Exhibit 10.18

 

COMMERCIAL SUPPLY AND SERVICES AGREEMENT - DRUG SUBSTANCE

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COMMERCIAL SUPPLY AND SERVICES AGREEMENT
- DRUG SUBSTANCE -

[***]

Effective Date: 7th December 2017

by and between

Ultragenyx Europe GmbH

Innere Margarethenstrasse 5

4051 Basel,
Switzerland

 

(„Customer“)

 

and

 

Rentschler Biopharma SE,

Erwin-Rentschler-Str. 21, 88471 Laupheim,

Germany

 

(„Rentschler“)

 

hereinafter called each or together "Party" or "Parties".

 

 

Preamble

WHEREAS, Rentschler is a company engaged in the field of pharmaceutical contract
development, services and manufacturing and has the know-how, expertise,
capability, experience and the infrastructure necessary to undertake certain
commercial Services (as defined hereinafter); and

WHEREAS, Customer is a company engaged in the pharmaceutical field focussing on
development of rare disease therapies and is eager to engage Rentschler as a
contract manufacturing organization for the Product (as defined hereinafter);
and

WHEREAS, Customer is planning to reach commercial stage in the near term for the
Product; and

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WHEREAS, Rentschler has agreed to manufacture and supply certain amounts of the
Product to the Customer for commercial demands in the Territory (as defined
hereinafter) subject to the terms and conditions set forth herein; and

WHEREAS, Both Parties agree to work in a partnership model and are committed to
establish the appropriate level of trust and transparency. Each Party hereto has
a duty of good faith and fair dealing in connection with its performance under
this Agreement. Each Party shall perform its obligations under this Agreement in
a diligent, legal, ethical and professional manner so as to advance the purposes
and intent of this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the Parties agree as follows:

1.

Scope of the Agreement & Schedules

1.1.

Rentschler will perform on a non-exclusive basis the Services upon the terms and
conditions of this Agreement as well as its Schedules.

1.2.

Attached to this Commercial Supply Agreement (“Agreement”) are the following
Schedules which form an integral part of this Agreement:

 

Schedule A:

Definitions used in this Agreement;

 

Schedule B:

Commercial Terms for the Services;

 

Schedule C:

Legal Terms, including liabilities and limitation of liabilities;

 

Schedule D:

Latest agreed version of the Quality Agreement defining the delineation of the
pharmaceutical responsibilities. This Schedule will be executed directly between
Ultragenyx Pharmaceutical Inc., part of Ultragenyx group of companies (that is
providing pursuant to separate intra group agreements quality oversight and
support services on behalf of the Customer) and Rentschler.

 

Schedule E:

Compliance

1.3.

In the case of any inconsistencies between this Agreement, the Schedules and /
or an Offer referring to it, this Agreement shall prevail, except for quality
aspects and the definition of Territory after the Effective Date for which
Schedule D shall prevail.

1.4.

Neither Party shall alter or adjust this Agreement or any Schedule to it without
the prior written permission of the other Party.

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2.

Customer’s Responsibilities

2.1.

Customer shall be responsible to

 

(i)

provide complete and accurate requirements to define the Specifications;

 

(ii)

provide Rentschler with complete and accurate information (Material Data Safety
Sheet) and sufficient FOC Material necessary to perform the Services.

2.2.

Customer shall supply FOC Material to Rentschler according to Schedule B in line
with [***] (Incoterm 2010). Customer is responsible that such material is (i)
suitable for the Manufacturing of the Product, (ii) fits for the Services and
(iii) pharmaceutically compliant.

2.3.

Customer shall inform Rentschler’s incoming goods department
(wareneingang@rentschler.de) and the project manager of any delivery at least
[***] Business Days before any such delivery to Rentschler is initiated.

2.4.

In case that Customer provides cell substrates, cell lines or cell banks,
Customer provides only aliquots to Rentschler and safeguards that the primary
seed lot, master cell bank or working cell bank as applicable is stored safely
in another place. Customer confirms that it will provide all safety data and
information available that are relevant for Rentschler’s safety requirements.

2.5.

Both Parties shall comply with Schedule E.

3.

Rentschler Responsibilities

3.1.

Rentschler shall comply with cGMP and with recognized industry standards,
including, but not limited to applicable ICH guidelines and the pertaining laws
and regulations.

3.2.

Rentschler will make available and maintain an adequate manufacturing site,
validated processing equipment, the manufacturing processes for the products of
the Customer in a validated state, trained and competent personnel with relevant
knowledge and experience, and will ensure sufficient capacity to store the FOC
material and the excipients needed and render the Services, and Manufacture of
Product.

3.3.

All the responsibilities and obligation listed under section 3.1. and 3.2. will
be covered by Rentschler at their own expenses.

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3.4.

Rentschler will notify the Customer immediately but not later than within [***]
Business Days in the event of any potential failure to deliver Product within
the agreed time lines.

3.5.

Rentschler will render the Services in a professional and workman-like manner in
accordance with this Agreement, including the Quality Agreement.

3.6.

Rentschler will Manufacture the Product in accordance with the terms of this
Agreement and the responsibilities as set out in the Quality Agreement.

3.7.

Rentschler has to provide the Customer with a [***] Material inventory report by
the [***] reflecting the inventory of FOC Material on the last day of the
previous calendar month.

4.

Governance Model

4.1.

The partnership model includes a Steering Committee (as described in clause 4.2)
and a Joint Working Team (as described in clause 4.13) focussing on operational
execution. The Joint Working Team will be led by a project / relationship
manager of each Party (“Joint Working Team Leads”).

4.2.

The Parties shall establish a Steering Committee consisting of 4 (four)
permanent senior management individuals (“Committee Members”). Each Party will
nominate [***] Committee Members.

4.3.

Either Party may replace its Committee Members by notice to the other Party.

4.4.

The Committee Members shall be appropriately qualified and experienced in order
to make a meaningful contribution to the Steering Committee meetings.

4.5.

The purpose of the Steering Committee is to

 

(i)

establish and maintain an effective and efficient collaboration between the
Parties;

 

(ii)

confirming the Joint Working Team Leads appointed by each Party;

 

(iii)

oversee the Joint Working Team’s performance in business review meetings;

 

(iv)

evaluate in good faith and ratify any technical, business process and / or
quality Improvements proposed by the Joint Working Team;

 

(v)

act as escalation body for issue resolution;

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(vi)

define the framework for continuous Improvement, mutual long-term objectives and
priorities.

 

(vii)

any other topics assigned to it in compliance with this Agreement of following
the mutual decision of the Parties.

4.6.

The Steering Committee shall conduct its discussions in good faith with a view
to operating to the mutual benefit of the Parties.

4.7.

The Steering Committee shall meet as often as the Committee Members may
determine (to this purpose the request of the Committee Members of each Party
would be sufficient), but in any event no less than [***] per Calendar Year.
Meetings can be held face-to-face or by teleconference, with minimum [***] per
year. Either Party may request a meeting within [***] Business Days in urgent
cases.

4.8.

The agenda (including, any pre-read material) shall be distributed to the
participants latest [***] Business Days prior to the meeting. In addition to any
other topics to be discussed in the agenda of the relevant meeting, the
following matters shall be invariably discussed during the meetings of the
Steering Committee:

 

(i)

company updates and strategic outlooks;

 

(ii)

decisions requested from the Joint Steering Committee;

 

(iii)

performance review (services, quality, relationship, financials);

 

(iv)

performance review of the Joint Working Team;

 

(v)

risk evaluation and associated risk mitigation projects;

 

(vi)

review status of past meeting action items;

 

(vii)

approval of target setting for Key Performance Indicators defined by Joint
Working Team.

4.9.

Each Party may invite individuals with special skills to attend such meetings
where it is considered to be relevant and appropriate.

4.10.

All decisions of the Steering Committee shall be made in good faith in the best
interests of this Agreement and require a unanimous vote. In the event that the
Steering Committee is unable to reach a decision on any matter after good faith
attempts to resolve such disagreement in a commercially reasonable fashion and
in any event if the Steering Committee is unable to decide within [***] Business
Days, then such matter should be referred to the Executive Leadership of both
Parties, who together shall use reasonable and good faith efforts to reach a

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decision by consensus within [***] Business Days after such matter is referred
to them.

4.11.

If the Executive Leadership does not reach consensus in accordance with clause
4.10., either Party may commence dispute resolution proceedings in accordance
with the relevant provisions set out in this Agreement.

4.12.

The Steering Committee shall take minutes of its meetings and resolutions, which
shall be promptly circulated to the Parties after each meeting for agreement. In
case of any disagreement clauses 4.10. and 4.11. shall apply.

4.13.

The Parties shall establish a Joint Working Team, consisting of subject matter
experts at minimum in the field of manufacturing operations, quality (“Joint
Working Team Members”).

4.14.

Either Party may replace its Joint Working Team Members by notice to the other
Party.

4.15.

The Joint Working Team Members shall be appropriately qualified and experienced
in order to make a meaningful contribution to the Joint Working Team meetings.

4.16.

The purpose of the Joint Working Team is to:

 

(i)

drive and improve performance of Services and the Joint Working Team;

 

(ii)

deliver on Service goals;

 

(iii)

target setting for Key Performance Indicators (to be established; every Calendar
Year by the 4th quarter of the preceding Calendar Year) that shall include
performance and Yield values agreed by the Joint Working Team Members and
approved by the Steering Committee;

 

(iv)

manage and reduce aggregate risk, including lead times and safety stock
management of Third Party Material;

 

(v)

manage issues related to Services;

 

(vi)

manage post-approval changes;

 

(vii)

maintain a collaborative and constructive relationship (at operational level);

 

(viii)

potentially propose any Improvement to the Steering Committee.

4.17.

The Joint Working Team shall conduct its discussion in good faith with a view to
operating to the mutual benefit of the Parties.

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4.18.

The Joint Working Team shall meet as often as the Joint Working Team Members may
determine, but in any event [***]. Meetings can be held face-to-face or by
teleconference, with minimum [***] per year.

4.19.

In addition to any other topics to be discussed in the agenda of the relevant
meeting, the following matters shall be invariably discussed during the Joint
Working Team meetings:

 

(i)

team member updates;

 

(ii)

performance review (services, quality, relationship, financials) by means of
defined Key Performance Indicators;

 

(iii)

risk evaluation and associated risk mitigation projects;

 

(iv)

review status of past meeting action items.

4.20.

The Joint Working Team Members may invite individuals with special skills to
attend such meetings where it is considered to be relevant and appropriate.
Individuals belonging to a third party have to be mutually agreed. These invited
individuals do not have voting powers.

4.21.

The quorum for the validity of the Joint Working Team meetings shall be [***]
for each Party.

4.22.

All decisions of the Joint Working Team shall be made in good faith in the best
interests of this Agreement and require a unanimous vote. In the event that the
Joint Working Team is unable to reach a decision on any matter after good faith
attempts to resolve such disagreement in a commercially reasonable fashion. Then
such matter should be referred to and decided by the Steering Committee in a
timely manner.

4.23.

The Joint Working Team shall take minutes of its meetings and resolutions, which
shall be promptly circulated to the Parties after each meeting for agreement.

5.

Financial Audits

In case of Customer’s doubts of Rentschler’s compliance with respect to FOC
Material and Third Party Material inventory management, Rentschler shall make
available to Customer or to a certified public accountant (CPA) reasonably
acceptable to Rentschler, upon Customer’s reasonable request and with an
appropriate period of notice during the regular office hours during the Term (or
after the Term for activities started during the Term but with effects after the
Term),

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books, records and other documentation relevant to the Services. For the
avoidance of doubt Customer shall bear the cost of the CPA.

6.

Term and Termination

6.1.

This Agreement is effective as of the last date of signature (“Effective Date”)
and will expire (if not terminated earlier in accordance with the Agreement’s
provisions) 5 (five) years thereafter (“Initial Term”). The Agreement will be
automatically extended for another 5 (five) years following the Initial Term.
Customer may withdraw from this Agreement at will (without cause) with a
pre-notice of 18 (eighteen) months at any time following the Initial Term.
Rentschler may withdraw from this Agreement at will (without cause) with a
pre-notice of 36 (thirty-six) months at any time following the Initial Term.

6.2.

This Agreement may be terminated by the non-breaching Party giving written
notice of such termination to the other party if the other Party breaches a
material provision of this Agreement (including any delay for reasons
attributable to Rentschler in fulfilling Customer’s orders, which would lead to
a market stock-out as long as Customer has fulfilled its obligation and is able
to prove such fulfilment to have an appropriate safety stock of the product at
all times during the Term of the Agreement to eliminate the risk of a market
stock out and such breach remains uncured for [***] days following the breaching
party’s receipt of written notice of such breach from the non-breaching party.

6.3.

Each Party shall be entitled to terminate this Agreement with immediate effect
if:

 

(i)

any requirement / obligation mentioned in Schedule E is violated / breached by
the respective other Party and / or its Affiliates;

 

 

(ii)

a Material Change in Control and Business Model of the respective other Party;

 

 

(iii)

the respective other Party infringes Party’s Intellectual Property Rights.

 

6.4.

Customer shall be entitled to terminate this Agreement with immediate effect if
Rentschler loses the right to operate under this Agreement following any
decision from the competent authorities and / or revocation of the necessary
approvals / regulatory permits (including FDA taking control of Rentschler
following a consent decree).

6.5.

Unless otherwise agreed in writing termination or expiration of this Agreement
for any reason shall not relieve either Party or its Affiliates from their
obligations under this Agreement until the date of such termination or
expiration or to perform such obligations as described in Schedule E) that will
survive for [***] years after the expiration or termination of this Agreement.

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6.6.

Either Party may terminate this agreement at any time if Rentschler is unable to
deliver the Services agreed in this Agreement. In the event of Force Majeure for
a period greater than [***] consecutive calender months.

6.7.

In any event of termination (including termination at will as per clause 6.1) of
this Agreement triggered by any of the Parties or resulting from a Force Majeure
event and upon written notice by Customer (“Transfer Request”), Rentschler will
start immediately to make available, in accordance with sections 2 and 3,
Schedule C of this Agreement, the manufacturing technology from Rentschler to
Customer or a third party designated by the Customer and provide reasonable
technical assistance to the Customer or such third party to operate the
manufacturing process developed under the Master Service Agreement (dated August
31, 2012) and this Agreement in order to enable the Customer or such third party
to continue the manufacturing and supply of Products (“Technology Transfer”).
Rentschler shall make reasonable efforts to complete the Technology Transfer
within [***] months. The successful completion of the Technology Transfer shall
be confirmed by the Joint Steering.

6.8.

Rentschler shall initiate Technology Transfer within [***] days after written
notice from Customer requesting such initiation (“Initiation Notice”), which
Initiation Notice may be made by Customer within [***] months after the date of
the Transfer Request.

6.9.

Such a Technology Transfer cost will be borne by the Customer unless terminated
by the Customer in line with the section 6.4. or terminated by Rentschler
according to section 6.1. In case of Force Majeure such a Technology Transfer
cost will be equally borne by both Parties.

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Rentschler Biopharma SE

 

Date:             December 6, 2017

Signature:     /s/ Klaus Schoepe

Name:           Dr. Klaus Schoepe

Position:        SVP Project Management

 

 

If second signature is required:

 

Date:             December 6, 2017

Signature:     /s/ Thomas Lottner

Name:           Thomas Lottner

Position:        VP Commercial Management

 

Ultragenyx Europe GmbH

 

Date:             January 2, 2018

Signature:     /s/ Shalini Sharp

Name:           Shalini Sharp

Position:        CFO

 

If second signature is required:

 

Date:             December 15, 2017

Signature:     /s/ Stefano Portolano

Name:           Stefano Portolano

Position:        SVP, Regional Head, Europe

 

SCHEDULE A

 

DEFINITIONS

 

•

Additional Services means any service specifically qualified as an additional
service in any approved Rentschler Offer, except all activities involved in
converting FOC Material into Product and according to the quality standards set
forth in the Quality Agreement including costs of in-process control, quality
assurance, quality control and release, deviation and complaint handling,
storage of FOC Material until delivery notice, storage of purchased material
procured by Rentschler and of Product until delivery notice, disposal of waste.

•

Affiliate shall mean with respect to a Party, any person, corporation, company,
partnership or other entity that controls, is controlled by, or is under common
control with that Party. For the purpose of this definition, “control” shall
mean direct ownership of [***] of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or [***] of the equity
interest in the case of any other type of legal entity, status as a general
partner in any partnership, or any other arrangement whereby the entity or
person controls or has the right to control the board of directors or equivalent
governing body of a corporation or other entity, or

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the ability to cause the direction of the management or policies of a
corporation or other entity.

•

BSE shall mean Bovine Spongiform Encephalopathy

•

Business Day shall mean each day of the week save for Saturday, Sunday and
public holidays in Germany or Switzerland or the United States of America.

•

Calendar Year shall mean a period of 12 (twelve) consecutive months
corresponding to the calendar year commencing on the first day of January.

•

Confidential Information means contents of this Agreement and any information
regarding the other Party’s business and / or its Affiliates’ business as well
as information relating to the Product disclosed by one Party and / or its
Affiliates to the other Party pursuant to this Agreement.

•

Delivery Date means the date of delivery requested by Customer in a Purchase
Order.

•

Drug Substance means Customer’s active pharmaceutical ingredient manufactured
under GMP condition for human use.

•

DSP stands for downstream processing and describes the process of Drug Substance
Manufacturing starting with the filtration of the unprocessed fluid until the
formulation of bulk Drug Substance.

•

Equipment means any equipment system to support manufacturing and / or packaging
of Customer’s Product.

•

Executive Leadership shall mean for the purpose of this Agreement the Chief
Technical Operations Officer of the Customer and the Chief Executive Officer of
Rentschler respectively (or whoever is on these roles ad interim).

•

Exit Fee shall mean the fee to be paid by the Customer in accordance with the
provision of section 2 of Schedule B.

•

Facility shall mean Rentschler’s manufacturing facilities located in Laupheim,
Germany.

•

Final Release shall mean Product is quality released by Customer or Customer’s
delegate as per the Quality Agreement in Schedule D.

•

FOC (Free of Charge) Material means cell lines and other materials be supplied
by Ultragenyx to Rentschler free of charge.

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•

Force Majeure shall have the meaning as provided in Schedule C, section 8.

•

Good Manufacturing Practices or cGMP means the current good manufacturing
practices including EU GMP Guide, 21 CFR, ICH Q7A, 21 CFR, EU guide and their
current official interpretations applicable to the manufacturing of drug
substances.

•

Hidden Defects means a defect of FOC Material or Product already present at the
time of delivery but not detectable at the time of the inspection.

•

Improvement means technical and business process optimization that is beneficial
for the manufacturing process, product quality, financial aspect or supply of
Customer’s Product.

•

“Intellectual Property Rights” means rights in patents, patent applications
(including all utility and design patents and patent applications), inventions,
trademarks, service marks, trade names, internet domain names, rights in
designs, rights in get-up and trade dress, goodwill and the right to sue for
passing off or unfair competition, copyrights, (including all computer
applications, programs and other software, including without limitation
operating software, network software, firmware, middleware, and design software
rights in computer software and databases), database rights, industrial property
rights, moral rights of authors, rights to use, and protect the confidentiality
of, confidential information (including know-how and trade secrets), utility
models, any common law rights arising from use of the foregoing, all rights of
renewal, continuations, divisions, extensions and the like relating to the
foregoing, and other intellectual property rights, in each case whether
registered or unregistered and including any applications and rights to apply
for the grant of any such rights and all rights and forms of protection having
an equivalent or similar effect anywhere in the world.

•

Joint Working Team Members shall mean the team selected by the Steering
Committee in accordance with the criteria set out under section 4.15 of this
Agreement.

•

Key Performance Indicators, shall mean a quantifiable measure used to evaluate
the performance of Rentschler in meeting the objectives of this Agreement as
defined by the Joint Working Team and approved by the Steering Committee.

•

Manufacture or Manufacturing means compounding, harvesting, filling or
processing, producing, testing and packaging of FOC Material and purchased
material to obtain Customer’s Product by Rentschler in accordance to the Product
specification.

•

Material Change in Control or Business Model shall mean any of the following:
(i) the sale or disposition of all or substantially all of the assets of a Party
to a Third

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Party, (ii) the acquisition by a Third Party, of [***] of a Party’s outstanding
shares of voting capital stock (e.g. capital stock entitled to vote generally
for the election of directors), or (iii) the merger or consolidation of a Party
with or into another corporation. References in this definition to a Third Party
shall also include Affiliates in case Affiliate has no comparable financial
resources and financial reputation as Customer or Rentschler has.

•

Offer shall mean Rentschler’s quotation containing the details of the proposed
Services subject to Customer’s binding order.

•

Product shall mean the Drug Substance manufactured by Rentschler and to be
delivered to Customer.

•

Purchase Order shall mean a firm order placed by Customer issued by Customer
with a corresponding purchase order number to Rentschler reflecting forecasted
Services within the Binding Forecast.

•

TSE shall mean Transmissible Spongiform Encephalopathy.

•

Quality Agreement shall be drafted substantially in the same form as Schedule D.

•

Quarantined Production means a Manufacturing of Product with any material not
released by the quality department of Rentschler before such Manufacturing. Such
Manufacturing requires explicit request by Customer.

•

Quarantined Shipment means a shipment of Product before the quality release by
Rentschler in accordance with the Quality Agreement.

•

Rentschler Know-How means all know-how or intellectual property relating to
Rentschler’s background know-how in the field of the manufacturing and
Rentschler’s operations of drug delivery, medical devices, drug process
development services as well as regulatory, packaging and quality issues.

•

Rentschler Offer means any quote proposed for Additional Services approved by
the Customer.

•

Services means all activities related to Manufacturing of Customer’s Product as
described in this Agreement and Schedule D which do not include Additional
Services.

•

Service Fee means the fee paid by the Customer for each Services as itemized in
Schedule B.1 in this Agreement and includes all activities involved in
converting FOC Material into Product and according to the quality standards set
forth in the Technical Quality Agreement including costs of in-process control,
quality

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assurance, quality control and release, packaging, storage of FOC Material.Fees
for Third Party Materials and Third Party Services are not included and are
covered separately.

•

Specifications means the written Product specifications as mutually agreed.

•

Steering Committee shall mean the committee selected by the Parties in
accordance with the criteria set out under section 4 of this Agreement.

•

Third Party means any Person other than Customer, Rentschler and their
respective Affiliates

•

Third Party Material means all materials procured by Rentschler for the
Manufacturing of the Product.

•

Third Party Services means all services procured by Rentschler for the
Manufacturing of the Product (e.g. laboratory services, hazardous waste disposal
etc.).

•

Technical Release means the release of the Product by Rentschler in accordance
with Schedule D.

•

Territory shall mean the following countries: EU, USA, Brazil, Mexico, Colombia,
Chile, Japan, Turkey or any different country as agreed by the Parties in the
Quality Agreement during the term of this Agreement after the Effective Date.

•

USP stands for upstream processing and describes the process of Drug Substance
Manufacturing starting from thawing of the cell line until the harvest of the
unprocessed fluid.

•

Yield shall mean the amount of Drug Substance manufactured in a production
batch, as agreed in writing by the Joint Working Team in compliance with section
4.16 (iii) of the Agreement.

 

•

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SCHEDULE B

 

COMMERCIAL TERMS

1.

Order Processing

Rentschler will quote the Additional Services to Customer by written Rentschler
Offer referring to this Agreement.

Upon agreement between the Parties about such Rentschler Offer, Rentschler will
provide the Additional Services as described in the respective Rentschler Offer.

2.

Forecast and Purchase Orders

The Parties hereby establish a forecast procedure, comprising a binding rolling
forecast period and a non-binding long-term range as follows:

Within [***] weeks after the Effective Date Customer will provide a good faith
rolling forecast covering the next [***] months which Customer will update
within the first [***] weeks of each calendar quarter, specifying the Product,
the ordered quantity (number of batches) and the expected Technical Release
month (“Long Range Forecast”). The first [***] months of each Long Range
Forecast shall become binding for the Customer as to the quantity of Product,
for which purchase orders must be placed during such [***] month period (the
“Binding Forecast”), and sent together with the Binding Forecast, and the
remaining [***] months of each Long Range Forecast shall be non-binding. Any
Long Range Forecast and the respective updates will only become effective upon
confirmation by Rentschler, which has to be provided within [***] Business Days.
If Rentschler does not confirm the Long Range Forecast within [***] Business
Days Customer may immediately escalate this topic to the Steering Committee for
resolution.

Any cancellation or reduction in the quantity of Product ordered during the
period of the Binding Forecast by Customer will be subject to the Exit Fee
mentioned below. For the avoidance of doubt, if Customer increases the Long
Range Forecast over the previously submitted Long Range Forecast Rentschler is
not obliged to reserve resources as long as the Long Range Forecast is not
confirmed by Rentschler.

Customer shall issue written purchase orders corresponding to the firm and
binding quantities defined in the Binding Forecast to Rentschler. Each Purchase
Order shall state the expected day of delivery (“Delivery Date”). Rentschler
shall confirm the received Purchase Orders within [***] Business Days.

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If Customer does not issue a Purchase Order as foreseen in the respective part
of the Binding Forecast or if Customer cancels any purchase order already
issued, Customer shall be pay an Exit Fee as follows:

Time period between cancellation and the start date of the USP / DSP reservation

Exit Fee (percentage of the Service Fee applicable to the Product in the
cancelled Purchase Order)

[***]

[***]

[***]

[***]

The start date of the USP / DSP reservation shall be [***] days prior to the
requested Delivery Date of the corresponding batch.

For the avoidance of any doubts the pre-notice provided for by this section 2
(i) and (ii) will be calculated with reference to the expected Delivery Date
indicated in the Long Range Forecast.

Rentschler will use reasonable commercial efforts to allocate the reserved
production capacity of the above mentioned orders to other Customer’s orders. If
such allocation will be successful, the Exit Fee will equal to [***] in case of
2 (i) and [***] in case of 2 (ii).

For the months [***] until [***] Customer can request the postponement of
maximum [***] months of the Delivery Date of a binding purchase order by written
communication without the payment of any Exit Fee. Rentschler will evaluate such
postponement request and confirm Customer such postponement if practicable. Such
postponement shall only become effective after confirmation by Rentschler. For
the avoidance of doubt, if the postponed Delivery Date is later than month [***]
of the Binding Forecast a cancellation of the batch by Customer is not possible.

3.

Delivery

3.1

Delivery of FOC Material by Customer.

Customer shall deliver all FOC Materials with a notice time of at least [***]
prior to the intended Delivery Date.

On written request by Customer, the Parties can agree on a Quarantined
Production. In this case, Rentschler conducts a preliminary analysis (identity,

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sterility and BSE / TSE) of the FOC Materials and uses the FOC Materials in the
manufacture before their complete release.

3.2Delivery of Product by Rentschler

Any delivery of Product by Rentschler to Customer or to a third Party named by
Customer will be based on [***] (Incoterms 2010).

In urgent cases, Customer may request in writing to Rentschler for:

 

(i)

a Quarantined Shipment; or

 

(ii)

a Quarantined Production

Customer assumes all risks, responsibilities and costs associated with a
Quarantined Shipment or Quarantined Production, unless the reason for the
non-compliance of the Product is caused by Rentschler.

3.3

Rentschler will use their best endeavour to improve constantly the processes and
the technology pertaining to the execution of this Agreement. Rentschler shall
communicate the Improvements to the Steering Committee, who will evaluate in
good faith if any mutual benefit may derive from the communicated Improvement.

4.

Key Performance Indicators

The performance or non-performance in whatever shape or form of the agreed Key
Performance Indicators (section 4.8 (vii) and 4.16 (iii) shall in no respect
constitute a material breach (section 6.1 of this Agreement) of this Agreement
and shall have no impact with respect to the fees (section 5 of this Schedule
B). For the time being the purpose of the Key Performance Indicators shall only
be to evaluate performance against mutually defined goals.

5.

Fees

Customer will pay to Rentschler a Service Fee as defined in Schedule B.1 and /
or fee for Additional Services following the acceptance of a Rentschler’s Offer.

The Service Fee and fee for Additional Services do not contain value-added tax
(VAT). If Rentschler’s Services or Additional Services are subject to VAT,
Customer will be charged for the VAT incurred in addition.

The Service Fee will always be invoiced in two instalments. [***] of the fees
will be upon start date of vial thaw; the remaining [***] will be invoiced upon
release of the respective batch of Product.

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The fees for the Additional Services will be paid according to the payment
schedule contained in any approved Rentschler’s Offer.

All payments must be made in Euro and are payable within [***] days from date of
invoice or a designated date where the payment will fall due.

Rentschler may adjust the Service Fees [***]. Any increase will be calculated
with an average value based on [***] of the [***] and [***] of the [***]. If
Rentschler chooses not to adjust the price for [***] or more years (“Period”),
Rentschler may adjust the price on the respective next [***] as if Rentschler
had made use of its right to adjust the price [***] during the Period. The
decision for any potential adjustment proposal in excess of [***] will be
deferred to the Steering Committee. Rentschler shall provide Customer with all
the official referenced sources justifying any adjustment in accordance with
this clause with a [***] Business Day notice.

 

6.

Third Party Services

Rentschler shall agree with Customer on Third Parties Services, and shall
contract and pay for the supply of all Third Party Services necessary to render
Services in accordance with this Agreement. For all Third Party Services,
Rentschler shall invoice Customer for the costs paid to the Third Party for the
Third Party Services and Customer will reimburse Rentschler following the
presentation of an itemized invoice, for all Third Party Services costs actually
incurred by Rentschler for procurement of such Third Party Services. For the
avoidance of doubt, there will be no mark-up on Third Party Services necessary
to render Services in accordance with this Agreement.

7.

Third Party Material

Except for FOC, Rentschler shall contract with Third Parties and pay for the
supply of all Third Party Materials necessary to manufacture the Product in
accordance with this Agreement. Customer will reimburse Rentschler following the
presentation of an itemized invoice, for all Third Party Material costs actually
incurred by Rentschler for procurement of such Third Party Materials. For the
avoidance of doubt, there will be no mark-up on Third Party Materials necessary
to render Services in accordance with this Agreement. For the avoidance of
doubt, costs for preparation of process media and process buffers (direct labour
without overhead and profit contribution) are invoiced as Third Party Material
costs.

Rentschler will promptly inform Customer if it encounters supply problems,
including delays and / or delivery of non-conforming Third Party Material with
respect to any supply of purchased material for Manufacturing of Product and
Rentschler must take reasonable measures to correct such problems and the
Customer may in their discretion provide assistance in agreement with

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Rentschler.Rentschler should ensure sufficient safety stocks available of any
such Third Party Material based on best market practice and on Rentschler’s
experience with its suppliers and their respective contractual agreements. The
definition of such safety stock levels should be reviewed periodically and
mutually agreed by the Joint Working Team.

8.

Special Costs

All costs concerning the further use or importation by Customer into a country
of Territory any Product resulting from the Services are to be borne by
Customer, especially administration fees connected with the marketing of the
Product, even if the respective administrative authority should charge
Rentschler directly. In such case, Customer ensures that the respective amounts
are received by Rentschler on Rentschler’s bank account within [***] calender
days. Customer will inform Rentschler about any administrative requirement
applicable to Rentschler of any country Customer is marketing its Product as
soon as possible.

9.

Additional Services

Upon request by Customer, Rentschler will perform the following Additional
Services but are not limited to which are further defined as follows:

 

(i)

stability Studies of Product;

 

(ii)

cGMP audits as outlined in Schedule D;

 

(iii)

inspections of Health Authorities other than EU and FDA;

 

(iv)

accommodation of “Persons in Plant” Rentschler will accommodate and grant
reasonable access during working hours for “Person in Plant” at no cost for the
Customer. If such an access will exceed [***] Business Days, Rentschler will
have the right to charge Customer an amount of [***] EUR for any Business Days
of access in excess of [***] Business Days.

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SCHEDULE B.1

Service Fees

The Service Fees are (i) for [***] batch of Product [***] EUR, (ii) for a
campaign of [***] consecutive batches of Product [***] EUR, (iii) for a campaign
of [***] consecutive batches of Product [***] EUR.

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SCHEDULE C

LEGAL TERMS

1.

1.

Scope

These terms are applicable for any engagement or order relating to the Services
and Additional Services as requested by Customer and shall prevail and supersede
any conflicting terms as provided by the Customer.

2.

Results

2.1

Neither Party shall, as a result of this Agreement, acquire any right, title, or
interest in any intellectual property that the other Party owns or controls as
of the Effective Date of this Agreement, or that the other Party obtains
ownership or control of separately and apart from the performance of the
Services under this Agreement ("Background Intellectual Property").

2.2

Customer shall own exclusively all rights, titles, and interests in any and all
intellectual property that Rentschler conceives, invents, reduces to practice,
develops or makes, solely or jointly with Customer, in the course of performance
of the Services or as a result of using Customer's Background Intellectual
Property.

2.3

Notwithstanding the foregoing, Rentschler shall own all rights, titles and
interests in any intellectual property regarding Know How that Rentschler
develops, conceives, invents, reduces to practice or makes in the course of
performance of the Services that (i) relates to the Rentschler Background
Intellectual Property; (ii) Rentschler’s Know How, (iii) which is severable from
the Product, and (iii) does not reveal or disclose any Confidential Information
of Customer.

3.

Intellectual Property

3.1

For any Inventions both parties shall cooperate in good faith to allocate the
rights and the costs which are associated with the possible protection of the
Inventions.

3.2

If the performance of the Services and / or Additional Services requires the use
of Intellectual Property Rights of Rentschler, Rentschler hereby grants to
Customer the necessary rights of use to these Intellectual Property Rights
solely for the marketing, distribution and sale of the Products. In addition,
Rentschler grants to Customer the necessary rights of use to these Intellectual
Property Rights for the manufacture of the Products by Customer itself of the
Products. Such licenses are granted on a worldwide basis, non-exclusively and
royalty-free, unless expressly otherwise agreed.

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3.3

If the performance of this Agreement requires the use of Intellectual Property
Rights of Customer or of third parties, Customer hereby grants to or procures
for Rentschler the necessary rights of use to these Intellectual Property Rights
solely for the performance of the Services and / or Additional Services on a
worldwide basis, non-exclusively and free of fees.

All documents which Rentschler receives from Customer for the fulfilment of the
Services remain the property of Customer.

Rentschler may in each case archive a copy of all documents and data produced at
or in connection with the Services in copy, and will not use this archive copy
for any purposes other than to abide by the relevant commercial and tax law
provisions or to the extent to which these documents and this data are suitable
as proof of a circumstance on the basis of which an otherwise mandatory existing
liability of Rentschler, in particular pursuant to the Product Liability Act,
the Medical Products Act or the Pharmaceuticals Act, could be excluded.

Notwithstanding anything to the contrary in this Agreement, Rentschler shall not
be required to destroy any computer files stored securely by Rentschler that are
created during automatic system back-up.

3.4

Each Party shall be obliged to acquire the inventions and rights on the
inventions made under this Agreement of its employees, consultants, agents and
representatives to the extent necessary to secure the other Party’s rights set
out in this section 3. Employee invention compensation claims arising under the
German Law on Employee Inventions (Gesetz über Arbeitnehmererfindungen /
ArbnErfG) and / or comparable legislation as may be applicable in other
countries shall be reimbursed by the Party up to [***] EUR, that is exclusively
entitled to own such invention, following the allocation of Intellectual
Property Right ownership as set out in this Agreement. In case of proposed
reimbursements above [***] EUR the Steering Committee shall decide on the
respective reimbursement amount.

4.

Defective Product

4.1

IF AND TO THE EXTENT PERMITTED BY LAW, THE PRODUCT IS DELIVERED TO CUSTOMER “AS
IS” FOLLOWING COMPLETION OF THE CHECKS DESCRIBED UNDER SECTION 4.2 AND
RENTSCHLER MAKES NO WARRANTIES, REPRESENTATIONS OR GUARANTEES NOR ANY TERMS
AND/OR CONDITIONS OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED WHETHER BY
STATUTE, COMMON LAW, CUSTOM, COURSE OF DEALING OR OTHERWISE, INCLUDING ANY
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR

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A PARTICULAR PURPOSE. FOR THE AVOIDANCE OF ANY DOUBTS THIS PROVISION WILL NOT
APPLY TO ANY HIDDEN DEFECTS OF THE PRODUCT.

4.2

Customer shall examine the Product Manufactured and delivered by or on behalf of
Rentschler for compliance with the Specifications, intactness, shortage,
identity or any defect without undue delay. Should any of the Products fail to
meet the Specifications, or in the event of any other claim, Customer shall
inform Rentschler in writing without undue delay, latest within [***] Business
Days after receipt of the Product. Hidden Defects can be claimed in writing
within [***] Business Days after being detected by Customer. If Customer fails
to notify the defect within such period, Customer shall be deemed to have
accepted the consignment.

4.3

In the event Customer notifies Rentschler within the period mentioned in
section. 4.2 above that any of the Products does not conform with the
Specifications or is otherwise defective and Rentschler agrees with it,
Rentschler shall conduct its own evaluation within the time frame define in the
Quality Technical Agreement and Schedule D. Rentschler will then repeat the
Service free of charge, if Customer agrees to that. This is Customer’s sole and
exclusive remedy. If Rentschler fails to remedy, Rentschler will reimburse
Customer for the damages caused by the default up to the limits of liabilities
as described in section 5 below. If Rentschler pays the compensation, Rentschler
is no longer obliged to perform the respective concerned Service.

4.4

In the event Rentschler disagrees with the results obtained by Customer the
issue shall be submitted to an independent testing laboratory, jointly defined
by the Steering Committee, whose decision shall be binding on both Parties. The
costs of such test shall be borne by the Party found to be at fault.

5.

Indemnification and Limitation of Liability

5.1

The Parties shall indemnify, defend and hold each other and their respective
Affiliates, officers, employees and agents harmless from and against any and all
losses, costs, damages, fees or expenses, including but not limited to claims on
patent infringement and / or infringement of any third party intellectual
property rights, as well as product liability claims, complaints or procedures,
relating to the Product or otherwise caused by the Services or the Additional
Services. (“Losses”) incurred in connection with or arising out of any:

 

(i)

Third Party claims, demands, suits, proceedings or causes of actions (“Claims”)
to the extent arising out of the breach of any Party to provisions of this
Agreement;

 

(ii)

Third Party Claims to the extent arising out of any neglicence or willful
misconduct of the Parties in the performance of any obligations under this
Agreement.

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5.2

All indemnification claims in respect of any person seeking indemnification
(collectively the “Indemnitees” and each an “Indemnitee”) under section 5.1
shall be made by the corresponding Party (the “Indemnified Party”). The
Indemnified Party shall give to the other Party (the “Indemnifying Party”)
prompt written notice (“Indemnification Claim Notice”) of any Losses or the
discovery of any fact upon which such Indemnified Party intends to base an
indemnification request pursuant to clause 5.1. Each Indemnification Claim
Notice must contain a description of the Claim and the nature and the amount of
such Loss (to the extent that the nature and the amount are known at such time).
Together with the Indemnification Claim Notice, the Indemnified Party shall
furnish promptly to the Indemnifying Party copies of all the notices and
documents (including court papers) received by any Indemnitee in connection with
the Third Party Claim. The Indemnifying Party shall not be obligated to
indemnify the Indemnified Party to the extent any admission or statement made by
the Indemnified Party materially prejudices the defence of such Third Party
Claim. Where required the Indemnifying Party shall promptly send a copy of the
Indemnification Claim Notice to its relevant insurers and shall permit them to
exercise rights of subrogation.

5.3

At its option the Indemnifying Party may assume control of the defence of any
Third Party Claim by giving written notice to the Indemnified Party within [***]
Business Days after the Indemnifying Party’s receipt of an Indemnification Claim
Notice.

5.4

If the Indemnifying Party chooses not to take control of the defence or
prosecute any Third Party Claim, the Indemnified Party shall retain control of
the defence thereof, but no Indemnified Party or Indemnitee shall admit any
liability with respect to, or settle, compromise or discharge, any such Third
Party Claim without the prior written consent of the Indemnifying Party, which
consent shall not be unreasonably withheld or delayed.

5.5

Rentschler excludes any liability for punitive or exemplary damages, recall
costs or loss of profit or indirect or consequential damages or damages on
Customer Material provided that they do not depend on any wilful misconduct,
gross negligence or breach of any provision of this Agreement.

5.6

The Parties overall liability, including the obligation to indemnify, arising
out of or in connection with this Agreement, whether in contract or tort,
statutory or otherwise is limited to the amount of [***] of the [***]. This
limitation does not apply in case of liability arising out of willful misconduct
or gross negligence of any of the party including death or personal injury
resulting from its negligence, or any liability for fraud, fraudulent
misrepresentation or any other liability that cannot be restricted by law.

5.7

If Rentschler’s cooperation is required in administrative procedures, especially
in procedures of admission, customs or of importation, Customer indemnifies
Rentschler from any liability which may arise out of this cooperation. That
applies,

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in particular, in cases, where Rentschler, on Customer’s request, makes
statements or applications at or towards governmental authorities or where
Rentschler participates in making those statements or applications.

6.

Insurance

Either Party shall, at its sole cost and expense, obtain and maintain in force
for the Term an adequate and suitable insurance in the minimum amounts set forth
below with a reputable insurance company to cover its liability under this
Agreement.

Comprehensive products liability insurance, with combined single limits of [***]
EUR for each claim with respect to personal injury and / or damage to property
and [***] EUR aggregate.

Upon execution of this Agreement, each Party shall furnish to the other party a
written statement by the insurer evidencing such coverages referred herein that
must remain in place for the entire duration of this Agreement and for [***]
years after termination triggered in compliance with section 6 of the Agreement.
For the avoidance of doubt, each Party is allowed to change the insurer during
the validity term of this clause provided that all the conditions described in
this sections are properly met.

7.

Confidentiality

Each of the Parties will keep the Confidential Information of the respective
other Party secret. Parties will use the Confidential Information only for the
Services / Additional Services.

Each Party shall limit the disclosure of the other Party’s Confidential
Information to Affiliates, officers or employees, and in case of Rentschler to
the employees of Rentschler, Inc., who reasonably require the same in
performance of activities related to this Agreement in order to perform the
Services / Additional Services and who are obligated to treat the same as
confidential in the same manner and to the same extent as provided herein. The
receiving Party will use its reasonable efforts to ensure that any Affiliate,
employee or officer to which it discloses Confidential Information will retain
such information in strict confidence. Rentschler is allowed to share the
Confidential Information with those third party suppliers which are listed in
the respective Offer.

The receiving Party may disclose Confidential Information to a governmental,
administrative or other regulatory body or during judicial process to the extent
required by mandatory law. In case of such disclosure, the receiving Party shall
provide the disclosing Party – as far as legally possible - with written notice
of such

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request or requirement so that the disclosing Party may seek a protective order
or other appropriate remedy. If the receiving Party is unable to inform the
disclosing Party before the information is disclosed pursuant to this paragraph,
it shall to the extent permitted by law inform the disclosing Party of the full
circumstances of disclosure and the Confidential Information which has been
disclosed immediately after the disclosure. The receiving Party agrees further
to provide immediately notice to the disclosing Party in the case of any
unauthorized use of Confidential Information.

The provisions of this section do not apply to information which receiving Party
proves that:

 

(i)

the receiving Party already knew, the prior knowledge of which it can document
by prior written records;

 

(ii)

is or becomes public knowledge other than through the receiving Party’s breach
of this promise of confidentiality;

 

(iii)

the receiving Party receives in good faith from a third party not in violation
of an obligation of confidentiality or

 

(iv)

the receiving Party independently develops, discovers or arrives at without use
of or reference to the Confidential Information.

For the avoidance of doubt, no provision in this Agreement shall restrict each
Party’s right to disclose the existence of a business relationship between the
Parties to potential customers.

8.

Force Majeure

Neither Party is liable to the other Party for failure or delay to the extent
and for so long as such failure or delay results from causes beyond the
reasonable control of such Party, including fires, earthquakes, floods,
embargoes, wars, acts of war (whether war is declared or not), terrorist acts,
insurrections, riots, civil commotion, strikes, lockouts or other labour
disturbances, acts of God or other acts, omissions or delays in acting by any
administrative authority or other party.

In the event of occurrence of force majeure, each Party will use their
commercially reasonable efforts to mitigate the adverse consequences.

9.

Miscellaneous

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No change of this Agreement is valid unless it is in writing and signed by the
Parties. This applies also to the foregoing sentence.

In case one of the clauses is invalid or unenforceable, the other clauses remain
unaffected by this. The Parties shall negotiate in good faith if they wish to
replace such invalid or unenforceable clause.

Any notice or request required or permitted to be given under or in connection
with this Agreement or the subject matter hereof shall be given by prepaid
registered or certified first class airmail, e-mail or telefax to the recipient
at its address set forth on the first page of this Agreement or to such other
address as may have therefore been furnished in writing by the recipient to the
sending Party. Any such aforementioned notice or request concerning this
Agreement shall be effective upon receipt by the Party to which it is addressed.

Neither Party may assign or transfer this Agreement or any rights or obligations
hereunder, by operation or law or otherwise, without the prior written consent
of the other Party, except that a Party may make such an assignment or transfer,
by operation of law or otherwise, without the other Party’s consent to its
Affiliate(s) or to an entity that acquires all or substantially all the business
of such Party, whether in a merger, consolidation, reorganization, acquisition,
sale or otherwise. Notwithstanding anything to the contrary contained herein, in
the event of an assignment to an Affiliate pursuant to this section 9, the
assigning Party consents, acknowledges, covenants and guarantees that it shall
remain jointly and severally liable, along with the assignee, to the non –
assigning Party for all the obligations contained herein. This Agreement shall
be binding on the successors and permitted assigns of the assigning Party, and
the name of a Party appearing herein shall be deemed to include the name(s) of
such Party’s successors and permitted assigns to the extent necessary to carry
out the intent of this Agreement. Any assignment or attempted assignment by
either Party in violation of this section 9, shall be null and void and of no
legal effect.

This Agreement and any potential subsequent amendment to it, may be executed in
two or more counterparts, each of which shall be deemed an original and all of
which shall constitute together the same instrument. In the event that any
signature is delivered by facsimile transmission or by e-mail delivery of a .pdf
format data file, such signature shall create a valid and binding obligation of
the party executing (or on whose behalf such signature is executed) with the
same force and effect as if such facsimile or “.pdf” signature page where an
original thereof.

This Agreement is governed by the laws of Switzerland. All disputes out of or in
connection with this Agreement and / or any Offer shall be exclusively settled
by the competent court in Basel, Switzerland.

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COMMERCIAL SUPPLY AND SERVICES AGREEMENT - DRUG SUBSTANCE
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SCHEDULE D

 

QUALITY AGREEMENT

 

 

 

Current version of the Quality Agreement executed separately by the Parties
(Rentschler contract no. B15B-4301)

 

 

 

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Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions marked [***].

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COMMERCIAL SUPPLY AND SERVICES AGREEMENT - DRUG SUBSTANCE
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SCHEDULE E

 

COMPLIANCE

 

1.

Compliance

For Rentschler, it is a matter of course that group members of Rentschler comply
with the law and any and all other relevant provisions applicable in the
countries where they operate. Rentschler expects the same from its business
partners.

2.

Anti-Corruption

Neither Party shall perform any actions that are prohibited by local and other
anti-corruption laws that may be applicable to one or both Parties to the
Agreement. Without limiting the foregoing, neither Party shall make any
payments, or offer or transfer anything of value, to any government official or
government employee, to any political party official or candidate for political
office or to any other Third Party related to this Agreement in a manner that
would violate Anti-Corruption Laws.

3.

Export

Each Party hereby acknowledges that this Agreement is or might be subject to one
or more export control laws, regulations or the like, and agrees that it will
not transfer, export or re-export any such item, including any documentation,
information or product that incorporates, is derived from or otherwise reveals
such, without complying with all applicable export control laws, regulations and
like, including obtaining and / or cooperating with the other Party in securing
all appropriate licenses and authorizations.

Customer specifically certifies that it will not transfer, export, or re-export
any item under this Agreement to any country or entity subject to export control
restrictions and / or embargoes under any applicable laws, regulations and the
like.

4.

Dealing with Internal Knowledge, Confidentiality

In principle, company and operational secrets must be treated with
confidentiality. This shall also apply to any other information (such as
customer information) whose confidentiality is in the interest of Rentschler’s
customers.

5.

Data Privacy

Both Parties must comply with the applicable statutory and operational
principles regarding the protection of data regarding employees, customers, and
investors. In order to protect personal data either Party must observe the
necessary diligence in the context of the assigned task.

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Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions marked [***].

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COMMERCIAL SUPPLY AND SERVICES AGREEMENT - DRUG SUBSTANCE
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6.

Documentation of Business Transactions

The documentation of any and all business transactions must be complete,
transparent, and in compliance with the statutory provisions as well as with any
provisions and processes.

7.

Social Responsibility

Rentschler respects the dignity of every human being and is committed to the
compliance with and the protection of human rights.

Rentschler does not tolerate any kind of child labor as well as any exploitation
of children and adolescents. Minimum age for the admission to employment must
not be under the age for the fulfilment of compulsory education and in no case
under 15 (fifteen) years.

Rentschler disapproves of any form of forced labor.

8.

No Discrimination

Rentschler creates a working atmosphere characterized by respectful cooperation
and to strictly oppose to any kind of discrimination on grounds of race or
ethnic origin, gender, religion or philosophy of life, disability, age, or
sexual identity.

9.

EHS (Environmental, Health and Safety)

It is Rentschler’s policy to operate in a safe and responsible manner with
respect to the environment and health of our employees, our customers and the
communities where we operate.

Rentschler will not compromise environmental, health or safety values for other
interests; value human life above all else and manage risks accordingly.

Rentschler pursues and continually improves an EHS system and processes to
achieve an EHS incident-free environment.

Rentschler complies with applicable laws and set standards and for suppliers.

Rentschler uses its EHS knowledge to enhance the safety and well-being of the
communities.

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Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions marked [***].