Execution Version
 
Exhibit 10.10

CONTRACT MANUFACTURING AGREEMENT
API AND DRUG PRODUCT
This Agreement is made as of 20 January 2020 (the Effective Date) between
Siegfried AG    
Untere Bruehlstrasse 4, 4800 Zofingen, Switzerland (Siegfried);
and
Jazz Pharmaceuticals Ireland Limited
5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland (Jazz).
Recitals
A.
Siegfried is engaged in the business of, among other things, providing
development and/or manufacturing services with regard to drug substances and
drug products for the pharmaceutical industry;

B.
Jazz is engaged in the business of, among other things, developing, producing,
formulating, distributing and commercializing pharmaceutical products;

C.
Jazz desires to have Siegfried Manufacture and supply to Jazz Product (as
defined herein) in commercial quantities; and

D.
Siegfried, subject to the terms and conditions of this Agreement, desires to
Manufacture and supply Product to Jazz.

Now, therefore, the Parties agree as follows:
1.
Definitions

Unless elsewhere defined in this Agreement, each of the capitalized terms used
in this Agreement (other than the names of the Parties and the headings of the
Sections) shall have the meanings indicated below. Such meanings shall apply
equally to all forms of such terms, including singular and plural forms, unless
otherwise clearly indicated.
1.1
Active Pharmaceutical Ingredient/API shall mean the active pharmaceutical
ingredient(s) set forth in Annex 1.1.

/s/ Henn        /s/ KG
Siegfried        Jazz

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1.2
Affiliate shall mean with respect to any Party any person or entity Controlling,
Controlled by, or under common Control with a Party at any time during the Term
of this Agreement. For purposes of this definition, the term Control shall mean
the power to direct or cause the direction of the management and policies of an
entity, whether through the ownership of voting stock, by contract or otherwise.
In the case of a corporation, the term Control shall mean the direct or indirect
ownership of at least fifty per cent (50%) of the outstanding voting stock.

1.3
Agreement shall mean this Contract Manufacturing Agreement, including its
Annexes (and appendices, if applicable), and including the Quality Agreement, in
each case as may be amended from time to time according to the applicable terms
and conditions of this Agreement or the Quality Agreement.

1.4
Alternative Manufacturer shall have the meaning as set out in Section 12.10.

1.5
API Manufacturing Site shall mean Siegfried’s facilities located at Untere
Bruehlstrasse 4, 4800 Zofingen, Switzerland.

1.6
Applicable Laws shall mean all laws, rules and regulations applicable to the
Manufacturing of API at the API Manufacturing Site or to the Manufacturing of
Drug Product at the Drug Product Manufacturing Site, respectively, including
without limitation the (i) U.S. Federal Food, Drug and Cosmetic Act, and all
rules and regulations thereunder, (ii) EU Commission Directives 2001/83/EC as
amended, and 2003/94/EC, and Directive 91/412/EEC, (iii) cGMP Regulations, and
(iv) the counterparts to the foregoing in other jurisdictions, to the extent
that Siegfried performs any Manufacturing in such jurisdiction.

1.7
Arising Intellectual Property Rights means all Intellectual Property Rights
which are made, developed or reduced to practice by a Party in the performance
of, or in connection with or related to, this Agreement.

1.8
Batch shall mean a specific quantity of Product or other Material that is
intended to have uniform character and quality, within specified limits, and is
produced during the same cycle of manufacture.

1.9
Business Day shall mean a day (not being a Saturday or Sunday) on which banks
are open for business in Zurich, Switzerland, Hal-Far, Malta or Dublin, Ireland,
as the context requires.

1.10
cGMP shall mean good manufacturing practices as described in regulations and
guidance documents pertaining to manufacturing and quality control practice
applicable for respective Product as may be further defined in the Quality
Agreement.

1.11
Change shall mean any change to the Specifications, Master Batch Record, Raw
Materials, Consigned Materials, Designated Vendor, API Manufacturing Site or the
Drug Product Manufacturing Site, such Change being either (i) a Required Change
(as

/s/ Henn        /s/ KG
Siegfried        Jazz

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defined in Section 6.5), (ii) a Customer Change (as defined in Section 6.6), or
(iii) a Siegfried Change (as defined in Section 6.7).
1.12
Chemistry, Manufacturing and Control/CMC shall mean the part of pharmaceutical
development that deals with the nature of the API or Drug Product, respectively,
the manner in which both are made, and the manner by which the manufacturing
process is shown to be in control.

1.13
Confidential Information shall have the meaning as set out in Section 10.1.

1.14
Consigned Materials shall mean the materials that are owned by Jazz or that are
to be provided by or on behalf of Jazz to Siegfried for the Manufacture of the
API or Drug Product, respectively; including without limitation the Key Material
and API (in accordance with Section 5.2).

1.15
Designated Vendor shall have the meaning as set out in Section 6.4.

1.16
Delivery Shortfall shall have the meaning as set out in Section 14.2.

1.17
Drug Product shall mean the drug product containing the API (film-coated tablets
in bulk form), as set forth in Annex 1.2.

1.18
Drug Product Manufacturing Site shall mean Siegfried’s Affiliate (Siegfried
Malta Limited) facilities located in HHF070 Hal Far Industrial Estate, Hal Far
BBG 3000, Malta.

1.19
DEA shall mean the United States Drug Enforcement Administration or any
successor entity thereto.

1.20
Effective Date shall have the meaning set forth on the front page of this
Agreement.

1.21
EMA shall mean the European Medicines Agency or any successor entity thereto.

1.22
Entitled Person shall have the meaning as set out in Section 10.3.

1.23
Equipment means any equipment used in the Manufacture of a Product by Siegfried
hereunder.

1.24
FDA shall mean the United States Food and Drug Administration or any successor
entity thereto.

1.25
Forecast shall have the meaning as set out in Section 3.2.

1.26
Force Majeure Event shall have the meaning as set out in Section 16.3.

1.27
Hidden Defects shall mean a failure of Product to conform to the Specifications
upon delivery, such failure not being discoverable by Jazz or its designee upon
reasonable physical inspection upon receipt of the Product pursuant to Section
4.3.

/s/ Henn        /s/ KG
Siegfried        Jazz

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1.28
Improvement shall mean any result, data, documentation, invention, improvement,
innovation, development, discovery, computer program, device, trade secret,
method, know-how, process, technique or the like, whether or not written or
otherwise fixed in any form or medium, regardless of the media on which
contained and whether or not patentable or copyrightable.

1.29
Initial Period shall have the meaning as set forth in Section 12.1.

1.30
Intellectual Property Rights shall mean, without limitation, all Improvements,
inventions, patent applications, rights in patents, registered or unregistered
design rights, copyrights, database rights, trademarks, trade names, know-how,
trade secrets and other industrial or intellectual property rights of whatever
kind.

1.31
Key Material shall mean the key starting material as set forth in Annex 1.3.

1.32
Losses shall mean all liabilities, claims, demands, actions, suits, losses,
damages, costs and expenses (including reasonable attorney's fees) incurred by a
Party.

1.33
Manufacture/Manufacturing/Manufactured shall mean all activities with respect to
the manufacturing of the API or Drug Product, respectively, including, without
limitation, the purchase of Raw Materials and primary packaging materials,
production, quality control, quality assurance, release testing and stability
testing, packaging and release of Product for shipment (but excluding, without
limitation, (i) release of Drug Product for the market and (ii) shipment).

1.34
Manufacturing Site shall mean the API Manufacturing Site, the Drug Product
Manufacturing Site, or both of them, as the case may be.

1.35
Marketing Authorization/MA shall mean the formal authorization (and associated
documentation) granted or issued by a Regulatory Authority necessary for the
lawful marketing and sale of the Drug Product in the respective
country/countries of the Territory over which such Regulatory Authority has
jurisdiction.

1.36
Master Batch Record shall mean the production Batch record for the Manufacture
of the API or Drug Product, developed by Siegfried in part from the Technology,
specifying the process, manufacture, deviations and testing of the API or Drug
Product, respectively.

1.37
Materials shall mean Raw Materials and/or Consigned Materials.

1.38
Non-Conformance Claim shall have the meaning as set out in Section 4.3.

1.39
Order shall mean a purchase order issued by Jazz for a certain quantity of
Product.

1.40
Order Confirmation shall mean a confirmation issued by Siegfried that an Order
posted by Jazz shall be executed.

/s/ Henn        /s/ KG
Siegfried        Jazz

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1.41
Party/Parties shall mean either Jazz or Siegfried, or both, as the context may
require.

1.42
Pre-Existing Intellectual Property Rights of a Party means all Intellectual
Property Rights owned, conceived, developed, first reduced to practice or
otherwise made or acquired by such Party prior to the Effective Date hereof,
including all modifications, adjustments or improvements thereto (to the extent
such modifications, adjustments or improvements do not constitute any of the
other Party’s Arising Intellectual Property Rights in accordance with Section
11.2 or Section 11.3, as the case may be).

1.43
Product/Products shall mean the API or the Drug Product or the two of them, as
the context may require.

1.44
Quality Agreement shall mean the quality technical agreement between Jazz and
Siegfried which defines the quality assurance responsibilities of each Party in
respect of Product quality and compliance under cGMP Regulations, as may be
amended from time to time.

1.45
Raw Materials shall mean all raw materials, excipients, and processing, filling
and packaging components, which are not Product or Consigned Materials and which
are necessary to manufacture the API or Drug Product, respectively, as set forth
in the relevant Master Batch Record.

1.46
Recall shall have the meaning as set out in Section 7.6.

1.47
Regulatory Authority shall mean the governmental authority or authorities, which
are responsible for approving the conduct of clinical trials, marketing and sale
of pharmaceutical products and shall be EMA and FDA.

1.48
Specifications shall mean the description of technical requirements the API or
Drug Product has to conform to, as set out in detail in the Quality Agreement.

1.49
Technology shall mean all information, Intellectual Property Rights and data in
any form that Jazz has disclosed or will disclose, directly or indirectly, to
Siegfried that may be necessary or useful for Manufacture of the API or Drug
Product, respectively, as the same may be modified from time to time by Jazz in
its sole discretion. All Technology shall constitute Confidential Information of
Jazz, subject to Section 10.5.

1.50
Term shall have the meaning as set out in Section 12.2.

1.51
Territory shall mean the United States of America (with its territories,
possessions, and protectorates, such as the Commonwealth of Puerto Rico), the
member states of the European Union and/or European Economic Area (EU/EEA),
Canada, United Kingdom (notwithstanding it being a member of the EU/EEA as of
the Effective Date), Switzerland, Turkey, Australia, New Zealand, Brazil,
Mexico, and any other country, which the Parties agree in writing to add to this
definition of Territory in an amendment to this Agreement.

/s/ Henn        /s/ KG
Siegfried        Jazz

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2.
Scope of Work

2.1
Appointment. Jazz hereby appoints Siegfried, and Siegfried accepts such
appointment, to (i) Manufacture and supply the Drug Product for or on behalf of
Jazz at the Drug Product Manufacturing Site, (ii) Manufacture and supply the API
for or on behalf of Jazz at the API Manufacturing Site, whereas the API may be
supplied to Jazz or may be used by Siegfried in the Manufacture of the Drug
Product and (iii) act as a broker for the transport of the API (owned by Jazz)
from the API Manufacturing Site to the Drug Product Manufacturing Site, subject
to the terms and conditions set forth in this Agreement.

2.2
Siegfried Malta Limited. Siegfried has entered into this Agreement on behalf of
itself and its Affiliate, Siegfried Malta Limited, through which Siegfried shall
be performing certain activities hereunder. Siegfried shall procure that
Siegfried Malta Limited shall be bound by the applicable terms and conditions of
this Agreement as if it were a direct Party hereto and shall procure the due
performance thereof by Siegfried Malta Limited. Jazz shall only be entitled to
engage and communicate directly with Siegfried Malta Limited upon prior consent
of Siegfried.

2.3
Purchase Commitment. Subject to Section 2.3, during the Term, Jazz (and any of
its Affiliates, or any transferee or successor in interest to Jazz’s business or
Product) shall order and purchase at least sixty percent (60%) of its
requirements for the API and forty percent (40%) of its requirements for the
Drug Product from Siegfried.

Subject to this minimum purchase commitment and Section 2.4 below, the Parties
further agree on the following pricing mechanism:
a)
For the API: [ * ]; or

b)
For the Drug Product: [ * ]:

/s/ Henn        /s/ KG    
Siegfried        Jazz

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c)
During the Term, but not more often than [ * ], upon reasonable prior written
notice to Jazz and to such an extent as will not interfere with the normal
operations of Jazz, an independent certified public accountant selected by
Siegfried and reasonably acceptable to Jazz will have reasonable access during
normal business hours to inspect, at Siegfried’s expense, Jazz’s books of
accounts and other records pertaining to the purchase of API and Drug Product as
may reasonably be necessary for the purpose of determining Jazz’s compliance
with the minimum purchase commitment provided for under this Agreement. Prior to
commencing any such inspection and/or audit, the accountant shall enter into a
reasonable and customary confidentiality agreement with Jazz which prohibits the
disclosure of any information, except as provided in said confidentiality
agreement or pursuant to court order, relating to Jazz and/or its Affiliates to
any person or entity, including Siegfried, except that such accountant may issue
a report to Siegfried, which report shall also be provided to Jazz, the sole
purpose of which will be to report to Siegfried on Jazz’s compliance or
non-compliance with such minimum purchase commitment. Siegfried shall treat all
information received from Jazz and/or its Affiliates and/or the accountant
hereunder as Jazz’s Confidential Information. In the event of any dispute
between Jazz and Siegfried regarding the findings of any such inspection or
audit, the Parties shall initially attempt in good faith to resolve the dispute
amicably between themselves. The costs for such an audit shall be borne by Jazz
in case of the discovery of any inaccuracies resulting in non-compliance with
Jazz’s minimum purchase commitment.

d)
In the event (i) Siegfried does not deliver conforming Product as per Sections
3.7 and 14.1 or (ii) Jazz notifies Siegfried in writing that Jazz has reasonable
and material quality concerns regarding Siegfried’s Manufacture of the Product
(including without limitation due to the occurrence of any major or critical
deviations that have not been properly investigated by Siegfried (in Jazz’s
reasonable discretion) or any material breach by Siegfried of its obligations
under the Quality Agreement that remain uncured after [ * ] as per Section
12.4), the Parties agree that Jazz may, upon written notice to Siegfried,
temporally purchase (i) more than forty-percent (40%) of its requirements of API
and/or (ii) more than sixty-percent (60%) of its requirements of Drug Product
from other suppliers without constituting a breach of its obligations under
Section 2.3 and without any penalty, surcharge or Volume Shortfall payment being
due or owing (pursuant to Section 2.3a) or 2.3b)). This Section 2.3 c) will
apply only to the extent and for so long as Siegfried does not deliver
conforming Product as per Sections 3.7 and 14.1 (excluding any Force

/s/ Henn        /s/ KG
Siegfried        Jazz

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Majeure Event or any reason caused due to an act or omission of Jazz); provided,
however, that, if Siegfried resumes the capability to deliver (conforming)
Product comprising at least eighty percent (80%) of Jazz’s outstanding Product
requirements, the requirements of this Section 2.3 shall be deemed to be
reinstated (provided, however, that Jazz shall not be liable for any penalty,
surcharge or Volume Shortfall payment in respect of any Product orders it
committed to with another supplier during the period in which Siegfried did not
or could not deliver conforming Product).
2.4
Exclusivity.

Without limiting Siegfried’s other obligations hereunder (including without
limitation its obligations under Sections 10 and 11), during the Term of this
Agreement, neither Siegfried nor any of Siegfried’s Affiliates engaged by Jazz
(or any of Jazz’s Affiliates) within the previous [ * ] shall develop, make,
have made, use, sell, have sold, solicit, import or commercialize, or assist any
third party in any of the foregoing (other than Jazz or its designee pursuant to
this Agreement) with respect to
(i)
Product and/or

(ii)
any drug product containing the API

that directly or indirectly uses, relies on, references, incorporates, derives
from or relates to in any way, in whole or in part, any of the Technology
(except technology that is general knowledge and publicly known or in the public
domain), Jazz’s Confidential Information or Jazz’s Intellectual Property Rights
(including without limitation Jazz’s Pre-Existing Intellectual Property Rights
and Jazz’s Arising Intellectual Property Rights). For the avoidance of doubt,
Jazz acknowledges that nothing in this Agreement shall be construed as a
representation or inference that Siegfried will not enter into business
relationships with other third parties regarding products that are similar to or
that may compete with any Product, Technology or process covered by this
Agreement subject always to Siegfried’s compliance with its obligations
hereunder (including without limitation its obligations under Sections 10 and
11) and provided always that none of Jazz’s Technology, Jazz’s Confidential
Information and/or Jazz’s Intellectual Property Rights (including Jazz’s
Pre-Existing Intellectual Property Rights and Jazz’s Arising Intellectual
Property Rights) shall be used or disclosed in breach of this Agreement.
2.5
Controlled Substance. The Parties acknowledge that the API (and thus the Drug
Product) may become scheduled under the Federal Controlled Substances Act and/or
respective laws in other countries of the Territory (collectively, the FCSA).
Jazz shall promptly inform Siegfried if the API will be subject to the FCSA, and
the Parties will confer and discuss in good faith the necessary activities to be
taken as needed to comply with the FCSA, and the allocation of costs therefore,
including without limitation, amending this Agreement and obtaining the
necessary licenses, authorizations and regulatory requirements.

2.6
Relationship Management. Upon execution of this Agreement, each Party shall
forthwith appoint one of its employees to be a relationship manager responsible
for liaison

/s/ Henn        /s/ KG
Siegfried        Jazz

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between the Parties. Those representatives shall meet periodically as agreed to
review the current status of the business relationship, including, but not
limited to, Equipment and facilities updates, current and anticipated need of
each Product (current and anticipated inventory (as per Section 5.4), current
and anticipated manufacturing capacity, planned work or changes to the
Manufacturing Site, supply chain concerns, in particular without limitations,
Materials in short supply or vendor performance, and manage any issues that have
arisen. [ * ], the Parties shall organize business review meetings to discuss
operational and strategic aspects relating to the execution of this Agreement as
well as any issues communicated by either Party to the other Party. With the
prior agreement of the Parties, the frequency of the meetings may be increased.
The meetings may also be organized through media (teleconferences or
videoconferences) and each Party shall bear its own costs in relation with all
meetings organized under this Section 2.6.
2.7
Information. Jazz shall provide to Siegfried the Technology and such other
information in Jazz's possession relating to the Products, which are useful and
necessary for Siegfried in performing its obligations hereunder, in particular
any information concerning any potential hazards involved in Manufacturing
Product and other Safety, Health and Environment (SHE) requirements related to
the handling of the Product or any waste. The Technology provided by Jazz to
Siegfried hereunder shall be subject to the terms and conditions set forth in
Sections 10 and 11.

3.
Ordering, Purchase and Supply of Product

3.1
Jazz shall submit to Siegfried, upon [ * ] and then [ * ], an estimated (good
faith) demand forecast of Jazz’s requirements of each Product for the next [ *
].

3.2
Jazz shall submit to Siegfried, on a [ * ] basis, [ * ] prior to the beginning
of each month, an estimated (good faith) demand forecast of Jazz’s requirements
of each Product for the next [ * ], as follows (each, a “Forecast”):

3.2.1
Drug Product Forecast: Jazz’s [ * ] forecast for Drug Product shall set forth:

(i)    the placed Orders for the next [ * ], which shall be binding on the
Parties with respect to quantities and delivery dates;
(ii)    the estimated forecast for the next [ * ], which shall not be binding.
3.2.2
The total lead-time for Manufacture of Drug Product shall be [ * ], provided
sufficient quantity of API is available to Drug Product Manufacturing Site at
least [ * ] prior to the confirmed delivery date.

/s/ Henn        /s/ KG
Siegfried        Jazz

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3.2.3
API Forecast: Jazz’s [ * ] forecast for API shall set forth:

(i)    the placed Orders for the next [ * ], which shall be binding on the
Parties with respect to quantities and delivery dates;
(ii)    the estimated forecast for the [ * ], which shall not be binding.
3.2.4
The total lead-time for Manufacture of API shall be [ * ], provided sufficient
quantity of Key Material is available to Siegfried at least [ * ] prior to the
confirmed delivery date. In case (i) the Key Material is not available to
Siegfried in sufficient quantity at least [ * ] prior to the confirmed delivery
date or (ii) the API ordered by Jazz was not reflected in the [ * ] forecast,
the Parties shall jointly agree on the lead time.

3.3
Siegfried shall use commercially reasonable efforts to supply Jazz, no later
than [ * ], with a written summary report of the agreed Consigned Materials, API
and Drug Product inventory for such prior month in the form used by Siegfried
for its customers, in order that Jazz may properly account for the inventory
held by Siegfried (and its Affiliates) pursuant to this Agreement. The Parties
may agree that additional specialized reports shall be prepared by Siegfried in
accordance with Jazz's reasonable instructions. The costs for such additional
reports will be borne by Jazz.

3.4
Jazz acknowledges that Siegfried will rely on the accuracy of Jazz’s Forecasts
in planning its Manufacture, storage and transport of Product as well as its
acquisitions of Raw Materials, as set forth in Section 5. If at any time Jazz
finds that a Forecast is inaccurate in a material respect, Jazz shall inform
Siegfried without delay and the Parties shall confer and discuss without delay
how to proceed.

3.5
Jazz shall make all purchases of Product hereunder by submitting Orders to
Siegfried in accordance with the respective Product Forecast. Each such Order
shall be in writing and shall specify (i) the Product ordered, (ii) the quantity
ordered), (iii) the price pursuant to Annex 1.4, and (iv) the requested delivery
date, giving Siegfried no less than the number of days in advance of requested
delivery to Jazz pursuant to Section 3.2 (the Lead Time). Lead Times for Product
deliveries for validation campaigns and/or initial requirements of Product for
launch in a country of the Territory shall be agreed upon between the Parties in
good faith.

3.6
In accordance with Section 3.2.3 or 3.2.4, Siegfried shall use commercially
reasonable efforts to execute Orders which exceed by [ * ] of the forecasted
quantities. Orders exceeding [ * ] of the forecasted quantities shall be
discussed between the Parties, but are only binding upon confirmation by
Siegfried. Subject to this Section 3, Siegfried shall confirm to Jazz by way of
an Order Confirmation that it will meet Jazz’s quantity requirements in
accordance with the delivery date(s) within [ * ] from the date of

/s/ Henn        /s/ KG
Siegfried        Jazz

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the receipt of an Order from Jazz, whereupon the Order shall be confirmed,
final, and binding on Siegfried.
3.7
Siegfried shall promptly and without undue delay notify Jazz in writing of any
anticipated delay or of any circumstance rendering it unable to Manufacture
and/or supply Product in accordance with the delivery date(s) and the estimated
duration of such delay/circumstance(s). Upon such written notice, the Parties
will work together to agree upon a revised delivery schedule and the Parties
shall proceed in accordance with Section 14.1.

3.8
The Product shall be delivered from Siegfried to Jazz [ * ] (Incoterms 2010) API
Manufacturing Site or Drug Product Manufacturing Site, and at the price as set
out in Annex 1.4. To clarify, Jazz assumes all responsibilities and liability
arising out of the shipment, transport, storage, handling and use of the Product
after delivery by Siegfried to Jazz in accordance with the agreed [ * ]
Incoterms.

4.
Product Delivery and Conformance

4.1
Jazz shall procure the pick-up and shipment of the Product at the agreed
delivery date. A storage fee shall apply for Product which is not picked-up and
shipped at that agreed delivery date through no fault of Siegfried or upon
mutual agreement and thus stored by or on behalf of Siegfried for more than [ *
] from the agreed delivery date, such storage fee shall be [ * ]. Upon prior
written notice to Jazz, Siegfried shall have the right to ship Product that have
been stored more than [ * ] from the agreed delivery date to Jazz or its
designee.

4.2
Siegfried will provide to Jazz the documentation set forth in the Quality
Agreement with each shipment of Product. Siegfried acknowledges that Jazz will
rely on the accuracy and completeness of such documentation in its determination
of conformance of Product with Specifications, cGMP, the Quality Agreement and
Applicable Law.

4.3
Upon delivery of Product to Jazz (or its designee), Jazz shall carry out a
reasonable physical inspection, or shall procure a designee to carry out a
reasonable physical inspection, of the Product within [ * ] in order to
determine compliance with the Specifications, the Quality Agreement, Applicable
Law and cGMP at the time of delivery and all stages of Manufacture prior
thereto. If, in either Party's opinion or determination, any Product
Manufactured does not comply with the Specifications, the Quality Agreement,
Applicable Law or cGMP upon delivery or at any stage of Manufacture prior
thereto, then such Party shall promptly notify the other Party in writing
thereof (which may include email notification) (Non-Conformance Claim). If Jazz
does not notify Siegfried within [ * ] after delivery of the Product, then the
Product is deemed accepted, provided that Jazz retains the right to reject the
Product at a later time in the case of Hidden Defects as set out in Section 4.4.

/s/ Henn        /s/ KG
Siegfried        Jazz

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4.4
Jazz retains the right to reject Product for a period of [ * ] after delivery to
Jazz (or its designee) in case of Hidden Defects (which may include, without
limitation, a Hidden Defect caused by or arising due to a material error in the
documentation supplied by Siegfried under Section 4.2), provided that Jazz
notifies Siegfried in writing within [ * ] of discovering the Hidden Defect.

4.5
Any Non-Conformance Claim made by Jazz shall specify in reasonable detail the
nature and basis for the claim and cite Siegfried’s relevant Batch numbers or
other information to enable specific identification of the Product involved.
Siegfried shall review any Non-Conformance Claim made by Jazz and provide Jazz
with the results of such (interim) review without undue delay and, in any event,
within [ * ] of receipt of Jazz’s Non-Conformance Claim, as set forth in the
Quality Agreement. If such review by Siegfried confirms that the identified
Product did not comply with the Specifications, Applicable Law, the Quality
Agreement or cGMP upon delivery or at any stage of Manufacture, then Jazz shall
have the right to reject such Product and the Parties shall proceed according to
Section 14.1. The nonconforming Product shall be disposed or delivered, at
Siegfried’s expense, to such destination as agreed by the Parties, in compliance
with applicable environmental laws and regulations. Neither Party shall use or
dispose of Product that does not, or of which either Party claims that it does
not, conform to the Specifications, the Quality Agreement, Applicable Law and
cGMP upon delivery or at any stage of Manufacture thereof, without the other
Party's prior written consent.

4.6
Any Non-Conformance Claim made by Siegfried shall specify in reasonable detail
the nature and basis for the claim and cite Siegfried’s relevant Batch numbers
or other information to enable specific identification of the Product involved.
Jazz shall review any Non-Conformance Claim made by Siegfried and provide
Siegfried with the results of such review within [ * ] of receipt of Siegfried’s
Non-Conformance Claim. If such review by Jazz confirms that the identified
Product did not comply with the Specifications, Applicable Law, the Quality
Agreement or cGMP upon delivery or at any stage of Manufacture, then Siegfried
shall have the right to reject such Product and the Parties shall proceed
according to Section 14.1. The nonconforming Product shall be disposed or
delivered, at Siegfried’s expense, to such destination as agreed by the Parties,
in compliance with applicable environmental laws and regulations. Neither Party
shall use or dispose of Product that does not, or of which either Party claims
that it does not, conform to the Specifications, the Quality Agreement,
Applicable Law and cGMP upon delivery or at any stage of Manufacture thereof,
without the other Party's prior written consent.

4.7
If the Parties fail to agree as to whether a quantity of Product conforms to the
Specifications, Applicable Law, the Quality Agreement or cGMP upon delivery or
at any stage of Manufacture, the Parties shall have the Batch in dispute and/or
relevant data or information investigated, tested and/or further analyzed by an
independent testing laboratory or consultant (if the Parties mutually agree to
refer to a consultant) selected by agreement between the Parties. The decision
of the independent testing laboratory or

/s/ Henn        /s/ KG
Siegfried        Jazz

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consultant shall be deemed final as to any dispute over Product conformance with
Specifications, Applicable Law, the material provisions of the Quality Agreement
or cGMP upon delivery or at any stage of Manufacture. Should the laboratory or
consultant determine that the delivered Product does not conform to the
Specifications, the Quality Agreement, Applicable Law or cGMP upon delivery or
at any stage of Manufacture, then Siegfried shall bear all costs for the
independent laboratory or consultant, and all shipment, disposal and other
reasonable, direct costs and expenses for conducting the investigations and Jazz
shall have the right to reject such Batch of Product and the Parties shall
proceed according to Section 14.1. However, in case of wrongful rejection of
Drug Product by Jazz, then Jazz shall bear the expenses of returning any
rejected Drug Product to Siegfried and shall compensate Siegfried the
reasonable, direct costs and expenses for conducting the investigations,
including without limitation, related to the shipment of the Product (initial or
replacement shipment, as the case may be) and any pending purchase price payment
still due as set out in this Agreement.
5.
Purchase, Storage and Transport of Materials

5.1
In accordance with Jazz’s Forecast and Orders placed, Siegfried will obtain
sufficient quantities of all Raw Materials at Siegfried’s costs and expenses in
sufficient quantities and of good quality as necessary to enable Siegfried to
Manufacture and supply Product in accordance with Jazz’s requirements. Jazz
shall also bear the mutually agreed costs of all material to be used as
reference standards or impurity standards in the Manufacture of Products, unless
otherwise mutually agreed in writing.

5.2
Jazz shall obtain all right, title and interest in and to the API upon release
by Siegfried, whereupon such (released) API becomes Consigned Materials. Jazz
shall cause that the Key Material will be supplied in good quality as necessary
to enable Siegfried to Manufacture Product in accordance with Jazz’s Forecast
and Orders (see i.a. Section 3.2.4 above), at Jazz’s costs and expenses. Any
import duties, taxes or other fees due to governmental authorities regarding
Consigned Materials shall be paid by Jazz.

5.3
Jazz shall solely and exclusively retain all right, title and interest in and to
all Consigned Material released by Siegfried and Jazz shall insure such
Consigned Material against loss and damage. Siegfried shall be liable for any
loss of or damage to such Consigned Material, including destruction and shipping
costs, if such loss or damage was caused by Siegfried’s gross negligence or
willful misconduct.

5.4
Any inventory level of Key Material and Consigned Materials (particularly of
consigned API) shall only be established upon mutual agreement and at Jazz’s
reasonable cost and expenses. Siegfried shall adopt appropriate warehousing
controls to rotate Consigned Materials stock as mutually agreed (based on the
First-In/First-Out (FiFo) principle unless otherwise agreed in writing), unless
otherwise instructed by Jazz and agreed by Siegfried.

/s/ Henn        /s/ KG
Siegfried        Jazz

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5.5
Siegfried agrees that, without prior written consent by Jazz, Consigned
Materials shall: (i) be used solely for the purpose of the Manufacture and
supply of Product; (ii) be used in compliance with all Applicable Laws; and
(iii) not be transferred to any third party, except to any Affiliate or
subcontractor of Siegfried as agreed in the Quality Agreement or otherwise in
writing with Jazz (and Siegfried remains fully and directly responsible for the
acts and omissions of such Affiliate or subcontractor, as if performed by
Siegfried), unless otherwise agreed by the Parties in writing.

5.6
Until otherwise notified by Jazz to Siegfried with at least [ * ] prior notice
or otherwise agreed by the Parties in writing, Siegfried shall act as a broker
with regard to the transport of API owned by Jazz (Consigned Material) from the
API Manufacturing Site to the Drug Product Manufacturing Site, at Jazz’s
reasonable and prior-agreed cost and expenses, and Siegfried shall appoint a
qualified and approved subcontractor, as specified in the Quality Agreement and
Jazz may monitor and approve Siegfried’s shipping and freight practices as may
be agreed in the Quality Agreement or otherwise in writing between the Parties.
Siegfried shall only be responsible for the acts and omissions of all such
logistics providers, if due Siegfried’s gross negligence or willful misconduct.

5.7
Jazz agrees to reimburse Siegfried all reasonable cost and expenses incurred for
the amount of inventory of Materials required to be written off as a result of
Jazz requiring a change of Materials, in particular, without limitation, changes
to specification or vendors, provided however, that Siegfried shall use
commercially reasonable efforts to limit such loss of Materials.

5.8
Upon reasonable request of Jazz or expiration or termination of the Agreement,
Siegfried will make such Consigned Materials available for collection by or on
behalf of Jazz in good and usable condition and Jazz will pick-up such Consigned
Materials within [ * ], at Jazz’s cost and expenses.

6.
Manufacture of Product

6.1
The terms of the Quality Agreement shall be deemed incorporated by reference
into this Agreement.

6.2
Siegfried shall maintain the Manufacturing Sites and Equipment in a state of
repair and operating efficiency consistent with the requirements of the
Applicable Laws, cGMP, Specifications, the Quality Agreement, and Master Batch
Record. Further details with regard to the Manufacturing Site shall be set forth
in the Quality Agreement.

6.3
Siegfried shall obtain sufficient quantities of all Raw Materials to Manufacture
and supply Product in accordance with Jazz’s Forecast and shall ensure that such
Raw Materials comply with the Specifications. Jazz shall reimburse Siegfried all
costs and expenses reasonably incurred as a result of a change in the
Specifications of such Raw Materials.

/s/ Henn        /s/ KG
Siegfried        Jazz

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6.4
If Jazz, in its sole discretion, designates certain Raw Material or any other
vendors, other than Siegfried or its Affiliates (each a Designated Vendor), then
Siegfried shall obtain respective Raw Material(s) only from such Designated
Vendors. Jazz shall reimburse Siegfried all costs and expenses reasonably
incurred as a result from appointing or changing a Designated Vendor. Siegfried
shall not be liable or responsible for any acts or omissions of such Designated
Vendor, including without limitation, a delayed delivery, delivery of
non-conforming Raw Material or other supply failure (unless and to the extent
any such acts or omissions of such Designated Vendor arise as a result of
Siegfried’s negligence or wilful misconduct or any breach by Siegfried of its
obligations hereunder).

6.5
In the event that either Party becomes aware and notifies the other Party that
any Change is mandated by Applicable Laws (including, without limitation cGMP
Regulations) or by a competent Regulatory Authority (Required Change), then
Siegfried shall promptly (i) advise Jazz as to any quality assurance effect
scheduling and, if applicable, Product price adjustments, which may reasonably
and necessarily result therefrom, and (ii) make any necessary Required Change.
Prior to implementation of such Required Change, the Parties shall negotiate in
good faith on: (a) the allocation of the implementation costs with regard to the
Product and any other products, (b) if applicable, the new Product price after
the Required Change has been implemented; and (c) any other amendments to this
Agreement which may be necessitated by such Required Change; provided always
that all costs associated with Required Changes directly related to the
Manufacturing Site that are not required solely to permit Siegfried to
Manufacture the Product, or a group of products including the Product, shall be
borne by Siegfried. Siegfried and Jazz shall cooperate in making any Required
Changes and use commercially reasonable efforts to implement any Required
Changes promptly in a manner that minimizes any effect on the supply hereunder
to Jazz of the Product meeting Specifications.

6.6
In the event Jazz wishes to effect a Change which is not a Required Change
(Customer Change), Jazz shall advise Siegfried in writing of such Customer
Change as set forth in the Quality Agreement. If Siegfried (acting reasonably
and promptly) deems, in its reasonable discretion, such Customer Change as
implementable, then Siegfried shall provide (a) if applicable, an estimate of
all reasonable, necessary and vouched implementation costs to be borne by Jazz,
(b) if applicable, the new proposed Product price after the Customer Change has
been implemented (if necessitated by such Customer Change), (c) the timing for
implementation and (d) if applicable, an estimated amount of any Raw Materials
rendered obsolete as a result of the Customer Change and respective costs to be
borne by Jazz. Subject to Jazz’s approval, Siegfried shall implement such
Customer Change. Jazz shall bear the approved implementation costs (which
include the costs for the Raw Materials rendered obsolete) and the new Product
Price, if applicable, shall apply after the implementation.

6.7
In the event Siegfried wishes to effect a Change which is not a Required Change
(Siegfried Change), Siegfried shall advise Jazz in writing of such Siegfried
Change as

/s/ Henn        /s/ KG
Siegfried        Jazz

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16 / 37

set forth in the Quality Agreement. Siegfried Changes will only be implemented
following the approval of Jazz (acting reasonably and promptly), such approval
not to be unreasonably conditioned, withheld or delayed. Unless otherwise agreed
by the Parties, Siegfried’s implementation costs of the Siegfried Changes will
be borne by Siegfried. Both Parties shall negotiate in good faith (a) the timing
for implementation and (b) an estimated amount of any Raw Material rendered
obsolete as a result of the Siegfried Change. In allocating the costs, the
Parties should consider whether such Siegfried Change is beneficial to either or
both Parties.
7.
Audits, Notification and Recall

7.1
Jazz has the right to carry out audits as set forth in the Quality Agreement.
While on the Manufacturing Site, Jazz shall comply with all of Siegfried’s
applicable policies regarding, safety, health, data protection, confidentiality
and the like which Siegfried, in its sole discretion, deems relevant.

7.2
Siegfried shall provide Jazz and its designees with reasonable access to its
Manufacturing Site and the areas in which Materials or Product is Manufactured,
stored, handled or shipped, and Jazz and its designees shall be permitted to
review Siegfried’s standard operating procedures related to Manufacture,
storage, handling, general facilities, equipment and procedures required for
compliance with cGMP.

7.3
Siegfried will use commercially reasonable efforts to obtain the right for Jazz
to have similar audit rights for Siegfried’s subcontractors, as set forth in the
Quality Agreement.

7.4
Siegfried shall permit any Regulatory Authority to inspect relevant facilities,
Equipment and records (including those of its Affiliates) at their request and
shall resolve, and procure the resolution by its Affiliates, of all issues
raised by a Regulatory Authority, if and to the extent such issues are relevant
for the Manufacture of the Product or other cGMP-related obligations under this
Agreement.

7.5
Each Party shall notify the other Party promptly of any serious or unexpected
adverse reaction from the use of the Drug Product, which is reported to it or of
which it becomes aware otherwise.

7.6
In the event either Party believes it may be necessary to conduct a recall or
other similar action with respect to the Drug Product (each a Recall), the
Parties shall consult with each other as to how best to proceed. If Siegfried
reasonably requests a Recall and Jazz declines to act accordingly, Siegfried
shall not be liable for any consequences or damages thereafter. Under no
circumstances shall Siegfried be prohibited hereunder from taking any action
that it is required to take by applicable law.

7.7
This Section applies to Affiliates of Siegfried and Siegfried shall procure the
adherence of its Affiliates hereto and Jazz’s right of audit thereof.

/s/ Henn        /s/ KG
Siegfried        Jazz

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8.
Compensation and Terms of Payment

8.1
In consideration for the services under the terms of this Agreement, Jazz shall
pay Siegfried the prices as specified in, and in accordance with the payment
terms set forth in, Annex 1.4.

8.2
All pricing, payments, credits, allowances or other monetary adjustments under
this Agreement shall be in [ * ], as agreed between the Parties and set forth in
the Annex 1.4.

8.3
The Parties may adjust prices upon mutual agreement based on (i) Raw Material
price changes, (ii) indices, (iii) exchange rate variations as set forth in the
Annex 1.4 or as otherwise agreed in writing.

8.4
Invoices shall be issued by Siegfried and sent to Jazz upon release of the
Product.

8.5
Jazz shall pay such invoices to Siegfried within [ * ] after the date of receipt
of such invoice. Each invoice shall, to the extent applicable, identify the Jazz
Order number, Product quantities, unit price, freight charges and the total
amount to be remitted by Jazz. Notwithstanding the foregoing, Jazz may withhold
any amounts invoiced by Siegfried that it disputes in good faith and in writing
prior to such [ * ] after the date of receipt of the respective invoice. If Jazz
disputes any invoice, Jazz shall within [ * ] after such invoice is furnished to
it notify Siegfried in writing that it disputes the accuracy or appropriateness
of such invoice and specify the particular respects in which such invoice is
inaccurate or inappropriate. The Parties will make good faith efforts to resolve
any disputes within [ * ] thereafter. Any amounts that are disputed by Jazz and
which the Parties determine are due following resolution of such dispute shall
not be due until [ * ] following such resolution.

8.6
In the event any undisputed sum is not paid when due, then Jazz shall pay
interest at a rate of [ * ] on the amount of such undisputed late sum (from the
original due date until the date such undisputed late sum is paid).

9.
Regulatory Affairs

9.1
Jazz shall be responsible for all regulatory filings in connection with the
Product.

9.2
All information, documents and updates with regard to the Manufacture of Product
which are in the possession of Siegfried and required by any Regulatory
Authority shall, as reasonably requested by Jazz in connection with a submission
for such regulatory filings, be as is provided by Siegfried to Jazz, free of
charge.

/s/ Henn        /s/ KG
Siegfried        Jazz

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9.3
Siegfried shall further provide Jazz, at Jazz’s costs and expenses, with
reasonable assistance in preparing or reviewing the regulatory filing or
formulating responses to any questions and/or inquiries (i.e., deficiency
letters) with respect to the above submissions.

9.4
Jazz shall provide, and Siegfried shall review, the CMC and other portions of
Jazz’s proposed regulatory filings relating to Siegfried’s Manufacturing
procedures or otherwise related to Siegfried’s key obligations hereunder before
the regulatory filings are submitted with relevant Regulatory Authorities and
Jazz shall consider Siegfried’s comments thereto in good faith.

9.5
The Parties acknowledge that the ultimate decision of whether any Drug Product
will be approved for marketing and sale rests with the Regulatory Authorities of
the respective market in the Territory and that Siegfried shall not be liable
for the failure of the Regulatory Authorities to issue such Marketing
Authorization approval other than due to Siegfried’s gross negligence or willful
misconduct or material breach of any of its obligations, warranties or
undertakings hereunder.

9.6
The Parties acknowledge that the Manufacturing Site and/or the Drug Product
Manufacturing Site has the required certifications from the Regulatory
Authorities (the FDA, the EMA), which currently allows the Product distribution
also in Canada and Australia by GMP certificates mutual recognition. In case a
Product launch in other specific countries of Territory would require additional
certifications, Parties will discuss in good faith and agree in prior on the
plausibility, and costs and timelines associated.

10.
Confidential Information

10.1
Confidential Information shall mean any information of whatever kind (including
without limitation, data, compilations, formulae, models, patent disclosures,
procedures, processes, projections, protocols, results of experimentation and
testing, specifications, strategies and techniques), and all tangible and
intangible embodiments and oral disclosures thereof of any kind whatsoever,
(including without limitation, samples, apparatus, compositions, documents,
drawings, machinery, patent applications, records and reports), which has been
or will be disclosed by or on behalf of one Party (Disclosing Party) to the
other Party (Receiving Party) in connection with this Agreement, and which is
confidential or proprietary to the Disclosing Party or an Affiliate thereof,
including, without limitation, any and all information pertaining to the
Products and information which relates to the business of either Party,
including business plans, strategies, operations, policies, procedures, pricing,
techniques, accounts, marketing plans, financial plans and status, and personnel
of either Party; provided that such information was designated in writing as
"Confidential" or "Proprietary" information at the time of the initial
disclosure or by confirmation in writing to the Receiving Party within [ * ] of
the initial disclosure and further provided always that, notwithstanding the
foregoing, information shall be subject to the obligations set forth herein and
constitute Confidential Information, even if not identified or marked as
confidential or proprietary, if the Receiving Party knows, or in the exercise of
reasonable business

/s/ Henn        /s/ KG
Siegfried        Jazz

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judgment should know, such information to be confidential or proprietary to the
Disclosing Party.
10.2
Each Receiving Party agrees to retain in strict confidence any Confidential
Information of the Disclosing Party (or its Affiliates or contractors), whether
disclosed prior to, or after the Effective Date and not to use any such
Confidential Information for any purpose except pursuant to, and in order to
carry out, the terms and objectives of this Agreement, and not to disclose,
divulge or otherwise communicate any such Confidential Information to any third
party.

10.3
The Receiving Party may disclose Confidential Information of the Disclosing
Party to its Affiliates or its (or its Affiliate's) officers, directors,
employees, agents, consultants, licensees, subcontractors or representatives
(each an Entitled Person), who, in each case, (i) need to know such information
for purposes of the implementation and performance by the Receiving Party of
this Agreement, and (ii) are subject to confidentiality and non-use restrictions
covering the Confidential Information that are at least as stringent at those
contained herein, provided that the Receiving Party shall, nevertheless, remain
fully liable for any breach by any of its Entitled Persons of their
confidentiality obligations in respect of the Confidential Information.

10.4
Each Party agrees to use with respect to Confidential Information of the other
Party at least the same standard of care as it uses to protect proprietary or
confidential information of its own of comparable sensitivity and to exercise
every reasonable precaution to prevent and restrain the unauthorized disclosure
of such Confidential Information by any of its Entitled Persons.

10.5
The provisions of Section 10.1 shall not apply to any Confidential Information
disclosed hereunder which (a) was independently developed or independently known
by the Receiving Party prior to its disclosure to the Receiving Party by the
Disclosing Party, as evidenced by written or electronic records; or (b) was
before or after the date of such disclosure in the public domain or lawfully
disclosed to the Receiving Party by an independent, unaffiliated third party
rightfully in possession of the Confidential Information and not under any
confidentiality obligation with regard to such Confidential Information; or (c)
is required to be disclosed by the Receiving Party to the officials of a
Regulatory Authority or to comply with applicable laws, to defend or prosecute
litigation or to comply with Applicable Law, judicial orders or valid subpoenas,
provided that the Receiving Party provides prior written notice of such intended
disclosure to the Disclosing Party and takes reasonable and lawful actions to
avoid and/or minimize the degree of such disclosure. The burden of proof of the
foregoing exceptions shall lie with the Receiving Party. Specific information
disclosed as part of the Confidential Information shall not be deemed to be in
the public domain or in prior possession of the Receiving Party merely because
it is included in more general information in the public domain or in the prior
possession of the Receiving Party.

/s/ Henn        /s/ KG
Siegfried        Jazz

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10.6
Except as otherwise expressly stated under this Agreement, nothing herein shall
be construed as giving either Party any right, title or interest in or ownership
of the Confidential Information of the other Party.

10.7
Except as may be required by law or regulation (including securities law and
related filings), or in response to a valid subpoena or other judicial order,
neither Party shall disclose the terms of this Agreement without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, except that the Parties may disclose the terms of this Agreement to
the Parties' or third parties' accountants and attorneys, provided any such
attorney or accountant receiving information concerning the terms of this
Agreement is either bound by professional secrecy or agrees to be bound by
confidentiality obligations equal to this Section 10 with respect to such
information.

10.8
The Parties acknowledge that any breach of this Section 10 may constitute
irreparable harm, and that the non-breaching Party shall be entitled to seek
specific performance or injunctive relief to enforce this Section 10 in addition
to whatever remedies such Party may otherwise be entitled to at law.

10.9
Upon termination or expiration of this Agreement (in whole or in part), each
Party shall immediately deliver to the other (and cause any of its Entitled
Persons to so deliver), at such Party’s expense, all Confidential Information of
the other Party (in the case of partial termination, that relates to the
Terminated Product), including without limitation any and all copies,
duplications, summaries and/or notes thereof or derived thereof, regardless of
the format, and all remaining samples of Product (or, in the case of partial
termination, Terminated Product), provided however, that both Parties may keep
(i) such original documents, copies and samples as required by law or (ii) one
set of such information in its legal files or archives for the sole purpose of
monitoring its compliance with its obligations hereunder and neither Party shall
be required to delete copies made in routine back up of its information
technology systems (if access to such material is limited to members of such
Party’s information technology department only). Any information retained by a
Party pursuant to this Section 10.9 shall be subject to the confidentiality
obligations set forth herein.

11.
Intellectual Property

11.1
Siegfried acknowledges that Jazz Confidential Information and Jazz’s
Pre-Existing Intellectual Property Rights provided to, utilized or observed by
Siegfried pursuant to this Agreement shall be and remain the sole and exclusive
property of Jazz. Likewise, Jazz acknowledges that Siegfried Confidential
Information and Siegfried’s Pre-Existing Intellectual Property Rights utilized
by Siegfried pursuant to this Agreement shall be and remain the sole and
exclusive property of Siegfried.

11.2
All rights, title, and interest in and to any Arising Intellectual Property
Rights shall be the sole and exclusive property of Jazz to the extent any such
Arising Intellectual Property Rights (i) incorporate, (ii) are derived from or
(iii) relate to any of Jazz’s Pre-Existing

/s/ Henn        /s/ KG
Siegfried        Jazz

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Intellectual Property Rights, Jazz Product(s) (including without limitation
Product development and use, whether patentable or not, Product Manufacture,
manufacturing processes and procedures, Product analytical processes,
procedures, methods or results and any route(s) of synthesis) and/or Jazz
Confidential Information (Jazz Arising Intellectual Property Rights), and
Siegfried hereby assigns, and transfers to Jazz its entire right, title and
interest in and to any and all Jazz Arising Intellectual Property Rights. Jazz
shall have the sole right to file and seek protection for any Jazz Arising
Intellectual Property Rights. During the Term of this Agreement and for a period
of [ * ] thereafter, upon request by Jazz and at Jazz’s reasonable expense,
Siegfried shall, and shall cause its employees and Affiliates and employees of
its Affiliates, to promptly take all reasonable acts and things and execute all
documents as Jazz may reasonably request, to transfer, assign and vest in Jazz
the ownership and registration of Jazz Arising Intellectual Property Rights, and
thereafter Jazz shall be responsible for and shall control, at its sole expense,
the preparation, prosecution, maintenance and enforcement of all patent
applications, resulting patents, and any other forms of Jazz Arising
Intellectual Property Rights. In the event Jazz decides to file and prosecute
patent applications on any Jazz Arising Intellectual Property Rights, Siegfried
shall provide Jazz with reasonable assistance to obtain and defend such Jazz
Arising Intellectual Property Rights at Jazz's reasonable cost and expense.
11.3
Jazz agrees that, as between Siegfried and Jazz, Siegfried shall own all Arising
Intellectual Property Rights of a general nature generated or derived by
Siegfried in the course of performing its obligations hereunder which (i) do not
incorporate, (ii) are not derived from, (iii) are not specific to or dependent
upon and (iv) do not relate in any way, either directly or indirectly, in whole
or in part, to (a) Jazz’s Pre-Existing Intellectual Property Rights, (b) Jazz
Arising Intellectual Property Rights, (c) Jazz Confidential Information and/or
(d) Jazz Product(s) (Siegfried Arising Intellectual Property Rights) and Jazz
hereby assigns, and transfers to Siegfried its entire right, title and interest
in and to any and all Siegfried Arising Intellectual Property Rights. Siegfried
hereby grants Jazz a non-exclusive, worldwide, irrevocable, transferable,
royalty-free license to use such Siegfried Arising Intellectual Property Rights
to the extent that, and limited to, the development, manufacturing, sale,
commercialization or any other use of the Product is dependent upon such
license.

11.4
In the event of patent infringement or regulatory litigation or other legal
proceedings, involving the Product, Siegfried shall have the right to suspend
further supply of the Product to the extent this is required by a court order or
arbitral award or order (whether interim or final). Such suspension shall be
deemed a temporary suspension of Siegfried’s supply obligations under this
Agreement; provided, that if such suspension continues for more than [ * ], the
Parties shall jointly attempt in good faith to modify this Agreement to resolve
the situation but if they are unable to do so within the following [ * ] either
Party may terminate this Agreement by notice to the other Party.

/s/ Henn        /s/ KG
Siegfried        Jazz

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12.
Term and Termination

12.1
This Agreement shall become effective on the Effective Date and, unless earlier
terminated in accordance with this Section 12 or other applicable term of this
Agreement, shall continue in full force and effect until December 31, 2024
(Initial Period).

12.2
Unless earlier terminated in accordance with any applicable term of this
Agreement, this Agreement shall automatically renew for consecutive periods of
one (1) year each unless one of the Parties notifies the other of its election
not to renew the Agreement, either in whole or in part, at least eighteen (18)
months prior to the end of the Initial Period or the renewal term then in
effect, in which case this Agreement shall terminate, either in whole or in part
(as the case may be), upon the expiration of such term (Term).

12.3
Either Party may terminate the Agreement immediately, by providing written
notice to the other Party following the occurrence of any of the following
events:

(a)
the liquidation or dissolution of the other Party, or the commencement of
insolvency procedures or any proceeding under any bankruptcy, insolvency or
moratorium law, or any other law or laws for the relief of debtors which
proceeding is not dismissed within [ * ], or the appointment of any receiver,
trustee or assignee to take possession of the properties of the other Party;

(b)
the sale, lease or other disposition of at least seventy-five percent (75%) of
the other Party’s business or assets, to a person other than an Affiliate of
such Party; or

(c)
the cessation of all or substantially all of the other Party’s business
operations.

12.4
If a Party breaches a material term or condition of this Agreement, the
non-breaching Party shall have the right to terminate this Agreement, either in
whole or in part, after [ * ] prior written notice to the other Party unless any
such breach is cured within said [ * ]. Termination shall be in addition to all
other rights and remedies available to the non-breaching Party at law or in
equity.

12.5
This Agreement may be terminated, in whole or in part, by [ * ] written notice
given by Jazz to Siegfried, as follows:

(a)
If any required license, permit or certificate of Siegfried is not approved or
not issued, or is withdrawn or suspended, by any Regulatory Authority; or

(b)
If Drug Product is withdrawn or deleted by any Regulatory Authority so that
there are no remaining markets available;

(c)
If Jazz decides to permanently cease the commercialisation of Product.

/s/ Henn        /s/ KG
Siegfried        Jazz

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12.6
This Agreement may be terminated, in whole or in part, by [ * ] written notice
given by Siegfried to Jazz, as follows:

(a)
If Jazz does not commercially launch any Drug Product within [ * ] after receipt
of approval from any Regulatory Authority;

(b)
If Jazz ceases commercial sale of Drug Product after commercial launch; or

(c)
If Jazz does not purchase at least the total volume of Drug Product that
requires Siegfried to Manufacture [ * ] of API during any [ * ] period after
commercial launch of the Drug Product.

12.7
Any and all references to termination of this Agreement “in part” or “partial
termination” throughout this Agreement shall mean that the applicable Party may,
subject to and in accordance with the provisions of this Agreement, terminate
this Agreement solely in respect of the Manufacture and supply of either (i) the
API or (ii) the Drug Product (hereinafter referred to as the “Terminated
Product”), in which case:

(a)
the Agreement shall be terminated solely in respect of the Terminated Product;

(b)
the Agreement shall continue in full force and effect in respect of the other
non-terminated Product(s) (the “Non-Terminated Product”);

(c)
the provisions of the Agreement (including, without limitation, all applicable
references to “Product”) shall be construed accordingly; and

(d)
for the avoidance of doubt, the terms of Section 2.3 shall apply accordingly
solely in respect of the Non-Terminated Product and Jazz shall have no further
obligations pursuant thereto in respect of the Terminated Product.

12.8
Upon expiration or termination of this Agreement, in whole or in part, Siegfried
shall have the right to deliver to Jazz (and Jazz shall have the obligation to
take delivery of) all Product (or, in the case of partial termination, all
Terminated Product) already Manufactured by Siegfried pursuant to any Order and
the remaining Materials that relate to the Terminated Product maintained by
Siegfried pursuant to Section 5 and Jazz shall pay the price for such Products
or Terminated Product (as the case may be) or Materials, provided however, that
Siegfried uses commercially reasonable efforts to limit such loss of Materials.

12.9
Neither the expiration nor the termination of this Agreement, in whole or in
part, shall relieve the Parties of their obligations (in the case of partial
termination, as they relate to the Terminated Product) incurred prior to such
expiration or termination. All provisions that, by their express or implied
terms, are meant to survive termination of the Agreement, in particular all
rights and obligations set forth in Sections 8 (Compensation and Terms of
Payment), 10 (Confidential Information), 11 (Intellectual Property), 14.1
(Liability and Indemnity), 16 (Miscellaneous) and 17 (Applicable Law and Dispute
Resolution) shall continue irrespective of such termination.

/s/ Henn        /s/ KG
Siegfried        Jazz

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12.10
At all times during the Term, Jazz shall have the right to make Product and to
have Product made by an Affiliate or third party manufacturer (Alternative
Manufacturer) on its behalf, subject to the terms and conditions of this
Agreement, including, without limitation Sections 2.3 (Purchase Commitment), 10
(Confidentiality), and 11 (Intellectual Property). Prior to appointing such an
Alternative Manufacturer, Jazz and Siegfried shall, without delay, confer and
discuss in good faith if and how any Affiliate of Siegfried may be appointed as
alternative manufacturing site.

12.11
In the event Jazz intends to engage an Alternative Manufacturer at any time
(including during the Term or upon termination of this Agreement in whole or in
part), Siegfried shall, at the request of Jazz and subject to Jazz’s reasonable
cooperation, provide documents already prepared by Siegfried as may be necessary
or helpful for the technology transfer of the manufacturing process for Product
and the regulatory qualification to Jazz or the Alternative Manufacturer
(including all know-how necessary or reasonably useful to enable Jazz or the
Alternative Manufacturer to manufacture Product), provided that Siegfried will
not be required to (i) prepare, translate or otherwise generate documents,
unless otherwise agreed by Siegfried (acting reasonably ) and at Jazz’
reasonable costs and expenses, (ii) provide Siegfried Confidential Information,
or (ii) grant licenses to Siegfried Pre-Existing Intellectual Property Rights or
Siegfried Arising Intellectual Property Rights to a third party Alternative
Manufacturer.

12.12
In the event of transfer to Jazz or its Affiliate, at the request of Jazz and
subject to Jazz’s reasonable cooperation, the Parties shall confer and discuss a
technology transfer plan prepared by Jazz and agreed by Siegfried (such
agreement not to be unreasonably withheld, conditioned or delayed), including
applicable fees (Jazz Technology Transfer Plan). Such Jazz Technology Transfer
Plan may, as applicable, provide for reasonable technical assistance regarding
the manufacture, testing and supply of Product, including access to technical
personnel, as may be helpful for Jazz or its Affiliate to implement such process
to manufacture Product. Subject to Siegfried’s approval and consent of the scope
of the Jazz Technology Transfer Plan and cost and expenses therefore (such
approval and consent not to be unreasonably withheld, conditioned or delayed),
Siegfried shall implement the Jazz Technology Transfer Plan and Jazz shall
reimburse Siegfried for all reasonable costs and expenses incurred by Siegfried
to conduct such technology transfer and technical assistance, unless otherwise
mutually agreed in writing.

13.
Representations and Warranties

13.1
Each Party represents and warrants to the other Party (i) that it has the legal
power, authority and right to enter into this Agreement and to perform its
respective obligations set forth herein, (ii) that this Agreement has been duly
executed and delivered by each Party and constitutes the valid and binding
obligation of such Party, enforceable against such Party in accordance with its
terms, and (iii) the execution, delivery and performance by such Party of this
Agreement and its compliance with the terms hereof does not and will not
conflict with or result in a breach of any term of, or constitute a

/s/ Henn        /s/ KG
Siegfried        Jazz

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default under (i) any agreement or instrument binding or affecting it or its
property; (ii) its charter documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental authority entered against it
or by which any of its property is bound.
13.2
Siegfried represents, warrants and covenants to Jazz that all Product
Manufactured pursuant to this Agreement shall conform with Specifications,
Applicable Law and the Master Batch Record upon delivery and all Product has
been Manufactured in accordance with cGMP and the material provisions of the
Quality Agreement.

13.3
Jazz represents, warrants and covenants that the Technology and the Consigned
Materials provided to Siegfried by or on behalf of Jazz hereunder, and used by
Siegfried for the performance of its obligations in accordance with the terms of
this Agreement and Jazz’s instructions, does not infringe or misappropriate and,
to the best of Jazz’ knowledge, will not infringe or misappropriate the
Intellectual Property Rights of any third party.

13.4
EXCEPT AS EXPRESSLY WARRANTED IN THIS AGREEMENT, NEITHER PARTY EXTENDS ANY OTHER
WARRANTIES OR REPRESENTATIONS COVERING THE PRODUCT OR THE TECHNOLOGY, EXPRESS OR
IMPLIED, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING
THE WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH
PARTY’S LIABILITY UNDER THESE WARRANTY PROVISIONS SHALL BE STRICTLY LIMITED TO
THE REMEDIES PROVIDED FOR UNDER THIS AGREEMENT.

14.
Liability and Indemnity

14.1
If Siegfried is unable to meet the delivery dates or other agreed time lines
regarding the delivery of Product, or in case Product does not comply with
Specifications, Applicable Law, cGMP or the Quality Agreement upon delivery and
is rejected by Jazz (acting reasonably) in accordance with Section 4, Siegfried
shall promptly, at Jazz’s election: (i) for delayed delivery, use all
commercially reasonable efforts to deliver the delayed Product as soon as
possible after the original delivery date (or such later date as may be agreed
by Jazz, acting reasonably), at no additional cost to Jazz and Siegfried shall
bear the reasonable and documented transport costs for expedited delivery; (ii)
for non-conforming Product, (a) replace any rightfully rejected Product with
conforming Product as soon as possible (or such later date as may be as agreed
by Jazz, acting reasonably) at no additional cost to Jazz or, if delivery of
conforming Product is not possible within reasonable additional time, Siegfried
shall refund to or credit Jazz all amounts paid by Jazz to Siegfried for such
rightfully rejected Product, and (b) Siegfried shall bear the reasonable and
documented transport, packaging, and destruction costs for such non-conforming
Product. As agreed by the parties pursuant to Section 2.3, and upon Jazz’
written notification as per Section 2.3, Jazz may temporally purchase (i) more
than forty-percent (40%) of its requirements of API and/or (ii) more than
sixty-percent (60%) of its requirements of Drug Product from other suppliers
without constituting a breach of its

/s/ Henn        /s/ KG
Siegfried        Jazz

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obligations under Section 2.3 and without any penalty, surcharge or Volume
Shortfall payment being due or owing (pursuant to Section 2.3a) or 2.3b)).
Except in the case of Siegfried’s gross negligence or willful misconduct, and
with the exception of the remedy set forth under Section 14.2 below, such
delivery, replacement, credit or refund shall be the only remedy available to
Jazz in case of late deliveries or non-conforming Product.
14.2
If Siegfried fails to deliver conforming Drug Product within a grace period of [
* ] after the original delivery date on [ * ] consecutive occasions within [ * ]
(excluding, without limitation, due to any Force Majeure Event or any reason
caused due to an act or omission of Jazz) (Delivery Shortfall), Jazz shall be
entitled to terminate this Agreement, either in whole or in part, upon [ * ]
written notice to Siegfried.

14.3
Siegfried shall indemnify, defend and hold Jazz, its directors, officers,
employees and Affiliates, harmless against all Losses arising out of or in
connection with third party claims, suits, actions, demands or judgments to the
extent arising out of (i) the breach of any of Siegfried's obligations,
warranties or representations under this Agreement, except to the extent such
Losses are caused by Jazz’s negligence or willful misconduct.

14.4
Jazz shall indemnify, defend and hold Siegfried, its directors, officers,
employees and Affiliates harmless against all Losses, arising out of or in
connection with third party claims, suits, actions, demands or judgments to the
extent arising out of (i) the breach of any of Jazz's obligations, warranties or
representations under this Agreement, of (ii) the death of or injury to any
person or any damage to property caused by Jazz’ commercialization or use of
Product except to the extent such Losses are caused by Siegfried's negligence or
willful misconduct.

14.5
With respect to any indemnification obligation under this Agreement, the
following conditions shall be applicable:

(a)
The Party seeking to be indemnified shall notify the indemnifying Party promptly
in writing of any claim which may give rise to an obligation on the part of the
indemnifying Party hereunder; and

(b)
the indemnifying Party shall be allowed to timely take the sole control of the
defense of any such action and claim, including all negotiations for the
settlement, or compromise of such claim or action at its sole expense; and

(c)
the Party to be indemnified shall, at the expense of the indemnifying Party,
render reasonable assistance, information, co-operation and authority to permit
the indemnifying Party to defend such action; and

(d)
no settlement or compromise shall be binding on a Party hereto without its prior
written consent, which consent shall not be unreasonably withheld, conditioned
or delayed.

/s/ Henn        /s/ KG
Siegfried        Jazz

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14.6
During the Term of this Agreement, Siegfried and Jazz shall each obtain and
carry in full force and effect adequate commercial, general liability insurance
as common in the industry, including product liability insurance, which shall
protect the Parties with respect to liability claims covered by Sections 14.3
and 14.4. Such insurance shall be written by a reputable insurance company and
shall be endorsed to include product liability coverage. A Party shall provide
another Party on request with a copy of certificates of insurance evidencing the
same.

14.7
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR SPECIAL, PUNITIVE, INCIDENTAL,
INDIRECT (EXCEPT WITH RESPECT TO THE INDEMNIFICATION AGAINST CLAIMS OF THIRD
PARTIES UNDER SECTION 14), OR CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR ANY
THIRD PARTY, INCLUDING BUT NOT LIMITED TO CLAIMS BASED ON LOST PROFITS, LOSS OF
TIME, LOSS OF OPPORTUNITY OR ANY OTHER ECONOMIC LOSS SUFFERED OR INCURRED AS A
RESULT OF THIS AGREEMENT.

14.8
WITH THE EXCEPTION OF ANY LIABILITY ARISING DUE TO GROSS NEGLIGENCE, FRAUD,
WILFUL MISCONDUCT OR BREACH OF SECTION 10 (CONFIDENTIAL INFORMATION) OR SECTION
11 (INTELLECTUAL PROPERTY) HEREOF, AND IF AND TO THE EXTENT PERMITTED BY
APPLICABLE LAW, EACH PARTY'S MAXIMUM LIABILITY UNDER THIS AGREEMENT SHALL BE
LIMITED TO [ * ].

15.
Anti-Bribery and Anti-Corruption

15.1
Each Party shall comply fully at all times with all applicable laws and
regulations, including without limitation any applicable anti-corruption laws,
regulations and standards, of the territories in which Jazz or Siegfried,
respectively, conduct business or activities hereunder or which are relevant to
the operation of this Agreement (including but not limited to the U.S. Foreign
Corrupt Practices Act and the U.K. Bribery Act 2010) (collectively, the
Anti-Corruption Laws). Each Party will ensure that its personnel have read,
understood and shall comply with the Anti-Corruption Laws.

15.2
Each Party shall at all times comply with their respective code of conducts. Any
non-compliance of the Anti-Corruption Laws or otherwise relevant in connection
with this Agreement shall be reported to the other Party without any delay.
Siegfried acknowledges that Jazz’s Code of Conduct is available online at
www.jazzpharmaceuticals.com or will be handed out as a hard copy upon request.
Jazz acknowledges that Siegfried’s Code of Business Conduct is available online
at www.siegfried.ch or will be handed out as a hard copy upon request.

15.3
Without limiting its obligations under Sections 15.1 and 15.2, each Party agrees
that it has not, and covenants that it will not, in connection with the
performance of this Agreement, promise, authorize, ratify or offer to make, or
take any act in furtherance of any payment or transfer of anything of value,
directly or indirectly: (i) to any individual

/s/ Henn        /s/ KG
Siegfried        Jazz

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including Government Officials; or (ii) to an intermediary for payment to any
individual including Government Officials; or (iii) to any political party. For
the purpose of this Section, “Government Official” means: (a) any officer or
employee of a government or any department, agency or instrument of a
government: (b) any person acting in an official capacity for or on behalf of a
government or any department, agency, or instrument of a government; (c) any
officer or employee of a company or business owned in whole or part by a
government; (d) any officer or employee of a political party or any person
acting in an official capacity on behalf of a political party; and/or (f) any
candidate for political office.
15.4
Without limiting its obligations under Sections 15.1 and 15.2, each Party agrees
and covenants that no payments or transfers of value shall be made, promised,
authorized, ratified or offered with the purpose or effect of public or
commercial bribery, acceptance of or acquiescence in extortion, kickbacks or
other unlawful or improper means of securing an improper advantage or obtaining
or retaining business.

15.5
Each Party agrees and covenants that it has not permitted and will not permit
anyone acting on its behalf to violate the Anti-Corruption Laws.

16.
Miscellaneous

16.1
No set-off. Neither Party shall be entitled to set off any of its rights or
obligations under this Agreement against the rights or obligations of another
Party without having first obtained the prior written consent of that other
Party.

16.2
Sub-contracting. Other than laboratory services as is necessary, Siegfried shall
not be permitted to subcontract Manufacturing under this Agreement to any third
party (other than certain activities hereunder to Siegfried Malta), without
Jazz’s prior written consent. If a subcontractor is appointed by Siegfried,
Siegfried shall be responsible for all work performed by, and all acts,
omissions and breaches of, such subcontractor as if performed or made by itself.

16.3
Force Majeure. A Party shall be excused from performing its obligations under
this Agreement (other than obligations of payment) to the extent that its
performance is delayed or prevented by any cause beyond such Party’s reasonable
control, including, but not limited to, act of God (such as extreme weather),
fire, (naturally caused) flood, explosion, disease, war, insurrection, civil
strike, riots, government action power failure or energy shortages (Force
Majeure Event). Performance shall be excused only to the extent of and during
the reasonable continuance of such disability. Any deadline or time for
performance specified in this Agreement that falls due during or subsequent to
the occurrence of any of the disabilities referred to herein shall be
automatically extended for a period of time equal to the period of such
disability. The prevented Party shall immediately notify the other Party if, by
reason of any Force Majeure Event, the prevented Party is unable to meet any
deadline or time for performance specified in this Agreement. In the event that
such Force Majeure Event cannot be removed or

/s/ Henn        /s/ KG
Siegfried        Jazz

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overcome within [ * ] (or such other period as the Parties jointly shall
determine) from the date the Party affected first became affected, then the
non-prevented Party may at any time after the expiration of such period, by
written notice to the other Party, either (i) suspend this Agreement, in whole
or in part, for as long as such Force Majeure Event continues to exist, or (ii)
terminate this Agreement, in whole or in part, with immediate effect.
16.4
Precedence of Agreement. Unless expressly agreed otherwise in writing, the terms
outlined in this Agreement shall prevail over any terms and conditions outlined
in any Order or Order Confirmation for Product and any general terms and
conditions of a Party, and such terms and conditions are hereby expressly
excluded. In case of discrepancies between this Agreement and an Annex hereto,
the provisions of this Agreement shall prevail.

16.5
No assignment. This Agreement is binding upon and shall inure to the benefit of
the Parties hereto and their successors and permitted assigns. This Agreement
and any rights or obligations hereunder may be assigned or delegated only (i)
with the consent of the other Party, not to be unreasonably withheld,
conditioned or delayed, or (ii) by Jazz to its Affiliates or to the successor to
all or substantially all of the business of Jazz (whether by merger,
consolidation, asset transfer or similar transaction) to which this Agreement
relates. Any other assignment or delegation by either Party without the prior
written consent of the other Party is void.

16.6
No waiver. The failure by either Party at any time to enforce any of the terms,
provisions or conditions of this Agreement or to exercise any right hereunder
shall not constitute or be construed to constitute a waiver of the same or
affect that Party's rights thereafter to enforce or exercise the same.

16.7
Independent Parties. Nothing in this Agreement shall be deemed or construed to
constitute or create between the Parties hereto a partnership, joint venture,
agency, or other relationship other than as expressly set forth herein. Neither
Party shall have authority to speak for, represent or obligate the other Party
in any way without prior written consent of the other Party.

16.8
Entire Agreement. This Agreement (together with the Quality Agreement) contains
the full understanding of the Parties with respect to the subject matter hereof
and supersedes all prior understandings and writings relating thereto (other
than, for the avoidance of doubt, the Master Development Services Agreement and
any Confidential Disclosure Agreement executed by the Parties and/or their
Affiliates, each of which shall remain in full force and effect in accordance
with its respective terms). No waiver, alteration or modification of any of the
provisions hereof shall be binding unless made in writing and signed by the
Parties.

16.9
Severability. If any portion of this Agreement is held invalid by a court of
competent jurisdiction, such portion shall be deemed to be of no force and
effect and this Agreement shall be construed as if such portion had not been
included herein, provided

/s/ Henn        /s/ KG
Siegfried        Jazz

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however, if the deletion of such provision materially impairs the commercial
value of this Agreement to either Party, the Parties shall attempt to
renegotiate such provision in good faith. The fact that any provision of this
Agreement shall be prohibited or unenforceable in any jurisdiction shall not
invalidate or render unenforceable such provision in any other jurisdiction. To
the extent permitted by applicable law, the Parties to this Agreement waive any
provision of law that renders any provision of this Agreement prohibited or
unenforceable in any respect.
16.10
Notices. Any notice required under this Agreement shall be effective only if it
is in writing and (i) delivered in person or (ii) deposited with a nationally
recognized overnight courier service, or (iii) sent by registered mail or (iv)
dispatched by e-mail (pdf), in which case such notice is to be confirmed by
registered mail within [ * ]; in either case any notice is to be addressed to
the applicable address set forth below or any other address as designated by
either Party.

 
if to Siegfried
Siegfried AG 
Untere Brühlstrasse 4, 4800 Zofingen, Switzerland
Attention: [ * ]
Email: [ * ]
 
with a copy to:
Siegfried AG 
Untere Brühlstrasse 4, 4800 Zofingen, Switzerland
Legal Department
Email: [ * ]
 
if to Jazz:
Jazz Pharmaceuticals Ireland Limited 
Waterloo Exchange, Waterloo Road, Dublin 4, Ireland 
Attention: Legal Department
Fax/e-mail: [ * ]

Either Party may change the above addresses, but no such change shall have any
effect until the other Party has been properly notified with written notice of
the change of the address.
16.11
Compliance with Laws. Each Party shall comply with all Applicable Law governing
its performance of the terms of this Agreement, including, but not limited to,
those relating to health, safety and the environment, fair labor practices,
unlawful discrimination, debarment, supply chain transparency and modern
slavery, anti-corruption and anti-bribery laws.

16.12
Hardship. If during the Term of this Agreement, the performance of the Agreement
should lead to unreasonable hardship for the one or the other Party, both
Parties shall undertake reasonable endeavors to discuss in good faith a possible
amicable resolution or possible amendment to this Agreement in light of the
change in circumstances; provided always, however, that (i) neither Party shall
have any obligation to amend this Agreement or to waive or modify any of its
rights under this Agreement and (ii)

/s/ Henn        /s/ KG
Siegfried        Jazz

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notwithstanding any claim of unreasonable hardship by a Party pursuant to this
Section 16.12, each Party shall remain fully liable for the performance of its
obligations and duties under this Agreement unless and until, and only to the
extent that, the Parties mutually agree in writing to alter or modify such
obligations or duties by amending the provisions hereof (which alteration or
modification shall only be binding if made in writing and signed by both Parties
in accordance with the terms of this Agreement).
17.
Applicable Law and Dispute Resolution

17.1
This Agreement shall be governed by German laws without regard to its conflict
of laws provisions and the provisions of the UN Convention regarding Contracts
on the International Sale of Goods (Vienna Convention).

17.2
All disputes arising out of or in connection with this Agreement, including
disputes on its conclusion, binding effect, amendment or termination, shall be
resolved exclusively by arbitration in accordance with the Arbitration Rules of
the German Arbitration Institute (DIS) in force on the date on which the Notice
of Arbitration is submitted in accordance with these Rules, agree as follows:

a)
The number of arbitrators shall be three (3).

b)
The seat of the arbitration shall be Hannover, Germany.

c)
The arbitral proceedings shall be conducted in English.

17.3
Notwithstanding any other provision of this Agreement, each Party shall still be
entitled to access the courts in Hannover, Germany, to obtain appropriate
injunctive relief.

[remainder of page intentionally left blank]

/s/ Henn        /s/ KG
Siegfried        Jazz

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List of Annexes

Annex
Description
Content
1.1
API
Description of API
1.2
Drug Product
Description of Drug Product
1.3
Key Material
Description of Key Material
1.4
Commercial Terms
Price, MOQ and other commercial terms

Intending to be bound by the provisions hereof, each of the parties hereto have
caused this Agreement to be executed personally or by its duly authorized
representative, to be effective as of the Effective Date.

Siegfried AG
 
 
 
 
 
 
   /s/ Luca Parlanti
   /s/ Marco Henneböhle
 
Name / function
Name / function
 
Dr. Luca Parlanti
Dr. Marco Henneböhle
 
Head of Exclusive Sales
Director Business Development
 
Drug Substance
Exclusive Synthesis Europe
 
Siegfried AG
Siegfried AG
 
 
 
 
 
 
 
Jazz Pharmaceuticals Ireland Limited
 
 
 
 
 
/s/ Kathleen Gibbons
 
 
Name / function
 
 
 
 
 
Kathleen Gibbons
 
 
VP, Finance
 
 

/s/ Henn        /s/ KG
Siegfried        Jazz

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ANNEX 1.1 - API

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[ * ]

/s/ Henn        /s/ KG    
Siegfried        Jazz

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ANNEX 1.2 – Drug Product
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

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ANNEX 1.3 - Key Material
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

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ANNEX 1.4 – Commercial Terms
[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz

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[ * ]

/s/ Henn        /s/ KG
Siegfried        Jazz