Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine as follows: (a) One Million Dollars ($1,000,000) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment; (b) [*] upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and (c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone due under this Section 3.2.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDA. (d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
Appears in 2 contracts
Sources: License Agreement, License Agreement (TEKMIRA PHARMACEUTICALS Corp)
Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Vincristine as follows:
(a) One Million Dollars [*] within ten ($1,000,00010) upon on days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Vincristine (the first patient is enrolled in any clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA”), of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be satisfied by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) [*] by the FMV as of the date Sphingosomal Vincristine NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollment;the Designated EU States before the Sphingosomal Vincristine NDA is accepted, then [*] the milestone payment due under this Section 3.1.1
(a) will be paid by Hana to INEX immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the acceptance of the Sphingosomal Vincristine NDA by the FDA; and
(b) [*] upon within ten (10) days following Hana’s receipt of the date approval by the first patient is enrolled in a Phase II clinical trial FDA of the Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone payment due under this Section 3.2.1(c3.1.1
(b) will be paid by Hana to INEX immediately upon the approval of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the approval of an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine by the FDA.
(dc) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (cb) of this Section 3.2.1 3.1.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine.
Appears in 1 contract
Milestone Payments. Hana (a) Each Antev Vendor shall be entitled to receive additional contingent consideration (collectively, the "Contingent Consideration") upon the following milestones in respect of Teverelix:
(i) within 30 days of the earlier of (i) the statistically significant achievement of the primary endpoint in the Phase 2 clinical trial, or (ii) securing the results of the Phase 2 clinical trial that allows development to progress towards registration for Advanced Prostate Cancer patients, in each case conducted under the issued IND (No. 134308), the Purchaser shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine as follows:
(a) One Million Dollars (each Antev Vendor a cash payment equal to $1,000,000) upon on 2.00 per Consideration Share issued to such Antev Vendor at the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollmentClosing;
(bii) [*] upon within 30 days of the date earlier of (i) the first patient is enrolled statistically significant achievement of the primary endpoint in a the Phase II 2 clinical trial or (ii) securing the results of Sphingosomal Vinorelbine the Phase 2 clinical trial that allows development to progress towards registration for Prevention of Recurrence of AUR, in each case conducted pursuant under the issued IND (No. 147579), the Purchaser shall pay to an IND sponsored by Hanaeach Antev Vendor a cash payment equal to $7.50 per Consideration Share issued to such Antev Vendor at the Closing;
(iii) within 30 days following FDA NDA approval for the hormone therapy for Advanced Prostate Cancer with increased cardiovascular risk indication, the Purchaser shall make a cash payment to the Antev Vendors in the aggregate amount of $20,000,000, which payment shall be made by Hana issuing allocated and paid to INEX a number of additional shares of Common Stock determined by dividing [*] by each Antev Vendor pro rata to their respective pro rata interest in the FMV as of Consideration Shares issued to the date of such first patient enrollmentAntev Vendors at the Closing; and
(civ) [*] upon within 30 days following FDA NDA approval for the approval by prevention of recurrence of AUR indication, the FDA Purchaser shall make a cash payment to the Antev Vendors in the aggregate amount of an NDA relating to Sphingosomal Vinorelbine$20,000,000, which payment shall be made by Hana issuing allocated and paid to INEX a number of additional shares of Common Stock determined by dividing [*] by each Antev Vendor pro rata to their respective pro rata interest in the FMV as of Consideration Shares issued to the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of Antev Vendors at the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone due under this Section 3.2.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDAClosing.
(db) For the avoidance of doubt, the Purchaser's obligations to fund the Contingent Consideration are transferrable and assignable, upon notice given in accordance with Section 14.3, in the context of a bona fide arm's length change of control, merger, sale, licensing or similar transaction involving the Purchaser and/or Antev; provided, however, that, before such transfer or assignment, such transferee or assignee has executed and delivered to the Antev Vendors' Representatives a deed of undertaking agreeing to be bound by and assume performance of the Purchaser's payment obligations hereunder in respect of Contingent Consideration.
(c) If any of the Contingent Consideration becomes payable, the Purchaser shall promptly so notify the Antev Vendors' Representatives and shall, within the time periods prescribed by Section 2.3(a), pay the applicable aggregate amount by wire transfer of immediately available funds to an account designated by the Antev Vendors' Representatives in writing. If so requested by the Antev Vendors' Representatives following the Closing, the Purchaser shall promptly take such actions as reasonably requested by the Antev Vendors' Representatives as may be necessary to, in conjunction with the Antev Vendors' Representatives, engage a mutually agreed third party paying agent on terms acceptable to each of the milestone payments Purchaser and the Antev Vendors' Representatives (each acting reasonably), and at the cost of the Purchaser. The Parties acknowledge and agree that, notwithstanding anything else contained herein, the payment of any Contingent Consideration by the Purchaser as described in subparagraphs (a), (bthis Section 2.3(c) and (c) shall fully satisfy the Purchaser's obligations to pay such Contingent Consideration to the Antev Vendors for the purposes of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence Agreement.
(d) The allocation of the events described Contingent Consideration among the Antev Vendors as set forth in each such subparagraphthis Section 2.3 is an arrangement between the Antev Vendors. For exampleThe Purchaser shall not be concerned with, or have any liability to the Antev Vendors with respect to, any allocation of, or failure of any Antev Vendor or any other person to allocate, the milestone payment described in subparagraph (a) above will be due only once, upon Contingent Consideration among the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by HanaAntev Vendors as so set forth.
Appears in 1 contract
Sources: Securities Exchange Agreement (Medicus Pharma Ltd.)
Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Vincristine as follows:
(a) One Million Dollars [*] within ten ($1,000,00010) upon on days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Vincristine (the first patient is enrolled in any clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA”), of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be satisfied by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) [*] by the FMV as of the date Sphingosomal Vincristine NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollment;the Designated EU States before the Sphingosomal Vincristine NDA is accepted, then [*] the milestone payment due under this Section 3.1.1
(a) will be paid by Hana to INEX immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the acceptance of the Sphingosomal Vincristine NDA by the FDA; and
(b) [*] upon within ten (10) days following Hana’s receipt of the date approval by the first patient is enrolled in a Phase II clinical trial FDA of the Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone payment due under this Section 3.2.1(c3.1.1(b) will be paid by Hana to INEX immediately upon the approval of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the approval of an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine by the FDA.
(dc) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (cb) of this Section 3.2.1 3.1.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine. 20 *Confidential Treatment Requested.
Appears in 1 contract
Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Vincristine as follows:
(a) One Million Dollars [*] within ten ($1,000,00010) upon on days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Vincristine (the first patient is enrolled in any clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA”), of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be satisfied by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) [*] by the FMV as of the date Sphingosomal Vincristine NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollment;the Designated EU States before the Sphingosomal Vincristine NDA is accepted, then [*] the milestone payment due under this Section 3.1.1
(a) will be paid by Hana to INEX immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the acceptance of the Sphingosomal Vincristine NDA by the FDA; and
(b) [*] upon within ten (10) days following Hana’s receipt of the date approval by the first patient is enrolled in a Phase II clinical trial FDA of the Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone payment due under this Section 3.2.1(c3.1.1
(b) will be paid by Hana to INEX immediately upon the approval of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the approval of an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine by the FDA.
(dc) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (cb) of this Section 3.2.1 3.1.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine. *Confidential Treatment Requested.
Appears in 1 contract
Sources: License Agreement
Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine as follows:
(a) One Million Dollars ($1,000,000) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment;; INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) [***] Dollars ($[***]) upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(c) [***] ($[***]) upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [***] the milestone due under this Section 3.2.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
Appears in 1 contract
Milestone Payments. Hana shall pay to INEX TEKMIRA milestones payments in respect of Sphingosomal Vinorelbine Topotecan as follows:
(a) One Million Dollars ($1,000,000) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment;Deleted.
(b) [***] upon Dollars ($[***]) within ten (10) days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Topotecan (the first patient is enrolled in a Phase II clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaTopotecan NDA”), which payment shall be made satisfied by Hana issuing to INEX TEKMIRA a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date Sphingosomal Topotecan NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollmentthe Designated EU States before the Sphingosomal Topotecan NDA is accepted, then [***] ([***]) the milestone payment due under this Section 3.3.1(b) will be paid by Hana to TEKMIRA immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to TEKMIRA immediately upon the acceptance of the Sphingosomal Topotecan NDA by the FDA; andand INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) [***] Dollars ($[***]) upon the approval by the FDA of an NDA relating to a Sphingosomal VinorelbineTopotecan NDA, which payment shall be made by Hana issuing to INEX TEKMIRA a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine Topotecan is approved by the FDA, [***] the milestone due under this Section 3.2.1(c3.3.1(c) will be paid by Hana to INEX TEKMIRA immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX TEKMIRA immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine Topotecan by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
Appears in 1 contract
Sources: Amendment No. 1 to the Amended and Restated Agreement (Hana Biosciences Inc)
Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Topotecan as follows:
(a) One Million [***] Dollars ($1,000,000[***]) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment;
(b) [*] upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and;
(cb) [***] Dollars ($[***]) upon the approval date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Topotecan conducted pursuant to an IND sponsored by the FDA of an NDA relating to Sphingosomal VinorelbineHana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(c) [***] Dollars ($[***]) upon the approval by the FDA of an NDA relating to Sphingosomal Topotecan, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine Topotecan is approved by the FDA, [***] the milestone due under this Section 3.2.1(c3.3.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine Topotecan by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 3.3.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
Appears in 1 contract
Milestone Payments. Hana shall pay to INEX INEX, milestones payments in respect of Sphingosomal Vinorelbine Topotecan as follows:
(a) One Million Dollars ($1,000,000) [*] upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) [*] by the FMV as of the date of such first patient enrollment;; *Confidential Treatment Requested.
(b) [*] upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal VinorelbineTopotecan, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine Topotecan is approved by the FDA, [*] the milestone due under this Section 3.2.1(c3.3.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine Topotecan by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 3.3.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
Appears in 1 contract
Sources: License Agreement
Milestone Payments. Hana shall pay to INEX milestones milestone payments in respect of Sphingosomal Vinorelbine Vincristine as follows:
(a) One Million [***] Dollars ($1,000,000[***]) upon on within ten (10) days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Vincristine (the first patient is enrolled in any clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA”), of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be satisfied by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand [***] Dollars ($500,000[***]) by the FMV as of the date Sphingosomal Vincristine NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollment;the Designated EU States before the Sphingosomal Vincristine NDA is accepted, then [***] ([***]) the milestone payment due under this Section 3.1.1
(a) will be paid by Hana to INEX immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the acceptance of the Sphingosomal Vincristine NDA by the FDA; and
(b) [***] upon Dollars ($[***]) within ten (10) days following Hana’s receipt of the date approval by the first patient is enrolled in a Phase II clinical trial FDA of the Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [***] ([***]) the milestone payment due under this Section 3.2.1(c3.1.1
(b) will be paid by Hana to INEX immediately upon the approval of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the approval of an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine by the FDA.
(dc) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (cb) of this Section 3.2.1 3.1.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine.
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Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine as follows:
(a) One Million Dollars ($1,000,000) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment;
(b) [*] upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone due under this Section 3.2.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.3.2.1
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Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Vincristine as follows:: INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(a) One Million [***] Dollars ($1,000,000[***]) upon on within ten (10) days following the date FDA’s acceptance for review of an NDA submission by Hana relating to Sphingosomal Vincristine (the first patient is enrolled in any clinical trial of “Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA”), of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid payment shall be satisfied by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand [***] Dollars ($500,000[***]) by the FMV as of the date Sphingosomal Vincristine NDA filing date; provided however, if a Regulatory Submission equivalent to an NDA is accepted in any of such first patient enrollment;the Designated EU States before the Sphingosomal Vincristine NDA is accepted, then [***] (***) the milestone payment due under this Section 3.1.1
(a) will be paid by Hana to INEX immediately upon the acceptance of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the acceptance of the Sphingosomal Vincristine NDA by the FDA; and
(b) [***] upon Dollars ($[***]) within ten (10) days following Hana’s receipt of the date approval by the first patient is enrolled in a Phase II clinical trial FDA of the Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(c) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [***] (***) the milestone payment due under this Section 3.2.1(c3.1.1
(b) will be paid by Hana to INEX immediately upon the approval of that equivalent filing in any of the Designated EU States, and the remaining balance will be paid by Hana to INEX immediately upon the approval of an the Sphingosomal Vincristine NDA relating to Sphingosomal Vinorelbine by the FDA.
(dc) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (cb) of this Section 3.2.1 3.1.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine.
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Milestone Payments. Hana In addition to the Closing Payments, Timber shall pay to INEX milestones payments the Seller (or its permitted designee, as determined by the Seller in respect of Sphingosomal Vinorelbine as followsits sole discretion), if earned, the following payments:
(a) One Million Dollars ($1,000,000) upon on the date initiation of a Phase 3 pivotal trial, as agreed with the FDA, and defined as the first patient is enrolled in any clinical such trial for the Product, a one-time payment of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment4 million;
(b) [*] upon FDA approval of an NDA filed by Timber for an approved label indication (“FDA Approval”) for the date treatment with the first patient is enrolled Product of congenital ichthyosis, or a substantially similar indication, a one-time payment of $7 million;
(c) upon European EMA approval, to be pursued at Timber’s sole discretion, of an MAA filed by Timber or an Affiliate thereof, for an approved label indication (“EMA Approval”), for the treatment with the Product of congenital ichthyosis, or a substantially similar indication, a one-time payment of $2 million;
(d) upon Japanese PMDA approval, to be pursued at Timber’s sole discretion, of an MAA filed by Timber or an Affiliate thereof, for an approved label indication (“PMDA Approval”), for the treatment with the Product of congenital ichthyosis, or a substantially similar indication, a one-time payment of $4 million;
(e) during the period commencing upon FDA approval of the Product and ending upon a Generic Product Entry Date in a Phase II clinical trial the US, earn-out payments equal to seventeen (17%) percent of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaNet Sales, which payment shall be made by Hana issuing reduced to INEX five (5%) percent following a number of additional shares of Common Stock determined by dividing [*] by Generic Product Entry Date in the FMV as US;
(f) during the period commencing upon non-US regulatory approval of the date Product, and ending upon a Generic Product Entry Date outside of such first patient enrollmentthe US, on a market-by-market basis, earn-out payments equal to ten (10%) percent of Net Sales outside of the US, which shall be reduced to three (3%) percent following a Generic Product Entry Date (on a market-by-market basis) outside of the US; and
(cg) [*] upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [*] by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] the milestone due under this Section 3.2.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of $200 million in annual Net Sales in any calendar year of the events described Product in each such subparagraph. For examplethe Territory after FDA approval, the milestone a one-time payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana$10 million.
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Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine Topotecan as follows:
(a) One Million [***] Dollars ($1,000,000[***]) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand Dollars ($500,000) has been paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand Dollars ($500,000) by the FMV as of the date of such first patient enrollment;
(b) [*] upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; andINFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(cb) [***] Dollars ($[***]) upon the approval date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Topotecan conducted pursuant to an IND sponsored by the FDA of an NDA relating to Sphingosomal VinorelbineHana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(c) [***] Dollars ($[***]) upon the approval by the FDA of an NDA relating to Sphingosomal Topotecan, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine Topotecan is approved by the FDA, [***] the milestone due under this Section 3.2.1(c3.3.1(c) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine Topotecan by the FDA.
(d) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (b) and (c) of this Section 3.2.1 3.3.1 above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (a) above will be due only once, upon the date the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine Topotecan conducted pursuant to an IND sponsored by Hana. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (a) in connection with any subsequent clinical trials sponsored by Hana.
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Milestone Payments. Hana shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine as follows:
(aA) One Million [***] Dollars ($1,000,000[***]) upon on the date the first patient is enrolled in any clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, of which INEX acknowledges Five Hundred Thousand [***] Dollars ($500,000[***]) has been shall be paid by wire transfer to INEX of immediately available funds and the remaining Five Hundred Thousand [***] Dollars ($500,000[***]) has been shall be paid by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing Five Hundred Thousand [***] Dollars ($500,000[***]) by the FMV as of the date of such first patient enrollmentenrolment;
(bB) [***] Dollars ($[***]) upon the date the first patient is enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by Hana, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such first patient enrollment; and
(cC) [***] Dollars ($[***]) upon the approval by the FDA of an NDA relating to Sphingosomal Vinorelbine, which payment shall be made by Hana issuing to INEX a number of additional shares of Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as of the date of such FDA approval; provided however, if a Regulatory Submission equivalent to an NDA is approved in any of the Designated EU States before an NDA relating to Sphingosomal Vinorelbine is approved by the FDA, [*] one half the milestone due under this Section 3.2.1(c5.7(b)(C) will be paid by Hana to INEX immediately upon approval of that equivalent filing and the remaining balance will be paid by Hana to INEX immediately upon the approval of an NDA relating to Sphingosomal Vinorelbine by the FDA.
(dD) For the avoidance of doubt, each of the milestone payments described in subparagraphs (a), (bA) and (cB) of this Section 3.2.1 5.7(b)(i) above represent one-time payments to INEX, and shall be due only upon the first occurrence of the events described in each such subparagraph. For example, the milestone payment described in subparagraph (aA) above will be due only once, upon following the date FDA’s acceptance for review of the first patient is enrolled in a clinical trial of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by HanaVincristine NDA. No additional milestone payments to INEX shall be due from Hana pursuant to subparagraph (aA) in connection with any subsequent clinical trials sponsored NDA submission by HanaHana relating to Sphingosomal Vincristine.
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