually achieved, Merck then any and all of milestones (i), (ii) and (iii) which were not previously actually achieved for such Licensed Product Family shall pay be deemed to Metabasis have thereby been achieved for such Licensed Product Family, and the following non-refundable, non-creditable (except as expressly set forth below in this Section 5.4) milestone payments for such deemed-achieved milestones shall also be payable within such 21 days. MILESTONE MILESTONE PAYMENT
(whether such milestone is achieved by Merck or a Related Party):
Milestone 1 i) Upon dosing of the first patient in the first [***] upon approval Clinical Trial by Company or under rights from Company for entry into formal Good Laboratory Practices safety assessment studies of a Collaboration Compound; provided that such [Licensed Product in a Licensed Product Family* [ ***]. If no such [***], this milestone will be deemed to have been triggered. Milestone 2
(ii) Upon dosing of the first patient in the first [***] upon administration Clinical Trial by Company or under rights from Company for a Licensed Product in a Licensed Product Family* [ ***]
(iii) Upon submission of Collaboration Compound or Product 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 human indication of a Licensed Product in Phase I Clinical Trial. Milestone 3 [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 [ ***] 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 * such milestone payments described above in this Section 5.4 shall only be payable [***], as the case may be, to 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 once per Licensed 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:
Milestone 1: [***]Family.
Appears in 1 contract
Samples: License Agreement (MEI Pharma, Inc.)
Milestone Payments. Subject to the terms and conditions in this Agreement, Merck COMPANY shall pay to Metabasis WHXXXXXXX xhe amounts below upon achievement by COMPANY or its AFFILIATE of certain milestone events as set forth in the following table below.
(i) Payments will be due in respect of the achievement of the milestone 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: [***]: [***] [***]: [***] [***]: [***] [***]: [***]
(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 (except as expressly set forth below in this Section 5.4) milestone payments (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 within [***] upon approval for entry into formal Good Laboratory Practices safety assessment studies after achievement of a Collaboration Compound; provided that such [***]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 no such [***]the first LICENSED PRODUCT, this POLYPEPTIDE, LICENSED PROCESS or DISCOVERED PRODUCT does not meet all milestones, any paid milestone will be deemed to have been triggered. Milestone 2 [***] upon administration considered fulfillment of Collaboration Compound or Product to that milestone obligation, which shall not be paid again on 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, next product to 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 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 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 events set forth in the preceding paragraph, upon the achievement of such milestone, both the milestone payment applicable Section 4.1(c) above are intended 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 milestonesuccessive. In the event that Merck has exercised its option for continued Exclusive Efforts in accordance any Phase I clinical trial is combined with Section 2.10a 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 by Merck for on achievement of each the preceding milestone shall be payable upon achievement of the foregoing milestones 1 through 7 shall be adjusted as follows:
Milestone 1: [***]following milestone.
Appears in 1 contract
Milestone Payments. Subject to Alnylam will pay MIT the terms and conditions in this Agreement, Merck shall pay to Metabasis the following non-refundable, non-creditable (except as expressly 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 this Section 5.4respect of the achievement of such milestone events for each first Licensed Product containing an xxXXX 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 xxXXX Therapeutic(s) and/or an siRNA Therapeutic(s) towards at least one Target that was also a Target of the discontinued Licensed Product, milestone payments already paid for the discontinued Licensed Product will not be due for achievement of the same milestone event(s) by the substituted Licensed Product. Filing of an Investigational New Drug Application (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 equivalent) $ [***] upon approval for entry into formal Good Laboratory Practices safety assessment studies Dosing of first patient in a Collaboration Compound; provided that such [***]. If no such [***], this milestone will be deemed to have been triggered. Milestone Phase 2 clinical trial (or equivalent) $ [***] upon administration Dosing of Collaboration Compound first patient in a Phase 3 clinical trial (or Product to the first human in Phase I Clinical Trial. Milestone 3 equivalent) $ [***] upon administration of Collaboration Compound or Product to the first human in Phase II Clinical Trial. Milestone 4 First Commercial Sale $ [***] upon administration · In the event of Collaboration Compound 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. Filing of Investigational New Drug Application (or Product to the first human in Phase III Clinical Trial. Milestone 5 equivalent) $ [***] upon NDA approval for Product Dosing of first patient in United States. Milestone 6 a Phase 2 clinical trial (or equivalent) $ [***] upon NDA approval for Product Dosing of first patient in Japan. Milestone 7 a Phase 3 clinical trial (or equivalent) $ [***] upon NDA approval for Product in the first European Market. Each of the milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to reach such milestone; provided that First Commercial Sale $ [***] shall [***] Collaboration Compounds· The milestone events set forth in the two tables above are intended to be successive. In addition and notwithstanding the foregoing, or Products containing such Collaboration Compoundsif any milestone is reached without achieving a preceding milestone, as then the case may be, to reach each such amount which would have been payable on achievement of the preceding milestone will be payable upon achievement of the next successive 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 Alnylam will notify Metabasis in writing MIT within thirty ten (30) days upon the achievement of each milestone, and shall make the appropriate milestone payment within thirty (3010) 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 above milestones by Alnylam or any 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:
Milestone 1: [***]Affiliates or Sublicensees.
Appears in 1 contract
Samples: License and Collaboration Agreement (Isis Pharmaceuticals Inc)
Milestone Payments. Subject Provided XXXXXX has exercised the option set forth in Section 2.3 above, XXXXXX shall make the MILESTONE PAYMENTS to LIPOXEN in accordance with the occurrence of the MILSTONE EVENTS provided in Schedule III hereto for POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS, as the case may be (subject to the terms and conditions deductions set out in Section 8.2). The MILESTONE PAYMENTS shall be in addition to any royalty or other payments due under this Agreement, Merck AGREEMENT. Once a MILESTONE EVENT has been reached LIPOXEN shall pay submit an invoice to Metabasis XXXXXX for the following non-refundable, non-creditable 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 as expressly set forth below in this Section 5.4) milestone payments (whether such milestone is achieved by Merck or a Related Party):
Milestone 1 that XXXXXX shall be required to make an additional [***] upon approval MILESTONE PAYMENT in the event:
(i) XXXXXX has entered into clinical trials for entry into formal Good Laboratory Practices safety assessment studies the development of a Collaboration Compound; provided that POTENTIAL PRODUCT for a specific label indication, and
(ii) XXXXXX 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 development of the POTENTIAL PRODUCT in clinical trials is not due to the failure to meet satisfactory clinical endpoints (a “CLINICAL FAILURE”). If no In such [***]event, this milestone will be deemed to have been triggered. Milestone 2 the [***] upon administration on the selection of Collaboration Compound one or Product more lead candidates to be developed for the first human new label indication. Any label indication in Phase I Clinical Trialthe same disease area shall be considered the same label indication. Milestone 3 For example, an indication for the [***] 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 and an indication 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 milestone payments described above in this Section 5.4 shall be payable [***], as the case may be, to reach such milestone; provided that [***] shall be considered the same label indication. For clarity, in the event XXXXXX 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 Xxxxxx 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 Xxxxxx 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 XXXXXX terminates the development of a POTENTIAL PRODUCT with a targeted indication [***] Collaboration Compounds, or Products containing such Collaboration Compounds, as the case may be, prior to reach each such milestone. Each milestone payment shall be payable only upon the initial achievement of such milestone initiating clinical trials 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, elects to develop a Collaboration Compound or Product reaches different POTENTIAL PRODUCT with 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:
Milestone 1: targeted indication [***]] then no additional MILESTONE PAYMENT shall be due. For example, if XXXXXX terminates the development of a POTENTIAL PRODUCT with a targeted indication [***] after initiating clinical trials, and there has been no CLINICAL FAILURE, and elects to develop a different POTENTIAL PRODUCT with a targeted indication of [***] then an additional [***] MILESTONE PAYMENT shall be due upon the selection of the lead candidate.
Appears in 1 contract
Samples: Exclusive Research, Development and License Agreement (Xenetic Biosciences, Inc.)