Common use of Final Decision-Making Authority Clause in Contracts

Final Decision-Making Authority. If the Executive Officers are unable to reach unanimous agreement on any such matter within [***] Business Days after the meeting between the Executive Officers, then, subject to Section 7.5.4 (Exercise of Decision-Making Authority), the following will apply: (a) if the escalated matter relates to a dispute over (i) whether the [***] have been met with respect to a Category 3 Program, or (ii) [***], then, in each case ((i) and (ii)): (i) each Party will appoint an independent Third Party expert having at least 15 years of pharmaceutical and biotechnology industry experience and such Third Party experts will appoint a third independent Third Party expert (the “Third Party Experts”) to resolve such matter; (ii) each Party will be entitled, within [***] Business Days after the appointment of the final Third Party Expert, to make a written submission to the Third Party Experts explaining the basis for such Party’s position; (iii) the Third Party Experts will render a decision on such matter within [***] Business Days after such Third Party Experts’ receipt of the last such written submission by the Parties, which decision will be final and binding on the Parties; and (iv) each Party will be responsible for its own costs and expenses; provided, however, that the fees of the Third Party Experts will be borne by the Party against which the Third Party Experts decide; (b) if the escalated matter relates to approval of (i) [***], (ii) [***], (iii) [***], or (iv) [***], then neither Party will have final decision-making authority with respect to such matter [***]; (c) if the escalated matter relates to [***], then [***] neither Party will have final decision-making authority with respect to such matter and the Parties will continue operating under the status quo prior to such dispute [***]; (d) if the escalated matter relates to [***], then Arrowhead will have final decision-making authority with respect to such matter; and (e) if the escalated matter relates to [***], then [***] Sarepta will have final decision-making authority with respect to such matter.

Final Decision-Making Authority. If the Executive Senior Officers are unable not able to reach unanimous agreement agree on the resolution of any such matter issue under Section 2.8.1 within [***_____] Business Days days after the meeting between the Executive Officerssuch issue was first referred to them, then, subject to Section 7.5.4 (Exercise of Decision-Making Authority), the following will apply: (a) if the escalated matter relates to a dispute over (i) whether the [***] have been met with respect to a Category 3 Program, or (ii) [***], then, in each case ((i) and (ii)): (i) each Party will appoint an independent Third Party expert having at least 15 years of pharmaceutical and biotechnology industry experience and such Third Party experts will appoint a third independent Third Party expert (the “Third Party Experts”) to resolve such matter; (ii) each Party will be entitled, within [***] Business Days after the appointment of the final Third Party Expert, to make a written submission to the Third Party Experts explaining the basis for such Party’s position; (iii) the Third Party Experts will render a decision on such matter within [***] Business Days after such Third Party Experts’ receipt of the last such written submission by the Parties, which decision will be final and binding on the Parties; and (iv) each Party will be responsible for its own costs and expenses; provided, however, that the fees of the Third Party Experts will be borne by the Party against which the Third Party Experts decide; (b) if the escalated matter relates to approval of (i) [***], (ii) [***], (iii) [***], or (iv) [***], then neither Party will Orchard shall have final decision-making authority with respect to such matter any issue that relates to (i) the Pre-Clinical Research, (ii) the Manufacturing Process (including the incorporation of any Manufacturing Process Improvements) or Manufacture of the Licensed Product prior to the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory, and (iii) the identity of the Third Party drug product 33 Manufacturer referenced in Section 2.2.10, for clarity, in each case (i) to (iii), that does not relate to the Clinical Development Plan or any submission to or other communications with a Regulatory Authority in respect of the Licensed Product (each, an “Orchard Decision Matter”), provided that Orchard shall not use its final decision-making authority: (a) to require Pharming to violate any Applicable Law or any agreement it, at the time of making the relevant decision, has with a Third Party; (b) to increase the total level of FTE effort or costs to be incurred by Pharming under the Pre-Clinical Plan by more than [***]; _____] from those set out in the last version of the Pre-Clinical Budget or NTCR Budget (as applicable), including for the NTCR Activities included therein, that was approved by Pharming or, if there have not been any, the version of the Pre-Clinical Plan set out in Schedule 1.123; (c) if to materially increase or decrease the escalated obligations to be performed by Pharming under this Agreement; (d) to reallocate obligations of a Party to the other Party under the Pre-Clinical Plan; (e) to materially reduce the level of resources to be provided by ▇▇▇▇▇▇▇ to the Collaboration; (f) with respect to any matter that is reasonably determined by Pharming as materially adversely affecting the safety of the Licensed Product; or (g) with respect to any amendment to the Pre- Clinical Plan to include or amend any endpoints of the preclinical in vivo proof of concept NTCR study; and further provided that, Orchard shall not, and shall procure that its JSC representatives: (1) shall not unreasonably withhold, condition or delay its approval of any Third Party drug Manufacturer proposed by Pharming and (2) shall not withhold, condition or delay approval of the incorporation of any Manufacturing Process Improvements disclosed under Section 2.2.7 and licensed by Pharming under Section 3.7; and (b) Pharming shall have final decision-making authority with respect to: (i) from the date of the first IND filing and for the rest of the Term, 34 any issue that relates to the Clinical Development Plan, (ii) at any time during the Term, any submission to or other communications with a Regulatory Authority in respect of the Licensed Product, and (iii) the Manufacturing Process (including the incorporation of any Manufacturing Process Improvements) or Manufacture of the Licensed Product on or subsequent to the submission of the first Drug Approval Application in respect of the Licensed Product by Pharming, its Affiliates or Sublicensees to the applicable Regulatory Authority anywhere in the Territory, provided that Pharming shall not use its final decision-making authority to (a) require Orchard to violate any Applicable Law or any agreement it, at the time of making the relevant decision, has with a Third Party; (b) increase the Costs to be incurred by Orchard under the Clinical Development Plan by more than [***]_____] from those set out in the last version of the Clinical Development Plan or NTCR Budget (as applicable), then (c) materially amend the NTCR Activities included in the Clinical Development Plan, (d) increase the amount of time to be spent by ▇▇▇▇▇▇▇, its Affiliates or Subcontractors in performing any activities by more than [***_____] neither from those set out in the last version of the Clinical Development Plan for (e) reallocate obligations under the Clinical Development Plan from a Party will to the other Party. For clarity, prior to the date of the first IND filing, Pharming shall not have final decision-making authority with respect to such matter and the Parties will continue operating under the status quo prior to such dispute [***]; (d) if the escalated matter any issue that relates to [***], then Arrowhead will have final decision-making authority the Clinical Development Plan (including with respect to the initial Clinical Development Plan set out in Section 2.7), which must be agreed by the JSC on a unanimous basis provided that, Orchard shall not (and shall procure that its JSC representatives shall not) unreasonably withhold, condition or delay approval of any such matter; and issue (e) if the escalated matter relates to [***], then [***] Sarepta will have final decision-making authority including with respect to such matterthe initial Clinical Development Plan submitted by Orchard under Section 2.7). 35 2.

Final Decision-Making Authority. If the Executive Officers are unable not able to reach unanimous agreement agree on the resolution of any such matter escalated to them within [***] Business Days after such matter was first referred to them, then no action will be taken as to the meeting between escalated matter until a joint decision can be made by the Executive OfficersParties, then, subject to Section 7.5.4 (Exercise of Decision-Making Authority), except that the following will apply: (ai) prior to the Opt-In/Out Date, if the escalated disputed matter relates is related to a dispute over (i) whether the [***] have been met with respect to a Category 3 Program, or (ii) [***], then, in each case ((i) and (ii)): (i) each Party will appoint an independent Third Party expert having at least 15 years of pharmaceutical and biotechnology industry experience and such Third Party experts will appoint a third independent Third Party expert (the “Third Party Experts”) to resolve such matter; (ii) each Party will be entitled, within [***] Business Days after the appointment of the will have final Third Party Expertdecision-making authority, to make a written submission to the Third Party Experts explaining the basis for such Party’s position; (iii) the Third Party Experts will render a decision on such matter within [***] Business Days after such Third Party Experts’ receipt of the last such written submission by the Parties, which decision will be final and binding on the Parties; and (iv) each Party will be responsible for its own costs and expenses; provided, however, that that, if Takeda has ​ exercised its right to assume the fees of the Third Party Experts will be borne by the Party against which the Third Party Experts decide; (b) if the escalated matter relates Assumed Pre-OIOO Date U.S. Regulatory Activities pursuant to approval of (i) [***]Section ‎5.1(a)(ii), (ii) [***], (iii) [***], or (iv) [***], then neither Party Takeda will have final decision-making authority with respect to the scope of such activities so assumed; (ii) after the Opt-In/Out Date and unless Protagonist has exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right (in which case the limited discontinuation shall apply solely with respect to the applicable Licensed Product), then with respect to Rusfertide or such other Licensed Product, as applicable: (1) if the disputed matter is related to the [***], Protagonist will have final decision-making authority unless the implementation of such matter would cause an [***], (2) [***], Takeda will have final decision-making authority [***], (3) [***], then Protagonist (in the case of clause (1) ) or Takeda (in the case of clause (2)) will have final decision-making authority to undertake the implementation of such matter and the Parties will [***], and (4) [***], then Protagonist (in the case of clause (1)) or Takeda (in the case of clause (2)) will have final decision-making authority to implement such matter, [***]; (ciii) prior to the Opt-In/Out Date, if the escalated matter relates disputed change is related to [***], then [***] neither Party will have the final decision-decision making authority with respect to such matter and the Parties will continue operating under the status quo authority; (iv) prior to such dispute the Opt-In/Out Date, if the disputed change is related to [***]; (dv) after the Opt-In/Out Date and unless Protagonist has exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right (in which case the limited discontinuation shall apply solely with respect to the applicable Licensed Product), then with respect to Rusfertide or such other Licensed Product, as applicable: (1) [***], [***] will have final decision-making authority [***], (2) if the disputed matter is related to a change to the [***]: A. if such proposed change is necessitated as a result of [***], then the Parties will implement such change and [***], and B. if such proposed change is not in response to a [***]; (vi) if the escalated matter relates to a disagreement with respect to the [***], then Arrowhead such matter will have final decision-making authority be resolved in accordance with respect to such matter[***]; and​ (evii) if the escalated matter relates pertains to [***], then such matter will be resolved in accordance with Section [***]; and (viii) for clarity, [***] Sarepta will shall have final the sole decision-making authority right with respect to such matter[***].

Final Decision-Making Authority. If for any reason the Executive Officers are unable Steering Committee cannot resolve any matter properly referred to reach unanimous agreement on any such matter within [***] Business Days after the meeting between the Executive Officers, then, subject to Section 7.5.4 (Exercise of Decision-Making Authority)it, the following will applymatter shall be referred to a senior pharmaceutical executive of Neurocrine and a senior pharmaceutical executive of Pfizer for resolution. Neither of such senior pharmaceutical executives shall at the time of determination be a member of any Committee or subcommittee, and at such time shall be senior to Committee or subcommittee members appointed by such party. If such senior pharmaceutical executives after discussing the matter in good faith and attempting to find a mutually satisfactory resolution to the issue, fail to come to consensus, the final decision-making authority shall be allocated as follows: (a) if The senior pharmaceutical executive of Neurocrine will have the escalated matter relates to a dispute over final decision-making authority for decisions regarding: (i) whether the [***] have been met with respect to a Category 3 Program, or ]; (ii) [***], then, in each case ((i) and (ii)): (i) each Party will appoint an independent Third Party expert having at least 15 years of pharmaceutical and biotechnology industry experience and such Third Party experts will appoint a third independent Third Party expert (the “Third Party Experts”) to resolve such matter; (ii) each Party will be entitled, within [***] Business Days after the appointment of the final Third Party Expert, to make a written submission to the Third Party Experts explaining the basis for such Party’s position; (iii) the Third Party Experts will render a decision on such matter within [***] Business Days after such Third Party Experts’ receipt of the last such written submission by the Parties, which decision will be final and binding on the Parties; and] (iv) each Party will be responsible for its own costs [***]. *** Certain information on this page has been omitted and expenses; filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. provided, however, that Neurocrine's final decision-making authority with respect to the fees above-mentioned items shall terminate, and Pfizer shall thereafter assume final decision-making authority, with respect to each of the Third Party Experts will be borne by IR Product and the Party against which MR Product on the Third Party Experts decide;earlier of [***]. (b) if The following matters will be matters with respect to which consensus decision making by the escalated matter relates parties will be required ("Consensus Matters"). Consensus Matters must be by unanimous decision of the parties and neither party will have final decision making authority with respect to approval of these matters. The following matters are Consensus Matters: (i) [***], ; (ii) [***], (iii) [***], or ; (iv) [***], then neither Party will . *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (c) The senior pharmaceutical representative of Pfizer shall have the final decision-making authority with respect to such matter the following: (i) [***]; (cii) if the escalated matter relates to [***], then [***] neither Party will have final decision-making authority with respect to such matter and the Parties will continue operating under the status quo prior to such dispute [***]; (diii) if the escalated matter relates to [***], then Arrowhead will have final decision-making authority with respect to such matter; and; (eiv) if the escalated matter relates to [***], then (v) [***] Sarepta will ]. (d) If a committee or subcommittee has made a decision with respect to a matter without referral to the senior pharmaceutical executives as provided in this Section 3.9, a party cannot be deemed to have final decision-making authority breached Section 2.12 of this Agreement with respect to such matterdecision.