Development and Commercialization Milestone Payments Sample Clauses

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 000 Xxxxxxxxx Xxx, Xxxxxxxxxx XX 00000 (“Elkurt”) and Ocean Biomedical Inc, a Delaware corporation with an address at 00X000 Xxxxxx XxXxxxx, Xxx Xxxxx, XX 00000 (“Licensee”).
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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. 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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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. 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. 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. 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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Related to Development and Commercialization Milestone Payments

  • Development Milestone Payments (i) In addition to the Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth below (each, a “Development Milestone”), Parent shall, or shall cause the Surviving Corporation to, [**] after the occurrence of each Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Payment” and collectively, the “Development Milestone Payments”): (A) Upon FDA approval of Reslizumab for the treatment of eosinophilic esophagitis, a cash payment of [**]; (B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; (C) If Res 5-0010 Asthma Study Completion has not occurred on or prior to the Closing Date, then upon the occurrence of the Res 5-0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “Res 5-0010 Asthma Payment”); (D) Upon FDA approval of Reslizumab for any asthma indication, a cash payment of [**]; (E) Upon marketing authorization of Reslizumab for the treatment of any asthma indication being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; and (F) Upon FDA approval of an Oral Anti-TNF Product, a cash payment of [**].

  • 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 xxxxx; 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.

  • Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

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