Takeda Italia General Conditions to Purchases of Goods and Services

Definitions
CUSTOMER or TAKEDA: Takeda Italia S.p.A., Company with Sole Quotaholder, an Italian
corporation, with its principal place of business at Via Elio Vittorini, 129 -00144 Rome, fully
paid-up share capital Euro 11.250.000,00, Fiscal Code, VAT and "Registro delle impresedi Roma“ No. 00696360155, REA RM No. 1356432 subject to the activity of direction andcoordination carried out by Takeda Pharmaceutical Company Limited having its registeredoffice at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka,540-8645 Japan
SUPPLIER or COMPANY: the subject in whose name the purchase order is made out.
GENERAL PURCHASE CONDITIONS or GPC: this document containing the general rules
governing the purchase order;
SPECIAL CONDITIONS: the conditions contained in each purchase order;
OFFER: the offer made by the Supplier;
COMMERCIAL BUSINESS RELATIONSHIP or CBR: the business relationship between
Customer and Supplier;
TECHNICAL SPECIFICATION: the document identifying of object of the supply;
STATEMENT OF WORK or SOW - (a formal document that captures and defines thework activities, deliverables, and timeline a vendor must execute in performance ofspecified work for a client. The SOW usually includes detailed requirements and pricing,with standard regulatory and governance terms and conditions.:
Art.1 General Requirements
The General Purchase Conditions form part of the purchase order and are applied as
essential clauses of the same.

Only the Special Conditions reported in the individual purchase orders shall prevail overthe General Purchase Conditions and may constitute a departure from or an amendmentof the same.
The General Purchase Conditions and the Special Conditions shall not be modified or
added to by the Supplier.
The General Purchase Conditions shall apply to all purchase orders passed to the
Supplier.
Art. 2 Acceptance of purchase order
The Supplier undertakes to formalize the acceptance of the purchase order by sending to
Takeda Italia S.p.A. the order confirmation duly stamped and signed, exclusively by fax tothe fax number indicated by Takeda itself when the order is forwarded to the Supplier.
Failing the above, Takeda Italia S.p.A. may unilaterally cancel the purchase order.
The initial fulfilment of a purchase order shall constitute full acceptance of the same and of
all the conditions and references contained in it.
Art. 3 Delivery terms
The delivery terms specified in the purchase order are contractually binding and essential
for the Supplier, who shall not depart from them, unless specifically agreed to in writing
with Takeda Italia S.p.A..
In the case of late deliveries, Takeda Italia S.p.A., at its discretion, reserves the right to:- cancel the purchase order by right and procure the products/services ordered and notdelivered by the agreed date, without prejudice to the right to compensation for damages
and the recovery of any additional costs incurred for the purchase of the products/services
from other sources;- apply to the Supplier, in addition and without prejudice to any right to termination and todamages for additional costs incurred by Takeda Italia S.p.A., a penalty of 1% (one percent) of the value of the supply undelivered at the agreed date, for each complete week ofdelay.
The total amount of the penalty shall not exceed 10% (ten per cent) of the value of the
supply purchase order delivered late.
Art. 4 Force Majeure
The delivery terms may be extended in the event of force majeure (such events may
include, for instance, earthquakes, fires, floods, epidemics) that actually prevent thefulfilment of the purchase order.
The Supplier shall immediately inform Takeda Italia S.p.A. in writing of the Force Majeure.
If the Force Majeure event causes a delay in the delivery greater than 30 (thirty) days,
Takeda Italia S.p.A. shall have the right to cancel the purchase order at any time, bymeans of a registered notification with advice of receipt or telefax to the Supplier.
Art. 5 Shipping and packaging
The supply, in the case of goods, shall always be accompanied by the shipping document
referring to:- Purchase order number;- Supplier code;- Shipping date;- Item code and description;- quantity;- weight;- mode of shipment.
The supply shall be packed appropriately and, in any, case, according to the current
practices, in order to prevent damage, deterioration, fault or loss while in transit.
The Supplier shall, in any case, bear responsibility for any damage to the supply until
arrival at the agreed destination.

Art. 6 Improvement of Efficiency
Takeda Italia S.p.A. reserves the right to request the Supplier to make adjustments ormodifications to the supply.
The Supplier undertakes to implement such adjustments or modifications in compliancewith the times and the relevant economic conditions previously agreed with Takeda Italia
S.p.A., provided that they are compatible with his technical and design skills.
Art.7 Quality Control
The acceptance of the supply is subject to the verification of the conformity with theconditions and quantities requested in the purchase order by Takeda Italia S.p.A.
The ordered supply shall be delivered at the destination specifically indicated by Takeda
Italia S.p.A., which reserves the right to check the quantity and quality.
In case of negative outcome of the check carried out both on product quantity and quality,
the supply shall be rejected or returned at the expense of the Supplier, who undertakes toreplace it in accordance with the terms and modes specified by Takeda Italia S.p.A.
In case of dispute regarding the no conformity of the supply with the purchase order, inderogation to the terms provided for in art. 1495 of the civil code, the guarantee is valid for
35 (thirty-five) days.
In case of products to be supplied by separate deliveries, any no conformity found in one
consignment of the purchase order shall give Takeda Italia S.p.A. the right to cancel theorder and/or not to collect the subsequent consignments, thereby cancelling any residual
order.
Art. 7 BIS Privacy Audit. If applicable to the typology of the Services, Company is available, toreceive privacy audit from personnel of Takeda or from other Takeda Affiliates or from theirrespective delegates at any time, with a prior notification of at least 10 days, with the aim to verify
the compliance of activities performed by the Company versus the privacy applicable legislationand content of the agreement (including its technical enclosures).

Art.8 Warranties
Company represents and warrants to Takeda that:a.

at all times during the term of the CBR, Company will hold all permits,
licenses and authorizations necessary to supply the services and to enable it
to comply with its other obligations under this CBR, and Company has allnecessary rights to grant the assignments and grant or procure the grant of
the licenses set out in Section 15;b.

there are no commitments, conflicts of interest or other circumstances which
will prevent or otherwise inhibit Company providing the services; andc.

Company will perform all the services pursuant to this Agreement and each
SOW in a timely and professional manner, in full compliance at all times withall applicable laws and regulations, codes and guidelines.

d.

Supplier Code of Conduct. Takeda is committed to responsible businesspractices and holds its Suppliers to similar expectations. Takeda Group issignatory of the United Nations Global Compact (www.unglobalcompact.org).
Takeda Supplier Code of Conduct supports Takeda commitment to uphold
the UN Global Compact’s 10 universally accepted principles in the areas ofhuman rights, labor, environment and anticorruption, as applied to our
supplier community. Company acknowledges receipt of Takeda’s Supplier
Code of Conduct. Takeda intends to evaluate its supplier’s fulfilment of theprinciples set forth in the Supplier Code of Conduct in connection withawarding business to and maintaining business with our suppliers. Company

agrees to cooperate with Takeda’s reasonable requests to records, facilities
and personnel for review by Takeda or Takeda’s designated third party inorder to permit Takeda to evaluate Company’s fulfilment of the principles set
forth in the Supplier Code and to fulfil Takeda’s own obligations. Takeda
expects Company to engage in good faith discussions regarding any areas inwhich the principles set forth in the Supplier Code of Conduct are not fulfilled,
and actions Company will take to better fulfil the expectations set forth in the
Supplier Code of Conduct. Failure of Company to meet the expectations in
the Supplier Code may affect Takeda’s willingness to award business to or
maintain business with the Company.
e.

Diversity. Company acknowledges Takeda’s commitment to diversity, bothfor its own workforce, and within its supplier base through Takeda’s Supplier
Diversity Program. Takeda’s Supplier Diversity Program seeks to increase
opportunities for small businesses and diverse businesses (businesses
owned or operated by historically underutilized population groups, such as
women, minorities, veterans, persons with disabilities , persons representing
a variety of sexual orientation or identity and others) to participate in
Takeda’s contracts and subcontracts.

To that end, for any permitted

subcontract under this Agreement, Company agrees to seek out and provide
commercially reasonable opportunities for small and diverse businesses as
described above to participate in such subcontracts to the extent consistent
with the efficient performance of Services. Takeda invites and encourages
small and diverse suppliers to identify themselves as part of the contracting
process. If Company is not a small or diverse business, Company agrees,
upon the request of Takeda, to report spend with small and diverse
businesses: (i) subcontracted under this agreement, and/or (ii) generally (notdirectly for this Agreement).

In addition, Company agrees to provide

information concerning its workforce diversity efforts to Takeda upon request.
Art. 9 Invoices
Company shall submit invoices to Takeda for all Fees and Authorized Expenses incurredin connection with the services in a format acceptable to Takeda and containing theelements specified herein as well as any elements specified in the applicable SOW. Each
such invoice shall: (a) identify the applicable project by name and Purchase Order number;(b) be accompanied by appropriate documentation supporting any Authorized Expenses
claimed; (c) include a breakdown of Fees and Authorized Expenses; and (d) include otherline item descriptions for applicable charges consistent with those line item descriptions
included in the applicable Purchase Order. Any invoice has to be sent to Takeda in theelectronic format via SDI “Sistema di interscambio” including the codice unico didestinazione IRKA1JB. In no event shall Company submit invoices to Takeda for any
project more frequently than monthly unless otherwise agreed in the SC. Company’s final
invoice shall reconcile all payments made against the budget.

Except as expressly

approved by Takeda in a SOW, Takeda will not prepay Company any Fees or Authorized
Expenses.
Art. 10 Subcontracting
Company may not subcontract the performance of any of the services to third parties
without Takeda’s prior written consent. Company shall at all times remain primarily liable
for the full and proper performance of all of its obligations under this GPC including any
obligations provided through any permitted subcontractor, and shall be fully responsible for
all actions or omissions of its subcontractors, also with reference to the economic
obligations for the activities performed by the subcontractors. If the services requireCompany to pay any permitted third parties, Company agrees that it shall disburse
promptly funds received from Takeda to the appropriate third parties.

Company represents and warrants, holding Takeda harmless from any responsibilities,
that Company and its subcontractors are in compliance with any regulations applicable tothe activities/services provided with particular regard to: (i) labour law, salaries andretirements benefits of its employee; (ii) the rules on working time, the weekly rest periods,
holidays period etc; (iii) the applicable legislation on safety and health. In any case,Company agrees to indemnify and hold harmless Takeda should Company and/ or any
subcontractors appointed by the Company put in place malpractice and fraud in violation of
the applicable labour law applicable in Italy.

Art. 11 Right to audit
Company shall maintain accurate books and records of all services performed, Fees
charged and Authorized Expenses incurred. During the term of this GPC and for five (5)years following its expiration or earlier termination, Takeda shall have the right, at its own
expense, to audit Company’s books and records during normal business hours for the
purpose of verifying Company’s compliance with the terms of this Agreement, the accuracyof the invoices submitted by Company and the amounts paid or payable by Takeda orCompany hereunder. This section shall survive any expiration or other termination of the
CBR.

Art. 12 Confidentiality and Injunctive reliefa.

All Confidential Information is disclosed in confidence and shall only be usedin performance of the Receiving Party's rights or obligations under this GPC.
For the avoidance of doubt, the provisions of this section also apply to
SOWs.

b.

Subsection 5(A) shall not apply to Confidential Information which:(i)

was in the possession of the Receiving Party as evidenced by written
records pre-dating disclosure under or in connection with thisAgreement;(ii)

was or becomes generally available to the public other than throughthe willful or negligent act or omission of the Receiving Party or any of
its employees, agents or permitted subcontractors;(iii)

was disclosed to the Receiving Party by a third party who had thelegal right to make such disclosure, was not obligated byconfidentiality and nonuse obligations and did not bind the Receiving
Party to such obligations; or(iv)

was required to be disclosed by the Receiving Party to comply withapplicable laws or government regulations; provided, however, that
the Receiving Party promptly notified the Disclosing Party in writing ofsuch requested disclosure, gave the Disclosing Party the opportunity
to prevent or limit the disclosure through appropriate legal means andused its best efforts to maintain the confidentiality of the Confidential
Information being disclosed to the greatest extent possible.

c.

The Receiving Party shall use at least the same degree of care, but no lessthan a reasonable degree of care, to safeguard the Confidential Informationof the Disclosing Party as it employs with respect to its own information of asimilar nature.

In the event of unauthorized disclosure or loss of theDisclosing Party's Confidential Information, the Receiving Party shallimmediately notify the other party in writing and use its best endeavors toprevent any further disclosure or unauthorized use thereof.
d.

Without limiting either party’s remedies in any way, the parties acknowledge
and agree that any actual or threatened breach of the confidentiality and nonuse obligations in this GPC relating to the Confidential Information would
cause irreparable harm for which remedies at law would not be adequate.
Therefore, in the event of any breach or anticipatory breach of this section,
each party shall be entitled to seek specific performance and other injunctive
and equitable relief without limiting any of its other available rights andremedies.

e.

The Receiving Party shall not produce printed copies, or copy or otherwise
duplicate material containing Confidential Information, unless this isnecessary for the purposes of the GPC. The Receiving Party undertakes,
upon termination of the CBR (or earlier if requested by the Disclosing Party
and the Confidential Information is not needed for the Receiving party tocarry out its obligations or exercising its rights under this GPC), to use
commercially reasonable efforts to return or destroy all documents andelectronic files containing Confidential Information as well as all copies andprints thereof.

f.

Subsection 12(F) shall not apply to Confidential Information which the
Receiving Party is required to retain under the Receiving Party's written
document retention policies, applicable laws, and Confidential Information
remaining on the Receiving Party's standard computer back-up devices.

g.

This section shall survive any expiration or termination of this GPC for aperiod of ten (10) years thereafter.

Notwithstanding the above, theconfidentiality obligations under this GPC shall extend in perpetuity in relation
to sensitive information (including customer information as well as Personal
Information and Personal Data) and trade secrets, whether present or future.
Art. 13 Indemnity and liabilitya.

Company shall indemnify, defend and hold Takeda harmless from any third
party liability, loss, claim, injury, damage or expense (including reasonable
attorneys’ fees and costs) incurred by Takeda as a result of and to the extent
of: (i) any negligent or willful act or omission by Company or its employees,
agents or subcontractors in the performance of the Services; (ii) any breachof this GPC by Company; or (iii) any patent infringement, copyright
infringement, trademark infringement, title claim or misappropriation claim
resulting from Takeda’s possession or use of materials or deliverables
provided by Company hereunder except to the extent such claim arises fromand as a result of materials provided to Company by Takeda.

b.

Takeda shall indemnify, defend and hold Company harmless from any third
party liability, loss, claim, injury, damage or expense (including reasonable
attorneys’ fees and costs) incurred by Company as a result of and to theextent of: (i) any negligent or willful act or omission by Takeda or its
employees, agents or subcontractors; (ii) any breach of this GPC by Takeda;
or

(iii)

any

patentinfringement,

copyright

infringement,

trademarkinfringement, title claim or misappropriation claim resulting from Company’s
possession or use of materials or deliverables provided by Takeda hereunder
except to the extent such claim arises from and as a result of materials ordeliverables provided to Takeda by Company.

c.

To the extent permitted by applicable law, except for a breach by either party(or its employees or agents) of its obligations under Section 12 hereof,
neither party shall be liable to the other party under this GPC for any special,incidental, punitive, consequential or other indirect or exemplary damages
arising in any way out of or under this GPC including, without limitation, lost
profits, whether in tort, contract or otherwise, even if such party has beenadvised of the possibility of such damages.

Art. 14 Insurance
Each party shall use reasonable efforts to maintain insurance issued by a recognized
insurer during the term of the CBR and for a reasonable period after termination of thisGPC commensurate with industry practice and necessary to have a reasonable coveragerelating to its obligations and indemnitees under this GPC.
Art. 15 Intellectual Propertya.

All Company IP shall be Company’s sole property. To the extent that any
deliverable provided by Company pursuant to a SOW incorporates any
Company IP, Company hereby grants to Takeda a non-exclusive, royaltyfree, worldwide, irrevocable, perpetual, non-transferable and non-assignable
license to use, reproduce and distribute such Company IP for Takeda’s
internal business purposes only.

Takeda agrees not to sublicense, sell,transfer, assign, enable for access via the Internet or World Wide Web or
perform or display any Company IP licensed to Takeda hereunder for any
third party other than a third party engaged by Takeda to perform a service tothe extent necessary to permit such third party to perform its duties for
Takeda.

b.

All Takeda IP shall be promptly disclosed to Takeda, and title thereto shallimmediately vest in Takeda. Company agrees that all Work are “works forhire,” shall be the sole and exclusive property of Takeda and copyrighttherein shall immediately vest in Takeda. To the extent that any property,
ideas, and materials are not “work for hire,” Company hereby assigns to
Takeda, and shall require anyone working for Company to assign to Takeda,
all rights including copyright in such property, ideas and materials. Company
shall

executeandobtainexecutionofany

documents(including

assignments) necessary to accomplish the intent of this paragraph with no
obligation for additional payment by Takeda beyond that identified in the
SOW.

During the term of this GPC and thereafter, Company shall fully

cooperate with and assist Takeda in filing and prosecuting patent, trademark
and copyright applications and otherwise protecting its rights to the Work andother intellectual property described in this section. In this regard, Company
shall execute such assignments and other documents as Takeda deems
necessary to protect its right, title and interest in and to any such Work orother intellectual property.
c.

If and to the extent allowed under applicable law, (i) Company hereby
waives, or agrees not to enforce any claims Company might have forviolation of, any Moral Rights to which Company is now or may at any time in
the future be entitled, and (ii) Company has obtained waivers of Moral Rightsfrom each person employed other otherwise engaged by Company who will
provide services pursuant to this GPC, and written confirmation from each ofthem that they shall not enforce any claims they may have for violation of any
Moral Rights, in each case to which they are now or may at any time in the
future be entitled. To the extent that Company has not, as at the date a

SOW is entered into, obtained any and all of the waivers and confirmations
referred to in this Subsection 8 (C) from each person employed or otherwise
engaged by Company who will provide Services under such SOW, Company
shall obtain any and all such waivers and confirmations within ten (10)business days of the full execution of such SOW.
Art. 16 Compliance with anti-corruptions laws and Lgs. D. 231/2001
A). Compliance with Anti-Corruption Laws. In performing Services for Takeda,
Company and its employees and agents: (i) shall not offer to make, make, promise,authorize or accept any payment or giving anything of value, including but notlimited to bribes, either directly or indirectly to any public official, regulatory authority
or anyone else for the purpose of influencing, inducing or rewarding any act,omission or decision in order to secure an improper advantage, or obtain or retain
business; and (ii) shall comply with all anti-corruption and anti-bribery Applicable
Laws. Company and its employees and agents shall not make any payment orprovide any gift to a third party in connection with Company’s performance of thisAgreement except as may be expressly permitted in this Agreement or a SOW
without first identifying the intended third-party recipient to Takeda and obtaining
Takeda’s prior written approval. Company shall notify Takeda immediately upon
becoming aware of any breach of Company’s obligations under this subsection.
Company shall require each employee and agent of Company who will perform
services pursuant to this Agreement to participate in any anti-corruption training
reasonably required by Takeda.
B) Company Assistance; Notice of Government Inspection.

Company shallpromptly comply with any request from Takeda for information and assistance toenable Takeda to ensure and confirm compliance with Applicable Laws.
Company shall immediately notify Takeda upon becoming aware of any
governmental or regulatory review, audit or inspection of Company’s facilities,

processes or products that might relate to the Services.
C) Furthermore, Company is hereby informed that Takeda follows and applies its own
Organization, Management and Control Model under Lgs.D. 231/2001 and theprinciples contained in its Ethics Code of Conduct and in its Global

Code of

Conduct, both available at www.takeda.com/it-it (collectively the: “Codes”).
Company declares and guarantees to knowledge and accept the Codes. Takeda
shall not endorse in any way any conduct or action on the part of its suppliers orclients contrasting with the principles stated in its Codes and, consequently,
reserves the right to verify that the Company’s activities are carried out incompliance with the present contract and with any SoW. Any conduct proven to be
in contrast with these principles shall constitute immediate cause for termination ofthis contract and of any relevant SoW and related Purchase Order by Takeda, savethe further claims. Finally, the Company is informed that it can send to the following
certified email address: odvtakedaitalia@pec.it, reports concerning detailed
information of illegal or alleged conduct for which there is a reasonable suspicion
that one of the violations relevant pursuant to Lgs. D. 231/2001 has occurred or may
occur.

Art. 17 No Exclusion or Debarment
Company shall not use in any capacity, in connection with the performance of theServices, the services of any person who: (i) is debarred or otherwise excluded or
disqualified, (ii) has been convicted of a criminal offense related to the provision ofhealthcare items or services; or (iii) is otherwise subject to any restrictions or sanctions by
any government agency.
Art.18 Withdrawal

Takeda Italia S.p.A. reserves the right to withdraw from the purchase order at any time, bymeans of a registered notification with advice of receipt or a telefax to the Supplier, with 15(fifteen ) days notice. In case of withdrawal, Takeda shall pay to the Supplier, uponpresentation of supporting documents, the amounts due for the activities
carried out until the time of withdrawal, with the explicit exclusion of the loss of profits.
Where Takeda Italia S.p.A. has expressly and formally requested the Supplier to prepare a
specific stock of materials that can only be used by Takeda Italia S.p.A. for its needs andcannot be otherwise marketed, the same undertakes to collect and/or pay the value of thesame.
Art.19 Cancellation
In the case of a violation or a non observance on the part of the Supplier of one or moreclauses contained in the General Purchase Conditions or in the Special Conditions,Takeda Italia S.p.A. shall have the right to cancel the purchase order, under article 1456 of
the civil code, by registered notification with advice of receipt or telefax to the Supplier,save for Takeda Italia S.p.A.’s right to request to be indemnified for greater damages
incurred.
Takeda Italia S.p.A. is entitled, at its discretion, to cancel the purchase order whereanother company buys the majority share of the Supplier or in case of take-over, due to
shutdown of the Supplier, insolvency or if the same should find himself in a situation ofreceivership, trusteeship or arrangement with creditors.
Art. 20 Applicable law and place of jurisdiction
The purchase order shall be governed and interpreted, from all viewpoints, by the ItalianLaws, with the exception of those that are expressly stated in the General Purchase
Conditions and Special Conditions. Any disagreement arising from or connected with thepurchase order are subject to the exclusive jurisdiction of Rome, excluding any otherjurisdiction prescribed by the law.

Art. 21 Obligation deriving from GDPR
21.1 Company represents and warrants that will comply with the provisions contained in
EU Regulation 679/2016 (GDPR) regarding the protection of personal data.
21.2 Company represents and warrants to have adopted any advisable security measure
in order to avoid the risks of destruction or loss, also accidental, of said data, of non
authorized access thereto or of the process thereof which should not have beenauthorized.
Art. 22 Miscellanea
It is clearly understood that in case of any conflict between the present GPC and the offer
and/or the purchase conditions proposed by the Company, the present GPC will prevail.

July 2019