Exhibit 10.18

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

KEY INTERMEDIATE SUPPLY AGREEMENT

 

THIS KEY INTERMEDIATE SUPPLY AGREEMENT (this “Agreement”) is made as of this
28th day of August 2017 (“Effective Date”), by and among NABRIVA THERAPEUTICS
IRELAND DAC (“NABRIVA”), and SEL BIOCHEM XINJIANG CO., LTD (“SEL”) and FOUNTAIN
INTERNATIONAL DEVELOPMENT HOLDING LIMITED (“FOUNTAIN”). NABRIVA, SEL, and
FOUNTAIN are hereinafter collectively referred to as the “Parties.”

 

WHEREAS, NABRIVA wishes to purchase from SEL bulk Key Intermediate for use in
manufacturing drug substance and drug product for commercial sale by NABRIVA
worldwide and for certain clinical and other related purposes;

 

WHEREAS, NABRIVA wishes to use FOUNTAIN for processing forecasts, purchase
orders, payments, issuing invoices, and coordinating transportation, on behalf
of SEL;

 

WHEREAS, SEL has suitable facilities and equipment and sufficient qualified
personnel to perform their respective services as set forth in the Agreement,
manufacture Key Intermediate in bulk form, and is willing to provide such Key
Intermediate on the terms and conditions set forth below.

 

NOW, THEREFORE, the hereto, intending to be legally bound, agree as follows:

 

I.                                        DEFINITIONS

 

As used in this Agreement:

 

1.1                               “Adverse Experience” or “AE” shall mean any
unfavorable and unintended change in the structure, function, or chemistry of
the body temporally associated with any use of a product or of a derivative
thereof containing Key Intermediate, whether or not the adverse experience is
considered to be related to the use of such product, including but not limited
to any of the following:  an unexpected side effect, injury, toxicity or
sensitivity reaction, which may include an experience of unexpected incidence
and severity; an adverse experience occurring in the course of the use of a drug
product in professional practice; an adverse experience occurring in clinical
studies; an adverse experience occurring from drug overdose, whether accidental
or intentional; an adverse experience occurring from drug abuse; an adverse
experience occurring from drug withdrawal; and any significant failure of
expected pharmacological action.

 

1.2                               “Affiliate” means any corporation or other
business entity which, directly or indirectly, is controlled by, controls, or is
under common control with NABRIVA or SEL. For this purpose, “control” shall be
deemed to mean direct or indirect ownership of fifty percent (50%) or more of
the voting stock or other voting equity of such entity.

 

1.3                               “Confidential Information” means all
information, data, know-how and all other business, technical and financial data
disclosed hereunder by one Party or any of its Affiliates to the other party or
any of its Affiliates, except any portion thereof which:

 

(a)                                 at the time of disclosure, is public
knowledge;

 

(b)                                 after disclosure, becomes public knowledge
by publication or otherwise, except by breach of this Agreement by the
recipient;

 

(c)                                  the recipient can demonstrate by its
written records was in the recipient’s possession at the time of such
disclosure, and which was not acquired, directly or indirectly, from the
disclosing party or its Affiliates;

 

(d)                                 is lawfully disclosed to the recipient on a
non-confidential basis by a third party who is not obligated to the disclosing
party or any other third party to retain such Confidential Information in
confidence;

 

(e)                                  results from research and development by
the recipient independent of such disclosure as shown by competent evidence; or

 

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(f)                                   is required to be disclosed by applicable
law, regulation, or the order of a court of competent jurisdiction; provided, in
each case the Party so disclosing information timely informs the other Party and
uses its reasonable efforts to limit the disclosure and maintain confidentiality
to the extent possible and, if possible, permits the other Party to attempt by
appropriate legal means to limit such disclosure.

 

Confidential Information disclosed orally, visually and/or in another intangible
form shall be identified by the disclosing Party to the receiving Party as
confidential at the time of such disclosure and confirmed in writing to the
receiving Party within [**] days after such disclosure.

 

1.4                               “Key Intermediate” means CAS 125-65-5,
molecular formula C22H34O5, and is more commonly known as pleuromutilin having
those specifications as set forth on Schedule A hereto.

 

1.5                               “Material Breach” means a Party’s failure to
perform a major part of its obligations under this Agreement, which prevents
this Agreement from being performed in a timely manner or defeats the purpose of
the Agreement.

 

1.6                               “Quality Technical Agreement” means the form
of quality assurance/quality control agreement to be entered into by NABRIVA and
SEL as set forth in Schedule B.

 

1.7                               “Purchase Price” shall have the meaning set
forth in Section 6.3 hereof.

 

II.                                   PURCHASE AND SALE

 

2.1                               Purchase and Sale.  SEL agrees to manufacture
and supply to NABRIVA or a NABRIVA Affiliate (or a designee of the foregoing)
those quantities of Key Intermediate ordered pursuant to purchase orders placed
by NABRIVA and/or its Affiliate from time to time in accordance with this
Agreement. Key Intermediate supplied hereunder may be used by NABRIVA and its
Affiliates and/or licensees for all purposes, including without limitation,
manufacturing of drug substance and drug product for worldwide commercial sale
by NABRIVA or for clinical and other related purposes.

 

2.2                               Cooperation. The Parties will reasonably
cooperate with each other as may be necessary and customary in consideration of
industry practice, and will disclose all material information necessary to
enable each other to perform their duties under this Agreement in a timely
fashion.

 

2.3                               Specific Duties.  In addition to its general
obligations relating to the manufacture and supply of Key Intermediate, SEL
shall be responsible for performing the following services at SEL’s cost:

 

(i)                                     manufacture of Key Intermediate under
cGMP with fermentation starting materials (cell bank and fermentation media) as
GMP starting materials.

 

(ii)                                  full validation of analytical methods
according to ICH and use of compendia methods as required in connection with Key
Intermediate manufacturing.

 

(iii)                               quality control and testing of all Key
Intermediate in order to monitor compliance with all applicable standards and
specifications required by this Agreement, including any Schedules hereto;

 

(iv)                              conducting stability testing of Key
Intermediate in accordance with the procedures set forth in the Quality
Technical Agreement;

 

(v)                                 summarizing implemented changes and
supplying latest versions of approved critical documentation, and providing
other information necessary for NABRIVA to prepare, submit, obtain and maintain
all regulatory filings relating to the Key Intermediate (and/or drug product or
drug substance produced using Key Intermediate) under the terms of this
Agreement; and

 

(vi)                              performing such other services as agreed upon
in writing by the Parties.

 

(vii)                           filing of the appropriate and required
documentation, including Drug Master File (DMF) in the US and required
international counterparts.

 

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2.4                               No Subcontracting.  SEL and FOUNTAIN shall not
subcontract any aspect of their obligations under this Agreement, except with
the prior written consent of NABRIVA.

 

2.5                               Joint and Several Liability.  As consideration
for NABRIVA agreeing to enter into this Agreement, each of SEL and FOUNTAIN
shall be jointly and severally liable to NABRIVA for their respective
obligations under this Agreement and any other agreement, document or instrument
executed in connection herewith. To the extent that SEL or FOUNTAIN is in breach
of its obligations, NABRIVA shall be entitled to bring a cause of action and to
seek recovery against either SEL or FOUNTAIN irrespective of whether such party
is the entity responsible for such breach.

 

2.6                               FOUNTAIN’s Responsibility.  FOUNTAIN will be
responsible for receiving forecasts, purchase orders, payments, issuing
invoices, and coordinating transportation on behalf of SEL.

 

III.                              KEY INTERMEDIATE QUANTITY, QUALITY AND
MANUFACTURING PROCESSES; TECHNICAL ASSISTANCE

 

3.1                               Quantity. SEL agrees to reserve capacity for
the quantities of Key Intermediate as defined in Schedule C. SEL shall have no
obligation to supply quantities in excess of those set forth in Schedule C, but
shall use its commercially reasonable efforts to accommodate NABRIVA’s demand
for excess quantities.

 

3.2                               Specification; Quality Standards; Changes. 
All Key Intermediate manufactured and sold by SEL to NABRIVA under this
Agreement will meet the Key Intermediate specifications and minimum shelf life
requirements set forth in Schedule A hereto (the “Specifications”), as well as
the quality assurance standards established in the Quality Technical Agreement.
Such Specifications, as well as the terms and conditions of the Quality
Technical Agreement, are subject to modification from time to time by mutual
written agreement of the Parties. Notwithstanding the foregoing, if NABRIVA
finds it necessary or desirable to change the Specifications, the quality
assurance standards, or any other aspect of the manufacturing process for Key
Intermediate, NABRIVA may deliver a request for such change to SEL and SEL shall
use best efforts to make any change identified in such request. Prior to
implementation of any changes, the Parties agree to negotiate in good faith in
an attempt to reach agreement on (a) the new price for any Key Intermediate
manufactured and supplied hereunder by SEL which embodies such changes, based
solely on the effect of such changes on SEL’s manufacturing costs for the Key
Intermediate, (b) the reasonable timing required to implement changes and
(c) any other amendments to this Agreement which may be necessitated by such
changes (e.g., an adjustment to the lead time for purchase orders). The Parties
agree that NABRIVA’s obligation to bear cost increases in subsection (a) above
will be limited to those cost increases that relate solely to the production of
the Key Intermediate; costs for other changes affecting SEL’s good manufacturing
compliance (“cGMP”) or affecting other products generally will be borne by SEL.

 

3.3                               Manufacturing Processes. SEL has furnished to
NABRIVA a copy of its purification procedures for the Key Intermediate, and SEL
shall not modify such procedures without NABRIVA’s prior written consent. In the
Quality Technical Agreement, the Parties will agree upon the equipment to be
used to produce the Key Intermediate. For clarity, SEL will not be required to
disclose confidential details of equipment used to make Pleuromutilin prior to
purification.

 

3.4                               Documentation. NABRIVA has provided SEL with
analytical methods, product specifications, product impurities, degradation
products, and reference standards for manufacturing Key Intermediate as set
forth in the attached Schedule A.SEL shall promptly provide NABRIVA, on an
ongoing basis, with all available safety data and information concerning the Key
Intermediate, process, and related materials, including without limitation any
new information developed or learned by SEL in connection with the manufacturing
of Key Intermediate hereunder (excluding in each case any confidential aspects
of the fermentation process used by SEL). In addition, SEL shall provide all the
change control and regulatory documentation as required by the EU and US
authorities so as to maintain licenses, either by directly disclosing such
information to NABRIVA or, where applicable, by filing such information with
such authorities and permitting NABRIVA to reference such filing(s).

 

3.5                               Communication. SEL and NABRIVA will respond to
requests for support, information and approvals within [**] working days. If a
complete response is not possible within such [**]day period, the Party owing
the response shall communicate within such [**]day period the reason for the
delay and when the response will be available.

 

3.6                               Quality Technical Agreement.  Within [**] days
after the date of this Agreement, representatives of the Parties’ Quality
Assurance departments shall meet to review and revise, if necessary, the
attached Quality Technical Agreement outlining responsibilities and key contacts
for Key Intermediate quality and compliance related issues. SEL will provide
NABRIVA with certain production and control information for review prior to
release as specified in the Quality Technical Agreement. The Quality Technical
Agreement will also address, without limitation, annual product reviews,
returned goods, regulatory audits, compliance with FDA current Good
Manufacturing Practices, and such other quality related concerns deemed
appropriate.

 

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IV.                               CONFIDENTIAL INFORMATION

 

4.1                               The Parties acknowledge that each Party has,
prior to the Effective Date, provided its Confidential Information to the other
Party in connection with the manufacture and supply of the Key Intermediate, and
further acknowledge that all such Confidential Information (as well as any
additional Confidential Information provided by one party to the other
hereunder) shall be subject to the provisions of this Section IV.
Notwithstanding anything to the contrary herein, the following shall be deemed
to be the Confidential Information:  (a) any and all information, knowledge,
technology, and trade secrets relating to the Key Intermediate that is provided
by NABRIVA to the SEL or FOUNTAIN, whether before, on, or after the Effective
Date; and (b) any and all manufacturing records or other information or
documentation delivered to NABRIVA by SEL relating to the manufacture of Key
Intermediate hereunder; and (c) any Product-Related Inventions (as defined
below).

 

4.2                               During the term of this Agreement and for [**]
years thereafter, all Confidential Information shall be held in confidence by
the receiving party, shall not be used by the receiving party for any purpose
except as provided hereunder and shall not be disclosed to third parties except
as provided in Section 4.4 or as may otherwise be permitted by the advance
written consent of the disclosing party. Any Affiliate, director, officer,
employee, consultant, or agents who receives Confidential Information shall be
advised as to the confidential nature thereof and the prohibitions contained
herein, and any copies of any portions of any Confidential Information that are
disclosed to as provided in this Section will be identified as confidential.

 

4.3                               Notwithstanding Section 4.2, each Party may
disclose Confidential Information of the other Party to its Affiliates,
directors, officers, employees, agents or consultants who have a need to know
exclusively in connection with the performance of their duties in satisfying the
obligations of such Party hereunder and who are subject to written obligations
of confidentiality and non-use that are no less restrictive than those set forth
herein. Any Affiliate, director, officer, employee, agent or consultant who
receives Confidential Information shall be advised as to the confidential nature
thereof and the prohibitions contained herein. All copies of any portions of any
Confidential Information distributed as provided in this Section will be
identified as confidential.

 

4.4                               Upon termination of this Agreement, and upon
the request of the disclosing party, the receiving party shall return or destroy
all Confidential Information and any copies thereof in its possession, except
that each Party may retain one copy of Confidential Information solely for
archival purposes. Termination of this Agreement shall not operate to extinguish
either Party’s obligation to treat Confidential Information as provided herein,
and the same shall continue in effect in accordance with this Section.

 

4.5                               Nothing contained herein shall be deemed to
grant to either Party, either expressed or implied, a license or other right or
interest in the Confidential Information of the other or in any patent,
trademark or other similar property of the other.

 

4.6                               Neither party shall use the name of the other
in any press releases or other statements to the public (including publicity,
promotional materials, or advertising), nor publicly disclose the existence of
this Agreement for any purpose (other than as may be required by applicable law
or regulation), without the prior written consent of the other, which shall not
be unreasonably withheld or delayed.

 

V.                                    FORECASTS AND ORDERS

 

Orders and Forecasts.

 

5.1                               NABRIVA undertakes to purchase from SEL not
less than [**] percent ([**]%) of NABRIVA’S Key Intermediate requirements per
year per the forecast in Schedule D (the “SEL Share”); provided, however,
NABRIVA shall be free to obtain from third party any portion of the SEL Share
after receiving written confirmation from SEL that SEL is unable or unwilling to
supply. Upon the execution of this Agreement, NABRIVA shall provide SEL and
FOUNTAIN with a purchase order with NABRIVA’s Key Intermediate requirements for
the [**] month period commencing with the month following the Effective Date of
this Agreement. NABRIVA shall also provide a non-binding forecast of its
requirements for Key Intermediate for an additional [**] month period following
the initial [**] month period. The [**] month forecast shall represent NABRIVA’s
reasonable estimates only, not purchase orders, to facilitate SEL’s planning.
NABRIVA agrees to purchase Key Intermediate in not less than full lot
quantities, which as of the Effective Date are approximately [**] per batch. SEL
hereby undertakes to keep a stock of raw materials and intermediate components,
adequate to meet NABRIVA’s Key Intermediate order. Such stock, to approximately
correspond to six-month Key Intermediate supplies to NABRIVA, shall be agreed in
good faith and in due time between the parties after execution of this
Agreement.

 

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5.2                               Forecasts Changes and Forecast Updates. On or
before the [**] day of each month thereafter, NABRIVA shall provide SEL and
FOUNTAIN with an additional [**] month purchase order to supplement the
remaining [**] months of firm purchase orders, thereby establishing a new [**]
month period of purchase orders, and shall provide an updated forecast of its
estimated requirements of Key Intermediate for the [**] months succeeding such
new [**] month period of firm purchase orders. Provided NABRIVA’s purchase
orders do not exceed SEL’s reserve capacity set forth in Schedule C, SEL shall
accept all NABRIVA purchase orders and shall supply NABRIVA in accordance with
them, provided however that in case of any conflict or inconsistency between the
terms of said orders and the terms and conditions of this Agreement, the terms
of this Agreement shall prevail. NABRIVA can increase or decrease its firm order
quantities with SEL’s prior agreement and SEL can adjust its shipping quantities
with NABRIVA’s prior agreement. Parties shall use their commercially reasonable
efforts to accommodate reasonable change requests from the other. SEL shall use
commercially reasonable efforts to execute all orders received and accepted
pursuant to this Section within [**] days from the date of receipt of the
relevant order.

 

5.3                               To make the implementation of orders and
delivery more efficient, the emails about Forecasts and Orders among Nabriva,
SEL and FOUNTAIN should be forwarded to each other.

 

VI.                               PRICE, SHIPMENT AND PAYMENT

 

6.1                               SEL’s Responsibilities. SEL will properly
manufacture the Key Intermediate so that it may be lawfully and safely shipped
to NABRIVA or its designee worldwide and shall package the Key Intermediate for
shipment in accordance with the Specifications. SEL and FOUNTAIN will prepare
and execute all reasonably necessary shipping documents, consisting of Packing
List, Dangerous Goods Declaration, and MSDS. NABRIVA will choose the carrier and
the designee by indicating both on its purchase order provided to FOUNTAIN.

 

6.2                               Terms of Shipment. FOUNTAIN will invoice Key
Intermediate FCA (Incoterms 2010) Shihezi. SEL shall arrange for transportation
to final destination in accordance with NABRIVA’s written instructions,
including use of the common carrier designated by NABRIVA. If NABRIVA does not
designate a common carrier, SEL may select the common carrier. Risk of loss
shall pass from SEL to NABRIVA when the Key Intermediate is delivered to the
common carrier. All transport and insurance costs will be borne by NABRIVA.

 

6.3                               Price. FOUNTAIN shall invoice NABRIVA the
Purchase Price for all Key Intermediate delivered as set forth in Schedule D
attached hereto. FOUNTAIN shall send its invoice at the time of shipment.

 

6.4                               Terms of Payment. NABRIVA will pay FOUNTAIN
the Purchase Price including pre-paid transportation and insurance costs, if
any, in U.S. Dollars net [**] days from the date of AWB (air waybill) or [**]
days from the date of B/L (bill of lading) and receipt of invoice from FOUNTAIN,
together with copies of all documentation required for Key Intermediate release
as provided in the Quality Technical Agreement. FOUNTAIN shall pay SEL in [**]
working days after receiving the payment from NABRIVA. Late payments shall bear
interest at the then-current United States prime rate as reported in the Wall
Street Journal eastern edition, or if less, the highest rate permitted under
applicable law.

 

VII.                          INSPECTION AND ANALYSIS

 

7.1                               Inspection by SEL.  SEL will analyze each Key
Intermediate lot for compliance with the Specifications set forth in Schedule A.
SEL or its authorized representative will send to NABRIVA a Certificate of
Analysis and a Certificate of Compliance (together with any other documentation
required under the Quality Technical Agreement(including Wood Pallets
Declaration, Melamine Declaration, TSE and Jatropha Declaration, Residual
Solvents Declaration, Elemental Impurities Declaration and Change Control
Commitment) prior to, or together with, each shipment of Key Intermediate. In
this regard, SEL agrees to retain all records and documents necessary to fulfill
the requirements established by all applicable regulatory agencies.

 

7.2                               Inspection by NABRIVA.NABRIVA or its
authorized representative will visually inspect and test all shipments upon
their receipt and will report any reasonably discernible defects in the Key
Intermediate to SEL and FOUNTAIN within [**] days of its receipt of the Key
Intermediate and related records. Any defects not reasonably discernible will be
reported to SEL and FOUNTAIN by NABRIVA within [**] business days of NABRIVA’s
discovery of the same.

 

7.3                               Non-Conforming Key Intermediate. If any Key
Intermediate does not meet the warranties set forth in Section IX as determined
by NABRIVA’s testing and inspection of the Key Intermediate and/or review of the
documentation provided by SEL, NABRIVA shall provide written notice to SEL of
such findings within [**] business days of such testing and/or inspection. Such
written notice shall set forth the results of such tests and/or inspection and
the basis for such claim of non-conformance. SEL shall have [**] business days
to respond to NABRIVA’s written notice. If

 

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SEL is unable to resolve such non-conformance within [**] days or is unable to
provide NABRIVA with a plan to address such non-conformance before Nabriva’s
inventory of conforming Key Intermediate is exhausted, the Parties shall discuss
the situation in good faith and mutually agree whether SEL will either
(i) replace said Key Intermediate at no charge to NABRIVA and pay all round-trip
shipping charges to and from the destination of the original shipment,
(ii) refund to NABRIVA the Purchase Price for the rejected Key Intermediate and
any applicable shipping costs (including customs duties), or (iii) credit
NABRIVA’s account in an amount equal to the Purchase Price for the rejected Key
Intermediate and any applicable shipping costs (including customs duties).If
requested by SEL, NABRIVA will cooperate with FOUNTAIN to promptly return
Non-Conforming Key Intermediate to SEL and SEL will pay all return shipment
costs. Otherwise, SEL shall reimburse NABRIVA for the reasonable costs incurred
by NABRIVA in properly disposing of such non-conforming Key Intermediate. Any
notice given hereunder shall specify the manner in which the Key Intermediate
fails to conform to the purchase order therefor or fails to meet such warranty
or the Specifications. SEL shall not re-work or re-process such non-conforming
Key Intermediate without NABRIVA’s prior written consent.

 

7.4                               Independent Testing.  If NABRIVA notifies SEL
that any Key Intermediate does not meet the warranties in Section IX, and SEL
does not agree with NABRIVA’s position, the Parties will attempt to reach a
mutually acceptable resolution of the dispute. If they are unable to do so after
a reasonable period of time (such period not to exceed [**] days from the date
of original notification), the matter will be submitted to an independent
testing laboratory acceptable to both parties. Both parties will accept the
judgment of the independent laboratory. The cost of such testing will be borne
by the party whose position is determined to have been in error.

 

VIII.                     REGULATORY MATTERS; REGULATORY FILINGS AND APPROVALS

 

8.1                               General.

 

(a)                                 SEL shall be responsible for obtaining and
maintaining all site licenses for the manufacture of the Key Intermediate and
shall comply with other applicable regulations promulgated by, but not limited
to, the United States Food and Drug Administration (“FDA”) in connection with
SEL’s manufacture of the Key Intermediate.

 

(b)                                 NABRIVA shall be responsible for obtaining
and maintaining all regulatory licenses and approvals for the use of the Key
Intermediate for all the purposes set forth in Section 2.1 above.

 

IX.                               REPRESENTATIONS AND WARRANTIES

 

9.1                               General.

 

(a)                                 SEL represents and warrants to NABRIVA that
(i) it has and will maintain throughout the term of this Agreement, the
expertise, with respect to personnel and equipment, to fulfill the obligations
established hereunder, and has obtained all requisite material licenses,
authorizations and approvals required by federal, state or local government
authorities including, but not limited to, the FDA to manufacture the Key
Intermediate in accordance with this Agreement; (ii) the production facility,
equipment and personnel to be employed will be qualified to manufacture Key
Intermediate according to current Good Manufacturing Practices (“cGMP”) at the
time each such batch of Key Intermediate is produced, and that the production
facility to be employed is in compliance with all applicable material laws and
regulations;  (iii) there are no pending or uncorrected citations or adverse
conditions noted in any inspection of the production facility to be employed
which would cause the Key Intermediate to be misbranded or adulterated within
the meaning of the United States Federal Food, Drug and Cosmetic Act, as
amended, or other applicable laws; (iv)  the execution, delivery and performance
of this Agreement by SEL does not conflict with, or constitute a breach of any
order, judgment, agreement, or instrument to which SEL is a party; (v) the
execution, delivery and performance of this Agreement by SEL does not require
the consent of any person or the authorization of (by notice or otherwise) any
governmental or regulatory authority; and (vi) SEL has not been debarred by the
FDA under the Generic Drug Enforcement Act of 1992 (or by any analogous agency
or under any analogous law or regulation), and neither it nor, to its knowledge,
any of its officers or directors has ever been convicted of a felony under the
laws of the United States for conduct relating to the development or approval of
a drug product or relating to the marketing or sale of a drug product, and
further, to its knowledge, that no individual or firm debarred by any
governmental authority will participate in the performance, supervision,
management or review of the production of Key Intermediate supplied to NABRIVA
under this Agreement.

 

(b)                                 NABRIVA represents and warrants to SEL that
(i) the execution, delivery and performance of this Agreement by NABRIVA does
not conflict with, or constitute a breach of any order, judgment, agreement, or
instrument to which NABRIVA is a party;(ii) it is the owner of or has the right
to use the Key Intermediate, and (iii) the

 

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execution, delivery and performance of this Agreement by NABRIVA does not
require the consent of any person or the authorization of (by notice or
otherwise) any governmental or regulatory authority (other than those relating
to the granting of approval to commercialize the product containing the Key
Intermediate).

 

9.2                               Manufacturing Warranty. SEL represents and
warrants that: (a) all Key Intermediate supplied to NABRIVA will be manufactured
in accordance with cGMPs and the Quality Technical Agreement in effect at the
time of manufacture; (b) all Key Intermediate manufactured by SEL, at the time
of delivery to the common carrier, (i) will not be adulterated or misbranded,
and (ii) will conform to Specifications as established in Schedule A hereto; and
(iii) will be free and clear of any lien, security interest or encumbrance; and
(c) each document provided with or in a connection with the shipment of the Key
Intermediate (such as a Certificate of Analysis, Certificate of Compliance, Wood
Pallets Declaration,  Melamine Declaration, TSE and Jatropha Declaration,
Residual Solvents Declaration, Elemental Impurities Declaration, and Change
Control Commitment) is accurate.

 

9.3                               Anti-Bribery. SEL and FOUNATIN represents,
warrants and agrees that it has been at all times and will continue to be in
compliance with all potentially applicable anti-corruption/anti-bribery laws,
including but not limited to the U.S. Foreign Corrupt Practices Act of 1977, the
U.K.’s Bribery Act 2010, and any anti-corruption/anti-bribery laws in the
jurisdictions where it operates. SEL and FOUNATIN represents, warrants and
agrees that no bribes, payments, kickbacks, gifts, hospitality, donations,
loans, or anything of value have been or will be made or received, offered,
promised, or authorized, directly or indirectly, to improperly influence any act
or decision of any person or entity, induce any person or entity to do or omit
to do any act in violation of any person’s or entities’ lawful duties, or secure
any improper advantage. The failure of SEL or FOUNTAIN to strictly comply with
this Section 9.3 shall constitute a Material Breach and will result in NABRIVA
having the right to terminate this Agreement pursuant to Section 16.2.

 

9.3                               Warranty Disclaimer. EXCEPT AS EXPRESSLY
STATED IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS ANY WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.

 

X.                                    QUALITY CONTROL, RECORDS AND INSPECTIONS

 

10.1                        Samples.  SEL will maintain samples of Key
Intermediate as required by applicable regulatory standards or as otherwise
mutually agreed by NABRIVA and SEL. SEL will be responsible for maintaining
retention samples of the Key Intermediate as may be required by applicable
regulatory standards.

 

10.2                        Validation.  SEL will validate all process, methods,
equipment, utilities, facilities and computers used in the formulation, storage,
testing and release of Key Intermediate in conformity with all applicable laws
and regulations. NABRIVA will have the right to review the results of said
validation upon request.

 

10.3                        Quality Compliance.  SEL will provide NABRIVA with
timely notification of all significant deviations, notes to file, and other
deficiencies that may reasonably be expected to impact the quality of the Key
Intermediate, as well as all FDA or other applicable regulatory authority
reports regarding testing, manufacture, bulk packaging or labeling of the Key
Intermediate.

 

10.4                        Manufacturing Records.  SEL will maintain complete
and accurate records relating to the Key Intermediate and the manufacture, bulk
packaging, labeling and testing thereof for the period required by applicable
regulatory standards, and SEL shall provide copies thereof (but excluding
records that disclose confidential aspects of the fermentation process used by
SEL) to NABRIVA upon NABRIVA’s request. The records (excluding records that
disclose confidential aspects of the fermentation process used by SEL) shall be
subject to audit and inspection under this Section X.

 

10.5                        Batch Records. Records which include the information
relating to the manufacturing, bulk packaging and quality operation for each lot
of Key Intermediate will be prepared by SEL at the time such operations occur.
SEL will prepare such records in accordance with cGMP’s, the Specifications and
the Quality Technical Agreement.

 

10.6                        Records Retention.  SEL will retain records and
documents relating to the manufacture and supply of Key Intermediate for periods
meeting all applicable regulations of the FDA, or other applicable regulatory
authority.

 

10.7                        Regulatory Inspections. SEL will promptly inform
NABRIVA of any contact, inspection or audit by any governmental agency related
to or affecting the Key Intermediate. SEL will promptly provide NABRIVA with
copies of any government-issued inspection observation reports (including
without limitation FDA Form 483s and equivalent forms from other regulatory
bodies) and agency correspondence that may reasonably be expected to adversely
affect the Key Intermediate or SEL’s ability to supply Key Intermediate
hereunder. SEL and NABRIVA will cooperate in resolving

 

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any concerns with any governmental agency. SEL will also inform NABRIVA of any
action taken by any governmental agency against SEL or any of its officers and
employees which may reasonably be expected to adversely affect the Key
Intermediate or SEL’s ability to supply Key Intermediate hereunder within 24
hours after the action is taken.

 

10.8                        NABRIVA Inspections. NABRIVA employees or NABRIVA
authorized representatives will have the right during normal business hours, at
reasonable intervals and upon giving SEL at least [**] working days advance 
notice, to conduct [**], at NABRIVA’s sole expense, of SEL’s facilities used in
the manufacturing, bulk packaging, storage, testing, shipping or receiving of
Key Intermediate for the purpose of verifying the compliance of the Key
Intermediate manufacture with the requirements provided for in this Agreement
and with cGMP, provided however that, if circumstances arise that in NABRIVA’s
reasonable judgement require that its representatives inspect SEL’s
manufacturing facilities more than [**], the Parties shall discuss such
circumstances and agree in good faith upon additional inspections and
appropriate means for addressing such circumstances. All such employees and
representatives shall be bound by the same confidentiality obligations as
contained herein and shall abide at all times with SEL’s rules and regulations
applicable to site visits, including without limitation safety rules and
regulations. Such inspections may include GMP inspections and system audits.
Persons conducting such inspections will have access only to documents, records,
reports, data, procedures, facilities, regulatory submissions, and all other
information required to be maintained by applicable government regulations
relating to the Key Intermediate. SEL shall take appropriate actions to adopt
reasonable suggestions of NABRIVA to correct any deficiencies identified by such
inspection or audit. In addition, NABRIVA shall have the right to observe from
time to time the manufacture, bulk packaging and quality control testing of Key
Intermediate by SEL. No testing of the Key Intermediate by NABRIVA and no
inspection or audit by NABRIVA of the SEL production facility under this
Agreement shall operate as a waiver of or otherwise diminish SEL’s
responsibility with respect to Key Intermediate quality under this Agreement.
The duration of an inspection or audit will be limited to no more than [**] days
(inspections or audits that last over [**] days will be charged to NABRIVA at
SEL’s specified FTE (Full Time Equivalent) rates), being however understood that
in any case said inspections and audits may not interfere with SEL’s normal
operations.

 

XI.                               COMPLAINTS, ADVERSE EVENTS AND RECALLS

 

11.1                        Key Intermediate Complaints and AEs. NABRIVA shall
maintain complaint files with respect to the pharmaceutical product containing
Key Intermediate in accordance with cGMPs. In the event that SEL should receive
any complaints and or AE notices with respect to the pharmaceutical product
containing Key Intermediate, SEL will promptly notify NABRIVA by facsimile
transmission within [**] working days of its receipt thereof. All such notices
shall be sent to the attention of the:

 

Director, Medical Affairs at NABRIVA

Facsimile number [**]

 

NABRIVA shall promptly provide SEL with copies of any complaints received by
NABRIVA relating to the pharmaceutical product containing Key Intermediate if
such complaints might relate to the manufacture or bulk packaging of the Key
Intermediate. SEL and NABRIVA shall promptly investigate  such complaints to
determine if the complaint is relate to the manufacture or bulk packaging of the
Key Intermediate and, if so, required corrective and preventive actions to be
implemented, if any. NABRIVA shall have the exclusive responsibility for
responding to all complaints, and for promptly providing SEL with a copy of any
responses to complaints relating to the pharmaceutical product containing the
Key Intermediate if such complaints relate to the manufacture of bulk packaging
of Key intermediate. NABRIVA or its affiliates shall have responsibility for
reporting all complaints relating to the pharmaceutical product containing Key
Intermediate to the FDA and any other regulatory authorities, including, but not
limited to, complaints relating to the manufacture or bulk packaging of the Key
Intermediate as well as adverse experience (AE) reports. NABRIVA will correspond
with complainants as to any complaints associated with pharmaceutical product
containing Key Intermediate, whether received during or after the term hereof.
SEL will assist NABRIVA in investigating complaints relating to the
pharmaceutical product containing Key Intermediate if such complaints relate to
the manufacture or bulk packaging of the Key Intermediate, by analyzing Key
Intermediate and manufacturing processes to determine the nature and cause of an
alleged Key Intermediate manufacturing defect or alleged Key Intermediate
failure. SEL will also reasonably assist NABRIVA, if so expressly required by
NABRIVA from time to time, in the investigation of any Adverse Experience (AE)
reported to either party when such AEs are reasonably believed to be
attributable to the manufacture or bulk packaging of the Key Intermediate. If
NABRIVA determines that any reasonable physical, chemical, biological or other
evaluation should be conducted in relation to an AE or complaint relating to the
manufacture or bulk packaging of the Key Intermediate, SEL will reasonably
conduct the evaluation and use its reasonable effort to provide NABRIVA with a
written report of such evaluation within [**] days from receipt of NABRIVA’s
written request for same, together with samples of the Key Intermediate from the
relevant lot. The obligations and responsibility in connection with the above
AEs and the management of the same shall pertain exclusively to NABRIVA.

 

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11.2                        Recall Action.  If NABRIVA should elect or be
required to initiate a recall of pharmaceutical product manufactured using Key
Intermediate supplied hereunder, or a withdrawal or field correction of such
pharmaceutical product, SEL will assist NABRIVA (and/or its Affiliate(s)) in
connection with such recall, withdrawal, or field correction, including, without
limitation, by conducting an investigation to determine the extent to which the
Key Intermediate contributed to the need for such recall, withdrawal, or field
correction. All regulatory authority contacts and coordination of any recall
activities will be initiated by, and will be the sole responsibility of,
NABRIVA.

 

11.3                        Recall Expenses.  If a recall or a withdrawal of any
pharmaceutical product containing Key Intermediate is necessary for any reason,
SEL and NABRIVA shall each bear the costs of the recall in proportion to each
Party’s responsibility, if any, for the error necessitating the recall or
withdrawal. Such recall costs include, but are not limited to, all reasonable
costs and expenses of NABRIVA associated with implementing any such recall or
withdrawal, including notification, packaging, shipping, distribution, and
destruction costs and required reimbursements to third parties, and all costs
and expenses associated with obtaining replacement product (including API).

 

11.4                        Recall Records. SEL will maintain complete and
accurate records for such periods as may be required by applicable law or
regulation.

 

XII.                          INSURANCE

 

12.1                        SEL does not have Public Liability, Products
Liability, or Professional Liability Insurance. For risk evaluation and
mitigation purposes, SEL agrees to allow Nabriva’s authorized insurance agents
to inspect non-confidential areas of SEL’s production facility (Pleuromutilin
purification, warehouse, solvent storage, fire protection, etc.) and to make
non-binding recommendations to reduce risks. In the absence of reasonable cause,
insurance inspections will be no more frequent than [**].

 

XIII.                     INVENTIONS

 

13.1                        NABRIVA shall own and retain all right, title, and
interest in and to any and all ideas, works, information, inventions,
improvements or the like (whether patentable or unpatentable), along with all
intellectual property rights, that has been or shall be developed by NABRIVA
prior to or in the course of performing its duties and obligations under this
Agreement.

 

13.2                        SEL shall own and retain all right, title, and
interest in and to any and all ideas, works, information, inventions,
improvements or the like (whether patentable or unpatentable), along with all
intellectual property rights, that has been or shall be developed by this SEL in
the course of performing its duties and obligations under this Agreement;
provided NABRIVA shall have a perpetual, non-exclusive, assignable, royalty free
license to use such ideas, works, information, inventions, improvements or the
like (whether patentable or unpatentable), and intellectual property rights in
connection with NABRIVA’s use of the Key Intermediate.

 

13.3                        NABRIVA and the SEL shall jointly own all right,
title, and interest in and to any and all ideas, works, information, inventions,
improvements or the like (whether patentable or unpatentable) that are developed
jointly by SEL and NABRIVA in the course of performing work for NABRIVA and that
relate to the Key Intermediate, along with all intellectual property rights,
with respect thereto (the “Product-Related Inventions”).  All Product-Related
Inventions automatically will be considered as Confidential Information under
the terms of Section IV.

 

XIV.                      INDEMNIFICATION

 

14.1                        By SEL and FOUNTAIN.  SEL and FOUNTAIN will
indemnify and hold NABRIVA, its Affiliates, directors, officers, employees,
agents, successors, and assigns harmless from any and all liability, damage,
loss, cost, or expense (including reasonable attorneys’ fees) (“Losses”), to the
extent arising out of or resulting from any third party claim, suit or action
(“Claim”) related to  any negligence or willful conduct by SEL or FOUNTAIN or
its Affiliates, or any breach by SEL or FOUNTAIN of any of its obligations,
representations and/or warranties hereunder, except to the extent such Losses or
Claims result from the matters contemplated in Section 14.2.

 

14.2                        By NABRIVA.  NABRIVA will indemnify and hold SEL,
their Affiliates, directors, officers, employees, agents, successors, and
assigns harmless from any and all Losses, to the extent arising out of or
resulting from any Claim related to (i) any pharmaceutical products manufactured
using the Key Intermediate, to the extent such products are sold by or on behalf
of NABRIVA or its Affiliates or  (ii) any negligence or willful misconduct by
NABRIVA or its Affiliates, or any breach by NABRIVA of any of its obligations,
representations and/or warranties hereunder in each case, except to the extent
such Losses or Claims result from the matters contemplated in Section 14.1.

 

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14.3                        By Each Party.  In the event that negligence or
willful misconduct of SEL and/or FOUNTAIN and NABRIVA contribute to any Loss,
SEL and/or FOUNTAIN and NABRIVA will each indemnify and hold harmless the other
with respect to that portion of the Loss attributable to its negligence or
willful misconduct.

 

14.4                        Procedures.  In the event that one Party receives
notice of a Claim for which it is entitled to indemnification by the other
Party, the Party receiving notice shall give prompt notification to the
indemnifying Party. The Party being indemnified shall cooperate fully with the
indemnifying Party throughout the pendency of the Claim, and the indemnifying
Party shall have complete control over the conduct and disposition of the Claim
including the retention of legal counsel engaged to handle such matter. The
indemnifying party hereunder will not be liable for any costs associated with
the settlement of any Claim brought against it or the other Party unless it has
received prior notice of the settlement negotiations and has agreed to the
settlement.

 

XV.                           LIMITATION OF LIABILITY

 

NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT SHALL SEL OR
NABRIVA BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS OR REVENUES,
ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREMENT. NOTWITHSTANDING THE
FOREGOING, NOTHING IN THIS SECTION XV IS INTENDED TO OR SHALL LIMIT OR RESTRICT
THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO ANY
THIRD PARTY CLAIMS UNDER SECTION 14.1 OR 14.2 OR THE DAMAGES AVAILABLE FOR
BREACH OF THE CONFIDENTIALITY OBLIGATIONS IN SECTION IV.

 

XVI.                      TERMINATION

 

16.1                        This Agreement shall become effective and remain in
effect for a period of five (5) years from the Effective Date (the “Initial
Term”) and, unless either of the Party gives written notice of non-renewal at
least two (2) years prior to the end of the Initial Term (or any renewal term),
this Agreement shall be renewed for consecutive terms of three (3) years.

 

16.2                        Breach.  If either Party hereto commits a Material
Breach hereunder, the other Party may, at its option, terminate this Agreement
by giving the breaching Party at least [**] days prior written notice of its
intent to terminate this Agreement, which notice shall specify the breach and
the termination date, unless the breaching Party cures said breach prior to the
specified termination date.

 

16.3                        Insolvency.  Either Party may terminate this
Agreement immediately in its entirety if the other Party files a petition of
bankruptcy, is adjudged bankrupt, takes advantage of any insolvency act, or
executes a bill of sale, deed of trust, or assignment for the benefit of
creditors.

 

16.4                        Survival.  The rights and obligations contained in
Sections covering representations and warranties, indemnification and
confidentiality will survive termination of this Agreement, as will any rights
to payment or other rights or obligations that have accrued under this Agreement
prior to termination. Termination will not affect the liability of either party
by reason of any act, default, or occurrence prior to said termination.

 

16.5                        Transfer.  If either Party terminates this
Agreement, SEL will upon request and for a period of no more than [**] months,
and at NABRIVA’s expense, provide reasonable assistance in transferring
manufacturing of Key Intermediate to a facility owned by NABRIVA or a third
party selected by NABRIVA.

 

16.6                        Upon termination or expiration of this Agreement,
NABRIVA shall pay all balances due and SEL shall return to NABRIVA or NABRIVA’s
nominee any and all materials in its stock and belonging to NABRIVA and shall
deliver to NABRIVA, against payment of the applicable price, any remaining Key
Intermediate.

 

XVII.                 GOVERNING LAW AND ALTERNATIVE DISPUTE RESOLUTION

 

17.1                        This Agreement shall be governed by and construed in
accordance with the law of Singapore.

 

17.2                        The Parties understand and appreciate that their
long term mutual interest will be best served by effecting a rapid and fair
resolution of any claims or disputes which may arise out of services performed
under this Agreement or from any

 

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dispute concerning Agreement terms. Therefore, both Parties agree to use their
best efforts to resolve all such disputes as rapidly as practicable on a fair
and equitable basis. Toward this end the Parties agree to develop and follow a
process for presenting, rapidly assessing, and settling claims on a fair and
equitable basis.

 

17.3                        If the matter has not been resolved utilizing the
process set forth in Section 17.2, any dispute shall be submitted to binding
arbitration for final decision.

 

17.4                       It is expressly agreed that arbitration shall be held
in English language in Singapore in accordance with the Rules of Arbitration of
the International Chamber of Commerce.

 

XVIII.            MISCELLANEOUS

 

18.1                        Headings.  The headings and captions used herein are
for the convenience of the Parties only and are not to be construed to define,
limit or affect the construction or interpretation hereof.

 

18.2                        Severability. In the event that any provision of
this Agreement is found to be invalid or unenforceable, then the offending
provision shall not render any other provision of this Agreement invalid or
unenforceable, and all other provisions shall remain in full force and effect
and shall be enforceable, unless the provisions which have been found to be
invalid or unenforceable, to the fullest extent permitted by law. If any such
affected provision materially affects the commercial basis of this Agreement,
the Parties shall negotiate in good faith so as to amend the provisions of this
Agreement so as to preserve and afford to each Party the full extent of benefits
that this Agreement is intended to provide.

 

18.3                        Entire Agreement.  This Agreement, including all
those Schedules appended hereto, contains the entire agreement of the Parties
regarding the subject matter hereof and supersedes all prior agreements,
understandings or conditions (whether oral or written) regarding the same.
Further, this Agreement may not be changed, modified, amended or supplemented
except by a written instrument signed by the duly authorized representatives of
the Parties. Neither Party has relied on any representation except as may be
expressly set forth herein.

 

18.4                        Assignability.  This Agreement and the rights
hereunder may not be assigned or transferred by either Party without the prior
written consent of the other Party, provided however, that either Party may
assign this Agreement to an Affiliate, and provided further that in the event of
a merger, acquisition or sale of all or substantially all of the assets of a
Party, the rights and obligations of such Party under this Agreement may be
assigned to the survivor of such Party in that transaction, provided that the
survivor agrees to be bound by the terms and conditions of the Agreement. This
Agreement shall be binding upon and inure to the benefit of each Party’s
successors and permitted assigns.

 

18.5                        Further Assurances.  Each Party hereto agrees to
execute, acknowledge and deliver such further instruments, and to take such
other actions, as may be necessary or appropriate to carry out the purposes and
intent of this Agreement.

 

18.6                        Waiver.  The waiver by either Party of a breach of
any provisions contained herein shall be effective only if made in writing and
shall in no way be construed as a waiver of any succeeding breach of such
provision or the waiver of the provision itself.

 

18.7                        Force Majeure.  A Party shall not be liable for
nonperformance or delay in performance (other than of obligations regarding
confidentiality) caused by any event reasonably beyond the control of such party
including, without limitation, wars, hostilities, revolutions, riots, civil
disturbances, national emergencies, strikes, lockouts, unavailability of
supplies, epidemics, fires, floods, earthquakes, other forces of nature,
explosions, embargoes, or any other Acts of God, or any laws, proclamations,
regulations, ordinances, or other acts or orders of any court, government or
governmental agency. Any occurrence of Force Majeure shall be reported promptly
to the other party. A Party whose performance has been excused will perform such
obligation as soon as is reasonably practicable after the termination or
cessation of such event or circumstance. The other Party has no right to demand
indemnity for damage, provided however that, in the event that Force Majeure
preventing performance shall continue for more than six (6) months, either Party
may terminate this Agreement with a written notice to the other without any
liability hereunder, except the obligation to make payments due to such date.

 

18.8                        Remedies.  Each party agrees and acknowledges that
its disclosure of Confidential Information in breach of this Agreement may cause
irreparable harm to other party, and therefore that any such breach or
threatened breach may entitle such Party to seek injunctive relief, in addition
to any other legal remedies available in a court of competent jurisdiction.

 

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18.9                        Good Faith. The Parties agree to perform this
Agreement in a spirit of good faith and fair dealing, and each will seek to
avoid intentionally doing anything that would deprive the other of the full
benefits contemplated hereunder. Neither Party will use any affiliate or third
party as a means of avoiding its responsibilities under this Agreement. The
Parties agree to communicate openly and in a spirit of co-operation to ensure
that all services are rendered in accordance with the highest degree of
professional competence, cGMPs and any other applicable law, regulation or
regulatory requirement.

 

18.10                 Independent Contractors.  The Parties are independent
contractors under this Agreement. Nothing contained in this Agreement is to be
construed so as to constitute NABRIVA and SEL and FOUNTAIN as partners, agents
or employees of the other, including with respect to this Agreement. Neither
Party hereto shall have any express or implied right or authority to assume or
create any obligations on behalf of, or in the name of, the other party or to
bind the other Party to any contract, agreement or undertaking with any third
party unless expressly so authorized in writing by the other Party.

 

18.11                 Counterparts.  This Agreement shall be executed by the
duly authorized officers of the Parties. This Agreement may be executed in one
(1) or more counterparts, including by facsimile or other electronic
transmission, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

18.12                 Notices.  Except as otherwise expressly stated herein, all
notices, consents or approvals required by this Agreement shall be in writing
and sent by overnight courier service, certified or registered air mail, postage
prepaid, or by facsimile or email (confirmed by such certified or registered
mail) to the Parties at the following addresses or such other addresses as may
be designated in writing by the respective Parties. Notices shall be deemed
effective on the date of mailing.

 

If to NABRIVA:

 

Nabriva Therapeutics Ireland DAC

25-28 Northwall Quay

Dublin 1

Ireland

Attention: [**]

Email address: [**]

 

With copy to:

 

Nabriva Therapeutics AG

Leberstrasse 20

1110 Vienna

Austria

Attention: [**]

Email address: [**]

 

All FOUNTAIN invoices and/or charges in billing should be directed to the
Accounting Department at:

 

Nabriva Therapeutics Ireland DAC

c/o Nabriva Therapeutics AG

Leberstrasse 20

1110 Vienna

Austria

Attention: Accounts Payable

Email: [**]

 

If to SEL:

 

Zhejiang University Sunny Technology Co., Ltd.

Address: 9th Floor, Building A, Paradise Software Park

No.3 Xi dou men road, Hangzhou 310012, China

Attn.: [**]

 

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Facsimile[**]

Email: [**]

 

If to FOUNTAIN:

 

Fountain International Development Holding Limited

MNB2926 RM1007

10/F Ho King CTR 2-16

Fa yuen St Mongkok, Hong Kong.

Attention: Mrs. Lena Bu

Facsimile: [**]

Email: [**]

 

All NABRIVA purchase orders shall be sent to:

 

Fountain International Development Holding Limited

MNB2926 RM1007

10/F Ho King CTR 2-16

Fa yuen St Mongkok, Hong Kong.

Attention: Mrs. Lena Bu

Facsimile: [**]

Email: [**]

 

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IN WITNESS WHEREOF, the undersigned Parties have caused this Agreement to be
executed as of the date first above written.

 

 

NABRIVA THERAPEUTICS IRELAND DAC

 

 

 

 

 

By:

/s/ Colin Broom

 

 

Name: Colin Broom

 

 

Title: CEO

 

 

 

 

 

SEL BIOCHEM Xinjiang Co, LTD

 

 

 

 

 

By:

/s/ Grace Xu

 

 

Name: Grace Xu

 

 

Title:   Vice President

 

 

 

 

 

FOUNTAIN INTERNATIONAL DEVELOPMENT HOLDING LIMITED

 

 

 

 

 

By:

/s/ Lena Bu

 

 

Name: Lena Bu

 

 

Title: General manager

 

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Schedule A

 

Key Intermediate Specifications

 

The Parties have agreed upon all those applicable specifications for the Key
Intermediate (Pleuromutilin) as set forth hereunder. The Parties shall agree
upon any modifications to the specifications here below in writing.

 

·                  Include packaging specifications

 

·                  Include minimum shelf life

 

·                  Include analytical methods, product specifications, product
impurities, degradation products, and reference standards provided by Nabriva

 

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Schedule B

 

SEL undertakes to comply with the cGMP, where applicable, the Specifications,
relevant DMF in the country to which Key Intermediate shall be delivered, the
know-how and any other requirements agreed in writing between the Parties
applicable to the manufacture, storage (including raw materials) and delivery of
the Key Intermediate. The respective responsibilities of SEL and NABRIVA with
regard to applicable cGMP regulations shall be defined in detail in the Quality
Technical Agreement.

 

Form of Quality Technical Agreement

 

The Quality Technical Agreement will be revised, if necessary, within [**] days
from the execution date of this Agreement.

 

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Schedule C

 

SEL Reserve Capacity

 

The minimum annual capacity to be reserved by SEL for the Initial Term of this
Agreement is [**]/year.

 

[**] months before the expiry of the said Initial Term the Parties shall meet
and discuss to seek an agreement in good faith on the minimum annual capacity to
be reserved by SEL for the further term of this Agreement following the Initial
Term.

 

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Schedule D

 

Purchase Price

 

Nabriva’s forecast to SEL is:

 

2018     [**]

 

2019     [**]

 

2020     [**]

 

2021     [**]

 

2022     [**]

 

Pricing

 

2018-2022                                    [**]

 

If the above quantity is exceeded, the excess quantity will be at [**]. For
example:

 

2018-2022 for a cumulative order of [**], the excess [**] will be at [**]

 

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