Patent Enforcement and Defense. (a) Each Party shall notify the other within fifteen (15) Business Days of becoming aware of any alleged or threatened infringement by a Third Party of any of the MyoKardia Licensed Patents or Sanofi Licensed Patents or Joint Program Patents, including (i) any such alleged or threatened infringement on account of a Third Party’s manufacture, use or sale of a Product in the Field or (ii) any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application for Regulatory Approval under Applicable Law in any country other than the United States) or other MAA for a Product in the Field and (iii) any declaratory judgment action filed by a Third Party that is developing, manufacturing or commercializing a Product in the Field alleging the invalidity, unenforceability or non-infringement of any of the MyoKardia Licensed Patents, Joint Program Patents or Sanofi Licensed Patents ((i)-(iii), collectively, “Product Infringement”). (b) Sanofi shall have the first right to bring (or defend) and control any legal action in connection with any Product Infringement outside the United States, and any Product Infringement in the United States on account of a Third Party’s manufacture, use or sale of a DCM1 Product, (collectively, “Sanofi Product Infringement”) at its own expense (but subject to reimbursement by MyoKardia for its share of U.S.-related expenses under the DCM1 [***] Option, if exercised by MyoKardia), as it reasonably determines appropriate, and MyoKardia shall have the right to be represented in any such action by counsel of its choice. Prior to Sanofi’s commencing any such action, and periodically during the course of such action, the Parties shall meet to discuss Sanofi’s proposed strategy for such action and the progress thereof, and Sanofi shall reasonably consider any comments thereto made by MyoKardia; provided that Sanofi shall have final decision making authority with respect to litigation strategy for such action. In any event, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. If Sanofi decides not to bring such legal action to enforce a Sanofi Sole Program Patent or other Sanofi Licensed Patent to the extent such Sanofi Licensed Patent is reasonably necessary or reasonably useful for MyoKardia to perform its obligations or exercise its rights hereunder (excluding any Sanofi Licensed Patent that claims a device, diagnostic, formulation technology or manufacturing process technology proprietary to Sanofi that is generally applicable to products other than Products ), MyoKardia Licensed Patent or Joint Program Patent, it shall so inform MyoKardia promptly and MyoKardia shall have the right to bring and control any legal action in connection with such Sanofi Product Infringement at its own expense as it reasonably determines appropriate after consultation with Sanofi; provided that in connection with such action, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world. (c) For any Product Infringement in the United States on account of a Third Party’s manufacture, use or sale of an HCM1 Product or HCM2 Product, MyoKardia shall have the exclusive right to bring (or defend) and control any legal action in connection with such Product Infringement at its own expense as it reasonably determines appropriate, and Sanofi shall have the right to be represented in any such action by counsel of its choice. Prior to MyoKardia’s commencing any such action, and periodically during the course of such action, the Parties shall meet to discuss MyoKardia’s proposed strategy for such action and the progress thereof, and MyoKardia shall reasonably consider any comments thereto made by Sanofi; provided that MyoKardia shall have final decision making authority with respect to litigation strategy for such action. In any event, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world. If MyoKardia decides not to bring such legal action to enforce a MyoKardia Licensed Patent, Sanofi Licensed Patent or a Joint Program Patent it shall so inform Sanofi promptly and Sanofi shall have the right to bring and control any legal action in connection with such Product Infringement at its own expense as it reasonably determines appropriate after consultation with MyoKardia; provided that in connection with such action, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. In the event there is Product Infringement relating to an HCM1 Product or HCM2 Product both inside and outside the United States, the Parties shall coordinate in good faith regarding enforcement strategy. (d) MyoKardia shall have the exclusive right to enforce the MyoKardia Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Sanofi shall have the exclusive right to enforce the Sanofi Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Each Party shall have the right to enforce the Joint Program Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission (e) The Party initiating the suit or other action under Section 10.4(b) or Section 10.4(c) shall have the sole and exclusive right to select counsel for such suit or other action; provided, that (x) the other Party shall provide reasonable assistance in connection with such suit or other action, including if required under Applicable Law in order for the initiating Party to initiate and/or maintain such suit or other action, joining such suit or other action as a party, (y) the other Party shall have the right to participate and be represented by its own counsel in any such suit or other action at its own expense, and (z) the Party initiating the suit or other action shall keep the other Party reasonably informed, consult with such other Party with respect to the proposed strategy (including settlement) of such suit or other action and consider in good faith any comments such other Party may provide. (f) At the request of the Party bringing or defending the action against any Product Infringement, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required (at the enforcing Party’s expense). In connection with a proceeding with respect to a Product Infringement covered by this Section 10.4, the Party bringing the action shall not enter into any settlement admitting the invalidity of, or otherwise impairing the other Party’s rights in, the MyoKardia Licensed Patents, Sanofi Licensed Patents (however this restriction, with respect to any Sanofi Licensed Patents, shall apply to Sanofi as the Party conducting the Proceeding, only if the Sanofi Licensed Patents relate solely to the Products) or Joint Program Patents without the prior written consent of such other Party. (g) Any recoveries resulting from an enforcement action relating to a claim of Product Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses (the “Remainder”) shall be shared by the Parties as follows: (i) For any enforcement action against a Product Infringement outside the United States, (A) if Sanofi is the enforcing Party, the Remainder shall be retained by Sanofi and deemed Net Sales outside the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6 (to the extent the Product Infringement occurred during the Royalty Term for the applicable Product); and (B) if MyoKardia is the enforcing party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi. (ii) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of a DCM1 Product in the United States, (A) if Sanofi is the enforcing Party and MyoKardia has not exercised the DCM1 [***] Option, the Remainder shall be retained by Sanofi and deemed Net Sales in the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6; (B) if Sanofi is the enforcing Party and MyoKardia has exercised the DCM1 [***] Option, the Remainder shall be deemed Net Sales in the United States and shared between the Parties pursuant to Section 9.7; and (C) if MyoKardia is the enforcing Party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission (iii) For any enforcement action against a Product Infringement in the United States on account of a Third Party’s manufacture, use or sale of an HCM1 Product or an HCM2 Product, the Remainder shall be retained by MyoKardia and deemed Net Sales in the United States and subject to a royalty payment to Sanofi in accordance with Section 9.6. (iv) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of an Expanded Use Product, the Remainder shall be allocated as agreed by the Parties pursuant to Section 4.8.
Appears in 2 contracts
Samples: License and Collaboration Agreement (MyoKardia Inc), License and Collaboration Agreement (MyoKardia Inc)
Patent Enforcement and Defense. (a) Each Party shall promptly notify the other within fifteen Party (15but in any case no later than [***] after becoming aware) Business Days of becoming aware of any alleged or threatened infringement by a Third Party of any of the MyoKardia Licensed Patents or Sanofi RevMed Licensed Patents or Joint Program Patents, and RevMed shall promptly notify Sanofi (but in any case no later than [***] after becoming aware) of any alleged or threatened infringement by a Third Party of any of the Sanofi Sole Program Patents, in each case including (i) any such alleged or threatened infringement on account of a Third Party’s manufacture, use or sale of a Product in the Field or (ii) any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application for Regulatory Approval under Applicable Law in any country other than the United States) or other MAA for a Product in the Field and (iii) any declaratory judgment action filed by a Third Party that is developing, manufacturing or commercializing a Product in the Field alleging the invalidity, unenforceability or non-infringement of any of the MyoKardia RevMed Licensed Patents, Joint Program Patents or Sanofi Licensed Sole Program Patents ((i)-(iii), collectively, “Product Infringement”).
(b) Sanofi Sanofi, at its sole cost and expense, shall have the first right sole and exclusive right, but not the obligation, to bring (or defend) and control any legal action in connection with any Product Infringement outside the United States, and any Product Infringement in the United States on account of a Third Party’s manufacture, use or sale of a DCM1 Product, (collectively, “Sanofi Product Infringement”) at its own expense (but subject to reimbursement by MyoKardia for its share of U.S.-related expenses under the DCM1 [***] Option, if exercised by MyoKardia)expense, as it reasonably determines appropriate, and MyoKardia shall have the right to be represented in any such action by counsel of its choice. Prior to Sanofi’s commencing any such action, and periodically during the course of such action, the Parties shall meet to discuss Sanofi’s proposed strategy for such action and the progress thereof, and Sanofi shall reasonably consider any comments thereto made by MyoKardia; provided that Sanofi shall have final decision making authority with respect to litigation strategy for such action. In any event, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. If Sanofi decides not to bring such legal action to enforce a Sanofi Sole Program Patent or other Sanofi Licensed Patent to the extent such Sanofi Licensed Patent is reasonably necessary or reasonably useful for MyoKardia to perform its obligations or exercise its rights hereunder (excluding any Sanofi Licensed Patent that claims a device, diagnostic, formulation technology or manufacturing process technology proprietary to Sanofi that is generally applicable to products other than Products ), MyoKardia Licensed Patent or Joint Program Patent, it shall so inform MyoKardia promptly and MyoKardia shall have the right to bring and control any legal action in connection with such Sanofi Product Infringement at its own expense as it reasonably determines appropriate after consultation with Sanofi; provided that in connection with such action, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world.
(c) For any Product Infringement in the United States on account of a Third Party’s manufactureRevMed, use or sale of an HCM1 Product or HCM2 Productat its sole cost and expense, MyoKardia shall have the exclusive right to bring (or defend) sole and control any legal action in connection with such Product Infringement at its own expense as it reasonably determines appropriate, and Sanofi shall have the right to be represented in any such action by counsel of its choice. Prior to MyoKardia’s commencing any such action, and periodically during the course of such action, the Parties shall meet to discuss MyoKardia’s proposed strategy for such action and the progress thereof, and MyoKardia shall reasonably consider any comments thereto made by Sanofi; provided that MyoKardia shall have final decision making authority with respect to litigation strategy for such action. In any event, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world. If MyoKardia decides not to bring such legal action to enforce a MyoKardia Licensed Patent, Sanofi Licensed Patent or a Joint Program Patent it shall so inform Sanofi promptly and Sanofi shall have the right to bring and control any legal action in connection with such Product Infringement at its own expense as it reasonably determines appropriate after consultation with MyoKardia; provided that in connection with such action, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. In the event there is Product Infringement relating to an HCM1 Product or HCM2 Product both inside and outside the United States, the Parties shall coordinate in good faith regarding enforcement strategy.
(d) MyoKardia shall have the exclusive right to enforce the MyoKardia Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Sanofi shall have the exclusive right to enforce the Sanofi RevMed Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Each Party shall have the right to enforce the Joint Program Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(e) The Party initiating the suit or other action under Section 10.4(b) or Section 10.4(c) Sanofi shall have the sole and exclusive right to select counsel for such suit or other action; providedenforce the Sanofi Sole Program Patents at its sole cost and expense.
(d) [***]
(e) At the request of Sanofi, that (x) the other Party RevMed shall provide reasonable assistance in connection with such suit or other action, including if required under Applicable Law in order for the initiating Party to initiate and/or maintain such suit or other action, joining such suit or other action as a party, (y) the other Party shall have the right to participate and be represented by its own counsel in any such suit or other action at its own expense, and (z) the Party initiating the suit or other action shall keep the other Party reasonably informed, consult with such other Party with respect to the proposed strategy (including settlement) of such suit or other action and consider in good faith any comments such other Party may provide.
(f) At the request of the Party bringing or defending the action against any Product Infringement, the other Party shall provide reasonable assistance in connection therewithaction, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required (at the enforcing PartySanofi’s expense). In connection with a proceeding with respect to a Product Infringement covered by this Section 10.4, the Party bringing the action Sanofi shall not enter into any settlement admitting the invalidity of, or otherwise impairing the other PartyRevMed’s rights in, the MyoKardia Licensed Patents, Sanofi RevMed Licensed Patents (however this restriction, with respect to any Sanofi Licensed Patents, shall apply to Sanofi as the Party conducting the Proceeding, only if the Sanofi Licensed Patents relate solely to the Products) or Joint Program Patents without the prior written consent of such other PartyRevMed.
(gf) Any recoveries resulting from an enforcement action relating to a claim of Product Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses (the “Remainder”) shall be shared by the Parties as follows:
(i) For any enforcement action against a Product Infringement outside the United States. The Remainder shall, (A) if Sanofi is the enforcing Party, the Remainder shall be retained by Sanofi and deemed Net Sales outside the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6 (to the extent the Product Infringement occurred during the Royalty Term for the applicable Product); and (B) if MyoKardia is the enforcing party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi.
(ii) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of a DCM1 Product in the United States, (A) if Sanofi is the enforcing Party and MyoKardia has not exercised the DCM1 [***] Option, the Remainder shall be retained by Sanofi and deemed Net Sales in the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6; (B) if Sanofi is the enforcing Party and MyoKardia has exercised the DCM1 [***] Option, the Remainder shall be deemed Net Sales in the United States and shared between the Parties pursuant to Section 9.7; and (C) if MyoKardia is the enforcing Party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(iii) For any enforcement action against a Product Infringement in the United States on account of a Third Party’s manufacture, use or sale of an HCM1 Product or an HCM2 Product, the Remainder shall be retained by MyoKardia and deemed Net Sales in the United States and subject to a royalty payment to Sanofi in accordance with Section 9.6.
(iv) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of an Expanded Use Product, the Remainder shall be allocated as agreed by the Parties pursuant to Section 4.8.
Appears in 2 contracts
Samples: Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.), Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.)
Patent Enforcement and Defense. (a) Each Party shall will promptly notify the other within fifteen (15) Business Days of becoming aware Party of any alleged infringement, misappropriation, or threatened infringement other violation by a Third Party of any of the MyoKardia Licensed Patents or Sanofi Licensed Patents or Joint Program MPAG Products Patents, including (i) the MPAG Products Know-How, or any such alleged Joint IP, New Manufacturing IP or threatened infringement on account of a Third Party’s manufacture, use or sale of a Product Option Period Manufacturing IP in the Field or (ii) in the Territory of which it becomes aware, including any “patent certification” filed in the United States under 21 42 U.S.C. §355(b)(2262(i)(2) or 21 U.S.C. §355(j)(2262(k) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States and of any request for declaratory judgment, opposition, nullity action, interference, inter-partes reexamination, inter-partes review, post-grant review, derivation proceeding, or a comparable application for Regulatory Approval under Applicable Law in any country other than the United States) or other MAA for a Product in the Field and (iii) any declaratory judgment similar action filed by a Third Party that is developing, manufacturing or commercializing a Product in the Field alleging the invalidity, unenforceability or non-infringement of any of the MyoKardia Licensed Patents, Joint Program MPAG Products Patents or Sanofi Licensed Patents Patent Rights included in the Joint IP, New Manufacturing IP or Option Period Manufacturing IP ((i)-(iii), collectively, collectively “Product Third Party Infringement”).
(b) Sanofi shall [***] will have the first right to bring (or defend) and control any legal action in connection with any Product Third Party Infringement outside to the United Statesextent the applicable MPAG Products Patents, and any Product Infringement in MPAG Products Know-How, Joint IP, New Manufacturing IP or Option Period Manufacturing IP (i) relate exclusively to the United States on account of a Third Party’s manufacture, use MPAG Compounds or sale of a DCM1 Product, Products or (collectively, “Sanofi Product Infringement”ii) at its own expense (but subject do not primarily relate to reimbursement by MyoKardia for its share of U.S.-related expenses under the DCM1 [***] Option, if exercised by MyoKardiaor a designed ankyrin repeat protein product other than a Product (“[***] Third Party Infringement”), . [***] right to control such legal action shall be at its own expense as it reasonably determines appropriateappropriate (including deciding on any litigation strategy), and MyoKardia [***] shall have the right right, at its own expense, to be represented in any such action by counsel of its own choice. Prior If [***] fails to Sanofi’s commencing bring an action or proceeding with respect to, or to terminate, infringement of any such action[***] Third Party Infringement (1) within [***] following the notice of alleged infringement or (2) prior to [***] before the time limit, if any, set forth in the appropriate laws and periodically during regulations for the course filing of such actionactions, the Parties shall meet to discuss Sanofi’s proposed strategy for such action and the progress thereofwhichever comes first, and Sanofi shall reasonably consider any comments thereto made by MyoKardia; provided that Sanofi shall have final decision making authority with respect to litigation strategy for such action. In any event, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. If Sanofi decides not to bring such legal action to enforce a Sanofi Sole Program Patent or other Sanofi Licensed Patent to the extent such Sanofi Licensed Patent is reasonably necessary or reasonably useful for MyoKardia to perform its obligations or exercise its rights hereunder (excluding any Sanofi Licensed Patent that claims a device, diagnostic, formulation technology or manufacturing process technology proprietary to Sanofi that is generally applicable to products other than Products ), MyoKardia Licensed Patent or Joint Program Patent, it shall so inform MyoKardia promptly and MyoKardia [***] shall have the right, to bring and control any such action at its own expense and by counsel of its own choice, and [***] shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if [***] notifies [***] in writing prior to [***] before such time limit for the filing of any such action that [***] intends to file such action before the time limit, then [***] shall be obligated to file such action before the time limit.
(c) [***] will have the first right to bring and control any legal action in connection with any Third Party Infringement that is not [***] Third Party Infringement (“[***] Third Party Infringement”). [***] right to control such Sanofi Product Infringement legal action shall be at its own expense as it 264813180 v3 reasonably determines appropriate after consultation with Sanofi; provided that in connection with such action, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect (including deciding on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world.
(c) For any Product Infringement in the United States on account of a Third Party’s manufacturelitigation strategy), use or sale of an HCM1 Product or HCM2 Product, MyoKardia and [***] shall have the exclusive right to bring (or defend) and control any legal action in connection with such Product Infringement right, at its own expense as it reasonably determines appropriateexpense, and Sanofi shall have the right to be represented in any such action by counsel of its own choice. Prior If [***] fails to MyoKardia’s commencing bring an action or proceeding with respect to, or to terminate, infringement of any such action[***] Third Party Infringement (i) within [***] following the notice of alleged infringement or (ii) prior to [***] before the time limit, if any, set forth in the appropriate laws and periodically during regulations for the course filing of such actionactions, the Parties shall meet to discuss MyoKardia’s proposed strategy for such action and the progress thereofwhichever comes first, and MyoKardia shall reasonably consider any comments thereto made by Sanofi; provided that MyoKardia shall have final decision making authority with respect to litigation strategy for such action. In any event, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world. If MyoKardia decides not to bring such legal action to enforce a MyoKardia Licensed Patent, Sanofi Licensed Patent or a Joint Program Patent it shall so inform Sanofi promptly and Sanofi [***] shall have the right right, to bring and control any legal such action in connection with such Product Infringement at its own expense as it reasonably determines appropriate after consultation with MyoKardiaand by counsel of its own choice, and [***] shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided provided, however, that if [***] notifies [***] in connection with writing prior to [***] before such action, Sanofi shall not take time limit for the filing of any such action that MyoKardia reasonably believes would [***] intends to file such action before the time limit, then [***] shall be likely obligated to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in file such action before the world. In the event there is Product Infringement relating to an HCM1 Product or HCM2 Product both inside and outside the United States, the Parties shall coordinate in good faith regarding enforcement strategytime limit.
(d) MyoKardia shall have If a Party initiates proceedings in accordance with this Section 10.6, the exclusive right other Party agrees to enforce be joined as a party plaintiff where necessary and to give the MyoKardia Licensed Patents first Party reasonable assistance and authority to file and prosecute the proceedings. The costs and expenses of each Party incurred pursuant to this Section 10.6 will be borne by the Party initiating such proceedings. If one Party initiates proceedings in accordance with this Section 10.6, the other Party may join such proceedings as a party plaintiff where necessary for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Sanofi shall have the exclusive right such other Party to enforce the Sanofi Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Each Party shall have the right seek lost profits or other appropriate damages or compensation with respect to enforce the Joint Program Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commissionsuch infringement.
(e) The Party initiating the suit Any damages or other action under Section 10.4(b) or Section 10.4(c) shall have the sole and exclusive right to select counsel for such suit or other action; provided, that (x) the other Party shall provide reasonable assistance in connection with such suit or other action, including if required under Applicable Law in order for the initiating Party to initiate and/or maintain such suit or other action, joining such suit or other action as a party, (y) the other Party shall have the right to participate and be represented by its own counsel in any such suit or other action at its own expense, and (z) the Party initiating the suit or other action shall keep the other Party reasonably informed, consult with such other Party with respect to the proposed strategy (including settlement) of such suit or other action and consider in good faith any comments such other Party may provide.
(f) At the request of the Party bringing or defending the action against any Product Infringement, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required (at the enforcing Party’s expense). In connection with a proceeding monetary awards recovered with respect to a Product Third Party Infringement covered by brought pursuant to this Section 10.4, the Party bringing the action shall not enter into any settlement admitting the invalidity of, or otherwise impairing the other Party’s rights in, the MyoKardia Licensed Patents, Sanofi Licensed Patents (however this restriction, with respect to any Sanofi Licensed Patents, shall apply to Sanofi as the Party conducting the Proceeding, only if the Sanofi Licensed Patents relate solely to the Products) or Joint Program Patents without the prior written consent of such other Party.
(g) Any recoveries resulting from an enforcement action relating to a claim of Product Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses (the “Remainder”) shall 10.6 will be shared by the Parties as follows:
(i) For the amount of such recovery will first be applied to the Parties’ reasonable out-of-pocket expenses incurred in connection with such Third Party Infringement legal action (which amounts will be allocated pro rata if insufficient to cover the totality of such expenses); then
(ii) any enforcement action against a Product remaining proceeds constituting direct or actual damages for acts of infringement will be paid to, or retained by, MPAG in respect of any Third Party Infringement outside the United Statesbrought and controlled by MPAG, (A) if Sanofi is the enforcing Party, the Remainder shall and Novartis in respect of any Third Party Infringement brought and controlled by Novartis; provided that any amounts received by Novartis will be retained by Sanofi and deemed included in Net Sales outside the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6 (to the extent the Product Infringement occurred during the Royalty Term for the applicable Product)Calendar Quarter in which such amounts are received by Novartis; and and
(Biii) if MyoKardia is the enforcing party, the Remainder shall any remaining proceeds constituting punitive or treble damages will be allocated between the Parties as follows: the Party that brought and controlled the Third Party Infringement action will retain [***] percent ([***]%) to MyoKardia of such proceeds and the other Party will receive [***] percent ([***]%) to Sanofiof such proceeds.
(iif) For any enforcement action against Notwithstanding anything to the contrary under this Section 10.6, neither Party may enter a Product Infringement on account settlement, consent judgment or other voluntary final disposition of a Third suit under this Section 10.6 that disclaims, limits the scope of, admits the invalidity or unenforceability of, or grants a license, covenant not to sue or similar immunity under any Patent Rights Controlled by the other Party or its Affiliates without first obtaining the written consent of the Party that Controls the relevant Patent Rights; provided, that either Party shall be entitled, without the consent of the other Party’s manufacture, use to enter into a settlement, consent judgment or sale other voluntary final disposition of a DCM1 Product in suit that primarily relates to the United States, (A) if Sanofi is the enforcing Party and MyoKardia has not exercised the DCM1 [***] Option, the Remainder shall be retained by Sanofi and deemed Net Sales in the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6; (B) if Sanofi is the enforcing Party and MyoKardia has exercised the DCM1 [***] Option, the Remainder shall be deemed Net Sales in the United States and shared between the Parties pursuant to Section 9.7; and (C) if MyoKardia is the enforcing Party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(iii) For any enforcement action against a Product Infringement in the United States on account establishment of a Third Party’s manufacture, use date by which the a generic or sale of an HCM1 Product or an HCM2 Product, the Remainder shall biosimilar product will be retained by MyoKardia and deemed Net Sales in the United States and subject permitted to a royalty payment to Sanofi in accordance with Section 9.6be Commercialized.
(iv) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of an Expanded Use Product, the Remainder shall be allocated as agreed by the Parties pursuant to Section 4.8.
Appears in 1 contract
Patent Enforcement and Defense. (a) Each Party shall will promptly notify the other within fifteen (15) Business Days of becoming aware Party of any alleged infringement, misappropriation, or threatened infringement other violation by a Third Party of any of the MyoKardia Licensed Patents or Sanofi Licensed Patents or Joint Program MPAG Products Patents, including (i) the MPAG Products Know-How, or any such alleged Joint IP, New Manufacturing IP or threatened infringement on account of a Third Party’s manufacture, use or sale of a Product Option Period Manufacturing IP in the Field or (ii) in the Territory of which it becomes aware, including any “patent certification” filed in the United States under 21 42 U.S.C. §355(b)(2262(i)(2) or 21 U.S.C. §355(j)(2262(k) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States and of any request for declaratory judgment, opposition, nullity action, interference, inter-partes reexamination, inter-partes review, post-grant review, derivation proceeding, or a comparable application for Regulatory Approval under Applicable Law in any country other than the United States) or other MAA for a Product in the Field and (iii) any declaratory judgment similar action filed by a Third Party that is developing, manufacturing or commercializing a Product in the Field alleging the invalidity, unenforceability or non-infringement of any of the MyoKardia Licensed Patents, Joint Program MPAG Products Patents or Sanofi Licensed Patents Patent Rights included in the Joint IP, New Manufacturing IP or Option Period Manufacturing IP ((i)-(iii), collectively, collectively “Product Third Party Infringement”).
(b) Sanofi shall [***] will have the first right to bring (or defend) and control any legal action in connection with any Product Third Party Infringement outside to the United Statesextent the applicable MPAG Products Patents, and any Product Infringement in MPAG Products Know-How, Joint IP, New Manufacturing IP or Option Period Manufacturing IP (i) relate exclusively to the United States on account of a Third Party’s manufacture, use MPAG Compounds or sale of a DCM1 Product, Products or (collectively, “Sanofi Product Infringement”ii) at its own expense (but subject do not primarily relate to reimbursement by MyoKardia for its share of U.S.-related expenses under the DCM1 [***] Option, if exercised by MyoKardiaor a designed ankyrin repeat protein product other than a Product (“[***] Third Party Infringement”), . [***] right to control such legal action shall be at its own expense as it reasonably determines appropriateappropriate (including deciding on any litigation strategy), and MyoKardia [***] shall have the right right, at its own expense, to be represented in any such action by counsel of its own choice. Prior If [***] fails to Sanofi’s commencing bring an action or proceeding with respect to, or to terminate, infringement of any such action[***] Third Party Infringement (1) within [***] following the notice of alleged infringement or (2) prior to [***] before the time limit, if any, set forth in the appropriate laws and periodically during regulations for the course filing of such actionactions, the Parties shall meet to discuss Sanofi’s proposed strategy for such action and the progress thereofwhichever comes first, and Sanofi shall reasonably consider any comments thereto made by MyoKardia; provided that Sanofi shall have final decision making authority with respect to litigation strategy for such action. In any event, Sanofi shall not take any action that MyoKardia reasonably believes would be likely to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in the world. If Sanofi decides not to bring such legal action to enforce a Sanofi Sole Program Patent or other Sanofi Licensed Patent to the extent such Sanofi Licensed Patent is reasonably necessary or reasonably useful for MyoKardia to perform its obligations or exercise its rights hereunder (excluding any Sanofi Licensed Patent that claims a device, diagnostic, formulation technology or manufacturing process technology proprietary to Sanofi that is generally applicable to products other than Products ), MyoKardia Licensed Patent or Joint Program Patent, it shall so inform MyoKardia promptly and MyoKardia [***] shall have the right, to bring and control any such action at its own expense and by counsel of its own choice, and [***] shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if [***] notifies [***] in writing prior to [***] before such time limit for the filing of any such action that [***] intends to file such action before the time limit, then [***] shall be obligated to file such action before the time limit.
(c) [***] will have the first right to bring and control any legal action in connection with any Third Party Infringement that is not [***] Third Party Infringement (“[***] Third Party Infringement”). [***] right to control such Sanofi Product Infringement legal action shall be at its own expense as it 264813180 v3 reasonably determines appropriate after consultation with Sanofi; provided that in connection with such action, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect (including deciding on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world.
(c) For any Product Infringement in the United States on account of a Third Party’s manufacturelitigation strategy), use or sale of an HCM1 Product or HCM2 Product, MyoKardia and [***] shall have the exclusive right to bring (or defend) and control any legal action in connection with such Product Infringement right, at its own expense as it reasonably determines appropriateexpense, and Sanofi shall have the right to be represented in any such action by counsel of its own choice. Prior If [***] fails to MyoKardia’s commencing bring an action or proceeding with respect to, or to terminate, infringement of any such action[***] Third Party Infringement (i) within [***] following the notice of alleged infringement or (ii) prior to [***] before the time limit, if any, set forth in the appropriate laws and periodically during regulations for the course filing of such actionactions, the Parties shall meet to discuss MyoKardia’s proposed strategy for such action and the progress thereofwhichever comes first, and MyoKardia shall reasonably consider any comments thereto made by Sanofi; provided that MyoKardia shall have final decision making authority with respect to litigation strategy for such action. In any event, MyoKardia shall not take any action that Sanofi reasonably believes would be likely to have an adverse effect on any Sanofi Licensed Patent or Joint Program Patent anywhere in the world. If MyoKardia decides not to bring such legal action to enforce a MyoKardia Licensed Patent, Sanofi Licensed Patent or a Joint Program Patent it shall so inform Sanofi promptly and Sanofi [***] shall have the right right, to bring and control any legal such action in connection with such Product Infringement at its own expense as it reasonably determines appropriate after consultation with MyoKardiaand by counsel of its own choice, and [***] shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided provided, however, that if [***] notifies [***] in connection with writing prior to [***] before such action, Sanofi shall not take time limit for the filing of any such action that MyoKardia reasonably believes would [***] intends to file such action before the time limit, then [***] shall be likely obligated to have an adverse effect on any MyoKardia Licensed Patent or Joint Program Patent anywhere in file such action before the world. In the event there is Product Infringement relating to an HCM1 Product or HCM2 Product both inside and outside the United States, the Parties shall coordinate in good faith regarding enforcement strategytime limit.
(d) MyoKardia shall have If a Party initiates proceedings in accordance with this Section 10.6, the exclusive right other Party agrees to enforce be joined as a party plaintiff where necessary and to give the MyoKardia Licensed Patents first Party reasonable assistance and authority to file and prosecute the proceedings. The costs and expenses of each Party incurred pursuant to this Section 10.6 will be borne by the Party initiating such proceedings. If one Party initiates proceedings in accordance with this Section 10.6, the other Party may join such proceedings as a party plaintiff where necessary for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Sanofi shall have the exclusive right such other Party to enforce the Sanofi Licensed Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. Each Party shall have the right seek lost profits or other appropriate damages or compensation with respect to enforce the Joint Program Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commissionsuch infringement.
(e) The Party initiating the suit Any damages or other action under Section 10.4(b) or Section 10.4(c) shall have the sole and exclusive right to select counsel for such suit or other action; provided, that (x) the other Party shall provide reasonable assistance in connection with such suit or other action, including if required under Applicable Law in order for the initiating Party to initiate and/or maintain such suit or other action, joining such suit or other action as a party, (y) the other Party shall have the right to participate and be represented by its own counsel in any such suit or other action at its own expense, and (z) the Party initiating the suit or other action shall keep the other Party reasonably informed, consult with such other Party with respect to the proposed strategy (including settlement) of such suit or other action and consider in good faith any comments such other Party may provide.
(f) At the request of the Party bringing or defending the action against any Product Infringement, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required (at the enforcing Party’s expense). In connection with a proceeding monetary awards recovered with respect to a Product Third Party Infringement covered by brought pursuant to this Section 10.4, the Party bringing the action shall not enter into any settlement admitting the invalidity of, or otherwise impairing the other Party’s rights in, the MyoKardia Licensed Patents, Sanofi Licensed Patents (however this restriction, with respect to any Sanofi Licensed Patents, shall apply to Sanofi as the Party conducting the Proceeding, only if the Sanofi Licensed Patents relate solely to the Products) or Joint Program Patents without the prior written consent of such other Party.
(g) Any recoveries resulting from an enforcement action relating to a claim of Product Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses (the “Remainder”) shall 10.6 will be shared by the Parties as follows:
(i) For the amount of such recovery will first be applied to the Parties’ reasonable out-of-pocket expenses incurred in connection with such Third Party Infringement legal action (which amounts will be allocated pro rata if insufficient to cover the totality of such expenses); then
(ii) any enforcement action against a Product remaining proceeds constituting direct or actual damages for acts of infringement will be paid to, or retained by, MPAG in respect of any Third Party Infringement outside the United Statesbrought and controlled by MPAG, (A) if Sanofi is the enforcing Party, the Remainder shall and Novartis in respect of any Third Party Infringement brought and controlled by Novartis; provided that any amounts received by Novartis will be retained by Sanofi and deemed included in Net Sales outside the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6 (to the extent the Product Infringement occurred during the Royalty Term for the applicable Product)Calendar Quarter in which such amounts are received by Novartis; and and
(Biii) if MyoKardia is the enforcing party, the Remainder shall any remaining proceeds constituting punitive or treble damages will be allocated between the Parties as follows: the Party that brought and controlled the Third Party Infringement action will retain [***] percent ([***]%) to MyoKardia of such proceeds and the other Party will receive [***] percent ([***]%) to Sanofiof such proceeds.
(iif) For any enforcement action against Notwithstanding anything to the contrary under this Section 10.6, neither Party may enter a Product Infringement on account settlement, consent judgment or other voluntary final disposition of a Third suit under this Section 10.6 that disclaims, limits the scope of, admits the invalidity or unenforceability of, or grants a license, covenant not to xxx or similar immunity under any Patent Rights Controlled by the other Party or its Affiliates without first obtaining the written consent of the Party that Controls the relevant Patent Rights; provided, that either Party shall be entitled, without the consent of the other Party’s manufacture, use to enter into a settlement, consent judgment or sale other voluntary final disposition of a DCM1 Product in suit that primarily relates to the United States, (A) if Sanofi is the enforcing Party and MyoKardia has not exercised the DCM1 [***] Option, the Remainder shall be retained by Sanofi and deemed Net Sales in the United States and subject to a royalty payment to MyoKardia in accordance with Section 9.6; (B) if Sanofi is the enforcing Party and MyoKardia has exercised the DCM1 [***] Option, the Remainder shall be deemed Net Sales in the United States and shared between the Parties pursuant to Section 9.7; and (C) if MyoKardia is the enforcing Party, the Remainder shall be allocated [***] percent ([***]%) to MyoKardia and [***] percent ([***]%) to Sanofi. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(iii) For any enforcement action against a Product Infringement in the United States on account establishment of a Third Party’s manufacture, use date by which the a generic or sale of an HCM1 Product or an HCM2 Product, the Remainder shall biosimilar product will be retained by MyoKardia and deemed Net Sales in the United States and subject permitted to a royalty payment to Sanofi in accordance with Section 9.6be Commercialized.
(iv) For any enforcement action against a Product Infringement on account of a Third Party’s manufacture, use or sale of an Expanded Use Product, the Remainder shall be allocated as agreed by the Parties pursuant to Section 4.8.
Appears in 1 contract