Additional Termination Rights. (a) BMS has the right to terminate this License Agreement upon delivery of written notice to MPP upon the occurrence of any of the following: (i) the failure of MPP to ensure a sufficient supply of the Licensed Products in the formulations and strengths listed in Schedule A to meet substantially the needs in the Territory, other than isolated, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMS; (ii) the failure of MPP to comply with BMS's reasonable requests under Sections 5(b) through (c) of this License Agreement; (iii) any failure by the MPP of ensuring compliance with relevant OFAC regulations under Section 2.8 of this License Agreement; (iv) if in the reasonable opinion of BMS, control (through ownership or otherwise) or MPP changes; (b) either of BMS and MPP will have the right to terminate any Sublicense Agreement, upon delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following; (i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable to proceed or continue with the commercialization of the Licensed Product in the Territory; (ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory; (iii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 of this License Agreement; (iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement; (v) the occurrence of a direct or indirect change of control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or (vi) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world, which in BMS’s and MPP’s judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed Products.
Appears in 4 contracts
Samples: License and Technology Transfer Agreement, License and Technology Transfer Agreement, License and Technology Transfer Agreement
Additional Termination Rights. (a) BMS has AbbVie will have the right to terminate this License Agreement Agreement, at AbbVie's sole discretion, upon delivery of written notice to MPP upon in the occurrence event of any of the following:
(i) the failure of MPP to ensure a sufficient supply of the Licensed Products in the formulations and strengths listed in Schedule A to meet substantially the needs in the Territory, other than isolated, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMS;
(ii) the failure of MPP to comply with BMS's reasonable requests under Sections 5(b) through (c) of this License Agreement;
(iii) any failure by the MPP of ensuring compliance with relevant OFAC regulations under Section 2.8 4.5 of this License Agreement;, and
(ivii) if the uncured material breach of any of MPP's obligations under Section 4 of this Agreement, where notice and opportunity to cure shall follow those provisions set forth in the reasonable opinion of BMS, control (through ownership or otherwise) or MPP changes;Section 7.2.
(b) either Each of BMS AbbVie and MPP will have the right to terminate any Sublicense AgreementSublicense, upon delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following;
: (i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable to proceed or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section 2.7(c)2.3 and 2.6, a cross-cross border diversion of the Licensed Compound and/or Compounds or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Compounds or Licensed Products for use in any country outside of the Territory;
Territory in breach of this Agreement; (ii) any Exploitation of the Licensed Compounds outside the Field or outside the Territory where such Exploitation would infringe any AbbVie Patent granted and in force; (iii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 of this License Agreement;
the Sublicense; (iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement;
(v) the occurrence of a direct or indirect change Change of control Control of Sublicensee that has not been consented to by BMS AbbVie and MPP in writing; and/or
or (viv) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world, pursuant to which AbbVie is joined in BMS’s and MPP’s judgmentlitigation or risks payment of fines, may reflect unfavorably on BMS, MPP, their reputation fees or the Licensed Productsdamages.
Appears in 2 contracts
Samples: License Agreement, License Agreement
Additional Termination Rights. In addition to the termination rights provided in Section 15.2 above and any other termination rights provided in this Agreement, the following termination provisions shall also apply:
(a) BMS has Retailer shall have the right to terminate this License Agreement as set forth in Section 1.5(d)(i)(A) and Section 1.5(d)(v). In addition, upon delivery of not less than ninety (90) days’ prior written notice to MPP upon the occurrence of any of the following:
(i) the failure of MPP to ensure a sufficient supply of the Licensed Products in the formulations Bank and strengths listed in Schedule A to meet substantially the needs in the TerritoryGreen Dot, other than isolated, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMS;
(ii) the failure of MPP to comply with BMS's reasonable requests under Sections 5(b) through (c) of this License Agreement;
(iii) any failure by the MPP of ensuring compliance with relevant OFAC regulations under Section 2.8 of this License Agreement;
(iv) if in the reasonable opinion of BMS, control (through ownership or otherwise) or MPP changes;
(b) either of BMS and MPP will Retailer shall have the right to terminate any Sublicense Agreementthis Agreement if Retailer makes an election to do so pursuant to Section 1.5(c)(ii) (Bank’s change in Operating Procedures), or 1.5(d)(iii) (Bank’s change in terms to comply with Applicable Law); provided, however, that Retailer may exercise its rights under this paragraph upon delivery of thirty (30) days’ prior written notice to Bank and Green Dot if Bank changes the Operating Procedures or the Walmart MoneyCard Terms during a Termination Period.
(b) Bank shall have the right to terminate this Agreement upon written notice to the relevant Sublicensee(sother Parties if required to do so by a Governmental Authority. Bank shall provide notice of such termination at least ninety (90) days in advance, or shall otherwise provide prior notice as permitted by such Governmental Authority.
(c) Bank shall have the right, upon ninety (90) days’ prior written notice to the occurrence of other Parties, to terminate this Agreement if the Applicable Law or Network Operating Regulations (or interpretations thereof) applicable to any aspect of the following;Program, other than to fees and charges, change in a way, which, in Bank’s commercially reasonable judgment, could have a material adverse effect on the Program; provided, however, that if the Applicable Law or Network Operating Regulations requires that termination be effective in less than ninety (90) days, the Agreement shall terminate at the end of the period as required by the Applicable Law or Network Operating Regulations.
(d) Notwithstanding anything to the contrary contained in this Agreement, Bank may engage Retailer in the good faith renegotiation of this Agreement if the federal or state laws (or interpretations thereof) applicable to fees and charges imposed by Bank under the Program change in a way, which in Bank’s commercially reasonable judgment, could have a material adverse effect on the profitability of the Program to Bank. In the event of a renegotiation pursuant to this Section 15.3(d), if new terms acceptable to Bank and Retailer are not agreed upon in writing within ninety (90) days after the date renegotiations begin, Bank or Retailer may terminate this Agreement and the Agreement Termination Date shall be deemed the earlier of: (i) one hundred eighty (180) days after Bank or Retailer delivers notice of termination to the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable to proceed other Parties; or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice the date Bank is required to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory;
(iii) any failure by the Sublicensees initiate changes to such Program to comply with the quality requirements under Section 6.2 of this License Agreement;
(iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement;
(v) the occurrence of a direct Applicable Law or indirect change of control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or
(vi) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world, which in BMS’s and MPP’s judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed ProductsNetwork Operating Regulations.
Appears in 1 contract
Additional Termination Rights. (a) BMS Shionogi has the right to terminate this License Agreement upon delivery of written notice to MPP GARDP upon the occurrence of any of the following:
(i) the failure of MPP GARDP to ensure a sufficient supply use reasonable best efforts to conduct the activities and achieve the objectives for which it is responsible in the Market Access Plan with the objective of promoting affordable access to the Licensed Products Product through its Sublicensees in the formulations and strengths listed in Schedule A to meet substantially the needs countries in the Territory, other than isolated, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has Territory selected pursuant to the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMSMarket Access Plan;
(ii) the failure of MPP GARDP to comply with BMS's Shionogi’s reasonable requests in connection with a breach under Sections 5(b2.3(n) through (c) of this License Agreementq);
(iii) any failure by the MPP GARDP of ensuring compliance with relevant OFAC regulations under Section 2.8 2.9 of this License Agreement;; or
(iv) if if, in the reasonable opinion of BMSShionogi, control (through ownership or otherwise) or MPP of GARDP changes;.
(b) either of BMS and MPP GARDP will have the right to to, and will at Shionogi’s request, terminate any Sublicense Agreement, upon by delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following;:
(i) the occurrence of any material safety issue that BMS Shionogi reasonably believes makes it inadvisable to proceed or continue with the commercialization Commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products Product whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, or has sold Licensed Compound and/or Licensed Products Product for use in any country outside of the Territory;
(iii) any failure by the Sublicensees Sublicensee to comply with the quality requirements under Section 6.2 of this License AgreementAgreement for any Licensed Product that is Commercialized or intended for Commercialization;
(iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products Product in at least one country in the the Territory for all within four (4) years of the formulation and strengths listed in Schedule A start of technical transfer pursuant to Section 4.2 to the Sublicensee, or if there is no technical transfer to the Sublicensee, within thirty four (304) months years of the Effective Date of each the applicable Sublicense Agreement Agreement;
(v) the occurrence of a direct or indirect change of control of Sublicensee (with control having the meaning set out in the definition of Affiliate in Section 1.1), unless Shionogi and GARDP have previously confirmed in writing that has they would not been consented to by BMS and MPP in writingterminate the Sublicense Agreement based on such change of control; and/or
(vi) in the event of any serious or intentional violation of any laws and regulations or intentional misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the worldworld which, which in BMSShionogi’s and MPPGARDP’s judgment, may reflect unfavorably on BMSShionogi, MPPGARDP, their reputation or the Licensed ProductsProduct.
(c) GARDP will have the right to terminate this License Agreement upon sixty (60) days advance written notice to Shionogi if it is unable despite its reasonable best efforts to raise required funding for the performance of GARDP’s obligations under this License Agreement and the Collaboration Agreement, and such termination in and of itself shall not constitute a breach of GARDP’s obligations under the Agreement or give rise to the payment of damages; provided, however, that the foregoing shall not relieve GARDP of liability in respect of any other breach or noncompliance with this Agreement or affect any other right or remedy available to Shionogi with respect thereto.
Appears in 1 contract
Additional Termination Rights. (a) BMS has will have the right to terminate this License Agreement Agreement, at BMS's sole discretion, upon delivery of written notice to MPP upon the occurrence of any of the following:
(i) the failure of MPP to ensure a sufficient supply of the Licensed Products in the formulations and strengths listed in Schedule A to meet substantially the needs in the Territory, other than isolated, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMS;
(ii) the failure of MPP to comply with BMS's reasonable requests under Sections 5(b) through (c) of this License Agreement;
(iii) any failure by the MPP of ensuring compliance with relevant OFAC regulations under Section clause 2.8 of this License Agreement;
(iviii) if in the reasonable opinion of BMS, control (through ownership or otherwise) or of MPP changes;.
(b) either Either of BMS and MPP will have the right to terminate any Sublicense Agreement, upon delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following;:
(i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable to proceed or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section clause 2.7(c), a cross-cross border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory;
(iiiii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 clause 7.2 of this License Agreement;
(iviii) the failure by the respective Sublicensee Sublicensees to file for registration all of Develop and Commercialize the Licensed Products in the the Territory for all of the formulation and strengths listed in Schedule A within thirty (30) months three years of the Effective Date effective date of each the Sublicense Agreement Agreement;
(viv) the occurrence of a direct or indirect change Change of control Control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or;
(viv) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s 's intellectual property rights by a Sublicensee anywhere in the world, which in BMS’s 's and MPP’s 's judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed Products.
Appears in 1 contract
Additional Termination Rights. (a) BMS has Confidential materials omitted and filed separately with the right to terminate this License Agreement upon delivery of written notice to MPP upon the occurrence of any of the following:Securities and Exchange Commission. Asterisks denote omissions.
(i) Prior to completion of the failure Core Development Plan for T2DM, Sanofi may terminate this Agreement on a country-by-country basis with respect to the affected country or region or on a Licensed Product-by-Licensed Product basis with respect to the affected Licensed Products upon [**] written notice if (a) [**] notifies Sanofi or Lexicon that there is a material safety issue regarding a given Licensed Product, the Licensed Products generally, or the entire class of MPP to ensure a sufficient supply SGLT1 or SGLT2 inhibitors, and recommends or requires that Sanofi or Lexicon cease the Development of the Licensed Products Product based on applicable risk-benefit profiles, (b) with respect to any Decision Point, Positive Results are not achieved in all material respects, as determined in accordance with Section 3.1.3 (a “Positive Results Failure”), (c) Sanofi’s Commercially Reasonable Efforts obligations hereunder do not require the formulations and strengths listed completion of the Core Development Plan due to the occurrence of a Fundamental Event, or (d) the Exploitation of the LX4211 Product by Sanofi, its Affiliates or any of their Sublicensees infringes any Patent or any other intellectual property right of a Third Party in Schedule A to meet substantially the needs any Major Market in the Territory, other than isolatedsuch that Sanofi or any of its Affiliates or Sublicensees cannot Exploit the LX4211 Product in such country as contemplated hereunder without infringing the Patent of such Third Party, temporary shortages of less than 90 days if such shortage and Sanofi is not cured able to obtain a license to such Third Party Patent on commercially reasonable terms; provided that, termination pursuant to this clause (other than by means of d) shall be limited to the country(-ies) in which such Third Party Patent would be infringed. If Sanofi is entitled to terminate this Agreement, either in its entirety or on a reallocation of country-by-country basis or with respect to any Licensed Products that has Products, Sanofi shall have the effect of creating shortage elsewhere) right to cease conducting any further activities under this Agreement in connection with 90 days after written notice Development with respect to MPP by BMS;any Terminated Product or Terminated Territory (subject only to compliance with Applicable Laws and ethical obligations).
(ii) At any time after completion of the failure of MPP Core Development Plan for T2DM, Sanofi may terminate this Agreement in its entirety or on a country-by-country or Licensed Product-by-Licensed Product basis, for any or no reason, upon (a) [**] prior written notice to comply Lexicon, with BMS's reasonable requests under Sections 5(brespect to any country in which the Parties are neither Developing nor Commercializing any Licensed Product, or (b) through (c) of this License Agreement;[**] prior written notice to Lexicon, with respect to all other countries.
(iii) If Sanofi terminates this Agreement for any failure by the MPP of ensuring compliance with relevant OFAC regulations or no reason, whether under this Section 12.3.2 or under any other Section(s), or if Lexicon terminates this Agreement under Section 2.8 12.3.1, as to two or more Major Markets in the European Union, such termination shall constitute termination of this License Agreement;Agreement as to the entire European Union and thereupon the entire European Union shall become a Terminated Territory.
(iv) If Sanofi terminates this Agreement for any or no reason, whether under this Section 12.3.2 or under any other Section(s), or if in the reasonable opinion of BMSLexicon terminates this Agreement under Section 12.3.1, control (through ownership or otherwise) or MPP changes;
(b) either of BMS and MPP will have the right to terminate any Sublicense Agreement, upon delivery of written notice as to the relevant Sublicensee(s) upon United States and the occurrence of any of the following;
(i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable European Union, this Agreement shall also terminate as to proceed or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory;
(iii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 of this License Agreement;
(iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation other countries and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement;
(v) the occurrence of a direct or indirect change of control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or
(vi) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world, which in BMS’s and MPP’s judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed Productsthereupon such other countries shall become Terminated Territories.
Appears in 1 contract
Samples: Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.)
Additional Termination Rights. (a) BMS has If Buyer fails to obtain Lender’s approval of the Loan Assumption on or before the expiration of the Contingency Period, then Sellers may terminate this Agreement by delivering written notice to Buyer at any time after expiration of the Contingency Period but prior to the date that Lender’s approval of the Loan Assumption is obtained.
(b) If Buyer first obtains Lender’s approval of the Loan Assumption after expiration of the Contingency Period, then Buyer shall have the right to terminate this License Agreement upon delivery of by delivering written notice to MPP upon Sellers (Buyer’s Loan Assumption Rejection Notice”) on or before the occurrence date that is five (5) Business Days after Buyer receives Lender’s written approval of the Loan Assumption if such Lender’s approval does not meet all of the following requirements: (1) the same shall be on terms and with documentation that is reasonable in the context of a CMBS assumption; (2) the same shall permit Buyer to assume the Loan without material adverse modification in or addition to any of the following:economic terms of, or the exposure of liability to Buyer or any guarantor of the entity that takes title to the Property in connection with, the Loan Documents (it being understood that any change in rate, term, extension options, prepayment, amortization, cash management or sweeps or reserves, or expansion of non-recourse carve-outs loans, or any liability or recourse to any person or entity other than the entity that takes title to the Property, shall be deemed to be a material adverse change) or, in the event of such modification, the express, prior approval of such modification by Buyer in its sole and absolute discretion; (3) the Loan Assumption shall provide that Buyer and any principals or guarantors of Buyer who execute any guaranties or indemnities in connection with the Loan shall not be responsible for any obligations or liabilities under the Loan or the Loan Documents that accrue or arise before the Closing Date; and (4) reasonable modifications are made to the transfer provisions to allow certain reasonable requested direct and indirect limited liability company interests (or other equity interests if applicable) of Buyer to be subsequently transferred without notice to or consent by Lender.
(c) If (i) Buyer delivers Buyer’s Termination Notice to Sellers prior to the failure of MPP to ensure a sufficient supply end of the Licensed Products in the formulations and strengths listed in Schedule A to meet substantially the needs in the TerritoryContingency Period, other than isolatedas it may be extended, temporary shortages of less than 90 days if such shortage is not cured (other than by means of a reallocation of Licensed Products that has the effect of creating shortage elsewhere) with 90 days after written notice to MPP by BMS;
(ii) Lender’s approval of the failure Loan Assumption is not obtained prior to the end of MPP to comply with BMS's reasonable requests under Sections 5(bthe Contingency Period, as it may be extended, and Sellers exercise the termination right set forth in Section 6(a) through (c) of this License Agreement;
or (iii) any failure by Buyer delivers Buyer’s Loan Assumption Rejection Notice within the MPP of ensuring compliance with relevant OFAC regulations under time specified in Section 2.8 of this License Agreement;
(iv6(b) if in the reasonable opinion of BMSabove then, control (through ownership or otherwise) or MPP changes;
(b) either of BMS and MPP will have the right to terminate any Sublicense Agreement, upon delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following;
(i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable to proceed or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory;
(iii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 of this License Agreement;
(iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement;
(v) the occurrence of a direct or indirect change of control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or
(vi) in the event of any serious or intentional violation of (i), (ii) and/or (iii), this Agreement shall terminate without the further action of any laws and regulations or misappropriation party. Upon any such termination, Escrow Holder shall return the Deposit (if any) to Buyer and, except for those provisions of a Third Party’s intellectual property rights by a Sublicensee anywhere in this Agreement which expressly survive the worldtermination of this Agreement, which in BMS’s and MPP’s judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed Productsparties hereto shall have no further obligations hereunder.
Appears in 1 contract
Samples: Purchase and Sale Agreement (Plymouth Industrial REIT Inc.)
Additional Termination Rights. (a) BMS has Confidential materials omitted and filed separately with the right to terminate this License Agreement upon delivery of written notice to MPP upon the occurrence of any of the following:Securities and Exchange Commission. Asterisks denote omissions.
(i) Prior to completion of the failure Core Development Plan for T2DM, Sanofi may terminate this Agreement on a country-by-country basis with respect to the affected country or region or on a Licensed Product-by-Licensed Product basis with respect to the affected Licensed Products upon [**] written notice if (a) a Regulatory Authority, institutional review board or data safety monitoring board notifies Sanofi or Lexicon that there is a material safety issue regarding a given Licensed Product, the Licensed Products generally, or the entire class of MPP to ensure a sufficient supply SGLT1 or SGLT2 inhibitors, and recommends or requires that Sanofi or Lexicon cease the Development of the Licensed Products Product based on applicable risk-benefit profiles, (b) with respect to any Decision Point, Positive Results are not achieved in all material respects, as determined in accordance with Section 3.1.3 (a “Positive Results Failure”), (c) Sanofi’s Commercially Reasonable Efforts obligations hereunder do not require the formulations and strengths listed completion of the Core Development Plan due to the occurrence of a Fundamental Event, or (d) the Exploitation of the LX4211 Product by Sanofi, its Affiliates or any of their Sublicensees infringes any Patent or any other intellectual property right of a Third Party in Schedule A to meet substantially the needs any Major Market in the Territory, other than isolatedsuch that Sanofi or any of its Affiliates or Sublicensees cannot Exploit the LX4211 Product in such country as contemplated hereunder without infringing the Patent of such Third Party, temporary shortages of less than 90 days if such shortage and Sanofi is not cured able to obtain a license to such Third Party Patent on commercially reasonable terms; provided that, termination pursuant to this clause (other than by means of d) shall be limited to the country(-ies) in which such Third Party Patent would be infringed. If Sanofi is entitled to terminate this Agreement, either in its entirety or on a reallocation of country-by-country basis or with respect to any Licensed Products that has Products, Sanofi shall have the effect of creating shortage elsewhere) right to cease conducting any further activities under this Agreement in connection with 90 days after written notice Development with respect to MPP by BMS;any Terminated Product or Terminated Territory (subject only to compliance with Applicable Laws and ethical obligations).
(ii) At any time after completion of the failure of MPP Core Development Plan for T2DM, Sanofi may terminate this Agreement in its entirety or on a country-by-country or Licensed Product-by-Licensed Product basis, for any or no reason, upon (a) [**] prior written notice to comply Lexicon, with BMS's reasonable requests under Sections 5(brespect to any country in which the Parties are neither Developing nor Commercializing any Licensed Product, or (b) through (c) of this License Agreement;[**] prior written notice to Lexicon, with respect to all other countries.
(iii) If Sanofi terminates this Agreement for any failure by the MPP of ensuring compliance with relevant OFAC regulations or no reason, whether under this Section 12.3.2 or under any other Section(s), or if Lexicon terminates this Agreement under Section 2.8 12.3.1, as to two or more Major Markets in the European Union, such termination shall constitute termination of this License Agreement;Agreement as to the entire European Union and thereupon the entire European Union shall become a Terminated Territory.
(iv) If Sanofi terminates this Agreement for any or no reason, whether under this Section 12.3.2 or under any other Section(s), or if in the reasonable opinion of BMSLexicon terminates this Agreement under Section 12.3.1, control (through ownership or otherwise) or MPP changes;
(b) either of BMS and MPP will have the right to terminate any Sublicense Agreement, upon delivery of written notice as to the relevant Sublicensee(s) upon United States and the occurrence of any of the following;
(i) the occurrence of any material safety issue that BMS reasonably believes makes it inadvisable European Union, this Agreement shall also terminate as to proceed or continue with the commercialization of the Licensed Product in the Territory;
(ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Products whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, has sold Licensed Compound and/or Licensed Products for use in any country outside of the Territory;
(iii) any failure by the Sublicensees to comply with the quality requirements under Section 6.2 of this License Agreement;
(iv) the failure by the respective Sublicensee to file for registration all of the Licensed Products in the the Territory for all of the formulation other countries and strengths listed in Schedule A within thirty (30) months of the Effective Date of each Sublicense Agreement Agreement;
(v) the occurrence of a direct or indirect change of control of Sublicensee that has not been consented to by BMS and MPP in writing; and/or
(vi) in the event of any serious or intentional violation of any laws and regulations or misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world, which in BMS’s and MPP’s judgment, may reflect unfavorably on BMS, MPP, their reputation or the Licensed Productsthereupon such other countries shall become Terminated Territories.
Appears in 1 contract
Samples: Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.)