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Exhibit 10.1
CERTAIN INFORMATION IDENTIFIED BY “[***]” HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.
MARKET ACCESS SERVICES AGREEMENT
This Market Access Services Agreement (this “Agreement”) is entered into as of August 1, 2020 (the “Effective Date”) by and between Sunovion Pharmaceuticals Inc., a Delaware corporation, having a principle place of business at 84 Waterford Drive, Marlborough, MA 01752 (“Sunovion”) and Myovant Sciences GmbH, a Swiss company, having a principle place of business at Viadukstrasse 8, 4051 Basel, Switzerland (“Myovant”).  Sunovion and Myovant may individually be referred to as a “Party” and collectively as the “Parties”.
A.    Sunovion is a biopharmaceutical company that has certain capabilities with respect to the distribution and marketing of pharmaceutical products and related services;
B.    Myovant is a biopharmaceutical company seeking support with respect to certain distribution and marketing related activities for newly approved products; and
C.    Sunovion and Myovant desire to enter into this Agreement in which Myovant would engage Sunovion to provide the Services (as defined below) for the Products (as defined below) to Myovant.
THEREFORE, in consideration of the mutual covenants and promises contained herein, and for good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, intending to be legally bound hereby, it is understood and agreed upon by and between the Parties as follows:
1.DEFINITIONS
The capitalized terms used in this Agreement shall have the meanings as defined below: 
1.1“3PL Contract” has the meaning set forth in Section 4.2.1.
1.2“3PL Provider” means a Third Party that provides logistics services with respect to pharmaceutical products.
1.3“3PL Services” means the Sunovion activities required in connection with Sunovion’s facilitation of Myovant’s use of Sunovion’s 3PL Providers to ensure fulfillment by 3PL Providers of all Product orders, as further described on Exhibit A.
1.4“AAA” has the meaning set forth in Section 15.11.2.
1.5“Account Directors” has the meaning set forth in Section 4.4.1.
1.6“Affiliate” means, with respect to either Myovant or Sunovion, any corporation, company, partnership, joint venture or firm which controls, is controlled by or is under common control with Sunovion or Myovant, as the case may be, but other than any Myovant Excluded Affiliate (with respect to Myovant).  As used in the definition of Affiliate, “control” means (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), and (b) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect at least fifty percent (50%) of the members of the governing body of such non-corporate entity.  Notwithstanding the foregoing, for purposes of this Agreement, Myovant shall not be an Affiliate of 
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Sunovion and Sunovion shall not be an Affiliate of Myovant; and a Myovant Excluded Affiliate shall only be deemed an Affiliate of Myovant if (i) Myovant provides written notice to Sunovion that Myovant wishes to include such Myovant Excluded Affiliate as an Affiliate of Myovant for the purposes of this Agreement, or (ii) Myovant delegates any obligations of Myovant under this Agreement to such Affiliate. 
1.7“Agreement” has the meaning set forth in the introductory paragraph.
1.8“Alliance Manager” has the meaning set forth in Section 2.10.
1.9“AMP” means the average manufacturer price, as defined in 42 U.S.C. § 1396r-8(k)(1) and any regulations and guidance promulgated thereunder, including 42 C.F.R. § 447.500 et seq.
1.10“Applicable Law” means any federal, state, or local law, rule or regulation that may exist from time to time that applies to the obligations of the Parties under this Agreement.  Applicable Law includes (a) the Prescription Drug Marketing Act of 1987, (b) the federal healthcare program Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and related implementing regulations, and any similar state law, (c) the federal False Claims Act (31 U.S.C. §§ 3729 et seq.); (d) the Federal Civil Monetary Penalty statute and any similar state law; (e) the Foreign Corrupt Practices Act; (f) anti-corruption and improper payments regulations; (g) the Federal Food, Drug and Cosmetic Act, (h) the DSCSA and any associated implementing FDA regulations and guidance; and (i) state product distribution licensing and pedigree laws (to the extent not preempted by federal law).
1.11“ASP” means the manufacturer’s average sales price as defined in 42 U.S.C. § 1395w-3a(c) and 42 C.F.R. § 414.800, et seq.
1.12“Best Price” means the “best price” as defined in 42 U.S.C. § 1396r-8(c)(1)(C) and any regulations and guidance promulgated thereunder, including 42 C.F.R. § 447.500 et seq.
1.13“Break-Up Fee” has the meaning set forth in Section 14.7.2.
1.14“Business Day” means a day (other than a Saturday, Sunday or a public holiday) on which the banks are generally open for the transaction of general banking in Marlborough, Massachusetts, USA.
1.15“Business Terms” means the written terms provided by Myovant to Sunovion setting forth key business and legal constraints and goals, which, subject to Section 7.1, shall be used by Sunovion in connection with its performance of the MAAD Services and the Contracting Services and as otherwise specified in this Agreement or agreed upon by the Parties in writing.
1.16“cGMP” means the applicable regulatory standards and requirements for current good manufacturing practices promulgated by the FDA under and in accordance with the Federal Food, Drug & Cosmetic Act, Title 21, Parts 210, 211 and 600 of the U.S. Code of Federal Regulations, including any applicable and binding guidance documents published, as all such standards, requirements and guidance may be updated or amended from time to time.
1.17“Change of Control” means any of the following events during the Term: (a) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the total voting power of the stock then outstanding of a Party normally entitled to vote in elections of directors; (b) a Party consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into such Party, in either event pursuant to a transaction (or series of transactions) in which more than fifty percent (50%) of the total voting power of the stock outstanding of the surviving entity normally entitled to vote in elections of directors is not held by the same parties as held at least fifty percent (50%) of the outstanding shares of voting stock of the Party immediately preceding such consolidation or merger; or (c) such Party conveys, transfers, assigns or leases to any Third Party, or otherwise disposes of, all or substantially all of its assets.
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1.18“Chargeback Offsets” has the meaning set forth in Section 2 of Exhibit E.
1.19“Claims” means any complaints, charges, demands, claims, hearings, investigations, actions, inquiries, proceedings, arbitrations or suits.
1.20“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to its performance of its obligations under this Agreement, including, with respect to Sunovion, the Services, reasonable, diligent, good-faith efforts to perform such obligations as such Party would normally use to accomplish activities that are similar to such obligations on behalf of itself for its own products under similar circumstances while exercising reasonable business judgment, provided, however, that the foregoing diligence standard shall not be interpreted to be less than any diligence standard imposed by operation of Applicable Law.  With respect to a Party’s obligations, Commercially Reasonable Efforts requires that the Party: (i) promptly assign responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis; (ii) set and consistently seek to achieve specific confidential, proprietary and meaningful objectives for carrying out such obligations; and (iii) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives.
1.21“Confidential Information” means all non-public or proprietary business financial, scientific or technical information in whatever form (oral, visual or written) furnished or made available to, or otherwise acquired by, a Party from the other Party in connection with this Agreement.  Confidential Information shall also include (a) subject to Section 9.7, the terms and conditions of this Agreement, any Project Plan and any Dashboard, (b) all derivative information prepared by or on behalf of Receiving Party (such as notes, drawings, plans, projections, analyses, records and materials) that incorporates or reflects Confidential Information, and (c) with respect to Myovant, the Government Pricing Report.
1.22“Contracting Services” means the Sunovion activities required in connection with supporting and maintaining new and existing Myovant Market Access Contracts, as further described on Exhibit D.
1.23“Dashboard” has the meaning set forth in Section 6.3.3.
1.24“Disclosing Party” means the Party that discloses Confidential Information to the other Party.
1.25“Dispute” has the meaning set forth in Section 15.11.
1.26“Dollar” or “$” means the United States dollar.
1.27“DS Fees” has the meaning set forth in Section 2 of Exhibit E.
1.28“DSCSA” means the Drug Supply Chain Security Act, 21 U.S.C. § 201 et seq. and any implementing regulations or guidance thereunder.
1.29“DSP” means Sumitomo Dainippon Pharma Ltd., a Japanese company with its principal place of business at 6-8 Doshomachi 2-Chome, Chuo-ku, Osaka, 541-0045, Japan.
1.30“Effective Date” has the meaning set forth in the introductory paragraph.
1.31“Escrow Fund” means the escrow fund established by the Parties in accordance with Section 8.1.
1.32“Escrow Fund Minimum Amount” has the meaning set forth in Section 8.1.2.
1.33“Excluded” has the meaning set forth in Section 11.1.6.
1.34“Excluded Party” has the meaning set forth in Section 11.1.6.
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1.35“FDA” means the United States Food and Drug Administration and any successor entity thereto
1.36“FSS” means the Federal Supply Schedule administered by the VA.
1.37“FTE” means full time employee equivalent over a twelve (12) month period (including normal vacations, sick days and holidays).  The portion of an FTE year devoted by an employee to a particular activity or Service shall be determined by dividing the number of full working days during any twelve (12) month period devoted by such employee to such activity or Service by [***] (i.e., the total number of working days during such twelve (12) month period). 
1.38“FTE Rate for Regulatory Services” means [***] per FTE per working day.
1.39“Government Contracts” means (a) any Medicaid Rebate Program agreement, PHS 340B Program agreement, or VA Master Agreement (including the pharmaceutical pricing agreement attached thereto), in each case, as described in Section 1927(a) of the Social Security Act, (b) any Medicare Part D Coverage Program agreement as described in Section 1860D-43 of the Social Security Act, (c) any FSS contract with the Secretary of Veterans Affairs, (d) any TriCare Rebate Program agreement with the Secretary of Defense, (e) state supplemental Medicaid Rebate Program agreements, and (f) to the extent mutually agreed by the Parties, other agreements comparable to the agreements described in (a) or (e) that are with state or local government agencies or authorities or agents thereof.
1.40“Government Entities” mean the government entities that are a party to a Myovant Government Contract.
1.41“Government Pricing Programs” has the meaning set forth in Section 1 of Exhibit F.
1.42“Government Pricing Report” has the meaning set forth in Section 1 of Exhibit F.
1.43“GPO” means a group purchasing organization.
1.44“GPO/IDN Contract” means a Sunovion GPO/IDN Contract or a Myovant GPO/IDN Contract.
1.45“GPO/IDN Fees” has the meaning set forth in Section 2 of Exhibit E.
1.46“GPR Services” mean the Sunovion activities required in connection with government price reporting, as further described on Exhibit F.
1.47“IDN” means an integrated delivery network.
1.48“Initial Term” has the meaning set forth in Section 14.1.
1.49“JGC” has the meaning set forth in Section 2.1.
1.50“Losses” means liabilities, losses, damages, awards, settlements, judgments, interest, costs, fines and expenses (including all reasonable attorneys’ fees and expenses).
1.51“MAAD Customer Targets” means the regional Market Access Customers and Government Entities set forth on Exhibit J.
1.52“MAAD Services” or “Market Access Account Director Services” mean the Sunovion activities required in connection with the onboarding and maintenance of MAAD Customer Targets, as further described on Exhibit C.
1.53“Market Access Customer Fees” has the meaning set forth in Section 2 of Exhibit E.
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1.54“Market Access Customers” means any Payor or other Third Party as agreed upon by the Parties in writing.
1.55“Material Wholesaler Contracts” mean certain contracts by and between Sunovion and the Material Wholesalers.
1.56“Material Wholesalers” mean those certain Wholesalers comprised of [***], or their respective Affiliates.
1.57“Medicaid Rebate Program” means the rebate program established pursuant to 42 U.S.C. §1396r-8.
1.58“Medicare Program” means the program established pursuant to 42 U.S.C. 1395 et seq. (title XVIII of the Social Security Act).
1.59“Monthly Flat Service Charge” means, subject to Section 8.2.2, (a) [***] per calendar month for the [***], (b) [***] for the [***], and (c) an adjusted amount for each year after the [***] consistent with Section 8.2.2; provided that, (x) if the Term begins after the first day of a calendar month, such amount shall be multiplied by a fraction where the numerator is the number of days in such calendar month that are on or after the Effective Date and the denominator is the number of days in such calendar month, and (y) if the Term ends before the last day of a calendar month, such amount shall be multiplied by a fraction where the numerator is the number of days in such calendar month that are on or before the effective date of the termination or expiration of this Agreement and the denominator is the number of days in such calendar month.
1.60 “Myovant” has the meaning set forth in the introductory paragraph.
1.61“Myovant Excluded Affiliate” means (a) any Myovant Parent Affiliate and (b) any direct or indirect subsidiary of a Myovant Parent Affiliate, other than the Myovant Parent, that is controlled (as defined in Section 1.6 (Definition of “Affiliate”)) by such Myovant Parent Affiliate but is not controlled (as defined in Section 1.6 (Definition of “Affiliate”)) by the Myovant Parent or Myovant.
1.62“Myovant Government Contract” means a Government Contract covering a Product to which Myovant is a party.
1.63“Myovant GPO/IDN Contract” means a contract between Myovant and a GPO or IDN that is not a Sunovion GPO or Sunovion IDN, as applicable, that covers a Product.
1.64“Myovant Indemnitees” has the meaning set forth in Section 12.1.
1.65“Myovant Market Access Contract” means a contract by and between Myovant and a Market Access Customer for the coverage, purchase, or dispensing of a Product.
1.66“Myovant Parent” means, with respect to Myovant, any Person of which Myovant is a direct, wholly-owned subsidiary.  For clarity, as of the Effective Date, the Myovant Parent is Myovant Sciences Ltd.
1.67“Myovant Parent Affiliate” means any Person that controls (as defined in Section 1.6 (Definition of “Affiliate”)) the Myovant Parent, including, as of the Effective Date, Sumitovant and DSP.
1.68“Myovant Promotional Materials” has the meaning set forth in Section 5.4.2.
1.69“Myovant Specialty Distributor Contract” means contracts by and between Myovant and a Specialty Distributor to covering the Prostate Cancer Product.
1.70“NDA” means new drug application filed with the FDA for authorization to market any and each of the Products.
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1.71“Non-FAMP” means the non-federal average manufacturer price as defined in 38 U.S.C. § 8126, the VA Master Agreement, and any regulations and guidance promulgated thereunder.
1.72“Party” and “Parties” the meaning set forth in the introductory paragraph.
1.73“Pass-Through Expenses” means (a) the Market Access Customer Fees, (b) the DS Fees, (c) the GPO/IDN Fees, (d) the out-of-pocket costs and expenses incurred by or on behalf of Sunovion in connection with Sunovion’s provision to Myovant of reports other than the Sunovion Reports and that are specific to, and customized by Sunovion for, the Products, (e) the costs and expenses paid to a third-party recall vendor that arise in connection with the Regulatory Services, (f) reasonable travel expenses that are incurred by Sunovion, its Affiliates or a third-party service provider in connection with the performance of the Services that are incurred in accordance with a travel policy to be agreed upon in writing by the Parties, (g) software license fees, costs and expenses reasonably incurred by Sunovion or its Affiliates in connection with modification of the information technology systems reasonable necessary or useful for Sunovion to perform the Services and that have been pre-approved by Myovant in writing; provided that any costs expressly set forth herein shall be deemed to be approved by Myovant, and (h) any additional costs and expenses incurred by Sunovion in connection with the Services as agreed by the Parties in writing; in each case, (a) through (h), to the extent such amounts are not paid from the Escrow Fund in accordance with Section 8.1.3 and to the extent incurred in accordance with Section 8.2.5.
1.74“Payor” means any health maintenance organization, preferred provider organization, self-insured employer, employee group, exclusive provider or similarly funded (directly or indirectly) health benefits program, administrator, managed care organization, pharmacy benefit manager, or other health organization.
1.75“Pedigree Information” means, with respect to a Product, at least the information (which includes the Product Identifiers, Transaction History and Transaction Information (as such terms are defined in the DSCSA)) that Sunovion is required to provide to its down-stream authorized trading partners pursuant to the DSCSA.
1.76“Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
1.77“PHS 340B Program” means the drug discount program, available to “covered entities”, that is administered by the Health Resources and Services Administration pursuant to 42 U.S.C. § 256b.
1.78“Product Contracts” means any Sunovion Wholesaler Contracts, 3PL Contracts, and Sunovion GPO/IDN Contracts, and any other contracts to which Sunovion is a party, in each case, that is a contract to which a Product has been added in fulfillment of Sunovion’s obligations under this Agreement.
1.79“Product Invention” has the meaning set forth in Section 10.1.
1.80“Products” means both the Prostate Cancer Product and the Women’s Health Product.
1.81“Project Plans” has the meaning set forth in Section 6.3.1.
1.82“Prostate Cancer Product” means relugolix monotherapy (relugolix 120 mg).
1.83“RCP Payments” means Rebate Payments, Chargeback Offsets, Market Access Customer Fees, DS Fees, and GPO/IDN Fees.
1.84“RCP Services” mean the Sunovion activities required in connection with the validation, processing and payment of the RCP Payments, as further described on Exhibit E.
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1.85“Rebate Payment” has the meaning set forth in Section 2 of Exhibit E.
1.86“Receiving Party” means the Party that receives Confidential Information from the other Party.
1.87“Records” has the meaning set forth in Section 6.6.
1.88“Regulatory Service Charge” has the meaning set forth in Section 4.8.
1.89“Regulatory Services” mean regulatory-related activities, as further described on Exhibit G.
1.90“Renewal Term” has the meaning set forth in Section 14.1.
1.91“Service Charge” has the meaning set forth in Section 8.2.1.
1.92“Services” means the 3PL Services; Wholesaler, GPO, and IDN Services; MAAD Services; Contracting Services; GPR Services; RCP Services; Regulatory Services; and Training Services.
1.93“Specialty Distributors” means [***], and any other distributors agreed to by the Parties in writing from time to time.
1.94“Subcommittee” has the meaning set forth in Section 2.8.
1.95“Sunovion” has the meaning set forth in the introductory paragraph.
1.96“Sunovion Administrative Affiliate” means Sumitomo Dainippon Pharma America, Inc.
1.97“Sunovion GPO/IDN Contract” means contracts by and between Sunovion and a GPO or IDN to which the Women’s Health Product has been or will be added by written agreement between Sunovion and such GPO or IDN.
1.98“Sunovion GPOs” means any GPO that is a party to a Sunovion GPO/IDN Contract.
1.99“Sunovion IDNs” means any IDN that is a party to a Sunovion GPO/IDN Contract.
1.100“Sunovion Indemnitees” has the meaning set forth in Section 12.2.
1.101“Sunovion Property” has the meaning set forth in Section 10.3.
1.102“Sunovion Reports” has the meaning set forth in Section 6.3.
1.103“Sunovion Wholesaler Contract” means contracts by and between Sunovion and a Wholesaler to which the Women’s Health Product has been or will be added by written agreement between Sunovion and such Wholesaler.
1.104“Sumitovant” means Sumitovant Biopharma Ltd., a Bermuda exempted company by shares.
1.105“Term” has the meaning set forth in Section 14.1.
1.106“Territory” means the United States, the District of Columbia, and all of the United States’ territories and possessions.
1.107“Third Party” means any Person other than a Party or an Affiliate of a Party.
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1.108“Training Services” mean the Sunovion activities related to the provision of certain training to Myovant and/or Sunovion employees on certain details related to the Services and the Products, as further described on Exhibit H.
1.109“TriCare Rebate Program” means the rebate program described in the final rule published by the Department of Defense at 74 Fed. Reg. 11,279 to implement Section 703 of the National Defense Authorization Act of 2008, and includes rebates pursuant to any voluntary rebate agreement described therein.
1.110“VA” means the United States Department of Veterans Affairs.
1.111“VA Master Agreement” means an agreement between a pharmaceutical manufacturer and the VA to implement the provisions of the Veterans Health Care Act of 1992, 38 U.S.C. § 8126.
1.112“Wholesaler” means any wholesaler or distributor of pharmaceutical products or similar trade partner.
1.113“Wholesaler, GPO, and IDN Services” mean the Sunovion activities required in connection with the performance of Sunovion’s obligations under, or in connection with, the Sunovion Wholesaler Contracts, Myovant Specialty Distributor Contracts, GPO/IDN Contracts, and Myovant Market Access Contracts, as further described on Exhibit B.
1.114“Women’s Health Product” means relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg).
1.115“Work Product” has the meaning set forth in Section 10.1.
2.JOINT GOVERNANCE COMMITTEE
2.1Joint Governance Committee.  Within [***] after the Effective Date, the Parties shall establish a joint governance committee (the “JGC”), which shall be responsible for overseeing the performance of the Services as set forth in Section 2.3.
2.2Composition.  The JGC shall consist of three (3) representatives from each Party, each with the requisite experience and seniority to enable such representative to make decisions on behalf of the Party it represents with respect to the issues falling within the jurisdiction of the JGC.  From time to time, each Party may substitute one (1) or more of its representatives to the JGC on written notice to the other Party.  Each individual appointed by a Party as a representative to the JGC shall be an employee of such Party or of such Party’s Affiliate.  Sunovion shall select from its representatives of the JGC the initial chairperson for the JGC.  Each July 1 after the Effective Date, the Party that does not have its representative serving as chairperson shall select from its representatives of the JGC the chairperson for the following calendar year.  The JGC may allow observers from a Party to attend its meetings upon the other Party’s prior written consent.
2.3Responsibilities.  The JGC shall:
2.3.1.review and update the MAAD Customer Targets set forth on Exhibit J as necessary;
2.3.2.establish coverage goals with respect to each Product;
2.3.3.agree upon in writing the number of FTEs necessary for Sunovion to provide the Regulatory Services;
2.3.4.identify any training to be provided by Sunovion to Sunovion field colleagues as part of the Training Services; 
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2.3.5.review Business Terms and deviations from the Business Terms, in each case, that are escalated to the JGC pursuant to Section 7.1;
2.3.6.review disputes escalated to the JGC pursuant to Section 7.2;
2.3.7.review and approve changes to the Escrow Fund Minimum Amount in accordance with Section 8.1.2;
2.3.8.evaluate and approve appropriate incentive-based programs and methodologies to encourage the Account Directors to achieve certain milestones or objectives that are consistent with the Business Terms;
2.3.9.establish an efficient and secure method of transmission for the Records, including the Government Pricing Report;
2.3.10.establish a process for the review and written approval by the Parties of any policies and procedures specified in this Agreement, including to ensure Services are performed in accordance with Applicable Law;
2.3.11.establish the process by which Account Directors and Sunovion’s federal account director team will obtain input from Myovant’s market access leadership team and pricing and contracting committee for purposes of providing MAAD Services, Contracting Services, or as otherwise necessary to perform the Services hereunder;
2.3.12.establish procedures by which Account Directors will coordinate reactive Myovant medical science liaison activities with such MAAD Customer Targets;
2.3.13.issue advice and guidance to Account Directors with respect to their performance of the MAAD Services;
2.3.14.establish a written validation process to confirm that invoices for RCP Payments are attributable to eligible Product utilization only and are consistent with the terms and conditions of the applicable Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, GPO/IDN Contract or Myovant Market Access Contract;
2.3.15.review and approve any amendments to the Services; provided that any such amendments or updates shall be memorialized in a writing signed by a representative of the JGC from each Party;
2.3.16.review the activities of any Subcommittees established by the JGC, and resolve any disagreement between the designees of Sunovion and Myovant on any Subcommittee;
2.3.17.(a) establish, during the Term, key performance metrics in connection with the Services, and, (b) track such metrics; 
2.3.18.provide a forum for discussing and recommending consensus resolution of any disputes within the jurisdiction of the JGC; and
2.3.19.perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing.
2.4.Meetings.  The JGC shall meet [***] during the [***] of the Term, and [***] thereafter, or as otherwise agreed to by the Parties.  The meetings may be conducted as in-person meetings, teleconferences or video conferences, as agreed to by the Parties, with the location of in-person meetings alternating between a location designated by Sunovion and a location designated by Myovant, with Sunovion designating the place of the first in-person meeting; provided in each case that any in-person meeting shall be held within 
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the United States.  The chairperson of the JGC shall be responsible for calling meetings of the JGC on no less than [***] notice unless exigent circumstances require shorter notice.  Each Party shall make all proposals for agenda items at least [***] in advance of the applicable meeting and shall provide all appropriate information with respect to such proposed items at least [***] in advance of the applicable meeting; provided, that under exigent circumstances requiring input by the JGC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably conditioned, withheld or delayed).  The chairperson of the JGC shall prepare and circulate, or cause to be prepared and circulated, for review and approval of the Parties minutes of each meeting within [***] after the meeting.  The Parties shall strive to agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JGC. 
2.5.Procedural Rules.  The JGC shall have the right to adopt standing rules as necessary for the JGC to conduct business; provided that that such rules are not inconsistent with this Agreement.  A quorum of the JGC shall exist whenever there is present at a meeting at least [***] representatives appointed by each Party.  Representatives of the Parties on the JGC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by and be heard by, the other participants.  Representation by proxy shall be allowed.
2.6.Decision-Making.  The JGC shall take action by consensus of the Parties at a meeting at which a quorum exists.  Each Party shall have a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) authorized representative of each Party and expressly approving such action of the JGC.  Except for matters outside the jurisdiction and authority of the JGC, as applicable (including as set forth in Section 2.7), if the JGC cannot, or does not, reach consensus on an issue within [***] after such issue is first presented to the JGC for consideration, then either Party shall have the right to refer such issue to the Chief Executive Officers of the Parties for attempted resolution by good faith negotiations during a period of at least [***] in accordance with Section 15.11.  Any final decision mutually agreed to by the Chief Executive Officers of the Parties in writing shall be conclusive and binding on the Parties.
2.7.Limitations on Authority.  Without limitation to the foregoing, the Parties hereby agree that matters explicitly reserved to the consent, approval, discretion or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and decision-making authority of the JGC, including amendment, modification or waiver of compliance with this Agreement, which must occur in accordance with Section 15.9 (Waiver and Amendments).
2.8.Subcommittees.  From time to time, the JGC may establish and delegate duties to sub-committees or directed teams (each, a “Subcommittee”) on an “as-needed” basis to oversee specific Services.  Each such Subcommittee shall be constituted and shall operate as the JGC determines; provided that each Subcommittee shall have equal representation from each Party, unless otherwise mutually agreed.  Subcommittees may be established on an ad hoc basis for purposes of a specific Service or on such other basis as the JGC may determine.  Each Subcommittee and its activities shall be subject to the oversight, review and approval of, and shall report to, the JGC.  In no event shall the authority of the Subcommittee exceed that specified for the JGC.  All decisions of a Subcommittee shall be by consensus.  Any disagreement between the designees of Sunovion and Myovant on a Subcommittee shall be referred to the JGC for resolution.
2.9.Expenses.  Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JGC or any Subcommittee.  For purposes of clarity, the foregoing travel and related costs and expenses shall not be Pass-Through Expenses.
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2.10.Alliance Manager.  Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the JGC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an “Alliance Manager”).  Each Party shall be responsible for all travel and related costs and expenses for its Alliance Manager.  For purposes of clarity, the foregoing travel and related costs and expenses shall not be Pass-Through Expenses.  Each Party may replace its Alliance Manager at any time by notice in writing to the other Party.
3.APPOINTMENT
3.1Subject to the terms and conditions of this Agreement, Myovant hereby appoints Sunovion, and Sunovion hereby accepts such appointment, to be Myovant’s (a) “co-licensed partner” (for the purposes of the DSCSA), as that term is defined by the DSCSA, with regard to the Products, and (b) (i) an exclusive distributor of the Women’s Health Product, and (ii) a non-exclusive distributor of the Prostate Cancer Product, in each case (i) and (ii), in the Territory.  For avoidance of doubt, Sunovion shall not be considered an “exclusive distributor” as that term is defined by the DSCSA with respect to any Product.
4.Sunovion Obligations.
4.1Generally; Efforts; Product Contracts.  
4.1.1.During the Term, Sunovion shall, subject to Section 5, use Commercially Reasonable Efforts to perform, or cause to be performed by the Sunovion Administrative Affiliate, Sunovion’s obligations under this Agreement, including those in Sections 4.2 through 4.9.  
4.1.2.Sunovion shall provide copies of Product Contracts to support Myovant’s compliance with Applicable Law, Government Contracts, and for Myovant’s review and validation of Sunovion’s Government Pricing Report and underlying government pricing calculation methodologies (including ensuring that such methodologies align with Myovant’s reasonable assumptions).  Sunovion may redact certain provisions of the Product Contracts that (i) are related to a Sunovion product, or (ii) are required to maintain an obligation of confidentiality to the counterparty to such Product Contract and are not related to the applicable Product. 
4.2.3PL Services.   
4.2.1No later than [***] after the Effective Date, Sunovion shall, subject to Section 4.1 and Myovant’s termination right under Section 14.6.1: (a) add the Products to the contract(s) by and between Sunovion and its 3PL Provider(s) (excluding any quality agreement) (the “3PL Contract(s)”), (b) negotiate rates for (i) [***], and (ii) [***], and (c) provide reasonable evidence to Myovant that the obligations under (a) and (b) have been fulfilled.
4.2.2After Sunovion’s fulfilment of Sunovion’s obligations pursuant to Section 4.2.1, unless this Agreement is earlier terminated by Myovant pursuant to Section 14.6.1, Sunovion shall, subject to Section 4.1, perform the 3PL Services.  In the performance of the 3PL Services, Sunovion shall ensure that neither Sunovion nor a 3PL Provider takes title to the Products.
4.3Wholesaler, GPO, and IDN Services.
4.3.1.Sunovion shall, subject to Section 4.1: 
(a)(i) add the Women’s Health Product to Sunovion GPO/IDN Contracts and Sunovion Wholesaler Contracts, (ii) negotiate rates for the Women’s Health Product under such Sunovion GPO/IDN Contracts and Sunovion Wholesaler Contracts that [***]; provided that, [***] and subject to Section 5.3.3, (1) [***], and (2) [***], and (iii) provide reasonable evidence to Myovant that the obligations under (i) and (ii) have been fulfilled.
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(b)(i) [***] after the Effective Date, engage in discussions with each of the Material Wholesalers [***], and (ii) provide a summary of such discussions to Myovant.
4.3.2Sunovion shall, subject to Section 4.1, configure, or cause to be configured, the appropriate software by [***] to enable Sunovion to perform its obligations under this Agreement with respect to the Prostate Cancer Product, provided that (a) Sunovion shall not be obligated to perform any obligations under this Agreement that requires such configured software until such software configuration is complete, and (b) the reasonable, out-of-pocket costs and expenses incurred by or on behalf of Sunovion in connection therewith shall be deemed to be Pass-Through Expense to the extent such amounts are not in excess of amounts permitted in accordance with Section 8.2.5.  Sunovion shall provide Myovant regular updates on the progress of such configuration activities and, if Sunovion anticipates that such software configuration will be delayed after [***], then it shall promptly notify Myovant of such potential delay and the projected length of such delay, and discuss with Myovant the potential actions to minimize such delay.
4.3.3After Sunovion’s fulfilment of Sunovion’s obligations pursuant to Section 4.3.1 with respect to the Women’s Health Product and Section 4.3.2 with respect to the Prostate Cancer Product, unless this Agreement is earlier terminated by Myovant pursuant to Section 14.6.2, Sunovion shall, subject to Section 4.1, perform the Wholesaler, GPO, and IDN Services with respect to Products covered by a Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, GPO/IDN Contract, or Myovant Market Access Contract.  
4.4MAAD Services. 
4.4.1Sunovion shall provide [***] FTEs shall be allocated across [***] Sunovion employees with the title “[***]” in the Territory and [***] FTEs shall be allocated across Sunovion’s [***].
4.4.2Sunovion shall promptly inform Myovant if the Business Terms do not permit Sunovion to perform the MAAD Services.  If Sunovion believes that it needs additional Business Terms, then it shall specify such additional Business Terms and Myovant shall use Commercially Reasonable Efforts to provide such Business Terms.
4.4.3Sunovion shall, subject to Section 4.1, perform the MAAD Services.
4.5Contracting Services.  
4.5.1Sunovion shall, subject to Section 4.1, configure, or cause to be configured, the [***] by [***] to enable Sunovion to perform its obligations under this Agreement, provided that (a) Sunovion shall not be obligated to perform any obligations under this Agreement that requires such configured software until such software configuration is complete, and (b) the reasonable, out-of-pocket costs and expenses incurred by or on behalf of Sunovion in connection therewith shall be deemed to be Pass-Through Expense to the extent such amounts are not in excess of the amounts permitted in accordance with Section 8.2.5.  Sunovion shall provide Myovant regular updates on the progress of such configuration activities and, if Sunovion anticipates that such software configuration will be delayed after [***], then it shall promptly notify Myovant of such potential delay and the projected length of such delay, and discuss with Myovant the potential actions to minimize such delay.
4.5.2Sunovion shall, subject to Section 4.1, perform the Contracting Services.
4.6RCP Services.  Sunovion shall, subject to Section 4.1 and Section 4.3.2 as Section 4.3.2 relates to the Prostate Cancer Product, perform the RCP Services.
4.7GPR Services.  
4.7.1Sunovion shall, subject to Section 4.1, perform the GPR Services.
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4.7.2In connection with the GPR Services, (a) the Parties have agreed upon the form and format of the Government Pricing Report, and (b) Sunovion agrees to meet (by teleconference or in-person, as agreed upon by the Parties) with Myovant after the delivery of each Government Pricing Report at a mutually agreeable time, which shall not be [***], to discuss the Government Pricing Report and applicable executive summary.
4.8Regulatory Services.   
4.8.1In connection with the Regulatory Services, Sunovion shall provide the necessary number of FTEs as agreed upon in writing by the Parties from time to time at the FTE Rate for Regulatory Services (the “Regulatory Service Charge”).
4.8.2Sunovion shall, subject to Section 4.1, perform the Regulatory Services.
4.9Training Services.  Sunovion shall, subject to Section 4.1, perform the Training Services.
5.Myovant Obligations.
5.1Generally; Efforts.  During the Term, Myovant shall use Commercially Reasonable Efforts to perform its obligations under this Agreement, including, without limitation, the obligations set forth in this Section 5.
5.23PL Services.  
5.2.1In connection with the 3PL Services, subject to Section 5.1, Myovant shall provide to Sunovion in writing information requested by Sunovion and reasonably necessary for Sunovion to perform the 3PL Services within [***] after the Effective Date.
5.2.2Prior to consignment of the Product to a 3PL Provider pursuant to the terms of a 3PL Contract, Myovant shall, subject to Section 5.1 (a) release the Product in accordance with (i) cGMP, and (ii) any serialization requirements under the DSCSA and policies and procedures to be agreed upon by the Parties in writing; (b) transmit all Pedigree Information related to the Product to Sunovion, and (c) Sunovion shall have received and verified such Pedigree Information.
5.2.3In connection with the 3PL Services, Myovant shall, subject to Section 5.1, (a) coordinate shipment of the Product, at Myovant’s cost and expense, to the 3PL Provider designated by Sunovion; (b) cause the Product to be consigned to Sunovion; (c) use Commercially Reasonable Efforts to enter into a quality agreement with each 3PL Provider and Sunovion prior to consignment of any Product to Sunovion; and (d) refrain from actions which would cause Sunovion to be in material breach of any covenant, representation, or warranty contained in any agreement by and between Sunovion and a 3PL Provider to which a Product has been consigned, provided that a copy of such agreement, or a copy or summary of the applicable provisions in such agreement, has been provided to Myovant in advance for review.
5.3Wholesaler, GPO, and IDN Services.  
5.3.1For avoidance of doubt, [***].
5.3.2In connection with the Wholesaler, GPO, and IDN Services, Myovant shall, subject to Section 5.1, (a) provide to Sunovion in writing information as requested and reasonably necessary for Sunovion to perform the Wholesaler, GPO, and IDN Services within [***] after the Effective Date (and updated as necessary thereafter), (b) comply with the terms and conditions of the applicable Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, or GPO/IDN Contract and any policies and procedures agreed upon in writing by the Parties regarding Product returns, provided that a copy of any Sunovion Wholesaler Contract or Sunovion GPO/IDN Contract, or a copy or summary of the applicable provisions in such Sunovion Wholesaler Contract or Sunovion GPO/IDN Contract, has been provided to Myovant in 
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advance for review, (c) promptly provide Sunovion with any information requested by Sunovion that is necessary for Sunovion to properly complete Product returns, and (d) upon the reasonable request by Sunovion, cooperate with Sunovion in the conduct of any investigation regarding a Product ordered by a Wholesaler, Specialty Distributor or GPO/IDN.
5.3.3Myovant shall, subject to Section 5.1, ensure that (a) its directors, officers, employees, contractors and agents, as applicable, use best efforts to confer with Sunovion at least [***] in advance of any communication with a Sunovion GPO or Sunovion IDN relating to a GPO/IDN Contract to align on a meeting strategy to employ in connection with the Wholesaler, GPO and IDN Services, and (b) a Sunovion representative has an opportunity to participate in any such communication with such Sunovion GPO or Sunovion IDN in connection with the Wholesaler, GPO, and IDN Services unless Sunovion elects in writing not to participate.
5.4MAAD Services.  
5.4.1In connection with the MAAD Services, Myovant shall, subject to Section 5.1, provide to Sunovion in writing the Business Terms specified on Schedule 5.4.1 necessary for Sunovion to perform the MAAD Services at least [***] prior to the date on which FDA commits to complete its review of the NDA for the applicable Product pursuant to the Prescription Drug User Fee Act.
5.4.2Subject to Section 7.4, Myovant shall be solely responsible for the development of disease state and/or Product-specific training materials (the “Myovant Promotional Materials”) for use by Sunovion’s Account Directors and for training Sunovion’s Account Directors.  All reasonable out-of-pocket costs and expenses related to an Account Director’s training, including travel, material development and material production expenses (but not including time), shall be the sole cost of Myovant, and shall be subject to approval by Myovant in advance of such training.  At the request of Myovant, training will be provided to Sunovion field colleagues for a fee agreed upon by the Parties that shall be added to the Monthly Flat Service Charge.
5.5Contracting Services.
5.5.1In connection with the Contracting Services, Myovant shall, subject to Section 5.1, (a) provide un-redacted copies of each Myovant Market Access Contracts, Myovant Government Contracts, Myovant GPO/IDN Contracts, and Myovant Specialty Distributor Contracts entered into by Myovant to Sunovion to the extent not already provided, provided that Sunovion shall not use such Myovant Market Access Contracts, Myovant Government Contracts, Myovant GPO/IDN Contracts, and Myovant Specialty Distributor Contracts for any purpose other than in furtherance of Sunovion’s obligations under this Agreement, and (b) identify a Myovant employee to be a dedicated liaison that will communicate with Sunovion from time to time as reasonably requested by Sunovion to complete the Contracting Services.
5.5.2Myovant shall, subject to Section 5.1, be responsible for ensuring that the Myovant Market Access Contract, Myovant Government Contracts, Myovant GPO/IDN Contracts, and Myovant Specialty Distributor Contracts permit Sunovion to perform the RCP Services and the GPR Services.
5.6RCP Services.  Upon Sunovion’s reasonable request from time to time, Myovant shall provide assistance to Sunovion in connection with Sunovion’s performance of the RCP Services to the extent such performance relates to a contract to which Sunovion is not a party.
5.7GPR Services.  Myovant hereby acknowledges and agrees that it (a) [***], (b) [***], and (c) is solely responsible for (i) entering the information contained in the Government Pricing Report into the Centers for Medicare & Medicaid Services Drug Data Reporting System (or other applicable system), and (ii) certifying and submitting such government pricing data to the applicable government authority in accordance with Applicable Laws, in each case (i) and (ii), as required under Applicable Law, including under the Government Pricing Programs, and applicable state laws, rules and regulations.  Government 
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Pricing Report shall be confidential information of Myovant, and Sunovion shall have an express right to use the Government Pricing Report solely for the performance of the GPR Services.
5.8Regulatory Services.  
5.8.1Solely in connection with the Regulatory Services, upon written notice from Sunovion to Myovant which notice shall identify the cause triggering the audit, Myovant shall permit Sunovion to conduct a for-cause audit of Myovant’s quality systems that solely relate, as reasonably determined by Myovant, to Sunovion’s performance of the Regulatory Services, provided that such audit is at Sunovion’s sole cost and expense, during normal business hours and at an agreed upon date and time.
5.8.2Myovant shall promptly, but in no event less than [***], notify Sunovion in the event that a recall is issued for any Product.
5.9Training Services.  Myovant shall, upon reasonable request by Sunovion, provide to Sunovion’s Account Directors certain training to enable Sunovion to perform the Services.  Such training may, to the extent feasible, be administered virtually or as otherwise agreed upon by the Parties.
6.OPERATIONS
6.1Title and Risk of Loss.  At no time during the Term shall Sunovion or 3PL Provider have title to the Products.  At all times during the Term, title to the Products shall either be with Myovant or an applicable Wholesaler or Specialty Distributor, and, as between Myovant and Sunovion, risk of loss of Products shall be with Myovant at all times; provided that to the extent the risk of loss of the Products are contractually assigned to a 3PL Provider, Wholesaler, or Specialty Distributor pursuant to 3PL Contract, Sunovion Wholesaler Contract, or Myovant Specialty Distributor Contract respectively, Sunovion shall, subject to Section 4.1, enforce any rights of such contractual assignment of risk of loss for the benefit of Myovant.
6.2Regulatory Responsibility.  Except as expressly set forth in this Agreement, as between Sunovion and Myovant, Myovant (as the owner and applicant of the NDA for each Product) shall be solely responsible, at Myovant’s sole cost and expense, for all regulatory obligations related to the Products, including without limitation annual product reports, drug listing updates, serious adverse event reports, field alerts, and DSCSA reporting and recordkeeping.  Subject to Section 6.5 and Applicable Law, Myovant, not Sunovion, shall have the sole right to interact with FDA regarding the Products.
6.3Project Plans and Dashboards. 
6.3.1Certain activities described in Section 6.3.2 that will be performed by the Parties in connection with, or pursuant to, this Agreement will be described in written project plans (collectively, “Project Plans”), which shall be agreed in writing by the Parties no later than [***]; provided that such Project Plans (a) with respect to such activities that are performed by a Party, may be modified by such Party from time to time upon written notice to the other Party, and (b) shall not change the scope of, or be inconsistent with, the Parties’ obligations under this Agreement.  Each Project Plan shall be substantially consistent in form with the template attached as Schedule 6.3.1.
6.3.2The Project Plans will cover the following activities: [***]
6.3.3The personnel designated by each Party shall deliver a weekly dashboard for each Project Plan (each, a “Dashboard”), which may be circulated internally within each Party.  In the case where a Project Plan includes activities performed by each Party, such personnel shall work together in good faith to agree on each weekly Dashboard prior to internal circulation.  Each Dashboard shall be substantially consistent in form with the template attached as Schedule 6.3.3.   
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6.4Sunovion Reporting Obligations.  Sunovion shall (a) provide the reports set forth on Exhibit I (collectively, the “Sunovion Reports”) to Myovant at the frequency that corresponds to each such report; and (b) within a reasonable period of time, provide to Myovant any information that is reasonably requested by Myovant and necessary for Myovant to perform its obligations hereunder, subject to Myovant paying any Pass-Through Expenses incurred by Sunovion in accordance with Section 8.2.5.
6.5Myovant Reporting Obligations.  In connection with the Services, Myovant shall (a) submit a report to Sunovion (i) within [***] after the end of each calendar year describing the [***] for the current calendar year, (ii) within [***] prior to launch of a Product, the [***], and (iii) within [***] prior to launch of a Product, the [***], (b) within a reasonable period of time, provide to Sunovion any report or Product-related information that is reasonably requested by Sunovion or necessary for Sunovion to perform the Services, (c) provide Sunovion with copies of all submissions to any regulatory authority that are reasonably requested by Sunovion or are necessary for Sunovion to perform the Services, and (d) on [***], prepare in good faith a [***] to enable Sunovion to adequately prepare for performance of the Services.
6.6Records; Record Retention; Records Audits.  Sunovion will maintain all Work Product generated by Sunovion in connection with the Services (collectively, the “Records”) for a period of [***] or as required by Applicable Laws, whichever is longer.  Sunovion will, at the direction and written request of Myovant, promptly deliver Records to Myovant or its designee, or dispose of the Records.  Sunovion shall develop a process to transmit Records from Sunovion to Myovant in the event that Myovant requires such Records for an audit by a Third Party, including a government authority.
7.Decision-Making Authority; Discretion; Review Rights.
7.1Myovant Business Terms and Deviations.  Myovant’s pricing and contracting committee will have final decision-making authority with respect to the Business Terms and any deviations from such Business Terms.  If, at any time, Sunovion reasonably determines that (a) Business Terms, or (b) a deviation from such Business Terms during the negotiation of the applicable contract, in either case, do not comply with Applicable Law or pose (i) pricing-related reputational risk, (ii) legal risk, or (iii) compliance risk, in any case, to Sunovion or its Affiliates, such Business Terms or such deviation shall be escalated to the JGC. 
7.2Wholesaler, GPO, and IDN Disputes.  [***].
7.3Product Price Increases.  [***].  Any dispute that arises in connection with the foregoing shall be escalated to the respective Chief Executive Officers of Myovant and Sunovion.  If the Parties respective Chief Executive Officers are not able to resolve the dispute, then, upon mutual consent, the Parties may escalate the dispute to the Parties’ ultimate parent company, DSP, for further discussion, for so long as DSP controls (as defined in Section 1.6) each Party (directly or indirectly).  For clarity, (i) if the dispute is not escalated to DSP (as a result of no mutual consent or that DSP no longer controls (as defined in Section 1.6) each Party (directly or indirectly)), or (ii) if DSP is unable to resolve the dispute, then, in either case, Myovant will have final decision-making authority with respect to all pricing decisions relating to the Products.
7.4Myovant Promotional Materials.  [***]. 
8.FINANCIAL TERMS
8.1Escrow Fund.  
8.1.1At least [***] prior to the launch of a Product (a) the Parties shall establish the Escrow Fund at a reputable banking institution agreed upon by the Parties, and (b) Myovant shall place [***] into the Escrow Fund for [***].  Any agreement by and among such banking institution, Sunovion and Myovant shall (x) not require Sunovion to seek approval from Myovant to withdraw funds from the Escrow Fund if such withdrawal is in connection with Sunovion’s performance of the RCP Services, (y) permit Sunovion to transfer funds from the Escrow Fund to an intermediate Sunovion bank account to enable Sunovion to 
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complete RCP Payments in connection with Sunovion’s performance of the RCP Services, and (z) permit Myovant to withdraw any amount in excess of the Escrow Fund Minimum Amount at any time.
8.1.2Notwithstanding the foregoing, during [***], Myovant shall ensure that the Escrow Fund shall not have less than [***] (the “Escrow Fund Minimum Amount”) for any period of time that is longer than [***].  The JGC shall discuss in good faith an adjustment to the Escrow Fund Minimum Amount [***] after the launch of such Product and every [***] thereafter.  In the event that Myovant fails to timely fund the Escrow Fund, Sunovion may terminate this Agreement if such failure to fund the Escrow Fund is not cured within [***] of receipt of notice of such failure from Sunovion.
8.1.3Sunovion shall use the funds on the Escrow Fund only as described in numbered Section 2 of Exhibit E and Section 8.2.3, or as otherwise approved in writing by Myovant.  Upon Sunovion’s receipt of payment from a Wholesaler, Specialty Distributor, or GPO/IDN for an applicable invoice, Sunovion shall promptly transfer such amount to the Escrow Fund. 
8.1.4Within [***] after the end of each calendar year in which there is an Escrow Fund, the Parties shall reconcile the amount remaining in Escrow Fund against all of the RCP Payments and other withdrawals initiated by Sunovion as permitted by this Agreement.  After such reconciliation, in the event that the Escrow Fund has an amount that is less than the Escrow Fund Minimum Amount, or such other amount as determined by the JGC from time to time, Myovant shall reconcile any shortfall within [***].
8.2Fees; Invoices; Payments.  
8.2.1In consideration for performance of the Services by Sunovion, Myovant shall (a) pay to Sunovion an amount equal to the sum of (i) the Monthly Flat Service Charge, and (ii) any agreed to Regulatory Service Charge (the sum of (i) and (ii), the “Service Charge”), and (b) reimburse Sunovion for any documented Pass-Through Expenses incurred in accordance with Section 8.2.5.  Sunovion and Myovant hereby acknowledge and agree that the Services Charge constitutes the fair market value in an arms-length transaction for the Services that Sunovion has agreed to perform thereunder, and has not been determined in any manner that takes into account the volume or value of any current or future referrals or business otherwise generated between Myovant and Sunovion, and is designed to fit within the personal services and management contracts safe harbor to the federal Anti-Kickback Statute, 42 C.F.R. § 1001.952(d) and shall comply with the requirements of any bona fide service fee requirements, as applicable under pertinent government price reporting standards.
8.2.2Subject to the remainder of this Section 8.2.2, Sunovion reserves the right to adjust all fees [***], including the Monthly Flat Service Charge and Regulatory Service Charge, upon reasonable prior written approval of Myovant, such approval not to be unreasonably withheld, conditioned or delayed.  Determination of the Monthly Flat Service Charge for the [***] and each year thereafter shall be subject to good faith negotiation between the Parties that will take into consideration any evidence that Sunovion provides in connection with a proposed increase to the Monthly Flat Service Charge.  The Parties agree that it shall be unreasonable for Myovant to reject a fee increase if Sunovion provides evidence that such fee increase results solely from a fee increase by any vendor engaged by Sunovion on Myovant’s behalf.  
8.2.3At the end of each calendar month, Sunovion shall submit (a) an invoice to Myovant for an amount equal to the sum of (i) the Service Charges, and (ii) the Pass-Through Expenses incurred by Sunovion in connection with the Services during the prior calendar month in accordance with Section 8.2.5, and (b) reasonable documentation to Myovant as evidence of any Pass-Through Expenses and, with respect to Pass-Through Expenses incurred in connection with 3PL Contracts and Sunovion Wholesaler Contracts, sufficient to permit Myovant to confirm that rates are [***].  Myovant shall pay Sunovion all undisputed invoice amounts within thirty (30) days after receipt thereof.  If Myovant disputes any invoice, it shall notify Sunovion in writing of such dispute within thirty (30) days after receipt thereof and the Parties’ respective Chief Financial Officer (or a designee) shall discuss in good faith to resolve such dispute.  If 
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such dispute is not resolved within ten (10) days of such dispute notice, then either Party may refer such dispute for resolution in accordance with Section 15.11.
8.2.4Sunovion agrees that, in the performance of the Services, it shall not make any “payments or transfers of value,” as that phrase is defined under the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and any implementing regulations thereunder (the “Sunshine Act”), that may be reportable under the Sunshine Act without prior Myovant approval.  The Parties agree that the process for reviewing and approving potentially reportable “payments or transfers of value” and the handling of any reporting obligations thereunder shall be discussed and resolved by the JGC.
8.2.5Before Pass-Through Expenses are incurred, the Parties shall work in good faith to agree in writing on all such Pass-Through Expenses, including, as applicable, on one or more written budgets that set forth such Pass-Through Expenses.  For clarity, the Market Access Customer Fees, DS Fees, GPO/IDN Fees and Pass-Through Expenses related to a 3PL Contract will be deemed to be approved upon addition of a Product to the applicable Myovant Market Access Contract, Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, GPO/IDN Contract, or 3PL Contract.  Notwithstanding anything in this Agreement to the contrary, Myovant shall have no obligation to pay any Pass-Through Expense that is not approved in writing by Myovant before being incurred.
8.3Taxes.  Myovant shall be responsible for all sales, use and excise taxes, and any other similar taxes, duties and charges of any kind imposed by any federal, state or local governmental entity (a) on any amounts payable by Myovant hereunder, and (b) related to the Products, including without limitation the branded prescription drug fee pursuant to 26 C.F.R. Parts 51 and 602; provided, that, in no event shall Myovant pay or be responsible for any taxes imposed on, or with respect to, Sunovion’s income, revenues, gross receipts, personnel or real or personal property or other assets.
8.4Financial Records; Financial Audits.  Sunovion will keep all financial records relating to its use of the Escrow Fund and performance of the Services for a period of [***] or as required by Applicable Laws, whichever is longer.  Myovant, or its independent auditors or representatives, may, at Myovant’s sole cost and expense, during normal business hours, and upon reasonable notice, review and inspect Sunovion’s financial records solely related to (a) Sunovion’s use of funds from the Escrow Fund, and (b) the Service Charges and Pass-Through Expenses invoiced to Myovant or paid by Myovant, in each case, for the purpose of determining if use of the Escrow Fund and invoices submitted by Sunovion reflect the terms and conditions agreed to under this Agreement.  Myovant or its independent auditors or representatives may conduct such financial audit no more than one time per calendar year during the Term and for a period of twelve (12) months thereafter, or more frequently for good cause.  Myovant shall be responsible for the cost of any such audit, except that, if the auditor determines that Myovant has overpaid any amounts owed to Sunovion hereunder by [***] ([***]) or more, Sunovion shall pay the costs and expenses of such audit, and any overpaid amounts that are discovered, together with reasonable interest on such overpaid amounts.  The results of such audit shall be final and binding, absent manifest error.
8.5Regulatory/Compliance Records; Regulatory/Compliance Audits.  Sunovion shall keep reasonable regulatory and compliance records relating to its performance of the Services for a period of [***] after the end of performing such Services.  Myovant, or its independent auditors or representatives, may, no more than one (1) time per calendar year, during normal business hours, and upon reasonable notice, review and inspect Sunovion’s regulatory and compliance records relating to Sunovion’s performance of the Services.
9.Confidentiality
9.1Obligations of Confidentiality.  During the Term and thereafter, Receiving Party agrees to (a) hold all Confidential Information in confidence and not, directly or indirectly, publish, disseminate or otherwise disclose, deliver or make available to any Third Party or Affiliates any Confidential Information, except as expressly permitted in this Agreement or, with respect to Sunovion, to the Sunovion Administrative Affiliate; provided that Sunovion may disclose Confidential Information to DSP (i) upon receipt of prior 
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written consent from Myovant, not to be unreasonably denied, or (ii) to the extent such Confidential Information relates to obligations of Sunovion under this Agreement; (b) use Confidential Information solely in furtherance of the purpose of this Agreement, (c) treat Confidential Information with the same degree of care that Receiving Party uses to protect its own confidential information, but in no event with less than a reasonable degree of care, (d) reproduce Confidential Information solely as necessary to further the purpose of this Agreement, (e) provide Confidential Information through a permission-controlled system to its employees on need-to-know basis solely to the extent that such Confidential Information is reasonably necessary for exercise of its rights or fulfillment of its obligations under this Agreement, and (f) notify Disclosing Party upon discovery of any unauthorized use or disclosure of any Confidential Information or any other breach of this Section 9 by Receiving Party and to cooperate with Disclosing Party in every reasonable way to help Disclosing Party regain possession of the Confidential Information and prevent its further unauthorized use.
9.2Exceptions.  Receiving Party shall have no obligations of confidentiality and non-use with respect to any Confidential Information which:
9.2.1is, or later becomes, generally available to the public or trade by the use, publication or the like, through no fault of, or act, or failure to act on the part of Receiving Party, as evidenced by the then existing publication or other public dissemination of such information in written or other documentary form;
9.2.2is obtained, after the Effective Date, by Receiving Party from a Third Party on a non-confidential basis and such Third Party had the legal right to disclose such Confidential Information to Receiving Party;
9.2.3is independently developed by the Receiving Party without reliance on Disclosing Party’s Confidential Information, as evidenced by the contemporaneous written records of Receiving Party that are maintained in the ordinary course of business; or
9.2.4Receiving Party already knows prior to the date of any disclosure by Disclosing Party, as evidenced by the contemporaneous written records of Receiving Party that are maintained in the ordinary course of business. 
9.3Disclosures Required by Law.  In the event that Receiving Party is (a) requested in any judicial or administrative proceeding or by any governmental or regulatory authority to disclose any Confidential Information, Receiving Party shall give Disclosing Party prompt notice of such request so that Disclosing Party may seek an appropriate protective order, or (b) compelled by a judicial or administrative proceeding or by any governmental or regulatory authority to disclose any Confidential Information, in either case, Receiving Party shall give Disclosing Party prompt prior written notice of such event and shall furnish only that portion of such Confidential Information that is legally required and shall exercise all reasonable efforts to obtain reliable assurance that confidential treatment will be afforded to such Confidential Information.
9.4Work Product.  Notwithstanding that Sunovion will be the Disclosing Party with respect to the Work Product, (a) the Work Product shall be deemed to be the Confidential Information of Myovant, and (b) Myovant shall be deemed to be the “Disclosing Party” and Sunovion shall be deemed to be the “Receiving Party” with respect thereto.
9.5Ownership.  All Confidential Information is and will remain the sole and exclusive property of Disclosing Party.  Except for the limited right to use Confidential Information solely in accordance with this Agreement, no ownership interests, rights or licenses whatsoever, either express or implied, are granted hereunder by Disclosing Party to Receiving Party under any patents or patent applications, copyrights, trademarks, trade secrets, or other intellectual property rights now or hereafter acquired, developed, or controlled by Disclosing Party.  Disclosing Party retains all rights and remedies afforded under all patent, copyright, trade secret, and other Applicable Law for protecting confidential, proprietary, or trade secret information.
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9.6Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance.  The restrictions imposed by this Section 9.6 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Party’s counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon.
9.7Publicity.  Neither Party shall issue any other public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed.  In the event a Party is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon; provided, however, that the contents of any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter that has been reviewed and approved by a Party may be re-released by the other Party without the approving Party’s additional written consent for such re-release.
9.8Injunctive Relief.  Each Party agrees that (a) the Disclosing Party may be irreparably injured by an impending or existing breach of this Section 9; (b) money damages would not be an adequate remedy for any such breach; and (c) the Disclosing Party will be entitled to seek equitable relief, including injunctive relief and specific performance, without proof of damages or having to post a bond, as a remedy for any such breach.  Such injunctive relief shall be in addition to any other rights or remedies to which the Disclosing Party may otherwise be entitled.
10.OWNERSHIP; INVENTIONS; License Grant
10.1Ownership.  Myovant shall own all: (a) materials, data, analyses, reports and other work product related solely to a Product generated by Sunovion or its subcontractors in connection with the Services, including the Government Pricing Report (“Work Product”); and (b) all inventions (whether patentable or not), improvements, developments and intellectual property rights, in each case, that (i) are conceived, reduced to practice, made or authored by Sunovion or its subcontractors (whether solely or jointly with Myovant) under this Agreement, and (ii) relate solely to a Product (“Product Inventions”).  All other ownership rights shall be determined in accordance with United States patent laws.
10.2Assignment.  Sunovion shall disclose all Work Product and Product Inventions to Myovant promptly after they are conceived, reduced to practice, made or authored.  Sunovion hereby assigns (and shall cause its subcontractors to assign) to Myovant all of Sunovion’s (and its subcontractors’) right, title and interest in any and all Work Product and Product Inventions without any additional consideration, and Sunovion shall assist (and shall cause its subcontractors to assist) Myovant in the prosecution, maintenance and enforcement of such Product Inventions, at Myovant’s reasonable expense.  Sunovion shall require its Affiliates, and its and their employees, consultants and subcontractors, to assign to Sunovion all right, title and interest in any and all Work Product and Product Inventions, and shall require each to assist Sunovion, in each case such that Sunovion can fulfill its obligations under the foregoing assistance.
10.3Sunovion Property.  Notwithstanding Section 10.1, Sunovion will retain all right, title and interest in and to (a) all materials, data, analyses, reports and other work product that do not solely relate to the Products and are generated by or on behalf of Sunovion (whether alone or jointly with others) under this Agreement, including any Project Plans prepared by or on behalf of Sunovion, (b) all programs, methodologies, policies, processes, platforms, technologies and other materials developed or licensed by Sunovion prior to 
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or apart from performing the Services or its obligations under this Agreement ((a) and (b) collectively, the “Sunovion Property”), regardless of whether such Sunovion Property is used in connection with Sunovion’s performance of the Services or its obligations under this Agreement, and (c) any improvements and modifications made by Sunovion to Sunovion Property.
10.4License Grant.  Myovant hereby grants to Sunovion a non-exclusive license, with the right to grant sublicenses solely to the extent that is necessary for performing the Services in accordance with this Agreement, under any intellectual property rights owned or controlled by Myovant, including with respect to the Work Product, solely for Sunovion’s use in connection with its performance of the Services.  Except as otherwise expressly provided herein, nothing in this Agreement is intended to grant to either Party any rights under any intellectual property right of the other Party.
11.Representations, warranties and covenants 
11.1Mutual.  Each of the Parties hereby represent, warrant and covenant to the other Party that:
11.1.1it is and will remain a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of organization.
11.1.2the execution and delivery of this Agreement has been authorized by all requisite corporate action;
11.1.3this Agreement is and will remain a valid and binding obligation of it, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors;
11.1.4it is under no contractual or other obligation or restriction that is inconsistent with its execution or performance of this Agreement;
11.1.5during the Term, it will not, directly or indirectly, enter into any agreement, either written or oral, that would constitute an actual conflict with its responsibilities under this Agreement; 
11.1.6it, its Affiliates, and each of their respective officers, directors, employees and subcontractors, as applicable: (a) have not been debarred and are not subject to a pending debarment, and will not use in any capacity in connection with the Services, any person who has been debarred or is subject to a pending debarment, pursuant to section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a, (b) are not ineligible to participate in any federal procurement or non-procurement programs or any “Federal Health Care Programs” (as that term is defined in 42 U.S.C. 1320a-7b(f)), including, but not limited to, Medicare, Medicaid, or TRICARE (c) are not included on the List of Excluded Individuals and Entities maintained by the Department of Health and Human Services Office of Inspector General (“OIG”) or the General Services Administration’s System for Award Management exclusion database (d) are not disqualified by any government or regulatory agencies from performing specific services, and are not subject to a pending disqualification proceeding (collectively “Excluded”) (in the event that a Party, during the term of this Agreement, is or becomes Excluded (the “Excluded Party”), the other Party may terminate this Agreement immediately without further obligation upon written notice to the Excluded Party); and 
11.1.7it, its Affiliates, and each of their respective officers, directors, employees and subcontractors, as applicable, have not been convicted of a criminal offense related to the provision of healthcare items or services, and are not subject to any such pending action.  
Each Party will promptly notify the other Party if it, its Affiliates or any of their respective officers, directors, employees and subcontractors, as applicable, are or become subject to the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of such Party’s knowledge, is threatened.  The non-breaching Party shall have the right to immediately terminate this Agreement if the representation and warranties in Section 11.1.6 is or becomes untrue.
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11.2.Sunovion.  Sunovion hereby represents, warrants and covenants to Myovant that:
11.2.1it will perform the Services in accordance with Applicable Law; 
11.2.2it will ensure that any Product Contracts include obligations with respect to compliance with laws (or a right to indemnification for a counterparty’s failure to comply with laws) and obligations of confidentiality no less restrictive than those included in this Agreement, subject to any customary qualifications ordinarily applied to such obligations;
11.2.3it will not employ or contract with any individual or entity to perform any of the Services under this Agreement who is debarred, disqualified, excluded, or otherwise sanctioned by any local state, federal, or international governmental body, or is subject to an administrative, civil, or criminal proceeding which could result in such sanctions by a governmental body; and
11.2.4it has obtained and will maintain, at all times during the Term, the required licenses, permits and authorizations necessary to perform the Services and/or commercialize the Products in the Territory. 
11.3Myovant.  Myovant hereby represents, warrants, and covenants to Sunovion that:
11.3.1it will perform its obligations in furtherance of the Services in accordance with Applicable Law;
11.3.2it will provide current, accurate and complete sales and pricing data under the Myovant Government Contracts, Myovant Market Access Contracts, Myovant Specialty Distributor Contracts, and Myovant GPO/IDN Contracts or otherwise to Sunovion for purposes of Sunovion’s performance of the Services;
11.3.3it will obtain and maintain, at all times during the Term, the required licenses necessary to commercialize the Products in the Territory;
11.3.4the Products (a) are free from defect in design, material and workmanship, (b) are manufactured and commercialized in compliance with Applicable Law, including in accordance with cGMP, (c) have been approved by FDA prior to sale, (d) are not articles which may not be introduced into interstate commerce, (e) are not infringing upon the patents, trademarks or other intellectual property rights of any Third Party, and (f) comply with all traceability aspects of the DSCSA;
11.3.5[***];
11.3.6[***];
11.3.7[***]; and
11.3.8[***].
[***].
12.INDEMNIFICATION; LIMITATION OF LIABILITY
12.1Indemnification by Sunovion.  Sunovion agrees to indemnify, defend and hold Myovant, its Affiliates, and its and their respective officers, directors, employees, subcontractors, and agents (collectively, the “Myovant Indemnitees”) harmless from and against any and all Losses resulting from any Claims by a Third Party to the extent such Claim results from, arises from or out of, relates to, is in the nature of, or is caused by (a) any non-compliance of any federal, state or local governmental laws, rules, regulations or statutes by a 3PL Provider that is a party to a 3PL Contract, where such non-compliance relates to such 3PL Provider’s failure to hold all necessary licenses, permits, and authorizations necessary to provide the 3PL 
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Services or otherwise damages Myovant, (b) a breach of any representation, warranty or covenant of Sunovion set forth anywhere in this Agreement, (c) disputes that result from Sunovion exercising its final decision-making authority set forth in Section 7.2(a); provided that if such dispute results from the JGC’s final decision-making authority set forth in Section 7.2(b), then the Parties shall negotiate in good faith an appropriate allocation of responsibility under the circumstances, (d) any recall, quarantine, warning or withdrawal of any Product solely caused by Sunovion’s performance of the Services, (e) government pricing calculations performed by Sunovion on behalf of Myovant in connection with the GPR Services solely to the extent such calculations were not performed in accordance with Sunovion’s government price calculation methodologies approved in writing by Myovant, and (f) the negligence, gross negligence or willful misconduct of Sunovion in connection with this Agreement; except, in each case (clauses (a) through (f)), to the extent that such Losses (or part thereof) results from a Claim that is an indemnifiable event pursuant to Section 12.2, in which case Myovant shall indemnify the Sunovion Indemnitees for such Losses (or part thereof) in accordance with Section 12.2.
12.2Indemnification by Myovant.  Myovant agrees to indemnify, defend and hold Sunovion, its Affiliates, and its and their respective officers, directors, employees, permitted subcontractors and permitted agents (collectively, the “Sunovion Indemnitees”) harmless from and against any and all Losses resulting from any Claims by a Third Party to the extent such Claim results from, arises from or out of, relates to, is in the nature of, or is caused by (a) death of, or bodily injury to, any person on account of the use of any Product, (b) disputes that arise between Myovant and a Market Access Customer, Government Entity, Specialty Distributor or a GPO or IDN that is not a Sunovion GPO or Sunovion IDN that relate to a Myovant Market Access Contract, Myovant Government Contract, Myovant Specialty Distributor Contract or a Myovant GPO/IDN Contract, respectively, (c) disputes that result from Myovant exercising its final decision-making authority set forth in Section 7.2(c); provided that if such dispute results from the JGC’s final decision-making authority set forth in Section 7.2(b), then the Parties shall negotiate in good faith an appropriate allocation of responsibility under the circumstances; (d) any recall, quarantine, warning or withdrawal of any Product not solely caused by Sunovion’s performance of the Services, (e) government pricing calculations performed by Sunovion on behalf of Myovant in connection with the GPR Services; provided that such calculations were performed by Sunovion in accordance with Sunovion’s government price calculation methodologies approved in writing by Myovant, (f) a breach of any representation, warranty or covenant of Myovant set forth in this Agreement, and (g) the negligence, gross negligence or willful misconduct of Myovant in connection with this Agreement; except, in each case (clauses (a) through (g)), to the extent that such Losses (or part thereof) results from a Claim that is an indemnifiable event pursuant to Section 12.1, in which case Sunovion shall indemnify the Myovant Indemnitees for such Losses (or part thereof) in accordance with Section 12.1. 
12.3Indemnification Procedure.  The indemnifying party’s agreement and obligation to indemnify, defend and hold the other harmless is conditioned on the indemnified party: 
12.3.1promptly providing written notice to the indemnifying party of any Claim resulting from, arising from or out of, relating to, in the nature of, or caused by the indemnified activities set forth in Section 12.1 and Section 12.2, at most within [***] after becoming aware of such Claim; provided that failure to provide prompt notice will relieve the indemnifying party of its indemnification obligations only to the extent that indemnifying party has been materially prejudiced as a result of such failure;
12.3.2permitting the indemnifying party to assume full responsibility to select its choice of counsel, investigate, prepare for and defend against any such Claim; provided that the indemnified party shall have the right to retain separate legal counsel and participate in any defense of any Claim at its own expense;
12.3.3reasonably assisting the indemnifying party, at the indemnifying party’s reasonable expense, in the investigation of, preparation for, and defense of any such Claim; and
12.3.4not compromising or settling such Claim without the indemnifying party’s written consent.  
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The indemnifying party may not, without the indemnified party’s written consent, compromise or settle any Claim resulting from, arising from or out of, relating to, in the nature of, or caused by the indemnified activities set forth in Section 12.1 and Section 12.2 if such compromise or settlement admits liability on behalf of or imposes any restrictions or obligations on the indemnified party.  The indemnifying party shall make quarterly payments to the indemnified parties for any documented Losses resulting from such Claim.
12.4.Limitations of Liability. 
12.4.1EXCEPT WITH REGARD TO DAMAGES ARISING FROM A PARTY’S (A) BREACH OF SECTION 9 (CONFIDENTIALITY), (B) OBLIGATIONS UNDER SECTION 12.1 (INDEMNIFICATION BY SUNOVION) AND SECTION 12.2 (INDEMNIFICATION BY MYOVANT), (C) FAILURE TO COMPLY WITH APPLICABLE LAW, (D) GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, AND (E) FRAUD, IN NO EVENT SHALL A PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, EXEMPLARY, PUNITIVE, AND SPECIAL DAMAGES. 
12.4.2EXCEPT WITH REGARD TO LOSSES ARISING FROM A PARTY’S (A) BREACH OF SECTION 9 (CONFIDENTIALITY), (B) OBLIGATIONS UNDER SECTION 12.1 (INDEMNIFICATION BY SUNOVION) AND SECTION 12.2 (INDEMNIFICATION BY MYOVANT), (C) FAILURE TO COMPLY WITH APPLICABLE LAW, (D) GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, AND (E) FRAUD, IN NO EVENT SHALL SUNOVION’S LIABILITY FOR LOSSES IN CONNECTION WITH THIS AGREEMENT EXCEED [***] THE SERVICE CHARGES ACTUALLY PAID BY MYOVANT TO SUNOVION UNDER THIS AGREEMENT DURING THE [***] PERIOD PRECEDING THE EVENT GIVING RISE TO SUCH LOSSES.
12.4.3NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, (A) SUNOVION SHALL NO LIABILITY FOR THIRD PARTY CLAIMS ARISING OUT OF GOVERNMENT PRICING CALCULATIONS PERFORMED BY SUNOVION ON BEHALF OF MYOVANT UNDER THIS AGREEMENT; PROVIDED THAT SUCH CALCULATIONS WERE PERFORMED BY SUNOVION IN ACCORDANCE WITH SUNOVION'S GOVERNMENT PRICE CALCULATION METHODOLOGIES APPROVED IN WRITING BY MYOVANT, AND (B) TO THE EXTENT ANY PRODUCTS ARE LOST OR DAMAGED WHILE IN THE CUSTODY OF A 3PL PROVIDER, THE TERMS OF SECTION 6.1 SHALL APPLY AND MYOVANT HEREBY AGREES TO THE LOSS AND DAMAGE LIMITATIONS SET FORTH IN THE APPLICABLE CONTRACT BETWEEN SUNOVION AND SUCH 3L PROVIDER.
13.INSURANCE
13.1Myovant Insurance.  Myovant shall (a) maintain (i) general liability insurance including premises and operations, broad form property damage, independent contractors, and contractual liability covering its obligations under this Agreement, with a combined single limit of not less than [***] on a per occurrence and aggregate basis, and (ii) product liability insurance including contractual liability for all products and completed operations and any work supplied pursuant to the terms and conditions of this Agreement, not less than [***] on a per occurrence and aggregate basis, and (b) add Sunovion as an additional insured to all of the above state policies.  
13.2Sunovion Insurance.  Sunovion shall (a) maintain (i) general liability insurance including premises and operations, broad form property damage, independent contractors, and contractual liability covering its obligations under this Agreement, with a combined single limit of not less than [***] on a per occurrence and aggregate basis, and (ii) product liability insurance including contractual liability for all products and completed operations and any work supplied pursuant to the terms and conditions of the Agreement, no less than [***] on a per occurrence and aggregate basis, and (b) add Myovant as an additional insured to all of the above stated policies.  
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13.3Claims-Made Policies.  If any of the above stated policies are on a claims-made basis, then the insured party shall maintain such policy in effect through a period of not less than [***] following the termination or expiration of this Agreement.
14.TERM; TERMINATION
14.1Term.  This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the terms of this Agreement, shall continue in full force and effect for [***] (the “Initial Term”).  Thereafter, this Agreement will automatically extend for additional [***] (each, a “Renewal Term”, each Renewal Term collectively with the Initial Term, the “Term”), unless either Party provides the other Party written notice of non-renewal of this Agreement not later than [***] prior to the expiration of the Initial Term or then current Renewal Term, in which case this Agreement shall terminate upon the expiration of the Initial Term or then current Renewal Term.
14.2Termination by for Material Breach.  Either Party may terminate this Agreement upon [***] prior written notice to the other Party if the other Party materially breaches this Agreement and fails to cure the breach during such notice period.
14.3Termination for Insolvency.  Subject to applicable bankruptcy laws, either Party may terminate this Agreement effective immediately in the event that the other Party: (a) has become insolvent (defined as such Party being subject to a voluntary or involuntary bankruptcy petition which is not dismissed ) or has been dissolved or liquidated, has filed itself a petition, case or other proceeding under the applicable bankruptcy laws relating to bankruptcy, dissolution, liquidation, winding up or reorganization; (b) makes a general assignment for the benefit of creditors; or (c) has a receiver, custodian, trustee or other person exercising similar functions appointed for all or substantially all of its assets.
14.4Termination upon Change in Law.  Upon the enactment, promulgation, rescission, modification, or interpretation (by a competent judiciary or regulatory authority) of any state or federal law or regulation after the Effective Date, which (a) materially adversely affects the manner in which either Party is obligated to perform under this Agreement; (b) renders this Agreement or any provision hereof illegal or unenforceable; (c) has the effect of requiring any material terms applicable under this Agreement to be extended or offered to any Third Parties; or (d) imposes additional payment obligations or costs to either Party, the affected Party may, in each case, after good faith discussion with the other Party in an attempt to resolve any issues to the mutual satisfaction of the Parties, terminate this Agreement.
14.5Termination for Change of Control.  In the event of a Change of Control of either Party, the other Party may terminate this Agreement upon [***] prior written notice to the Party that underwent a Change of Control (or its successor).
14.6Termination by Myovant.
14.6.1Upon written notice to Sunovion, Myovant may terminate this Agreement if Sunovion has not [***] at rates that are [***] by the date that is [***] after the Effective Date; provided that prior to any such termination by Myovant, the Parties will cooperate in good faith to identify and negotiate in good faith the execution of alternative services that may be provided to Myovant by Sunovion in lieu of such termination at the discretion of Myovant; provided, further, that if Sunovion fulfils all of its obligations pursuant to Section 4.2.1 before Myovant terminates this Agreement pursuant to this Section 14.6.1, then Myovant shall no longer have the right to terminate this Agreement pursuant to this Section 14.6.1.
14.6.2Upon written notice to Sunovion, Myovant may terminate this Agreement if (a) [***] provide feedback to Sunovion that the [***] definitively cannot be added to the Material Wholesaler Contracts [***],  (b) Sunovion has failed to [***], or (c) the [***] software configurations required by Sections 4.3.2 and 4.5.1 are not completed by [***] and, as a result, Sunovion is unable to perform the related Services; provided that prior to any such termination by Myovant, the Parties will cooperate in good faith to identify 
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and negotiate in good faith the execution of alternative services that may be provided to Myovant by Sunovion in lieu of such termination at the discretion of Myovant; provided, further, that if Sunovion (i) [***], or (ii) substantially completes the [***] software configurations, as applicable, such that Sunovion is able to perform the related Services, in either case, before Myovant terminates this Agreement pursuant to this Section 14.6.2, then Myovant shall no longer have the right to terminate this Agreement pursuant to this Section 14.6.2.
14.6.3Myovant may terminate this Agreement as follows: (a) for any reason upon [***] prior written notice, provided that such termination shall only be effective upon the expiration of such [***] notice period if Sunovion has received the Break-Up Fee; or (b) only with respect to the Women’s Health Product or Prostate Cancer Product upon [***] prior written notice, provided that (i) [***], and (ii) such termination shall only be effective upon the expiration of such [***] notice period if Sunovion has received the Break-Up Fee.
14.7Effect of Termination or Expiration.
14.7.1Upon expiration of this Agreement or termination of this Agreement for any reason, neither Myovant nor Sunovion will have any further obligations under this Agreement, except that:
(a)any liabilities, to the extent that Myovant is liable, that relate to the Services provided before the termination or expiration this Agreement shall be the responsibility of Myovant even if claims for such liabilities are first made after the termination or expiration this Agreement;
(b)each Party will promptly return to the other Party all Confidential Information and all copies of Confidential Information associated with this Agreement, provided that each Party may retain one copy of Confidential Information to determine its obligations hereunder, provided such Party’s obligations set forth in Section 9 shall continue to apply to such retained copy; and
(c)Sunovion shall (i) use Commercially Reasonable Efforts to remove the Products from Sunovion GPO/IDN Contracts, Sunovion Wholesaler Contracts, and Sunovion 3PL Contracts in a timeframe agreed upon by the JGC and shall cooperate with and provide information to Myovant, in a form reasonably requested by Myovant, solely to the extent needed for Myovant to fulfill its ongoing obligations under and in compliance with Applicable Laws, any Myovant Government Contracts, Myovant GPO / IDN Contracts, Myovant Market Access Contracts, and Myovant Specialty Distributor Contracts, and (ii) upon Myovant’s request, provide, at Myovant’s expense which shall be agreed upon by the Parties in good faith, reasonable assistance to transition the Services to Myovant or its designee;
(d)with respect to any termination by Sunovion under Section 14.5, Sunovion shall, at the request of Myovant (i) continue to perform the Services under this Agreement for a period of up to [***] after the date such termination became effective, provided that Myovant continues to perform its obligations under this Agreement, including making all payments due under Section 8, and (ii) provide, at Myovant’s expense which shall be agreed upon by the Parties in good faith, reasonable assistance to transition the Services to Myovant or its designee;  
(e)the terms and conditions under Sections 1 (Definitions), 8.2 (Fees; Invoices; Payments), 8.3 (Taxes), 9 (Confidentiality), 10 (Ownership; Inventions), 12 (Indemnification; Limitation of Liability), 14.7 (Effect of Termination or Expiration) and 15 (Miscellaneous) will survive any such termination or expiration of this Agreement.
14.7.2Upon notice of termination of this Agreement by Sunovion pursuant to Section 14.5 following a Change of Control of Myovant, or by Myovant pursuant to Section 14.6.3, Myovant shall pay to Sunovion, prior to the effective date of such termination, a break-up fee of (a) [***] ([***]), if this Agreement is terminated within [***] of the Effective Date, or (b) [***] ([***]), if this Agreement is terminated later 
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than [***] after the Effective Date and before [***] of the Effective Date (each, (a) and (b), a “Break-Up Fee”); provided, that if Myovant terminates this Agreement solely with respect to one (1) of the Products pursuant to Section 14.6.3(b), Myovant shall only be obligated to pay [***] ([***]) of the Break-Up Fee; provided further, that, if Myovant subsequently terminates this Agreement with respect to the remaining Product, Myovant shall be obligated to pay [***] ([***]) of the Break-Up Fee.  For the avoidance of doubt, there is no Break-Up Fee if this Agreement is terminated, in its entirety or with respect to one (1) of the Products, later than [***] after the Effective Date.
15.MISCELLANEOUS
15.1Publicity.  Neither Party may use the other Party’s name or company artwork (for example, logo) on a website or in any form of advertising, promotion or publicity, including press releases, without the prior written consent of the other Party.  This term does not restrict a Party’s ability to use the other Party’s name in filings with the United States Securities and Exchange Commission or foreign equivalent, the United States Food and Drug Administration, or other governmental agencies, or when required by law to make a public disclosure.
15.2Notices.  All notices must be in writing and sent to the address for the recipient set forth below or at such other address as the recipient may specify in writing under this procedure.  All notices must be given (a) by personal delivery, with receipt acknowledged, or (b) by first class, prepaid certified or registered mail, return receipt requested, or (c) by prepaid national express delivery service.  Notices will be effective upon receipt or at a later date stated in the notice.
						
	If to SUNOVION:
	If to MYOVANT:

	Sunovion Pharmaceuticals Inc.
84 Waterford Drive
Marlborough, MA 01752
Attn: President and CEO
	Myovant Sciences GmbH 
c/o Myovant Sciences, Inc. 
2000 Sierra Point Parkway
Brisbane, CA 94405
Attn: President and CFO

	With a copy to:
Sunovion Pharmaceuticals Inc.
84 Waterford Drive
Marlborough, MA 01752
Attn: General Counsel
	With a copy to:
Myovant Sciences GmbH 
c/o Myovant Sciences, Inc. 
2000 Sierra Point Parkway
Brisbane, CA 94405
Attn: General Counsel

	With a copy to (which shall not constitute notice):

Reed Smith LLP
506 Carnegie Center
Suite 300
Princeton, NJ 08540-7839
Attn: Diane Frenier
	

15.3Assignment.  Neither Party will assign, transfer or otherwise dispose of this Agreement in whole or in part to any Third Party without the prior written consent of the other Party; provided that (i) Myovant may assign this Agreement without such consent, in whole or in part, to any Affiliate, and (ii) Sunovion may assign this Agreement without such consent to the Sunovion Administrative Affiliate; provided further that such Affiliate remains an Affiliate of the assigning Party during the Term.  Any successor or assignee of rights or obligations permitted hereunder must, in writing to the other Party, expressly assume performance 
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of such rights or obligations.  Any permitted assignment will be binding on the successors of the assigning Party.  No assignment will relieve either Party of the performance of any accrued obligation that such Party may then have under this Agreement.  This Agreement shall be binding upon, and inure to the benefit of the Parties and their respective legal representatives, heirs, successors and permitted assigns.  Any assignment or attempted assignment by either Party in violation of the terms of this Section 15.3 will be null, void and of no legal effect.
15.4Change of Control.
15.4.1Each Party (or its successor) shall provide the other Party with written notice of any Change of Control within [***] following the closing date of such transaction.
15.4.2If: (a) Myovant undergoes a Change of Control and Sunovion does not terminate this Agreement pursuant to Section 14.5, or (b) Sunovion undergoes a Change of Control and Myovant does not terminate this Agreement pursuant to Section 14.5, then, in each case, the Party that undergoes a Change of Control shall (i) ensure that all activities performed by or on behalf of such Party for the benefit of its successor are kept separate from the activities performed under or in connection with this Agreement; and (ii) establish and cause its applicable Affiliates to establish reasonable internal safeguards that prevent any Confidential Information of the other Party from being utilized for the benefit of the successor of the Party that undergoes a Change of Control.
15.5Independent Contractor.  All Services will be rendered by Sunovion as an independent contractor of Myovant for federal, state and local income tax purposes and for all other purposes.  Neither Party will represent itself to be a partner or joint venturer of or with the other Party.
15.6Severability; Reformation.  If for any reason a court of competent jurisdiction finds any provision of this Agreement or any portion of such a provision to be invalid or unenforceable, such provision will be reformed to the extent required to make the provision valid and enforceable to the maximum extent permitted by Applicable Law.
15.7Entire Agreement.  This Agreement, including the attached Exhibits, each of which is incorporated herein, constitutes the entire agreement between the Parties with respect to the specific subject matter of this Agreement, and supersedes all negotiations, prior discussions, agreements or understandings, whether written or oral, with respect to the subject matter hereof.
15.8Force Majeure.  Nonperformance of either Party shall be excused to the extent that such performance is rendered impossible by fire, flood, earthquake, mass disaster, governmental acts, orders or restrictions, terrorism, epidemic, pandemic, or any other reason where failure to perform is beyond the reasonable control of the non-performing Party and is not caused by the non-performing Party’s negligence.  If any condition contemplated by this Section 15.8 shall continue for a period of [***], the non-breaching Party shall have the option of terminating this Agreement and, in such event, neither Party shall incur any liability for performance or payment other than for the Services satisfactorily provided up to and including the date of termination.
15.9Waiver and Amendments.  The failure of any Party to insist on the performance of any obligation hereunder will not be deemed to be a waiver of such obligation.  No waiver of any term, provision or condition of this Agreement in any one or more instances will be deemed to be or construed as a further or continuing waiver or a waiver of any other term, provision or condition of this Agreement.  No waiver, modification, release or amendment of any term, provision or condition of this Agreement (including the attached Exhibits) will be valid or effective unless evidenced by an instrument in writing executed by an officer authorized to execute such waiver, modification, release or amendment.
15.10Governing Law. The validity, interpretation and enforcement of this Agreement, matters arising out of or related to this Agreement or its making, performance or breach, and related matters shall be governed by 
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the laws of the State of Delaware without reference to choice of law doctrine.  The Parties expressly reject any application to this Agreement of (a) the United Nations Convention on Contracts for the International Sale of Goods, and (b) the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980.
15.11Dispute Resolution.  
15.11.1Subject to Section 7.2 and 7.3, if a dispute arises between the Parties in connection with or relating to this Agreement, including disputes that arise within the scope of the JGC, or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 15.11.  Any Dispute shall first be referred to the Chief Executive Officers of the Parties, who shall confer in good faith on the resolution of the issue.  Any final decision mutually agreed to by the Chief Executive Officers shall be conclusive and binding on the Parties.  If the Chief Executive Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Chief Executive Officers) after such issue was first referred to them, then, either Party may, by written notice to the other Party, submit such Dispute to non-binding mediation.  In the event that non-binding mediation is unable to resolve such Dispute, a Party shall submit such Dispute to binding arbitration in accordance with Section 15.11.2.
If any Dispute has not been resolved by good faith negotiations between the Parties pursuant to Section 15.11.1, then the Parties shall endeavor to settle the dispute by submitting the matter to binding arbitration by the American Arbitration Association (“AAA”) in New York, New York.  Such arbitration may be conducted under the commercial rules then in effect for the AAA except as provided herein.  All such proceedings shall be held in English and a transcribed record prepared in English.  Each Party shall choose one (1) arbitrator within [***] of receipt of notice of the intent to arbitrate.  Such arbitrators shall thereafter choose a third arbitrator within [***] of their appointment.  Any arbitrator chosen by the Parties or arbitrators will not have a material financial interest in any Party and will have significant experience with the arbitration of similar large, complex, commercial disputes between pharmaceutical companies.  Each Party in any arbitration proceeding commenced hereunder shall bear such Party’s own costs and expenses (including expert witness and attorneys’ fees) of investigating, preparing and pursuing such arbitration claim.  Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name, intellectual property or Confidential Information.  If the Dispute involves scientific or technical matters, any arbitrator chosen hereunder shall have educational training and/or experience sufficient to demonstrate a reasonable level of knowledge in the applicable field.  The award rendered by the arbitrators with respect to such Dispute shall be written, final and non-appealable, and judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  The existence and contents of the arbitration shall be kept confidential by each Party except to the extent that disclosure may be required to fulfil a legal duty, protect or pursue a legal right, or enforce or challenge an award in legal proceedings.

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15.12Headings.  This Agreement contains headings only for convenience and the headings do not constitute a form or part of this Agreement, and should not be used in the construction of this Agreement.
15.13Counterparts.  This Agreement may be executed in any number of counterparts, each of which will be deemed to be an original, and all of which together will constitute one and the same instrument.

[Signature Page to Follow]

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives, effective as of the Effective Date.
															
		Sunovion Pharmaceuticals Inc.			Myovant Sciences, GmbH
					
					
	By:	/s/ Thomas E. Gibbs
		By:	/s/ Slava Rakov
					
	Name:	Thomas E. Gibbs
		Name:	Slava Rakov
					
	Title:	SVP, Chief Commercial		Title:	Director and VP Medical Affairs

Exhibit A — 3PL 
Exhibit B — WHOLESALER, GPO, AND IDN SERVICES
Exhibit C — MAAD SERVICES
Exhibit D — CONTRACTING SERVICES
Exhibit E — RCP SERVICES
Exhibit F — GPR SERVICES
Exhibit G — REGULATORY SERVICES
Exhibit H — TRAINING SERVICES
Exhibit I — SUNOVION REPORTS
Exhibit J – MAAD Customer Targets
Schedule 5.4.1 – BUSINESS TERMS
Schedule 6.3.1 – PROJECT PLAN TEMPLATE
Schedule 6.3.3 – DASHBOARD TEMPLATE

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Exhibit A — 3PL SERVICES
To the extent that Sunovion is able to add a Product to the 3PL Contract(s), 3PL Services shall include the following obligations:
1.Communication Activities.  Upon request by a 3PL Provider, Sunovion shall facilitate communication between Myovant and such 3PL Provider to which Products have been consigned.
2.Additional 3PL Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit B — WHOLESALER, GPO, AND IDN SERVICES
With respect to the Products, the Wholesaler, GPO and IDN Services shall include the following obligations:
1.Order Management.  Sunovion shall manage and process all orders (and adjustments thereto) for the Products from Market Access Customers, Wholesalers, Specialty Distributors, GPOs, and IDNs (or downstream GPO member or IDN that ordered Product pursuant to an applicable GPO/IDN Contract) in accordance with the terms and conditions of the applicable Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, or GPO/IDN Contract.  Such order management and processing shall consist of (a) the necessary interaction with the applicable Wholesaler, Specialty Distributor, GPO, or IDN (or downstream GPO member or IDN) to process orders, (b) causing the shipment of the Products to the applicable Wholesaler, Specialty Distributor, GPO or IDN (or downstream GPO member or IDN) via a 3PL Provider, and (c) submission of invoices to an applicable Wholesaler, Specialty Distributor, GPO, or IDN (or downstream GPO member or IDN) for such Products.
2.Payment Management.  Upon Sunovion’s receipt of payment from a Market Access Customer, Wholesaler, Specialty Distributor, GPO, or IDN (or downstream GPO members or IDNs) for an applicable Product invoice, Sunovion shall promptly transfer such amount to the Escrow Fund.
3.Product Return Management.  Sunovion shall process returns of the Products from Market Access Customers, Wholesalers, Specialty Distributors, GPOs, and IDNs (or downstream GPO members or IDNs) in accordance with the terms and conditions of the applicable Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, or GPO/IDN Contract.
4.Quality Complaints and Adverse Event Reporting.  Sunovion shall communicate all quality complaints and adverse event reports related to a Product received by Sunovion in connection with a Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, Myovant Market Access Contract, or GPO/IDN Contract to Myovant or Myovant’s designee in a timely manner consistent with Applicable Law and any other policies and procedures agreed upon by the Parties. 
5.Additional Wholesaler, GPO and IDN Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit C — MAAD SERVICES
With respect to the Products, the MAAD Services shall include the following obligations:
1.Management of MAAD Customer Targets.  Sunovion shall, or shall cause its Account Directors to, subject to Section 2.3.11, with input from Myovant’s market access leadership team and Myovant’s pricing and contracting committee, and the JGC, (a) manage relationships with the MAAD Customer Targets by (i) organizing meetings with such MAAD Customer Targets, and (ii) presenting the Myovant Promotional Materials to and coordinating reactive Myovant medical science liaison activities with such MAAD Customer Targets pursuant to procedures determined by the JGC, and (b) where necessary to obtain coverage of the Products, use Commercially Reasonable Efforts to negotiate discount arrangements for such MAAD Customer Targets that are consistent with the Business Terms.
2.Customer Target Contract Negotiation.  Upon direction by Myovant, and in coordination with Myovant market access, legal, and other appropriate personnel as agreed upon by the Parties, Account Directors shall facilitate negotiation of the key terms of contracts with the MAAD Customer Targets on behalf of Myovant consistent with the Business Terms; provided that Sunovion shall use Commercially Reasonable Efforts to use the contract template provided by Myovant and to implement the Business Terms; provided, further that, Sunovion shall notify Myovant if use of such contract template or implementation of the Business Terms is not feasible and Myovant shall have the right to review and approve the final template utilized.
3.Incentive Program.  Sunovion shall, in collaboration with Myovant and the JGC, establish and execute an appropriate incentive-based program to encourage the Account Directors to achieve certain milestones or objectives that are in-line with the Business Terms.
4.Escalation Procedures.  Subject to Section 7.1, Sunovion shall, with advice and guidance from Myovant, develop, or cause a Third Party to develop, a mechanism to permit Account Directors to escalate to Myovant’s pricing and contracting committee proposed instances of deviation from the Business Terms.
5.Additional MAAD Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit D — CONTRACTING SERVICES
Contracting Services shall include the following obligations with respect to Products:
1.Market Access Contract Management.  Upon direction by Myovant, Sunovion shall, subject to final review and approval by Myovant, facilitate execution of Myovant Market Access Contracts on behalf of Myovant that are consistent with the Business Terms; provided that Sunovion shall use the contract template provided by Myovant; provided further that Sunovion shall notify Myovant if use of such contract template is not feasible.  In connection with the foregoing, Sunovion shall reasonably coordinate with Myovant market access, legal, and other appropriate personnel as agreed upon by the Parties.  For the avoidance of doubt, each contract for which Sunovion provides Contracting Services shall be executed by Myovant and the applicable Market Access Customer.
2.System Coordination.  Sunovion shall incorporate the necessary information from each of the Myovant Market Access Contracts, Myovant Government Contracts, Myovant Special Distributor Contracts, and Myovant GPO/IDN Contracts into the necessary Sunovion systems (and shall ensure that necessary information from each of the Sunovion contracts related to Products, including Sunovion Wholesaler Contracts, 3PL Contracts, and Sunovion GPO/IDN Contracts, are appropriately incorporated into the appropriate Sunovion systems) to facilitate performance of the RCP Services and GPR Services; and
3.Additional Contracting Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit E — RCP SERVICES
RCP Services shall include the following obligations with respect to the Products:
1.RCP Payment Validation.  Sunovion shall validate all invoices for RCP Payments received from Market Access Customers, GPOs, IDNs, Wholesalers, Specialty Distributors, 3PL Providers, and Government Entities to ensure such invoices are consistent with the terms and conditions of the applicable contract and apply to eligible utilization of the applicable Products only, using a validation process agreed upon in writing by the Parties.
2.RCP Payment Administration.  Sunovion shall process and pay, using funds from the Escrow Fund and pursuant to the terms and conditions of the applicable contract, all validated RCP Payments, including: 
(a) validated Product rebate invoices and claim submissions received from a Market Access Customer or a Government Entity, in each case attributable to eligible Product utilization pursuant to a Myovant Market Access Contract or Myovant Government Contract, as applicable (such payments, the “Rebate Payments”),  
(b) validated chargeback submissions received from Wholesalers, Specialty Distributors, and Government Entities, in each case attributable to eligible Product utilization pursuant to a Sunovion Wholesaler Contract, Myovant Specialty Distributor Contract, or Myovant Government Contract, as applicable (such amount, the “Chargeback Offsets”), 
(c) validated administrative fees attributable to eligible Product utilization owed to a Market Access Customer pursuant to an applicable Myovant Market Access Contract (such fees, the “Market Access Customer Fees”), 
(d) validated distribution fees or similar service fee claims attributable to eligible Product utilization owed to a Wholesaler or Specialty Distributor pursuant to an applicable Sunovion Wholesaler Contract or Myovant Specialty Distributor Contract (such fees, the “DS Fees”), and 
(e) validated administrative fees attributable to eligible Product utilization owed to the applicable GPO or IDN pursuant to a GPO/IDN Contract (such fees, the “GPO/IDN Fees”). 
3.RCP Payment Adjustments.  Sunovion shall (a) process adjustments to RCP Payments consistent with the applicable contract, and (b) subject to Section 7.2, escalate to Myovant contract disputes related to the applicable Product that arise under the Sunovion Wholesaler Contracts, Myovant Specialty Distributor Contracts, GPO/IDN Contracts, Myovant Market Access Contracts and Myovant Government Contracts.
4.Additional RCP Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit F — GPR SERVICES
GPR Services shall include the following obligations with respect to the Products:
1.Government Pricing Reports.  Sunovion shall, solely with respect to the Products and to enable Myovant to comply with its submission requirements to Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and the VA, provide to Myovant the applicable price reporting metrics required under the Medicaid Rebate Program, the PHS 340B Program, Medicare Part B, the VA Federal Supply Schedule contract, and the VA Master Agreement (“Government Pricing Programs”), including, but not limited to: (a) the monthly AMP within [***] after the end of each calendar month, and (b) the ASP, Best Price, quarterly AMP, 340B Ceiling Price, the Non-FAMP, and other metrics required under the Government Pricing Programs within [***] after the end of each calendar quarter or other applicable reporting period, and (c) any recalculations of such metrics that are necessary to comply with Applicable Law, including, but not limited to, restatements due to updated data, calculation errors, or changes to Sunovion’s methodologies, policies, and procedures, in each case (a) through (c), such metrics and any recalculations thereto shall be determined in accordance with Applicable Law and [***] and shall be reported to Myovant in a form and format agreed to by the JGC  (each, a “Government Pricing Report”).  Sunovion acknowledges and agrees that each Government Pricing Report shall be delivered timely to Myovant.  Sunovion shall certify to Myovant that each such Government Pricing Report provided by Sunovion to Myovant is accurate and consistent with Sunovion’s government pricing calculation methodologies, policies and procedures.  [***].
2.Revised Government Pricing Report.  In the event a Party discovers that any Government Pricing Report or executive summary is incomplete or inaccurate, (a) such Party shall promptly notify the other Party, and (b) Sunovion agrees to revise such Government Pricing Report and re-submit it to Myovant (“Revised Government Pricing Report”) as follows: (i) where such incompletion or inaccuracy is discovered prior to the date the relevant metrics must be submitted to the applicable Government Pricing Program, Sunovion shall use Commercially Reasonable Efforts to submit the Revised Government Pricing Report to Myovant within [***] of such discovery, and (ii) where such incompletion or inaccuracy are discovered after the date when the relevant metrics must be submitted, Sunovion must submit the Revised Government Pricing Report to Myovant within [***] of such discovery.
3.Additional GPR Service Activities.  Sunovion shall perform any other services, including any services related to state supplemental Medicaid rebate agreements, (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit G — REGULATORY SERVICES
Regulatory Services shall include the following obligations:
1.Product Recall Activities.  Sunovion shall (a) interface with the applicable Wholesalers and Specialty Distributors, (b) cooperate with Myovant, in each case, in the event that a Product is recalled or is subject to an investigation under DSCSA for being a suspect or illegitimate product, or is otherwise subject to a product hold, and (c) except as required by Applicable Law, not provide any communication to any regulatory or other Third Party, including customers of the Products, without prior written consent of Myovant; and
2.Additional Regulatory Service Activities.  Sunovion shall perform any other services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit H — TRAINING SERVICES
1.Training Activities.  Sunovion shall from time to time train Myovant and/or Sunovion employees on certain details related to the Services and the Products. 
2.Additional Training Service Activities.  Sunovion shall perform any services (which may result in additional fees being added to this Agreement, subject to customary, good faith negotiation) that are agreed upon in writing by the Parties from time to time.

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Exhibit 10.2

CERTAIN INFORMATION IDENTIFIED BY “[***]” HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

COMMERCIAL MANUFACTURING & SUPPLY AGREEMENT
BY AND BETWEEN

EXCELLA GMBH & CO. kG,

AND

MYOVANT SCIENCES GMBH.

DATE:  April 04, 2019

[Myovant 28 March 2019]
CONFIDENTIAL

MANUFACTURING & SERVICES AGREEMENT
This Manufacturing & Services Agreement (the “Agreement”) is made effective as of April 04, 2019 (the “Effective Date”) by and between Excella GmbH & Co. KG, a company having its registered office at Ntirnberger Str. 12, 90537 Feucht, Germany and registered with the Amtsgericht Nürnberg under the number HRA 17667 (“Excella” or “Supplier”) and Myovant Sciences GmbH, a company having its principal place of business at Viaduktstrasse 8, 4051 Basel, Switzerland (“Myovant”). Myovant and Supplier are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Myovant is a pharmaceutical company engaged in the development and commercialization of treatments for endocrine-related diseases or disorders;
WHEREAS, Supplier is a pharmaceutical contract development and manufacturing organization; and
WHEREAS, Myovant desires to procure a supply of Product(s) (defined below) from Supplier, and Supplier desires to provide such Product(s), all in accordance with the terms and conditions hereof.
NOW, THEREFORE, and in consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms used in this Agreement shall have the meanings specified below:
1.1“Affiliate” means, with respect to a particular person or entity, a Person that controls, is controlled by, or is under common control with such person or entity, other than any Excluded Affiliate (with respect to Myovant). For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise.
1.2“Applicable Laws” means any, applicable federal, state, local, municipal, foreign, or other law, statute, legislation, constitution, principle of common law, code, treaty ordinance, regulation, rule, or order of any kind whatsoever put into place under the authority of any Governmental Authority, including the FFDCA, Prescription Drug Marketing Act, the Generic Drug Enforcement Act of 1992 (21 U.S.C. §335a et seq.), U.S. Patent Act (35 U.S.C. §1 et seq.), Federal Civil False Claims Act (31 U.S.C. §3729 et seq.), and the Anti-Kickback Statute (42 U.S.C. §1320a-7b et seq.), all as amended from time to time, together with any rules, regulations, and compliance guidance promulgated thereunder. “Applicable Law” will include the applicable regulations and guidance of the FDA that constitute Good Manufacturing Practices (and, if and as appropriate under the circumstances, other comparable regulation and guidance of any applicable Governmental Authority).
1.3“Batch” means a specific quantity of a Product that (a) is intended to have uniform character and quality pursuant to the Specifications and (b) is produced according to a single order during the same Manufacturing cycle.
1.4“Batch Documentation” means, with respect to a Product, the documentation provided to Myovant or its designee at the time of delivery of such Product, as agreed upon by the Parties in the Quality Agreement or as required by Applicable Laws.
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1.5“Business Day” means a day other than Saturday, Sunday, or any other day on which commercial banks located in the State of New York, U.S., Nurnberg, Germany or Zurich, Switzerland are authorized or obligated by Applicable Law to close.
1.6“Calendar Year” means the twelve (12) month period ending on December 31; provided, however, that (a) the first Calendar Year of the Term will begin on the Effective Date and end on December 31, 2019 and (b) the last Calendar Year of the Term will end upon the expiration or termination of this Agreement.
1.7“CMC” means chemistry, manufacturing, and controls.
1.8“Commercial Product” means a final, packaged pharmaceutical product consisting of: (a) the Drug Product; (b) the Drug Product and the Myovant Companion Product co-packaged together; or (c) Relugolix in a fixed-dose combination with any other active pharmaceutical ingredient(s).
1.9“Commercialization” means all activities undertaken by or on behalf of a Party to promote, market, sell, and distribute a Commercial Product, including: (a) sales force efforts, detailing, advertising, marketing, the creation and approval of promotional materials, sales or distribution, pricing, customer and government contracting, and medical affairs, including medical education, medical information, clinical science liaison activities, and health economics and outcomes research; (b) product security activities that may include enhancing supply chain security, implementing brand protection technologies, intelligence gathering, forensic analysis, customs recordation, and anti-counterfeiting enforcement action, such as taking Internet countermeasures, collaborating with law enforcement and seeking criminal restitution; (c) management of any risk evaluation and mitigation strategies (REMS) programs; (d) importing, exporting, transporting, customs clearance, warehousing, invoicing, handling, and delivering Commercial Product to customers; and (e) other similar activities relating to Commercial Product. When used as a verb, “Commercialize” means to engage in Commercialization activities.
1.10“Confidential Information” means all non-public or proprietary Information disclosed by a Party to the other Party under this Agreement, which may include ideas, inventions, discoveries, concepts, compounds, compositions, formulations, formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, technology, inventories, machines, techniques, development, designs, drawings, computer programs, skill, experience, documents, apparatus, results, clinical and regulatory strategies, regulatory documentation, information and submissions pertaining to or made in association with Regulatory Materials, data (including pharmacological, toxicological, and clinical data, raw data, analytical and quality control data, manufacturing data and descriptions, patent and legal data, market data, financial data or descriptions), devices, assays, chemical formulations, specifications, material, product samples and other samples, physical, chemical and biological materials and compounds, and the like, without regard as to whether any of the foregoing is marked “confidential” or “proprietary,” or disclosed in oral, written, graphic, or electronic form. Confidential Information will include the terms and conditions of this Agreement.
1.11“Credit Note” means a credit memo issued by one Party to the other Party and usable by this Party as: (i) an offset against amounts payable to the other Party or, (ii) if no such amounts are outstanding at the time of termination or expiration of this Agreement, for a refund from the other Party which the other Party shall pay no later than forty five (45) days after any such termination or expiration.
1.12“Detectable Defect” is defined in Section 10.1.
1.13“Drug Product” means a final pharmaceutical product consisting of bulk oral solid dosage tablets containing Relugolix.
1.14“Drug Substance” means the active pharmaceutical ingredient Relugolix.
1.15“Excluded Affiliate” means (1) for Myovant: (a) any Myovant Parent Affiliate or (b) any direct or indirect subsidiary of a Myovant Parent Affiliate, other than any Myovant Parent, that (i) is controlled (as defined in Section 1.1) by such Myovant Parent Affiliate but is not controlled by Myovant or any Myovant Parent and (ii) is 

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established for the development and commercialization of compounds and products other than the Drug Product and (2) for Supplier: Fareva S.A.
1.16“Excluded Territory” means, subject to Section 6.3, Japan, China Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, and Vietnam.
1.17“Expiration Date” is defined in Section 10.2.
1.18“Facility” means Supplier’s facility located at [***] or another facility as otherwise mutually agreed upon by the Parties in writing pursuant to Section 8.3.
1.19“FDA” means the United States Food and Drug Administration, and any successor agency thereto.
1.20“FFDCA” means the Federal Food, Drug and Cosmetic Act under United States Code, Title 21, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto.
1.21“Firm Order” is defined in Section 7.1.2.
1.22“Firm Order Period” is defined in Section 7.1.2. 
1.23“Force Majeure Event” is defined in Section 20.1. 
1.24“GnRH” means gonadotropin-releasing hormone.
1.25“Good Manufacturing Practices” or “GMP” means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 210, 211, 600 and 610 and all applicable FDA guidelines and requirements, (b) the principles detailed in the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time, and (c) cooperation with the conduct of any inspection by qualified persons to ensure compliance with the foregoing standards.
1.26“Governmental Authority” means any multi-national, national, federal, state, local, provincial, municipal, or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, or other tribunal).
1.27“Information” means information, discoveries, compounds, compositions, formulations, formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, techniques, designs, drawings, correspondence, computer programs, documents, apparatus, results, strategies, regulatory documentation, information and submissions pertaining to, or made in association with, filings with any Government Authority, data, including pharmacological, toxicological, non-clinical and clinical data, raw data, analytical and quality control data, manufacturing data and descriptions, market data, financial data or descriptions, devices, assays, chemical formulations; specifications, material, product samples and other samples, physical, chemical and biological materials and compounds, and the like, in written, electronic, oral or other tangible or intangible form, now known or hereafter developed, whether or not patentable.
1.28“Intellectual Property Rights” means any proprietary  rights with respect to inventions, apparatuses, methods, processes, works of authorship or marks, including: (i) patents, patent applications, and certificates of invention; (ii) trade secrets, know-how, and similar rights in confidential or proprietary information; (iii) copyrights and moral rights; (iv) trademarks, trade names, logos, trade dress, and similar indicia of origin; and (y) similar proprietary rights under any laws and in any jurisdiction throughout the world.
1.29“Latent Defect” is defined in Section 10.2.

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1.30“Manufacture” or “Manufacturing” means all activities by or on behalf of a Party related to the manufacturing of any Product, or any ingredient thereof, including test method development and stability testing, formulation, manufacturing scale-up, manufacturing for Development or Commercialization, labeling, filling, processing, packaging, in-process and finished Product(s) testing, shipping, storing, or release of any Product or any ingredient thereof, quality assurance and quality control activities related to manufacturing and release of any Product, ongoing stability tests, and regulatory activities related to any of the foregoing. When used as a noun, “Manufacture” or “Manufacturing” means any and all activities involved in Manufacturing.
1.31“Myovant Background IP” the Intellectual Property Rights owned or controlled by Myovant or its Affiliate(s) as of the Effective Date or thereafter.
1.32“Myovant Companion Product” means any pharmaceutical product or preparation containing estradiol and/or norethindrone acetate that is (a) Manufactured, used, sold, offered for sale, imported or otherwise developed or Commercialized by or on behalf of Myovant, its Affiliates or any Myovant Licensee and (b) is co-packaged or co-formulated with Drug Product.
1.33“Myovant Licensee” has the meaning set forth in Section 3.1.
1.34“Myovant Parent” means, with respect to Myovant, any Person of which Myovant is a wholly owned subsidiary. For clarity, as of the Effective Date, the Myovant Parent is Myovant Sciences Ltd.
1.35“Myovant Parent Affiliate” means any Person that controls (as defined in Section 1.1) the Myovant Parent, including, as of the Effective Date, Roivant Sciences Ltd.
1.36“Myovant Technology” means all Intellectual Property Rights that are owned or controlled by Myovant or its Affiliates as of the Effective Date and during the Term solely to the extent the use or practice of such Intellectual Property Rights is necessary for the Manufacture of Product(s) to be supplied to Myovant in accordance with the terms and conditions of this Agreement.
1.37“NDA” means a (a) New Drug Application or supplemental New Drug Application as contemplated by Section 505(b) of the FFDCA, submitted to the FDA pursuant to 21 C.F.R. § 314, including any amendments thereto or (b) any comparable applications filed in or for countries or jurisdictions outside of the United States to obtain Regulatory Approval to Commercialize a Commercial Product in that country or jurisdiction.
1.38“Notified Party” has the meaning set forth in Section 6.2.
1.39“Permits” means any licenses, permits, registrations, certifications or other approvals from a Governmental Authority.
1.40“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.
1.41“Product(s)” means Drug Substance and/or RSM, as applicable. 
1.42“Project Invention” is defined in Section 15.2.
1.43“Purchase Order” is defined in Section 7.1.3
1.44“Qualified Territory” means the countries in the Territory that are listed on Exhibit A.
1.45“Quality Agreement” means the Quality Assurance Agreement between the Parties for the supply of Product(s) under this Agreement to be entered into in accordance with Section 8.4.

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1.46“Quality Release” means certification by Supplier’s quality control department that each Product that is Manufactured by or on behalf of Supplier complies with the Quality Agreement and Supplier’s quality release specifications as confirmed by release testing.
1.47“Recall” means a Party’s removal or correction of Commercial Product following (a) notice or request of any Regulatory Authority or (b) the good faith determination by such Party that an event, incident, or circumstance has occurred that required such a recall of such Commercial Product. A Recall does not include a market withdrawal or a stock recovery.
1.48“Regulatory Approval” means the approval(s), authorizations or reviews (including “safe-to-proceed” letters) of the applicable Regulatory Authority(ies) in a country or jurisdiction that are necessary to conduct research and clinical development of a pharmaceutical product or to market, promote, sell or distribute a pharmaceutical product.
1.49“Regulatory Authority” means any applicable Governmental Authority involved in granting Regulatory Approval or issuing a Recall for a Commercial Product or Product(s), including the FDA.
1.50“Regulatory Materials” means regulatory applications, filings, submissions, notifications, registrations, Regulatory Approvals, or other submissions, including any written correspondence or meeting minutes, made to, made with, or received from any Regulatory Authority submitted to a Regulatory Authority in any country for the purpose of obtaining Regulatory Approval from that Regulatory Authority (including all NDAs, and associated common technical documents) and any amendments and supplements thereto, and all data and other information contained in, and Regulatory Authority correspondence relating to, any of the foregoing. Regulatory Materials include the Product NDAs, and amendments and supplements thereto.
1.51“Regulatory Qualifications” is defined in Section 17.2.1(a).
1.52“Relugolix” means the GnRH receptor antagonist that, as of the Effective Date, is being developed by Myovant or its Affiliates.
1.53“Rolling Forecast” is defined in Section 7.1.1.
1.54“RSM” means regulatory starting material needed for the Manufacture of Drug Substance as specified on Schedule 1.54 as may be updated from time to time at Myovant’s sole option by written notice to Supplier.
1.55“RSM Option Payment” is defined in Section 7.1.3(a). 
1.56“Scope of Work” is defined in Section 13.2.
1.57“Shelf-Life” is defined in Section 7.2.1.
1.58“Specifications” means, with respect to a country or region, the specifications for the design, composition, Manufacture, packaging, and/or quality control of the Product(s) applicable to such country or region, as set forth in Exhibit B attached hereto, which may be amended from time-to-time.
1.59“Subcontractor” is defined in Section 3.3
1.60“Supplier Background IP” means the Intellectual Property Rights owned or controlled by Supplier as of the Effective Date or thereafter.
1.61“Supplier Technology” means pre-existing products, materials, tools, methodologies, technologies or Intellectual Property Rights of Supplier embodied in the Project Inventions; provided that Supplier documents its pre-existing ownership of any such Supplier Technology embodied in any Project Invention.

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1.62“Technology Transfer Plan” shall have the meaning assigned to it in Section 13.1.
1.63“Term” is defined in Section 19.1.
1.64“Territory” means all countries in the world except for the Excluded Territory.
1.65“Third Party” means a Person other than Supplier, Myovant or their respective Affiliates.
1.66“United States” or “U.S.” means the United States of America and its territories, districts, commonwealths and possessions (including the Commonwealth of Puerto Rico).
ARTICLE 2
PRODUCT SUPPLY
2.1Purchase and Supply. Subject to the terms and conditions set forth in this Agreement and the Quality Agreement, Supplier shall supply to Myovant or, at Myovant’s request, any Myovant Licensee or their designees, and Myovant shall obtain from Supplier, certain quantities of Product(s) ordered in accordance with this Agreement. For clarity, Myovant may use, sell or otherwise transfer to any Third Party the Product(s) supplied hereunder, or any Commercial Product that incorporates such Product(s), as necessary to meet some or all of the requirements of Myovant, its Affiliates, Subcontractors and Myovant Licensees in connection with the Commercialization of Commercial Product as authorized and contemplated herein. At Myovant’s request, Supplier shall negotiate in good faith with any Myovant Licensee to supply Product(s) directly to such Myovant Licensee under substantially the same terms and conditions as this Agreement, including pricing.
2.2Exclusivity. During the Term and for a period of [***] thereafter, Supplier shall not, without Myovant’s written consent, develop, Manufacture or supply any Drug Substance or RSM, or any product containing Relugolix, for or to any Third Party.
ARTICLE 3
GRANT OF RIGHTS
3.1License Grants to Myovant. Subject to the terms and conditions of this Agreement, Supplier hereby grants to Myovant a worldwide, perpetual, irrevocable, non-exclusive, royalty-free, fully paid-up, license (with the right to sublicense) to: (a) the Supplier Technology and the Supplier Background IP as necessary for Myovant’s use of the Project Inventions for any and all purposes; and (b) the Supplier Technology and Supplier Background IP as far as necessary and for the sole purpose to package, market, distribute, offer to sell, sell and have sold Product(s), either on its own or as part of a Commercial Product. For clarity, Myovant will have the right to grant sublicenses, through multiple tiers, of the rights granted to Myovant under this Section 3.1 to its Affiliate(s) and/or any Third Parties (each, a “Myovant Licensee”).
3.2License Grants to Supplier. Subject to the terms and conditions of this Agreement, Myovant hereby grants to Supplier:
 (a)a worldwide, perpetual, irrevocable, non-exclusive, fully royalty-free, fully paid-up license, without the right to grant sublicenses, under the Project Inventions to manufacture products other than (i) the Product(s), or (ii) products that compete with the Product(s), in each case if and to the extent that the Project Inventions are also capable to be used for the manufacturing by Supplier of products other than the Products; and
 (b)a non-exclusive, non-transferrable, non-sublicensable license under the Myovant Technology solely to the extent necessary to permit Supplier to perform its obligations under this Agreement during the Term.
3.3Subcontractors. In performing its activities under this Agreement, Supplier may engage consultants, subcontractors or other vendors to conduct its obligations thereunder or hereunder (each, a 

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“Subcontractor”); provided that (a) Supplier remains responsible for (i) the management of its Subcontractors, (ii) fulfillment by its Subcontractors of all obligations set forth under this Agreement as if the Subcontractor were a party hereto, and (iii) any breach of this Agreement by a Subcontractor, and (b) Supplier will terminate promptly any Subcontractor, and will give the other Party notice of such termination, in the case of any material breach of this Agreement by a Subcontractor. In the event that Supplier wishes to engage a Subcontractor to perform any obligations subject to oversight by any Regulatory Authority, then, without limiting the generality of the foregoing, Supplier shall: (A) provide prior written notice to Myovant, which notice must identify, at a minimum, the Person whom would be acting as such a Subcontractor and a description of the work to be conducted by such Person; and (B) not permit any such Subcontractor to perform any work in connection with this Agreement until Myovant has provided written consent. Without limitation, such contracts entered into with Subcontractors will contain provisions, including those relating to Intellectual Property Rights, confidentiality, and non-use that are no less restrictive than those set forth in this Agreement.
3.4No Implied License. No license or other right is or will be created or granted hereunder by implication, estoppel, or otherwise. All licenses and rights are or will be granted only as expressly provided in this Agreement.
ARTICLE 4
PRICE
4.1Price. In consideration for all Manufacturing activities performed and materials used by Supplier or its Subcontractors in the Manufacture of Product(s) under this Agreement, including other raw materials, consumables, maintenance, direct and indirect labor costs, depreciation and a profit margin thereon, Myovant shall pay Supplier for quantities of Product(s) delivered to Myovant, its Affiliates or their designees under this Agreement pursuant to a Firm Order in accordance with Section 7.1.2, and pursuant to the corresponding Purchase Order in accordance with Section 7.1.3, in accordance with the applicable prices set forth in Schedule 4.1. For clarity, Supplier may Manufacture the Drug Substance using RSM that is Manufactured by Supplier or, at Myovant’s option as indicated in the applicable Firm Order and corresponding Purchase Order, using RSM provided by or on behalf of Myovant.
4.2Invoicing. Supplier shall submit an invoice to Myovant for Product(s) no earlier than release by Supplier of such Product(s) in accordance with the Quality Agreement and make available for shipment of such Product(s) to Myovant in accordance with Section 7.2 and Section 9.1; provided, however, that Supplier may submit a request for Deposit Payment for RSM Option Payments in accordance with Section 7.1.3(a). In addition, Supplier shall deliver each such invoice to: [***]. Each invoice shall be accompanied by the following information: applicable Purchase Order number(s), quantities of Product(s), the corresponding prices and lot numbers for each of the foregoing in accordance with Section 4.1, any applicable credit for RSM Option Payments received by Supplier in accordance with Section 7.1.3(a), freight charges and the total amount to be remitted by Myovant; in each case, in accordance with this Agreement. Without limiting the generality of the foregoing, each invoice submitted to Myovant shall be accompanied by the relevant Batch Documentation for such shipment of Product(s). Myovant shall pay such invoices in accordance with Article 14.
4.3Currency. All payments hereunder shall be made in Euros.
ARTICLE 5
MANUFACTURING FACILITIES
5.1Facility. The Parties acknowledge and agree that Supplier will Manufacture the Product(s) under this Agreement only at the Facility.

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ARTICLE 6
REGULATORY ACTIVITIES AND RESPONSIBILITIES
6.1General Obligations of Supplier; Audits. Supplier shall, or shall cause its Affiliates or Third Parties on its behalf to, (a) perform its obligations under this Agreement in compliance with all Applicable Laws, including all GMPs, and in accordance with the Quality Agreement, (b) undertake all regulatory activity with respect to the Manufacture of the Product(s), including components thereof in accordance with this Agreement and as otherwise required by Applicable Laws or Regulatory Authorities. Supplier shall be responsible for maintaining all Permits and establishment fees required by any Regulatory Authority with respect to any Supplier Manufacturing facility where any aspect of the Product(s) is Manufactured, including but not limited to the Facility. Supplier shall support Myovant in audits of quality and compliance systems of Supplier (not more than one (1) Myovant audits in any twelve (12) month period) in addition to other customary matters related to regulatory compliance. Additional “for cause” audit(s) that are required to address legitimate quality concerns will not be considered an annual audit and will be at no cost to Myovant.
6.2Communication with Regulatory Authorities. Notwithstanding anything to the contrary in the Quality Agreement, following receipt by a Party (the “Notified Party”) or its Affiliate(s) or Subcontractor(s) of any regulatory inquiry or communication, or the occurrence of any inspection, regarding the Manufacture of Product(s) and/or Commercial Product in compliance with GMP, the Notified Party shall promptly (but in no event later than three (3) Business Days after the Notified Party receives such inquiry or communication or twenty-four (24) hours such without-notice-inspection commences, as applicable) notify the other Party in writing thereof. If the Notified Party or its Affiliate(s) or Subcontractor(s) receive notice of an inspection or an inspection visit by any Governmental Authority that directly involves Product(s) or Commercial Product or is likely to materially impact Supplier’s ability to supply Product(s) to Myovant hereunder, the Notified Party shall give the other Party prompt written notification thereof (but in no event later than three (3) Business Days after Notified Party receives such notice) and the Notified Party shall provide the other Party with copies of applicable documentation with respect thereto, and’ such other Party shall have a reasonable opportunity to review and comment on the Notified Party’s proposed response; provided, however, that such other Party’s opportunity to review and comment shall not be extended so as to cause any response of the Notified Party to be later than is required by such Governmental Authority. Unless prohibited by Applicable Law, the Notified Party shall allow a representative of the other Party to be present at and observe any inspection by any Governmental Authority concerning Product(s) or Commercial Product. All other communications with Regulatory Authorities, including without limitations any regulatory audits, shall be governed by the Quality Agreement.
6.3Expansion of Qualified Territory. If, after the Effective Date, Myovant obtains Regulatory Approval to market, promote or use Commercial Product in any country or jurisdiction of the Territory other than those within the Qualified Territory as of the date of such Regulatory Approval, then: (a) Supplier shall, at Myovant’s request, exert reasonable efforts to obtain Regulatory Qualifications as promptly as possible in such new country(ies) or jurisdiction(s), and (b) such new country(ies) or jurisdiction(s) will automatically be added to the Qualified Territory and the representations, warranties and covenants described herein will apply with respect thereto; provided, however, that in the event the business case for seeking such Regulatory Qualifications of Supplier, as requested by Myovant, does not reasonably justify the efforts related to this country, then the Parties agree to meet and to negotiate the cost responsibility before starting the Regulatory Qualifications process.
ARTICLE 7
FORECASTING AND ORDERING
7.1Forecasts and Purchase Orders. 
7.1.1Forecasts. No, later than the period as specified below under “Lead Time” prior to the intended supply of the first commercial batches, and thereafter no later than the [***] during the remainder of the Term, Myovant shall submit to Supplier, at the contact information provided below, Myovant’s [***] forecast for its desired quantities of the Product(s) to be delivered to Myovant [***] covering the period specified below under “Forecast Period” (each, a “Rolling Forecast”). Myovant will submit each Rolling Forecast to the addressee listed 

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in Schedule 7.1.1, which Supplier may update or change by providing written notice to Myovant in accordance with Section 20.2 of this Agreement. The Rolling Forecast shall set forth the [***].
7.1.2Binding Quantities. With respect to each Rolling Forecast submitted by Myovant in accordance with Section 7.1.1, the first number of months specified below under “Firm Order Period” (each as applicable, a “Firm Order Period”) [***] (“Firm Order”). [***].
												
	Product	Lead Time	Forecast Period	Firm Order Period
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]

7.1.3Purchase Orders.
(a)Issuance and Acceptance. With its submission of the first Rolling Forecast, Myovant shall submit a separate purchase order for Product(s) (each, a “Purchase Order”) for the Firm Order Period as set forth in the first Rolling Forecast to Supplier. Each Purchase Order shall specify [***]. Thereafter, with each Rolling Forecast submitted to Supplier pursuant to Section 7.1.1, Myovant shall submit a Purchase Order for the month of the Rolling Forecast that has become a Firm Order for the first time (i.e., the month for which no Purchase Order was previously submitted). With respect to [***], the Parties will consult and mutually agree in writing on [***] and each such payment, a “RSM Option Payment”). [***]. To the extent of any conflict between a Purchase Order and this Agreement, this Agreement shall control.
(b)Deviations from the Firm Order Period. If the quantity set forth in a Purchase Order exceeds the quantity set forth in the corresponding month of the Firm Order Period, Supplier shall use reasonable efforts to satisfy the amount contained in a Purchase Order; provided, however, that (i) Supplier shall not reject any Purchase Order that, considered in the aggregate with other Purchase Orders placed pursuant to a Finn Order Period in a Rolling Forecast, is for an aggregate quantity of Product(s) totaling up to [***] of the quantities identified in such Firm Order Period, and (ii) Supplier shall not be in breach of this Agreement if it does not deliver quantities in excess of [***] of the quantity set forth in corresponding month of the Firm Order Period. For the avoidance of doubt, such reasonable efforts shall not require Supplier to reschedule or otherwise delay either any Manufacturing runs for any other product or any planned shut-down of a Manufacturing facility, including without limitation the Facility.
(c)Cancellations. If Myovant cancels any Firm Order for Drug Substance or RSM, then Myovant shall make the applicable payment as set forth in Schedule 7.1.3. If Myovant pays [***] of such Firm Order, then Supplier shall deliver the Drug Substance or RSM pursuant to Section 7.2. If Myovant reimburses Supplier for raw materials and/or intermediates, then Supplier shall store such raw materials in suitable conditions, and use such raw materials and/or intermediates to fulfill the next subsequent Firm Orders of Drug Substance or RSM.
7.2Delivery. Subject to Section 20.1, Supplier shall supply the Product(s) ordered under a Purchase Order by way of delivery pursuant to Article 9. If Supplier is unable to meet the specified delivery date, Supplier shall promptly notify Myovant and provide to Myovant an alternative delivery date which is as close to the original delivery date as reasonably possible.
7.2.1.Shelf-Life. With respect to the manufacture of Product(s) under this Agreement, at the time Product is made available for shipment to Myovant, such Product shall have no less than [***] of its Shelf-Life remaining. For purposes of this Section 7.2.1, the term “Shelf-Life” means the length of time that elapses between the date that such Product is released by Supplier and the date that such Product must be re-tested as determined by Supplier based on current stability results as of the date such Product is made available for shipment by Supplier to Myovant. For illustrative purposes, [***]. In the case of such remaining Shelf-Life at delivery being (or anticipated 

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to be) less than the foregoing, then Supplier shall notify Myovant in writing promptly after Supplier’s receipt of the applicable Purchase Order and may deliver the Product on a schedule agreed to in writing by Myovant.
7.2.2.Testing by Supplier.  Prior to delivery by Supplier pursuant to Section 9.1, Supplier shall undertake release testing to obtain a Quality Release for each Batch of the Product(s) that is Manufactured pursuant to a Purchase Order and in accordance with the terms of the Quality Agreement.
7.2.3.Provision of Records. With each Batch of Product(s) delivered by Supplier pursuant to Section 9.1, Supplier shall provide for each Batch all Batch Documentation, including a certificate of analysis, Quality Release and certificate of conformance, in each case in accordance with the terms of the Quality Agreement.
7.2.4.Delayed Deliveries. Supplier shall notify Myovant immediately if Supplier believes that it may not be able to deliver the Product(s) by the delivery date specified in the relevant Purchase Order. Upon such notice, the Parties shall discuss in good faith ways in which the delay can be avoided (or if it cannot be avoided, shortened) and Supplier shall consider and implement in good faith any reasonable suggestion by and discussion/agreement with Myovant to avoid or mitigate the delay. Notwithstanding the foregoing, unless otherwise agreed to in writing by both Parties, if Supplier delivers the Product(s) more than [***] after the delivery date specified in the relevant Purchase Order, and the failure to deliver is not as a result of a Force Majeure Event and attributable to Supplier, then Supplier shall discount the price for the affected shipment(s) of Product(s) by per each [***] period exceeding the aforementioned [***] after such delivery date, up to [***] of the price for such Product(s) over a period ending [***] after such originally specified delivery date. At Myovant’s option, any such discounted amounts under this Section 7.2.4 shall be payable to Myovant as a set-off against other payments that Myovant may ‘owe Supplier. If Supplier has not delivered such Product(s) after such [***] period has elapsed, then, in addition to any other remedies Myovant may have under this Agreement, Myovant shall be entitled to deduct the applicable RSM Option Payment (or applicable portion thereof) from any other payments that Myovant may owe Supplier. If Supplier fails to deliver Product(s) in the quantities and by the delivery dates specified in the relevant Purchase Order or based on the mutual agreement for any [***] in a Calendar Year, and the failure to deliver is not as a result of a Force Majeure Event, Myovant shall, notwithstanding anything in this Agreement to the contrary, have the right to terminate this Agreement due to a material breach by Supplier without notice or cure period. Myovant’s exercise of its rights and remedies set forth in this Section 7.2.4 shall not limit or waive any of its other rights or remedies set forth herein or which may otherwise be available in law or equity.
7.3Notice of Potential Inability to Supply. Supplier shall inform Myovant of any events that may prevent Supplier from fulfilling its supply obligations with respect to amounts of Product(s) ordered pursuant to any portion of any Firm Order as soon as reasonably practicable after becoming aware of such events, but in no event less than forty-eight (48) hours after Supplier obtains knowledge of any potential delay in Manufacturing or supply of Product(s) hereunder. In the event Supplier notifies Myovant of a potential inability to supply Product(s), the Parties shall discuss in good faith how to resolve or avoid (or, if not capable of resolution or avoidance, shorten) such supply problems. Without limiting the generality of the foregoing, Supplier will consider and implement in good-faith any reasonable suggestion of Myovant to resolve or avoid, or otherwise or shorten, any delay in Manufacturing or supply of Product(s).
7.4Supply Shortage. If Supplier is unable to deliver [***] of the quantities of Product(s) that have been ordered by Myovant in accordance with Section 7.1.3, then Supplier shall fulfill any and all outstanding Purchase Orders from Myovant giving reasonable priority compared to any orders from Third Parties.
ARTICLE 8
MANUFACTURING
8.1Conformance with GMP. Supplier shall supply the Product(s) that conforms to GMPs, Applicable Laws, the Specifications, the Quality Agreement, the Product(s) NDAs and Regulatory Approvals, and other terms of this Agreement, including Section 7.2.1 (Shelf-Life).

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8.2Modifications. Supplier shall not modify the Specifications, Manufacturing, and testing processes, in each case, employed with regard to the Manufacture of the Product(s) or any component thereof, other than as agreed in writing.
8.3Manufacturing Location. Supplier shall supply Product(s) for which the final Manufacturing processes have been performed solely at the Facility, in each case unless otherwise mutually agreed in writing.
8.4Quality Agreement. Within [***] of execution of this Agreement (or such later date as the Parties may agree in writing), the Parties will enter into the Quality Agreement, which will define roles and responsibilities, change control, release authority, GMP requirements, sampling, testing and retain plans, specifications, preventative maintenance, dispute resolution and other aspects related to quality of Product(s). In addition, the Quality Agreement will detail the Parties’ obligations with respect to regulatory audits and will control over this Agreement with respect to quality issues to the extent this Agreement, including without limitation Section 6.1, contradicts the Quality Agreement.
8.5Resources. Supplier agrees to allocate adequate resources to execute its obligations under this Agreement, including all Scopes of Work. Each Party agrees to respond promptly in the performance of their respective obligations beginning upon the execution of this Agreement or upon the execution of the applicable Scope of Work, as the case may be.
ARTICLE 9
DELIVERY, TITLE AND RISK OF LOSS
9.1Shipment Terms; Title; Risk of Loss. Except as otherwise provided under Article 13 of this Agreement, all Product(s) will be shipped to Myovant or its designee [***] to Myovant’s designated site, freight collect, by a common carrier designated by Myovant in the Purchase Order, at Myovant’s expense. Title and risk of loss will transfer to Myovant, and delivery shall be deemed to have occurred, when goods are placed at Myovant’s or its designee’s disposal.
9.2Labeling and Packaging. Supplier shall label and package Product(s) in accordance with Applicable Laws, and Myovant’s reasonable instructions, regarding pharmaceutical products shipped in bulk for further processing, labeling, or repackaging.
ARTICLE 10
NON-CONFORMING PRODUCT(S)/RETURNS
10.1Claims for Detectable Defects. Myovant shall notify Supplier within ten (10) Business Days after receipt by Myovant or its designated dosage form (with respect to Drug Substance) manufacturer or drug substance (with respect to RSM) manufacturer of any shipment of the Product(s) supplied by or on behalf of Supplier of the existence and nature of any defect in or failure of the Product(s) to comply with Section 6.1 or Section 8.1 at the time of delivery that could have been detected by a reasonable physical inspection of the Product(s) at the time of delivery (“Detectable Defects”). If such notice is not provided within such thirty (30) days period, then such Product(s) will be deemed not to have any Detectable Defects, Myovant will be deemed to have accepted the Product(s), and Supplier will have no further responsibility for such Detectable Defects. A non-conformity relating to stability of the Product(s) shall not be considered a Detectable Defect.
10.2Claims for Latent Defects. Myovant shall notify Supplier within ten (10) Business Days upon discovery of any defect in or failure of the Product(s) to comply with Section 6.1 or Section 8.1 that is not a Detectable Defect (such defect or failure, a “Latent Defect”). Claims that are submitted by Myovant shall state the nature of the alleged defect, including how such alleged defect was discovered, in detail reasonably sufficient to enable Supplier to identify the nature of the alleged defect or to dispute the same, and to determine that the defect existed at the time of delivery. However, Myovant may only claim for Latent Defects for Product sold before the applicable expiration date listed on the container/labels of a Product and approved by the relevant Regulatory Authority, including any extensions or updates from time to time after the transfer of title and loss from Supplier to 

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Myovant according to Article 9.1 (the “Expiration Date”). For clarity, if Myovant discovers that a Product that was sold before its expiration date had a Latent Defect at the time of such sale, then Myovant may make a claim for such Latent Defect at any time, including after such expiration date.
10.3Provision of Samples. Myovant shall, when notifying Supplier of an alleged defect, provide samples of any allegedly defective Product(s) and copies of written reports or investigations performed by or on behalf of Myovant on such allegedly defective Product(s).
10.4Referral to Independent Laboratory. In the event of a dispute between the Parties as to any defect in a Product(s), including whether a defect was a Detectable Defect, a Latent Defect or whether such defect existed at the time of delivery, that cannot be resolved within thirty (30) days of a claim being made to Supplier pursuant to Section 10.1 or Section 10.2, the matter shall promptly (but in no case later than ten (10) Business Days after the expiration of such thirty (30) day period) be submitted to an independent laboratory to be mutually agreed between the Parties. The independent laboratory will examine the Product(s) at issue and determine the existence and, if relevant, the timing of any defect in the Product(s). The decision of the independent laboratory shall be binding on the Parties, except in the case of fraud. Myovant shall bear the costs of the independent laboratory if the independent laboratory finds that the Product(s) was not defective or that such defect did not exist at the time of delivery. Supplier shall bear the costs of the independent laboratory if the independent laboratory finds that the Product(s) was defective at the time of delivery.
10.5Credit Note; Replacement Product(s); Defective Product(s). Following a claim from Myovant pursuant to Section 10.1 or Section 10.2, and without limiting any of Myovant’s remedies with respect to any breach by Supplier of this Agreement, or the remedies set forth in Sections 7.2.4 or 7.4, Supplier’s sole obligation with respect to replacing defective Product(s) in the event that Supplier accepts Myovant’s claim as valid or the independent laboratory decides in favor of Myovant’s claim, shall be to either, at Myovant’s election: (a) provide Myovant with a Credit Note equal to (i) the price paid by Myovant for the defective Product(s) and (ii) the costs paid by Myovant, if any, to any independent laboratory used in connection in accordance with Section 10.4 with respect to such determination; or (b) replace the defective Product(s) as soon as commercially practicable. Any Product that is agreed or determined to be defective shall be, as directed by Supplier, either destroyed by Myovant or returned to Supplier, in both cases at Supplier’s expense. Except for Supplier’s obligations under Article 12 and Article 18, Supplier shall have no liability for defective Product(s) other than as provided in this Article 10.
ARTICLE 11
STORAGE, HANDLING AND TRANSPORT
11.1Supplier’s Responsibilities. The Product(s) shall be Manufactured by or on behalf of Supplier and stored, handled, packaged, and transported in accordance with the requirements of this Agreement, the Quality Agreement and all Applicable Laws. Supplier shall maintain appropriate quality assurance and quality control standards and record-keeping practices, including systems, resources and procedures in order to satisfy these obligations.
11.2Notice of Inspections by Regulatory Authorities.  The Parties’ obligations with respect to any inspections or audits by any Regulatory Authority related to the Product(s) shall be governed by Section 6.2 and the Quality Agreement.
ARTICLE 12
RECALL
Each Party will promptly notify the other Party upon its determination that any event, incident, or circumstance has occurred, including but not limited to any field alert made pursuant to 21 C.F.R. part 314.81(b)(1), that may result in the need for a Recall or market withdrawal of a Product(s) and/or Commercial Product (but in no event later than twenty-four (24) hours and in all cases prior to the execution of such Recall or market withdrawal). For all such Recalls, the Parties will reasonably consult with each other with respect to the actions to be taken to address such Recall. Subject to this Article 12, for all Recalls, market withdrawals, and stock recoveries that are 

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taken with respect to any Commercial Product and/or any Product(s) that is in Myovant’s possession or control, Myovant will be responsible for execution, and Supplier will take such actions as reasonably requested by Myovant in connection therewith and otherwise reasonably cooperate in all such efforts. All expenses incurred in connection with any Recall (including expenses for notification, destruction, and return of the affected Product(s) and/or Commercial Product and any refund to customers of amounts paid for such Product(s) and/or Commercial Product) will be the sole responsibility of Supplier (except to the extent such Recall is caused by the Myovant Companion Product or in any other way not attributable to Supplier).
ARTICLE 13
TECHNOLOGY TRANSFER; SUPPORT SERVICES
13.1Technology Transfer. At Myovant’s request, and at its cost in accordance with a mutually agreed Scope of Work in accordance with Section 13.2, Supplier shall transfer to Myovant or its designee all know-how and technology necessary or useful for the Manufacture of Drug Substance and RSM. Myovant shall initiate and oversee such technology transfer, and shall in good faith assess the progress of such transfer until it is completed to contents agreed by the Parties. Upon such request by Myovant for a technology transfer, the Parties will work in good faith to establish a mutually agreed, detailed technology transfer plan, including tasks, deliverables, timelines and budgets (the “Technology Transfer Plan”). Upon adoption of the Technology Transfer Plan, each Party will perform such tasks as are assigned to it as described therein. For clarity, if Supplier elects to transfer the manufacture of any Product(s) to another facility within the [***] of affiliated companies, including [***], then Supplier will bear the cost of such transfer.
13.2Support Services. Beginning on the Effective Date and continuing during the Term, upon reasonable request of Myovant, Supplier shall provide Myovant or its designee with reasonable technical, regulatory, CMC and other related services in support of the Manufacturing of Product(s) (collectively, the “Support Services”). Any Support Services provided by Supplier will be documented in work orders, executed by both Parties and substantially in the form attached as Exhibit C (each a “Scope of Work”). Each Scope of Work shall include milestone payments as mutually agreed. In addition, the Parties may mutually agree to adjust activities and/or costs under any Scope of Work, with discussions regarding such adjustments to be conducted in good faith by each Party. Supplier will perform Support Services from Supplier’s or its Affiliates’ facilities unless otherwise expressly set forth in a Scope of Work.
13.3Reimbursement for Support Services. Myovant shall compensate Supplier in accordance with the milestone achievements and corresponding payment terms for Supplier’s achievement thereof as set forth in any applicable Scope of Work. Supplier shall invoice Myovant within thirty (30) days after the end of each month during the Term for all milestone payments accrued by Supplier through its provision of the Support Services in each then-current Scope of Work, which shall include a brief description of work performed, and Myovant shall pay such invoice in accordance with Article 14.
ARTICLE 14
PAYMENT TERMS
14.1Payment Terms. Myovant shall pay any amount invoiced by Supplier pursuant to Section 4.2 that is not disputed in writing by Myovant within forty-five (45) days after receipt of such invoice and, with respect to payments for Product(s), a determination, in accordance with Section 10.1, that such Product(s) does not have any Detectable Defects. Myovant shall make all payments for invoices issued by Supplier in Euros via an Automatic Clearing House payment to Supplier’s account designated below, if any, or to such other account as Supplier may specify by written notice to Myovant in accordance with Section 20.2.
[***]
14.2Taxes. Myovant shall pay any applicable taxes, including sales, use, excise, value-added, service, goods and services, and consumption taxes imposed by relevant taxing authorities as a result of payments it makes to Supplier pursuant to this Agreement. All other taxes, including but not limited to income tax, gross receipts tax 

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and foreign withholding tax, applicable to payments Myovant makes to Supplier pursuant to this Agreement shall be the sole responsibility of Supplier. Each Party will provide to the other Party any resale exemption, multiple points of use certificates, treaty certification and other exemption information reasonably requested by the other Party.
14.3Late Payment. If Myovant does not pay or dispute in writing any invoiced amount within thirty (30) days of issuance of such invoice, simple interest shall thereafter accrue on the sum due to Supplier until the date of payment at the per annum rate of [***] or the maximum rate allowable by Applicable Laws, whichever is lower.
ARTICLE 15
INTELLECTUAL PROPERTY
15.1Background IP. Except as otherwise set forth explicitly herein, Myovant will have and retain full and exclusive right, title and ownership interest in and to the Myovant Background IP. Supplier will have and retain full and exclusive right, title and ownership interest in and to the Supplier Background IP.
15.2Project Inventions. All discoveries, inventions, improvements, processes, formulations, methods, data and information generated, developed or derived by or on behalf of Supplier under this Agreement (i) from Myovant Technology or Myovant’s Confidential Information, (ii) from any Product or (iii) in the provision of the Manufacturing services, shall in each case belong to Myovant to the extent that it is not generally applicable to the business of Supplier and is unrelated to the manufacture or supply of Products (each, a “Project Invention”). Supplier hereby assigns to Myovant all of Supplier’s right, title and interest in, to and under each Project Invention. At Myovant’s request and expense, Supplier shall cooperate with Myovant in connection with applying for, prosecuting and enforcing any Intellectual Property Rights that claim or cover any Project Invention. Notwithstanding the foregoing, Supplier will retain ownership of any Supplier Technology, subject to the license granted to Myovant in accordance with Section 3.1.
ARTICLE 16
CONFIDENTIALITY
16.1Nondisclosure and Non-Use. Each Party agrees that, during the Term and for a period of [***] thereafter, a Party (the “Receiving Party”) receiving Confidential Information of the other Party (the “Disclosing Party”) will (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own confidential or proprietary information of similar kind and value, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose, except to exercise its right and perform its obligations under this Agreement (it being understood that this Section 16.1 will not create or imply any rights or licenses not expressly granted under this Agreement). Notwithstanding anything to the contrary in the foregoing, the obligations of confidentiality and non-use with respect to any trade secret within such Confidential Information will survive for so long as such Confidential Information remains protected as a trade secret under Applicable Law.
16.2Exceptions. The obligations in Section 16.1 will not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent evidence:
16.2.1is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder;
16.2.2is known to the Receiving Party or any of its Affiliates at the time of its receipt, and not through a prior disclosure by the Disclosing Party, without any obligation to keep it confidential or any restriction on its use, prior to such disclosure by the Disclosing Party;
16.2.3is subsequently disclosed to the Receiving Party or any of its Affiliates on a non-confidential basis by a Third Party that, to the Receiving Party’s knowledge. is not bound by a similar duty of confidentiality or restriction on its use;

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16.2.4is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party or any of its Affiliates, generally known or available, either before or after it is disclosed to the Receiving Party;
16.2.5is independently discovered or developed by or on behalf of the Receiving Party or any of its Affiliates without the aid, use of, access to, or application of any of the Confidential Information belonging to the Disclosing Party; or
16.2.6is the subject of written permission to disclose provided by the Disclosing Party.
16.3.Authorized Disclosure.
16.3.1Permitted Disclosure. Notwithstanding the provisions of Section 16.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party only to the extent such disclosure is reasonably necessary in the following instances: (a) filing of Regulatory Materials in order to obtain or maintain Regulatory Approvals; (b) prosecuting or defending litigation; (c) complying with Applicable Law or regulation or order of any or court or Government Authority, including responding to a subpoena in a Third Party litigation; (d) to its Affiliates, sublicensees or prospective sublicensees, Subcontractors or prospective Subcontractors, payors, consultants, agents, and advisors on a “need-to-know” basis in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, each of whom prior to disclosure must be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are substantially similar to those set forth in this Article 16 (but which obligations may be of shorter duration for Third Parties, but at least five’ (5) years); or (e) to any actual or potential sources of financing (debt, equity, or otherwise) with respect to the Receiving Party or its Affiliate(s), including but not limited to bona fide third party institutional lenders who are or may be engaged to provide debt financing to the Receiving Party or its Affiliate(s); provided, however, that, in each of the above situations, the Receiving Party will remain responsible for any failure by any Person who receives Confidential Information pursuant to Article 16 to treat such Confidential Information as required under this Article 16.
16.3.2Notice; Confidential Treatment. If and whenever any Confidential Information is disclosed in accordance with this Section 16.3, such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement). Notwithstanding the foregoing, if a-Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 16.3.1(a), (b), or (c), then it will, except where illegal, (a) give reasonable advance notice to the other Party of such disclosure and use not less than the same efforts to secure confidential treatment of or a protective (or similar) order for such Information as it would to protect its own Confidential Information from disclosure, and (b) only disclose the minimum amount of Confidential Information reasonably required for the purpose of such disclosure.
16.4Terms of this Agreement. The Parties acknowledge that this Agreement and all of the respective terms of this Agreement will be treated as Confidential Information of both Parties. Neither Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, except to a Third Party in connection with (a) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (b) the entry into any agreement with respect to the Development, Manufacture, or Commercialization of a Commercial Product, (c) a merger, consolidation, or similar transaction by such Party or its Affiliates or (d) the sale of all or substantially all of the assets of such Party or its Affiliates to which this Agreement relates; provided that (i) all such disclosures are made in accordance with this Article 16; (ii) such Third Party executes a non-use and non-disclosure agreement with confidentiality and non-use obligations similar to those contained in this Agreement and (iii) Myovant may disclose this Agreement or any of its respective terms to a competitor of Supplier’s only with Supplier’s written consent, not to be unreasonably withheld or delayed.
16.5Publicity. Each Party agrees not to issue any press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby that contains information not 

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previously publicly disclosed without the prior written consent of the other Party, not to be unreasonably withheld, conditioned, or delayed.
16.6Equitable Relief. Given the nature of the Confidential Information and the competitive damage that could result to a Party upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article 16. In addition to all other remedies, a Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Article 16.
ARTICLE 17
REPRESENTATIONS AND WARRANTIES
17.1Mutual Representations, Warranties and Covenants. Each Party hereby represents, warrants and covenants to the other Party that:
17.1.1Corporate Existence. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated.
17.1.2Corporate Power, Authority and Binding Agreement. As of the Effective Date, (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.
17.2Further Supplier Representations, Warranties and Covenants. Supplier hereby represents, warrants and covenants to Myovant that:
17.2.1
(a)Supplier possesses, as of the Effective Date and, with respect to any country added to the Qualified Territory in accordance with Section 6.3, as of the date such country is added, all regulatory qualifications, certifications, licenses and permits necessary to Manufacture Product(s) that may, subject to Myovant possessing the applicable Regulatory Approval, be lawfully promoted, sold and used (collectively, “Regulatory Qualifications”) in each country within the Qualified Territory.
(b)Supplier will maintain such Regulatory Qualifications at all times during the Term with respect to the Qualified Territory as of the Effective Date.
(c)If and to the extent Supplier obtains, in accordance with Section 6.3, applicable Regulatory Qualifications for countries or jurisdictions added after the Effective Date to the Qualified Territory, the Supplier will maintain such Regulatory Qualifications at all times thereafter during the Term.
(d)Supplier shall allocate such resources as necessary to execute its obligations under this Agreement, including each Scope of Work.
(e)Supplier shall not, nor permit any of its Affiliates to, sell or otherwise transfer or dispose of any equipment or tools, if any, or consumables funded by Myovant, if any, including any transfer of such equipment or tools to another facility (other than the Facility) of Supplier or its Affiliates, without Myovant’s prior written consent.
17.2.2All Product(s) supplied pursuant to this Agreement, upon delivery to Myovant or Myovant’s designee in accordance with Section 9.1:

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(a)will have been Manufactured, tested, released, stored, supplied and otherwise handled in accordance with all Applicable Laws and GMPs, and the Product(s) NDAs and the applicable Specifications;
(b)will have been Manufactured in facilities that are in compliance with Applicable Laws;
(c)will have been Manufactured in accordance with the Quality Agreement and will conform with the certificates provided pursuant to the Quality Agreement;
(d)shall not be adulterated or misbranded within the meaning of the FFDCA; and
(e)may be introduced into interstate commerce pursuant to the FFDCA;
17.2.3Supplier, its Affiliates and any employee of, contractor of or other Person retained by Supplier or its Affiliates, in each case directly or indirectly performing any activities under this Agreement, are not currently, have never been, and, to the best of Supplier’s knowledge, are not the subject of a proceeding that could lead to Supplier, any of its Affiliates or any such employee of Supplier or its Affiliates becoming, as applicable, (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs or in any similar state program, (iii) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or could otherwise lead to be excluded, debarred, suspended or declared ineligible, but has not yet been excluded, debarred, suspended, or otherwise declared ineligible, nor has any such Person to Supplier’s knowledge engaged in conduct that could lead to such exclusion, debarment, suspension, or ineligibility. Supplier shall not engage, directly or indirectly, any Person to perform services hereunder if that Person has ever been, is currently, or, to the best of Supplier’s knowledge, is the subject of a proceeding that could lead to that Person becoming, as applicable, any of (i)-(iv) above. If Supplier receives notice of, or otherwise becomes aware of, the debarment, proposed debarment or such other exclusion, suspension, restriction or sanction of itself, or any employee of Supplier or an Affiliate of Supplier that is performing any activities under this Agreement, then Supplier shall notify Myovant immediately and Myovant shall have the right to immediately terminate this Agreement.
17.2.4Each employee of, contractor of or other Person retained by Supplier or its Affiliates, in each case directly or indirectly performing any activities under this Agreement, has entered into, or will enter into prior to commencing the Manufacturing and other services under this Agreement, a written agreement which assigns to Supplier all Project Inventions created by such Supplier personnel during the course of his or her employment by, or other provision of services to, Supplier.
17.3.Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, THERE ARE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, MADE BY SUPPLIER (OR ANY OF ITS AFFILIATES), WITH RESPECT TO THE PRODUCT(S) OR OTHERWISE, INCLUDING: (A) ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; (B) ANY IMPLIED WARRANTIES ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE IN THE TRADE; (C) ANY WARRANTY OF DESCRIPTION OR OTHERWISE CREATED BY ANY AFFIRMATION OF FACT OR PROMISE OR SAMPLE OR MODEL; OR (D) NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 18
INDEMNIFICATION; NO CONSEQUENTIAL DAMAGES; INSURANCE; 
LIMITATION OF LIABILITY
18.1Indemnification by Myovant. Myovant hereby agrees to defend, indemnify, and hold harmless Supplier and its Affiliates, and each of their respective directors, officers, employees, agents and representatives 

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(each, a “Supplier Indemnitee”) from and against any and all claims, suits, actions, demands or other proceedings brought by any Third Party (each, a “Claim”) and all liabilities, expenses, damages, or losses, including reasonable legal expense and attorneys’ fees but excluding lost profits (collectively, “Losses”), to which any Supplier Indemnitee may become subject as a result of any such Claim to the extent such Claim arise or result from: (a) the Manufacture or Commercialization of the Product(s) or Commercial Product in the Territory, in each case, by or on behalf of Myovant, its Affiliate, or its Sublicensee; (b) the breach by Myovant of any warranty, representation, covenant, or agreement made by Myovant in this Agreement; (c) the negligence, gross negligence or willful misconduct of Myovant, its Affiliate, or its Sublicensee, or any officer, director, employee, agent, or representative thereof; and (d) the failure to comply with Applicable Law by or on behalf of Myovant in connection with the Product(s) or Commercial Product, or this Agreement; except, with respect to each of subsections (a) through (d) above, to the extent such Losses arise directly from the negligence, gross negligence, or willful misconduct of any Supplier Indemnitee or the breach by Supplier of any warranty, representation, covenant, or agreement made by Supplier in this Agreement.
18.2Indemnification by Supplier.  Supplier hereby agrees to defend, indemnify, and hold harmless Myovant and its Affiliates and each of their respective directors, officers, employees, agents and representatives (each, an “Myovant Indemnitee”) from and against any and all Losses to which any Myovant Indemnitee may incur, suffer, or be required to pay as a result of, or arising in connection with, any Claim to the extent such Claims arise or result directly from: (a) the breach by Supplier of any warranty, representation, covenant, or agreement made by Supplier in this Agreement; (b) the negligence, gross negligence, or willful misconduct of Supplier or its Affiliates or Subcontractors, or any officer, director, employee, agent or representative thereof; and (c) the failure to comply with Applicable Law by or on behalf of Supplier in connection with the Product(s) or this Agreement; except, with respect to each of subsections (a) through (c) above, to the extent such Losses result directly from the negligence, gross negligence, or willful misconduct of any Myovant Indemnitee, or the breach by Myovant of any warranty, representation, covenant, or agreement made by Myovant in this Agreement.
18.3Indemnification Procedures.
18.3.1Notice. Promptly after a Supplier Indemnitee or a Myovant Indemnitee (each, an “Indemnitee”) receives notice of a pending or threatened Claim, such Indemnitee will give written notice of the Claim to the Party from whom the Indemnitee is entitled to receive indemnification pursuant to Section 18.1 or Section 18.2, as applicable (the “Indemnifying Party”). However, an Indemnitee’s delay in providing or failure to provide such notice will not relieve the Indemnifying Party of its indemnification obligations, except to the extent it can demonstrate prejudice due to the delay or lack of notice.
18.3.2Defense. Upon receipt of notice under Section 18.3.1 from the Indemnitee, the Indemnifying Party will have the duty to either compromise or defend, at its own expense and by counsel (reasonably satisfactory to Indemnitee), such Claim. The Indemnifying Party will promptly (and in any event not more than twenty (20) days after receipt of the Indemnitee’s original notice) notify the Indemnitee in writing that it acknowledges its obligation to indemnify the Indemnitee with respect to the Claim pursuant to this Article 18 (Indemnification; Insurance) and of its intention either to compromise or defend such Claim. Once the Indemnifying Party gives such notice to the Indemnitee, (a) the Indemnifying Party will have the right to control the defense and settlement of such Claim, subject to this Section 18.3 and (b) the Indemnifying Party is not liable to the Indemnitee for the fees of other counsel or any other expenses subsequently incurred by the Indemnitee in connection with such defense, other than the Indemnitee’s reasonable expenses of investigation and cooperation. However, the Indemnitee will have the right to employ separate counsel and to control the defense of a Claim at its own expense.
18.3.3Cooperation. The Indemnitee will cooperate fully with the Indemnifying Party and its legal representatives in the investigation and defense of any Claim. The Indemnifying Party will keep the Indemnitee informed on a reasonable and timely basis as to the status of such Claim (to the extent the Indemnitee is not participating in the defense of such Claim) and conduct the defense of such Claim in a prudent manner.
18.3.4Settlement. If an Indemnifying Party assumes the defense of a Claim, no compromise or settlement of such Claim may be effected by the Indemnifying Party without the lndemnitee’s written consent 

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(which consent will not be unreasonably withheld, conditioned, or delayed), unless: (a) there is no finding or admission of any violation of law or any violation of the rights of any person and no effect on any other claims that may be made against the Indemnitee; (b) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party; and (c) the Indemnitee’s rights under this Agreement are not adversely affected. If the Indemnifying Party fails to assume defense of a Claim within a reasonable time, the Indemnitee may settle such Claim on such terms as it deems appropriate with the consent of the Indemnifying Party (which consent will not be unreasonably withheld, conditioned, or delayed), and the Indemnifying Party will be obligated to indemnify the Indemnitee for such settlement as provided in this Article 18.
18.4Insurance.  Supplier shall maintain Commercial General Liability insurance for e.g. corporate property, drug, drug substance, recall and logistics during the Term, but in no event shall such insurance be in an amount less than [***] per occurrence/annual aggregate during the Term.  In addition, during the term of Commercialization of any Commercial Product and for a period of at least [***] thereafter, Supplier shall maintain Product Liability and Professional Liability insurance in an amount not less than [***] per occurrence and annual aggregate that covers occurrences during the period in which there is any Commercialization of Commercial Product and, if such policy is a claims-made policy, for a period of at least [***] thereafter. Supplier shall provide a certificate of insurance evidencing such coverage to Myovant upon its written request. Supplier shall notify Myovant [***] in advance of cancelation of any such insurance.
18.5No Consequential or Punitive Damages. NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER OR FOR ANY LOSS OR INJURY TO THE OTHER PARTY’S PROFITS OR GOODWILL ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. THIS SECTION 18.5 DOES NOT APPLY TO A BREACH OF A PARTY’S OBLIGATIONS UNDER ARTICLE 16 (CONFIDENTIALITY) OR TO A PARTY’S OBLIGATIONS PURSUANT TO SECTION 18.1 (INDEMNIFICATION BY MYOVANT) AND 18.2 (INDEMNIFICATION BY SUPPLIER).
18.6Limitation of Liability. Except for violations of law, fraud, willful misconduct, gross negligence, a breach of its obligations of confidentiality and non-use, or its indemnity obligations, Supplier’s liability to Myovant under this Agreement for any and all claims for losses (whether grounded in contract, tort, indemnity or otherwise) shall not exceed [***] prior to the date such claim or loss first arose.
ARTICLE 19
TERM AND TERMINATION
19.1Term. This Agreement shall commence on the Effective Date and shall continue until the [***] of the Effective Date (the “Initial Term”). At the end of the Initial Term, this Agreement shall continue automatically for additional [***] periods (each, a “Renewal Term,” and together with the Initial Term, the “Term”) under the same terms and conditions until terminated in accordance with the terms hereof or until a Party provides at least [***] written notice of non-renewal to the other Party prior to expiration of the then-current Initial Term or Renewal Term, as applicable.
19.2Termination.
19.2.1Termination for Material Breach. Either Party shall be entitled to terminate this Agreement in the event that the other Party commits a material breach of this Agreement and such other Party fails to cure such breach within [***] of receiving a notice of default from the non-defaulting Party, by giving a notice of termination to such other Party (after expiration of such cure period, if applicable), with the termination to take effect on the date specified therein.
19.2.2Termination for Bankruptcy. Either Party may terminate this Agreement by written notice to the other Party upon occurrence of any of the following events: (a) a voluntary petition of bankruptcy is filed by the other Party in any court of competent jurisdiction; (b) an involuntary petition for bankruptcy of the other 

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Party is filed by such Party’s creditors in any court of competent jurisdiction and is not vacated within [***] after filing; (c) a receiver is appointed or applied for to manage any part of a Party’s assets related to this Agreement; or (d) this Agreement is assigned by the other Party for the benefit of its creditors.
19.3Consequences of Termination.
19.3.1Termination of this Agreement by Myovant for Supplier’s Material Breach or Bankruptcy. If this Agreement is terminated by Myovant pursuant to Section 19.2.1 (Termination for Material Breach) or Section 19.2.2 (Termination for Bankruptcy), then Myovant may elect to cancel any Purchase Order(s) without any liability for amounts due thereunder and will be released from any liability for any Firm Orders then in effect for Product(s).
19.3.2Termination of this Agreement by Supplier for Myovant’s Material Breach or Bankruptcy. If this Agreement is terminated by Supplier pursuant to Section 19.2.1 (Termination for Material Breach) prior to a final, binding determination that Myovant materially breached this Agreement or pursuant to Section 19.2.2 (Termination for Bankruptcy), then Supplier shall continue to supply Product(s) pursuant to this Agreement until the Technology Transfer Plan is complete or a Third Party supplier is able to Manufacture and supply Product(s) to Myovant in sufficient quantity and quality to replace Supplier’s obligations under this Agreement, whichever occurs first. However, the start of production of such Products shall be subject to an upfront payment to be made by Myovant including the cost of any raw materials and intermediates used for the production and the price of the Products itself.
19.3.3Transition of Manufacturing. Upon the expiration or any termination of the Agreement, the Parties will discuss in good faith the transition of Manufacture and supply activities of the Product(s). Upon reasonable request by Myovant, Supplier may assist so far as reasonably needed in the transition by participating in the technology transfer activities to Myovant or Myovant’s third party supplier. Such activities by Supplier shall be limited to documentation and consulting services and at all times, Myovant shall remain the owner and assessor of the transfer. Such activities by Supplier will be at Myovant’s expense unless the MSA is terminated for cause solely attributable to Supplier.
19.4Survival of Obligations. Termination or expiration of this Agreement shall not relieve a Party of any obligation to make a payment that was owed prior to or on the effective date of such termination, including amounts invoiced prior to such termination or expiration, nor prejudice either Party’s right to obtain performance of any obligation provided for in this Agreement that expressly survives termination or expiration. All provisions of this Agreement that, in accordance with their terms, are intended to have effect after the expiration or termination of this Agreement shall survive such termination or expiration, including Sections 3.13.1, 3.2(a), 3.4, 17.2.4, 19.3, this 19.4, and 19.5 and Articles 1, 6 (solely to the extent necessary to fulfill any obligation to a Regulatory Authority after termination or expiration), 10, 12, 14, 15, 16 (for the period specified in Section 16.1), 18 and 20.
19.5Remedies. Except as otherwise expressly provided herein, exercise by a Party of its rights under this Article 19 shall not limit remedies which may otherwise be available to a Party in law or equity.
ARTICLE 20
GENERAL PROVISIONS
20.1Force Majeure Event. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by causes beyond the reasonable control of the affected Party, including embargoes, war, acts of war (whether war be declared or not), acts of terrorism, sabotage, insurrections, riots, civil commotions, strike, fire, floods, earthquake, or other acts of God, or acts, omissions or delays in acting by any governmental authority, and which in each case is not caused by the gross negligence or intentional misconduct of such Party (each such event or cause, a “Force Majeure Event”) and the nonperforming Party promptly provides notice of such prevention to the other Party. Such excusal shall be continued so long as the condition constituting a Force Majeure Event continues and the nonperforming Party takes reasonable efforts to mitigate the condition. If a Force Majeure Event persists for more than ninety (90) days, the Parties will 

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discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such Force Majeure Event.
20.2Notices. Any notice, request, or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be hand delivered or sent by a recognized overnight delivery service, expenses prepaid, or by facsimile (with transmission confirmed), to the following addresses or to such other addresses as a Party may designate by written notice in accordance with this Section 20.2:
If to Supplier:
Excella GmbH & Co KG
Nürnberger Str. 12
90537 Feucht
Germany
If to Myovant:
Myovant Sciences GmbH
Viaduktstrasse 8
4051 Basel
Switzerland
Copy to:
Myovant Sciences, Inc.
2000 Sierra Point Parkway
9th Floor
Brisbane, CA 94005
Attention: General Counsel
20.3Dispute Resolution.
20.3.1Exclusive Dispute Resolution Mechanism. The Parties agree that the procedures set forth in this Section 20.3 will be the exclusive mechanism for resolving disputes, actions, claims, controversies, suits, or proceedings between the Parties arising in whole or in part out of, related to, based upon or in connection with this Agreement, the Quality Agreement or the subject matter of either (each, a “Dispute”, and collectively, the “Disputes”).
20.3.2Resolution by Executive Officers. Except as otherwise provided in this Section 20.3.2, in the event of any Dispute that is not resolved, the Parties will first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves on an informal basis for a period of ten (10) Business Days after receipt of written notice of such Dispute by a Party. If such Dispute is not resolved by the Parties’ informal discussions within such ten (10) Business Day period, either Party may, by written notice to the other Party, refer the Dispute to the senior executive officer (or his or her delegate) (each, an “Executive Officer”) of the other Party for attempted resolution by good faith negotiation within ten (10) Business Days after such notice is received. Each Party may, in its sole discretion, seek resolution of any and all Disputes that are not resolved under this Section 20.3.2 in accordance with Section 20.3.3.
20.3.3Arbitration. If the Parties are unable resolve a given Dispute pursuant to Section 20.3.2 within ten (10) Business Days of referring such dispute to the Executive Officers, either Party may have the given Dispute settled by binding arbitration in the manner described below:
(a)Arbitration Request.  If a Party intends to begin an arbitration to resolve a dispute arising under this Agreement, such Party shall provide written notice (the “Arbitration Request”) to the 

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other Party of such intention and the issues for resolution. From the date of the Arbitration Request and until such time as the dispute has become finally settled, the running of the time periods as to which a Party must cure a breach of this Agreement becomes suspended as to the subject matter of the dispute.
(b)Additional Issues. Within ten (10) days after the receipt of the Arbitration Request, the other Party may, by written notice, add additional issues for resolution.
(c)Arbitration Procedure.  Except as expressly provided herein, the sole mechanism for resolution of any claim, dispute or controversy arising out of or in connection with or relating to this Agreement or the breach or alleged breach thereof shall be arbitration by the International Chamber of Commerce (“ICC”) in New York, USA, or in such other venue as the Parties agree, under New York law except as provided herein. All proceedings shall be held in English and a transcribed record prepared in English. The Parties shall choose, by mutual agreement, one arbitrator within thirty (30) days of receipt of notice of the intent to arbitrate. If no arbitrator is appointed within the times herein provided or any extension of time that is mutually agreed on, the ICC shall make such appointment within thirty (30) days of such failure. The award rendered by the arbitrator shall not include costs of arbitration, attorneys’ fees or costs for expert and other witnesses. Within forty-five (45) days of initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures directed at assuring that the arbitration will be concluded and the award rendered within no more than six (6) months from selection of the arbitrator. Failing such agreement, the ICC will design and the Parties will follow procedures directed at meeting such a time schedule. The arbitrator (i) shall not have any power or authority to add to, alter, amend or modify the terms of this Agreement but shall specify rules sufficient to allow reasonable discovery by the Parties; (ii) shall establish and enforce appropriate rules to ensure that the proceedings, including the decision, be kept confidential and that all Confidential Information of the Parties be kept confidential and be used for no purpose other than the arbitration; (iii) shall have the power to enforce specifically this Agreement and the terms and conditions hereof in addition to any other remedies at law or in equity; and (iv) shall issue all decisions in writing. Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name, proprietary information, trade secrets, know-how or any other proprietary right or otherwise to avoid irreparable harm. If the issues in dispute involve scientific or technical matters, any arbitrator chosen hereunder shall have educational training and/or experience sufficient to demonstrate a reasonable level of knowledge in the field of biotechnology. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.
20.4Audits.
20.4.1Facility Audits. In addition, in accordance with the Quality Agreement, Myovant shall have the right, upon at least [***] notice to Supplier, and such date to be reasonably agreed upon by the Parties, either by itself or through independent outside auditors or consultants, not more than once per Calendar Year during the Term of this Agreement, unless reasonable cause is shown, to inspect and audit, at its sole expense and during normal business hours and in a manner that does not interfere unreasonably with operations, any areas in the Facility or any other Manufacturing facilities in which any portion of the Manufacturing, packaging or other activities with respect to any Product(s) is performed, including any Regulatory Materials and other information reasonably related to the subject matter set forth herein located at the Facility or such Manufacturing facility. The information obtained during the course of such audit shall be considered Confidential Information and subject to Article 16.
20.5Relationship of the Parties. It is expressly agreed that Supplier, on the one hand, and Myovant, on the other hand, will be independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture or agency. Neither Supplier nor Myovant will have the authority to make any statements, representations or commitments of any kind, or to take any action which will be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party will be employees of that Party and not of the other Party and all expenses and obligations incurred by reason of such employment will be for the account and expense of such Party.

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20.6Designation of Affiliates. Each Party may discharge any obligations and exercise any rights hereunder through delegation of its obligations or rights to any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.
20.7Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective heirs, successors and permitted assigns. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned; provided, however, that each Party may, without the other Party’s prior written consent: (a) assign its rights and obligations under this Agreement to its Affiliate or, in the case of Myovant, to its licensee, provided that any assignment by Supplier to an Affiliate must occur in connection with the sale or other transfer to such Affiliate of all or substantially all of the assets of the business to which this Agreement relates; and (b) assign this Agreement to its successor in connection with the sale or other transfer of all or substantially all of the assets of the business to which this Agreement relates (whether such transaction occurs by way of a sale of assets, merger, consolidation or similar transaction). Any successor or assignee of rights or obligations permitted hereunder will, in writing to the other Party, expressly assume performance of such rights or obligations. Any permitted assignment will be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 20.7 will be null, void and of no legal effect. Notwithstanding anything to the contrary in this Agreement or the Quality Agreement, this Agreement may only be assigned to an assignee to whom the Quality Agreement is assigned at the same time, and the Quality Agreement may only be assigned to an assignee to whom this Agreement is assigned at the same time. For clarity, any assignment by Supplier under this Section 20.7 shall not result in any change to the requirement that Supplier (including its assignee) shall Manufacture the Product(s) only at the Facility in accordance with Section 5.1.
20.8Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision will be considered severed from this Agreement and will not serve to invalidate any remaining provisions hereof. The Parties will make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
20.9Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver will be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party will not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
20.10Construction; Rules of Construction. Interpretation of this Agreement will be governed by the following rules of construction: (a) words in the singular will be held to include the plural and vice versa, and words of one gender will be held to include the other gender as the context requires; (b) references to the terms “Section”, “Exhibit”, or “Schedule” are to a Section, Exhibit, or Schedule of this Agreement unless otherwise specified; (c) the terms “hereof’, “hereby”, “hereto”, and derivative or similar words refer to this entire Agreement; (d) references to “€” or “Euros” will mean the currency of the Eurozone; (e) the word “including” and words of similar import when used in this Agreement will mean “including without limitation,” unless otherwise specified; (f) the word “or” will not be exclusive; (g) references to “written” or “in writing” include in electronic form; (h) the titles and headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement; (i) each of the Parties has participated in the negotiation and drafting of this Agreement and if an ambiguity or question of interpretation should arise, this Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or burdening either Party by virtue of the authorship of any of the provisions in this Agreement or any interim drafts of this Agreement; (j) the word “shall” will be construed to have the same meaning and effect as the word “will”; (k) references to “days” will 

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mean calendar days, unless otherwise specified; and (l) a reference to any Person includes such Person’s successors and permitted assigns.
20.11Further Assurance. Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof.
20.12Governing Law. This Agreement was prepared in the English language, which language will govern the interpretation of, and any dispute regarding, the terms of this Agreement. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof will be governed by and construed under the laws of the State of New York, without giving effect to any choice of law principles that would require the application of the laws of a different state and excluding the United Nations Convention on Contracts for the International Sale of Goods.
20.13Entire Agreement.  This Agreement, including the Exhibits and Schedules hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions, or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change, or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party except as otherwise expressly provided in Section 6.3. In the event of any inconsistency between the body of this Agreement and the Exhibits or Schedules to this Agreement or any subsequent agreements ancillary to this Agreement, unless otherwise expressly stated to the contrary in such Exhibit, Schedule or subsequent ancillary agreement, the terms contained in this Agreement will control.
20.14Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. This Agreement may be executed by facsimile, .pdf or other electronically transmitted signatures and such signatures will be deemed to bind each Party hereto as if they were the original signatures.
[Signature Page Follows]

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THIS MANUFACTURING & SERVICES AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
															
	MYOVANT SCIENCES GMBH		EXCELLA GMBH & CO. KG

															
	Signature:	/s/ Sascha Bucher		Signature:	/s/ Pablo Magnani

															
	Name:	Sascha Bucher		Name:	/s/ Pablo Magnani

															
	Title:	head of transactions		Title:	VP Manufacturing & Sales API

															
	Date:	4/8/2019		Date:	April/ 4th/ 2019

															
				EXCELLA GMBH & C S KG

															
				Signature:	/s/ Jürgen Bank

															
				Name:	 Jürgen Bank

															
				Title:	General Manager

															
				Date:	April 4, 2019

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