Common use of Milestone Payments Clause in Contracts

Milestone Payments. Xencor shall report to Cardinal Health once a year the status of each cell-line transferred to Xencor and pay to Cardinal Health the applicable milestone payments set forth below (if any) for each cell line transferred to Xencor pursuant to this Section 7.3(B) within […***…] after the achievement of each applicable milestone by a Product produced using such cell line, with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing party.

Appears in 4 contracts

Sources: Development and Manufacturing Services Agreement (Xencor Inc), Development and Manufacturing Services Agreement (Xencor Inc), Development and Manufacturing Services Agreement (Xencor Inc)

Milestone Payments. Xencor Subject to the terms and conditions of this Agreement, MERCK shall report to Cardinal Health once a year the status of each cell-line transferred to Xencor and pay to Cardinal Health ARRIS the applicable following milestone payments set forth below payments: (if anya) for each cell line transferred to Xencor pursuant to this Section 7.3(B) within [***] after upon [***] set forth in Section [***] of this Agreement; (b) [***] upon [***] of a [***]; (c) [***] upon [***] of a Program Compound for [***] as defined by MERCK; (d) [***] upon [***] of [***] using a Program Compound; (e) [***] upon [***] of [***] using a Program Compound; (f) [***] upon [***] a Licensed Product for [***]; (g) [***] upon [***] a Licensed Product in the [***]. ARRIS shall notify MERCK in writing within [***] upon the achievement of the milestone described in (b) above, and MERCK shall pay ARRIS the appropriate milestone payment within [***] of its receipt of such notice. MERCK shall notify ARRIS in writing within [***] upon the achievement of [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. each milestone described in (a) and (c) through (g) above, and upon such notice shall pay ARRIS the appropriate milestone payment. The milestone payments described in (a) through (c) above 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. The milestone payments described in (d) through (g) above shall be payable only upon the achievement of each applicable such milestone by a Product produced using such cell line, with for the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: [***] a particular milestone event. Notwithstanding the foregoing, if a Program Compound is approved and marketed as a Licensed Product, and MERCK elects to develop or to continue developing, e.g., as a second generation product, another Program Compound (which does not contain the same Program Compound or any salt form, different formulation, or stereo-isomer thereof as such Licensed Product) as a Licensed Product, MERCK shall make the required payment for [***] described in [***] any such [***…] ], which shall include payment of all milestone payments described in [***] that were [***] of such Licensed Product. [***] of each milestone payment made for the achievement of a milestone described in (f) and (g) as set forth above [***] for the Program Compound for which such milestone was paid; PROVIDED, HOWEVER, that the [***] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have Program Compound [***] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing partyyear.

Appears in 2 contracts

Sources: Research Collaboration and License Agreement (Celera CORP), Research Collaboration and License Agreement (Celera CORP)

Milestone Payments. Xencor Cypress shall report to Cardinal Health once a year make the status of each cellfollowing non-line transferred to Xencor refundable and pay to Cardinal Health the applicable non-creditable milestone payments set forth below (if any) for each cell line transferred to Xencor pursuant to this Section 7.3(B) BioLineRx within [...***...] days after the first achievement of each applicable milestone by event for a Product produced using such cell linein the Field in the Cypress Territory as set forth in this Section 8.2 by Cypress or its Affiliates or sublicensees. Each milestone payment by Cypress to BioLineRx hereunder shall be payable only once, with regardless of the amounts number of times achieved by the Products, provided that, if more than one sales milestones that are triggered by annual aggregate Net Sales that have not been previously paid are triggered at the end of any particular calendar year, then each and every of such sales milestones shall be deemed to be determined based on how many cell lines Xencor has licensed have been achieved upon the end of such calendar year and on whether the corresponding milestone payments triggered by each and every of such cell line is to be used by Xencor or its designee: […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] sales milestones shall become due at the end of such calendar year; provided, however, that if Xencor licenses such cumulative milestone payments imposes a cell line pursuant financial burden upon Cypress, the timing of such payments may be reasonably adjusted by up to this Section 7.3(B[...***...]. *** Confidential Treatment Requested [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] Sales Milestones [...***...] [...***...] *** Confidential Treatment Requested [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] (a) after The [...***...] regulatory milestone #1 may be paid as follows, in Cypress’ sole discretion: (i) [...***...] in cash; or (ii) subject to the achievement approval of one the Tel Aviv Stock Exchange (“TASE’s Approval”), [...***...] in cash and [...***...] in consideration of the purchase of that number of ordinary shares of BioLineRx (the “Ordinary Shares") equal to the lower of (A) [...***...] divided by the average of the closing price of the Ordinary Shares on the [...***...] days preceding the date on which regulatory milestone #1 (Initiation of the first Phase 3 Clinical Trial for a Product) occurs, and (B) [...***...] of BioLineRx’s issued share capital (where such number of Ordinary Shares (as set forth in (A) or more milestones (B), as applicable) is referred to as the “Share Amount”). If the value represented by a Product produced using such cell linethe Share Amount is less than [...***...], then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not cash consideration will be due for such cell line. Following conduct adjusted so that the total consideration in respect of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have regulatory milestone #1 will equal [...***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing party....

Appears in 1 contract

Sources: License Agreement (Cypress Bioscience Inc)

Milestone Payments. Xencor Gen-Probe shall report pay to Cardinal Health once Corixa the following non-refundable, non-creditable fees to the extent they become due during any Royalty Period in the United States computed under Section 2.16.1: (a) One Million Six Hundred Thousand Dollars ($1,600,000) within thirty (30) days of the Effective Date. (b) One Million Six Hundred Thousand Dollars ($1,600,000) by January 31st, 2006. (c) One Million Six Hundred Thousand Dollars ($1,600,000) by January 31st, 2007. (d) [...***...] upon the [...***...] submission of an application to the FDA for approval to market a year Licensed Product. (e) [...***...] upon the status [...***...] of the first [...***...]. (f) [...***...] upon the [...***...] Marketing Approval of a Licensed Product. (g) [...***...] upon each submission of an application to the FDA for approval to market a Licensed Product that includes any Marker for which such fee has not already been paid. (h) [...***...] upon Marketing Approval of each cellLicensed Product incorporating one or more Markers for which such fee has not already been paid. (i) [...***...] upon reaching Net Sales [...***...] in a calendar year for each Licensed Product for which such fee has not already been paid. (j) [...***...] upon reaching Net Sales of [...***...] in a calendar year for each Licensed Product incorporating one or more Markers for which such fee has not already been paid. (k) In the event that a Licensed Product is directed at [...***...] or more different Markers and one of the Markers was used in a Licensed Product ***CONFIDENTIAL TREATMENT REQUESTED incorporating [...***...] or [...***...]Markers for which Gen-line transferred to Xencor and pay to Cardinal Health Probe had reached Net Sales of [...***...] in a calendar year, then the applicable milestone payments set forth below (if anyin Sections 5.1(g), 5.1(h), 5.1(i) for each cell line transferred to Xencor pursuant to this Section 7.3(Band 5.1(j) within shall be [...***...] after for such Licensed Product of the achievement of each applicable milestone by a Product produced using such cell line, with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line type that is to be used by Xencor or its designee: […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] provided, however, that if Xencor licenses a cell line pursuant to described in this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i5.1(k), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing party.

Appears in 1 contract

Sources: License Agreement (Gen Probe Inc)

Milestone Payments. Xencor Subject to the terms and conditions in this Agreement, MERCK shall report to Cardinal Health once a year the status of each cell-line transferred to Xencor and pay to Cardinal Health NITROMED the applicable following milestone payments set forth below payments: (if anya) for each cell line transferred to Xencor pursuant to this Section 7.3(BUpon [**] $[**]. (b) Upon [**] $[**]. (c) Upon [**] $[**]. (d) Upon [**] $[**]. (e) Upon [**] $[**]. (f) Upon [**] (g) Upon [**] MERCK shall notify NITROMED in writing within [***…] after days upon the achievement of each applicable milestone by a Product produced using milestone, such cell line, with the amounts of such milestones notice to be determined based on how many cell lines Xencor has licensed and on whether such cell line is accompanied by payment of the appropriate milestone payment. The payment under Section 5.3(a) shall be made only once. The payment under the milestones described in Section 5.3(b) through (d) shall be made once for each individual Indication (by way of example, payment under Section 5.3(b) may be made up to be used by Xencor or its designee: [***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] providedtimes, however, that if Xencor licenses a cell line pursuant to this Section 7.3(Bonce for each Indication in subsections (i) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph - (iii) shall not be due for such cell line. Following conduct of an audit pursuant to in Section 5.1 hereof of 1.17) and the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies milestone described in Sections 5.3(e) through (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(Bg) shall be paid by as follows: (i) each of such milestones shall be payable no more than [**] for each Indication, irrespective of the non-prevailing partynumber of Licensed Products for which such milestone is achieved; (ii) with respect to each Licensed Product, each of such milestones shall be payable only upon the first occurrence of such milestone for each Indication; (iii) for no more than [**] Indications for a specific Licensed Product; (iv) for purpose of the foregoing, Licensed Products which contain the same [**] shall be considered to be the same Licensed Product; and (v) as a result of the foregoing limitations, each of such milestones shall be payable a maximum of [**] times. For example, if Licensed Product X is developed for [**] Indications, the milestones are paid for each of such Indications; if Licensed Product Y is developed for all [**] Indications and is developed as well for an additional disease state within one of these Indications, the milestones are paid for the [**] Indications, [**].

Appears in 1 contract

Sources: Research Collaboration and License Agreement (Nitromed Inc)

Milestone Payments. Xencor As additional consideration for the license and other rights granted under this Agreement, during the Term, Licensee shall report make the following non-creditable, non-refundable milestone payments to Cardinal Health once a year Mount Sinai within sixty (60) days after the status occurrence of each cell-line transferred to Xencor of the following events, and pay to Cardinal Health a report in accordance with Section 5.6, whether Licensee or its Sublicensee achieves the applicable milestone payments set forth below (if any) events: Acceptance by a Regulatory Authority of […***…], for each cell line transferred to Xencor pursuant to this Section 7.3(B) within a Licensed Product […***…] after the achievement of each applicable milestone by a Product produced using such cell line, with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: U.S. Dollars ($[…***…] USD) Initiation of the first […***…], for a Licensed Product […***…] U.S. Dollars ($[…***…] USD) Initiation of the first […***…], for a Licensed Product […***…] U.S. Dollars ($[…***…] USD) Receipt of the first […***…], for a Licensed Product […***…] U.S. Dollars ($[…***…] USD) Receipt of the first […***…], for a Licensed Product […***…] U.S. Dollars ($[…***…] provided, however, USD) In the event that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Licensed Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) is marketed under this subparagraph (iii) shall not be due an EUA for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from ], such Licensed Product shall be deemed to have received Regulatory Approval in the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each applicable jurisdiction for purposes of the payment amounts milestones set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by 4.2. If a particular Licensed Product is […***…] ([…***…]%“Skipped Milestone”); provided, however, that such payments shall not Skipped Milestone will be reduced in the event that Xencor elects deemed to so transfer such cGMP activities during any period of time following the have been achieved […***…] period (“Achieved Milestone”). Payment for so long as Cardinal Health any Skipped Milestone that is continuing to diligently and timely pursue owed in accordance with the resolution provisions of this Section shall be due within sixty (60) days after the occurrence of the relevant Critical cGMP)Deficiency or has resolved such deficiencyAchieved Milestone. If Cardinal Health The milestones set forth in this Section 4.2 are successive and Xencor disagree as not creditable against any other obligations of Licensee. For the avoidance of doubt, each milestone event set forth above is payable only once, regardless of the number of times the milestone event is achieved, and the total, cumulative milestone payments payable to whether any audit finding is a Critical cGMP Deficiency, then the parties Mount Sinai hereunder shall appoint a qualified third party cGMP expert within in no event exceed […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within U.S. Dollars ($[…***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing partyUSD).

Appears in 1 contract

Sources: Exclusive License Agreement (Sorrento Therapeutics, Inc.)

Milestone Payments. Xencor shall report 8.3.1 In the Therapeutic Field. Subject, in the case of Sublicenses, to Cardinal Health once a year Section 8.4.3(c) below, within thirty (30) days following the status achievement of each cellof the following milestones with respect to each CuraGen Product for use in the Therapeutic Field, on a CuraGen Product-line transferred by-CuraGen Product basis, CuraGen shall give written notice to Xencor ABX thereof and shall pay to Cardinal Health ABX the applicable corresponding milestone payments set forth below described below. Subject, in the case of Sublicenses, to Section 8.4.3(a) below, within thirty (30) days following the achievement of each of the following milestones with respect to each ABX Product for use in the Therapeutic Field, on an ABX Product-by-ABX Product basis, ABX shall give written notice to CuraGen thereof and shall pay to CuraGen the corresponding milestone payments described below. [_______] [______________________________] [_______] [______________________________] Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential Investment under Rule 406 of the Securities Act. [_______] [______________________________] [_______] [______________________________] [_______] [______________________________] If, at the time when any milestone payment listed in this Section 8.3.1, with respect to a Product for use in the Therapeutic Field, is due from a party, such party has not paid all other milestone payments (if any) for each cell line transferred to Xencor pursuant to previously listed in this Section 7.3(B8.3.1 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) within […***…] previously listed in this Section 8.3.1 with respect to such Product. If, at the time of the First Commercial Sale by a party, its Affiliate or their respective Sublicensee of a Product for use in the Therapeutic Field, such party has not paid all milestone payments (if any) listed in this Section 8.3.1 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) listed in this Section 8.3.1 with respect to such Product. If at any time a party abandons the development of a Product after the achievement of each applicable milestone by a Product produced using such cell line, with payment to the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement other party of one or more milestones by a milestone payments under this Section 8.3.1 and subsequently commences or continues the development of another Product produced using such cell linedirected to the same Licensed Antigen as the abandoned Product, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health party shall have […***…] from the time of receipt of such summary no obligation to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party pay to the other party. The parties shall provide party a milestone payment upon the expert with all relevant information on occurrence of a milestone event for the disputed audit finding within […***…] following the appointment of subsequent Product for which such cGMP expert. The cGMP expert shall prepare and deliver party previously has paid to the parties other party a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed milestone payment under this Section 7.3(B) shall be paid by 8.3.1 for the non-prevailing partyabandoned Product.

Appears in 1 contract

Sources: Collaboration Agreement (Curagen Corp)

Milestone Payments. Xencor In, addition to the payments provided for in Section 3.3 above, PFIZER shall report to Cardinal Health once a year make the status of each cellfollowing non-line transferred to Xencor and pay to Cardinal Health the applicable refundable milestone payments set forth below to INHALE upon occurrence of the following events: (if anya) for each cell line transferred to Xencor pursuant to this Section 7.3(B[ * ] [ * ]; (b) within […***…[ * ] after the achievement of each applicable milestone by [ * ]; (c) [ * ] [ * ] (d) [ * ] [ * ]; (e) [ * ] [ * ]; (f) [ * ] [ * ]; and (g) [ * ] [ * ]. All or a Product produced using such cell line, with the amounts portion of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to payments may be used by Xencor or INHALE to fund its designee: […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) research activities under this subparagraph Agreement. (iiih) Except for the Device referred to in Section 3.4(c), INHALE shall not deliver to PFIZER clinical materials and Devices unless requested to do so by PFIZER via written request from PFIZER’s JDC Co-Chairperson to INHALE’s JDC Co-Chairperson. (i) Pfizer’s Co-Chairperson must provide INHALE’s Co-Chairperson with written notice [ * ] Devices or clinical [ * ], or such other time as the JDC may determine to be due for reasonable, of receipt by PFIZER of such cell lineDevices and clinical materials. Following conduct of an audit pursuant If PFIZER fails to Section 5.1 hereof provide such notice within the allotted time period, such Devices and clinical materials shall be deemed accepted by PFIZER, unless, prior to making the associated milestone payments, [ * ] that was not discovered during such time period despite [ * ] of the Facility by qualified representatives Devices or clinical materials. (j) In partial consideration of Xencorthe grant of the license under INHALE Patent Rights and INHALE Know-How in [ * ], Xencor PFIZER shall promptly provide a written summary also make non-refundable payments to INHALE in the amount of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period[ * ], then Xencor may elect to transfer such cGMP activities to a third party CMO[ * ], and each of [ * ]. In addition, if the milestone payment amounts set forth provided for in subparagraphs (i), (ii), Section 3.4(d) becomes due and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor PFIZER elects to so transfer such cGMP activities during any period initiate a development program for the Products in [ * ], PFIZER shall make an additional non-refundable payment of time following the […***…] period [ * ]. Thereafter, for so long as Cardinal Health is continuing to diligently PFIZER retains the license under INHALE Patent Rights and timely pursue INHALE Know-How in [ * ], PFIZER shall make the resolution following non-refundable payments upon occurrence of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as following events: (i) [ * ]; (ii) [ * ]; (iii) [ * ]. (k) The payments by PFIZER to whether any audit finding is a Critical cGMP DeficiencyINHALE due under Sections 3.4(b), then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written(c), reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B(d) & (e) shall be paid made [ * ]. The payments due under Sections 3.4(f) and (g) shall be made [ * ]. With respect to the payment by PFIZER to INHALE due under Section 3.4(b), the non-prevailing party[ * ] referred to therein shall be deemed successful and PFIZER shall be deemed to have elected to proceed unless [ * ] PFIZER notifies INHALE in writing that it has elected not to proceed with the Project or requires more time to determine [ * ]. The payments due under Section 3.40(j) shall be made at the times specified in Section 3.40(j). [ * ].

Appears in 1 contract

Sources: Collaborative Development and License Agreement (Nektar Therapeutics)

Milestone Payments. Xencor shall report to Cardinal Health once a year Within [...***...] following the status first occurrence of each cell-line transferred of the events set forth below with respect to Xencor and a Product, Sepracor shall pay to Cardinal Health ACADIA the applicable milestone payments payment set forth below (if any) for each cell line transferred to Xencor pursuant to this Section 7.3(B) within whether such milestone is achieved by Sepracor, its Affiliate or, except as expressly set forth below, any of their respective Sublicensees): Designation of Product Candidate $[...***...] after the achievement Acceptance of each applicable milestone by a Product produced using such cell line, with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: IND [...***...] $[...***...] Successful Completion of [...***...] of Product $[...***...] Dosing of first patient in [...***...] of Product $[...***...] Filing of NDA for Product in [...***...] $[...***...] Approval of NDA for Product in [...***...] $[...***...] Approval of NDA for Product in [...***...] $[...***...] Approval of NDA for Product in [...***...] $[...***...] Each of the milestone payments described in this Section 7.4 shall be payable one time for each Product containing a particular active ingredient, regardless of the number of indications for which such Product is developed or commercialized; provided, however, that if Xencor licenses (a) development of a cell line Product is abandoned after one or more of the milestone payments under this Section 7.4 has been made (a “Dropped Product”) and (b) another Product containing a different active ingredient is developed for substantially the same indication as a replacement for such Dropped Product, then only those milestone payments under this Section 7.4 that were not previously made with respect to such Dropped Product shall be payable with respect to the replacement Product. All payments made to ACADIA pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line7.4 are non-refundable and, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (except as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i)the preceding sentence, (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall may not be reduced in the event that Xencor elects credited against any other payments payable by Sepracor to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed ACADIA under this Section 7.3(B) shall be paid by the non-prevailing partyAgreement.

Appears in 1 contract

Sources: License, Option and Collaboration Agreement (Acadia Pharmaceuticals Inc)

Milestone Payments. Xencor shall report (a) In consideration of the licenses and rights granted by Valeant to Cardinal Health once a year the status of each cell-line transferred to Xencor and LICENSEE hereunder LICENSEE will pay to Cardinal Health Valeant the applicable following non-refundable, non-creditable Milestone Payments, provided that the amounts below, together with the milestone payments set forth below (if any) for each cell line transferred to Xencor due Metabasis under Section 4.2 of the Metabasis License Agreement, constitute the full amount of the milestones due Metabasis and Valeant pursuant to the terms of both this Section 7.3(BAgreement and the Metabasis License Agreement: (i) within [Intentionally omitted] (ii) [...***…] after the achievement of each applicable milestone by a Product produced using such cell line, with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: ...] (iii) [...***...] […EXECUTION COPY - VALEANT SCHERING LICENSE ***…] CONFIDENTIAL TREATMENT REQUESTED 12. (iv) [...***…] ...] (v) [...***…] ...] (vi) [...***...] and (vii) [...***…] ...] (b) Each Milestone Payment due under Section 4.2(a) will be due only once for the first Product in respect of which the indicated Milestone occurs, regardless of the substitution for the Licensed Compound of a Substitute Compound pursuant to Article III. LICENSEE will notify Valeant in writing within [...***...] of the occurrence of each Milestone and will make all Milestone Payments within [...***...] […***…] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct receipt of an audit pursuant to Section 5.1 hereof invoice from Valeant for payment of the Facility by qualified representatives Milestone substantially in the form of Xencor, Xencor shall promptly provide a written summary Exhibit B. For the avoidance of doubt the subsequent occurrence of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time similar event in respect of receipt any Product, including in respect of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (iadditional indication(s), (ii), and (iii) will not give rise to any additional obligation of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that LICENSEE to make a Milestone Payment with respect to such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing partysubsequent event.

Appears in 1 contract

Sources: Development and License Agreement (Valeant Pharmaceuticals International)

Milestone Payments. Xencor shall report (a) In addition to Cardinal Health once a year the status of each cell-line transferred to Xencor and pay to Cardinal Health the applicable milestone payments set forth below (if any) for each cell line transferred to Xencor pursuant Closing Payment, subject to this Section 7.3(B2.3.2, Purchaser shall pay or cause to be paid to Seller the following additional amounts (each, a “Milestone Payment”) within […upon the achievement by or on behalf of Purchaser or its Affiliates, licensees, sublicensees or transferees, if any, of the following events with respect to the Product and the Third Generation Product (each, a “Milestone Event”): ***…] after the achievement of each applicable milestone by a Product produced using such cell line, Certain information on this page has been omitted and filed separately with the amounts Commission. Confidential treatment has been requested with respect to the omitted portions. (i) $12,500,000 upon the FDA’s granting of such milestones to be determined based on how many cell lines Xencor Regulatory Approval of an NDA for a Third Generation Product that practices a patent listable in the Orange Book that has licensed and on whether such cell line an expiration date which is to be used by Xencor January 1, 2025 or its designee: later; (ii) [***…] ]; (iii) [***…] ]; (iv) [***…] ]; (v) [***…] ]; (vi) [***…] ]; and (vii) [***…] […***…] […***…] […***…] provided]. (b) For the avoidance of doubt, however(i) notwithstanding anything to the contrary herein, that if Xencor licenses a cell line pursuant to this Section 7.3(B) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) each Milestone Payment shall not be due for such cell line. Following conduct of an audit pursuant and payable only once; and, (ii) with respect to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have […***…] from the time of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts Milestone Events set forth in subparagraphs (i)Sections 2.3.2(a)(ii) through 2.3.2(a)(vii) above, (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the more than one Milestone Event is achieved in [***…] period ], Purchaser shall pay Seller Milestone Payments for so long as Cardinal Health each Milestone Event that is continuing achieved unless, with respect to diligently and timely pursue the resolution any such Milestone Event, Seller has previously been paid for achieving such Milestone Event. By way of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiencyexample only, then the parties shall appoint a qualified third party cGMP expert within (A) if aggregate Net Sales reach [***…] after a written request by either party to ], Purchaser shall pay Seller the other party. The parties shall provide the expert Milestone Payments associated with all relevant information on the disputed audit finding within Sections 2.3.2(a)(ii) ([***…] following the appointment of such cGMP expert. The cGMP expert shall prepare ]) and deliver to the parties a written, reasoned opinion conferring its decision within 2.3.2(a)(iii) ([***]); and (ii) if aggregate Net Sales reach [***] after receiving during the information on following [***], Purchaser shall pay Seller the disputed audit finding from Milestone Payment associated with Section 2.3.2(a)(iv) ([***]), but would not pay Seller the parties. Milestone Payments associated with Sections 2.3.2(a)(ii) or 2.3.2(a)(iii) since Seller had previously received Milestone Payments with respect to those Milestone Events. (c) The opinion of such cGMP expert shall be final Milestone Payment due and binding on the parties. The fees and expenses of any cGMP expert appointed payable under this Section 7.3(B2.3.2(a)(i) shall be paid by Purchaser to Seller promptly (but no more than thirty (30) days) following the nonoccurrence of the Milestone Event and all Milestone Payments due and payable under Sections 2.3.2(a)(ii) through 2.3.2(a)(vii) shall be paid by Purchaser to Seller promptly (but no more than seventy-prevailing partyfive (75) days) following the end of the Calendar Year in which the applicable Milestone Event occurred (but subject to the limitation in Section 2.3.2(b) that each Milestone shall be due and payable only once), in each case, by wire transfer of immediately available funds to the account designated by Seller by notice to Purchaser. (d) Purchaser shall, and shall cause its Affiliates, licensees and sublicensees engaged in the Exploitation of any Seller Product to keep copies of the case study reports related to the in vitro and in vivo abuse liability studies in the development plan set forth in Section 2.3.2(d) of the Seller Disclosure Schedule (the “Development Plan”) and keep reasonable, correct and complete books and records substantiating the Net Sales amounts recognized in each Calendar Year, in each case, as related to achieving the ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Milestone Events (the “Milestone Information”) and shall maintain such Milestone Information until the third (3rd) year following the end of the Calendar Year to which such Milestone Information relates. Until the first Calendar Year following the Calendar Year in which the Reporting Period terminates, Purchaser shall provide Seller, (i) on a quarterly basis, not later than forty-five (45) days after the end of each Calendar Quarter other than the Calendar Quarter ended December 31, the quarterly Net Sales Reports; and (ii) on an annual basis, not later than sixty (60) days after the end of each Calendar Year, the annual Net Sales Reports, in each case as provided in Section 6.13. Seller’s inspection and audit rights with respect to the Milestone Information and Net Sales Reports are set forth in Section 6.13. (e) Prior to the expiration of the Reporting Period, if Purchaser and its Affiliates transfer, sell, license, convey or otherwise dispose of all or substantially all of Seller’s and its Affiliates’ rights in the Product Business or, with respect to Section 2.3.2(a)(i), the rights to the Third Generation Product, Purchaser shall (i) remain responsible for all of its obligations with respect to the Milestone Payments set forth in this Section 2.3.2; and (ii) cause the transferee, licensee or assignee of such transferred material rights to comply with this Section 2.3.2.

Appears in 1 contract

Sources: Asset Purchase Agreement (Zogenix, Inc.)

Milestone Payments. Xencor The appropriate party shall report to Cardinal Health once a year the status of each cell-line transferred to Xencor and pay to Cardinal Health the applicable other the following milestones, as applicable: (a) Allergan will pay to ACADIA the milestone payments set forth in the amounts listed below (if any) for each cell line transferred to Xencor pursuant to this Section 7.3(B) the first Allergan Development Candidate developed for the treatment or prevention of […***…] disorders that is biologically active against a given Licensed Target as demonstrated in the course of the Collaboration, within […***…] after notice of the achievement occurrence of the following events, provided that Allergan shall be required to pay each applicable such milestone by a Product produced using such cell lineonly once for each Licensed Target and in no event shall Allergan be required to pay more than […***…] pursuant to this Section 6.3(a) for each Licensed Target: (1) Designation of an Allergan Development Candidate […***…] (2) Filing of IND for an Allergan Development Candidate […***…] (3) Initiation of the first pivotal (e.g., with the amounts of such milestones to be determined based on how many cell lines Xencor has licensed and on whether such cell line is to be used by Xencor or its designee: Phase III) trial for an Allergan Development Candidate in […***…] […***…] ] (4) First filing of an NDA on an Allergan Development Candidate in […***…] […***…] ] (5) First Regulatory Approval of an Allergan Development Candidate in […***…] […***…] (b) Allergan will pay to ACADIA the milestone payments in the amounts listed below for the first Allergan Development Candidate developed for any indication in the Allergan Field other than the treatment and prevention of […***…] diseases and disorders that is biologically active against a given Licensed Target as demonstrated in the course of the Collaboration, within […***…] after notice of the occurrence of the following events, provided that Allergan shall be required to pay each such milestone only once for each Licensed Target and in no event shall Allergan be required to pay more than […***…] pursuant to this Section 6.3(b) for each Licensed Target: (1) Designation of an Allergan Development Candidate […***…] (2) Filing of IND for an Allergan Development Candidate […***…] (3) Initiation of Phase II trials for an Allergan Development Candidate in […***…] […***…] (4) Initiation of the first pivotal (e.g., Phase III) trial for an Allergan Development Candidate in […***…] […***…] provided, however, that if Xencor licenses a cell line pursuant to this Section 7.3(B] (5) after the achievement of one or more milestones by a Product produced using such cell line, then the payment(s) associated with such previously-achieved milestone(s) under this subparagraph (iii) shall not be due for such cell line. Following conduct First filing of an audit pursuant to Section 5.1 hereof of the Facility by qualified representatives of Xencor, Xencor shall promptly provide a written summary of any audit observations to Cardinal Health. Cardinal Health shall have NDA on an Allergan Development Candidate in […***…] from the time […***…] (6) First Regulatory Approval of receipt of such summary to resolve to Xencor’s reasonable satisfaction any Critical cGMP Deficiencies (as defined below) specifically identified an Allergan Development Candidate in such summary. If Cardinal Health fails to resolve any such Critical cGMP Deficiency to Xencor’s reasonable satisfaction within such […***…] period, then Xencor may elect to transfer such cGMP activities to a third party CMO, and each of the payment amounts set forth in subparagraphs (i), (ii), and (iii) of this Section 7.3(B) shall be reduced by […***…] ([…***…]%); provided, however, that such payments shall not be reduced in the event that Xencor elects to so transfer such cGMP activities during any period of time following the […***…] period for so long as Cardinal Health is continuing to diligently and timely pursue the resolution of the relevant Critical cGMP)Deficiency or has resolved such deficiency. If Cardinal Health and Xencor disagree as to whether any audit finding is a Critical cGMP Deficiency, then the parties shall appoint a qualified third party cGMP expert within […***…] after a written request by either party to the other party. The parties shall provide the expert with all relevant information on the disputed audit finding within […***…] following the appointment of such cGMP expert. The cGMP expert shall prepare and deliver to the parties a written, reasoned opinion conferring its decision within […***…] after receiving the information on the disputed audit finding from the parties. The opinion of such cGMP expert shall be final and binding on the parties. The fees and expenses of any cGMP expert appointed under this Section 7.3(B) shall be paid by the non-prevailing party.

Appears in 1 contract

Sources: Collaborative Research, Development and License Agreement (Acadia Pharmaceuticals Inc)