Rights and Duties Upon Termination. 11.1 Upon termination of this Sublicense Agreement (other than for Novartis' breach), Novartis shall have the right to retain any sums already paid by Vanda hereunder, and Vanda shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense Agreement. 11.2 Upon early termination of this Sublicense Agreement in its entirety or with respect to any country, under Sections 10.1 or 11.6 or due to a breach hereof by Vanda, Vanda shall notify Novartis of the amount of Product that Vanda, its Affiliates and Sublicensees then have on hand for sale in each country, the sale of which would, but for the termination, be subject to royalty, and Vanda, its Affiliates and Sublicensees shall thereupon be permitted to sell that amount of Product, provided that Vanda shall pay the royalty thereon to Novartis, or HMRI, as the case may be, at the time provided for. 11.3 Expiration or termination of this Sublicense Agreement or termination on a country-by-country basis shall terminate all outstanding obligations and liabilities between the parties arising from this Sublicense Agreement except those described in Sections 6.2 (with sole respect to Novartis confidentiality) 6.3, 6.4, 6.5, 6.6, 6.8, 9.1, 9.2, 10.1, 10.2, 10.3, 11.1, 11.2, 11.4, 11.5, 11.6, 12.5, 12.6, 12.7, 14.1 and 14.2, which sections shall survive such termination. In addition, any other provision required to interpret and enforce the parties' rights and obligations under this Sublicense Agreement shall also survive, but only to the extent required for the full observation and performance of the surviving obligations under this Sublicense Agreement. 11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, of the Sublicense Agreement in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a party's performance or nonperformance under this Sublicense Agreement. 11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense Agreement in its entirety due to breach hereof by Vanda or pursuant to Sections 10.1, 10.2 or 11.6, Vanda's rights in the Compound and Product shall cease, Vanda, its Affiliates and Sublicensees shall cease manufacture, development, marketing and sale of the Compound and Product in the Territory, and all originals and copies of Know-How, data, results and other information collected and/or generated by Vanda, its Affiliates and Sublicensees relating to the Compound or Product prior to termination shall be delivered to Novartis within [*] thereafter, except for one copy thereof which may be retained in Vanda's legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any IND or other regulatory filing effected prior to termination shall be assigned by Vanda to Novartis (or its designee(s), which designee may be HMRI or Titan), [*], if not already assigned to Novartis. Vanda shall provide to Novartis, within [*] of Novartis' request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and from regulatory agencies, as well as the safety database for the Product. 11.6 If (a) Vanda is precluded from selling the Product in a particular country in the Territory by virtue of infringement of Third Party patent rights, or (b) there is a holding of invalidity or unenforceability of any Patent, from which no further appeal can be taken, that materially affects Vanda's ability to commercialise the Product in a particular country in the Territory, Vanda shall have the right but not the obligation to terminate this Sublicense Agreement in such country. At Vanda's option, this Sublicense Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either the United States or two of the Major Market Countries. Within [*] of any such termination, subject to the following sentence, Novartis shall repay to Vanda if the Sublicense Agreement has been terminated in its entirety, that portion of the up front license fee and milestone payments it has received from Vanda up to the date of termination. In the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller portion of the upfront license fee and milestone payments Novartis has received from Vanda up to such date which shall be repaid to Vanda; provided, however, if ---------- [*] 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.
Appears in 1 contract
Rights and Duties Upon Termination. 11.1 Upon termination of this Sublicense Agreement (other than by Vanda for Novartis' ’ breach), Novartis whether the Sublicense Agreement is terminated in its entirety or with respect only to the parties’ rights and obligations in connection with the U.S./Canadian Territory, all of Novartis’ license rights to the Vanda Know-How and the Vanda Trademarks shall have the right to retain any sums already paid by Vanda hereunder, and Vanda shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense Agreementimmediately cease.
11.2 Upon early termination of this Sublicense Agreement in its entirety or with respect to the ROW Territory or the U.S./Canadian Territory or any country, portion thereof under Sections 10.1 or 11.6 or due to a breach hereof by VandaVanda or Novartis, Vanda the party whose territory has been terminated shall notify Novartis the other party of the amount of Product that Vandait, its Affiliates and Sublicensees then have on hand for sale in each country, the sale of which would, but for the termination, be subject to royalty, and Vandasuch party, its Affiliates and Sublicensees shall thereupon be permitted to sell that amount of Product, provided that Vanda such party shall pay the royalty thereon to Novartisthe other party, or HMRISanofi-Aventis, as the case may be, at the time provided for.
11.3 Expiration or termination of this Sublicense Agreement or termination on a country-by-country basis shall terminate all outstanding obligations and liabilities between the parties with respect to the applicable countr(y)(ies) arising from this Sublicense Agreement except those described in Sections 6.2 (with sole respect to Novartis confidentiality) 6.3, 6.4, 6.55.5, 6.6, 6.8, 6.9, 6.10. 6.11, 7.3, 8.9, 8.10, 8.11, 9.1, 9.210, 10.111, 10.212, 10.314, 11.116, 11.217, 11.418, 11.519, 11.620, 12.521, 12.622, 12.723, 14.1 24, 25, 27 and 14.2, Section 3 of Appendix C which sections shall survive such termination. In addition, each party shall pay all sums accrued hereunder which are then due in accordance with the terms hereof except as otherwise defined in this Sublicense Agreement, and any other provision required to interpret and enforce the parties' ’ rights and obligations under this Sublicense Agreement shall also survive, but only to the extent required for the full observation and performance of the surviving obligations under this Sublicense Agreement. For the avoidance of doubt, in the event of a termination of this Sublicense Agreement with respect to the ROW Territory (or any portion thereof) or the U.S./Canadian Territory (or any portion thereof), the parties’ rights and obligations with respect to the non-terminated country(y)(ies), those Sections of the Sublicense Agreement shall survive any such termination in accordance with their terms.
11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, of the Sublicense Agreement in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a party's ’s performance or nonperformance under this Sublicense Agreement.
11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense Agreement with respect to the ROW Territory in its entirety due to breach hereof by Vanda or pursuant to Sections 10.1, 10.2 or 10.1or 11.6, Vanda's ’s rights in the Compound and Product shall cease, Vanda, its Affiliates and Sublicensees shall cease manufacture, development, marketing and sale of the Compound and Product in the ROW Territory, and all originals and copies of Know-How, dataData, results and other information collected and/or generated by Vanda, its Affiliates and Sublicensees relating to the Compound or Product prior to termination shall be delivered to Novartis within [*] thirty (30) days thereafter, except for one copy thereof which may be retained in Vanda's ’s legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any ex-U.S. equivalent to an IND or other regulatory filing effected prior to termination shall be assigned by Vanda to Novartis (or its designee(s), which designee may be HMRI Sanofi-Aventis or Titan), [*]at Novartis’ request and expense, if not already assigned to Novartis. Vanda shall provide to Novartis, within [*] thirty (30) days of Novartis' ’ request, copies of all regulatory correspondence, including, but not limited to, any ex-U.S. equivalents to IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and from regulatory agencies, as well as the safety database for the ProductProduct managed by Vanda.
11.6 If (a) Vanda is precluded from selling the Product in a particular country in the ROW Territory by virtue of infringement of Third Party patent rights, or (b) there is a holding of invalidity or unenforceability of any Patent, from which no further appeal can be taken, that materially affects Vanda's ’s ability to commercialise commercialize the Product in a particular country in the ROW Territory, Vanda shall have the right but not the obligation to terminate this Sublicense Agreement in such country. At Vanda's ’s option, this Sublicense Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either the United States or two of the Major Market Countries. Within [*] ninety-five (95) days of any such termination, subject to the following sentence, Novartis shall repay to Vanda if the Sublicense Agreement has been terminated in its entirety, that portion of the up any up-front license fee and milestone payments it has received from Vanda up to the date of termination. In the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller portion of the upfront license fee and milestone payments Novartis has received from Vanda up to such date which shall be repaid to Vanda; provided, however, if ---------- [*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONthe Titan Agreement has been terminated only with respect to such certain countries under Section 11.6 of the Titan Agreement, Novartis shall be obligated to make such repayments to Vanda but only to the extent Novartis has been repaid the corresponding portion of the up-front license fee and milestone payments owed to it pursuant to Section 11.6 of the Titan Agreement. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONSIf the parties are unable to agree on such smaller portions within ninety (90) days, the issue shall be submitted for determination by arbitration in accordance with Section 16.2.
Appears in 1 contract
Rights and Duties Upon Termination. 11.1 11.01 Upon termination of this Sublicense Agreement (other than for Novartis' breach)Agreement, Novartis JAGOTEC shall have the right to retain any sums already paid by Vanda SB hereunder, and Vanda SB shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense Agreement.due. –15–
11.2 11.02 Upon early termination of this Sublicense Agreement AGREEMENT in its entirety or with respect to any countrycountry under Paragraphs 10.04, under Sections 10.1 10.05 or 11.6 or due to a breach hereof by Vanda10.06, Vanda SB shall notify Novartis JAGOTEC of the amount of Product that Vanda, its Affiliates and Sublicensees PRODUCT the Selling Party (as defined in Paragraph 1.12) then have on hand for sale in each countryhand, the sale of which would, but for the termination, be subject to royalty, and Vanda, its Affiliates and Sublicensees the Selling Party shall thereupon be permitted to sell that amount of ProductPRODUCT in such country or countries of the TERRITORY in which the termination is effective, during a period of not more than [Confidential Information Has Been Omitted And Furnished Separately To The Securities And Exchange Commission], provided that Vanda SB shall pay the royalty thereon to Novartis, or HMRI, as the case may be, at the time herein provided for, and provided further, that the rights granted to SB under this AGREEMENT with respect to manufacturing PRODUCT in such country or countries of the TERRITORY in which the termination is effective shall immediately terminate upon such termination.
11.3 Expiration or termination 11.03 Termination of this Sublicense Agreement or termination on a country-by-country basis AGREEMENT shall terminate all outstanding obligations and liabilities between the parties arising from this Sublicense Agreement AGREEMENT and the LETTER except those described in Sections 6.2 Paragraphs 2.02, 3.07, 4.01, 4.02 (with sole respect to Novartis confidentiality) 6.3second sentence), 6.46.02, 6.56.03 (second and third sentence), 6.66.03 (all other sentences, 6.8but only for the time period specified), 9.16.04, 9.26.05, 10.16.06, 10.26.07, 10.36.08, 11.17.01, 11.27.04, 11.47.05, 11.57.06, 11.67.07, 12.57.08 and Articles 8, 12.69, 12.7, 14.1 and 14.2, which sections shall survive such termination11 through 23. In addition, any other provision required to interpret and enforce the parties' rights and obligations under this Sublicense Agreement AGREEMENT and the LETTER shall also survive, but only to the extent required for the full observation and performance of this AGREEMENT and the surviving obligations under this Sublicense AgreementLETTER.
11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, 11.04 Termination of the Sublicense Agreement AGREEMENT in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a equity to either party's performance or nonperformance under this Sublicense Agreement.
11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense Agreement in its entirety due to breach hereof by Vanda or pursuant to Sections 10.1, 10.2 or 11.6, Vanda's rights in the Compound and Product shall cease, Vanda, its Affiliates and Sublicensees shall cease manufacture, development, marketing and sale of the Compound and Product in the Territory, and all originals and copies of Know-How, data, results and other information collected and/or generated by Vanda, its Affiliates and Sublicensees relating to the Compound or Product prior to termination shall be delivered to Novartis within [*] thereafter, except for one copy thereof which may be retained in Vanda's legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any IND or other regulatory filing effected prior to termination shall be assigned by Vanda to Novartis (or its designee(s), which designee may be HMRI or Titan), [*], if not already assigned to Novartis. Vanda shall provide to Novartis, within [*] of Novartis' request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and from regulatory agencies, as well as the safety database for the Product.
11.6 If (a) Vanda is precluded from selling the Product in a particular country in the Territory by virtue of infringement of Third Party patent rights, or (b) there is a holding of invalidity or unenforceability of any Patent, from which no further appeal can be taken, that materially affects Vanda's ability to commercialise the Product in a particular country in the Territory, Vanda shall have the right but not the obligation to terminate this Sublicense Agreement in such country. At Vanda's option, this Sublicense Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either the United States or two of the Major Market Countries. Within [*] of any such termination, subject to the following sentence, Novartis shall repay to Vanda if the Sublicense Agreement has been terminated in its entirety, that portion of the up front license fee and milestone payments it has received from Vanda up to the date of termination. In the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller portion of the upfront license fee and milestone payments Novartis has received from Vanda up to such date which shall be repaid to Vanda; provided, however, if ---------- [*] 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.
Appears in 1 contract
Samples: License Agreement
Rights and Duties Upon Termination. 11.1 Upon termination of this Sublicense Agreement (other than for Novartis' breach)Agreement, Novartis TITAN shall have the right to retain any sums already paid by Vanda NOVARTIS hereunder, and Vanda NOVARTIS shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense Agreement.
11.2 Upon early termination of this Sublicense Agreement in its entirety under Sections 10.1 or 11.6 or with respect to any country, under Sections 10.1 or 11.6 or due to a breach hereof by VandaNOVARTIS, Vanda NOVARTIS shall notify Novartis TITAN of the amount of Product PRODUCT that VandaNOVARTIS, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES then have on hand for sale in each country, the sale of which would, but for the termination, be subject to royalty, and VandaNOVARTIS , its Affiliates AFFILIATES and Sublicensees SUBLICENSEES shall thereupon be permitted to sell that amount of ProductPRODUCT, provided that Vanda NOVARTIS shall pay the royalty thereon to Novartis, TITAN or HMRI, as the case may be, at the time herein provided for.
11.3 Expiration or termination of this Sublicense Agreement or termination on a country-by-country basis shall terminate all outstanding obligations and liabilities between the parties arising from this Sublicense Agreement except those described in Sections 6.2 (with sole respect to Novartis TITAN confidentiality) 6.3, 6.4, 6.5, 6.6, 6.8, 9.1, 9.2, 10.110.1(b), 10.2, 10.3, 11.1, 11.2, 11.4, 11.5, 11.6, 12.5, 12.6, 12.7, 14.1 and 14.2, which sections shall survive such termination. In addition, any other provision required to interpret and enforce the parties' rights and obligations under this Sublicense Agreement shall also survive, but only to the extent required for the full observation and performance of the surviving obligations under this Sublicense Agreement.
11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, of the Sublicense Agreement in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a party's performance or nonperformance under this Sublicense Agreement.
11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense Agreement in its entirety due to breach hereof by Vanda or NOVARTIS and pursuant to Sections 10.1, 10.2 or 11.6, Vanda's NOVARTIS' rights in the Compound COMPOUND and Product PRODUCT shall cease, VandaNOVARTIS, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES shall cease manufacture, development, marketing and sale of the Compound COMPOUND and Product PRODUCT in the TerritoryTERRITORY, and all originals and copies of KnowKNOW-HowHOW, data, results and other information collected and/or generated by VandaNOVARTIS, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES relating to the Compound COMPOUND or Product PRODUCT prior to termination shall be delivered to Novartis TITAN within [*] thirty (30) days thereafter, except for one copy thereof which may be retained in Vanda's NOVARTIS' legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any IND or other regulatory filing effected prior to termination shall be assigned by Vanda NOVARTIS to Novartis TITAN (or its designee(s), which designee may could be HMRI or TitanHMRI), [*]at TITAN's request and expense, if not already assigned to NovartisTITAN. Vanda NOVARTIS shall provide to NovartisTITAN, within [*] thirty (30) days of Novartis' TITAN 's request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and to/from regulatory agencies, as well as the safety database for the ProductPRODUCT.
11.6 If (a) Vanda NOVARTIS is precluded from selling the Product PRODUCT in a particular country country(ies) in the Territory TERRITORY by virtue of infringement of Third Party THIRD PARTY patent rights, or (b) there is a holding of invalidity or unenforceability of any PatentPATENT, from which no further appeal can be taken, that materially affects Vanda's ability to commercialise the Product in a particular country in the Territory, Vanda shall have the right but not the obligation to terminate this Sublicense Agreement in such country. At Vanda's option, this Sublicense Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either the United States or two of the Major Market Countries. Within [*] of any such termination, subject to the following sentence, Novartis shall repay to Vanda if the Sublicense Agreement has been terminated in its entirety, that portion of the up front license fee and milestone payments it has received from Vanda up to the date of termination. In the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller portion of the upfront license fee and milestone payments Novartis has received from Vanda up to such date which shall be repaid to Vanda; provided, however, if ---------- [*] 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.appeal
Appears in 1 contract
Rights and Duties Upon Termination. 11.1 Upon termination of this Sublicense Agreement (other than for Novartis' breach)License Agreement, Novartis HMRI shall have the right to retain any sums already paid by Vanda TITAN hereunder, and Vanda TITAN shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense License Agreement.
11.2 Upon early termination of this Sublicense License Agreement in its entirety under Sections 10.2 or 11.6 or with respect to any country, under Sections 10.1 or 11.6 or due to a breach hereof by VandaTITAN, Vanda TITAN shall notify Novartis HMRI of the amount of Product COMPOUND and PRODUCT that VandaTITAN, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES then have on hand for sale in each country, the sale of which would, but for the termination, be subject to royalty, and VandaTITAN, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES shall thereupon be permitted to sell that amount of ProductCOMPOUND and PRODUCT, provided that Vanda TITAN shall pay the royalty thereon to Novartis, or HMRI, as the case may be, HMRI at the time herein provided for.
11.3 Expiration or termination of this Sublicense License Agreement or termination on a country-by-country basis shall terminate all outstanding obligations and liabilities between the parties arising from this Sublicense License Agreement except those described in Sections 6.2 (with sole respect to Novartis HMRI confidentiality) ), 6.3, 6.4, 6.5, 6.6, 6.8, 9.1, 9.2, 10.1, 10.2, 10.3, 11.1, 11.2, 11.4, 11.5, 11.6, 12.5, 12.6, 12.7, 14.1 and 14.2, and the terms of Appendix D, which sections and appendix shall survive such termination. In addition, any other provision required to interpret and enforce the parties' rights and obligations under this Sublicense License Agreement shall also survive, but only to the extent required for the full observation and performance of the surviving obligations under this Sublicense License Agreement.
11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, of the Sublicense License Agreement in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a party's performance or nonperformance non-performance under this Sublicense License Agreement.
11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense License Agreement in its entirety due to breach hereof by Vanda or TITAN and pursuant to Sections 10.1, 10.2 or 11.6, VandaTITAN's rights in the Compound COMPOUND and Product PRODUCT shall cease, VandaTITAN, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES shall cease manufacture, development, marketing and sale of the Compound COMPOUND and Product PRODUCT in the TerritoryTERRITORY, and all originals and copies of KnowKNOW-HowHOW, data, results and other information collected and/or generated by VandaTITAN, its Affiliates AFFILIATES and Sublicensees SUBLICENSEES relating to the Compound COMPOUND or Product PRODUCT prior to termination shall be delivered to Novartis HMRI within [*] thirty (30) days thereafter, except for one copy thereof which may be retained in VandaTITAN's legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any IND or other regulatory filing effected prior to termination shall be assigned by Vanda TITAN to Novartis HMRI (or its designee(s), which designee may be HMRI or Titan), [*]at HMRI's request and expense, if not already assigned to NovartisHMRI. Vanda TITAN shall provide to NovartisHMRI, within [*] one (1) month of Novartis' HMRI's request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and to/from regulatory agencies, as well as the safety database for the ProductPRODUCT.
11.6 If (a) Vanda TITAN is precluded from selling the Product COMPOUND or PRODUCT in a particular country country(ies) in the Territory TERRITORY by virtue of infringement of Third Party THIRD PARTY patent rights, or (b) there is a holding of invalidity or unenforceability of any PatentPATENT, from which no further appeal can be taken, that materially affects VandaTITAN's ability to commercialise the Product commercialize COMPOUND or PRODUCT in a particular country country(ies) in the TerritoryTERRITORY, Vanda TITAN shall have the right (but not the obligation obligation) to terminate this Sublicense License Agreement in such countrycountry(ies). At VandaTITAN's option, this Sublicense License Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either Xxxxxxx 00.0 xxxxx xx xxx Xxxxxx Xxxxxx, the United States or two of the Major Market CountriesEUROPEAN UNION and/or Japan. Within [*] ninety (90) days of any such termination, subject to the following sentence, Novartis HMRI shall repay to Vanda TITAN: (i) if the Sublicense License Agreement has been terminated in its entirety, that portion of the up front all upfront license fee fees and milestone payments (including in the form of TITAN common stock) it has received from Vanda TITAN up to the date of termination. In termination and (ii) if the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense License Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller what portion of the upfront license fee fees and milestone payments Novartis HMRI has received from Vanda TITAN up to such date which shall be repaid to Vanda; providedTITAN. If the parties are unable to agree on such portion within ninety (90) days, however, if ---------- [*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONSthe issue shall be submitted for determination by arbitration in accordance with Section 14.2.
Appears in 1 contract
Samples: Worldwide License Agreement (Titan Pharmaceuticals Inc)
Rights and Duties Upon Termination. 11.1 Upon termination of this Sublicense Agreement (other than for Novartis' breach), Novartis shall have the right to retain any sums suns already paid by Vanda hereunder, and Vanda shall pay all sums accrued hereunder which are then due except as otherwise defined in this Sublicense Agreement.
11.2 Upon early termination of this Sublicense Agreement in its entirety or with respect to any country, under Sections 10.1 or 11.6 or due to a breach hereof by Vanda, Vanda shall notify Novartis of the amount of Product that Vanda, its Affiliates and Sublicensees then have on hand for sale in each country, the sale of which would, but for the termination, be subject to royalty, and Vanda, its Affiliates and Sublicensees shall thereupon be permitted to sell that amount of Product, provided that Vanda shall pay the royalty thereon to Novartis, or HMRI, as the case may be, at the time provided for.
11.3 Expiration or termination of this Sublicense Agreement or termination on a country-by-country basis shall terminate all outstanding obligations and liabilities between the parties arising from this Sublicense Agreement except those described in Sections 6.2 (with sole respect to Novartis confidentiality) 6.3, 6.4, 6.5, 6.6, 6.8, 9.1, 9.2, 10.1, 10.2, 10.3, 11.1, 11.2, 11.4, 11.5, 11.6, 12.5, 12.6, 12.7, 14.1 and 14.2, which sections shall survive such termination. In addition, any other provision required to interpret and enforce the parties' rights and obligations under this Sublicense Agreement shall also survive, but only to the extent required for the full observation and performance of the surviving obligations under this Sublicense Agreement.
11.4 Except as otherwise specifically provided for herein, termination, in whole or in part, of the Sublicense Agreement in accordance with the provisions hereof shall not limit remedies to the parties which may be otherwise available in law or equity, including consequential, incidental or indirect damages (such as loss of sales, profits, or goodwill) arising out of a party's performance or nonperformance under this Sublicense Agreement.
11.5 Subject to Section 11.2 and other express provisions hereof, upon early termination of this Sublicense Agreement in its entirety due to breach hereof by Vanda or pursuant to Sections 10.1, 10.2 or 11.6, Vanda's rights in the Compound and Product shall cease, Vanda, its Affiliates and Sublicensees shall cease manufacture, development, marketing and sale of the Compound and Product in the Territory, and all originals and copies of Know-How, data, results and other information collected and/or generated by Vanda, its Affiliates and Sublicensees relating to the Compound or Product prior to termination shall be delivered to Novartis within [*] thirty (30) days thereafter, except for one copy thereof which may be retained in Vanda's legal or other appropriately restricted files solely for the purpose of establishing the extent of its obligations hereunder. Any IND or other regulatory filing effected prior to termination shall be assigned by Vanda to Novartis (or its designee(s), which designee may be HMRI or Titan), [*]at Novartis' request and expense, if not already assigned to Novartis. Vanda shall provide to Novartis, within [*] thirty (30) days of Novartis' request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA submission, NDA Postmarketing Reports, and reports of written/phone contacts to and from regulatory agencies, as well as the safety database for the Product.
11.6 If (a) Vanda is precluded from selling the Product in a particular country in the Territory by virtue of infringement of Third Party patent rights, or (b) there is a holding of invalidity or unenforceability of any Patent, from which no further appeal can be taken, that materially affects Vanda's ability to commercialise the Product in a particular country in the Territory, Vanda shall have the right but not the obligation to terminate this Sublicense Agreement in such country. At Vanda's option, this Sublicense Agreement may be terminated in its entirety if the events described in subsection (a) or (b) of this Section 11.6 occur in either the United States or two of the Major Market Countries. Within [*] ninety-five (95) days of any such termination, subject to the following sentence, Novartis shall repay to Vanda if the Sublicense Agreement has been terminated in its entirety, that portion of the up front license fee and milestone payments it has received from Vanda up to the date of termination. In the event that the Sublicense Agreement is terminated pursuant to Section 11.6 of the Sublicense Agreement, Novartis shall be obligated to make the foregoing repayments to Vanda, but only to the extent that it has been repaid its own up-front license fee and milestone payments due to Novartis under Section 11.6 of the Titan Agreement. If this Sublicense Agreement has been terminated only with respect to certain country(ies), the parties shall negotiate in good faith a smaller portion of the upfront license fee and milestone payments Novartis has received from Vanda up to such date which shall be repaid to Vanda; provided, however, if ---------- [*] 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.11.6
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