Exhibit 10.5
EXECUTION COPY

COMMERCIAL MANUFACTURING & SUPPLY AGREEMENT
BY AND BETWEEN
TAKEDA PHARMACEUTICAL COMPANY LIMITED
AND
MYOVANT SCIENCES GMBH
DATE: MAY 30, 2018

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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COMMERCIAL MANUFACTURING & SUPPLY AGREEMENT
This Commercial Manufacturing & Supply Agreement (the “Agreement”) is made
effective as of May 30, 2018 (the “Effective Date”) by and between Takeda
Pharmaceutical Company Limited, a company having its principal place of business
at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan (“Takeda”) and
Myovant Sciences GmbH, a company having its principal place of business at
Viaduktstrasse 8, 4051 Basel, Switzerland (“Myovant”). Myovant and Takeda are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties.”
RECITALS
WHEREAS, Takeda’s Affiliate, Takeda Pharmaceuticals International AG (“TPIZ”)
and Myovant Parent (as defined below), Myovant Sciences Ltd. (f/k/a Roivant
Endocrinology Ltd.) (“Myovant Ltd.”), are parties to that certain License
Agreement dated April 29, 2016 (“License Agreement”) pursuant to which TPIZ
granted to Myovant Ltd. a license in the Licensee Territory and the Takeda
Territory (as defined in the License Agreement) under certain patents, patent
applications, know-how and other proprietary information for the further
Development and Commercialization of the TAK-385 Licensed Products in accordance
with the terms and conditions set forth in the License Agreement;
WHEREAS, the Parties entered into that certain Letter of Intent (the “Letter of
Intent”) as of March 9, 2018 regarding the procurement by Myovant of the Drug
Substance (as defined herein), as manufactured by Takeda at the [***] (as
defined herein) and supplied to Myovant; and
WHEREAS, in accordance with the License Agreement and the terms and conditions
set out below, Takeda, on behalf of TPIZ, now agrees to provide certain
quantities of Drug Substance and Myovant agrees to receive from Takeda certain
quantities of Drug Substance in order to Commercialize the TAK-385 Licensed
Product, as further described below.
NOW, THEREFORE, and in consideration of the mutual covenants contained in this
Agreement and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties, intending to be legally bound,
agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms used in this Agreement shall have the meanings
specified below; and all other capitalized terms used but not otherwise defined
in this Agreement shall have their respective meanings set forth in the License
Agreement, provided that solely with respect to such terms in the License
Agreement, (i) all references to “Licensee” and “Takeda” in such other
capitalized terms shall be deemed to refer to Myovant and Takeda hereunder
(respectively) and all references to “Affiliate” in any such capitalized terms
shall refer to “Affiliate” as defined below, (ii) all references to a “Party”
and the “Parties” in any such capitalized terms shall be deemed to refer to a
Party and the Parties hereunder (respectively), (iii) all references to the
“Effective Date” and the “Agreement” in any such capitalized terms shall be
deemed to refer to the Effective Date hereunder and this Agreement
(respectively), (iv) all references to the “Term” in any such capitalized terms
shall be deemed to refer to the Term hereunder. For convenience, a glossary of
such capitalized terms from the License Agreement that are used herein, as
excerpted and redacted for the purposes hereof, is attached hereto as Exhibit D;
provided, however, that if there is any inadvertent conflict between the terms
on such Exhibit D and the same terms in the License Agreement, the terms in the
License Agreement shall control unless the context duly requires otherwise.
1.1    “Affiliate” means, with respect to a particular person or entity, a
Person that controls, is controlled by, or is under common control with such
person or entity, other than any Excluded Affiliate (with respect to Myovant).
For the purposes of this definition, the word “control” (including, with
correlative meaning, the terms “controlled by” or “under common control with”)
means the actual power, either directly or indirectly through one or more
intermediaries, to direct or cause the direction of the management and policies
of such entity, whether by the ownership of fifty percent (50%) or more of the
voting stock of such entity, or by contract or otherwise.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.2     “Batch Documentation” means the documentation provided to Myovant or the
Qualified Designee (as defined below) at the time of delivery of Drug Substance,
as agreed upon by the Parties in the Quality Agreement or as required by
Applicable Laws.
1.3     “Detectable Defect” shall have the meaning set forth in Section 9.1
hereof.
1.4     “Drug Product” means a final, packaged or unpackaged pharmaceutical
product for use solely for administration to humans consisting of any TAK-385
Licensed Product. For clarity, such pharmaceutical product under the Takeda
Clinical Manufacturing and Supply Agreement shall not be included herein.
1.5    “Drug Substance” means the active pharmaceutical ingredient for the
chemical compound coded by Takeda as TAK-385, the structure of which is set
forth on Schedule 1.138 of the License Agreement, with the Specifications (as
defined below), and is Manufactured pursuant to Section 7.1 hereof. For clarity,
such pharmaceutical ingredient under the Takeda Clinical Manufacturing and
Supply Agreement shall not be included herein.
1.6    “Excluded Affiliate” means (a) any Myovant Parent Affiliate (as defined
below) or (b) any direct or indirect subsidiary of a Myovant Parent Affiliate,
other than any Myovant Parent (as defined below), that (i) is controlled (as
defined in Section 1.1 hereof) by such Myovant Parent Affiliate but is not
controlled by Myovant or any Myovant Parent and (ii) is established for the
development and commercialization of compounds and products other than the
Licensed Compounds and Licensed Products.
1.7    “Firm Order” is defined in Section 6.1.2(b) hereof.
1.8    “Firm Order Period” is defined in Section 6.1.2(b) hereof.
1.9    “Fiscal Year” or “FY” means a twelve (12) month period ending on March
31st in a given Calendar Year of the Term; provided, however, that (a) the first
Fiscal Year of the Term shall begin on the Effective Date and end on March 31st,
2019; and, (b) the last Fiscal Year of the Term shall end upon the expiration or
termination of this Agreement.
1.10    “FTE Rate” is defined in Schedule 4.2.3 hereto.
1.11    “[***]” means the Manufacturing facility of Drug Substance operated by
Takeda and located in [***].
1.12     “Initial Firm Order” is defined in Section 6.1.2(a) hereof.
1.13    “Initial Firm Order Period” is defined in Section 6.1.2(a) hereof.
1.14    “JPY” means Japanese Yen.
1.15     “Myovant Parent” means any Person of which Myovant is a wholly owned
subsidiary. For clarity, as of the Effective Date, the Myovant Parent is Myovant
Sciences Ltd.
1.16    “Myovant Parent Affiliate” means any Person that controls (as defined in
Section 1.1 hereof) the Myovant Parent, including, as of the Effective Date,
Roivant Sciences Ltd.
1.17    “[***]” means that certain compound or substance as further described in
Schedule 1.17 hereto including its specifications.
1.18    “Permits” means any licenses, permits, registrations, certifications or
other approvals from a Governmental Authority as needed for the Manufacturing of
Drug Substance at the [***] hereunder.
1.19    “Project Work Order” shall have the meaning set forth in Section 12.1
hereof.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
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1.20    “Qualified Designee” means any Sublicensee or Subcontractor, including a
contract manufacturing organization duly engaged by Myovant to Manufacture the
Drug Substance for Myovant (“CMO”).
1.21    “Quality Agreement” means the Quality Assurance Agreement between the
Parties for the supply of Drug Substance under this Agreement to be entered into
in accordance with Section 7.5 hereof.
1.22    “Quality Release” means certification by Takeda’s quality control
department that Drug Substance Manufactured by or on behalf of Takeda complies
with the Quality Agreement and Takeda’s quality release specifications as
confirmed by release testing.
1.23    “Specifications” means the specifications for the design, composition,
Manufacture, packaging, and/or quality control of the Drug Substance, as set
forth in Exhibit A attached hereto, which may be duly amended from time-to-time.
1.24    “Subcontractor” means, with respect to a Party, any consultant,
subcontractor, distributor, co-promotion partner, or other vendor engaged by
such Party to conduct its obligations under this Agreement, the Quality
Agreement and/or the License Agreement.
1.25    “Technical Support Services” shall have the meaning set forth in
Section 12.1 hereof.
ARTICLE 2
DRUG SUBSTANCE SUPPLY; GOVERNANCE
2.1    Purchase and Supply. Subject to the terms and conditions set forth in
this Agreement, the License Agreement and the Quality Agreement, Takeda shall
supply to Myovant, and Myovant shall obtain from Takeda, certain quantities of
Drug Substance under this Agreement. Except as otherwise provided in the License
Agreement: (a) Myovant shall, and shall ensure that its Affiliates and Qualified
Designees, use the Drug Substance only in the Field in the Licensee Territory,
and (b) Myovant shall not, and shall not permit its Affiliates and Qualified
Designees to, use the Drug Substance directly or indirectly (i) in the Takeda
Territory, or (ii) in a manner that is reasonably likely to directly or
indirectly enable a Third Party to use the Drug Substance in contravention of
subsection (i) above. For clarity, Myovant may at its sole cost and
responsibility, use, sell or otherwise transfer to any Third Party the Drug
Substance supplied hereunder, or any Drug Product that incorporates such Drug
Substance, as necessary to duly satisfy the applicable requirements of Myovant,
its Affiliates and Qualified Designees in connection with the performance of
Manufacture, Development or Commercialization of Drug Product in the Field in
the Licensee Territory as authorized under the License Agreement.
2.2    Governance.
2.2.1    Role of the JRC. The JRC shall oversee all activities under this
Agreement, including under the Quality Agreement. For purposes of such
oversight, each Party may designate appropriate ad hoc personnel, including from
quality and regulatory functions, to attend meetings of the JRC in a non-voting
capacity and in accordance with Section 2.3.1 of the License Agreement.
2.3    Joint Manufacturing Working Group.
2.3.1    Establishment; Responsibilities. The Parties have established, under
the License Agreement, a joint manufacturing working group (the “Joint
Manufacturing Working Group” or “JMWG”), which shall have, with respect to this
Agreement, the responsibilities set forth in this Section 2.3. For clarity,
Section 4.1 of the License Agreement and the “Transition Plan” described therein
shall remain in full force and effect for Licensed Compounds including the Drug
Substance under this Agreement; provided, however, that the disclaimers set
forth in Section 4.2.2 (Takeda Materials Disclaimer) of the License Agreement
will not negate any express warranties made by Takeda in this Agreement. The
JMWG shall be responsible for overseeing, reviewing and coordinating activities
related to the supply of Drug Substance under this Agreement and operational
decisions with respect thereto, including as follows:

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
3

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(a)    The implementation of activities under the Drug Substance Transition Plan
(as defined below);
(b)
The creation of the Gain-sharing Report and implementation of changes described
therein, as set forth in Section 7.3 (Continuous Improvement) hereof.

For clarity, the JMWG shall have no authority to amend or waive compliance with
any provision of this Agreement.
2.3.2    JMWG Membership. Promptly after the Effective Date, each Party will
designate at least one (1) representative for the JMWG and provide the other
Party with written notice of such representative; provided that (a) a Party may
designate additional representatives to the extent such Party reasonably
determines that the matters coming before the JMWG require additional subject
matter expertise and (b) each Party will at all times have equal numbers of
representatives on the JMWG. Either Party may designate substitutes for its JMWG
representative(s) if one (1) or more of such Party’s designated representatives
is unable to be present at a meeting. From time to time during the Term, each
Party may replace its JMWG representative(s) by written notice to the other
Party specifying the prior representative and their replacement.
2.3.3    Meetings; Expenses. Unless otherwise agreed by the JMWG, the JMWG will
meet [***] until the First Commercial Sale of the first Drug Product. After such
First Commercial Sale of the first Drug Product and during the remainder of the
Term, unless otherwise agreed by the JMWG, the JMWG will meet [***]. Additional
meetings of the JMWG may be held with the consent of each Party (such consent
not to be unreasonably withheld, conditioned, or delayed). In the case of any
dispute referred to the JMWG, such meeting will be held within [***] Business
Days following referral to the JMWG, or as soon as reasonably possible. The JMWG
may meet either (a) in person at either Party’s facilities or at such locations
as the Parties may otherwise agree or (b) by teleconference or videoconference.
Additional non-members of the JMWG having relevant experience may from time to
time be invited to participate in a JMWG meeting. Non-member employees of a
Party or its Affiliates will only be allowed to attend if: (i) the other Party’s
representatives have consented to the attendance (such consent not to be
unreasonably withheld, conditioned, or delayed); and (ii) such non-employee
participant is subject to written confidentiality and non-use obligations
substantially similar as those set forth in this Agreement. Each Party will be
responsible for all of its own expenses incurred in connection with
participating in any such JMWG meetings, including all travel and all expenses
associated therewith. The Parties will share equally any Third Party expenses
reasonably incurred in connection with an off-site JMWG meeting (e.g., fees for
a meeting room out of the Parties' facilities).
2.3.4    JMWG Decisions. The JMWG will use good faith efforts to reach unanimous
agreement with respect to all matters within the JMWG’s authority in accordance
with Section 2.3.1 hereof. Should the JMWG not be able to reach agreement with
respect to any such matter, then such matter shall be referred to the JRC. For
clarity, any member of the JMWG shall, after the conclusion of such good faith
efforts, have the authority to refer to the JRC any matter properly before the
JMWG for which no agreement has been reached after such good faith efforts.
2.3.5    Contact Persons. Each Party will appoint a person who will oversee
contact between the Parties for all matters relating to this Agreement (each, a
“Contact Person”), which person may be replaced at any time upon written notice
to the other Party. Each Contact Person will work together to manage and
facilitate the communication between the Parties under this Agreement. The
Contact Persons will not have decision-making authority with respect to any
matter under this Agreement.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
4

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ARTICLE 3
PRICE
3.1    Price. Myovant shall pay Takeda for the price for Drug Substance as
follows in Section 3.1.1 and Section 3.1.2 hereof:
3.1.1    [***]. Without prejudice to Section 6.1.2 hereof, and in addition to
any fees and costs reasonably accrued to or incurred by Takeda in accordance
with Section 6.1.4(b) hereof, Myovant shall pay Takeda an amount of the price
intended to [***] and used to Manufacture the Drug Substance for Myovant under
this Agreement for its Commercialization of Drug Product under the License
Agreement, as follows:
(a)    [***]. For the Drug Substance to be delivered to Myovant, its Affiliates
or their Qualified Designees during the Term on or before [***] i.e., such Drug
Substance under the Letter of Intent, Myovant shall pay Takeda a fixed amount of
[***] of Drug Substance for such [***] used to Manufacture such Drug Substance
as set forth in Schedule 3.1 hereto.
(b)    [***]. For the Drug Substance to be delivered to Myovant, its Affiliates
or their Qualified Designees [***] Myovant shall pay Takeda a fixed amount of
[***] of Drug Substance for such [***] used to Manufacture such Drug Substance
as set forth in Schedule 3.1 hereto.
(c)    [***]. For the Drug Substance to be delivered to Myovant, its Affiliates
or their Qualified Designees during the Term on or after [***] Myovant shall pay
Takeda that certain amount intended to [***] provided, however, that: (i) Takeda
shall use its commercially reasonable efforts to [***] (ii) [***] shall not be
[***] under substantially similar terms and conditions, [***] and (iii) [***] in
the Manufacture of Drug Substance under this Agreement.
(d)    [***]. With respect to all Drug Substance delivered under this Agreement,
the amounts that Myovant is obligated to pay under this Section 3.1.1 for such
Drug Substance are based solely on [***].
3.1.2    Drug Substance Manufacturing by Takeda. In consideration for all other
Manufacturing activities performed and materials [***] used by Takeda or its
Affiliates in the Manufacture of Drug Substance under this Agreement, including
[***] Myovant shall pay Takeda an amount of the price for Drug Substance to be
delivered to Myovant, its Affiliates or their Qualified Designees under this
Agreement pursuant to the corresponding Purchase Order in accordance with
Section 6.1.3 hereof, which shall be subject to the applicable Firm Order in
accordance with Section 6.1.2 hereof, as follows:
(a)    [***]. For the Drug Substance to be delivered to Myovant, its Affiliates
or their Qualified Designees during the Term on or before [***] i.e., such Drug
Substance under the Letter of Intent, an amount of [***] of such Drug Substance
as set forth in Schedule 3.1 hereto.
(b)    [***]. For the Drug Substance to be delivered to Myovant, its Affiliates
or their Qualified Designees during the Term between [***] Myovant shall pay
Takeda a fixed amount of [***] of such Drug Substance as set forth in Schedule
3.1 hereto.
(c)    [***]. and Thereafter: For the Drug Substance to be delivered to Myovant,
its Affiliates or the Qualified Designee during the Term on or after [***], that
certain amount of the price per kilogram of such Drug Substance; provided,
however, that: (i) Takeda shall use its commercially reasonable efforts to [***]
and, (ii) on or before [***], the Parties will review such price and renegotiate
in good faith an increase or decrease therein as reasonably needed. For clarity,
there shall be no change to the price under this Section 3.1.2(c) except
pursuant to a mutual written amendment or a substitution of Schedule 3.1 hereto,
in each case in accordance with Section 19.13 hereof.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
5

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3.2    Invoicing. Takeda shall submit to Myovant an invoice for the Drug
Substance upon delivery thereof to Myovant hereunder. In addition, Takeda shall
send each such invoice to: [***]. Each invoice shall be accompanied by the
following information: an applicable Purchase Order number(s), [***] for each of
the foregoing in accordance with Section 3.1 hereof, and [***] in each case, in
accordance with this Agreement. Without limiting the generality of the
foregoing, each invoice so submitted to Myovant shall be accompanied by [***],
and any other payment information or documentation with respect to the [***] as
reasonably needed, available, and permitted to do so. Myovant shall pay such
invoices in accordance with Article 13 hereof.
3.3    Currency; Exchange Rate. The prices as referred to in Sections 3.1.1(a)
and 3.1.2(a) hereof; and those in Sections 3.1.1(b) and 3.1.2(b) hereof, are set
given the prevailing [***] exchange rate [***] announced by [***] on: [***] and
thereafter, on [***] (or, in the case of bank holiday, the first regular
business day thereof) [***]. Except as otherwise agreed on by the Parties in
writing, any impact on such prices due to the currency fluctuation of more than
[***] from the applicable Base Exchange Rate, as measured at the time payment is
due under this Agreement, shall be [***] borne and duly settled by both Parties.
ARTICLE 4
TECHNOLOGY TRANSFER
4.1    General. For the purposes of technology transfer process described in
Section 4.2 of the License Agreement with respect to Drug Substance, this
ARTICLE 4 sets forth the rights and duties of the Parties to provide technology
transfer services with respect to the Manufacture of Drug Substance. For
clarity, Section 4.2 of the License Agreement shall remain in full force and
effect.
4.2    Technology Transfer.
4.2.1    Transition Plan. In accordance with the transition plan attached hereto
as Exhibit B (the “Drug Substance Transition Plan”), as may be amended or
modified by the Parties from time to time upon mutual written agreement, Takeda
shall use reasonable efforts to make available to Myovant's initial CMO all
Takeda Know-How [***] that is reasonably necessary or useful to enable the
Manufacture of Drug Substance up until the successful completion of the
applicable process validation protocol for such CMO to Myovant's reasonable
satisfaction (the “Transition Completion”), including without limitation all
Inventions and other improvements to the Manufacture of Drug Substance
discovered or developed in connection with this Agreement, by or on behalf of
Myovant (the “Takeda Manufacturing Know-How”), by providing copies or samples of
relevant documentation, materials, and other embodiments of such Takeda
Manufacturing Know-How, including data within reports, notebooks, and electronic
files. Takeda shall perform the tasks and deliver each deliverable pursuant to
the Drug Substance Transition Plan. If the Parties disagree on the occurrence of
Transition Completion, then either Party may refer such disagreement to the JRC
for a final determination that shall be binding on both Parties in accordance
with the terms of License Agreement as applicable. Except as otherwise expressly
specified in the Drug Substance Transition Plan, Takeda shall be permitted to
make such Takeda Manufacturing Know-How available in such form as Takeda
determines in its sole reasonable discretion, including, if Takeda so elects, in
the form such Takeda Manufacturing Know-How is maintained by Takeda. If
reasonably requested by Myovant or such Qualified Designee, Takeda may translate
any Takeda Manufacturing Know-How into English as part of the Transition
Services to be performed by Takeda in accordance with Section 4.2.3 hereof. For
clarity, Takeda shall be only required to perform the activities set forth in
the Drug Substance Transition Plan with respect to Myovant or such Qualified
Designee. If Myovant wishes to transfer the Takeda Know-How to any other
Qualified Designee, then Myovant (and its initial Qualified Designee) shall be
solely responsible for such technology transfer thereto; provided, however, that
if Myovant reasonably requests Takeda’s assistance, Takeda may provide such
assistance as far as reasonably needed and available to Takeda. In any event,
all the technology transfer services conducted by Takeda hereunder shall be at
Myovant’s sole cost and expense.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
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4.2.2    Takeda Materials. Any materials, including [***] provided by Takeda in
connection with the transfer of the Takeda Manufacturing Know-How hereunder (the
“Takeda Materials”) shall remain the sole property of Takeda. Subject to the
foregoing and any other obligations as applicable hereunder and the License
Agreement, Myovant may, in connection with transferring the Takeda Manufacturing
Know-How to any Qualified Designee, transfer Takeda Materials thereto; provided,
however, that Myovant shall (a) itself retain legal control of all such Takeda
Materials, including, but not limited to, the right to require any Qualified
Designee to return all such Takeda Materials to Myovant at Myovant’s request,
(b) use such Takeda Materials only in the fulfillment of obligations or exercise
of rights under this Agreement, including, but not limited to, to transfer the
Takeda Manufacturing Know-How to Qualified Designees, (c) not use such Takeda
Materials or deliver the same to, or for the benefit of, any Third Party (other
than Qualified Designees), without Takeda’s prior written consent, and (d) not
use such Takeda Materials in research or testing involving human subjects except
as expressly provided under this Agreement or the License Agreement.
4.2.3     Transition Services. Takeda shall perform certain services to
facilitate the technology transfer described in Section 4.2.1 hereof in
accordance with the Drug Substance Transition Plan (the “Transition Services”).
Myovant shall reimburse Takeda as described on Schedule 4.2.3 hereto for all
internal costs, and external costs, charges, and expenses, in each case,
reasonably incurred by Takeda in connection with any Transition Services
requested by Myovant and agreed to by Takeda, including, but not limited to,
those so incurred heretofore. For clarity, the FTE Rate set forth in such
Schedule shall be applicable only under this Agreement, and shall not be
construed to amend any terms of the FTE and FTE Rate in the License Agreement
whatsoever and howsoever. Myovant shall be responsible for any Third Party
expenses incurred by either Party in connection with the Transition Services.
Takeda shall invoice Myovant for any reimbursement for any Transition Services
to which it is entitled under this Section 4.2.3 [***], and Myovant shall pay
all invoices submitted by Takeda within [***] of the date of receipt of the
invoice. Myovant stipulates that such cooperation shall not require Takeda to
conduct any research or Development activities.
4.2.4    Additional Transition Services. With respect to any Transition Services
outside the scope of the Drug Substance Transition Plan, at the reasonable
written request of Myovant, Takeda shall negotiate in good-faith, and may (in
any event, shall not be obligated, but will not unreasonably refuse, to) provide
such additional Transition Services, as reasonably needed and available, in
order to support transfer of Manufacturing technology and additional Takeda
Materials, including without limitation by providing documentation, information
and other materials reasonably available and necessary for the Manufacture of
Drug Substance or taking any action(s) reasonably available and necessary to
comply with any request or demand of any Regulatory Authority, to Myovant or the
Qualified Designees (“Additional Transition Services”). For clarity, Takeda
shall not be obligated (but will not unreasonably refuse) to conduct hereunder
any experiments and studies whatsoever for the data and information on the Drug
Substance not available to Takeda then. Myovant shall reimburse Takeda for such
Additional Transition Services under the same terms as provided in Section 4.2.3
hereof. At the reasonable written request of Myovant for any Additional
Transition Services for the transfer of documentation, information and other
materials reasonably available and necessary for the Manufacture of Drug
Product, further, the Parties shall negotiate in good-faith, and may (as for
Takeda, in any event, shall not be obligated to) enter into a subsequent
transition plan therefor (the “Drug Product Transition Plan”). The Drug Product
Transition Plan so entered shall set forth the timelines, obligations,
deliverables and other duties of each Party with respect to the transfer of
Takeda Materials reasonably available and necessary for the Manufacture of Drug
Product. In any event, Takeda shall not be required to conduct any of the
Additional Transition Services hereunder for [***].

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
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4.2.5    Improvements to Manufacturing Technology. Subject to the applicable
terms and conditions of the License Agreement, among others, those in its
Article 10 (Intellectual Property Matters) and Sections 13.1 (Term) and 13.13
(Survival), during the Term and thereafter, each Party shall promptly disclose
to the other Party in writing any [***] relating to the Manufacture of Drug
Substance, including pursuant to Section 7.3 hereof (such [***], the
“Manufacturing Improvements”), including with each such notice a detailed
technical description and a summary of the potential costs and benefits of such
Manufacturing Improvements. Promptly upon receipt of such notice, the Parties
shall in good faith discuss whether such Manufacturing Improvement(s) should be
implemented by the disclosing Party and, upon the other Party’s request, a
process to transfer such Manufacturing Improvement(s) to such other Party at the
cost and expense of such other Party in accordance with Section 4.2.3 hereof (in
the case of a transfer from Myovant to Takeda, such provisions shall apply
mutatis mutandis). For clarity, Takeda may in its sole reasonable discretion,
implement any of such Manufacturing Improvements as needed to conduct the
Manufacture of TAK-385 Licensed Compound and/or TAK-385 Licensed Product for the
Development and Commercialization thereof in Takeda Territory, subject to the
terms and conditions of change control as applicable to the Drug Substance under
the Quality Agreement.
ARTICLE 5
REGULATORY ACTIVITIES AND RESPONSIBILITIES
5.1    General Obligations of Takeda. Takeda shall, or shall cause its
Affiliates or Third Parties on its behalf to, (a) perform its obligations under
this Agreement in compliance with all Applicable Laws, including all GMPs, and
in accordance with the Quality Agreement, (b) undertake all regulatory activity
with respect to the Manufacture of the Drug Substance hereunder, including
components thereof, such as the [***], in accordance with the License Agreement
(among others, its Sections 6.1 (Regulatory Materials and Regulatory Approvals),
6.2 (Regulatory Cooperation), 7.1 (Commercialization Responsibilities) and 7.2
(Commercialization Diligence Obligations), given its Section 5.2 (Development
Diligence Obligations)) and as otherwise required by Applicable Laws or
Regulatory Authorities. Subject to any other terms of this Agreement as
applicable, including those in Section 7.2 (Modifications) hereof, Takeda shall
be responsible for obtaining and maintaining all Permits and fees required by
any Regulatory Authority with respect to any Takeda Manufacturing facility where
any aspect of the Drug Substance is Manufactured hereunder.
5.2    General Obligations of Myovant. Other than Takeda’s responsible Permits
and fees related to Takeda’s Manufacturing facilities pursuant to Section 5.1
hereof, Myovant shall obtain and maintain at its expense during the Term all
permits as well as all Regulatory Approvals required for Myovant to use the Drug
Substance in accordance with the License Agreement and fulfill its obligations
under this Agreement and the Quality Agreement. Myovant shall, and shall ensure
that its Affiliates, Sublicensees and Subcontractors: (a) comply with the
requirements and restrictions of any permits and other Applicable Laws
applicable to the use of the Drug Substance in accordance with the License
Agreement; (b) use the Drug Substance in compliance with Applicable Laws; and
(c) comply with Myovant’s obligations under this Agreement.
5.3    Communication with Regulatory Authorities. Notwithstanding anything to
the contrary in the License Agreement, including but not limited to Article 6
therein, or the Quality Agreement, Takeda shall promptly notify Myovant
following receipt by Takeda of any regulatory inquiry or communication, or the
occurrence of any inspection, regarding the Manufacture of Drug Substance in
compliance with GMP. If Takeda or its Affiliate(s) or Subcontractor(s) receive
notice of an inspection or an inspection visit by any Governmental Authority
that directly involves Drug Substance or is likely to materially impact Takeda’s
ability to supply Drug Substance to Myovant hereunder, Takeda shall give Myovant
prompt written notification thereof (but in no event later than [***] after
Takeda receives such notice) and Takeda shall provide Myovant with copies of
applicable documentation with respect thereto, and Myovant shall have a
reasonable opportunity to review and comment on Takeda’s proposed response;
provided, however, that Myovant’s opportunity to review and comment shall not be
extended so as to cause any response of Takeda to be later than is required by
such Governmental Authority. Unless prohibited by Applicable Law, Takeda shall
allow a representative of Myovant to be present at and observe any inspection by
any Governmental Authority concerning Drug Substance. All other communications
with Regulatory Authorities, including without limitations any regulatory
audits, shall be governed by the License Agreement and Quality Agreement.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
8

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ARTICLE 6
FORECASTING AND ORDERING
6.1    Forecasts and Purchase Orders.
6.1.1    Forecasts. Not later than [***] of the Effective Date of this
Agreement, Myovant shall submit to Takeda, Myovant’s forecast for its desired
quantities of the Drug Substance to be delivered to Myovant on a Calendar
Quarter-by-Calendar Quarter basis for the first proceeding [***] full Calendar
Quarters of the Term (the “Initial Rolling Forecast”). No later than the [***]
Business Day of each Calendar Quarter during the remainder of the Term, Myovant
shall provide to Takeda a rolling forecast for the then proceeding [***]
Calendar Quarters (the Initial Rolling Forecast and each such subsequent
forecast, a “Rolling Forecast”). Myovant shall submit each Rolling Forecast to
the addressee of contact for Takeda listed in Schedule 6.1.1 hereto, which
addressee Takeda may change by providing a written notice to Myovant from time
to time during the Term. The Rolling Forecast shall set forth the desired
quantity of Drug Substance in full lot increments or decrements.
6.1.2    Binding Quantities.
(a)    Initial Firm Order. Myovant shall order and hereby orders, and Takeda
shall supply to Myovant, the Drug Substance set forth on Schedule 6.1.2(a) (the
“Initial Firm Order”), which sets forth the quantities of Drug Substance to be
delivered through the [***] (such period, the “Initial Firm Order Period”).
Notwithstanding anything in this Agreement to the contrary, Takeda hereby
irrevocably accepts the Initial Binding Order.
(b)    Subsequent Firm Orders. After the Initial Firm Order Period, the first
[***] of each Rolling Forecast for Drug Substance submitted by Myovant (the
Initial Firm Order Period and each such subsequent period, as applicable, a
“Firm Order Period”) shall be, unless Takeda otherwise notifies Myovant not
later than [***] Business Days after Takeda's actual receipt thereof, binding
upon Myovant and Takeda, and shall constitute a firm order (the Initial Firm
Order and each such subsequent firm order, a “Firm Order”). For clarity, the
Rolling Forecast issued in accordance with Section 6.1.1 on the [***]. The
remainder of each Rolling Forecast that is not within the Firm Order Period
shall be non-binding upon Myovant and Takeda, and may be changed by Myovant
thereafter, subject to Takeda's rights and remedies available hereunder, among
others, those pursuant to Sections 6.1.2 through 6.1.4 (both inclusive) hereof.
(c)    Notwithstanding anything to the contrary in this Agreement other than
Section 18.3 (Consequences of Termination) hereof, as for the Initial Firm Order
or any Firm Order, if Myovant makes reductions with respect to the Initial Firm
Order Period or any Firm Order Period in any subsequent Rolling Forecast or
otherwise and fails to accordingly order and purchase such Drug Substance for
any reason whatsoever, then, subject to Section 17.2 hereof, Myovant shall [***]
reasonably accrued to or incurred by Takeda arising out of or in connection with
such change or failure and pursuant to Section 6.1.4 hereof (and without
prejudice to those for the experiment, return and otherwise disposal thereof);
provided, however, that Takeda makes its commercially reasonable efforts to
[***].
6.1.3    Purchase Orders.
(a)    Issuance and Acceptance. In addition to its submission of a Rolling
Forecast, Myovant shall submit to Takeda, a purchase order for Drug Substance (a
“Purchase Order”) in the quantity set forth in the Initial Firm Order and any
subsequent Firm Order. Each Purchase Order shall specify (i) the quantity of
Drug Substance and (ii) the desired delivery date and location, on the basis of
[***], in each case in accordance with the Initial Firm Order or such Firm Order
(as applicable), no later than [***] before the desired delivery date of Drug
Substance. Such Purchase Order shall be accepted by Takeda unless, excluding
with respect to Purchase Orders for the Initial Binding Order, Takeda otherwise
notifies Myovant not later than [***] Business Days after Takeda's actual
receipt thereof. For clarity, Takeda shall accept all Purchase Orders that
correspond to the Initial Firm Order. To the extent of any conflict between a
Purchase Order and this Agreement, this Agreement shall control.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
9

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(b)    Deviations from the Firm Order. If the quantity set forth in a given
Purchase Order exceeds the quantity set forth in the corresponding Firm Order,
Takeda shall use its reasonable efforts to satisfy the amount contained in such
Purchase Order; provided, however, that Takeda shall not be required to
Manufacture and supply the quantity set forth in such Purchase Order that
exceeds the quantity set forth in the corresponding Firm Order. For the
avoidance of doubt, such reasonable efforts shall not require Takeda [***]. For
clarity, further, Myovant cannot issue a Purchase Order that is less than the
quantity set forth in the corresponding Firm Order for Drug Substance.
6.1.4    [***].
(a)    Reimbursement by Myovant. The Parties acknowledge that: (a) Takeda will
order [***] from Third Parties based on the quantities and delivery dates
specified in each Rolling Forecast for delivery of Drug Substance under this
Agreement unless Takeda otherwise notifies Myovant not later than [***] Business
Days after Takeda's actual receipt thereof; and (b) the sum that Myovant is
obligated to pay Takeda for Drug Substance in accordance with Section 3.1.1
hereof is based on the costs of [***] in the Manufacture of such Drug Substance
under this Agreement. Therefore, if (i) in any Rolling Forecast, Myovant reduces
the quantity of Drug Substance forecast during the first [***] Calendar Quarters
of such Rolling Forecast from the quantity that was forecasted for the same
period in the then immediately prior Rolling Forecast, and (ii) Takeda incurs
any non-cancellable costs for purchase of [***] that (A) is no longer needed to
Manufacture Drug Substance under this Agreement as a result of such reduction
and (B) cannot be used or sold by Takeda or its Affiliates for some other
purpose, including to satisfy Takeda’s own requirements for [***], then Myovant
shall pay Takeda [***] provided, however, that in no event shall Myovant be
obligated to [***].
(b)    Storage Fees. If Myovant notifies Takeda that Myovant wishes to delay the
delivery of Drug Substance forecast during the first [***] Calendar Quarters of
any Rolling Forecast and requests that Takeda store [***] for use in the
Manufacture of such delayed Drug Substance, then Myovant and Takeda will discuss
reasonable storage fees that would, upon written agreement, be paid by Myovant
for storage of such [***].
6.2    Delivery. Subject to Section 19.1 hereof, Takeda shall supply the Drug
Substance under a Purchase Order as accepted in accordance with Section 6.1.3(a)
by way of delivery pursuant to Article 8 hereof. If Takeda is unable to meet the
specified delivery date thereunder, Takeda shall notify Myovant as soon as
reasonably practicable after becoming aware thereof, and both Parties shall
promptly discuss with each other the then optimal solution in good faith. By way
of example, Takeda may provide to Myovant an alternative delivery date which is
as close to the originally agreed delivery date as reasonably possible. Delivery
by Takeda of up to [***] of the quantity of Drug Substance under a given
Purchase Order shall be accepted by Myovant in full satisfaction of Takeda’s
obligation to supply such Purchase Order, subject to Myovant’s inspection of the
Drug Substance in accordance with Section 9.1 hereof.
6.2.1    Shelf-Life. With respect to the Manufacture of Drug Substance under
this Agreement, the length of time that elapses between the date that such Drug
Substance was Manufactured and the date that such Drug Substance must be
re-tested as determined by Takeda (the “Shelf-Life”) shall be no less than [***]
months. For Drug Substance with a Shelf-Life of [***] months, the remaining
Shelf-Life at the time such Drug Substance is delivered to Myovant shall be no
less than [***] months. For Drug Substance with a Shelf-Life of [***] months,
the remaining Shelf-Life at the time such Drug Substance is delivered to Myovant
shall be no less than [***] months. In the case of such remaining Shelf-Life at
delivery being (or anticipated to be) less than the foregoing, then Takeda shall
notify Myovant promptly after Takeda’s receipt of the applicable Purchase Order
and may deliver the Drug Substance on a schedule agreed to in writing by
Myovant.
6.2.2    Testing by Takeda. Prior to delivery by Takeda pursuant to Section 8.1
hereof, Takeda shall undertake release testing to obtain a Quality Release for
each batch of the Drug Substance that is Manufactured pursuant to a Purchase
Order and in accordance with the terms of the Quality Agreement.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
10

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6.2.3    Provision of Records. With each batch of Drug Substance delivered by
Takeda pursuant to Section 8.1 hereof, Takeda shall provide all Batch
Documentation for such batch, including a certificate of analysis, Quality
Release and certificate of conformance, in accordance with the terms of the
Quality Agreement.
6.2.4    Delayed Deliveries. Takeda shall notify Myovant as soon as reasonably
practicable after becoming aware that it will not be able to deliver the Drug
Substance by the delivery date specified in the relevant Purchase Order as
accepted in accordance with Section 6.1.3(a), and both Parties shall promptly
discuss with each other the then optimal solution in good faith. If Takeda
delivers Drug Substance more than [***] days after the delivery date specified
in the relevant Purchase Order and such failure is not attributable to Myovant,
then Takeda shall allocate inventory of Drug Substance in accordance with
Section 6.5 hereof. Except as expressly set forth in this Agreement or otherwise
agreed on by the Parties in writing, if Takeda materially fails to deliver Drug
Substance by the delivery dates under the applicable Purchase Order(s) as
accepted for [***] consecutive Calendar Quarters in a Fiscal Year, then Myovant
shall have the right to terminate this Agreement pursuant to Section 18.2.1
hereof.
6.3    Notice of Potential Inability to Supply. Takeda shall inform Myovant of
any events that may prevent Takeda from fulfilling its supply obligations with
respect to amounts of Drug Substance pursuant to any portion of any Firm Order
as soon as reasonably practicable after becoming aware of such events. In the
event Takeda notifies Myovant of a potential inability to supply Drug Substance,
the Parties shall promptly discuss with each other the then optimal solution in
good faith. If Takeda’s inability to fulfill its supply obligation is due to the
[***] and/or [***] or because [***] of Takeda and/or its supplier is such that
Takeda and/or its supplier is unable to meet the demand for Drug Substance
requested by Myovant, and except as otherwise set forth herein, [***], including
Myovant and Takeda, by way of example, in such proportion as the [***].
6.4    Supply Shortage; Allocation. Notwithstanding anything to the contrary
herein, within [***] days after the occurrence of any failure to deliver at
least [***] of the quantities of Drug Substance in accordance with Purchase
Orders as accepted for delivery in [***] consecutive Calendar Quarters (a
“Supply Shortage”), and except as otherwise set forth herein and upon
consultation with Myovant in good faith, then Takeda shall allocate deliveries
of Drug Substance in accordance with Section 6.5 hereof. Takeda shall use its
commercially reasonable efforts to minimize the duration of any Supply Shortage
6.5    Allocation. If an event occurs that requires Takeda to allocate Drug
Substance in accordance with either Section 6.2.4 (Delayed Delivery) or Section
6.4 (Supply Shortage) hereof (an “Allocation Event”), then Takeda shall: (a)
provide Myovant, no later than [***] after the Allocation Event, with [***]; (b)
allocate and deliver to Myovant, as soon as possible but no later than [***]
after such Allocation Event, that [***] (such fraction, the “Allocation
Proportion”); and (c) [***] pursuant to all applicable Purchase Orders, deliver
to Myovant no later than the [***] a quantity of Drug Substance equal to the
[***], in addition to [***]. For example and without limitation, if Takeda is
obligated to deliver [***].
ARTICLE 7
MANUFACTURING
7.1    Conformance with GMP. Takeda shall Manufacture and supply the Drug
Substance that conforms to GMPs, Applicable Laws, the Specifications, the
Quality Agreement and any other applicable terms of this Agreement, including
Sections 6.2.1 (Expiration Date) and 7.4 (Manufacturing Location) hereof.
7.2    Modifications. Takeda shall not modify the Specifications, Manufacturing,
and testing processes, in each case, employed with regard to the Manufacture of
the Drug Substance or any component thereof, including the [***] (a
“Manufacturing Change”), other than in accordance with this Section 7.2.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
11

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7.2.1    Modifications Required by Regulatory Authorities in Myovant Territory.
Notwithstanding anything to the contrary herein, if any Regulatory Authority in
the Licensee Territory requires, even before, upon or after its Regulatory
Approval as applicable to the Drug Substance supplied hereunder, that Myovant
implement a Manufacturing Change (each, a “Required Modification”), then Takeda
shall, upon receipt of written notice from Myovant describing in reasonable
detail such Required Modification, discuss in good faith such Required
Modification, including its [***], and prepare and deliver to Myovant, as soon
as possible but no later than [***] days after such notice, a written reasonable
estimate of (a) [***] for implementing such Required Modification, (b) a [***]
such Required Modification, (c) any [***] to fulfill Firm Orders and (d) [***]
substantially in connection with such Required Modification (collectively, the
“Estimate”). The Parties shall discuss with each other such Estimate in good
faith to reach agreement thereon, including but not limited to any change in
Firm Orders [***] Myovant shall pay for Drug Substance, as well as any
regulatory impacts on the TAK-385 Licensed Product or TAK-385 Licensed Compound
for the Takeda Territory. Upon the mutual written agreement on any terms and
conditions as applicable (the “Manufacturing Change Order”), both Parties shall
duly: (i) implement the applicable Regulatory Modification(s) in accordance with
the Manufacturing Change Order; and (ii) provide each other with all Regulatory
Materials that are required by Regulatory Authorities in the Licensee Territory
and Takeda Territory in connection with such Required Modification.
7.2.2    Modifications Not Required by Regulatory Authorities. If either Party
wishes to make any Manufacturing Change other than a Required Modification (an
“Optional Modification”), then such Party shall notify the other Party in
writing of such proposed Optional Modification. Promptly thereafter, the Parties
shall discuss in good faith (a) [***] Optional Modification, (b) its [***] for
the Manufacturing of Drug Substance or Drug Product or on any Regulatory
Approvals or applications for Regulatory Approvals anywhere in the world for any
TAK-385 Licensed Product and (c) [***] Optional Modification.
7.3    Continuous Improvement. The Parties, through the JMWG, JRC and other ad
hoc meetings held between the Parties from time to time during the Term, shall
make reasonable efforts to strive to identify ways to improve the processes for
Manufacture of the Drug Substance and optimize the costs of Manufacture and the
price for Drug Substance. Without limiting the generality of the foregoing, the
JMWG shall develop [***] for Manufacture of the Drug Substance, and shall [***].
In the event that either Party, or any of their respective Affiliates,
Subcontractors or Sublicensees, identifies or otherwise becomes aware of any
measures for improving performance of the Manufacturing obligations hereunder,
then such Party shall promptly notify the other Party of such improvement, and
the Parties shall negotiate in good faith each Party’s responsibility for
implementing such measures and associated costs. Without limiting the generality
of the foregoing, no later than [***] days following the end of each Fiscal Year
(or upon such other frequency as mutually agreed upon by the Parties), the JMWG
shall cooperate to create a written proposal describing [***] in the Manufacture
of Drug Substance that have been identified pursuant to this Agreement (“[***]
Report”), including any input received from Myovant and Takeda for achieving
[***]. The Parties, through the JMWG, shall consider in good faith the [***]
Report to develop a plan for implementing such changes in the Manufacture of
Drug Substance hereunder.
7.4    Manufacturing Location. Subject to the terms and conditions of change
control in accordance with the Quality Agreement, Takeda shall duly Manufacture
the Drug Substance supplied hereunder at the [***] by using the [***].
7.5    Quality Agreement. Upon the full execution of this Agreement and no later
than [***] days thereafter, the Parties shall use commercially reasonable
efforts to enter into the Quality Agreement, which shall define roles and
responsibilities, change control, release authority, GMP requirements, sampling,
testing and retain plans, specifications, preventative maintenance, dispute
resolution and other aspects related to quality of Drug Substance, including the
[***]. The Quality Agreement shall be governed by this Agreement. In the case of
any conflict with the terms of Quality Agreement, the terms of this Agreement
shall prevail.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
12

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ARTICLE 8
DELIVERY, TITLE AND RISK OF LOSS
8.1    Shipment Terms; Title; Risk of Loss. All Drug Substance shall be
delivered to Myovant or the Qualified Designees, [***], shipped by a common
carrier designated by Myovant in the Purchase Order, at Myovant’s expense. Title
and risk of loss shall transfer to Myovant, and delivery shall be deemed to have
occurred, when [***]. Myovant shall procure, at its cost, [***] to the Drug
Substance for the shipping.
8.2    Importer of Record, etc. Myovant shall be responsible for any and all
aspects whatsoever of the shipping of Drug Substance hereunder, including but
not limited to: (a) customs and other regulatory clearance of the Drug
Substance; (b) payment of all tariffs, duties, customs, fees, expenses and
charges payable in connection with the exportation, importation and delivery of
the Drug Substance; and (c) keeping all records, documents, correspondence and
tracking information required by Applicable Laws arising out of or in connection
with the exportation, importation and delivery of such Drug Substance.
ARTICLE 9
NON-CONFORMING PRODUCT/RETURNS
9.1    Claims for Detectable Defects. Myovant shall notify Takeda within [***]
days after receipt by Myovant or its designated dosage form manufacturer of any
shipment of the Drug Substance supplied by or on behalf of Takeda of the
existence and nature of any defect in or failure of the Drug Substance to comply
with Section 5.1 or Section 7.1 hereof at the time of delivery hereunder that
could have been detected by a reasonable physical inspection of the Drug
Substance at such time (“Detectable Defects”). If such notice is not provided
within such [***] day period, then such Drug Substance shall be deemed not to
have any Detectable Defects, Myovant shall be deemed to have accepted the Drug
Substance, and Takeda shall have no further responsibility for such Detectable
Defects. For the purposes hereof, a non-conformity relating to stability of the
Drug Substance shall not be considered a Detectable Defect.
9.2    Claims for Non-Detectable Defects. Myovant shall notify Takeda within
[***] Business Days upon discovery of any defect in or failure of the Drug
Substance to comply with Section 5.1 or Section 7.1 hereof that is not a
Detectable Defect. Claims that are submitted by Myovant shall state the nature
of the alleged defect, including how such alleged defect was discovered, in
detail reasonably sufficient to enable Takeda to identify the nature of the
alleged defect or to dispute the same, and to determine that the defect existed
at the time of delivery.
9.3    Provision of Samples. Myovant shall, when notifying Takeda of an alleged
defect, provide samples of any allegedly defective Drug Substance and copies of
written reports or investigations performed by or on behalf of Myovant on such
allegedly defective Drug Substance.
9.4    Referral to Independent Laboratory. In the event of a dispute between the
Parties as to any defect in a Drug Substance, including whether a defect was a
Detectable Defect or whether such defect existed at the time of delivery
hereunder, that cannot be resolved within [***] days of a claim being made to
Takeda pursuant to Section 9.1 or Section 9.2 hereof, the matter shall promptly
(but in no case later than [***] Business Days after the expiration of such
[***] day period) be submitted to an independent, qualified laboratory to be
mutually agreed between the Parties. Such independent laboratory will examine
the Drug Substance at issue and determine the existence and, if relevant, the
timing of any defect in the Drug Substance. The decision of such independent
laboratory shall be binding on the Parties, except in the case of fraud. Myovant
shall bear the costs of such independent laboratory if such independent
laboratory finds that the Drug Substance was not defective or that such defect
did not exist at the time of delivery hereunder. Takeda shall bear the costs of
such independent laboratory if such independent laboratory finds that the Drug
Substance was defective at the time of delivery hereunder.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
13

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9.5    [***]; Defective Product. Following a claim from Myovant pursuant to
Section 9.1 or Section 9.2 hereof, and without limiting any of Myovant’s
remedies with respect to any breach by Takeda of this Agreement or otherwise
hereunder, Takeda’s sole obligation with respect to replacing defective Drug
Substance in the event that Takeda accepts Myovant’s claim as valid or the
independent, qualified laboratory as duly agreed above in Section 9.4 hereof
decides in favor of Myovant’s claim, shall be to either, at Myovant’s election,
(a) provide Myovant, within [***] days after Takeda's receipt of the written
notice of election by Myovant, with [***] or (b) [***]. Any Drug Substance that
is agreed or determined to be defective shall be, as directed by Takeda, either
destroyed by Myovant or returned to Takeda, in both cases at Takeda’s expense.
Except for Takeda’s obligations under Article 11 and Article 17 hereof, Takeda
shall have no liability for defective Drug Substance other than as provided in
this Article 9.
ARTICLE 10
STORAGE, HANDLING AND TRANSPORT
10.1    Takeda’s Responsibilities. Before the delivery of Drug Substance
hereunder, the Drug Substance and [***] to be used for the Manufacture thereof
shall be stored, handled, packaged, and transported in accordance with the
requirements of this Agreement, the Quality Agreement and all Applicable Laws.
Takeda shall maintain appropriate quality assurance and quality control
standards and record-keeping practices, including systems, resources and
procedures in order to satisfy these obligations.
10.2    Myovant Storage, Handling and Transport of Drug Substance. Upon or after
the delivery of Drug Substance hereunder, Myovant shall be responsible to store,
handle and transport the Drug Substance in accordance with the terms hereof,
obtain at its sole expense all equipment, facilities and personnel necessary
therefor and pay all other costs and expenses in connection therewith. If
Myovant, for any reason (other than as a result of a claim for a defect pursuant
to Section 9.1 or Section 9.2 hereof), refuses to take delivery or possession of
any Drug Substance, Myovant shall, notwithstanding Section 17.2 hereof, promptly
upon receipt of an invoice from Takeda, reimburse Takeda for [***] fees that
Takeda may have incurred prior to such refusal by Myovant.
10.3    Notice of Inspections by Regulatory Authorities. The Parties’
obligations with respect to any inspections or audits by any Regulatory
Authority related to the Drug Substance shall be governed by Section 5.3 hereof
and the Quality Agreement.
ARTICLE 11
RECALL
The Parties’ obligations with respect to a recall of the Drug Substance or Drug
Product shall be governed, as applicable, by the Quality Agreement and the
License Agreement, including Section 6.4.2 (Recalls) of the License Agreement;
provided, however, that for purposes of this Article 11: (a) Takeda shall have
the obligations of TPIZ under such Section 6.4.2, and Myovant shall have the
obligations of Myovant Ltd. thereunder; and (b) all references in such Section
6.4.2 to the License Agreement shall refer to this Agreement.
ARTICLE 12
TECHNICAL SUPPORT SERVICES
[Intentionally left blank]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
14

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12.1    Technical Support Services. Beginning on the Effective Date and
continuing until the termination of this Agreement, upon the mutual agreement at
the reasonable request of Myovant, Takeda may provide Myovant or the Qualified
Designees with reasonable technical, regulatory, CMC and other related services
in support of the Manufacturing of Drug Substance or Drug Product that Takeda is
not required to provide under any other provision of this Agreement (the
“Technical Support Services”). Any Technical Support Services provided by Takeda
shall be documented in work orders, executed by both Parties and substantially
in the form attached as Exhibit C (each a “Project Work Order”). Such Technical
Support Services may be provided from Takeda’s or its Affiliates’ facilities
unless otherwise expressly set forth in a Project Work Order. Unless otherwise
expressly provided in a Project Work Order, any Inventions or other Information
arising out of Takeda’s performance of the any Technical Support Services shall
be governed by Article 14 of this Agreement. In furtherance of the Technical
Support Services, the Parties may agree that Takeda will ship small quantities
of Drug Substance or Drug Product to Myovant or the Qualified Designees. Unless
otherwise agreed on by the Parties in the applicable Project Work Order, any
such shipment shall be subject to the applicable terms and conditions, including
but not limited to those in Article 8 or Article 9, of this Agreement.
12.2    Reimbursement for Additional Technical Support Services. Myovant shall
compensate Takeda for those FTEs providing the Additional Technical Support
Services as described in Schedule 4.2.3 hereto, and shall reimburse Takeda for
all reasonable documented out-of-pocketed expenses incurred by Takeda to perform
Additional Technical Support Services, provided that, unless otherwise agreed in
a Project Work Order, any such out-of-pocket expenditure over [***] shall be
approved in advance by Myovant. Takeda shall invoice Myovant within [***] days
after the end of each Calendar Quarter for [***] incurred by Takeda during the
preceding Calendar Quarter for the Additional Technical Support Services, which
shall include a record of FTE hours by individual and date and a brief
description of work performed, and Myovant shall pay such invoice in accordance
with Article 13 hereof.
ARTICLE 13
PAYMENT TERMS
13.1    Payment Terms. Myovant shall pay any amount invoiced by Takeda pursuant
to this Agreement that is not disputed in writing by Myovant within [***] days
after receipt of such invoice, subject to the terms and conditions, as
applicable to Drug Substance not having Detectable Defects, in Section 9.1
hereof. Myovant shall make all payments for invoices issued by Takeda in
Japanese Yen by wire-transfer to Takeda’s account designated below or to such
other account as Takeda may specify by written notice to Myovant in accordance
with Section 19.2 hereof.
Bank Name:
[***]
Branch:
[***]
Address:
[***]
Account #:
[***]
Beneficiary’s
Name:
Takeda Pharmaceutical Company Limited
Beneficiary’s
Address:
[***]

13.2    Taxes. Myovant shall pay any applicable taxes, including [***] imposed
by relevant taxing authorities as a result of payments it makes to Takeda
pursuant to this Agreement (“Payments”). All [***] tax, gross receipts tax and
foreign withholding tax, applicable to payments Myovant makes to Takeda pursuant
to this Agreement shall be the sole responsibility of Takeda. Each Party will
provide to the other Party any resale exemption, multiple points of use
certificates, treaty certification and other exemption information reasonably
requested by the other Party.
13.3    Late Payment. If Myovant fails to pay and fails to dispute any invoiced
amount within [***] days of receipt of such invoice, simple interest shall
thereafter accrue on the sum due to Takeda until the date of payment at the per
annum rate of [***] over the then-current prime rate quoted by Citibank in New
York City or the maximum rate allowable by Applicable Laws, whichever is lower.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
15

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ARTICLE 14
INTELLECTUAL PROPERTY
Any Inventions or other Information arising in furtherance of this Agreement
shall be subject to the Parties’ obligations set forth in the License Agreement,
including those set forth in Article 10 of the License Agreement; provided,
however, that for purposes of this Article 14: (a) Takeda shall have the
obligations of TPIZ under Article 10 of the License Agreement and Myovant shall
have the obligations of Myovant Ltd. under Article 10 of the License Agreement;
and (b) all references in Article 10 to the License Agreement shall refer to
this Agreement.
ARTICLE 15
CONFIDENTIALITY
A Party’s obligations with respect to any Confidential Information of the other
Party received in furtherance of this Agreement shall be governed by the License
Agreement, including Article 12 of the License Agreement; provided, however,
that for purposes of this Article 15: (a) Takeda shall have the obligations of
TPIZ under Article 12 of the License Agreement and Myovant shall have the
obligations of Myovant Ltd. under Article 12 of the License Agreement; and (b)
all references in Article 12 to the License Agreement shall refer to this
Agreement.
ARTICLE 16
REPRESENTATIONS AND WARRANTIES
16.1    Mutual Representations, Warranties and Covenants. Each Party hereby
represents, warrants and covenants to the other Party that:
16.1.1    Corporate Existence. As of the Effective Date, it is a company or
corporation duly organized, validly existing, and in good standing under the
laws of the jurisdiction in which it is incorporated.
16.1.2    Corporate Power, Authority and Binding Agreement. As of the Effective
Date, (a) it has the corporate power and authority and the legal right to enter
into this Agreement and perform its obligations hereunder; (b) it has taken all
necessary corporate action on its part required to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder; and
(c) this Agreement has been duly executed and delivered on behalf of such Party,
and constitutes a legal, valid, and binding obligation of such Party that is
enforceable against it in accordance with its terms.
16.1.3    Debarment. As of the Effective Date, neither it nor any of its
Affiliates (a) has been debarred by a Regulatory Authority, (b) is subject to
debarment proceedings by a Regulatory Authority or (c) will use, in any
capacity, in connection with the activities to be performed under this
Agreement, any Person that has been debarred, or who is the subject of debarment
proceedings by any Regulatory Authority. If either Party learns that a Person
performing on its behalf under this Agreement has been debarred by any
Regulatory Authority, or has become the subject of debarment proceedings by any
Regulatory Authority, such Party shall promptly notify the other Party and shall
prohibit such Person from further performance on its behalf under this
Agreement.
16.2    Further Takeda Representations, Warranties and Covenants.
16.2.1    Takeda (a) represents and warrants that it is, as of the Effective
Date, in compliance with the representations and warranties described in Section
11.2.7 (No Debarment) of the License Agreement, and (b) covenants that it will
at all times during the Term comply with the covenants described in Section
11.3.2 (No Debarment) of the License Agreement; provided, however, for purposes
of this Section 16.2.1, Takeda shall have the obligations of TPIZ under Section
11.2.7 and Section 11.3.2 of the License Agreement. If Takeda breaches this
Section 16.2.1, then Myovant may terminate this Agreement in accordance with
Section 18.2.1 (Termination for Material Breach), provided that the cure period
stated therein shall not apply and Myovant may terminate this Agreement
immediately upon written notice to Takeda in the case of such debarment against
Takeda itself.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
16

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16.2.2    Takeda hereby represents, warrants and covenants to Myovant that all
Drug Substance supplied pursuant to this Agreement, upon delivery to Myovant or
the Qualified Designees in accordance with Section 8.1 hereof:
(a)    will have been Manufactured, tested, released, stored, supplied and
otherwise handled in accordance with all Applicable Laws and GMPs, and the
applicable Specifications;
(b)    will have been Manufactured in facilities that are in compliance with
Applicable Laws;
(c)    will have been Manufactured in accordance with the Quality Agreement and
will conform with the certificates provided pursuant to the Quality Agreement;
(d)    shall not be adulterated or misbranded within the meaning of the FFDCA;
and
(e)    may be introduced into interstate commerce pursuant to the FFDCA.
16.3    Myovant Representation, Warranties and Covenants. Myovant hereby
represents, warrants and covenants to Takeda that it shall discharge its
obligations pursuant to this Agreement in accordance with all Applicable Laws as
well as the License Agreement.
16.4    Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
THERE ARE NO REPRESENTATIONS OR WARRANTIES OR COVENANTS OF ANY KIND, EXPRESS OR
IMPLIED, WRITTEN OR ORAL, MADE BY TAKEDA (OR ANY OF ITS AFFILIATES), WITH
RESPECT TO THE DRUG SUBSTANCE OR OTHERWISE, INCLUDING: (A) ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; (B) ANY
IMPLIED WARRANTIES ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR
USAGE IN THE TRADE; (C) ANY WARRANTY OF DESCRIPTION OR OTHERWISE CREATED BY ANY
AFFIRMATION OF FACT OR PROMISE OR SAMPLE OR MODEL; OR (D) NON-INFRINGEMENT OF
THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 17
INDEMNIFICATION; NO CONSEQUENTIAL DAMAGES; INSURANCE
17.1    Indemnification Under the License Agreement. The Parties agree that the
indemnification of any Losses resulting from the Claim shall be governed by the
License Agreement, including Article 15 thereof; provided, however, that for
purposes of this Section 17.1: (a) Takeda shall have the obligations of TPIZ
under Article 15 of the License Agreement and Myovant shall have the obligations
of Myovant Ltd. under Article 15 of the License Agreement; and (b) all
references in Article 15 to the License Agreement shall refer to this Agreement,
including in clause (c) of Section 15.1 (Indemnification by Licensee) of the
License Agreement and clause (c) of Section 15.2 (Idemnification by Takeda) of
the License Agreement.
17.2    No Consequential or Punitive Damages. The Parties agree that the
limitation of liability hereunder shall be governed by the License Agreement,
including Section 16.4 thereof.
17.3    Insurance. Each Party agrees to procure and maintain in full force and
effect during the Term insurance policies in accordance with its obligations
under the License Agreement, including Section 16.4 thereof.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
17

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ARTICLE 18
TERM AND TERMINATION
18.1    Term. This Agreement shall commence on the Effective Date and unless
earlier terminated in accordance with the terms hereof, shall continue until the
fifth (5th) anniversary of the Effective Date (the “Initial Term”). At the end
of the Initial Term, this Agreement shall continue automatically for additional
consecutive one (1) year periods (each, a “Renewal Term,” and together with the
Initial Term, the “Term”) under the same terms and conditions unless earlier
terminated in accordance with the terms hereof or unless a Party provides at
least twelve (12) calendar months’ written notice of non-renewal or otherwise to
the other Party prior to expiration of the then-current Initial Term or Renewal
Term, as applicable.
18.2    Termination.
18.2.1    Termination for Material Breach. Either Party shall be entitled to
terminate this Agreement in the event that the other Party commits a material
breach of this Agreement and such other Party fails to cure such breach within
ninety (90) days of receiving a notice of default from the non-defaulting Party,
by giving a notice of termination to such other Party (after expiration of such
cure period, if applicable), with the termination to take effect on the date
specified therein.
18.2.2    Termination for Bankruptcy. Either Party may terminate this Agreement
by written notice to the other Party upon occurrence of any of the following
events: (a) a voluntary petition of bankruptcy is filed by the other Party in
any court of competent jurisdiction; (b) an involuntary petition for bankruptcy
of the other Party is filed by such Party’s creditors in any court of competent
jurisdiction and is not vacated within [***] calendar days after filing; (c) a
receiver is appointed or applied for to manage any part of a Party’s assets
related to this Agreement; or (d) this Agreement is assigned by the other Party
for the benefit of its creditors.
18.2.3    Termination for Convenience. Each Party shall have the right to
terminate this Agreement in whole or in part, including without limitation any
and all Project Work Orders then-in-effect, for any rational reason upon one
hundred eighty (180) days’ prior written notice to the other Party; provided,
however, that all Purchase Orders or Firm Orders, including the Initial Firm
Order, that duly exist hereunder as of the effective date of such termination
shall remain in effect and be binding on both Parties until the full performance
thereof.
18.2.4    Termination of License Agreement. Without limiting the generality of
the foregoing, in the event that the License Agreement is terminated in
accordance with its terms, this Agreement, including without limitation any
Purchase Order(s) or Project Work Orders then-in-effect, shall automatically
terminate in its entirety as of the effective date of termination of the License
Agreement.
18.3    Consequences of Termination.
18.3.1    Technology Transfer. Following the expiration or any termination of
this Agreement (other than due to the termination of the License Agreement),
Takeda shall, and shall ensure its Affiliates and Subcontractors, at Myovant’s
reasonable request: provide the Transition Services as set forth in Section
4.2.3 hereof in order to minimize the interruption of the flow of work caused
by: such expiration or termination of this Agreement; and, shall continue to
supply Drug Substance to Myovant applying the terms and conditions of this
Agreement mutatis mutandis until the completion of such Transition Services. All
reasonable costs and expenses incurred by Takeda therefor shall be borne by
Myovant; provided, however, that in the event that Myovant terminates this
Agreement pursuant to Section 18.2.1 (Termination for Material Breach) hereof,
then, notwithstanding any other provision of this Agreement to the contrary, all
such reasonable costs and expenses shall be borne by Takeda.
18.3.2    Termination of the License Agreement by Myovant. If this Agreement
terminates in accordance with Section 18.2.3 because the License Agreement is
terminated by Myovant Ltd. pursuant to Sections 13.3 (Termination for Material
Breach), 13.7 (Termination for Patent Challenge) or 13.8 (Termination for
Insolvency) of the License Agreement, due to a reason attributable to TPIZ,
then, unless otherwise agreed on by the Parties in writing and so far as legally
permissible:

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
18

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(a)    Myovant shall be released from any liability to Takeda for any Purchase
Order(s) and any Firm Orders then in effect for Drug Substance and for the [***]
hereunder; and
(b)    Myovant shall have no liability with respect to raw materials on hand or
work in progress at Takeda hereunder as of the effective date of such
termination.
18.3.3    Other Terminations of the License Agreement. Except for (a) TPIZ’s
termination of the License Agreement pursuant to Sections 13.3 (Termination for
Material Breach), 13.6 (Termination for Cessation of Activities), 13.7
(Termination for Patent Challenge) or 13.8 (Termination for Insolvency) thereof
and (b) Myovant’s termination of the License Agreement pursuant to Section 13.2
(Termination at Will) thereof, and unless otherwise agreed on by the Parties in
writing, the following provisions shall apply if this Agreement terminates in
accordance with Section 18.2.4 (Termination of License Agreement) hereof because
the License Agreement is terminated by either party thereto, including by
Myovant pursuant to Section 13.3 (Termination for Material Breach), by Myovant
pursuant to Section 13.4 (Termination by Licensee for Safety Reasons), by
Myovant pursuant to Section 13.5 (Termination for Commercial Viability), or by
Myovant pursuant to Section 13.8 (Termination for Insolvency), subject to any
provisions in the License Agreement as applicable:
(a)    Myovant may cancel any Purchase Order or other binding commitments
without any liability for such cancelations except that Myovant shall reimburse
Takeda within [***] days of the effective date of termination for any and all
unrecoverable costs and expenses whatsoever, including but not limited to any
and all non-cancellable or otherwise sunk costs for [***], reasonably accrued to
or incurred by Takeda theretofore; provided, however, that, upon such
termination, Takeda makes its commercially reasonable efforts to minimize such
costs and expenses by canceling commitments (including for [***]) and
substituting other production; and,
(b)    Takeda shall repurchase all remaining inventory of Drug Substance in
possession of Myovant and its Affiliates or Sublicensees as of the effective
date of such termination at the price for which such inventory was purchased by
Myovant hereunder; provided, however, that Myovant makes its commercially
reasonable efforts to minimize such inventory, upon consultation with Takeda,
ensuring an uninterrupted supply of the Drug Product as needed for the patients
in the Licensee Territory.
18.3.4    Termination of this Agreement by Takeda for Myovant’s Material Breach
or Bankruptcy. If this Agreement is terminated by Takeda pursuant to Section
18.2.1 (Termination for Material Breach) or Section 18.2.2 (Termination for
Bankruptcy) hereof, Myovant shall not be released from any liability to Takeda
for any Purchase Order(s) and any Firm Orders then in effect for Drug Substance
and for the [***] hereunder.
18.3.5    Termination of this Agreement by Myovant for Takeda’s Material Breach
or Bankruptcy. If this Agreement is terminated by Myovant pursuant to Section
18.2.1 (Termination for Material Breach) or Section 18.2.2 (Termination for
Bankruptcy) hereof, then, unless otherwise agreed on by the Parties in writing
and so far as legally permissible, Myovant may elect to cancel any Purchase
Order(s) without any liability for amounts due thereunder and shall be released
from any liability to Takeda for any Purchase Order(s) and any Firm Orders then
in effect for Drug Substance and for the [***] hereunder.
18.3.6    Termination of this Agreement by Either Party for Convenience. If this
Agreement is terminated by either Party pursuant to Section 18.2.3 (Termination
for Convenience) hereof, then: (a) each Party shall pay the other Party any and
all amounts due and owing hereunder existing as of the effective date of such
termination; and (b) all Purchase Orders or Firm Orders, including the Initial
Firm Order, that duly exist hereunder as of the effective date of such
termination shall remain in effect and be binding on both Parties until the full
performance thereof.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
19

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18.4    Survival of Rights and Obligations. Termination or expiration of this
Agreement shall not relieve a Party of any obligation to make a payment that was
owed prior to or on the effective date of such termination, including amounts
invoiced prior to such termination or expiration, nor prejudice either Party’s
right to obtain performance of any obligation provided for in this Agreement
that expressly survives termination or expiration, including for Purchase Orders
and Firm Orders that are not cancelled in accordance with Section 18.3 hereof.
All provisions of this Agreement that, in accordance with their terms, are
intended to have effect after the expiration or termination of this Agreement
shall survive such termination or expiration, including Sections 3.1 (Price)
(solely for such surviving Purchase Orders and Firm Orders), 3.2 (Invoicing),
3.3 (Currency; Exchange Rate), 4.2.5 (Improvements to Manufacturing Technology),
5.3 (Communication with Regulatory Authorities), 6.1.2 (Binding Quantities)
(solely for such surviving Purchase Orders and Firm Orders), 6.1.3 (Purchase
Orders) (solely for such surviving Purchase Orders and Firm Orders), 6.2
(Delivery) (solely for such surviving Purchase Orders and Firm Orders), 6.3
(Notice of Potential Inability to Supply) (solely for such surviving Purchase
Orders and Firm Orders), 6.4 (Supply Shortage; Allocation) (solely for such
surviving Purchase Orders and Firm Orders), 10.2 (Myovant Storage, Handling and
Transport of Drug Substance), 12.2 (Reimbursement for Additional Technical
Support Services), 16.4 (Disclaimer), 18.3 (Consequences of Termination), 18.4
(Survival of Rights and Obligations) and 18.5 (Remedies) and Articles 1
(Definitions), 4 (Technology Transfer) (except for its Section 4.2.5
(Improvements to Manufacturing Technology); and, solely to the extent necessary
to fulfill any obligation to a Regulatory Authority after such termination or
expiration), 7 (Manufacturing) (solely for such surviving Purchase Orders and
Firm Orders), 8 (Delivery, Title and Risk of Loss) (solely for such surviving
Purchase Orders and Firm Orders), 9 (Non-Conforming Product/Returns), 11
(Recall), 13 (Technical Support Services), 14 (Intellectual Property), 15
(Confidentiality), 17 (Indemnification; No Consequential Damages; Insurance) and
19 (General Provisions) hereof.
18.5    Remedies. Except as otherwise expressly provided herein, exercise by a
Party of its rights under this Article 18 shall not limit remedies which may
otherwise be available to a Party in law or equity.
ARTICLE 19
GENERAL PROVISIONS
19.1    Force Majeure Event. Both Parties shall be excused from the performance
of their obligations under this Agreement to the extent that such performance is
prevented by a force majeure and the nonperforming Party promptly provides
notice of such prevention to the other Party. For the purposes hereof, a “force
majeure” means a cause beyond the affected Party's reasonable control, including
acts of God, fires, floods, earthquakes, labor strikes, acts of war, terrorism
or civil unrest. Such excusal shall be continued so long as the condition
constituting such force majeure continues and the nonperforming Party takes
reasonable efforts to mitigate the condition. Notwithstanding the foregoing, a
Party shall not be excused from making payments owed hereunder at the time of
such force majeure because of such force majeure. If a force majeure persists
for more than [***] days, the Parties will discuss in good faith the
modification of the Parties’ obligations under this Agreement in order to
mitigate the delays caused by such force majeure.
19.2    Notices. Any notice, request, or other communication permitted or
required under this Agreement will be in writing, will refer specifically to
this Agreement and will be hand delivered or sent by a recognized overnight
delivery service, expenses prepaid, or by facsimile (with transmission
confirmed), to the following addresses or to such other addresses as a Party may
designate by written notice in accordance with this Section 19.2:
If to Takeda:
Takeda Pharmaceutical Company Limited
1-1, Doshomachi 4-chome,
Chuo-ku, Osaka 540-8645
Attention: Vice President, Production Control Department
Facsimile: [***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
20

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If to Myovant:
Myovant Sciences GmbH
Viaduktstrasse 8
4051 Basel
Switzerland
Copy to:
Myovant Sciences, Inc.
2000 Sierra Point Parkway
9th Floor
Brisbane, CA 94005
Attention: General Counsel
19.3    Dispute Resolution. Any dispute, controversy, or claim between the
Parties that may arise from time to time pursuant to this Agreement relating to
either Party’s rights or obligations hereunder that is not resolved through good
faith negotiation between the Parties shall be resolved in accordance with
Article 14 of the License Agreement.
19.4    Audits. Each Party will maintain complete and accurate records in
sufficient detail to permit the other Party to confirm the accuracy of the
calculation of any amounts due under this Agreement. In accordance with Section
9.6 of the License Agreement, each Party shall have the right to have an
independent certified public accountant verify the accuracy of the calculation
of such amounts due under this Agreement. In addition, in accordance with the
Quality Agreement, Myovant shall have the right, upon at least [***] Business
Days’ notice to Takeda, and such date to be reasonably agreed upon by the
Parties, either by itself or through independent outside auditors or
consultants, not more than [***] during the Term of this Agreement, unless
reasonable cause is shown, to inspect and audit, at its sole expense and during
normal business hours and in a manner that does not interfere unreasonably with
operations, any areas in Takeda’s Manufacturing facility or any other facilities
in which any portion of the Manufacturing, packaging or other activities with
respect to any Drug Substance or [***] is performed. The information obtained
during the course of such audit shall be considered Confidential Information and
subject to Section 3.4 (Subcontractors) and the provisions of Article 12
(Confidentiality) of the License Agreement.
19.5    Relationship of the Parties. It is expressly agreed that Takeda, on the
one hand, and Myovant, on the other hand, will be independent contractors and
that the relationship between the two Parties will not constitute a partnership,
joint venture or agency. Neither Takeda nor Myovant will have the authority to
make any statements, representations or commitments of any kind, or to take any
action which will be binding on the other, without the prior written consent of
the other Party to do so. All persons employed by a Party will be employees of
that Party and not of the other Party and all expenses and obligations incurred
by reason of such employment will be for the account and expense of such Party.
19.6    Designation of Affiliates. Each Party may discharge any obligations and
exercise any rights hereunder through delegation of its obligations or rights to
any of its Affiliates. Each Party hereby guarantees the performance by its
Affiliates of such Party’s obligations under this Agreement, and will cause its
Affiliates to comply with the provisions of this Agreement in connection with
such performance. Any breach by a Party’s Affiliate of any of such Party’s
obligations under this Agreement will be a breach by such Party, and the other
Party may proceed directly against such Party without any obligation to first
proceed against such Party’s Affiliate.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
21

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19.7    Assignment. This Agreement shall be binding upon and inure to the
benefit of the Parties and their respective heirs, successors and permitted
assigns. Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other Party,
which consent shall not be unreasonably withheld, delayed or conditions;
provided, however, that Myovant may, without Takeda’s prior written consent (but
with a written notice to Takeda in a timely manner): (a) assign its rights and
obligations under this Agreement in whole or in part to one or more of its
Affiliates; and (b) assign this Agreement in connection with the sale or other
transfer of all or substantially all of the assets of the business to which this
Agreement relates (whether such transaction occurs by way of a sale of assets,
merger, consolidation or similar transaction); provided, further, that any
assignment by Myovant shall be permitted only if such assignment is consistent
with Sections 5.5 and 5.6 of the License Agreement. Any successor or assignee of
rights or obligations permitted hereunder will, in writing to the other Party,
expressly assume performance of such rights or obligations. Any permitted
assignment will be binding on the successors of the assigning Party. Any
assignment or attempted assignment by either Party in violation of the terms of
this Section 19.7 will be null, void and of no legal effect.
19.8    Severability. If any one or more of the provisions of this Agreement is
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, the provision will be considered severed
from this Agreement and will not serve to invalidate any remaining provisions
hereof. The Parties will make a good faith effort to replace any invalid or
unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be
realized.
19.9    Waiver and Non-Exclusion of Remedies. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver will be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party hereto of any right hereunder or of the
failure to perform or of a breach by the other Party will not be deemed a waiver
of any other right hereunder or of any other breach or failure by such other
Party whether of a similar nature or otherwise. The rights and remedies provided
herein are cumulative and do not exclude any other right or remedy provided by
Applicable Law or otherwise available except as expressly set forth herein.
19.10    Construction; Rules of Construction. Interpretation of this Agreement
will be governed by the following rules of construction: (a) words in the
singular will be held to include the plural and vice versa, and words of one
gender will be held to include the other gender as the context requires; (b)
references to the terms “Section”, “Exhibit”, or “Schedule” are to a Section,
Exhibit, or Schedule of this Agreement unless otherwise specified; (c) the terms
“hereof’, “hereby”, “hereto”, and derivative or similar words refer to this
entire Agreement; (d) references to “$” or “Dollars” will mean the currency of
the United States; (e) the word “including” and words of similar import when
used in this Agreement will mean “including without limitation,” unless
otherwise specified; (f) the word “or” will not be exclusive; (g) references to
“written” or “in writing” include in electronic form; (h) the titles and
headings contained in this Agreement are for reference purposes only and will
not affect in any way the meaning or interpretation of this Agreement; (i) each
of the Parties has participated in the negotiation and drafting of this
Agreement and if an ambiguity or question of interpretation should arise, this
Agreement will be construed as if drafted jointly by the Parties and no
presumption or burden of proof will arise favoring or burdening either Party by
virtue of the authorship of any of the provisions in this Agreement or any
interim drafts of this Agreement; (j) the word “shall” will be construed to have
the same meaning and effect as the word “will”; (k) references to “days” will
mean calendar days, unless otherwise specified; and (l) a reference to any
Person includes such Person’s successors and permitted assigns.
19.11    Further Assurance. Each Party will duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof.
19.12    Governing Law. This Agreement was prepared in the English language,
which language will govern the interpretation of, and any dispute regarding, the
terms of this Agreement. This Agreement and all disputes arising out of or
related to this Agreement or any breach hereof will be governed by and construed
under the laws of the State of New York, without giving effect to any choice of
law principles that would require the application of the laws of a different
state.

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
22

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19.13    Entire Agreement. This Agreement, including the Exhibits and Schedules
hereto, sets forth the complete, final and exclusive agreement and all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto with respect to the subject matter
hereof and supersedes, as of the Effective Date, all prior agreements and
understandings between the Parties with respect to the subject matter hereof,
except for the License Agreement as expressly set forth herein. There are no
covenants, promises, agreements, warranties, representations, conditions, or
understandings, either oral or written, between the Parties other than as are
set forth herein and therein. No subsequent alteration, amendment, change, or
addition to this Agreement will be binding upon the Parties unless reduced to
writing and signed by an authorized officer of each Party. For clarity, if the
Parties wish to modify any Exhibit or Schedule hereto, a modifying Exhibit or
Schedule may be substituted for such Exhibit or Schedule without an amendment to
this Agreement in its entirety; provided that such modifying Exhibit or Schedule
is fully executed by a duly authorized representative of each Party, whereupon
such modifying Exhibit or Schedule shall be deemed to replace the corresponding
prior Exhibit or Schedule. In the event of any inconsistency between this
Agreement and the Licensee Agreement, unless expressly stated to the contrary
herein, the terms contained in the License Agreement will control. In the event
of any inconsistency between the body of this Agreement and the Exhibits or
Schedules to this Agreement or any subsequent agreements ancillary to this
Agreement, unless otherwise expressly stated to the contrary in such Exhibit,
Schedule or subsequent ancillary agreement, the terms contained in this
Agreement will control.
19.14    Counterparts. This Agreement may be executed in two or more
counterparts, each of which will be deemed an original, but all of which
together will constitute one and the same instrument. This Agreement may be
executed by facsimile, .pdf or other electronically transmitted signatures and
such signatures will be deemed to bind each Party hereto as if they were the
original signatures.
[Signature Page Follows.]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
23

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, THIS COMMERCIAL MANUFACTURING & SUPPLY AGREEMENT IS EXECUTED
by the respective duly authorized representatives of the Parties, effective as
of the Effective Date.

MYOVANT SCIENCES GMBH

 
TAKEDA PHARMACEUTICAL COMPANY LIMITED
Signature:
/s/ Mark Altmeyer
 
Signature:
/s/ [***]
Name:
Mark Altmeyer
 
Name:
[***]
Title:
Director
 
Title:
Head of [***]
Date:
June 1, 2018
 
Date:
28. May. 2018

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

EXHIBIT A

SPECIFICATIONS

Test item
Analytical Procedure
Acceptance criteria
[***]
[***]

[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

EXHIBIT B

TRANSITION PLAN

 
Item
Takeda
Myovant
Myovant initial [***]
[***]
[***]
[***]
[***]

Activities
Comments
Timeline
[***]
[***]
[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

EXHIBIT C

FORM OF PROJECT WORK ORDER

PWO #[INSERT]

This Project Work Order #__ (this “Work Order”), is entered into as of
__________, 20__ (the “Work Order Effective Date”), by and between Takeda
Pharmaceutical Company Limited (“Takeda”), and Myovant Sciences GmbH
(“Myovant”), pursuant and subject to the terms and conditions of that certain
Commercial Manufacturing & Supply Agreement, dated _________, 2018, by and
between Takeda and Myovant (the “Agreement”). Any capitalized term not otherwise
defined herein shall have the meaning set forth in the Agreement. In the event
of any conflict between the Agreement and any provision of this Work Order, the
Agreement will control unless the Parties’ mutual agreement to alter the terms
of the Agreement is expressly set forth in this Work Order as fully executed,
and such alteration shall only apply to this Work Order and shall not be
construed as an amendment to the terms of the Agreement. Takeda and Myovant,
intending to be legally bound, hereby agree to following terms:

1.
Description of Services: [INSERT]

2.
Project Start Date: [INSERT]

3.
Estimated Completion Date: [INSERT]

4.
Purchase Order No.: [INSERT]

5.
Fees: [INSERT]

6.
Expenses: [INSERT]

7.
Payment Terms and Schedule: [INSERT]

8.
Other Terms (if any): [INSERT]

[Signature page follows.]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties have caused this Project Work Order to be
executed and delivered by their respective duly authorized representatives as of
the Work Order Effective Date.

MYOVANT SCIENCES GMBH

 
TAKEDA PHARMACEUTICAL COMPANY LIMITED
Signature:
 
 
Signature:
 
Name:
 
 
Name:
 
Title:
 
 
Title:
 
Date:
 
 
Date:
 

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

EXHIBIT D

GLOSSARY
“Applicable Law” means any applicable federal, state, local, municipal, foreign,
or other law, statute, legislation, constitution, principle of common law, code,
treaty ordinance, regulation, rule, or order of any kind whatsoever put into
place under the authority of any Governmental Authority, including the FFDCA,
Prescription Drug Marketing Act, the Generic Drug Enforcement Act of 1993 (21
U.S.C. §335a et seq.), U.S. Patent Act (35 U.S.C. §1 et seq.), Federal Civil
False Claims Act (31 U.S.C. §3729 et seq.), and the Anti-Kickback Statute (42
U.S.C. §1320a-7b et seq.), all as amended from time to time, together with any
rules, regulations, and compliance guidance promulgated thereunder. “Applicable
Law” will include the applicable regulations and guidance of the FDA and
European Union (and national implementations thereof) that constitute Good
Laboratory Practices, Good Manufacturing Practices, and Good Clinical Practices
(and, if and as appropriate under the circumstances, ICH guidance or other
comparable regulation and guidance of any applicable Governmental Authority).
[See License Agreement Section 1.4]

“Business Day” means a day other than Saturday, Sunday, or any other day on
which commercial banks located in the State of New York, U.S., Zurich,
Switzerland, Bermuda, or Japan, are authorized or obligated by Applicable Law to
close. [See License Agreement Section 1.9]

“Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30, and December 31;
provided, however, that (a) the first Calendar Quarter of the Term will begin on
the Effective Date and end on June 30, 2018 and (b) the last Calendar Quarter of
the Term will end upon the expiration or termination of this Agreement. [See
License Agreement Section 1.10]

“Calendar Year” means the twelve (12) month period ending on December 31;
provided, however, that (a) the first Calendar Year of the Term will begin on
the Effective Date and end on December 31, 2018 and (b) the last Calendar Year
of the Term will end upon the expiration or termination of this Agreement. [See
License Agreement Section 1.11]

“Claim” means any claim, suit, action, demand, or other proceeding brought by
any Third Party. [See License Agreement Sections 1.14, 15.1]
 

“Clinical Trial” means any clinical trial in humans that is conducted in
accordance with Good Clinical Practices and is designed to generate data in
support or maintenance of an IND or NDA, or other similar marketing application,
including any Phase I Clinical Trial, Phase II Clinical Trial, Phase III
Clinical Trial, Phase IIIb Clinical Trial, or any post-approval clinical trial
in humans. [See License Agreement Section 1.15]

“CMC” means chemistry, manufacturing, and controls. [See License Agreement
Section 1.16]

“Commercialization” means all activities undertaken by or on behalf of a Party
to promote, market, sell, and distribute a Licensed Product, including: (a)
sales force efforts, detailing, advertising, marketing, the creation and
approval of promotional materials, sales or distribution, pricing, customer and
government contracting, and medical affairs, including medical education,
medical information, clinical science liaison activities, and health economics
and outcomes research; (b) product security activities that may include
enhancing supply chain security, implementing brand protection technologies,
intelligence gathering, forensic analysis, customs recordation, and
anti-counterfeiting enforcement action, such as taking Internet countermeasures,
collaborating with law enforcement and seeking criminal restitution; (c)
management of any risk evaluation and mitigation strategies (REMS) programs; (d)
importing, exporting, transporting, customs clearance, warehousing, invoicing,
handling, and delivering the Licensed Products to customers; and (e) other
similar activities relating to the Licensed Products. When used as a verb,
“Commercialize” means to engage in Commercialization activities. [See License
Agreement Section 1.20]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“Confidential Information” means all non-public or proprietary Information
disclosed by a Party to the other Party under this Agreement, which may include
ideas, inventions, discoveries, concepts, compounds, compositions, formulations,
formulas, practices, procedures, processes, methods, knowledge, know-how, trade
secrets, technology, inventories, machines, techniques, development, designs,
drawings, computer programs, skill, experience, documents, apparatus, results,
clinical and regulatory strategies, regulatory documentation, information and
submissions pertaining to or made in association with Regulatory Materials, data
(including pharmacological, toxicological, and clinical data, raw data,
analytical and quality control data, manufacturing data and descriptions, patent
and legal data, market data, financial data or descriptions), devices, assays,
chemical formulations, specifications, material, product samples and other
samples, physical, chemical and biological materials and compounds, and the
link, without regard as to whether any of the foregoing is marked “confidential”
or “proprietary,” or disclosed in oral, written, graphic, or electronic form.
Confidential Information will include the terms and conditions of this
Agreement. [See License Agreement Section 1.26]

“Control” means, with respect to any Information, Patent Right, Trademark or
other Intellectual Property Right, ownership or possession by a Party, including
its Affiliates, of the ability (without taking into account any rights granted
by one Party to the other Party under the terms of this Agreement) to grant
access, a license, or a sublicense to such Information, Patent Right, Trademark
or other Intellectual Property Right without (a) violating the terms of any
agreement or other arrangement with, (b) being required to make any payment to,
or (c) necessitating the consent of, in each case ((a) – (c)), any Third Party,
at such time that the Party would be first required under this Agreement to
grant the other Party such access, license, or sublicense. [See License
Agreement Section 1.29]

“Cover” or “Covered” or “Covering” means, with respect to a particular subject
matter at issue and a relevant Patent Right, that the manufacture, use, sale,
offer for sale, or importation of the subject matter would fall within the scope
of a claim in the Patent Right. [See License Agreement Section 1.30]

 
“Development” means all non-clinical and clinical research and drug development
activities undertaken by or on behalf of a Party, including toxicology,
pharmacology, and other non-clinical efforts, statistical analysis, the
performance of Clinical Trials, CMC development, or other activities reasonably
necessary in order to obtain or maintain Regulatory Approval of a Licensed
Product. When used as a verb, “Develop” means to engage in Development
activities. [See License Agreement Section 1.32]

“EMA” means the European Medicines Agency, or any successor thereto having the
administrative authority to regulate the marketing of human pharmaceutical
products or biological therapeutic products, delivery systems, and devices in
the European Union. [See License Agreement Section 1.37]

“Endometriosis” means a condition resulting from the presence of endometrial
tissue outside the uterus. [See License Agreement Section 1.38]

“Exploit” or “Exploitation” means to Develop, Manufacture, and Commercialize.
When used as a verb, “Exploit” and “Exploiting” mean to engage in Exploitation
and “Exploited” has a corresponding meaning. [See License Agreement Section
1.41]

“Field” means the treatment, prevention, cure, or control of any human disease,
disorder, illness, or condition, including the Men’s Health Field and the
Women’s Health Field. [See License Agreement Section 1.44]

“First Commercial Sale” means, on a Licensed Product-by-Licensed Product and
country-by-country basis, the first sale of a Licensed Product by Licensee, its
Affiliates, or its Sublicensees to an end user or prescriber for use,
consumption, or resale of a Licensed Product in a country where Regulatory
Approval of the Licensed Product has been obtained. [See License Agreement
Section 1.45]

“FDA” means the U.S. Food and Drug Administration, or any successor agency
thereto. [See License Agreement Section 1.42]

“FFDCA” means the Federal Food, Drug and Cosmetic Act under United States Code,
Title 21, as amended from time to time, together with any rules, regulations,
and requirements promulgated thereunder (including all additions, supplements,
extensions, and modifications thereto). [See License Agreement Section 1.43]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“FTE” means the equivalent of the work of one duly qualified employee of a Party
full time for one year (consisting of a total of [***] hours per year) carrying
out scientific or technical work under this Agreement. Overtime, and work on
weekends, holidays and the like will not be counted with any multiplier (e.g.,
time-and-a-half or double time) toward the number of hours that are used to
calculate the FTE contribution. The portion of an FTE billable by such Party for
one individual during a given accounting period will be determined by dividing
the number of hours worked directly by said individual on the work to be
conducted under this Agreement during such accounting period and the number of
FTE hours applicable for such accounting period based on [***] working hours per
Calendar Year. [See License Agreement Section 1.46]

“Good Clinical Practices” or “GCP” means the then-current standards, practices,
and procedures for the design, conduct, performance, monitoring, auditing,
recording, analyses and reporting of Clinical Trials, including (a) those
promulgated or endorsed by the FDA as set forth in the guidelines adopted by the
ICH, titled “Guidance for Industry E6 Good Clinical Practice: Consolidated
Guidance” (or any successor document) including related regulatory requirements
imposed by the FDA, as they may be updated from time to time, (b) the
Declaration of Helsinki (2013), as amended at the 64th World Medical Association
in October 2013 and any further amendments or clarifications thereto, (c) U.S.
Code of Federal Regulations Title 21, § 50 (Protection of Human Subjects), § 56
(Institutional Review Boards) and § 312 (Investigational New Drug Application),
and (d) the equivalent Applicable Laws in any relevant country, in each case
((a)-(d)), that provide for, among other things, assurance that the clinical
data and reported results are credible and accurate and protect the rights,
integrity, and confidentiality of Clinical Trial subjects. [See License
Agreement Section 1.51]

 
“Good Laboratory Practices” or “GLP” means the then-current standards,
practices, and procedures for laboratory activities of pharmaceuticals
(promulgated or endorsed by the FDA as set forth in 21 C.F.R. § 58 (or any
successor statute or regulation) or the Good Laboratory Practice principles of
the Organization for Economic Co-Operation and Development (OECD)), including:
(a) related regulatory requirements imposed by the FDA, as they may be updated
from time to time; (b) applicable guidelines promulgated under the ICH; and (c)
such standards of good laboratory practice as are required by the European Union
and other organizations and governmental agencies in countries in which the
studies of a pharmaceutical product are conducted to the extent such standards
are no less stringent than United States Good Laboratory Practice. [See License
Agreement Section 1.52]

“Good Manufacturing Practices” or “GMP” means all applicable then-current
standards for Manufacturing, including, as applicable, (a) the principles
detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 201,
211, 600 and 610 and all applicable FDA guidelines and requirements, (b) the
principles detailed in European Directive 2003/94/EC for medicines and
investigational medicines for human use and the applicable guidelines stated in
the Eudralex guidelines, (c) the principles detailed in the applicable ICH
guidelines, (d) the principles detailed in the equivalent Applicable Laws in any
relevant country, each as may be amended and applicable from time to time, and
(e) cooperation with the conduct of any inspection by qualified persons to
ensure compliance with the foregoing standards. [See License Agreement Section
1.53]

“Governmental Authority” means any multi-national, national, federal, state,
local, provincial, municipal, or other governmental authority of any nature
(including any governmental division, subdivision, department, agency, bureau,
branch, office, commission, council, court, or other tribunal). [See License
Agreement Section 1.54]

“ICH” means International Conference on Harmonization. [See License Agreement
Section 1.56]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“IND” means an Investigational New Drug application as defined in the FFDCA, or
a clinical trial authorization application for a pharmaceutical product filed
with a Regulatory Authority in any other regulatory jurisdiction outside the
U.S., the filing of which is necessary to commence or conduct clinical testing
of such pharmaceutical product in humans in such jurisdiction. [See License
Agreement Section 1.58]

“Information” means information, discoveries, compounds, compositions,
formulations, formulas, practices, procedures, processes, methods, knowledge,
know-how, trade secrets, techniques, designs, drawings, correspondence, computer
programs, documents, apparatus, results, strategies, regulatory documentation,
information and submissions pertaining to, or made in association with, filings
with any Governmental Authority or Patent Office, data, including
pharmacological, toxicological, non-clinical and clinical data, raw data,
analytical and quality control data, manufacturing data and descriptions, market
data, financial data or descriptions, devices, assays, chemical formulations,
specifications, material, product samples and other samples, physical, chemical
and biological materials and compounds, and the like, in written, electronic,
oral or other tangible or intangible form, now known or hereafter developed,
whether or not patentable, and any copyrights therein. [See License Agreement
Section 1.63]

“Intellectual Property Rights” means all rights in Patent Rights, Trademarks,
copyrights, design rights, database rights, moral rights, Information,
Inventions, and any and all other intellectual property or proprietary rights
(whether registered or unregistered) now known or hereafter recognized in any
jurisdiction, and all applications and rights to apply for any of them, anywhere
in the world. [See License Agreement Section 1.66]
“Inventions” means any and all inventions, improvements, discoveries, and
developments, whether or not patentable, made, conceived, or reduced to practice
in the course of performance of this Agreement whether made, conceived, or
reduced to practice solely by, or on behalf of, Takeda, Licensee, the Parties
jointly, or any Affiliate of either Party. [See License Agreement Section 1.67]

“JNDA” means a Japanese new drug application and any other applicable submission
to the PMDA for pharmaceutical, biologic, or device approval. [See License
Agreement Section 1.68]

 
“Joint Inventions” means any Inventions that are made jointly by employees,
agents, or independent contractors of each Party in the course of performing
activities under this Agreement, together with all Intellectual Property Rights
therein. [See License Agreement Sections 1.61, 10.1]

“Joint Know-How” means all Information and Inventions jointly generated by
Licensee and Takeda during the Term that pertain to the Exploitation of the
Licensed Compounds or Licensed Products in the Field in the Territory. Joint
Know-How excludes any Information contained within or Inventions Covered by a
published Joint Patent Right. [See License Agreement Section 1.70]

“Joint Patent Rights” means all Patent Rights Covering Joint Inventions. [See
License Agreement Section 1.71]

“JRC” means the Joint Review Committee established pursuant to Section 2.2.1 of
the License Agreement. [See License Agreement Sections 1.73, 2.2.1]

“Licensed Compound” means a TAK-385 Licensed Compound. [See License Agreement
Section 1.76]

“Licensed Product” means any TAK-385 Licensed Product. [See License Agreement
Section 1.77]

“Licensed Product IND” means any IND filed related to a Licensed Product,
whether in existence as of the Effective Date or filed by a Party with a
Regulatory Authority during the Term, including any supplements or amendments
thereto. The Licensed Product INDs as of the Effective Date are set forth on
Schedule 1.78(a) (TAK-385 Licensed Product INDs) of the License Agreement. [See
License Agreement Section 1.78]

“Licensee Know-How” means all Information and Inventions Controlled by Licensee
or its Affiliates (other than the Takeda Know-How and Joint Know-How) during the
term that are necessary to Exploit a Licensed Compound or Licensed Product.
Licensee Know-How excludes any Information contained within or Inventions
Covered by a published Licensee Patent Right. [See License Agreement Section
1.83]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“Licensee Patent Rights” means all Patent Rights Controlled by Licensee or its
Affiliates (other than the Takeda Patent Rights and Joint Patent Rights) as of
the Effective Date or during the Term that Cover a Licensed Compound or any
Licensed Product or are otherwise necessary to Exploit a Licensed Compound or a
Licensed Product. [See License Agreement Section 1.85]

“Licensee Territory” means with respect to the TAK-385 Licensed Compound or a
TAK-385 Licensed Product, worldwide excluding the Takeda Territory. [See License
Agreement Section 1.90]

“MAA” means an application for Regulatory Approval (but excluding any
application for approval of pricing or reimbursement for a Licensed Product by
any Governmental Authority) filed with the EMA. [See License Agreement Section
1.92]

“Manufacture” or “Manufacturing” means all activities by or on behalf of a Party
related to the manufacturing of a Licensed Compound or a Licensed Product, or
any ingredient thereof, including test method development and stability testing,
formulation, manufacturing scale-up, manufacturing for Development or
Commercialization, labeling, filling, processing, packaging, in-process and
finished Licensed Product or any ingredient thereof, quality assurance and
quality control activities related to manufacturing and release of a Licensed
Compound or a Licensed Product, ongoing stability tests, and regulatory
activities related to any of the foregoing. When used as a noun, “Manufacture”
or “Manufacturing” means any and all activities involved in Manufacturing. [See
License Agreement Section 1.94]

“Men’s Health Field” means the treatment, prevention, cure, or control of
symptoms associated with prostate cancer. [See License Agreement Section 1.97]

“NDA” means a (a) New Drug Application or supplemental New Drug Application as
contemplated by Section 505(b) of the FFDCA, submitted to the FDA pursuant to 21
C.F.R. § 314, including any amendments thereto or (b) any comparable
applications filed in or for countries or jurisdictions outside of the United
States to obtain Regulatory Approval to Commercialize a Licensed Product in that
country or jurisdiction. References to “NDA” herein will refer to a JNDA or MAA
as applicable. [See License Agreement Section 1.98]
 

“Patent Office” means a Governmental Authority that administers and regulates
patents, such as the Japan Patent Office, United States Patent and Trademark
Office, or other similar Governmental Authority. [See License Agreement Section
1.107]

“Patent Rights” means all: (a) patents, including any utility or design patent;
(b) patent applications, including provisionals, non-provisionals,
substitutions, divisionals, continuations, continuations in-part or renewals;
(c) patents of addition, restorations, extensions, supplementary protection
certificates, registration or confirmation patents, patents resulting from
post-grant proceedings, re-issues, and re-examinations; (d) other patents or
patent applications claiming priority directly or indirectly to: (i) any such
specified patent or patent application specified in (a) through (c), or (ii) any
patent or patent application from which a patent application specified in (a)
through (c) claim direct or indirect priority; (e) inventor’s certificates; (f)
other rights issued from a Governmental Authority similar to any of the
foregoing specified in (a) through (e); and (g) in each of (a) through (f),
whether such patent, patent application or other right arises in the U.S. or any
other jurisdiction in the world. [See License Agreement Section 1.108]

“Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated association,
joint venture or similar entity or organization, including a government or
political subdivision, department or agency of a government. [See License
Agreement Section 1.111]

“Phase III Clinical Trial” means a pivotal clinical trial of a pharmaceutical
product, with a defined dose or a set of defined doses, which trial is designed
to ascertain efficacy and safety of such product, for the purpose of enabling
the preparation and submission of an NDA with the applicable Regulatory
Authority and to provide an adequate basis for physician labeling, as described
in 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or, with
respect to any other country or jurisdiction, the equivalent of such a clinical
trial in such other country or jurisdiction. [See License Agreement Section
1.113]

“PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency and any
successor entity. [See License Agreement Section 1.114]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“Recall” means a Party’s removal or correction of a Licensed Product following
(a) notice or request of any Regulatory Authority or (b) the good faith
determination by such Party that an event, incident, or circumstance has
occurred that required such a recall of such Licensed Product. A Recall does not
include a market withdrawal or a stock recovery. [See License Agreement Section
1.118]

“Regulatory Authority” means any applicable Governmental Authority involved in
granting Regulatory Approval or issuing a Recall for a Licensed Product in the
Territory, including in the U.S. the FDA, in the E.U. the EMA, and in Japan the
PMDA. [See License Agreement Section 1.121]

“Regulatory Approval” means any approval (including any supplement, amendment,
amendment, or pre- and post-approval), license, registration, or authorization
of any national, regional, state, or local regulatory authority, department,
bureau, commission, council or other Governmental Authority, that is necessary
for the Commercialization of a pharmaceutical product in a country or regulatory
jurisdiction (including, where required, approval of any application for pricing
or reimbursement for such pharmaceutical product by any regulatory authority).
[See License Agreement Section 1.120]

“Regulatory Materials” means regulatory applications, filings, submissions,
notifications, registrations, Regulatory Approvals, or other submissions,
including any written correspondence or meeting minutes, made to, made with, or
received from any Regulatory Authority, submitted to a Regulatory Authority
(including all INDs, NDAs, and associated common technical documents) and any
amendments and supplements thereto, and all data and other information contained
in, and Regulatory Authority correspondence relating to, any of the foregoing.
Regulatory Approvals may include the Licensed Product INDs, and amendments and
supplements thereto. [See License Agreement Section 1.123]

“Sublicensee” means a Third Party granted a sublicense to a Party’s rights under
the License Agreement. [See License Agreement Sections 1.137, 3.3.1]

 
“TAK-385 Licensed Compound” means (a) the chemical compound coded by Takeda as
TAK-385 and the structure of which is set forth on Schedule 1.138 (TAK-385
Licensed Compound) of the License Agreement; (b) any compound other than TAK-385
that is Covered by any Takeda Patent Right set forth on Schedule 1.151 (Takeda
Patent Rights) of the License Agreement that also Covers TAK-385; and (c) any
[***] of any compound described in clause (a). [See License Agreement Section
1.139]

“TAK-385 Licensed Product” means any pharmaceutical product, including all
forms, presentations, strengths, doses, and formulations (including any method
of delivery) containing a TAK-385 Licensed Compound. [See License Agreement
Section 1.140]

“Takeda Know-How” means (a) all Information and Inventions Controlled by Takeda
or its Affiliates as of the Effective Date that are necessary or reasonably
useful to Exploit a Licensed Compound or a Licensed Product and (b) all
Information and Inventions developed after the Effective Date and Controlled by
Takeda or its Affiliates (other than Licensee Know-How and Joint Know-How)
during the Term that are necessary to Exploit a Licensed Compound or a Licensed
Product. Takeda Know-How excludes any Information contained within or Inventions
Covered by a published Takeda Patent Right. [See License Agreement Section
1.147]
“Takeda Patent Rights” means those Patent Rights set forth on Schedule 1.151
part (a) (TAK-385 Patent Rights) of the License Agreement, and all Patent Rights
(other than Licensee Patent Rights and Joint Patent Rights Controlled by Takeda
during the Term that Cover any Invention made by or on behalf of Takeda after
the Effective Date that Covers a Licensed Compound or any Licensed Product or is
otherwise necessary to Exploit any Licensed Compound or Licensed Product. [See
License Agreement Section 1.151]

“Takeda Territory” means, solely related to the TAK-385 Licensed Compound and
TAK-385 Licensed Products, Japan, China, Hong Kong, Indonesia, Korea, Malaysia,
Philippines, Singapore, Taiwan, Thailand, and Vietnam, including, in each case,
the territories and possessions of each of the foregoing. [See License Agreement
Section 1.156]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

--------------------------------------------------------------------------------

“Territory” means the Licensee Territory and the Takeda Territory. When used to
refer to a Party’s Territory, “Territory” means the Licensee Territory with
respect to Licensee and the Takeda Territory with respect to Takeda. [See
License Agreement Section 1.161]

“Third Party” means a Person other than Takeda or Licensee or their respective
Affiliates. For clarity, “Third Party” includes Excluded Affiliates. [See
License Agreement Section 1.162]

 
“Trademark” means any trademark, trade name, service mark, service name, brand,
domain name, trade dress, logo, slogan, or other indicia of origin or ownership,
including the goodwill and activities associated with each of the foregoing.
[See License Agreement Section 1.165]

“Uterine Fibroids” means the condition in which a non-cancerous tumor originates
from the uterus. [See License Agreement Section 1.170]

“Women’s Health Field” means the treatment, prevention, cure, or control of
symptoms associated with Uterine Fibroids or Endometriosis. [See License
Agreement Section 1.173]

Schedule 1.17
[***]

Chemical Composition:

[***]

Specification:

Item
Specification
[***]
[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Schedule 3.1

Prices
[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Schedule 4.2.3

Fee Schedule for Transition Services

[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Schedule 6.1.1

Takeda Recipient of Rolling Forecasts

Takeda Contact:

[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Schedule 6.1.2(a)

Initial Binding Order

[***]

[***] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.