CONFIDENTIAL

 

Exhibit 10.1

 

INTELLECTUAL PROPERTY LICENSE AGREEMENT

 

This INTELLECTUAL PROPERTY LICENSE AGREEMENT (this “Agreement”) is entered into
as of May 14, 2015 (the “Effective Date”), by and between ATOSSA GENETICS INC.,
a Delaware Corporation, with its principal offices located at 2345 Eastlake Ave
E., Seattle, WA 98102, U.S.A. (“Atossa”), and BESINS HEALTHCARE LUXEMBOURG
SARL., a corporation, with its principal office located at 2-8 rue Julien
Vesque, L-2668 Luxembourg, acting on behalf of itself and its Affiliates
(collectively “Besins”). Atossa and Besins may be referred to herein
individually as a “Party” or collectively as the “Parties.”

 

RECITALS

 

WHEREAS, the Parties are engaged in the research, development, formulation,
manufacturing, and marketing of new pharmaceutical products;

 

WHEREAS, Atossa desires to obtain certain rights and licenses from Besins in
order to develop, formulate, manufacture, and market new pharmaceutical products
on the terms and conditions set forth herein;

 

WHEREAS, Besins desires to grant certain rights and licenses to Atossa to enable
Atossa to develop, formulate, manufacture, and market new pharmaceutical
products on the terms and conditions set forth herein; and

 

NOW, THEREFORE, in consideration of the mutual promises hereinafter set forth,
and intending to be legally bound hereby, Atossa and Besins hereby agree as
follows.

 

ARTICLE 1

Defined Terms

1.1 General. Capitalized terms and expressions in this Agreement will have the
meanings set forth herein, whether used in their singular or plural form.
Non-capitalized terms and expressions will have their common and ordinary
meaning.

 

1.2 “Action” shall have the meaning set forth in Section 3.2(b).ii.b.

 

1.3 “Additional Indication” means (i) breast cancer and (ii) other breast
diseases described in Besins Core IP or Besins Regulatory Information.

 

1.4 “Affiliate” means, with respect to a Party, a corporation, partnership or
other entity controlling, controlled by or under common control with such Party,
but only for so long as such relationship exists, where the word “control,” as
used in this Section 1.4, means ownership, directly or indirectly, of at least
fifty percent (50%) of the stock or shares having the right to vote for the
election of directors or, in the case of a non-corporate entity, the power to
direct the management of such entity.

 

1

CONFIDENTIAL

 

1.5 “Afimoxifene Gel” means API in the form of a hydroalcoholic gel or solution
that is formulated for dosing a mammal. “Besins Afimoxifene Gel” means any
Afimoxifene Gel described in Besins Platform IP or Besins Core IP, whether or
not encompassed by a Valid Claim thereof.

 

1.6 “Agreement” shall have the meaning set forth in the preamble to this
Agreement.

 

1.7 “API” means 4-Hydroxytamoxifen (4-OHT). For clarity, the term “API” includes
the E-isomer form of 4-OHT, and the Z-isomer form of 4-OHT, either alone or in a
combination thereof.

 

1.8 “Applicable Law” means all international, national, state, regional and
local laws, regulations, rules and guidelines applicable to performing under
this Agreement, including without limitation, all Regulatory Requirements.

 

1.9 “Atossa Background IP” means all Intellectual Property conceived,
discovered, developed, acquired, made, reduced to practice, owned or Controlled
by or for Atossa or an Affiliate thereof before the Effective Date. For clarity,
Atossa Background IP includes (i) any patent claiming Afimoxifene Gel as
described in Exhibit A and any patent issuing from a pending patent application
claiming Afimoxifene Gel as described in Exhibit A, such Exhibit A shall be a
part of this Agreement; (ii) any continuation or divisional patents and patent
applications based on, corresponding to, or claiming the priority date(s) of the
foregoing (i); (iii) any reissues, re-examinations, substitutions, supplementary
protection certificates, registrations, validations, continued prosecutions,
continuations or divisions of or to any of the foregoing (i) – (ii); (iv) any
continuation-in-part of or to any of the foregoing (i) – (iii) wherein any added
material in the continuation-in-part does not claim any Besins Afimoxifene Gel
or the use of any Afimoxifene Gel in the Field; (v) any term extension or other
right which provides exclusive rights beyond the original patent expiration date
of the foregoing (i) – (iv); and (vi) all foreign counterparts of any of the
foregoing (i)-(v), whether filed before or after the Effective Date. For
avoidance of doubt, all Intellectual Property conceived discovered, developed,
acquired, made, or reduced to practice by or for Atossa or an Affiliate thereof,
which does not claim any Besins Afimoxifene Gel or the use of any Afimoxifene
Gel in the Field, shall not be considered Atossa Foreground IP; such
Intellectual Property shall be Background IP regardless of when it was
conceived, discovered, developed, acquired, made, or reduced to practice.

 

1.10 “Atossa Foreground IP” means all Intellectual Property claiming any Besins
Afimoxifene Gel or claiming any uses of any Afimoxifene Gel in the Field
conceived, discovered, developed, made or reduced to practice by or for Atossa
or an Affiliate thereof during the Term in connection with obtaining Regulatory
Approval, Development, and/or Commercialization of Afimoxifene Gel in the Field,
including (i) any new patent applications and issued or granted patents claiming
any Besins Afimoxifene Gel or the use of any Afimoxifene Gel in the Field filed
or authorized to be filed by or for Atossa or an Affiliate thereof, (ii) any new
patent applications and issued patents based on, corresponding to, or claiming
the priority date(s) of the foregoing (i); (iii) any reissues, re-examinations,
substitutions, supplementary protection certificates, registrations,
validations, continuations, continued prosecutions, divisions, or
continuations-in-part of or to any of the foregoing (i) – (ii), to the extent
any such continuation-in-part claims any Besins Afimoxifene Gel or the use of
any Afimoxifene Gel in the Field; (iv) any term extension or other right which
provides exclusive rights beyond the original patent expiration date of any of
the foregoing (i) – (iii); and (v) all foreign counterparts of any of the
foregoing (i) – (iv). For clarity, Atossa Foreground IP may include claims in
continuations-in-part of Atossa Background IP if any added claims in such
continuation-in-part describes any Besins Afimoxifene Gel or the use of any
Afimoxifene Gel in the Field. Atossa Foreground IP does not include any Atossa
Background IP, Atossa Regulatory Information or Atossa Know-How owned or
Controlled by Atossa or an Affiliate thereof, Besins Core IP, Besins Platform
IP, or Regulatory Information or Know-How owned or Controlled by Besins or an
Affiliate thereof before the Effective Date. Atossa Foreground IP shall be
listed in an Exhibit B, such Exhibit B shall become of this Agreement and be
updated bi-annually.

 

2

CONFIDENTIAL

 

1.11 “Atossa Indemnitees” shall have the meaning set forth in Section 9.2.

 

1.12 “Besins Core IP” means all Intellectual Property directed to the use of
Afimoxifene Gel in the Field and Controlled by Besins or an Affiliate thereof
before the Effective Date. For clarity, Besins Core IP includes (i) any patents
described in Exhibit C and any patents issuing from a pending patent application
described in Exhibit C, which shall be a part of this Agreement and be updated
bi-annually; (ii) any continuation, continuation-in-part, or divisional patents
and patent applications based on, corresponding to, or claiming the priority
date(s) of the foregoing (i); (iii) any reissues, re-examinations,
substitutions, supplementary protection certificates, registrations,
validations, continued prosecutions, continuations, continuations-in-part, or
divisions of or to any of the foregoing (i) – (ii); (iv) any term extension or
other right which provides exclusive rights beyond the original patent
expiration date of the foregoing (i) – (iii); and (v) all foreign counterparts
of any of the foregoing (i) – (iv), whether filed before or after the Effective
Date.

 

1.13 “Besins Platform IP” means any Besins Intellectual Property directed to
Afimoxifene Gel and Controlled by Besins or an Affiliate thereof before the
Effective Date. For clarity, Besins Platform IP includes (i) any patents
described in Exhibit D and any patents issuing from a pending patent application
described in Exhibit D, which shall be a part of this Agreement and be updated
bi-annually; (ii) any continuation, divisional or continuation-in-part patents
and patent applications based on, corresponding to, or claiming the priority
date(s) of the foregoing (i); (iii) any reissues, re-examinations,
substitutions, supplementary protection certificates, registrations,
validations, continued prosecutions, continuations, divisions or
continuations-in-part of or to any of the foregoing (i) – (ii); (iv) any term
extension or other right which provides exclusive rights beyond the original
patent expiration date of the foregoing (i) – (iii); and (v) all foreign
counterparts of any of the foregoing (i) – (iv), whether filed before or after
the Effective Date.

 

3

CONFIDENTIAL

 

1.14 “cGMP” means the current Good Manufacturing Practices as promulgated under
the U.S. Food & Drug Administration regulations at 21 C.F.R., Parts 210, 211,
600 and 610, FDA guidance, FDA current review and inspection standards, and
current industry standards, as the same may be amended or re-enacted from time
to time.

 

1.15 “Clinical Development” means clinical drug development activities with
respect to, or required or necessary for, IND and/or Regulatory Approval of
Afimoxifene Gel, or for Commercialization of Afimoxifene Gel, including, among
other things: analytical, test method development, stability testing,
formulation, process development, manufacturing scale-up, development stage
manufacturing, pre-clinical studies, Clinical Studies (including pre- and
post-approval clinical studies), and/or other studies or activities (including
regulatory affairs and activities, quality assurance/control activities, and
performance with respect to clinical materials, statistical analysis and report
writing, product approval and product registration.

 

1.16 “Clinical Study” means a clinical research study involving human subjects,
and for a Phase 2 Clinical Study, its principal purpose is determining dose and
evaluating safety and efficacy of the Afimoxifene Gel in the target patient
population, or a similar clinical study prescribed by the Regulatory Authority
in the Territory, which is equivalent of the clinical trial described in 21
C.F.R. § 312.21(b), as may be amended, in the United States of America, and for
a Phase 3 Clinical Study, it is designed to establish safety and efficacy of the
Afimoxifene Gel, which trial is intended to support Regulatory Filing and
Regulatory Approval for the Afimoxifene Gel in the Territory, as the case may
be, and which is equivalent of the clinical trial described in 21 C.F.R. §
312.21(c), as may be amended, in the United States of America..

 

1.17 “Commercialize,” “Commercialization” “Commercializing” or “Commercialized”
means any and all activities relating to and including promotion, marketing,
distribution, selling, having sold, offering for sale, having offered for sale,
manufacturing, having manufactured, importing, having imported, exporting,
having exported, and sales of Afimoxifene Gel in the Territory in accordance
with Applicable Law, including advertising, product support, consumer and
physician education, managed market activities, market share generation trials,
market and consumer research, customer support, detailing, distributing,
labeling, pricing, coverage, and reimbursement.

 

4

CONFIDENTIAL

 

1.18 “Commercially Reasonable Efforts” means those efforts employed by a Party,
consistent with that level of attention and care, and providing of funding and
manpower, that such Party devotes to its other programs and products of similar
market potential, and which efforts are consistent with pharmaceutical industry
custom and practice and with the then-current stage of pharmaceutical product
life cycle.

 

1.19 “Confidential Information” means any and all non-public data, information
and technology and all tangible and intangible embodiments thereof, that is (i)
Controlled by a Party or its Affiliates (“Disclosing Party”) and is disclosed or
supplied in any form by or on behalf of such Disclosing Party to the other Party
or its Affiliates (“Receiving Party”) in any media or format, whether written,
oral, graphic, or other tangible form or electronic form, in connection with
this Agreement or otherwise observed by the Receiving Party, and (ii) is not
published or otherwise in the public domain, including, without limitation: (a)
Intellectual Property, Data and Development Records of a Party; (b) information
or material provided in written, oral, graphic or other tangible form or
electronic form that is marked as “Confidential” at the time it is delivered to
the Receiving Party or confirmed and marked as “Confidential” within thirty days
after disclosure; and (c) any information or material that, by its nature or by
the circumstances surrounding its disclosure, ought, in good faith, to be
treated as confidential.

 

1.20 “Control” when used in reference to a particular item of information
(including Information) or Intellectual Property right, means the legal
authority or right of a Party (i) to grant a license or sublicense of
Intellectual Property rights to the other Party, or (ii) to grant access and/or
a right to use, or to otherwise disclose, proprietary or Trade Secret
Information to the other Party, without breaching the terms of any agreement
with a Third \Party, infringing upon the Intellectual Property rights of a Third
Party, or misappropriating the proprietary or Trade Secret Information of a
Third Party, and without incurring material additional costs to procure such
Third Party rights beyond those already incurred. The terms “Controlled” and
“Controlling” shall be interpreted accordingly.

 

1.21 “Data” means any and all analyses, computations, charts, computer or device
readings or outputs, data, diagrams, graphs, information, results (whether
qualitative, quantitative, or otherwise) pertaining to Afimoxifene Gel and
obtained or produced by or for either Party, its officers, directors, employees,
subcontractors, agents and Affiliates, together with all documentation thereof.

 

1.22 “Development,” “Develop,” or “Developing” means to engage in Pre-Clinical
Development or Clinical Development of Afimoxifene Gel.

 

5

CONFIDENTIAL

 

1.23 “Development Plan” means Atossa’s plan for Developing Afimoxifene Gel in
the Field in the Territory under this Agreement as amended, modified, or
supplemented from time to time by Atossa in good faith, and includes Development
milestones and periods for accomplishing those milestones in accordance with
industry standards. Atossa’s Development Plan is listed in Appendix E, which
shall be part of this Agreement.

 

1.24 “Development Record” means all documentation that is owned or Controlled by
a Party (e.g., “Besins Development Record” or “Atossa Development Record”) that
relates to Data and/or to performance of Development and Commercialization of
Afimoxifene Gel and necessary to support the filing of patent and/or regulatory
application(s) and to obtain Regulatory Approval of and Commercialize
Afimoxifene Gel in the Field including, without limitation, all applications,
submissions, licenses, registrations for Regulatory Approval, know-how, primary
source documents, testing results, manufacturing records including manufacturing
designs and protocols, compliance and quality assurance documents, research
notes and records, Clinical Development notes and records, regulatory filings
and communications, including without limitation, any INDs and NDAs related to
Afimoxifene Gel, drug master files, packaging and labeling information, clinical
trial protocols and amendments thereof, investigator brochures, safety reports,
annual reports, raw data, and other related Development records regardless of
format or media.

 

1.25 “Effective Date” shall have the meaning set forth in the preamble.

 

1.26 “Encumbered” means any encumbrance or restriction on the right of Besins to
grant a license to the full extent described in Sections 2.1 of this Agreement,
as applicable, that was (i) licensed by Besins to a Third Party under an
agreement executed prior to the Effective Date, or (ii) subject to a security
interest or lien.

 

1.27 “Field” initially means the treatment and prevention of Hyperplasia of the
breast, and may be expanded to include one or both Additional Indications in
accordance with Section 4.2 of this Agreement.

 

1.28 “First Commercial Sale” means the first arm’s length commercial sale of
Afimoxifene Gel in the Territory to a Third Party by Atossa, or its Affiliate or
Sublicensees, after Regulatory Approval has been obtained in the country of
sale, but excluding: (i) any sale or other transfer of a Afimoxifene Gel by
Atossa or any of its Affiliates or Sublicensees to a Third Party for use solely
in Clinical Trial(s) in connection with obtaining Regulatory Approval; and (ii)
any sale or other transfer between or among Atossa and its Affiliates or its
Sublicensees for resale by Atossa, such Affiliate or Sublicensee to a Third
Party, until such time as there is a subsequent resale to a Third Party by
Atossa or any such Affiliate or Sublicensee.

 

6

CONFIDENTIAL

 

1.29 “Force Majeure” means any event beyond the reasonable control of a Party,
including, acts of public enemy, acts of God, fires, floods, epidemics, and
unusually severe weather, embargoes, war, riot, or acts of terrorism.

 

1.30 “IND” means (i) an Investigational New Drug Application, as defined in the
U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations
promulgated thereunder, that is required to be filed with the FDA before
beginning clinical testing of a pharmaceutical product in human subjects; and
(ii) any foreign counterpart of a U.S. IND.

 

1.31 “Indication” shall mean any human therapeutic and prophylactic use(s) for
Afimoxifene Gel.

 

1.32 “Intellectual Property” means (i) Know-How, (ii) any (a) patents and patent
applications, (b) any reissues, re-examinations, substitutions, supplementary
protection certificates, registrations, validations, continuations,
continuations-in-part, continued prosecutions, or divisions of or to any of the
foregoing (a); (c) any term extension or other right which provides exclusive
rights beyond the original patent expiration date of any of the foregoing (a) –
(b); and (d) all foreign counterparts of any of the foregoing (a) – (c), whether
filed before or after the Effective Date, (iii) any information, data, know-how,
invention (whether patentable or not), technology, techniques, Development
Records, Manufacturing Information, and Regulatory Information that derives
actual or potential economic value from not being generally known to or readily
ascertainable by proper means by other persons who can obtain economic value
from its disclosure or use and is the subject of reasonable efforts to maintain
its secrecy; (iv) all Trade Secret-associated rights or protections granted
under applicable laws of the United States, applicable state laws, and/or
applicable laws in foreign jurisdictions; and (v) all other intellectual
property and proprietary rights, including Copyrights, Trade Dress, and
Trademarks, in each case whether or not subject to statutory registration or
protection.

 

1.33 “Losses” shall have the meaning set forth in Section 9.2.

 

1.34 “Know-How” means any proprietary or non-public information and/or data
related to the Field, Afimoxifene Gel, or Regulatory Information, or which are
otherwise necessary or useful to Development, Commercialization, or obtaining
Regulatory Approval of Afimoxifene Gel for use in the Field, and which are
possessed, known, learned, invented, developed, owned, or controlled by a Party
(e.g., “Besins Know-How” or “Atossa Know-How”), whether or not protected by
Intellectual Property rights or any applications for such rights, including but
not limited to: (i) information relating to concepts, discoveries, Data,
designs, technical information, know-how, knowledge, clinical data,
formulations, ideas, inventions, methods, models, procedures, processes,
specifications, designs for experiments and tests (including processing
testing), test results, and assays; (ii) information related to identity,
specification, release, stability indication of API, excipient, finished goods,
rework criteria, batch records, suppliers, and laboratory records; (iii)
information germane to making, using, selling, offering for sale, importing,
exporting Afimoxifene Gel or practicing methods related to Afimoxifene Gel in
the Field; and (iv) information contained in submissions to regulatory
authorities.

 

7

CONFIDENTIAL

 

1.35 “Manufacturing Information” means information, Data, Know-How, technology,
techniques and any other information that is owned or Controlled by or for a
Party (e.g., “Besins Manufacturing Information” or “Atossa Manufacturing
Information”) that relates to manufacturing of Afimoxifene Gel. Such
manufacturing information includes, without limitation, all information related
to GMP and cGMP protocols, development data, Development Records, pilot phase
and commercial process development, scale up, qualification, calibration,
maintenance, validation and testing protocols, specifications, and data, and
includes information related to identity, specification, release, stability
indication of API, excipient, formulation, finished goods, rework criteria,
batch records, suppliers, and tangible materials, and true, accurate and
complete books, records, reports and accounts in connection with the Afimoxifene
Gel manufacturing as well as any other books and records as may be required from
time to time by any applicable legal and regulatory requirement such as drug
master files and regulatory audits, facility audits, audit reports, warning
letters, and remediation activities and reports, and other regulatory
communications regarding manufacturing activities.

 

1.36 “Net Sales” means the gross revenue received by Atossa, its Affiliates,
their respective Sublicensees and Atossa Third-Party Resellers for the sale of
Afimoxifene Gel to Third Parties other than Besins and its Affiliates and
Sublicensees (whether end-users, wholesalers or otherwise) in an arm’s-length
transaction, less the amount of the following deductions: (i) normal and
customary trade, cash and quantity discounts actually given, credits, price
adjustments or allowances for damaged products, returns or rejections of
products, and allowance or rebates for retroactive price reductions; (ii)
chargeback payments and rebates (or the equivalent thereof), if any, granted to
group purchasing organizations, managed health care organizations or to federal,
state/provincial, local and other governments, including their agencies, or to
trade customers, wholesalers or other distributors; (iii) freight, shipping
insurance and other transportation expenses directly related to shipments or
deliveries of Afimoxifene Gel (if actually borne by Atossa, its Affiliates or
Sublicenses without reimbursement from any Third Party); (iv) sales taxes,
value-added taxes, excise taxes, tariffs and duties of importation, and other
taxes and any other similar government charges actually borne by Atossa, its
Affiliates or Sublicensees in connection with the sale or delivery of
Afimoxifene Gel without reimbursement from any Third Party (but not including
taxes assessed against the income derived from such sale); and (v) provisions
for actual uncollectible accounts determined in accordance with U.S. generally
accepted accounting principles, International Financial Reporting Standards, or
such other accounting practices as Atossa or its Affiliates or Sublicensees may,
at their sole discretion, adopt, as consistently applied by Atossa, its
Affiliates, or Sublicensees (as applicable).

 

8

CONFIDENTIAL

 

1.37 “NDA” means a New Drug Application or similar application or submission
filed with a Regulatory Authority in a country or a group of countries to obtain
marketing approval for a Afimoxifene Gel in that country or in that group of
countries.

 

1.38 “Pre-Clinical Development” means drug development activities, including
toxicology studies, bioanalytical test method development, pre-formulation and
formulation, process development, manufacturing design and scale up, quality
assurance/control and performance with respect to studies and materials.

 

1.39 “Regulatory Approval” means any approval, authorization, license, permit or
registration granted or issued by a Regulatory Authority necessary for, or that
otherwise governs, the research and development, Clinical Study, manufacture,
handling, use, storage, import, export, transport, distribution or
Commercialization of Afimoxifene Gel, including without limitation, where
applicable, labeling, pricing and/or reimbursement approval.

 

1.40 “Regulatory Authority” means, with respect to any particular country,
territory or union, the governmental authority, body, commission, agency or
other instrumentality of such country, territory or union with the primary
responsibility for the evaluation or approval of pharmaceutical products before
such pharmaceutical product may be tested, marketed, promoted, distributed or
sold in such country, including such governmental bodies that have jurisdiction
over the pricing of such pharmaceutical product.

 

1.41 “Regulatory Information” means information, data, know-how, technology,
techniques, and any other information that is owned or Controlled by a Party
(e.g., “Besins Regulatory Information” or “Atossa Regulatory Information”) that
relates to Regulatory Approval of Afimoxifene Gel, including Data, practices,
methods, techniques, preclinical and clinical results, including safety and
efficacy, regulatory filings, IND, drug master files, regulatory audits and
audit reports, warning letters, remediation activities, and remediation reports,
packaging, compositions of matter, specifications, tests (including processing
testing), assays, and methods. Besins Regulatory Information includes IND 59,081
and IND 66,076.

 

1.42 “Regulatory Requirements” means all applicable approvals, licenses,
registrations, and authorizations and all other requirements of each applicable
Regulatory Authority in relation to Afimoxifene Gel, including each of the
foregoing which is necessary for, or otherwise governs, the research (clinical
and non-clinical) and Development, manufacture, handling, use, storage, import,
transport, distribution or Commercialization of Afimoxifene Gel.

 

9

CONFIDENTIAL

 

1.43 “Sublicensee” means any Party or Third Party to which a Party has granted a
sublicense under the licenses granted to the Party herein.

 

1.44 “Supplier” means any supplier operating under an agreement with a Party or
an Affiliate or Sublicensee thereof (e.g. “Atossa Supplier” or “Besins
Supplier”) to manufacture or supply Afimoxifene Gel.

 

1.45 “Term” shall have the meaning set forth in Section 8.1.

 

1.46 “Terminated Country” means a country in the Territory wherein rights of
Atossa granted hereunder have been terminated in accordance with Section 4.3(a),
4.3(b), 4.3(c) or 4.3(d).

 

1.47 “Terminated Indication” means an Indication in the Field to which the
rights granted to Atossa hereunder have been terminated in accordance with
Section 4.3(a), 4.3(b), 4.3(c) or 4.3(d).

 

1.48 “Territory” means worldwide.

 

1.49 “Third Party” means any person or entity other than Atossa or Besins and
their respective Affiliates.

 

1.50 “Third Party Action” shall have the meaning set forth in Section
3.2(b).iii.a.

 

1.51 “Third Party Resellers” means Sublicensees, Suppliers, and distributors
engaged by a Party and/or its Affiliates and Sublicensees (e.g., “Atossa Third
Party Resellers” or “Besins Third Party Resellers”) to distribute the
Afimoxifene Gel.

 

1.52 “Valid Claim” means a claim of (a) an issued and unexpired patent (the term
of such patent to include any term extension or other right which provides
exclusive rights beyond the original patent expiration date) included within the
Besins Core IP or Besins Platform IP unless the claim has been held revoked,
unenforceable or invalid by the final, un-reversed, and un-appealable decision
of a court or other body of competent jurisdiction, has been irretrievably
abandoned or disclaimed, or has otherwise been finally admitted or finally
determined by the relevant authority to be invalid, un-patentable or
unenforceable, whether through reissue, reexamination, disclaimer, consent
decree, or otherwise, (b) a pending patent application within the Besins Core IP
or Besins Platform IP, to the extent the claim continues to be prosecuted in
good faith, or (c) a pending patent application or issued patent within the
Atossa Foreground IP that describes Besins Afimoxifene Gel or the use of any
Afimoxifene Gel in the Field.

 

10

CONFIDENTIAL

 

ARTICLE 2

License Grants

 

2.1Besins Core IP, Besins Platform IP, and Afimoxifene Gel.

 

Subject to terms and conditions set forth in this Agreement, during the Term,
Besins hereby grants to Atossa and its Affiliates:

 

(a) an exclusive (even as to Besins and its Affiliates), transferable license
(with the right to sublicense in accordance with Section 2.1(d) through multiple
tiers under terms and conditions at least as restrictive as this Agreement)
under Besins Core IP and under Besins Platform IP to make, have made,
manufacture, have manufactured, use, sell, have sold, offer to sell, have
offered to sell, import, have imported, export, have exported, and otherwise
transfer, dispose of, distribute, or Develop and improve Afimoxifene Gel for the
sole purposes of obtaining Regulatory Approval and Commercialization of
Afimoxifene Gel in the Field in the Territory during the Term and practicing any
method claimed in the Besins Core IP and Besins Platform IP in the Field in the
Territory during the Term; and

 

(b) a right to access, review and reference Besins IND 59,081 and IND 66,076 to
the extent that such access, review, and reference may be useful to Develop
Afimoxifene Gel for the sole purposes of obtaining Regulatory Approval and
Commercialization of Afimoxifene Gel in the Field in the Territory, which right
shall be exclusive in the Field in the Territory.

 

(c) Notwithstanding the licenses granted under Section 2.1(a), Atossa
acknowledges that Besins retains for itself and its Affiliates and Sublicensees
the right to make, have made, manufacture, have manufactured, use, sell, have
sold, offer to sell, have offered to sell, import, have imported, export, have
exported, and otherwise transfer, dispose of, distribute, or Develop and improve
Afimoxifene Gel for use outside the Field worldwide or for use in the Field on a
Terminated Indication-by-Terminated Indication basis and/or in a Terminated
Country. Atossa hereby recognizes that Besins or its Affiliates may establish a
direct relationship with any Atossa Supplier with a prior ninety (90) business
days’ notice in writing to Atossa of its intent to do so and that Atossa may not
take any action to restrict this right, provided that (i) Atossa Supplier
provides written assurance to Besins that any relationship between Besins and
Atossa Supplier shall not negatively impact the ability of Atossa Supplier to
satisfy its supply obligations to Atossa, and (ii) Besins will ensure that any
Afimoxifene Gel supplied to Besins by Atossa Supplier is labeled only for uses
outside the Field. Further, for the same purpose, Besins shall be granted
reasonable access from Atossa to any Afimoxifene Gel specifications, Data,
Information and Development Records inclusive, as may be updated or modified
from time to time during the Term, in reasonably completed and accurate form,
and Besins shall treat the foregoing as Confidential Information pursuant to
Article 6.

 

11

CONFIDENTIAL

 

(d) Sublicense(s): The term of the sublicenses hereunder granted by Atossa to
Third Parties through multiple tiers shall be equal to the Term of this
Agreement. In the event of any sublicense of any rights hereunder, the
sublicensor of such rights shall provide Besins with written notice of, and a
copy of the agreement memorializing such sublicense within thirty (30) days of
execution of the sublicense. For any country of the Territory for which
Commercialization has not been (or is not anymore) sublicensed by Atossa, Besins
shall have a right of first refusal to Commercialize the Afimoxifene Gel in the
Field during the Term on terms as least as favorable to Besins as Atossa or its
Affiliates would offer to a Third Party, provided however that Besins has its
own commercial operations of breadth, depth and scope equal to such Third Party
and including having sufficient manpower in this country.

 

2.2Atossa Foreground IP.

 

Subject to terms and conditions set forth in this Agreement, Atossa hereby
grants to Besins and its Affiliates an irrevocable, perpetual, non-exclusive,
royalty-free, fully paid, non-transferable license (with the right to sublicense
through multiple tiers under terms and conditions at least as restrictive as
this Agreement) under Atossa Foreground IP to make, have made, use, sell, have
sold, offer to sell, have offered to sell, import, have imported, export, have
exported, and otherwise transfer, dispose of, and distribute Afimoxifene Gel
outside the Field worldwide or in the Field on a Terminated
Indication-by-Terminated Indication basis and/or in a Terminated Country.

 

2.3Covenants Not to Sue.

 

(a) Besins hereby covenants, on behalf of itself and its Affiliates, successors
and assigns, not to sue or otherwise bring a claim against Atossa or its
Affiliates or Atossa Third Party Resellers, during the Term, asserting that
their conduct of the following activities infringes any Regulatory Information
and/or Intellectual Property that is Controlled by Besins and not licensed to
Atossa pursuant to this Agreement: (i) making, having made, manufacturing,
having manufactured, using, selling, having sold, offering to sell, having
offered to sell, importing, having imported, exporting, have exported, or
otherwise transferring, disposing of, distributing, or Developing Afimoxifene
Gel for the sole purposes of obtaining Regulatory Approval and Commercialization
of Afimoxifene Gel for any Indication in the Field and practicing in the Field
in the Territory any method using Afimoxifene Gel claimed by intellectual
property that is Controlled by Besins and not licensed to Atossa pursuant to
this Agreement. In addition to Atossa and its Affiliates, the covenant set forth
in this Section 2.3(a) shall extend to (1) Third Parties, including Sublicensees
and Atossa Suppliers, to whom Atossa has granted sublicenses to the rights
obtained by Atossa under Section 2 of this Agreement, or who purchase or
otherwise receive Afimoxifene Gel for use in the Field from Atossa consistent
with the terms of this Agreement; (2) other of Atossa’s Sublicensees of the
rights obtained by Atossa under Section 2 of this Agreement, including Atossa
Third Party Resellers and customers who receive Afimoxifene Gel for use in the
Field in the Territory consistent with the terms of this Agreement; and (3) any
successors and assigns of Atossa or Affiliates thereof.

 

12

CONFIDENTIAL

 

(b) Atossa hereby covenants, on behalf of itself and its Affiliates, successors
and assigns, not to sue or otherwise bring a claim against Besins or its
Affiliates or Besins Third Party Resellers, during the Term, asserting that
their conduct of the following activities infringes any Regulatory Information
and/or Intellectual Property that is Controlled by Atossa and not licensed to
Besins pursuant to this Agreement: (i) making, having made, manufacturing,
having manufactured, using, selling, having sold, offering to sell, having
offered to sell, importing, having imported, exporting, have exported, or
otherwise transferring, disposing of, distributing, or Developing Afimoxifene
Gel for the sole purposes of obtaining Regulatory Approval and Commercialization
of any Besins Afimoxifene Gel for any Indication outside the Field worldwide or
inside the Field on a Terminated Indication-by-Terminated Indication basis
and/or in a Terminated Country and practicing any method using Besins
Afimoxifene Gel outside the Field worldwide or inside the Field on a Terminated
Indication-by-Terminated Indication basis and/or in a Terminated Country claimed
by intellectual property that is Controlled by Atossa and not licensed to Besins
pursuant to this Agreement, provided however, such conduct shall not infringe
any Regulatory Information and/or Intellectual Property conceived, developed or
Controlled by Atossa which does not claim Besins Afimoxifene Gel. In addition to
Besins and its Affiliates, the covenant and restrictions set forth in this
Section 2.3(b) shall extend to (1) Third Parties, including Sublicensees and
Besins Suppliers, to whom Besins has granted sublicenses to the rights obtained
by Besins under Section 2 of this Agreement, or who purchase or otherwise
receive Besins Afimoxifene Gel from Besins consistent with the terms of this
Agreement; (2) other of Besins’ Sublicensees of the rights obtained by Besins
under Section 2 of this Agreement, including Besins Third Party Resellers and
customers who receive Besins Afimoxifene Gel consistent with the terms of this
Agreement; and (3) any successors and assigns of Besins or Affiliates thereof.

 

2.4No Implied Right or License.

 

Nothing contained in this Agreement will be implied to grant to one Party any
ownership right or license right with respect to the other Party’s Intellectual
Property other than as expressly provided herein.

 

13

CONFIDENTIAL

 

ARTICLE 3

Intellectual Property

3.1Ownership.

 

(a)Besins Intellectual Property.

 

Notwithstanding the licenses granted hereunder, Besins shall retain sole and
exclusive ownership of all rights, title, and interest in and to Besins Core IP
and Besins Platform IP.

 

(b)Atossa Background Intellectual Property.

 

Atossa shall retain sole and exclusive ownership of all rights, title, and
interest in and to Atossa Background IP at all times.

 

(c)Atossa Foreground Intellectual Property.

 

Notwithstanding the licenses granted hereunder, Atossa shall retain sole and
exclusive ownership of all rights, title, and interest in and to Atossa
Foreground IP.

 

3.2Protection of Intellectual Property.

 

(a) Patent Filing, Prosecution and Maintenance.

 

i. Rights and Obligations of Besins

 

Besins shall retain the exclusive right, but not the obligation, to prepare,
file, prosecute and maintain all registerable rights in the Besins Core IP and
Besins Platform IP (collectively “Besins IP”) at all times during the Term of
this Agreement at the sole expense of Besins. Besins shall provide Atossa a
reasonable and meaningful opportunity to review and comment on such patent
preparation, filing, prosecution and maintenance related to the Besins Core IP
and Besins Platform IP and shall consider such input from Atossa.

 

ii. Rights and Obligations of Atossa

 

Atossa shall have the exclusive right, but not the obligation, to prepare, file,
prosecute, and maintain, at the sole expense of Atossa, all registerable rights
in the Atossa Background IP, Atossa Data, Atossa Regulatory Information, Atossa
Manufacturing Information, and Atossa Developments Records at all times. During
the Term, Atossa shall have the exclusive right, but not the obligation, to
prepare, file, prosecute, and maintain, at its sole cost and sole discretion,
all registerable rights in the Atossa Foreground IP with a legal counsel of
Atossa’s sole choosing. Inventorship and authorship regarding Atossa Foreground
IP shall be determined in accordance with U.S. patent and copyright laws. Atossa
shall provide Besins a reasonable and meaningful opportunity to review and
comment on such patent preparation, filing, prosecution and maintenance related
to the Atossa Foreground IP and shall consider such input from Besins. Besins
shall reasonably assist Atossa and Atossa’s patent counsel, by consulting with
Atossa’s patent counsel regarding any Atossa Foreground IP and its preparation,
filing, prosecution and maintenance; by providing technical and scientific
advice; and by executing all papers and documents reasonably required to
effectuate this Section 3.2(a).ii.

 

14

CONFIDENTIAL

 

iii. Option to Continue to Prosecute and Maintain Patents included in Besins IP.

 

In the event Besins or its Affiliates or any of their respective successors in
interest desires to cease prosecution and/or maintenance of any patents or
patent applications (“Besins Discontinued Patent”) within the Besins IP, it will
promptly notify Atossa in writing of its intent to do so. If such Besins
Discontinued Patent is within Besins Core IP, Besins shall permit Atossa to
continue prosecution or maintenance of such Besins Discontinued Patent within
Besins Core IP at Atossa’s sole expense. If such Besins Discontinued Patent is
within Besins Platform IP and if such Discontinued Patent is not licensed to a
Third Party as of the date Besins sends notification in accordance with this
subsection, Besins shall permit Atossa to continue prosecution or maintenance of
such Besins Discontinued Patent within Besins Platform IP. If Atossa elects to
continue prosecution or maintenance of any such Besins Discontinued Patent,
Besins shall execute such documents and perform such acts at Atossa’s sole
expense as may be reasonably necessary to permit Atossa to prosecute and
maintain such Besins Discontinued Patent.

 

iv. Option to Continue to Prosecute and Maintain patents included in
Atossa Foreground IP

 

In the event Atossa or its Affiliates or any of their respective successors in
interest desires to cease prosecution and/or maintenance of any patents or
patent applications (“Atossa Discontinued Patent”) within the Atossa Foreground
IP, it will promptly notify Besins in writing of its intent to do so, and if
such Discontinued Patent is not licensed to a Third Party as of the date Atossa
sends notification in accordance with this subsection, Atossa shall permit
Besins to continue prosecution or maintenance of such Atossa Discontinued
Patent(s), at Besins’ sole expense. If Besins elects to continue prosecution or
maintenance of such Atossa Discontinued Patent(s), Atossa shall execute such
documents and perform such acts at Besins’ sole expense as may be reasonably
necessary to permit Besins to prosecute and maintain such Atossa Discontinued
Patent.

 

v. Notice of Patent Events.

 

Starting from the Effective Date of this Agreement, (i) Besins shall provide to
Atossa semiannually a written update of any change in status of the patent
portfolio in Besins Core IP and Besins Platform IP (Exhibits C and D), and (ii)
Atossa shall provide to Besins semiannually a written update to the status of
Atossa Foreground IP (Exhibit B).

 

15

CONFIDENTIAL

 

vi. Trademarks.

 

Atossa, at its sole discretion, may elect to use Trademarks and trade dress
licensed to it under Besins Core IP and Besins Platform IP, or to develop and
use trademarks and trade dress of its own selection for use with Afimoxifene
Gel.

 

(b) Enforcement and Defense of Intellectual Property.

 

i. Notice. If either Party becomes aware or reasonably believes that any Besins
IP is being infringed in the Territory by a Third Party, or if a Third Party
claims that any Besins IP is invalid or unenforceable in the Territory, it shall
immediately disclose to the other Party in writing any such actual, threatened
or suspected infringement of, or any action alleging invalidity or
unenforceability of, any Besins IP.

 

ii. Infringement by Third Party.

 

a. Besins shall have the first right, but not the obligation, to enforce and
defend any Besins IP in the Territory at its sole cost, including, without
limitation, to sue and collect damages for infringement, including past
infringement or misappropriation, occurring prior to the Effective Date of this
Agreement. Atossa shall have the first right, but not the obligation, to enforce
any Atossa Background IP, Atossa Foreground IP, and Besins Discontinued Patents
(collectively “Atossa IP”), including, without limitation, to sue and collect
damages for infringement, including past infringement or misappropriation,
and/or to defend against any Third Party claim of invalidity or unenforceability
of any Atossa IP.

 

b. During the Term, Besins shall continue to have the right, but not the
obligation, to enforce and defend any Besins IP, including any Atossa
Discontinued Patents (each, an “Action”).

 

(i) If the alleged infringing activities are outside the Field or in a
Terminated Country, then the right is exclusive to Besins, at Besins’ sole cost
and expense, and Besins shall be entitled to retain any monetary recovery
received by way of judgment or settlement or any other amounts collected
relating to the Action or settlement or termination thereof. Atossa agrees to
assist Besins, at Besins’ expense, in any such Action, including by signing (or
causing its Affiliates or personnel to sign) such documents as Besins shall
reasonably request and, if necessary for Besins to bring or maintain such
Action, joining in the Action as a party at Besins’ sole expense.

 

16

CONFIDENTIAL

 

(ii) If the alleged infringing activities are in the Field in the Territory,
then Atossa shall have the right, but not the obligation, to participate in such
an Action at Atossa’s sole expense. If Atossa elects not to join in the Action,
Atossa nevertheless agrees to assist Besins, at Besins’ expense, in any such
Action, including by signing (or causing its Affiliates or personnel to sign)
such documents as Besins shall reasonably request and, if necessary for Besins
to bring or maintain such Action, joining in the Action as a party at Besins’
sole expense, and Besins shall be entitled to retain any monetary recovery
received by way of judgment or settlement or any other amounts collected
relating to the Action or settlement or termination thereof. If Atossa elects to
join the Action, then Besins and Atossa shall reasonably cooperate in such
Action and the settlement or termination thereof, and each Party shall be
entitled to share any monetary recovery received by way of judgment or
settlement or any other amounts collected relating to the Action or settlement
or termination thereof, to the extent such monetary recovery exceeds the
Parties’ legal fees and costs incurred in such enforcement or defensive Action.

 

(iii) If the alleged infringing activities are in the Field in the Territory,
and Besins notifies Atossa in writing of its intent not to take any measures
against the alleged infringing activities, or fails to take any action within 45
days of a written request from Atossa that it do so, then Atossa shall have the
right, but not the obligation, to do so at Atossa’s sole expense, and Atossa
will retain any monetary recovery received by way of judgment or settlement or
any other amounts collected relating to the Action or settlement or termination
thereof. Besins agrees to assist Atossa, at Atossa’s expense, in any such
Action, including by signing (or causing its Affiliates or personnel to sign)
such documents as Atossa shall reasonably request and, if necessary for Atossa
to bring or maintain such Action, joining in the Action as a party at Atossa’s
sole expense.

 

iii. Third Party Claims.

 

a. Notice. Each Party shall immediately disclose to the other Party in writing
any warning letter or other written notice of infringement or misappropriation
received by a Party, or any action, suit or proceeding brought against a Party
alleging infringement of a patent or misappropriation of intellectual property
of any Third Party with regard to any aspect of the conduct by or for either
Party pursuant to Development and Commercialization activities, or with respect
to Afimoxifene Gel under this Agreement (each, a “Third Party Action”).

 

b. Right to Defend. Atossa shall have the first right, but not the obligation,
to defend against any Third Party Action in the Territory, through counsel of
its choosing reasonably satisfactory to Besins. Besins shall have the right, but
not the obligation, to participate, at its own cost, in such an Action with
counsel reasonably satisfactory to Atossa. If Atossa declines or fails to assert
its intention to defend such claim within sixty (60) days of receipt/sending of
notice thereof, then Besins shall have the right, but not the obligation, to
defend such Third Party claim at its sole cost. If only one Party defends such a
Third Party Action, the Party defending the Action shall have the sole and
exclusive right to select counsel for such Third Party Action.

 

17

CONFIDENTIAL

 

c. Consultation; Settlement. If both Besins and Atossa elect to participate in
the Action, the Parties shall consult with one another on all material aspects
of the defense of Third Party Actions. Each Party shall have a reasonable
opportunity for meaningful participation in decision-making and formulation of
defense strategy. The Parties shall reasonably cooperate with each other in all
such Third Party Actions or proceedings, including in the settlement or
termination thereof.

 

ARTICLE 4

Further Development, Regulatory Activities, and Commercialization

 

4.1Responsibilities and Rights.

 

During the Term and except as otherwise expressly provided herein, Atossa, at
its sole discretion, will have the exclusive right and be responsible for
Developing and Commercializing Afimoxifene Gel in the Field in the Territory,
filing applications for, and obtaining Regulatory Approvals for Afimoxifene Gel
in the Field throughout the Territory. Atossa shall exclusively oversee,
monitor, and coordinate all regulatory actions, communications and filings with
and submissions to Regulatory Authorities, with respect to Afimoxifene Gel in
the Field in the Territory, unless otherwise determined by Atossa. Atossa shall
have the sole right, and shall be exclusively responsible, for corresponding and
meeting with Regulatory Authorities with regard to Afimoxifene Gel in the Field
in the Territory. Atossa shall have the exclusive right to file for, request,
obtain and maintain any regulatory exclusivity rights conferred or granted by
Regulatory Approval for Afimoxifene Gel and to conduct or prosecute any
proceedings or actions to enforce such regulatory exclusivity rights. Atossa
shall provide non-proprietary Data that it determines is reasonably necessary to
obtain any such approvals, authorizations, permits or licenses. Upon sixty (60)
business day prior written request by Besins, Atossa will provide Besins the
opportunity to review any Atossa IND. The Parties agree that Atossa, at its sole
discretion, will select dose concentrations for use of Afimoxifene Gel in the
Field in the Territory.

 

Except as otherwise expressly provided herein, Atossa shall have the sole
discretion to, determine and manage its own commercial strategy to market,
promote and sell Afimoxifene Gel in the Field in the Territory.

 

18

CONFIDENTIAL

 

4.2Expansion of Field

 

Atossa may expand the Field to include an Additional Indication for which Besins
or its Affiliates or Sublicensees has not already started Development or
authorized a Third Party to start Development, upon sixty (60) business days’
prior written notice to Besins and upon providing Besins with a Development Plan
for the Additional Indication that shall supplement and become part of the
Development Plan disclosed in Exhibit E (see below). The following Milestone
Payments by Atossa will be due:

 

IND Milestone: $5,000,000 for the exclusive right to review, access, and
reference a Besins IND for each Additional Indication.

 

Phase 3 Milestone: $20,000,000 when Atossa or its Affiliate or Sublicensee
commences a Phase 3 clinical trial for each Additional Indication.

 

If Besins has started Development in an Additional Indication, Atossa may
nevertheless request to expand the Field to include the Additional Indication,
and Atossa may expand the Field to include the Additional Indication with
Besins’ written consent and payment of the above Milestone Payments.

 

Atossa or its Affiliate or Sublicensee shall not initiate any Clinical Study for
an Additional Indication without first expanding the Field as described in this
section.

 

4.3Development, Commercialization, Reversion of Rights.

 

(a) Development Plan. During the Term of the Agreement, the Parties shall meet
in person, by video conference or telephonically, approximately every six
months, to discuss the status of Development of Afimoxifene Gel under the
Development Plan (the “Half-Yearly Meeting”). Atossa shall provide Besins with
an initial Development Plan which shall cover an eighteen (18) month period
commencing on the Effective Date and which shall become a part of this Agreement
as Exhibit E. Atossa shall provide Besins with updated Development Plan at each
Half-Yearly Meeting, such updated Development Plan shall include Development
plans for additional six (6) months and such updated Development Plan shall
become a part of Exhibit E and this Agreement. Thirty (30) days before any
Half-Yearly Meeting Atossa shall provide to Besins a written half-yearly status
report, which shall be ratified at the Half-Yearly Meeting, such ratification
shall not be unreasonably withheld, denied or delayed. Atossa shall use
Commercially Reasonable Efforts to follow the Development Plan. Upon request by
Besins in writing, Atossa within ninety (90) days of receiving such request will
provide Besins with copies of Atossa Data, Atossa Regulatory Information, Atossa
Manufacturing Information, and Atossa Development Records on the use of
Afimoxifene Gel in the Field in the Territory.

 

(b) Atossa may, in its sole discretion, stop the Development and/or
Commercialization of Afimoxifene Gel for an Indication in the Field in the
Territory, as a whole or on a country-by-country basis, for any reason, upon
sixty (60) business days’ prior written notice to Besins. If Atossa elects to
stop Developing or Commercializing Afimoxifene Gel for an Indication in the
Field in the Territory, as a whole or on a country-by-country basis, the rights
and license granted to Atossa under Article 2 shall terminate as to that
Indication (a “Terminated Indication”) and/or country (a “Terminated Country”)
and revert to Besins on the date of receipt by Besins of such written notice.

 

19

CONFIDENTIAL

 

(c) Notwithstanding anything to the contrary in this Agreement, Besins, in its
sole discretion, may terminate the licenses granted under Sections 2.1(a) and
(b) on an Indication-by-Indication or a country-by-country basis if (i) Atossa
fails to Commercialize Afimoxifene Gel for such Indication (a “Terminated
Indication”) and/or in such country (a “Terminated Country”) in the Territory
within three (3) years of the First Commercial Sale of Afimoxifene Gel for use
in such Indication anywhere in the Territory (which failure to launch was not
caused by Besins’ breach of its obligations hereunder or otherwise due to
matters outside of Atossa’s control) or (ii) the First Commercial Sale has not
occurred five (5) years after the Effective Date (which failure to launch was
not caused by Besins’ breach of its obligations hereunder), and Besins notifies
Atossa in writing that such licenses are being terminated, and such licenses
shall revert to Besins on the date of receipt by Atossa of such written notice.

 

(d) If Atossa fails to accomplish any aspect of the Development Plan for an
Indication or in a country within the Territory within 6 months of date set
forth in the Development Plan (which failure to accomplish was not caused by
Besins’ breach of its obligations hereunder and/or due to circumstances
reasonably outside of Atossa’s control), then Besins shall send Atossa a written
notice of such defect and give Atossa a reasonable opportunity and time to cure
such defect. In the event that Atossa fails to cure such defect, Besins in its
sole discretion may terminate the licenses granted under Sections 2.1(a) and (b)
as to that Indication (a “Terminated Indication”) and/or country (a “Terminated
Country”), provided that Besins notifies Atossa in writing that such licenses
are being terminated. Such licenses shall revert to Besins on the date of
receipt by Atossa of such written notice.

 

(e) In the event that any licenses granted under Sections 2.1(a) and (b) revert
to Besins under Section 4.3(b), (c), or (d), all rights and licenses granted by
Atossa or its Affiliates to Atossa Affiliates, Atossa Sublicensees and any Third
Party shall be terminated for any Terminated Indication(s) and/or in any
Terminated Country(ies), and Atossa (for itself and its Affiliates) shall grant
Besins and its Affiliates (i) irrevocable, perpetual, exclusive, royalty-free,
fully paid, transferable license to continue the Development and/or
Commercialization of Afimoxifene Gel for any Terminated Indication(s) and/or in
any Terminated Country(ies), and (ii) irrevocable, perpetual, exclusive,
royalty-free, fully paid license to rights existing as of the date of
termination under Sections 4.3(b), (c), and (d) under Atossa Foreground IP,
Atossa Know-How, Atossa Manufacturing Information, Atossa Data, Atossa
Development Records, Atossa Regulatory Information, and Atossa Regulatory
Approvals to Develop and Commercialize Afimoxifene Gel for any Terminated
Indication(s) and/or in any Terminated Country(ies).

 

20

CONFIDENTIAL

 

4.4Obligations of Besins.

 

The Parties agree that an important purpose of this Agreement is to increase
patient access to Afimoxifene Gel in the Field in the Territory. Besins agrees
that Atossa shall have the exclusive right to make decisions in all matters
regarding Development, Regulatory Approval and Commercialization of Afimoxifene
Gel in the Field in the Territory.

 

Besins shall timely file all appropriate and necessary notices, documents,
licenses and registrations with all Regulatory Authorities within the Territory
(including, without limitation, Food and Drug Administration (FDA), European
Medicines Agency (EMEA), The National Institute for Health and Care Excellence
(NICE), granting Atossa the authorization to review, access, and reference
Besins Regulatory Information solely with respect to Afimoxifene Gel in the
Field in the Territory. Besins will furnish, at its sole cost, copies of IND
59,081 and IND 66,076 within ten (10) days of the Effective Date to permit
Atossa to engage in Development and Commercialization activities and obtain
Regulatory Approval under this Agreement. Besins will promptly provide Atossa
with all Besins Regulatory Information, Besins Developmental Records, Besins
Manufacturing Information, Besins Know-How, and such other information as
necessary to accomplish Development and Commercialization of Afimoxifene Gel
under this Agreement. Besins will promptly notify and disclose in writing any
past, present and future violations of applicable laws and regulations,
including regulatory compliance warning letters related to any Afimoxifene Gel.
The obligation to disclose regulatory compliance violations regarding
Afimoxifene Gel shall survive the expiration or termination of this Agreement.

 

Besins shall cooperate and use Commercially Reasonable Efforts to assist Atossa
and/or any Sublicensee in procuring supply of the API for use in the Field in
the Territory. In the event Atossa supplies the APIto Besins, Besins shall
manufacture or have manufactured Afimoxifene Gel for Atossa at a cGMP quality
that is at least the minimum acceptable to Regulatory Authorities in amounts
sufficient to conduct at least Phase II clinical trials according to the
Development Plan. Besins shall further cooperate and assist with technology
transfer of all Manufacturing Information, packaging and labeling information to
Atossa and/or Atossa Supplier or Sublicensee in order for Atossa to manufacture
Afimoxifene Gel and perform Development and Commercialization activities under
this Agreement and prepare all filings and submissions necessary to obtain
Regulatory Approval of Afimoxifene Gel. Besins will provide Atossa any
exclusivity or other regulatory exclusivity waivers as may be required by the
applicable Regulatory Authority in order to use, make, have made manufacture,
have manufactured, sell, offer for sale, import, have imported, export, have
exported, distribute, or otherwise transfer Afimoxifene Gel in the Territory for
use in the Field. Besins shall cooperate with Atossa to provide all other
commercially reasonable assistance reasonably requested by Atossa, its
Affiliates and Sublicensees in order to enable compliance with Atossa’s
obligations under Section 4.1.

 

21

CONFIDENTIAL

 

ARTICLE 5

Financial Consideration

 

 

5.1Intellectual Property Royalties to Besins.

 

(a) Royalties.

 

i. Know-How and Regulatory Information Royalties

 

As consideration for the licenses granted to Atossa and its Affiliates under
this Agreement as of the Effective Date under Besins Know-How and Regulatory
Information, beginning on the date of a First Commercial Sale of Afimoxifene Gel
in the Field Atossa shall pay to Besins royalties equal to 8% (eight percent) of
Net Sales of Afimoxifene Gel for use in the Field, on a country-by-country basis
in the Territory.

 

ii. Patent Royalties

 

In addition to the Know-How and Regulatory Information Royalties, as
consideration for the licenses granted to Atossa and its Affiliates under this
Agreement under Besins patents, beginning on the date of a First Commercial Sale
of Afimoxifene Gel in the Field, Atossa shall pay to Besins additional royalties
equal to 1% (one percent) of Net Sales of Afimoxifene Gel for use in the Field
in countries with a Valid Claim, on a country-by-country basis in the Territory,
subject to the following adjustments:

 

If pursuant to Section 3.2.iii, Atossa elects to prosecute and maintain Besins
Discontinued Patents, or if Besins elects not to enforce and defend any Besins
Discontinued Patents in the Territory during the Term and Atossa elects to
enforce and defend such Besins Discontinued Patents, royalty payments due to
Besins under this Section 5.1(a)ii will be reduced by the costs, including
attorney fees, incurred by Atossa of such prosecution, maintenance, enforcement
and defense of such Besins Discontinued Patents. For clarity, adjustments under
this Section 5.1(a)ii shall not exceed 1% (one percent) of Net Sales of
Afimoxifene Gel for use in the Field in countries with a Valid Claim, on a
country-by-country basis in the Territory.

 

22

CONFIDENTIAL

 

(b) Payment. All such royalty payments shall be paid semi-annually, within sixty
(60) days after close of each six month period as provided below. Royalty
payments shall be paid in US Dollars. With regards to sales in currencies other
than US Dollars, conversion from local currency into US Dollars shall be the
rate of exchange of the local currency to the US Dollar on the last day of the
applicable 6-month period, as reported in The Wall Street Journal.

 

(c) Late Payments. Late royalty payments shall incur interest at the rate equal
to the one percent (1.0%) per month, calculated from the date such payments were
originally due.

 

(d) Mode of Payment: Payments will be made by wire transfer, and shall be sent
to an account specified in writing by Besins.

 

(e) Records. For the purpose of computing royalties due to Besins hereunder, the
year shall be divided into two parts ending on June 30 and December 31. Not
later than sixty (60) days after each June 30 and December 31 in each calendar
year during the Term, Atossa shall submit to Besins a full and detailed report
of royalty payments due to Besins under the terms of this Agreement for the
preceding half year (hereinafter the “Half-Year Report”), setting forth the Net
Sales upon which such royalties are computed. If no royalty payments are due, a
statement shall be sent to Besins stating such fact. Payment of the full amount
of any royalty payments due to Besins for the half year represented in any Half
Year Report shall accompany each such Half-Year Report. Atossa shall keep for a
period of at least three (3) years after the date of entry, full, accurate and
complete books and records consistent with sound business and accounting
practices and in such form and in such detail as to enable the determination of
the royalty payment amounts due to Besins pursuant to the terms of this
Agreement.

 

(f) Audit. Upon at least twenty (20) business days advance written notice and
during Atossa’s regular business hours, Besins’ authorized representatives shall
have the right to inspect the books of accounts and records of Atossa insofar as
they relate to the sale of Afimoxifene Gel, or performance of Atossa’s, its
Affiliates, or any of their Sublicensees’ obligations hereunder, in order to
ascertain or verify the amount of royalty payments due to Besins hereunder and
the accuracy of the information provided to Besins in the Half-Year Reports.
Such audits shall be conducted during normal business hours and shall not
unreasonably interfere with Atossa’s conduct of its business. Each such audit
shall be at Besins’ expense unless a particular audit reveals an underpayment of
greater than five percent (5%) of the amount that should have been paid to
Besins for the period audited, in which case Atossa shall bear the reasonable
expense of such audit. Besins will direct its representative to provide a copy
of the audit report to Atossa. If any such audit reveals any inaccuracy in any
statement, the necessary adjustments in such statements and the payments thereof
will be promptly made and shall bear interest calculated at the late payment
rate identified in Section 5.1(c) from the date the underpayment was made until
paid. All audit rights shall survive the termination of this Agreement in full
for a period of two (2) years (except with respect to audit rights as to any
taxes or government surcharges which shall survive for the applicable statute of
limitations, including any extensions thereof).

 

23

CONFIDENTIAL

 

(g) Challenge. Besins shall have 60 days from receipt or acceptance by Besins of
any Half-Year Report or corresponding royalty payment to challenge the validity
or accuracy of such report or payment. Notwithstanding the foregoing, in the
event any audit conducted pursuant to Section 5.1 reveals any underpayment for a
prior period, nothing in this Section 5.1(g) shall serve to limit any rights of
Besins relating to such underpayment.

 

5.2Taxes.

 

In the event that Atossa determines it is required by any Applicable Law to
withhold any taxes from any payment made pursuant to this Agreement
(“Withholding Taxes”), Atossa shall promptly provide written notice of the same
to Besins and (i) withhold such Withholding Taxes from such payment; (ii) remit
such Withholding Taxes to the appropriate governmental authority; (iii) pay to
Besins the amount due as set forth in this Agreement, reduced by the amount of
Withholding Taxes withheld and remitted to the appropriate governmental
authority; and (iv) obtain and furnish to Besins a Withholding Tax receipt or
other evidence of such remittance from the appropriate governmental authority.
Notwithstanding the foregoing, if Besins is entitled under any applicable tax
treaty to a reduction of rate of, or the elimination of, applicable Withholding
Tax, it may deliver to Atossa or the appropriate governmental authority (with
the assistance of Atossa 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 Atossa of its obligation to
withhold tax, and Atossa shall apply the reduced rate of withholding, or
dispense with withholding, as the case may be, provided that Atossa has received
evidence of Besins’ delivery of all applicable forms (and, if necessary, its
receipt of appropriate governmental authorization).

 

5.3Other Taxes.

 

Except as provided in Section 5.2, all taxes or duties in connection with
payments made by Atossa shall be borne by Besins.

  

ARTICLE 6

Confidentiality and Publications

 

6.1Confidential Information.

 

The Receiving Party will not use any Confidential Information of a Disclosing
Party except for the purposes of performing its respective obligations under
this Agreement. Each Receiving Party will maintain Confidential Information of
the other Party in strict confidence and will use a standard of care, including
procedures to prevent unauthorized disclosure or use of the other Party’s
Confidential Information and to prevent it from becoming disclosed or being
accessed by unauthorized persons, that is at least as stringent as those used to
protect Confidential Information of Receiving Party’s own, but which shall in no
event be less than a reasonable degree of care. The Receiving Party shall
immediately advise the Disclosing Party of any unauthorized disclosure, loss, or
use of Confidential Information of which Receiving Party becomes aware. Upon any
termination or expiration of this Agreement, each Receiving Party agrees that
all Confidential Information of the Disclosing Party, whether in written,
graphic, or other tangible form, shall be returned to the Disclosing Party upon
written request or destroyed at Disclosing Party’s instruction, and a
certificate of destruction duly signed by an authorized person on behalf of
Receiving Party will be provided to the Disclosing Party. A single archival copy
may be retained by the Receiving Party’s legal department or counsel to meet
Receiving Party’s obligations under this Agreement and any requirements of
Applicable Law. A deletion of electronic files containing or constituting
Confidential Information shall be considered to be the destruction or return of
such Confidential Information for purposes of this Agreement, provided that the
deleted files must not be retrievable other than through extraordinary data
salvage methods.

 

24

CONFIDENTIAL

 

6.2Restrictions.

 

Unless required by Applicable Law, the Receiving Party will not to disclose any
Confidential Information of the Disclosing Party to any Third Party without the
prior written consent of the Disclosing Party, except to its employees, agents,
consultants, directors and officers that have a need to know such information to
effectuate the purpose of this Agreement (each, a “Representative”); provided,
that any such Representative shall be informed of the confidentiality provisions
of this Agreement and shall be bound by a confidentiality agreement with the
Receiving Party containing terms at least as restrictive as those contained in
this Agreement and including post-employment confidentiality survival terms
consistent with Section 6.1 of this Agreement (the "Representative Agreement").
The Receiving Party shall be liable for the actions or inactions of its
Representatives that would constitute a breach of Article 6 of this Agreement
were such Representatives a party hereto.

 

6.4Exclusions.

 

Notwithstanding anything herein to the contrary, Confidential Information will
not include information that: (i) is now or subsequently becomes generally
available to the public through no act or omission of the Receiving Party or its
Representatives; (ii) the Receiving Party can demonstrate in its contemporaneous
written records to have had lawfully in its possession prior to disclosure to it
by or on behalf of the Disclosing Party; (iii) is independently developed by the
Receiving Party or individuals obligated to assign to the Receiving Party
without use, directly or indirectly, of any Confidential Information of the
Disclosing Party as evidenced by its contemporaneous written records; (iv) the
Receiving Party lawfully obtains without obligation of confidentiality from a
Third Party who has the right to disclose; or (v) is required by law or
regulation to be disclosed, provided that the Receiving Party has provided
prompt, advance written notice to the Disclosing Party so as to enable the
Disclosing Party to seek a protective order or otherwise seek to prevent or
limit disclosure of such Confidential Information, and the Receiving Party will
reasonably cooperate in such efforts by the Disclosing Party; or (vi) pursuant
to Section 6.9 of this Agreement; provided that if any disclosure must be made,
the Receiving Party will only disclose Confidential Information to the extent it
is required to be disclosed.

 

25

CONFIDENTIAL

 

6.5Third Party Information.

 

Further, for avoidance of doubt, Confidential Information of the Disclosing
Party shall include Confidential Information received by the Disclosing Party
from a Third Party. Prior to disclosure of such Third Party Confidential
Information to the Receiving Party, the Disclosing Party shall determine that it
has the right to make such disclosure, and will use its Commercially Reasonable
Efforts to advise the Receiving Party that the disclosure includes Third Party
Confidential Information.

 

6.6Affiliates and Sublicensees.

 

This Article 6 and the obligations herein shall apply to each Party and its
officers, directors, employees, subcontractors, agents, Affiliates,
Representatives, and Sublicensees. Each Receiving Party shall be responsible for
causing such persons to comply with the obligations set forth in this Article 6.

 

6.7Term.

 

A Receiving Party’s obligations under this Article 6 will continue for a period
of seven (7) years following expiration or termination of this Agreement, or,
with respect to Trade Secrets, for such longer period as may be provided by
applicable law.

 

6.8Relief.

 

Each Receiving Party agrees that any unauthorized disclosure, loss or use of
Confidential Information may cause irreparable harm entitling the Disclosing
Party to seek injunctive relief, in addition to any other remedies available to
it at law or in equity.

 

26

CONFIDENTIAL

 

6.9Public Announcements.

 

Except as required by Applicable Law, the material terms of this Agreement will
be considered Confidential Information of both Parties. Notwithstanding the
foregoing sentence, (a) either Party may disclose such terms as are required, in
the reasonable judgment of such Party and its counsel, to be disclosed in its
publicly-filed financial statements or other public statements, pursuant to
Applicable Laws, regulations and stock exchange rules (e.g., the rules of the
U.S. Securities and Exchange Commission, NASDAQ, NYSE or any other stock
exchange on which securities issued by either Party may be listed); and (b)
either Party shall have the further right to disclose the material financial
terms of this Agreement under a confidentiality obligation no less protective
than those set forth in this Agreement, to any potential acquirer, licensee,
lender, merger partner or potential providers of financing and their respective
advisors. Neither Party shall make any other statement to the public regarding
the execution and/or any other aspect of the subject matter of this Agreement
without the prior review and consent of the other Party, except: (i) where a
Party reasonably believes disclosure is required under Applicable Laws, (ii) the
Parties shall have the right to announce the terms and existence of this
Agreement in a press release at its execution, and (ii) either Party may use the
text of a public statement previously approved by the other Party for
disclosure. Attached as Exhibit F is the form of press release mutually agreed
to by the Parties that either Party may release to announce the entry into this
Agreement.

 

6.10Publications.

 

Atossa shall have the exclusive right to publish the Atossa Data, Atossa
Development Record, Atossa Background IP, and Atossa Foreground IP at its sole
discretion in the Territory. For avoidance of doubt, Besins shall have no right
of publication of Atossa Data, Atossa Development Records, Atossa Background IP,
Atossa Foreground IP, Atossa Know-How, and Atossa Manufacturing Information
under this Agreement without Atossa’s prior written consent, and Atossa shall
have no right of publication of Besins Core IP or Besins Platform IP without
Besins’ prior written consent, which shall not be unreasonably withheld,
conditioned, or delayed.

 

ARTICLE 7

Representations and Warranties

 

7.1Authority.

 

Each Party represents and warrants to the other Party that, as of the Effective
Date:

 

(a) it is a corporation duly organized, validly existing, and in good standing
under the laws of the jurisdiction wherein it is organized;

 

27

CONFIDENTIAL

 

(b) it has the full power and authority under the laws of the state or country
of its incorporation to enter into this Agreement and carry out its provisions,
that the person executing this Agreement on its behalf has been authorized to do
so by all requisite corporate action;

 

(c) that its execution of and performance under this Agreement will not violate
or breach any obligation or restriction (including, without limitation, any
confidentiality or non-competition obligation or any exclusivity restriction) to
which such Party is legally bound by contract, judicial order or otherwise; and
no notice is required to or from any Third Party in connection with the
transactions contemplated by this Agreement; and

 

(d) upon full execution of this Agreement by the Parties hereto, this Agreement
is a legal and valid obligation of the Party, binding upon the Party, and
enforceable against the Party in accordance with the terms of this Agreement.

 

7.2Besins Representations and Warranties.

 

As of the Effective Date and throughout the Term, Besins represents, warrants,
and covenants that to the best of its knowledge:

 

(a) its officers, directors, employees, subcontractors, agents, and Affiliates
and any person who is performing or has performed under this Agreement is not
under investigation by: (i) the FDA for debarment or disqualification action or
is presently not debarred or disqualified pursuant to the Generic Drug
Enforcement Act of 1992 (21 U.S.C. 301 et seq.); or (ii) any other Regulatory
Authority for debarment or disqualification action or is not presently debarred
or disqualified by any other Regulatory Authority;

 

(b) it will provide a written certification, if requested by Atossa, to the
representation and warranty of Section 7.2.a, and to promptly notify Atossa if
any person who has performed activities under this Agreement is debarred or
disqualified by the FDA or any other Regulatory Authority, but no later than ten
(10) days after such disbarment or disqualification;

 

(c) there is no action, suit, claim, investigation or proceeding pending or, to
the best of its knowledge, threatened in writing against it that, if adversely
decided, would be likely to adversely affect Besins’ ability to enter into this
Agreement or perform its obligations hereunder;

 

(d) there is no action, claim, demand, suit, proceeding, arbitration, grievance,
citation, summons or subpoena served upon it and it has not received any written
notice of any ongoing inquiry, investigation or threat of any nature, civil,
criminal, regulatory or otherwise, in law or in equity, relating to the
activities contemplated and rights granted under this Agreement;

 

(e) it is not a party to any agreement that would prevent it from fulfilling its
obligations under this Agreement;

 

28

CONFIDENTIAL

 

(f) there are no Encumbrances on Besins IP, Besins Manufacturing Information,
INDs, Besins Regulatory Information, and Besins Development Record and it owns
or upon their creation will own the rights and has or will have the right and
power to grant the license rights granted to Atossa under this Agreement;

 

(g) its performance under this Agreement does not and will not violate any
Intellectual Property or proprietary rights of any Third Party, nor has any
claim of such infringement been threatened or asserted; and

 

(h) it has provided Atossa with all material information responsive to Atossa’s
diligence inquiries and such information in true and correct and does not
contain any material omissions.

 

7.3FCPA.

 

(a) Each of the Parties warrants that it shall not make any payment, either
directly or indirectly, of money or other assets, including but not limited to
the compensation Parties derives from this Agreement, or provide any gifts,
entertainment or other thing of value (hereinafter collectively referred as a
“Payment”) to government or political party officials, employees of state-owned
entities, specifically including employees of state-owned medical/clinical
facilities, officials of international organizations, candidates for public
office, or representatives of other businesses or persons acting on behalf of
any of the foregoing (collectively “Officials”) where such Payment would
constitute violation of any law, including the U.S. Foreign Corrupt Practices
Act of 1977, 15 U.S.C. §§ 78dd-1, et seq. (“FCPA”). In addition, regardless of
legality, the Parties shall make no Payment either directly or indirectly to
Officials if such Payment is for the purpose of influencing decisions or actions
with respect to the subject matter of this Agreement or any other aspect of its
business.

 

(b) Each Party warrants that it is familiar with the restrictions of all
applicable anti-bribery/anti-corruption laws, including the FCPA, and that such
Party shall provide appropriate training and education to anyone performing work
on such Party’s behalf under this Agreement on all such laws, including the
FCPA.

 

(c) Each Party shall report to the other in writing any suspected or actual
violation of any anti-bribery/anti-corruption laws relating to this agreement
immediately.

 

7.4Atossa Representations and Warranties.

 

As of the Effective Date, Atossa represents, warrants, and agrees that to the
best of its knowledge:

 

(a)    its officers, directors, employees, subcontractors, agents, and
Affiliates and any person who is performing or has performed under this
Agreement is not under investigation by: (i) the FDA for debarment or
disqualification action or is presently not debarred or disqualified pursuant to
the Generic Drug Enforcement Act of 1992 (21 U.S.C. 301 et seq.); or (ii) any
other Regulatory Authority for debarment or disqualification action or is not
presently debarred or disqualified by any other Regulatory Authority;

 

29

CONFIDENTIAL

 

(b)   it will provide a written certification, if requested by Besins, to the
representation and warranty of Section 7.4.a, and to promptly notify Besins if
any person who has performed activities under this Agreement is debarred or
disqualified by the FDA or any other Regulatory Authority, but no later than ten
(10) days after such disbarment or disqualification;

 

(c)    its officers, directors, employees, subcontractors, agents, and
Affiliates shall comply with all Applicable Law, during the Term of and in the
performance of this Agreement, and that Atossa’s actions in establishing and
performing this Agreement have been and will be consistent with ethical business
practices and without the influence of any association with an Besins employee,
officer or director that would amount to a conflict of interest;

 

(d)   there is no action, suit, claim, demand, or proceeding pending or, to the
best of its knowledge, threatened in writing against it that, if adversely
decided, would be likely to adversely affect Atossa’s ability to enter into this
Agreement or perform its obligations hereunder; and there is no action, claim,
demand, suit, proceeding, arbitration, grievance, citation, summons or subpoena
served upon it and it has not received any written notice of any ongoing
inquiry, investigation or threat of any nature, civil, criminal, regulatory or
otherwise, in law or in equity, relating to the activities contemplated and
rights granted under this Agreement; and it is not a party to any agreement that
would prevent it from fulfilling its obligations under this Agreement there are
no Encumbrances on Atossa Know-How, Atossa Data, Atossa Background IP, Atossa
Development Record, and Atossa Foreground IP, Atossa Manufacturing Information,
and Atossa Regulatory Information and it owns or upon their creation will own
the rights and has or will have the right and power to grant the license rights
granted to Besins under this Agreement; and

 

(e)    its performance under this Agreement does not and will not violate any
Intellectual Property or proprietary rights of any Third Party, nor has any
claim of such infringement been threatened or asserted.

 

30

CONFIDENTIAL

 

ARTICLE 8

Term and Termination

 

8.1Expiration.

 

This Agreement will commence on the Effective Date and, unless otherwise earlier
terminated pursuant to Section 8.2, will expire on a country-by-country basis,
fifteen (15) years after the First Commercial Sale of Afimoxifene Gel in the
Field in the applicable country in the Territory.

 

8.2Termination.

 

(a) Mutual Termination. The Parties may terminate this Agreement at any time
upon their mutual written agreement.

 

(b) Unilateral Termination. Besins may unilaterally terminate this Agreement in
accordance with Sections 4.3(c) and (d). Atossa may unilaterally terminate this
Agreement in accordance with Section 4.3(b).

 

(c) Breach. Either Party, in its sole discretion, may terminate this Agreement
if the other Party has materially breached this Agreement upon delivery of a
sixty (60) days advance written notice to the other Party describing the breach
and demanding its cure, and if the breaching Party has not cured the breach
within the sixty (60) day period following receipt of such written notice of
breach.

 

(d) Bankruptcy. Either Party, in its sole discretion, may terminate this
Agreement, effective immediately, upon written notice to the other Party upon:
(i) the making by the other Party of an assignment for the benefit of creditors;
(ii) the filing by the other Party of a voluntary petition in bankruptcy; (iii)
the failure by the other Party to dismiss, within ninety (90) days of filing, a
proceeding in bankruptcy against the other Party; (iv) appointment of a trustee
or receiver (or similar official) of all or a substantial part of the property
of the other Party under bankruptcy, insolvency or receivership laws; or (v)
assumption of this Agreement by or on behalf of the other Party in any
bankruptcy, insolvency or receivership proceeding.

 

31

CONFIDENTIAL

 

8.3Effect of Expiration or Termination.

 

(a) In the event of expiration or termination of this Agreement, (i) Atossa
shall remain the sole and exclusive owner of Atossa IP, Atossa Know-How, Atossa
Regulatory Information, Atossa Development Record, and Atossa Manufacturing
Information, subject to licenses granted under Sections 2.2, 4.3(e) and 8.3(c),
and (ii) Besins shall remain the sole and exclusive owner of Besins IP, Besins
Regulatory Information, Besins Manufacturing Information, and Besins Development
Record, subject to the licensed rights under Section 8.3(b).

 

(b) Non-exclusive License to Atossa. Upon expiration of this entire Agreement
under Section 8.1 (but not termination under Section 8.2), and to the extent not
terminated under Section 4.3, the exclusive royalty-bearing right and license
granted to Atossa under Section 2.1(a) and (b) of this Agreement shall be
converted to an irrevocable, perpetual, world-wide, royalty free, fully paid-up,
non-exclusive, transferable right and license in the Field in the Territory.

 

(c) Non-exclusive License to Besins. Upon expiration of this entire Agreement
under Section 8.1 (but not termination under Section 8.2), and to the extent not
terminated under Section 4.3, Atossa hereby grants to Besins and its Affiliates
an irrevocable, perpetual, worldwide, non-exclusive right and license under
Atossa Foreground IP to Develop and Commercialize Afimoxifene Gel in the Field
in the Territory. As consideration for the license granted in this Section
8.3(c), Besins shall pay to Atossa royalties equal to 4% (four percent) of
Besins Nets Sales in the Field in any country of the Territory with a Valid
Claim, on a country-by-country basis. “Besins Nets Sales” means the gross
revenue received by Besins, its Affiliates, their respective Sublicensees and
Besins Third Party Resellers for the sale of Afimoxifene Gel to Third Parties
other than Atossa and its Affiliates and Sublicensees (whether end-users,
wholesalers or otherwise) in an arm’s-length transaction, less the amount of the
following deductions: (i) normal and customary trade, cash and quantity
discounts actually given, credits, price adjustments or allowances for damaged
products, returns or rejections of products, and allowance or rebates for
retroactive price reductions; (ii) chargeback payments and rebates (or the
equivalent thereof), if any, granted to group purchasing organizations, managed
health care organizations or to federal, state/provincial, local and other
governments, including their agencies, or to trade customers, wholesalers or
other distributors; (iii) freight, shipping insurance and other transportation
expenses directly related to shipments or deliveries of Afimoxifene Gel (if
actually borne by Besins, its Affiliates or Sublicenses without reimbursement
from any Third Party); (iv) sales taxes, value-added taxes, excise taxes,
tariffs and duties of importation, and other taxes and any other similar
government charges actually borne by Besins, its Affiliates or Sublicensees in
connection with the sale or delivery of Afimoxifene Gel without reimbursement
from any Third Party (but not including taxes assessed against the income
derived from such sale); and (v) provisions for actual uncollectible accounts
determined in accordance with U.S. generally accepted accounting principles,
International Financial Reporting Standards, or such other accounting practices
as Besins or its Affiliates or Sublicensees may, at their sole discretion,
adopt, as consistently applied by Besins, its Affiliates, or Sublicensees (as
applicable).

 

32

CONFIDENTIAL

 

(d) Accrued Obligation. Expiration or termination of this Agreement for any
reason will not release either Party from any liability which has already
accrued to the other Party or which is attributable to any event occurring or
failing to occur during the Term of this Agreement prior to such expiration or
termination.

 

(e) Survival. As between the Parties, the rights and obligations of Atossa and
Besins which by intent or meaning have validity beyond expiration or termination
of this Agreement as set forth above, including, but not limited to, rights with
respect to confidentiality, indemnification and liability limitations, shall
survive the termination or expiration of this Agreement.

 

(f) Termination of the entire Agreement under Section 8.2 by either Party
terminates all rights and licenses granted by such Party and its Affiliates to
its Affiliates, Sublicensees and any Third Party. Termination of this Agreement
by Atossa shall automatically terminate any and all sublicenses given by Atossa
that grant to any Third Party any right under any Besins Intellectual Property.

 

(g) Remedies in Addition. The termination provisions of this Article 8 will not
be exclusive, but rather will be in addition to any rights or remedies at law or
in equity, or under this Agreement.

 

ARTICLE 9

Indemnification

 

9.1Generally.

 

Each Party specifically reserves any common law right of indemnity and/or
contribution which such Party may have against the other.

 

9.2Indemnification of Atossa.

 

Besins shall indemnify, defend and hold Atossa, its officers, directors,
employees, subcontractors, agents and Affiliates (“Atossa Indemnitees”),
harmless from and against any and all liabilities, obligations, claims, demands,
judgments, losses, deficiencies, costs, damages, expenses, fines, royalties,
governmental penalties or punitive damages, interest, settlement amounts,
awards, and judgments, (including reasonable, out-of-pocket attorneys’,
consultants’ and other professional fees and disbursements) (collectively,
“Losses”) sustained by the Atossa Indemnitees arising from or out of any Third
Party action, claim, demand, injunction, investigation, inquiry, proceeding,
regulatory action, request or suit (collectively, “Claim(s)”) related to:

 

33

CONFIDENTIAL

 

(a) Besins’, its officers’, directors’, employees’, subcontractors’, agents’ or
Affiliates’: (i) breach of any of its representations, warranties, agreements,
covenants or obligations contained in or made pursuant to this Agreement; (ii)
performance of Development under this Agreement by any of the Besins’
Indemnitees; (iii) acts or omissions in performance by any of the Besins’
Indemnitees of this Agreement; (iv) failure by any of the Besins’ Indemnitees to
comply with Applicable Law; (v) Development, manufacturing or other activities
related to Afimoxifene Gel prior to the Effective Date and any commercialization
of Afimoxifene Gel by any of the Besins’ Indemnitees prior to the Effective
Date, and (vi) negligence, gross negligence or willful misconduct of any of
Besins’ Indemnities, except in each case, to the extent such Losses arise from
the gross negligence or willful misconduct of the Atossa; or a material breach
of this Agreement by Atossa, which is not timely cured.

 

(b) Infringement, misappropriation or encroachment of any Third Party’s
personal, contractual or property rights by any of the Besins’ Indemnitees.

 

9.3Indemnification of Besins.

 

Atossa shall indemnify, defend and hold Besins, its officers, directors,
employees, subcontractors, agents or Affiliates (“Besins Indemnitees”) harmless
from and against any and all Losses sustained by the Besins Indemnitees arising
from or out of any Third Party Claims related to:

 

(a) Atossa’s, its officers’, directors’, employees’, subcontractors’, agents’,
or Affiliates’: (i) breach of any of its representations, warranties,
agreements, covenants or obligations contained in or made pursuant to this
Agreement; (ii) performance of Development under this Agreement by any of the
Atossa Indemnitees; (iii) acts or omissions in performance of this Agreement by
any of the Atossa Indemnitees; (iv) failure by any of the Atossa Indemnitees to
comply with Applicable Law; (v) Development, manufacturing or other activities
related to Afimoxifene Gel following the Effective Date and commercialization of
Afimoxifene Gel by any of the Atossa Indemnitees; and (vi) negligence, gross
negligence or willful misconduct of any of the Atossa Indemnities, except in
each case, to the extent such Losses arise from the gross negligence or willful
misconduct of the Besins or a material breach of this Agreement by Besins, which
is not timely cured; and

 

(b) Infringement, misappropriation or encroachment of any Third Party’s
personal, contractual or property rights by any of the Atossa’s Indemnitees.

 

34

CONFIDENTIAL

 

9.4Notice; Settlement.

 

Each Party will promptly notify the other Party of any claim or liability for
which indemnification is sought upon becoming aware thereof, provided that any
delay or failure to give such notice will not relieve the indemnifying Party of
its obligations hereunder except to the extent that the indemnifying Party is
actually and materially prejudiced by such delay or failure. The Atossa
Indemnitee(s) and Besins Indemnitees may respectively each, at their sole
discretion and expense, participate and appear with the indemnifying Party in
the defense of any Claim conducted by the indemnifying Party. The indemnifying
Party may not settle any Claim, and no Party shall be responsible for or be
bound by any settlement that imposes an obligation on it, without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed. Each indemnified Party shall cooperate with
and provide to the other all information and assistance which the other Party
may reasonably request in connection with any Claim entitling any Party to
indemnification hereunder.

 

9.5No Action.

 

If the indemnifying Party does not acknowledge its indemnification obligation
hereunder with respect to a Claim and/or elects not to defend such Claim, the
indemnified Party shall have the right, but not the obligation, to defend and
settle such Claim until such time as the indemnifying Party acknowledges in
writing its indemnification obligation hereunder with respect to such Claim
and/or elects in writing to defend and settle such Claim in accordance with the
indemnification provisions of this Article 9.

  

ARTICLE 10

Limitation of Liability and Insurance

 

10.1Limitation of Liability.

 

Except for the Parties’ obligations of Confidentiality set forth in Article 6
and the Parties’ obligations of Indemnification pursuant to Article 10, IN NO
EVENT SHALL EITHER PARTY (INCLUDING THE BESINS INDEMNITEES OR ATOSSA
INDEMNITEES, AS APPLICABLE) OR ANY OF ITS AFFILIATES BE LIABLE TO THE OTHER
PARTY (INCLUDING THE BESINS INDEMNITEES OR ATOSSA INDEMNITEES, AS APPLICABLE) OR
ANY OF ITS AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR
PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT
LIABILITY OR OTHERWISE ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY
BREACH THEREOF, EXCEPT TO THE EXTENT THAT ANY SUCH DAMAGES ARE PAYABLE TO A
THIRD PARTY AS PART OF INDEMNIFICATION OF A THIRD PARTY CLAIM.

 

35

CONFIDENTIAL

 

10.2Insurance - Minimum Requirements.

 

(a) Except as stated in Section 10.2.b below, from the Effective Date and for so
long as Atossa is conducting the Development and Commercialization of
Afimoxifene Gel hereunder, Atossa will, at its own cost, procure and continue in
effect comprehensive general liability insurance that includes product liability
coverage and coverage at the Commercialization stage for claims related to the
Development and Commercialization of Afimoxifene Gel, with limits of not less
than one million dollars ($1,000,000.00) per occurrence for death or bodily
injury and not less than three million dollars ($3,000,000.00) in aggregate.

 

(b) If Besins receives a license pursuant to Section 5.2 hereto, during the Term
and for five years after expiration or termination of this Agreement, Besins
will, at its own cost, procure and continue in effect comprehensive general
liability insurance that includes product liability coverage at the
Commercialization stage and coverage for claims related to the Development and
Commercialization of Afimoxifene Gel, with limits of not less than one million
dollars ($1,000,000.00) per occurrence for death or bodily injury and not less
than three million dollars ($3,000,000.00) in aggregate.

 

(c) Notice. Each Party shall provide evidence of such insurance upon written
request by the other Party. Each Party shall notify the other Party in writing
at least thirty (30) days prior to any cancellation, reduction in coverage or
non-renewal of such policy.

 

(d) Non-limiting. It is understood that this insurance shall not be construed as
limiting either Party’s indemnification obligations under this Agreement.

  

ARTICLE 11

Dispute Resolution

 

11.1General.

 

Any occurrence of any breach, controversy, claim, default, or dispute relating
to, arising out of or in any way connected to any provision or performance of
this Agreement between the Parties (“Dispute”) shall be discussed in good faith
by the Parties in an effort to resolve the Dispute.

 

36

CONFIDENTIAL

 

11.2Officers.

 

If a Dispute cannot be resolved within thirty (30) days pursuant to discussions
conducted in accordance with Section 11.1, either Party may, by written notice
to the other Party, have such Dispute referred to the EVP of Research &
Development for Besins and to the Chief Executive Officer at Atossa for
resolution in which case the Parties shall cause the EVP of Research &
Development for Besins and the Chief Executive Officer at Atossa to meet (in
person or telephonically) during the following thirty (30) day period to discuss
resolution of the Dispute.

 

11.3Venue.

 

If a Dispute cannot be resolved in accordance with Sections 11.1 and 11.2, each
of the Parties (i) agree that any legal suit, action or proceeding arising out
of or relating to this Agreement and/or the transactions contemplated hereby
will be instituted exclusively in the courts located in the State of Delaware
(ii) waive any objection which it may have or hereafter to the venue of any such
suit, action or proceeding, and (iii) irrevocably consents to the jurisdiction
of the courts located in the State of Delaware, in any such suit, action or
proceeding.

  

ARTICLE 12

Miscellaneous Provisions

 

12.1Accounting Procedures.

 

All monetary amounts expressed in this Agreement are expressed in U.S. dollars.
Each Party shall calculate all amounts hereunder and perform other accounting
procedures required hereunder and applicable to it in accordance with the
conventions, rules and procedures promulgated by the U.S. generally accepted
accounting principles.

 

12.2Affiliates.

 

Each Party shall have the right to have any of its obligations hereunder
performed, or its rights hereunder exercised, by, any of its Affiliates with
prior written notice to the other Party, and the performance of such obligations
by any such Affiliate(s) shall be deemed to be performance by the Party;
provided, that any such delegation by a Party to any of its Affiliates shall not
relieve the delegating Party of any of its obligations under this Agreement and
the delegating Party shall ensure the performance of its obligations under this
Agreement in accordance with the terms and conditions of this Agreement and that
any failure of any Affiliate performing any obligations of the delegating Party
hereunder shall be deemed to be a failure by the delegating Party to perform
such obligations. Each Party and any of its Affiliate performing any of the
Party’s obligations or receiving any benefits under this Agreement shall be
responsible for all acts or omissions of the Party or its Affiliates’ directors,
officers, employees, contractors or consultants, and each Party and any such
Affiliate shall be jointly and severally liable hereunder, and each Party shall
have the right to enforce the terms of this Agreement against any such Affiliate
of the other Party as if it were a Party.

 

37

CONFIDENTIAL

 

12.3Amendments.

 

No waiver, modification or amendment of any provision of this Agreement shall be
valid or effective unless made in a writing referencing this Agreement and
signed by a duly authorized officer of each Party.

 

12.4Assignment; Binding.

 

Parties will have the right at its sole discretion to, assign, delegate or
otherwise transfer (whether voluntarily, by operation of law or otherwise) this
Agreement, or any of its rights or obligations hereunder with prior written
consent of the other Party which shall not be unreasonably withheld, delayed or
conditioned; provided, however, that either Party may assign this contract to an
Affiliate or to an acquirer in connection with the merger or acquisition of the
Party or all or substantially all the assets of the Party. Subject to the
foregoing, this Agreement will be binding upon and will inure to the benefit of
the Parties and their respective successors and permitted assigns. Any
assignment by a Party in violation of this provision shall be void.

 

12.5Compliance with Laws.

 

Each Party shall conduct, and shall use Commercially Reasonable Efforts to cause
its Affiliates and subcontractors and its and its Affiliates’ and
subcontractors’ employees, contractors and consultants to conduct, all
activities contemplated under this Agreement in accordance with all Applicable
Law. Each Party shall be liable for any action or inaction that would constitute
a breach of this Agreement or breach of any Applicable Laws by its respective
Affiliates, subcontractors and/or their respective employees or consultants,
were such Affiliates, subcontractors and/or their respective employees or
consultants a party hereto.

 

12.6Construction.

 

This Agreement has been negotiated by the Parties and their respective counsel
and will be interpreted fairly in accordance with its terms and without any
strict construction in favor of or against either Party. Except where expressly
stated otherwise in this Agreement, the following rules of interpretation apply
to this Agreement: (a) “include,” “includes” and “including” are not limiting
and shall be deemed to be followed by “without limitation”; (b) definitions
contained in this Agreement are applicable to the singular as well as the plural
forms of such terms; (c) references to an agreement, statute or instrument mean
such agreement, statute or instrument as from time to time amended, modified or
supplemented; (d) captions and other headings to this Agreement are for
convenience only, and shall have no force or effect in construing or
interpreting any of the provisions of this Agreement or any other legal effect;
(e) references to “Parties,” “Article,” “Section,” “Exhibit” or “Schedule” refer
to the Parties to, an Article or Section of, or any Exhibit or Schedule to, this
Agreement unless otherwise indicated; (f) the word “will” shall be construed to
have the same meaning and effect as the word “shall” and vice versa; and (g) the
word “or” has, except where otherwise indicated, the inclusive meaning
represented by the phrase “and/or”.

 

38

CONFIDENTIAL

 

12.7Counterparts.

 

This Agreement may be executed (including, without limitation, by facsimile,
electronic, or PDF signature) in one or more counterparts, each of which will be
deemed an original instrument, and all of which will constitute one and the same
agreement.

 

12.8Force Majeure.

 

If the performance by a Party of any obligation under this Agreement, is
prevented or impaired by an event of Force Majeure, the affected Party claiming
an event of Force Majeure shall be excused from performance so long as such
situation continues to prevent or impair performance, provided that the affected
Party: promptly notifies the other Party in writing of the full particulars of
the cause or event and the date of first occurrence thereof as soon as possible
after the event; provides a date when full performance is expected to be
resumed; and keeps the other Party informed of any further developments. The
Party so affected shall use all Commercially Reasonable Efforts to remove the
cause of non-performance, and each Party shall resume performance hereunder with
the utmost dispatch when such cause is removed, unless this Agreement has been
terminated according to its terms

 

12.9Governing Law.

 

This Agreement will be governed by the laws of the State of Delaware applied to
contracts made and to be wholly performed in the State of Washington.

 

12.10Limited Rights and Obligations.

 

Each Party hereby acknowledges and agrees that the scope of the relationship
between the Parties will be limited to the purposes and activities expressly set
forth herein, and that the rights and obligations of the Parties with respect to
each other will be limited to those expressly prescribed in this Agreement.
Neither Party has any right, obligation or responsibility not specifically
provided herein or authorized after the Effective Date by the mutual written
agreement of the Parties, and nor will such right, obligation or responsibility
will be implied by the terms and conditions of this Agreement or the conduct of
the Parties hereunder.

 

39

CONFIDENTIAL

 

12.11Notices.

 

Any consent, notice or report required or permitted to be given or made under
this Agreement by one of the Parties to the other shall be in writing and
addressed to such other Party at its address indicated below, or to such other
address as the addressee Party shall have last furnished in writing to the
addressor Party, and shall be considered effective and/or received: (i) upon the
date of receipt by the addressee Party if hand delivered; (ii) if sent via
electronic mail, upon the date a personalized electronic mail confirmation or
acknowledgment of receipt is sent; (iii) upon the date delivered by the U.S.
postal service via registered or certified mail, or by reputable courier
service, in each case, as indicated with a written confirmation or
acknowledgement of receipt.

 

If to Atossa: Steven Quay, CEO and President   ATOSSA GENETICS, INC.   2345
Eastlake Ave E, Suite 201   Seattle, WA, 98102. U.S.A.         If to Besins:
Leslie Grunfeld, CEO   Besins Healthcare Holding Ltd   AGildo Pastor Center   7
rue du Gabian,   98000 Monaco   lgrunfeld@besins-healthcare.com       With a
copy to:   François Brault, Head of Legal Affairs:  
fbrault@besins-healthcare.com

 

12.12Relationship of the Parties.

 

The Parties acknowledge that this Agreement does not create a fiduciary
relationship between them, and that the Parties are independent contractors of
the other, and that nothing in this Agreement is to make either Party an agent,
legal representative, subsidiary, joint venturer, partner, employee or servant
of the other for any purpose whatsoever. Neither Party nor its agents have any
authority of any kind to bind the other Party in any respect whatsoever, and the
relationship of the Parties is, and at all times will continue to be, that of
independent contractors.

 

40

CONFIDENTIAL

 

12.13Severability.

 

In the event that any provisions of this Agreement are determined for any reason
to be invalid or unenforceable by a court of competent jurisdiction, the
remainder of the Agreement will remain in full force and effect without that
provision. In such event, the Parties will in good faith negotiate a substitute
clause for any provision declared invalid or unenforceable, which will most
nearly approximate the intent of the Parties.

 

12.14Use of Names.

 

Except as provided in Section 6.10, neither Party will use the name, symbol or
logo of the other Party without the other Party’s prior written consent except
as required by law. Each Party shall keep the other Party informed about any of
its activities that involve using the other Party’s name.

 

12.15Waiver.

 

The waiver of or failure to enforce by one Party any breach of any term,
covenant, or condition contained in this Agreement will not be construed or
deemed to be a waiver of any subsequent or similar breach of the same or any
other term, covenant, representation, warranty, or condition; nor will any delay
or omission on the part of either Party to exercise or avail itself of any right
or remedy that it has or may have hereunder operate as a waiver of any right or
remedy.

 

12.16Solicitation of Employees.

 

The Parties agree that during the term of this Agreement and during the twelve
(12) month period commencing on the date that such term expires or is
terminated, they shall not for any reason, either directly or indirectly, on
their own behalf or in the service of or on behalf of others, solicit, recruit
or attempt to persuade any person to terminate such person’s employment with the
other Party, whether or not such person is a full-time employee or whether or
not such employment is pursuant to a written agreement or is at-will; provided
that either Party may hire an employee of the other in the event such employee
answers a general advertisement for employment (not targeted to employees of the
other Party) or seeks employment without any prior solicitation by the hiring
Party.

 

SIGNATURES FOLLOW ON THE NEXT PAGE

 

41

CONFIDENTIAL

 

IN WITNESS WHEREOF, the undersigned, intending to be legally bound, have duly
executed this Agreement as of the date first above written.

 

BESINS HEALTHCARE.  ATOSSA GENETICS INC.     By: /s/ Leslie Grunfeld By: /s/
Steven C. Quay     [signature] [signature]     Name: Leslie Grunfeld Name:
Steven C. Quay     Title: CEO Title: CEO

 

42

CONFIDENTIAL

 

Exhibit A – Atossa Background IP Claiming Afimoxifene Gel.

 

None

 

43

CONFIDENTIAL

 

Exhibit B – Atossa Foreground IP

 

None. To be completed after execution of Agreement when IP is developed.

 

44

CONFIDENTIAL

 

Exhibit C – Besins Core IP

 

A Hyperplasia & Benign Breast Disease     Country Application # Registration #
Status 1
Australia                                                                       
2005227072 2005227072 Granted/Registered 2
Austria                                                                         
05716433.7 1748770 Granted/Registered 3
Belgium                                                                         
05716433.7 1748770 Granted/Registered 4
Canada                                                                          
2559748 2559748 Granted/Registered 5
China                                                                           
200580009172.4 1946387 Granted/Registered 6
Denmark                                                                         
05716433.7 1748770 Granted/Registered 7 European Patent
Application                                                      05716433.7
1748770 Granted/Registered 8
Finland                                                                         
05716433.7 1748770 Granted/Registered 9
France                                                                          
05716433.7 1748770 Granted/Registered 10
Germany                                                                         
05716433.7 1748770 Granted/Registered 11
Greece                                                                          
05716433.7 1748770 Granted/Registered 12 Hong
Kong                                                                       
07102275.5 HK1096595 Granted/Registered 13
Ireland                                                                         
05716433.7 1748770 Granted/Registered 14
Italy                                                                           
05716433.7 1748770 Granted/Registered 15
Japan                                                                           
2007-504377 5072588 Granted/Registered 16
Luxembourg                                                                      
05716433.7 1748770 Granted/Registered 17
Mexico                                                                          
PA/A/2006/010914 262962 Granted/Registered 18
Monaco                                                                          
05716433.7 1748770 Granted/Registered 19
Netherlands                                                                     
05716433.7 1748770 Granted/Registered 20 New
Zealand                                                                     
549817 549817 Granted/Registered 21
Norway                                                                          
20064609   Application Pending 22 PCT
Application                                                                 
PCT/EP2005/003286   Case Closed 23
Poland                                                                          
05716433.7 1748770 Granted/Registered 24
Portugal                                                                        
05716433.7 1748770 Granted/Registered 25 Russian
Federation                                                              
2006137280 2357726 Granted/Registered 26
Spain                                                                           
05716433.7 1748770 Granted/Registered 27
Sweden                                                                          
05716433.7 1748770 Granted/Registered 28
Switzerland                                                                     
05716433.7 1748770 Granted/Registered 29
Turkey                                                                          
05716433.7 1748770 Granted/Registered 30 United
Kingdom                                                                  
05716433.7 1748770 Granted/Registered 31
USA                                                                             
10/805528 7507769 Granted/Registered 32
USA                                                                             
12/397487 8048927 Granted/Registered

 

45

CONFIDENTIAL

 

B Breast Cancer         Country Application # Registration # Status 1
Australia                                                                       
2003294973 2003294973 Granted/Registered 2
Canada                                                                          
2519980 2519980 Granted/Registered 3 European Patent
Application                                                      03785958.4
1608353 Granted/Registered 4 European Patent
Application                                                      08103007.4
1952810 Granted/Registered 5 European Patent
Application                                                      08103014.0
1941871 Granted/Registered 6
France                                                                          
03785958.4 1608353 Granted/Registered 7
France                                                                          
08103007.4 1952810 Granted/Registered 8
France                                                                          
08103014.0 1941871 Granted/Registered 9
Germany                                                                         
03785958.4 1608353 Granted/Registered 10
Germany                                                                         
08103007.4 1952810 Granted/Registered 11
Germany                                                                         
08103014.0 1941871 Granted/Registered 12 Hong
Kong                                                                       
06107310.2 HK1086193 Granted/Registered 13 Hong
Kong                                                                       
08113909.5 HK1119950 Granted/Registered 14
Ireland                                                                         
03785958.4 1608353 Granted/Registered 15
Ireland                                                                         
08103007.4 1952810 Granted/Registered 16
Ireland                                                                         
08103014.0 1941871 Granted/Registered 17
Israel                                                                          
170807 170807 Granted/Registered 18
Italy                                                                           
03785958.4 1608353 Granted/Registered 19
Italy                                                                           
08103007.4 1952810 Granted/Registered 20
Italy                                                                           
08103014.0 1941871 Granted/Registered 21
Japan                                                                           
2004-570040 5490346 Granted/Registered 22
Luxembourg                                                                      
03785958.4 1608353 Granted/Registered 23
Luxembourg                                                                      
08103007.4 1952810 Granted/Registered 24
Luxembourg                                                                      
08103014.0 1941871 Granted/Registered 25
Mexico                                                                          
PA/a/2005/010597 279293 Granted/Registered 26
Netherlands                                                                     
03785958.4 1608353 Granted/Registered 27
Netherlands                                                                     
08103007.4 1952810 Granted/Registered 28
Netherlands                                                                     
08103014.0 1941871 Granted/Registered 29 New
Zealand                                                                     
542499 542499 Granted/Registered 30
Norway                                                                          
20054526 333805 Granted/Registered 31 PCT
Application                                                                 
PCT/EP2003/015029   Case Closed 32
Spain                                                                           
03785958.4 1608353 Granted/Registered 33
Spain                                                                           
08103007.4 1952810 Granted/Registered 34
Spain                                                                           
08103014.0 1941871 Granted/Registered 35
Switzerland                                                                     
03785958.4 1608353 Granted/Registered 36
Switzerland                                                                     
08103007.4 1952810 Granted/Registered 37
Switzerland                                                                     
08103014.0 1941871 Granted/Registered 38 United
Kingdom                                                                  
03785958.4 1608353 Granted/Registered 39 United
Kingdom                                                                  
08103007.4 1952810 Granted/Registered 40 United
Kingdom                                                                  
08103014.0 1941871 Granted/Registered 41
USA                                                                             
12/353890 8475814 Granted/Registered

 

46

CONFIDENTIAL

 

C Mastalgia         Country Application # Registration # Status 1
Australia                                                                       
2003303033 2003303033 Granted/Registered 2
Austria                                                                         
03813146.2 1572178 Granted/Registered 3
Belgium                                                                         
03813146.2 1572178 Granted/Registered 4
Bulgaria                                                                        
03813146.2 1572178 Granted/Registered 5
Canada                                                                          
2509660 2509660 Granted/Registered 6
Cyprus                                                                          
03813146.2 1572178 Granted/Registered 7 Czech
Republic                                                                
03813146.2 1572178 Granted/Registered 8
Denmark                                                                         
03813146.2 1572178 Granted/Registered 9
Estonia                                                                         
03813146.2 1572178 Granted/Registered 10 European Patent
Application                                              03813146.2 1572178
Granted/Registered 11
Finland                                                                         
03813146.2 1572178 Granted/Registered 12
France                                                                          
03813146.2 1572178 Granted/Registered 13
Germany                                                                         
03813146.2 1572178 Granted/Registered 14
Greece                                                                          
03813146.2 1572178 Granted/Registered 15 Hong
Kong                                                                       
05108810.6 HK1075403 Granted/Registered 16
Hungary                                                                         
03813146.2 1572178 Granted/Registered 17
Ireland                                                                         
03813146.2 1572178 Granted/Registered 18
Italy                                                                           
03813146.2 1572178 Granted/Registered 19
Japan                                                                           
2004-560487 4938237 Granted/Registered 20
Luxembourg                                                                      
03813146.2 1572178 Granted/Registered 21
Mexico                                                                          
PA/A/2005/006526 256654 Granted/Registered 22
Monaco                                                                          
03813146.2 1572178 Granted/Registered 23
Netherlands                                                                     
03813146.2 1572178 Granted/Registered 24 New
Zealand                                                                     
540494 540494 Granted/Registered 25 PCT
Application                                                                 
PCT/EP2003/015028   Case Closed 26
Portugal                                                                        
03813146.2 1572178 Granted/Registered 27
Romania                                                                         
03813146.2 1572178 Granted/Registered 28
Slovakia                                                                        
03813146.2 1572178 Granted/Registered 29
Slovenia                                                                        
03813146.2 1572178 Granted/Registered 30
Spain                                                                           
03813146.2 1572178 Granted/Registered 31
Sweden                                                                          
03813146.2 1572178 Granted/Registered 32
Switzerland                                                                     
03813146.2 1572178 Granted/Registered 33
Turkey                                                                          
03813146.2 1572178 Granted/Registered 34 United
Kingdom                                                              03813146.2
1572178 Granted/Registered 35
USA                                                                             
10/734640 7786172 Granted/Registered

 

47

CONFIDENTIAL

 

D Breast Density         Country Application # Registration # Status 1 European
Patent Application                                                     
03813147.0 1572171 Granted/Registered 2 European Patent
Application                                                      08103001.7  
Application Pending 3 European Patent
Application                                                      09000839.2  
Application Pending 4
France                                                                          
03813147.0 1572171 Granted/Registered 5
Germany                                                                         
03813147.0 1572171 Granted/Registered 6 Hong
Kong                                                                       
05110203.7 HK1077512 Granted/Registered 7 Hong
Kong                                                                       
09100877.9   Application Pending 8 Hong
Kong                                                                       
09109465.8   Application Pending 9
Japan                                                                           
2004-560488 4684655 Granted/Registered 10
Japan                                                                           
2010-279107   Case Closed 11 PCT
Application                                                                 
PCT/EP2003/015030   Case Closed 12 United
Kingdom                                                                  
03813147.0 1572171 Granted/Registered 13
USA                                                                             
10/734644 7485623 Granted/Registered

 

48

CONFIDENTIAL

 

E Gynomastia         Country Application # Registration # Status 1
Australia                                                                       
2004298349 2004298349 Granted/Registered 2
Austria                                                                         
04803913.5 1694319 Granted/Registered 3
Belgium                                                                         
04803913.5 1694319 Granted/Registered 4
Canada                                                                          
2549824 2549824 Granted/Registered 5 Czech
Republic                                                                  
04803913.5 1694319 Granted/Registered 6
Denmark                                                                         
04803913.5 1694319 Granted/Registered 7 European Patent
Application                                                      04803913.5
1694319 Granted/Registered 8
Finland                                                                         
04803913.5 1694319 Granted/Registered 9
France                                                                          
04803913.5 1694319 Granted/Registered 10
Germany                                                                         
04803913.5 1694319 Granted/Registered 11
Greece                                                                          
04803913.5 1694319 Granted/Registered 12 Hong
Kong                                                                       
07100340.0 HK1094768 Granted/Registered 13
Hungary                                                                         
04803913.5 1694319 Granted/Registered 14
Ireland                                                                         
04803913.5 1694319 Granted/Registered 15
Italy                                                                           
04803913.5 1694319 Granted/Registered 16
Japan                                                                           
2006-543519 5069469 Granted/Registered 17
Luxembourg                                                                      
04803913.5 1694319 Granted/Registered 18
Mexico                                                                          
PA/A/2006/006834 262238 Granted/Registered 19
Monaco                                                                          
04803913.5 1694319 Granted/Registered 20
Netherlands                                                                     
04803913.5 1694319 Granted/Registered 21 New
Zealand                                                                     
547744 547744 Granted/Registered 22
Norway                                                                          
20062904   Application Pending 23 PCT
Application                                                                 
PCT/EP2004/014295   Case Closed 24
Poland                                                                          
04803913.5 1694319 Granted/Registered 25
Portugal                                                                        
04803913.5 1694319 Granted/Registered 26
Romania                                                                         
04803913.5 1694319 Granted/Registered 27 South
Africa                                                                    
2006/05579 2006/05579 Granted/Registered 28
Spain                                                                           
04803913.5 1694319 Granted/Registered 29
Sweden                                                                          
04803913.5 1694319 Granted/Registered 30
Switzerland                                                                     
04803913.5 1694319 Granted/Registered 31
Turkey                                                                          
04803913.5 1694319 Granted/Registered 32 United
Kingdom                                                                  
04803913.5 1694319 Granted/Registered 33
USA                                                                             
11/009390 7968532 Granted/Registered

 

49

CONFIDENTIAL

 

F Breast Scarring         Country Application # Registration # Status 1
Australia                                                                       
2004246812 2004246812 Granted/Registered 2
Austria                                                                         
04740032.0 1631275 Granted/Registered 3
Belgium                                                                         
04740032.0 1631275 Granted/Registered 4
Canada                                                                          
2528431 2528431 Granted/Registered 5
Denmark                                                                         
04740032.0 1631275 Granted/Registered 6 European Patent
Application                                                      04740032.0
1631275 Granted/Registered 7
France                                                                          
04740032.0 1631275 Granted/Registered 8
Germany                                                                         
04740032.0 1631275 Granted/Registered 9 Hong
Kong                                                                       
06103609.1 HK1082203 Granted/Registered 10
Ireland                                                                         
04740032.0 1631275 Granted/Registered 11
Italy                                                                           
04740032.0 1631275 Granted/Registered 12
Japan                                                                           
2006-515986 4682129 Granted/Registered 13
Luxembourg                                                                      
04740032.0 1631275 Granted/Registered 14
Mexico                                                                          
PA/A/2005/013435 257512 Granted/Registered 15
Monaco                                                                          
04740032.0 1631275 Granted/Registered 16
Netherlands                                                                     
04740032.0 1631275 Granted/Registered 17 New
Zealand                                                                     
544031 544031 Granted/Registered 18 PCT
Application                                                                 
PCT/EP2004/006583   Case Closed 19
Portugal                                                                        
04740032.0 1631275 Granted/Registered 20
Spain                                                                           
04740032.0 1631275 Granted/Registered 21
Sweden                                                                          
04740032.0 1631275 Granted/Registered 22
Switzerland                                                                     
04740032.0 1631275 Granted/Registered 23
Turkey                                                                          
04740032.0 1631275 Granted/Registered 24 United
Kingdom                                                                  
04740032.0 1631275 Granted/Registered 25
USA                                                                             
10/858399 7767717* Granted/Registered

 

* As this specific patent (US7,767,717) is co-owned by Besins with Northwestern
University, U.S.A., the Parties agree that, should Atossa exercise its option
under Section 4.2 to expand the Field to the Additional Indication “other breast
diseases” to include equivalent licenses under US7,767,717, then Besins shall
make its best efforts to ensure that Atossa be authorized to obtain licensing
rights from the co-owner and to assist Atossa in negotiating exclusivity with
the co-owner.

 

50

CONFIDENTIAL

 

Exhibit D – Besins Platform IP

 

A Formulations         Country Application # Registration # Status 1
Australia                                                                       
2003294973 2003294973 Granted/Registered 2
Canada                                                                          
2519980 2519980 Granted/Registered 3 European Patent
Application                                                      08103014.0
1941871 Granted/Registered 4
France                                                                          
08103014.0 1941871 Granted/Registered 5
Germany                                                                         
08103014.0 1941871 Granted/Registered 6 Hong
Kong                                                                       
08113909.5 HK1119950 Granted/Registered 7
Ireland                                                                         
08103014.0 1941871 Granted/Registered 8
Italy                                                                           
08103014.0 1941871 Granted/Registered 9
Japan                                                                           
2004-570040 5490346 Granted/Registered 10
Luxembourg                                                                      
08103014.0 1941871 Granted/Registered 11
Mexico                                                                          
PA/a/2005/010597 279293 Granted/Registered 12
Netherlands                                                                     
08103014.0 1941871 Granted/Registered 13 New
Zealand                                                                     
542499 542499 Granted/Registered 14
Norway                                                                          
20054526 333805 Granted/Registered 15 PCT
Application                                                                 
PCT/EP2003/015029   Case Closed 16
Spain                                                                           
08103014.0 1941871 Granted/Registered 17
Switzerland                                                                     
08103014.0 1941871 Granted/Registered 18 United
Kingdom                                                                  
08103014.0 1941871 Granted/Registered 19
USA                                                                             
10/734638 7704516 Granted/Registered

 

51

CONFIDENTIAL

 

B E/Z Isomers         Country Application # Registration # Status 1
Argentina                                                                       
P050101125   Application Pending 2
Australia                                                                       
2005227073 2005227073 Granted/Registered 3
Austria                                                                         
05735277.5 1727532 Granted/Registered 4
Belgium                                                                         
05735277.5 1727532 Granted/Registered 5
Bulgaria                                                                        
05735277.5 1727532 Granted/Registered 6
Canada                                                                          
2557806 2557806 Granted/Registered 7
China                                                                           
200580009171.X 101080222 Granted/Registered 8 Czech
Republic                                                                  
05735277.5 1727532 Granted/Registered 9
Denmark                                                                         
05735277.5 1727532 Granted/Registered 10 European Patent
Application                                                      05735277.5
1727532 Granted/Registered 11 European Patent
Application                                                      09175781.5
2147670 Granted/Registered 12 European Patent
Application                                                      10180921.8
2269599 Granted/Registered 13
Finland                                                                         
05735277.5 1727532 Granted/Registered 14
France                                                                          
05735277.5 1727532 Granted/Registered 15
France                                                                          
09175781.5 2147670 Granted/Registered 16
France                                                                          
10180921.8 2269599 Granted/Registered 17
Germany                                                                         
05735277.5 1727532 Granted/Registered 18
Germany                                                                         
09175781.5 2147670 Granted/Registered 19
Germany                                                                         
10180921.8 2269599 Granted/Registered 20
Greece                                                                          
05735277.5 1727532 Granted/Registered 21 Hong
Kong                                                                       
07104159.2 HK1098674 Granted/Registered 22 Hong
Kong                                                                       
10106178.9   Application Pending 23
Hungary                                                                         
05735277.5 1727532 Granted/Registered 24
India                                                                           
2453/KOLNP/2006 251984 Granted/Registered 25
Ireland                                                                         
05735277.5 1727532 Granted/Registered 26
Ireland                                                                         
09175781.5 2147670 Granted/Registered 27
Ireland                                                                         
10180921.8 2269599 Granted/Registered 28
Israel                                                                          
177778 177778 Granted/Registered 29
Israel                                                                          
215897   Granted/Registered 30
Italy                                                                           
05735277.5 1727532 Granted/Registered 31
Italy                                                                           
09175781.5 2147670 Granted/Registered 32
Italy                                                                           
10180921.8 2269599 Granted/Registered 33
Japan                                                                           
2007-504378 5489407 Granted/Registered 34
Luxembourg                                                                      
05735277.5 1727532 Granted/Registered 35
Luxembourg                                                                      
09175781.5 2147670 Granted/Registered 36
Luxembourg                                                                      
10180921.8 2269599 Granted/Registered 37
Mexico                                                                          
PA/A/2006/010928 279114 Granted/Registered 38
Monaco                                                                          
05735277.5 1727532 Granted/Registered 39
Netherlands                                                                     
05735277.5 1727532 Granted/Registered 40
Netherlands                                                                     
09175781.5 2147670 Granted/Registered 41
Netherlands                                                                     
10180921.8 2269599 Granted/Registered 42 New
Zealand                                                                     
549664 549664 Granted/Registered 43
Norway                                                                          
20064765   Application Pending 44 PCT
Application                                                                 
PCT/EP2005/003455   Case Closed 45
Poland                                                                          
05735277.5 1727532 Granted/Registered 46
Portugal                                                                        
05735277.5 1727532 Granted/Registered 47
Romania                                                                         
05735277.5 1727532 Granted/Registered 48 Russian
Federation                                                              
2006137282 2389483 Granted/Registered 49 South
Africa                                                                    
2006/07291 2006/07291 Granted/Registered 50
Spain                                                                           
05735277.5 1727532 Granted/Registered 51
Spain                                                                           
09175781.5 2147670 Granted/Registered 52
Spain                                                                           
10180921.8 2269599 Granted/Registered 53
Sweden                                                                          
05735277.5 1727532 Granted/Registered 54
Switzerland                                                                     
05735277.5 1727532 Granted/Registered 55
Switzerland                                                                     
09175781.5 2147670 Granted/Registered 56
Switzerland                                                                     
10180921.8 2269599 Granted/Registered 57
Taiwan                                                                          
094108588 I401078 Granted/Registered 58
Turkey                                                                          
05735277.5 1727532 Granted/Registered 59 United
Kingdom                                                                  
05735277.5 1727532 Granted/Registered 60 United
Kingdom                                                                  
09175781.5 2147670 Granted/Registered 61 United
Kingdom                                                                  
10180921.8 2269599 Granted/Registered 62
USA                                                                             
10/805530   Application Pending

 

52

CONFIDENTIAL

 

C 4X Formulation         Country Application # Registration # Status 1
Algeria                                                                         
070224 5132 Granted/Registered 2
Armenia                                                                         
200700834 011295 Granted/Registered 3
Australia                                                                       
2005293712 2005293712 Granted/Registered 4
Austria                                                                         
05803579.1 1799201 Granted/Registered 5
Azerbaijan                                                                      
200700834 011295 Granted/Registered 6
Belarus                                                                         
200700834 011295 Granted/Registered 7
Belgium                                                                         
05803579.1 1799201 Granted/Registered 8
Brazil                                                                          
PI0518139-9   Application Pending 9
Bulgaria                                                                        
05803579.1 1799201 Granted/Registered 10
Canada                                                                          
2582174 2582174 Granted/Registered 11
China                                                                           
200580035353.4 101065120 Granted/Registered 12
Colombia                                                                        
07036907 1377 Granted/Registered 13
Croatia                                                                         
05803579.1 1799201 Granted/Registered 14
Cyprus                                                                          
05803579.1 1799201 Granted/Registered 15 Czech
Republic                                                                  
05803579.1 1799201 Granted/Registered 16
Denmark                                                                         
05803579.1 1799201 Granted/Registered 17
Ecuador                                                                         
SP-07-7396   Application Pending 18
Estonia                                                                         
05803579.1 1799201 Granted/Registered 19 Eurasian
Patent                                                                 
200700834 011295 Granted/Registered 20 European Patent
Application                                                      05803579.1
1799201 Granted/Registered 21
Finland                                                                         
05803579.1 1799201 Granted/Registered 22
France                                                                          
05803579.1 1799201 Granted/Registered 23
Georgia                                                                         
9987/01 P 2010 4889 B Granted/Registered 24
Germany                                                                         
05803579.1 1799201 Granted/Registered 25
Greece                                                                          
05803579.1 1799201 Granted/Registered 26 Hong
Kong                                                                       
07111311.2 HK1103027 Granted/Registered 27
Hungary                                                                         
05803579.1 1799201 Granted/Registered 28
Iceland                                                                         
05803579.1 1799201 Granted/Registered 29
India                                                                           
1133/KOLNP/2007   Application Pending 30
Ireland                                                                         
05803579.1 1799201 Granted/Registered 31
Israel                                                                          
182298 182298 Granted/Registered  
Italy                                                                           
05803579.1 1799201 Granted/Registered 32
Japan                                                                           
2007-536126 5047800 Granted/Registered 33
Kazakhstan                                                                      
200700834 011295 Granted/Registered 34
Kyrgyzstan                                                                      
200700834 011295 Granted/Registered 35
Latvia                                                                          
05803579.1 1799201 Granted/Registered 36
Lithuania                                                                       
05803579.1 1799201 Granted/Registered 37
Luxembourg                                                                      
05803579.1 1799201 Granted/Registered 38
Macedonia                                                                       
05803579.1 1799201 Granted/Registered 39
Mexico                                                                          
MX/A/2007/004371 263103 Granted/Registered 40
Moldova                                                                         
200700834 011295 Granted/Registered 41
Monaco                                                                          
05803579.1 1799201 Granted/Registered 42
Morocco                                                                         
PV29815 28927 Granted/Registered 43
Netherlands                                                                     
05803579.1 1799201 Granted/Registered 44 New
Zealand                                                                     
554206 554206 Granted/Registered 45
Nigeria                                                                         
186/07 NG/C/2007/909 Granted/Registered 46
Norway                                                                          
20072463   Application Pending 47
OAPI                                                                            
1200700149 13780 Granted/Registered 48 PCT
Application                                                                 
PCT/EP2005/011654   Case Closed 49
Poland                                                                          
05803579.1 1799201 Granted/Registered 50
Portugal                                                                        
05803579.1 1799201 Granted/Registered 51
Romania                                                                         
05803579.1 1799201 Granted/Registered 52 Russian
Federation                                                              
200700834 011295 Granted/Registered 53
Serbia                                                                          
05803579.1 1799201 Granted/Registered 54
Singapore                                                                       
2007027055 131527 Granted/Registered 55
Slovakia                                                                        
05803579.1 1799201 Granted/Registered 56
Slovenia                                                                        
05803579.1 1799201 Granted/Registered 57 South
Africa                                                                    
2007/03016 2007/03016 Granted/Registered 58 South
Korea                                                                     
10-2007-7008384 10-1294947 Granted/Registered 59
Spain                                                                           
05803579.1 1799201 Granted/Registered 60
Sweden                                                                          
05803579.1 1799201 Granted/Registered 61
Switzerland                                                                     
05803579.1 1799201 Granted/Registered 62
Tajikistan                                                                      
200700834 011295 Granted/Registered 63
Tunisia                                                                         
SN07.139   Application Pending 64
Turkey                                                                          
05803579.1 1799201 Granted/Registered 65
Turkmenistan                                                                    
200700834 011295 Granted/Registered 66
Ukraine                                                                         
a200705192 87335 Granted/Registered 67 United
Kingdom                                                                  
05803579.1 1799201 Granted/Registered 68
USA                                                                             
60/638359   Case Closed 69
USA                                                                             
11/249122   Application Pending 70
Uzbekistan                                                                      
IAP20070138 IAP03817 Granted/Registered 71 Viet
Nam                                                                        
1-2007-00777   Application Pending

 

53

CONFIDENTIAL

 

D Dermis         Country Application # Registration # Status 1
Australia                                                                       
2010311523 2010311523 Granted/Registered 2
Brazil                                                                          
BR112012010083.1   Application Pending 3
Canada                                                                          
2778689   Application Pending 4
China                                                                           
201080059696.5   Application Pending 5 European Patent
Application                                                      10768983.8  
Application Pending 6 Hong
Kong                                                                       
12112691.3   Application Pending 7
India                                                                           
1111/MUMNP/2012   Application Pending 8
Israel                                                                          
219236   Application Pending 9
Japan                                                                           
2012-535814 5727494 Granted/Registered 10 PCT
Application                                                                 
PCT/EP2010/066283   Case Closed 11 Russian
Federation                                                              
2012121708   Application Pending 12 South
Africa                                                                    
2012/02855 2012/02855 Granted/Registered 13
USA                                                                             
12/912310   Application Pending

 

E Stable Gel         Country Application # Registration # Status 1 European
Patent Application                                                     
04712591.9 1594545 Granted/Registered 2
France                                                                          
0302083 2851470 Granted/Registered 3
France                                                                          
04712591.9 1594545 Granted/Registered 4
Germany                                                                         
04712591.9 1594545 Granted/Registered 5 Hong
Kong                                                                       
06105598.9 HK1084590 Granted/Registered 6
Japan                                                                           
2006-502159 4925103 Granted/Registered 7 PCT
Application                                                                 
PCT/FR2004/000393   Case Closed 8 United
Kingdom                                                                  
04712591.9 1594545 Granted/Registered 9
USA                                                                             
10/436380 7611727 Granted/Registered

 

54

CONFIDENTIAL

 

Exhibit E – Afimoxifene Gel Development Plan

 

[image_002.jpg] 

 

55

CONFIDENTIAL

 

Exhibit F – Press Release

 

[image_001.jpg]

 

 

 

Atossa Genetics Acquires

 

Rights to Clinical Stage Proprietary Afimoxifene Gel for

 

Potential Treatment of Hyperplasia of the Breast

 

Sixteen Completed Clinical Studies Provide Support for Phase 2 Program

  

SEATTLE, May __, 2015 -- Atossa Genetics, Inc. (NASDAQ: ATOS) today announced
that it has acquired from Besins Healthcare an exclusive license to Besins’
patented gel formulation of 4-Hydroxytamoxifen, or Afimoxifene Gel, which Atossa
intends to develop for the potential treatment of hyperplasia of the breast.

 

Steven C. Quay, M.D., Ph.D., President and CEO, commented, “Atossa’s strategy is
to improve breast health through a three step approach: providing our patented
medical devices to collect nipple aspirate fluid, testing the fluid for the
presence of hyperplasia, and then treating the hyperplasia with the local
delivery of a proprietary pharmaceutical. Obtaining the rights to Besins’
Afimoxifene Gel represents considerable advancement towards developing the
crucial third step of this process.”

 

”Besins has developed substantial pre-clinical and clinical data that we intend
to utilize to advance the Afimoxifene Gel, to be used in conjunction with our
devices and laboratory tests. We intend to secure a manufacturing source for a
clinical supply of Afimoxifene Gel and to advance the clinical development into
a Phase II clinical trial using our proprietary devices, laboratory tests and
the Afimoxifene Gel. Besins is a recognized leader in the development and
commercialization of hormone therapies and we believe their proprietary
Afimoxifene Gel may, in conjunction with our breast aspirator devices and
cytology tests, be developed as a local treatment for hyperplasia,” commented
Dr. Quay.

 

Leslie Grunfeld, CEO of Besins Healthcare, commented, “ Besins Healthcare has
spent a number of years developing and advancing Afimoxifene Gel. We are pleased
that Atossa, who are focused on breast health, will continue the development for
the treatment of local hyperplasia in conjunction with their existing
technology. Various studies have shown that Afimoxifene Gel could be effective
for other related indications and we are hopeful to be able to develop these in
the future”.

 

56

CONFIDENTIAL

 

Key terms of the license are:

 

·Exclusive world-wide rights to develop and commercialize Afimoxifene Gel for
the potential treatment and prevention of hyperplasia of the breast.

 

·No upfront or milestone payments to Besins.

 

·Royalty of 8% - 9% of net sales for the first 15 years of commercialization.

 

·Atossa has the non-exclusive right to also develop Afimoxifene Gel for breast
cancer and other breast diseases (subject to milestone payments for these
additional indications).

 

·Atossa obtains access to Besins’ pre-clinical and clinical studies and data for
the treatment of breast pain with Afimoxifene Gel, which include animal,
toxicity, and clinical trials with 144 patients. Results from additional 82
patients have been published from pre-surgical studies in invasive breast cancer
and ductal carcinoma in situ, or DCIS, conducted respectively in France and the
United States. Across all indications, over 450 patients have been treated with
Afimoxifene Gel.

 

·Besins has the right of first refusal to commercialize the Afimoxifene Gel on a
country-by-country basis in countries where they have a marketing presence.

 

“One of our four key objectives for 2015 is to commence a clinical study using a
local therapy to treat a serious breast health condition. This new exclusive
license arrangement with Besins significantly advances this key objective,”
continued Dr. Quay.

 

About Atossa Genetics

 

Atossa Genetics Inc. is focused on improving breast health through the
development of laboratory services, medical devices and therapeutics. The
laboratory services are being developed by its subsidiary, The National
Reference Laboratory for Breast Health, Inc. The laboratory services and the
Company's medical devices are being developed so they can be used as companions
to therapeutics to treat various breast health conditions. For more information,
please visit www.atossagenetics.com.

 

About Besins Healthcare

 

Besins Healthcare is a privately owned pharmaceutical company specialized in the
development and worldwide diffusion of innovative drugs for the well-being of
men and women throughout their lives. Over the last 30 years Besins Healthcare
has established a strong and reputable name in the production of innovative
drugs for the treatment of gynecological, fertility and obstetrical conditions
as well as androgen deficiency.

 

57

CONFIDENTIAL

 

Besins has become a renowned player in the area of hormonal therapies.
Innovative products from Besins Healthcare are distributed in more than 90
countries around the world through subsidiary companies as well as a network of
business partners.

 

About Afimoxifene and Afimoxifene Gel

 

Afimoxifene (4-hydroxytamoxifen), an active metabolite of tamoxifen, is an
anti-estrogen with an affinity for estrogen receptor that is up to 50 fold
higher compared with that of tamoxifen. Afimoxifene Gel is a proprietary
transdermal gel formulation of Afimoxifene protected by 10 patent families. It
can be dispensed from a convenient metered-dose container. Besins has completed
a comprehensive preclinical pharmacology and toxicology package on Afimoxifene
Gel and its manufacturing CMC package is expected to be sufficient to support
Atossa’s Phase 3 Program. A total of 16 Phase-1 and -2 studies have been
conducted in a variety of indications in the United States, United Kingdom,
France, Poland, and Czech Republic. These studies enrolled over 450 patients
total, and results were published in leading medical journals such as the
Journal of Clinical Oncology (J Clin Oncol 2005;23:2980-87), Clinical Cancer
Research (Clin Cancer Res 2014;20:3672-82), and Breast Cancer Research and
Treatment (Breast Cancer Res Treat 2007;106:389-97). Systemic distribution of
topically delivered Afimoxifene Gel was minimal with little difference in
adverse events between Afimoxifene Gel and placebo. The occurrence of hot
flushes or night sweats, vaginal dryness, vaginal bleeding, and nipple discharge
were similar between the treatment arm and placebo.

 

Forward-Looking Statements

 

Forward-looking statements in this press release are subject to risks and
uncertainties that may cause actual results to differ materially from the
anticipated or estimated future results, including the risks and uncertainties
associated with actions by the FDA, the outcome or timing of regulatory
approvals needed by Atossa to sell its products, responses to regulatory
matters, Atossa's ability to achieve its objectives, continue to manufacture and
sell its products, recalls of products, the safety and efficacy of Atossa's
products and services, performance of distributors, whether Atossa can launch
and commercialize in the United States and foreign markets the additional tests,
devices and therapeutics in its pipeline in a timely and cost effective manner,
and other risks detailed from time to time in Atossa's filings with the
Securities and Exchange Commission, including without limitation its periodic
reports on Form 10-K and 10-Q, each as amended and supplemented from time to
time. Atossa does not undertake any obligation to update any forward looking
statement.

 

58

CONFIDENTIAL

 

Contact:

 

Atossa Genetics, Inc.:           Steven C. Quay, Ph.D., M.D.     Chief Executive
Officer and President     (O) 800-351-3902           Kyle Guse     CFO and
General Counsel     (O) 800-351-3902           Investor Relations:    
CorProminence LLC     Scott Gordon     President     516-222-2560    
scottg@corprominence.com         Besins:         Leslie Grunfeld         CEO    
      (O) +377 97 98 32 38  

 

59