Milestone Payments. NIBRI shall make milestone payments in accordance with this Section 3.5: (a) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] of the achievement of such milestone; and (b) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:
Appears in 2 contracts
Sources: Collaboration and Option Agreement (Myogen Inc), Collaboration and Option Agreement (Myogen Inc)
Milestone Payments. NIBRI Subject to the terms and conditions in this Agreement, Merck shall make pay to Metabasis the following non-refundable, non-creditable (except as expressly set forth below in this Section 5.4) milestone payments in accordance with (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 Section 3.5: (a) with respect milestone will be deemed to each Myogen Compound, have been triggered. Milestone 2 [***] upon administration of Collaboration Compound or NIBRI Product to the first human in Phase I Clinical Trial. Milestone 3 [***] upon administration of Collaboration Compound having an effect on a High Priority Targetor 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 defined below (whether the case may be, to reach such milestone; provided that [***] shall [***] Collaboration Compounds, or not an OptionProducts containing such Collaboration Compounds, as defined belowthe case may be, has been exercised)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; and (b) with respect to each Myogen Compound. If, for any reason, a Collaboration Compound or NIBRI Compound Product reaches a particular milestone specified above without having an effect on a Low Priority Target 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 (as to which NIBRI has exercised its Option), payment within [/\#/\] 30) days of exercise the achievement of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially soughtsuch milestone. In the event that a Myogen CompoundMerck has exercised its option for continued Exclusive Efforts in accordance with Section 2.10, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound the amount payable by Merck for achievement of each of the foregoing milestones 1 through 7 shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced adjusted as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. follows:
Milestone 1: [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:***]
Appears in 2 contracts
Sources: Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc), Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc)
Milestone Payments. NIBRI shall make BMPI will provide Luitpold written notice of the achievement of each of the milestone payments in accordance with this Section 3.5: events (a) and (b) set forth below and Luitpold shall pay the relevant milestone amounts within thirty (30) days of such notice. Luitpold shall provide BMPI written notice within thirty (30) days of the achievement of each of the milestone events (c)-(h) set forth below and Luitpold shall pay the relevant amounts to BMPI as milestone payments with respect such notice; provided, however, that Luitpold shall be required to each Myogen Compoundpay such amounts if, Collaboration Compound and only if, its achievement of the applicable milestone obligates BMPI to make a milestone payment to any Licensor:
(a) Fifteen Million Dollars ($15,000,000) within thirty (30) days after the date on which regulatory approval is first received in the United States to market the Licensed Products in the Field of Use, of which ** shall be payable for the rights granted under the Licensed Patents identified with an asterisk (*) on Exhibit A and ** shall be payable for the rights granted under the Licensed Patents not identified with an asterisk (*) on Exhibit A; ** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(b) Five Million Dollars ($5,000,000) on the second anniversary of the Approval Date of which ** shall be payable for the rights granted under the Licensed Patents identified with an asterisk (*) on Exhibit A and ** shall be payable for the rights granted under the Licensed Patents not identified with an asterisk (*) on Exhibit A;
(c) upon filing an Investigational New Drug Application or NIBRI Compound having an effect on equivalent foreign filing for regulatory approval of a High Priority TargetLicensed Product in the Field of Extended Use;
(d) upon initiation of a Phase III or pivotal clinical trial, as "Phase III" is defined below by Title 21: chapter 1 - Food and Drug Administration, Department of Health and Human Services for a Licensed Product in the Field of Extended Use;
(whether e) upon filing a Biologies License Application or not an Optionequivalent foreign filing for a Licensed Product in the Field of Extended Use;
(f) upon receipt of FDA approval to market a Licensed Product in the Field of Extended Use;
(g) on the first anniversary of receipt of FDA approval to market a Licensed Product in the Field of Extended Use; and
(h) on the second anniversary of receipt of FDA approval to market a Licensed Product in the Field of Extended Use. Luitpold shall provide BMPI with written notice of the achievement of any milestone, as defined below, has been exercised)accompanied by the applicable milestone payment, within [/\#/\] of thirty (30) days after the achievement of such milestone; and . Milestones (bc) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target through (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments h) shall be payable only once with respect to deemed achieved by Luitpold if achieved by Luitpold, an Affiliate of Luitpold, a particular Myogen CompoundDistributor, Collaboration Compound or NIBRI Compoundan agent or contractor of Luitpold, even though that Myogen Compound, Collaboration Compound an Affiliate or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially soughta Distributor. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, Luitpold pays for any milestone payments previously paid with respect payment described in (c) through (e) above, BMPI will be obligated to refund such Myogen Compound, Collaboration Compound individual milestone payment(s) to Luitpold if BMPI subsequently achieves any or NIBRI Compound shall be fully creditable toward all of the same milestone due with respect to another Myogen Compoundmilestones that, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place but for Luitpold's previous payment of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct milestone, would have triggered a milestone payment obligation from any milestone payments otherwise due BMPI to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:a Licensor.
Appears in 2 contracts
Sources: Exclusive Sublicense Agreement (Biomimetic Therapeutics, Inc.), Exclusive Sublicense Agreement (Biomimetic Therapeutics, Inc.)
Milestone Payments. NIBRI Subject to the terms and conditions in this Agreement, MERCK shall make pay to deCODE the following milestone payments in accordance with this Section 3.5: payments:
(a) with respect to MERCK will pay a milestone of [CONFIDENTIAL TREATMENT REQUESTED].
(b) MERCK will pay a milestone of [CONFIDENTIAL TREATMENT REQUESTED]. MERCK shall notify deCODE in writing within thirty (30) days upon the achievement of the milestone for each Myogen CompoundProduct or Test, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below and shall make the appropriate milestone payment within thirty (whether or not an Option, as defined below, has been exercised), within [/\#/\] 30) days of the achievement of such milestone; and (b) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), . The milestone payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once upon the [**] achievement of such milestone for any Test or Product containing a unique IRCT Compound and no amounts shall be due hereunder for [**] achievement of such milestone with respect to other Tests or Products containing that IRCT Compound. No milestone payment shall be due under 5.3 (a) for any Product containing a particular Myogen Compound, Collaboration Related IRCT Compound if a milestone under Section 5.3(a) has been paid for a Product containing an IRCT Compound that the Related IRCT Compound was derived from or NIBRI Compound, even though that Myogen Compound, Collaboration the Related IRCT Compound or NIBRI is [CONFIDENTIAL TREATMENT REQUESTED] unless the Product also contains an IRCT Compound may be subsequently developed that would otherwise qualify for indications other than those for which regulatory approval was initially soughtthe milestone under this Section 5.3. In the event that MERCK makes a Myogen payment under Section 5.3(a) for a Product containing a Related IRCT Compound, Collaboration Compound or NIBRI Compound fails in development, any it shall have no further obligation to make milestone payments previously paid with respect to such Myogen under Section 5.3(a) for (i) any other Product containing that Related IRCT Compound, Collaboration ; (ii) the IRCT Compound that it is a [CONFIDENTIAL TREATMENT REQUESTED] of under Section 1.60(a); or NIBRI (iii) any other compound that is a Related IRCT Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as because it is a lead Compound in place [CONFIDENTIAL TREATMENT REQUESTED] of the failed IRCT Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:(ii).
Appears in 2 contracts
Sources: License and Research Collaboration Agreement (Decode Genetics Inc), License and Research Collaboration Agreement (Decode Genetics Inc)
Milestone Payments. NIBRI Contractor shall make milestone payments be paid for the portion of the Contract Price constituting the Firm Price and Fixed Price in accordance with the Milestone Payment Schedule in Exhibit F-1. The applicable portion of the Firm Price and Fixed Price shall be invoiced by Contractor upon the completion (or substantial completion as provided below) of each Milestone. Invoices for Milestone Payments for Major Equipment shall be issued separately from invoices for other Milestone Payments. The Milestone Payment due upon Substantial Completion of a Unit shall be two percent (2%) of the Firm Price and Fixed Price for the Unit. Submittal of each invoice by Contractor for a Milestone Payment shall constitute a representation by Contractor that it has performed and provided the Work required for such payment in accordance with this Section 3.5: Agreement or otherwise covered by such invoice. Payment shall be due from Owner within twenty (20) Days for Milestone Payments for Major Equipment and within thirty (30) Days for other Milestone Payments, in each case, following receipt of the invoice. Milestones are not required to be completed in the sequence set forth in Exhibit F-1, nor must invoices for completed Milestones be submitted in the sequence set forth in Exhibit F-1, and Milestones may be performed and invoiced ahead of the time for the performance of such Work under the Project Schedule, provided that Contractor may not submit an invoice for a Milestone performed out of sequence or ahead of time to the extent that the total invoiced for Milestones during any calendar month would exceed the aggregate of the Milestones for such calendar month as set forth in Exhibit F-1 plus (a) with respect twenty-five million dollars ($25,000,000) or less, unless Owner has agreed to each Myogen Compoundsuch out of sequence or early Milestone Payment, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below such agreement not to be unreasonably withheld; (whether or b) more than twenty-five million dollars ($25,000,000) but not an Option, as defined below, has been exercisedmore than fifty million dollars ($50,000,000), within [/\#/\] Contractor has notified Owner at least ninety (90) Days in advance of the achievement submission of an invoice that would cause such milestoneamount to be exceeded, and Owner has agreed to such out of sequence or early Milestone Payment, such agreement not to be unreasonably withheld; and (bc) with respect more than fifty million dollars ($50,000,000), Contractor has notified Owner at least one hundred eighty (180) days in advance of submission of an invoice that would cause such amount to each Myogen Compoundbe exceeded, Collaboration Compound and Owner has agreed to such out of sequence or NIBRI Compound having an effect early Milestone Payment. If agreed by Owner, Contractor shall have the option to invoice for substantially completed Milestones on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achievedpro rata basis. Except as explicitly The agreement between Owner and Contractor shall be set forth belowin a Change Order, milestone payments provided, however, that the provisions pertaining to Change Disputes shall be payable only once with respect not apply to the request by Contractor to invoice for a particular Myogen Compound, Collaboration Compound Milestone on a pro rata basis or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:Change Order resulting therefrom.
Appears in 2 contracts
Sources: Engineering, Procurement and Construction Agreement (South Carolina Electric & Gas Co), Engineering, Procurement and Construction Agreement
Milestone Payments. NIBRI (a) Acquirer shall make pay, or cause to be paid to the Company Securityholders, the following milestone payments (each a “Milestone Payment”) after deducting any Unpaid Company Transaction Expenses payable in connection with the payment of any Milestone Payments and after deducting any amounts set off against the Milestone Payments in accordance with this Section 3.5: 8.8 as follows:
(ai) If 2022 Net Revenue equals or exceeds $[***], an amount equal to the product of (A) 2022 Net Revenue multiplied by (B) [***] (the “2022 Net Revenue Milestone Payment”); provided that the 2022 Net Revenue Milestone Payment shall not exceed $25,000,000. For the avoidance of doubt, if 2022 Net Revenue is less than $[***], the 2022 Net Revenue Milestone Payment shall equal $0.
(ii) If (A) the Surviving Corporation receives written notification by Palmetto or Noridian of expanded Medicare coverage for the IDgenetix Test (or written notification of a Molecular Diagnostic Services’ LCD with respect expanded Medicare coverage that applies to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercisedthe IDgenetix Test), within that includes coverage for use of the IDgenetix Test in connection with (each of the following in clauses (1) through (6), an “Indication”) (1) anxiety, (2) schizophrenia, (3) bipolar disorder, (4) post-traumatic stress disorder, (5) obsessive-compulsive disorder and (6) attention deficit hyperactivity disorders (the “First Expanded Coverage Event”) by [/\#/\***] of and (B) the achievement of such milestone; proof of reimbursement for all Claims submitted to Noridian (with a minimum of [***] Claims per each Indication) at a rate of $[***] per test for each Indication (the “Second Expanded Coverage Event”) by [***], $10,000,000 (the “Expanded Coverage Milestone Payment”). For the avoidance of doubt, if the First Expanded Coverage Event does not occur by [***], the Expanded Coverage Milestone Payment shall equal $0, and if the Second Expanded Coverage Event does not occur by [***], the Expanded Coverage Milestone Payment shall equal $0. “Claim” means any claim submitted by or on behalf of a healthcare provider enrolled in the Medicare Provider Enrollment, Chain and Ownership System (PECOS) that (x) relates to a molecular pathology procedure under [***] and (by) with respect relates to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within diagnosis [/\#/\***] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Castle Biosciences Inc)
Milestone Payments. NIBRI Subject to Section 5.4, within thirty (30) calendar days following the occurrence of each of the events set forth below with respect to a Product, MSK shall make pay to ACADIA the milestone payments set forth below: Each of the milestone payments described in accordance with this Section 3.5: 5.3 shall be payable only one time for each Product, regardless of the number of indications, dosage forms, formulations, line extensions and modes of administration in the Field for which such Product is developed or commercialized; provided, further, that (i) if (a) with respect to each Myogen Compound, Collaboration Compound development of a Product is abandoned after one or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, more of the milestone payments under this Section 5.3 has been exercised), within [/\#/\] of the achievement of such milestone; made (a “Dropped Product”) and (b) a different Product (the “Replacement Product”) is developed for any indication as a replacement for such Dropped Product, then only those milestone payments under this Section 5.3 that were not previously made with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments Dropped Product shall be payable only once with respect to the Replacement Product and (ii) the milestone payments payable pursuant to this Section 5.3 shall be […***…] for any Product (other than a Replacement Product) that reaches the applicable milestone event after the initial Product has reached such milestone event, provided, however, that such […***…] milestone payments for such Product shall not become due so long as such Product has a possibility of becoming the Replacement Product. If any milestone event (the “Most Recent Milestone”) is achieved with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any Product without MSK having paid milestone payments previously paid for achievement of earlier milestone events with respect to such Myogen CompoundProduct (or, Collaboration Compound or NIBRI Compound if applicable, the Dropped Product that it is replacing), then MSK shall be fully creditable toward pay to ACADIA any missed milestone payments at the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of time the failed Compound that acts on the same Myogen Target or Collaboration TargetMost Recent Milestone payment is due. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; All payments made to ACADIA pursuant to this Agreement prior Section 5.3 are non-refundable and may not be credited against any other payments payable by MSK to exercise of an Option shall be treated as payments made ACADIA under the License this Agreement. 20. *** Confidential Treatment Requested 5.4 [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:…***…]
Appears in 1 contract
Sources: Collaboration and License Agreement (Acadia Pharmaceuticals Inc)
Milestone Payments. NIBRI As further consideration to Inspire for the license and other rights granted to Genentech under this Agreement, and subject to Section 7.2(e), Genentech shall, upon the first occurrence of each event set forth below with respect to the first Product in the specified Field, (i) pay to Inspire the following milestone payments or (ii) within three (3) business days after the date of the milestone event, with respect to those items in this Section 7.2 marked with an asterisk (*), purchase from Inspire, and Inspire shall issue and sell to Genentech equity of Inspire as provided in the Stock Purchase Agreement:
(a) With respect to Field A: ------------------------ Milestone Event Milestone Payment --------------- ----------------- [CONFIDENTIAL TREATMENT REQUESTED] -27-
(b) With respect to Field B: ----------------------- Milestone Event Milestone Payment --------------- ----------------- [CONFIDENTIAL TREATMENT REQUESTED]
(c) With respect to Field D: ----------------------- Milestone Event Milestone Payment --------------- ----------------- [CONFIDENTIAL TREATMENT REQUESTED]
(d) With respect to Future Generation Compounds, if Genentech decides to undertake the development of a Product that is a Future Generation Compound, and if Genentech has not yet contributed to the funding of Inspire's discovery efforts for generating such Future Generation Compound either through a separate research agreement agreed upon by both Parties or by retroactively reimbursing Inspire for its fully-allocated discovery costs relating to such Future Generation Compound, then at the time Genentech begins the development of such Product, it shall make such reimbursement. Such reimbursement shall be made only once, regardless of how many indications such Product may be suited for. Notwithstanding this Section 7.2(d), all other milestone payments required by Sections 7.2(a), 7.2(b) and 7.2(c) shall remain payable as provided in such sections. Such reimbursement shall be made in accordance with this Section 3.5: the Financial Appendix.
(ae) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] of the achievement of such milestone; and (b) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that Genentech's development of a Myogen CompoundProduct in a particular Field (an "Original Product") terminates and, Collaboration Compound at or NIBRI Compound fails after the time of such termination, Genentech is engaged, or subsequently becomes engaged in developmentclinical development of any other Product in such Field (a "Replacement Product"), any then Genentech shall be entitled to a credit against milestone payments previously paid due pursuant to Section 7.2 with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same Replacement Product in the amount equal to all milestone due payments actually paid by Genentech to Inspire with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:Original Product.
Appears in 1 contract
Sources: Development, License and Supply Agreement (Inspire Pharmaceuticals Inc)
Milestone Payments. NIBRI shall make Within [***] following the occurrence of each of the milestone payments in accordance with this Section 3.5: (a) events listed below with respect to each Myogen Compoundthe Licensed Product, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] Sage shall provide written notice to CyDex of the achievement of such milestone; milestone event, and within [***] of the occurrence of each of the milestone events, pay to CyDex the applicable non-refundable milestone fee listed next to each such event in further consideration of the rights granted Sage hereunder. The milestone payments (beach payable only one time regardless of the number of times achieved by the Licensed Product and regardless of the number of the Licensed Products there may be under this Agreement) are as follows. If any such milestone is achieved before all prior sequential milestones have been actually achieved, then any and all prior sequential milestones which were not previously actually achieved shall be deemed to have thereby been achieved, and the milestone payments for such deemed-achieved milestones shall also be payable within such [***]. MILESTONE MILESTONE PAYMENT
(i) Upon submission to the FDA of the first investigational new drug application by Sage $ 300,000
(ii) Upon dosing of the first patient in the first Phase II study by Sage or under rights from Sage for a Licensed Product $ 1,500,000
(iii) Upon dosing of the first patient in the first Phase III or pivotal study by Sage or under rights from Sage for a Licensed Product $ 1,500,000
(iv) Upon acceptance for filing by the FDA of the first NDA $ 2,500,000
(v) Upon receipt of the first Marketing Approval from the FDA $ 12,000,000
(vi) Upon receipt of the second Marketing Approval from the FDA $ 5,000,000
(vii) Cumulative Net Sales for all Licensed Products hereunder exceed $250,000,000 $ 4,000,000
(viii) Cumulative Net Sales for all Licensed Products hereunder exceed $500,000,000 $ 4,000,000
(ix) Cumulative Net Sales for all Licensed Products hereunder exceed $1,000,000,000 $ 5,000,000
(x) Cumulative Net Sales for all Licensed Products hereunder exceed $2,000,000,000 $ 10,000,000 *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to each Myogen Compoundthe omitted portions. EXECUTION COPY For avoidance of doubt, Collaboration Compound or NIBRI Compound having an effect on Net Sales under any other agreements entered into pursuant between the parties shall not be accumulated with Net Sales under this Commercial License Agreement for any purposes under this Agreement. If, at any time during the term of this Agreement, Sage has paid milestone payments in connection with the development of a Low Priority Target Licensed Product containing [***] (as to which NIBRI has exercised its Optionbut not including the use of such compounds in combination) under any other Commercial License Agreement with CyDex, and Sage subsequently terminates development of such product(s), payment within [/\#/\] days of exercise of the Option for then, all prior milestones achieved. Except as explicitly set forth below, such milestone payments shall be creditable, on a dollar-for-dollar basis, against amounts that thereafter become due and payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:4.1(b).
Appears in 1 contract
Milestone Payments. NIBRI Each Payor shall make a milestone payments payment to Payee based on achievement of each of the milestone events listed below by such Payor or its Related Parties for Licensed Products that are directed to a particular Target. Such Payor shall notify Payee in accordance with this Section 3.5: (a) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] writing of the achievement of each such milestone; milestone event and (b) with respect pay to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), Payee the applicable payment amount set forth below within [/\#/\**] days of exercise such Payor’s or its Related Parties’ achievement of the Option such milestone event for all prior milestones achievedeach such Licensed Product. Except as explicitly set forth below, Each milestone payments payment by such Payor to Payee hereunder shall be payable only once by a Payor and its Related Parties with respect to each Target, regardless of the number of times the same milestone is achieved with respect to such Target by a Licensed Product. For clarity, once a Payor has made a particular milestone payment with respect to a Licensed Product that is directed to a particular Myogen CompoundTarget, Collaboration Compound or NIBRI Compoundsuch Payor will have no obligation to make such milestone payment again with respect to any other Licensed Product that is directed to a particular Target, even though such Payor will have no obligation to make such milestone payment again with respect to any other 20 Licensed Product that Myogen Compoundis directed to the same Target. For example, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In in the event that further clinical development of a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid Licensed Product with respect to which one or more milestones payments have been made (an “Original Product”) is halted, and such Myogen CompoundLicensed Product is replaced in development by a different Licensed Product (a “Backup Product”), Collaboration Compound or NIBRI Compound then such Payor shall not be fully creditable toward the same milestone due obligated to make any payments with respect to another Myogen Compoundmilestones achieved by the Backup Product for which such Payor has already made a milestone payment with respect to the Original Product. However, Collaboration Compound if such Original Product or NIBRI Compound advanced as Backup Product is subsequently directed to a lead Compound in place of different Target, then such Payor shall be obligated to make any payments with respect to the failed Compound that acts on the same Myogen Target milestones achieved by such Original Product or Collaboration Backup Product directed to such different Target. NIBRI may deduct from Except as set forth above, each milestone payment shall be nonrefundable and non-creditable against any milestone other payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. Milestone Event Payment Amount US$ [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Appears in 1 contract
Sources: Sponsored Research Agreement
Milestone Payments. NIBRI Subject to the terms and conditions of this Agreement, Audentes shall pay to Maugeri the respective milestone payments set forth below, for the first Product to achieve each of the milestones set forth below. Audentes shall notify Maugeri in writing within [*] following the achievement of each milestone event set forth in this Section 4.1, and shall make the appropriate milestone payments in accordance with this Section 3.5: (a) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), payment within [/\#/\*] of after the achievement of such milestone event. The milestone payments set forth in this Section 4.1 shall be payable one time only. In no event will any milestone payment be paid more than once, even if additional Products subsequently achieve the same milestone; . First patient dosed with the first Product in a Phase II Clinical Trial [*] First patient dosed with the first Product in a Phase III Clinical Trial [*] FDA marketing approval for the first Product [*] .
(a) Subject to Sections 4.2(b) and 4.3, Audentes shall pay Maugeri royalties equal to [*] percent ([*]%) of aggregate annual Net Sales of Products, on a country by country and Product by Product basis, in each country in which Product is covered by a Valid Claim of a patent included in the Licensed IP. The royalties due to Maugeri pursuant to this Section 4.2(a) shall be payable on a country-by-country and Product-by-Product basis until the expiration of the last Valid Claim covering such Product in such country.
(b) lf, in connection with respect the manufacture, use, or commercialization of a Product, Audentes is obligated to each Myogen Compoundmake payments to any Third Parties, Collaboration Compound or NIBRI Compound having an effect then Audentes may offset against the royalty owed to Maugeri for that Product [*] percent ([*]%) of those amounts payable to such Third Parties, provided that in no event would any such offsets result in reducing royalties due to Maugeri pursuant to Section 4.2(a) to less than [*] percent ([*]%) of annual aggregate Net Sales of Products by Audentes, its Affiliates and Sublicensees. . Sales of Product between Audentes its Affiliates, and Sublicensees shall not be subject to royalties hereunder. Royalties shall be calculated on a Low Priority Target (as to which NIBRI has exercised Audentes’, its Option), payment within [/\#/\] days of exercise Affiliates’ and Sublicensees’ sales of the Option for all prior milestones achievedProducts to a Third Party. Except as explicitly set forth below, milestone payments Royalties shall be payable only once for any given sale of Product. For purposes of determining Net Sales, the Product shall be deemed to be sold when invoiced. Net Sales shall not include, and no royalties shall be payable on, transfers of Products that are used as samples or in clinical trials or other transfers or dispositions for pre-clinical, clinical or regulatory purposes. Royalty Payments . Royalties due pursuant to Section 4.2 shall be payable [*]. Audentes shall delivery a written report to Maugeri within [*] after the end of each [*] that shows, with respect to a particular Myogen Compoundeach country and each Product, Collaboration Compound or NIBRI Compoundthe sales volume, even though that Myogen Compoundgross sales amount, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made Net Sales calculated pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under Section 1.16 and the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:exchange rate for each currency.
Appears in 1 contract
Milestone Payments. NIBRI COMPANY shall make pay to SDRMI the milestone payments in accordance upon first achievement of the following milestones whether by COMPANY or its AFFILIATES or SUBLICENSEES:
(i) First regulatory approval for clinical development or an investigational new drug (IND) of first Licensed Product. COMPANY shall issue a total of 300,000 shares of Common Stock of COMPANY, $0.0001 par value per share (Common Stock), and 100,000 shares of series A Preferred Convertible Stock of COMPANY, $0.001 par value per share (Preferred Stock) with a term of 10 years to SDRMI as a one time milestone payment. Such issuance shall be recorded on the Stock Transfer Ledger of COMPANY on the EFFECTIVE DATE and the Shares shall be delivered to SDRMI within thirty (30) days of the occurrence of the Milestone. COMPANY represents to SDRMI that, as of the EFFECTIVE DATE, the aggregate number of Shares equals 1,300,000 shares or 3% of the COMPANY issued and outstanding Common Stock calculated on a Fully Diluted Basis. For purposes of this Section 3.5: (a3(b)(i). Milestone payment in this Section 3(b)(i) with respect shall be paid for the first LICENSED PRODUCT to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] of the achievement of achieve such milestone; milestone and (b) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to once.
(ii) First commercial sale or first market approval for clinical uses of a particular Myogen CompoundLicensed Product for each disease indication. COMPANY shall pay 1,000,000 shares of Common Stock of COMPANY or 1% of the COMPANY then issued and outstanding Common Stock calculated on a Fully Diluted Basis, Collaboration Compound or NIBRI Compoundwhichever is larger, even though that Myogen Compoundwithin thirty (30) days of the occurrence of each Milestone. For clarity, Collaboration Compound or NIBRI Compound may a Licensed Product under this Article 3 shall be subsequently developed a different Licensed Product from a predecessor only if such latter Licensed Product requires a new IND for indications other than those regulatory development and commercialization; for example and without limitation, label expansions for a Licensed Product will not constitute a new Licensed Product for purposes of this Article 3. In addition, if a Licensed Product for which regulatory approval was initially sought. In Licensee has previously made Milestone payments hereunder does not reach the event that a Myogen Compoundmarket, Collaboration Compound or NIBRI Compound fails in development, any milestone all such Milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound SDRMI shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone against all future Milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:owed.
Appears in 1 contract
Milestone Payments. NIBRI shall make milestone payments in accordance with this Section 3.5: (a) Effective commencing on the Effective Date, as further partial consideration for the grant of the rights and licenses hereunder, on a Product-by-Product basis, Company shall pay, or cause to be paid, to MRKDG the non-refundable milestone payments set forth below (each, a “Regulatory Milestone Payment”) for the first Product containing or comprising Pimasertib, as well as for the first Product containing or comprising 103B (in each case whether a monotherapy or in the form of a Combination Product or for concomitant or sequential use with respect other therapeutics) to each Myogen achieve the corresponding Regulatory Milestone Event, provided that for the second Product (containing the respective other Compound) to achieve the corresponding Regulatory Milestone Event, such Regulatory Milestone Payments shall be reduced by [*] 1 [*] [*] 2 [*] [*] 3 [*] [*] 4 [*] [*] 5 [*] [*] Each of the foregoing Regulatory Milestone Payments in this Section 6.2(a) shall be payable a maximum of [*] per Compound regardless of the number of times the applicable Regulatory Milestone Event was achieved by a Product containing or comprising the respective Compound, Collaboration Compound and no Regulatory Milestone Payment shall be due hereunder for any subsequent or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] of the repeated achievement of such milestone; and Regulatory Milestone Event by a Product containing or comprising such Compound. For the avoidance of doubt, the maximum amount payable by Company to MRKDG pursuant to this Section 6.2(a) [*] assuming in each case that each of the Regulatory milestone events in this Section 6.2(a) were achieved.
(b) with respect Company shall pay to MRKDG the applicable non-refundable milestone payments set forth below (each, a “Commercial Milestone Payment”) when cumulative Net Sales within the Territory for all Products reach each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly thresholds set forth below. [*] [ *] [*] [ *] [*] [ *] [*] [ *] The achievement of a higher Commercial Milestone Event shall also trigger the payment of a lower Commercial Milestone Event in the event such lower Commercial Milestone Event had not been triggered prior to achievement of the higher Commercial Milestone Event. For clarity, in such case both the payment of lower milestone payments and the higher milestone shall be triggered. Each of the foregoing Commercial Milestone Payments in this Section 6.2(b) shall be payable only once with respect to a particular Myogen Compoundmaximum of [*] as set forth in the foregoing chart regardless of the number of times the applicable Commercial Milestone Event was achieved, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound and no Commercial Milestone Payment shall be fully creditable toward due hereunder for any subsequent or repeated achievement of such Commercial Milestone Event. For the same milestone due with respect avoidance of doubt, the maximum amount payable by Company to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made MRKDG pursuant to this Agreement prior Section 6.2(b) is [*] assuming that each of the milestone events in this Section 6.2(b) were achieved.
(c) Company shall notify MRKDG in writing [*] after a Regulatory Milestone Event or Commercial Milestone Event has occurred.
(d) Payment of any Regulatory Milestone Payment or Commercial Milestone Payment by Company to exercise of an Option MRKDG shall be treated as payments made under due within [*] upon receipt of a corresponding invoice from MRKDG for the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:applicable Milestone Payment notified by Company to MRKDG pursuant to Section 6.2(c).
Appears in 1 contract
Sources: License Agreement (Day One Biopharmaceuticals Holding Co LLC)
Milestone Payments. NIBRI shall make milestone The payments referenced in accordance with this Section 3.5: Sections 3.2.2(a) through 3.2.2(f) below are referred to herein as the "MILESTONE PAYMENTS."
(a) Purchaser will pay to Seller a payment in the amount of [CONFIDENTIAL TREATMENT] within ten (10) business days after the first dosing (with respect to each Myogen Compound, Collaboration Compound either Product or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] placebo) of the achievement of first patient in the First Phase III Trial; provided, however, that such milestonepayment shall be made to Seller in any event not later than [CONFIDENTIAL TREATMENT] (the "FIRST BACK-END MILESTONE Date"); and provided, further, that for the avoidance of doubt, the First Back-End Milestone Date is subject to any Abandonment Review Extension or Force Majeure Extension.
(b) with respect Purchaser will pay to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on Seller a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule [CONFIDENTIAL TREATMENT] within ten (10) business days after the first dosing (with either Product or placebo) of the first patient in the License AgreementSecond Phase III Trial; payments made pursuant to this Agreement prior to exercise of an Option provided, however, that such payment shall be treated as payments made under to Seller in any event not later than the License AgreementFirst Back-End Milestone Date; and provided, further, that for the avoidance of doubt, the First Back-End Milestone Date is subject to any Abandonment Review Extension or Force Majeure Extension.
(c) Purchaser will pay to Seller a payment in the amount of [CONFIDENTIAL TREATMENT] within ten (10) business days after the last dosing (with either Product or placebo) of the last patient in the Second Phase III Trial; provided, however, that such payment shall be made to Seller in any event not later than [CONFIDENTIAL TREATMENT] (the "SECOND BACK-END MILESTONE Date"); and provided, further, that for the avoidance of doubt, the Second Back-End Milestone Date is subject to any Abandonment Review Extension or Force Majeure Extension.
(d) Purchaser will pay to Seller a payment in the amount of [CONFIDENTIAL TREATMENT] within ten (10) business days after the issuance of the Carcinogenicity Study Report; provided, however, that such payment shall be made to Seller in any event not later than the Second Back-End Milestone Date; and provided, further, that for the avoidance of doubt, the Second Back-End Milestone Date is subject to any Abandonment Review Extension or Force Majeure Extension. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Asset Purchase Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:Retigabine
(e) Purchaser will pay to Seller a payment in the amount of [CONFIDENTIAL TREATMENT] upon acceptance for filing by the FDA of the first NDA for the Product for the first Indication.
(f) Purchaser will pay to Seller a payment in the amount of [CONFIDENTIAL TREATMENT] upon FDA Approval.
Appears in 1 contract
Sources: Asset Purchase Agreement (Valeant Pharmaceuticals International)
Milestone Payments. NIBRI shall make milestone payments in accordance with this Section 3.5: (a) with respect to each Myogen CompoundPfizer shall pay Incyte, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, non-creditable (except as defined below (whether or not an Option, as defined below, has been exercisedset forth in this Section 8.2), within [/\#/\] non-refundable, milestone payment (each, an “Event Milestone Payment”) for Pfizer Products in respect of each of the achievement following events (each, an “Event Milestone”) in the particular amounts specified below within twenty (20) Business Days after the occurrence of such milestone; and the relevant Event Milestone. Event Milestone “M” means million *** *** *** *** *** Event Milestone “M” means million *** *** *** *** *** *** *** *** *** *** *** *** *** Event Milestone “M” means million *** *** *** TOTAL *** *The Event Milestone Payments in this column shall only apply if the Compound that Pfizer develops for any Pfizer Indication in the *** is ***. ** The Event Milestone Payments in this column shall apply to any Compound that Pfizer develops for any Pfizer Indication in the ***, other than ***.
(b) with respect All Event Milestone Payments set forth in this Section 8.2 shall be paid ***. For purposes of this Section 8.2, ***.
(c) if a Phase II(b) Trial or a Phase III Trial of a Pfizer Product Commences, or a Pfizer Product is the subject of an NDA that has been filed or accepted for filing, such Pfizer Product shall be deemed to each Myogen Compoundhave achieved all the Event Milestones prior to that stage of development, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI and if the related Event Milestone Payment for any of such earlier Event Milestones has exercised its Option)not been previously paid and would otherwise be due under this Section 8.2, payment it shall then be paid. *** within [/\#/\] days of exercise *** Business Days after the occurrence of the Option earlier of (i) the *** or (ii) the ***.
(d) Notwithstanding anything to the contrary in this Section 8.2, ***. The Parties agree that for all prior milestones achievedpurposes of determining the Event Milestone Payments payable under this Section 8.2, ***. Except as explicitly set forth below, milestone payments shall be payable only once with respect to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed *** The examples below are for indications other than those for which regulatory approval was initially soughtillustrative purposes only. Example 1: *** Example 2: *** Example 3: *** Example 4: *** ***
(e) In the event that a Myogen CompoundParty has given the other Party any notice of termination of this Agreement under Section 11, Collaboration Compound or NIBRI Compound fails in developmentno further Event Milestone Payments shall become due during such notice period. If such notice of termination is the subject of a dispute, any milestone payments previously paid with respect to such Myogen Compound, Collaboration Compound or NIBRI Compound dispute shall be fully creditable toward the same milestone due resolved in accordance with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen under this Section 3.5 the amount of any withholding 11.3(d) and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:Article 14.
Appears in 1 contract
Sources: Collaborative Research and License Agreement (Incyte Corp)
Milestone Payments. NIBRI shall make milestone payments in accordance with this Section 3.5: (a) with respect Fosun shall make the following one-time, nonrefundable milestone payments to Revance within [*] Business Days following the first achievement of each Myogen Compoundof the following milestone events for a Product, Collaboration Compound or NIBRI Compound having an effect on a High Priority Targetsubject to the limitations and additional provisions set forth below in this Section 6.02: [*] = Certain confidential information contained in this document, as defined below (whether or not an Option, as defined belowmarked by brackets, has been exercisedomitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 1a. Acceptance of Submission of BLA by FDA for 1st Aesthetic Indication $[*] 1b. Approval of BLA by FDA for 1st Aesthetic Indication $[*] 1c. Approval of BLA by NMPA for 1st Aesthetic Indication $[*] 2a. Approval of BLA by FDA for 1st Therapeutic Indication* $[*] 2b. Approval of BLA by NMPA for 1st Therapeutic Indication $[*] 3a. Approval of BLA by FDA for 2nd Therapeutic Indication $[*] 3b. Approval of BLA by NMPA for 2nd Therapeutic Indication $[*] 4a. Approval of BLA by FDA for 3rd Therapeutic Indication $[*] 4b. Approval of BLA by NMPA for 3rd Therapeutic Indication $[*] * If the Therapeutic Indication approved by the FDA in Milestone Nos. 2-4 above is related to either of two preferred Therapeutic Indications to be defined in the Development Plan (each of which a “Preferred Indication”), then the “a” of such milestone payment shall be increased by USD $[*] and the “b” of such milestone payment shall be increased by USD $[*]. If either or both of the Preferred Indication is not among the above three (3) approved Therapeutic Indications by the FDA, then USD $[*] shall be paid within [/\#/\*] Business Days upon the approval of BLA by NMPA for each Preferred Indication. However, [*] and [*] shall be the achievement of such milestone; and Preferred Indication if [*] the Preferred Indication in the Development Plan.
(b) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), payment within [/\#/\] days of exercise Each of the Option for all prior milestones achieved. Except as explicitly set forth below, milestone in Section 6.02(a) is eligible to be earned individually.
(c) No payments pursuant to Section 6.02(a) shall be payable only once with respect creditable against any other payments Fosun is obligated to a particular Myogen Compound, Collaboration Compound or NIBRI Compound, even though that Myogen Compound, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In the event that a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid with respect make to such Myogen Compound, Collaboration Compound or NIBRI Compound shall be fully creditable toward the same milestone due with respect to another Myogen Compound, Collaboration Compound or NIBRI Compound advanced as a lead Compound in place of the failed Compound that acts on the same Myogen Target or Collaboration Target. NIBRI may deduct from any milestone payments otherwise due to Myogen Revance under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:.
Appears in 1 contract
Milestone Payments. NIBRI Each Payor shall make a milestone payments payment to Payee based on achievement of each of the milestone events listed below by such Payor or its Related Parties for Licensed Products that are directed to a particular Target. Such Payor shall notify Payee in accordance with this Section 3.5: (a) with respect to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a High Priority Target, as defined below (whether or not an Option, as defined below, has been exercised), within [/\#/\] writing of the achievement of each such milestone; milestone event and (b) with respect pay to each Myogen Compound, Collaboration Compound or NIBRI Compound having an effect on a Low Priority Target (as to which NIBRI has exercised its Option), Payee the applicable payment amount set forth below within [/\#/\**] days of exercise such Payor’s or its Related Parties’ achievement of the Option such milestone event for all prior milestones achievedeach such Licensed Product. Except as explicitly set forth below, Each milestone payments payment by such Payor to Payee hereunder shall be payable only once by a Payor and its Related Parties with respect to each Target, regardless of the number of times the same milestone is achieved with respect to such Target by a Licensed Product. For clarity, once a Payor has made a particular milestone payment with respect to a Licensed Product that is directed to a particular Myogen CompoundTarget, Collaboration Compound or NIBRI Compoundsuch Payor will have no obligation to make such milestone payment again with respect to any other Licensed Product that is directed to a particular Target, even though such Payor will have no obligation to make such milestone payment again with respect to any other Licensed Product that Myogen Compoundis directed to the same Target. For example, Collaboration Compound or NIBRI Compound may be subsequently developed for indications other than those for which regulatory approval was initially sought. In in the event that further clinical development of a Myogen Compound, Collaboration Compound or NIBRI Compound fails in development, any milestone payments previously paid Licensed Product with respect to which one or more milestones payments have been made (an “Original Product”) is halted, and such Myogen CompoundLicensed Product is replaced in development by a different Licensed Product (a “Backup Product”), Collaboration Compound or NIBRI Compound then such Payor shall not be fully creditable toward the same milestone due obligated to make any payments with respect to another Myogen Compoundmilestones achieved by the Backup Product for which such Payor has already made a milestone payment with respect to the Original Product. However, Collaboration Compound if such Original Product or NIBRI Compound advanced as Backup Product is subsequently directed to a lead Compound in place of different Target, then such Payor shall be obligated to make any payments with respect to the failed Compound that acts on the same Myogen Target milestones achieved by such Original Product or Collaboration Backup Product directed to such different Target. NIBRI may deduct from Except as set forth above, each milestone payment shall be nonrefundable and non-creditable against any milestone other payments otherwise due to Myogen under this Section 3.5 the amount of any withholding and similar taxes required under applicable law to be withheld from such payments and paid to applicable tax authorities. The schedule below corresponds to an identical schedule in the License Agreement; payments made pursuant to this Agreement prior to exercise of an Option shall be treated as payments made under the License Agreement. [/\#/\]CONFIDENTIAL TREATMENT REQUESTED Collaboration and Option Agreement - Confidential - Page 15 MILESTONE DEVELOPMENTAL MILESTONE: PAYMENT ------------------------ ------- Pre-Clinical Milestones:**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Appears in 1 contract
Sources: Sponsored Research Agreement (Alnylam Pharmaceuticals, Inc.)