[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.
Execution Copy

LICENSE AGREEMENT
between
MELINTA THERAPEUTICS, INC.
and
A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
dated as of September 29, 2018

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TABLE OF CONTENTS
Page
ARTICLE I - DEFINITIONS; INTERPRETATION    1
1.1Definitions    1
1.2Interpretation    14
ARTICLE II - LICENSE    15
2.1License Grant    15
2.2Sublicensees    15
2.3Limitations on Activities of Licensee    16
2.4No Implied Obligations; Retained Rights    17
2.5Registration    17
ARTICLE III - REGULATORY MATTERS    17
3.1Regulatory Approvals, Pricing Approvals, and Regulatory Activities    17
3.2Disclosure of Regulatory Data and Regulatory Materials    19
3.3Regulatory Approval Variations    20
3.4Pharmacovigilance    20
ARTICLE IV - PRODUCT SUPPLY AND MANUFACTURING    20
4.1Supply Agreement    20
4.2Technology Transfer    20
4.3Licensee Responsibilities    21
ARTICLE V - DEVELOPMENT AND MEDICAL AFFAIRS    21
5.1Responsibility for Development and Medical Affairs; Efforts    21
5.2Development and Medical Affairs Plans    22
5.3Development Plan Budget and Medical Affairs Plan Budget    23
5.4Amendments to Plans and Plan Budgets    23
5.5Collaborative Development and AST Activities    23
5.6Development Costs, Medical Affairs Expenses, and Collaboration Costs    25
5.7Rights to Regulatory Materials    26
5.8Reporting    27
ARTICLE VI - GOVERNANCE    27
6.1Joint Steering Committee    27
6.2Subcommittees    28
6.3Authority    29
6.4Meetings; Decision-Making    30
6.5Alliance Manager    31

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ARTICLE VII - FINANCIAL TERMS    31
7.1Upfront Payment    31
7.2Regulatory Milestones    31
7.3Launch Milestones    32
7.4Sales Milestones    33
7.5Royalties    34
7.6Late Payments    36
7.7Changes to Royalties    36
7.8Changes in Regulatory Scheme in Licensed Territory    36
7.9Payments    36
7.10Upstream Agreements    37
7.11Financial Records    37
7.12Audits    37
7.13Tax Matters    38
ARTICLE VIII - COMMERCIALIZATION    39
8.1Product Commercialization    39
8.2Commercialization Plan    40
8.3Educational Materials    41
8.4Trademarks    42
8.5Compliance with Laws    42
8.6Customer Support    44
8.7Product Information    44
8.8Records    44
8.9Additional Obligations    45
8.10Insurance    45
ARTICLE IX - INTELLECTUAL PROPERTY    46
9.1Intellectual Property Ownership    46
9.2Protection of Rights    46
9.3Prosecution and Maintenance    46
9.4Product Infringement Claims    47
9.5Personnel Obligations    48
ARTICLE X - REPRESENTATIONS AND WARRANTIES    49
10.1Representations and Warranties of Each Party    49
10.2Additional Company Representations and Warranties    49
10.3Warranty Disclaimer    50
10.4Limitation of Damages    50
ARTICLE XI - INDEMNIFICATION    50
11.1Indemnification by Licensee    50

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11.2Indemnification by Company    51
11.3Conditions and Limitations of Indemnification Obligation    51
ARTICLE XII - CONFIDENTIALITY    52
12.1Confidentiality; Exceptions    52
12.2Authorized Disclosure    52
12.3Disclosure of Agreement    53
ARTICLE XIII - TERM AND TERMINATION    53
13.1Term    53
13.2Termination by Company for Breach    53
13.3Termination by Licensee for Breach    54
13.4Termination of Countries within the Licensed Territory    54
13.5Insolvency Event; Bankruptcy Rights    54
13.6Effect of Termination    55
13.7Survival    56
ARTICLE XIV - DISPUTES    57
14.1Disputes    57
14.2Dispute Resolution    57
14.3Exclusions    58
ARTICLE XV - MISCELLANEOUS    59
15.1Force Majeure    59
15.2Performance by Affiliates    59
15.3Independent Contractors    59
15.4Notices    59
15.5Governing Law    60
15.6Entire Agreement    60
15.7Assignment    60
15.8Severability    61
15.9Headings    61
15.10Export Control    61
15.11Waiver    61
15.12Counterparts    61

Exhibit A −    Commercialization Activities
Schedule 1.1     Company Patents
Schedule 1.3     Upstream Agreements
Schedule 7.8(a)     Example of Payment Amount Adjustment
Schedule 8.2(d)     The Initial Commercial Forecasts for the Initial Products in
the EU

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Schedule 10.2(e)    Regulatory Commitments

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LICENSE AGREEMENT
This License Agreement (this “Agreement”) is entered into and effective as of
September 28, 2018 (the “Effective Date”), by and between Melinta Therapeutics,
Inc., a company organized and existing under the laws of the State of Delaware,
with its principal place of business located at 300 Tri-State International,
Suite 200, Lincolnshire, IL 60069, U.S.A. (“Company”), and A. Menarini Industrie
Farmaceutiche Riunite S.r.L, a company organized and existing under the laws of
Italy, with its principal place of business located at 3, Via Sette Santi, 50131
Florence, Italy (“Licensee”). Company and Licensee are each referred to herein
by name or as a “Party” or, collectively, as the “Parties.”
RECITALS
WHEREAS, Company is engaged in the Development and Commercialization of the
Products (each, as defined below);
WHEREAS, Licensee has the capability and resources to Develop and Commercialize
the Products in the Field in the Licensed Territory (each, as defined below);
WHEREAS, Company desires to grant Licensee, and Licensee desires to accept from
Company, an exclusive license under the Company IP (as defined below) to
Commercialize the Products in the Field in the Licensed Territory, all on the
terms and subject to the conditions stated herein;
WHEREAS, Company desires to grant Licensee, and Licensee desires to accept from
Company, a license under the Company IP to Develop and Manufacture (each, as
defined below) the Products in the Field in the Licensed Territory for the sole
purpose of Commercializing such Products in the Field in the Licensed Territory,
all on the terms and subject to the conditions stated herein; and
WHEREAS, following the execution of this Agreement, the Parties shall enter into
certain supply and quality agreements (collectively, the “Supply Agreements”) in
accordance with Article IV of this Agreement.
AGREEMENT
Now, therefore, in consideration of the foregoing, and for other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties agree as follows:

ARTICLE I - DEFINITIONS; INTERPRETATION

1

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1.1    Definitions. When used in this Agreement, capitalized terms will have the
meanings as defined below and throughout this Agreement.
“Accounting Standards” shall mean, with respect to Company, U.S. Generally
Accepted Accounting Principles, and, with respect to Licensee, Italian
Accounting Standards, in each case, consistently applied.
“Adjusted Royalty Threshold” shall have the meaning set forth in Section 7.5(b).
“Affiliate” shall mean, with respect to a Party, any other Person that controls,
is controlled by, or is under common control with that Party. For the purpose of
this definition, “control” shall mean, direct or indirect, ownership of fifty
percent (50%) or more of the shares of stock entitled to vote for the election
of directors, in the case of a corporation, or fifty percent (50%) or more of
the equity interest in the case of any other type of legal entity, status as a
general partner in any partnership, or any other arrangement whereby the entity
or Person controls or has the right to control the board of directors or
equivalent governing body of a corporation or other entity, or the ability to
cause the direction of the management or policies of a corporation or other
entity. In the case of entities organized under the laws of certain countries,
the maximum percentage ownership permitted by law for a foreign investor may be
less than fifty percent (50%), and in such case such lower percentage shall be
substituted in the preceding sentence, provided, that such foreign investor has
the power to direct the management and policies of such entity.
“Agreement” shall have the meaning set forth in the Preamble.
“Alliance Manager” shall have the meaning set forth in Section 6.5.
“Ancillary Agreements” shall mean the Supply Agreements, the PV Agreement and
any other agreements between the Parties contemplated hereunder.
“Anti-Corruption Laws” shall mean all applicable laws, regulations, orders,
judicial decisions, conventions and international financial institution rules
regarding corruption, bribery, ethical business conduct, money laundering,
political contributions, gifts and gratuities, or lawful expenses to public
officials, healthcare professionals, and private persons, agency relationships,
commissions, lobbying, books and records, and financial controls, including the
FCPA and the UK Bribery Act.
“Applicable Law” shall mean any and all applicable laws, rules, regulations,
directives, guidance and orders of any Governmental Authority, as well as
applicable industry codes, including (a) Directive 2001/83/EC of the European
Parliament and of the Council of 6 November 2001 on the Community code relating
to medicinal products for human use, and the relevant implementing laws in the
Licensed Territory, (b) U.S. Export Control Laws, (c) GDPR and the relevant
national laws of individual EU Member States, and (d) Anti-Corruption Laws and
Trade Control Laws.
“Asia-Pacific” shall mean Australia, China, Hong Kong, India, Indonesia,
Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand,
and Vietnam, as their boundaries are defined as of the Effective Date, and any
successors thereto.

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“AST Activities” shall mean antibiotic susceptibility tests.
“AST Costs” shall mean, with respect to a Product, the costs and expenses
incurred by or on behalf of a Party or its Affiliates, including FTE costs and
Out-of-Pocket Costs, attributable or reasonably allocable to any AST Activities
as set forth in the Collaboration Plan and Collaboration Budget, and in
accordance with the applicable Accounting Standards’ expense recognition
provisions, including the costs of internal personnel engaged in such AST
Activities, which costs shall be determined based on the FTE Rate and
represented in the FTE costs.
“Audit Team” shall have the meaning set forth in Section 7.12(a).
“Base Exchange Rate” shall have the meaning set forth in Section 7.8(a).
“Business Day” shall mean any day that is not a Saturday or Sunday, or other day
that is not a public holiday in Florence, Italy or a recognized federal holiday
in the U.S.
“Calendar Half” shall mean a period of six (6) consecutive months ending on the
last day of June and December, respectively; provided that the first Calendar
Half of the Term shall be the period from the Effective Date through December
31, 2018.
“Calendar Quarter” shall mean a period of three (3) consecutive months ending on
the last day of March, June, September or December, respectively; provided that
the first Calendar Quarter of the Term shall be the period from the Effective
Date through September 30, 2018.
“Calendar Year” shall mean a period of twelve (12) consecutive calendar months
ending on December 31st; provided that the first Calendar Year of the Term shall
be the period from the Effective Date through December 31, 2018.
“CIS” shall mean Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan,
Moldova, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan, as their
boundaries are defined as of the Effective Date, and any successors thereto.
“Claim” or “Claims” shall mean any charge, allegation, notice, civil, criminal
or administrative claim, demand, complaint, cause of action, Proceeding or
investigation.
“Collaboration Activities” shall have the meaning set forth in Section
5.5(a)(ii).
“Collaboration Budget” shall have the meaning set forth in Section 5.5(a)(ii).
“Collaboration Plan” shall have the meaning set forth in Section 5.5(a)(ii).
“Collaboration Proposal” shall have the meaning set forth in Section 5.5(a)(i).
“Commercial Forecast” shall have the meaning set forth in Section 8.2(d).
“Commercialization Costs” shall mean, with respect to a Product, all costs and
expenses incurred by or on behalf of Licensee or its Affiliates attributable or
reasonably allocable to the Commercialization of such Product in the Field in
the Licensed Territory. Commercialization Costs shall include: (a) costs of
internal personnel engaged in such efforts; (b) costs associated with the

3

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purchase or Manufacture and distribution of such Product (including samples);
(c) costs associated with any patient assistance programs; (d) costs associated
with any recall or withdrawal of such Product; and (e) costs associated with the
advertising and marketing of such Product, but excluding, in each case, any
Medical Affairs Expenses.
“Commercialization Plan” shall have the meaning set forth in Section 8.2(a).
“Commercialization Plan Budget” shall have the meaning set forth in Section
8.2(b).
“Commercialization Report” shall have the meaning set forth in Section 8.1(d).
“Commercialize”, “Commercialization” and “Commercializing” shall mean to import,
market, advertise, warehouse, distribute and sell, and Educate potential
prescribers about, any product, including responsibility for pricing and
reimbursement and interacting with any Regulatory Authority regarding the
foregoing.
“Commercially Reasonable Efforts” shall mean, with respect to activities devoted
to a Product, that level of efforts, expertise, and resources consistent with
the usual practice followed by a global commercial-stage biopharmaceutical
company relating to Development or Commercialization (as applicable) of any
other pharmaceutical product owned by it or to which it has exclusive or
co-exclusive rights, which is of similar market potential and at a similar stage
in development or product life.
“Company” shall have the meaning set forth in the Preamble.
“Company IP” shall mean the Company Know-How and the Company Patents.
“Company Know-How” shall mean all Know-How that is Controlled by Company or its
Affiliates as of the Effective Date or at any time during the Term, including
Know-How constituting New IP, and is necessary or useful for the Development,
Manufacture, and/or Commercialization of any Product in the Field in the
Licensed Territory in accordance with the terms of this Agreement.
“Company Marks” shall mean the trademark(s) and/or logo(s) of any Products
Controlled by Company and under which such Product is marked by or on behalf of
Company.
“Company Patents” shall mean all Patents granted or pending in a country or
jurisdiction within the Licensed Territory that are Controlled by Company or its
Affiliates as of the Effective Date or at any time during the Term, including
Company Patents constituting New IP, that have one or more Valid Claims that
Cover the Development, Manufacture or Commercialization of any Product. The list
of Company Patents as of the Effective Date is attached hereto as Schedule 1.1.
Such Schedule 1.1 shall be updated or corrected by Company from time to time
during the Term as necessary to make such list of Company Patents complete,
provided that a failure to update or correct such list shall not have any effect
on the scope of this definition.
“Competing Product” shall mean any pharmaceutical product containing (i)
carbapenem in association with a beta-lactamase inhibitor, (ii) a glycopeptide
or (ii) a tetracycline, in each case approved or being commercialized for an
indication for which the corresponding Product is approved

4

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or being Developed or Commercialized by Company or its Affiliates outside the
Licensed Territory. For clarity, “Competing Product” with respect to clause (i)
shall include any antibiotic product comprising both a beta lactamase inhibitor
and beta lactam compound for use in gram negative infections.
“Compound” shall mean: (a) with respect to any Vabomere Product, a combination
of meropenem and vaborbactam; (b) with respect to any Orbactiv Product,
oritavancin; and (c) with respect to any Minocin IV Product, minocycline
hydrochloride.
“Confidential Information” shall have the meaning set forth in Section 12.1.
“Control” shall mean, with respect to any Know-How, Patents or other
Intellectual Property rights, that the applicable Party or its Affiliates owns
or has a license under such Know-How, Patents or other Intellectual Property
rights and, in each case, has the legal right to assign, or grant a license,
sublicense or other applicable right to or under, such Know-How, Patents or
other Intellectual Property rights to the other Party as provided for herein
without violating the terms of any agreement or other arrangement with any Third
Party.
“COGS” shall mean, with respect to any Product, the fully burdened cost of all
resources and operations carried out by or on behalf of Company in order to
Manufacture such Product, packaged in bulk form, such cost to be established in
accordance with applicable Accounting Standards. For clarity, with respect to
any Product purchased by Licensee from Company pursuant to the applicable Supply
Agreement, “COGS” for such Product shall be established by Company prior to the
first shipment of such Product to Licensee, and thereafter, updated on at least
a Calendar Year basis, in accordance with the Supply Agreements.
“Costs” shall mean Development Costs or AST Costs, as applicable. “Costs
Estimate” shall have the meaning set forth in Section 5.6(b). “Costs Report”
shall have the meaning set forth in Section 5.6(b).
“Cover”, “Covering” or “Covered” shall mean, with respect to a Product, that,
but for a license granted to a Person under a Valid Claim of a Patent, the
Development, Manufacture, Commercialization or other exploitation of such
Product in the Field in the Licensed Territory by such Person would infringe
such Valid Claim.
“CTA” shall mean a clinical trial application or other application or approval
of any Regulatory Authority for authorization to commence or continue any
Development activities for a product in the applicable jurisdiction.
“Data Room” shall mean the electronic data room maintained at
https://bdr110008.bmcgroup.com/Default.aspx.
“Develop” or “Development” shall mean activities relating to the pre-clinical
and clinical drug development of a product or the updating or review of product
labeling, including test method development and stability testing, assay
development, toxicology, formulation, quality assurance/quality control
development, statistical analysis, pharmacokinetic studies, microbiology
studies,

5

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microbial surveillance studies, clinical trials (including research to design
clinical trials), whether pre- or post-Regulatory Approval, and any other
research and development activities with respect to a product.
“Development Costs” shall mean, with respect to a Product, the costs and
expenses incurred by or on behalf of a Party or its Affiliates, including FTE
costs and Out-of-Pocket Costs, attributable or reasonably allocable to the
Development of a Product, which costs and expenses are consistent with and set
forth in the Development Plan or Collaboration Plan, as applicable, and in
accordance with the applicable Accounting Standards’ expense recognition
provisions. Development Costs shall include: (a) the costs of internal personnel
engaged in such efforts, which costs shall be determined based on the FTE Rate
and represented in the FTE costs; (b) the preparation of medical writing and
publishing; (c) the costs associated with conducting clinical trials, including
(i) the preparation, collation and/or validation of data from such clinical
trials, (ii) the cost of contract research organizations, (iii) costs associated
with Manufacturing and distributing such Product (including clinical samples),
including, if applicable, recalling or withdrawing such Product, in each case,
to the extent used in clinical trials, (iv) expenses incurred to purchase and/or
package comparator and combination drugs, and (v) costs and expenses of disposal
of clinical samples; and (d) the costs associated with conducting any
post-Regulatory Approval clinical trials for such Product, including any Phase
IV Studies. For clarity, Out-of-Pocket Costs includes costs paid to Third
Parties for the acquisition of Third Party Intellectual Property.
“Development Plan” shall have the meaning set forth in Section 5.2(a).
“Development Plan Budget” shall have the meaning set forth in Section 5.3(a).
“Disclosing Party” shall have the meaning set forth in Section 12.1.
“Education” shall mean those activities normally undertaken by a pharmaceutical
company’s representatives and scientific liaisons to educate potential
prescribers regarding the use of a particular prescription or other
pharmaceutical product for indication(s) for which such product has received
Regulatory Approval, including detailing. When used as a verb, “Educate” shall
mean to engage in such activities.
“Educational Materials” shall mean those documents and other materials normally
used by a pharmaceutical company’s representatives and scientific liaisons for
Educational purposes,
“Effective Date” shall have the meaning set forth in the Preamble.
“EMA” shall mean the European Medicines Agency and any successor Governmental
Authority thereto (including any successor Governmental Authority thereto with
respect to any country formerly in the EU) having substantially the same
function.
“European Commission” or “EC” shall mean the executive of the EU that promotes
its general interest.

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“EU” shall mean the European Union, as their boundaries are defined as of the
Effective Date, and any successors thereto.
“Europe” shall mean Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Kosovo, Latvia,
Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Monaco, Montenegro, the
Netherlands, Norway, Poland, Portugal, Romania, San Marin Republic, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, and
Vatican City, as their boundaries are defined as of the Effective Date, and any
successors thereto.
“Expert” shall mean a person with no less than fifteen (15) years of
pharmaceutical industry experience and expertise relating to the field in which
the expertise is required (e.g. Manufacturing, Development, Commercialization
and/or licensing) but excluding any current or former employee or consultant of
either Party or such Party’s Affiliates or any Sublicensees.
“Expert Committee” shall mean a panel of three (3) Experts, one (1) Expert
selected by Company, one (1) Expert selected by Licensee, and one (1) Expert
selected jointly by the two (2) other Experts, such Expert to be chairman of
such panel of the three (3) Experts.
“Expert Resolution” shall have the meaning set forth in Section 14.2(b).
“Experts Meeting” shall have the meaning set forth in Section 14.2(b)(i).
“FCPA” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78dd-1, et
seq.) as amended.
“Field” shall mean any systemic use of a Product for the therapeutic treatment
of any bacterial infection, but excluding in all cases, any topical or
ophthalmic uses.
“Finance Officers” shall have the meaning set forth in Section 5.6(b).
“First Commercial Sale” shall mean, with respect to a Product, on a
country-by-country basis, the first sale of such Product to a Third Party by
Licensee or any of its Affiliates or Sublicensees in a country in the Licensed
Territory after receipt of Regulatory Approval for such Product in such country
in the Licensed Territory. Sales for test marketing, sampling and Educational
uses, clinical study purposes or compassionate or similar uses shall not be
considered a First Commercial Sale.
“Force Majeure Event” shall have the meaning set forth in Section 15.1.
“FTE” shall mean a full-time equivalent person based upon of a total of 1,760
hours per year of Development, Medical Affairs Activities or other relevant
activities under this Agreement with respect to a Product.
“FTE Rate” shall mean the rate per FTE (which may be prorated on a daily basis
as necessary) of [***] per annum with respect to activities conducted pursuant
to this Agreement, subject to annual adjustment on each anniversary of the
Effective Date by the change in the rate of the Employment Cost Index for total
compensation for the “management, professional and related”

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occupational group, as published by the U.S. Department of Labor, Bureau of
Labor Statistics (or any similar index agreed upon by the Parties if such index
ceases to be compiled and published).
“GDPR” means Regulation (EU) 2016/679 of the European Parliament and of the
Council of 27 April 2016 on the protection of natural persons with regard to the
processing of personal data and on the free movement of such data, and repealing
Directive 95/46/EC.
“Generic Product” means, with respect to a Product in a given country, another
product (either generic or branded) containing the applicable Compound in the
same form and dosage and approved for the same indication(s) as such Product,
which is lawfully being sold in such country and which may be sold in place of
such Product.
“Governing Law” shall have the meaning set forth in Section 15.5.
“Governmental Authority” shall mean any international, national, domestic,
foreign, regional, local or other governmental or regulatory authority of the
U.S., the EU, any member state of the EU or any other applicable country or
jurisdiction, including any or supra-national authority.
“Gross Ex-Factory Price” shall have the meaning set forth in Section 7.3.
“HAP/VAP Study” shall mean a clinical study evaluating the efficacy of a
Product, alone or in combination with other antibiotic products, to treat
hospital acquired pneumonia or ventilator associated pneumonia.
“I.C.C.” shall mean the International Chamber of Commerce.
“IMI” shall mean the Innovative Medicines Initiative.
“Improvement” shall mean, subject to Sections 5.5 and 5.6, (a) modifications to
the current processing techniques, formulation or uses of the Compound, (b)
modifications to the current manufacturing, processing techniques, formulation
or uses of the Product and (c) any new indication of the Product provided that
all items in (a), (b), (c) are made and available to Company and do not require
any specific Development Plan as provided for hereunder.
“Indemnified Party” shall have the meaning set forth in Section 11.3.
“Indemnifying Party” shall have the meaning set forth in Section 11.3.
“Initial Products” shall mean (a) the Orbactiv Product for which, as of the
Effective Date, the EC has approved an MAA to Commercialize such Product in the
Field in the EU (such approval, the “Orbactiv EU MA”); and (b) the Vabomere
Product for which, as of the Effective Date, Rempex London Ltd, an Affiliate of
Company, has filed an MAA to Commercialize such Product in the Field in the EU
(the approval of such MAA, if granted, the “Vabomere EU MA”).
“Intellectual Property” shall mean, collectively, all intellectual property
rights and similar proprietary rights, including trademarks, copyrights,
Know-How and Patents, whether registered or unregistered, and all applications
and registrations to register, and renewals and extensions of, any of the
foregoing.

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“Interested Person” shall have the meaning set forth in Section 8.5(g).
“JDC” shall have the meaning set forth in Section 6.2.
“JPC” shall have the meaning set forth in Section 6.2.
“JSC” shall have the meaning set forth in Section 6.1(a).
“Know-How” shall mean any and all ideas, techniques, information, know-how,
data, prototypes, research results, writings, inventions, discoveries, and other
technology (including any proprietary materials), whether or not patentable or
copyrightable.
“Licensed Territory” shall mean (a) Europe; (b) CIS; and (c) Asia-Pacific.
“Licensed Territory-Required Development Activities” shall have the meaning set
forth in Section 5.1(a).
“Licensee” shall have the meaning set forth in the Preamble.
“Licensee Marks” shall have the meaning set forth in Section 8.4.
“Licensee Medical Affairs Activities” shall have the meaning set forth in
Section 5.1(b).
“Loss of Market Exclusivity” shall mean, with respect to a Product, on a
country-bycountry basis, that the following has occurred: (a) a Third Party has
launched a Generic Product in such country, and (b) the Net Sales of such
Product in such country during any three (3) consecutive calendar months after
such launch are less than [***] of Net Sales of such Product in such country in
the three (3) complete consecutive calendar month period immediately prior to
such launch.
“Losses” shall have the meaning set forth in 11A .
“MAA” shall mean (a) a marketing authorization application submitted to a
Regulatory Authority, or any successor application or procedure, and (b) all
supplements and amendments that may be filed with respect to the foregoing.
“Major Countries” shall mean Australia, China, France, Germany, Italy, Russia,
South Korea, Spain, and the United Kingdom.
“Manufacture” or “Manufacturing” means any and all activities and operations
involved in or relating to the manufacturing, production, labeling or packaging
of a product, whether for pre-clinical, clinical or commercial purposes.
“Orbactiv EU MA” shall have the meaning set forth in the definition of Initial
Products.
“Measurement Date” shall have the meaning set forth in Section 7.8(a).
“Medical Affairs Activities” shall mean the activities related to the
dissemination of scientific information, coordination of medical information
requests and field based medical scientific liaisons with respect to a product,
including: (a) any associated activities of medical scientific liaisons and the
provision of medical information services with respect thereto; (b)

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advisory boards; (c) conduct of scientific meetings; (d) publications; and (e)
any health economics and research studies. For clarity, “Medical Affairs
Activities” excludes Development.
“Medical Affairs Expenses” shall mean, with respect to a Product, the costs and
expenses incurred by or on behalf of Licensee or its Affiliates, including FTE
costs and Out-of-Pocket Costs, attributable or reasonably allocable to any
Medical Affairs Activities, and in accordance with the applicable Accounting
Standards’ expense recognition provisions, including the costs of internal
personnel engaged in such Medical Affairs Activities, which costs shall be
determined based on the FTE Rate and represented in the FTE costs.
“Medical Affairs Plan” shall have the meaning set forth in Section 5.2(b).
“Medical Affairs Plan Budget” shall have the meaning set forth in Section
5.3(b).
“Minocin IV Product” shall mean any pharmaceutical product in finished
pharmaceutical form currently approved by the U.S. Food and Drug Administration
as Minocin for Injection.
“Net Sales” shall mean, with respect to a Product, the respective gross amounts
invoiced to a Third Party by Licensee, including its Affiliates, or Sublicensees
on account of respective sales of such Product by Licensee, such Affiliates or
Sublicensees, less the total of: [***].
“New IP” shall have the meaning set forth in Section 9.1.
“Orbactiv Product” shall mean any pharmaceutical product in finished
pharmaceutical form containing oritavancin as an active pharmaceutical
ingredient in any dosage, form, formulation, or mode of administration, whether
used alone or as a fixed dose or co-packaged combination.
“Orbactiv Reformulation Studies” shall mean any studies required in order to
develop a novel formulation of oritavancin with cyclodextrin in order to reduce
the Orbactiv Product’s infusion time and volume.
“Out-of-Pocket Costs” shall mean, with respect to certain activities hereunder,
direct expenses paid or payable by either Party or its Affiliates to Third
Parties (other than employees of such Party or its Affiliates) that are
specifically identifiable and incurred to conduct such activities for a Product,
and have been recorded in accordance with the Accounting Standards applicable to
such Party.
“Party” or “Parties” shall have the meaning set forth in the Preamble.
“Patents” shall mean any and all patents and patent applications, including any
continuations, continuations-in-part, divisions, provisionals or any substitute
applications claiming priority to such patents and patent applications, any
patent issued with respect to any such patent applications, any reissue,
re-examination, renewal or extension (including any supplemental patent
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing.

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“Pediatric Studies” shall mean any studies for the Vabomere Product or the
Orbactiv Product required by both the European Pediatric Investigational Plan
(PIP) and the U.S. Pediatric Study Plan (PSP).
“Person” shall mean, as applicable, any natural person or any corporation,
partnership, limited liability company, business association, joint venture or
other entity.
“Phase IV Study” shall mean a human clinical trial which is conducted with
respect to a product after Regulatory Approval of such product has been obtained
from an appropriate Regulatory Authority, and includes (a) trials conducted
voluntarily for enhancing marketing or scientific knowledge of an approved
indication or (b) trials conducted after Regulatory Approval due to request or
requirement of a Regulatory Authority or as a condition of a previously granted
Regulatory Approval.
“Post-Approval Development Activities” shall mean any additional Development
activities required by any applicable Regulatory Authority with respect to a
product to maintain any Regulatory Approval following the receipt of such
Regulatory Approval.
“Pricing Approval” shall mean such governmental approval, agreement,
determination or decision establishing prices for a Product in the Field that
can be charged or reimbursed in regulatory jurisdictions where the applicable
Governmental Authorities approve or determine the price or reimbursement of
pharmaceutical products. In countries of the Licensed Territory where, according
to local regulations, prices are formally determined before the application for
reimbursement, Pricing Approval shall be considered obtained when the effective
price for reimbursement is approved.
“Proceeding” shall mean any action, arbitration, hearing, litigation or suit
(whether civil, criminal, administrative, investigative or informal) by or
before, or otherwise involving, any Governmental Authority or arbitrator.
“Product” shall mean any Vabomere Product, Orbactiv Product and/or Minocin IV
Product.
“Public Official or Entity” shall mean (a) any officer, employee, agent,
representative, department, agency, de facto official, corporate entity,
instrumentality or subdivision of any government, military or international
organization, including any state-owned or affiliated company or hospital, or
(b) any candidate for political office, any political party or any official of a
political party.
“PV Agreement” shall have the meaning set forth in Section 3.4.
“Receiving Party” shall have the meaning set forth in Section 12.1.
“Reference Exchange Rate” shall have the meaning set forth in Section 7.8(a).
“Regulatory Approval” shall mean, collectively, approvals, establishment
licenses, registrations and authorizations (including marketing authorizations
but excluding Pricing Approvals) of any Regulatory Authority necessary for the
Commercialization of a product in any country or region.

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“Regulatory Authority” shall mean any applicable Governmental Authority
responsible for granting approvals for the Development, Manufacture or
Commercialization of a Product in the Licensed Territory.
“Regulatory Commitments” shall mean the commitments to Regulatory Authorities
with respect to the Development of the Products in the Licensed Territory as of
the Effective Date, as listed on Schedule 10.2.
“Regulatory Data” shall mean all regulatory information, materials, data and
results relating to a Product which are necessary for Regulatory Approvals and
Pricing Approvals for such Product, including but not limited to the e-CTD
dossiers submitted to and approved by applicable Regulatory Authorities,
in-vitro Product testing data and study data, data queries, data tables reports
and case report forms generated during any pre-clinical or clinical study or
registry study, for such Product.
“Regulatory Exclusivity” shall mean, with respect to a Product, on a
country-by-country or jurisdiction-by-jurisdiction basis, the ability to exclude
Third Parties from Commercializing such Product in such country or jurisdiction,
either through data exclusivity rights, orphan drug designation, or such other
rights conferred by a Regulatory Authority in such country or jurisdiction,
other than through Patents.
“Regulatory Materials” shall mean all regulatory applications, submissions,
notifications, communications, correspondence, registrations, Regulatory
Approvals, Pricing Approvals and/or other filings or approvals made to, received
from or otherwise conducted with a Regulatory Authority for the Development or
Commercialization of a Product in a particular country or jurisdiction,
including, any CTAs.
“Regulatory Plan” shall have the meaning set forth in Section 3.1(b).
“Restricted Party” shall have the meaning set forth in Section 8.5(c).
“Rules” shall have the meaning set forth in Section 14.2(a)(i).
“Senior Officers” shall mean, with respect to Company, its Chief Financial
Officer, and, with respect to Licensee, its Corporate Director Licensing and
Business Development.
“Significant Loss of Market Exclusivity” shall have the same meaning as Loss of
Market Exclusivity except that “[***]” shall be substituted for the reference to
“[***]” therein.
“Sublicensee” shall have the meaning set forth in Section 2.2.
“Successor Entity” shall have the meaning set forth in Section 13.6(d).
“Supply Agreements” shall have the meaning set forth in the Recitals.
“Term” shall have the meaning set forth in Section 13.1.

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“Terminated Country” shall mean any country in the Licensed Territory pursuant
to which this Agreement is terminated under Section 13.2, or Section 13.4. For
clarity, (a) a Terminated Country shall no longer be deemed within the Licensed
Territory; and (b) upon termination of this Agreement in its entirety, each
country within the Licensed Territory shall be deemed a Terminated Country,
“Terminated Product” shall mean with respect to any Product, all Vabomere
Products, Orbactiv Products, or Minocin IV Products, as applicable, pursuant to
which this Agreement is terminated under Section 13.2, Section 13.3, Section
13.4, or Section 15.1. For clarity, (a) a Terminated Product shall no longer be
deemed a Product; and (b) upon termination of this Agreement in its entirety,
each Product shall be deemed a Terminated Product.
“Third Party” shall mean any entity other than Company, Licensee or their
respective Affiliates.
“Third Party Claims” shall have the meaning set forth in Section 11.1.
“Trade Control Laws” shall mean all statutory and regulatory requirements
related to export controls, economic sanctions, trade embargoes, imports of
goods, and payment of custom duties.
“Transfer Price” shall mean, with respect to a Product, COGS for such Product,
calculated in accordance with Section 7.5(b).
“Trigger Price” shall have the meaning set forth in Section 7.3.
“Two Countries” shall have the meaning set forth in Section 7.6.
“UK Bribery Act” shall mean the UK Bribery Act 2010, as amended.
“Upstream Agreements” shall mean any and all agreements with Third Parties under
which any Company IP was acquired by or licensed to Company or its Affiliate
(and under which Company or any such Affiliate has any remaining obligations)
and which covers the Development, Manufacturing or Commercialization of a
Product in the Field and is licensed or sublicensed to Licensee hereunder. The
Upstream Agreements existing as of the Effective Date are set forth on Schedule
1.3. Company shall update such Schedule 1.3 upon any modification to the list of
Upstream Agreements existing as of the Effective Date.
“Upstream Party(ies)” shall mean any Third Party(ies) that are a party to any
Upstream Agreement.
“U.S.” shall mean the United States of America, including all possessions and
territories thereof.
“U.S. Export Control Laws” shall mean all applicable U.S. laws and regulations
relating to the export or re-export of commodities, technologies or services,
including the Export Administration Act of 1979, 24 U.S.C. §§ 2401-2420, the
International Emergency Economic

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Powers Act, 50 U.S.C. §§ 1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§
I et seq., the Arms Export Control Act, 22 U.S.C. §§ 2778-2779, the
International Boycott Provisions of Section 999 of the U.S. Internal Revenue
Code of 1986, the U.S. Department of Commerce’s Export Administration
Regulations, the U.S. Department of State’s International Traffic in Arms
Regulations, and the economic sanctions programs administered by the U.S.
Department of Treasury’s Office of Foreign Asset Controls.
“Vabomere EU MA” shall have the meaning set forth in the definition of Initial
Product.
“Vabomere Product” shall mean any pharmaceutical product in finished
pharmaceutical form containing a combination of meropenem and vaborbactam as
active pharmaceutical ingredients in any dosage, form, formulation, or mode of
administration, whether used alone or as a fixed dose or co-packaged
combination.
“Valid Claim” means, with respect to any country: (a) a claim of an issued and
unexpired Patent (as may be extended through supplementary protection
certificate or patent term extension or the like) to the extent such claim has
not been revoked, held invalid or unenforceable by a patent office, court or
other governmental agency of competent jurisdiction in a final and
non-appealable judgment (or judgment from which no appeal was taken within the
allowable time period) and which claim has not been disclaimed, denied or held
or admitted to be invalid or unenforceable through reissue, re-examination or
disclaimer or otherwise; and (b) a claim of a pending patent application.

1.2    Interpretation. Unless the context of this Agreement otherwise requires:
(a) words of any gender include each other gender; (b) words using the singular
or plural number also include the plural or singular number, respectively; (c)
the terms “hereof,” “herein,” “hereby,” and derivative or similar words refer to
this entire Agreement; (d) the terms “Section” or “Exhibit” refer to the
specified Section or Exhibit of this Agreement; (e) the term “including” means
“including without limitation”; (f) “days” refers to calendar days; (g) the
words “shall” and “will” have the same meaning; and (h) references to a
particular statute or regulation include all rules and regulations thereunder
and any predecessor or successor statute, rules or regulations, in each case as
amended or otherwise modified from time-to-time. All accounting terms used but
not otherwise defined herein shall have the meanings ascribed to such terms
under the applicable Accounting Standards as applied to a Party. All references
to “$” amounts hereunder shall be deemed to be U.S. Dollars, all references to
“€” shall be deemed to be Euro, and all payments due hereunder shall be made in
U.S. Dollars.

ARTICLE II -     LICENSE

2.1    License Grant. Subject to the terms and conditions set forth in this
Agreement, Company hereby grants Licensee, during the Term, (a) an exclusive
(even as to Company), nontransferable (except in accordance with Section 15.7)
license, with the right to sublicense (solely in accordance with Section 2.2),
under the Company IP, to Commercialize Products in the Field in the Licensed
Territory, and (b) a non-exclusive, non-transferable (except in accordance with
Section 15.7) license, with the right to sublicense (solely in accordance with
Section 2.2), under the Company IP to Develop and Manufacture Products in the
Field in the Licensed Territory for the sole purpose of Commercializing such
Products in the Field in the Licensed Territory. For clarity, no license is
granted to Develop, Manufacture and/or Commercialize any pharmaceutical
ingredient other than a Compound in any Product. In addition, it is understood
that (x) Licensee shall, with Company’s approval, not to be unreasonably
withheld, have the right to receive a technology transfer, by or on behalf of
Company, of Company Know-How to enable Licensee to Manufacture or have
Manufactured Products in a cGMP-compliant facility in the Licensed Territory
solely for Commercialization in the Field in the Licensed Territory in
accordance with the terms of this Agreement and the Supply Agreements; (y)
Licensee shall reimburse Company for any internal and external costs and
expenses incurred by Company in connection with such technology transfer in
accordance with Article IV and the Supply Agreements; and (z) until such
technology transfer with respect to a Product is complete, Licensee’s right to
Manufacture or have Manufactured such Product shall be limited to that set forth
in Article IV. Notwithstanding the foregoing, Company retains all rights and
licenses under the Company IP to perform its obligations under this Agreement
and the Ancillary Agreements, whether itself or through its Affiliates or other
Third Parties. For clarity, for purposes of this Section 2.1, references to
“Company IP” shall include Improvements and the license granted under this
Section 2.1 to Licensee is extended to Improvements.

2.2    Sublicensees. Licensee may not grant any sublicenses of the licenses
granted under Section 2.1 to any Person without the prior written consent of
Company (the recipient of any such sublicense, a “Sublicensee”), such consent
not to be unreasonably withheld or delayed; provided, that no such consent shall
be required in connection with the grant of a sublicense hereunder to an
Affiliate of Licensee. Any sublicense granted to a Sublicensee under this
Agreement shall be pursuant to a written agreement that subjects such
Sublicensee to all relevant restrictions and limitations set forth in this
Agreement, including the confidentiality provisions of Article XII, and permits
Licensee to disclose, on a strictly need to know basis, the material terms
thereof to Company and any Upstream Parties, subject to Article XII. Licensee
shall notify Company at least twenty (20) days in advance of granting any
sublicense to a Third Party Sublicensee and shall provide Company with a summary
of the material terms of the proposed sublicense agreement (along with any other
supporting documentation that Company may reasonably request) for Company’s
review and comment. Such notification shall include confirmation to Company in
writing that such sublicense agreement complies with the terms and conditions of
this Agreement. Licensee shall be jointly and severally responsible with its
Sublicensees to Company for failure by its Sublicensees to comply with this
Agreement.

2.3    Limitations on Activities of Licensee.
(a)    During the Term, Licensee shall not, and shall cause its Affiliates and
Sublicensees not to, either directly or indirectly, itself or in collaboration
with any Third Party, (i) Commercialize any Competing Product in the Licensed
Territory without Company’s prior written consent, other than Products in
accordance with this Agreement; or (ii) without prejudice to the application of
EU Applicable Laws in terms of free movement of goods, Develop, Manufacture, or
Commercialize any Product outside the Licensed Territory or outside the Field.
Solely with respect to the Commercialization of the Vabomere Product and
Orbactiv Product in the EU, the restrictions set forth in this Section 2.3 shall
be limited, on a country-by-country basis, to a period beginning on the
Effective Date and ending five (5) years from the first commercial sale of the
Vabomere Product and Orbactiv Product, respectively, in the relevant EU country.
(b)    Unless otherwise expressly authorized by Company in writing, Licensee
shall not, and shall cause its Affiliates and Sublicensees not to (i) seek
prospective purchasers for any Product outside of the Licensed Territory or the
Field, (ii) engage in any advertising or Educational activities relating to any
Product directed to prospective purchasers outside the Licensed Territory or the
Field, or (iii) solicit or accept orders for any Product from any prospective
purchaser for sale outside the Licensed Territory or the Field. if Licensee, any
Affiliate or Sublicensee receives any order from a prospective purchaser to
purchase any Product for sale outside the Licensed Territory or the Field,
Licensee shall not, and shall cause such Affiliate or Sublicensee not to, accept
that order and shall immediately refer such order to Company. Licensee shall
not, and shall cause its Affiliates and Sublicensees not to, deliver or tender
(or cause to be delivered or tendered) such Product to a prospective purchaser
for sale outside the Licensed Territory or use outside the Field. Without
prejudice to application of EU Applicable Laws in terms of free movement of
goods, Licensee shall not, and shall cause its Affiliates and Sublicensees to
not, sell any Product to a purchaser if it knows or has reason to believe that
such purchaser intends to resell or otherwise distribute or provide such Product
to a prospective purchaser outside the Licensed Territory or for use outside the
Field.
(c)    Licensee acknowledges and agrees that the restrictions set forth in this
Section 2.3 are considered by the Parties to be reasonable for the purposes of
protecting the goodwill and value of Company’s business with respect to the
Products. Licensee acknowledges that Company may be irreparably harmed and that
monetary damages may not provide an adequate remedy to Company in the event the
covenants contained in this Section 2.3 were not complied with in accordance
with their terms. Accordingly, Licensee agrees that any breach by it of any
provision of this Section 2.3 shall entitle Company to injunctive and other
equitable relief to secure the enforcement of these provisions, in addition to
any other remedies (including damages) which may be available to Company at law
or in equity as well as the right to terminate this Agreement pursuant to
Section 13.2.
(d)    It is the desire and intent of the Parties that the provisions of this
Section 2.3 be enforced to the fullest extent permissible under the Applicable
Law and public policies of each jurisdiction in which enforcement is sought. If
any provisions of this Section 2.3 relating to the time period, scope of
activities or geographic area of restrictions is declared by a court of
competent jurisdiction or arbitrator to exceed the maximum permissible time
period, scope of activities or geographic area, as the case may be, the time
period, scope of activities or geographic area shall be reduced to the maximum
which such court or arbitrator deems enforceable. If any provisions of this
Section 2.3 other than those described in the preceding sentence are adjudicated
to be invalid or unenforceable, the invalid or unenforceable provisions shall be
deemed amended in such manner as to render them enforceable and to effectuate as
nearly as possible the original intentions and agreement of the Parties.

2.4    No Implied Obligations; Retained Rights. Except as expressly set forth in
this Agreement, no right, title or interest with respect to any Product or any
Intellectual Property right of Company or its Affiliates is granted by Company
to Licensee hereunder. Company retains all rights and interests other than
expressly granted under this Agreement. For clarity, Company retains the right,
whether itself, or through its Affiliates or other Third Parties, to Develop or
Manufacture the Products in the Licensed Territory for the purpose of
Commercializing Products outside the Licensed Territory and within the Licensed
Territory for Development, Manufacturing, or Commercialization outside the
Field.

2.5    Registration. During the Term, and subject to the terms and conditions of
this Agreement, Licensee shall have the right, at its sole cost and expense, to
be registered as the exclusive licensee of those Company Patents owned by
Company with respect to the Products at all patents offices in the Licensed
Territory where such Company Patents are filed and where such registration is
permitted. Licensee shall be responsible for such registrations at its cost and,
to the extent necessary and reasonable, Company shall cooperate in connection
therewith. The Parties shall fairly and timely cooperate to perform such
registration as promptly as possible after the Effective Date. Such
registrations shall not disclose any terms of this Agreement other than the
relevant Company Patents, the fact that they are exclusively licensed to
Licensee under this Agreement and any other relevant information which may be
required by the patent offices in order to proceed with registration. Licensee
shall terminate or withdraw such registrations promptly following expiration or
termination of this Agreement, and if Licensee fails to terminate or withdraw
such registrations, Licensee hereby authorizes Company to do so on its behalf.

ARTICLE III -     REGULATORY MATTERS

3.1    Regulatory Approvals, Pricing Approvals, and Regulatory Activities.
(a)    General. Subject to the terms and conditions of this Agreement and except
as otherwise provided herein, as between Company and Licensee, Licensee, at its
sole cost and expense, shall be responsible for preparing, obtaining,
maintaining and renewing all Regulatory Approvals and Pricing Approvals that are
necessary for the Commercialization of each Product in the Field in each country
or jurisdiction of the Licensed Territory, including complying with all
requirements imposed on the holder of such Regulatory Approvals by such
Regulatory Authority to maintain such Regulatory Approvals, including the
Regulatory Commitments; provided, that Licensee shall only be responsible for
preparing, obtaining, maintaining and renewing the Vabomere EU MA and Orbactiv
EU MA following their transfer to Licensee, respectively, as contemplated by
Section 3.1(c). Licensee shall not take, and shall cause its Affiliates and
Sublicensees not to take any steps that would reasonably be expected to
undermine the validity of any such Regulatory Approvals. Without limiting the
foregoing, Licensee shall not withdraw, vary or transfer to a Third Party any
Regulatory Approvals or Pricing Approvals for a Product in the Field in the
Licensed Territory without Company’s prior written consent, not to be
unreasonably withheld or delayed.
(b)    Regulatory Plan. Licensee shall prepare and update at least once per
Calendar Year, on a Product-by-Product basis, a plan for the regulatory strategy
for obtaining, maintaining and renewing all Regulatory Approvals in the Field in
the Licensed Territory for such Product (as amended from time to time, the
“Regulatory Plan”), subject to the review and approval of the JSC.
(c)    Ownership and Transfer of Regulatory Approvals and Pricing Approvals.
Subject to this Section 3.1(c) and Section 13.6(d), all Regulatory Approvals and
Pricing Approvals for a Product in the Field in the Licensed Territory shall be
in the name of and owned by Licensee, its Affiliates or Sublicensees. At
Licensee’s sole cost and expense, the Parties will cooperate, to transfer from
the MAA holder to Licensee or its Affiliate (i) the Orbactiv EU MA and any
existing Orbactiv Product Pricing Approvals together with any related documents
as soon as practicable following the Effective Date, and (ii) the Vabomere EU MA
together with any related documents as soon as practicable following the MAA
holder’s receipt of notice of grant of such Vabomere EU MA from the EC (the date
of such receipt, the “Vabomere EU Approval Date”), In furtherance thereof,
Company shall cause the MAA holder to submit to EMA the applications for the
transfers of such MAs as soon as practicable but in any event within sixty (60)
days of the Effective Date or the Vabomere EU Approval Date, as applicable.
Prior to such transfer, subject to Sections 3.1(d) and 3.1(e), Company and
Licensee shall cooperate in preparing the responses and additional documentation
in response to any related questions posed by EMA concerning each such transfer,
or other matter pertaining to the Orbactiv EU MA or Vabomere EU MA. Licensee
will promptly reimburse Company for all of its reasonable external costs and
expenses incurred in connection with each such transfers, except for those costs
and expenses related to finding of documents which must be in possession of the
MAA holder under the Applicable Law at the Effective Date. Company shall
cooperate at no cost with Licensee in the eCTD publishing operations during the
evaluation phase by EMA of the relevant MA transfer.
(d)    Regulatory Submissions. Licensee shall provide Company for review and
comment copies in English of all Regulatory Materials to be submitted (other
than routine correspondence, administrative documents and excluding documents
related to Pricing Approval) by or on behalf of Licensee prior to the relevant
submission in order to allow sufficient time for Company review and, whenever
possible, at least thirty (30) days in advance of their intended date of
submission to a Regulatory Authority in the Licensed Territory. Company shall
provide any comments in the due course in order not to delay Licensee activities
under the Regulatory Plan. Licensee shall incorporate all reasonable comments
thereto provided by Company, and shall remove any of Company’s Confidential
Information that Company identifies as commercially sensitive. If such removal
prejudices the attainment or maintenance of the Regulatory Approval, the Parties
shall discuss in good faith and agree on a solution which, notwithstanding such
removal, allows Licensee to attain or maintain the relevant Regulatory Approval.
Licensee shall promptly notify Company of any Regulatory Materials (other than
routine correspondence, administrative documents and excluding documents related
to Pricing Approval) submitted by or on behalf of Licensee to or received from
any Regulatory Authority in the Licensed Territory and shall provide Company as
soon as reasonably practicable: (1) with copies in English of such Regulatory
Materials received by any Regulatory Authority; and, upon request, (ii) with
Licensee’s statements that the Regulatory Material submitted to any Regulatory
Authority was fully in conformity with the final version of Regulatory Material
as agreed with Company under this Section 3.1(d).
(e)    Regulatory Meetings. Licensee shall provide Company with reasonable
advance notice of all meetings, conferences and discussions (whether in person
or by telephone or video conference) scheduled with any Regulatory Authority in
the Licensed Territory concerning the Products, and shall consider in good faith
in the preparation of such meetings, conferences or discussion any input timely
provided by Company. To the extent not prohibited by Applicable Law, Company
shall have the right to participate in any such meetings, conferences or
discussions (at Company’s sole cost and expense) and Licensee shall facilitate
such participation. If Company elects not to participate in such meetings,
conferences or discussions, Licensee shall provide Company with written
summaries of such meetings, conferences or discussions in English as soon as
practicable after the conclusion thereof.
(f)    Diligence. Licensee shall use Commercially Reasonable Efforts to: (i)
prepare, obtain, maintain, and renew all necessary Regulatory Approvals for the
Commercialization of the Products in the Field in the Licensed Territory,
including using Commercially Reasonable Efforts to prepare, obtain, maintain,
and renew all necessary Regulatory Approvals for (A) the Vabomere Product in the
Field in each of the Major Countries and (B) subject to Section 5.2(a), the
Minocin IV Product in the Field in the EU; and (ii) perform all activities under
each Regulatory Plan. In connection therewith, Licensee shall use Regulatory
Data and/or the Regulatory Materials provided by Company to Licensee, which use
shall be in compliance with all Applicable Laws, including laws governing
protection of personal data in the Licensed Territory. If additional quality,
pre-clinical or clinical data is required by Applicable Law to obtain Regulatory
Approvals in the Licensed Territory for such Product, subject to Section 5.1 and
Article VI, Licensee, at its sole cost and expense, shall be responsible for
conducting such necessary additional quality, pre-clinical or clinical
Development; provided however, that the foregoing shall not limit Licensee’s
diligence or other obligations under this Agreement.
(g)    Pricing. In addition, Licensee shall use Commercially Reasonable Efforts
to prepare, obtain, and maintain all necessary Pricing Approvals for each
Product for which Regulatory Approval has been obtained in the Licensed
Territory. In connection therewith, Licensee shall use Regulatory Data and/or
the Regulatory Materials provided by Company to Licensee, which use shall be in
compliance with all Applicable Laws, including laws governing protection of
personal data in the Licensed Territory. Licensee shall have final
decision-making authority to determine and establish the price and terms of sale
{including any rebates or discounts) for each Product in the Field for each
country in the Licensed Territory; provided that (A) all such pricing decisions
(including rebates or discounts) shall be made in a manner (i) intended to
optimize the economic value of such Product in the Licensed Territory; (ii)
consistent with the Commercialization Plan; and (iii) in conformance with
Applicable Law; and (B) Licensee shall not withdraw any Pricing Approvals for a
Product in the Licensed Territory without Company’s prior written consent.

3.2    Disclosure of Regulatory Data and Regulatory Materials. Company has
disclosed in the Data Room (and shall complete the disclosure within thirty (30)
days from Licensee’s request), the Regulatory Data and Regulatory Materials
(including but not limited to any available e-CTD dossier and all material
related working documents) that are (a) approved by or submitted to the relevant
Regulatory Authority or in Company’s possession and Control as of the Effective
Date and (b) are reasonably necessary or useful for Licensee to use, to obtain
and maintain Regulatory Approvals and Pricing Approvals for a Product in the
Field in the Licensed Territory in accordance with this Agreement.

3.3    Regulatory Approval Variations. Company will provide to Licensee each
calendar quarter, a twelve (12)-month plan for any foreseen variation to be
applied to the Regulatory Approval, including the Manufacturing process/sites
involved in the Manufacturing of a Product. Licensee will have the right to
discuss with the Company timelines and applicability of such changes to the
Licensed Territory. Company will be responsible for providing to Licensee all
supporting documents reasonably requested by Licensee for purposes of preparing
and submitting the relevant variation to applicable Regulatory Authorities for
approval in the Licensed Territory. Upon reasonable request, Licensee shall
provide Company with an estimated timeline for the approval of such variation in
the Licensed Territory. In no event will Licensee be required to implement any
variation not applicable to the Licensed Territory. In case Licensee submits or
plans to submit a variation to a Regulatory Authority, Company shall be entitled
to implement such variation on the applicable Product destined for the Licensed
Territory only after relevant approval by such Regulatory Authority is received
or after Licensee’s written confirmation about the possibility to proceed before
submission to such Regulatory Authority (under the so-called DO and TELL
procedure).

3.4    Pharmacovigilance. The Parties shall negotiate in good faith and enter
into one or more pharmacovigilance agreement(s) in compliance with Applicable
Law (a) within ninety (90) days of the Effective Date with respect to the
Initial Products, and (b) with respect to any other Product, prior to submission
of the first MAA for such Product in the Field in the Licensed Territory (the
“PV Agreement(s)”), which PV Agreements shall include provisions addressing the
roles, responsibilities and activities of the Parties.

ARTICLE IV -     PRODUCT SUPPLY AND MANUFACTURING

4.1    Supply Agreement
The Parties shall, as soon as reasonably practicable following the execution of
this Agreement, negotiate in good faith and enter into the Supply Agreements.
The Supply Agreements shall include reasonable and customary terms and
conditions addressing the supply of Products by or on behalf of Company to
Licensee in its bulk and primary packaged but unreleased form, including
providing for a purchase price for each Product equal to COGS for such Product,
as in effect from time to time; provided, however that Licensee will reimburse
Company for any VAT, customs, or other taxes or duties that become payable as a
result of Licensee’s purchase of such Products from Company for sale in a
country in the Licensed Territory where such taxes or duties would be due and
payable.

4.2    Technology Transfer
For the avoidance of doubt, the details of the technology transfer referenced in
Section 2.1 shall be set forth in such Supply Agreements and be consistent with
industry-standard terms and conditions for such technology transfer, including
(a) requiring Licensee to provide at least twelve (12) months prior written
request for any such technology transfer; and (b) a budget, on a FTE basis,
setting forth the estimated amount for which Licensee will reimburse Company for
its internal and external costs and expenses in connection with implementing any
such technology transfer. Company will use commercially reasonable efforts
(which, however, will not require Company to make any payments or incur any
liabilities or obligations) to cause such transfer from the appropriate Third
Party. Furthermore, in the event of a technology transfer, subject to the
applicable Supply Agreement, such Supply Agreement shall continue in accordance
with its terms until Licensee is capable of Manufacturing or having Manufactured
the applicable Product for all the countries in the Licensed Territory.

4.3    Licensee Responsibilities
Notwithstanding any other provision of this Agreement, Licensee, at its sole
cost and expense, shall be responsible for labeling, packaging (other than
primary packaging), releasing and distributing the Products in the Field in the
Licensed Territory in compliance with all Applicable Laws related thereto,
including all quality related obligations and any incremental Manufacturing
validations required by local Government Authorities in the Licensed Territory.
For production planning purposes, at the first JDC meeting following the
Effective Date, Licensee will provide a preliminary non-binding production
forecast for the Initial Products.

ARTICLE V -     DEVELOPMENT AND MEDICAL AFFAIRS

5.1    Responsibility for Development and Medical Affairs; Efforts.
(a)    Development. Licensee, Licensee, at its sole cost and expense, shall be
responsible for all Development activities directed to obtaining and maintaining
Regulatory Approvals and Pricing Approvals for each Product in the Field solely
in the Licensed Territory, including any Post-Approval Development Activities,
provided, that, for the avoidance of doubt, without the prior written consent of
Company, Licensee may not conduct any clinical studies of any Product or any
other Development activities with respect to any Product other than those
Development activities expressly required by applicable Regulatory
Authority(ies) as a condition of granting Regulatory Approvals in the Licensed
Territory for such Product in the Field, including Post-Approval Development
Activities (collectively, “Licensed Territory-Required Development Activities”),
provided, that (i) such Licensed Territory-Required Development Activities shall
be subject to JDC review and approval in accordance with Section 5.2 and Article
VI and (ii) Licensee shall only be responsible for Development activities with
respect to the Vabomere EU MA and Orbactiv EU MA following their transfer to
Licensee, respectively, as contemplated by Section 3.1(c). Company shall
reasonably assist and cooperate with Licensee also by delivering to Licensee any
necessary document to allow Licensee to perform the above with respect to those
Development Activities which are under Company’s control as provided hereunder.
(b)    Medical Affairs. Licensee shall be responsible for all Medical Affairs
Activities to be conducted with respect to each Product in the Field solely in
the Licensed Territory (“Licensee Medical Affairs Activities”) in accordance
with the Medical Affairs Plan.
(c)    Third Party Activities. Licensee shall not, and shall cause its
Affiliates and Sublicensees not to, permit any Third Parties on its behalf to,
initiate, sponsor, participate in or conduct, directly or indirectly, any
Development activity for a Product other than Licensed Territory-Required
Development Activities, including the evaluation of such Product for use in
additional fields or applications or outside the Licensed Territory or outside
the Field, and Licensee shall not, and shall cause its Affiliates and
Sublicensees not to, sell or transfer such Product for any such purpose without
Company’s prior written approval. In the event that Licensee, its Affiliates or
Sublicensees becomes aware that a Third Party desires to purchase such Product
for such purpose, Licensee, such Affiliate or Sublicensee shall promptly notify
Company of such potential activities and shall not supply such Product without
Company’s prior written approval.
(d)    Diligence. Licensee shall use Commercially Reasonable Efforts to (i)
Develop the Products in the Field in the Licensed Territory, including to (A)
Develop a Vabomere Product in the Field in each of the Major Countries; and (B)
subject to Section 5.2(a), Develop a Minocin IV Product in the Field in the EU;
and (ii) perform all activities under each Development Plan and each Medical
Affairs Plan.

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5.2    Development and Medical Affairs Plans.
(a)    Development Plan. Licensee shall conduct the Development of each Product
in accordance with Section 5.1(a) pursuant to a Development plan, prepared by
Licensee in consultation with Company through the JDC (as amended from time to
time, the “Development Plan”), which shall include the following components: (i)
a high-level description of Licensee’s conduct of the Development of such
Product in the Field in each of the applicable countries within the Licensed
Territory, including the indications for which such Product is to be Developed;
and (ii) a description provided by Licensee of all Licensed Territory-Required
Development Activities for such Product. Licensee shall submit the initial
Development Plan and any amendments thereto to the JDC for review and approval
in accordance with Article VI. The initial Development Plan with respect to the
Development of the first Vabomere Product in Asia-Pacific shall be discussed
during the first JDC meeting following the Effective Date. Licensee will provide
Company with the initial Development Plan for the Development of the Minocin TV
Product in the EU within six (6) months of the earliest of (A) Licensee’s entry
into an agreement with MI for the Clinical Development Plan of Minocin IV, (B)
Licensee’s determination to Develop Minocin IV independently, as indicated by
Licensee to the JDC or (C) twelve (12) months from the Effective Date.
Notwithstanding the foregoing, Licensee shall have the right but not the
obligation to provide Company with the initial Development Plan for the
Development of the Minocin IV Product in the EU. Should Licensee not submit any
Development Plan for the Development of the Minocin IV Product in the EU
timelines indicated above, Company shall have the right, as its sole and
exclusive remedy, to partially terminate this Agreement with reference to the
Minocin IV Product pursuant to Section 13.4.
(b)    Medical Affairs Plan. Licensee shall conduct the Licensee Medical Affairs
Activities pursuant to a Medical Affairs Activities plan, prepared by Licensee
in consultation with Company through the JDC (as amended from time to time, the
“Medical Affairs Plan”), which shall include a description of all Medical
Affairs Activities conducted in the Licensed Territory for such Product.
Licensee shall submit the initial Medical Affairs Plan and any amendments
thereto to the JDC for review and approval in accordance with Article VI.

5.3    Development Plan Budget and Medical Affairs Plan Budget.
(a)    Development Plan Budget. Licensee shall be responsible, in consultation
with Company through the JDC, for preparing a detailed budget of the estimated
Development Costs for conducting the Development activities for a Product set
forth in the applicable Development Plan, including FTE costs and Out-of-Pocket
Costs, for each applicable Calendar Year (as amended from time to time, the
“Development Plan Budget”). Licensee shall submit the initial Development Plan
Budget and any amendments thereto to the JDC for review and approval in
accordance with Article VI. The initial Development Plan Budget with respect to
the Development of the first Vabomere Product in Asia-Pacific will be discussed
during the first JDC following the Effective Date. Subject to Section 5.2(a),
Licensee will discuss with Company the initial Development Plan Budget for the
Development of the Minocin IV Product in the EU together with delivery of the
initial Development Plan for the Development of the Minocin IV Product in the
EU.
(b)    Medical Affairs Plan Budget. Licensee shall be responsible, in
consultation with Company through the JDC, for preparing a detailed budget for
Medical Affairs Expenses relating to the Licensee Medical Affairs Activities
conducted for a Product in the Licensed Territory set forth in the Medical
Affairs Plan for each Calendar Year covered by the Medical Affairs Plan (as
amended from time to time, the “Medical Affairs Plan Budget”). Licensee shall
submit the initial Medical Affairs Plan Budget and any amendments thereto to the
JDC for review and approval in accordance with Article VI.

5.4    Amendments to Plans and Plan Budgets. From time to time, Licensee may
(or, at the reasonable request of Company, shall) prepare and submit amendments
to the then-current Development Plan, Development Plan Budget, Medical Affairs
Plan and/or Medical Affairs Plan Budget for review by the JDC in accordance with
5.2 and 5.3 and Article VI. Such amended Development Plan or Medical Affairs
Plan shall reflect any changes, re-prioritization of studies within,
reallocation of resources or responsibilities with respect to, or additions to
the then-current Development Plan or Medical Affairs Plan, as the case may be,
and such amended Development Plan Budget or Medical Affairs Plan Budget shall
specify with reasonable detail any amendments to the Development Plan Budget or
Medical Affairs Plan Budget, as the case may be, in connection therewith. If
approved by the JDC, the amended Development Plan, Development Plan Budget,
Medical Affairs Plan and/or Medical Affairs Plan Budget shall become effective
for the applicable period and shall supersede the previous Development Plan,
Development Plan Budget, Medical Affairs Plan and/or Medical Affairs Plan Budget
for the applicable period. The Parties shall endeavor to have the JDC approve
any amendments to the Development Plan, Development Plan Budget, Medical Affairs
Plan or Medical Affairs Plan Budget applicable to a given Calendar Year no later
than October I’ of the preceding Calendar Year.

5.5    Collaborative Development and AST Activities.
(a)    Collaborative Development Activities and AST Activities.
(i)    At any time during the Term, either Party (the “Submitting Party”) may
(but shall not be required to) submit to the JDC a proposal to collaborate with
the other Party (the “Other Party”) to conduct (A) Development activities with
respect to a Product, including quality and preclinical activities, Phase IV
Studies and other clinical studies, investigator studies and health economics
outcomes research, in connection with the Development of such Product; or (B)
AST Activities, in the case of each of (A) and (B), that would affect the
Product in the Field (each, a “Collaboration Proposal”). Any such proposal shall
be submitted in writing as far in advance as reasonably practicable, and shall
contain, at a minimum, (x) information supporting the rationale for the proposed
Development activity or AST Activity related to such Product from a scientific,
regulatory and commercial standpoint, (y) an estimated Developmental or AST
Activity critical path, and (z) an estimate of the total Development Costs to
conduct such Development activity or AST Costs to conduct such AST Activity,
broken out by FTE costs and Out-of-Pocket Costs for each Calendar Year for the
proposed activities. In any event, Company shall submit to the JDC a proposal to
collaborate with Licensee on the Pediatric Studies within ninety (90) days from
the Effective Date. If Company decides, in its sole discretion, to conduct the
HAP/VAP Study and/or the Orbactiv Reformulation Studies, then Company shall
submit to the JDC a proposal to collaborate with Licensee on the applicable
study in accordance with this Section 5.5.
(ii)    In the event the JDC approves such Collaboration Proposal, then the
Parties shall, through the JDC, create (A) a plan that includes a detailed
description of the Development activities or AST Activities, as applicable, to
be undertaken by each of the Parties (each, a “Collaboration Plan”, and such
activities, “Collaboration Activities”), and (B) a detailed budget for all
Development Costs or AST Costs, as applicable, in each case, broken out by FTE
costs and Out-of-Pocket Costs and an allocation of such Costs between the
Parties (each, a “Collaboration Budget”). Such Collaboration Plan and
Collaboration Budget, each as amended from time to time in accordance with this
Agreement, shall be subject to the review and approval of the JDC. In the event
the JDC approves such Collaboration Plan and Collaboration Budget, the Parties
will use Commercially Reasonable Efforts to perform their respective
Collaboration Activities under such Collaboration Plan, and the Costs incurred
in connection with such Collaboration Plan will be allocated and paid in
accordance with the Collaboration Budget.
(iii)    From time to time, either Party may prepare and submit reasonable
amendments to the then-current Collaboration Plan or Collaboration Budget for
review and approval by the JDC in accordance with this Section 5.5 and Article
VI. If approved by the JDC, the amended Collaboration Plan and Collaboration
Budget shall become effective for the applicable period and shall supersede the
previous Collaboration Plan and/or Collaboration Budget for the applicable
period. In the event the JDC does not unanimously agree on such amendment, then
the Collaboration Activities will continue in accordance with the
then-applicable Collaboration Plan and Collaboration Budget.
(b)    Right to Proceed with Collaboration Plan. If (i) the Other Party declines
or does not elect to participate in the Collaboration Activities proposed under
a Collaboration Proposal; or (ii) the JDC does not approve such Collaboration
Proposal, Collaboration Plan, or Collaboration Budget; then, (A) where Company
was the Submitting Party, Company may proceed with such additional Development
activity or AST Activity on its own and at its own cost; or (B) where Licensee
was the Submitting Party, Licensee may not proceed with any such additional
Development activity or AST Activity without Company’s prior written approval,
except with respect to any such Development activity included in the
Collaboration Plan or Collaboration Proposal that is a Licensed
Territory-Required Development Activity, in which case Licensee may proceed with
such activity on its own and at its own cost and in accordance with the other
applicable provisions of this Agreement. To the extent the Submitting Party is
permitted to proceed with such Development activities or AST Activity, it shall
be solely responsible for all of the Costs incurred in connection with such
Development activity or AST Activity, and subject to this Section 5.5(b) and
Section 9.1(a), the Other Party shall not have any rights with respect to
clinical, non-clinical and quality data and related Regulatory Materials arising
out of such Development activity or AST Activity, including any of the rights
described in Section 5.7 (other than that data and related Regulatory Materials
arising out of any Licensed Territory-Required Development Activity).
(c)    Future Access by Other Party. To the extent that the (i) Other Party
declines or does not elect to participate in the Collaboration Activities
proposed under a Collaboration Proposal; or (ii) the JDC does not approve a
Collaboration Proposal, Collaboration Plan, or Collaboration Budget, and the
Other Party later desires to access or use such clinical, non-clinical or
quality data or related Regulatory Materials, the Submitting Party shall grant
to the Other Party the right to access and use such data and materials upon the
Other Party’s payment of a portion of the Development Costs or AST Costs, as
applicable, as mutually agreed in good faith by the Parties. If the parties fail
to agree after thirty (30) days, either Party may submit the dispute for
resolution pursuant to Expert Resolution in accordance with Section 14.2(b).

5.6    Development Costs, Medical Affairs Expenses, and Collaboration Costs.
(a)    Allocation of Costs. Responsibility for Development Costs, Medical
Affairs Expenses, and AST Costs shall be allocated between the Parties as
follows: (i) Licensee shall be responsible for all (A) Development Costs
incurred in connection with any Development activities for the Products in the
Field in the Licensed Territory under a Development Plan, and (B) Medical
Affairs Expenses incurred in connection with Licensee Medical Affairs
Activities; (ii) Company and Licensee shall be responsible for the Costs
incurred under a Collaboration Plan in accordance with the approved
Collaboration Budget or in accordance with the Parties’ mutual agreement, to be
negotiated in good faith, on the appropriate cost sharing arrangement pursuant
to Section 5.5(c); and (iii) the Party permitted to proceed with a Collaboration
Plan under Section 5.5(b) shall be responsible for all Costs incurred under such
Collaboration Plan.
(b)    Calculation and Payment of Costs. Within sixty (60) days of the Effective
Date, the Parties, through the JSC, will mutually agree upon the format and
content of the Costs Estimate and the Costs Report. Within twenty (20) days
after the end of the fifth month of each Calendar Half, Company and Licensee
shall submit to a finance officer designated by Company and a finance officer
designated by Licensee (the “Finance Officers”) a report setting forth a
non-binding estimate of the Costs in US Dollars to be incurred by it under any
Collaboration Plan and Collaboration Budget in accordance with this Agreement
during such Calendar Half, including the calculation of the other Party’s
portion thereof based on Section 5.6(a) (each such report, a “Costs Estimate”).
Within fifteen (15) days after the end of each Calendar Quarter Half, Company
and Licensee shall submit to the Finance Officers a report setting forth all
Costs actually incurred by it in accordance with this Agreement under such
Collaboration Plan and Collaboration Budget during such Calendar Half (each such
report, a “Costs Report”). Each such Costs Report will specify in reasonable
detail all applicable Costs in US Dollars, the applicable Reference Exchange
Rate used to calculate such amounts if incurred in currencies other than US
Dollars, and, if reasonably requested by Company or Licensee, any invoices from
Third Parties or other supporting documentation will be promptly provided to
such Party. Subject to Section 5.6(c), within thirty (30) days after receipt of
a Costs Report, the Finance Officers will confer and agree in writing on whether
a reconciliation payment is due from Licensee to Company or Company to Licensee,
and if so, the amount of such reconciliation payment, so that Company and
Licensee share the Costs equally. Company or Licensee, as applicable, if
required to pay such reconciliation payment, will submit such payment to
Licensee or Company, respectively, as applicable, within thirty (30) days of
receipt of the other Party’s invoice for such amount; provided, however, that in
the event of any disagreement with respect to the calculation of such
reconciliation payment, any undisputed portion of such reconciliation payment
will be paid in accordance with the foregoing timetable and the remaining,
disputed portion will be paid within thirty (30) days after the date on which
Company and Licensee, using good faith efforts, resolve the dispute.
(c)    Notwithstanding the foregoing, neither Company nor Licensee shall be
responsible for making any payment or reimbursement to the other Party for Costs
to the extent not specified in, or exceeding by more than ten percent (10%) the
amounts corresponding thereto set forth in, the applicable Collaboration Budget.
Any amount incurred by a Party that exceeds the then-approved Collaboration
Budget by more than ten (10%) shall be borne solely by such Party, unless
otherwise agreed to by the other Party.

5.7    Rights to Regulatory Materials. Solely with respect to Regulatory Data
and Regulatory Materials arising out of Collaboration Activities or to which
Company elects to receive rights pursuant to Section 5.5(b), Licensee hereby
grants to Company a right of reference or use to any and all Regulatory
Materials and Regulatory Data, generated by or on behalf of Licensee pursuant to
such Collaboration Activities or to which Company elects to receive such rights
to (a) Develop and Manufacture Products in the Licensed Territory solely for
Commercialization outside of the Licensed Territory and the Field, and (b) to
Commercialize Products outside of the Licensed Territory and the Field. Solely
with respect to Regulatory Data and Regulatory Materials arising out of
Collaboration Activities or to which Licensee elects to receive rights pursuant
to Section 5.5(b), Company hereby grants to Licensee a right of reference or use
to any and all Regulatory Materials and Regulatory Data, generated by or on
behalf of Company pursuant to such Collaboration Activities or to which Licensee
elects to receive such rights solely to use such Regulatory Materials and
Regulatory Data in connection with activities conducted pursuant to the license
granted to Licensee pursuant to Section 2.1. Each Party agrees to sign, and to
cause its Affiliates and, in the case of Licensee, Sublicensees to sign, from
time to time, promptly upon request, any instruments reasonably requested by the
other Party, at such Party’s cost and expense, in order to effect such grant.
Each Party shall, and shall cause its Affiliates and, in the case of Licensee,
Sublicensees to, maintain complete and accurate records of all results and data
made pursuant to its efforts under Section 5.5. Such records shall appropriately
reflect all work done and results achieved in the performance of such activities
in sufficient detail and in good scientific manner appropriate for patent and
regulatory purposes. In any agreement between either Party and a clinical
research organization related to additional Development activity, the
contracting Party shall reserve the right to use and have used by Third Parties
all data derived from clinical trials related to such additional Development
activity from such clinical research organization in any event.

5.8    Reporting. Licensee shall, and shall cause its Affiliates and
Sublicensees to, upon Company’s reasonable request, meet with the Company and
the applicable Upstream Party to discuss the status of its progress in achieving
its Development obligations for a Product in the Field in the Licensed Territory
under this Agreement.

ARTICLE VI -     GOVERNANCE
The Parties acknowledge that the overall purpose of the committees and
subcommittees described in this Article VI is to provide joint oversight to the
activities and transactions contemplated by this Agreement. Such committees and
subcommittees create a forum to ensure timely communications and coordinated
activities in relation to this Agreement and the transactions contemplated
thereby.

6.1    Joint Steering Committee.
(a)    Formation; Representatives. The Parties shall establish a joint steering
committee (the “JSC”) within thirty (30) days after the Effective Date that will
have the responsibility for the overall coordination and oversight of the
Parties’ activities under this Agreement. As soon as practicable following the
Effective Date (but in no event more than thirty (30) days following the
Effective Date), each Party shall designate its initial three (3)
representatives on the JSC. Each Party’s representatives and any substitute for
a representative shall be bound by the obligations of confidentiality set forth
in Article VII. A representative from Company shall act as the chairperson of
the JSC. The chairperson shall not have any greater authority than any other
representative on the JSC and shall conduct the following activities of the JSC:
(i) calling meetings of the JSC; (ii) preparing and issuing minutes of each such
meeting within thirty (30) days thereafter; and (iii) preparing and circulating
an agenda for the upcoming meeting; provided that the chairperson shall include
any agenda items proposed by Licensee. Each Party shall be free to change its
representatives on notice to the other or to send a substitute representative to
any JSC meeting; provided, however, that each Party shall ensure that at all
times during the existence of the JSC, its representatives on the JSC are
appropriate in terms of expertise and seniority (including at least one member
of senior management) for the then-current stage of Development and
Commercialization of the Products and have the authority to bind such Party with
respect to matters within the purview of the JSC.
(b)    Scope of Authority. The responsibilities of the JSC shall be to oversee
the Parties’ activities under this Agreement and to serve as a forum for good
faith communication and information exchange between the Parties. During the
Term, the responsibilities of the JSC shall include the following:
(i)    general oversight of and periodic review of the overall goals and
progress of the Parties’ activities hereunder;
(ii)    review and approval of the Regulatory Plan prepared by Licensee, as
contemplated under Section 3.1(k), and any amendments thereto;
(iii)    review and discussion of the Commercialization Plan and
Commercialization Plan Budget prepared by Licensee, as contemplated under 8.2(a)
and 8.2(b), and reviewed and commented on by the JPC, as contemplated under
Section 6.2(b), and any amendments thereto;
(iv)    review of Licensee’s activities in connection with the Commercialization
of the Products in the Field in the Licensed Territory, including Licensee’s
Commercialization Reports;
(v)    review and approval of the form of Costs Estimate and Costs Report as
contemplated under Section 5.6, including any amendments or changes thereto; and
(vi)    serving as a vehicle for resolving issues escalated by the Parties to
the JSC.

6.2    Subcommittees. The JSC may establish and disband such subcommittees as
deemed necessary by the JSC to provide oversight of, and as a channel for
communications between, the Parties in connection with activities under this
Agreement. Each such subcommittee shall consist of the same number of
representatives designated by each Party, which number shall be mutually agreed
by the Parties. Each Party shall be free to change its representatives on notice
to the other or to send a substitute representative to any subcommittee meeting;
provided, however, that each Party shall ensure that at all times during the
existence of any subcommittee, its representatives on such subcommittee are
appropriate in terms of expertise and seniority for the then-current stage of
Development and Commercialization of the Products in the Field in the Licensed
Territory and have the authority to bind such Party with respect to matters
within the purview of the relevant subcommittee. Each Party’s representatives
and any substitute for a representative shall be bound by the obligations of
confidentiality set forth in Article XII. Except as expressly provided in this
Agreement, no subcommittee shall have the authority to bind the Parties
hereunder and each subcommittee shall report to, and any decisions shall be made
by, the JSC. The initial subcommittees of the JSC will be the Joint Development
Committee (the “JDC”) and the Joint Product Committee (the “JPC”).
(a)    Joint Development Committee.
(i)    The .1-DC will have the responsibility for the overall coordination and
oversight of the Development of the Products in the Field in the Licensed
Territory in accordance with the applicable Development Plan and oversight of
the Development of any Product under a Collaboration Plan. As soon as
practicable following the Effective Date (but in no event more than thirty (30)
days following the Effective Date), each Party shall designate its initial two
(2) representatives on the JDC. Company shall appoint a person from among its
representatives on the JDC to serve as the chairperson of the JDC. The
chairperson shall not have any greater authority than any other representative
on the JDC and shall conduct the following activities of the JDC: (A) calling
meetings of the JDC; (B) preparing and issuing minutes of each such meeting
within thirty (30) days thereafter; and (C) preparing and circulating an agenda
for the upcoming meeting; provided that the chairperson shall include any agenda
items proposed by Licensee.
(ii)    The JDC shall have responsibility for: (A) overseeing the flow and
transfer of information between the Parties related to each of the Development
Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan
Budget, any Collaboration Plan, and any Collaboration Budget pursuant to 5.2,
5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating the
Development of the Products in the Field in Licensed Territory; (C) overseeing,
reviewing and coordinating Medical Affairs Activities with respect to each
Product in the Field in the Licensed Territory; (D) reviewing and approving the
Development Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs
Plan Budget and all amendments thereto; (E) reviewing and approving each
Collaboration Proposal; (F) developing, reviewing, and approving each
Collaboration Plan and Collaboration Budget and all amendments thereto; (G)
overseeing, reviewing and coordinating the conduct of each Collaboration Plan;
and (H) as applicable, reviewing the other Development activities and Medical
Affairs Activities being conducted by the Parties.
(b)    Joint Product Committee.
(i)    The JPC shall oversee Commercialization of the Products in the Field in
the Licensed Territory. As soon as practicable following the Effective Date (but
in no event more than thirty (30) days following the Effective Date), each Party
shall designate its initial two (2) representatives on the JPC. The JPC shall be
composed of appropriate and key executives of Company together with an equal
number of appropriate and key executives from Licensee. Licensee shall appoint a
person from among its representatives on the JPC to serve as the chairperson of
the JPC. The chairperson shall not have any greater authority than any other
representative on the JPC and shall conduct the following activities of the JPC:
(A) calling meetings of the JPC; (B) preparing and issuing minutes of each such
meeting within thirty (30) days thereafter; and (C) preparing and circulating an
agenda for the upcoming meeting; provided that the chairperson shall include any
agenda items proposed by Company.
(ii)    The JPC shall be responsible for: (A) overseeing, reviewing and
coordinating the Commercialization of the Products in the Field in the Licensed
Territory; (B) setting overall objectives and plans related to Commercialization
of the Products in the Field in the Licensed Territory; (C) reviewing and
commenting on the Commercialization Plan and all amendments thereto; (D)
reviewing and commenting on the Commercial Forecast; (E) determining the timing,
content and form of the Commercialization Report; (F) reviewing
Commercialization issues for each Product in the Field in the Licensed Territory
that will have an impact on Commercialization of such Product in the Field
outside the Licensed Territory; (G) reviewing Commercialization issues for a
Product in the Field outside the Licensed Territory that will have an impact on
Commercialization of such Product in the Field in the Licensed Territory; (H)
providing a forum for the Parties to discuss the Commercialization of each
Product in the Field in the Licensed Territory; and (I) such other
responsibilities as may be assigned to the JPC pursuant to this Agreement or as
may be mutually agreed upon by the Parties from time to time.

6.3    Authority. The JSC and any subcommittee shall have only the powers
assigned expressly to it in this Article VI and elsewhere in this Agreement, and
shall not have any power to amend, modify or waive compliance with this
Agreement. In furtherance thereof, each Party shall retain the rights, powers
and discretion granted to it under this Agreement and no such rights, powers or
discretion shall be delegated or vested in the JSC or any subcommittee unless
such delegation or vesting of rights is expressly provided for in this Agreement
or the Parties expressly so agree in writing.

6.4    Meetings; Decision-Making.
(a)    Meetings. The JSC shall meet at least twice per Calendar Year and each of
the subcommittees shall meet at least once per Calendar Quarter during the Term;
provided further, that each subcommittee shall ensure that its representatives
meet and communicate with the Party’s representatives on such frequency as is
reasonably necessary to carry out such subcommittee’s responsibilities, whether
daily, weekly, monthly, or otherwise, and whether relating to Development,
Manufacturing, or Commercialization responsibilities. In addition, a Party may
call a meeting of the JSC or each of the subcommittees upon reasonable notice to
the other Party. At each meeting, the Parties shall provide updates on the
status of their respective responsibilities. The meetings of the JSC and each of
the subcommittees may be held by means of a telephone, video conference call or
in person as mutually agreed by the Parties; provided that at least one (1)
meeting per Calendar Year shall be held in person at Company’s offices and at
least one (1) meeting per Calendar Year shall be held in person at Licensee’s
offices. The JSC and each of the subcommittees may take action by vote at a
meeting or telephone or video conference call, or pursuant to a written vote.
Each Party shall bear its own travel and lodging expenses related to
participation in and attendance at such meetings by its JSC or subcommittee
representatives.
(b)    Decision-Making.
(i)    Subject to the provisions of this Section 6.4(b), actions to be taken by
the JSC and each of the subcommittees shall be taken only following a unanimous
vote, with each Party having one (1) vote. If any subcommittee fails to reach
unanimous agreement on a matter before it for decision for a period in excess of
thirty (30) days, the matter shall be referred to the JSC.
(ii)    If the JSC fails to reach unanimous agreement on a matter before it for
decision for a period in excess of thirty (30) days, either Party may elect to
submit such issue to the Parties’ Senior Officers and the JSC will submit in
writing the respective positions of the Parties to their respective Senior
Officers. Such Senior Officers will use good faith efforts, in compliance with
this Section 6.4(b)(ii), to resolve promptly such matter, which good faith
efforts will include at least one meeting between such Senior Officers within
fifteen (15) days after the JSC’s submission of such matter to them. If the
Senior Officers are unable to reach unanimous agreement on any such matter
within thirty (30) days of such matter being referred to them, the matter will
be decided in accordance with Section 6.4(b)(iii).
(iii)    If the Parties’ Senior Officers are unable to reach unanimous agreement
in accordance with Section 6.4(b)(ii), then (A) Company shall have final
decision-making authority with respect to any and all matters (i) relating to
Development of the Products, but excluding Licensed Territory-Required
Development Activities, and (ii) subject to Section 3.1(d), relating to the
inclusion of Company Confidential Information in any Regulatory Materials and/or
Regulatory Data submitted to Regulatory Authorities in the Licensed Territory;
(B) Licensee shall have final decision-making authority with respect to any and
all matters (i) relating to the conduct of Licensed Territory-Required
Development Activities, except as provided for in this Section
6.4(b)(iii)(A)(ii), (ii) relating solely to Commercialization of the Products in
the Field in the Licensed Territory (but excluding for clarity, approval of any
form of Commercialization Reports or other reports), (iii) and Medical Affairs
Activities for a Product in the Field in the Licensed Territory; and (C) neither
Party shall have final decision-making authority with respect to Collaboration
Proposals, Collaboration Plans, Collaboration Budgets or Collaboration
Activities conducted thereunder. Notwithstanding anything to the contrary, (X)
no exercise of a Party’s final decision-making authority on any such matters
may, without the other Party’s prior written consent, result in a material
decrease or increase in the other Party’s or its Affiliates’ obligations, costs
or expenses under this Agreement, any Development Plan or Commercialization Plan
or require the other Party to perform additional activities not contemplated by
this Agreement; and (Y) no exercise of a Party’s final decision-making authority
on any such matters may conflict with or amend this Agreement without both
Parties’ prior written consent, In exercising its final decision-making
authority under this Section 6.4(b)(iii), each Party shall consider in good
faith the interests of the other Party.
(c)    Limited Authority. The JSC and any subcommittee shall have only the
powers assigned expressly to it in this Article VI and elsewhere in this
Agreement, and shall not have any power to amend, modify or waive compliance
with this Agreement. In furtherance thereof, each Party shall retain the rights,
powers and discretion granted to it under this Agreement and no such rights,
powers or discretion shall be delegated or vested in the JSC or any subcommittee
unless such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing.

6.5    Alliance Manager. Each Party shall appoint one of its employees or of its
Affiliates as an “Alliance Manager” for this Agreement. Each Party’s Alliance
Manager shall be responsible for coordinating with the other Party’s Alliance
Manager regarding adherence to this Agreement. Each Alliance Manager will also:
(a) be the point of first referral in all matters of conflict resolution; (b)
identify and bring disputes to the attention of the JSC in a timely manner; and
(c) coordinate cooperative efforts. For clarity, the Alliance Manager’s role as
the “point of first referral” does not diminish the obligation of each Party’s
representatives to communicate with the other Party’s representatives or to
attempt to resolve any disputes or issues between or among the representatives,
prior to bringing such disputes to the attention of the Alliance Manager.

ARTICLE VII -     FINANCIAL TERMS

7.1    Upfront Payment. Licensee shall pay the non-refundable, non-creditable
amount of Seventeen Million Euro (€ 17,000,000) within ten (10) Business Days of
the Effective Date, which amount shall be deemed payment in part in respect of
the milestone payment due to the applicable Upstream Party upon achievement of
the regulatory milestones referenced in Section 7.2 below. Such payment shall be
made, in Company’s discretion, either to Company, or directly to the applicable
Upstream Party, as provided in Section 7.10 below.

7.2    Regulatory Milestones. Company shall notify Licensee promptly of the
achievement of the first milestone event set forth below and Licensee shall
notify Company immediately upon the achievement of the second milestone event
set forth below. Licensee shall make the corresponding non-refundable,
non-creditable payment amount set forth below no later than fifteen (15)
Business Days from receipt of the relevant invoice issued by Company following
notice of such achievement, which amount shall be deemed payment in part in
respect of the milestone payment due to the applicable Upstream Party. Such
payments shall be made, in Company’s discretion, either to Company or directly
to the applicable Upstream Party, as provided in Section 7.10 below.
Milestone Event
Payment Amount
First EMA approval of an MAA for the first Vabomere Product
€15,000,000
[***]
€ [***]

The Parties acknowledge and agree that Company is obligated to pay one of the
Upstream Parties a milestone payment upon the same event and in an amount
corresponding to the Minocin IV Approval Milestone (the “Upstream Minocin IV
Approval Milestone”). At any time, in the event of and following Licensee’s
submission to the JDC of the initial Development Plan for the Minocin IV Product
pursuant to Section 5.2(a), Licensee may request that Company seek to negotiate
with the applicable Upstream Party to lower or remove the Upstream Minocin IV
Approval Milestone in order to make such Development Plan commercially viable.
Upon such request, Company shall use good faith efforts (for up to sixty (60)
days) to renegotiate the Upstream Minocin IV Approval Milestone and if Company
is successful in such negotiations, the Minocin IV Approval Milestone shall be
lowered to an amount equal to the renegotiated Upstream Minocin IV Approval
Milestone or removed, as applicable.

7.3    Launch Milestones. Licensee shall notify Company immediately upon the
achievement of the milestone event set forth below and shall make the
corresponding nonrefundable, non-creditable payment to Company set forth below
not later than thirty (30) days from receipt of the relevant invoice issued by
Company following Licensee’s notice of the achievement of such milestone event:
Milestone Event
Payment Amount
[***]
€ [***]
[***]
€ [***]
€ [***]

[***]
Notwithstanding the foregoing, Licensee’s failure to notify Company in
accordance with this Section 7.3 shall not relieve it of its obligation to make
the payments set forth above.

7.4    Sales Milestones. Licensee shall notify Company immediately upon the
achievement of each milestone event set forth below and shall make the
corresponding nonrefundable, non-creditable payment set forth below not later
than fifteen (15) Business Days from receipt of the relevant invoice issued by
Company upon Licensee’s notice of the achievement of such milestone event, which
amount shall be deemed payment in part in respect of the milestone payment due
to the applicable Upstream Party upon achievement of the applicable milestone
event. Such payments shall be made, in Company’s discretion, either to Company
or directly to the applicable Upstream Party, as provided in Section 7.10 below.
Milestone Event
Payment Amount
First achievement of Net Sales for all Products in the Licensed Territory during
any four (4) consecutive Calendar Quarters equaling or exceeding €[***]
€ [***]
First achievement of Net Sales for all Products in the Licensed Territory during
any four (4) consecutive Calendar Quarters equaling or exceeding €[***]
€ [***]
First achievement of Net Sales for all Products in the Licensed Territory during
any four (4) consecutive Calendar Quarters equaling or exceeding €[***] in the
Licensed Territory
€ [***]
First achievement of Net Sales for all Products in the Licensed Territory during
any four (4) consecutive Calendar Quarters equaling or exceeding €[***] in the
Licensed Territory
€ [***]

For clarity, if more than one (1) milestone event under this Section 7.4 is
achieved in the same period, the payments applicable to such achieved milestone
events shall be paid simultaneously. Notwithstanding the foregoing, Licensee’s
failure to notify Company in accordance with this Section 7.4 shall not relieve
it of its obligation to make the payments set forth above.

7.5    Royalties.
(a)    Licensee shall pay Company royalties on Net Sales of each Product sold
during a Calendar Year by Licensee, its Affiliates and Sublicensees in the
Licensed Territory as follows:
Ratio of Transfer Price for a Product to Net Sales
for such Product during the Calendar Year
Royalty  
(% of Net Sales)
Less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***] but less than or equal to [***]
[***]
Greater than [***]
[***]

(b)    Notwithstanding the foregoing Section 7.5(a), following successful
completion of the technology transfer referenced in Section 2.1 (including
qualification of a Third Party contract manufacturer) should Licensee obtain a
reduction of COGS below the Adjusted Royalty Threshold, then the royalty rate
shall be adjusted in order to attribute [***] of the benefit deriving from such
saving to each Party, as follows:
Ratio of Transfer Price for a Product to Net Sales for such
Product during a Calendar Year
Savings
Royalty
(%of Net Sales)
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

“Adjusted Royalty Threshold” shall mean the lower of [***] and the ratio of
Transfer Price to Net Sales, measured as of completion of the technology
transfer referred to above.
(c)    Transfer Price. COGS for each Product shall be determined by Company
immediately prior to the first sale of such Product under the applicable Supply
Agreement, and thereafter updated on a Calendar Year basis in accordance with
such Supply Agreement. For clarity, the Supply Agreements shall set forth the
process for establishing COGS in the event the Parties agree to tech transfer
Manufacturing for a Product from Company to Licensee or its designee.
(d)    Royalty Term. Royalties payable under this Section 7.5 shall be paid by
Licensee on a Product-by-Product and country-by-country basis during the Term at
the rates set forth in Section 7.5(a).
(e)    Reduction for Loss of Market Exclusivity. Notwithstanding the foregoing,
on a country-by-country basis, in the event of a (1) Loss of Market Exclusivity
with respect to a Product in a country, the royalty rate applicable to such
country for such Product will be [***] of the rate that would otherwise be
payable under Section 7.5(a) on Net Sales of the Product in such country, and
(ii) Significant Loss of Market Exclusivity with respect to a Product in a
country, the royalty rate applicable to such country for such Product will be
[***] of the rate that would otherwise be payable under Section 7.5(a) on Net
Sales of the Product in such country. Any royalty reduction provided for in this
Section 7.5(e) shall take effect retroactively as of the first day of the three
(3) consecutive calendar months taken as a reference for the occurrence of the
Loss of Market Exclusivity or the Significant Loss of Market Exclusivity, as the
case may be.
(f)    Royalty Reports; Payments.
(i)    Within fifteen (15) Business Days after the end of the second month of
each Calendar Quarter following First Commercial Sale, Licensee shall provide
Company with a non-binding estimate of Net Sales by Licensee, its Affiliates and
Sublicensees and the amount of royalties due thereon with respect to such
Calendar Quarter.
(ii)    Within fifteen (15) Business Days after the end of each Calendar Quarter
following First Commercial Sale, Licensee shall provide Company with a report of
Net Sales by Licensee, its Affiliates and Sublicensees setting forth, in U.S.
Dollars, on a Product-byProduct and country-by-country basis with respect to
such Calendar Quarter: (A) gross sales of Product, (B) Net Sales, (C) deductions
taken to calculate Net Sales based on gross sales, and (D) the amount of
estimated royalties due to Company, including the method used to calculate the
royalties and the exchange rates used and any documentation to support such
calculation as may be requested by Company from time to time; it being
understood that such royalties shall be adjusted to reflect the actual Transfer
Price for such Product in accordance with Section 7.5(f)(iii). Royalty payments
shall be made by Licensee to Company concurrently with the delivery of the
foregoing report to Company.
(iii)    Within thirty (30) days of receipt by Company of the report for the
final Calendar Quarter in a Calendar Year, Company shall make a calculation of
the difference between the initial Transfer Price and COGS to be paid for such
Product supplied in such Calendar Year, and shall promptly notify Licensee of
such calculation, including its effect on the royalty rate and royalties due. In
the event of an underpayment by Licensee for such Calendar

7.6    Late Payments. Any amount due under this Agreement that is not received
by the due date shall be subject to an annual charge equal to the lesser of (a)
[***] on Year, Licensee shall pay such difference within thirty (30) days of
such reconciliation, and in the event of an overpayment, such amount shall be
credited against royalties payable for the following Calendar Quarter.

7.7    Changes to Royalties. The Parties acknowledge and agree that, solely with
respect to the sale of the Orbactiv Product in the Philippines and Malaysia (the
“Two Countries”), the royalties payable by Licensee to Company hereunder may be
less than the aggregate royalties owed by Company to the Upstream Parties plus a
reasonable profit pursuant to the Upstream Agreements. In such event, the
Parties shall in good faith discuss and agree upon a revised financial structure
for the Two Countries such that Licensee is able to earn a reasonable profit and
the Company receives royalties on sales of the Orbactiv Product no less than the
aggregate royalties owed to such Upstream Parties plus a reasonable profit.

7.8    Changes in Regulatory Scheme in Licensed Territory. In the event there is
any change under Applicable Law in the Licensed Territory with respect to
Regulatory Approval process, period of Regulatory Exclusivity or other matters
in respect of pharmaceutical products, which change may have a material impact
on the value of the business of a Product in the Licensed Territory, the Parties
shall revise in good faith the financial terms of this Agreement and evaluate
whether any amendments to such financial terms are necessary in order to
appropriately reflect the actual value of the business and maintain the
commercial viability of such Product in the Licensed Territory following such a
change under Applicable Law.

7.9    Payments.
(a)    Adjustments to Payment Amounts. The Parties acknowledge and agree that
all payments due under this Agreement are based on an exchange rate of 1.1773
U.S. Dollars per Euro (the “Base Exchange Rate”). In the event that the average
exchange rate of U.S. Dollars to Euro over the last ten (10) Business Days
preceding the last day of a Calendar Quarter (the “Measurement Date”)
immediately preceding the payment date for a payment to be made in Euros under
this Agreement (such exchange rate, the “Reference Exchange Rate”) is greater
than [***] of the Base Exchange Rate or less than [***] of the Base Exchange
Rate, such payment shall be adjusted up or down, as applicable, to reflect the
Reference Exchange Rate in effect on the Measurement Date. Licensee shall notify
Company of the Reference Exchange Rate as of the applicable Measurement Date by
written notice delivered prior to or contemporaneously with delivery of such
payment. An example of such adjustment is set forth on Schedule 7.8(a).
(b)    Currency. All payments made pursuant to this Agreement, including to an
Upstream Party, shall be made in U.S. Dollars by electronic transfer in
immediately available funds via a bank wire transfer to such bank account
designated by a Party, or to the Upstream Party designated by Company. For
purposes of converting currencies for purposes of any payments hereunder, from
time to time, such conversion shall be effected at the exchange rate quoted by
The Wall Street Journal, New York edition as of such time. Company shall provide
evidence of such exchange rate to Licensee upon Licensee’s request. annual rate
over the then-current 30-day LIBOR rate reported in The Wall Street Journal, New
York edition, and (b) the maximum rate permitted by Applicable Law governing
this Agreement. The defaulting Party shall pay all of the other Party’s costs
and expenses (including reasonable attorney’s fees) to enforce and preserve such
Party’s rights and cost of collection.

7.10    Upstream Agreements. For clarity, the Parties acknowledge and agree that
Company is solely responsible for compliance with the payment and all other
obligations under the Upstream Agreements; provided, that upon written notice
from Company to Licensee at least five (5) Business Days prior to a payment
becoming due to Company hereunder, in lieu of making such payment to Company,
Licensee shall make such payment or a portion thereof, as directed by Company,
to one or more Upstream Parties in accordance with wire transfer instructions
provided by Company to Licensee, which payment shall be made at least three (3)
Business Days prior the date such payment is due. Upon request, Licensee shall
provide Company with written evidence of such payments made. In no event a
payment shall be made to any Upstream Party if such payment may be in violation
of any Applicable Law.

7.11    Financial Records. Each Party shall keep complete and accurate books and
records in accordance with its Accounting Standards. Each Party shall keep such
books and records for at least five (5) years following the end of the Calendar
Year to which they pertain or longer as required by Applicable Law. With respect
to royalties and milestones, such records shall include adjustments as needed to
meet International Financial Reporting Standards and be in sufficient detail to
support calculations of royalties and milestones due to Company or paid to any
Upstream Party pursuant to Section 7.10. Company and Licensee shall also keep
complete and accurate records and books of accounts containing all data
reasonably required for the calculation and verification of COGS and Costs,
including internal FTEs utilized by either Party in any Collaboration
Activities. Licensee shall provide additional information reasonably requested
by Company relating to the calculation of Net Sales to the extent needed by
Company in order to comply with the Upstream Agreements.

7.12    Audits.
(a)    Upon at least fifteen (15) days’ prior written notice, either Party or
its representatives may, which in the case of Company may include the Upstream
Parties, audit, or cause an internationally-recognized independent accounting
firm selected by it (except one to whom the audited party has a reasonable
objection) (the “Audit Team”) to audit during ordinary business hours the books
and records of the other Party, its Affiliates, or in the case of Licensee any
Sublicensees, relevant to the correctness of any payment made or required to be
made to or by such party, and any report underlying such payment (or lack
thereof), pursuant to the terms of this Agreement. Prior to commencing its work
pursuant to this Agreement, the Audit Team shall enter into an appropriate
confidentiality and non-use agreement with the audited party. For clarity, with
respect to audits performed on behalf of an Upstream Party, such audits shall be
limited to the review of such books and records necessary to confirm payment
made or required to be made to such Upstream Party pursuant to this Agreement.
(b)    In respect of each audit of the audited party’s books and records: (i)
the audited party may be audited only once per Calendar Year, unless such audit
reveals an underpayment of more than five percent (5%); and (ii) the auditing
party shall only be entitled to audit books and records of an audited party from
the five (5) Calendar Years prior to the Calendar Year in which the audit
request is made.
(c)    The audit report and basis for any determination by an Audit Team shall
be made available first for review and comment by the audited party, and the
audited party shall have the right, at its expense, to request a further
determination by such Audit Team as to matters which the audited party disputes
(to be completed no more than thirty (30) days after the first determination is
provided to such audited party and to be limited to the disputed matters). If
the Parties disagree as to such further determination, the auditing party and
the audited party shall mutually select an internationally-recognized
independent accounting firm that shall make a final determination as to the
remaining matters in dispute that shall be binding upon the auditing and audited
parties. Such accountants shall not disclose to the auditing party any
information relating to the business of the audited party except that which
should properly have been contained in any report required hereunder the extent
necessary to verify the payments, calculations, and reports required to be made
pursuant to the terms of this Agreement.
(d)    If the audit shows any under-reporting or underpayment, or overcharging
by any party, that under-reporting, underpayment or overcharging shall be
reported to the audited party and the underpaying or overcharging Party shall
remit such underpayment or reimburse such overcompensation (together with
interest at the annual interest rate of one percent (1%) over bank prime loan
rate as published in the U.S. Federal Bulletin H.15 or its successor on the last
Business Day of the applicable Calendar Quarter prior to the audit) to the
underpaid or overcharged Party within twenty (20) days after receiving the audit
report. Further, if the audit for an annual period shows an under-reporting or
underpayment or an overcharge by any Party for that period in excess of five
percent (5%) of the amounts properly determined, the underpaying or overcharging
Party, as the case may be, shall reimburse the applicable underpaid or
overcharged auditing party conducting the audit, for its respective audit fees
and reasonable Out-of-Pocket Costs in connection with said audit, which
reimbursement shall be made within twenty (20) days after receiving appropriate
invoices and other support for such audit-related costs.

7.13    Tax Matters. The royalties, milestones and other amounts payable by
Licensee to Company pursuant to this Agreement shall not be reduced on account
of any taxes other than withholding taxes that are required by Applicable Law.
Company alone shall be responsible for paying any and all taxes other than
withholding taxes required by Applicable Law to be deducted and paid on
Company’s behalf by Licensee levied on account of, or measured in whole or in
part by reference to, any payments it receives. The Parties will cooperate in
good faith to obtain the benefit of any relevant tax treaties to minimize as far
as reasonably possible any taxes which may be levied on any payments such as
withholding taxes applicable in the country of Licensee or any country in the
Licensed Territory. Licensee shall deduct or withhold from the payments any
taxes that it is required by Applicable Law to deduct or withhold.
Notwithstanding the foregoing, if Company is entitled under any applicable tax
treaty to a reduction of the rate of, or the elimination of, applicable
withholding tax, it may deliver to Licensee or the appropriate Governmental
Authority (with the assistance of Licensee to the extent that this is reasonably
required and is expressly requested in writing) the prescribed forms necessary
to reduce the applicable rate of withholding or to relieve Licensee of its
obligation to withhold tax, and Licensee shall apply the reduced rate of
withholding tax, or dispense with withholding tax, as the case may be, provided
that Licensee has received evidence of Company’s delivery of all applicable
forms (and, if necessary, its receipt of appropriate governmental authorization)
at least thirty (30) days prior to the time that the payment is due. If, in
accordance with the foregoing, Licensee withholds any amount, it shall make
timely payment to the proper taxing authority of the withheld amount, and send
to Company proof of such payment within thirty (30) days following that latter
payment.

ARTICLE VIII -     COMMERCIALIZATION

8.1    Product Commercialization.
(a)    General. Licensee shall be responsible, at its sole cost and expense, for
the Commercialization of each Product in the Field in the Licensed Territory,
including reimbursement, storage, shipment, transportation, and invoicing of
customers. Licensee shall use Commercially Reasonable Efforts to: (i)
Commercialize each Product in the Field in the Licensed Territory for which
Regulatory Approval has been obtained, including Commercializing a Vabomere
Product in each of the Major Countries and, subject to Section 5.2(a), a Minocin
IV Product in the EU; (ii) maximize Net Sales of the Products in the Field in
the Licensed Territory; and (iii) perform its activities under each applicable
Commercialization Plan.
(b)    Storage of Product. Licensee shall store and handle all Products in
accordance with the applicable storage and handling requirements in each
Product’s specifications and in compliance with Applicable Law. Company or its
designated representatives may inspect Licensee’s storage, warehouse and
distribution facilities during regular business hours upon reasonable notice to
ensure Licensee’s compliance with this Section 8.1(b). Licensee shall not sell
any Product with an expired shelf life and shall dispose of such Product with an
expired shelf life in the manner required by Company and in accordance with all
Applicable Law. Such disposal of expired Product shall be at Licensee’s sole
cost and expense.
(c)    Commercialization Requirements. Without limiting Section 8.1(a),
Licensee’s Commercialization activities hereunder shall include, at a minimum,
the following:
(i)    Field Force Activities. Licensee shall provide such internal
administrative and logistical support of its sales representative field force as
is usual and customary in the pharmaceutical industry in the Licensed Territory,
consistent with its normal practices, including: (A) training, maintaining and
managing its sales representatives; (B) distributing samples and literature
through its (or its Affiliate’s or Sublicensee’s) sales representatives or other
customary methods; (C) disseminating Educational Materials; (D) responding to
inquiries regarding Products; (E) providing adequate administrative support
services (such as an electronic territory management system); and (F) setting,
monitoring and executing sales representative incentives (if any) related to the
Commercialization of the Products in the Licensed Territory.
(ii)    Detailing. Without limiting the types of Educational efforts Licensee
may undertake, following receipt of Pricing Approval, Licensee and its sales
representatives shall conduct face-to-face discussions with licensed physicians
and other health care practitioners for the purpose of Educating such physicians
and practitioners about each such Product in the Field.
(iii)    Minimum Commitments for the Vabomere Product. On a Major
Country-by-Major Country basis, and without limiting Section 8.1(a), until the
end of the first one hundred twenty (120) months after the date of the First
Commercial Sale of the first Vabomere Product in such Major Country, Licensee
will (A) maintain and use the equivalent of sixty (60) FTEs to conduct such
field force and detailing activities in such Major Country and (B) expend at
least [***] in Commercialization Costs covering its Commercialization activities
in such Major Country.
(d)    Reporting Obligations. No later than December 15th of each Calendar Year
during the Term, Licensee shall provide to Company and the JPC a written report
(each, a “Commercialization Report”) summarizing in reasonable detail the
Commercialization activities undertaken during such Calendar Year by Licensee in
connection with the then-applicable Commercialization Plan for each Product. The
JPC shall determine the timing, content and form for such Commercialization
Report.

8.2    Commercialization Plan.
(a)    General. The Commercialization of each Product in the Field in the
Licensed Territory shall be described in a rolling twelve (12)-month plan (as
amended from time to time, the “Commercialization Plan”), to be prepared by
Licensee and submitted to the JPC for review and comment. Outlines of the
Commercialization Plans for the Initial Products in the EU will be delivered to
the Company prior to the first JPC meeting. The JPC will meet within thirty (30)
days of the Effective Date to review and comment on full Commercialization Plans
for the Initial Products in the EU, based upon such outlines. Licensee will
submit Commercialization Plans for other Products and for other countries or
jurisdictions in the Licensed Territory no less than (12) months prior to the
anticipated date of receipt of the first Regulatory Approval for such Product to
the JPC for review, and the JPC will seek to comment on such Commercialization
Plan within one-hundred eighty (180) days of the submission to the JPC. The
Commercialization Plan shall describe in detail the pre-launch, launch and
subsequent Commercialization of such Product, including the items specified in
Exhibit A and the following components: (i) overall goals of the Licensee with
regard to the Commercialization of such Product in the Field in the Licensed
Territory; (ii) anticipated activities relating to Education, messaging,
branding, marketing and training with respect to, and other aspects of
Commercialization of, such Product; and (iii) activities required pursuant to
Section 8.1(c).
(b)    Commercialization Plan Budget. Licensee shall be responsible for
preparing a detailed budget for Commercialization Costs relating to the
activities set forth in the Commercialization Plan for each Product for each
Calendar Year covered by the Commercialization Plan (as amended from time to
time, the “Commercialization Plan Budget”), Licensee shall submit each initial
Commercialization Plan Budget and any amendments thereto to the JPC for review
and comment in accordance with Article VI. The Commercialization Plan Budgets
for the Initial Products in the EU shall be discussed at the first JPC after the
Effective Date.
(c)    Amendments to the Commercialization Plan and the Commercialization Plan
Budget. On a semiannual basis (no later than April 1st and October 1st of each
Calendar Year), or more often as the Parties deem appropriate, Licensee shall
prepare and recommend amendments to the then-current Commercialization Plan for
review and comment by the JPC in accordance with Article VI. Such amended
Commercialization Plan shall cover the immediately following twelve (12) months
of Commercialization of such Product and shall reflect any changes,
re-prioritization of activities within, reallocation of resources with respect
to, or additions to the then-current Commercialization Plan. In addition,
Licensee shall prepare semiannual updates to the Commercialization Plan Budget
(without necessarily having to amend the corresponding Commercialization Plan)
no later than April 1st and October 1st of each Calendar Year in order to
reflect changes in such budget for the following Calendar Year and submit such
amendment for review by the JPC in accordance with Section 8.1 and Article VI.
Each such amended Commercialization Plan Budget shall specify with reasonable
detail the budget for the items described in the Commercialization Plan. Once
reviewed and commented on by the JPC, the amended Commercialization Plan and/or
Commercialization Plan Budget shall become effective for the applicable period
as of the date specified in the Commercialization Plan and/or Commercialization
Plan Budget and shall supersede the previous Commercialization Plan and/or
Commercialization Plan Budget for the applicable period.
(d)    Commercial Forecast. Licensee shall be responsible for preparing annual
commercial forecasts setting forth the projected monthly Net Sales of each
Product in the Field in the Licensed Territory for the upcoming twelve (12)
months (as updated in accordance with Section 8.2(e), the “Commercial
Forecast”). The initial Commercial Forecast shall be submitted to the JPC for
review and comment no later than six (6) months prior to anticipated launch of a
Product in the Licensed Territory, and all subsequent Commercial Forecasts shall
be submitted to the JPC for review and comment by October lst of each Calendar
Year. Licensee shall consider in good faith any comments of the JPC. The initial
Commercial Forecast for each of the first Vabomere Product and the first
Orbactiv Product in the EU are attached hereto as Schedule 8.2(d).
(e)    Updates to the Commercial Forecast. Licensee shall update the Commercial
Forecast semiannually, or more often as the Parties deem appropriate, and submit
such updates to the JPC for review. Licensee shall update and submit such
semiannual updates to the Commercial Forecast no later than April 1st and
October 1st of each Calendar Year, Licensee shall consider in good faith any
comments of the JPC.

8.3    Educational Materials.
(a)    Licensee shall bear the cost and expense of preparing sales literature
and other Educational Materials for a Product in the Field in the local country
language(s) of the Licensed Territory, and shall arrange and pay for the
translation of all Educational Materials and scientific literature for use in
the Education about such Product as may be necessary for the sale of such
Product in the Licensed Territory; provided that all final copies of any such
translated materials shall be provided to Company, at Licensee’s sole cost and
expense, in advance of any use by Licensee for review, All materials prepared by
or for Licensee for the Licensed Territory shall comply with Applicable Law and
Licensee shall provide (in English translated versions) to Company for its
review and approval all corporate Educational Materials to be used in the
Licensed Territory. Should Company not reply within fifteen (15) days from the
receipt of any such material, such material shall be considered as approved. In
no event shall approval of such material be unreasonably withheld by Company,
and following any such approval, Licensee shall not make any further revisions
to such materials without Company’s further review. Any liability or Sublicensee
or customer Claims arising from any sales literature and other Educational
Materials for such Product provided or used by Licensee in the Licensed
Territory shall be the sole responsibility of Licensee, and Licensee shall
indemnify Company for any such liabilities and Claims pursuant to Section
11.1(c).
(b)    Company may from time to time make available to Licensee marketing and
technical information concerning a Product to the extent that Company considers
such information and materials necessary or useful to prepare for the Education
of potential prescribers about such Product for use in the Licensed Territory.
All such marketing and technical information will be available only in the
English language and such material so provided shall remain the property of
Company and Licensee shall promptly return the same to Company upon termination
of the Agreement at the written request of Company.

8.4    Trademarks. Subject to the terms of this Section 8.4 and the prior
written approval of Company (not to be unreasonably withheld or delayed),
Licensee shall have the right to select the trademark(s) and/or logo(s) under
which to Commercialize a Product in the Field in the Licensed Territory
(“Licensee Marks”). Licensee shall not register any Company Marks or confusingly
similar marks. Licensee shall be responsible for the registration, maintenance
and defense of any Licensee Marks as approved by Company for use in connection
with the Commercialization of a Product in the Field in the Licensed Territory,
as well as all expenses associated therewith. For clarity, by virtue of this
Agreement, no Party shall acquire any proprietary right or similar right in the
other Party’s trademark(s) and/or logo(s) and, therefore, Licensee Marks shall
remain the exclusive property of Licensee or its Affiliates (subject to the
license grant set forth in Section 13.6(b)), and Company Marks shall remain the
exclusive property of Company or its Affiliates.

8.5    Compliance with Laws.
(a)    Licensee shall comply with all Applicable Law pertaining to the
Commercialization of each Product in the Licensed Territory or otherwise
pertaining to the performance by Licensee of its obligations or the exercise of
its rights under this Agreement, including the maintenance of ongoing quality
assurance and testing procedures to comply with applicable regulatory
requirements. Licensee shall notify Company promptly in writing of any changes
in such laws and regulations in the Licensed Territory which may have a material
impact on the implementation of this Agreement. Licensee shall Commercialize
each Product only for its approved indications in the Field.
(b)    Licensee agrees, in its performance of and exercise of its rights under
this Agreement, to comply with all Applicable Law in the Licensed Territory.
(c)    In connection with this Agreement, Licensee shall not, directly or
indirectly, Commercialize any Product or engage in any other transaction in, to
or with any sanctioned countries/regions (including Cuba, Iran, North Korea,
Sudan, Syria, and Crimea) or any Person that appears on a restricted party list
maintained by the U.S. Government, including (i) the List of Specially
Designated Nationals & Blocked Persons, Office of Foreign Assets Control, U.S.
Treasury Department; (ii) the List of Debarred Parties administered Directorate
of Defense Trade Controls, U.S. State Department; (iii) the Denied Persons List,
Bureau of Industry and Security, U.S. Department of Commerce; (iv) the Entity
List, Bureau of Industry and Security, U.S. Department of Commerce; (v) the
Unverified List, Bureau of Industry and Security, U.S. Department of Commerce;
(vi) the Palestinian Legislative Counsel (PLC) List, Office of Foreign Assets
Control, U.S. Treasury Department; (vii) Foreign Sanctions Evaders List, Office
of Foreign Assets Control, U.S. Treasury Department; or (viii) Sectoral
Sanctions Identification List Office of Foreign Assets Control, U.S. Treasury
Department (any such Person on any such restricted party list, a “Restricted
Party”). Licensee represents and warrants that it is not a Restricted Party and
is not owned or controlled by, or acting on behalf of, a Restricted Party.
Licensee agrees that it will notify Company promptly upon the occurrence of any
event that would constitute a breach of this covenant or render the foregoing
representation and warranty incorrect.
(d)    Each Party represents and warrants that it shall take no action that
would cause the other Party to be in material violation of Applicable Law in the
Licensed Territory. Further, each Party shall immediately notify the other Party
if it has ascertained that a material violation of Applicable Law in connection
with the performance of or exercise of its rights under this Agreement has taken
place.
(e)    Licensee and its employees, agents and Sublicensees, if any, and Company
and its employees, agents and designees involved in the performance of this
Agreement, have not and shall not, in connection with this Agreement, directly
or indirectly through Third Parties, pay, receive, promise or offer to pay, or
authorize the payment of, anything of value or give any promise or offer to
give, or authorize the giving of anything of value, to or from a Public
Official, Entity or other Person for purposes of corruptly obtaining or
retaining business for or with, or directing business to, any Person, including
Company or Licensee, by (i) influencing any official act, decision or omission
of such Public Official or Entity, (ii) inducing such Public Official or Entity
to do or omit to do any act in violation of the lawful duty of such Public
Official or Entity, (iii) securing any improper advantage, or (iv) inducing such
Public Official or Entity to affect or influence any act or decision of another
Public Official or Entity.
(f)    Licensee and its employees, agents and Sublicensees, if any, and Company
and its employees, agents and designees involved in the performance of this
Agreement, have not and shall not, in connection with this Agreement, directly
or indirectly through Third Parties, promise, offer or provide any illegal
payment, gratuity, emolument, bribe, kickback, excessive gift or hospitality or
other illegal or unethical benefit to a customer or a Third Party customer or to
a Public Official or Entity. In addition, each Party and its employees and
agents shall ensure that no part of any payment, commission, reimbursement or
fee paid by the other Party pursuant to this Agreement or otherwise will be
used, directly or indirectly, as a corrupt payment, gratuity, emolument, bribe,
kickback, excessive gift or hospitality or other illegal or unethical benefit to
a Third Party customer or to a Public Official or Entity. Licensee hereby
covenants that: (i) it will promptly notify Company in the event it becomes
aware that it or its Affiliates or Sublicensees has been convicted for
violations of any Anti-Corruption Law with respect to any Product; and (ii) upon
Company’s request after receiving any such notice, Licensee will (or will cause
such Affiliate or Sublicensee to) immediately terminate its relationship with
such Affiliate or Sublicensee with respect to the Product.
(g)    No owner, shareholder (direct or beneficial) or other individual with any
direct or indirect beneficial interest in Licensee, or any immediate family
relation of any such person who may be in a position to influence the business
under this Agreement (each, an “Interested Person”), is a Public Official or
Entity. Licensee shall notify Company immediately if, during the term of this
Agreement, (i) any Interested Person becomes a Public Official or Entity or (ii)
any Public Official or Entity acquires a legal or beneficial interest in
Licensee.
(h)    Each Party agrees that in the event that any of the covenants contained
in this Section 8.5 are not complied with in accordance with their terms, the
non-defaulting Party shall have the right, at its sole discretion, to terminate
this Agreement immediately upon written notice to the defaulting Party.
(i)    Each Party agrees to reasonably cooperate with the other Party with
respect to any investigation or audit relating to the performance of this
Agreement and Applicable Law in the Licensed Territory.
(j)    Licensee agrees that in any sublicenses granted by Licensee to a Third
Party pursuant to the exercise of Licensee’s rights under this Agreement,
Licensee shall include in such sublicenses applicable anti-corruption provisions
substantially similar in scope as those set forth in this Section 8.5.

8.6    Customer Support. Licensee shall be fully responsible for all technical
and medical support of Licensee’s customers in the Field in the Licensed
Territory.

8.7    Product Information. Licensee shall distribute each Product with all
packaging, warranties, disclaimers, patient consent forms and product
information as required by Applicable Law in the Licensed Territory. In no event
shall Company assume any liability for materials created or used by Licensee.

8.8    Records. Licensee shall maintain complete and accurate books and records
with respect to the sale and distribution of all Products in accordance with the
applicable Accounting Standards and as required by regulatory requirements that
are applicable to the Licensed Territory. Without prejudice to Sections 7.11 and
7.12, Company shall have the right, during reasonable business hours and with
reasonable prior notice, to inspect (i) such books and records and (ii) the
facilities of Licensee, its Affiliates and Sublicensees which are used or
provided in connection with the sale, administration and stocking of any Product
for regulatory affairs reasons. Licensee shall, and shall cause its Affiliates
and Sublicensees to, maintain all records and reports required under this
Agreement relating to any Product for a period of five (5) years or longer as
required by Applicable Law.

8.9    Additional Obligations.
(a)    The Parties understand, acknowledge and agree that the continued
maintenance of an image of excellence and a high level of ethical marketing of a
Product is essential to the success of sales of such Product in the Licensed
Territory. Accordingly, Licensee agrees that its Commercialization efforts will
not reflect unfavorably on, or dilute in any way, the image of excellence of
Company and the high level of ethical marketing practiced by Company and its
other distributors. Licensee shall not take any action, or omit to take any
action, that, directly or indirectly, would impair such image or lower the
prestige of such Product or of Company.
(b)    Licensee agrees that it will: (i) present each Product fairly to
potential customers; (ii) not disparage in any manner such Product, Company, and
any trademarks (including Company Marks), trade names or service marks owned or
used by Company, whether in connection with sales of such Product or otherwise;
(iii) not modify such Product or any such trademarks, trade names or service
marks in any way except as permitted by this Agreement; (iv) attempt to register
or otherwise assert any rights in or to any trademarks, trade names or service
marks owned or used by Company in connection with such Product; and (v) do all
things reasonably necessary and appropriate to promote the reputation of such
Product and the value of any such trademarks, trade names or service marks.

8.10    Insurance.
(a)    Without limiting its other obligations under this Agreement, each Party
shall effect and maintain at its own expense with reputable insurance companies
a Third Party and product liability insurance policy with a limit of liability
not lower than [***] for any occurrence or series of occurrences arising out of
any event or series of events in connection with a Product; the policy shall be
extended to any “product recall” with a sublimit not lower than [***].
(b)    Notwithstanding the foregoing, each Party may self-insure any or a
portion of the above required insurance and agrees to maintain such coverage for
(i) a minimum of five (5) years after the expiration of this Agreement, or (ii)
five (5) years after the end of the selling and distribution process of Product
by Licensee, whichever is longer.
(c)    Upon request of the other Party, either Party will provide the other
Party with a certificate of insurance issued by any Third Party insurer or by
the broker which shall include the details of any Third Party policy, including:
the name of the insurer, the insured business activity, the policy number, the
effective date, the expiration date and the limits of liability applied.
(d)    Each Party shall indemnify and hold harmless the other Party (including
after termination or expiration of this Agreement) from and against all Losses
payable or owed by such Party in connection with any Third Party Claim to the
extent arising from a failure of a Party to keep in effect and maintain any of
the insurance coverage required under this Section 8.10 (including insurance
premiums).

ARTICLE IX -     INTELLECTUAL PROPERTY

9.1    Intellectual Property Ownership.
(a)    The Parties acknowledge and agree that, as between the Parties, except
for the rights expressly granted herein, all right, title and interest in and to
any Company Intellectual Property rights in or covering a Product shall reside
solely in Company. Any inventions made, developed, conceived or reduced to
practice by or on behalf of Licensee, its Affiliates or Sublicensees in the
course of performance of this Agreement or the Supply Agreements, including
Regulatory Data, and any Intellectual Property relating thereto (collectively,
the “New IP”) and, shall be owned solely by Company. In connection with the
foregoing: (i) Licensee hereby does, and shall cause its Affiliates and
Sublicensees to, assign and transfer to Company all right, title, and interest
in and to such New IP and agrees to take all further acts reasonably required to
evidence such assignment and transfer to Company; and (ii) such New IP shall
constitute Company Know-How or Company Patents, as applicable, for purposes of
this Agreement.
(b)    All Intellectual Property owned by a Party as of the Effective Date shall
continue to be owned by such Party, and except as expressly set forth in this
Agreement, neither Party shall have any rights to any Intellectual Property of
the other Party.

9.2    Protection of Rights.
(a)    Licensee shall not (and shall cause its Affiliates and Sublicensees not
to) dispute or contest or assist others, directly or indirectly, to dispute or
contest the validity of any of Company’s Intellectual Property rights concerning
any Product. If Licensee so disputes or contests or assists others to dispute or
contest the validity of any of the foregoing rights of Company, Company shall
have the right to terminate this Agreement immediately upon written notice to
Licensee.
(b)    Licensee shall not omit or alter any Patent numbers, trade names,
trademarks, numbers, serial numbers or other Company markings affixed on any
Product obtained from Company under the Supply Agreements, or alter any
Product’s labeling, except with the prior written consent of Company.
(c)    Licensee is not authorized to use the trademark and trade name “Melinta
Therapeutics, Inc.” (or any portion thereof) in any manner except to indicate,
during the Term and only in the Field and in the Licensed Territory, that it is
an authorized licensee of Company and if applicable, Developer of the Product
with respect to the Field and the Licensed Territory. Any such usage on the
packaging of the Products shall be in accordance with the Supply Agreement.
Nothing herein shall be construed to grant, transfer or assign to Licensee any
right, title or interest in or to any Company Marks.

9.3    Prosecution and Maintenance. Subject to the rights of the applicable
Upstream Party, Company shall have the right, but not the obligation, to file,
prosecute and maintain Company Patents that constitute Company IP in the
Licensed Territory at Company’s sole cost and expense. In such case Licensee
shall, upon the request of Company, provide Company with all reasonable
assistance and cooperation in connection therewith. Company will keep Licensee
reasonably informed of the status of the prosecution and maintenance of such
Company Patents, including with respect to the status of any material filings
and material communications with any patent authority within the Licensed
Territory. Subject to the rights of the applicable Upstream Party, should
Company decide not to file, prosecute and/or maintain any such Company Patent in
any country in the Licensed Territory, then Licensee shall have the right, but
not the obligation, at its cost and expense, to file, prosecute and/or maintain
such Company Patent in the Licensed Territory at Licensee’s sole cost and
expense.

9.4    Product Infringement Claims.
(a)    Response to Third Party Infringement. Licensee shall (and shall cause its
Affiliates and Sublicensees to) promptly (and in no event later than ten (10)
days) advise Company in writing of any infringement or potential infringement or
unauthorized use of the Company IP by Third Parties of which Licensee (or such
Affiliate or Sublicensee) becomes aware relating to any Product in the Licensed
Territory. Subject to the rights of the applicable Upstream Party, Company shall
have the first right, but not the obligation, to institute any Proceedings
against such alleged infringers at Company’s sole cost and expense. In such
case, (i) Licensee agrees to cooperate with and assist Company in any such
action, suit or other Proceeding, and (ii) subject to the last sentence of this
Section 9.4(a), Company shall have sole control over and the exclusive right to
prosecute and/or negotiate and approve any settlement of such suits. Should
Company decide not to institute any Proceeding against such alleged infringers
within ninety (90) days from Company’s receipt of notice from Licensee or from
the Company’s knowledge of the infringement (whichever occurs first) then
subject to the rights of the applicable Upstream Party, Licensee shall have the
right, but not the obligation, to institute any Proceedings against such alleged
infringers at Licensee’s sole cost and expense. In such case, (A) Company agrees
to cooperate with and assist Licensee in any such action, suit or other
Proceeding and (B) subject to the last sentence of this Section 9.4(a), Licensee
shall have sole control over and the exclusive right to defend and/or negotiate
and approve any settlement of such suits. Notwithstanding the foregoing, neither
Party shall settle or compromise any action, suit or other Proceeding described
in this Section 9.4(a) without the prior written consent of the other Party,
which consent shall not unreasonably withheld or delayed.
(b)    Recovery. Except as otherwise agreed to by the Parties, any monetary
award recovered from a Third Party in connection with any Proceeding described
in Section 9.4(a) in respect of the Licensed Territory related to a Product in
the Field, whether the recovery is by settlement or otherwise, shall be shared
as follows:
(i)    the Party that initiated and prosecuted the action shall recover all of
its costs and expenses (including all court and reasonable attorneys’ fees)
incurred in connection with the action (which, in the case of Company, may
include costs and expenses of, and reimbursed to, any Upstream Party pursuant to
the applicable Upstream Agreement);
(ii)    the other Party then shall, to the extent possible, recover its
reasonably documented costs and expenses (including reasonable attorneys’ fees)
incurred in connection with the action (which, in the case of Company, may
include costs and expenses of, and reimbursed to, any Upstream Party, pursuant
to the applicable Upstream Agreement);
(iii)    the amount of any recovery for lost sales of the Product in the Field
in the Licensed Territory shall be retained by Licensee, net of an amount that
shall be paid to Company equal to the royalty that would have been payable to
Company under Section 7.5(a) if such recovery or settlement proceeds were to
constitute Net Sales of the Product at issue; and
(iv)    the remainder of any recovery for any other damages, if any, to the
extent related to a Product in the Field in the Licensed Territory shall be
split equally between the Parties.
With respect to any infringement or potential infringement or unauthorized use
of the Company IP by Third Parties both inside and outside the Licensed
Territory, the Parties shall in good faith allocate any recoveries attributable
to such infringement or unauthorized use between that occurring in the Licensed
Territory (which shall be allocated between the Parties as provided above in
this Section 9.4(b)) and that occurring in territories outside the Licensed
Territory (which shall be retained in full by Company).
(c)    Infringement of Third Party Intellectual Property. Subject to Section
11.2(d), in the event of any Third Party Claim that the Manufacture, use or sale
of a Product in the Licensed Territory infringes the Intellectual Property
rights of such Third Party, (i) Company shall have the first right, but not the
obligation, to defend (including the right to settle) such Claim, in its sole
discretion and at its sole cost and expense, and (ii) if it decides not to
defend such Claim, then Licensee shall have the right, but not the obligation,
to defend (including the right to settle) such Claim; provided that Licensee
shall not agree to settle or compromise any such Claim without the prior written
consent of Company, which consent shall not be unreasonably withheld or delayed.
(d)    No Liability for Unauthorized Uses or Modifications. Company shall have
no liability for any infringement Claim resulting from the use or combination of
any Product with goods, materials or services not supplied by Company, or any
modification or alteration of such Product, where such infringement Claim
results from such use, combination, modification or alteration, including such
unauthorized use in any Development by or on behalf of Licensee of such Product.

9.5    Personnel Obligations. Prior to beginning any work under this Agreement,
each officer, director, employee, agent and outside advisor of Licensee, its
Affiliates or Sublicensees shall be bound by non-disclosure and invention
assignment obligations which are consistent with the obligations of Licensee, as
appropriate, in this Article IX, including: (a) promptly reporting to the
Company any invention, discovery, process or other Intellectual Property
relating to a Product; (b) assigning to the Company all of his, her or its
right, title and interest in and to any invention, discovery, process or other
Intellectual Property relating to a Product; (c) taking actions reasonably
necessary to secure Patent protection; (d) performing all acts and signing,
executing, acknowledging and delivering any and all documents required for
effecting the obligations and purposes of this Agreement; and (e) abiding by the
obligations of confidentiality and non-use set forth in Article VII.

ARTICLE X -     REPRESENTATIONS AND WARRANTIES

10.1    Representations and Warranties of Each Party. Each Party hereby
represents and warrants to the other Party as of the Effective Date that:
(a)    such Party is duly organized, validly existing and in good standing under
the laws of the jurisdiction of its incorporation and has full corporate power
and authority to enter into this Agreement and to carry out the provisions
hereof;
(b)    such Party has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder;
(c)    this Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, binding obligation, enforceable against
it in accordance with the terms hereof;
(d)    the execution, delivery and performance of this Agreement by such Party
does not conflict with any agreement or any provision thereof, or any instrument
or understanding, oral or written, to which it is a party or by which it is
bound, nor violate any Applicable Law of any Governmental Authorities having
jurisdiction over such Party; and
(e)    neither such Party nor any Affiliate thereof has been excluded from
participation in any government healthcare program, debarred or disqualified
from or under any other federal program, convicted of any offense defined in 42
U.S.C. § 1320a-7, or otherwise deemed ineligible for participation in any
healthcare programs, nor is aware of any pending or potential actions that would
give rise to any such ineligibility.

10.2    Additional Company Representations and Warranties. Company hereby
represents and warrants to Licensee as of the Effective Date that:
(a)    Company is entitled to grant the rights and licenses granted to Licensee
as set forth in this Agreement;
(b)    Company has not granted in the Licensed Territory any right or license in
or to any of the Company IP in the Licensed Territory that is in conflict with
the rights or licenses granted to Licensee under this Agreement;
(c)    Company has not granted as of the Effective Date any liens or security
interests to the Company IP other than under any licenses or sublicenses or as
security for debt financing of the Company, in each case, that would not
conflict or otherwise interfere with the rights or licenses granted to Licensee
under this Agreement;
(d)    as of the Effective Date, Company has not received any written notice
that the Development, Manufacture or Commercialization of the Product in the
Licensed Territory infringes or misappropriates any Patents or any Know-How
Controlled by a Third Party; and
(e)    as of the Effective Date, no commitments to Regulatory Authorities have
been undertaken with reference to the Products in the Licensed Territory other
than those expressly set forth in Schedule 10.2(e). No representation or
warranty is made (i) that Schedule 10.2(e) is a list of all commitments that may
be required by applicable Regulatory Authorities in connection with Regulatory
Approvals of the Products after the Effective Date or (ii) regarding the
likelihood of meeting the deadlines included therein.
With specific reference to the Vabomere Product, Company hereby represents and
warrants to Licensee that no Third Party (including the U.S. Government) may
claim any right under the Contract between Rempex Pharmaceuticals, Inc and the
United States of America for the advanced development of Carbavance executed
31/1-4/2/2014 or under the Other Transaction Agreement between The Medicines
Company and the United States of America, Department of Health and Human
Services executed 15/09/2016 or under any other contract which may restrict the
exercise by Licensee of the rights and licenses granted from Company to Licensee
under this Agreement or which may restrict the exclusive commercial exploitation
of the Product in the Licensed Territory by Licensee notwithstanding the rights
of the United States of America under the aforementioned Contract and Other
Transaction Agreement or under any other contract, including those rights set
forth in Public Law 96-517 (35 U.S.C. §§ 200-212).

10.3    Warranty Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NO
WARRANTIES, EXPRESS OR IMPLIED, ARE GIVEN IN RESPECT OF THE PRODUCT, AND ANY
IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PURPOSE OR NON-INFRINGEMENT
OF THIRD PARTY INTELLECTUAL PROPERTY IS HEREBY EXPRESSLY DISCLAIMED.

10.4    Limitation of Damages. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT
OR OTHERWISE, EXCEPT IN CASE OF (A) DELIBERATE BREACH OF CONTRACT OF A PARTY,
(B) WILLFUL MISCONDUCT OF A PARTY, OR (C) INDEMNIFICATION UNDER SECTIONS 11.1
AND 11.2, NO PARTY WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES,
EXPENSES, LOST PROFITS, LOST SAVINGS OR INTERRUPTIONS OF BUSINESS.

ARTICLE XI -     INDEMNIFICATION

11.1    Indemnification by Licensee. Licensee shall defend, indemnify and hold
harmless Company, its Affiliates, and their respective officers, directors and
employees, from and against any damages, losses, liabilities, costs and expenses
(including court and arbitration costs and reasonable attorneys’ fees), judicial
or arbitration damage awards, and settlement payments (collectively, “Losses”)
payable or owed by such parties in connection with any Claims of Third Parties
(“Third Party Claims”) to the extent arising from: (a) activities of -Licensee,
its Affiliates and Sublicensees under this Agreement, including the Development,
Manufacture, and Commercialization of a Product (including product liability
Claims arising from the Development, Manufacturing, and Commercialization of
such Product in the Licensed Territory); (b) any breach by Licensee, its
Affiliates or Sublicensees of a representation, warranty, covenant or agreement
of Licensee under this Agreement; (c) Product claims, whether written or oral,
made by Licensee, its Affiliates or Sublicensees in its advertising, publicity
or sale of, or Education of potential prescribers about, a Product; (d) handling
by Licensee, its Affiliates or Sublicensees of a Product or changes, additions
or modifications to a Product by or on behalf of Licensee or made at Licensee’s
request; (e) any Intellectual Property Claims arising out of Licensee’s, its
Affiliates’ and Sublicensees’ use of any Licensee Marks or modifications to any
Product provided by Company; or (f) any negligence or intentional misconduct or
omissions by Licensee, its Affiliates or Sublicensees.

11.2    Indemnification by Company. Company shall defend, indemnify and hold
harmless Licensee, its Affiliates and Sublicensees, and their respective
officers, directors and employees, from and against any Losses payable or owed
by such parties in connection with any Third Party Claim to the extent arising
from: (a) activities of Company, its Affiliates and its designees under this
Agreement, including the Development and Manufacturing of Product; (b) any
breach by Company or its Affiliates of a representation, warranty, covenant or
agreement of Company under this Agreement; (c) Licensee’s, its Affiliates’ and
Sublicensees’s use of Product claims, whether written or oral, in their
advertising, publicity or sale of or Education of potential prescribers about, a
Product where such claims were provided by Company, its Affiliates or designees;
(d) subject to Section 9.4(d), any Intellectual Property Claims arising out of
Licensee’s, its Affiliates’ and Sublicensees’ sale of a Product in the Field in
the Licensed Territory in accordance with the terms and conditions of this
Agreement, but excluding any New IP or any Intellectual Property Claims arising
out of Licensee’s, its Affiliates’ or Sublicensees’ use of any Licensee Marks;
or (e) any negligence or intentional misconduct or omissions by Company or its
Affiliates.

11.3    Conditions and Limitations of Indemnification Obligation. A Person
entitled to indemnification pursuant to either Section 11.1 or Section 11.2,
will hereinafter be referred to as an “Indemnified Party.” A Party obligated to
indemnify an Indemnified Party hereunder will hereinafter be referred to as an
“Indemnifying Party.” In the event an Indemnified Party is seeking
indemnification under either Section 11.1 or Section 11.2, the Indemnified Party
shall inform the Indemnifying Party as soon as reasonably practicable after it
receives notice thereof, it being understood and agreed that the failure by an
Indemnified Party to give notice of a Third Party Claim as provided in this
Section 11.3 shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that such
Indemnifying Party is actually and materially prejudiced as a result of such
failure to give notice. The Indemnified Party shall permit the Indemnifying
Party to assume direction and control of the defense of Third Party Claim and,
at the Indemnifying Party’s expense, shall cooperate as reasonably requested in
the defense of such Third Party Claim. The Indemnified Party shall have the
right to retain its own counsel at its own expense; provided that, if the
Indemnifying Party assumes control of such defense and the Indemnified Party
reasonably concludes, based on advice from counsel, that the Indemnifying Party
and the Indemnified Party have conflicting interests with respect to such Third
Party Claim, the Indemnifying Party shall be responsible for the cost of one
counsel for the Indemnified Party (and all other Indemnified Parties in
connection with the same Third Party Claim or multiple Third Party Claims
arising out of the same events or circumstances). The Indemnifying Party may not
settle such Third Party Claim, or otherwise consent to an adverse judgment in
such Third Party Claim, without the Indemnified Party’s prior written consent
not to be unreasonably withheld or delayed; provided that the Indemnifying Party
shall not require such consent with respect to the settlement of any Third Party
Claim (i) where the sole relief provided is for monetary damages that are paid
in full by the Indemnifying Party, (ii) which would not materially diminish or
limit or otherwise adversely affect the rights, activities or financial
interests of the Indemnified Party, and (iii) which does not result in any
finding or admission of fault by the Indemnified Party. The Indemnified Party
may not settle such Third Party Claim, or otherwise consent to an adverse
judgment in such Third Party Claim, without the Indemnifying Party’s prior
written consent not to be unreasonably withheld or delayed.

ARTICLE XII -     CONFIDENTIALITY

12.1    Confidentiality; Exceptions. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree that the
receiving Party (the “Receiving Party”) shall keep confidential and shall not
publish or otherwise disclose or use for any purpose other than as provided for
in this Agreement any information or other confidential and proprietary
information and materials, patentable or otherwise, in any form (written, oral,
photographic, electronic, magnetic or otherwise) which is disclosed to it by the
other Party (the “Disclosing Party”) or otherwise received or accessed by a
Receiving Party in the course of performing its obligations or exercising its
rights under this Agreement, including trade secrets, Know-How, inventions or
discoveries, proprietary information, formulae, processes, techniques and
information relating to the Disclosing Party’s past, present and future
marketing, financial and research, Development, Manufacturing, or
Commercialization activities of any product or potential product or useful
technology of the Disclosing Party (collectively, “Confidential Information”),
except to the extent that it can be established by the Receiving Party that such
Confidential Information: (a) was in the lawful knowledge and possession of the
Receiving Party prior to the time it was disclosed to, or learned by, the
Receiving Party, or was otherwise developed independently by the Receiving
Party, as evidenced by written records kept in the ordinary course of business,
or other documentary proof of actual use by the Receiving Party; (b) was
generally available to the public or otherwise part of the public domain at the
time of its disclosure to the Receiving Party; (c) became generally available to
the public or otherwise part of the public domain after its disclosure and other
than through any act or omission of the Receiving Party in breach of this
Agreement; or (d) was disclosed to the Receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
Disclosing Party not to disclose such information to others. All information
disclosed under any confidentiality agreement entered into between Company and
Licensee prior to the Effective Date relating to the Products, shall be deemed
to be Confidential Information and such agreement shall be superseded by the
terms hereof and terminated effective as of the Effective Date. Notwithstanding
this Section 12.1, New IP disclosed and assigned to Company by or on behalf of
Licensee pursuant to Section 9.1(a) shall be considered the Confidential
Information of Company.

12.2    Authorized Disclosure. Except as expressly provided otherwise in this
Agreement, a Receiving Party shall be entitled to disclose Confidential
Information of the Disclosing Party as follows: (a) to the Receiving Party’s
Affiliates, employees, officers, directors, agents, consultants, legal counsel
and/or other Third Parties under appropriate confidentiality provisions no less
stringent than those in this Agreement, in connection with the performance of
its obligations or exercise of its rights under this Agreement; (b) to the
extent such disclosure is reasonably necessary in defending litigation,
complying with applicable governmental regulations or otherwise required by
Applicable Law; provided, however, that if a Receiving Party is required by
Applicable Law to make any such disclosure of a Disclosing Party’s Confidential
Information it will give reasonable advance notice, where practicably possible,
to the Disclosing Party of such disclosure requirement and, except to the extent
inappropriate in the case of Patents, will use its reasonable efforts to secure
confidential treatment of such Confidential Information required to be
disclosed; (c) to potential or actual acquirers, merger candidates, licensees or
investors or venture capital firms, investment bankers or other financial
institutions, lenders or investors, and professional advisors thereof, provided,
that in connection with such disclosure, such Receiving Party shall inform each
such disclosee of the confidential nature of such Confidential Information and
cause each such disclosee to treat such Confidential Information as
confidential; or (d) to the extent mutually agreed to in writing by the Parties;
provided, however, that, in each of the above situations, the Receiving Party
shall remain responsible for any failure by any Person who receives the
Confidential Information pursuant to this Section 12.2 to treat such
Confidential Information as required under this Article VII.

12.3    Disclosure of Agreement. Licensee shall not, and shall cause its
Affiliates and Sublicensees not to, issue any press release or other public
disclosure regarding the Agreement or the Parties’ activities hereunder, or any
results or data arising hereunder, except (a) with Company’s prior written
consent, or (b) for any disclosure that is reasonably necessary to comply with
applicable national securities exchange listing requirements or Applicable Law.
The Parties agree to consult with each other reasonably and in good faith with
respect to the text and timing of any such press releases prior to the issuance
thereof, and Company may not unreasonably withhold consent to such releases.
Company shall not issue an initial press release, or any subsequent press
release or public disclosure that involves Licensee, except with Licensee’s
prior written consent, not to be unreasonably withheld. Except to the extent
required by Applicable Law or as otherwise permitted in accordance with this
Section 12.3, neither Party shall make any public announcements concerning this
Agreement or the subject matter hereof without the prior written consent of the
other, which shall not be unreasonably withheld or delayed. Notwithstanding the
foregoing, to the extent information regarding this Agreement has already been
publicly disclosed in the same context, either Party may subsequently disclose
the same information to the public without the consent of the other Party.

ARTICLE XIII -     TERM AND TERMINATION

13.1    Term. The term of this Agreement shall commence on the Effective Date
and, unless sooner terminated as provided in this Agreement, shall continue in
effect so long as Licensee, its Affiliates or Sublicensees are selling any
Product in the Licensed Territory (the “Term”).

13.2    Termination by Company for Breach. Company shall have the right to
terminate this Agreement during the Term upon sixty (60) days’ notice if
Licensee materially breaches this Agreement and does not cure such breach within
sixty (60) days following written notice by Company, except as otherwise
provided in this Agreement. Any termination by Company under this Section 13.2
may be made in Company’s sole discretion with respect to: (a) a Product (i.e.
all Vabomere Products, Orbactiv Products, and/or Minocin IV Products); (b) the
Licensed Territory in its entirety; or (c) in the case of a breach which is
specific to a country in the Licensed Territory, such country. Effective upon
such termination under clause (a), such Product shall be deemed a Terminated
Product, and effective upon such termination under clause (c), such country
shall be deemed a Terminated Country. Notwithstanding the foregoing, Company
shall be entitled to terminate this Agreement immediately in the event of a
breach of Section 9.2(a) in accordance with the terms of such section.

13.3    Termination by Licensee for Breach. Licensee shall have the right to
terminate this Agreement in whole or with respect to a Product (i.e. all
Vabomere Products, Orbactiv Products, and/or Minocin IV Products) or on a
country-by-country basis, during the Term upon sixty (60) days’ notice if
Company materially breaches this Agreement with respect to such Product or
country and does not cure such breach within sixty (60) days following written
notice by Licensee. Effective upon such termination (a) with respect to a
Product, such Product shall be deemed a Terminated Product; (b) with respect to
a country, such country shall be deemed a Terminated Country.

13.4    Termination of Countries within the Licensed Territory.
(a)    If at any time during the Term following the one (1) year anniversary of
the Effective Date, Company receives a bona fide offer from a Third Party to
Develop and Commercialize any Product within the Field in the Licensed
Territory, and at the time of Company’s receipt of such offer, (i) Licensee is
not currently and actively Developing or Commercializing the applicable Product
in the Field in such country, whether itself or through its Affiliates or
Sublicensees, and (ii) either (A) the JSC has not approved a Licensee-submitted
Development Plan or Commercialization Plan for such Product in such country, or
(B) where the First Commercial Sale of such Product in the Field in such country
has not occurred for a period of twelve (12) months despite having received a
Regulatory Approval or Pricing Approval (whichever occurs later) for such
Commercialization, then the Parties will meet and discuss in good faith
Licensee’s intentions to Develop and Commercialize such Product in such country.
If within six (6) months of the commencement of such discussions (x) Licensee
elects not to Develop or Commercialize such Product in such country, (y) the JSC
does not approve a Development Plan for such Product in such country, or (z) the
First Commercial Sale of such Product in the Field in such country has not
occurred despite having received Regulatory Approval or Pricing Approval
(whichever occurs later) for such Commercialization, then Company shall have the
right to terminate this Agreement in part with respect to such Product in such
country immediately upon written notice, with each such Product deemed a
Terminated Product and each such country deemed a Terminated Country. If the
right to terminate this Agreement is exercised in accordance with Section 13.4,
such exercise shall be the sole and exclusive remedy available to Company and in
lieu of any other remedy under the laws or hereunder for the events having given
rise to the right to terminate under this Section 13.4.
(b)    Company shall have the right to terminate this Agreement with respect to
Minocin IV pursuant to Section 5.2(a).

13.5    Insolvency Event; Bankruptcy Rights. Either Company or Licensee may
terminate this Agreement in the event that the other Party becomes insolvent or
is subject to reorganization, winding up, dissolution, bankruptcy, liquidation
proceedings, judicial or extrajudicial reorganization, or other similar
Applicable Law now or thereafter in effect, or makes an assignment for the
benefit of creditors, during the Term of this Agreement. Termination under this
Section 13.5 shall be effective immediately. Notwithstanding the foregoing, in
the event that this Agreement is terminated or rejected by a Party or its
receiver or trustee under applicable bankruptcy laws due to such Party’s
bankruptcy then all rights and licenses granted under or pursuant to this
Agreement by such Party to the other Party are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the United States Bankruptcy Code and any
similar law or regulation in any other country, licenses of rights to
“intellectual property” as defined under Section 101(52) of the United States
Bankruptcy Code. The Parties agree that all intellectual property rights
licensed hereunder, including without limitation, any patents or patent
applications of a Party in any country covered by the license grants under this
Agreement, are part of the “intellectual property” as defined under Section
101(52) of the United States Bankruptcy Code subject to the protections afforded
the non-terminating Party under the Section 365(n) of the United States
Bankruptcy Code, and any similar law or regulation in any other country.

13.6    Effect of Termination. Except as otherwise provided in this Agreement,
upon termination of this Agreement, in whole or in part with respect to a
Terminated Product or a Terminated Country, the following consequences shall
apply:
(a)    Licensee’s rights and each of Licensee and Company’s obligations under
this Agreement with respect to each Terminated Product and each Terminated
Country, as applicable, shall terminate, except as otherwise contemplated by
this Section 13.6.
(b)    All Company Marks, trade names, Company Patents, copyrights, designs,
drawings, formulas or other data, photographs, samples, literature, and sales
and Educational aids of any kind related to a Terminated Product or a Terminated
Country shall be the sole and exclusive property of Company. Within sixty (60)
days after the effective date of termination of this Agreement with respect to
such Terminated Product or Terminated Country, as applicable, Licensee shall
return to Company or destroy all tangible items bearing, containing, or
contained in, any of the foregoing with respect to the Terminated Product and
the Terminated Country, in its possession or control and provide written
certification of such destruction, or prepare such tangible items for shipment
to Company, as Company may direct, at Company’s sole cost and expense. Licensee
shall not make or retain any copies of any confidential or proprietary items or
information, which may have been entrusted to it following termination of this
Agreement in its entirety. Effective upon the termination of this Agreement, in
whole or in part, Licensee shall cease to use all trademarks and trade names of
Company with respect to the Terminated Country or Terminated Product, or with
respect to the Terminated Product itself. In the event of the termination of
this Agreement by Company pursuant to Section 13.2 or Section 13.4, Licensee
hereby grants to Company a perpetual, exclusive license, with the right to
sublicense, to use the Licensee Marks in connection with the Manufacture,
Development, use and Commercialization of such Terminated Product in the
Terminated Country, and upon termination of this Agreement in its entirety, in
any country in the world. Company shall, on a country-by-country basis, pay
Licensee a royalty of one percent (1 %) of Net Sales of each Terminated Product
sold by Company under a Licensee Mark in a country within a Terminated Country.
(c)    Licensee shall not be released from paying any amount which may then be
owed to Company. In the event of any termination of this Agreement, all
obligations owed by Licensee to Company and to its Affiliates with respect to
such Terminated Country and Terminated Product, as applicable, shall become due
and payable on the effective date of termination,
(d)    All rights and title in and to any and all Regulatory Data and Regulatory
Materials provided by or on behalf of Company to Licensee and any Regulatory
Data and Regulatory Materials generated by or on behalf of Licensee on the basis
of this Agreement shall immediately revert to Company, and Licensee shall have
no residual rights to such data or materials. Company may, in its reasonable
discretion in accordance with Applicable Law, appoint itself, an Affiliate or
Third Party as successor to Licensee with respect to any applicable CTA,
Regulatory Approval or Pricing Approval (the “Successor Entity”). Licensee shall
and shall cause its Affiliates and Sublicensees to transfer and assign to
Company or the Successor Entity, as applicable, all CTAs, Regulatory Approvals,
Pricing Approvals, permits, filings and authorizations (including reimbursement
authorizations), if any, obtained by or on behalf of Licensee, including those
obtained from or on behalf of Company in connection with activities undertaken
under this Agreement, not later than the effective date of such termination or
as soon as practicable if this Agreement is terminated immediately without prior
notice. Licensee shall and shall cause its Affiliates and Sublicensees to
reasonably cooperate, at Company’s request and expense, in making any filings,
executing any instruments or taking other actions reasonably necessary to make
such transfer of the foregoing. In case the transfer is not allowed under
Applicable Law, Licensee shall apply for the cancellation of the CTA, Regulatory
Approval and/or Pricing Approval, as the case may be, simultaneously provide
full cooperation to Company or its duly qualified designee in connection with
the new application of the CTA, Regulatory Approval and/or Pricing Approval in
Company’s (or its designee’s) own name. If for any reason Licensee fails to
cooperate in connection with such transfer, or cancellation, pursuant to this
Section 13.6, Licensee hereby authorizes Company to effect such transfer or
cancellation on behalf of Licensee. Prior to the CTA, Regulatory Approval and/or
Pricing Approval being issued by the Regulatory Authority in the name of Company
or its designee, Licensee agrees to provide Company or its designee, within a
reasonable time from receipt of Company’s written request, the necessary written
authorizations, statements and documents required under Applicable Law for
Company or its designee to, freely and without interruption, Develop and
Commercialize any such Terminated Product in a Terminated Country under
Licensee’s Regulatory Approval and/or Pricing Approval.
(e)    If not prohibited by Applicable Law, Licensee shall, at Company’s
request, promptly assign to Company all of Licensee’s and its Affiliates’ and
Sublicensees’ rights and obligations under tender contracts for such Terminated
Country with any Third Parties that grant to such Third Parties rights to
purchase a Product to the extent that such tender contract relates to such
Terminated Product.
(f)    The termination of this Agreement for any reason shall be without
prejudice to any rights that shall have accrued to the benefit of any Party
prior to such termination, including the payment obligations hereunder and any
and all Losses or remedies arising from any breach hereunder. Such termination
shall not relieve any Party from obligations which are expressly indicated to
survive termination of this Agreement.

13.7    Survival. Subject to Section 13.6(f), the provisions of 2.4, 2.5 (last
sentence only), 3.4 (so long as any Product is on the market), 5.6(b) (with
respect to Costs incurred prior to expiration or termination of this Agreement),
7.8, 7.9, 7.10, 7.11, 7.12, 8.8, 8.10, 9.1, 9.4, 10.3, 10.4, 13.6 and this 13.7,
and Article I, Article XI, Article XII, Article XIV and Article XV shall survive
the expiration or termination of this Agreement for any reason. Except as
otherwise set forth herein, all other rights and obligations of the Parties
shall cease upon expiration or termination of this Agreement.

ARTICLE XIV -     DISPUTES

14.1    Disputes. Subject to Section 14.3 and unless otherwise provided in this
Agreement, any and all Claims, disputes or controversies arising under, out of
or in connection with this Agreement or the Ancillary Agreements shall be
referred to the Parties’ Senior Officers, who shall use good faith efforts, in
compliance with this Section 14.1, to resolve promptly such matter, which good
faith efforts will include at least one meeting between such Senior Officers
within fifteen (15) days after the referral of such matter to them. If the
Senior Officers are unable to reach unanimous agreement on any such matter
within thirty (30) days of such matter being referred to them, either Party may
elect to submit such dispute to the Parties’ CEOs. Such CEOs will use good faith
efforts, in compliance with this Section 14.1, to resolve promptly such matter,
which good faith efforts will include at least one meeting between such CEOs
within ten (10) days after the submission of such dispute to them. If the CEOs
are unable to reach unanimous agreement on any such dispute within twenty (20)
days of such matter being referred to them, either Party shall be free to
initiate the arbitration Proceedings outlined in Section 14.2.

14.2    Dispute Resolution.
(a)    Arbitration. Subject to Section 14.2(b), any unresolved disputes between
the Parties shall be resolved by final and binding arbitration as follows:
(i)    Whenever a Party decides to institute arbitration proceedings, it shall,
as promptly as practicable, give written notice to that effect to the other
Party. Arbitration shall be held in New York, New York (if Licensee initiates
arbitration) or Florence, Italy (if Company initiates arbitration) according to
the commercial arbitration rules of the I.C.C. (the “Rules”). The arbitration
shall be conducted by a panel of three (3) arbitrators. Each Party shall, within
thirty (30) days after the institution of the arbitration proceedings, appoint
an arbitrator, and such arbitrators shall together, within thirty (30) days,
select a third arbitrator as the chairman of the arbitration panel. Each
arbitrator shall be conflict-free with respect to each Party and its Affiliates
and any Sublicensees and have significant experience in the pharmaceutical
research and Development and Commercialization business. If either Party fails
to appoint an arbitrator as provided above or the two (2) initial arbitrators
are unable to select a third arbitrator within such thirty (30) day period, then
such arbitrator(s) shall be promptly appointed in accordance with the Rules. The
arbitration shall be conducted in accordance with the Rules.
(ii)    The arbitrators shall render their opinion within thirty (30) days of
the final arbitration hearing. Decisions of the panel of arbitrators shall be
based on the application of the Governing Law and, absent manifest error, shall
be final and binding on the Parties. Judgment on the award so rendered may be
entered in any court of competent jurisdiction and the Parties hereby consent to
the jurisdiction of such court for purposes of enforcement of such award. Each
Party shall pay its attorneys’ fees and the fees of its appointed arbitrator.
The fees of the third arbitrator and the costs of arbitration shall be paid by
the Parties as the arbitrators determine. Except in a proceeding to enforce the
results of the arbitration or as otherwise required by Applicable Law, neither
Party nor any arbitrator may disclose the existence, content or results of any
arbitration hereunder without the prior written consent of both Parties.
(b)    Expert Resolution. If a Party submits an unresolved dispute for binding
arbitration pursuant to Section 5.5(c), such dispute shall be resolved as
follows (the “Expert Resolution”):
(i)    The Parties shall set a date for a meeting of the Expert Committee (the
“Experts Meeting”), which date shall be no more than sixty (60) days after the
date the Expert Resolution is initiated. The Experts Meeting shall be held in a
location determined by the Expert Committee. Each Party shall appoint one (1)
Expert for the Expert Committee within ten (10) days after the date the Expert
Resolution is demanded under this Section 14.2(b). The two (2) Experts shall
appoint the third Expert within ten (10) days after the date the second Expert
has been appointed. The Expert Resolution shall be “baseball” style;
accordingly, at least fourteen (14) days prior to the date of the Expert
Resolution, each Party shall provide the Expert Committee with a brief outlining
its position. Briefs may be no more than thirty (30) pages, and must clearly
provide and identify the Party’s position with respect to the disputed matter.
After receiving both Parties’ opening briefs, the Expert Committee will
distribute each Party’s brief to the other Party. Seven (7) days in advance of
the Expert Resolution, the Parties shall submit and exchange response briefs of
no more than fifteen (15) pages. The Parties’ briefs may include or attach
relevant exhibits in the form of documentary evidence, any other material
voluntarily disclosed to the other Party in advance, or publicly available
information. The Parties’ briefs may also include or attach demonstratives
and/or expert opinion based on the permitted documentary evidence. The Experts
Meeting shall consist of a one (1) day hearing of no longer than eight (8)
hours, such time to be split equally between the Parties, in the form of
presentations by counsel and/or employees and officers of the Parties. No live
witnesses shall be permitted except expert witnesses whose opinions were
provided with the Parties’ briefs.
(ii)    No later than ten (10) days following the Experts Meeting, the Expert
Committee shall issue their written decision. The Expert Committee shall select
one Party’s proposed positions as their decision, and shall not have the
authority to render any substantive decision other than to select the proposal
submitted by either Company or Licensee. The Expert Committee shall have no
discretion or authority with respect to modifying the positions of the Parties.
The Expert Committee’s decision shall be final and binding on the Parties and
may be enforced in any court of competent jurisdiction. The Parties shall
equally share the costs and expenses in connection with such Expert Resolution
proceeding and the Expert Committee fees and expenses. Except in a proceeding to
enforce the results of the Expert Resolution proceeding or as otherwise required
by Applicable Law, neither Party nor any expert may disclose the existence,
content or results of any Expert Resolution proceeding hereunder without the
prior written consent of both Parties.

14.3    Exclusions. Nothing in this Article XIV shall preclude a Party from (a)
seeking and obtaining in any competent court injunctive or equitable relief to
preserve the status quo or prevent immediate harm to the Party, or (b)
submitting any dispute, controversy or Claim relating to the scope, validity,
enforceability or infringement of any Patents or Marks to a court of competent
jurisdiction, including before any patent or trademark administrative body, in
the country in which such Patent or Mark was granted or arose, Each Party hereby
consents to the jurisdiction of such courts for purposes of such injunctive or
equitable relief and to service of process by delivery of notice pursuant to
Section 15.4.

ARTICLE XV -     MISCELLANEOUS

15.1    Force Majeure. Nonperformance by either Party shall be excused to the
extent that performance is rendered beyond such Party’s reasonable control by
industrial conflicts, mobilization, requisition, embargo, currency restriction,
insurrection, general shortage of transport, material or power supply, fire,
flood, earthquake, explosion, stroke of lightning, other force majeure and
similar casualties or other events beyond either Party’s reasonable control, as
well as default in deliveries from subcontractors due to such circumstances as
defined in this Section 15.1 (a “Force Majeure Event”). If a Force Majeure Event
exists for more than one hundred eighty (180) days, then the performing Party
shall have the right to terminate this Agreement with respect to the affected
Product upon written notice to the non-performing Party, in which case such
Product shall become a Terminated Product.

15.2    Performance by Affiliates. Licensee agrees to cause its Affiliates to
comply with the provisions of this Agreement that are applicable to such
Affiliates and to guarantee the payment and performance thereof. Any breach by
Licensee’s Affiliates of any of Licensee’s obligations under this Agreement will
be deemed a breach by Licensee, and Company may proceed directly against
Licensee without any obligation to first proceed against Licensee’s Affiliates.

15.3    Independent Contractors. It is understood that both Parties are
independent contractors and are engaged in the operation of their own respective
businesses. Neither Party is the agent of the other for any purpose whatsoever,
and neither Party has any authority, express or implied, to enter into any
contracts or assume any obligations for the other, to pledge the credit of the
other or make any warranties or representations on behalf of the other, except
where expressly authorized in writing to do so, Nothing in this Agreement or in
the activities of either Party shall be deemed to create an agency, partnership
or joint venture relationship.

15.4    Notices. All notices, requests, claims, demands and other communications
hereunder shall be in writing, in the English language, and shall be given (and
shall be deemed to have been duly given upon receipt) by: (a) delivery in
person, or (b) an internationally recognized overnight delivery, or (c)
registered or certified mail, postage prepaid, return receipt requested, and in
the case of (b) and (c), with a courtesy notice also provided by e-mail, which
copy shall not constitute notice, to the following address (or at such other
address for which such Party gives notice hereunder):
If to Licensee:    A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Via Sette Santi n.3
50131 Firenze, Italy
Attention: General Manager
Facsimile: +39 0555680592
If to Company:    Melinta Therapeutics, Inc.
300 Tri-State International Suite 200
Lincolnshire, IL 60069, U.S. Attention: CFO
    Email: pestrem@melinta.com
Copy to:    Hogan Lovells US LLP
Attention: Adam H. Golden
    Email: adam.golden@hoganlovells.com

Until
December 31, 2018:     875 Third Avenue
New York, NY 10022, U.S.

From and after
January 1, 2019:    390 Madison Avenue
New York, NY 10017, U.S.
Notices shall be considered delivered when received in accordance with the
provisions of this Section 15.4, subject to proof of receipt, as evidenced by
the applicable courier’s receipt.

15.5    Governing Law. This Agreement (including any claim or controversy
arising out of or relating to this Agreement) shall be governed by the law of
the State of New York without regard to conflict of law principles that would
result in the application of any Applicable Law other than the laws of the State
of New York (the “Governing Law”).

15.6    Entire Agreement. This Agreement, including the Exhibits, the Ancillary
Agreements and any other agreements referenced herein, sets forth the entire
agreement and understanding of the Parties relating to the subject matter
hereof, and supersedes all prior oral and written, and all contemporaneous oral,
agreements, understandings and arrangements. No modification of or amendment to
this Agreement shall be effective unless signed by the Parties.

15.7    Assignment. Each Party agrees that its rights and obligations under this
Agreement may not be transferred or assigned, directly or indirectly, to any
Person without the prior written consent of the other Party; provided, however,
that Company may assign this Agreement without Licensee’s consent to (a) any of
its Affiliates, (b) in connection with a sale or transfer (by means of a merger,
stock sale or otherwise) of all or substantially all of Company’s assets or
business, or all or substantially all of Company’s assets or business with
respect to a Product; or (c) as collateral securing any debt financing.
Following any such assignment or transfer, the assigning or transferring Party
shall in any event remain jointly and severally liable with any such assignee
towards the other Party unless otherwise agreed in writing between the Parties.
Notwithstanding the foregoing, Company shall be entitled to assign, without any
need or approval from Licensee, its rights to receive any payments under this
Agreement to any Person. Any attempted assignment by any Party in violation of
this Section 15.7 shall be null and void. Subject to the foregoing, this
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective successors and permitted assigns.

15.8    Severability. If any provision of this Agreement is held to be invalid
by a court of competent jurisdiction or arbitrator, then the remaining
provisions shall remain, nevertheless, in full force and effect. The Parties
agree to renegotiate in good faith any term held invalid and to be bound by the
agreed substitute provision in order to give the most approximate effect
intended by the Parties.

15.9    Headings. The headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or interpretation of
this Agreement. Any article, section, recital, exhibit, schedule or party
references are to this Agreement unless otherwise stated. No Party or its
counsel shall be deemed to be the drafter of this Agreement for purposes of
construing the provisions hereof, and all provisions of this Agreement shall be
construed in accordance with their fair meaning, and not strictly for or against
any Party.

15.10    Export Control. Licensee understands and acknowledges that Company is
subject to regulation by agencies of the U.S. Government, including the U.S.
Food and Drug Administration and the U.S. Department of Commerce, which prohibit
and/or regulate export or diversion of certain products and technology to
certain countries. Any and all obligations of Company to provide Products, as
well as any other technical information and assistance shall be subject in all
respects to such U.S. laws and regulations as shall from time to time govern the
license and delivery of technology and products abroad by Persons subject to the
jurisdiction of the U.S, including the Administration Act of 1979, as amended,
any successor legislation, and the Export Administration Regulations issued by
the Department, of Commerce, Bureau of Import Administration. Licensee agrees to
cooperate with Company, including providing required documentation, in order to
obtain export licenses or exemptions therefrom. Licensee shall comply with such
Export Administration Regulations, and other U.S. laws and regulations governing
exports in effect from time to time.

15.11    Waiver. No waiver of any term or condition of this Agreement shall be
valid or binding on either Party unless agreed in writing by the Party to be
charged. The failure of either Party to enforce at any time any of the
provisions of the Agreement, or the failure to require at any time performance
by the other Party of any of the provisions of this Agreement, shall in no way
be construed to be a present or future waiver of such provisions, nor in any way
affect the validity of either Party to enforce each and every such provision
thereafter.

15.12    Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but both of which together shall constitute
one and the same instrument. Copies of executed counterparts transmitted by
email with PDF attachment shall be considered original executed counterparts.

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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have
caused this License Agreement to be executed by their duly authorized
representatives as of the Effective Date.
LICENSEE:

A. MENARINI INDUSTRIE FARMACEITICHE RIUNITE S.R.L.

By:     /s/ Stefano Pieri    
Name:
Title:

COMPANY:

MELINTA THERAPEUTICS, INC.

By:     /s/ Peter J. Milligan    
Name: Peter J. Milligan
Title: Chief Financial Officer

[Signature Page to License Agreement]

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