Exhibit 10.6
CERTAIN Information Identified by “[***]”
HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD
LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.
Execution Version
AGREEMENT FOR THE MANUFACTURE &
SUPPLY OF CLINICAL TRIAL MATERIAL BY AND BETWEEN
TAKEDA PHARMACEUTICAL COMPANY LIMITED,
AND
MYOVANT SCIENCES LTD.
DATE: JUNE 7, 2016

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AGREEMENT FOR THE MANUFACTURING & SUPPLY OF CLINICAL
TRIAL MATERIAL
This Agreement for the Manufacturing & Supply of Clinical Trial Material (the
“Agreement”) is made effective as of June 7, 2016 (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 Ltd. (f/k/a Roivant Endocrinology Ltd.), an
exempted limited company incorporated under the laws of Bermuda, a having its
registered office at 2 Church Street, Hamilton, Bermuda (“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 are parties to that certain License Agreement dated April 29, 2016
(“License Agreement”) pursuant to which TPIZ granted to Myovant a license in the
Licensee Territory and the Takeda Territory under certain patents, patent
applications, know-how and other proprietary information for the further
Development and Commercialization of the TAK-3 85 Licensed Products in
accordance with the terms and conditions set forth in the License Agreement;
WHEREAS, under the License Agreement, Takeda agreed to provide to Myovant the
Initial Clinical Supply [***] and to manufacture and supply additional amounts
of TAK-385 Licensed Compound or TAK-385 Licensed Product, in each case, as
required by Myovant to complete the TAK-385 Development Plan, and Myovant agreed
to purchase such additional amounts of TAK-385 Licensed Compound and TAK-385
Licensed Product;
WHEREAS, in accordance with the terms of the License Agreement and on the terms
and conditions set out below, Takeda, on behalf of TPIZ, now agrees to provide
Drug Substance or Drug Product (as defined below) and Myovant agrees to receive
from Takeda, all of Myovant’s requirements for such Drug Substance or Drug
Product in order to complete all Clinical Trials contemplated under the TAK-385
Development Plan.
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:
1.1 “Batch Documentation” means the documentation provided to Myovant at the
time of delivery of Drug Substance or Drug Product, as agreed upon by the
Parties in the Quality Agreement.
1.2 “Credit Note” means a credit memo issued by Takeda to Myovant and usable by
Myovant as: (i) an offset against amounts payable to Takeda by Myovant or, (ii)
if no such amounts are outstanding at the time of termination or expiration of
this Agreement, for a refund from Takeda to Myovant which Takeda shall pay to
Myovant no later than [***] days after any such termination or expiration.
1.3 “Direct Expenses” means those material and services expenses captured in
invoices and the like which are specifically attributable to Manufacture of the
Drug Substance or Drug Product, including [***].
1.4 “Drug Product” means a final, unpackaged pharmaceutical product for use
solely for administration to humans in Clinical Trials consisting of: (a) the
TAK-385 Licensed Product or (b) a placebo version of each formulation of a
pharmaceutical product in sub-Section (a), where, in each case, such Drug
Product has been Manufactured in accordance with the Specifications and
Applicable Laws. The formulations of Drug Product as of the Effective Date are
set forth on Exhibit B.
1.5 “Drug Substance” means the active pharmaceutical ingredient for the TAK-385
Licensed Compound that has been Manufactured in accordance with the
Specifications and Applicable Laws.

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1.6 “Indirect Expenses” means labor expenses, including [***], and other
indirect production expenses such as [***], and expenses for process development
and analytical methods development, but excluding, in each case, any Direct
Expenses.
1.7 “Initial Shipment” means the Drug Product to be shipped by Takeda promptly
after the Effective Date of this Agreement. The number of tablets of Drug
Product to be shipped as part of the Initial Shipment is set forth on Exhibit C.
1.8 “Manufacturing Expenses” means (a) with respect to Drug Substance or Drug
Product that is Manufactured by a Third Party the actual purchase price paid by
Takeda or its Affiliate to such Third Party for such Drug Substance or Drug
Product, and (b) with respect to Drug Substance or Drug Product that is
Manufactured directly by Takeda or its Affiliate the Direct Expenses and
Indirect Expenses incurred in connection with the Manufacture of the Drug
Substance or Drug Product, [***], such calculation being based upon accepted
industry standards and the applicable Accounting Standard. Manufacturing
Expenses shall not include any: [***].

1.9 “Permits” means any licenses, permits, registrations, certifications or
other approvals from a Governmental Authority.
1.10 “Project Work Order” shall have the meaning set forth in Section 11.1.
1.11 “Quality Agreements” means the Quality Assurance Agreements for Drug
Product and Drug Substance between the Parties.
1.12 “Quality Release” means certification by Takeda’s quality control
department that Drug Substance or Drug Product Manufactured by or on behalf of
Takeda complies with its quality release specifications as confirmed by release
testing.
1.13 “Specifications” means the specifications for the design, composition,
manufacture, packaging, and/or quality control of the Drug Substance and Drug
Product as set forth in Exhibit A, which may be amended from time-to-time.
1.14 “Technical Support Services” shall have the meaning set forth in Section
11.1.
ARTICLE 2
PRODUCT SUPPLY
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, all of Myovant’s requirements
for any Drug Substance, Drug Product for its use contemplated under the TAK-385
Development Plan.
2.2 Takeda Reservation of Rights. Any rights of Takeda not expressly granted to
Myovant under the provisions of this Agreement, the License Agreement or the
Quality Agreement are retained by Takeda.
2.3 Myovant’s Rights Outside the Licensee Territory. Except as otherwise
provided in the License Agreement: (a) Myovant shall, and shall ensure that its
Affiliates, Sublicensees and Subcontractors, use the Drug Substance or Drug
Product only in the Field in the Licensee Territory, and (b) Myovant shall not,
and shall not permit its Affiliates, Sublicensees and Subcontractors to, use the
Drug Substance or Drug Product 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 or Drug Product in
contravention of subsection (i) above.
ARTICLE 3
MANUFACTURING EXPENSES
3.1 Drug Substance and Drug Product. Takeda shall provide to Myovant the Initial
Clinical Supply [***] to Myovant. In the event the Initial Clinical Supply is
insufficient to conduct and complete the activities contemplated under the
TAK-385 Development Plan, Myovant shall pay [***] of the actual Manufacturing
Expenses incurred by Takeda in Manufacturing such additional Drug Substance and
Drug Product. For the avoidance of doubt, Myovant shall [***] Takeda for all
Manufacturing Expenses incurred by Takeda related to the re-working or
re-processing of any Drug Substance or Drug Product that was manufactured by
Takeda prior to the Effective Date of this Agreement.

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3.2 Invoicing. Takeda shall submit an invoice to Myovant within [***] days after
the end of each Calendar Quarter for all such Manufacturing Expenses incurred by
Takeda during the preceding Calendar Quarter and Myovant shall pay such invoice
in accordance with Article 12. For the avoidance of doubt, the first invoice
submitted by Takeda pursuant to this Section 3.2 may include Manufacturing
Expenses incurred by Takeda in furtherance of its Manufacture of additional Drug
Substance or Drug Product that was not part of the Initial Clinical Supply.
ARTICLE 4
REGULATORY ACTIVITIES AND RESPONSIBILITIES
4.1 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 and Drug Product for use
by Myovant in accordance with the License Agreement and as otherwise required by
Applicable Laws or Regulatory Authorities. Takeda shall be responsible for
maintaining all Permits and establishment fees required by any Regulatory
Authority with respect to any Takeda Manufacturing facility where any aspect of
the Drug Substance or Drug Product is Manufactured.
4.2 General Obligations of Myovant. Other than Takeda’s Permits and
establishment fees related to Takeda’s manufacturing facilities, 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 or Drug
Product in accordance with the License Agreement and fulfill its obligations
under this Agreement, the License 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 or Drug Product in
accordance with the License Agreement; (b) use the Drug Substance or Drug
Product in compliance with Applicable Laws and the TAK-385 Licensed Product
INDs; and (c) comply with Myovant’s obligations under this Agreement.
4.3 Communication with Regulatory Authorities. All other communications with
Regulatory Authorities shall be governed by the License Agreement, including
Article 6 of the License Agreement.
ARTICLE 5
FORECASTING AND ORDERING
5.1 Forecasts and Purchase Orders.
5.1.1 Forecast Issuance and Acceptance. Attached hereto at Exhibit C is
Myovant’s forecast of its desired quantities of the Drug Substance and each
formulation of Drug Product contemplated under the TAK-385 Development Plan.
Within [***] Business Days of the Effective Date of this Agreement, Myovant
shall submit to Takeda, at the contact information provided below, Myovant’s
forecast for its desired quantities of the Drug Substance and each formulation
of Drug Product to be delivered to Myovant on a Calendar Quarter-by-Calendar
Quarter basis for the first [***] Calendar Quarters of the Term (the “Initial
Rolling Forecast”). For clarity, the Initial Rolling Forecast shall not include
the Initial Shipment. 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 proceeding [***] Calendar Quarters (“Rolling
Forecast”). Myovant will submit each Rolling Forecast to the addressee listed
below, which Takeda may update or change by providing written notice to Myovant
in accordance with Section 18.2 of this Agreement. The Rolling Forecast shall
set forth the desired quantity of Drug Substance and each formulation of Drug
Product in full lot increments. Takeda will accept each forecast or provide an
alternative proposal to Myovant within [***] Business Days after receipt of such
forecast. Subject to Takeda’s express rights under this Agreement, Takeda will
not unreasonably reject any portion of Myovant’s forecasts.
Takeda Contact: [***]
5.1.2 Binding Quantities. The first [***] Calendar Quarters of each Rolling
Forecast submitted by Myovant shall constitute a firm order (“Firm Order
Period”). The [***] Calendar Quarter of each Rolling Forecast shall be binding
upon Myovant within plus or minus [***] of the amount set forth for such
Calendar Quarter in full lot increments (“Binding Order Period”). The final
[***] Calendar Quarters of each Rolling Forecast shall be non-binding upon
Myovant.
5.1.3 Purchase Orders.

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(a) Issuance and Acceptance. With its submission of the Initial Rolling
Forecast, Myovant shall submit a separate purchase order (each, a “Purchase
Order”) for each Calendar Quarter of the Firm Order Period as set forth in the
Initial Rolling Forecast to Takeda (each a “Purchase Order”). Thereafter, with
each Rolling Forecast submitted to Takeda pursuant to Section 5.1.1, Myovant
shall submit a Purchase Order for the [***] Calendar Quarter of the Rolling
Forecast (i.e., the Calendar Quarter for which no Purchase Order was previously
submitted). Within [***] Business Days of Takeda’s receipt of each Purchase
Order, Takeda will accept such Purchase Order by providing a confirmation of
receipt of the Purchase Order. To the extent of any conflict between a Purchase
Order and this Agreement, this Agreement shall control.
(b) Deviations from the Firm Order Period. If the quantity set forth in a
Purchase Order exceeds the quantity set forth in the corresponding Calendar
Quarter of the Firm Order Period, Takeda shall use reasonable efforts to satisfy
the amount contained in a Purchase Order; provided, however, that Takeda shall
not be in breach of this Agreement if it does not deliver the quantity set forth
in a Purchase Order that exceeds the quantity set forth in corresponding
Calendar Quarter of the Firm Order Period. For the avoidance of doubt, such
reasonable efforts shall not require Takeda to [***]. In the event Myovant
issues a Purchase Order in a given Calendar Quarter for a quantity of Drug
Substance or formulation of Drug Product that is less than the quantity set
forth in the corresponding Calendar Quarter of the Binding Order Period, Takeda
may deliver, at its discretion, either the quantity set forth in the Purchase
Order or the quantity set forth in the corresponding Calendar Quarter of the
Binding Order Period; provided that, in either circumstance, Myovant shall [***]
Takeda for [***] of the actual Manufacturing Expenses incurred by Takeda in
accordance with Section 3.1. In the event that any Purchase Order quantity
deviates from the quantity set forth in the corresponding Calendar Quarter of
the Firm Order Period, Takeda shall inform Myovant within [***] Business Days
after receipt of such Purchase Order of its best estimate of the quantity it
anticipates delivering under such Purchase Order, which estimate shall not be
binding upon Takeda.
5.1.4 Initial Shipment. Within [***] Business Days of the Effective Date of this
Agreement, the Initial Shipment will be delivered to Myovant in accordance with
Section 7.3.
5.2 Delivery. Subject to Section 18.1, Takeda shall supply the Drug Substance
and formulation of Drug Product ordered under a Purchase Order by way of
delivery pursuant to Article 7. If Takeda is unable to meet the specified
delivery date, Takeda shall promptly notify Myovant and provide to Myovant an
alternative delivery date which is as close to the original delivery date as
reasonably possible. Delivery by Takeda of up to [***] of the quantity of Drug
Substance or Drug Product in the Purchase Order will 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 or Drug Product in accordance with
Section 8.1. Myovant will be invoiced for the actual quantities of the Drug
Substance or Drug Product shipped, excluding the Initial Clinical Supply, for
which Myovant shall not be charged.
5.2.1 Testing by Takeda. Prior to delivery by Takeda pursuant to Section 7.1,
Takeda shall undertake release testing to obtain a Quality Release for each
batch of the Drug Substance or Drug Product that is Manufactured pursuant to a
Purchase Order accepted by Takeda.
5.2.2 Provision of Records. With each batch of Drug Substance or Drug Product
delivered by Takeda pursuant to Section 7.1, Takeda shall provide all Batch
Documentation for such batch, including a certificate of analysis and
certificate of conformance.
5.3 Notice of Potential Inability to Supply. Takeda shall inform Myovant of any
events that may prevent Takeda or its designee from fulfilling its supply
obligations with respect to amounts ordered pursuant to any Purchase Order as
soon as reasonably practicable after becoming aware of such events. In the event
Takeda notifies Myovant of a potential inability to supply a Drug Substance or a
formulation of Drug Product, the Parties shall discuss in good faith how to
resolve such supply problems. Notwithstanding the foregoing, if Takeda’s
inability to fulfill its supply obligation is due to the unavailability of
adequate raw materials and/or resources or because the manufacturing capacity
for the Drug Substance or Drug Product of Takeda and/or its supplier is such
that Takeda and/or its supplier is unable to meet the demand for the Drug
Substance or Drug Product requested by Myovant, then [***].
ARTICLE 6
MANUFACTURING
6.1 Conformance with cGMP. Takeda shall supply the Drug Substance and Drug
Product that conforms to GMPs, Applicable Laws and the TAK-385 Licensed Product
INDs. Takeda shall be entitled, at its cost and expense, to modify the
Specifications, Manufacturing, and testing processes, in each case, employed
with regard to the Manufacture of the Drug

4

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Substance or Drug Product from time to time, subject to approval, solely to the
extent required by Applicable Laws or Regulatory Authorities.
6.2 Manufacturing by Affiliates and Third Parties. Takeda shall have the right,
from time to time, in its sole discretion and following a critical technical
risk assessment to use an alternative site for the Manufacture of the Drug
Substance or Drug Product or appoint any Affiliate or Third Party to Manufacture
or supply the Drug Substance or Drug Product to Myovant hereunder; provided that
such site, Affiliate or Third Party has been approved, solely to the extent
required by Applicable Law, for such Manufacture by the applicable Regulatory
Authorities. Such Manufacturing and supply changes shall not alter the rights,
obligations and liabilities of the Parties as set out under this Agreement.
Takeda shall promptly notify Myovant if Myovant is required pursuant to
Applicable Law to make any changes to the TAK-385 Licensed Product INDs related
to the appointment of a Third Party to Manufacture of the Drug Substance or Drug
Product.
6.3 Quality Agreement. Promptly after the Effective Date, the Parties will
execute the Quality Agreement.
ARTICLE 7
DELIVERY, TITLE AND RISK OF LOSS
7.1 Shipment Terms; Title; Risk of Loss. Except for the Initial Shipment and as
otherwise provided under Article 11 of this Agreement, all Drug Substance and
Drug Product will be shipped to Myovant EXW (Incoterms 2010) from Takeda’s
designated site, freight collect, by a common carrier designated by Myovant in
the Purchase Order, at Myovant’s expense. Title and risk of loss will transfer
to Myovant, and delivery shall be deemed to have occurred, when goods are placed
at Myovant’s disposal, not cleared for export and not loaded onto any collecting
vehicle. Myovant shall procure, at its cost, insurance covering damage or loss
to the Drug Substance and Drug Product during shipping.
7.2 Importer of Record. Except for the Initial Shipment and as otherwise
provided under Article 11 of this Agreement, Myovant shall be the “Importer of
Record” of all Drug Substance and Drug Product supplied by Takeda under this
Agreement. As the Importer of Record, Myovant shall be responsible for all
aspects of importing such Drug Substance and Drug Product, including: (a)
customs and other regulatory clearance of the Drug Substance and Drug Product;
(b) payment of all tariffs, duties, customs, fees, expenses and charges payable
in connection with the importation and delivery of the Drug Substance and Drug
Product; and (c) keeping all records, documents, correspondence and tracking
information required by Applicable Laws arising out of or in connection with the
importation or delivery of such Drug Substance and Drug Product.
7.3 Initial Shipment. The Initial Shipment will be shipped to Myovant DAP
(Incoterms 2010) to Myovant’s designated site. Title and risk of loss will
transfer to Myovant when the Initial Shipment is available for unloading at
Myovant’s designated site. Myovant will be responsible for import clearance of
the Initial Shipment.
ARTICLE 8
NON-CONFORMING PRODUCT/RETURNS
8.1 Claims for Detectable Defects. Myovant shall notify Takeda within [***]
Business Days after receipt of any shipment of the Drug Substance or Drug
Product supplied by or on behalf of Takeda of the existence and nature of any
defect in or failure of the Drug Substance or Drug Product to comply with
Section 4.1 or Section 6.1 at the time of delivery that could have been detected
by a reasonable physical inspection of the Drug Substance or Drug Product at the
time of delivery (“Detectable Defects”). If such notice is not provided within
such [***] Business Day period, then such Drug Substance or Drug Product will be
deemed to be in compliance with this Agreement, Myovant will be deemed to have
accepted the Drug Substance or Drug Product, and Takeda will have no further
responsibility for such Detectable Defects. A non-conformity relating to
stability of the Drug Substance or Drug Product shall not be considered a
Detectable Defect.
8.2 Claims for Non-Detectable Defects. Myovant shall notify Takeda within [***]
Business Days upon discovery of any defect in or failure of the Drug Substance
or Drug Product to comply with Section 4.1 or Section 6.1 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.
8.3 Provision of Samples. Myovant shall, when notifying Takeda of an alleged
defect, provide samples of any allegedly defective Drug Substance or Drug
Product and copies of written reports or investigations performed by or on
behalf of Myovant on such allegedly defective Drug Substance or Drug Product.

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8.4 Referral to Independent Laboratory. In the event of a dispute between the
Parties as to any defect in a Drug Substance or Drug Product, including whether
a defect was a Detectable Defect or whether such defect existed at the time of
delivery, that cannot be resolved within [***] days of a claim being made to
Takeda pursuant to Section 8.1 or Section 8.2, the matter shall promptly (but in
no case later than [***] Business Days after the expiration of such [***] day
period) be submitted to an independent laboratory to be mutually agreed between
the Parties. The independent laboratory will examine the Drug Substance or Drug
Product at issue and determine the existence and, if relevant, the timing of any
defect in the Drug Product. The decision of the independent laboratory shall be
binding on the Parties, except in the case of fraud. Myovant shall bear the
costs of the independent laboratory if the independent laboratory finds that the
Drug Product or Drug Substance was not defective or that such defect did not
exist at the time of delivery. Takeda shall bear the costs of the independent
laboratory if the independent laboratory finds that the Drug Product or Drug
Substance was defective at the time of delivery.
8.5 Credit Note; Replacement Product; Defective Product. Following a claim from
Myovant pursuant to Section 8.1 or Section 8.2, Takeda’s sole obligation in the
event that Takeda accepts Myovant’s claim as valid or the independent laboratory
decides in favor of Myovant’s claim, shall be to either, at Takeda’s election:
(a) provide Myovant with a Credit Note equal to the actual Manufacturing
Expenses paid by Myovant for the defective Drug Substance or Drug Product; or
(b) replace the defective Drug Substance or Drug Product as soon as commercially
practicable. Any Drug Substance or Drug Product 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 10 and Article 16, Takeda shall have no liability for
defective Drug Substance or Drug Product other than as provided in this Article
8.
ARTICLE 9
STORAGE, HANDLING AND TRANSPORT
9.1 Takeda’s Responsibilities. The Drug Substance and Drug Product shall be
Manufactured by or on behalf of Takeda, 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.
9.2 Myovant’s Responsibilities. The Drug Substance and Drug Product shall be
stored, handled, packaged, and transported in accordance with the requirements
of this Agreement, the Quality Agreement and all Applicable Laws. Myovant shall
maintain appropriate quality assurance and quality control standards and
record-keeping practices, including systems, resources and procedures in order
to satisfy these obligations.
9.3 Myovant Storage, Handling and Transport of Product. Myovant shall obtain at
its sole expense all equipment, facilities and personnel necessary for Myovant
to store, handle and transport the Drug Substance and Drug Product in accordance
with the terms hereof and shall 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 8.1 or Section 8.2), refuses to take delivery or
possession of any Drug Substance or Drug Product, Myovant shall, notwithstanding
Section 16.2, promptly upon receipt of an invoice from Takeda, reimburse Takeda
for any resulting direct, out-of-pocket, storage, warehousing, handling or
transportation fees that Takeda may have incurred prior to such refusal by
Myovant.
9.4 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 or Drug Product shall be governed by the Quality Agreement.
ARTICLE 10
PRODUCT 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 of the License Agreement.
ARTICLE 11
TECHNICAL SUPPORT SERVICES
11.1 Technical Support Services. Beginning on the Effective Date and continuing
until the earliest of the [***] anniversary of the Effective Date, the
termination of this Agreement or the termination of the License Agreement, upon
reasonable request of Myovant, Takeda shall provide Myovant with: (a) reasonable
technical assistance to effect the transfer to

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Myovant or its designee of the Takeda Manufacturing Know-How, including the
then-current process for the Manufacture of the Drug Substance and Drug Product,
and facilitate the implementation of Manufacture of the Drug Substance and Drug
Product at the facilities of Myovant or its designee, and (b) other reasonable
technical, regulatory and CMC related services in support of the Development of
the Licensed Compound and Licensed Product ((a) and (b) collectively, the
“Technical Support Services”). Any Technical Support Services provided by Takeda
will be documented in work orders, executed by both Parties and substantially in
the form attached as Exhibit D (each a “Project Work Order”). Technical Support
Services will 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 will
be governed by Article 13 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. Unless otherwise agreed by the
Parties, any such shipment shall not be subject to Article 7 or Article 8 of
this Agreement; rather, the terms of such shipment shall be separately agreed by
the Parties and may be stated in the applicable Project Work Order.
11.2 Reimbursement for Technical Support Services. Myovant shall compensate
Takeda for those FTEs providing the Technical Support Services at the FTE Rate,
and shall reimburse Takeda for all reasonable documented out-of-pocketed
expenses incurred by Takeda to perform Technical Support Services, provided that
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 all FTE expenses and Third Party expenses incurred by
Takeda during the preceding Calendar Quarter in furtherance of the Technical
Support Services, which shall include a tally of FTE hours by individual and
date and a brief description of work performed, and Myovant shall pay such
invoice in accordance with Article 12.
ARTICLE 12
PAYMENT TERMS
12.1 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. Myovant shall make all payments for invoices
issued by Takeda in Japanese Yen via an Automatic Clearing House payment to
Takeda’s account designated below or to such other account as Takeda may specify
by written notice to Myovant in accordance with Section 18.2.
 
 
 
 
 
Bank Name:
 
[***]
 
 
Branch:
 
[***]
 
 
Address:
 
[***]
 
 
Account #:
 
[***]
 
 
Beneficiary’s Name:
 
[***]
 
 
Beneficiary’s Address:
 
[***]
 
 

12.2 Taxes. Myovant shall pay any applicable taxes, including [***] as a result
of payments it makes to Takeda pursuant to this Agreement (“Payments”). All
other taxes, including but not limited to [***], 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.
12.3 Late Payment. If Myovant does not pay or dispute in writing 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.
ARTICLE 13
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.

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ARTICLE 14
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.
ARTICLE 15
REPRESENTATIONS AND WARRANTIES
15.1 Mutual Representations, Warranties and Covenants. Each Party hereby
represents, warrants and covenants to the other Party that:
15.1.1 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.
15.1.2 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.
15.1.3 Debarment. 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.
15.2 Takeda Representations, Warranties and Covenants. Takeda hereby represents,
warrants and covenants to Myovant that all Drug Substance and Drug Product
supplied to Myovant pursuant to this Agreement, upon delivery to Myovant in
accordance with Section 7.1:
15.2.1 will have been Manufactured, tested, released, stored, supplied and
otherwise handled in accordance with all Applicable Laws and GMPs), and the
TAK-385 Licensed Product INDs;
15.2.2 will have been Manufactured in facilities that are in compliance with
Applicable Laws;
15.2.3 will have been Manufactured in accordance with the Quality Agreement and
will conform with the certificates provided pursuant to the Quality Agreement;
15.2.4 shall not be adulterated or misbranded within the meaning of the FFDCA;
and
15.2.5 may be introduced into interstate commerce pursuant to the FFDCA.
15.3 Myovant Representation, Warranties and Covenants. Myovant hereby
represents, warrants and covenants to Takeda that:
15.3.1 it shall discharge its obligations pursuant to this Agreement in
accordance with all Applicable Laws; and
15.3.2 it shall maintain the Drug Substance and Drug Product in a facility that
is properly equipped to store the Drug Substance and Drug Product and shall
maintain product security measures in accordance with Applicable Law; and
15.3.3 in the event it formulates the Drug Substance into a pharmaceutical
product and packages such Drug Product for use in Development, it shall do so,
and shall distribute such Drug Product, in accordance with all Applicable Laws
and the TAK-385 Licensed Product INDs.

8

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15.4 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
THERE ARE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
WRITTEN OR ORAL, MADE BY TAKEDA (OR ANY OF ITS AFFILIATES), WITH RESPECT TO THE
PRODUCTS 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 16
INDEMNIFICATION; NO CONSEQUENTIAL DAMAGES; INSURANCE
16.1 Indemnification Under the License Agreement. The Parties agree that the
indemnification of any Losses resulting from the Claim of a Third Party will be
governed by the License Agreement, including Article 15 thereof.
16.2 No Consequential or Punitive Damages. NEITHER PARTY HERETO WILL BE LIABLE
FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR
MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS
HEREUNDER OR FOR ANY LOSS OR INJURY TO THE OTHER PARTY’S PROFITS OR GOODWILL
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES. THIS SECTION 16.2 DOES NOT APPLY TO A BREACH OF A
PARTY’S OBLIGATIONS UNDER ARTICLE 14 OR TO A PARTY’S OBLIGATIONS PURSUANT TO
SECTION 16.1.
16.3 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 15.4 thereof.
ARTICLE 17
TERM AND TERMINATION
17.1 Term. This Agreement shall commence on the Effective Date and shall
continue until the termination of the License Agreement (the “Term”); provided,
however, that either Party may terminate this Agreement pursuant to the notice
periods provided for in Article 13 of the License Agreement.
17.2 Consequences of Termination.
17.2.1 Termination of the License Agreement for Takeda Breach. The following
provisions shall apply if the License Agreement is terminated by Myovant
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:
(a) Myovant may cancel any Purchase Order; and
(b) Myovant shall have no liability with respect to raw materials on hand or
work in progress at Takeda as of the effective date of such termination.
17.2.2 Other Terminations of the License Agreement. Except for Myovant’s
termination of the License Agreement pursuant to Sections 13.3, 13.7 or 13.8 of
the License Agreement, the following provisions shall apply if the License
Agreement is terminated by either Party:
(a) Myovant may cancel any Purchase Order;
(b) Myovant shall promptly, at Myovant’s cost and at Takeda’s election, destroy
its remaining inventory of the Drug Substance or Drug Product or return it to
Takeda; and
(c) Myovant shall [***] Takeda within [***] days of the effective date of
termination for all [***] Manufacturing Expenses incurred by Takeda on its
behalf to meet all Purchase Orders submitted to Takeda on or before the
effective date of termination of this Agreement, except to the extent that
Takeda, using good faith efforts to do so, is able to incorporate, integrate or
otherwise use or sell such components, raw materials or work-in-progress,
including any Drug Substance or Drug Product, in the normal course of Takeda’s
business operations.

9

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17.3 Survival of Obligations. Termination or expiration of this Agreement shall
not relieve a Party of any obligation to make a payment that was owed prior to
or on the effective date of such termination, including amounts invoiced prior
to such termination or expiration, nor prejudice either Party’s right to obtain
performance of any obligation provided for in this Agreement that expressly
survives termination or expiration. All provisions of this Agreement that, in
accordance with their terms, are intended to have effect after the expiration or
termination of this Agreement shall survive such termination or expiration,
including Sections 2.2, 2.3, 3.2, 9.2, 9.3, 11.2, 15.4, 17.3 and 17.4 and
Articles 4 (solely to the extent necessary to fulfill any obligation to a
Regulatory Authority after termination or expiration), 8, 10, 12, 14, 16 and 18.
17.4 Remedies. Except as otherwise expressly provided herein, exercise by a
Party of its rights under this Article 17 shall not limit remedies which may
otherwise be available to a Party in law or equity.
ARTICLE 18
GENERAL PROVISIONS
18.1 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 Force Majeure and the nonperforming Party promptly provides notice
of such prevention to the other Party. Such excusal shall be continued so long
as the condition constituting 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.
18.2 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 18.2:
If to Takeda:
Takeda Pharmaceutical Company Limited
1-1, Doshomachi 4-chome,
Chuo-ku, Osaka 540-8645
Attention: Vice President, Production Control Department
Facsimile: (+81) 6-6204-2943
Copy to:
Takeda Pharmaceuticals U.S.A., Inc.
One Takeda Parkway
Deerfield, IL 60015
Attention: General Counsel, Legal Department
Facsimile: 224-554-7831
If to Myovant:
Myovant Sciences Ltd.
Clarendon House
2 Church Street
Hamilton HM 11
Bermuda
Attention: Corporate Secretary
Copy to:
Myovant Sciences, Inc.
320 West 37th Street
5th Floor
New York, NY 10018

10

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Attention: SVP, Finance & Operations
18.3 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.
18.4 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 [***] per Fiscal Year during the Term of this
Agreement, unless reasonable cause is shown, to inspect and audit, at its sole
expense and during normal business hours and in a manner that does not interfere
unreasonably with operations, any areas in Takeda’s Manufacturing facility or
any other facilities of Manufacturer or its Affiliates in which any portion of
the Manufacturing, packaging or other activities with respect to any Drug
Substance or Drug Product 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.
18.5 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.
18.6 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.
18.7 Assignment. Neither Party may assign or transfer this Agreement or any
rights or obligations hereunder without the prior written consent of the other
except that: (a) each Party may assign its rights and obligations under this
Agreement in whole or in part to one or more of its Affiliates without the
consent of the other Party; and (b) each Party may 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), but, with respect to assignment by Myovant, 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 18.7 will be null, void and of no legal
effect.
18.8 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.
18.9 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.

11

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18.10 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.
18.11 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.
18.12 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.
18.13 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.
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. 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.
18.14 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]

12

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THIS AGREEMENT FOR THE MANUFACTURE & SUPPLY OF CLINICAL TRIAL MATERIAL IS
EXECUTED by the authorized representatives of the Parties as of the Effective
Date.
 
 
 
 
 
 
 
 
 
MYOVANT SCIENCES LTD.
 
 
 
TAKEDA PHARMACEUTICAL
COMPANY LIMITED
 
 
 
 
 
Signature:
 
/s/ Marianne L. Romeo
 
 
 
Signature:
 
/s/ S. Yanai
 
 
 
 
 
Name:
 
Marianne L. Romeo
 
 
 
Name:
 
Shigeo Yanai
 
 
 
 
 
Title:
 
Head, Global Transactions & Risk
 
 
 
Title:
 
Head of Pharmaceutical Technology
 
 
Management
 
 
 
 
 
R&D Laboratories, CMC Center
 
 
 
 
 
Date:
 
June 7, 2016
 
 
 
Date:
 
June 8, 2016

13

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EXHIBIT A
Specifications for Drug Substance and Drug Product
[Appears on following page]

A-1

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

Specifications of TAK-385 Drug Substance
[***]
Specifications of TAK-385 Drug Product, T4-B 40 mg and 120 mg Tablets
[***]
Specifications of TAK-385 PlaceboT4-B 40 mg Tablets
[***]

A-2

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

EXHIBIT B
Formulations of Drug Product
[Appears on following page]

B-1

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

TAK-385 Tablet Formulations
[***]

B-2

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

EXHIBIT C

Initial Rolling Forecast

Myovant Forecast of Desired Quantities of Drug Substance and Formulation of Drug
Product

[***]

C-1

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

EXHIBIT C_A

[***]

C-2

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

EXHIBIT D
Project Work Order
This Project Work Order (the “PWO”), effective as of [DATE] (the “PWO Effective
Date”), is incorporated into and shall be governed by the Agreement for the
Manufacturing & Supply of Clinical Trial by and between Takeda Pharmaceutical
Company Limited and Myovant Sciences Ltd., (“Myovant”), dated of June 7, 2016.
For the purposes of this PWO, “Takeda” shall mean Takeda Pharmaceutical Company
Limited or the Takeda Affiliate that signs this PWO. Capitalized but undefined
terms shall have the meanings first ascribed to them in the Agreement.
1.
Description of Services:

2.
Project Start Date:

3.
Estimated Completion Date:

4.
Description of Services:

5.
Company Purchase Order No.:

6.
Fees. In consideration for Takeda’s performance of the Services under this PWO,
Myovant shall compensate Takeda on an hourly basis as invoiced by Takeda using
the following rate(s):

FTE Rate: amount of [***] for an FTE per Calendar Year.
7.
Expenses. Myovant shall reimburse Takeda for reasonable out-of-pocket expenses
actually incurred by Takeda in connection with the Services. For this PWO,
Takeda’s reimbursable out-of-pocket expenses for performing the Services shall
not exceed $[***] without Myovant’s prior written consent.

8.
Payment Terms and Schedule. Takeda shall invoice Myovant on a Calendar Quarter
basis for fees and expenses incurred in performing the Services. Invoices shall
be sent via e-mail in pdf format, to accounting@roivant.com (Attn: Myovant).

Myovant shall pay all undisputed amounts set forth on Takeda’s invoices within
[***] days after receipt. Any amount invoiced by Takeda that is not disputed in
writing by Myovant within [***] days after receipt of Takeda’s invoice for such
amount will be deemed to be accepted by Myovant.

D-1

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

MYOVANT SCIENCES LTD.
 
TAKEDA PHARMACEUTICAL
COMPANY LIMITED
 
 
Signature: ___________________________
 
Signature: ___________________________
 
 
Name: ______________________________
 
Name: ______________________________
 
 
Title: _______________________________
 
Title: _______________________________
 
 
Date: _______________________________
 
Date: _______________________________

D-2

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FIRST AMENDMENT
TO THE
AGREEMENT FOR THE MANUFACTURE & SUPPLY OF CLINICAL TRIAL MATERIAL
This First Amendment to the Agreement for the Manufacture and Supply of Clinical
Trial Material (the “Amendment”) is entered into effective August 19, 2016 (the
“Amendment Date”) by and between Myovant Sciences Ltd. (“Myovant”) and Takeda
Pharmaceutical Company Limited (“Takeda”). Each of Myovant and Takeda may be
referred to individually herein as a “Party” and jointly as the “Parties”.
WHEREAS, Myovant and Takeda are parties to that certain Agreement for the
Manufacture and Supply of Clinical Trial Material dated June 7, 2016 (the
“Supply Agreement”); and
WHEREAS, Myovant and Takeda wish to clarify certain matters relating to the
Supply Agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Myovant and Takeda,
intending to be legally bound, hereby agree as follows:
1.
Capitalized terms used herein and not otherwise defined shall have the meaning
ascribed in the Supply Agreement.

2.
Section 17.1 of the Supply Agreement is hereby superseded and replaced in its
entirety to read as follows:

17.1 Term. This Agreement shall commence on the Effective Date and shall
continue until the termination of the License Agreement, unless terminated
earlier in accordance with subsection (a) or (b) below (the “Term”).
(a)
Termination for Material Breach.

(i)Either Party (the “Non-Breaching Party”) may terminate this Agreement in its
entirety in the event the other Party (the “Breaching Party”) has materially
breached this Agreement and such material breach has not been cured (A) within
[***] Business days of receiving notice thereof with respect to any breach of
any undisputed payment obligation under this Agreement and (B) within [***] days
of receiving notice thereof with respect to any other breach (as applicable, the
“Cure Period”). The written notice describing the alleged material breach will
provide sufficient detail to put the Breaching Party on notice of such material
breach. Any termination of this Agreement pursuant to this Section 17.1 will
become effective at the end of the Cure Period, unless the Breaching Party has
cured any such material breach prior to the expiration of such Cure Period.
(ii)If the Parties reasonably and in good faith disagree as to whether there has
been a material breach, including whether such breach was material and whether
such breach has been cured, the Party that disputes whether there has been a
material breach may contest the allegation in accordance with Article 14 of the
License Agreement. The Parties agree that the failure to deliver at least [***]
of any Drug Substance or Drug Product ordered via a Purchase Order issued in
accordance with Section 5.1.3 in any [***] month period shall be deemed a
material breach of this Agreement; provided that Myovant can establish that such
delivery shortfall caused, or is reasonably likely to cause, a material delay in
the timelines contemplated in the then-current Development Plan. Notwithstanding
anything to the contrary contained in this Section 17.1, the Cure Period for any
Dispute will run from the date that written notice was first provided to the
Breaching Party by the Non-Breaching Party through the resolution of such
Dispute pursuant to Article 14 of the License Agreement, and it is understood
and acknowledged that, during the pendency of a Dispute pursuant this Section
17.1, all of the terms and conditions of this Agreement will remain in effect,
and the Parties will continue to perform all of their respective obligations
under this Agreement.
(iii)If Myovant terminates this Agreement pursuant to this Section 17.1(a) for
Takeda’s material breach, then Section 17.2.1 of this Agreement shall apply. If
Takeda terminates this Agreement pursuant to this Section 17.1(a) for Myovant’s
material breach, then Section 17.2.2 of this Agreement shall apply, except that
Myovant shall not be permitted to cancel any pending Purchase Orders where
Takeda either: (1) has Manufactured the Drug Product or Drug Substance to be
delivered pursuant to the Purchase Order prior to the effective date of the
termination, or (2) cannot, despite good faith efforts, re-allocate to a
different program any Manufacturing slot that was scheduled to be used for a
pending Purchase Order.
(b)
Termination for Convenience. Myovant may terminate this Agreement at will, in
its sole discretion, on not less than [***] prior written notice to Takeda. If
Myovant terminates this Agreement pursuant to this Section

1

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17.1(b), then Section 17.2.2 of this Agreement shall apply; except that Myovant
shall not be permitted to cancel any Purchase Orders where [***].
3.
Except as expressly set forth herein, all terms and conditions of the Supply
Agreement remain in full force and effect.

4.
This Amendment 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 Amendment 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.

2

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

This Amendment is accepted and agreed by the Parties through their duly
authorized representatives below as of the Amendment Date.
 
 
 
 
 
 
 
 
 
TAKEDA PHARMACEUTICALS COMPANY LIMITED
 
 
 
MYOVANT SCIENCES LTD.
 
 
 
 
 
By:
 
/s/ Shigeo Yanai
 
 
 
By:
 
/s/ Marianne L. Romer
 
 
 
 
 
Name:
 
Shigeo Yanai
 
 
 
Name:
 
Marianne L. Romer
 
 
 
 
 
Title:
 
Japan Head of Formulation Development, Pharmaceutical Sciences
 
 
 
Title:
 
Head, Global Transactions & Risk Management

3