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Common use of Enforcement and Defense Clause in Contracts

Enforcement and Defense. 9.3.1 The Parties shall give notice to each other of (i) any infringement of Patent Rights covering Collaboration Information and Inventions or (ii) any infringement, misappropriation or misuse of Collaboration Information and Inventions, or Company Background IP, that may come to its attention. Merck and Company shall thereafter consult and cooperate fully to determine a course of action, including the commencement of legal action by either or both Merck and Company, to terminate any such infringement, misappropriation or misuse. (a) Merck, upon notice to Company, shall have (i) the sole right to initiate and prosecute such legal action at its own expense and in the name of Merck and/or Company, or to control the defense of any declaratory judgment action, in each case to the extent concerning Patent Rights within Antibody Binder IP and (ii) the first right to initiate and prosecute such legal action at its own expense and in the name of Merck and/or Company, or to control the defense of any declaratory judgment action, in each case to the extent concerning Patent Rights within Collaboration Candidate IP and Other Collaboration IP. (b) Company, upon notice to Merck, shall have the (i) sole right to initiate and prosecute such legal action at its own expense and in the name of Company, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Company Background IP and Platform IP owned solely by Company, and (ii) first right to initiate and prosecute such legal action at its own expense and in the name of Company, and if necessary, Merck, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Platform IP owned jointly by the Parties [***]. (c) Each Party shall have the right to be represented by counsel of its own choice. 9.3.2 Merck shall promptly inform Company if it elects not to exercise its first right under Section 9.3.1(a) to initiate and prosecute legal action concerning Patent Rights within Collaboration Candidate IP, Other Collaboration IP [***] and Company shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Company and, if necessary, Merck. Company shall promptly inform Merck if it elects not to exercise its first right under Section 9.3.1(b) to initiate and prosecute legal action concerning Patent Rights within Platform IP owned jointly by the [***] and Merck shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Merck and/or Company. The costs of any agreed-upon course of action to terminate such infringement, misappropriation or misuse, including the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the initiating Party. Each Party shall have the right to be represented by counsel of its own choice. 9.3.3 For any action under Section 9.3.1 or 9.3.2, 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 9.3. 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. 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. [***] 9.3.4 Any recovery obtained by either or both Merck and Company in connection with or as a result of any action contemplated by this Section, whether by settlement or otherwise, shall be shared in order as follows: (a) [***]. 9.3.5 Company shall inform Merck of any certification regarding any Patent Rights within Collaboration Candidate IP or Antibody Binder IP 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 five (5) days of receipt. Merck has the first right to initiate and prosecute any legal action as a result of such 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 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 Merck’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 9.3.3 and 9.3.4. 9.3.6 Company shall promptly inform Merck of any matter of which it becomes aware concerning the submission of an application to the United States Food and Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 U.S.C. §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 the Marketing Authorization for a Licensed Product held by Merck or its Related Party (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within [***] Business Days of receipt. Company shall review the Biosimilar Application to the extent necessary to determine to whose attention at Merck it needs to be directed. Company shall use reasonable efforts to not open any sealed contents, if any, within the envelope containing the Biosimilar Application. If Company does open the sealed contents of any Biosimilar Application, or if the Biosimilar Application is not contained within a sealed envelope inside the delivery packaging, Company shall (a) not substantively review the Biosimilar Application, (b) so notify Merck, and (c) cooperate with Merck to obtain the relevant applicant’s consent to forward the Biosimilar Application to Merck. Merck shall choose the recipients of information under 42 U.S.C. §262 (l)(1)(B)(ii).

Appears in 2 contracts

Samples: Exclusive License and Research Collaboration Agreement (Artiva Biotherapeutics, Inc.), Exclusive License and Research Collaboration Agreement (Artiva Biotherapeutics, Inc.)

Enforcement and Defense. 9.3.1 The Parties shall give notice to each other of either: (i) any infringement by a Third Party of Program Collaboration Patent Rights covering Collaboration Information and Inventions Rights; or (ii) any infringement, misappropriation or misuse of Program Collaboration Information and Inventions, or Company Background IP, that may come to its attention. Merck and Company Sutro shall thereafter consult and cooperate fully to determine a course of action, including the commencement of legal action by either or both Merck and CompanySutro, to terminate any such infringement, infringement of Program Collaboration Patent Rights or any such misappropriation or misuse. (a) misuse of Program Collaboration IP. Merck, upon notice to CompanySutro, 50 *Confidential Treatment Requested. shall have (i) the sole right to initiate and prosecute such legal action at its own expense and in the name of Merck and/or Company, or to control the defense of any declaratory judgment action, in each case to the extent concerning Patent Rights within Antibody Binder IP and (ii) the first right to initiate and prosecute such legal action at its own expense and in the name of Merck and/or CompanySutro, or to control the defense of any declaratory judgment action, in each case action relating to the extent concerning such Program Collaboration Patent Rights within Collaboration Candidate IP and Other or Program Collaboration IP. (b) Company, upon notice to Merck, shall have the (i) sole right to initiate and prosecute such legal action at its own expense and in the name of Company, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Company Background IP and Platform IP owned solely by Company, and (ii) first right to initiate and prosecute such legal action at its own expense and in the name of Company, and if necessary, Merck, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Platform IP owned jointly by the Parties [***]. (c) . Each Party shall have the right to be represented by counsel of its own choice. 9.3.2 Merck shall promptly (and in sufficient time for Sutro to bring an action to avoid any statutory deadline) inform Company Sutro if it elects not to exercise its first right under Section 9.3.1(a) 9.3.1 to initiate and prosecute legal action concerning Patent Rights within Collaboration Candidate IPaction, Other Collaboration IP [***] and Company Sutro shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the its name of Company and, if necessary, Merck’s name. Company shall promptly inform Merck if it If Sutro elects not to exercise its first right under Section 9.3.1(b) to initiate and prosecute legal action concerning Patent Rights within Platform IP owned jointly by do so, the [***] and Merck shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Merck and/or Company. The costs of any agreed-upon course of action to terminate such infringement, infringement of Program Collaboration Patent Rights or misappropriation or misusemisuse of Program Collaboration IP, including the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the initiating PartySutro. Each Party shall have the right to be represented by counsel of its own choice. 9.3.3 For any action under Section 9.3.1 to terminate any infringement of Program Collaboration Patent Rights or 9.3.2any misappropriation or misuse of Program Collaboration IP, in the event that a 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 shall 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 9.3. In connection with any action or potential action, Merck and Company will Sutro 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 reviewreview of the Program Collaboration Patent Rights. Each Party shall keep the other informed of developments in any action or proceeding. For any proceeding [***] not controlled by Merck, Company Sutro shall obtain prior approval from Merck of any settlement offer or settlement agreement. [***]agreement that could potentially cause Merck to accept any liability or make any payment. 9.3.4 Any recovery obtained by either or both Merck and Company Sutro in connection with or as a result of any action contemplated by this SectionSection 9.3, whether by settlement or otherwise, shall be shared in order as follows: (a) [***]9.3.4.1 the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action; 9.3.4.2 the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and 9.3.4.3 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. 9.3.5 Company Each Party shall inform Merck the other Party of any certification regarding any Program Collaboration Patent Rights within Collaboration Candidate IP or Antibody Binder IP 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 five (5) days of [*] after receipt. Merck has the first right to initiate and prosecute any legal action as a result of such 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 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 Merck’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 9.3.3 and 9.3.4. 9.3.6 Company shall promptly inform Merck of any matter of which it becomes aware concerning the submission of an application to the United States Food and Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 U.S.C. §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 the Marketing Authorization for a Licensed Product held by Merck or its Related Party (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within [***] Business Days of receipt. Company shall review the Biosimilar Application to the extent necessary to determine to whose attention at Merck it needs to be directed. Company shall use reasonable efforts to not open any sealed contents, if any, within the envelope containing the Biosimilar Application. If Company does open the sealed contents of any Biosimilar Application, or if the Biosimilar Application is not contained within a sealed envelope inside the delivery packaging, Company shall (a) not substantively review the Biosimilar Application, (b) so notify Merck, and (c) cooperate with Merck to obtain the relevant applicant’s consent to forward the Biosimilar Application to Merck. Merck shall choose the recipients of information under 42 U.S.C. §262 (l)(1)(B)(ii).that

Appears in 1 contract

Samples: Exclusive Patent License and Research Collaboration Agreement (Sutro Biopharma Inc)

Enforcement and Defense. 9.3.1 8.3.1 The Parties shall give notice to each other of either (i) any infringement of Company Patent Rights covering Collaboration Information and Inventions or Joint Patent Rights, or (ii) any infringement, misappropriation or misuse of Collaboration Information and Inventions, or Company Background IPKnow-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 such infringement, misappropriation infringement of Company Patent Rights or misuse. (a) Joint Patent Rights. Merck, upon notice to Company, shall have (i) the sole first right to initiate and prosecute such legal action with respect to the Company Compound Specific Patent Rights or Joint Patent Rights at its own expense and in the name of Merck and/or CompanyMerck, or to control the defense of any declaratory judgment action, in each case action relating to the extent concerning Company Compound Specific Patent Rights within Antibody Binder IP and (ii) the first right to initiate and prosecute such legal action at its own expense and in the name of Merck and/or Company, or to control the defense of any declaratory judgment action, in each case to the extent concerning Joint Patent Rights within Collaboration Candidate IP and Other Collaboration IP. (b) Rights. Company, upon notice to Merck, shall have the (i) sole right to initiate and prosecute such legal action at its own expense and in the name of Company, or to control the defense of any declaratory judgment action, in each case concerning action relating to Company Non-Product Patent Rights within Company Background IP and Platform IP owned solely by Company, and (ii) first right to initiate and prosecute such legal action at its own expense and in the name of Company, and if necessary, Merck, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Platform IP owned jointly by the Parties [***]. (c) Rights. Each Party shall have the right to be represented by counsel of its own choice.. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 9.3.2 8.3.2 Merck shall promptly inform Company if it elects not to exercise its first right under Section 9.3.1(a) 8.3.1 to initiate and prosecute legal action concerning related to Company Compound Specific Patent Rights within Collaboration Candidate IPor Joint Patent Rights, Other Collaboration IP [***] and Company shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Company and, if necessary, Merck. If Company shall promptly inform Merck if it elects not to exercise its first right under Section 9.3.1(b) to initiate and prosecute legal action concerning Patent Rights within Platform IP owned jointly by do so, the [***] and Merck shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Merck and/or Company. The costs of any agreed-upon course of action to terminate such infringement, misappropriation infringement of Company Compound Specific Patent Rights or misuseJoint Patent Rights, including without limitation the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the initiating PartyCompany. Each Party shall have the right to be represented by counsel of its own choice. 9.3.3 8.3.3 For any action under Section 9.3.1 to terminate any infringement of Company Patent Rights or 9.3.2Joint Patent Rights, or any misappropriation or misuse of Company Know-How, 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 9.38.3.1. 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 reasonable pre-litigation reviewreview 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 Merckto terminate any infringement of Company Compound Specific Patent Rights or Joint Patent Rights under this Section 8.3, Company the controlling Party shall obtain prior approval from Merck the other Party of any settlement offer or settlement agreement. [***], such approval not to be unreasonably withheld, conditioned, or delayed. 9.3.4 8.3.4 Any recovery obtained by either or both Merck and Company in connection with or as a result of any action contemplated by this Section, whether by settlement or otherwise, shall be shared in order as follows: (a) [***]first to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated on a pro rata basis if insufficient to cover the totality of such expenses); and (b) 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. 9.3.5 8.3.5 Company shall inform Merck of any certification regarding any Patent Rights within Collaboration Candidate IP or Antibody Binder IP 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 five (5) days of receipt. Merck has the first right to initiate and prosecute any legal action as a result of such 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 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 Merck’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 9.3.3 and 9.3.4. 9.3.6 Company shall promptly inform Merck of any matter of which it becomes aware concerning the submission of an application to the United States U.S. Food and & Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 U.S.C. §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 the Marketing Authorization for a Licensed Product held by Merck or its Related Party Biosimilar (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within [***] Business Days of receipt. Notwithstanding the foregoing provisions of Section 8.3, 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 Compound Specific Patent Rights or Joint Patent Rights with respect to any Biosimilar Application, including selection of any patents for listing, and Company shall review have no rights in connection with the Biosimilar Application to the extent necessary to determine to whose attention at Merck it needs to be directed. Company shall use reasonable efforts to not open any sealed contents, if any, within the envelope containing the Biosimilar Applicationcontrol of such legal action. If Company does open inadvertently opens the CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED sealed contents of any Biosimilar Application, or if the Biosimilar Application is not contained within a sealed envelope inside the delivery packaging, Company shall (a) not substantively review the Biosimilar Application, (b) so notify Merck, and (c) cooperate with Merck to obtain the relevant applicant’s consent to forward the Biosimilar Application to Merck. Merck shall choose the recipients of information under 42 U.S.C. §262 (l)(1)(B)(iil). For any action with respect to any infringement of Company Compound Specific 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 reasonably cooperate with Merck and provide Merck with information and assistance that Merck may reasonably request at Merck’s expense, including as set forth in Section 8.3.3.

Appears in 1 contract

Samples: Research Collaboration and Exclusive License Agreement (Janux Therapeutics, Inc.)

Enforcement and Defense. 9.3.1 The Parties (i) Each Party shall give notice to each the other Party of (iA) any declaratory judgment action pertaining to the Licensed Intellectual Property or Purchased Intellectual Property, or (B) any infringement of Patent Rights covering Collaboration Information and Inventions the Patents included in the Licensed Intellectual Property or Purchased Intellectual Property, or (iiC) any infringement, misappropriation or misuse of Collaboration Information and Inventions, Know-how included in the Licensed Intellectual Property or Company Background IPPurchased Intellectual Property, that may come to its attentionthat Party’s attention (hereinafter “Legal Proceeding”). Merck and Company shall thereafter consult and cooperate fully With regard to determine any Legal Proceeding that relates to the Purchased Compound or to any claim in a course Patent included in the Purchased Intellectual Property or Licensed Intellectual Property that covers, either generically or specifically, the Purchased Compound or methods of actionmaking and/or using same, including the commencement of legal action by either or both Merck and Company, to terminate any such infringement, misappropriation or misuse. (a) Merck, upon notice to Company, Buyer shall have (i) the sole first right to initiate initiate, prosecute and prosecute control such legal action proceeding, in its sole discretion, at its own expense and in the name of Merck and/or CompanySeller and Buyer, including the right to settle any such proceeding. To the extent Buyer does not exercise its first right to initiate or prosecute such Legal Proceeding, Seller may initiate or prosecute such Legal Proceeding at its own expense. With regard to control the defense of any declaratory judgment action, in each case Legal Proceeding that does not relate to the extent concerning Purchased Compound and that relates solely to claims in a Patent Rights within Antibody Binder IP and (ii) in the Licensed Intellectual Property or Purchased Intellectual Property that do not cover, either generically or specifically, the Purchased Compound or methods of making and/or using same, Seller shall have the first right to initiate initiate, prosecute and prosecute control such legal action Legal Proceeding at its own expense and in the name of Merck and/or CompanySeller and Buyer as necessary, or including the right to control settle any such proceeding. Each Party shall promptly inform the defense of any declaratory judgment action, in each case other Party if it elects not to exercise such first right and the extent concerning Patent Rights within Collaboration Candidate IP and Other Collaboration IP. (b) Company, upon notice to Merck, other Party shall thereafter have the (i) sole right to initiate and prosecute such legal action at its own expense and Legal Proceeding in the name of Company, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Company Background IP Buyer and Platform IP owned solely by Company, and (ii) first right to initiate and prosecute such legal action at its own expense and in the name of Company, and if necessary, Merck, or to control the defense of any declaratory judgment action, in each case concerning Patent Rights within Platform IP owned jointly by the Parties [***]. (c) Each Party shall have the right to be represented by counsel of its own choice. 9.3.2 Merck shall promptly inform Company if it elects not to exercise its first right under Section 9.3.1(a) to initiate and prosecute legal action concerning Patent Rights within Collaboration Candidate IP, Other Collaboration IP [***] and Company shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Company and, if necessary, Merck. Company shall promptly inform Merck if it elects not to exercise its first right under Section 9.3.1(b) to initiate and prosecute legal action concerning Patent Rights within Platform IP owned jointly by the [***] and Merck shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of Merck and/or Company. The costs of any agreed-upon course of action to terminate such infringement, misappropriation or misuse, including the costs of any legal action commenced or the defense of any declaratory judgment, shall be paid by the initiating PartySeller. Each Party shall have the right to be represented by counsel of its own choicechoice in any Legal Proceeding. 9.3.3 (ii) If a Party elects not to initiate and prosecute an action as provided in Section 3.04(d)(i), and the other Party elects to do so, the costs of any agreed-upon course of action to terminate infringement or misappropriation or misuse, including the costs of any Legal Proceeding commenced or the defense of any declaratory judgment, shall be paid by the Party initiating and prosecuting such action. (iii) For any action under Section 9.3.1 or 9.3.2Legal Proceeding, 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 shall execute and cause its Affiliates to execute all documents necessary for the such other Party to initiate litigation to prosecute and maintain such action under this Section 9.3. 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. 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. [***]. 9.3.4 (iv) Any recovery obtained by either or both Merck Buyer and Company Seller in connection with or as a result of any action contemplated by this SectionSection 3.04(d), whether by settlement or otherwise, shall be shared in order as follows: (a1) [***]the Party that initiated and prosecuted the action shall recoup all of its reasonable costs and expenses incurred in connection with the action; (2) the other Party shall then, to the extent possible, recover its reasonable costs and expenses incurred in connection with the action; (3) the amount of any recovery remaining shall then be allocated between the Parties as follows: (i) any compensatory damages shall be allocated to Buyer to the extent such damages relate to the Purchased Compound, and otherwise shall be allocated to Seller; and (ii) any punitive damages shall be awarded to the Party initiating the action. 9.3.5 Company (v) The Parties shall inform Merck each other of any certification regarding any Patent Rights within Collaboration Candidate IP the Patents included in the Licensed Intellectual Property or Antibody Binder IP Purchased Intellectual Property or Purchased Intellectual Property that 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 provisions, or any similar provisions in a country in the Territory other than the United States, and shall provide the other Party with a copy of such certification within five (5) days of receipt. Merck has the first right to initiate and prosecute any legal action as a result of such 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 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. CompanySeller’s and MerckBuyer’s rights and obligations with respect to the initiation and prosecution of any legal action as a result of such certification and or any recovery obtained as a result of such legal action shall be as defined provided in Sections 9.3.3 and 9.3.4Section 3.04(d) hereof. 9.3.6 Company (vi) The Parties hereto shall promptly inform Merck of cooperate with each other, including providing necessary information, documents and assistance as the other Party may reasonably request, in obtaining patent term restoration or supplemental protection certificates or their equivalents in any matter of which it becomes aware concerning the submission of an application to the United States Food and Drug Administration under Section 351(k) of the U.S. Public Health Services Act (42 U.S.C. §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 the Marketing Authorization for a Licensed Product held by Merck or its Related Party (“Biosimilar Application”). Company shall provide Merck with the unopened Biosimilar Application within [***] Business Days of receipt. Company shall review the Biosimilar Application Territory where applicable to the extent Patents included in the Licensed Intellectual Property or Purchased Intellectual Property. If elections with respect to obtaining such patent term restoration or supplemental protection certificates or their equivalents are to be made with respect to the Purchased Compound in: (A) any Patent in the Purchased Intellectual Property, or (B) any Patent included in the Licensed Intellectual Property that exclusively contains claims that specifically or generically cover the Purchased Compound or methods of making and/or using same, Buyer shall have the right to make the election and Seller agrees to abide by such election; provided that in the event Buyer elects not to file a patent term restoration or supplemental protection certificate or their equivalents, Buyer shall (y) promptly inform Seller of its intention not to file and (z) grant to Seller the right to file such patent term extension and provide necessary information, documents and assistance as Seller may reasonably request. For the avoidance of doubt, no patent term restoration or supplemental protection certificate application shall be filed in any Patent included in the Purchased Intellectual Property on any product other than the Purchased Compound without the express written consent of Buyer, which consent shall not be unreasonably withheld with respect to determine a jurisdiction at issue once Buyer has made an election with respect to whose attention at Merck it obtaining patent term restoration or supplemental protection certificate in that jurisdiction. If Buyer reasonably determines that any Patent included in the Licensed Intellectual Property or Purchased Intellectual Property needs to be directedlisted in the Food And Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (or an equivalent in a foreign jurisdiction) (the “Orange Book”), Seller shall abide by such determination. Company Seller shall use reasonable efforts to not open any sealed contentscooperate fully with Buyer, if anyincluding providing necessary documents, within information and assistance regarding the envelope containing the Biosimilar Application. If Company does open the sealed contents listing of any Biosimilar Application, or if such Patent in the Biosimilar Application is not contained within a sealed envelope inside the delivery packaging, Company shall (a) not substantively review the Biosimilar Application, (b) so notify Merck, and (c) cooperate with Merck to obtain the relevant applicant’s consent to forward the Biosimilar Application to Merck. Merck shall choose the recipients of information under 42 U.S.C. §262 (l)(1)(B)(ii)Orange Book.

Appears in 1 contract

Samples: Asset Purchase Agreement (Intermune Inc)