Development and Regulatory Milestones. With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone:
1. Effective Date $ 7,000,000
2. Successful Completion of On-Going Phase I/II Trial $ 10,000,000
3. [**] $ [**] [**] $ 12,500,000 [**] $ [**]
4. [**] $ [**]
5. [**] $ [**]
6. [**] $ [**] Total Development and Regulatory Milestone Payments 132,500,000
Development and Regulatory Milestones. Buyer shall pay (which payments shall not be creditable against any other obligations of Buyer hereunder) a non-refundable payment for each of the milestone events set forth in this Section 3.2 (each a “Development and Regulatory Milestone”), whether the Development and Regulatory Milestone is achieved by Buyer, its Affiliates or Licensees, or any Third Party acting on behalf of Buyer, its Affiliates or Licensees. Payment for each of the Development and Regulatory Milestones shall be made only once regardless of how many times a Product achieves the corresponding Development and Regulatory Milestone, and no payment shall be due for any Development and Regulatory Milestone which is not achieved. The Development and Regulatory Milestones shall be as follows: Development and Regulatory Milestone Payment [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Buyer shall provide Seller with written notice within thirty (30) days after the achievement of the corresponding Development and Regulatory Milestone. The payment pertaining to each Development and Regulatory Milestone, other than the BLA Approval Milestone Payment which shall be governed in accordance with Section 3.2(a), shall be made by Buyer to Seller within ninety (90) days after the achievement of the corresponding Development and Regulatory Milestone.
Development and Regulatory Milestones. In partial consideration of the rights granted by Xxxxxxx to Forest hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.3), Forest shall pay to Xxxxxxx the applicable milestone payment within [*] Business Days after the achievement of each of the following milestone events: Acceptance by the FDA of an NDA for a Licensed Product $[*] Approval of an NDA for a Licensed Product in the United States and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to the United States or this Agreement in its entirety within 10 Business Days after receipt of such approval $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in a Major European Market and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt of such Milestone Regulatory Approvals $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to Japan or this Agreement in its entirety prior to such Milestone Regulatory Approvals $[*] Approval of an NDA (or supplement thereto) for a Licensed Product in the United States for an Indication that (a) [*] and (b) [*], and [*] (the “New Indication Milestone”) $[*]; provided that [*] If the New Indication Milestone has not already been achieved, approval of an NDA (or supplement thereto) for a Licensed Product in the United States for [*] that [*] that is [*], and [*]. For clarity, [*]. $[*]
Development and Regulatory Milestones. Licensee shall inform MedImmune within [***] Business Days after the occurrence of each of the milestone events listed below. In partial consideration of the rights granted by MedImmune to Licensee hereunder, Licensee shall pay to MedImmune the following one-time payments within [***] days after receipt of an invoice for the achievement of each of the following milestone events which shall be nonrefundable, noncreditable and fully earned upon the achievement of the applicable milestone event:
(i) [***];
(ii) [***];
(iii) [***];
(iv) [***];
(v) [***];
(vi) [***];
(vii) [***];
(viii) [***];
(ix) [***];
(x) [***]; and
(xi) [***]. Each milestone payment in this Section 5.2.1 shall be payable [***]. If, at any time, with respect to a Licensed Product, the achievement of a milestone described in Section 5.2.1 has occurred with respect to which a payment is due hereunder and any of the preceding milestones in this Section 5.2.1 have not been due or been paid , then each such skipped milestone payment shall become due and payable [***], with respect to which payment is due.
Development and Regulatory Milestones. (i) In partial consideration of the rights granted by Global BioLife to Prophase hereunder and subject to the terms and conditions set forth in this Agreement, Prophase shall pay to Global BioLife a milestone payment according to Section 4.02(b) after the achievement of each of the following regulatory milestones:
A. successful completion of a first Phase 3 Study which may be required by FDA for the first Licensed Product, nine-hundred thousand dollars ($900,000); and
B. Regulatory Approval of an NDA for the first Licensed Product, one million dollars ($1,000,000).
Development and Regulatory Milestones. Milestone Event Payment to Company
Development and Regulatory Milestones. Merck shall pay to NGM the amounts set forth below, which shall be non-refundable and non-creditable, on the first achievement by or on behalf of Merck or any Related Party of each of the following milestone events for each Program Compound (or Product containing or comprising such Program Compound, as applicable) or Small Molecule Collaboration Compound (or Small Molecule Product containing or comprising such Small Molecule Collaboration Compound, as applicable) (each, a “Milestone Product”); provided, however, that for any Milestone Product that is advanced following and on account of failure of an earlier Milestone Product (such newly advanced Milestone Product, a “Back-up Product/Compound”), Merck shall not be obligated to make milestone payment(s) to NGM with respect to the subsequent achievement by such Back-up Product/Compound of any milestone event that was previously achieved (and for which the applicable milestone payment was made to NGM) by the relevant failed Milestone Product; provided, further, that: (a) the milestone payments under this Section 9.5.1 for a Milestone Product shall be [*] for any [*] that [*]; and (b) no milestone payments shall be due under this Section 9.5.1 with respect to any Product for which NGM exercises its NGM ANS Option under Article 7: [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
Development and Regulatory Milestones. Celgene shall pay Vividion the following one-time amounts after the first achievement by or on behalf of Celgene or its Affiliates or Licensee Partners of the corresponding development and regulatory milestone events set forth below with respect to the first Licensed Product to achieve such milestone events. [Parties to include in execution version solely where the Licensed Program under this Agreement is a Vividion Cereblon Program, any Early Opt-Out Program or the First Program]
Development and Regulatory Milestones. Ultragenyx shall pay to BRI the following one-time, non-refundable, non-creditable development and regulatory milestone payments upon the achievement of the corresponding milestone by Ultragenyx or any of its Affiliates or sublicensees: (i) [***] $ [***] (ii) [***] $ [***] (iii) [***] $ [***] (iv) [***] $ [***] (v) [***] $ [***] (vi) [***] $ [***] (vii) [***] $ [***] (viii) [***] $ [***] (ix) [***] $ [***] (x) [***] $ [***]
Development and Regulatory Milestones. In partial consideration for the rights granted under this Agreement regarding the Collaboration Products, in each case upon initial achievement of the applicable milestone by or on behalf of SGEN or its Sublicensees for each Collaboration Product, SGEN will pay PIRS the corresponding non-refundable (subject to Section 4.4.2.2) and non-creditable lump sum payments set forth below. Development Event [***] [***] [***] [***] [***] Dollars ($[***]) [***] [***] Initiation of Phase 1 Clinical Study [***] Dollars ($[***]) Initiation of Phase 2a Clinical Study or Initiation of Phase 1 Clinical Study Expansion Cohorts (whichever comes first) [***] Dollars ($[***]) Initiation of Pivotal Clinical Study [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) [***] filing with [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) [***] filing with [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) [***] filing in [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) Marketing Approval in the [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) Marketing Approval in the [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) Marketing Approval in [***] [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***]) Maximum Total [***] Dollars ($[***]) [***] Dollars ($[***]) [***] Dollars ($[***])
