Development and Commercialization Milestone Payments Sample Clauses

The Development and Commercialization Milestone Payments clause outlines the financial obligations that arise when certain predefined stages or achievements are reached during the development and commercialization of a product. Typically, this clause specifies the milestones—such as regulatory approvals, product launches, or sales targets—and the corresponding payments that must be made by one party to another upon reaching each milestone. Its core practical function is to incentivize progress and ensure that compensation is tied to tangible achievements, thereby aligning the interests of the parties and managing financial risk throughout the product's lifecycle.
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Development and Commercialization Milestone Payments. Milestone [Separate milestone payments are due on a Licensed Product-by-Licensed Product basis] Payment Filing of an IND or the equivalent outside the U.S. [####] Enrollment of first patient in a Phase I clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase II clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase III clinical trial in the U.S. or the equivalent trial outside the U.S. [####] First Regulatory Approval of Licensed Product in each of the U.S., Europe and Asia (milestone payment due up to three times total; one time for each such regulatory approval) [####] This First Amendment to License Exclusive Agreement (this “Amendment”) is entered into as of March 21, 2021 (the “Amendment Date”), by and between Elkurt, Inc., a Rhode Island corporation with an address at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ (“Elkurt”) and Ocean Biomedical Inc, a Delaware corporation with an address at ▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Licensee”).
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Development and Commercialization Milestone Payments. Milestone [Separate milestone payments are due on a Licensed Product-by-Licensed Product basis] Payment Filing of an IND or the equivalent outside the U.S. [####] Enrollment of first patient in a Phase I clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase II clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase III clinical trial in the U.S. or the equivalent trial outside the U.S. [####] First Regulatory Approval of Licensed Product in each of the U.S., Europe and Asia (milestone payment due up to three times total; one time for each such regulatory approval) [####] RIH #154; SCRI reference: SCRI. 243 “PfsLSP-1 a Vaccine for Falciparum Malaria” BR112014013170-8-Brazil filed 11/30/12 12854476.4-EP filed 11/30/12 The following terms, conditions, rights and duties shall be deemed to be a part of the License Agreement and shall be included therein, and shall be in addition to any terms in the Agreement.
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Development and Commercialization Milestone Payments. Subject to the terms and conditions of this Agreement and in further consideration for the license granted herein, Licensee shall make each of the following one-time, non-refundable, non-creditable milestone payments to Lilly for the first Licensed Product to achieve such milestone: The earlier of: (i) filing and acceptance of an NDA or equivalent for a Licensed Product in the United States $[**] NDA approval for a Licensed Product in the United States $[**] NDA approval or equivalent for a Licensed Product by the European Medicines Agency or in any Major European Country $[**] NDA approval or equivalent for a Licensed Product in Japan $[**] First Commercial Sale of a Licensed Product in the United States $[**] First Commercial Sale of a Licensed Product in a Major European Country $[**] First Commercial Sale of a Licensed Product in Japan $[**]
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Development and Commercialization Milestone Payments. Subject to the terms and conditions of this Agreement and in further consideration for the license granted herein. Licensee shall make each of the following non-refundable, non-creditable milestone payments to Merck for each Licensed Product:
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Development and Commercialization Milestone Payments. Subject to the terms and conditions of this Agreement and in further consideration for the licenses granted in this Agreement, Licensee shall make each of the following non-refundable, non-creditable milestone payments to Merck and/or Cerecor in U.S. dollars, as indicated below, for each Licensed Product: [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
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Development and Commercialization Milestone Payments. On a Licensed Program-by-Licensed Program basis, Verastem will pay the applicable amount set forth in Table 9.4.2(a) (Development and Commercialization Milestones) associated with each milestone event described below (each event, a “Development and Commercialization Milestone Event,” and each respective payment, a “Development and Commercialization Milestone Payment”) for the achievement by Verastem, its Affiliates, or its Sublicensees of the applicable Development and Commercialization Milestone Event by the first Licensed Product under a Licensed Program: ​ [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] *For the avoidance of doubt, each of the milestones set forth in Table 9.4.2(a) may be triggered by a Sublicensee of Verastem.
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Development and Commercialization Milestone Payments. Subject to the terms and conditions of this Agreement and in further consideration for the license granted herein, Licensee shall make each of the following one-time, non-refundable, non-creditable milestone payments to Lilly for the first Licensed Product to achieve such milestone: The first subject dosed in a Phase 2 Clinical Trial. $* * * * The first subject dosed in a Phase 3 Clinical Trial. * * * * Acceptance for filing of an NDA or equivalent for a Licensed Product in the United States $* * * * NDA approval for a Licensed Product in the United States $* * * * * * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. NDA approval or equivalent for a Licensed Product by the European Medicines Agency or in any Major European Country $* * * * NDA approval or equivalent for a Licensed Product in Japan $* * * * First Commercial Sale of a Licensed Product in the United States $* * * * First Commercial Sale of a Licensed Product in a Major European Country $* * * * First Commercial Sale of a Licensed Product in Japan $* * * *
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Development and Commercialization Milestone Payments. If any of the events listed below in this Section (each, a “Development Milestone”) is achieved, then Benitec shall pay 4D Molecular, within **** calendar days of the successful completion of each Development Milestone, the non-refundable payment listed opposite that Development Milestone below in this Section 6.3. Payments shall be made in US dollars by wire transfer from a US bank account designated by Benitec to a US bank account designated by 4D Molecular. a. For the first time each of the Development Milestones listed in this Section 6.3(a) is achieved by the first Product to achieve such Development Milestone, Benitec shall be obligated to make each payment set out in the table below (to be clear, only once ever over the life of this Agreement): **** **** **** **** **** **** **** **** **** **** If any Development Milestone in the foregoing table (“Later Milestone”) is achieved without a Development Milestone that appears earlier in the table (“Earlier Milestone”) having been achieved and the corresponding payment paid to 4D Molecular, then the Earlier Milestone shall be deemed achieved, and the corresponding payment shall be due, upon achievement of the Later Milestone, in addition to the payment corresponding to the Later Milestone in such table being due. b. For the second Product to achieve, and for each subsequent Product that has not ever before achieved, a given Development Milestone listed below (nor to be clear has it achieved the same Development Milestone under subsection (a)), when such second and each such subsequent Product first achieves such given Development Milestone below, Benitec shall be obligated to make each payment set out in the table below, only upon the first achievement of the applicable Development with respect to each such Product: **** **** **** **** **** **** **** **** **** **** If any Development Milestone in the foregoing table is achieved without a Development Milestone that appears earlier in the table having been achieved and the corresponding payment paid to 4D Molecular, then the earlier Development Milestone shall be deemed achieved, and the corresponding payment shall be due, upon achievement of the later Development Milestone, in addition to the payment corresponding to the later Development Milestone in such table being due. c. It is understood that the payments for Development Milestones in the table of subsection (a) shall be paid one time only each. It is understood that the payments for Development Milest...
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Development and Commercialization Milestone Payments. Milestone [Separate milestone payments are due on a Licensed Product-by-Licensed Product basis] Payment Filing of an IND or the equivalent outside the U.S. [####] Enrollment of first patient in a Phase I clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase II clinical trial in the U.S. or the equivalent trial outside the U.S. [####] Enrollment of first patient in a Phase III clinical trial in the U.S. or the equivalent trial outside the U.S. [####] First Regulatory Approval of Licensed Product in each of the U.S., Europe and Asia (milestone payment due up to three times total; one time for each such regulatory approval) [####]
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Related to Development and Commercialization Milestone Payments

  • Development Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”): (i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study); (ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and (ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless ​ of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection ▇▇▇▇▇; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.