CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED Amendment No. 1 to Market Access Services Agreement

EXHIBIT 10.2

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

Amendment No. 1 to

Market Access Services Agreement

This Amendment No. 1 (this “Amendment”) to the Agreement (defined below) is entered into by and between Sunovion Pharmaceuticals Inc., a Delaware corporation, having a principle place of business at ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Sunovion”) and Urovant Sciences GmbH, a Swiss corporation, having a principle place of business at ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (“Urovant”).  Sunovion and Urovant may individually be referred to as a “Party” and collectively as the “Parties”. This Amendment is effective as of December 21, 2020 (the “Amendment Effective Date”). Capitalized terms used in this Amendment that are not defined in this Amendment shall have the meaning set forth in the Agreement.

Recitals

A. Urovant and Sunovion are parties to a Market Access Services Agreement, dated June 17, 2020 (the “Agreement”);

B. Pursuant to the Agreement, among other things, Urovant engaged Sunovion to perform market access services for certain pharmaceutical products; and

C. The Parties now wish to amend the Agreement in certain respects.

NOW 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:

 

Confidential & Proprietary

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““Monthly Flat Service Charge” means, subject to Section 8.2.2, (i) (a) [* * *] per calendar month through October 31, 2020, and (b) [* * *] per calendar month from November 1, 2020 through the end of the first year of the Term, (ii) [* * *] for the second year of the Term, and (iii) an adjusted amount for each year after the second year of the Term consistent with Section 8.2.2; provided that, (i) if a contract year 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 first day of the contract year and the denominator is the number of days in such calendar month, and (ii) if a contract year 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 last day of the contract year and the denominator is the number of days in such calendar month.”

““Pass-Through Expenses” means written and documented (a) Payor Fees, (b) DS Fees, (c) GPO/IDN Fees, (d) reasonable out-of-pocket costs and expenses incurred by or on behalf of Sunovion in connection with the 3PL Services, (e) reasonable costs and expenses owed 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 mutually 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 reasonably necessary for Sunovion to perform the Services and that have been pre-approved by Urovant in writing, and (h) any additional out-of-pocket costs and expenses incurred by Sunovion in connection with the Services as mutually agreed by the Parties in writing; provided that any costs set forth in clauses (a) through (f) above shall be deemed to be approved by Urovant.”

 

 

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“State Transparency Reporting Services.  Sunovion shall provide the State Transparency Reporting Services.”

“In connection with the 3PL Services, Urovant shall, subject to Section 5.1, (a) cause Product to be consigned to Sunovion upon receipt by a 3PL Provider; (b) use Commercially Reasonable Efforts to enter into a quality agreement with each 3PL Provider and Sunovion prior to consignment of any Product to Sunovion; (c) provide to Sunovion evidence of a property certificate evidencing its cargo and/or transit insurance and static inventory insurance relevant to the applicable logistics line(s); and (d) refrain from actions which would cause Sunovion to be in material breach of any

 

 

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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 in writing to Urovant in advance for review.”

“State Transparency Reporting Services.  Urovant hereby acknowledges and agrees that certain State Transparency Reporting Laws require reporting of information to applicable states that is related to activities with respect to which Sunovion may not have knowledge.  Accordingly, (a) each Party shall notify the other Party in writing about the existence of any new or additional laws, statutes, rules or regulations that may be similar or substantially comparable to the State Transparency Reporting Laws in the same states or other states (“New Reporting Laws”), and (b) within a reasonable time period of such notice, Urovant shall notify Sunovion in writing if any such New Reporting Laws should be added to the State Transparency Reporting Laws, in which case, upon Sunovion’s agreement (which may be conditioned on an increase Monthly Flat Service Charge, if applicable), the State Transparency Reporting Laws shall be automatically amended to include such New Reporting Law(s).  Urovant shall be solely responsible for (x) approving reports or data that are prepared by Sunovion and that are required to be submitted or transmitted to applicable states or Third Parties in accordance with the State Transparency Reporting Laws, and (y) certifying such reports and data, if applicable.  Sunovion shall be solely responsible for submitting or transmitting reports or data that are required to be submitted or transmitted to applicable states or Third Parties in accordance with the State Transparency Reporting Laws and that have been approved in writing by Urovant.  Such reports and data are deemed to be the Confidential Information of Urovant.”

“Indemnification by Urovant. Urovant 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: (i) death of, or bodily injury to, any person on account of the use of any Product, (ii) disputes that arise between Urovant and a Market Access Customer, Government Entity, or a GPO or IDN that is not a Sunovion GPO

 

 

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or Sunovion IDN that relate to a Urovant Market Access Contract, Urovant Government Contract, or a Urovant GPO/IDN Contract, respectively, (iii) disputes that arise between Sunovion or Urovant and a Wholesaler, Sunovion GPO, or Sunovion IDN that relate directly to the use of any Product; provided that if such dispute does not solely relate to the use of any Product, then the Parties shall negotiate in good faith an appropriate allocation of responsibility under the circumstances; (iv) any recall, quarantine, warning or withdrawal of any Product, (v) government pricing calculations performed by Sunovion on behalf of Urovant in connection with the GPR Services; provided that such calculations were performed by Sunovion in accordance with Sunovion’s government price calculation methodologies approved by Urovant pursuant to Section 5.5, (vi) any report that is approved in writing by Urovant prior to submission or transmission by Sunovion as part of the State Transparency Reporting Services; and that is submitted or transmitted (or any report not submitted or transmitted or not properly submitted or transmitted) by or on behalf of Urovant to an applicable state or Third Party pursuant to the State Transparency Reporting Laws, (vii) a breach of any representation, warranty or covenant of Urovant set forth in this Agreement, and (viii) the negligence, gross negligence or willful misconduct of Urovant in connection with this Agreement; except, in each case, 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 Urovant Indemnitees for such Losses (or part thereof) in accordance with Section 12.1.”

“NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, (A) SUNOVION SHALL HAVE NO LIABILITY FOR THIRD PARTY CLAIMS SOLELY ARISING OUT OF (I) GOVERNMENT PRICING CALCULATIONS PERFORMED BY SUNOVION ON BEHALF OF UROVANT UNDER THIS AGREEMENT; PROVIDED THAT SUCH CALCULATIONS WERE PERFORMED BY SUNOVION IN ACCORDANCE WITH SUNOVION’S GOVERNMENT PRICE CALCULATION METHODOLOGIES APPROVED BY UROVANT PURSUANT TO SECTION 5.5, OR (II) ANY REPORT THAT IS APPROVED BY UROVANT PRIOR TO SUBMISSION OR TRANSMISSION BY SUNOVION AS PART OF THE STATE TRANSPARENCY REPORTING SERVICES (OR ANY REPORT NOT SUBMITTED OR TRANSMITTED OR NOT PROPERLY SUBMITTED OR TRANSMITTED) BY OR ON BEHALF OF UROVANT TO AN APPLICABLE STATE OR THIRD PARTY PURSUANT TO THE STATE TRANSPARENCY REPORTING LAWS (EXCEPT FOR ANY

 

 

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NEGLIGENCE, GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR BREACH OF THE AGREEMENT BY SUNOVION RELATED TO SUCH REPORT) , AND (B) TO THE EXTENT ANY PRODUCTS ARE LOST OR DAMAGED WHILE IN THE CUSTODY OF A 3PL PROVIDER, UROVANT HEREBY AGREES TO THE LOSS AND DAMAGE LIMITATIONS SET FORTH IN THE APPLICABLE CONTRACT BETWEEN SUNOVION AND SUCH 3PL PROVIDER AND SUNOVION SHALL HAVE NO LIABILITY WITH RESPECT THERETO OTHER THAN TO USE COMMERCIALLY REASONABLE EFFORTS TO ENFORCE SUCH CONTRACT.”

 

 

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[Signature Page to Follow]

 

 

 

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed in duplicate by their duly authorized representatives, effective as of the Amendment Effective Date.  

 

 

 

 

 

Confidential & Proprietary

[Signature Page to Amendment No. 1 to the Market Access Services Agreement]

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Attachment 1

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:

Confidential & Proprietary

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Attachment 2

EXHIBIT K

STATE TRANSPARENCY REPORTING SERVICES

 

Confidential & Proprietary