In this task, you're given a passage that represents a legal contract or clause between multiple parties. Your job is to write questions that ask the basic details corresponding to the legal contracts or clauses. Avoid questions that can be answered correctly without actually understanding the paragraph, and which might have multiple answers. The answer to each question should be unambiguous.

[EX Q]: Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

Exhibit 10.75

COLLABORATION & ENDORSEMENT AGREEMENT

THIS COLLABORATION & ENDORSEMENT AGREEMENT (the Agreement) is dated as of this 15th day of June, 2015 (Effective Date), between The Naked Brands Group, Inc., a Delaware corporation (Naked), and Wade Enterprises, LLC (Wade Enterprises), an Alaska limited liability company f/s/o Dwyane Wade (Athlete and together with Wade Enterprises, collectively Wade). Wade Enterprises, Athlete and together with Naked, are each referred to herein as a Party and collectively, the Parties.

AGREEMENT

1. Engagement. Naked hereby engages Wade for collaboration in business development for, and his endorsement as set forth herein of, the following items, which shall be known herein as Innerwear: Briefs, trunks, boxer briefs and boxers, non-athletic undershirts (i.e., t-shirts intended to be worn as innerwear and not intended specifically for athletic purposes), non-athletic lounge apparel (bottoms and tops), sleepwear (including pajama bottoms and tops), and robes (as may be expanded to include other mutually agreed upon innerwear and lounge apparel) which may now or hereafter during the Term be manufactured, distributed, marketed and/or sold by Naked (collectively, the Naked Products), and Wade hereby accepts such engagement. The Parties agree that the territory of such engagement shall be worldwide (the Territory).

2. Term of Agreement. The initial term of this Agreement shall be for a period of four (4) years, commencing on the Effective Date, which term may be extended for up to three (3) years by written agreement of both Parties prior to the expiration date of the initial term or any extension thereof (collectively, the Term). Each twelve-month period beginning on the Effective Date shall be known as a Contract Year. In the event that either Wade or Naked wishes to extend the Term of the Agreement as contemplated above, it shall provide the other Party with written notice at least ninety (90) days prior to the expiration of the Term. The other Party will then have a period of fourteen (14) days from the date of the notice to indicate whether it also desires to extend the Term, on the terms and conditions set forth herein and if no such indication is made, the other Party will be deemed to have declined the offer to extend. Notwithstanding the foregoing, Wade agrees that for a period of ninety (90) days prior to the expiration of the Term (unless the Agreement is terminated by Wade as permitted hereunder), Naked shall have the exclusive right to negotiate for continued endorsement by Athlete of the Naked Products. For a period of six (6) months at the end of the Term (the Sell-off Period); provided that the Agreement was not terminated by Wade as permitted herein, Naked will have the right to continue to sell the Wade Products (defined below) for which orders have already been placed at the end of the Term on the terms and conditions herein.

3. Use of Wade Image.

During the Term and subject to the limitations set forth in this Agreement, Naked shall have an exclusive right and license in the Territory to use Athlete's name, nickname, initials, autograph, image, likeness, photographs, biographical details, facsimile signature, voice, videos, electronic media depictions, any words, symbols or other depictions, as well as any other identifying attributes that would identify Athlete to the public, including any trade mark(s), copyrights which Wade has, as set forth on Schedule A attached hereto, and all multimedia assets that Wade owns or has right to use (collectively, the Wade Image) solely for the advertising, endorsement, promotion, or sale of the Naked Products (including the Wade Products) in the Territory as follows:

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

(1) On Naked's website(s) (Website);

(2) In social media channels, including, but not limited to Facebook, Instagram, Twitter, YouTube, Google+, Tumblr and other mutually agreeable channels, with reasonable frequency, to promote Naked Products and Wade Products;

(3) In marketing and media opportunities in connection with the Wade Services (as defined below); and

(4) For use on the packaging of the Naked Products and Wade Products and on Wade Products themselves.

All uses of Wade Image in connection with this Agreement shall be subject to the prior written approval of Wade, which Wade shall not unreasonably withhold. Naked agrees to submit to Wade or its authorized agent a copy of all new promotional and/or advertising material using Wade Image at least ten (10) days prior to the release to the general public. Wade and its authorized agent agree that they shall not unreasonably withhold such approval. In the absence of disapproval within three (3) business days of Wade's or  authorized agent's receipt of a request for approval, said advertising or promotional material shall be deemed approved. Any such usage featuring Athlete shall be and remain the property of Naked except as otherwise set forth herein; however, Naked shall have the right to such use only during the Term. Wade may use said materials in whole or in part for Wade's personal portfolio, website or otherwise. Such usage may not be sold or transferred. For the avoidance of doubt, that certain logo designed by Athlete prior to the date hereof (the Logo) shall remain the sole property of Wade and Naked shall have license during the Term to use the Logo for the advertising, endorsement, promotion, or sale of the Naked Products (including the Wade Products) in the Territory in accordance with the terms and conditions of the Agreement. During the Sell-off Period, Naked shall have the license to use the Logo solely on packaging and presentation of Wade Products already offered for sale at retail outlets or on-line in accordance with the terms and conditions of the Agreement.

Wade will allow Naked to use any quotes that are attributed to Wade to promote the Naked Products and Wade Products in any advertising campaign. Wade will allow Naked to use any such attributed quotes that Naked  requires to promote the Naked Products and Wade Products, subject to Wade's right to approve such quotes in writing, which approval shall not be unreasonably withheld.

The Parties acknowledge and agree that Athlete's  accomplishments and recognition as an outstanding basketball player, individual  and fashion icon, as well as his character, fame, likeness, image and reputation are the essence of this Agreement.

Wade hereby warrants that he is not a party to any agreement,  contract or understanding which would prevent, limit or hider his performance of any of the obligations under this Agreement, provided that Naked acknowledges that it is aware of Athlete's obligations under his existing endorsement agreement with Li Ning for athletic shoes and athletic apparel and nothing  herein shall obligate Athlete to endorse any athletic apparel other than Li Ning's.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

4. Exclusivity. Wade agrees that during the Term of this Agreement, he will not represent or perform as a representative, spokesperson or provide Wade Services for, nor furnish services  or materials, or allow the use of the Wade Image to be used for the advertising,  endorsement, promotion, or sale of Innerwear in the Territory. Furthermore, Wade will not engage in any business or other transaction or have any financial or personal interest in any entity whose primary or core business is selling or  manufacturing Innerwear during the Term. Endorsement of any Innerwear other than the Naked Products or Wade Products without the express written consent of Naked will constitute a material breach of this Agreement.

5. Wade Services. During the  Term and subject to the limitations set forth in this Agreement, Wade agrees to  provide Naked with the following services (collectively, the Wade Services):

A. During the first Contract Year, Wade will be available for (i) one production day for the purpose of creating marketing assets for Naked Products for unlimited use in advertisements and the media and (ii) one production day for creating marketing assets for Wade Products and Naked Products for unlimited use in advertisements and the media, each as permitted herein. Wade shall be available to render services at such production day for a maximum of three (3) consecutive hours, not including scheduled breaks, during each such production day period; provided that, in the event an additional production day is reasonably required for the creation of marketing assets related to the Wade Product packaging, Athlete will be available to render services for up to an additional three (3) hours in either the first Contract Year or the second Contract Year but not both. The scheduling and content of said production days shall be mutually determined by Wade and Naked, subject to Wade's professional availability;

B. Beginning in the second Contract Year, Wade will be available for a maximum of one (1) production day for creating marketing assets for Wade Products and Naked Products for unlimited use in advertisements and the media, for a maximum of three (3) consecutive hours, not including scheduled breaks, during such production day period. The scheduling and content of said production days shall be mutually determined by Wade and Naked, subject to Wade's professional availability;

C. During each Contract Year, Wade will be available for two (2) personal appearances (each, a Personal Appearance) on behalf of Naked and the Naked Products and Wade Products in the media, including publicity shoots, interviews, print, television, radio and social media channels, each appearance for a maximum of sixty (60) consecutive minutes to be scheduled at a time mutually agreeable to Naked and Wade;

Wade has rights to websites or other social media channels promoting himself or any other promotional activity that is independent of this Agreement (Independent Promotions), including Wade's Facebook,  Instagram, Twitter and Google+ channels and Wade's YouTube channel. Wade agrees,  to generously and positively promote Naked Products and Wade Products in any  such Independent Promotions on a mutually agreed upon basis with reasonable frequency and in a manner consistent with drawing attention to the Wade/Naked relationship and promoting the Naked Products and Wade Products. Naked, in its sole and absolute discretion, may preview all references and other such materials referring to Naked in the Independent Promotions prior to the public dissemination of such Independent Promotions. Wade agrees to immediately remove all such materials in his Independent Promotions that Naked, in its sole and absolute discretion requests be removed. Naked has the right to request such removals at any time, even if Naked previously approved the Independent Promotions, and Naked agrees that all social media promotions it requests of Athlete shall comply with all applicable rules and regulations. Naked may also provide material regarding the Naked Products and Wade Products to Wade, and Wade agrees to include such materials in his Independent Promotions; and

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

E. Wade is currently engaged in  partnerships whereby its partners are selling and distributing other Athlete  endorsed products. Wade will use reasonable efforts to facilitate an introduction to Naked to existing sales and distributions channels and accounts.

F. Naked may reasonably request an additional production session(s), or a media tour or personal appearance(s), subject to mutual agreement by the Parties.

At all Personal Appearances, Wade will be available to sign a reasonable number of photographs, autographs, and any other items requested by and provided by Naked at its sole cost and expense, which Naked will have the right to distribute as giveaways but never for sale. If requested, Wade will pass out a reasonable number of samples of the Wade Product. Wade will also permit himself to be reasonably photographed at the Personal Appearances with customers and fans.

6. Commercial Materials. The results of the production days listed in subsections A and B in Section 5 may be used solely for the promotion of the Naked Products (including the Wade Products) and are hereinafter referred to individually and collectively as the Commercial Materials. Wade shall have the right of prior written approval with respect to his photographs, likeness and statements. During the Term, Naked shall have the right in the Territory to the unlimited broadcast use and re-use of the Commercial Materials in the Territory. During the Term, Naked shall have the right in the Territory to use the Wade Image in the Commercial Materials, for publication and display, as Naked shall in its sole discretion determine, in print magazines, including but not limited to, point-of-sale  material, product packaging, Naked's Annual Report, other shareholder communications, internal sales and marketing pieces, as well as the right to use  the same at meetings held or attended by Naked or for trade purposes. Naked shall have the right at any time during the term of this Agreement to make any  revision or versions of all or any part of the Commercial Materials to conform  to the requirements of individual markets as Naked may desire, subject to Wade's  reasonable approval as aforesaid. Naked may also propose to use the Commercial Materials as part of cooperative advertising and retail tie in promotions  subject to Wade's prior written approval which shall not be unreasonably withheld, provided that withholding approval because a potential tie in conflicts with one of Athlete's existing sponsors shall not be deemed  unreasonable. Notwithstanding the foregoing, in no case shall the Commercial Materials feature any commercial tie in or other use that could be perceived as an endorsement by Athlete of any products or services other than the Naked Products. Naked shall comply with all applicable rules and regulations  (including the NBA's) in its use of the Commercial Materials hereunder.

7. Design of Wade Products.

Naked and Wade (either Athlete or a team and/or agent and/or designer designated by Athlete, referred to as the Wade Team) agree to collaborate on the design and manufacture of a new line of Innerwear under the brand Wade By Naked or such other brand name as the Parties agree (collectively, the Wade Products). Athlete will have the title of Creative Director for the Wade Products, which title shall be featured on the Commercial Materials. During the Term and subject to the limitations set forth in this Agreement, the Wade Team and Naked agree that the process for approving designs for Wade Products will be as follows:

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

(1) Naked will develop detailed designs for each Wade Product, which shall include rough drawings, to be provided to Wade for review and comment;

(2) The Wade Team will provide Naked with comments on such designs within ten (10) days after they are provided to the Wade Team;

(3) Upon receipt of the Wade Team's comments, Naked will review such comments and work diligently to incorporate them into the design within commercial reason and thereafter, develop and create a prototype for such Wade Product for the Wade Team's approval;

(4) Within ten (10) days after the Wade Team's receipt of the prototype either in hand or via a photograph by email, the Wade Team shall review the prototype and provide any additional comments; and

(5) Upon the Wade Team's written approval of a prototype, such Wade Product will be considered approved for production (the Production Approval).

(6) In addition to the foregoing Wade Products, Naked shall have the right to produce and distribute, on a non-exclusive basis, printed or branded tee-shirts subject to Wade's existing endorsement agreements.

The Wade Team and Naked will collaborate to establish a mutually acceptable marketing campaign for Wade Products, and will schedule regular phone calls, video conferences, and/or other meetings to timely complete development of Wade Products.

8. Royalties. As consideration for Wade's services under this Agreement, Naked will pay Wade royalties as follows:

A. Royalties. Naked will report, and Wade will be paid, royalty payments at [***]

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

B. Payment Terms. Wade Product Royalties described above in Section 8A will be paid on a quarterly basis on the first day of each of the months of July, October, January, and April and shall be accompanied by backup documentation reasonably satisfactory to Wade.

C. [***]

D. Withholding Taxes. Wade will  be solely responsible for withholding and paying any and all federal, state and  local taxes, including but not limited to payroll, unemployment, social security and income taxes and any other payments which may be owed by Wade as a result of or in connection with payments made by Naked for Wade Services rendered under this Agreement. Wade acknowledges that he is not qualified for and will not receive any Naked employment benefits or other incidents of employment as a result of the Agreement.

E. Equity Ownership. Wade is hereby granted a warrant (the Grant Warrant) exercisable for a period of seven (7) years from the date of issuance for the number of shares of Common Stock equal to [***] shares of Common Stock (the Wade Grant), subject to the following terms:

(1) Exercise Price. The Grant Warrant will have an exercise price equal to the then-fair market value per  share of Common Stock as quoted on the OTCQB as of the Effective Date (the FMV Exercise Price). The form of the Grant Warrant shall be agreed to by the Parties.

(2) Vesting Schedule. The Grant Warrant will become exercisable for: (a) fifty percent (50%) of the Wade Grant on the one year anniversary of the Effective Date (the First Installment); (b) twenty-five percent (25%) of the Wade Grant on the second  anniversary of the Effective Date (the Second Installment); and (c) the remaining twenty-five percent (25%) of the Wade Grant will vest on the third anniversary of the Effective Date (the Third Installment and together with the First Installment and the Second Installment, the  Installments and each an Installment);  provided  however, that in the event of a change of control of Naked, the entire  unvested portion of the Grant Warrant will immediately vest. For purposes hereof, a change of control shall mean the sale of at least fifty percent (50%) of the assets of Naked, a merger or consolidation of Naked with, by or into another entity, or a change in the ownership of more than fifty percent (50%) of the voting capital stock of Naked in one or more related transactions.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

(3) Exercise Upon Termination of the Agreement. In the event that the Agreement is terminated in accordance with Section 12A, than the [***] term of the Grant Warrant [***] shall expire ninety (90) days thereafter. [***]

(6) Designee of Wade Grant. Pursuant to the request of Wade, Naked shall issue [***] to Wade's exclusive representative, CAA Sports LLC. This grant shall be issued pursuant to the same terms and conditions as the Wade Grant, with the exception of the terms of [***].

(7) [***]

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

(8)  Grant Documents.  All  warrants referenced herein shall be issued pursuant to separate, mutually  negotiated grant documents, which shall contain all the terms referenced herein and shall be negotiated and executed promptly after the execution of the Agreement.

9. Board Membership.

A. Advisory Board. Upon entering into this Agreement, Athlete will join the Advisory Board of Naked (Advisory Board). As a member of the Advisory Board, Athlete agrees to the following:

(1) Athlete will participate in at least one (1) scheduled Advisory Board meeting by phone or in-person, provided that such meeting is held in Miami on a date acceptable to Wade.

(2) Athlete will provide Naked with access to Wade's contacts and Wade's expertise and breadth of experience as it pertains to the business of Naked;

(3) Wade will provide any reasonable additional assistance as may be mutually agreed upon by Naked and Wade from time to time; and

(4) Wade grants Naked the right to publicly identify Wade as a member of the Advisory Board, Creative Director, Stockholder, and Partner of Naked, and in the event that Wade joins the Board, as Director, and may include his name and biography in materials published by Naked, including any prospectus or offering materials or to publish any other information regarding Wade in any documents required to be filed pursuant to applicable laws and regulations.

B. Board of Directors. Further, Athlete will have the option in his sole discretion of becoming a member of the Board of Directors of Naked (the Board) (for a period of eighteen (18) months commencing on the Effective Date and provided that the Agreement has not  been terminated). If Athlete elects to become a member of the Board, he must satisfy the following requirements on an annual basis:

(1) Wade will participate in at least  four (4) scheduled board meetings, two (2) of which Wade must attend in-person, provided that at least one meeting is held in Miami, FL or, if no such meeting is held in Miami, FL then one (1) meeting if all meetings are held in New York, NY or another location. Subject to legal compliance requirements, Wade may  designate an individual acceptable to Naked serve as his representative to the meetings of the Board;

(2)  Wade will attend, subject to his  availability in his sole discretion, fundraising events and meetings with  potential investors, placement agents and representatives of the same at the request of Naked to be scheduled at the convenience of each of Naked and Wade;

If, while serving on the Board Wade does not satisfy any of the  above-listed requirements on more than one (1) occasion, the other members of the Board may remove Wade from the Board upon written notice to Wade.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

10. Wade Obligations. During the Term of this Agreement, Athlete agrees to comply with the following obligations:

A. Comply with all rules and regulations of the National Basketball Association and its governing bodies rules and regulations;

B. Not do anything which damages Wade's name, reputation, or image in the eyes of a reasonable observer;

C.  Exercise reasonable constraints to  avoid taking any actions which damages Naked, its name, reputation, image, the  Naked Products and Wade Products;

D. When promoting the Naked Products or  Wade Products, mention when appropriate the name of Naked and/or the Naked Products and Wade Products in interviews with the press, social media channels and broadcast media;

E. Wear the Naked Products and/or Wade Products when appropriate and refrain from wearing any other Innerwear products that would be visible to the public.

11. Non-compete; Confidentiality. Wade represents and warrants that during the Term and in  the Territory, neither Wade nor any of his agents, representatives or employees will solicit, initiate, or encourage any proposal for an endorsement by Wade of any Innerwear to commence during the Term, or participate in any discussions or negotiations for the same. Wade will execute a non-disclosure and confidentiality agreement in a form mutually acceptable to each of Wade and Naked.

12. Termination.

A. Naked shall have the right to terminate this Agreement upon ten (10) days prior written notice to Wade in the event Wade fails to perform the Wade Services or breaches any other covenant or agreement set forth herein (including the essence of this Agreement), and fails to cure same (if curable) within seven (7) days of receipt of written notice. Such termination shall relieve Naked of its obligation to provide any further consideration pursuant to this Agreement provided that Wade shall retain all warrants he has received hereunder that have vested as of the date of such termination. In the event of such termination as a result of a material breach of this Agreement by Wade (i) Wade's contractual liabilities and obligations until the date of termination still exist notwithstanding such termination, (ii)  Naked shall be under no obligation to sell any Wade Products but shall nevertheless owe the Royalty on any Wade Products sold; and (iii) notwithstanding anything to the contrary herein, Wade shall forfeit all warrants he has received hereunder. Naked shall not have waived any of its rights at law or in equity by exercising any provision of this section.

B. Wade shall have the right to  terminate this Agreement upon ten (10) days prior written notice to Naked in the  event of the occurrence of any of the following: (i) Naked is adjudicated as insolvent or declares bankruptcy; or (ii) Naked fails to provide consideration due pursuant to this Agreement, within ten (10) days following the date such consideration is due hereunder (or, if Wade elects to receive stock in lieu of the cash consideration, if Naked fails to instruct its transfer agent to issue the appropriate amount of Common Stock to Wade within ten (10) days following the date such consideration is due in the event such consideration is payable in Common Stock); provided that Naked is notified in writing of such non-payment by Wade and such payment by Naked is not made within three (3) days following such notification; or (iii) Naked breaches any  covenant or agreement set forth herein and fails to cure same (if curable)  within seven (7) days of receipt of written notice. Furthermore, Naked agrees that such termination shall not relieve it of its obligation to provide consideration as contemplated hereunder. Wade shall not have waived any of his rights at law or in equity by exercising any provision of this section.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

C. The Agreement shall be deemed terminated if neither Naked nor Wade elect to extend the Agreement as set forth in Section 2 hereof.

D. Naked's rights to the use of Wade Image shall end immediately should this Agreement be terminated pursuant to Section 12(A) or Section 12(B) above.

13. Notices. All notices provided for herein shall be given in writing by hand delivery, courier service,  or by certified mail return receipt requested to the addresses of the Parties set forth as follows (unless change of address by notice to the other Party is given as provided in this Section 13):

  If to Wade: If to Naked:         CAA Sports LLC Naked Brand Group, Inc.   405 Lexington Avenue, 19th Floor 10th Floor - 95 Madison Avenue   New York, NY 10174 New York, NY 10016   Attn: Lloyd Frischer Attn: Joel Primus         With a copy to: With a copy to:         Andrew B. Latack, Esq. Duane Morris LLP   at the same address 1540 Broadway, 14th Floor     New York, NY 10036     Attn: Nanette C. Heide, Esq.

14. Intellectual Property.

All rights to the use of the names, trademarks, service marks, symbols, logos, domain names, trade secrets, confidential know-how, patents, copyrights, any pending applications with respect to any of the foregoing, and  any other intellectual property and related proprietary rights, interests and protections (Intellectual Property Rights) in connection with Wade Products will be jointly owned by Wade and Naked. Wade will retain all ownership of the Intellectual Property Rights in connection with Wade Image including, for the avoidance of doubt, the Logo. For the avoidance of doubt, no rights are being granted hereunder to any intellectual property belonging to the NBA or its member clubs (including but not limited to the Miami Heat).

Subject to Section 14A, Naked will retain all ownership of the Intellectual Property Rights in connection with the Naked Products, the Naked brand and any and all related brands. All advertising material produced  hereunder will be and remain the absolute property of Naked. Wade acknowledges that he does not now have and in the future will assert no right, title or interest of any kind or nature whatsoever therein, or in or to any component part or tape, dub or copy or element or character or characterization thereof.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

15. Representations and Warranties of Naked and Wade.

A. Wade relies upon Naked's skill  and judgment and also upon the following  representations of Naked which  shall be in effect throughout the term of this Agreement:

(1) Naked's products will be merchantable and fit for the purpose for which they are intended, and

(2) Naked's products will conform at all times to all applicable federal, state and local laws, rules, regulations, ordinances, and other enactments and industry standards, including, but not limited to, those relating to product safety.

B. Wade Enterprises and Athlete hereby jointly and severally represent to Naked the following:

(1) Authorization. Wade Enterprises is an entity duly organized and validly existing in good standing under the laws of its jurisdiction of organization. Wade Enterprises and Athlete  each have the requisite power and authority to enter into, execute and deliver  the Agreement to which it is a party and to perform all of the obligations to be  performed by each of them hereunder. The Agreement and the obligations and  transactions contemplated hereby have been, duly authorized, executed and  delivered by each of them, and the Agreement constitutes each of their valid and binding obligation, enforceable against such Party in accordance with its terms.

(2)  No Conflicts. Neither the  execution and delivery of this Agreement nor the performance or consummation of  the transactions contemplated hereby or thereby by either Wade Enterprises or Athlete will conflict with, result in the breach of, constitute a default under or accelerate the performance required by the terms of: (i) any law, rule or  regulation of any government or governmental or regulatory agency; (ii) any judgment, order, writ, decree, permit or license of any court or governmental or regulatory agency to which such Party may be subject; (iii) any contract,  agreement, commitment or instrument to which Wade Enterprises or Athlete is a  party; or (iv) Wade Enterprises' constituent documents or other governing instruments (or constitute an event which, with the passage of time or action by a third party, would result in any of the foregoing). The execution and delivery  of this Agreement by Wade Enterprises and Athlete and the performance and consummation of the transactions contemplated hereby do not require any registration, filing, qualification, consent or approval under any material law, rule, regulation, judgment, order, writ, decree, permit or license to which such Party is subject.

16. Indemnity.

Naked shall be solely responsible for all liability arising out  of production, distribution and sale of its product. Naked hereby agrees to indemnify, defend and hold harmless Wade Enterprises, Athlete, his agents,  representatives and employees (referred to collectively as Wade Indemnities) from and against any and all claims, actions, causes or action, damages, injuries, expenses, liabilities (joint and several), penalties fines, attorneys' fees, court costs, and any other expenses incurred by Wade Indemnities arising out of (1) breach by Naked of any of the terms, representations or warranties made by Naked in  this Agreement; or (2) Naked product liability or trademark patent or other  proprietary right infringement; or (3) errors, omissions, fraudulent or negligent acts by Naked, its employees, agents or subcontractors in connection with (i) any advertising featuring Athlete; (ii) the performance of Naked's  duties and obligations under this Agreement; (iii) the production, distribution, promotion, marketing and sales of products including related product packaging; and/or (iv) the operation and management of its production and distribution facilities, however caused. Naked shall not be obligated to indemnify Wade with respect to damages which are the result of the gross negligence or willful misconduct of Wade.

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

Athlete and Wade Enterprises, jointly and severally, hereby agree to indemnify, defend and hold harmless Naked, its shareholders, directors, officers, employees, agents, and affiliates (referred to collectively as Naked Indemnities) from and against any and all claims, actions, causes or action, damages, injuries, expenses, liabilities (joint and several), penalties fines, attorneys' fees, court costs, and any other expenses incurred by Naked Indemnities arising out of or are in any way connected directly or indirectly with any and all claims, suits, actions, costs, and other expenses, fines, judgments, investigations, proceedings, demands, liabilities, and obligations of any nature whatsoever, with respect to Wade Enterprises' or Athlete's breach of its respective representations and warranties, uncured  breach of this Agreement or Athlete's gross negligence or willful misconduct.

17. Relationship of Parties. Nothing contained in this Agreement shall be deemed or construed to place the Parties in the relationship of partners, joint venturers, principal-agents, or employer-employee, it being understood that the Parties are and will remain independent contractors in all respects and neither Party shall have any right to obligate or bind the other in any manner whatsoever.

18. Assignment. Neither this Agreement nor any of the rights or obligations contained herein may be assigned or transferred by either Party without the prior written consent of the other Party.

19. Expenses. Each Party will bear its own expenses with respect to the execution of this Agreement and the  transactions contemplated thereunder, including but not limited to legal fees.

20. Authority to Contract. Each of the Parties represents and warrants that it has full right and power to enter  into this Agreement, to perform all obligations to be performed by it hereunder, and to grant all rights hereunder granted without violating the legal or equitable rights of any other person or entity, and that the execution and performance of this Agreement will not conflict with or result in a breach of or default under any of the terms or conditions of any agreement to which either Party has agreed, or is a Party, or may be bound.

21. Construction of Agreement. Each Party acknowledges that it has participated in the negotiation of this Agreement and that no provision of this Agreement shall be construed against or be interpreted to the disadvantage of any Party by any court or other governmental or judicial authority by reason of such Party having or deemed to have structured, dictated or drafted such provision.

12

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

22.  Merger; Modification. This  Agreement constitutes the entire agreement with respect to the subject matter  contained herein and supersedes all previous communications and agreements between the Parties pertaining to the subject matter hereof, whether written or oral. The terms of this Agreement may not be modified, waived, amended,  discharged, terminated, or supplemented, or otherwise changed, except by a written document executed by each Party.

23.  No Waiver. A waiver by  either Party of any of the terms or conditions of this Agreement in any instance  shall not be deemed or construed to be a waiver of such term or condition for  the future, or of any subsequent breach thereof, or any other term or condition  of this Agreement. All remedies, rights, undertakings, obligations, and agreements contained in this Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party.

24. Severability. If any  provision of this Agreement, as applied to either Party or to any circumstance,  shall be adjudged by a court of competent jurisdiction to be void or unenforceable, whether at law or in equity, then such determination shall in no way affect any other provision of this Agreement, or the validity or enforceability of this Agreement.

25. Choice of Law. This Agreement, all amendments hereto, and any and all issues or controversies arising here from or related hereto, shall be governed by and construed exclusively in accordance with the laws of the State of New York.

26. Arbitration of Disputes. The parties agree to use commercially reasonable efforts to settle amicably any controversy, or claim arising out of the Agreement or any breach thereof through a dispute resolution process involving Wade and members from the senior management of Naked. If the parties do not otherwise agree, either party may present any unresolved dispute for arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association (the Rules) then in effect. Such arbitration will be held in New York, NY. The arbitration will be by a single arbitrator chosen by the parties, provided that if the parties fail to agree and to appoint a single arbitrator within twenty (20) business days from the date that one of the parties has made a demand for  arbitration, then the arbitrator will be chosen in accordance with the Rules.  The decision of the arbitrator will be final and binding on the parties and any  award of the arbitrator may be entered in any court of competent jurisdiction.

27. Attorneys' Fees. If any action is necessary to enforce the provisions of this Agreement, including any claims or demands, or to interpret this Agreement, the prevailing Party shall be entitled to reasonable attorneys' fees, costs and necessary disbursements in addition to any other relief to which it may otherwise be entitled.

28. Captions; Structure. Section headings used in this Agreement are for convenience of reference only and shall not in any way affect the interpretation of any section of this Agreement or of the Agreement itself.

29. Time is of the Essence. Time is of the essence with respect to the performance of the duties and obligations hereunder.

30. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which when taken together shall be construed as a single instrument. This Agreement may be executed by facsimile or other electronic transmissions, and signatures on any facsimile or electronic transmission copy hereof shall be deemed authorized original signatures.

13

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

31. No Third Party  Beneficiaries. This Agreement is not for the benefit of any third party and  shall be deemed not to give any right or remedy to such third party, whether referred to herein or not.

32. Recitals. The recitals contained in this Agreement are true and correct and are incorporated herein by reference.

[SIGNATURE PAGE TO FOLLOW]

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Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

IN WITNESS WHEREOF, the Parties have executed this Agreement on the day and date first above written.

WITNESS:   Naked Brand Group, Inc. (Naked)       By:     By: /s/ Carole Hochman       Date:   Title:       WITNESS:   Wade Enterprises, LLC (Wade)       By:     By: /s/ Dwyane Wade       Date:

15

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

Inducement Letter and Guarantee

In order to induce Naked to enter into this Agreement with Wade Enterprises, LLC, I agree to the execution and delivery of this Agreement by Wade Enterprises, LLC, and agree to render all the services herein provided to be rendered by me, to grant all the rights granted herein, and to be bound by and duly perform and observe each and all of the terms and conditions of this Agreement regarding performance or compliance on my part, and I hereby join in all warranties, representations, agreements and indemnities made by Wade Enterprises, LLC, and further confirm the rights granted to Naked under the Agreement. All notices to Wade Enterprises, LLC shall be deemed notices to me with the same effect as if given to me. I certify that my services are rendered as an employee of Wade Enterprises, LLC, and, unless substituted for Wade Enterprises, LLC by law, I agree to look solely to Wade Enterprises, LLC for payment of compensation for my services and the discharge all other obligations of an employer, subject to the terms of the Agreement.

By: /s/ Dwyane Wade     Name: Dwyane Wade     Date:     NAKED BRAND GROUP, INC.   By: /s/ Carole Hochman     Name:       Date:

16

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

SCHEDULE A

WADE TRADEMARKS AND COPYRIGHTS

Wade's Asterisk Logo



17

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

18

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015





Confidential Information has been omitted in places marked [***] and has been filed separately with the Securities and Exchange Commission.  Confidential Treatment has been requested with respect to this omitted information pursuant to an application for confidential treatment filed with  the Commission under Rule 406 under the Securities Act of 1934, as amended.

SCHEDULE B

[***]

19

Source: NAKED BRAND GROUP INC., POS AM (on S-1), 7/31/2015
[EX A]: Highlight the parts (if any) of this contract related to Post-Termination Services that should be reviewed by a lawyer. Details: Is a party subject to obligations after the termination or expiration of a contract, including any post-termination transition, payment, transfer of IP, wind-down, last-buy, or similar commitments?

[EX Q]: Exhibit 10.2

EXECUTION COPY

***Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

Collaboration Agreement

This Agreement is entered into with effect as of the Effective Date (as defined below)

by and between

F. Hoffmann-La Roche Ltd

with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland (Roche Basel)

and

Hoffmann-La Roche Inc.

with an office and place of business at 150 Clove Road, Suite 8, Little Falls, New Jersey 07424, U.S.A. (Roche US; Roche Basel and Roche US together referred to as Roche)

on the one hand

and

Foundation Medicine, Inc.

with an office and place of business at 150 Second Street, Cambridge, Massachusetts 02141 (FMI)

on the other hand.





Table of Contents   1. Definitions   7  1.1 Affiliate   7  1.2 Agreement   7  1.3 Agreement Term   7  1.4 [...***...] ctDNA [...***...]   7  1.5 Applicable Law   7  1.6 Approved Assay   7  1.7 Background IP   7  1.8 Business Day   8  1.9 Calendar Half   8  1.10 Calendar Quarter   8  1.11 Calendar Year   8  1.12 CDx   8  1.13 CDx Development Program   8  1.14 CLIA   8  1.15 Clinical Study   9  1.16 Commercially Reasonable Efforts   9  1.17 Confidential Information   9  1.18 Control   9  1.19 Cover  10  1.20 ctDNA  10  1.21 ctDNA Assay  10  1.22 ctDNA Platform  10  1.23 ctDNA Platform Development Program  10  1.24 ctDNA Working Group  10  1.25 Data Security Breach  10  1.26 Effective Date  10  1.27 Excepted Activities  11  1.28 Excluded Patent Rights  11  1.29 FDA  11  1.30 FDCA  11  1.31 FMI Background IP Patent Rights  11  1.32 FMI Decisions  11  1.33 FMI Development Costs  11  1.34 FMI Know-How  11  1.35 FMI Foreground Patent Rights  12  1.36 FTE  12  1.37 FTE Rate  12  1.38 Handle  12  1.39 HSR  12  1.40 Immunotherapy Testing Platform Development Program  12  1.41 Immuno-Platform Working Group  12  1.42 Initiation  12  1.43 Insolvency Event  12  1.44 Invention  13  1.45 IUO  13  1.46 JMC  13  1.47 JOC  13  1.48 Joint Know-How  13  1.49 Joint Patent Rights  13    ***Confidential Treatment Requested***

- 2 -





1.50 JOT  13  1.51 JRDC  13  1.52 Know-How  13  1.53 Molecular Information Platform Program  13  1.54 Molecular Information Platform Working Group  14  1.55 Party  14  1.56 Patent Rights  14  1.57 Performance Specifications  14  1.58 Personal Data  14  1.59 Phase I Study  14  1.60 Phase II Study  14  1.61 Phase III Study  14  1.62 PMA  15  1.63 Quality Standards  15  1.64 R&D Plan  15  1.65 Regulatory Approval  15  1.66 Regulatory Authority  15  1.67 Roche Background IP Patent Rights  15  1.68 Roche Group  15  1.69 Roche Know-How  15  1.70 Roche Foreground Patent Rights  15  1.71 ROW Territory  15  1.72 RUO  15  1.73 Study Data  16  1.74 Sublicensee  16  1.75 Territory  16  1.76 Third Party  16  1.77 US  16  1.78 US$  16  1.79 Work Stream  16  1.80 Additional Definitions  16  2. Grant of License  18  2.1 Licenses  18  2.2 Sublicense  20  2.3 Right to Subcontract  20  3. Research and Development Collaboration  20  3.1 Molecular Information Platform Program  20  3.2 Immunotherapy Testing Platform Development Program  23  3.3 ctDNA Platform Development Program  25  3.4 CDx Development Program  27  3.5 Samples, Handling and Disposal  29  3.6 Records; Reports; Audits  30  4. Diligence  31  5. Most Favored Customer  31  6. Governance  31  6.1 Joint Management Committee  31  6.2 JRDC  33  6.3 JOC  34  6.4 Alliance Director  34  6.5 Limitations of Authority  34  6.6 Expenses  35  6.7 Lifetime  35    - 3 -





7. Regulatory   35  8. Payment   35  8.1 FTE Funding   35  8.2 Molecular Information Platform Program Fees   35  8.3 Immunotherapy Testing Platform Development Budget and Fees   36  8.4 ctDNA Platform Financial Terms   37  8.5 CDx Development Financial Terms   38  8.6 General Terms   38  8.7 Disclosure of Payments   39  9. Accounting and reporting   39  9.1 Timing of Payments   39  9.2 Late Payment   39  9.3 Method of Payment   39  10. Taxes   39  11. Auditing   40  11.1 Right to Audit   40  11.2 Audit Reports   41  11.3 Over or Underpayment   41  11.4 Duration of Audit Rights   41  12. Intellectual Property   41  12.1 Ownership of Inventions, data and results   41  12.2 German Statute on Employee's Inventions   43  12.3 Prosecution and Maintenance of Patent Rights Claiming FMI Inventions   43  12.4 Prosecution and Maintenance of Roche Foreground Patent Rights and Joint Patent Rights   44  12.5 Joint Patent Team   44  12.6 CREATE Act   44  12.7 Infringement   44  12.8 Defense   46  12.9 Common Interest Disclosures   46  13. Representations and Warranties   47  13.1 Mutual Representations and Warranties   47  13.2 Activities   48  13.3 Safety Data   48  13.4 Third Party Patent Rights   48  13.5 Inventors   48  13.6 Grants   48  13.7 Ownership and Validity of Know-How   48  13.8 Data Protection (Privacy) and Security   48  13.9 No Other Representations   50  14. Indemnification   50  14.1 Indemnification by Roche   50  14.2 Indemnification by FMI   51  14.3 Procedure   51  15. Liability   51  16. Obligation Not to Disclose Confidential Information   51  16.1 Non-Use and Non-Disclosure   51  16.2 Permitted Disclosure &sbsp;52  16.3 Press Releases   52  16.4 Publications   52  16.5 Commercial Considerations   53    - 4 -





17. Term and Termination  53  17.1 Commencement and Term  53  17.2 Termination  53  17.2.1 Termination for Breach  53  17.2.2 Insolvency  53  17.2.3 Termination by Roche without Cause  54  17.2.4 Termination by Roche for Frustration of Purpose  54  17.3 Consequences of Termination  54  17.3.1 Termination in General  54  17.3.2 Termination by FMI for Breach by Roche or Roche's Insolvency; Termination by Roche Without Cause or for Frustration of Purpose  54  17.3.3 Termination by Roche for Breach by FMI or FMI Insolvency  56  17.3.4 Direct License  57  17.4 Other Obligations  57  17.5 Survival  57  18. Bankruptcy  57  19. Miscellaneous  58  19.1 Governing Law  58  19.2 Disputes  58  19.3 Arbitration  58  19.4 Assignment  59  19.5 Debarment and Exclusion  59  19.6 Independent Contractor  60  19.7 Unenforceable Provisions and Severability  60  19.8 Waiver  60  19.9 Appendices  60  19.10 Entire Understanding  61  19.11 Amendments  61  19.12 Invoices  61  19.13 Notice  61    - 5 -





Collaboration Agreement

WHEREAS, FMI has or is developing platforms for use in genomic testing, including development of a molecular information platform, an immunotherapy testing platform, a circulating tumor DNA platform, and a companion diagnostics platform; and

WHEREAS, Roche has expertise in the research, development, manufacture and commercialization of pharmaceutical and diagnostic products, including development of an immunotherapy platform; and

WHEREAS, Roche and FMI want to collaborate on the development of platforms for use in molecular information, immunotherapy, circulating tumor DNA, companion diagnostics, and in vitro diagnostic tests and kits; and

WHEREAS, Roche Holdings, Inc., an Affiliate of Roche, and FMI are concurrently herewith entering into a Transaction Agreement dated as of the date hereof (as it may be amended from time to time, the Transaction Agreement) which provides, among other things, for Roche to acquire a majority ownership of FMI upon the terms and subject to the conditions set forth in the Transaction Agreement; and

WHEREAS, in connection therewith, and as an inducement to Roche's and FMI's willingness to enter into the Transaction Agreement and to consummate the transactions contemplated thereby, FMI and Roche agree that Roche will work with FMI in the United States to educate relevant persons on next generation sequencing and/or comprehensive genomic profiling technology (US Education Collaboration Agreement), Roche and FMI will collaborate on the commercialization of certain FMI products outside of the United States (Ex-US Commercialization Agreement), and Roche and FMI may collaborate on development and commercialization of decentralized in vitro diagnostic (IVD) versions of FMI tests generated by FMI (IVD Collaboration), the above mentioned agreements, including the Transaction Agreement, being referred to collectively as the Related Agreements; and

WHEREAS, FMI and Roche intend that assays and other products generated under this Agreement will be commercialized in accordance with the Ex-US Commercialization Agreement and that the governance structure under this Agreement will apply to the US Education Collaboration Agreement and the Ex-US Commercialization Agreement.   - 6 -





NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

  1. Definitions

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

  1.1 Affiliate

The term Affiliate shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in this definition of Affiliate, the term control shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation (Chugai), shall not be deemed an Affiliate of Roche unless Roche provides written notice to FMI of its desire to include Chugai as an Affiliate of Roche. Moreover, FMI and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of Roche and its Affiliates existing as of the Effective Date, and Roche and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of FMI and its Affiliates existing as of the Effective Date. Affiliates coming into existence after the Effective Date shall be classified by the Parties as either Roche Affiliates or FMI Affiliates for the purposes of this Agreement.

  1.2 Agreement

The term Agreement shall mean this document including any and all appendices and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement.

  1.3 Agreement Term

The term Agreement Term shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 17, expiring on the date when all work has been completed or terminated under all R&D Plans.

  1.4 […***…] ctDNA […***…]

The term […***…] ctDNA […***…] shall mean an analytical validated clinical ctDNA Assay […***…].

  1.5 Applicable Law

The term Applicable Law shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including without limitation, any Regulatory Authority) and is in force as of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same are applicable to the performance by the Parties of their respective obligations under this Agreement.

  1.6 Approved Assay

The term Approved Assay means any assay or test intended for use in the diagnosis or evaluation of a disease or condition, excluding any IUO, and with respect to which any necessary Regulatory Approval is received in the relevant country, including PMA approval in the US, if applicable.

  1.7 Background IP

The term Background IP shall mean all intellectual property rights, including Patent Rights and Know-How, Controlled by a Party as of the Effective Date and all intellectual property rights Controlled by a Party after the Effective Date but arising from activities other than the activities conducted under this Agreement. Roche Background IP specifically excludes the Excluded Patent Rights and no licenses are granted to FMI under such Excluded Patent Rights.   ***Confidential Treatment Requested***

- 7 -





1.8 Business Day

The term Business Day shall mean 9.00am to 5.00pm local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in Switzerland, New Jersey or Massachusetts.

  1.9 Calendar Half

The term Calendar Half shall mean each period of six (6) consecutive calendar months, ending June 30 and December 31.

  1.10 Calendar Quarter

The term Calendar Quarter shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30 and December 31.

  1.11 Calendar Year

The term Calendar Year shall mean the period of time beginning on January 1 and ending December 31, except for the first Calendar Year which shall begin on the Effective Date and end on December 31.

  1.12 CDx

The term CDx shall mean any Products or Services that require Regulatory Approval, including by any medical device Regulatory Authority, under the device authorities of the Federal Food, Drug, and Cosmetic Act (or equivalent medical device or in vitro diagnostic medical device regime in other countries) for use in connection with a decision to treat, or the specifics of the actual treatment, of person, with a specific product, as more fully described below:

  (i) identifying a person having a specific disease or condition, or a molecular genotype or phenotype that predisposes a person to such disease or condition, to support a decision to treat such person with such specific product, whether for prophylactic or therapeutic purposes;

  (ii) defining the prognosis or monitoring the progress of a disease or condition in a person to support a decision to treat, or tocontinue to treat, such person with such specific product, whether for prophylactic or therapeutic purposes;

  (iii) supporting the selection of a particular therapeutic or prophylactic regimen, wherein at least one (1) potential therapeutic orprophylactic regimen involves the use of such specific product; and/or

  (iv) confirming such specific product's biological activity and/or optimizing dosing or the scheduled administration of such specificproduct.

  1.13 CDx Development Program

The term CDx Development Program shall mean the program for development by FMI of CDx Assays for select Roche products.

  1.14 CLIA

The term CLIA shall mean Clinical Laboratory Improvement Amendments as set forth by the Centers for Medicare & Medicaid Services which regulates all laboratory testing (except research) performed on humans in the U.S. and is certified by the Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality.   - 8 -





1.15 Clinical Study

The term Clinical Study shall mean a Phase I Study, Phase II Study, Phase III Study, as applicable.

  1.16 Commercially Reasonable Efforts

The term Commercially Reasonable Efforts shall mean, with respect to the performance of an obligation under this Agreement, such quality and level of effort as is required to carry out such obligation in a sustained manner, consistent with the efforts Roche or FMI, as applicable, devotes to a similar obligation in connection with an internally developed product or service that is at the same stage of development or commercialization, as applicable, in a similar market, with similar market potential, at a similar stage of product life, taking into account the existence of other competitive products or services in the market place or under development, the proprietary position of the product or service, the regulatory structure involved, the anticipated profitability of the product or service and other relevant factors. It is understood that such quality and level if effort may change from time to time based upon changing scientific, business and marketing and return on investment considerations.

  1.17 Confidential Information

The term Confidential Information shall mean any and all information, data or know-how (including Know-How), whether technical or non- technical, oral or written, that is disclosed by one Party or its Affiliates (Disclosing Party) to the other Party or its Affiliates (Receiving Party). Confidential Information shall not include any information, data or know-how that:

  (i) was generally available to the public at the time of disclosure, or information that becomes available to the public after disclosureby the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party or its Affiliates,

  (ii) can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt fromthe Disclosing Party,

  (iii) is obtained by the Receiving Party at any time lawfully from a Third Party under circumstances permitting its use or disclosure,

  (iv) is developed independently by the Receiving Party or its Affiliates as evidenced by written records other than throughknowledge of Confidential Information, or

  (v) is approved in writing by the Disclosing Party for release by the Receiving Party.

The terms of this Agreement shall be considered Confidential Information of the Parties.

  1.18 Control

The term Control shall mean (as an adjective or as a verb including conjugations and variations such as Controls Controlled or Controlling) (a) with respect to Patent Rights and/or Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights and/or Know-How as provided herein without violating the terms of any agreement or arrangement between such Party and any other party, where such ability derives from rights other than an assignment or license granted herein and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party.   - 9 -





1.19 Cover

The term Cover shall mean (as an adjective or as a verb including conjugations and variations such as Covered, Coverage or Covering) that the developing, making, using, offering for sale, promoting, selling, exporting or importing of a given product would infringe a valid claim under the Patent Rights. As used in the previous sentence, valid claim means, with respect to a particular country a claim in an issued and unexpired patent that has not lapsed or been disclaimed, revoked, held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed fo appeal and that has not been admitted to be invalid or unenforceable through re-examination, re-issue, disclaimer or otherwise, or lost in an interference proceeding.

  1.20 ctDNA

The term ctDNA shall mean circulating tumor DNA.

  1.21 ctDNA Assay

The term ctDNA Assay shall mean an assay developed on or utilizing FMI's ctDNA Platform (including instruments and software) for the detection of genomic alteration in ctDNA, including an RUO, IUO and Approved Assay.

  1.22 ctDNA Platform

The term ctDNA Platform shall mean Products or Services for testing of specimens to identify genomic alterations in ctDNA as a blood-based liquid biopsy, including FMI instruments, analytical methods, algorithms, procedures, techniques, software or platforms, intended for use in genomic analysis, and related technologies and any improvements to the foregoing, in each case Controlled by FMI as of the Effective Date or during the Agreement Term.

  1.23 ctDNA Platform Development Program

The term ctDNA Platform Development Program shall mean the program for development of ctDNA analysis platform by FMI for effective genomic profiling from liquid biopsy.

  1.24 ctDNA Working Group

The term ctDNA Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the ctDNA Platform Development Program a set forth herein.

  1.25 Data Security Breach

The term Data Security Breach means (a) the disclosure or misuse (by any means) of Personal Data; (b) the inadvertent, unauthorized and/or unlawful processing, access, disclosure, alteration, corruption, transfer, sale or rental, destruction or use of Personal Data; or (c) any other act or omission that compromises the security, confidentiality, and/or integrity of Personal Data.

  1.26 Effective Date

The term Effective Date shall mean the latest of (a) the date of the last signature of this Agreement, or (b) if a HSR filing is made, the second Business Day immediately following the earlier of: (i) the date upon which the waiting period under HSR expires or terminates early or (ii) the date upon which all requests to the Parties by the Federal Trade Commission or the Justice Department, as the case may be, with regard to the transaction contemplated by this Agreement   - 10 -





have been satisfactorily met and no objection on the part of the Federal Trade Commission or the Justice Department remains, or (c) the occurrence of the Acceptance Time (as defined in the Transaction Agreement).

  1.27 Excepted Activities

The term Excepted Activities shall mean […***…].

  1.28 Excluded Patent Rights

The term Excluded Patent Rights shall mean those Patent Rights listed in Appendix 1.28.

  1.29 FDA

The term FDA shall mean the Food and Drug Administration of the United States of America.

  1.30 FDCA

The term FDCA shall mean the Food, Drug and Cosmetics Act.

  1.31 FMI Background IP Patent Rights

The term FMI Background IP Patent Rights means Patent Rights that Cover Background IP that is Controlled by FMI.

  1.32 FMI Decisions

The term FMI Decisions shall mean decisions with respect to any of the following issues that come before the JMC:

  (i) […***…].

  (ii) […***…].

  (iii) […***…].

  (iv) […***…].

  1.33 FMI Development Costs

The term FMI Development Costs means all costs reasonably incurred or committed to by FMI to perform its obligations and activities hereunder, including without limitation, (i) personnel costs equal to the number of FTE's used to perform such obligations and activities multiplied by the FTE Rate, (ii) out-of-pocket costs for consultants, materials and services and (iii) facilities costs reasonably allocated to performance of such obligations and activities, including acquisition, maintenance and operation costs for such facilities.

  1.34 FMI Know-How

The term FMI Know-How shall mean the Know-How that FMI Controls at the Effective Date and during the Agreement Term.   ***Confidential Treatment Requested***

- 11 -





1.35 FMI Foreground Patent Rights

The term FMI Foreground Patent Rights shall mean the Patent Rights that FMI Controls and that Cover Inventions conceived of and reduced to practice after the Effective Date in the performance of the activities under this Agreement, excluding any Joint Patent Rights and any FMI Background IP Patent Rights.

  1.36 FTE

The term FTE shall mean a full-time equivalent person-year, based upon a total of no less than one thousand eight hundred (1,800) working hours per year, undertaken in connection with the conduct of research in a Work Stream. In no circumstance can the work of any given person exceed one (1) FTE.

  1.37 FTE Rate

The term FTE Rate shall mean the amount of […***…], on a fully burdened cost basis, which amount shall be subject to increase following the […***…] anniversary of the Effective Date by an amount equal to the increase in the Consumer Price Index as published by the U.S. Department of Labor, Bureau of Labor Statistics (the CPI) between the Effective Date and such date for a new FTE Rate not to exceed […***…] per FTE, and which such new FTE Rate shall be subject to subsequent increases upon the date of each renewal or extension period comprising the Agreement Term by an amount equal to the increase in the CPI as of such date.

  1.38 Handle

The term Handle shall mean all activities associated with prosecution and maintenance of a particular patent and patent application(s) derived from such patent, including preparing, filing, prosecuting and maintaining (including interferences, reissue, re-examination, pre- and post-grant proceedings, inter-parties reviews, derivation proceedings, applications for patent term adjustment and extensions, supplementary protection certificates and oppositions and other similar proceedings).

  1.39 HSR

The term HSR shall mean the Hart-Scott-Rodino Antitrust Improvements Act.

  1.40 Immunotherapy Testing Platform Development Program

The term Immunotherapy Testing Platform Development Program shall mean the program for development of an immunotherapy testing platform.

  1.41 Immuno-Platform Working Group

The term Immuno-Platform Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the Immunotherapy Testing Platform Development Program.

  1.42 Initiation

The term Initiation&1148; shall mean the date that a human is first dosed with the drug in a Clinical Study approved by the respective Regulatory Authority.

  1.43 Insolvency Event

The term Insolvency Event shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any jurisdiction); (iii) enters into   ***Confidential Treatment Requested***

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any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary course of business.

  1.44 Invention

The term Invention shall mean an invention that is made, i.e. conceived and reduced to practice, in performance of activities under this Agreement. Under this definition, an Invention may be made by solely by individuals having an obligation to assign rights in such invention to FMI (an FMI Invention), solely by individuals having an obligation to assign rights in such invention to Roche (a Roche Invention), or jointly by individuals having an obligation to assign rights in such invention to FMI and individuals having an obligation to assign rights in such invention to Roche (a Joint Invention).

  1.45 IUO

The term IUO shall mean an assay for investigational use only that meets certain clinical and manufacturing standards and which is used in clinical studies to gather data for submission to a Regulatory Agency in support of an Approved Assay.

  1.46 JMC

The term JMC shall mean the joint management committee described in Article 6.

  1.47 JOC

The term JOC shall mean the joint operating committee as mentioned in Section 6.3 and described in the Ex-US Commercialization Agreement.

  1.48 Joint Know-How

The term Joint Know-How shall mean Know-How that is made jointly by the Parties or their Affiliates or their Sublicensees in performance of activities carried out pursuant to this Agreement.

  1.49 Joint Patent Rights

The term Joint Patent Rights shall mean all Patent Rights Covering a Joint Invention.

  1.50 JOT

The term JOT shall mean a joint operating team described in Section 6.1.7.

  1.51 JRDC

The term JRDC shall mean the joint research and development committee described in Section 6.2.

  1.52 Know-How

The term Know-How shall mean data, knowledge, algorithms, business rules and information, including manufacturing data, toxicological data, pharmacological data, preclinical data, formulations, specifications, quality control testing data, which are necessary or useful for the discovery, manufacture, development or commercialization of Products and Services.

  1.53 Molecular Information Platform Program

The term Molecular Information Platform Program shall mean the program designed to generate insights for certain of Roche's clinical development portfolio from FMI's molecular information platform, comprised of tumor sample genomic analysis, database access, and dedicated FMI clinical and genomic expertise.

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1.54 Molecular Information Platform Working Group

The term Molecular Information Platform Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the Molecular Information Platform Program.

  1.55 Party

The term Party shall mean FMI or Roche, as the case may be, and Parties shall mean FMI and Roche collectively.

  1.56 Patent Rights

The term Patent Rights shall mean all rights under any patent or patent application, in any country of the Territory, including any patents issuing on such patent application, and further including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.

  1.57 Performance Specifications

The term Performance Specifications shall mean a set of minimum standards and specifications related to FMI's supply and delivery of Products and Services under this Agreement as set forth in the R&D Plans for each Work Stream or Task Orders, including standards with respect to classes of alterations detected and sequencing sensitivity and specificity (based on tissue requirements); provided, however, the Performance Specifications for the Molecular Information Platform Program are attached hereto as Exhibit 1.57.

  1.58 Personal Data

The term Personal Data shall mean any information that can be used to identify, locate or contact an individual (a Data Subject), including but limited to, (a) first name or initial and last name; (b) home or other physical address; (c) telephone number; (d) email address or online identifier associated with the individual; (e) social security number or other similar identifier; (f) employment financial or health information; or (g) any other information relating to an individual that is combined with any of the above.

  1.59 Phase I Study

The term Phase I Study shall mean a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  1.60 Phase II Study

The term Phase II Study shall mean a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  1.61 Phase III Study

The term Phase III Study shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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1.62 PMA

The term PMA shall mean a premarket approval application as defined under section 515 of the FDCA.

  1.63 Quality Standards

The term Quality Standards shall mean CLIA or QSR requirements, each as applicable, and other Applicable Laws. If requested by Roche, the JRDC will establish which such quality standards specifically apply to Products and Services within a given Work Stream.

  1.64 R&D Plan

The term R&D Plan shall mean a plan of research and development for each Work Stream other than the Molecular Information Platform Program. The initial R&D Plans are attached as Appendix 1.64 and outline the work expected to be performed by FMI for the relevant Work Stream. Such plans may be updated from time to time as provided in this Agreement.

  1.65 Regulatory Approval

The term Regulatory Approval shall mean any approvals, licenses, registrations, authorizations, or certifications by Regulatory Authority or any CE markings, necessary for the manufacture, sale or putting into service of a product in a regulatory jurisdiction in the Territory.

  1.66 Regulatory Authority

The term Regulatory Authority shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for a product or service.

  1.67 Roche Background IP Patent Rights

The term Roche Background IP Patent Rights means Patent Rights that Cover Background IP that is Controlled by Roche.

  1.68 Roche Group

The term Roche Group shall mean collectively Roche, its Affiliates and its Sublicensees, excluding FMI and FMI Affiliates.

  1.69 Roche Know-How

The term Roche Know-How shall mean all Know-How that Roche Controls during the Agreement Term.

  1.70 Roche Foreground Patent Rights

The term Roche Foreground Patent Rights shall mean the Patent Rights that Roche Controls (other than through licenses granted under this Agreement) and that Cover Inventions conceived of and reduced to practice after the Effective Date in the performance of the activities under this Agreement, excluding any Joint Patent Rights and the Excluded Patent Rights.

  1.71 ROW Territory

The term ROW Territory shall mean […***…].

  1.72 RUO

The term RUO shall mean an assay intended or approved for research use only.   ***Confidential Treatment Requested***

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1.73 Study Data

The term Study Data shall mean all data related to any Data Subject collected by or transferred to the Roche Group or business partners, in connection with any services that FMI may provide to Roche.

  1.74 Sublicensee

The term Sublicensee shall mean an entity to which Roche or FMI, as applicable, has licensed rights (through one or multiple tiers), other than through a Compulsory Sublicense, pursuant to this Agreement.

  1.75 Territory

The term Territory shall mean […***…].

  1.76 Third Party

The term Third Party shall mean a person or entity other than (i) FMI or any of its Affiliates or (ii) a member of the Roche Group.

  1.77 US

The term US shall mean the United States of America and its territories and possessions.

  1.78 US$

The term US$ shall mean US dollars.

  1.79 Work Stream

The term Work Stream shall mean each of the Molecular Information Platform Program, Immunotherapy Testing Platform Development Program, the ctDNA Platform Development Program, and the CDx Development Program.

  1.80 Additional Definitions

Each of the following definitions is set forth in the Section of this Agreement indicated below:   Definition   Section AAA   19.3 Accounting Period   9.1 Advanced Genomic Analyses   3.1.4 Alliance Director   6.2 Approved Markers   3.4.1 Assessment   10 Bankruptcy Code   18 Binding Orders   3.1.5 Biomarker IP   2.1.2 Breaching Party   17.2.1 CDx Assays   3.4.1 CDx Platform Working Group   3.4.2 Chairperson   6.1.1 Competent Authority Procedures   10 ctDNA Milestone Date   8.4 Create Act   12.6 Database Renewal Term   3.1.9 Database Queries   3.1.8   ***Confidential Treatment Requested***

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Definition   Section Data Subject   1.57 Decision Period   12.5 Disclosing Party   1.17 Ex-US Collaboration Agreement   Whereas Clause First ctDNA Milestone Date   8.4 FMI CDx IP   12.1.5 FMI-Derived Advanced Genomic Analysis Results   3.1.8 FMI Improvement IP   12.1.2 FMI Invention   1.44 Immuno-Biomarker Discovery Platform   3.2.1 Immuno-Clinical Study Assays   0 Immunotherapy Exclusivity Period   3.2.8 Immunotherapy Testing Platform Development Budget   8.3.1 Genomic Analyses   3.1.4 Indemnified Party   14.3 Indemnifying Party   14.3 Initial Roche ctDNA Assay   8.4 Initiating Party   12.5 Investigational Markers   3.4.1 IVD Collaboration   Whereas Clause Joint Invention   1.44 Materially Modified   8.3.2(i) Members   6.1.1 Molecular Information Database   3.1.8 Molecular Information Database Access   3.1.8 Non-Breaching Party   17.2.1 Payment Currency   9.3 Peremptory Notice Period   17.2.1 Products and Services   7 Profiling Renewal Term   3.1.9 Profiling Term   3.1.9 Publishing Notice   16.4 Publishing Party   16.4 Receiving Party   1.17 Related Agreements   Whereas Clause Reserved Capacity   3.1.4 Reserved Capacity Fees   8.2.1.1 Roche CDx Development IP   12.1.5 Roche ctDNA Sample Results   12.1.4 Roche Immunotherapy Sample Results   12.1.3 Roche Improvement IP   12.1.2 Roche Invention   1.44 Roche-Owned Advanced Genomic Analysis Results   12.1.2 Roche's Jurisdiction   10 Sample Profiling   3.1.4   - 17 -





Definition   Section Sample Results   3.1.6 Second ctDNA Milestone Date   8.4 Settlement   12.5 Signature Identification   3.2.1 Suit Notice   12.5 Task Orders   3.1.3 TPP   6.1.5.2 Transaction Agreement   Whereas Clause US Education Collaboration Agreement   Whereas Clause

  2. Grant of License

2.1 Licenses

  2.1.1 Research and Development Cross License

Each Party grants to the other Party during the time that a Work Stream is in effect, a non-exclusive right and license under Know-How and Patent Rights, including the Background IP, Controlled by such Party and that are necessary or useful solely to enable the other Party to perform the activities contemplated under this Agreement; […***…].

    2.1.2 Molecular Information Platform Licenses

Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to FMI's Affiliates, under any intellectual property rights arising directly from the Sample Results, or the correlation of the Sample Results to patient data (Biomarker IP) (i) to the extent such Biomarker IP becomes publicly known, for internal research purposes, (ii) to the extent such Biomarker IP becomes publicly known, to develop, make, have made, use, offer for sale, sell, import, and commercialize FMI's Products and Services relating to genomic analysis, and (iii) […***…].

Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to Affiliates, to use the Roche-Owned Advanced Genomic Analysis Results to develop, make, have made, use, offer for sale, sell, import and commercialize FMI's products and services relating to genomic analysis.

FMI hereby grants to Roche a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to Roche's Affiliates under any FMI Improvements for Roche's internal research purposes and to develop, make, have made, use, offer for sale, sell, import and commercialize Roche's products and services other than diagnostic products and services.

    2.1.3 Immunotherapy Testing Platform Licenses

Effective after the Immunotherapy Exclusivity Period, Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable to Affiliates, license to any intellectual property arising from the Immunotherapy Testing Platform Development Program Controlled by Roche (excluding Roche Immunotherapy Sample Results) to the extent necessary   ***Confidential Treatment Requested***

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for FMI to develop, make, have made, use, offer for sale, sell, import and commercialize the Immuno-Biomarker Discovery Platform, Signature Identification services, Clinical Study assays, CDx assays, or any other FMI testing or services (including that are part of the Genomic Analysis Platform).

FMI hereby grants to Roche a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable license to any intellectual property arising from the Immunotherapy Testing Platform Program Controlled by FMI for internal research purposes and to the extent necessary for Roche to research, develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products.

If FMI is unable or unwilling to develop and commercialize an Immuno Clinical Study assay or CDx assay resulting from the Immunotherapy Testing Platform Development Program in a given country within the Territory as specified in an R&D Plan for any reason other than a breach of this Agreement by Roche, and on the timeline agreed to in such R&D Plan, then, effective on the end of the timeline specified in such R&D Plan, FMI hereby grants to Roche a non-exclusive, royalty-free, perpetual, and sublicensable license under any intellectual property invented by FMI arising from the Immunotherapy Testing Platform Program or the Immunotherapy Testing Platform Development that is necessary for Roche to develop and commercialize such tests in such country in the Territory.

    2.1.4 ctDNA Licenses

FMI hereby grants to Roche (i) an exclusive, royalty-free, sublicensable, worldwide and perpetual license to any intellectual property rights arising from the ctDNA Development Platform Program that are necessary for Roche to develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products (including the use, formulation, methods of treatment, clinical data or other data, information or results relating to the Roche therapeutic product) solely for use in connection with such activities and such Roche products and (ii) a non-exclusive, royalty-free, worldwide and perpetual license, with the right to grant sublicenses solely to Roche Affiliates, to any intellectual property rights arising from the ctDNA Development Platform Program, for internal research purposes.

Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable license to any IP Controlled by Roche and developed under the ctDNA Platform Development Program (excluding Roche Immunotherapy Sample Results) to the extent necessary for FMI to research, develop, make, have made, use, offer for sale, sell, import and commercialize the ctDNA Assays.

    2.1.5 CDx Development Program

FMI hereby grants to Roche a non-exclusive license under the FMI CDx IP for internal research purposes, and to the extent necessary to research, develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products.

If FMI is unwilling or unable to develop and commercialize a CDx Assay for a given country in the Territory as specified in the R&D Plan, and on the timeline set forth in the relevant R&D Plan, for any reason other than a breach of this Agreement by Roche, then FMI hereby grants to Roche a non-exclusive, royalty-free, sublicensable, and perpetual license under any intellectual property invented by FMI arising from the CDx Development Program that is necessary for Roche to develop and commercialize a CDx Assay equivalent in such country in the Territory.   - 19 -





2.2 Sublicense

Except as otherwise provided herein, where the right to sublicense is granted under this Agreement, the licensee shall have the right to sublicense, and subcontract (subject to Section 2.3), through multiple tiers. Each sublicense granted hereunder to a Third Party shall be pursuant to a written agreement. Each sublicense granted hereunder by a Party shall include restrictions on the disclosure of the other Party's Confidential Information that are substantially similar to the protections provided herein. Each Party shall be liable for any action or failure to act by a sublicensee under a sublicense granted by such Party to the extent such action or failure to act on the part of such Party would constitute a breach of this Agreement by such Party.

  2.3 Right to Subcontract

Each Party shall have the right to subcontract the work performed under this Agreement in accordance with the applicable R&D Plan. Each such subcontract with a Third Party shall be pursuant to a written agreement. Each such subcontract by a Party shall include restrictions on the disclosure of the other Party's Confidential Information that are substantially similar to the protections provided herein. Each Party shall be liable for any action or failure to act by a subcontractor under a subcontract entered into by such Party to the extent such action or failure to act on the part of such Party would constitute a breach of this Agreement by such Party.

  3. Research and Development Collaboration

3.1 Molecular Information Platform Program

  3.1.1 Scope

Roche and FMI shall conduct the Molecular Information Platform Program pursuant to this Agreement under the direction of the Molecular Information Platform Working Group.

    3.1.2 Molecular Information Platform Working Group

The Parties shall establish the Molecular Information Platform Working Group within sixty (60) days after the Effective Date to operationalize the Molecular Information Platform Program. The Molecular Information Platform Working Group's activities will be overseen by JRDC.

    3.1.3 Task Orders

The Parties will conduct the Molecular Information Platform Program in accordance with agreed upon task orders (Task Orders) and in compliance with Performance Specifications and Quality Standards. Each Task Order will be substantially in the form set forth in Appendix 3.1.3. To the extent any terms set forth in a Task Order conflict with the terms set forth in this Agreement, the terms of this Agreement shall control.

    3.1.4 Sample Profiling and Reserved Capacity

FMI shall provide, and shall reserve capacity to provide, Roche with comprehensive profiling, analysis and reporting (Sample Profiling) of at least […***…] during the first […***…] immediately following the Effective date, and at least […***…] samples during the next […***…]   ***Confidential Treatment Requested***

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(Reserved Capacity) using FMI's platform for molecular genomic profiling of cancer samples (the Genomic Analysis Platform). The initial laboratory and computational biology activities performed on the Samples as part of Sample Profiling are Genomic Analyses. FMI will provide Sample Profiling in accordance with the Reserved Capacity during the Profiling Term and Profiling Renewal Term, using the then-current versions of the tests included in its Genomic Analysis Platform. The Sampling Profiles shall be provided in a specified format to be mutually agreed by the Parties. The JMC will discuss and decide upon the Reserved Capacity commitment for Profiling Renewal Terms, provided that any Reserved Capacity amount in excess of […***…] that would require FMI to increase its existing capacity will require FMI approval.

Sample Profiling will include advanced genomic analyses, i.e. advanced laboratory and computational biology activities in the field of cancer genomic sequencing and analysis performed on Samples, including […***…] (collectively, Advanced Genomic Analyses). Sample Profiling includes Genomic Analyses and Advanced Genomic Analyses.

FMI may adopt modifications to the Performance Specifications without Roche's consent, so long as such modifications do not result in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57 (which such material diminution would require the prior written consent of Roche). In the event […***…], and such change results in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57, Roche may, at its election, and upon written notice to FMI, terminate each Party's obligations under Reserved Capacity, including Roche's obligations under Section 8.2.1.1 to pay Reserved Capacity Fees and opt out of the price per Sample fees for Sample Profiling otherwise specified in Section 8.2.1.2, in each case, from the effect of such sequencing platform change. If Roche elects to terminate the Parties' obligations under Reserved Capacity and opts out of the per Sample pricing for Sample Profiling specified in Section 8.2.1.2, Sample Profiling shall then be performed, and fees for such Sample Profiling shall then be charged, on a per Sample basis at FMI's standard rates or on pricing terms to be mutually agreed in writing by the Parties (or as otherwise mutually agreed in writing by the Parties).

    3.1.5 Forecasting and Binding Orders

Not later than the first Business Day of […***…] during the Profiling Term and Profiling Renewal Terms, Roche will provide FMI with a rolling forecast of its estimated requirements for Sample Profiling for the following […***…], the rolling forecast for the […***…] of which shall be deemed to be a binding order for sample volume (including specifications for the number of samples to be run using each of FMI's different tests) (Binding Orders). Binding Orders will not impact FMI's commitment to provide services for at least the Reserved Capacity amount, and Roche's financial commitment to pay the Reserved Capacity Fee. FMI shall use Commercially Reasonable Efforts to fulfill requests for Sample Profiling exceeding the Reserved Capacity based on forecasts provided by Roche (each a Forecast) in advance of […***…] as specified below.

    3.1.6 Samples, Sample Results, Web-Portal

Roche will provide samples to FMI for Sample Profiling as provided for in Section 3.5. The results of the Sample Profiling (Sample Results) shall be provided by FMI to Roche in a timeframe to be agreed upon by the Parties. A sample report is attached as Appendix 3.1.6.   ***Confidential Treatment Requested***

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FMI will set up and utilize a basic web-portal for Roche to access Sample Results and patient reports for Roche Clinical Studies. This web-portal shall be similar to the portal that FMI provides to its other major pharmaceutical customers.

    3.1.7 Clinical Reports

FMI will provide Roche with clinical (e.g., FoundationOne® or FoundationOne® Heme) reports from Sample Profiling on reasonable request, to be specified in applicable Task Orders, to enable Roche to provide comprehensive information to physicians and patients.

    3.1.8 Database Insights

FMI will provide molecular information insights (Database Insights) arising from FMI's database of aggregated clinical genomic analysis results, which include genomic alterations (base substitutions, insertions and deletions, copy number alterations, and rearrangements) detected by the Genomic Analysis Platform across FMI's clinical testing experience in all disease ontologies (the Molecular Information Database), in response to queries supplied by Roche (Database Queries) or generated by FMI in response to discussions between the Parties about areas of interest for Roche (e.g., […***…]), utilizing a team of […***…] FMI FTEs with requisite training and experience to generate Database Insights (Molecular Information Database Access).

Database Insights and results of Advanced Genomic Analyses performed against the Molecular Information Database (which, for clarity, does not include Roche's Sample Results) (FMI-Derived Advanced Genomic Analysis Results) shall be deemed FMI Confidential Information. Roche and its Affiliates may use the Database Query Results and FMI-Derived Advanced Genomic Analysis Results for all purposes, except that Roche may not disclose the Database Query Results to Third Parties, other than as necessary for development, approval or commercialization of a therapeutic or diagnostic product owned or controlled by Roche, or as otherwise consistent with the terms of confidentiality contained in the Definitive Agreement.

    3.1.9 Molecular Information Database Access

As set forth in Section 3.1.8, FMI will provide Roche mediated (indirect through dedicated FMI FTEs) access to the Molecular Information Database to pose Database Queries and will provide the resulting Database Insights to Roche in a format to be mutually agreed by the Parties. FMI will also provide Roche with direct access to the Molecular Information Database for Roche to perform Database Queries and generate Database Insights, when such service is made available to Third Parties by FMI in the ordinary course of business.

    3.1.10 Duration and Extension

The term for Sample Profiling set forth in Section 3.1.4 shall commence on the Effective Date and continue for five (5) years thereafter (the Profiling Term). The Profiling Term may be extended at Roche's option, upon […***…] written notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Profiling Renewal Term).

The term for Database Insights under Section 3.1.8 shall commence on the Effective Date and continue for five (5) years thereafter (the Database Insights Term). The Database Insights   ***Confidential Treatment Requested***

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Term may be extended at Roche's option, upon […***…] notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Database Renewal Term).

During any Profiling Renewal Term and/or Database Renewal Term, if FMI increases the fees it charges to Third Parties for Sample Profiling and/or Database Insights, then FMI will notify Roche of such adjustment(s), and the Parties shall agree upon the fees to be charged to Roche during the Profiling Renewal Term and/or Database Renewal Term, subject to Article 5, for such Profiling Renewal Term and/or Database Renewal Term prior to its commencement.

If FMI is unable to provide Roche with the Reserved Capacity, or to provide Roche with deliverables meeting Performance Specifications for the Sample Profiling or the Database Queries or fails to comply with Quality Standards, then Roche will have the right to terminate the Sample Profiling and/or Database Insights, as applicable, as set forth in Section 17.3.3, subject to the notice and cure provisions therein.

  3.2 Immunotherapy Testing Platform Development Program

  3.2.1 Scope

Roche and FMI shall conduct the Immunotherapy Testing Platform Development Program pursuant to a mutually agreed R&D Plan under the direction of the Immuno-Platform Working Group. The purpose of the Immunotherapy Testing Platform Development Program is to develop an immunotherapy testing platform meeting the specifications set forth by the Immuno-Platform Working Group for profiling of cancer immunotherapy patients (the Immuno-Biomarker Discovery Platform). The Parties hope to further deploy the platform for use in Clinical Study sample profiling to identify possible signatures for immunotherapy response (Signature Identification). Roche may also, at its option, request that FMI develop CLIA immunotherapy testing Clinical Study assays for use in selecting or differentiating patients in Roche Clinical Studies in immuno-oncology (Immuno-Clinical Study Assays).

    3.2.2 Immuno-Platform Working Group

The Parties shall establish the Immuno-Platform Working Group within sixty (60) days after the Effective Date to operationalize the Immunotherapy Testing Platform Development. The Immuno-Platform Working Group's activities will be overseen by JRDC.

The Immuno-Platform Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The Immuno-Platform Working Group shall:

(i) serve as a forum for discussing the development of the Immuno-Biomarker Discovery Platform and related Products and Services, as well as Immuno-Clinical Study Assays, if applicable;

(ii) serve as a forum for coordinating the Parties' efforts to carry out the R&D Plan;

(iii) periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein;   ***Confidential Treatment Requested***

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(iv) discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of the Products and Services developed in the Immunotherapy Testing Platform Development Program; and

(v) such other responsibilities as may be assigned to the Immuno-Platform Working Group in or pursuant to this Agreement or as may be mutually agreed by the Parties in writing.

    3.2.3 R&D Plan

The Parties will conduct the Immunotherapy Testing Platform Development Program in accordance with an R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated […***…] by the Immuno- Platform Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the Immunotherapy Testing Platform Development Program and the FTE resources that will be dedicated to the activities contemplated within the scope of the Immunotherapy Testing Platform Development Program, including the responsibilities of each Party (ii) an overall timeline and specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall update the R&D Plan no later than […***…] before the first anniversary of the Effective Date. The JRDC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan. Any such changes shall be reflected in written amendments to the R&D Plan.

    3.2.4 Responsibilities of the Parties

FMI will work with Roche in accordance with the R&D Plan to develop the Immuno-Biomarker Discovery Platform, perform Signature Identification, and, as requested by Roche, develop Immuno Clinical Study Assays. Except for the contracts listed on Appendix 3.2.4, the Parties will meet and discuss existing contracts for activities that are Excepted Activities, and enact a plan for winding-down such contracts, where appropriate.

Roche will work with FMI in accordance with the R&D Plan established by the Immuno-Platform Working Group, including by providing relevant samples and associated data, immuno-oncology expertise, and bioinformatics support, in each case to the extent agreed to in the R&D Plan.

    3.2.5 Budget

A budget for the anticipated work for the Immunotherapy Testing Platform Development forms a part of the R&D Plan. Any changes to this budget shall be reviewed by the JRDC and then submitted to the JMC for approval.

    3.2.6 Duration

The initial term of the Immunotherapy Testing Platform Development Program will be five (5) years beginning on the Effective Date.

    3.2.7 Extension

Roche shall have the right to extend the Immunotherapy Testing Platform Development Program, upon [...***...] written notice to FMI as specified in Section 19.13, for up to six (6)   ***Confidential Treatment Requested***

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additional one (1) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Signature Identification Renewal Term), provided, for clarity, that during any Signature Identification Renewal Term, FMI's obligations under Section 16.1 shall continue to apply to any signature identified under this Agreement but that exclusivity under Section 3.2.8 shall not apply to the Immuno-Biomarker Discovery Platform.

    3.2.8 Exclusivity

Except for Excepted Activities, for the lesser of (i) […***…] after the Effective Date or (ii) […***…] (the Immunotherapy Exclusivity Period), FMI will work exclusively with Roche with respect to […***…]. Except with regard to Excepted Activities, FMI will not (i) work directly or indirectly with any Third Party in the field of […***…], (ii) use for the benefit of any Third Party the […***…] or (iii) transfer to or otherwise enable any Third Party to make use of any data, technology or results from the Immunotherapy Testing Platform Development Program for […***…].

Following the Immunotherapy Exclusivity Period, FMI shall have the right to work with Third Parties in the field of cancer immunotherapy, and to otherwise commercialize the Immuno-Biomarker Discovery Platform, subject to the Related Agreements.

    3.2.9 Excepted Activities

For any Excepted Activities, FMI shall provide copies of proposed publications Roche for review in accordance with Section 16.4.

    […***…]

For the first […***…] following commercial launch by FMI of any Immuno Clinical Study Assay(s) created during or derived from the Immunotherapy Testing Platform Development, Roche and its Affiliates will be entitled to […***…], for the purchase of any such Immuno Clinical Study Assay(s).

  3.3 ctDNA Platform Development Program

  3.3.1 Scope

Roche and FMI shall conduct the ctDNA Platform Development Program, pursuant to a mutually agreed R&D Plan under the direction of the ctDNA Working Group. The purpose of the ctDNA Platform Development Program is to develop ctDNA Assays meeting the specifications set forth in the R&D Plan.

    3.3.2 Working Group

The Parties shall establish the ctDNA Working Group within sixty (60) days after the Effective Date to operationalize the ctDNA Platform Development. The ctDNA Working Group's activities will be overseen by JRDC.   ***Confidential Treatment Requested***

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The ctDNA Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The ctDNA Working Group shall:

  (i) serve as a forum for discussing the development of the ctDNA Platform and ctDNA Products;

  (ii) serve as a forum for coordinating the Parties' efforts to carry out the R&D Plan;

  (iii) periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving thetimelines set forth therein;

  (iv) discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of thectDNA Products; and

  (v) such other responsibilities as may be assigned to the ctDNA Working Group in or pursuant to this Agreement or as may bemutually agreed by the Parties in writing.

    3.3.3 R&D Plan

FMI will develop the ctDNA Assays, leveraging ongoing efforts, in accordance with the R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated […***…] by the ctDNA Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the ctDNA Platform Development Program and the FTE resources that will be dedicated to the activities contemplated within the scope of the ctDNA Platform Development Program, including the responsibilities of each Party (ii) an overall timeline and specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall update the R&D Plan no later than […***…] before the first anniversary of the Effective Date. The JRDC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan subject to approval of the JMC. Any such changes shall be reflected in written amendments to the R&D Plan.

    3.3.4 Responsibilities of the Parties

FMI shall, subject to all terms and conditions of this Agreement, use Commercially Reasonable Efforts to Develop the Initial Roche ctDNA Assay and the ALK ctDNA Clinical Trial Assay in accordance with the R&D Plan. FMI will work with Roche in accordance with the R&D Plan to develop ctDNA Assays.

Roche will work with FMI in accordance with the R&D Plan, including by providing relevant Samples and associated data, in each case to the extent agreed to in the R&D Plan.

Roche assumes no liability for use of the Genomic Analyses obtained from Samples provided under this Agreement, except as and to the extent arising out of a breach by Roche of this Agreement.   - 26 -





  3.3.5 Budget

FMI will have sole control over, and responsibility for, the budget and funding for the anticipated work for the ctDNA Platform Development under the R&D Plan.

    3.3.6 Duration

The initial term of the ctDNA Platform Development Program will be twelve (12) months.

    3.3.7 Extension

The initial term of the ctDNA Platform Development Program may be extended by the mutual agreement of the Parties.

    […***…]

For the […***…] following commercial launch by FMI of any ctDNA Assay(s) created during or derived from the ctDNA Platform Development, Roche and its Affiliates will be entitled to […***…], for the purchase of any such ctDNA Assay(s).

    3.3.9 Commercialization

Subject to the Related Agreements, FMI shall have the right to commercialize the ctDNA Assays. The ctDNA Assays may be made commercially available to any customer, except that FMI shall not disclose to an Third Party the specific content of any ctDNA Assay developed specifically for Roche for use as a Clinical Study assay.

  3.4 CDx Development Program

  3.4.1 Scope

Roche and FMI shall conduct the CDx Development Program pursuant to a mutually agreed R&D Plan. The activities conducted in connection with the CDx Development Program will be overseen by the JRDC. The purpose of the CDx Development Program is to develop certain companion diagnostic tests or assays (the CDx Assays) for use in connection with certain Roche products. Such CDx Assays may include those developed at Roche's request in connection with markers that have not yet been approved by the FDA for the particular tumor type/indication for which Roche is developing the relevant therapeutic (Investigational Markers) and those developed by mutual agreement of the Parties in connection with markers that are included in one or more assays approved by the FDA for the particular tumor type/indication to indicate use of a Roche therapeutic (Approved Markers).

    3.4.2 Working Group

For each CDx Assay under development, the Parties shall establish a working group (the CDx Platform Working Group), to operationalize the CDx Development. The Parties shall establish the first CDx Platform Working Group within sixty (60) days after the Effective Date. Each CDx Platform Working Group's activities will be overseen by JRDC.   ***Confidential Treatment Requested***

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The CDx Platform Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The CDx Platform Working Group shall:

(i) serve as a forum for discussing the development of CDx Assays and related Products and Services;

(ii) serve as a forum for coordinating the Parties' efforts to carry out the R&D Plan;

(iii) periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein;

(iv) discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of the Products and Services developed in the CDx Development Program; and

(v) such other responsibilities as may be assigned to the CDx Platform Working Group in or pursuant to this Agreement or as may be mutually agreed by the Parties in writing.

    3.4.3 R&D Plan

The Parties will conduct the CDx Development Program in accordance with the R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated […***…] by the CDx Platform Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the CDx Development Program and the resources that will be dedicated to the activities contemplated within the CDx Development Program, including the responsibilities of each Party (ii) specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall prepare a plan for activities to be conducted no later than […***…] before the first anniversary of the Effective Date. The JMC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan. Any such changes shall be reflected in written amendments to the R&D Plan.

    3.4.4 Responsibilities of the Parties

FMI will provide CDx development and testing services, including, as required by the R&D Plan, providing FDA QSR laboratory capacity to support such testing. The CDx services will be based on individual CDx R&D Plans for specific Roche assets that will be agreed upon, signed by the Parties and thereby made a part of this Agreement as Appendices 3.4.4(a), 3.4.4(b) and so on. All CDx services will be performed with appropriate systems and documentation to support eventual FDA approval of a PMA or 510(k) or, if agreed by the Parties, approval from the relevant regulatory authorities for an ROW Territory in which FMI will deliver a CDx Assay for Roche therapeutics.

FMI will be responsible for performing the development work for the CDx Assays according to the individual CDx R&D Plans. Unless otherwise expressly agreed between the Parties, FMI will be responsible for seeking regulatory approval (including PMAs, 510(k)s or equivalent) for the CDx Assays. FMI will provide Roche with cross-reference letters, and shall otherwise coordinate regulatory submissions and related information, with Roche.   - 28 -





Roche is responsible for supplying FMI with the information and materials necessary for each CDx Assay to be developed under the CDx Development Program in accordance with the R&D Plan. Roche will be solely responsible for seeking regulatory approval for the associated Roche asset. Roche will provide FMI with cross-reference letters, and shall otherwise coordinate regulatory submissions and related information with FMI.

    3.4.5 Budget

Roche and FMI shall agree on a budget for each CDx Assay. The initial budget forms a part of the initial R&D Plan.

    3.4.6 Duration

The term of the CDx Development Program shall be five (5) years.

    3.4.7 Extension

Roche shall have the right to extend the term of the CDx Development Program, upon […***…] prior written notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI.

    3.4.8 Continuing Obligations

If work under an individual CDx R&D Plan is initiated during the initial term of the CDx Development Program or an extension thereof, then such work shall be completed as set forth in the applicable individual CDx R&D Plan after the initial term or extension, as applicable, in accordance with the terms set forth therein and herein (including with respect to funding obligations).

    3.4.9 Commercialization

Subject to the Related Agreements, FMI shall have the right to commercialize the CDx Assays.

  3.5 Samples, Handling and Disposal

  3.5.1 Samples

Roche will provide samples to FMI that meet the FMI specimen requirements attached hereto as Appendix 3.5.1 and in accordance with the applicable R&D Plan. FMI shall not transfer the Samples or other materials obtained or received in connection with this Agreement, or any derivatives thereof, to any Third Party without Roche's prior written approval. FMI shall use the Samples and material obtained or received in connection with this Agreement solely for the performance of activities permitted under this Agreement in FMI's laboratories under suitable containment conditions in accordance with all Applicable Law. FMI shall not analyze the Samples other than as expressly provided for in this Agreement. FMI may use such Samples in accordance with the applicable R&D Plan without any obligation of compensation to the subjects from whom such Samples were obtained or any other Third Party for the intellectual property associated with, or any use of, such Samples.   ***Confidential Treatment Requested***

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  3.5.2 Sample Handling and Disposal

All Samples provided to FMI by or on behalf of Roche shall have been collected or shall be collected, handled, and transferred in compliance with Applicable Law and any applicable policies of any institutional review board, privacy board, or ethics committee with jurisdiction over the collection, handling, and transfer of such material or information. Upon termination of the Agreement or the Work Stream requiring the use of the Samples, or upon completion of those activities requiring use of the Samples, FMI shall promptly return to Roche unused or remaining Samples, or, at FMI's option, securely dispose of all unused or remaining Samples and provide Roche with a written notice of such disposal.

Roche has authorization and all consents required for FMI to use the Samples in accordance with the R&D Plans and the Agreement. FMI shall use, store and handle all Samples in accordance with the R&D Plans and all Applicable Laws. In the event of withdrawal of a subject's consent, Roche will promptly notify FMI and FMI will destroy the corresponding unused Samples (as documented by written confirmation) or return such Samples to Roche for destruction.

  3.6 Records; Reports; Audits

  3.6.1 Progress Reports

At least […***…] during the time a Work Stream remains in effect, unless otherwise agreed by the Parties, FMI shall have the obligation to prepare and provide to the JRDC a summary presentation on the progress of the work performed by FMI in the course of each Work Stream during the preceding […***…]. Promptly upon expiry of such Work Stream, other than the Molecular Information Platform Program, FMI shall provide a final written report summarizing its activities under such Work Stream and the results thereof.

    3.6.2 Research Records

Each Party shall maintain records of each Work Stream (or cause such records to be maintained), except Roche shall not have such obligation for the Molecular Information Platform Program, in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Work Stream. All laboratory notebooks shall be maintained for no less than the term of any Patent Rights issuing therefrom.

In addition, during the Agreement and for […***…] thereafter, FMI shall maintain all data provided to FMI by Roche, the Genomic Results, the FMI Advanced Genomic Analysis Results, Database Insights Database Query Results, and documentation necessary to demonstrate FMI's compliance with the terms of this Agreement, including computerized records and files, in a secure area reasonably protected from fire, theft and destruction; provided, however, that with respect to raw genomic data, FMI shall only be required to retain the original, unprocessed BAM file generated from its sequencing process and no other raw genomic data or intermediate BAM files created in processing to generate the Results.

    3.6.3 Regulatory Inspections and Audit

Roche shall be entitled, upon reasonable notice and during FMI's regular business hours, to visit FMI's facility (and those facilities of its subcontractors), including FMI's CLIA-compliant   ***Confidential Treatment Requested***

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facilities, to audit for quality assurance purposes its facilities, documentation and procedures used in conducting its activities pursuant to this Agreement. Such audits may be conducted up to […***…] and Roche shall use reasonable effort not to disrupt ongoing operations during such audits. FMI shall provide Roche with prompt notice of any governmental or regulatory review, audit or inspection of any of its facilities involved in the development of the Molecular Information Platform, Immunotherapy Testing Platform, ctDNA Platform, or CDx Assays, and all Products and Services resulting therefrom, and FMI's CLIA-compliant facilities. FMI shall provide Roche with (a) the results of any such review, audit or inspection (including a copy of the relevant sections of the report) to the extent such results pertain to any activities under this Agreement; and (b) the opportunity to provide assistance to FMI in responding to any such review, audit or inspection.

  4. Diligence

Roche and FMI shall use Commercially Reasonable Efforts to perform their respective activities contemplated by this Agreement.

  5. Most Favored Customer

FMI agrees that the pricing terms for Products and Services provided by FMI to Roche herein, and services provided under the Molecular Information Platform Program, are, and will be, at least as favorable as the pricing terms granted by FMI to any existing customer or collaborator for such (or substantially similar) products or services. If FMI enters into any subsequent agreement with another customer or collaborator which provides for pricing terms for substantially the same product or services at substantially the same (or a lesser) scale, which pricing terms are more favorable than those contained herein, then FMI shall notify Roche and Roche will have the right to modify this agreement to provide Roche with those more favorable pricing terms. […***…].

  6. Governance

6.1 Joint Management Committee

Within sixty (60) days after the Effective Date, the Parties shall establish a JMC to ensure the smooth operation of the arrangements and activities envisaged under this Agreement.

    6.1.1 Members

The JMC shall be composed of six (6) persons (Members). Roche and FMI each shall be entitled to appoint three (3) Members with appropriate seniority and functional expertise. Each Party may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a Member shall notify the other Party at least ten (10) days prior to the next scheduled meeting of the JMC. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Both Parties may invite a reasonable number of additional experts and/or advisors to attend part or the whole JMC meeting with prior notification to the JMC. Members may be represented at any meeting by another person designated by the absent Member. One JMC representative from a Party shall chair (Chairperson) the JMC on a rotating annual calendar year basis, with the initial chairperson to be from Roche. The JMC will be made up of senior representatives from FMI and Roche, including alliance directors. The JMC may create and/or dissolve joint teams tasked with oversight of specific programs or projects, subject to overall governance by the JMC. The role of the alliance directors will be to facilitate communication and collaboration between the Parties.   ***Confidential Treatment Requested***

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  6.1.2 Responsibilities of the JMC

The JMC shall have the responsibility and authority to:

a) approve the R&D Plans;

b) establish, disband and set expectations and mandates for JRDC, JOC, JPT and JOTs, if applicable;

c) oversee the JRDC, JOC, JPT and JOTs, if applicable;

d) provide financial oversight for the Immunotherapy Testing Platform Development Program and the CDx Development Program; and

e) attempt to resolve any disputes escalated from the JRDC or JOC.

The JMC shall have no responsibility and authority other than that expressly set forth in this section.

    6.1.3 Meetings

The Chairperson or his/her delegate is responsible for sending invitations and agendas for all JMC meetings to all Members at least ten (10) days before the next scheduled meeting of the JMC. The venue for the meetings shall be agreed by the JMC. The JMC shall hold meetings at least twice per calendar year, either in person or by tele-/video-conference, and in any case as frequently as the Members of the JMC may agree shall be necessary, but not more than four times a year. The Alliance Director of each Party may attend the JMC meetings as a permanent participant.

    6.1.4 Minutes

The Chairperson is responsible for designating a Member to record in reasonable detail and circulate draft minutes of JMC meetings to all members of the JMC for comment and review within twenty (20) days after the relevant meeting. The Members of the JMC shall have ten (10) days to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all Members of the JMC within thirty-five (35) days of the relevant meeting. The Chairperson approves the final version of the minutes before its distribution.

    6.1.5 Decisions

  6.1.5.1 Decision Making Authority

The JMC shall decide matters within its responsibilities set forth in Section 6.1.2.

    6.1.5.2 ctDNA Platform

FMI will have final decision-making rights at the JMC with respect to the ctDNA Platform Development, provided that FMI may not change the timelines agree in Section 8.4, and any change to the Roche specifications (TPP) for a ctDNA Assay specifically requested by Roche as part of the R&D Plan will require Roche's prior approval.   - 32 -





  6.1.5.3 Consensus; Good Faith

The Members of the JMC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JMC. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.

    6.1.5.4 Failure to Reach Consensus

If the JMC is unable to decide a matter by consensus, then the escalation procedure in Section 6.1.5.5 shall be applied.

    6.1.5.5 Escalation

If the JMC is unable to decide a matter by consensus, then such matter shall be referred to the Chief Executive Officer of FMI or equivalent position or his/her nominee and the Chief Executive Officer of Roche or equivalent position or his/her nominee for resolution, who together shall use reasonable and good faith efforts to reach a decision by consensus within […***…] after the date such matter is referred to them. If the Parties still fail to reach a decision within such […***…]. Any such decision shall constitute a decision of the JMC. Notwithstanding the foregoing, neither Party may exercise deciding authority (i) to impose resource or financial burdens on the other Party for a Work Stream beyond the scope set forth in an agreed upon R&D Plan for such Work Stream or Reserved Capacity under the Molecular Information Platform Program, or (ii) that would violate or amend the terms of this Agreement. The JMC will exist for the Agreement Term.

    6.1.6 Information Exchange

FMI and Roche shall exchange the information in relation to its activities under this Agreement through the JMC and FMI and Roche may ask reasonable questions in relation to the above information and offer advice in relation thereto and Roche shall give due consideration to FMI's input. The JMC may determine other routes of information exchange.

    6.1.7 Subcommittees and Joint Operational Teams

The JMC has the right to establish sub-committees or JOTs. The JRDC shall be established within thirty (30) days after the JMC is established. The JOC shall be established as soon as the JMC deems it necessary.

  6.2 JRDC

The JRDC shall oversee the implementation of the Work Streams and to more generally identify opportunities for value creation in research and development activities between the Parties. The JDRC shall be composed of an equal number of persons from each Party, each person having appropriate seniority and functional expertise. Each Party may replace any a person and appoint another person to fill the vacancy arising from each such replacement. The JRDC will strive to reach consensus on any matters within the committee's authority with each Party having one (1) vote. Unresolved dispute at the JRDC will be escalated to the JMC.

    6.2.1 Responsibilities of the JRDC

The JRDC shall have the responsibility and authority to:

a) recommend the R&D Plans for approval by the JMC;

b) review and recommend for approval any revisions to the R&D Plans;   ***Confidential Treatment Requested***

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c) review and oversee the execution of the R&D Plans;

d) establish timelines and criteria for decision points;

e) determine whether criteria have been met, including whether the criteria as to whether milestones or events have been achieved;

f) review the efforts of the Parties and allocate those resources for the R&D Plans (including their budgets);

g) identify appropriate resources necessary to conduct the R&D Plans;

h) oversee the progress of the Work Streams;

j) monitor the development costs and manage reimbursement for FMI activities under this Agreement;

k) determine for Products and Services Performance Specifications and identify Quality Standards applicable to respective Work Streams; and

l) attempt to resolve any disputes.

The JRDC shall have no responsibility and authority other than that expressly set forth in this section.

  6.3 JOC

The JOC shall plan and oversee the commercial, co-marketing, educational, and/or promotion activities between the Parties and to serve as a forum for communicating generally about FMI's products and strategies for global commercialization, as such activities are further described in the US Education Collaboration Agreement and the Ex-US Commercialization Agreement. The JOC shall be composed of an equal number of persons from each Party, each person having appropriate seniority and functional expertise. A description of the roles, responsibilities, and workings of the JOC are described in the Ex-US Commercialization Agreement. Through the JOC, Roche may share with FMI knowledge and experience related to countries and markets outside the United States, and will support the design and implementation of a global expansion plan for FMI products. The JOC will strive to reach consensus on any matters within the committee's authority, with each Party having one (1) vote. Unresolved disputes at the JOC will be escalated to the JMC.

  6.4 Alliance Director

Each Party shall appoint one person to be the point of contact within each Party with responsibility for facilitating communication and collaboration between the Parties (each, an Alliance Director). The Alliance Directors shall be permanent participants of the JMC meetings (but not members of the JMC) and may attend JDRC, JOC and JOT meetings as appropriate. The Alliance Directors shall facilitate resolution of potential and pending issues and potential disputes to enable the JMC to reach consensus and avert escalation of such issues or potential disputes.

  6.5 Limitations of Authority

No committee, working group or individual shall have the authority to amend or waive any terms of this Agreement.   - 34 -





6.6 Expenses

Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with the JMC.

  6.7 Lifetime

The JMC shall exist during the Agreement Term.

  7. Regulatory

Subject to the Related Agreements, FMI, […***…], shall use Commercially Reasonable Efforts to pursue all regulatory affairs related to its products and services developed under this Agreement (collectively, Products and Services) in the Territory including the preparation, filing and maintenance of applications for regulatory approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold such Products and Services. Subject to the Related Agreements, FMI shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products and Services in all countries in the Territory. Subject to the Related Agreements, FMI or its Affiliates shall own and file in their discretion all regulatory filings and Regulatory Approvals for all Products and Services in all countries of the Territory. FMI shall supply Roche with a copy of all material communications related to Products and Services to or from the Regulatory Authorities. Upon request of Roche, FMI shall supply Roche with a copy of all such communications to or from the Regulatory Authorities.

Subject to the Ex-US Commercialization Agreement, FMI, […***…], shall report to appropriate Redulatory Authorities in accordance with local requirements all adverse events related to use of the Products and Services in the Territory.

  8. Payment

8.1 FTE Funding

Roche will be responsible for funding the FTEs in accordance with the R&D Plans and budgets at the FTE Rate for performance of the research and other activities for which FMI is responsible under the R&D Plans and for the database queries. Each individual included in the funded FTEs shall possess a bachelor's degree or higher in a relevant scientific discipline and shall be experienced in the type of research or other activities to be performed by such individual under this agreement.

  8.2 Molecular Information Platform Program Fees

  8.2.1 Sample Profiling Fees

  8.2.1.1 Reserved Capacity Fees

In consideration for the Reserved Capacity and provision of the Sample Results associated with the Reserved Capacity, and subject to any reduction resulting from the application of Article 5, Roche shall pay to FMI an amount equal to […***…] for […***…] of the Profiling Term [… ***…] for the […***…] of the Profiling Term (Reserved Capacity Fees). The Reserved Capacity Fees are paid as follows:

[…***…] equal installments of […***…] payable within […***…] of receipt by Roche of an invoice from FMI, beginning with receipt by Roche of a first invoice from FMI issued following the Effective Date and followed by […***…] additional invoices at […***…] intervals thereafter.   ***Confidential Treatment Requested***

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[…***…] equal installments of […***…] payable within […***…] of receipt by Roche of an invoice from FMI, beginning […***…] of the Effective Date and followed by […***…] additional invoices at […***…] intervals thereafter.

For renewal terms, the agreed upon Reserved Capacity Fee shall be paid within […***…] of receipt by Roche of an invoice from FMI at […***…] intervals.

The Reserved Capacity Fee payments shall be […***…] against Roche's Binding Order for such period, the amount of the Reserved Capacity Fee being […***…]. Actual Sample Profiling costs, based on delivery of Sample Results during the […***…] to which the Reserved Capacity Fee applies, shall be […***…]. If actual Sample Profiling exceeds the amount of Sample Profiling paid by the Reserved Capacity Fees, then […***…]. Roche shall pay FMI for […***…]. If a Binding Order causes Roche to […***…]. Fees for Binding Orders shall […***…].

    8.2.1.2 Per Sample Profiling Fees

The per Sample Profiling fees (notwithstanding the Reserved Capacity Fee) shall be as follows:

[…***…].

    8.2.2 Molecular Information Database Access and Database Queries Fees

For Molecular Information Database Access and performance of Database Queries by FMI, Roche will pay FMI a total of […***…] of the Database Term, (the Database Access Fee), which is comprised of funding for […***…] FTEs, each at the FTE Rate, for performance of such Database Queries and delivery of Database Insights, and a Database Access Fee of […***…]. Roche shall pay to FMI the Database Access Fee […***…] installments of […***…], each payable every […***…] of the Database term and within […***…] after receipt by Roche of an invoice from FMI.

  8.3 Immunotherapy Testing Platform Development Budget and Fees

  8.3.1 R&D Plan Budget

Roche shall be solely responsible for Roche's costs under the Immunotherapy Testing Platform Development Budget.

Roche will pay FMI […***…] of FMI Development Cost as agreed in the Immunotherapy Testing Platform Budget for development of the Immuno- Biomarker Discovery Platform.

Roche will pay […***…] of FMI Development Cost as agreed in the Immunotherapy Testing Platform Budget for Signature Identification.   ***Confidential Treatment Requested***

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Such reimbursement of FMI Development Cost shall be paid […***…] in arrears. Each […***…], FMI shall invoice Roche for its share of FMI Development Cost incurred in the previous […***…]. Invoices shall be payable within […***…] after receipt by Roche of an invoice from FMI.

    8.3.2 Payments for Achieving Certain Immunotherapy Testing Platform Development Events

In addition to payment of the Immunotherapy Testing Platform Development Budget as specified above, Roche shall pay FMI:

  (i) […***…] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, […***…].

  (ii) […***…] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, […***…].

  (iii) […***…] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, […***…].

    8.3.3 Immuno Clinical Study Assays requested by Roche

Roche will pay […***…] of FMI's Development Costs for development of Immuno Clinical Study Assays as may be requested by Roche, subject to an agreed upon budget for such development as provided for in Section 3.2.5.

    8.3.4 Immunotherapy CDx Assays

If the Parties chose to develop an Immunotherapy CDx Assay, they the Parties shall agree to Roche paying certain costs and milestones for such Immunotherapy CDx assay.

  8.4 ctDNA Platform Financial Terms

FMI will be responsible for all FMI Development Cost for the ctDNA Platform Development. As part of the agreed upon ctDNA R&D Plan, FMI will provide sample testing performed under such ctDNA R&D Plan at no cost to Roche (other than Roche's cost in supplying FMI the Samples specified in the ctDNA R&D Plan).

Roche will pay FMI […***…] if FMI successfully […***…] set forth in the R&D Plan (Initial Roche ctDNA Assay) within […***…] from [… ***…] (the First ctDNA Milestone Date). Payment by Roche shall be made within […***…] after achieving the First ctDNA Milestone Date and the receipt by Roche of an invoice from FMI.

In addition, Roche will pay FMI […***…] if FMI successfully […***…] as agreed to in the R&D Plan; provided that […***…] (the Second ctDNA Milestone Date). Payment by Roche shall be made within […***…] after achieving the Second ctDNA Milestone Date and the receipt by Roche of an invoice from FMI.

The Parties may develop additional ctDNA Assays for use as Clinical Study assays, subject to an agreed financial structure for such work under the R&D Plan. Such additional development work will be conducted, if at all, pursuant to an amendment to this Agreement or a separate written agreement between the Parties.   ***Confidential Treatment Requested***

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8.5 CDx Development Financial Terms

  8.5.1 CDx Development Costs

Roche shall pay FMI […***…] of FMI Development Cost for CDx Development of Investigational markers in compliance with the investigational CDx budget that forms part of the R&D Plan.

FMI shall pay […***…] of the FMI Development Cost for Approved Markers.

Such reimbursement of FMI Development Cost shall be paid […***…] in arrears. Each […***…], FMI shall invoice Roche for its share of the FMI Development Cost incurred in the […***…]. Invoices shall be payable within […***…] after receipt by Roche of an invoice from FMI.

    8.5.2 PMA Event Payments

For each PMA approval corresponding to a Roche product, Roche shall pay FMI […***…], within […***…] after the occurrence of such event and receipt by Roche of an invoice from FMI.

    8.5.3 Commercial Success Event Payments

Roche shall pay FMI the following milestone payments upon achievement of CDx Assay report volumes by tissue type within the first […***…] after […***…] of the associated CDx Assay as specified below:

  (i) CDx Assays Including Investigational/Approved Marker(s) for […***…]:

    […***…].

  (ii) CDx Assays Including Investigational/Approved Marker(s) for […***…]:

    […***…].

Upon achievement of each of the CDx Assay volumes under this Section 8.5.3, FMI shall timely notify Roche and payment shall be made by Roche within […***…] after achieving the applicable event and the receipt by Roche of an invoice from FMI.

In the event the Parties wish to develop another CDx Assay other than those specified above for […***…] and […***…] pursuant to a CDx R&D Plan, the Parties shall mutually agree to […***…] milestones and payments for achieving them.

  8.6 General Terms

All rates and costs set forth herein shall remain firm for the Agreement Term and the services to be performed under each Work Stream, unless otherwise agreed to in writing, shall be at the FTE Rate. FMI has an affirmative obligation to use Commercially Reasonable Efforts to negotiate favorable terms for all FMI Development Cost that will be passed through FMI to Roche. FMI shall extend to Roche the benefit of any and all discounts and savings provided to FMI in connection with FMI Development Cost that will be passed through to Roche. Roche shall […***…], any amounts in excess of the agreed upon budget.   ***Confidential Treatment Requested***

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8.7 Disclosure of Payments

FMI acknowledges that Roche may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law, including the US Sunshine Act.

  9. Accounting and reporting

9.1 Timing of Payments

Payments shall be made during the time periods set forth in this Agreement. If not stated explicitly, payments shall be made by Roche within [… ***…] after Roche receives an invoice from FMI.

  9.2 Late Payment

Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at […***…] points above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.

  9.3 Method of Payment

All amounts payable hereunder shall be paid in US dollars (the Payment Currency) to account(s) designated by FMI.

  10. Taxes

FMI shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to FMI under this Agreement.

If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to FMI, then Roche or its relevant Affiliates shall promptly pay such tax, levy or charge for and on behalf of FMI to the proper governmental authority, and shall promptly furnish FMI with receipt of payment. Roche shall be entitled to deduct any such tax, levy or charge actually paid from royalty or other payment due FMI or be promptly reimbursed by FMI if no further payments are due FMI. Each Party agrees to reasonably assist the other Party in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.   ***Confidential Treatment Requested***

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It is understood between the Parties that the agreed upon and/or applied remunerations and other payments under this Agreement for all transactions between (a) FMI and (b) Roche are based on arm's length and good faith considerations. Should such remunerations for products and services or other payments nevertheless be challenged by any Governmental Authority including any tax authority in the US, or in Switzerland or other jurisdiction of Roche or its relevant Affiliates (Roche's Jurisdiction):



(a) FMI and Roche or its relevant Affiliates shall fully co-operate with each other with the objective to convince the challenging authority that such remunerations for products and services and other payments are appropriate, including providing each other with copies of third party agreements if necessary to utilize as comparables to support the arm's length nature of transactions between FMI and Roche. In the event that the challenging authority is not convinced, the Parties shall request that the tax authorities in the US and in Roche's Jurisdiction initiate government-to-government procedures pursuant to the applicable bi- lateral convention for the avoidance of double taxation or similar treaty or convention (if any) between the US and Roche's Jurisdiction (Competent Authority Procedures).



(b) In the event that the US tax authorities determine that such remunerations for products and services or other payments are not appropriate and levy an assessment on FMI, and such assessment results in a refund (or similar payment or credit) by or from the tax authorities in Roche's Jurisdiction to Roche or its relevant Affiliate, then Roche shall pay (or shall ensure that Roche shall pay) the amount of such refund to FMI. In the event that the tax authorities in Roche's Jurisdiction determine that such remunerations for products and services or other payments are not appropriate and levy an assessment on Roche, and such assessment results in a refund (or similar payment or credit) by or from the US tax authorities to FMI then FMI shall pay (or shall ensure that FMI shall pay) the amount of such refund to Roche. Each Party shall use its reasonable efforts to obtain such refund (or similar payment or credit).

  (c) In the event of such an assessment by either tax authority (an Assessment), the Parties agree to making adjustments to the relevant remunerations for products and services or other payments to levels agreed to by the tax authorities in both the US and Roche's Jurisdiction as the result of Competent Authority Procedures.

  11. Auditing

11.1 Right to Audit

Each Party shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all payments payable under this Agreement, including, for Roche, the right to audit materials necessary to ensure compliance with the most favored customer provisions of Article 5. Such books of accounts shall be kept at their principal place of business. At the expense of the auditing Party, the auditing Party shall have the right to engage an internationally recognized, independent public accountant reasonably accept able to the other Party to perform, on behalf of such Party an audit of such books and records of the audited Party and its Affiliates, its licensees and Sublicensees, that are deemed necessary for the period or periods requested by the auditing Party and the correctness of any financial report or payments made under this Agreement, including with respect to benefits and terms complying with the most favored   - 40 -





customer provisions of Article 5. For avoidance of doubt, all audits under this Section shall be conducted solely by an independent public accountant as described in the foregoing sentence.

Upon timely request and at least […***…] prior written notice from the auditing Party, such audit shall be conducted in the countries specifically requested by the auditing Party, during regular business hours in such a manner as to not unnecessarily interfere with the audited Party's normal business activities, and shall be limited to results in the […***…] prior to audit notification.

Such audit shall not be performed more frequently than […***…] nor more frequently than […***…] with respect to records covering, or impacting in accordance with Article 5, any specific period of time.

All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying payment obligations, shall be treated as the audited Party's Confidential Information subject to the obligations of this Agreement and need neither be retained more than [… ***…] after completion of an audit hereof, if an audit has been requested; nor more than […***…] from the end of the […***…] to which each shall pertain; nor more than […***…] after the date of termination of this Agreement.

  11.2 Audit Reports

The auditors shall only state factual findings in the audit reports and shall not interpret the agreement. The auditors shall share all draft audit reports with the auditing Party before the draft report is shared with the audited Party and before the final document is issued. The final audit report shall be shared with the auditing Party at the same time it is shared with the audited Party.

  11.3 Over or Underpayment

If the audit reveals an overpayment by Roche, FMI shall reimburse Roche for the amount of the overpayment within […***…]. If the audit reveals an underpayment by Roche, Roche shall make up such underpayment with the next payment or, if no further payments are owed by Roche, Roche shall reimburse FMI for the amount of the underpayment within […***…]. The audited Party shall pay for the audit costs if the underpayment of the audited Party exceeds […***…] of the aggregate amount of royalty payments owed with regard to the period subject of the audit. Section 9.2 shall apply to this Section 11.3.

  11.4 Duration of Audit Rights

The failure of a Party to request verification of any calculation within the period during which corresponding records must be maintained under this Article 11 will be deemed to be acceptance of the payments and reports.

  12. Intellectual Property

12.1 Ownership of Inventions, data and results

  12.1.1 In General

Except as specifically set forth herein, FMI shall own all FMI Inventions, Roche shall own all Roche Inventions, and FMI and Roche shall jointly own all Joint Inventions. FMI and Roche each shall require all of its employees to assign all inventions related to Products and Services made by them to Roche and FMI, as the case may be.   ***Confidential Treatment Requested***

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The determination of ownership of Inventions shall be determined in accordance with US inventorship laws as if such Inventions were made in the US.

Except as otherwise expressly set forth herein, each Party shall retain full ownership and control of, and all rights in, its Background IP and any improvements or modifications thereto (Roche Improvement IP and FMI Improvement IP respectively). Roche Improvement IP shall mean any improvements or modifications to Roche's Background IP discovered, conceived or reduced to practice after the Effective Date in the performance of activities under this Agreement. FMI Improvement IP shall mean any improvements or modifications to FMI's Background IP discovered, conceived or reduced to practice after the Effective Date in the performance of activities under this Agreement. All materials, information, data and writings provided to FMI by or on behalf of Roche, in any form whatsoever, which were Controlled by Roche prior to being provided to FMI, shall remain the property of Roche; FMI shall acquire no right, title or interest in such materials, information, data and writings as the result of its activities under this Agreement.

Except as specifically set forth herein, this Agreement shall not be construed, by implication, necessity or otherwise as (i) giving any of the Parties any license, right, title, interest in or ownership to the Confidential Information; (ii) granting any license or right under any intellectual property rights; or (iii) representing any commitment by either Party to enter into any additional agreement.

    12.1.2 For the Molecular Information Platform Program

Subject to the license granted to FMI under Section 2.1.2, Roche shall exclusively own all right title and interest to any information, results, and intellectual property from any Clinical Study undertaken or supported by Roche, including, without limitation, the Sample Results and information and results from any Sample Profiling. FMI shall assign to Roche its rights to any intellectual property in or arising from the Sample Results (except for FMI Improvements).

Except as otherwise set forth herein, FMI shall exclusively own all right, title, and interest to any improvements or modifications to the FMI Genomic Analysis Platform that arise in connection with the performance of the work under the Molecular Information Platform Program.

Roche shall exclusively own all information, results, and intellectual property from Advanced Genomic Analyses performed on Roche samples (Roche-Owned Advanced Genomic Analysis Results), and any inventions arising from the Roche-Owned Advanced Genomic Analysis Results, and FMI will assign all rights to any such inventions to Roche (except for FMI Improvements).

    12.1.3 For the Immunotherapy Testing Platform Program

Subject to the license granted to FMI under Section 2.1.3, Roche shall exclusively own all data, results, and intellectual property therein arising from profiling samples provided by Roche to FMI for testing in the Immunotherapy Testing Platform Development (except for FMI Improvements) (Roche Immunotherapy Sample Results), and FMI shall assign to Roche all such intellectual property. FMI shall not disclose Roche Immunotherapy Sample Results to third parties or use such results in work with Third Parties.   - 42 -





Roche shall exclusively own, and FMI shall assign to Roche, all intellectual property arising from the Immunotherapy Testing Platform Development that Covers methods of treatment, stratifying patients, or identifying patients that would benefit from a particular treatment, and all other methods useful in connection with the therapeutic treatment of a patient.

To the extent third-party intellectual property must be licensed for the Immunotherapy Testing Platform Development, Roche and FMI shall jointly decide on an appropriate in-licensing strategy and negotiate a fair cost sharing between the Parties in good faith; provided however, that FMI shall retain the right to take such a license at its own cost on such terms as it shall determine if the Parties cannot reach a timely agreement on how to proceed.

    12.1.4 For the ctDNA Program

Subject to the license granted to FMI under Section 2.1.4, Roche shall exclusively own all data, results, and intellectual property arising from the profiling of Roche samples in the ctDNA Platform Development Program (Roche ctDNA Sample Results). FMI shall not disclose Roche ctDNA Sample Results to third parties or use such results in work with third parties.

    12.1.5 For the CDx Development Program

Subject to the license granted to Roche under Section 2.1.5, FMI shall exclusively own all intellectual property arising from the CDx Development that Covers the CDx Assays (FMI CDx IP).

Roche shall exclusively own all data, results, and intellectual property arising from analysis of its samples in the relevant CDx Development as well as all intellectual property arising from the CDx Development Program to the extent that it is reasonably related to or Covers the relevant Roche product including the use, formulation, and methods of treatment for the relevant Roche product (Roche CDx Development IP).

To the extent third-party intellectual property must be licensed for the Investigational CDx Development or commercialization of the Investigational CDx Assays, Roche and FMI shall jointly decide on an appropriate in-licensing strategy and negotiate a fair cost sharing between the Parties in good faith.

  12.2 German Statute on Employee's Inventions

In accordance with the German Statute on Employees' Inventions, each Party agrees to claim the unlimited use of any Invention conceived, reduced to practice, developed, made or created in the performance of, or as a result of, any Research Program by employees of any German Affiliates or any other persons acting on behalf of such German Affiliates. For the avoidance of doubt, each Party is responsible for fulfilling the obligations towards their employees under the German Statute of Employee's Inventions.

  12.3 Prosecution and Maintenance of Patent Rights Claiming FMI Inventions

FMI shall, at its own expense and discretion, (i) control and Handle all FMI Foreground Patent Rights, (ii) consult with Roche as to the Handling of such FMI Foreground Patent Rights, and (iii) furnish to Roche copies of all material documents relevant to any such Handling. FMI shall furnish such documents and consult with Roche in sufficient time before any action by FMI is due to allow Roche to provide comments thereon, which comments FMI must consider. At FMI's

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expense and reasonable request, Roche shall cooperate, in all reasonable ways with the Handling of all FMI Foreground Patent Rights. If FMI elects not to Handle any FMI Foreground Patent Rights under this Section 12.3, then FMI shall provide at least […***…] prior written notice to Roche. Thereafter, Roche shall have the right, but not the obligation to Handle any such notified FMI Foreground Patent Rights, at its sole expense and its sole discretion. Notwithstanding the foregoing, and for clarity, FMI shall have no obligations to Roche under this Section 12.3 in regard to FMI Foreground Patent Rights relating to the Genomic Analysis Platform or the Molecular Information Database (including, without limitation, methods, procedures, and algorithms related to or embodied in each) that do not incorporate or rely on the continued use of Roche Confidential Information.

  12.4 Prosecution and Maintenance of Roche Foreground Patent Rights and Joint Patent Rights

Roche shall, at its own expense and discretion, control and Handle (including abandon) all Roche Foreground Patent Rights and Joint Patent Rights. If Roche elects not to Handle any Patent Rights under this Section 12.4, then Roche shall provide at least […***…] prior written notice to FMI. Thereafter, FMI shall have the right, but not the obligation to Handle any such notified Patent Rights, at its sole expense and its sole discretion.

  12.5 Joint Patent Team

Where the Parties need to consult with each other on the Handling of Patent Rights, the Parties shall establish a joint patent team (JPT) and shall adopt procedures for interacting on patent matters. The JPT shall be subject to the oversight of the JMC. The JPT shall also serve as a forum for promptly notifying the other Party when an Invention is made by a Party.

  12.6 CREATE Act

It is the intention of the Parties that this Agreement is a joint research agreement as that phrase is defined in Public Law 108-53 (Create Act) and applied in 35 USC §103(c)(3). If either Party intends to overcome a rejection of a claimed invention within the FMI Foreground Patent Rights or Roche Foreground Patent Rights pursuant to the provisions of the Create Act, then the Parties, through the JPT, shall work together in good faith to agree in writing how any rejection should be overcome.

  12.7 Infringement

Each Party shall promptly provide written notice to the other Party during the Agreement Term of any (i) known infringement or suspected infringement by a Third Party of any FMI Background Patent Rights, FMI Foreground Patent Rights, Roche Background Patent Rights, Roche Foreground Patent Rights or Joint Patent Rights, or (ii) known or suspected unauthorized use or misappropriation by a Third Party of any FMI Background Know-How, FMI Know-How, Roche Background Know-How, Roche Know-How or Joint Know-How, and shall provide the other Party with all evidence in its possession supporting such infringement or unauthorized use or misappropriation.

Within […***…] after a Party provides or receives such written notice (Decision Period), the Party Handling enforcement of such Patent Right as set forth in this Section 2.7, in its sole discretion, shall decide whether or not to initiate such suit or action in the Territory and shall notify the other Party in writing of its decision in writing (Suit Notice).   ***Confidential Treatment Requested***

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For any FMI Background Patent Right or sole FMI Patent Right, FMI in its sole discretion shall decide whether or not to initiate such suit or action in the Territory. FMI shall have full discretion as to how it wishes to handle such suit and may reach Settlement under any terms and conditions it desires and retain all damages, settlement fees or other consideration received in connection therewith. Only if a Settlement could adversely affect Roche shall the written consent of Roche be required, which consent shall not be unreasonably withheld. The term adversely affect in the previous sentence shall include, among other things, […***…].

For any sole Roche Background Patent Right or Roche Patent Right, Roche, in its sole discretion, shall decide whether or not to initiate such suit or action in the Territory. Roche shall have full discretion as to how it wishes to handle such suit and may reach Settlement under any terms and conditions it desires and retain all damages, settlement fees or other consideration received in connection therewith. Only if a Settlement could adversely affect FMI shall the written consent of FMI be required, which consent shall not be unreasonably withheld.

If for a Joint Patent Right, Roche decides to bring a suit or take action, once Roche provides Suit Notice, Roche may immediately commence such suit or take such action. In the event that Roche (i) does not in writing advise FMI within the Decision Period that Roche will commence suit or take action, or (ii) fails to commence suit or take action within a reasonable time after providing Suit Notice, FMI shall thereafter have the right to commence suit or take action in the Territory and shall provide written notice Roche of any such suit commenced or action taken by FMI.

Upon written request, the Party bringing suit or taking action (Initiating Party) shall keep the other Party informed of the status of any such suit or action and shall provide the other Party with copies, to the extent the Initiating Party is lawfully permitted to do so, of all material documents or communications filed in such suit or action. The Initiating Party shall have the sole and exclusive right to select counsel for any such suit or action.

The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including the Initiating Party's attorneys' fees and court costs. Any damages, settlement fees or other consideration received as a result of such suit or action shall be allocated as follows:

(a) First, to reimburse the Initiating Party for its costs and, if any remains, to the other Party for any advisory counsel fees and costs; and

(b) Second, the balance, if any, shall be allocated […***…].

If the Initiating Party believes it is reasonably necessary or desirable to obtain an effective remedy, upon written request the other Party agrees to be joined as a party to the suit or action but shall be under no obligation to participate except to the extent that such participation is required as the result of its being a named party to the suit or action. At the Initiating Party's written request, the other Party shall offer reasonable assistance to the Initiating Party in connection therewith at no charge to the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other Party in rendering such assistance. The other Party shall have the right to participate and be represented in any such suit or action by its own counsel at its own expense.

The Initiating Party may settle, consent judgment or otherwise voluntarily dispose of the suit or action (Settlement) without the written consent of the other Party but only if such Settlement can be achieved without adversely affecting the other Party (including any of its Patent Rights). If a Settlement could adversely affect the other Party, then the written consent of the other Party would be required, which consent shall not be unreasonably withheld.   ***Confidential Treatment Requested***

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12.8 Defense

If an action for infringement is commenced against either Party, its licensees or its sublicensees related to such Party's conduct of a Work Stream within the scope of an R&D Plan then such Party shall defend such action at its own expense, and the other Party shall assist and cooperate with such Party, at its own expense, to the extent necessary in the defense of such suit. The defending Party shall have the right to settle the suit or consent to an adverse judgment thereto, in its sole discretion, so long as such settlement or adverse judgment does not adversely affect the rights of the other Party and its Affiliates (including any patent rights Controlled by any of them). The defending Party shall assume full responsibility for the payment of any award for damages, or any amount due pursuant to any settlement entered into by it with such Third Party.

If the manufacture, use, importation, offer for sale or sale of any Products and Services results in any claim, suit or proceeding alleging patent infringement or trade secret misappropriation against FMI or a member of the Roche Group, then such Party shall promptly notify the other Party hereto. The Parties shall cooperate with each other in connection with any such claim, suit or proceeding and shall keep each other reasonably informed of all material developments in connection with any such claim, suit or proceeding.

If a Third Party asserts that Patent Rights owned by or licensed to it are infringed by the development, manufacture, use, importation, offer for sale or sale of products arising out of this Agreement by a member of the Roche Group, or that its trade secrets were misappropriated in connection with such activity, then Roche shall have the exclusive right and responsibility to resolve any such claim, whether by obtaining a license from such Third Party, by defending against such Third Party's claims or otherwise, and shall be solely responsible for the defense of any such action, any and all costs incurred in connection with such action (including, without limitation, attorneys' and expert fees) and all liabilities incurred in connection therewith. Notwithstanding the above, Roche shall not enter into any settlement of any such claim without the prior written consent of FMI if such settlement would require FMI to be subject to an injunction or to make any monetary payment to Roche or any Third Party, or admit any wrongful conduct by FMI or its Affiliates, or would limit or restrict the claims of or admit any invalidity and/or unenforceability of any of the Patent Rights Controlled by FMI, or have any impact on activities outside the Field.

  12.9 Common Interest Disclosures

With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property and/or technology owned by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the Work Streams and/or Products and Services, and have a further common legal interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual property rights relating to the conduct of the Work Streams and/or Products and Services. Accordingly, the Parties agree that all such information and materials obtained by FMI and Roche from each other will be used solely for purposes of the Parties' common legal interests with respect to the conduct of the Agreement. All information and materials will be treated as protected by the attorney-client privilege, the work product privilege, and any other privilege or   - 46 -





immunity that may otherwise be applicable. By sharing any such information and materials, neither Party intends to waive or limit any privilege or immunity that may apply to the shared information and materials. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party without such other Party's prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be deemed to apply against any other Party.

  13. Representations and Warranties

13.1 Mutual Representations and Warranties

FMI and Roche each represent and warrant that:

(a) it has all requisite power and authority to enter into and perform its obligations under this Agreement;

(b) it has no outstanding agreement or obligation that is in conflict with any of the provisions of this Agreement or that would preclude its personnel from complying with the provisions hereof;

(c) all of its employees, officers and consultants have executed agreements requiring assignment to it of all Inventions made by such individuals during the course of and as a result of their participation in activities under this Agreement;

(d) the execution, delivery and performance of this Agreement by it and all instruments and documents to be delivered by it hereunder: (i) are within its corporate power; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in contravention of any provision of any of its formation or governing documents; (iv) to its knowledge, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which it is a party or by which it or any of its property is bound, which violation would have an adverse effect on its financial condition or on its ability to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products);

(e) there are no claims or investigations (other than with respect to the Parties' HSR filings), pending or threatened against it or any of its Affiliates, at law or in equity, or before or by any governmental authority relating to the matters contemplated under this Agreement or that would materially adversely affect its ability to perform its obligations hereunder; and

(f) neither it nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of its obligations hereunder.   - 47 -





13.2 Activities

Each Party will perform all activities under this Agreement (i) in a professional manner, (ii) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances, and (iii) in compliance with Applicable Law.

  13.3 Safety Data

FMI represents and warrants that FMI has disclosed to Roche and will immediately continue to disclose to Roche any relevant safety data relevant to the Work Streams and assays being developed thereunder.

  13.4 Third Party Patent Rights

FMI represents and warrants that FMI has no knowledge of the existence of any patent or patent application owned by or licensed to any Third Party that could prevent in the Territory the activities contemplated under this Agreement.

  13.5 Inventors

FMI represents and warrants that FMI has obtained the assignment of, or a license under, the FMI Background Patent Rights necessary to grant the licenses granted hereunder. FMI shall obtain the assignment of, or a license under, the FMI Foreground Patent Rights necessary to grant the licenses granted hereunder.

  13.6 Grants

FMI represents and warrants that, to the best of FMI's knowledge and belief, FMI has the lawful right to grant Roche and its Affiliates the rights and licenses described in this Agreement.

  13.7 Ownership and Validity of Know-How

FMI represents and warrants that FMI's Know-How is legitimately in the possession of FMI and has not been misappropriated from any Third Party. FMI has taken reasonable measures to protect the confidentiality of its Know-How.

  13.8 Data Protection (Privacy) and Security.

  13.8.1 Study Data Collection

FMI shall collect and process Study Data in accordance with the provisions of this Agreement and in compliance with Applicable Law with respect to the processing of Study Data, including but not limited to applicable international, US federal, state and local data protection and data security laws.

    13.8.2 Data Protection

To ensure the privacy and security of the health or medical data, including Study Data or other Personal Data related to this Agreement that FMI shall create, acquire, receive, maintain, or transmit as a result of entering into the Agreement, FMI shall implement adequate and reasonable safeguards to prevent the use or disclosure of such information other than as provided for in the Agreement, and to protect the confidentiality, integrity, and availability of such information. In addition, FMI shall protect all such data, in accordance with applicable international Data Protection laws and US federal and state laws and regulations.   - 48 -





  13.8.3 Privacy

FMI understands and agrees that the confidentiality, privacy and security requirements contained in this Agreement also apply to any permitted sub-contractors, temporary employees or other third-parties who receive any health or medical data, including Study Data, or other Personal Data, as a result of this Agreement. FMI will ensure that all of these parties enter substantially similar confidentiality, privacy and security agreements with Institution. Copies of such Agreements shall be provided to Roche within seven (7) business days upon written request of Roche.

    13.8.4 Training

FMI shall also ensure that its own employees, as well as any permitted subcontractors, temporary employees or other Third Parties who assist FMI in performing activities under the Agreement, and who have access to any health or medical data, including Study Data or other Personal Data, as a result of this Agreement receive appropriate privacy and security training, which shall be updated periodically in accordance with applicable laws, regulations, and industry standard, or as otherwise reasonably requested by Roche.

    13.8.5 Processing of Study Data

FMI, its Affiliates and agents shall not collect or process health or medical data, including Study Data or any other Personal Data related to this Agreement, in a manner that involves the transfer of such Personal Data from one jurisdiction to any other jurisdiction (the EEA constituting a single jurisdiction for this purpose), without prior written consent of Roche.

    13.8.6 Compliance

FMI undertakes to comply with its obligations (if any) under applicable legislation to notify any supervisory authority of its collection and processing activities under this Agreement and further agrees to take all such steps as Roche may reasonably require from time to time in order to enable Roche to comply with any notification obligation applicable to Roche.

    13.8.7 Data Collection

FMI will ensure that it does not collect any health or medical data, including Study Data, relating to individuals other than the categories of data specified in the protocol identified in the applicable Task Order and will collect and process Study Data for the sole purpose of the study identified in the applicable Task Order and not further process such data in any other manner.

    13.8.8 Disclosure

FMI will not disclose health or medical data, including Study Data or any other Personal Data related to this Agreement to any Third Party outside of the requirements of this Agreement without the prior permission in writing of Roche, except where such disclosure is required by any applicable law, regulation or supervisory authority, in which case the Institution will, wherever possible, notify Roche prior to complying with any such request for disclosure and shall comply with all reasonable directions of Roche with respect to such disclosure.   - 49 -





  13.8.9 Document Retention

FMI will have appropriate procedures in place for the destruction or purging of any medical or health data, including Study Data and any other Personal Data, related to this Agreement when the retention time that applies to the data has been reached.

    13.8.10 Procedures

FMI shall ensure that it has appropriate procedures in place to fulfill applicable International Data Protection laws and US federal and state or other legal requirements, should an individual request access to or changes to the health or medical data, including Study Data or any Personal Data related to this Agreement, maintained by Institution. Institution will notify Roche promptly (and in any event within […***…] after receipt) of any communication received from a Data Subject relating to the Data Subject a right to access, modify or correct Study Data and to comply with all instructions of Roche in responding to such communications.

    13.8.11 Survival

FMI's obligations to maintain privacy and security over medical or health data, including Study Data and other Personal Data received pursuant to this Agreement, will survive the termination or expiration of this Agreement.

    13.8.12 Security Breach

At any time during the processing of Persona Data, FMI shall notify Roche immediately (but no later than […***…] from the date) of any Data Security Breach involving Roche data. FMI shall assist and cooperate with Roche concerning any disclosures to affected parties, government or regulatory agencies and with any other remedial measures requested by Roche or mandated by Applicable Law.

  13.9 No Other Representations

EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT AND THE RELATED AGREEMENTS BEING ENTERED INTO BY THE PARTIES AT THIS TIME, THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS. IN NO EVENT SHALL EITHER FMI OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.

  14. Indemnification

14.1 Indemnification by Roche

Roche shall indemnify, hold harmless and defend FMI and its directors, officers, employees and agents from and against any and all losses, expenses, cost of defense (including without   ***Confidential Treatment Requested***

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limitation attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts FMI becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims arise out of Roche's and its Affiliates' actions or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of FMI.

  14.2 Indemnification by FMI

FMI shall indemnify, hold harmless and defend Roche and its directors, officers, employees and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims arise out of FMI's and FMI's Affiliates' actions or inactions in connection with activities under this Agreement, except to the extent that such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of Roche.

  14.3 Procedure

In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement (Indemnified Party), the Indemnified Party shall promptly notify the other Party (Indemnifying Party) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party's written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.

  15. Liability

THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. FMI AND ROCHE DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS.

  16. Obligation Not to Disclose Confidential Information

16.1 Non-Use and Non-Disclosure

During the Agreement Term and for […***…] thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information   ***Confidential Treatment Requested***

- 51 -





to Third Parties, without the Disclosing Party's prior written consent, and (iii) not use such Confidential Information other than for fulfilling its obligations or exercising its rights under this Agreement. If any Confidential Information is required to be disclosed by the Receiving Party or its Affiliates to comply with a court or administrative order, the Receiving Party or its Affiliates, prior to making such disclosure, shall furnish as much notice as is reasonable under the circumstances to the Disclosing Party to enable it to resist such disclosure.

  16.2 Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in Section 16.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press releases, patent rights, publications, and certain commercial considerations.

  16.3 Press Releases

Following the Effective Date, the Parties will issue a joint press release announcing the existence and selected key terms of this Agreement, in a form substantially similar to the template attached as Appendix 16.3.

Each Party shall provide the other with a copy of any draft press release related to the activities contemplated by this Agreement at least ten (10) Business Days prior to its intended publication for such other Party's review. The reviewing Party may provide the releasing Party with suggested modification to the draft press release. The releasing Party shall consider, and shall not unreasonably disregard, the reviewing Party's suggestions in issuing its press release. Notwithstanding the foregoing, each Party must comply with its obligations under Section 16.1 and 16.5.

  16.4 Publications

During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information in any publication or presentation. A Party (Publishing Party) shall provide the other Party with a copy of any proposed publication or presentation at least […***…] prior to submission for publication so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies (Publishing Notice) the Publishing Party in writing, within […***…] after receipt of the copy of the proposed publication or presentation, that such publication or presentation in its reasonable judgment (i) contains an invention, solely or jointly conceived and/or reduced to practice by the other Party, for which the other Party reasonably desires to obtain patent protection or (ii) could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party, the Publishing Party shall prevent such publication or delay such publication for a mutually agreeable period of time. In the case of inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such invention, and in no event less than [… ***…] from the date of the Publishing Notice.   ***Confidential Treatment Requested***

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16.5 Commercial Considerations

Nothing in this Agreement shall prevent a Party or its Affiliates from disclosing Confidential Information of the other Party to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of a product in the Territory and (ii) Third Parties acting on behalf of a Party, to the extent reasonably necessary to conduct the activities contemplated by this Agreement provided that such Third Parties are bound by confidentiality obligations with respect to such information that are no less stringent than those included in this Agreement.

  17. Term and Termination

17.1 Commencement and Term

This Agreement shall commence upon the Effective Date and continue for the Agreement Term.

  17.2 Termination

  17.2.1 Termination for Breach

A Party (Non-Breaching Party) shall have the right to terminate this Agreement on a Work Stream-by-Work Stream basis, or, for Roche, on an Approved Marker or Investigational Marker basis in the case of the CDx Development Program, in the event the other Party (Breaching Party) is in material breach of any of its material obligations under the applicable Work Stream (or obligations pertaining to an Approved Marker or Investigational Marker program). Failure of FMI to comply materially with Performance Specifications or Quality Standards shall be considered a material breach by FMI. For avoidance of doubt, a Non-Breaching Party shall only be permitted to terminate the Work Stream (or Approved Marker or Investigational Marker program) to which a material breach of a material obligation relates. The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach. Except in the event of a breach that, by its nature, is not amenable to cure, in which case termination may be made effective immediately, the Breaching Party shall have a period of […***…] after such written notice is provided (Peremptory Notice Period) to cure such breach or, absent withdrawal of the Non-Breaching Party's request for termination, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall terminate; provided that, if the Breaching Party has a bona fide dispute as to whether such breach: (i) occurred, (ii) pertains to a material obligation, or (iii) has been cured, the Breaching Party will so notify the Non-Breaching Party, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall not terminate and the expiration of the Peremptory Notice Period shall be tolled until such dispute is resolved pursuant to Section 19.2. If such dispute is resolved by finding that the Non-Breaching Party is entitled to terminate the relevant Work Stream (or Approved Marker or Investigational Marker program), the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach. If such breach is not cured within the Peremptory Notice Period, then absent withdrawal of the Non-Breaching Party's request for termination, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall terminate in accordance with the notice from the Non-Breaching Party as of the expiration of the Peremptory Notice Period.

    17.2.2 Insolvency

A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to   ***Confidential Treatment Requested***

- 53 -





terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within […***…] after the filing thereof.

    17.2.3 Termination by Roche without Cause

Roche shall have the right to terminate the Agreement in its entirety, or on a Work Stream-by-Work Stream basis, except for the ctDNA Work Stream, upon […***…] prior written notice, without cause. With regard to the CDx Development Program, Roche shall also have the right to terminate, without cause, the development of an Approved Marker and/or an Investigational Marker for inclusion in a CDx Assay, upon […***…] prior written notice; provided however that this right shall expire with respect to each Approved Marker for inclusion in a particular CDx Assay at such time as FMI has completed analytical validation for such Approved Marker. With regard to the Molecular Information Platform Program, Roche shall have the right to terminate without cause either or both of the Sample Profiling or Molecular Information Database Access activities individually.

    17.2.4 Termination by Roche for Frustration of Purpose

Roche shall have the right to terminate the ctDNA Platform Development Program upon […***…] prior written notice for frustration of purpose in the event that the Clinical Study for which the ctDNA Assay is being developed is canceled.

  17.3 Consequences of Termination

  17.3.1 Termination in General

Upon any termination of the Agreement, a Work Stream (or Approved Marker or Investigational Marker program), or this Agreement under Section 17.2.2, (i) FMI shall promptly return to Roche unused or remaining Samples that were provided for use in a terminated Work Stream (or related to the relevant Approved Marker or Investigational Marker), or, at Roche's option, securely dispose of all such unused or remaining Samples and provide Roche with a written notice of such disposal, (ii) each Party shall wind-down their activities under the Agreement in a manner that is intended to be expeditious and to mitigate losses arising from non-cancellable expenses and financial commitments to Third Parties, (iii) upon any termination by Roche under Section 17.2.3, or by FMI under Section 17.2.1 or Section 17.2.2, that includes the Immunotherapy Testing Platform Development Work Stream, the obligations in Section 3.2.8 shall terminate, (iv) each Party shall continue to Control its own intellectual property, including Patent Rights and Know-How, and Handle its own Patent Rights, and (v) Joint Patent Rights, if any, shall be handled by Roche subject to the provisions of Section 12.4 and 12.6, and each Party shall have the right to fully exploit such Joint Patent Rights.

17.3.2 Termination by FMI for Breach by Roche or Roche's Insolvency; Termination by Roche Without Cause or for Frustration of Purpose

Upon any termination by FMI for breach by Roche under Section 17.2.1, for Roche's Insolvency under Section 17.2.2, by Roche without cause under Section 17.2.3, or by Roche for frustration of purpose under Section 17.2.4:

  (i) The rights and licenses granted by FMI to Roche hereunder shall terminate for the terminated Agreement, or Work Stream, orportion of the Work Stream (as applicable, the Terminated Matter), on the effective date of termination;   ***Confidential Treatment Requested***

- 54 -





  (ii) All licenses granted by Roche to FMI hereunder pertaining to the Terminated Matter become fully paid up, perpetual andirrevocable;



(iii) Roche shall retain all licenses granted by FMI to Roche pertaining to intellectual property arising from work on the Terminated Matter prior to termination, provided, however, FMI shall be under no obligation to Handle any patent or patent application arising from Terminated Matters and may freely abandon (without offering Roche the right to Handle) or license (but, for clarity, not exclusively license or assign without Roche's consent if Roche retains license rights) such patent or patent application.

  (iv) Within […***…] after the effective date of termination and receipt by Roche of an invoice from FMI, Roche shall pay to FMI thefollowing amounts:



a. In the event of termination of the Molecular Information Platform Program Work Stream, Roche shall pay FMI all [… ***…] that would be owed over the remainder of the Agreement Term, or any […***…], plus any applicable incremental per Sample Profiling Fees for Sample Profiling performed by FMI during the year in which termination occurs that are […***…];



b. In the event of termination of the Immunotherapy Testing Platform Development Work Stream, (1) for avoidance of doubt, Roche shall pay FMI Roche's share of any FMI Development Costs incurred in connection with the Immunotherapy Testing Platform Development Work Stream as of the effective date of termination that were not previously paid by Roche; (2) (A) if the effective date of termination occurs prior to FMI's completion of the Immuno- Biomarker Discovery Platform, then Roche will pay FMI for the entirety of the FMI Development Costs FMI incurred in connection with FMI's performance of the Immunotherapy Testing Platform Development Work Stream, excluding any portion that was previously paid by Roche, or (B) if the effective date of termination occurs after FMI's commencement of Signature Identification services, then Roche will pay FMI for the entirety of the FMI Development Costs FMI incurred prior to the effective date of termination in connection with any ongoing performance of Signature Identification work by FMI, excluding any portion of such FMI Development Costs that was previously paid by Roche or that is payable by Roche under the foregoing clause (1); and (3) Roche shall pay FMI in accordance with Section 8.3.2 with respect to signatures developed by FMI prior to the effective date of termination.

  c. In the event of termination of the ctDNA Platform Development Program Work Stream, Roche shall have no contractual payment obligation under this Section 17.3.2; provided, however, that Roche shall be obligated to honor payment obligations triggered prior to the effective date of termination;



d. In the event of termination of the CDx Development Program Work Stream: for avoidance of doubt, Roche shall pay any FMI Development Costs in connection with the development of an Investigational Marker as specified by Section 8.5.1 incurred as of the effective date of termination that were not previously paid by Roche and any non-cancellable commitments reasonably incurred by FMI in   ***Confidential Treatment Requested***

- 55 -







anticipation of receiving PMA with regard to any Investigational Marker to the extent not re-allocable to FMI's other business activities, including without limitation, all accrued amounts under any individual CDx R&D Plan entered into by the Parties as described in Section 3.4.8 above; (ii) if the effective date of such termination is after FMI has completed analytical validation of any Investigational Marker for inclusion in a CDx Assay, then Roche shall remain obligated to pay a fee for each such terminated Investigational Marker equal to […***…] upon PMA approval; and (iii) the milestone payments specified under Section 8.5.3 shall apply with respect to CDx Assays containing any Approved Marker and/or Investigational Marker; and

  e. In the event of termination of the Agreement in its entirety under 17.2.2, Roche shall pay to FMI all amounts under theforegoing subsections (a) through (d) (inclusive) as applicable, if such fees become payable.



(v) FMI shall retain all rights and remedies available to it under law and equity in connection with breach by Roche under Section 17.2.1 or other termination under Section 17.2.2, Section 17.2.3, or 17.2.4, provided, however, that in the case of termination of the Molecular Information Platform Program under Section 17.2.1 or Section 17.2.3 above, FMI's exclusive remedy (other than for breach of confidentiality under Section 16.1) shall be the accelerated payments specified under Section 17.3.2(iv)a.

For avoidance of doubt, in the event FMI terminates the Agreement in its entirety due to Roche's Insolvency, all Work Streams and other activities under the Agreement will be deemed to be terminated and all of the applicable effects of termination in this Section 17.3.2 shall apply.

    17.3.3 Termination by Roche for Breach by FMI or FMI Insolvency

Upon any termination by Roche for breach by FMI under Section 17.2.1 or FMI's Insolvency, under Section 17.2.2:

  (i) The rights and licenses granted by Roche to FMI under Section 2.1 shall terminate for each terminated Work Stream, on theeffective date of termination, except that the rights granted to FMI under Section 2.1.2 shall survive such termination;

  (ii) All licenses granted by FMI to Roche hereunder pertaining to a terminated Work Stream become fully paid up, perpetual andirrevocable;

  (iii) The […***…] under Section 3.2.10 shall survive termination of the Immunotherapy Testing Platform Development Work Stream;

  (iv) The […***…] under Section 3.3.9 shall survive termination of the ctDNA Platform Development Program Work Stream;

  (v) Within […***…] after the effective date of termination and receipt by Roche of an accounting from FMI, FMI shall pay to Roche any unused Reserved Capacity Fees and Database Access Fees previously paid pursuant to Section 8.2.1.1 or any other unused and pre-paid amounts;   ***Confidential Treatment Requested***

- 56 -





  (vi) FMI shall transfer to Roche all FMI Know-How, other than FMI Know-How pertaining to the Molecular Information Platform Program, necessary for Roche to practice the Terminated Matter, solely for the purposes or practicing the Terminated Matter, including any necessary algorithms; and

  (vii) Roche shall retain all rights and remedies available to it under law and equity in connection with such breach by FMI.

For avoidance of doubt, in the event Roche terminates the Agreement in its entirety due to FMI's Insolvency, all Work Streams and other activities under the Agreement will be deemed to be terminated and all of the applicable effects of termination in this Section 17.3.3 shall apply.

    17.3.4 Direct License

Irrespective of anything to the contrary in this Agreement, any existing, permitted sublicense granted by a Party under this Agreement (and any further sublicenses thereunder) shall, upon a termination of the license granted hereunder that pertains to such sublicense, shall terminate; provided that if the licensee Party so requests in writing, the licensor Party shall negotiate with the relevant sublicensee towards the grant of a direct license of rights, provided that such sublicensee is not then in breach of its sublicense agreement with the licensee Party.

  17.4 Other Obligations

Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to make payments to FMI that are due and payable prior to the effective date of termination. Termination of this Agreement by a Party, for any reason, will release Roche from any obligation to any payments to FMI that would otherwise become due or payable on or after the effective date of termination.

  17.5 Survival

In addition to any provisions that expressly survive in accordance with Article 17.3, Article 1 (Definitions, to the extent necessary to interpret the Agreement), Section 3.5.2 (Sample Handling and Disposal, to the extent applicable), Section 10 (Taxes), Section 12.1 (Ownership of Inventions), Section 12.9 (Common Interest Disclosures), Section 13.8.11 (Survival of Privacy and Security Obligations), Article 14 (Indemnification), Article 16 (Obligation Not to Disclose Confidential Information), Section 17.3 (Consequences of Termination), Section 17.5 (Surival), Section 19.1 (Governing Law), and Section 19.3 (Arbitration) shall survive any expiration or termination of this Agreement for any reason. Notwithstanding the foregoing, any provision of this Agreement that is intended by its very nature to survive expiration or termination of this Agreement shall also survive.

  18. Bankruptcy

All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by FMI to Roche are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the Bankruptcy Code) licenses of rights to intellectual property as defined under Section 101(35A) of the Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties agree that Roche, as a licensee or sublicensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.   - 57 -





19. Miscellaneous

19.1 Governing Law

This Agreement shall be governed by and construed in accordance with the laws of New York, US, without reference to its conflict of laws principles, and shall not be governed by the United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention).

  19.2 Disputes

Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the dispute. The designated executive officers are as follows:   For FMI: CEO For Roche: Head of Roche Partnering

  19.3 Arbitration

Should the Parties fail to agree within […***…] after such dispute has first arisen, it shall be finally settled by arbitration in accordance with the Rules of American Arbitration Association (AAA) as in force at the time when initiating the arbitration. The tribunal shall consist of three arbitrators. The place of arbitration shall be New York, New York, US. The language to be used shall be English.

    19.3.1 Arbitrators

Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within […***…] of being requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within […***…] of being requested to do so, the other Party shall request the AAA to make such appointment.

The arbitrators nominated by the Parties shall, within […***…] from the appointment of the arbitrator nominated in the answer to the request for arbitration, and after consultation with the Parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the […***…] time limit, either Party shall be free to request the AAA to appoint the third arbitrator.

Where there is more than one claimant and/or more than one respondent, the multiple claimants or respondents shall jointly appoint one arbitrator.

Any Party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this clause.

The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation.

    19.3.2 Decisions; Timing of Decisions

The arbitrators shall render a written opinion setting forth findings of fact and conclusions of law with the reason therefor stated, within no later than […***…] from the date on which the arbitrators were appointed to the dispute. A transcript of the evidence adduced at the arbitration hearing shall be made and, upon request, shall be made available to each Party.   ***Confidential Treatment Requested***

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The time periods set forth in the AAA Arbitration Rules shall be followed; provided however that the arbitrators may modify such time periods as reasonably necessary to render a written opinion in accordance with this Section 19.3.2.

The Arbitrator is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys' fees, and to grant final, complete, interim, or interlocutory relief, including injunctive relief.

This arbitration agreement does not preclude either Party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either Party's domicile. Conservatory or interim measures sought by either Party in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either Party before the Arbitral Tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures.

In the event that any issue shall arise which is not clearly provided for in this Section 19.3, the matter shall be resolved in accordance with the AAA Arbitration Rules.

Any arbitration proceeding hereunder shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party's Confidential Information. Except as required by law, neither Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrators, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law.

Notwithstanding anything to the contrary in this Agreement, any and all issues regarding the scope, construction, validity and/or enforceability of any Patent Rights shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent Rights in question.

Notwithstanding anything to the contrary in this Agreement, any and all issues regarding a breach or alleged breach of a Party's obligations under Article 16 (Obligation Not to Disclose Confidential Information) shall be determined in a court of competent jurisdiction under the laws of New York, with express exclusion of its conflict of laws principles.

  19.4 Assignment

Neither Party shall have the right to assign the present Agreement or any part thereof to any Third Party other than Affiliates without the prior written approval of the other Party.

  19.5 Debarment and Exclusion

  19.5.1 Past Activities

Each Party represents and warrants that it has never been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care   - 59 -





Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the above-referenced statutes, such Party shall immediately notify the other Party in writing and such other Party shall have the right, but not the obligation, to terminate this Agreement, effective, at such other Party's option, immediately or at a specified future date.

    19.5.2 Future Activities

Each Party agrees that, to the best of its knowledge, none of its employees or agents conducting activities on its behalf under the Agreement is currently or will be during the term of this Agreement, debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party learns that any such employee or agent becomes so debarred, sanctioned, suspended, excluded or declared ineligible or is the subject of proceedings that may result in such debarment, sanction, suspension, exclusion or ineligibility, it will promptly so notify the other Party and will no longer allow such employee or agent to conduct activities under this Agreement.

  19.6 Independent Contractor

No employee or representative of either Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Party's prior written approval. For all purposes, and not- withstanding any other provision of this Agreement to the contrary, FMI legal relationship to Roche under this Agreement shall be that of independent contractor.

  19.7 Unenforceable Provisions and Severability

If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties. However the remainder of this Agreement will remain in full force and effect, provided that the material interests of the Parties are not affected, i.e. the Parties would presumably have concluded this Agreement without the unenforceable provisions.

  19.8 Waiver

The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Agreement will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. The waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision or condition.

  19.9 Appendices

All Appendices to this Agreement shall form an integral part to this Agreement.   - 60 -





19.10 Entire Understanding

This Agreement contains the entire understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral.

  19.11 Amendments

No amendments of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.

  19.12 Invoices

All invoices that are required or permitted hereunder shall be in writing and sent by FMI to Roche at the following address or other address as Roche may later provide:

F. Hoffmann-La Roche Ltd Kreditorenbuchhaltung 4070 Basel Switzerland

  19.13 Notice

All notices that are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:   if to FMI, to: Foundation Medicine, Inc. 150 Second Street Cambridge, Massachusetts 02141 Attn: Legal Department Facsimile No.: +1 617 418 2201

if to Roche, to: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel Switzerland Attn: Legal Department Facsimile No.: +41 61 688 13 96

and: Hoffmann-La Roche Inc. 150 Clove Road Suite 8 Little Falls, New Jersey 07424 US Attn. Corporate Secretary Facsimile No.: +1 973 890-8433   - 61 -





or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith.

[Signature Page Follows]   - 62 -





IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.   Foundation Medicine, Inc.

/s/ Steven J. Kafka

Name: Steven J. Kafka

Title: Chief Operating Officer   F. Hoffmann-La Roche Ltd

/s/ Jason Coloma /s/ Stefan Arnold

Name: Jason Coloma Name: Stefan Arnold

Title: Global Head of Venture & Innovation, Roche Partnering Title: Head Legal Pharma   Hoffmann-La Roche Inc.

/s/ John P. Parise

Name: John P. Parise

Title: Authorized Signatory





Appendix 1.28

Excluded Patent Rights

[…***…].   ***Confidential Treatment Requested***

A-1





Appendix 1.57

[…***…]   ***Confidential Treatment Requested***

A-2





Appendix 1.64

[…***…]   ***Confidential Treatment Requested***

A-3





Appendix 3.1.3 Form of Task Order

TASK ORDER FOR MOLECULAR INFORMATION PLATFORM AGREEMENT

This [Insert number of Task Order] Task Order is effective as of the last date below (Task Order # Effective Date.

TASK: [Insert Task Name] FMI Reference Number: [Insert FMI Reference Number]   Roche Contact: [Insert Roche Contact]

This Task is divided into the following six sections:

  A. Task Activities - Description of the Task Activities to be performed.

  B. Schedule - Task start date, projected end date and checkpoint dates (if any).

  C. Dependencies - Obligations, technology requirements.

  D. Deliverables - Identifiable work product resulting from the Task.

  E. Fee - Fixed price or time & materials rates and payment schedules.

  F. Special Terms - Terms applicable to this specific effort not addressed by this Agreement.

  A. Task Activities

[Describe Task Activities to be provided]

  B. Schedule

[Describe schedule for Task Activities to be provided and specify the duration of the Task Activities]

  C. Dependencies

[Describe dependencies as relating to the Task Activities]

  D. Deliverables

[Describe deliverables as relating to the Task Activities]

  E. Fee

[Describe payment schedule and form of payment for the Task Activities]

  F. Special Terms

[Describe any special terms for the Task Activities]

Signatures of Project Managers





FMI ROCHE

By:   By:

Name:   Name:

Title:   Title:

Date:   Date:     A-5





Appendix 3.1.6

[…***…]   ***Confidential Treatment Requested***

A-6





Appendix 3.2.4 Excluded Contracts

[…***…]   ***Confidential Treatment Requested***

A-7





Appendix 3.5.1

FMI Specimen Requirements

















Appendix 16.3

Form of Press Release   A-9
[EX A]: Highlight the parts (if any) of this contract related to Cap On Liability that should be reviewed by a lawyer. Details: Does the contract include a cap on liability upon the breach of a party’s obligation? This includes time limitation for the counterparty to bring claims or maximum amount for recovery.

[EX Q]: Exhibit 10.14 License and Development Agreement Agreement between NLS-1 Pharma AG Alter Postplatz 2 6370 Stans Switzerland Licensor / NLS and Eurofarma Laboratórios S.A. Avenida Vereador José Diniz 3465 04603-003 São Paulo Brazil Licensee / Eurofarma (Licensor and Licensee each a ʺPartyʺ collectively the ʺPartiesʺ) regarding Nolazol® (Mazindol CR) in ADHD - Latin America

Source: NLS PHARMACEUTICS LTD., F-1, 2/28/2020





License and Development Agreement

Table of Content WHEREAS 1 1. Definitions 1 2. Grant of License 4 2.1. Grant of rights 4 2.2. Restrictions 4 3. License Fees and Milestone Payments 5 3.1. Upfront Payment 5 3.2. Milestone payments 5 3.3. Royalties 6 3.4. Reports 6 3.5. Records and Audits 6 3.6. Payment Terms 7 4. Business Plan 7 5. Development Work 8 6. Further Development Work 8 7. Brand Name and Trademarks 9 8. Labelling and Packaging 9 9. Regulatory Obligations and Procedures 10 9.1. Regulatory Obligations and Procedures in General 10 9.2. Notifications 10 9.3. Regulatory Obligations of Licensee 10 9.4. Regulatory Obligations of Licensor 10 9.5. Pharmacovigilance 11 10. Cooperation and Joint Project Steering Committee 11 10.1. Cooperation 11 10.2. Transfer of Know-how 11 10.3. Joint Steering Committee 12 11. Commercialization 12 12. Supply 13 13. Property rights to Intellectual Property 13 14. Prosecution of Infringements of Intellectual Property 13 14.1. Notice 13 14.2. Action 13 14.3. Information 14 15. Representations and Warranties 14 15.1. Licensor Representations and Warranties 14 15.2. Licensee Representations and Warranties 14 15.3. Other Representations and Warranties 15 16. Liability and Limitations 15 17. Indemnities 16 17.1. Indemnities by the Licensor 16 17.2. Indemnities by the Licensee 16 17.3. Third party claims 16 18. Confidentiality 17 18.1. Confidentiality Obligations 17 18.2. Exceptions to Obligations 17 18.3. Survival of Confidentiality Obligations 18

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License and Development Agreement

19. Term and Termination 18 19.1. Term 18 19.2. Termination for Change of Control 18 19.3. Termination for Bankruptcy, Liquidation and similar proceedings 18 19.4. Early Termination for Material Breach 18 19.5. Early Termination by the Licensor 19 19.6. Early Termination by the Licensee 19 19.7. Consequences of Expiration or Termination 20 20. General Provisions 20 20.1. Amendments 20 20.2. Notices 20 20.3. Severability / Good Faith 20 20.4. No Waiver 21 20.5. No Assignment 21 20.6. Appendices 21 20.7. Public Announcements 21 21. Governing Law and Jurisdiction 21 Table of Appendices 23 Appendix A - [Template for Licensee Reports] 24 Appendix B - Preliminary Business Plan 25 Appendix C*- Purpose of the JSC pre and post MA * No such appendix completed by the parties.

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License and Development Agreement

WHEREAS A. NLS carries on the business of researching, developing and manufacturing certain pharmaceutical products and is the legal and beneficial owner of certain Intellectual Property, including Patents, Know-how and other materials (all words with capital letters are defined below); B. Eurofarma is a pharmaceutical company with expertise in researching, developing, manufacturing, marketing and sales of pharmaceutical products, including products in the Field, and has a distribution network throughout Latin America; C. Eurofarma wishes to receive an exclusive license from NLS to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, sell and have sold the Licensed Product in the Territory, and NLS wishes to grant a respective license on the terms and conditions set out in this Agreement; D. The Parties acknowledge that further development of the Products will be necessary to develop the required Dossier as defined hereunder for obtaining Marketing Authorisation(s) in the Territory and wish to collaborate on the further development of the Products. NOW, THEREFORE, the Parties agree as follows: 1. Definitions When used in this Agreement in capital letters, the terms and abbreviations set forth below, whether used in the singular or plural, shall have the following meaning: Affiliates means any company, enterprise, corporation or business entity which controls, is controlled by, or is under common control with, either the Licensor or Licensee. For this purpose, control shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through holding a majority of the voting rights of the entity, by contract or otherwise. Agreement shall mean this Agreement, including all of its Appendices. Appendix shall mean any appendix to this Agreement. Article shall mean an article of this Agreement. Change of Control shall mean any merger, consolidation or acquisition of a Party with, by or into another corporation, entity or person; or any change in the ownership of more than fifty percent (50%) of the voting capital stock or actual control over the voting rights in one or more related transactions. Confidential Information shall have the meaning set forth in Article 18.

Developed Intellectual Property

shall mean any and all changes, additional Know-how, improvements and inventions relating to the Intellectual Property (such as, without limitation, method of use patents) made after the Effective Date of this Agreement.

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License and Development Agreement

Distributor shall mean a company appointed by Licensee and agreed by Licensor in a country of the Territory for the import, selling, promotion and distribution of the Licensed Product in such country of the Territory. Dossier shall mean the registration file for the Licensed Product (which will be developed based on the Know-how and the Intellectual Property Rights) including any data, studies, documents, reports, correspondence with regulatory authorities, approvals and information that is necessary for obtaining and maintaining one or several Marketing Authorizations in the Territory. Effective Date shall be the date of the last signature on the last page of this Agreement.

Field shall mean the diagnosis, prevention, and treatment of DSM-V Attention Deficit and Hyperactivity Disorder (ADHD) in children, adolescents and adult populations. Indemnified Party shall have the meaning set forth in Article 17.3.

Intellectual Property shall mean Intellectual Property Rights and Know-how.

Intellectual Property Rights

shall mean with respect to the Licensed Product (as defined hereunder) any and all patents, copyright (including software), rights under data exclusivity laws, property rights in biological or chemical materials, names, trademarks, extension of the terms of any such rights (including supplementary protection certificates), applications for and the right to apply for any of the foregoing registered property rights, and similar or analogous rights anywhere in the world. Joint Steering Committee / JSC

shall have the meaning set forth in Article 10.3 of this Agreement.

Know-how shall mean with respect to the Licensed Product (as defined hereunder), all materials, laboratory, pre-clinical and clinical data, knowhow, trade secrets and all other scientific, technical, including manufacturing or regulatory information, patentable or otherwise, developed, applied or acquired by NLS which relates to the identification, characterization, expression, synthesis, use, or production of the Licensed Product and which is reasonably useful or necessary to research, develop, use, make, have made, import, distribute, offer for sale, and/or sell the Product. Launch shall mean the first commercial sale of a Licensed Product in a country of the Territory by the Licensee or an Affiliate of the Licensee or by a Distributor engaged by Licensee. Lead Countries Brazil, Mexico and Argentina.

License shall have the meaning set forth in Article 2.1 of this Agreement.

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License and Development Agreement

Licensed Product Any and all products that are manufactured, sold, or otherwise supplied by the Licensee (including any Affiliate or Distributor of the Licensee) and which incorporate, or their development makes use of, any Intellectual Property or Developed Intellectual Property. Licensee Know-how shall mean with respect to the Licensed Product (as defined hereunder) all know-how, trade secrets and scientific, technical, including manufacturing or regulatory information, developed, applied or acquired by Eurofarma which relates to the identification, characterization, expression, synthesis, use, or production of the Licensed Product and which is reasonably useful or necessary to research, develop, use, make, have made, import, distribute, offer for sale, and/or sell the Licensed Product. Losses shall have the meaning set forth in Article 17.1 of this Agreement. Marketing Authorisation / MA

in relation to the Licensed Product, shall mean those approvals necessary from one or more competent authorities in the Territory for manufacturing, importing, marketing, distributing, offering for sale and/or selling the Licensed Product in one or several countries of the Territory. Net Sales means the total of the gross invoice prices of Licensed Products sold or leased by the Licensee, an Affiliate, a Distributor, or any combination thereof, less the sum of the following actual and customary deductions where applicable and separately listed: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (in particular value-added tax); transportation charges; or credits to customers because of rejections or returns. For purposes of calculating Net Sales, transfers to an Affiliate or to a Distributor of Licensed Product under this Agreement for (i) end use (but not resale) by the Affiliate shall be treated as sales by Licensee at the list price of the Licensee in an arm- length transaction, or (ii) resale by an Affiliate shall be treated as sales at the list price of the Affiliate. Patents shall mean Brazilian Patent Application No. BR 11 2018 068143 filed on September 6, 2018, and Mexican Patent Application No. MX/a/2018/010864 filed on September 7, 2018, covering multi-layered formulation of Mazindol, including all provisional applications, continuations, divisions, extensions, re-examinations, certificates, reissues and Supplementary Protection Certificates. Phase III Clinical Trial shall mean a controlled clinical study of mazindol CR that aims to establish the therapeutic benefit and safety of mazindol CR in the Field in a larger patient sample in a manner sufficient to be included in the Dossier and obtain one or several Marketing Authorisations to market such Licensed Product in the Territory.

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License and Development Agreement

Report(s) shall have the meaning set forth in Article 3.4. Royalty / Royalties shall have the meaning set forth in Article 3.3. Territory The countries of Latin America Trademarks shall have the meaning set forth in Article 7. 2. Grant of License 2.1. Grant of rights Subject to the conditions and limitations set forth in this Agreement, the Licensor hereby grants to the Licensee, and the Licensee hereby accepts, (i) an exclusive, fee-bearing, non-transferable distribution right of the Licensed Product in the Territory during the Term (the Distribution), (ii) an exclusive, royalty-free, non-transferable license to the Licensor's Patents and Trademarks to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, sell and have sold the Licensed Product during the Term, without the right to sublicense (the License), and (iii) an exclusive, royalty-bearing, non-transferable license to the Intellectual Property (except Patents and Trademarks ) and the Developed Intellectual Property and a right to obtain the technology transfer of the Know-How to manufacture the Licensed Product in the Territory during the Term, pursuant to the conditions set forth in Article 2.3 below and elsewhere in this Agreement (the Technology Transfer), all to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, manufacture, have manufactured, sell and have sold the Licensed Product during the Term, without the right to sublicense. 2.2. Restrictions Licensee may extend the rights granted herein to register, import, export, store, handle, commercialize, promote, distribute and sell to its Affiliates and to its Distributors, provided that Licensee shall first provide to Licensor a written assurance from each of such Affiliate or Distributor to agree to be bound by, and to strictly comply with, all applicable terms, conditions, and obligations in this Agreement towards Licensor. Licensee shall not be entitled to assign the License or any of its rights under this Agreement or to grant any sub-licenses. 2.3. Technology Transfer After Licensor and Licensee have agreed to move forward to the Technology Transfer phase, the Parties will execute a separate Technology Transfer Agreement, which shall be at arms-length basis and pursuant to the conditions herein. For that purpose, Licensor hereby undertakes to transfer to Licensee all Know-how in order to enable Licensee to implement it in its plant to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, manufacture, have manufactured, sell and have sold the Licensed Product during the Term. Licensee undertake to use the transferred Know-how solely for the purposes and limits provided in this Agreement. For the avoidance of any doubt, the Know-how does not include Licensee Know-how Licensor shall render to Licensee all technical assistance necessary to enable Licensee to fully implement the Technology Transfer phase in Licensee's premises. The royalties provided in this Agreement already includes such technical assistance, unless the Parties otherwise mutually and in good-faith agree. In such case, the Parties will provide in separate agreement the additional conditions for the Technology Transfer, which shall be at arms-length basis.

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License and Development Agreement

3. License Fees and Milestone Payments 3.1. Upfront Payment Upon signature of this Agreement and no later than 20 days following it, Eurofarma shall pay to NLS, for the rights pursuant to Article 2.1(i), the non-refundable and non-deductible sum of USD 2'500'000 (in words: US dollars two and a half million). 3.2. Milestone payments Upon achievement of each of the milestone events set out below, Eurofarma shall pay to NLS the non-refundable and non- deductible amounts set out below next to such milestone event: 3.2.1. Clinical Milestones Upon successful completion by NLS in the US of the Phase III Clinical Trial for the treatment of ADHD in adults (successful completion meaning reaching the primary endpoints of the respective study) USD 500'000 Upon successful completion by NLS in the US of the last Phase III Clinical Trial for the treatment of ADHD in children (successful completion meaning reaching the primary endpoints of the respective study) USD 500'000 3.2.2. Regulatory Milestones Upon price approval of the Licensed Product in Brazil by the relevant agency USD 1'000'000 Upon receipt of a MA by the relevant agency of the Licensed Product in any other country in the Territory USD 1'000'000 3.2.3. Sales Milestones (single payments) Upon reaching annual Net Sales of USD 10 million USD 1'000'000 Upon reaching annual Net Sales of USD 50 million USD 2'000'000 Upon reaching annual Net Sales of USD 75 million USD 4'000'000 Upon reaching annual Net Sales of USD 100 million USD 6'000'000

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License and Development Agreement

3.3. Royalties For the Technology Transfer and as applicable for the License granted by NLS to Eurofarma under article 2.1(iii) hereabove, Eurofarma shall pay to NLS royalty payments (the Royalties) on the annual Net Sales in the Territory according to the following table:

Annual Net Sales in the Territory in USD:

Royalty in Percent of Net Sales under 10 million 7% 10 million to < 20 million 8% 20 million to < 30 million 9% 30 million and above 10% Royalty payments shall be paid quarterly within thirty (45) days following the close of the calendar quarter. 3.4. Reports After the first commercial sale of a Licensed Product anywhere in the Territory, Eurofarma shall submit to Licensor quarterly reports on or before 15 days after the last business day of the month following each quarter of the year, and this for each year. Each report (the Reports) shall cover Eurofarma's (and each Affiliate's, unless the Parties agree that such Affiliates shall submit its reports directly to Licensor) and Distributors' last recently completed quarter and shall show: (i) the gross sales and Net Sales during the last recently completed quarterly period and the Royalties, in USD, payable with respect thereto; (ii) the number of the Licensed Products sold in each country of the Territory; (iii) the method used to calculate the Royalties; and (iv) the exchange rates used to convert the country currency to USD, as applicable. The Licensee shall provide the above information using the form as shown in Appendix A and include information on the date of the first commercial sale of the Licensed Product in each country. If no sales of Licensed Product have been made by the Licensee during a reporting period, Licensee shall report such information in the corresponding Report(s). 3.5. Records and Audits The Licensee shall keep, and shall require its Affiliates and Distributors to keep, accurate and correct records of the Licensed Product used and sold under this Agreement. Such records shall be retained by the Licensee for ten (10) years following a given reporting period.

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License and Development Agreement

Subject to a written advance notice of thirty (30) calendar days, all relevant records supporting the preparation of the Reports shall be made available during normal business hours for inspection at the expense of Licensor by Licensor or by a selected representative of Licensor for the sole purpose of verifying the Reports and the accuracy of the payments made or due to Licensor under this Agreement. Such inspector shall not request any other documents or information other than these related to this purpose as determined in its sole discretion and the Licensee shall have no obligation to provide the inspector or Licensor any documents or information not related thereto. In the event that any such inspection shows an underreporting and underpayment by the Licensee to Licensor under the terms of this Agreement in excess of one percent (1%) for any twelve-month (12-month) period, then Licensee shall pay the cost of the audit as well as any additional sum that would have been payable to Licensor had the Licensee reported correctly, plus an interest charge at a rate of ten percent (10%) per year. Such interest shall be calculated from the date the correct payment was due to Licensor up to the date when such payment is actually made by the Licensee. For underpayment not in excess of one percent (1%) for any twelve-month (12-month) period, the Licensee shall pay the difference within thirty (30) days without having to pay for the inspection cost but with interest charge calculated as per the provisions of this Article. 3.6. Payment Terms All payments due to the Licensor according to this Agreement shall be in US dollar, unless the Parties mutually agree otherwise. All payments are exclusive of VAT and other applicable taxes. Royalties earned on Net Sales shall not be reduced by the Licensee for any taxes, fees, or other charges imposed by the government of any country on the payment of royalty income, except that all payments made by Licensee in fulfilment of the Licensors' tax liability in any particular country may be credited against earned Royalties or fees due to the Licensor for that country. The Licensee shall pay all bank charges resulting from the transfer of such Royalty payments. Except for article 3.1 hereabove, payments shall be made by wire transfer to the bank nominated by Licensor, in maximum 45 days after the issuance by NLS of the corresponding invoices, In the event any payment due under this Agreement is not made at the agreed term and/or for the corresponding full amount, a late payment charge of ten percent (10 %) p.a. is due, calculated on a pro-rata basis of the number of days between the date at which the outstanding amount was due for payment to Licensor and the date is actually paid. For the payments under Article 2.1(iii) above, referred to in Article 3.3, Licensor understands that any such payments may only be remitted by Licensee after this (or a corresponding) Agreement has been recorded by the Brazilian Patent and Trademark Office (INPI) and registered by the Brazilian Central Bank (Bacen), as required by Brazilian law. 4. Business Plan Prior to the signing of this Agreement, Eurofarma has prepared and presented to NLS a high-level business plan, focusing on the Lead Countries (the Preliminary Business Plan as per Appendix B). Following the signing of this Agreement and prior to the Launch in each of the Lead Countries, and in any other countries of the Territories as applicable, Eurofarma shall present to NLS its business plan in such countries (the Business Plan) consistent with commercially reasonable efforts to launch and market the Licensed Product in such countries of the Territory and consistent with the Preliminary Business Plan.

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License and Development Agreement

Eurofarma shall use reasonable commercial efforts to comply with the sales set out in the Preliminary Business Plan, and the Business Plan may be updated annually by Eurofarma based on updates on the clinical development timelines, market and economic changes and results from clinical trials, which shall be mutually accepted and agreed between the Parties. Except for critical changes in the assumptions considered in the Preliminary Business Plan, the sales shall not vary substantially. 5. Development Work The Parties acknowledge and agree that development work will need to be carried out in the US in order to seek a Marketing Authorization of mazindol CR for use in the Field in the United States (the Development Work). The Development Work will in particular consist of, but not be limited to: a. the design, conduct and execution of pre-clinical studies and Phase I Clinical Trial for the End of Phase II Meeting by NLS as the sponsor (the US Sponsor) in the US in accordance with the guidance and requests from the US FDA; b. the design, conduct and execution of Phase III Clinical Trials by the US Sponsor in the US in accordance with the guidance and requests from the US FDA; c. the development of the registration dossier which shall be submitted by NLS to the FDA to seek a marketing authorization of Nolazol® (mazindol CR) for the treatment of ADHD in the US (the FDA Dossier). The Parties further acknowledge and agree that: i. such Development Work shall be carried out by NLS under its sole responsibility and its sole discretion as the US Sponsor; ii. NLS shall bear the costs of the Development Work it carries out in the US for the purpose of filing an NDA and seeking a marketing authorization in the US; iii. NLS shall share with Eurofarma the final reports of the planned studies in the Development Work as soon as available which shall be only used by Eurofarma for the Dossier and for no other purposes. Such reports constitute Developed Intellectual Property and are the sole property and Confidential Information of Licensor. 6. Further Development Work The Parties acknowledge and agree that further development work on the Licensed Product may have to be carried out in order to seek and obtain MA of the Licensed Product in certain of the countries of the Territory (the Further Development Work). The Parties acknowledge and agree that: i) NLS shall have sole responsibility and control of such Further Development Work, irrespective of whether it is carried by NLS as sponsor, or delegated by NLS to Eurofarma in any countries of the Territory or to any other 3rd party at NLS sole discretion ii) Eurofarma shall provide at its own costs timely input to NLS on the specific data and information not planned by NLS to be included in the FDA Dossier which are to be requested by the regulatory authorities of any of the Lead Countries to seek a MA in the Lead Countries (the US Supplemental Data);

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License and Development Agreement

iii) NLS shall use commercially reasonable efforts to generate the US Supplemental Data at a shared cost between the Parties which shall be made available to Eurofarma for inclusion in the registration dossiers filed by Eurofarma to seek a MA; iv) If the regulatory authorities of any countries of the Territory request specific data to be generated locally in subjects of such countries in order to seek a MA, Eurofarma shall solely bear the respective costs of the studies needed to generate such data (the Local Supplemental Data); v) Eurofarma shall be responsible for the preparation and submission of the registration dossiers in the Lead Countries and in the other countries of the Territory seeking to obtain a MA in such countries; vi) Eurofarma shall be the responsible Party for the discussions with the regulatory health authorities or with the other relevant authorities of such countries of the Territory involved in the MA process; vii) any intellectual property, know-how, trade secrets, data, processes whether patentable or not which may arise from the Further Development Work and the Supplemental Data shall be solely owned by NLS and shall fall under NLS Intellectual Property Rights and any other rights as the case maybe, except any information that is or becomes public (non-confidential) other than as a direct or indirect result of a disclosure by Licensee or any of its representatives. Licensee Knowhow shall belong to Licensee; viii) as set forth in Article 10.3 below a Joint Steering Committee shall be set-up. The JSC shall solely have an advisory role to the Parties. NLS shall retain final responsibility for the design, conduct and execution of the Development Work and Further Development Work. 7. Brand Name and Trademarks The brand name for the Licensed Product in the Territory shall be Nolazol® (Brazilian trademark application No. 916475913 and in Mexico and elsewhere in the Territory to be provided by Licensor, collectively referred to as Trademark) and may be modified by another name chosen and solely owned by the Licensor, subject to such modified name being communicated to Licensee no later than 6 months before the market launch of the License Product in Brazil. The Licensor shall be free to select and register any names and trademarks for the Licensed Product at its sole discretion. Such trademarks and names shall be prepared and owned by the Licensor at its expense. The Licensor shall bear all costs associated with the use of such trademarks and names. During the entire validity of this Agreement, Licensor hereby grants to License an exclusive and royaltyfree right to use the Trademark in the Territory. During any sell-off period the license shall be non-exclusive. 8. Labelling and Packaging Licensee shall at its own expense create the labelling, localized product information and packaging for the Licensed Product. Licensor and Licensee shall cooperate in order to obtain the necessary regulatory and governmental approvals for such labelling and packaging.

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License and Development Agreement

9. Regulatory Obligations and Procedures 9.1. Regulatory Obligations and Procedures in General The Parties acknowledge that Marketing Authorisation(s) for the Licensed Product will have to be obtained for the purpose of this Agreement. The Parties will mutually agree on the regulatory pathway(s) to be used through the Joint Steering Committee. 9.2. Notifications Each of the Parties shall promptly notify the other party in writing of any technical or clinical advances, useful modifications, side effects or new government regulations relating to the Licensed Product that shall come to its knowledge. 9.3. Regulatory Obligations of Licensee (i) Eurofarma shall own the MAs pertaining to the commercialization of the Licensed Product in the Field in the Territory during the term of this Agreement or until its termination prior to its term as set forth in Articles 19.2 to 19.6. Upon expiration or termination, Eurofarma shall i) immediately transfer the MAs to the Licensor or to any other party designated by the Licensor and return all relevant documents prepared or submitted that are related to the MAs, including those documents, data or information generated post MA filings, in maximum 30 days after the notification of termination; if the Licensor does not decide and inform within this period to whom the MAs and documents shall be transferred, then the Licensee shall have no obligation to keep them actives ii) shall forfeit its ownership of the MAs in any and all of the countries of the Territory and with other regulatory agencies, without any form of compensation except for the compensation under the conditions set forth in Article 19.2 below and, iii) shall have no further claims of ownership and nor any other claims related to the MAs. (ii) Eurofarma shall solely bear the costs related to the required regulatory procedures and for the MA and the MA application, grant, maintenance, update, variation, defence and renewal, as the case may be, in the Territory throughout the term of this Agreement. (iii) In advance of their use and/or submission, Eurofarma shall furnish NLS with copies of all material correspondence to be sent to the competent regulatory authorities in the Territory, and all MA applications which are prepared for the Licensed Product. NLS shall have the right to comment and Eurofarma must comply with the requested changes by the NLS, provided that any such comments and/or changes are in compliance with the rules of the local and competent regulatory agencies. (iv) Subject to NLS prior written approval which may be granted at its own discretion and for its own reasons, Eurofarma may conduct certain work pre MA approval or post MA approval and in that case Eurofarma agrees to share with NLS any data from laboratory, preclinical, clinical, chemistry, manufacturing and control studies conducted in support of its regulatory filings for the development, approval, and marketing of the Licensed Product and after its marketing approval as the case may be, should Eurofarma conduct any such work on its own. Any contribution of NLS to the costs of such work (that do not fall under 9.3 (ii)) (including, without limitation, translation of documents) shall be the exclusive responsibility of NLS. 9.4. Regulatory Obligations of Licensor Licensor shall take all reasonable actions and render all reasonable assistance to help Licensee obtain and maintain the MA which are reasonably requested by the Licensee or required by the competent authorities in line with local requirements and/or necessary to avoid the imposition of any restriction or condition under the MA by the competent authorities.

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License and Development Agreement

Licensor shall provide the Licensee the Dossier, any updates and variations to the Dossier (such as monograph, method updates or stability data, new manufacturer or API supplier) without undue delay when such additional data is available to the Licensor. In any event, Licensor understands and agrees that any variations and/or updates shall only be implemented by Licensee once this is permissible according to applicable regulatory provisions. In case the corresponding regulatory agency requests any information on any updates and/or variations requested by NLS, the responsibility to provide such information shall be of NLS, and NLS shall be bound to any deadlines and other requirements posed by the regulatory agency. 9.5. Pharmacovigilance The Parties acknowledge that they may be required to submit adverse drug experience reports and supplemental information to governmental agencies with respect to the Products. Eurofarma shall assume full responsibility for all post MA approval Pharmacovigilance activities in the Territory Each Party has the right to receive in good faith all the safety documents referring to the product filed by the other Party to regulatory authorities including PSURs (Periodic Safety Update Report), PBRER (Periodic Benefit Risk Evaluation Report), RMP (Risk Management plans), but not limited to only these. Further, each Party agrees to report to the other Party any serious and unexpected adverse reaction with the use of mazindol CR in the Field within two business days of the initial receipt of a report or sooner if required for either Party to comply with regulatory requirements; and the Parties agree that the Licensee shall immediately report and notify in writing to NLS any adverse or suspected safety adverse events whether related or not to the Licensed Product (the SAE's and the SUSAR's). Parties shall then immediately set a Pharmacovigilance meeting or conference call to review such case and decide on course of action, in full compliance with their obligations under relevant laws and guidelines. Prior to the first commercial sale of the Licensed Product in the Territory, the Parties will negotiate and enter into a Safety Data Exchange Agreement further specifying the mutual obligations of the parties related to pharmacovigilance, to the extent that they deem this to be required under GCP's, applicable laws or other regulatory obligations, necessary or useful. 10. Cooperation and Joint Project Steering Committee 10.1. Cooperation The parties agree to cooperate in good faith with regard to all issues pertaining to the development of US Supplemental Data and Local Supplemental Data, to regulatory matters concerning the Licensed Product in any countries of the Territories, and the pre- marketing and commercial activities of the Licensed Products in countries of the Territories, as necessary and applicable. 10.2. Transfer of Know-how Each Party shall, at the other Party's request, transfer to the other Party any and all Know-how relating to each Licensed Product that the other Party reasonably needs in order to perform its obligations or exploit its rights under this Agreement. Each Party shall use such Know-how solely for the purpose of performing its obligations or exploiting its rights under this Agreement.

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License and Development Agreement

10.3. Joint Steering Committee Within 60 business days following the execution of this Agreement, the Parties shall set-up a joint project steering committee (the Joint Steering Committee or JSC), by each Party designating its initial members to serve on the Joint Steering Committee and notifying the other Party of its dates of availability for the first meeting of the Joint Steering Committee. The Joint Steering Committee shall be composed of senior members or representatives of NLS and Eurofarma with relevant competences in clinical development, regulatory, marketing and commercial matters and shall consist of an equal number of members appointed by each Party. The Parties will discuss und agree on the appropriate number of members. Each Party may change its members from time to time. The purpose of the Joint Steering Committee, by sharing the respective competences and experiences of the Parties shall be to as detailed below: i) facilitate the preparation of the Dossiers, identify data which may be necessary to be generated for the filings of the MA applications by the Licensee, in particular in the Lead Countries ii) agree on respective activities and responsibilities of the Parties pre-MA and post MA, in particular regarding regulatory, safety and clinical development matters pre-MA, label changes and other post MA matters iii) align the Parties on pricing strategy, sales, marketing and communication plans related to the Licensed Product, iv) annually review the performance of the Licensed Product in the Lead Countries, and other countries as applicable, against the Business Plan and propose measures to improve performance as relevant and applicable; The Business Plan shall provide sufficient details to enable an accurate assessment of the Licensed Product performance and of the resources allocated by Licensee to support its commercialization. The Joint Steering Committee shall meet a minimum of four times per calendar year at least once in person and otherwise by video- or telephone conference. The JSC shall solely have an advisory role to the Parties. Notwithstanding the above, in the event of a disagreement between the Parties on pricing strategy or on any other issues deemed material by one Party (the Dispute), the Dispute shall be escalated to the respective CEO's of the Parties within 30 days following its written notification by the relevant Party to the other Party. The content of Licensee's public communications on NLS, including its strategies, objectives, plans, management team, board of directors, shareholders, finances, product portfolio, intellectual property rights and patents, on the Licensed Product, its revenue and share potential, data, brand and any forward-looking statements claims shall be pre-approved by NLS. 11. Commercialization Subject to Article 10.3 above, Eurofarma shall be in charge and solely responsible for any pre-marketing, marketing, selling, warehousing, handling, distributing and all other commercial activities in relation to the Licensed Product in the countries of the Territory and these activities shall be determined by Eurofarma at its sole discretion and expenses, provided that Eurofarma shall use commercially reasonable efforts to commercialize the Licensed Product in the Lead Countries as a priority and in the other countries of the Territory.

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The Licensee shall use best commercial efforts to make the first commercial sale of the Licensed Product in the Territory within twelve (12) months after receipt of marketing authorization in a given country of the Territory. 12. Supply NLS will supply Eurofarma with the finished Licensed Product based on its COGS. The Parties will enter in due time into a separate manufacturing and supply agreement concerning the Licensed Product, with the possibility of tech-transfer during the term of the Agreement. 13. Property rights to Intellectual Property Both Parties acknowledge that all Intellectual Property existing at the Effective Date shall be and remain the sole property of the Licensor. All right, title and interest in and to any Developed Intellectual Property shall vest in and belong to the Licensor. The Licensee shall execute and deliver all reasonably necessary signatures and/or documents and take any further steps (or have his employees, agents and officers do the same) to the extent necessary to make any Developed Intellectual Property the sole property of the Licensor. The Licensee shall have right to use the Developed Intellectual Property for exploiting its rights granted in this Agreement until its expiration or termination as set forth in Article 19 hereunder. Licensee Know-how shall belong to the Licensee. The Licensee hereby grants to the Licensor an irrevocable, non-exclusive, royalty-free, perpetual, worldwide license to use of any Licensee Know-how. 14. Prosecution of Infringements of Intellectual Property 14.1. Notice Either Party shall give notice to the other Party of any actual or suspected infringement of the Intellectual Property or the Developed Intellectual Property or any unlicensed activity, misuse or unauthorized disclosure of the same by any third party in the Territory as soon as reasonably practicable following such Party becoming aware of it. 14.2. Action In the event of any actual or suspected third party infringement of the Intellectual Property or the Developed Intellectual Property in the Territory, NLS may take at its sole discretion any steps (including legal action) to prosecute the infringement. Licensee shall on request support NLS in all activities which involve the protection of the Intellectual Property and the Developed Intellectual Property and to prosecute the infringement. From the date of notice of a potential infringement, NLS shall have 5 (five) days to communicate to Eurofarma whether it will take actions against such potential infringements. If NLS resolves not to take any such action, the Licensee shall have the right, but not the obligation, to take all activities and steps to protect the Intellectual Property and the Developed Intellectual Property in the Territory, provided however, that the Licensee shall not accept pay, settle or compromise any such claim or proceedings without the prior written consent of NLS.

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License and Development Agreement

14.3. Information The Party in charge of the respective prosecution and legal action shall keep the other Party promptly and fully informed and documented as to the progress of any action. 15. Representations and Warranties 15.1. Licensor Representations and Warranties Licensor represents and warrants that each of the representations and warranties set out below are true and accurate in all respects: a) Authority and capacity The Licensor has the right to enter into this Agreement and any agreement or document referred to herein and perform its obligations hereunder, including granting the licences under Article 2. b) Financial Situation The Licensor has not committed an act of bankruptcy, proposed a compromise or arrangement to its creditors generally, had any petition in bankruptcy filed against it, filed a petition or undertaken any action proceeding to be declared bankrupt, to liquidate its assets or to be dissolved. c) Intellectual Property To the best of Licensor's knowledge (i) Licensor has good, unrestricted and merchantable title to the Intellectual Property licensed to the Licensee hereunder; (ii) no part of the Intellectual Property licensed to the Licensee hereunder has been unlawfully copied from third party materials; (iii) the use of the Intellectual Property will not infringe any third party intellectual property rights. d) Regulatory Compliance To the best of Licensor's knowledge there is no hearing, investigation or audit of any regulatory authority alleging any regulatory potential or actual non-compliance by Licensor or the Licensed Product under any applicable law or a lack of safety at the Effective Date. 15.2. Licensee Representations and Warranties Licensee represents and warrants that each of the representations and warranties set out below are true and accurate in all respects: a) Authority and Capacity The Licensee has the right to enter into this Agreement and any agreement or document referred to herein and to perform its obligations hereunder.

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b) Financial Situation The Licensee is not insolvent and has not committed an act of bankruptcy, proposed a compromise or arrangement to its creditors generally, had any petition in bankruptcy filed against it, filed a petition or undertaken any action proceeding to be declared bankrupt, to liquidate its assets or to be dissolved. c) Regulatory Compliance The Licensee is able to obtain and hold a MA for the Licensed Product under the laws of each country of the Territory and has (or will own at the time of the Launch in that country) any license required under the applicable law to import, sell and market the Licensed Product in the respective country. d) Intellectual Property The Licensee has made all inspections and investigations of the Intellectual Property deemed necessary and desirable by the Licensee and it has made its own evaluation of the Intellectual Property, except any evaluation on non- infringement or validity of such rights, which is not the responsibility of Licensee. 15.3. Other Representations and Warranties Save of the representations and warranties given in Article 15.1 the Licensor makes no further representation or warranty, either express, implied or statutory, written or oral, and any claims, regardless of their legal basis and nature, are, to the fullest extent permissible by law, hereby excluded (unless such claims arise under the representations and warranties of Licensor) and the Licensee waives any such claim or right other than in respect of the Representations and Warranties of the Licensor. This exclusion or waiver applies in particular to: a) any projection, forecast, other forward-looking statement relating to the Licensed Product; a) any success, profitability, value, commercial marketability or competitiveness of any product at the market or its eligibility for reimbursement by any social security institutions, governmental bodies, statutory health insurances and the like; b) any expectation or statement made that any future application for a MA will be granted; c) the extent, duration and validity of any MA, e.g. that any MA will be granted or that a granted MA will not be varied, suspended, revoked, withdrawn or cancelled or otherwise declared invalid by any competent regulatory authority in the Territory; d) the quality, safety or efficacy of any product and other characteristics of any product; e) the presence or absence of any future deficiencies. Accordingly, save as expressly set out in this Agreement, the Licensee shall not be entitled to terminate this Agreement or exercise any right or remedy which would have a similar effect, or to claim damages from the Licensor. 16. Liability and Limitations Either Party shall only be liable for direct losses incurred by the other Party as a direct consequence of a negligent or intentional breach of this Agreement by such liable Party, and shall not be liable for any punitive or indirect damages, losses caused by business interruptions, loss of revenues, loss of profit, damages and loss of goodwill, or any reputational damages, and both Parties waive any claims to such losses.

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In addition, neither Party shall be liable for any claim under this Agreement which is capable of remedy, unless and until the other Party has given such Party written notice containing full details of the breach and such Party has failed to remedy the breach within sixty (60) days of receipt of the notice. 17. Indemnities 17.1. Indemnities by the Licensor Without prejudice to any other provision of this Agreement, the Licensor shall indemnify, defend and hold harmless the Licensee from and against all liabilities, claims, demands, obligations, fines, penalties, judgements, losses or damages whatsoever (including without limitation, court costs, amounts paid in settlement and any legal, accounting and other expert fees and expenses reasonably incurred) (collectively Losses) suffered, incurred, sustained by or imposed on the Licensee resulting from or arising out of: a) any breach of the representations and warranties made by the Licensor; b) any non-performance or breach of any of the Licensor's obligations under this Agreement. 17.2. Indemnities by the Licensee Without prejudice to any other provision of this Agreement, Licensee shall indemnify, defend and hold harmless Licensor from and against all Losses suffered, incurred, sustained by or imposed upon Licensor resulting from or arising out of: a) any breach of the representations and warranties made by the Licensee; b) any non-performance or breach of any of the Licensee's obligations under this Agreement. 17.3. Third party claims If any claim is brought against a Party entitled to the benefit of an indemnity set out in this Agreement (the Indemnified Party) by any third party which is likely to result in a claim against the other Party who has given an indemnity under this Agreement (the Indemnifying Party), the Indemnified Party shall a) give notice of such third party claim to the Indemnifying Party as soon as reasonably practicable in reasonable detail, including a reasonable explanation of why the Indemnified Party assumes that it is entitled to indemnification under this Agreement; b) keep the Indemnifying Party promptly and fully informed and documented as to the progress of any such claim; c) subject to the Indemnified Party being entitled to employ its own legal advisors take all reasonable steps as to minimise or resolve such liability or dispute and, upon request by the Indemnifying Party, allow the Indemnifying Party to lead or direct the proceedings; d) cooperate with all reasonable requests of the Indemnifying Party in relation to such claim; and e) not accept, pay, settle or compromise any such claim without the prior written consent of the Indemnifying Party (such consent not to be unreasonably withheld, delayed or conditioned).

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License and Development Agreement

18. Confidentiality 18.1. Confidentiality Obligations a) Confidential Information shall mean any information that (i) is not publicly known (ii) has been imparted in circumstances in which the recipient ought reasonably to have known that the information had been imparted in confidence. This includes especially but not exclusively the information described in the clauses 18.1 b), c) and d). b) Each Party undertakes to maintain confidentiality as regards the execution and terms of this Agreement, and to abstain from disclosing the existence of this Agreement, its contents and all information provided to it by the other Party in connection with the negotiation of this Agreement without prior written approval of the other Party. c) The Licensee shall maintain confidentiality with regard to the Dossier and Know-how and any operations, processes, product information, product formulations, information regarding applications and submissions, know-how, designs, trade secrets, product plans, product development efforts, other commercial and product data, software, prototypes, samples and/or data sets related thereto, and any information or analysis derived from Confidential Information. For the avoidance of any doubt, the confidentiality of the Dossier and Know-how shall only apply to information that at the time of assessment is actually considered to be confidential, and not, under any circumstances, the information that lawfully is or has become available to the public. d) The Licensee shall protect any Know-how and any data as Confidential Information and shall not use the Know-how and data for any purpose except as expressly licensed hereby and in accordance with the provisions of this Agreement. Each Party (the Receiving Party) undertakes: (i.) to maintain as secret and confidential all Confidential Information obtained directly or indirectly from the other Party (the Disclosing Party) in the course of this Agreement and to respect the Disclosing Party's rights therein; (ii.) to use such Confidential Information only for the purposes of this Agreement; and (iii.) to disclose such Confidential Information only to those of its employees, contractors, and sub-licensees pursuant to this Agreement (if any) to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Agreement. 18.2. Exceptions to Obligations The provisions of clause 18.1 shall not apply to Confidential Information that the Receiving Party can demonstrate by reasonable, written evidence; (i.) is or has become generally available to the public other than as a direct or indirect result of a disclosure by the Receiving Party or any of its representatives; or (ii.) was, prior to its receipt by the Receiving Party from the Disclosing Party, in the possession of the Receiving Party and at its free disposal; or (iii.) is subsequently disclosed to the Receiving Party without any obligations of confidence by a Third Party who has not derived it directly or indirectly from the Disclosing Party; or (iv.) was or is developed by or on behalf of the Receiving Party independently of the Disclosing Party's Confidential Information; or

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License and Development Agreement

(v.) the Receiving Party is required to disclose to the courts of any competent jurisdiction, or to any government regulatory agency, or financial authority, provided that the Receiving Party shall (i) inform the Disclosing Party as soon as is reasonably practicable, and (ii) at the Disclosing Party's request seek to persuade the court, agency, or authority to have the information treated in a confidential manner, where this is possible under the court, agency, or authority's procedures. 18.3. Survival of Confidentiality Obligations The confidentiality obligations provided in this Article shall survive any termination or expiry of this Agreement for period of ten (10) years. 19. Term and Termination 19.1. Term This Agreement will come into effect on the Effective Date and shall continue in full force for ten (10) years from the Launch (the Initial Term), or the date of expiry of the last valid patent of the Licensed Product, whichever comes later, subject to clauses 19.2, 19.3, 19.4 and 19.5 hereunder. By mutual agreement of the Parties, the Initial Term may be extended by successive periods of three (3) years. If any relevant registration is not successfully reached with regards to any extension of the Agreement, the Parties shall cooperate and negotiate on arm's length basis in order to obtain a suitable solution and achieve a proper agreement that enables the Parties to fully comply with the rights, obligations and commitments herein set forth. 19.2. Termination for Change of Control In the event of a Change of Control of the Licensee, the Agreement may be terminated by Licensor with immediate effect without any compensation to Licensee or to any other parties. In the event of a Change of Control of the Licensor, the Agreement may be terminated by Licensee. In case of termination of the Agreement, NLS and Eurofarma shall immediately work on a transition out plan, with activities and timelines agreed by the Parties to ensure a proper handover of the Licensed Product so that its market position and the obligations to prescribers, patients and regulatory authorities are fulfilled in accordance with Eurofarma best practices. 19.3. Termination for Bankruptcy, Liquidation and similar proceedings This Agreement may be terminated by either Party, effective upon notice following the expiry of the cure period described hereafter, upon the filing or institution of any bankruptcy, reorganization, liquidation or receivership proceedings of the other Party, or upon the failure by the other Party for more than ninety (90) days to discharge or obtain the dismissal of any such actions filed against it. Such termination shall be effective upon receipt of notice from the affected Party. 19.4. Early Termination for Material Breach If either of the Parties fails to perform or violates any material term of this Agreement (the Breaching Party), then the other Party (the Other Party) may give written notice of default (Notice of Default) to the Breaching Party.

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If Licensee is the Breaching Party and fails to cure the default within sixty (60) calendar days upon receipt of the Notice of Default, the Licensor has the right to terminate this Agreement with immediate effect by written notice (Notice of Termination) to the Breaching Party. If Licensor is the Breaching Party and fails to cure the default within sixty (60) calendar days upon receipt of the Notice of Default, the Licensee has the right to terminate this Agreement with immediate effect by written notice (Notice of Termination) to the Breaching Party and shall be paid by Licensor an indemnity corresponding to the fair market value of the expected discounted cash flows of Licensee over the remaining lifetime of this Agreement. 19.5. Early Termination by the Licensor The Agreement may be terminated by NLS according to Article 19.4 in case Eurofarma fails to use commercially reasonable efforts to obtain a MA and to commercialize the Licensed Product in the Lead Countries, provided that the Supplemental Data, if any, was provided to Eurofarma. If Eurofarma has not made the first commercial sale within twelve (12) months after receipt of the MA in a Lead Country of the Territory, not for reasons outside of its control, or if Eurofarma has failed to use reasonable commercial efforts to meet the annual objectives of the most updated Business Plan during the Term, which may be amended by Eurofarma from time to time and accepted by NLS, then NLS may, upon sixty (60) days prior written notice to Eurofarma (unless Eurofarma makes such first commercial sale within such sixty-day period), terminate the rights granted to Eurofarma with respect to the Licensed Product in such country. 19.6. Early Termination by the Licensee i) Eurofarma may terminate the Agreement upon ninety (90) days prior written notice to NLS in case the US Supplemental Data to support the Dossier for Brazil is not or cannot be provided by NLS within the time limit agreed by the Parties or cannot be generated as part of the Local Supplemental Data for Brazil. ii) Eurofarma may terminate the Agreement in case the activities conducted by NLS under article 5, paragraphs a), b) and c) do not allow the Licensed Product to be approved by the US FDA. iii) Eurofarma may terminate the Agreement in case the Licensed Product fails to receive a MA from the US FDA or a MA is not granted on the Licensed Product in any of the Lead Countries despite reasonable commercial efforts by Eurofarma to seek and obtain such MA. iv). Eurofarma shall have the right to terminate the Agreement in case of fundamental changes in the market, competitive and economic conditions, outside of the Parties control, at the time of the launch of the Licensed Product in the territory which would make its commercialization not economically viable and provided that the Parties after good faith efforts fail to agree on an alternative plan to address this situation within 3 months following the notification by Eurofarma to NLS of its decision to terminate the Agreement under this clause.

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License and Development Agreement

19.7. Consequences of Expiration or Termination The expiration or termination of the Agreement shall have the following consequences: (i) The Licensee shall cease to use the License and cease to conduct any activities that would require the License, unless explicitly stated otherwise in this Article. (ii) Licensee or Affiliates or Distributors may sell off all previously purchased Licensed Products still in their warehouses within a period of six (6) months of the effective date of such termination (the Sell-Off Period) provided that the sale of such Licensed Products by Licensee or Affiliates or Distributors of the Licensee shall be subject to the terms of this Agreement, including but not limited to the rendering of reports and payment of royalties required under this Agreement. (iii) Promptly upon the request of Licensor, the Licensee shall, at the Licensor's sole discretion and election for each country of the Territory and each Licensed Product either withdraw or transfer all Marketing Authorizations in the Territory to the Licensor (or to a third party as the Licensor directs). Licensee shall take the required steps without any delay and the withdrawal or transfer shall be completed in maximum 90 days after the notification of the request; if the Licensor does not decide and inform within this period to whom the Marketing Authorizations and documents shall be transferred, then the Licensee shall have no obligation to keep them active. If a Marketing Authorization has been applied for, but not yet been granted in any country of the Territory, the same shall apply to the applicant status. (iv) The Licensee shall hand over to the Licensor any and all documents related to the regulatory status or containing Intellectual Property or Confidential Information of Licensor. (v) Termination shall not relieve either Party of its accrued obligations under this Agreement. (vi) With the exception of termination in case of material breach of its obligations by Licensor according to Article 19.4, upon termination, or early termination by the Licensee according to Article 19.6, Licensee shall pay Licensor any unpaid sums (fees, milestone payments, royalties, etc.) related to the Agreement. 20. General Provisions 20.1. Amendments This Agreement may only be modified or amended by a document duly signed by all Parties. Any provision contained in this Agreement may only be waived by a document duly signed by the Party waiving such provision. 20.2. Notices All notices or other communications to be given under or in connection with this Agreement shall be made in writing and shall be delivered by registered mail or overnight courier service to the address that is mentioned on the cover page of this Agreement or subsequently communicated in writing. All notices shall become effective on the day of their reception by the receiving Party, or if the receiving Party refuses its acceptance or does not collect it from the competent post office or mail service, on the date of the refusal. 20.3. Severability / Good Faith Should any part or provision of this Agreement be held to be invalid by any competent court, governmental or administrative authority having jurisdiction, the other provisions of this Agreement shall nonetheless remain valid. In this case, the Parties shall endeavour to negotiate a substitute provision that best reflects the economic intentions of the Parties without being unenforceable, and shall execute all agreements and documents required in this connection. The same shall apply if and to the extent that this Agreement is found to contain any gaps or omissions.

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20.4. No Waiver The failure of any of the Parties to enforce any of the provisions of this Agreement or any rights with respect thereto shall in no way be considered as a waiver of such provisions or rights or in any way affect the validity of this Agreement. 20.5. No Assignment This Agreement may not be assigned or otherwise transferred, nor may any right or obligations hereunder be assigned or transferred, by either Party without the prior written consent of the other Party; provided, however, that Licensor may, without such consent, assign this Agreement and its rights and obligations hereunder, in whole or in part, to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the Licensed Product or the business relating thereto, or in the event of its merger or consolidation or change in control or similar transaction. Licensor shall however refrain from any such permitted assignment if such permitted assignment is reasonably able to jeopardize Licensee's business of Licensed Product in the Territory. 20.6. Appendices All Appendices form an integral part of this Agreement. 20.7. Public Announcements No press releases or other public announcement concerning this Agreement shall be made by either Party unless the form and text of such announcement shall first have been approved by the other Party, except for any announcements based on reporting duties under applicable laws and regulations or stock exchange regulations. 21. Governing Law and Jurisdiction This Agreement shall be governed by and construed in accordance with the substantive laws of the Netherlands, excluding its rules of conflicts of law and the United Nations Convention on Contracts for the International Sale of Goods dated 11 April 1980 (CISG), as amended from time to time. All disputes arising out of or in connection with the present Agreement, including disputes on its conclusion, binding effect, amendment and termination, shall be finally resolved by binding arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce (ICC) by one or more arbitrators appointed in accordance with the said rules and experienced in the pharmaceutical business. The place of Arbitration shall be in The Hague, Netherlands, or in a place otherwise mutually agreeable. The arbitration shall be conducted in English.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed in two counterparts on the date first written above, whereby each Party shall execute and initialize one counterpart, each of which when so executed and delivered shall be an original but shall not be effective until each Party has executed at least one counterpart, but all counterparts shall together constitute one and the same agreement. NLS-1 Pharma AG /s/ Ronald Hafner /s/ Alex Zwyer Ronald Hafner Alex Zwyer Chairman of the Board CEO & Member of the Board of Directors Date: Eurofarma Laboratórios S.A. /s/ Julíana Mazza Reîs /s/ Martha Penna Name: Julíana Mazza Reîs Name: Martha Penna title: Eurofarma Laboratórios S.A. title: Vice Presîdente Inovaçäo Díretora de Gestào de PortfólÎo e LÎcenças Date: Witnesses: /s/ Bruno C.Z. Baptista /s/ Walker Lahmann Name: Bruno Castagnoli Zilli Baptista Name: Walker Lahmann Id.: Portfolio Management & Licensing Coordinator Id: Executive Director

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License and Development Agreement

Table of Appendices Number Name Appendix A [Template for Licensee Reports] Appendix B Preliminary Business Plan

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Appendix A - [Template for Licensee Reports] - to be provided by NLS to Eurofarma within 60 days following the effective date of signature of the Agreement

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Appendix B - Preliminary Business Plan Sales Forecast Latin America - in units (monthly treatments, considering both adult and pediatric indications) Forecast in Units YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 YEAR 6 YEAR 7 YEAR 8 YEAR 9 YEAR 10 TOTAL

BRAZIL 67.435 154.809 232.214 348.321 435.401 522.481 548.605 576.035 587.556 599.307 4.072.162 REST OF LATAM 21.931 71.105 135.482 206.698 259.783 299.791 343.867 327.768 287.040 276.346 2.229.813 TOTA LATAM 89.366 225.914 367.696 555.019 695.184 822.272 892.472 903.803 874.596 875.653 6.301.974

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[EX A]:
Highlight the parts (if any) of this contract related to Cap On Liability that should be reviewed by a lawyer. Details: Does the contract include a cap on liability upon the breach of a party’s obligation? This includes time limitation for the counterparty to bring claims or maximum amount for recovery.