Common use of Unilateral Activities Clause in Contracts

Unilateral Activities. (i) Subject to this Section 3.7, if the JDC, or the Senior Officers of the Parties, are unable to agree to matters relating to the joint Conduct by the Parties (or their licensees or Sublicensees) of a Clinical Study in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, or only one Party is interested in Conducting Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including a Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, a Party (or its licensee or Sublicensee) desiring to proceed with such activities (“ Proposed Unilateral Activities ”) shall prepare and provide to the JDC a proposed Development Plan and Budget with respect thereto; provided that the proposing Party shall have a good faith belief that any Proposed Unilateral Activities are scientifically reasonable. If either Party in good faith believes that any Proposed Unilateral Activities of the other Party could reasonably be expected to have a Material Adverse Effect on such first Party, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). If it is determined by the JDC or pursuant to such dispute resolution procedures that the Proposed Unilateral Activities could reasonably be expected to have a Material Adverse Effect on such first Party, the other Party (or its licensees or Sublicensees) shall not be permitted to conduct the Proposed Unilateral Activities. Upon the adoption of a Development Plan and Budget with respect to such Proposed Unilateral Activities, such activities shall constitute “ Unilateral Activities ” hereunder, and the Party proposing such activities (the “ Developing Party ”) shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement and such Development Plan and Budget. The other Party (the “ Opting-Out Party ”) shall be deemed to have opted-out (each an “ Opt-Out ”) with respect to such activities. The Developing Party may propose amendments to any Development Plan and Budget with respect to its Unilateral Activities at any time. The Developing Party shall provide to the JDC, in advance of the applicable meeting thereof, a detailed report regarding its Unilateral Activities and the Regulatory Data with respect thereto (and a summary of the Development Party’s regulatory activities) once every [***]. Each such report shall contain sufficient detail to enable the JDC to assess such Party’s compliance with the Development Plan and Budget.

Unilateral Activities. (i) Subject to this Section 3.7, if the JDC, or the Senior Officers of the Parties, are unable to agree to matters relating to the joint Conduct by the Parties (or their licensees or Sublicensees) of a Clinical Study in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, or only one Party is interested in Conducting Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including a Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, a Party (or its licensee or Sublicensee) desiring to proceed with such activities (“ “Proposed Unilateral Activities Activities”) shall prepare and provide to the JDC a proposed Development Plan and Budget with respect thereto; provided that the proposing Party shall have a good faith belief that any Proposed Unilateral Activities are scientifically reasonable. If either Party in good faith believes that any Proposed Unilateral Activities of the other Party could reasonably be expected to have a Material Adverse Effect on such first Party, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). If it is determined by the JDC or pursuant to such dispute resolution procedures that the Proposed Unilateral Activities could reasonably be expected to have a Material Adverse Effect on such first Party, the other Party (or its licensees or Sublicensees) shall not be permitted to conduct the Proposed Unilateral Activities. Upon the adoption of a Development Plan and Budget with respect to such Proposed Unilateral Activities, such activities shall constitute “ “Unilateral Activities Activities” hereunder, and the Party proposing such activities (the “ “Developing Party Party”) shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement and such Development Plan and Budget. The other Party (the “ “Opting-Out Party Party”) shall be deemed to have opted-out (each an “ “Opt-Out Out”) with respect to such activities. The Developing Party may propose amendments to any Development Plan and Budget with respect to its Unilateral Activities at any time. The Developing Party shall provide to the JDC, in advance of the applicable meeting thereof, a detailed report regarding its Unilateral Activities and the Regulatory Data with respect thereto (and a summary of the Development Party’s regulatory activities) once every [***]. Each such report shall contain sufficient detail to enable the JDC to assess such Party’s compliance with the Development Plan and Budget. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.

Unilateral Activities. (i) Subject to this Section 3.7, if the JDC, or the Senior Officers of the Parties, are unable to agree to matters relating to the joint Conduct by the Parties (or their licensees or Sublicensees) of a Clinical Study in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, or only one Party is interested in Conducting Specific terms in this Exhibit exhibit have been redacted because such confidential treatment for those terms are both not material and are of the type that the Company treats as private or confidentialhas been requested. These redacted terms have been marked in this Exhibit exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including a Combination Product) for a Licensed Indication in the Territory or related Party Development Activities, a Party (or its licensee or Sublicensee) desiring to proceed with such activities (“ “Proposed Unilateral Activities Activities”) shall prepare and provide to the JDC a proposed Development Plan and Budget with respect thereto; provided that the proposing Party shall have a good faith belief that any Proposed Unilateral Activities are scientifically reasonable. If either Party in good faith believes that any Proposed Unilateral Activities of the other Party could reasonably be expected to have a Material Adverse Effect on such first Party, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). If it is determined by the JDC or pursuant to such dispute resolution procedures that the Proposed Unilateral Activities could reasonably be expected to have a Material Adverse Effect on such first Party, the other Party (or its licensees or Sublicensees) shall not be permitted to conduct the Proposed Unilateral Activities. Upon the adoption of a Development Plan and Budget with respect to such Proposed Unilateral Activities, such activities shall constitute “ “Unilateral Activities Activities” hereunder, and the Party proposing such activities (the “ “Developing Party Party”) shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement and such Development Plan and Budget. The other Party (the “ “Opting-Out Party Party”) shall be deemed to have opted-out (each an “ “Opt-Out Out”) with respect to such activities. The Developing Party may propose amendments to any Development Plan and Budget with respect to its Unilateral Activities at any time. The Developing Party shall provide to the JDC, in advance of the applicable meeting thereof, a detailed report regarding its Unilateral Activities and the Regulatory Data with respect thereto (and a summary of the Development Party’s regulatory activities) once every [***]. Each such report shall contain sufficient detail to enable the JDC to assess such Party’s compliance with the Development Plan and Budget.

Unilateral Activities. (ia) Subject In the event the JSC cannot agree whether to this Section 3.7, if the JDC, or the Senior Officers of the Parties, are unable to agree to matters relating to the joint Conduct by the Parties (or their licensees or Sublicensees) of pursue a Clinical Study Trial in support of obtaining or maintaining Regulatory Approval of an indication for a Licensed Product (including Combination Product) other than an indication for a Licensed Indication in Product agreed upon by the Territory or related Party Development Activities, or only one Party is interested in Conducting Specific terms in this Exhibit have been redacted because such terms are both not material and are Parties as of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product (including a Combination Product) for a Licensed Indication in the Territory or related Party Development ActivitiesEffective Date), a Party (or its licensee or Sublicensee) desiring shall have the right, on written notice to the other Party, to proceed unilaterally with such activities (“ Proposed Unilateral Activities ”) shall prepare and provide Clinical Trial solely to the JDC a proposed Development Plan and Budget with respect thereto; provided that the proposing Party shall have a good faith belief that any Proposed Unilateral Activities are scientifically reasonable. If either Party support Regulatory Approval or Commercialization of such Licensed Product in good faith believes that any Proposed Unilateral Activities such Party’s portion of the other Party could reasonably be expected to have a Material Adverse Effect on Territory (such first Partyactivities, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). If it is determined by the JDC or pursuant to such dispute resolution procedures that the Proposed Unilateral Activities could reasonably be expected to have a Material Adverse Effect on such first Party, the other Party (or its licensees or Sublicensees) shall not be permitted to conduct the Proposed “Unilateral Activities. Upon the adoption of a Development Plan and Budget with respect to such Proposed Unilateral Activities, such activities shall constitute “ Unilateral Activities ” hereunder”), and the non-pursuing Party proposing such activities (the “ Developing Party ”) shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement and such Development Plan and Budget. The other Party (the “ Opting-Out Party ”) shall be deemed to have opted-out (each each, an “ ‘Opt-Out Out”) ), with respect to such activitiesUnilateral Activities, provided that, subject to Section 4.8(b), (i) the pursuing Party shall be solely responsible for all Development Expense incurred in connection with such Unilateral Activities, and (ii) the non-pursuing Party shall have no further financial obligation to support or otherwise fund any additional efforts in respect of such Unilateral Activities, and no obligation, responsibility, or authority regarding such additional efforts in respect of such Unilateral Activities; provided, however, that if the non-pursuing Party reasonably believes that the pursuing Party’s conduct of such Unilateral Activities would prevent or significantly impinge on such non-pursuing Party’s ability to undertake the Development or Commercialization of Licensed Product for agreed-upon indication(s) in such non-pursuing Party’s portion of the Territory, then the non-pursuing Party shall have the right to refer such decision to the Chief Executive Officer of Nuvelo and the Head of the Pharmaceutical Division of Bayer, and such dispute shall be resolved in accordance with Section 16.1. The Developing Party may propose amendments Until such dispute is resolved, the Parties shall refrain from taking action on the decision; provided that this Section shall not apply to any Development Plan decision relating to a Clinical Trial required by a Regulatory Authority, and Budget with respect to its Unilateral Activities at any time. The Developing the affected Party shall provide be entitled to the JDC, in advance of the applicable meeting thereof, a detailed report regarding its Unilateral Activities and the Regulatory Data with respect thereto (and a summary of the Development Party’s regulatory activities) once every [***]. Each conduct such report shall contain sufficient detail to enable the JDC to assess such Party’s compliance with the Development Plan and BudgetClinical Trial as so required.