Enforcement and Defense. 7.3.1 [****] 7.3.2 The Party having the first right to initiate and prosecute legal action pursuant to Section 7.3.1 shall promptly inform the other Party if it elects not to exercise its first right under Section 7.3.1 to initiate and prosecute legal action, and the other Party shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its name and, if necessary, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the action. Each Party shall have the right to be represented by counsel of its own choice. 7.3.3 For any action to terminate any infringement of Company Patent Rights or Joint Patent Rights or any misappropriation or misuse of Company Know-How pursuant to Section 7.3.1, in the event that a Party is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the Party to initiate litigation to prosecute and maintain such action under this Section 7.3. In connection with any action or potential action, Merck and Company will cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Joint Patent Rights. Each Party shall keep the other informed of developments in any action or proceeding. For any proceeding not controlled by Merck, Company shall obtain prior approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information and Inventions not controlled by Company, Merck shall obtain prior approval from Company of any settlement offer or settlement agreement. 7.3.4 Any recovery obtained by either or both Merck and Company in connection with or as a result of any action contemplated by this Section 7.3, whether by settlement or otherwise, shall be shared in order as follows: (a) the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action; (b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and (c) the amount of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party. 7.3.5 Company shall inform Merck of any matter of which it becomes aware concerning the submission of an application to the U.S. Food & Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 USC 262(k)), or to a similar agency under any similar provisions in a country in the Territory, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within three (3) days of receipt. Notwithstanding the foregoing provisions of Article 7, Merck shall have the sole right, in its discretion, to control any legal action and any activity taken to resolve a dispute with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including as defined in Section 7.3.3.
Appears in 5 contracts
Samples: Exclusive Patent License and Research Collaboration Agreement, Exclusive Patent License and Research Collaboration Agreement, Exclusive Patent License and Research Collaboration Agreement (Cue Biopharma, Inc.)
Enforcement and Defense. 7.3.1 11.4.1 Each Party shall promptly give the other Party notice of (i) any infringement of ACI Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights with respect to a Product, or (ii) any misappropriation or misuse of ACI Know-How or Xxxxxxx Know-How with respect to a Product, that may come to a Party’s attention. Xxxxxxx and ACI shall thereafter cooperate to determine a course of action to terminate any such infringement of ACI Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of ACI Know-How or Xxxxxxx Know-How. Xxxxxxx has the right but not the obligation to initiate and prosecute any such legal action at its own expense and in the name of ACI and Xxxxxxx (or just ACI or just Xxxxxxx if the laws of the jurisdiction so dictate), or to control the defense of any declaratory judgment action relating to such ACI Patent Rights, Xxxxxxx Patent Rights, Joint Patent Rights, ACI Know-How or Xxxxxxx Know-How. [*****]
7.3.2 The Party having the first right to initiate and prosecute legal action pursuant to Section 7.3.1 . Xxxxxxx shall promptly inform the other Party ACI if it elects not to exercise its first that right under Section 7.3.1 with respect to initiate ACI Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights and prosecute legal action, ACI Know-How and the other Party Xxxxxxx Know-How and ACI shall thereafter have the right at its sole cost to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of Xxxxxxx and, if necessary, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the actionACI. Each Party shall have the right to be represented by counsel of its own choice.
7.3.3 11.4.2 For any action to terminate any infringement of Company ACI Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Company ACI Know-How pursuant to Section 7.3.1or Xxxxxxx Know-How, in the event that a Party if Xxxxxxx is unable to initiate or prosecute such action solely in its own name, the other Party will ACI shall join such action voluntarily and will shall execute and cause its Affiliates to execute all documents necessary for the Party Xxxxxxx to initiate litigation to prosecute and maintain such action under this Section 7.3action. [*****]. In connection with any action or potential action, Merck Xxxxxxx and Company will ACI shall cooperate fully and will shall provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Joint Patent Rights. Each Party shall keep the other informed of developments in any action or proceeding. For any proceeding not controlled , including, to the extent permissible by Mercklaw, Company shall obtain prior the consultation and approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information negotiations and Inventions not controlled by Company, Merck shall obtain prior approval from Company the terms of any settlement offer or settlement agreementrelated thereto.
7.3.4 11.4.3 Any recovery obtained by either or both Merck Xxxxxxx and Company ACI in connection with or as a result of any action contemplated by this Section 7.3section, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which that initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action[*****];
(b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action[*****]; and
(c) the The amount of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.as follows: [*****] [*****]
7.3.5 Company 11.4.4 ACI shall inform Merck Xxxxxxx of any matter of which certification regarding any ACI Patent Rights it becomes aware concerning the submission of an application has received pursuant to the U.S. Food & Drug Administration under Section 351(keither 21 U.S.C. §§355(b)(2)(A)(iv) of the U.S. Public Health Services Act or (42 USC 262(k)), j)(2)(A)(vii)(IV) or to a similar agency under its successor provisions or any similar provisions in a country in the Territory, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company Territory other than the United States and shall provide Merck Xxxxxxx with a copy of the unopened Biosimilar Application certification within three (3) [*****] days of receipt. Notwithstanding ACI’s and Xxxxxxx’x rights with respect to the foregoing provisions initiation and prosecution of Article 7, Merck shall have the sole right, in its discretion, to control any legal action and as a result of certification or any activity taken recovery obtained as a result of such legal action shall be according to resolve a dispute with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including as defined in Section 7.3.3sections 11.4.1 through 11.4.3.
Appears in 3 contracts
Samples: License, Development and Commercialization Agreement (AC Immune SA), License, Development and Commercialization Agreement (AC Immune SA), License, Development and Commercialization Agreement (AC Immune SA)
Enforcement and Defense. 7.3.1 If either Party learns of any infringement of Merck Patents, Metabasis Patents or Joint Patents, or any misappropriation or misuse of Merck Inventions, Metabasis Inventions or Joint Inventions, such Party shall promptly notify the other Party of such infringement, misappropriation or misuse. Merck shall have the sole right to initiate and prosecute any legal action to enforce Merck Technology at its own expense and in the name of Merck, and to control the defense of any declaratory judgment action relating to Merck Technology. Metabasis shall have the sole right to initiate and prosecute any legal action to enforce Metabasis Technology at its own expense and in the name of Metabasis, and to control the defense of any declaratory judgment action relating to Metabasis Technology. The Parties shall decide on a case-by-case basis which Party will have the right to initiate and prosecute such legal action to enforce Joint Technology and to control the defense of any declaratory judgment action relating to Joint Technology and shall mutually agree upon how expenses thereof will be allocated between the Parties. Except as otherwise agreed by the Parties as part of a cost-sharing arrangement, any recovery obtained by either or both Merck and Metabasis in connection with or as a result of any action to enforce Joint Technology, whether by settlement or otherwise, shall first be applied to reimburse the costs and expenses of the Parties incurred in connection with the action, and any amounts remaining after such reimbursement shall be shared equally by the Parties. Neither Party shall settle any action regarding Joint Technology without the prior written consent of the other Party (which shall not be unreasonably withheld).
7.3.2 If either Party learns of any infringement of Prior Patents or Collaboration Patents, or any misappropriation or misuse of Prior Inventions or Collaboration Know-How, such Party *** Confidential Treatment Requested shall promptly notify the other Party of such infringement, misappropriation or misuse. Merck and Metabasis thereafter shall promptly consult and cooperate fully to determine a course of action including, without limitation, the commencement of legal action by either or both of Metabasis and Merck, to terminate any infringement of such Prior Patent or Collaboration Patent or any misappropriation or misuse of Prior Inventions or Collaboration Know-How. [****]
7.3.2 The Party having ] shall have the first right to initiate and prosecute such legal action pursuant at its own expense and in the name of [***] and, if necessary, [***], or to Section 7.3.1 control the defense of any declaratory judgment action relating to Prior Patents, Collaboration Patents, Prior Inventions or Collaboration Know-How, and [***] shall promptly inform pay [***] attorneys fees and costs associated with such action. If, within ninety (90) days following a request by [***] to [***] to initiate and prosecute such legal action or ten (10) days before the other Party time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, [***] fails to take such action, or if [***] informs [***] that it elects not to exercise such first right, [***](or its first right under Section 7.3.1 to initiate and prosecute legal action, and the other Party designee) thereafter shall thereafter have the right either to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of [***] and, if necessary, [***].
7.3.3 In any infringement action relating to any Prior Patent or Collaboration Patent, [***] shall not (and it will [***], except as required by law.
7.3.4 If [***] elects not to initiate and prosecute an infringement action as provided in Section 7.3.2, and [***] elects to do so, the name of the other Party. The costs of any agreed-upon incurred by [***] in such course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-Howaction, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid borne solely by the Party initiating and/or prosecuting the action. Each Party shall have the right to be represented by counsel of its own choice[***].
7.3.3 7.3.5 For any action to terminate any infringement of Company Patent Rights Prior Patents or Joint Patent Rights Collaboration Patents or any misappropriation or misuse of Company Prior Inventions or Collaboration Know-How pursuant to Section 7.3.1How, in the event that a if either Party is unable to initiate or prosecute such action solely in its own name, the other Party will shall join such action voluntarily and will execute and cause its Affiliates to shall execute all documents necessary for the Party to initiate litigation to prosecute and maintain such action under this Section 7.3action. In connection with any action or potential such action, Merck and Company will Metabasis shall cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Joint Patent Rightsrequests. Each Party shall keep the other informed of developments in any such action or proceeding. For any proceeding not controlled , including, to the extent permissible by Mercklaw, Company shall obtain prior the consultation and approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information and Inventions not controlled by Company, Merck shall obtain prior approval from Company of any settlement offer or settlement agreementthereto.
7.3.4 7.3.6 Any recovery obtained by either or both Merck and Company Metabasis in connection with or as a result of any action contemplated by this Section 7.3Sections 7.3.2 through 7.3.4, whether by settlement or otherwise, shall be shared in order as follows:
(a) the The Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action;
(b) the The other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and;
(c) Any remaining amounts after such reimbursement of the amount Parties costs and expenses shall [***].
7.3.7 Each Party shall inform the other Party of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.
7.3.5 Company shall inform Merck of certification regarding any matter of which Prior Patents, Collaboration Patents or Joint Patents it becomes aware concerning the submission of an application has received pursuant to the U.S. Food & Drug Administration under Section 351(keither 21 U.S.C. §§ 355(b)(2)(A)(iv) of the U.S. Public Health Services Act or (42 USC 262(k))j)(2)(A)(vii)(IV) or its successor provisions, or to a similar agency under Canada's Patented Medicines (Notice of Compliance) Regulations Article 5, or any similar provisions in a country in other than the TerritoryUnited States and Canada, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company and shall provide Merck the other Party with the unopened Biosimilar Application a copy of such certification within three five (35) days of receiptreceipt by such Party. Notwithstanding the foregoing provisions of Article 7, Merck shall have the sole right, in its discretion, to control any legal action Metabasis' and any activity taken to resolve a dispute Merck's rights with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection the initiation and prosecution of any patents for listing under 42 U.S.C. §262(l), and Company *** Confidential Treatment Requested legal action as a result of such certification or any recovery obtained as a result of such legal action shall have no rights be as defined in connection therewith. Sections 7.3.2 through 7.3.5.
7.3.8 For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Applicationunder Sections 7.3.2 through 7.3.4 for which the Parties are sharing expenses, in the event Party that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any contributing the greatest monetary amount shall control the action, Company but shall cooperate continue to consult with Merck the other Party on all major strategy decisions.
7.3.9 [***] shall give [***] timely written notice of the proposed settlement of any action under Sections 7.3.2 through 7.3.4 and provide Merck with information and assistance that Merck may reasonably requestshall not enter into any such settlement without the prior written consent of [***], including as defined in Section 7.3.3not to be unreasonably withheld.
Appears in 3 contracts
Samples: Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc), Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc), Exclusive License and Research Collaboration Agreement (Metabasis Therapeutics Inc)
Enforcement and Defense. 7.3.1 [****]
7.3.2 The 10.3.1 Each Party having shall promptly give the first other Party notice of (i) any infringement of Jxxxxxx Patent Rights or Joint Patent Rights, or (ii) any misappropriation or misuse of Jxxxxxx Know-How, that may come to a Party’s attention. Provention and Jxxxxxx shall thereafter cooperate to determine a course of action to terminate any infringement of Jxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Jxxxxxx Know-How. Provention has the right but not the obligation, within the Field, to initiate and prosecute any such legal action at its own expense and in the name of Jxxxxxx and Provention (or just Jxxxxxx or just Provention if the laws of the jurisdiction so dictate), or to control the defense of any declaratory judgment action relating to Jxxxxxx Patent Rights, Joint Patent Rights, or Jxxxxxx Know-How in the Field. The costs of any legal action commenced or the defense of any declaratory judgment shall be borne by Provention, but only to the extent Provention has exercised its right pursuant to Section 7.3.1 the immediately preceding sentence. Provention shall promptly inform the other Party Jxxxxxx if it elects not to exercise its first that right under Section 7.3.1 with respect to initiate Jxxxxxx Patent Rights or Joint Patent Rights and prosecute legal action, and the other Party Jxxxxxx shall thereafter have the right at its sole cost to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of Provention and, if necessary, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the actionJxxxxxx. Each Party shall have the right to be represented by counsel of its own choice.
7.3.3 10.3.2 For any action to terminate any infringement of Company Jxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Company Jxxxxxx Know-How pursuant to Section 7.3.1How, in the event that a Party if Provention is unable to initiate or prosecute such action solely in its own name, the other Party will Jxxxxxx shall join such action voluntarily and will shall execute and cause its Affiliates to execute all documents necessary for the Party Provention to initiate litigation to prosecute and maintain such action under this Section 7.3action. Each Party shall bear its own costs in such instance. In connection with any action or potential action, Merck Provention and Company will Jxxxxxx shall cooperate fully and will shall provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Joint Patent Rights. Each Party shall keep the other informed of developments in any action or proceeding. For any proceeding not controlled , including, to the extent permissible by Mercklaw, Company shall obtain prior the consultation and approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information negotiations and Inventions not controlled by Company, Merck shall obtain prior approval from Company the terms of any settlement offer or settlement agreementrelated thereto.
7.3.4 10.3.3 Any recovery obtained by either or both Merck Provention and Company Jxxxxxx in the Field in connection with or as a result of any action contemplated by this Section 7.3section, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which that initiated and prosecuted the action shall will recoup all of its costs and expenses incurred in connection with the action;
(b) the other Party shall will then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
(c) the The amount of any recovery remaining shall then will be allocated between as follows:
(i) if the Parties recovery is based upon Provention’s lost sales or profits, then Provention shall pay to Jxxxxxx the same royalties as set forth in Article 8 calculated on the Net Sales which formed the basis of Provention’s lost profits claim; and
(ii) if the recovery is based upon the allocation of a pro rata basis taking into consideration reasonable royalty, then the relative economic losses suffered by each Party that initiated and prosecuted the action shall receive seventy-five percent (75%) of such recovery, and the remaining twenty-five percent (25%) shall be allocated to the other Party.
7.3.5 Company shall inform Merck of any matter of which it becomes aware concerning the submission of an application to the U.S. Food & Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 USC 262(k)), or to a similar agency under any similar provisions in a country in the Territory, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within three (3) days of receipt. Notwithstanding the foregoing provisions of Article 7, Merck shall have the sole right, in its discretion, to control any legal action and any activity taken to resolve a dispute with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including as defined in Section 7.3.3.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (Provention Bio, Inc.), License, Development and Commercialization Agreement (Provention Bio, Inc.)
Enforcement and Defense. 7.3.1 [****]
7.3.2 The Party having Parties shall give notice to each other of either (i) any infringement of Company Product Related Patent Rights or Joint Patent Rights, or (ii) any misappropriation or misuse of Company Know-How or Joint Information and Inventions, that may come to its attention. MSD and Company shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action by either or both MSD and Company, to terminate any infringement of Company Product Related Patent Rights or Joint Patent Rightsor any misappropriation or misuse of Company Know-How or Joint Information and Inventions. MSD, upon notice to Company, shall have the first right to initiate and prosecute such legal action pursuant at its own expense and in the name of MSD and/or Company, or to Section 7.3.1 control the defense of any declaratory judgment action relating to Company Product Related Patent Rights or Joint Patent Rights or Company Know-How or Joint Information and Inventions. Each Party shall have the right to be represented by counsel of its own choice.
7.3.2 MSD shall promptly inform the other Party Company if it elects not to exercise its first right under Section 7.3.1 to initiate and prosecute legal action, and the other Party Company shall thereafter have the right and the discretion to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of Company and, if necessary, MSD. If Company elects to do so, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Product Related Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-HowHow or Joint Information and Inventions, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the actionCompany. Each Party shall have the right to be represented by counsel of its own choice.
7.3.3 For any action to terminate any infringement of Company Product Related Patent Rights or Joint Patent Rights or any misappropriation or misuse of Company Know-How pursuant to Section 7.3.1or Joint Information and Inventions, in the event that a Party is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the Party to initiate litigation to prosecute and maintain such action under this Section 7.3. In connection with any action or potential action, Merck MSD and Company will cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Product Related Patent Rights and or Joint Patent Rights. Each Party shall keep the other informed of developments in any action or proceedingproceeding provided that Company shall have final say on any action or proceedings that affects, or could reasonably be expected to affect Company's use and/or exploitation of the Company Information and Inventions, Company Know -How and/or Company Patent Rights for uses outside the scope of the provisions set forth in the Agreement. For any proceeding not controlled by MerckMSD, Company shall obtain prior approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information and Inventions not controlled by Company, Merck shall obtain prior approval from Company MSD of any settlement offer or settlement agreement.
7.3.4 Any recovery obtained by either or both Merck MSD and Company in connection with or as a result of any action contemplated by this Section 7.3, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action;
(b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
(c) the amount of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.
7.3.5 Each Party shall inform the other Party of any certification regarding any Joint Patent Rights it has received pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), or its successor provisions or any similar provisions in a country in the Territory other than the United States, and shall provide a copy of such certification within [***] of receipt. MSD has the first right to initiate and prosecute any legal action as a result of such certification; provided, however, that MSD shall inform Company of such decision to initiate such action within [***] of receipt of the certification, after which time Company shall have the right to initiate and prosecute such action. Regardless of which Party has the right to initiate and prosecute such action, both Parties shall, as soon as practicable after receiving notice of such certification, convene and consult with each other regarding the appropriate course of conduct for such action. The non-initiating Party shall have the right to be kept fully informed and participate in decisions regarding the appropriate course of conduct for such action, and the right to join and participate in such action. Company’s and MSD’s rights and obligations with respect to the prosecution of any legal action as a result of such certification and any recovery obtained as a result of such legal action shall be as defined in Sections 7.3.3 and 7.3.4 Company shall inform Merck MSD of any matter of which it becomes aware concerning the submission of an application to the U.S. Food & Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 USC 262(k)), or to a similar agency under any similar provisions in a country in the Territory, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck MSD is a reference product sponsor involving Company Product Related Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company shall provide Merck MSD with the unopened Biosimilar Application within three (3) days of receipt. Notwithstanding the foregoing provisions of Article 7Section 7.3, Merck MSD shall have the sole right, in its discretion, to control any legal action and any activity taken to resolve a dispute Dispute with respect to any infringement of Company Product Related Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company shall have no rights in connection therewith. For any action with respect to any infringement of Company Product Related Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck MSD is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck MSD to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck MSD and provide Merck MSD with information and assistance that Merck MSD may reasonably request, including as defined in Section 7.3.3.
Appears in 2 contracts
Samples: Research Collaboration and Option to License Agreement (4D Pharma PLC), Research Collaboration and Option to License Agreement (4D Pharma PLC)
Enforcement and Defense. 7.3.1 [****]
7.3.2 The Party having Parties shall give notice to each other of either (i) any infringement of Cocrystal Patent Rights or Collaboration Patent Rights, or (ii) any misappropriation or misuse of Cocrystal Know-How or Collaboration Information and Inventions, that may come to its attention. Merck and Cocrystal shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action by either or both Merck and Cocrystal, to terminate any infringement of Cocrystal Patent Rights or Collaboration Patent Rights or any misappropriation or misuse of Cocrystal Know-How or Collaboration Information and Inventions. Merck, upon notice to Cocrystal, shall have the first right to initiate and prosecute legal action pursuant at its expense and in the name of Merck and/or Cocrystal, or to Section 7.3.1 control the defense of any declaratory judgment action relating to Cocrystal Patent Rights, Cocrystal Know-How, Collaboration Patent Rights or Collaboration Information and Inventions. Each Party shall have the right to be represented by counsel of its own choice at its own expense.
7.3.2 Merck shall promptly inform the other Party Cocrystal if it elects not to exercise its first right under Section 7.3.1 to initiate and prosecute legal action, and the other Party Cocrystal shall thereafter have the right right, at its expense, to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of Cocrystal and, if necessary, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the actionMerck. Each Party shall have the right to be represented by counsel of its own choicechoice at its own expense.
7.3.3 For any action to terminate any infringement of Company Cocrystal Patent Rights or Joint Collaboration Patent Rights or any misappropriation or misuse of Company Cocrystal Know-How pursuant to Section 7.3.1or Collaboration Information and Inventions, in the event that a Party is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the Party to initiate litigation to prosecute and maintain such action under this Section 7.3. In connection with any action or potential action, Merck and Company Cocrystal will cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Cocrystal Patent Rights and Joint Collaboration Patent Rights. Each Party shall keep the other informed of developments in any action or proceedingproceeding and provide the other Party, upon request, with copies of documents filed in connection therewith. For any proceeding not controlled by Merckproceeding, Company the controlling Party shall obtain prior the approval from Merck the other Party of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information and Inventions , which approval shall not controlled by Company, Merck shall obtain prior approval from Company of any settlement offer be unreasonably withheld or settlement agreementdelayed.
7.3.4 Any recovery obtained by either or both Merck and Company Cocrystal in connection with or as a result of any action contemplated by this Section 7.3, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action;
(b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
(c) the amount of any recovery remaining shall then be allocated between the Parties on a pro pro-rata basis taking into consideration the relative economic losses suffered by each Party.
7.3.5 Company Each Party shall inform Merck the other Party of any matter of which certification regarding any Cocrystal Patent Rights or Collaboration Patent Rights it becomes aware concerning the submission of an application has received pursuant to the U.S. Food & Drug Administration under Section 351(keither 21 U.S.C. §§355(b)(2)(A)(iv) of the U.S. Public Health Services Act or (42 USC 262(k)j)(2)(A)(vii)(IV), or to a similar agency under its successor provisions or any similar provisions in a country in the TerritoryTerritory other than the United States, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company and shall provide Merck with the unopened Biosimilar Application a copy of such certification within three (3) days [*] of receipt. Notwithstanding Merck has the foregoing provisions first right to initiate and prosecute any legal action as a result of Article 7such certification; provided, however, that Merck shall inform Cocrystal of such decision to initiate such action within [*] of receipt of the certification, after which time Cocrystal shall have the sole rightright to initiate and prosecute such action. Regardless of which Party has the right to initiate and prosecute such action, both Parties shall, as soon as practicable after receiving notice of such certification, convene and consult with each other regarding the appropriate course of conduct for such action. The non-initiating Party shall have the right to be kept fully informed and participate in its discretiondecisions regarding the appropriate course of conduct for such action, and the right to control join and participate in such action. Cocrystal’s and Merck’s rights and obligations with respect to the prosecution of any legal action as a result of such certification and any activity taken to resolve recovery obtained as a dispute with respect to any infringement result of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company such legal action shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including be as defined in Section 7.3.3Sections 7.3.3 and 7.3.4.
Appears in 1 contract
Samples: Exclusive License and Research Collaboration Agreement (Cocrystal Pharma, Inc.)
Enforcement and Defense. 7.3.1 [****]
7.3.2 The 10.5.1 Each Party having shall promptly give the other Party notice of (i) any infringement of Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights, or (ii) any misappropriation or misuse of Vertex Know-How or Xxxxxxx Know-How, that may come to the first Party’s attention. Xxxxxxx and Vertex shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action by either or both Xxxxxxx and Vertex, to terminate any infringement of Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Vertex Know-How or Xxxxxxx Know-How, in the Territory. Vertex, upon notice to Xxxxxxx, shall have the first right to initiate and prosecute any such legal action pursuant in the name of Vertex and Xxxxxxx, or to Section 7.3.1 control the defense of any declaratory judgment action, relating to Vertex Patent Rights, Joint Patent Rights or Vertex Know-How in the Territory. Xxxxxxx, upon notice to Vertex, shall have the first right to initiate and prosecute any such legal action in the name of Xxxxxxx and Vertex, or to control the defense of any declaratory judgment action, relating to Xxxxxxx Patent Rights or Xxxxxxx Know-How in the Territory. [***] Each Party shall promptly inform the other Party if it elects not to exercise its first right under Section 7.3.1 to initiate and prosecute legal action, as described above and the other Party shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its name of and, if necessary, the name of the other first Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Joint Patent Rights or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the action. Each Party shall have the right to be represented by counsel of its own choice.choice [***]
7.3.3 10.5.2 For any action to terminate any infringement of Company Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Company Vertex Know-How pursuant to or Xxxxxxx Know-How, as permitted in accordance with Section 7.3.110.5.1, in the event that a the Party initiating the action is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the first Party to initiate litigation to prosecute and maintain such action under this Section 7.3action. In connection with any action or potential such action, Merck Xxxxxxx and Company Vertex will cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Joint Patent Rights. Each Party shall keep the other informed of developments in any such action or proceeding. For any proceeding not controlled , including, to the extent permissible by Mercklaw, Company shall obtain prior the consultation and approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information negotiations and Inventions not controlled by Company, Merck shall obtain prior approval from Company the terms of any settlement offer or settlement agreementrelated thereto.
7.3.4 10.5.3 Any recovery obtained by either or both Merck Xxxxxxx and Company Vertex in connection with or as a result of any action contemplated by this Section 7.3Section, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which initiated and prosecuted the action 10.5.4 Vertex shall recoup all of its costs and expenses incurred in connection with the action;
(b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
(c) the amount inform Xxxxxxx of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.
7.3.5 Company shall inform Merck of certification regarding any matter of which Vertex Patent Rights it becomes aware concerning the submission of an application has received pursuant to the U.S. Food & Drug Administration under Section 351(keither 21 U.S.C. §§355(b)(2)(A)(iv) of the U.S. Public Health Services Act or (42 USC 262(k)), j)(2)(A)(vii)(IV) or to a similar agency under its successor provisions or any similar provisions in a country in the Territory, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company Territory and shall provide Merck Xxxxxxx with a copy of such certification [***] Vertex’s and Xxxxxxx’x rights with respect to the unopened Biosimilar Application within three (3) days initiation and prosecution of receipt. Notwithstanding the foregoing provisions any legal action as a result of Article 7such certification or any recovery obtained as a result of such legal action shall be as defined in subsections 10.5.1 through 10.5.4; provided, Merck however, that Vertex shall have the sole right, in its discretion, first right to control initiate and prosecute any legal action and any activity taken to resolve a dispute with respect to any infringement shall inform Xxxxxxx of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Applicationsuch decision [***], in the event that Merck is unable case of certification regarding any Vertex Patent Rights it has received pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), or within a similarly appropriate time in the case of certifications or the like in countries outside of the United States, of receipt of the certification, after which time Xxxxxxx shall have the right to initiate or and prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including as defined in Section 7.3.3.
Appears in 1 contract
Enforcement and Defense. 7.3.1 [****]
7.3.2 The Each Party having shall notify the other Party of either (i) any infringement of Company Patent Rights, Joint Patent Rights or Company Background IP or (ii) any misappropriation or misuse of Company Know-How, that may come to its attention. Merck and Company shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action by either or both Merck and Company, to terminate any infringement of Company Patent Rights, Joint Patent Rights or Company Background IP or any misappropriation or misuse of Company Know-How. Merck, upon notice to Company, shall have the first right to initiate and prosecute such legal action pursuant at its own expense and in the name of Merck and/or Company, or to Section 7.3.1 control the defense of any declaratory judgment action relating to Company Patent Rights, Company Background IP, Company Know-How or Joint Patent Rights. Each Party shall have the right to be represented by counsel of its own choice.
7.3.2 Merck shall promptly inform the other Party Company if it elects not to exercise its first right under Section 7.3.1 to initiate and prosecute legal action, and the other Party Company shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its the name of Company and, if necessary, Merck. If Company elects to do so, the name of the other Party. The costs of any agreed-upon course of action to terminate infringement of Company Patent Rights or Rights, Joint Patent Rights or Company Background IP or misappropriation or misuse of Company Know-How, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and/or prosecuting the actionCompany. Each Party shall have the right to be represented by counsel of its own choice.
7.3.3 For any action to terminate any infringement of Company Patent Rights or Rights, Joint Patent Rights or Company Background IP or any misappropriation or misuse of Company Know-How pursuant to Section 7.3.1How, in the event that a Party is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the Party to initiate litigation to prosecute and maintain such action under this Section 7.3. In connection with any action or potential action, Merck and Company will cooperate fully and will provide each other with any information or assistance that either may reasonably request, including cooperating with regard to any pre-litigation review of the Company Patent Rights and Rights, Joint Patent RightsRights or Company Background IP. Each Party shall keep the other informed of developments in any action or proceeding. For any proceeding not controlled by Merck, Company shall obtain prior approval from Merck of any settlement offer or settlement agreement. For any proceeding specifically related to Platform Information and Inventions not controlled by Company, Merck shall obtain prior approval from Company of any settlement offer or settlement agreement.
7.3.4 Any recovery obtained by either or both Merck and Company in connection with or as a result of any action contemplated by this Section 7.3Section, whether by settlement or otherwise, shall be shared in order as follows:
(a) the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action;
(b) the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
(c) the amount of any recovery remaining shall then be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.
7.3.5 Company Each Party shall inform Merck the other Party of any matter of which certification regarding any Company Patent Rights or Joint Patent Rights it becomes aware concerning the submission of an application has received pursuant to the U.S. Food & Drug Administration under Section 351(keither 21 U.S.C. §§355(b)(2)(A)(iv) of the U.S. Public Health Services Act or (42 USC 262(k)j)(2)(A)(vii)(IV), or to a similar agency under its successor provisions or any similar provisions in a country in the TerritoryTerritory other than the United States, seeking approval of a biosimilar or interchangeable biological product with regard to which Merck is a reference product sponsor involving Company Patent Rights or Joint Patent Rights (“Biosimilar Application”). Company and shall provide Merck with the unopened Biosimilar Application a copy of such certification within three (3) [***] days of receipt. Notwithstanding Merck has the foregoing provisions first right to initiate and prosecute any legal action as a result of Article 7such certification; provided, however, that Merck shall inform Company of such decision to initiate such action within [***] days of receipt of the certification, after which time Company shall have the sole rightright to initiate and prosecute such action. Regardless of which Party has the right to initiate and prosecute such action, both Parties shall, as soon as practicable after receiving notice of such certification, convene and consult with each other regarding the appropriate course of conduct for such action. The non-initiating Party shall have the right to be kept fully informed and participate in its discretiondecisions regarding the appropriate course of conduct for such action, and the right to control join and participate in such action. Company’s and Merck’s rights and obligations with respect to the prosecution of any legal action as a result of such certification and any activity taken to resolve recovery obtained as a dispute with respect to any infringement result of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing under 42 U.S.C. §262(l), and Company such legal action shall have no rights in connection therewith. For any action with respect to any infringement of Company Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, in the event that Merck is unable to initiate or prosecute such action solely in its own name, Company will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute and maintain such action. In connection with any action, Company shall cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request, including be as defined in Section 7.3.3Sections 7.3.3 and 7.3.4.
Appears in 1 contract
Samples: Exclusive License and Research Collaboration Agreement (Proteostasis Therapeutics, Inc.)