FINCH THERAPEUTICS, INC. AND MILLENNIUM PHARMACEUTICALS, INC. AMENDED AND RESTATED AGREEMENT

1.

DEFINITIONS

2.

LICENSES; PROPRIETARY RIGHTS

3.

GOVERNANCE; INFORMATION SHARING

4.

DEVELOPMENT PROGRAM

5.

REGULATORY MATTERS

6.

MANUFACTURE AND SUPPLY

7.

COMMERCIALIZATION

8.

CONSIDERATION; PAYMENT

9.

PATENT

10.

CONFIDENTIALITY

11.

REPRESENTATIONS AND WARRANTIES

12.

RISK ALLOCATION

13.

TERM AND TERMINATION

14.

DISPUTE RESOLUTION

OpenBiome’s donor fecal samples and fecal microbiota preparations along with the associated de-identified donor health and donation records (defined as “OpenBiome Materials” in the “Material Access and License Agreement”);

information, results and data and other trade secrets, instruction, processes, method, formulae, techniques, compositions, materials and expert opinions owned or controlled by OpenBiome (defined as “Licensed Technology” in the “Material Access and License Agreement”);

certain quality and safety data collected from patients of fecal microbiota transplantation (defined as “Sponsored Program Data” in the Exhibit B of MSAA); and

To clarify mutual understanding on ownership of and the right to use Program Intellectual Property (as defined below)

To update the Development Cost (as defined below) as to CMC Development activities (as defined below)

To update the Development Plan (as defined below)

To enable collaboration of CMC Development and CMC Effort (as defined below)

To clarify and expand access and use of FMT Clinical Data (as defined below)

To include a new Development Program (as defined below) for Crohn’s Disease into the collaboration

To include an exclusive negotiation option for a new research program for [***] (as defined below) into the collaboration.

DEFINITIONS

with respect to any objective of any party, commercially reasonable, diligent, good faith efforts to accomplish such objective as [***] would normally use to accomplish a similar objective under similar circumstances; and

with respect to any objective relating to the Development or Commercialization of any Licensed Product for any indication by any party, efforts and resources normally used by [***] with respect to a product [***] which is of similar market potential at a similar stage in the development or life of such product, taking into account [***].

is known to the receiving party or any of its Affiliates, as evidenced by the receiving party’s competent records, before receipt thereof under this Agreement;

is disclosed to the receiving party or any of its Affiliates by a third person who is under no obligation of confidentiality to the disclosing party hereunder with respect to such information and who otherwise has a right to make such disclosure;

is or becomes generally known in the public domain or available to the public through no fault of the receiving party; or

is independently developed or acquired by or on behalf of the receiving party or any of its Affiliates, as evidenced by the receiving party’s competent records, without access to such information.

the microbial cocktail optimized for the treatment of ulcerative colitis that ▇▇▇▇▇ is evaluating in pre-clinical development as of the Original Effective Date, which cocktail has been [***];

[***]; and

any and all microbial cocktail that has less than [***] to more than [***] included in the final microbial cocktail described in clause (b).

the microbial cocktail optimized for the treatment of Crohn’s Disease that ▇▇▇▇▇ is evaluating in pre-clinical development as of the Restatement Effective Date, which cocktail has been [***];

[***]; and

any and all microbial cocktail that has less than [***] included in the final microbial cocktail described in clause (b).

one (1) microbial cocktail that falls under the definition of FIN-524 and is identified by Takeda’s NBE Declaration in accordance with the procedure described in Section 2.3(a);

(if applicable) another microbial cocktail that is selected by Takeda from FIN-524 Alternates as backup of item (a) in accordance with the procedure described in Section 2.3(a); and

any other microbial cocktail that has less than [***] to more than [***] contained in the microbial cocktail described in clause (a) or clause (b) (if applicable).

one (1) microbial cocktail that falls under the definition of FIN-525 and is identified by Takeda’s NBE Declaration in accordance with the procedure described in Section 2.3(a);

(if applicable) another microbial cocktail that is selected by Takeda from FIN-525 Alternates as backup of item (a) in accordance with the procedure described in Section 2.3(a); and

any other microbial cocktail that has less than [***] to more than [***] contained in the microbial cocktail described in clause (a) or clause (b) (if applicable).

the expiration of the last to expire Valid Claim of the ▇▇▇▇▇ Patent Rights (except for ▇▇▇▇▇ Patent Rights for which ▇▇▇▇▇ has the first right to file, prosecute and maintain and either elects not to prosecute or that are abandoned by ▇▇▇▇▇ or its licensors, each as provided in Section 9.1(b)) in such country that Covers the composition of matter of the Licensed Product;

the date that Regulatory Exclusivity of such Licensed Product expires; or

eight (8) years from the date of the First Commercial Sale of such Licensed Product in such country.

LICENSES; PROPRIETARY RIGHTS

Grant of Licenses; Right to Use.

License to Takeda. Subject to the terms of this Agreement, ▇▇▇▇▇ hereby grants to Takeda, and Takeda hereby accepts, an exclusive, royalty-bearing license (or sublicense, as the case may be), with the right to grant sublicenses in accordance with Section 2.1(c), under (i) the ▇▇▇▇▇ Patent Rights, (ii) the ▇▇▇▇▇ Intellectual Property and (iii) ▇▇▇▇▇’▇ interests in Joint Program Intellectual Property and Joint Patent Rights, to Develop, have Developed, Manufacture, have Manufactured, make, have made, use, have used, offer for sale, sell, have sold, Commercialize, have Commercialized and import Licensed Products in the Field in the Territory.

License to ▇▇▇▇▇. Subject to the terms of this Agreement, solely to perform Development and Manufacture on Licensed Products hereunder, Takeda hereby grants to ▇▇▇▇▇, and ▇▇▇▇▇ hereby accepts a co-exclusive (with Takeda), royalty-free license, without the right to sublicense, to use (i) the Takeda Intellectual Property, (ii) the Takeda Patent Rights and (iii) Takeda’s interests in Joint Program Intellectual Property and Joint Patent Rights.

Sublicense. The right of Takeda to grant sublicenses under Section 2.1(a) is subject to the requirement that each such sublicense shall be in writing and shall include provisions (i) acknowledging that such sublicense is subject to the applicable license(s) granted hereunder, (ii) requiring each sublicensee to perform all applicable obligations of Takeda hereunder in the applicable portion of the Territory (specifically including the obligation to make reports and keep and maintain records of sales to at least the same extent as required under this Agreement), (iii) allowing ▇▇▇▇▇ the same access and audit rights with respect to such records as permitted with respect to Takeda’s records hereunder, and (iv) prohibiting further sublicensing by the sublicensee (except for a case of further sublicense by sublicensee to any Affiliate of the sublicensee). Takeda shall at all times remain responsible for the performance of any of its sublicensees. In the event that Takeda (including a Takeda Affiliate) grants a sublicense to a Third Party, Takeda shall provide a copy of such sublicense it enters into to ▇▇▇▇▇ promptly following execution with redaction of Takeda’s sensitive information; provided that such redactions shall not prevent ▇▇▇▇▇ from determining the amounts due pursuant to this Agreement in respect of such sublicense.

Rights in Joint Program Intellectual Property.

[***].

[***].

[***].

[***].

For clarification, in each of the foregoing cases provided in Section 2.1(d)(ii) through 2.1(d)(iv), ▇▇▇▇▇ must be subject to any exclusive license granted to Takeda in this Section 2.1(a) as well as the exclusivity obligations set forth in Section 2.3.

Bankruptcy Code. The licenses granted under this Section 2.1 shall be treated as licenses of rights to “intellectual property” (as defined in Section 101(56) of Title 11 of the United States Code, as amended (the “Bankruptcy Code”)) for purposes of Section 365(n) of the Bankruptcy Code. The parties agree that the party holding the license from the other party may elect to retain and may fully exercise all of its rights and elections under the Bankruptcy Code, provided that it abides by the terms of this Agreement.

License ▇▇▇▇. Each party, as applicable, shall ▇▇▇▇ or have marked all containers or packages of Licensed Products that are the subject of the licenses granted under this Section 2.1 in accordance with the patent marking laws of the jurisdiction in which such Licensed Products are Manufactured or Commercialized.

Proprietary Rights; Ownership.

No Conveyance of Proprietary Rights.

Takeda’s Retained Rights. This Agreement does not convey to ▇▇▇▇▇ any rights in any Takeda Intellectual Property, Takeda Patent Rights, Takeda’s interest in Joint Program Intellectual Property or Joint Patent Rights or any other intellectual property or Patent Rights of Takeda by implication, estoppel or otherwise except for the rights expressly granted in Sections 2.1(b) and 2.1(d). Title to the Takeda Intellectual Property, Takeda Patent Rights, Takeda’s interest in Joint Program Intellectual Property or Joint Patent Rights, and any other intellectual property or Patent Rights of Takeda shall at all times remain vested in Takeda.

▇▇▇▇▇’▇ Retained Rights. This Agreement does not convey to Takeda any rights in any ▇▇▇▇▇ Intellectual Property, ▇▇▇▇▇ Patent Rights, ▇▇▇▇▇’▇ interest in Joint Program Intellectual Property or Joint Patent Rights or any other intellectual property or Patent Rights of ▇▇▇▇▇ by implication, estoppel or otherwise except for the rights expressly granted in Sections 2.1(a) and 2.1(d). Title to the ▇▇▇▇▇ Intellectual Property, ▇▇▇▇▇ Patent Rights, ▇▇▇▇▇’▇ interest in Joint Program Intellectual Property or Joint Patent Rights and any other intellectual property or Patent Rights of ▇▇▇▇▇ shall at all times remain vested in ▇▇▇▇▇.

Ownership of Program Intellectual Property.

General Rule. Inventorship of all Program Intellectual Property shall be determined in accordance with U.S. patent law (and other U.S. intellectual property law, if applicable). Ownership of all Program Intellectual Property shall follow the inventorship, whether patentable or not and whether to be Covered by Patent Rights. If required, patent counsel mutually acceptable to the parties and selected by the Joint Steering Committee shall determine inventorship of all Program Intellectual Property in accordance with U.S. patent law (and other U.S. intellectual property law, if applicable). [***].

[***].

[***].

[***].

[***].

Neither party shall use Program Intellectual Property Controlled solely by the other party or Confidential Information nor intellectual property rights of the other party except as otherwise expressly permitted in this Agreement.

Selection of Optimal FIN-524 and FIN-525 and Exclusivity.

Selection of Optimal FIN-524 and Optimal FIN-525.

NBE Declaration by Takeda. After the completion of the relevant Initial Product Development, Takeda may identify one (1) microbial cocktail that falls under the definition of FIN-524 as the Optimal FIN-524 cocktail, as a new biological entity, that Takeda will take forward as a FIN- 524 Licensed Therapeutic Product candidate and one (1) microbial cocktail that falls under the definition of FIN-525 as the Optimal FIN-525 cocktail, as a new biological entity, that Takeda will take forward as a FIN-525 Licensed Therapeutic Product candidate (in each case, the “NBE Declaration”).

[***] Diligent Efforts. Takeda shall use diligent efforts to identify an Optimal FIN-524 cocktail or an Optimal FIN-525 cocktail, as applicable, within [***] following Takeda’s receipt and acceptance, to its reasonable satisfaction, of a report of deliverables from the “In Vivo Evaluation Work Package” in accordance with Item II.11 of the Development Plan with respect to FIN-524 or a report of deliverables from certain work package(s) in accordance with the Development Plan with respect to FIN-525 (which must be scientifically and technically comparable to the “In Vivo Evaluation Work Package” in FIN-524 Development Program and the item number(s) of which shall be specified and confirmed in writing at the first JSC meeting held subsequent to the achievement of the first development milestone for FIN-525 provided in Section 8.2 (a-1)); provided, that each such report must include all the reporting items (e.g., the number of cocktails evaluated in vivo studies) specified and agreed at the Joint Development Committee. Takeda shall notify ▇▇▇▇▇ within [***] following receipt of such report whether it accepts or rejects the report. If Takeda rejects the report it shall provide ▇▇▇▇▇ with notice of rejection, including a reasonably specific description of the deficiencies alleged. ▇▇▇▇▇ will use Commercially Reasonable Efforts to cure any such deficiencies in an expedient manner and either “re-deliver” such report (or the missing elements) to Takeda within [***] following the notice of rejection or, if ▇▇▇▇▇ cannot accomplish such re-delivery within such [***] period deliver to Takeda within such [***] period a plan for curing said deficiencies. Takeda shall, following its receipt of the re-delivered report (or missing elements), accept or reject the report using the procedure specified above. If Takeda fails to designate an Optimal FIN-524 or an Optimal FIN-525, as applicable, by the expiration of the [***] period specified in this Section 2.3(a), Takeda’s right to designate an Optimal FIN-524 cocktail or an Optimal FIN-525, as applicable, shall expire.

Substitution from Alternates. Prior to the initiation of the first Phase III Clinical Trial for a FIN- 524 Licensed Therapeutic Product or FIN-525 Licensed Therapeutic Product, as applicable, Takeda may substitute another microbial cocktail that is selected by Takeda from FIN-524 Alternates or FIN-525 Alternates, as applicable, for the cocktail selected at the time of NBE Declaration and upon such selection such replacement microbial cocktail shall become the Optimal FIN-524 or the Optimal FIN-525, as applicable, for purposes of this Agreement.

Exclusivity-1.

FIN-524. During the period from the Original Effective Date until [***] following the FIN-524 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].

FIN-525. During the period from the Restatement Effective Date until [***]following the FIN-525 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].

Exclusivity-2.

FIN-524. During the remainder of the term of this Agreement following the date of the FIN- 524 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].

FIN-525. During the remainder of the term of this Agreement following the date of the FIN- 525 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].

▇▇▇▇▇’▇ Reserved Rights. The parties acknowledge and agree that the exclusive licenses granted to Takeda hereunder, with respect to the ▇▇▇▇▇’▇ Know-How and ▇▇▇▇▇ Patent Rights, shall not be construed to preclude ▇▇▇▇▇ from adding data that ▇▇▇▇▇ identifies in the course of its work pursuant to this Agreement that constitute ▇▇▇▇▇ Intellectual Property or Joint Program Intellectual Property (but not Takeda Intellectual Property) to its databases solely for the purpose of refining those databases (for clarification, ▇▇▇▇▇ may use such refined database for itself and for Third Parties) or using its proprietary computational systems and databases to screen FMT data sets for potential microbiome therapies for itself and for Third Parties; provided, that ▇▇▇▇▇ shall not:

▇▇▇▇▇ Accessible Phase I/II Clinical Data. Subject to the terms of this Agreement, Takeda hereby grants to ▇▇▇▇▇, and ▇▇▇▇▇ hereby accepts: a non-exclusive, royalty-free license, without the right to sublicense, to use ▇▇▇▇▇ Accessible FIN-524 Phase I/II Clinical Data and ▇▇▇▇▇ Accessible FIN-525 Phase I/II Clinical Data to design products in the Field other than GI Field; provided that ▇▇▇▇▇ notifies Takeda prior to exercising such license and pays the following considerations to Takeda.

Phase III Clinical Data. During the term of this Agreement, if ▇▇▇▇▇ notifies Takeda of its desires to obtain a non-exclusive license to use the ▇▇▇▇▇ Accessible FIN-524 Clinical Data generated in the course of any Phase III Clinical Trial or the ▇▇▇▇▇ Accessible FIN-525 Clinical Data generated in the course of any Phase III Clinical Trial in the Field other than GI Field, the parties shall negotiate in good faith reasonable terms and conditions of such license (including consideration payable from ▇▇▇▇▇ to Takeda).

New IBD Program Offer. If, at any time following [***], whichever occurs later, ▇▇▇▇▇ determines to commence the process for the development of a product for the treatment of Inflammatory Bowel Disease (whether by itself or by seeking to collaborate with any Third Party with respect to such development effort or to grant any Third Party rights to a therapeutic developed by ▇▇▇▇▇ for treatment of Inflammatory Bowel Disease), then ▇▇▇▇▇ shall, within [***], provide a written notice to Takeda, setting forth the intent of ▇▇▇▇▇ to commence a development process or license process and providing Takeda the right to negotiate for the participation in such collaboration or the acquisition of such license prior to the consummation of such collaboration or license process.

Offer Notice from Takeda. Takeda shall within [***] following the date of ▇▇▇▇▇’▇ notice either provide ▇▇▇▇▇ with (i) written notice that it has an interest in participating in such collaboration or acquiring such license (such notice, the “Offer Notice”); or (ii) written notice that it will not exercise its rights to collaborate with ▇▇▇▇▇ or to acquire such license.

Good Faith Negotiation; No Less Favored Treatment. If Takeda provides an Offer Notice, then ▇▇▇▇▇ and Takeda shall use their respective best efforts to negotiate in good faith a definitive agreement for collaboration with respect to such Inflammatory Bowel Disease treatment or the acquisition by Takeda of a license to such Inflammatory Bowel Disease treatment on mutually acceptable terms within [***] of the delivery of the Offer Notice. The [***] negotiation period may be extended by mutual agreement. If the parties are unable to agree upon the terms for such collaboration or the acquisition by Takeda of a license to such Inflammatory Bowel Disease treatment within such [***] period and the parties are unwilling to extend the period for closing such transaction, then Takeda’s right to collaborate with ▇▇▇▇▇ with respect to such Inflammatory Bowel Disease treatment or to acquire a license to such Inflammatory Bowel Disease treatment shall expire and ▇▇▇▇▇ shall be free to enter into any such agreement for the collaboration with respect to such Inflammatory Bowel Disease treatment or the license of such Inflammatory Bowel Disease treatment with any Third Party; provided, however, that any such collaboration agreement or license agreement shall contain economic terms that are in the aggregate no less favorable to ▇▇▇▇▇ than those last offered to Takeda. If ▇▇▇▇▇ wishes to offer such opportunity to a Third Party on economic terms that are in the aggregate less favorable to ▇▇▇▇▇ than those last offered to Takeda, ▇▇▇▇▇ shall first make an offer on such “improved” terms to Takeda in accordance with the procedure specified above and Takeda may either accept or reject such improved terms in their entirety but may not negotiate such terms.

GOVERNANCE; INFORMATION SHARING

Establishment of JDC and Members. Within ten (10) days after the Original Effective Date, a Joint Development Committee (“Joint Development Committee”) shall be established with the responsibilities and authority set forth in this Section 3.1 and shall exist until the submission of the first BLA with respect to the FIN-524 Licensed Product or FIN-525 Licensed Product, whichever occurs later, unless otherwise agreed between the parties. The Joint Development Committee shall consist of four (4) members, two (2) members to be appointed by each of ▇▇▇▇▇ and Takeda, and the Alliance Manager from each party. Each party may, with notice to the other, substitute any of its members serving on the Joint Development Committee and may invite ad hoc non-voting members as desired. The parties may also, by mutual agreement, increase or (subject to Section 3.1(d)) decrease the number of members serving on the Joint Development Committee; provided that the number of members representing each party remains equal. Takeda shall have the right to appoint one of its members to be the chairperson of the Joint Development Committee, whose term shall run for so long as the Joint Development Committee is in existence.

JDC Responsibilities. The Joint Development Committee shall have the responsibility and authority for the operational aspect of the Development of the Licensed Product in the Territory, including, without limitation, to (i) provide a forum for exchange of information related to the Development Programs; and (ii) discuss and propose to the Joint Steering Committee any material amendments or updates to the Development Plan.

Timing; Location; and Minutes. The Joint Development Committee shall hold meetings as mutually agreed by the parties, but in no event less than monthly unless Takeda and ▇▇▇▇▇ mutually agree, no later than ten (10) days in advance of any meeting following the initial meeting of the Joint Development Committee, that no new business has transpired that would require a meeting of the Joint Development Committee. The first meeting of the Joint Development Committee shall be held within forty-five (45) days of the Original Effective Date and shall be held in Somerville, Massachusetts. After the initial meeting, meetings may be held by telephone or video conference, provided that the parties shall meet in person at least once per quarter, and such meetings shall alternate between Cambridge, Massachusetts and Somerville, Massachusetts. Minutes of all meetings setting forth decisions of the Joint Development Committee shall be prepared by the Alliance Managers and circulated to both parties within five (5) Business Days after each meeting, and shall not become official until approved by both parties in writing; minutes shall be presented for approval as the first order of business at the subsequent Joint Development Committee meeting, or if it is necessary to approve the minutes prior to such subsequent meeting, then the parties shall approve the minutes within five (5) Business Days of receipt thereof.

Voting Rules. The quorum for Joint Development Committee meetings shall be two (2) members, provided there are at least one (1) member from each of ▇▇▇▇▇ and Takeda present. The Joint Development Committee will render decisions by unanimous vote. The members of the Joint Development Committee shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the Joint Development Committee.

Escalation to JSC. Disagreements among the Joint Development Committee will be resolved via good-faith discussions; provided, that in the event of a disagreement that cannot be resolved within [***] after the date on which the disagreement arose, the matter shall be referred and escalated to the Joint Steering Committee.

Establishment of JSC and Members Within (10) days after the Original Effective Date, a Joint Steering Committee (“Joint Steering Committee”) shall be established with the responsibilities and authority set forth in this Section 3.1 and shall exist until the submission of the first BLA with respect to the FIN-524 Licensed Product or FIN-525 Licensed Product, whichever occurs later, unless otherwise agreed between the parties. The Joint Steering Committee shall consist of four (4) members, two (2) members to be appointed by each of ▇▇▇▇▇ and Takeda, and the Alliance Manager from each party. Each party may, with notice to the other, substitute any of its members serving on the Joint Steering Committee and may invite ad hoc non-voting members as desired. The parties may also, by mutual agreement, increase or (subject to Section 3.2(d)) decrease the number of members serving on the Joint Steering Committee; provided that the number of members representing each party remains equal. Takeda shall have the right to appoint one of its members to be the chairperson of the Joint Steering Committee, whose term shall run for so long as the Joint Steering Committee is in existence.

JSC Responsibilities. The Joint Steering Committee shall have the responsibility and authority for overall collaboration strategy and budget, including, without limitation, to: (i) monitor the progress and status of the Development Programs and Program Intellectual Property; (ii) review and approve any material amendments or updates to the Development Plan (including annual approval of the Budget and any amendment thereto and selection of any Third Party to perform a part of Development Programs (e.g., contract research organization)) proposed by the Joint Development Committee; (iii) discuss the overall clinical and regulatory strategy and plan as described in the Development Plans; and (iv) any other functions as the parties may agree in writing (including, the formation of sub-team of itself as it may deem appropriate or necessary).

Timing; Location; and Minutes. The Joint Steering Committee shall hold meetings as mutually agreed by the parties, but in no event less than semi-annually unless Takeda and ▇▇▇▇▇ mutually agree, no later than thirty (30) days in advance of any meeting following the initial meeting of the Joint Steering Committee, that no new business has transpired that would require a meeting of the Joint Steering Committee. The first meeting of the Joint Steering Committee shall be held within forty-five (45) days of the Original Effective Date and shall be held in Somerville, Massachusetts. After the initial meeting, meetings may be held by telephone or video conference, [***]. Minutes of all meetings setting forth decisions of the Joint Steering Committee shall be prepared by the Alliance Managers and circulated to both parties within thirty (30) days after each meeting, and shall not become official until approved by both parties in writing; minutes shall be presented for approval as the first order of business at the subsequent Joint Steering Committee meeting, or if it is necessary to approve the minutes prior to such subsequent meeting, then the parties shall approve the minutes within thirty (30) days of receipt thereof.

Voting Rules. The quorum for Joint Steering Committee meetings shall be two (2) members, provided there are at least one (1) member from each of ▇▇▇▇▇ and Takeda present. The Joint Steering Committee will render decisions by unanimous vote. The members of the Joint Steering Committee shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the Joint Steering Committee.

JSC Decision. Disagreements among the Joint Steering Committee will be resolved via good-faith discussions; provided, that in the event of a disagreement that cannot be resolved within [***] after the date on which the disagreement arose, the matter shall be resolved pursuant to Section 14.1 (first sentence); provided that if the dispute cannot be resolved pursuant to Section 14.1 (first sentence) within [***], then, [***]. The Joint Steering Committee shall not have any authority to resolve disputes with respect to the interpretation, breach, termination or invalidity of the Agreement or matters concerning the prosecution or enforcement of Program Intellectual Property, which shall be addressed using the procedures specified in Section 9.

Establishment of JMC and Members Promptly after the Original Effective Date, a Joint Manufacturing Committee (“Joint Manufacturing Committee”) shall be established with the responsibilities and authority set forth in this Section 3.3 and shall exist until Takeda’s assumption of responsibility for Manufacturing of all Licensed Product. The Joint Manufacturing Committee shall consist of two (2) members, one (1) member to be appointed by each of ▇▇▇▇▇ and Takeda, and the Alliance Manager from each party. Each party may, with notice to the other, substitute any of its members serving on the Joint Manufacturing Committee and may invite ad hoc non-voting members as desired. The parties may also, by mutual agreement, increase or (subject to Section 3.3(d)) decrease the number of members serving on the Joint Manufacturing Committee; provided that the number of members representing each party remains equal. ▇▇▇▇▇ shall have the right to appoint one of its members to be the chairperson of the Joint Manufacturing Committee, whose term shall run for so long as the Joint Manufacturing Committee is in existence.

JMC Responsibilities. The Joint Manufacturing Committee shall have the responsibility and authority to (i) exchange information related to the Manufacturing and/or clinical or commercial supply of the Licensed Product required in Sections 6.1 and 6.2(a) (including, information relating to material changes to each party’s state of manufacturing capability); (ii) facilitate the preparation and execution of the Supply Agreement and Quality Agreement pursuant to Section 6.2(b), (iii) discuss and approve the overall strategy and plan for the Joint Manufacturing and/or clinical or commercial supply of the Licensed Product and any amendments thereto (including, selection of contract manufacturing organization); and (iv) discuss and approve the transition plan of Manufacturing responsibility from ▇▇▇▇▇ to Takeda pursuant to Section 6.2(c) (including, technology transfer plan ensuring a smooth transition).

Timing; Location; and Minutes. The Joint Manufacturing Committee shall hold meetings as mutually agreed by the parties, but in no event less than half-yearly unless Takeda and ▇▇▇▇▇ mutually agree. The first meeting of the Joint Manufacturing Committee shall be held within ninety (90) days of the Original Effective Date and shall be held in Somerville, Massachusetts. After the initial meeting, meetings may be held by telephone or video conference, [***]. Minutes of all meetings setting forth decisions of the Joint Manufacturing Committee shall be prepared by the Alliance Managers and circulated to both parties within thirty (30) days after each meeting, and shall not become official until approved by both parties in writing; minutes shall be presented for approval as the first order of business at the subsequent Joint Manufacturing Committee meeting, or if it is necessary to approve the minutes prior to such subsequent meeting, then the parties shall approve the minutes within thirty (30) days of receipt thereof.

Voting Rules. The quorum for Joint Manufacturing Committee meetings shall be two (2) members, provided there are at least one (1) member from each of ▇▇▇▇▇ and Takeda present. The Joint Manufacturing Committee will render decisions by unanimous vote. The members of the Joint Manufacturing Committee shall act in good faith to cooperate with one another and to reach scientifically and practically reasonable agreement with respect to issues to be decided by the Joint Manufacturing Committee.

Escalation to JSC. Disagreement among the Joint Manufacturing Committee will be resolved via good-faith discussions; provided, that in the event of disagreement that cannot be resolved within [***] after the date on which the disagreement arose, the matter shall be referred and escalated to the Joint Steering Committee.

Operating Principles. The parties hereby acknowledge and agree that the deliberations and decision- making of the Joint Steering Committee, Joint Development Committee and Joint Manufacturing Committee, and any subcommittee established by the Joint Steering Committee, Joint Development Committee and Joint Manufacturing Committee shall be in accordance with the following operating principles: (i) decisions should be made in a prompt manner; and (ii) the parties’ mutual objective is to maximize the clinical and commercial success of the Licensed Products in the Territory, consistent with sound and ethical business and scientific practices.

Expenses. The parties shall each bear all expenses of their respective representatives on the Joint Steering Committee, Joint Development Committee and Joint Manufacturing Committee and any subcommittee established under this Agreement and such costs shall not be included in any other category of expenses under this Agreement.

Delegation to Subcommittees. The Joint Steering Committee, Joint Development Committee and Joint Manufacturing Committee and any subcommittees established pursuant to this Agreement, will have only such powers as are specifically delegated to it in this Agreement, and will have no power to amend this Agreement or waive a party’s rights or obligations under this Agreement.

Development Plan. As of the Restatement Effective Date, the parties have agreed to the Development Plans for each Licensed Product, for which ▇▇▇▇▇ is primarily responsible to undertake pursuant to Section 4.3(a), a copy of which are attached as Attachment 1.

Budget. The Development Plan also includes a Budget covering the Development Plan. The parties agree that the following principles shall apply to Development Costs covered by the Budget and any amendment thereto:

▇▇▇▇▇’▇ Development Responsibility. Unless Takeda exercises the Phase II Development Option pursuant to Section 4.3(c), with respect to each of the Development Programs, ▇▇▇▇▇ shall have primary responsibility for performance of (i) the Initial Product Development, (ii) establishment of in vivo efficacy model for a targeting disease of the relevant Development Program and efficacy studies for such disease, (iii) the CMC Development; (iv) the Phase I Clinical Trial in the U.S., (v) the Phase II Clinical Trial in the U.S. and any other country(ies) within the Territory on which the parties agree at Joint Steering Committee (e.g., global Phase II Clinical Trial) and (vi) development of a Licensed Diagnostic Product/Method, in each case, in accordance with the Development Plan, including the Budget. In addition, following the Restatement Effective Date, ▇▇▇▇▇ shall have responsibility for performance of the FIN-524 Crohn Feasibility Study in accordance with the relevant Development Plan.

Takeda’s Development Responsibility.

Takeda may perform Development activities (including CMC Efforts) prior to the Completion of CMC Development; provided, in such case, a written plan for such Development activities must be first reviewed and approved by the JSC, with an affirmative vote casted by ▇▇▇▇▇’▇ JSC members (which shall not be unreasonably withheld, delayed or conditioned).

Further, upon the successful completion of the first Phase II Clinical Trial in the U.S. (including achievement of all clinical trial endpoint(s) to be designated in the Development Plan) for such Licensed Product, Takeda shall assume primary responsibility for the Phase III Clinical Trial in the U.S. for such Licensed Therapeutic Product in accordance with the Development Plan.

For the sake of clarification, under the license granted hereunder, after relevant NBE Declaration, Takeda has a right, not obligation, to perform any other Development activities than those for which Takeda is responsible for pursuant to this Section 4.3(b)(i) and 4.3(b)(ii) (including, Phase III in any countries other than the U.S.).

Takeda’s Phase II Development Option. With respect to a Development Program, Takeda has an option to (i) perform jointly with ▇▇▇▇▇ the Phase II Clinical Trial for which ▇▇▇▇▇ is originally responsible pursuant to Section 4.3(a) or (ii) assume primary responsibility for the Phase II Clinical Trial for which ▇▇▇▇▇ is originally responsible pursuant to Section 4.3(a) (“Phase II Development Option”). With respect to a Development Program, Takeda may exercise the Phase II Development Option at any time prior to the initiation of Phase I Clinical Trial in the U.S. with written notice to ▇▇▇▇▇ indicating the option Takeda wishes to take. If Takeda exercises the Phase II Development Option, the parties shall prepare the amendment to the Development Plan by reflecting the change of the parties’ responsibility. [***].

Standard of Performance. The parties shall use Commercially Reasonable Efforts to perform, or shall use Commercially Reasonable Efforts to ensure that its Third Party contractors perform, the Development activities for which each party is responsible pursuant to Section 4.3(a) or 4.3(b) in accordance with the Development Plan and in good scientific manner and in compliance with Applicable Laws.

Initial Program Development (Prior to NBE Declaration).

With respect to FIN-524 Development Program, ▇▇▇▇▇ will be responsible for all costs incurred during the Initial Product Development from the Original Effective Date until the date of the NBE Declaration; [***].

With respect to FIN-525 Development Program, ▇▇▇▇▇ will be responsible for all costs incurred during the Initial Product Development from the Restatement Effective Date until the date of the NBE Declaration; [***].

[***].

[***].

[***].

Record Keeping; Audit. ▇▇▇▇▇ shall keep and maintain for [***] complete and accurate records (which may include employee timesheets and other records which would enable a party to verify allocation of employees’ time to Development of Licensed Product) of Development Costs incurred by ▇▇▇▇▇ with respect to Development of the Licensed Product in sufficient detail to allow Takeda to confirm that such Development Costs were incurred in compliance with the approved Development Plan and Budget, or the Development Plan and budget referred to in Section 4.4(d), if applicable. Takeda shall have the right for a period of [***] after such Development Costs are incurred to appoint at its expense an independent certified public accountant reasonably acceptable to ▇▇▇▇▇ to audit the relevant records of ▇▇▇▇▇ to verify that the amount of such Development Costs was correctly determined. ▇▇▇▇▇ shall make its records available for audit by

Intentionally omitted.

Intentionally omitted.

Takeda’s Right to Use FMT Clinical Data. Takeda may use the FMT Clinical Data solely for the purpose of Development, Manufacturing and Commercialization of FIN-524, FIN-525 and any Licensed Products, including to re-analyze the FMT Clinical Data in order to aid in the design of the composition for FIN-524, FIN-525 and any Licensed Products or to substitute Optimal FIN-524 and Optimal FIN-600 pursuant to Section 2.3(a)(iii).

Analysis in Non-IBD Field. At any time during the term of this Agreement, Takeda may suggest and propose a plan by which analyses of the FMT Clinical Data may aid in the development of novel therapeutic, whether inside or outside of Inflammatory Bowel Disease, and by which analyses of FMT Clinical Data would be considered the initiating event to identify a novel therapeutic target lead in humans or in the microbiome itself. In this event, ▇▇▇▇▇ will have the sole right to decide whether it wants to engage in these analyses in terms of any of the underlying data related to the generation of FIN-524 or FIN-525 up to IND. If ▇▇▇▇▇ agrees to pursue such analyses, the parties shall negotiate in good faith a separate agreement for undertaking such analyses and pursuing the novel therapeutic target on mutually acceptable terms.

Extended Purposes of Use. At any time during the term of this Agreement, Takeda may suggest and propose a plan in which analyses of the FMT Clinical Data may inform on the development of a therapeutic entity or pathway under development at Takeda at this time or in the future initiated and pursued by or on behalf of Takeda independently from the collaboration with ▇▇▇▇▇ hereunder. In this event, ▇▇▇▇▇ will have the sole right to decide whether ▇▇▇▇▇ is willing to grant a license to use any of the underlying data related to generation of FIN-524 or FIN-525 up to IND, including FMT Clinical Data, for the purposes of the Takeda’s independent development program. If ▇▇▇▇▇ agrees to grant such a license, the parties shall negotiate in good faith a separate agreement for undertaking such analyses and pursuing the novel therapeutic target on mutually acceptable terms.

No Disclosure Obligation. For the avoidance of any doubt, ▇▇▇▇▇ shall have no obligation to disclose or reveal to Takeda any proprietary software or actual software code to be used in the above- mentioned analyses.

REGULATORY MATTERS

▇▇▇▇▇’▇ Responsibility.

Until the FIN-524 First Phase II Completion or FIN-525 First Phase II Completion, as applicable with respect to a Development Program (provided, if Takeda exercises a Phase II Development Option for a Licensed Product, until the completion of Phase I Clinical Trials in the U.S. of such Licensed Product), ▇▇▇▇▇ shall be solely responsible for taking all actions and conducting all communications with U.S. and each appropriate foreign Regulatory Authority(ies) required by Applicable Laws in respect of each Regulatory Filing in support of obtaining Regulatory Approval in accordance with the Development Plan and decision made at the Joint Development Committee and/or Joint Steering Committee.

▇▇▇▇▇ shall provide Takeda with a copy (which may be wholly or partly in electronic form) of all Regulatory Filings with respect to Licensed Product. ▇▇▇▇▇ shall provide Takeda with reasonable advance notice of any scheduled meeting with a Regulatory Authority relating to Development, such BLA and/or regulatory inspection (including, without limitation, GMP and PV inspection), and Takeda shall have the right, if and to the extent permitted by the relevant Regulatory Authority, to observe and to participate in any such meeting. ▇▇▇▇▇ shall promptly furnish Takeda with copies of all material correspondence, minutes of material meetings with any Regulatory Authority or any result of regulatory inspection in each case relating to the Licensed Product.

Takeda shall assist ▇▇▇▇▇ as reasonably necessary to review its filings, data, documentation, responses to Regulatory Authority questionnaires or queries regarding clinical data, and advise and support of any necessary inspections. Notwithstanding the foregoing, ▇▇▇▇▇ shall be primarily responsible for taking all actions and conducting all communications with each appropriate foreign Regulatory Authority required by Applicable Laws in respect of BLA.

Takeda’s Responsibility.

Except for the case of Section 5.1(a), Takeda shall be solely responsible for taking all actions and conducting all communications with each appropriate foreign or U.S. Regulatory Authority required by Applicable Laws in respect of each Regulatory Filing in support of obtaining Regulatory Approval, and all Regulatory Approvals obtained, for the Licensed Product for any indication in the Territory, including preparing and filing all reports (including adverse drug experience reports), amendments, supplements and other documents with such Regulatory Authority(ies) with respect to or as part of a BLA or other Regulatory Filing.

Takeda shall provide ▇▇▇▇▇ with a copy (which may be wholly or partly in electronic form) of all Regulatory Filings with respect to Licensed Product. Takeda shall provide ▇▇▇▇▇ with reasonable advance notice of any scheduled meeting with a Regulatory Authority relating to Development and/or such BLA or other Regulatory Filing, and ▇▇▇▇▇ shall have the right to silently observe (if and to the extent permitted by the relevant Regulatory Authority) and, if the parties mutually agree in advance, participate in any such meeting. Takeda shall promptly furnish ▇▇▇▇▇ with copies of all material correspondence or minutes of material meetings with any Regulatory Authority in each case relating to the Licensed Product.

▇▇▇▇▇ shall assist Takeda as reasonably necessary to support its filings and provide files suitable for submission on a timely basis, including all necessary data, documentation, responses to Regulatory Authority questionnaires or queries regarding clinical data, and advise and support of any necessary inspections. Notwithstanding the foregoing, Takeda shall be primarily responsible for taking all actions and conducting all communications with each appropriate foreign Regulatory Authority required by Applicable Laws in respect of each Regulatory Filing applicable to the Licensed Product.

MANUFACTURE AND SUPPLY

▇▇▇▇▇’▇ Supply Responsibility. Pursuant to the terms of this Agreement, ▇▇▇▇▇ shall be responsible for, and shall use Commercially Reasonable Efforts to, supply Takeda’s, its Affiliates’ or sublicensees’ requirements of Licensed Product for use in the Territory until such time as Takeda assumes responsibility for Manufacture of Licensed Products pursuant to Section 6.2(b). Until Takeda assumes responsibility for Manufacturing pursuant to Section 6.2(b), Takeda shall purchase its supply of Licensed Product exclusively from ▇▇▇▇▇ or its designated Third Party contract manufacturer. With respect to purchase of Licensed Product for Development of indications other than the indication that is the subject of the Development Plan, Takeda shall pay a price to ▇▇▇▇▇ equal to the Cost of Manufacture unless Takeda has previously paid for such manufacture as part of the Development Costs. To the extent that such purchase is a part of the Development Costs, payments and related matters shall be handled as set forth in Section 4.4.

Timing of Supply Responsibility Transition. With respect to a Licensed Product, the timing when Takeda assumes responsibility for Manufacture of such Licensed Product shall be discussed and determined by the Joint Manufacturing Committee; provided, the parties shall ensure the assumption occurs no later than six (6) months after (i) FIN-524 First Phase II Completion or FIN-525 First Phase II Completion, as applicable, so that Takeda can Manufacture the Licensed Products for Phase III Clinical Trial or (ii) if Takeda exercises a Phase II Development Option pursuant to Section 4.3(c), the completion of the Phase I Clinical Trial of the Licensed Product so that Takeda can Manufacture the Licensed Product for Phase II Clinical Trial.

Supply and Quality Agreements. The parties agree that at Takeda’s request ▇▇▇▇▇ shall enter into a Supply Agreement(s) and a Quality Agreement(s) for the supply of drug substance or clinical or commercial supply of Licensed Product required in Sections 6.1 and 6.2(a). The Supply Agreement(s) and Quality Agreement(s) shall be negotiated and managed by the Joint Manufacturing Committee.

Takeda’s Manufacturing Responsibility. Upon Takeda’s assumption of responsibility for Manufacture of a Licensed Product, Takeda shall:

at its sole expense, be responsible for and shall use its Commercially Reasonable Efforts to Manufacture the Licensed Products for further Development and Commercialization in the Territory;

purchase from ▇▇▇▇▇ the Licensed Product inventories (including the conformance lots) at a price equal to ▇▇▇▇▇’▇ Cost of Manufacture unless Takeda has already paid for such inventories as Development Costs;

reimburse ▇▇▇▇▇ for expenses in connection with the termination or modification of the then existing manufacturing agreements with Third Parties that are identified in such manufacturing agreements; and

assume all of ▇▇▇▇▇’▇ obligations under the manufacturing and supply agreements to which ▇▇▇▇▇ is a party and which Takeda has been made aware of, as of the date that Takeda notifies ▇▇▇▇▇ that Takeda will assume responsibility for Manufacture (including any new arrangements or extensions that the Joint Manufacturing Committee has reviewed and approved, required to be entered into between such date and the date Takeda assumes responsibility for Manufacture of the Licensed Product to minimize the threat of a supply interruption).

Seamless Transition; Technology Transfer. ▇▇▇▇▇ shall use Commercially Reasonable Efforts to avoid cancellation fees when engaging any contract manufacturer and the parties shall coordinate their efforts to reduce the likelihood of supply interruptions at the time Takeda assumes responsibility for Manufacture of a Licensed Product in commercial quantities. In accordance with a transition plan agreed at the Joint Manufacturing Committee, ▇▇▇▇▇ shall be primarily responsible to perform the technical transfer requirements without additional cost to Takeda in a timely manner to ensure a smooth transition of Manufacturing responsibilities to Takeda and an uninterrupted supply of clinical and commercial quantities of the Licensed Product.

COMMERCIALIZATION

CONSIDERATION; PAYMENT

Development Milestones.

Milestones for Licensed Therapeutic Products. Subject to Section 8.2(c) (and with respect to FIN- 525 Therapeutic Product subject to Section 8.2(a-2)), Takeda shall pay each of the following non- refundable, non-creditable payments to ▇▇▇▇▇ upon the first achievement of each of the following events with respect to a FIN-524 Licensed Therapeutic Product or a FIN-525 Therapeutic Product, as applicable, on a Development Program basis:

Milestone Event

[***] Stage

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

With respect to the FIN-525 Development Program, appropriate milestone events and amount allocated to respective events shall be discussed and determined in good faith by the parties promptly after the delivery by ▇▇▇▇▇ of a data package obtained from the FIN-524 Crohn Feasibility Study

Milestones for FIN-525 Licensed Therapeutic Products.

Notwithstanding Section 8.2(a-1), [***].

Notwithstanding Section 8.2(a-1), [***]. For the purpose of this Agreement, the foregoing product is treated as a FIN-525 Therapeutic Product and shall not treated as a FIN-524 Therapeutic Products.

For the avoidance of doubt, [***].

Milestones for Licensed Diagnostic Product/Method. Subject to Section 8.2(c), Takeda shall pay each of the following non-refundable, non-creditable payments to ▇▇▇▇▇ upon the first achievement of each of the following events with respect to (i) a FIN-524 Licensed Diagnostic Product/Method for the diagnosis of ulcerative colitis and (ii) a FIN-525 Licensed Diagnostic Product/Method for the diagnosis of Crohn’s Disease, as applicable:

Milestone Event

[***]

[***]

Milestone Payment Principle: Onetime Payment for the First Achievement. Each milestone payment identified in Section 8.2(a) and 8.2(b), shall be payable for the first Licensed Product that achieves the applicable milestone, on a Development Program basis, regardless of the number of Licensed

Reduced Milestone for Licensed Diagnostic Product/Method. [***].

Commercialization Milestones.

Milestone Event

[***]

[***]

[***]

Commercial Milestones for FIN-525.

Notwithstanding Section 8.3(a-1), [***].

Notwithstanding Section 8.3(a-1), [***].

For the avoidance of doubt, [***].

Royalties.

Royalty Rates. Takeda shall pay ▇▇▇▇▇ a royalty on a Licensed Product-by-Licensed Product basis based on annual aggregate Net Sales of a Licensed Product in each calendar year commencing with the First Commercial Sale of such Licensed Product in any country in the Territory and ending upon the last day of the last Royalty Term for such Licensed Product in such country, at the following rates:

Reduced Royalty Rates (Required Third Party License). If, as a result of any discussion of potential infringement or misappropriation of Third Party’s Patent Rights or Know-How pursuant to Section 9.3(a) or 9.3(b), the parties elect to enter into a license with such Third Party to avoid such infringement or misappropriation by (i) the Manufacture of such Licensed Product using the Licensed Technology that covers such Manufacture or (ii) solely with respect to the composition of matter or methods of use embodied or claimed in the Licensed Technology for such Licensed Product by the sale, offer for sale, use or importation of any Licensed Product in the Territory or the practice or use of any Licensed Technology, Program Patent Rights or Program Intellectual Property to Manufacture or have Manufactured any Licensed Product (each such license, a “Required Third Party License”) and Takeda owes [***] to such Third Party under the Required Third Party License, then Takeda may, beginning from the date that Takeda first makes or incurs any such payments, deduct the amount of [***] in any calendar quarter from the royalties payable hereunder to ▇▇▇▇▇ in such calendar quarter; provided, that the royalties payable to ▇▇▇▇▇ by Takeda shall not be reduced by more than [***] of the amount otherwise due in any calendar quarter; and provided, further that [***].

Reduced Royalty Rates (Non-Coverage by Valid Claim). Royalties shall be payable under Section 8.4(a) on a Licensed Product-by-Licensed Product basis for the applicable Royalty Term. Notwithstanding anything to the contrary in Section 8.4(a) or this Section 8.4(c), if any Licensed Product is sold in a country and is not Covered by a Valid Claim included in ▇▇▇▇▇ Patent Rights or Regulatory Exclusivity in such country at the time of sale, then royalty rates in such country shall be

Payment to OpenBiome. [***].

Remittance.

Royalty Payment Terms; Report. Any payments of royalties payable pursuant to Section 8.4 shall be made by Takeda within [***] after the end of each calendar quarter in which Net Sales occur, commencing with the calendar quarter in which the First Commercial Sale of a Licensed Product occurs. Within [***] after the end of each calendar quarter, commencing with the calendar quarter in which the First Commercial Sale of a Licensed Product occurs, Takeda shall deliver to ▇▇▇▇▇ a written report with respect to such calendar quarter stating the Net Sales, a top line summary of the deductions taken from gross sales (in each case on a country-by-country basis) and total Net Sales of the Licensed Product sold by Takeda, its Affiliates or sublicensees during such quarter in U.S. dollars (the “Royalty Report”). In each country where Net Sales have occurred in a currency other than U.S. dollars, such Net Sales will be converted to U.S. dollars at the end of the applicable calendar quarter using the quarter end rate of exchange. The rate of exchange to be used in computing the amount of currency equivalent in U.S. dollars under this Agreement will be made in accordance [***]. Royalties will be calculated based on the Royalty Report.

Interests. In the event that any payment due either party under this Agreement is not made when due, the amount due shall accrue interest [***], or, if lower, the maximum rate permitted by law, calculated from the due date until paid in full. Such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of the party to whom payment is due to any other remedy, legal or equitable, to which it may be entitled because of the delinquency of the payment.

Currency Conversion Restriction. If at any time legal restrictions within any country in the Territory prevent the conversion of the local currency and such currency cannot be removed from such country such that prompt remittance by the party owing a royalty of any royalties owed in respect of sales in such country is prevented, the party owing a royalty shall make payment through any lawful means or methods that may be available as such party shall reasonably determine. If royalties in any country cannot be remitted within [***] after the end of the relevant royalty period, then the party owing a royalty shall pay the other party in the local currency of such country by deposit of the relevant royalties in a bank account in such country designated by the other party.

Audits.

▇▇▇▇▇’▇ Audit Rights. During the term of the Agreement and for a period of [***] thereafter, Takeda, its Affiliates or sublicensees will keep complete and accurate records in sufficient detail to permit ▇▇▇▇▇ to confirm the completeness and accuracy of the information presented in each Royalty Report and all payments due hereunder. Takeda, its Affiliates or sublicensees will permit an independent, certified public accountant selected by ▇▇▇▇▇ and reasonably acceptable to Takeda, which acceptance will not be unreasonably withheld or delayed (the “Auditor”) to audit or inspect those records of Takeda that relate to Net Sales and Royalty Reports for one or more annual periods,

Additional Royalty Payment. In the event that the Auditor concludes that additional royalties were required for the annual period under review, the additional royalty payment will be paid within [***] of the date the Auditor delivers its report to the parties so concluding that such payments were underpaid, and excess royalties paid will be reimbursed to Takeda by ▇▇▇▇▇ within [***]. The payment of additional royalties to ▇▇▇▇▇ shall bear interest as described in Section 8.5(b). The fees charged by the Auditor will be paid by ▇▇▇▇▇ unless the audit discloses an underpayment of royalties paid or payable by Takeda for the annual period under review by more than [***] of the amount due, in which case Takeda shall pay (or reimburse ▇▇▇▇▇ for) the reasonable fees and expenses charged by the Auditor.

Taxes.

Cooperation and Coordination. The parties acknowledge and agree that it is their mutual objective and intent to appropriately calculate, to the extent feasible and legal, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use all commercially reasonable efforts to cooperate and coordinate with each other to achieve such objective.

Payment of Tax. A party receiving a payment pursuant to this Section 8 shall pay any and all taxes levied on such payment. If Applicable Laws require that taxes be deducted and withheld from a payment made pursuant to this Section 8, the remitting party shall: (1) deduct those taxes from the payment; (2) pay the taxes to the proper taxing authority; and (3) send evidence of the obligation together with proof of payment to the other party within [***] following that payment.

Tax Residence Certificate. A party receiving a payment pursuant to this Section 8 shall provide the remitting party appropriate certification from relevant revenue authorities that such party is a tax resident of that jurisdiction, if such receiving party wishes to claim the benefits of an income tax treaty to which that jurisdiction is a party. Upon the receipt thereof, any deduction and withholding of taxes shall be made at the appropriate treaty tax rate.

Assessment. Either party may, at its own expense, protest any assessment, proposed assessment, or other claim by any Governmental Authority for any additional amount of taxes, interest or penalties or seek a refund of such amounts paid if permitted to do so by Applicable Laws. The parties shall reasonably cooperate with each other in any protest by providing records and such additional information as may reasonably be necessary for a party to pursue such protest.

PATENT

Disclosure; Patent Prosecution.

Mutual Disclosure. Each of ▇▇▇▇▇ and Takeda shall promptly and fully disclose to the other in writing reasonably detailed written reports describing any Program Intellectual Property that may be Covered by Patent Rights, under the applicable U.S. patent laws, (whether to be owned jointly by the parties

Patent Prosecution by ▇▇▇▇▇. Subject to the last sentence of Section 9.1(a), ▇▇▇▇▇ shall file, prosecute, and maintain the ▇▇▇▇▇ Patent Rights, at ▇▇▇▇▇’▇ sole expense, in each Major Market Country in the Territory and in any other countries within the Territory upon which ▇▇▇▇▇ and Takeda agree. ▇▇▇▇▇ shall promptly furnish or have furnished to Takeda copies of all patents, patent applications, substantive patent office actions, and substantive responses received or filed in connection with such patents and patent applications. In the case of patent applications and responses, copies will be furnished to Takeda as soon as possible after ▇▇▇▇▇’▇ receipt of the same; provided, that ▇▇▇▇▇ shall furnish such copies at least [***] before filing or mailing, as the case may be. Takeda may itself or through its attorney offer comments and suggestions with respect to the matters that are the subject of this Section 9.1(b) and ▇▇▇▇▇ shall consider such comments and suggestions. If reasonably necessary, Takeda shall cooperate, at ▇▇▇▇▇’▇ expense, in the preparation, filing, prosecution and maintenance of any and all ▇▇▇▇▇ Patent Rights that are the subject of this Section 9.1(b). ▇▇▇▇▇ shall promptly provide notice to Takeda as to all matters that come to its attention that may affect the preparation, filing, prosecution or maintenance of any ▇▇▇▇▇ Patent Rights. In the event that ▇▇▇▇▇ elects not to file for patent protection, or elects not to prosecute or maintain a patent or patent application under, the ▇▇▇▇▇ Patent Rights described in this Section 9.1(b) in a particular country(ies), ▇▇▇▇▇ shall notify Takeda of such decision as soon as possible no later than [***] prior to the final deadline for any pending action or response that may be due with respect to such ▇▇▇▇▇ Patent Right with the applicable patent authority. In the event Takeda provides written notice expressing its interest in prosecuting and maintaining such Licensed Patent Right, ▇▇▇▇▇ shall cooperate with Takeda to permit Takeda to file, prosecute, and maintain such ▇▇▇▇▇ Patent Rights, at Takeda’s sole expense, subject to the provisions of Section 9.1(c).

Patent Prosecution by Takeda. Subject to the last sentence of Section 9.1(a), Takeda shall have the sole right, but not the obligation, to prepare, file, prosecute, and maintain each of (i) the Takeda Patent Rights and Joint Patent Rights throughout the Territory and (ii) the ▇▇▇▇▇ Patent Rights for which ▇▇▇▇▇ has the first right to file, prosecute and maintain and either elects not to prosecute or that are abandoned by ▇▇▇▇▇ or its licensors, each as provided in Section 9.1(b) in the relevant country(ies). With respect to Joint Patent Rights, Takeda shall use outside patent counsel reasonably acceptable to both parties, and such outside counsel shall be responsible to both Takeda and ▇▇▇▇▇, and shall use reasonable efforts to solicit both Takeda’s and ▇▇▇▇▇’▇ advice on material prosecution matters related thereto. Such outside patent counsel shall meet with Takeda and ▇▇▇▇▇ patent counsel on a regular basis as needed to discuss strategy for the preparation, filing, prosecution and maintenance of the Joint Patent Rights. Takeda shall be solely responsible for costs associated with the Takeda Patent Rights and ▇▇▇▇▇ Patent Rights for which Takeda is responsible under this Section 9.1(c), and Takeda and ▇▇▇▇▇ shall equally share costs associated with the Joint Patent Rights throughout the Territory. Takeda shall promptly furnish or have furnished to ▇▇▇▇▇ copies of all patents, patent applications, substantive patent office actions, and substantive responses received or filed in connection with such applications for Joint Patent Rights and ▇▇▇▇▇ Patent Rights at least [***] before filing or

Patent Term Extension. Takeda shall have the right to make the final decision on patent term extension with respect to a Licensed Product. The parties will cooperate with one another in connection with any request for patent term extension under 35 U.S.C. §156 in the U.S., or analogous statutes or regulations in other jurisdictions in the Territory, for patents relating to a Licensed Product.

Enforcement.

Actual or Threatened Infringement. If either party learns of any actual or threatened infringement or misappropriation or any attack on the validity or enforceability by a Third Party with respect to Joint Patent Rights, Joint Program Intellectual Property or Licensed Technology anywhere in the Territory, such party shall promptly notify the other party and shall provide such other party with available evidence of such events.

Enforcement by Takeda. Takeda shall have the first option to pursue any enforcement or defense of Licensed Technology, Joint Program Intellectual Property and Joint Patent Rights against infringement or misappropriation, including defense against a declaratory judgment action alleging invalidity or non-infringement of any of the Licensed Technology, Joint Program Intellectual Property and Joint Patent Rights; provided, that Takeda pays all costs and expenses related to the same, keeps ▇▇▇▇▇ reasonably informed of its progress and provides ▇▇▇▇▇ with copies of any substantive documents related to such proceedings and reasonable notice of all such proceedings. Takeda’s costs and expenses in prosecuting or defending such matters shall be subject to expense allocation (and reimbursement, if any) in accordance with Section 9.2(e). Takeda shall notify ▇▇▇▇▇ of its decision to exercise its right to enforce or defend Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights as soon as possible, but not later than [***] following its discovery or receipt of notice of the alleged infringement or misappropriation.

Enforcement by ▇▇▇▇▇.

If (A) Takeda notifies ▇▇▇▇▇ that it will not enforce any Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights in accordance with Section 9.2(b); (B) Takeda has exhausted all legal appeals with respect to causing the alleged infringement or misappropriation to cease or causing the person alleging the infringement or misappropriation to forebear, (C) Takeda fails to bring an infringement or misappropriation action within [***] following its discovery or receipt of notice of the alleged infringement or misappropriation or (D) Takeda is not diligently pursuing an infringement or misappropriation action or diligently defending the validity or enforceability of Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights at issue, then ▇▇▇▇▇ shall have the right to pursue the alleged infringer or party responsible for the alleged misappropriation or take control of any action initiated by, or being defended by, Takeda at ▇▇▇▇▇’▇ own expense.

Notwithstanding the foregoing (i), if Takeda has not initiated an infringement or misappropriation action as described under Section 9.2(c)(i)(C) above, or ceased to pursue such action, on the advice of outside patent counsel, then ▇▇▇▇▇ agrees not to (and shall cause, to the extent ▇▇▇▇▇ has the legally enforceable right to do so, its licensor(s) not to) initiate such an

Distribution of Recovery. Any recovery of damages or other sums recovered in a proceeding or action with regard to Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights handled by a party pursuant to Section 9.2(b) or 9.2(c) shall be applied first in satisfaction of any unreimbursed expenses and legal fees of the party bringing or defending the proceeding or action (the “Acting Party”) and next, if applicable, in satisfaction of the costs and expenses incurred by the other party in connection therewith, including reasonable attorneys’ fees involved in the prosecution and/or defense of any proceeding or action and, if after such reimbursement any funds shall remain from such damages or other sums recovered, the remaining recovery shall be [***]. No settlement, consent judgment or other voluntary final disposition of any suit regarding Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights may be entered into without the consent of the other party, which consent shall not be unreasonably withheld.

Cooperation in Enforcement. In any infringement or misappropriation suit that either party may institute to enforce Licensed Technology, Joint Program Intellectual Property or Joint Patent Rights, or in any declaratory judgment action alleging invalidity, non-infringement or non-misappropriation of any Licensed Technology brought against ▇▇▇▇▇ or Takeda, the other party shall, at the request and expense of the party initiating or defending the suit or action, cooperate and assist in all reasonable respects, having its employees testify when requested and making available relevant records, papers, information, specimens and the like. In addition, upon the reasonable request of the party instituting an action under Section 9.2(a) or 9.2(b), or if required by Applicable Law, the other party shall join such action and shall be represented using counsel of its own choice, at the requesting party’s expense; provided, that if Takeda does not initiate an action hereunder on the advice of outside patent counsel, then ▇▇▇▇▇ may not require Takeda to join such action but ▇▇▇▇▇ may have Takeda join such action as an involuntary party, but Takeda shall not be required to participate in such action.

Generic Entry. Notwithstanding any provisions of this Section 9.2 to the contrary, each party shall promptly give written notice to the other of any filing of which it becomes aware, for regulatory approval of a generic form of the Licensed Product if such filing becomes permissible in any country of the Territory during the term of this Agreement. Takeda shall then have the right to bring such an infringement action, in its sole discretion and at its own expense, in its own name and/or in the name of ▇▇▇▇▇ using the procedure set forth in Section 9.2(b). If Takeda does not wish to bring such action it shall notify ▇▇▇▇▇ promptly, in such a manner as to not prejudice such infringement action, and ▇▇▇▇▇ may bring such action using the procedure set forth in Section 9.2(c). For the avoidance of doubt, if Takeda does not initiate an infringement action hereunder on the advice of outside patent counsel, then ▇▇▇▇▇ agrees not to (and shall cause, to the extent ▇▇▇▇▇ has the legally enforceable right to do so, its licensor(s) not to) initiate such an action without Takeda’s prior consent not to be unreasonably withheld or delayed.

Third Party Licenses; Defense of Infringement Actions.

[***].

Third Party’s Patent Rights and Know-How. Each party shall bring to the attention of the other party, as soon as possible and in no event in a timeframe that would be prejudicial to the matter, all information regarding potential infringement or misappropriation of a Third Party’s Patent Rights or Know-How as a result of the Development, Manufacture, or Commercialization of Licensed Product in the Territory. The parties shall discuss such information and decide how to handle such matter. [***].

License from a Third Party. If, as a result of the discussions contemplated by Section 9.3(a) (last sentence) or 9.3(b),the parties do elect to enter into a license agreement, then the amounts (if any) payable to a Third Party shall be addressed in accordance with Section 8.4(b); provided, however, in the event that such license concerns the potential infringement or misappropriation of a Third Party Patent Right or Know-How detected as a result of [***], then (i) [***]; and (ii) Takeda may also, beginning from the date that Takeda first makes or incurs any such payments to a Third Party, [***]; provided, that [***]. If, as a result of such discussions the parties do not elect to enter into a license, or are unable to enter into a license with such Third Party and/or the Third Party proceeds with litigation against one or both parties, then the parties shall defend in close cooperation with each other against such litigation and such matter shall be addressed in accordance with Section 12.3.

Opposition against a Third Party. If, as a result of the discussions contemplated by Section 9.3(a) (last sentence) or 9.3(b), the parties agree that it is appropriate to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party based on its’ potential adverse impact on the patent freedom-to-operate with respect to the Development, Manufacture, or Commercialization of the Licensed Product, Optimal FIN-524, Optimal FIN-525, FIN-524 Alternates and FIN-525 Alternates (“Opposition”) in the U.S., Japan and the other Major Market Countries and the agreed Opposition is brought prior to the NBE Declaration with respect to each Development Program, then ▇▇▇▇▇ shall control such Opposition and shall be

No Duty of Inquiry. This Section 9.3 shall not be interpreted as placing on either party a duty of inquiry regarding Third Party intellectual property rights.

CONFIDENTIALITY

Confidentiality.

Confidentiality Obligation. During the term of this Agreement and for [***] thereafter, each party (i) shall maintain in confidence all Confidential Information of the other party; (ii) shall not use such Confidential Information for any purpose except as permitted by this Agreement; and (iii) shall not disclose such Confidential Information to anyone other than those of its Affiliates, sublicensees, prospective sublicensees, officers, directors, employees, consultants, agents or subcontractors who are bound by written obligations of nondisclosure and non-use no less stringent than those set forth in this Section 9 and to whom such disclosure is reasonably necessary or useful in connection with such party’s activities as contemplated in this Agreement. Each party shall ensure that such party’s Affiliates, sublicensees, prospective sublicensees, officers, directors, employees, consultants, agents and subcontractors comply with these obligations. Each party shall notify the other promptly on discovery of any unauthorized use or disclosure of the other’s Confidential Information, including, without limitation, the other’s trade secrets or proprietary information.

Permitted Disclosure. Notwithstanding the provisions of Section 10.1(a), a party receiving Confidential Information (the “Recipient”) may disclose Confidential Information to the extent such disclosure is

made in response to a valid and final order or subpoena of a court of competent jurisdiction or other governmental body of a country or any political subdivision thereof of competent jurisdiction; provided, that Recipient provides the other party with prior written notice of such disclosure (if practicable) in order to permit the other party to seek a protective order or other confidential treatment of such Confidential Information; and provided further that any Confidential Information so disclosed will be limited to that information that is legally required to be disclosed in such response to such court or governmental order or subpoena;

otherwise required by Applicable Laws; provided, that Recipient provides the other party with prior written notice of such disclosure (if practicable) in order to permit the other party to seek a protective order or confidential treatment of such Confidential Information; and provided further that any Confidential Information so disclosed will be limited to that information that is legally required by Applicable Law to be disclosed;

made by the Recipient to a Regulatory Authority, as required to conduct Development or obtain or maintain Regulatory Approvals; provided that reasonable efforts shall be used to ensure confidential treatment of such Confidential Information;

made by the Recipient to a Third Party as may be necessary or useful in connection with the Development, Manufacturing or Commercialization related to the Licensed Product; provided the Third Party is bound by written confidentiality obligations no less protective that those set forth in this Agreement;

made by Recipient to a U.S. or foreign tax authority to the extent legally required by Applicable Laws to be disclosed;

made by Recipient to its representatives or to third parties in connection with sublicensing or financing activities of the Recipient; provided that the Third Party is bound by written confidentiality obligations no less protective that those set forth in this Agreement;

made by Recipient or any of its representatives in the filing or publication of Patent Rights relating to the Licensed Product to the extent such disclosure in the filing or publication of Patent Rights is reasonably necessary for support of the Patent Rights;

made by Recipient to comply with Applicable Laws related to securities laws disclosure requirements or any disclosure requirements of any applicable stock market or securities exchange;

with respect to Confidential Information comprising CMC Pre-Transition Program Data and Results, made by Recipient to bona fide Third Party collaborators, contractors, and service providers; or

made by Recipient in compliance with Section 10.3.

Publications.

Proposal of Publication. Each party recognizes the mutual interest in obtaining valid patent protection and in protecting business interests and trade secret information. Consequently, except for disclosures permitted pursuant to Section 10.1(b), if a party wishes to make a publication containing (i) any ▇▇▇▇▇ Intellectual Property or subject of ▇▇▇▇▇ Patent Rights, or (ii) any Takeda Intellectual Property or subject of Takeda Patent Rights, the party disclosing or submitting such proposed publication (“Submitting Party”) shall send the other party (“Responding Party”) by expedited delivery a copy of the proposed publication to be submitted and shall allow the Responding Party a reasonable time period (but no more than [***] from the date of confirmed receipt) in which to determine whether the proposed publication contains subject matter for which patent protection should be sought (prior to publication of such proposed publication) for the purpose of protecting an invention, or whether the proposed publication contains Confidential Information of the Responding Party. Following the expiration of applicable time period for review, the Submitting Party shall be free to submit such proposed publication for publication and publish or otherwise disclose to the public such scientific or clinical results, subject to the procedures set forth in Section 10.2(b).

Review Process. If the Responding Party believes that the subject matter of the proposed publication contains Confidential Information or a patentable invention of the Responding Party, then prior to the expiration of the applicable time period for review, the Responding Party shall notify the Submitting Party in writing of its determination that such proposed publication contains such information or subject matter for which patent protection should be sought. On receipt of such written notice from the Responding Party, the Submitting Party shall delay public disclosure of such information or submission of the proposed publication for an additional period of [***] to permit preparation and filing of a patent application on the disclosed subject matter. The Submitting Party shall thereafter be free to publish or disclose such information, except that the Submitting Party may not disclose any Confidential Information of the Responding Party in violation of Sections 10.1 and 10.2; provided that the parties shall use reasonable efforts to provide scientifically meaningful equivalent information that is not Confidential Information for use in such disclosure.

REPRESENTATIONS AND WARRANTIES

▇▇▇▇▇ has no knowledge as of the Restatement Effective Date of any claims, judgments or settlements against ▇▇▇▇▇ or its licensor(s) pending, or threatened, that invalidate or seek to invalidate the ▇▇▇▇▇ Patent Rights. ▇▇▇▇▇ has no knowledge of any pending litigation against ▇▇▇▇▇ or any Affiliate of ▇▇▇▇▇ or any licensor of ▇▇▇▇▇ that alleges that any of ▇▇▇▇▇’▇ activities relating to the Licensed Products have violated, or by Developing Licensed Products would violate, any of the intellectual property rights of any Third Party (nor has it received any written communication threatening such litigation).

▇▇▇▇▇ has not previously assigned, transferred, conveyed or otherwise encumbered and will not assign, transfer, convey or otherwise encumber its right, title and interest in the Licensed Technology in a manner inconsistent with the terms hereof. There is and will be no agreement to which ▇▇▇▇▇ is a party and by which it is bound that would conflict with or be breached by ▇▇▇▇▇ granting Takeda the licenses in Section 2.1(a).

▇▇▇▇▇ is and will be the sole and exclusive owner of the Licensed Technology owned by ▇▇▇▇▇ and no other Person has any claim of ownership with respect to the Licensed Technology. ▇▇▇▇▇ has and will maintain the right to grant the license granted to Takeda under Section 2.1(a) on the terms set forth herein.

▇▇▇▇▇ has obtained the assignment of all interests and all rights of any and all third parties (including employees) involved in the creation of the ▇▇▇▇▇ Intellectual Property owned by ▇▇▇▇▇, and ▇▇▇▇▇ has taken and will take reasonable measures to protect the confidentiality of the confidential ▇▇▇▇▇ Intellectual Property to the extent that a failure to do so would have a material adverse effect on Takeda’s ability to Develop and Commercialize Licensed Products as contemplated by this Agreement.

▇▇▇▇▇ has no knowledge as of the Restatement Effective Date of any use, infringement or misappropriation of the ▇▇▇▇▇ Intellectual Property in derogation of the rights granted to Takeda in this Agreement.

There are no investigations, inquiries, actions or other proceedings pending before any Regulatory Authority or other government agency with respect to the Licensed Products being Developed by ▇▇▇▇▇, and ▇▇▇▇▇ has not received written notice threatening any such investigation, inquiry, action or other proceeding and ▇▇▇▇▇ has no knowledge that any of its licensors has received any such written notice.

▇▇▇▇▇ has and will maintain a right to access and use the OpenBiome Resources and any other resources necessary for ▇▇▇▇▇ to fulfil its responsibilities under this Agreement that are subject to an agreement with a Third Party as of the Restatement Effective Date. ▇▇▇▇▇ shall not amend, without the prior written consent of Takeda (such consent not to be unreasonably withheld or delayed), or voluntarily terminate, any of its rights under any Existing Agreement, in any manner that would materially and adversely affect Takeda’s rights and benefits under this Agreement during the term of this Agreement.

Disclaimers.

EXCEPT FOR THE WARRANTIES EXPRESSLY MADE IN SECTIONS 11.1 AND 11.2, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED (WHETHER WRITTEN OR ORAL), INCLUDING ANY WARRANTY OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON- INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.

THE REPRESENTATIONS AND WARRANTIES OF EACH OF ▇▇▇▇▇ AND TAKEDA EXTEND ONLY TO THE OTHER PARTY. NEITHER PARTY WILL BE LIABLE FOR ANY CLAIM OR DEMAND AGAINST SUCH OTHER PARTY BY A THIRD PARTY, EXCEPT TO THE EXTENT PROVIDED IN SECTIONS 12.2 AND 12.3.

RISK ALLOCATION

Infringement Indemnification.

Subject to the provisions of Section 12.4, ▇▇▇▇▇ shall defend, indemnify and hold harmless the Takeda Indemnified Party(ies) from and against any Losses imposed upon them by any Third Party and arising from or related to a Third Party claim that (i) use of ▇▇▇▇▇ Intellectual Property or practice of the ▇▇▇▇▇ Patent Rights by or on behalf of Takeda in accordance with the terms of this Agreement or (ii) use of ▇▇▇▇▇’▇ computational system and databases violates or infringes the intellectual property rights of any Third Party that qualify as a Required Third Party License. ▇▇▇▇▇ shall have no liability or obligation to Takeda under this Section 12.3(a) in the event and to the extent that the alleged infringement results from willful misconduct or negligent acts or omissions of Takeda or its Affiliates, or its or their respective employees, officers, directors or agents.

Subject to the provisions of Section 12.4, Takeda shall defend, indemnify and hold harmless the ▇▇▇▇▇ Indemnified Party(ies) from and against any Losses imposed upon them by any Third Party and arising from or related to a Third Party claim that use of the Takeda Intellectual Property or practice of the Takeda Patent Rights by ▇▇▇▇▇ in accordance with the terms of this Agreement violates or infringes the intellectual property rights of any Third Party. Takeda shall have no obligation or liability to ▇▇▇▇▇ under this Section 12.3(b) in the event and to the extent that the alleged infringement (i) is covered by Section 12.3(a) or (ii) results from willful misconduct or negligent acts or omissions of ▇▇▇▇▇ or its Affiliates, or its or their respective employees, officers, directors or agents.

If any notice of infringement or misappropriation is received by, or a suit is initiated against, Takeda or ▇▇▇▇▇ by a Third Party concerning the Development, Manufacture or Commercialization of Licensed Product in the Territory, the parties shall consult in good faith regarding the best response before either party responds to the Third Party. The parties will share equally the out-of-pocket costs and expenses of matters arising pursuant to this Section 12.3(c), but the allocation of any other costs shall be subject to Section 12.3(a) and 12.3(b), as applicable.

For the avoidance of doubt, with respect to any infringement action brought against ▇▇▇▇▇, Takeda or both parties alleging infringement, that is not subject to this Section 12.3: (i) Takeda shall have the final right to control such defense (including, settlement therefor) if Takeda is the sole defendant, (ii) ▇▇▇▇▇ shall have the final right to control such defense (including settlement) therefor if ▇▇▇▇▇ is the sole defendant and (iii) the parties shall jointly control such defense (including settlement therefor) if the parties are joint defendants and each party shall bear its own cost incurred, including its internal cost.

TERM AND TERMINATION

Termination.

By Either Party (Breach). Either party may terminate this Agreement with [***] notice if the other party commits a material breach (excluding non-payment), unless the breach is cured within the [***] notice period; provided, that with respect to non-payment breaches the notice and cure period shall be reduced to [***]; and provided further, that the [***] cure period may be extended if (i) the Joint Steering Committee unanimously determines that the breaching party is in the process of attempting in good faith to cure such breach, or (ii) the existence of a material breach is the subject of an Arbitration Request.

By Takeda (Without Cause). Takeda shall have the right to terminate this Agreement, in part or whole, on a Development Program basis, at any time after the Original Effective Date by providing [***] prior written notice to ▇▇▇▇▇. After delivery of such notice, with respect to the relevant Development Program, [***].

By Takeda (Valid Safety Issue). Notwithstanding the notice period applicable to termination under Section 13.2(b), Takeda may terminate this Agreement, in part or whole, on a Development Program basis, immediately following the withdrawal of Licensed Product from any market as a result of bona fide concerns based on specific and verifiable information that the Licensed Product is unsafe for administration to humans.

By Mutual Agreement. The parties may terminate this Agreement, in part or whole, on a Development Program basis, at any time upon mutual written agreement of the parties.

Effect of Termination.

General Effect. If termination is made by ▇▇▇▇▇ pursuant to Section 13.2(a) or by Takeda pursuant to Section 13.2(b), with respect to the terminated Development Program, then the following shall apply:

the parties will terminate all tasks then in process in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Takeda and ▇▇▇▇▇;

each party shall pay to the other party any monies due and owing up to the time of termination, including monies due in respect of Development activities undertaken through the date of termination even if such monies are not payable under the terms of Section 4.4 until a date following termination;

each party shall return to the other party or certify in writing to the other party that it has destroyed all documents and other tangible items it or its employees or agents have received or created pertaining, referring or relating to the Confidential Information or Program Intellectual Property owned solely by the other party; provided, that a party is permitted to retain one copy of such materials in its legal files to be used to verify compliance with its obligations hereunder,

Takeda shall, at ▇▇▇▇▇’▇ written request and at Takeda’s sole cost and expense, promptly assign and transfer to ▇▇▇▇▇, all of Takeda’s right, title, and interest in and to all Regulatory Filings, Regulatory Approvals, clinical trial agreements, and shall grant a royalty-free and non- exclusive license to use other data relating to the use, sale, offer for sale or importation of the Licensed Product in the Field in the Territory, including

data, materials, and information relating to non-clinical, pre-clinical and clinical activities and clinical trials;

copies of all correspondence and conversation logs (to the extent available) with Regulatory Authorities solely relating to the pre-clinical and clinical Development of Licensed Products in the Field in the Territory, and

samples of promotional, sales, marketing, and educational materials for the Licensed Product that describe the features or benefits of the Licensed Product, as such materials then currently exist that are related exclusively to the use, sale, offer for sale or importation of the Licensed Product in the Field (each of which shall be transferred in any event within [***] after Takeda’s receipt of such request);

Special Effect. If termination is made by either party pursuant to Section 13.2(a), then the restrictions set forth in Section 2.1(d)(i) shall not apply to the terminating party once the cure period expires in accordance with Sections 13.2(a) and 14, and the terminating party may use any Joint Program Intellectual Property or Joint Patent Rights for any purposes based on its interest therein.

Effect on Sublicensee. In the event the license granted to Takeda under Section 2.1(a) terminates for any reason, each of Takeda’s Third Party sublicensees at such time shall continue to have the rights and licenses set forth in their sublicense agreements; provided, that such sublicensee agrees in writing that (i) ▇▇▇▇▇ is entitled to enforce all relevant provisions directly against such sublicense and (ii) ▇▇▇▇▇ shall not assume, and shall not be responsible to such sublicensee for, any representations, warranties or obligations of Takeda to such sublicensee, other than to permit such sublicensee to exercise any rights to Licensed Products that are sublicensed under such sublicense agreement; and provided further, that Takeda shall have no liability to ▇▇▇▇▇ for any action or inaction of the sublicensees under any continuing license to the sublicensee.

No Further Liability. Except as otherwise provided herein, neither party shall be liable to the other party for any compensation or damages by reason of termination of this Agreement in accordance with this Section 13.

Survival and Acceleration of Pre-Accrued Obligations. Nothing herein shall be construed to release either party of any obligation which matured prior to the effective date of any termination. Either party’s liability for any uncontested charges, payments or expenses due to the other party that accrued prior to the termination date shall not be extinguished by termination, and such amounts (if not otherwise due on an earlier date) shall be immediately due and payable on the termination date.

DISPUTE RESOLUTION

Arbitration.

Arbitration Request. If a party intends to begin an arbitration to resolve a dispute arising under this Agreement after the provisions of Section 14.1 have been exhausted, such party shall provide written notice (the “Arbitration Request”) to the other party of such intention and the issues for resolution. From the date of the Arbitration Request and until such time as the dispute has become finally settled, the running of the time periods as to which a party must cure a breach of this Agreement becomes suspended as to the subject matter of the dispute. Unless the parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding. The arbitration proceeding shall be conducted in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (the “AAA”) and otherwise as set forth in this Section 14.2.

Addition of Issues. Within [***] after the receipt of the Arbitration Request, the other party may, by written notice, add additional issues for resolution; provided, that such issues have been subject to Section 14.1 and relate directly to the matter that is the subject of the applicable Arbitration Request.

AAA Arbitration. The arbitration shall be conducted by one (1) arbitrator selected in accordance with the AAA Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes as modified below, unless the matter in dispute has a value of at least [***] and either party wishes to have the arbitration conducted by a panel of three (3) arbitrators. The arbitrator(s) shall be experienced in the subject matter of the Arbitration Request as it applies to the biotechnology or pharmaceutical business. The parties shall cooperate to attempt to select the arbitrator(s) by agreement within [***] of the initiation of arbitration. If agreement cannot be reached within such [***], then that AAA will submit a list of [***] qualified arbitrators from which each party shall strike unacceptable entries; provided that each party shall not strike more than [***] of the names without cause, and rank the remaining names. The AAA shall appoint the arbitrator(s) with the highest combined ranking(s). If these procedures fail to result in selection of the required number of arbitrators, the AAA shall appoint the arbitrator(s), allowing each side challenges for cause. The arbitration shall be held in New York, New York and all proceedings and communications shall be conducted in English. The parties each use their best efforts to have the arbitration hearing held as soon as practicable and in any event within [***] after the selection of the arbitrator(s). At least [***] prior to the arbitration hearing, each party shall submit to the other party and the arbitrator(s) a copy of all exhibits on which such party intends to rely at the hearing, a pre-hearing brief [***], and a proposed ruling [***]. The proposed ruling shall be limited to proposed rulings and remedies on each issue, and shall contain no argument on or analysis of the facts or issues. Within [***] after close of the hearing, each party may submit a post-hearing brief [***] to the arbitrator(s).

Injunctions. Either party may apply first to the arbitrators for interim injunctive relief until the arbitration decision is rendered or the arbitration matter is otherwise resolved; provided, that if such party determines that such injunctive relief cannot be awarded in a timeframe adequate to protect such party’s interests, then a party may, without waiving any right or remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that party pending resolution of the arbitration matter pursuant to this Section 14.2. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a party’s compensatory damages. The parties further agree that the decision of the arbitrators shall be the sole, exclusive and binding remedy between them regarding determination of arbitration matters presented.

Disputed/Suspended Performance. The parties hereby agree that any disputed performance or suspended performance pending the resolution of an arbitration matter that the arbitrators determine to be required to be performed by a party must be completed within a reasonable time period following the final decision of the arbitrators.

Arbitration Costs. Each party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a party is the prevailing party, and if so, to award to that prevailing party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses), and/or the fees and costs of the arbitrators.

Confidentiality. Except to the extent necessary to confirm an award or decision or as may be required by Applicable Laws, neither a party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both parties.

Suspension of Termination Right. The parties agree that, in the event of an arbitration matter involving the alleged breach of this Agreement, neither party may terminate this Agreement until resolution of such matter pursuant to this Section 14.2, and any time period for cure will only commence after such resolution.

Waiver of Jury and Other Rights in Court Litigation. By agreeing to this binding arbitration provision, the parties understand that they are waiving certain rights and protections which may otherwise be available if a dispute between the parties were determined by litigation in court, including the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence.

GENERAL PROVISIONS

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