CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this document have
been redacted and have been separately filed with the Commission.

 

Exhibit No. 10.35

                                                                                                                                        
 

EXCLUSIVE LICENSE AGREEMENT

 

BY AND AMONG

 

GTC BIOTHERAPEUTICS, INC.,

 

LFB BIOTECHNOLOGIES S.A.S.,

 

LFB/GTC LLC

 

and

 

TG THERAPEUTICS, INC.

 

January, 30th , 2012

 

CONFIDENTIAL

 

 

 

 

TABLE OF CONTENTS

 

    Page       1. DEFINITIONS 2       2. LICENSE GRANTS; EXCLUSIVITY 18        
2.1 License 18   2.2 Right to Sublicense 20   2.3 No Other Rights 21   2.4
Exclusivity 21         3. DEVELOPMENT OF PRODUCTS 22           3.1 Development
Program 22   3.2 Development Diligence 23   3.3 Preparation of Development Plan
23   3.4 Compliance 24   3.5 Process Development services; Supply of Compounds
for Development 24   3.6 Use of Proprietary Materials 24         4. REGULATORY
ACTIVITIES 25           4.1 Responsibility for Regulatory Filings 25   4.2
Disclosure; Right of Access 25   4.3 Disclosure of Certain Events 26   4.4
Communication with Regulatory Authorities in the LICENSOR Commercialization
Territory 26         5. COMMERCIALIZATION OF PRODUCTS 26           5.1
Commercialization Plan 26   5.2 Responsibility for Commercialization of Products
27   5.3 Commercialization Diligence 27   5.4 Failure to Satisfy
Commercialization Diligence Obligations 27   5.5 Failure to achieve Sales
Targets 28   5.6 Compliance 29   5.7 No Unauthorized Sales 29   5.8 Records;
Reports 29   5.9 Supply of Product for Commercialization 29   5.10 Product
Recalls 30   5.11 Grant of Commercialization Option to LICENSOR 30         6.
SUPPLY OF THE COMPOUND 31           6.1 Supply of LFB-R603 for Development and
Commercialization 31   6.2 Supply of TG20 for Development and Commercialization
32   6.3 Contractual conditions for Process Development Services and supply of
Compounds for Development 33

 

i

 

 

7. PAYMENTS 33           7.1 Issuance of Equity 33   7.2 Milestone Payments 33  
7.3 Payment of Royalties; Royalty Rates; Sublicense Royalties; Accounting and
Records 34         8. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY 37      
    8.1 Confidentiality 37   8.2 Publicity 39   8.3 No Use of Name 39   8.4
Publications and Presentations 39         9. INTELLECTUAL PROPERTY RIGHTS 39    
      9.1 LICENSOR Intellectual Property Rights 39   9.2 Improvement 39   9.3
Joint Improvement 40   9.4 Patent Coordinators 40   9.5 Notice; Inventorship 41
        10. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS 41          
10.1 Patent Filing, Prosecution and Maintenance 41   10.2 Enforcement and
Defense 43   10.3 Trademark Prosecution and Registration 45         11. TERM AND
TERMINATION 46           11.1 Term 46   11.2 Termination 46   11.3 Consequences
of Termination of Agreement 46   11.4 Surviving Provisions 48         12.
REPRESENTATIONS AND WARRANTIES 49           12.1 Mutual Representations and
Warranties 49   12.2 Additional Representations of LICENSOR 49   12.3 Additional
Representations of TG 50         13. INDEMNIFICATION; INSURANCE 50          
13.1 Indemnification of LICENSOR by TG 51   13.2 Indemnification of TG by
LICENSOR 51   13.3 Conditions to Indemnification 52   13.4 Insurance 52   13.5
Warranty Disclaimer 52   13.6 No Warranty of Success 52   13.7 Limited Liability
52         14. MISCELLANEOUS 53           14.1 Disputes; Consent to Jurisdiction
53   14.2 Notices 53

  

ii

 

 

  14.3 Governing Law 54   14.4 Competition Law 55   14.5 Binding Effect 55  
14.6 Headings 55   14.7 Counterparts 55   14.8 Amendment; Waiver 55   14.9 No
Third Party Beneficiaries 55   14.10 Section 365(n) 55   14.11 Purposes and
Scope 56   14.12 Assignment and Successors 56   14.13 Force Majeure 56   14.14
Interpretation 56   14.15 Integration; Severability 57   14.16 Further
Assurances 57

 

 

 

iii

 

 

EXCLUSIVE LICENSE AGREEMENT

 

This EXCLUSIVE LICENSE AGREEMENT (this “Agreement”) is entered into as of
January 30th, 2012 (the “Effective Date”) by and among GTC Biotherapeutics,
Inc., a Massachusetts corporation with a principal place of business at 175
Crossing Boulevard, Framingham, Massachusetts 01701 (“GTC”), LFB Biotechnologies
S.A.S., a company organized under the laws of France with a principal place of
business at 3 avenue des Tropiques, B.P. 305-Les Ulis- 91958, Courtaboeuf Cedex,
France (“LFB”), LFB/GTC LLC, a New York limited liability company with a
principal place of business at 175 Crossing Boulevard, Framingham, Massachusetts
01701 (“LFB/GTC” and, collectively with GTC and LFB, “LICENSOR”) and TG
Therapeutics, Inc., a Delaware corporation with a principal place of business at
787 Seventh Avenue, 48th Floor, New York, New York 10019 (“TG”). Each of TG and
LICENSOR is sometimes referred to individually herein as a “Party” and
collectively as the “Parties.”

 

RECITALS

 

WHEREAS, LICENSOR is engaged in research and development activities on new
pharmaceutical products derived from or incorporating recombinant plasma
proteins and/or monoclonal antibodies;

 

WHEREAS, LICENSOR is the owner, licensee or sublicensee of certain patents,
technology and material related to the Compounds (as such term is defined
below);

 

WHEREAS, prior to the signature of the present Agreement, LICENSOR has entered
into the license agreements related to the Compound, including:

 

-A license agreement with Dr Hadam on an anti CD 20 monoclonal antibody, CAT
13.6.E12 and the hybridoma cell-line producing such murine antibody

-A license agreement with Pharming on the casein promoter

-A license agreement with Start/Viagen on the cloning and nuclear transfer
technology

 

WHEREAS, pursuant to the terms and conditions of that certain Option Agreement
by and between LICENSOR and TG, dated April 29, 2011 (the “Option Agreement”),TG
was granted an exclusive option (the “Option”) to obtain an exclusive license
under the Licensed Patent Rights and Licensed Technology (as such terms are
defined below) to research, develop, use, import, offer to sell and sell the
Compounds in the Field of Use (as such term is defined below) upon the
satisfaction by TG of a certain Option Condition (as defined in the Option
Agreement);

 

 

 

 

Whereas, the Option Condition has been satisfied and TG has timely exercised the
Option in accordance with the terms of the Option Agreement;

 

Whereas, pursuant to Section 3.4 of the Option Agreement, the Parties have
agreed, upon exercise of the Option, to enter into a license on the terms and
subject to the conditions set forth in this Agreement; and

 

Whereas, in furtherance of such transaction, LICENSOR and TG have also agreed to
enter into a Development Services and Manufacturing Agreement, Commercial Supply
Agreement and Stock Purchase Agreement on the terms described herein.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the Parties hereto, intending to be
legally bound, hereby agree as follows:

 

1.      DEFINITIONS

 

Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article 1 shall have the meanings specified.

 

1.1           “Acceptance” means, with respect to a Drug Approval Application
filed for a Product (a) in the United States, the receipt of written notice from
the FDA in accordance with 21 CFR 314.101(a)(2) that such Drug Approval
Application is officially “filed” and (b) in the European Union, receipt of
written notice of acceptance by the EMA of such Drug Approval Application for
filing under the centralized European procedure in accordance with any feedback
received from European Regulatory Authorities; provided, that, if the
centralized filing procedure is not used, then Acceptance shall be determined
upon the acceptance of such filing for such Drug Approval Application by the
applicable Regulatory Authority in any Major Market Country.

 

1.2           “Adverse Event” means any untoward medical occurrence in a human
clinical trial subject or in a patient who is administered a Compound or
Product, whether or not considered related to the compound or product, including
any undesirable sign (including abnormal laboratory findings of clinical
concern), symptom or disease associated with the use of a Compound or Product,
as defined more fully in 21 CFR §312.32.

 

1.3           “Affiliate” means, with respect to any Person, any other Person
that, directly or indirectly, controls, or is controlled by, or is under common
control with, such Person. For purposes of this definition, “control” means (a)
ownership of more than fifty percent (50%) of the shares of stock entitled to
vote for the election of directors in the case of a corporation, or more than
fifty percent (50%) of the equity interests in the case of any other type of
legal entity, (or such lesser maximum percentage permitted in those
jurisdictions where majority ownership by foreign entities is prohibited); (b)
status as a general partner in any partnership; or (c) any other arrangement
whereby a Person controls or has the right to control the board of directors of
a corporation or equivalent governing body of an entity other than a
corporation.

 

2

 

 

1.4           “Agreement” means this exclusive license agreement and its Exhibit
and Schedules listed in the table of content.

 

1.5            “Annual Net Sales” means, with respect to any Calendar Year, the
aggregate amount of Net Sales for such Calendar Year.

 

1.6           “Anticipated Date of Receipt of Marketing Authorization” means,
the date of receipt of Marketing Authorization from EMA set forth in the
Development Plan (Appendix XX)

 

1.7           “API” means the active pharmaceutical ingredient that is intended
to be used in the Manufacture of any Product.

 

1.8           “Applicable Laws” means any national, international, federal,
state or local laws, treaties, statutes, ordinances, rules and regulations,
including any rules, regulations, guidance or guidelines of Regulatory
Authorities having the binding effect of law, or of any national securities
exchanges or securities listing organizations or other government authorities
other than Regulatory Authorities, that are in effect from time to time during
the Term and applicable to a particular activity hereunder.

 

1.9           “Background Patent Rights” means any Patent Rights that are
Controlled by LICENSOR, other than Licensed Patent Rights, containing one or
more claims that could Cover any Compound or Product (including its Manufacture
or its formulation or a method of its delivery or of its use). For the sake of
clarity, the Background Patent Rights existing as of the Effective Date are
listed on Schedule 4.

 

1.10         “BLA” means (a) any Biologic License Application, as defined in the
FDCA and regulations promulgated thereunder, or any successor application or
procedure required to market and sell a Product in the Territory; and (b) all
supplements and amendments to the foregoing.

 

1.11          “Branding” means all matters relating to the branding of any
Product, including any matters related to the selection of any trademarks, brand
names, product logos, branding colors, trade dress, positioning and key messages
to be incorporated into Promotional Materials used for any Product in the
Territory.

 

1.12         “Business Day” means any day other than a Saturday or Sunday on
which banking institutions in New York, New York are open for business.

 

1.13         “Calendar Quarter” means the period beginning on the Effective Date
and ending on the last day of the calendar quarter in which the Effective Date
falls, and thereafter each successive period of three (3) consecutive calendar
months ending on March 31, June 30, September 30 or December 31; provided, that,
the final Calendar Quarter shall end on the last day of the Term.

 

3

 

 

1.14         “Calendar Year” means the period beginning on the Effective Date
and ending on December 31 of the calendar year in which the Effective Date
falls, and thereafter each successive period of twelve (12) months commencing on
January 1 and ending on December 31; provided, that, the final Calendar Year
shall end on the last day of the Term.

 

1.15         “Challenge” means any challenge to the validity or enforceability
of any of the Licensed Patent Rights before any administrative, judicial or
other governmental authority, court, tribunal or arbitration panel, including by
(a) filing a declaratory judgment action in which any of the Licensed Patent
Rights is alleged to be invalid or unenforceable; (b) citing prior art pursuant
to 35 U.S.C. §301, filing a request for re-examination of any of the Licensed
Patent Rights pursuant to 35 U.S.C. §302 and/or §311, or provoking or becoming a
party to an interference with an application for any of the Licensed Patent
Rights pursuant to 35 U.S.C. §135; or (c) filing or commencing any
re-examination, opposition, cancellation, nullity or similar proceedings against
any of the Licensed Patent Rights in any country.

 

1.16         “Change of Control” means, with respect to TG, a transaction or
series of related transactions (including any merger, consolidation, share
exchange, reorganization or combination) involving TG and any Third Party that
results in (a) the holders of outstanding voting securities of TG immediately
prior to such transaction ceasing to represent at least fifty percent (50%) of
the combined outstanding voting power of TG or of the surviving or continuing
entity immediately after such transaction or series of transactions; (b) any
Third Party (other than a trustee or other fiduciary holding securities under an
employee benefit plan) becoming the beneficial owner of fifty percent (50%) or
more of the combined voting power of the outstanding securities of TG (including
as a single Third Party all persons who in concert or act together as a “group”
for purposes of acquiring shares of TG, in accordance with Section 13(d) of the
Securities Act of 1934) (other than an investment transaction by an entity not
engaged in the pharmaceutical or biotechnology business, the purpose of which is
to raise capital for TG); or (c) the sale or other disposition to a Third Party
of all or substantially all of TG’s assets or business to which this Agreement
relates.

 

1.17         “Clinical Data” means any and all data (together with all Clinical
Trial reports and the results of analyses thereof) derived or generated from any
Clinical Trial of a Compound or Product or from testing of subjects or the
analysis of samples used in any such Clinical Trial.

 

1.18         “Clinical Trial” means, collectively, any Phase 1 Clinical Trial,
Phase 2 Clinical Trial, Phase 3 Clinical Trial, as applicable.

 

1.19         “Combination Product” means a single product that includes, in
combination with a Product, one or more therapeutically-active ingredients other
than a Product that are sold in a single package or as a unit at a single price
either as a fixed dosage form or as separate dosage forms.

 

1.20         “Commercialization” or “Commercialize” means any and all activities
directed to the offering for sale and sale of a Product after Marketing
Authorization has been obtained with respect to such Product, including, (a)
activities directed to marketing, promoting, detailing, distributing,
Manufacturing, importing, selling and offering to sell such Product; (b)
interacting with Regulatory Authorities regarding any of the foregoing; and (c)
seeking Pricing Approvals and Reimbursement Approvals for such Product (d) Post
Approval Clinical Trials. When used as a verb, “to Commercialize” and
“Commercializing” means to engage in Commercialization and “Commercialized” has
a corresponding meaning.

 

4

 

 

1.21         “Commercialization Plan” means, with respect to any Product, the
written report prepared by TG pursuant to Section 5.1 and submitted to LICENSOR
for its review that (a) describes the Commercialization activities that TG
reasonably expects to conduct with respect to such Product in the Territory, and
(b) sets forth (i) a non-binding estimate of projected sales of such Product in
the Territory, and (ii) a summary of all actual sales of such Product in the
Territory, as such report may be amended or updated by TG from time to time.
Without limiting the foregoing, each Commercialization Plan shall include,
without limitation, (a) demographics and market dynamics, market strategies, a
marketing plan (including advertising, detailing forecasts, Pricing strategies
pertaining to discounts and sales forecasts) for the Territory; (b) specific
Commercialization and marketing objectives, projected milestones, resource
allocation requirements and activities to be performed over such period
(including all anticipated Clinical Trials) (collectively, the
“Commercialization Targets”); (c) a timeline for such activities, including the
estimated launch date(s) in the Territory; (d) a sales and expense forecast
(including at least five (5) years of estimated sales and expenses in terms of
both volume and value) for the Territory; (e) Manufacturing plans and the
expected product profile; and (f) the expected Regulatory Filings to be required
and prepared, and the expected timetable for making such Regulatory Filings.

 

1.22          “Commercially Reasonable Efforts” means, with respect to the
activities of TG, and/or its Affiliates, Sublicensees, Distributors, in the
Development or Commercialization, as the case may be, of a particular Compound
and/or Product, the level of efforts and resources typically used and expected
from a pharmaceutical company of similar size for the development or
commercialization of products of comparable market potential, taking into
account all relevant factors including, as applicable, the stage of development,
observed efficacy and safety of the Product and relative to Competitive Products
in the marketplace, actual or anticipated Regulatory Authority approved
labeling, the nature and extent of market exclusivity (including patent
coverage, regulatory exclusivity and competitiveness of alternative products),
the cost and likelihood of obtaining Marketing Authorization, the actual or
projected profitability, and the reasonably expected and actual pricing,
reimbursement and formulary status. For purposes of clarity, Commercially
Reasonable Efforts shall be determined on a market-by-market and
Indication-by-Indication basis for a particular Compound and/or Product, and it
is anticipated that the level of effort may be different for different markets
and may change over time, reflecting changes in the status of the Compound or
Product and the market(s) involved.

 

1.23         “Competitive Entity” means any Third Party that (a) together with
its Affiliates and subsidiaries, collectively had worldwide sales of ethical
pharmaceutical products, in the Calendar Year that preceded the Change of
Control, of at least One Billion Dollars (U.S. $1,000,000,000), and (b) on the
date of such Change of Control is actively working on any research program
involving the expenditure of funds or the application of full time equivalents
in the aggregate amount of at least $500,000 per Calendar Year involving a
Competitive Program.

 

1.24         “Competitive Products” means any anti CD 20 monoclonal antibody for
use in the Field

 

5

 

 

1.25         “Competitive Program” means any program that involves the research,
development or commercialization of any (a) transgenically-derived chimeric
monoclonal antibody or (b) cell-product anti CD 20 monoclonal antibody for use
in the Field.

 

1.26         “Completion” means, with respect to any Clinical Trial, the date on
which all material data reasonably expected to be derived therefrom has been
generated and the final study report with respect thereto has been finalized. 

 

1.27         “Compounds” means, collectively, (i) TG20 and/or (b) LFB-R603.

 

1.28         “Confidential Information” means with respect to each Party, all
information, Technology and Proprietary Materials that is (i) TG Background
Technology, in the case of TG and (ii) Licensed Technology, in the case of
LICENSOR, and, that, in any case, is disclosed or provided by or on behalf of
such Party (the “Disclosing Party”) to the other Party (the “Receiving Party”)
or to any of the Receiving Party’s employees, consultants, Affiliates or
sublicensees; provided, that, none of the foregoing shall be Confidential
Information if: (A) as of the date of disclosure, it is known to the Receiving
Party or its Affiliates as demonstrated by contemporaneous written documentation
maintained in the ordinary course of business, other than by virtue of a prior
confidential disclosure to such Receiving Party; (B) as of the date of
disclosure it is in the public domain, or it subsequently enters the public
domain through no fault of the Receiving Party; (C) it is obtained by the
Receiving Party from a Third Party having a lawful right to make such disclosure
free from any obligation of confidentiality to the Disclosing Party; or (D) it
is independently developed by or for the Receiving Party without reference to or
use of any Confidential Information of the Disclosing Party as demonstrated by
contemporaneous written documentation maintained in the ordinary course of
business. For purposes of clarity, (a) unless excluded from Confidential
Information pursuant to the preceding sentence, any scientific, technical,
manufacturing or financial information of a Party that is disclosed through any
report (including any audit report) shall constitute Confidential Information of
the Disclosing Party; (b) all Clinical Data produced by TG in connection with
the Development of a Compound or Product and/or in the conduct of Clinical
Trials shall be Confidential Information of TG; and (c) any combination of
Confidential Information shall not be considered in the public domain or in the
possession of the Receiving Party merely because individual elements of such
Confidential Information are in the public domain or in the possession of the
Receiving Party unless the combination and its principles are in the public
domain or in the possession of the Receiving Party.

 

1.29         “Control” or “Controlled” means (a) with respect to Technology
(other than Proprietary Materials) or Patent Rights, the possession by a Party
(or an Affiliate of such Party, as applicable) of the right to grant a license
or sublicense to such Technology or Patent Rights as provided herein without
violating the terms of any agreement or arrangement with, infringing the Patent
Rights of, or misappropriating the proprietary or trade secret information of,
any Third Party and without violating any Applicable Laws and (b) with respect
to Proprietary Materials, the possession by a Party of the right to supply such
Proprietary Materials to the other Party as provided herein without violating
the terms of any agreement or arrangement with any Third Party and without
violating any Applicable Laws. Notwithstanding the foregoing, no Party (or
Affiliate of a Party, as applicable) shall be deemed to Control any Technology,
Proprietary Materials or Patent Rights solely by virtue of the license grants
set forth in this Agreement.

 

6

 

 

1.30          “Cover” or “Covered” means, with respect to a Product, that the
manufacture, use or sale of such Product in a particular country by an
unlicensed Third Party would infringe a Valid Claim.

 

1.31         “Development” or “Develop” means, with respect to a Product, (a)
all non-clinical and clinical drug development activities that are undertaken
after the Effective Date up to and including the date of obtaining of Marketing
Authorization of such Product to obtain including (i) the conduct of Clinical
Trials, toxicology and pharmacology testing, test method development and
stability testing, process development (“Process Development” as defined below
in Section 1.84) (including the Manufacture of validation and engineering
batches), formulation development, delivery system development, quality
assurance and quality control development, analytical method development, human
clinical studies and regulatory affairs activities and statistical analysis and
report writing; (ii) the preparation of Clinical Trial design and operations;
(iii) preparing and filing Drug Approval Applications, and (b) all activities
related to Manufacturing Development and (c) any and all other activities that
may be necessary or useful to obtain Regulatory Approval. When used as a verb,
“Developing” means to engage in Development and “Developed” has a corresponding
meaning.

 

1.32         “Development Plan” means, with respect to the Compound and/or any
Product, the non-binding written plan for, and estimated budget applicable to,
the Development activities anticipated to be conducted by TG for the Compound
and/or Product, as such written plan may be amended, modified or updated in
accordance with Section 3.1.3. Topics that may be covered in the plan, (a) the
Clinical Trials (including investigator-initiated clinical trials) that are
expected to be conducted and the expected timeline for conducting such Clinical
Trials; (b) the expected Drug Approval Applications to be required and prepared,
and the expected timetable for making such Drug Approval Applications; (c) the
pharmaceutical development and Manufacturing strategy, proposed timelines for
Manufacturing, acquisition, Manufacturing scale-up, formulation, filling and/or
shipping of the Product;

 

1.33         “Development Program” means (a) the Development activities to be
conducted by TG during the Term with respect to the Compounds and (b) the
Development activities to be conducted by LICENSOR during the Term under the
Development Services and Manufacturing Agreement as set forth in the Development
Plan and defined in 3.1.2.

 

1.34         “Distributor” means any Person that purchases Product from TG or
any of TG’s Affiliates or Sublicensees for purposes of resale of Product to end
users in the Territory (including any wholesalers, pharmacists or hospitals).

 

7

 

 

1.35         “Divest” means, with respect to a Competitive Program, a
divestiture of such Competitive Program to a Third Party by sale, license or
otherwise; provided, that, if such divestiture is made by TG by way of one or
more licenses or sublicenses, (a) TG and its Affiliates shall not hold or retain
any rights with respect to such Competitive Program other than (i) the right to
receive license fees, milestone payments and royalties on sales of products (or
other sources of revenue, including with respect to Manufacturing) with respect
to such Competitive Program, (ii) the right to defend claims of infringement,
(iii) the right to assert claims of infringement against Persons who may
infringe its intellectual property rights with respect to products with respect
to such Competitive Program and (iv) the right to otherwise control filings and
patent term extensions connected with any licensed or sublicensed Patent Rights,
and (b) TG and its Affiliates are not consulted with respect to, and do not
otherwise participate in, any decisions (other than those described in clauses
(ii), (iii) and (iv) above), or otherwise collaborate with any Third Party, with
respect to (x) the commercialization of products with respect to such
Competitive Program or (y) the commercial strategy with respect to products with
respect to such Competitive Program.

 

1.36         “Drug Approval Application” means, with respect to a Product in the
Territory, an application for Marketing Authorization for such Product in the
Territory. For purposes of clarity, Drug Approval Application shall include,
without limitation, (a) an NDA or BLA (for US) or MAA (for Europe); (b) a
counterpart of an NDA or BLA, sNDA or sBLA, or MAA in any country or region in
the Territory; and (c)and all supplements and amendments to the foregoing.

 

1.37         “EMA” means the European Medicines Agency or any successor agency
or authority thereto.

 

1.38         “Excluded Application” means (a) any application involving the
determination or monitoring of (i) the presence or absence of a disease; (ii)
the stage, progression or severity of a disease or (iii) the effect on a disease
of a particular treatment; (b) any application involving the selection of
patients for a particular treatment; and (c) any in vitro applications or uses.

 

1.39         “Executive Officer” means the Chief Executive Officer of LFB and
the Chief Executive Officer of TG.

 

1.40         “FDA” means the United States Food and Drug Administration or any
successor agency or authority thereto.

 

1.41         “FDCA” means the United States Federal Food, Drug, and Cosmetic
Act, as amended.

 

1.42         “Field” means the treatment, control, mitigation, prevention and/or
cure of all human therapeutic Indications. For purpose of clarity, the
definition of “Field” shall not include any Excluded Application.

 

1.43         “First Commercial Sale” means, with respect to a Product in the
Territory, the first sale, transfer or disposition for value to an end user of
such Product in the Territory after Marketing Authorization for such Product has
been received in the Territory; provided, that, a First Commercial Sale shall
not include: (a) any sale to an Affiliate, Sublicensee or Distributor (unless
the Affiliate, Sublicensee or Distributor is the last entity in the distribution
chain of the Product), (b) any use of a Product in Clinical Trials, pre-clinical
studies or other research or development activities, or (c) the disposal or
transfer of Products for a bona fide charitable purpose, including compassionate
use or named patient use.

 

8

 

 

1.44         “Force Majeure” means any occurrence beyond the reasonable control
of a Party that (a) prevents or substantially interferes with the performance by
such Party of any of its obligations hereunder and (b) occurs by reason of any
act of God, flood, fire, explosion, earthquake, strike, lockout, labor dispute,
casualty or accident, or war, revolution, civil commotion, act of terrorism,
blockage or embargo, or any injunction, law, order, proclamation, regulation,
ordinance, demand or requirement of any government or of any subdivision,
authority or representative of any such government.

 

1.45         “GLP” means the then-current Good Laboratory Practice Standards
promulgated or endorsed by the FDA or, in the case of foreign jurisdictions,
comparable regulatory standards promulgated or endorsed by the applicable
Regulatory Authority.

 

1.46         “GMP” means current Good Manufacturing Practices that apply to the
Manufacture of API and/or the clinical or commercial supply of Products,
including, without limitation, the United States regulations set forth under
Title 21 of the United States Code of Federal Regulations, parts 210 and 211, as
amended from time-to-time, as well as all applicable guidance published from
time-to-time by the FDA or, in the case of foreign jurisdictions, comparable
regulatory standards promoted or endorsed by the applicable Regulatory Authority
and the International Conference on Harmonization Guidelines ICHQ7A Good
Manufacturing Practice Guidance for API or the principles and guidelines of Good
Manufacturing Practices for Medicinal Products as defined with EC Directive
2003/94/EC and associated EC Guide to Good Manufacturing Practice.

 

1.47         “Good Clinical Practice” or “GCP” means the applicable regulations
or guidance relating to the design, conduct, recording, and reporting of
Clinical Trials that involve the participation of human subjects, when
generating Clinical Trial data intended to be submitted to Regulatory
Authorities, as set forth in the FDCA and any regulations or guidance documents
promulgated thereunder, including but not limited to the ICH E6 consolidated
guidance on Good Clinical Practice.

 

1.48         “Hadam License Agreement” means that certain License Agreement,
dated August 15, 2006, by and between LFB and Dr. Martin Hadam.

 

1.49         Hatch-Waxman Act” means the Drug Price Competition and Patent Term
Restoration Act of 1984, as amended.

 

1.50         “IND” means: (a) an Investigational New Drug Application, as
defined in the FDCA and regulations promulgated thereunder, or any successor
application or procedure required to initiate clinical testing of a Product in
humans in the Territory; and (b) all supplements and amendments to the
foregoing.

 

1.51         “Indication” means each separate and distinct disease, illness
and/or condition, interruption, cessation or disorder of a particular bodily
function, system, tissue type or organ, or sign or symptom of any such items or
conditions, regardless of the severity, frequency or route of any treatment,
dosage strength or patient class, for which Regulatory Approval is being sought.

 

9

 

 

1.52         Investigator’s Brochure” means a compilation of preclinical and
clinical data with respect to a new investigational drug that is proposed for
filing with a Regulatory Authority and used to provide information to clinical
investigators and Regulatory Authorities.

 

1.53         “Joint Improvement” means any Program Technology that is (a)
jointly conceived, developed or reduced to practice by one or more employees of,
or consultants to, TG and/or its Affiliates, Sublicensees, Distributors and one
or more employees of, or consultants to, LICENSOR or (b) conceived , developed,
or reduced to practice solely by one or more employees of, or consultants to TG
resulting from the use by TG in any material respect of the Licensed Technology,
Licensed Patent Rights, Background Patent Right or LICENSOR Materials.

 

1.54         “Joint Patent rights” means any Patent Rights related to Joint
Improvements.

 

1.55         “Knowledge” or “Known” means, with respect to a Party, the actual
knowledge of the Executive Officer or of any executive officer (as defined for
purposes of Section 14 of the Securities Exchange Act of 1934, as amended) of
such Party.

 

1.56         “LFB-R603” means the cell-culture produced chimeric monoclonal
antibody described on Schedule 3 attached hereto and incorporated herein by
reference.

 

1.57         “Licensed Patent Rights” means any Patent Rights that are
Controlled by LICENSOR during the Term and that (a) contain one or more claims
that Cover any Compound or Product; and (b) are necessary or useful for TG to
Develop and/or Commercialize any Compound or Product in the Field and in the
Territory. For purposes of clarity, (a) the Licensed Patent Rights existing as
of the Effective Date are listed on Schedule 4 attached hereto and (b) Schedule
4 shall be updated by LICENSOR by written notice to TG on an annual basis during
the Term to include any additional patents and patent applications not
previously listed; provided, that, the exclusion of a patent or patent
application from Schedule 4 shall not be deemed to be a conclusive indication of
whether that patent or application is or should be considered a “Licensed Patent
Right” for purposes of this Agreement.

 

1.58         “Licensed Technology” means any Technology that is Controlled by
LICENSOR during the Term and that (a) relates to any Compound or Product and (b)
is necessary or useful for TG to Develop, and/or Commercialize any Compound or
Product in the Field and in the Territory.

 

1.59         “Licensed Trademark” means the trademarks listed in Schedule 7,
together with all goodwill associated therewith.

 

1.60         “LICENSOR Commercialization Option Period” has the meaning set
forth in 5.11.

 

1.61         “LICENSOR Commercialization Territory” means France and Belgium.

 

1.62         “LICENSOR Materials” means any Proprietary Materials that are
Controlled by LICENSOR and used by LICENSOR, or provided by LICENSOR for use, in
the Development Program.

 

10

 

 

1.63         “LICENSOR Improvement” means any Program Technology that is
conceived or first reduced to practice by employees of, or consultants to,
LICENSOR alone or jointly with any Third Party, without the use, in any material
respect, of any TG Materials or Joint Improvement.

 

1.64         “Major European Market Country” means the United Kingdom, Germany,
France, Italy or Spain.

 

1.65         “Manufacture” or “Manufacturing” or “Manufactured” means all
activities related to the production of any API or Product, including the
manufacture, receipt, inspection, storage and handling of materials, and the
manufacture, processing, purification, packaging, labeling, warehousing, quality
control testing (including in-process release and stability testing), shipping
and release of API or Product.

 

1.66         “Manufacturing Development” means, with respect to any API or
Product, all activities related to the optimization of a commercial-grade
Manufacturing process for the Manufacture of such API or Product including, test
method development and stability testing, formulation, validation, productivity,
trouble shooting and next generation formulation, process development,
Manufacturing scale-up, strain improvements, development-stage Manufacturing,
and quality assurance/quality control development.

 

1.67         “Marketing Authorization” means, with respect to any Product, the
Regulatory Approval required by Applicable Laws to market and sell such Product
for use for any Indication in the Field in the Territory,. For purposes of
clarity, (a) “Marketing Authorization” in the United States means final approval
of an NDA or BLA, or, sNDA or sBLA (depending on the Product) permitting
marketing of the applicable Product in interstate commerce in the United States;
and (b) “Marketing Authorization” in the European Union means marketing
authorization for the applicable Product granted either by a Regulatory
Authority in any Major Market European Country or by the EMA pursuant to Council
Directive 2001/83/EC, as amended, or Council Regulation 2309/93/EEC, as amended
For the avoidance of doubt, Marketing Authorization does not include Pricing
Approvals and Reimbursement Approvals.

 

1.68         “NADA” means a New Animal Drug Application required by the US Food
and Drug Administration for the use of any genetically engineered animal in
which the gene coding for the API is stably integrated in the genome of the
animal

 

1.69         “NDA” means (a) any New Drug Application, as defined in the FDCA
and regulations promulgated thereunder, or any successor application or
procedure required to market and sell a Product in the Territory; and (b) all
supplements and amendments to the foregoing.

 

11

 

 

1.70      “Net Sales” means the gross amount billed or invoiced by TG or any of
its Affiliates or Distributors (each, a “Seller”) to Third Parties in the
Territory for sales or other dispositions or transfers for value of Products
less (a) allowances for trade, quantity and cash discounts actually allowed and
taken; (b) freight, transportation, insurance, postage charges and customs
duties included on a Seller’s bill or invoice or as a separate item; (c)
credits, rebates, allowances, and amounts repaid due to returns, recalls or
government regulations, including allowances for uncollectible amounts and/or
bad debts on previously sold Products; (d) retroactive price reductions that are
actually allowed or granted; (e) sales taxes, excise taxes, value-added taxes
and other taxes (other than income taxes) levied on the invoiced amount; and (f)
duties, tariffs and other governmental charges. In addition, Net Sales are
subject to the following:

 

(i)          Net Sales shall not include sales or transfers between TG and any
of its Affiliates, Sublicensees or Distributors unless such Affiliate,
Sublicensee or Distributor is the end user of the Product.

 

(ii)         If any Seller effects a sale, disposition or transfer of a Product
to a Third Party in a particular country other than on customary commercial
terms or for non-monetary consideration, the Net Sales of such Product to such
Third Party shall be deemed to be “the fair market value” of such Product. For
purposes of this subsection (ii), “fair market value” means the value that would
have been derived had such Product been sold as a separate product to another
customer in the country concerned on customary commercial terms.

 

(iii)        For purposes of this Agreement, “sale” shall mean any transfer or
other distribution or disposition, but shall not include transfers or other
distributions or dispositions of Product at no charge for academic research,
preclinical, clinical, or regulatory purposes (including the use of a Product in
Clinical Trials) or in connection with patient assistance programs or other
charitable purposes or to physicians or hospitals for promotional purposes
(including free samples to a level and in an amount which is customary in the
industry and/or which is reasonably proportional to the market for such
Product).

 

(iv)        For the purposes of determining royalty rates and the royalties
payable on Combination Products, Net Sales of Product shall be calculated by
multiplying the Net Sales of the Combination Product by the fraction A/A+B,
where A is the average selling price, during the royalty paying period in
question, of the Product sold separately in the country in which the sale of the
Combination Product is made, and B is the average selling price, during the
royalty period in question, of the other active ingredients or components sold
separately. In the event that such average selling price cannot be determined
for both Product and all other active ingredients and components included in the
Combination Product, Net Sales for purposes of determining payments under this
Agreement shall be calculated by multiplying the Net Sales of the Combination
Product by the fraction C/(C+D) where C is the standard fully-absorbed cost of
the Product portion of the combination, and D is the standard fully-absorbed
cost of the other active ingredient or component included in the Combination
Product, as determined by TG using its standard accounting procedures
consistently applied. In the event that the standard fully-absorbed cost of the
Product and/or the other active ingredients or components included in such
Combination Product cannot be determined, for the purposes of determining
royalties payable hereunder, the Parties shall negotiate in good faith to
determine an appropriate commercial value for all the components in the
Combination Product and calculate Net Sales of such Combination Product
accordingly.

 

12

 

 

1.71         “Patent Rights” means the rights and interests in and to issued
patents and pending patent applications (which, for purposes of this Agreement,
include certificates of invention, applications for certificates of invention
and priority rights) in any country or region, including all provisional
applications, substitutions, continuations, continuations-in-part, divisions,
renewals, all letters patent granted thereon, and all reissues, re-examinations
and extensions thereof, and all foreign counterparts of any of the foregoing.

 

1.72         “Person” means an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, incorporated
association, joint venture or similar entity or organization, including a
government or political subdivision, department or agency of a government.

 

1.73         “Phase 1 Clinical Trial” means a human clinical trial conducted for
a Product in any country that would satisfy the requirements of 21 CFR
312.21(a), as amended (or its foreign equivalent).

 

1.74         “Phase 2 Clinical Trial” means a human clinical trial conducted for
a Product for any Indication that would satisfy the requirements of 21 CFR
312.21(b), as amended (or its foreign equivalent) and is intended to explore one
or more doses, dose response, and duration of effect, and to generate initial
evidence of clinical activity and safety for such Product in the target patient
population.

 

1.75         “Phase 3 Clinical Trial” means a pivotal human clinical trial
conducted for a Product for any Indication that would satisfy the requirements
of 21 CFR 312.21(c), as amended (or its foreign equivalent) and is intended to
confirm with statistical significance the efficacy and safety of such Product
with respect to a particular Indication, and is performed to obtain Marketing
Authorization.

 

1.76          “Pivotal Clinical Trial” means (a) a Phase 3 Clinical Trial or,
(b) a Phase 2 Clinical Trial to the extent: (i) in the United States, the
protocol for that Phase 2 Clinical Trial shall have been reviewed by the FDA
under its current Special Protocol Assessment Guidelines (or equivalent
guidelines issued in the future), and any comments from the FDA on that protocol
are incorporated in the final protocol for that Phase 2 Clinical Trial or are
resolved to the FDA’s satisfaction as evidenced by further written
communications from the FDA; or (ii) a process with a comparable result –
acceptance of a Phase 2 Clinical Trial protocol as “potentially pivotal” – has
occurred with the EMA/CHMP in the European Union; or (iii) based on the results
of that Phase 2 Clinical Trial, either the FDA or the EMA has determined that
the Phase 2 Clinical Trial can be considered as a pivotal clinical trial for
purposes of obtaining Marketing Authorization.

 

1.77         “Post Approval Clinical Trials” means any Phase 4 clinical trial
and/or any clinical trial undertaken after any Marketing Approval is granted
such as Investigator sponsored study.

 

1.78         Pricing” means the determination of Product pricing at all levels,
including the Product list price (also referred to as Wholesale Acquisition
Cost) and the net price in which the Product is offered to purchasers and payers
(including both private sector and government entities).

 

13

 

 

1.79         “Pricing Approval” means, with respect to a Product in the
Territory, any pricing approvals, guidance or recommendations reasonably
necessary to market such Product in the Territory.

 

1.80         “Process Development” means with respect to a Product, all
activities related to process development of API or Product, including the(a)
raw materials selection, (b) manufacturing development, (c) test method
development of raw materials, (d) in-process products, (e) intermediate
products, API and Product, (f) formulation development, (g) stability studies of
raw material, buffers, intermediates products, API and Product, (h) viral safety
steps development and validation, (i) process robustness and process validation,
(j) analytical method validation for quality controls of raw materials,
intermediates, API and Product, (k) shipment validation, (l) container closure
study, (m) leachable and extractable study, (n) cleaning development and
validation, (o) column lifetime study, (p) filing support for regulatory
submissions.

 

1.81         “Product” means any pharmaceutical or medicinal item, substance,
formulation or dosage that is comprised of, or contains, a Compound (whether or
not such Compound is the sole active ingredient).

 

1.82         “Product Improvement” means any Program Technology related to or
concerning the Product and/or Licensed Technology, whether or not patentable,
copyrightable or otherwise protectable under any intellectual property rights.

 

1.83         “Program Technology” means any Technology or Proprietary Material
that is conceived and first reduced to practice (actually or constructively), by
TG and/or its Affiliates or jointly by the Parties, or by any Sublicensee or by
any Distributors, whether or not patentable, in the conduct of the Development
Program and/or in connection with the Commercialization of Products.

 

1.84         “Proprietary Materials” means any tangible chemical, biological or
physical materials that (a) are furnished by or on behalf of one Party to the
other Party in connection with this Agreement, whether or not specifically
designated as proprietary by such Transferring Party, or (b) that are otherwise
conceived or reduced to practice by TG in the conduct of the Development Program
and/or in connection with the Commercialization of Products.

 

1.85          “Regulatory Approval” means, with respect to the Territory, any
approval, product and establishment license, registration or authorization of
any Regulatory Authority required for the Manufacture, use, storage,
importation, exportation, transport or distribution of a Product in the
Territory, including any Marketing Authorization, Reimbursement Approval and
Pricing Approval .

 

1.86         “Regulatory Authority” means any national, international, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity with authority over the distribution, importation,
exportation, Manufacture, production, use, storage, transport, clinical testing,
marketing, Pricing or sale of a Product in the Territory, including the FDA and
the EMA.

 

14

 

 

1.87         “Regulatory Filings” means, collectively: (a) all INDs, NDAs, BLAs,
NADAs, MAAs establishment license applications, Drug Master Files, and all other
similar filings (including, without limitation, counterparts of any of the
foregoing in the Territory); (b) all supplements and amendments to any of the
foregoing; (c) all data and other information contained in, and correspondence
relating to, any of the foregoing; and (d) any and all orphan drug applications.

 

1.88         “Reimbursement Approval” means, with respect to a Product in the
Territory, any pricing reimbursement registration or listing on formularies and
all approval necessary to an optimal introduction of the Product on the market.

 

1.89         “Royalty Term” means with respect to each Product in each country
in the Territory, the period beginning on the date of First Commercial Sale of
such Product in such country and ending on the later of (a) the expiration of
the last to expire Valid Claim of the Licensed Patent Rights or TG Program
Patent Rights in such country that Covers the composition of matter,
Manufacture, use or sale of such Product, and (b) fifteen (15) years from the
date of the First Commercial Sale of such Product in such country.

 

1.90         Sales Target means that proportion of the total patient market for
the Product provided to Licensor by TG and expressed as either a percentage or
calculated number of vials of the Product as set forth in Schedule 3.

 

1.91         “Serious Adverse Event” means any untoward medical occurrence that,
at any dose, results in death, is life-threatening, requires inpatient
hospitalization or prolongation of existing hospitalization, results in
persistent or significant disability/incapacity, or is a congenital
anomaly/birth defect, as more full defined in 21 CFR § 312.32.

 

1.92         “Significant Development Event” means any of the following material
Development events, a summary of which shall be included in any Development
Report : (a) any material interaction and/or written correspondence between TG
and any Regulatory Authority with respect to the Compound or a Product; (b) any
material event with respect to any Clinical Trial involving the Compound and/or
a Product, including any such event that is ongoing as of the date of the
applicable Development Report, or is reasonably expected to occur or be
initiated within twelve (12) months of the date of the applicable Development
Report; and (c) any material result obtained in the conduct of any Clinical
Trial involving the Compound and/or a Product during the period covered by the
Development Report. For purposes of clarity, all information provided to
LICENSOR with respect to Significant Development Events, shall be deemed to be
Confidential Information of TG. For purposes of this definition, “material”
shall be defined as any event and/or result which have had or may have a
significant impact on the activities and timelines defined in the Development
plan of each Product.

 

1.93         sBLA” means a Supplemental Biologic License Application, as defined
in the FDCA and applicable regulations promulgated thereunder.

 

1.94         “sNDA” means a Supplemental New Drug Application, as defined in the
FDCA and applicable regulations promulgated thereunder.

 

15

 

 

1.95         “Sublicensee” means any Third Party to which TG grants a sublicense
in accordance with Section 2.2.

 

1.96         “Sublicense Agreement” means any agreement by and between a Party
and a Sublicensee which is entered into in accordance with Section 2.2.

 

1.97         “Sublicense Income” means any royalties on Sublicensee Net Sales
received by Licensee from its Sublicensees, excluding (a) payments made by a
Sublicensee in consideration of the issuance of equity or debt securities of
Licensee to the extent that the price paid for such equity does not exceed the
then fair market value of such equity as determined by TG’s Board of Directors
in good faith and separately confirmed by LICENSOR (it being understood that any
amounts paid in excess of fair market value shall be deemed to be Sublicense
Income) and (b) payments made by a Sublicensee which are used to support or fund
research and development activities to be undertaken by TG or any of its
Affiliates after the effective date of the Sublicense Agreement pursuant to a
budget for sponsored research which has been agreed to with the Sublicensee and
based on full-time equivalent or other cost-accounting methodologies that are
consistent with then current industry practices.

 

1.98         “Sublicense Royalties” means, in any country in which a Sublicense
Agreement is executed by TG, a payment equal to the greater of (a) * percent
(*%) of the amount of Sublicense Income received by TG from such Sublicense
Agreement in such country and (b) * percent (*%) of the Annual Net Sales of
Products by such Sublicensee in such country.

 

1.99         “Technology” means, collectively, all inventions, discoveries,
improvements, trade secrets and proprietary information and methods, whether or
not patentable or patented, including without limitation: (a) methods of
Manufacture or use of, and structural and functional information pertaining to,
chemical compounds; (b) compositions of matter, data, formulations, processes,
techniques, know-how and results (including any negative results) and (c)
results of clinical trials, pre-clinical trials and other Development
activities.

 

1.100 “Territory” means any country or jurisdiction in the world.

 

1.101 “TG20” means the transgenic-derived chimeric monoclonal antibody described
more fully on Schedule 5 attached hereto and incorporated herein by reference.

 

1.102 “TG Materials” means any Proprietary Materials that are Controlled by TG
and used by TG, or provided by TG for use, in the Development Program.

 

1.103 “Third Party” means (a) with respect to TG, any Person other than TG and
its respective Affiliates, Sublicensees and Distributors and (b) with respect to
LICENSOR, any Person other than its Affiliates.

 

 

*Confidential material redacted and filed separately with the Commission.

 

16

 

 

1.104 “Valid Claim” means any claim of (a) an issued unexpired patent that (i)
has not been finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction, (ii) has not been
permanently revoked, held invalid, or declared unpatentable or unenforceable in
a decision of a court or other body of competent jurisdiction that is
unappealable or unappealed within the time allowed for appeal, (iii) has not
been rendered unenforceable through terminal disclaimer or otherwise, and (iv)
is not lost through an interference proceeding that is unappealable or
unappealed within the time allowed for appeal; or (b) a claim of a pending
Patent application, which claim has not been abandoned or finally disallowed
without the possibility of appeal.

 

Additional Definitions. In addition, each of the following definitions shall
have the respective meanings set forth in the section of this Agreement
indicated below:

 

Definition   Section       Action   10.2.1(a)(ii) Anticipated Approval Notice  
5.11.1(a) Claims   13.1 Commercialization Report   5.6 Competitive Program
Transaction   2.4.2(a) Competitive Program Transaction Notice   2.4.2(a)
Development Report   3.3.1 Diligence Failure Notice   5.3 Disclosing Party  
1.24 Dispute   14.1 Effective Date   Preamble Filing Party   10.1.3 LFB  
Preamble LFB/GTC   Preamble LICENSOR   Preamble LICENSOR Commercialization
Option   5.1.1(b) LICENSOR Commercialized Product   5.1.1(b) LICENSOR
Indemnities   13.1 ICH   3.3 Indemnified Party   13.3 Indemnifying Party   13.3
Infringement   10.2.1(a)(i) Infringement Notice   10.2.1(a)(i) Losses   13.1
Manufacturing and Supply Agreement   3.4 Non-Publishing Party   8.4 Option  
Recitals Option Agreement   Recitals Party/Parties   Preamble Patent Coordinator
  9.4 Promotional Materials   5.9 Publishing Party   8.4 Recall   5.10 Receiving
Party   1.24 Recipient Party   3.5 Results   8.4

 

17

 

 

Definition   Section       Seller   1.60 Stock Purchase Agreement   7.1 TG  
Preamble TG Diligence Failure Notice   5.3 TG Indemnities   13.2 Term   11.1
Transferring Party   3.5

 

2.          LICENSE GRANTS; EXCLUSIVITY

 

2.1          License.

 

2.1.1           Grant of License to TG.

 

Subject to the terms and conditions of this Agreement, LICENSOR hereby grants to
TG an exclusive (including with respect to LICENSOR and their respective
Affiliates), worldwide, royalty-bearing license or sublicense (with respect to
Licensed Technology and/or Licensed Patent Rights licensed by Third Parties to
LICENSOR), including the right to grant sublicenses as provided in Section 2.2,
under the Licensed Technology and Licensed Patent Rights to Develop the
Compounds or Products as part of the Development Program and to Commercialize,
use, have used, Manufacture, have Manufactured, supply, sell, offer to sell,
import, have imported, market, and otherwise Commercialize Products in the
Field.

 

For the avoidance of doubt, the right granted by LICENSOR to TG to Manufacture
or have Manufactured the Product in the Field is subject to the terms and
conditions of Sections 3.5 and 5.9.

 

In addition, LICENSOR hereby grants to TG a non-exclusive, worldwide, fully paid
up license or sublicense, including the right to grant sublicenses as provided
in Section 2.2, under the Background Patent Rights to Develop the Compounds or
Products as part of the Development Program and to Commercialize, use, have
used, Manufacture, have Manufactured, and supply, sell, offer to sell, import,
have imported, market, and otherwise Commercialize Products in the Field.

 

2.1.2           Reversion. Should TG or its Sublicensee(s) stop the Development
or the Commercialization of any Product, any and all license granted to TG by
LICENSOR in respect of such Product shall automatically revert back to LICENSOR
(including licenses granted according to Sections 2.1.1 and 2.1.4). In such
case, TG commits to grant to LICENSOR an exclusive, royalties free license or
sublicense (with respect to Rights licensed by Third Parties to TG), including
the right to grant sublicenses, under the all Patent Rights Controlled by TG,
Joint Improvement and Joint Patent Right necessary or useful for LICENSOR to
Develop such Compounds or Product and/or use, have used, Manufacture, have
Manufactured, supply, sell, offer to sell, import, have imported, market, and
otherwise Commercialize such Products in the Field and in the Territory.

 

18

 

 

For the avoidance of doubt, the Development of a Product shall be considered
stopped if the aggregate amount spent by TG or its Sublicensee(s) on the
Development activities, up to the filing of the Drug Approval Application, is
less than (*)*$ per year for such Product for more than * years.

 

For the avoidance of doubt, the Commercialization of a Product shall be
considered as stopped if, after all Regulatory Approvals and Reimbursement
Approvals have been granted at least in the US or in one of Major European
Market Country when:

 

-the aggregate amount spent by TG or its Sublicensee(s) on the Commercialization
activities is less than $*per year for such Product; and

 

-or, a minimum of * percent (* %) of Sales Target has not been recorded for over
a period of more than * (*) years;

 

2.1.3        Disclosure of Technology. LICENSOR shall provide prompt written
notice to TG of all Licensed Patent Rights or Licensed Technology Controlled by
LICENSOR and their respective Affiliates that come under the Control of LICENSOR
or their respective Affiliates after the Effective Date during the Term.

 

2.1.4   Grant of License to Licensed Trademark.

 

(a)          Ownership of Trademarks. TG hereby acknowledges that LICENSOR has
already performed a Trademarks research and has registered the Licensed
Trademarks. However, TG is entitled to use and register any other trademarks, on
LICENSOR behalf, and at TG own cost, for Development and Commercialization
purposes.

 

(b)          Grant of License. Subject to the terms and conditions of this
Agreement, LICENSOR hereby grants to TG a royalty bearing an exclusive license
to use the Licensed Trademark solely for the purpose of registering, using,
Commercializing, importing, exporting, selling, offering for sale, and having
sold the Product in the Field in the Territory on the terms and subject to the
conditions set forth in this Agreement.

 

(c)          Covenants of TG. TG hereby agrees that all use of the Licensed
Trademark by TG, and any goodwill associated with the use of the Licensed
Trademark by TG, shall inure to the benefit of LICENSOR. TG hereby agrees that
nothing in this Agreement shall give TG any right, title or interest in the
Licensed Trademark other than the right to use the Licensed Trademark in
accordance with this Agreement. TG further agrees that it will not: (i) oppose
or assist any Third Party in opposing any application for registration,
re-registration or renewal of the Licensed Trademark; ii) apply for or otherwise
seek (or assist any Third Party in applying for or otherwise seeking) complete
or partial revocation, cancellation, invalidation or removal of the Licensed
Trademark from any register or (iii) challenge or bring (or assist any Third
Party in challenging or bringing) any proceeding or action in relation to the
use or ownership of the Licensed Trademark.

 

 

*Confidential material redacted and filed separately with the Commission.

 

19

 

 

(d)          Registration of Licensed Trademark. LICENSOR shall have the sole
right to apply for registration of the Licensed Trademark in the Territory to
the extent such registration has not already been obtained by LICENSOR at the
Effective Date and for paying all applicable fees, including all registration
and application fees and renewal fees. TG agrees that it will not apply for the
registration of the Licensed Trademark (or any mark confusingly similar thereto)
anywhere in the world.

 

(e)          Use of Licensed Trademark. TG shall use the Licensed Trademark
solely (i) in the manner specified in this Agreement and (ii) in connection with
the Product and not for any other goods or services. TG agrees not to use any
other trademark or service mark in combination with the Licensed Trademark
without the prior written consent of GTC. TG, at its sole cost and expense, will
provide to LICENSOR representative samples of all products, product packaging,
literature, brochures, signs, and advertising materials prepared by TG which
bear, display, or include any reference to the Licensed Trademark, and TG shall
obtain the written approval of LICENSOR with respect to all such materials prior
to the use thereof. TG will not distribute or otherwise use any samples or
materials or other media bearing or displaying the Licensed Trademark unless and
until LICENSOR has notified TG in writing of LICENSOR’s approval, which approval
shall not be reasonably withheld.

 

(f)          Notice. TG shall promptly notify LICENSOR (i) of any claim, threat,
lawsuit, filing, or other notice or allegation of infringement of which it is
aware regarding TG’s use of the Licensed Trademark and/or (ii) if it becomes
aware of the existence of any Third Party applications to register anywhere in
the world any mark or name which consists of or incorporates the Licensed
Trademark. LICENSOR shall have the sole right, but not the obligation, to bring
infringement, unfair competition, or other claims or proceedings involving the
Licensed Trademark and TG hereby acknowledges and agrees that it shall have no
such right. If requested by LICENSOR, TG shall cooperate with LICENSOR in
connection with any such action.

 

2.2          Right to Sublicense.

 

2.2.1           Sublicense. TG shall have the right to grant sublicenses under
the licenses granted to it under Section 2.1.1 to any Sublicensee; with LICENSOR
prior written notification provided, that, (a) the terms of each such sublicense
shall be consistent with the rights and obligations of TG under the Agreement;
(b) it shall be a condition of any such sublicense that such Sublicensee agrees
to be bound by the terms of this Agreement applicable to the Development and
Commercialization of Products in the Field in the Territory; (c) TG shall
provide LICENSOR with a copy of any such Sublicense Agreement within ten (10)
days of the execution of each such Sublicense Agreement; and (d) TG shall not be
relieved of its obligations pursuant to this Agreement as a result of such
sublicense, except to the extent such obligations are satisfactorily performed
by any such sublicense.

 

2.2.2           Grant of Rights to Distributors. TG or any of its Affiliates and
Sublicensees shall have the right, with LICENSOR prior written notification, to
appoint one or more Distributors for Products in the Territory. TG shall provide
LICENSOR with a copy of each such agreement with any Distributor within ten (10)
days of execution of such agreement.

 

20

 

 

2.3          No Other Rights.

 

2.3.1           TG shall have no rights to use or otherwise exploit Licensed
Technology, Licensed Patent Rights, or LICENSOR Proprietary Materials, and
LICENSOR shall have no rights to use or otherwise exploit TG Technology, TG
Patent Rights or TG Proprietary Materials, in each case, except as expressly set
forth in this Agreement.

 

2.4          Exclusivity.

 

2.4.1       Exclusivity Obligation. During the Term of this Agreement, TG shall
not, and shall cause each of its Affiliates to not, conduct any activity, either
on its own, or with, for the benefit of, or sponsored by, any Third Party, that,
in any case, involves the research, development or commercialization of any
other anti CD 20 monoclonal antibody, or any compound that embodies or is
derived from any anti CD 20 monoclonal antibody, for use in the Field that is
competitive with or adversely affects the Development or Commercialization of
any of the Compounds or Products, except hereunder in connection with the
research, Development and/or the Commercialization of the Compounds and
Products. Notwithstanding the foregoing, at TG’s request, LICENSOR may allow TG
to Develop and Commercialize all combinations with the Compounds and Products
which would be benefit in improving the Development and/or the Commercialization
of the Compounds and Products, such consent to not be unreasonably withheld.

 

2.4.2      Competitive Program Transaction.

 

(a)          Notice. If at any time during the Term, TG grants a sublicense or
other rights to any Third Party to utilize any Technology or Patent Rights
Controlled by TG or any of its Affiliates for the Development or
Commercialization of any of the Compounds or Products, or TG undergoes a Change
of Control, or if TG or any of its Affiliates acquires all or substantially all
of the assets or common stock of a Third Party (whether by asset or stock
purchase, merger, consolidation, share exchange or other similar transaction)
and, in any such case, such Third Party or any of such Third Party’s Affiliates
(in the case of a Third Party Sublicensee or a Third Party acquirer of TG), has
a Competitive Program (a “Competitive Program Transaction”), TG shall provide
LICENSOR with prompt written notice describing such Competitive Program
Transaction in reasonable detail which shall include a description of the nature
of such Competitive Program (the “Competitive Program Transaction Notice”). Such
Competitive Program Transaction Notice shall be provided by TG prior to
execution of such agreement, if permitted under Applicable Laws and not
prohibited by the terms of any agreement between TG or any of its Affiliates and
any Third Party, and otherwise as soon as practicable thereafter and, in any
event, not later than promptly following the consummation of the transaction
contemplated by such agreement.

 

(b)          Meeting of the Parties. As soon as practicable following LICENSOR’
receipt of any Competitive Program Transaction Notice, the Parties shall meet to
discuss whether, notwithstanding any provision hereof, such Competitive Program
would continue following such Competitive Program Transaction. In any such
meeting the Parties will review any restrictions applicable to such Competitive
Program that may prevent its combination with this Agreement, and other issues
that may impact the potential combination of such Competitive Program with this
Agreement.

 

21

 

 

(c)          Integration of Competitive Program. If TG and LICENSOR mutually
agree that such Competitive Program may be integrated into this Agreement, then
within * (*) * after such determination the Parties shall agree upon an
amendment to this Agreement that will provide either (X) (i) that each compound
or product that is part of the Competitive Program would be deemed to be a
Compound, whether or not such compound or product meets the standards or
criteria hereunder for a Compound and (ii) the Parties’ rights and obligations
under this Agreement will apply in all relevant respects to any such deemed
Compounds (including the payment of the milestones, royalties and Sublicense
Royalties set forth in this Agreement) or (Y) that the Development and
Commercialization diligence standards of this Agreement shall be revised to
ensure that the effort and resources that the Third Party applies (or TG, if TG
is the surviving entity) applied to the Competitive Program shall be equally
applied to the Development and Commercialization of the Compounds and Products.

 

(d)          Termination/Divesting of Competitive Program. If the Parties are
unable to reach agreement on the terms pursuant to which the integration of any
Competitive Program into this Agreement would occur, TG shall have an additional
* (*)* during which it shall determine whether to (i) terminate the Competitive
Program or (ii) Divest itself of the Competitive Program. If TG notifies
LICENSOR in writing that it will terminate such Competitive Program, TG shall
promptly terminate such Competitive Program as quickly as possible with due
regard for patient safety and the rights of any subjects that are participants
in any clinical studies relating to such Competitive Program and Applicable
Laws, and in any event within * (*)* after its delivery of such written notice
to LICENSOR. If TG notifies LICENSOR in writing that it will Divest itself of
the Competitive Program, then it shall do so as promptly as practicable but in
any event on or before * (*)* from the date of such notice; provided, that,
during the period during which such Divestiture is pending, TG shall maintaining
separate teams working on such Competitive Program and this Agreement. If TG
does not notify LICENSOR in writing at the conclusion of the * (*) * period
provided above that TG will terminate or Divest itself of such Competitive
Program, or if TG does so notify LICENSOR but fails to terminate or Divest the
Competitive Program within the periods provided above, LICENSOR shall have the
right to immediately terminate this Agreement by providing written notice to TG.

 

3.          DEVELOPMENT OF PRODUCTS

 

For the sake of clarity, in this Section 3, TG means TG, and where applicable,
its Affiliates, Sublicensees and Distributors.

 

3.1          Development Program.

 

3.1.1           Objective of Development Program. The objective of the
Development Program shall be the Development by TG of the Compounds and Products
in the Field in order to obtain Marketing Authorization for such Products in the
Field in the Territory as promptly as practicable.

 

 

*Confidential material redacted and filed separately with the Commission.

 

22

 

 

3.1.2           Responsibility for Development. TG shall have the sole right and
responsibility for, and shall have full control and authority over, at its sole
cost and expense (including without limitation all costs attributable to the
Manufacture and supply of Product for the conduct of Clinical Trials), the
Development of Products in the Territory, including conducting all Development
activities and establishing the methods and means by which it performs such
activities under this Agreement. TG shall have the right to engage Third Party
contractors to perform any of its Development activities in the Territory,
subject to the execution by each such Third Party contractor of an agreement
containing provisions with respect to confidentiality and assignment of
Technology that are consistent with, and comparable in scope to, Articles 7 and
8 of this Agreement. Notwithstanding the foregoing, from time to time during the
Term, TG may request in writing that LICENSOR perform certain Development
activities as part of the Development Program. If TG requests that LICENSOR
provide Development activities, LICENSOR will promptly provide a timeline and
budget for providing such services and will use Commercially Reasonable Efforts
to provide such services in accordance with the timeline and budget. Such
services shall be provided in accordance with the terms set forth in the
development services and manufacturing agreement (the “Development Services and
Manufacturing Agreement”) which shall be attached in Exhibit A as soon as it is
executed by the Parties. As described more fully in the Services Agreement,
LICENSEE shall provide such services, and TG shall pay for such services, based
on LICENSOR’S *; provided, that, (a) during the first six (6) months following
the Effective DateLICENSOR shall provide such services free of charge until such
date as an aggregate of * ($*) of such services have been provided (*) and (b)
for the remainder of the term of the Services Agreement, TG shall pay LICENSOR a
service fee for such services equal to LICENSOR’S * percent (*%).

 

3.2           Development Diligence.

 

TG, and/or its Affiliates, Sublicensee, Distributors shall use Commercially
Reasonable Efforts during the Term to (a) conduct Development activities with
respect to the Compounds and Products and (b) commit such resources (including
employees, consultants, contractors, facilities, equipment and materials) as it
deems necessary to conduct such Development activities. Without limiting the
foregoing, TG’s efforts described in this Section 3.2 shall comply with the
diligence obligations set forth in the Hadam License Agreement.

 

3.3           Preparation of Development Plan.

 

An initial Development Plan shall be prepared by TG for each Product and
submitted to the LICENSOR for its information no later than * (*)* after the
Effective Date and attached hereto as Schedule 1. During the period commencing
on and after such date and continuing for the remainder of the Term, TG shall
prepare and provide to the LICENSOR an additional Development Plans detailing
any amendments, modifications and/or updates to any existing Development Plan,
within * (*) * of the end of each Calendar Year. TG shall seek health authority
scientific advice to determine the pivotal studies deemed necessary for product
registration at the earliest possible time. The advice received should be
reflected in updated Development Plans. In the event of any conflict between the
terms of the Development Plan and the terms and conditions of this Agreement,
the terms and conditions of this Agreement shall prevail.

 

 

*Confidential material redacted and filed separately with the Commission.

 

23

 

 

3.4           Compliance.

 

TG and/or its Affiliates, Sublicensee, Distributors shall perform its
obligations under the Development Program in good scientific manner and in
compliance in all material respects with all Applicable Laws. For purposes of
clarity, with respect to each Development activity performed that will or would
reasonably be expected to be submitted to a Regulatory Authority in support of a
Regulatory Filing or Drug Approval Application, TG shall not willfully fail to
comply in all material respects with GLPs, GMPs or Good Clinical Practices (or,
if and as appropriate under the circumstances, International Conference on
Harmonization (“ICH”) guidance or other comparable regulation and guidance of
any Regulatory Authority in the Territory).

 

3.4.1           Records; Reports. TG and/or its Affiliates, Sublicensees,
Distributors shall (a) maintain records of its activities under the Development
Program in sufficient detail and in good scientific manner appropriate for
patent and regulatory purposes, which shall fully and properly reflect all work
performed and results achieved in the performance of the Development Program and
(b) keep LICENSOR regularly informed of the progress of its efforts to Develop
Products in the Territory, including without limitation, providing LICENSOR with
an annual development report (each, a “Development Report”) (to be delivered
with each annual update to the Development Plan) that summarizes: (a)
significant Development activities conducted during the preceding Calendar Year
and results obtained with respect to Compounds and Products (including the
status of all Clinical Trials), (b) Significant Development Events applicable to
the Compounds and/or Products, (c) a summary of all Program Technology conceived
or reduced to practice by TG over such period, (d) a non-binding estimate of the
expected timing of any milestone events with respect to Products and (e) such
other information that TG has in its possession as may be reasonably requested
from time to time by LICENSOR. The Development Plan and each Development Report
shall be deemed TG Confidential Information. Following the commencement of
Commercialization, Development Reports will no longer be required and will be
replaced by the annual Commercialization Report as described in Section 5.7.

 

3.5           Process Development services; Supply of Compounds for Development.

 

LICENSOR’s and TG’s rights and responsibilities pertaining the Process
Development and the supply of the Compound for the Development shall be governed
by Section 6 below.

 

3.6           Use of Proprietary Materials.

 

From time to time during the Term, either Party (the “Transferring Party”) may
supply the other Party (the “Recipient Party”) with Proprietary Materials of the
Transferring Party for use in the Development Program. In connection therewith,
each Recipient Party hereby agrees that (a) it shall not use such Proprietary
Materials for any purpose other than exercising its rights or performing its
obligations hereunder; (b) it shall use such Proprietary Materials only in
compliance with all Applicable Laws; (c) it shall not transfer any such
Proprietary Materials to any Third Party without the prior written consent of
the Transferring Party, except for the transfer of Products for use in Clinical
Trials or as otherwise expressly permitted hereby; (d) the Recipient Party shall
not acquire any right, title or interest in or to such Proprietary Materials as
a result of such supply by the Transferring Party; and (e) upon the expiration
or termination of the Development Program, the Recipient Party shall, if and as
instructed by the Transferring Party, either destroy or return any such
Proprietary Materials that are not the subject of the grant of a continuing
license hereunder.

 

24

 

 

4.          REGULATORY ACTIVITIES

 

For the sake of clarity, in this Section 4, TG means TG, and where applicable,
its Affiliates, Sublicensees and Distributors.

 

4.1           Responsibility for Regulatory Filings.

 

Subject to the remainder of this Article 4, (a) TG shall have the sole right and
responsibility, at its sole cost and expense, for preparing and filing all
Regulatory Filings and Drug Approval Applications required to Develop Compounds
and Commercialize Products in the Territory in its own name; (b) all Regulatory
Approvals for Products shall be solely owned by TG; and (c) TG shall have the
sole right and responsibility for (i) maintaining all Regulatory Filings and/or
Marketing Authorizations and (ii) reporting to any Regulatory Authority within
the Territory all Adverse Events and Serious Adverse Events related to any
Product if and to the extent required by Applicable Laws. To maximize market
protection of Product, TG shall file for any orphan drug designations as
appropriate within requisite timeframes prior to the submission of any Marketing
Authorization Application. Within twelve (12) months following the QA approval
of the Study Report of the last Clinical Trial as per the Development Program,
TG shall file, or cause to be filed, before the Regulatory Authorities in the
Territory, all authorization and registration applications required for the
promotion, marketing, distribution and sale of Product in the Territory. TG
shall exercise Commercially Reasonable Efforts to obtain Marketing
Authorizations with respect to the Product. Failure to meet this obligation will
be considered a material breach of the Agreement and LICENSOR shall have the
right to terminate the Agreement for breach of TG in accordance with Section
11.2.2.

 

4.2           Disclosure; Right of Access.

 

Upon request from LICENSOR, TG shall promptly provide LICENSOR with (a) a list
of all sites at which Clinical Trials with respect to Products are being
conducted by or on behalf of TG; (b) copies of all Clinical Trial protocols and
Investigator’s Brochures with respect to such Clinical Trials; and (c) access to
all data (including non clinical and Clinical Data), results and information
found in TG’s regulatory files produced by or on behalf of TG, or any of its
Affiliates or Sublicensees, in connection with the conduct by TG of Development
activities in its original format, without translation except that translations
shall be provided at no charge where such translations are produced in the
ordinary course of business. LICENSOR shall maintain the confidentiality of such
data, results and information and shall only have the right and license to use
such data (including Clinical Data), results and information provided by TG
under this Section 4.2 for the performance of its obligations and exercise of
its rights under this Agreement,

 

25

 

 

4.3           Disclosure of Certain Events.

 

The Parties hereby agree to report to each other all Adverse Events and/or
Serious Adverse Events with respect to the Product (whether occurring in any
Clinical Trial conducted with regard to the Product or in connection with the
commercialization of the Product in any country), within timeframes consistent
with its reporting obligations under Applicable Laws and in any event, if either
Party is actively conducting a clinical trial under its own IND or
commercializing the Product under its own Marketing Authorization, then the
other Party shall report such events no later than three (3) business days for
Serious Adverse Event, and quarterly for Adverse Events, which report shall, in
each case, include the circumstances and nature of such Serious Adverse Event or
Adverse Event as required for reporting under Applicable Laws. In addition, to
the extent requested by either Party, the other Party shall promptly provide to
the requesting Party any other information or materials that the requesting
Party may require to provide to any Regulatory Authority with respect to any
such Adverse Event or Serious Adverse Event. All disclosures made under this
Section 4.3 shall be deemed Confidential Information of the disclosing Party;
provided, that, the Party receiving such disclosures may, upon written notice to
the disclosing Party, report the occurrence, circumstances and nature of such
Adverse Event and/or Serious Adverse Event to any Regulatory Authority solely
insofar as such reporting is required to comply with Applicable Laws.

 

4.4           Communication with Regulatory Authorities in the LICENSOR
Commercialization Territory.

 

4.4.1           Participation in Meetings. TG shall use reasonable efforts to
provide LICENSOR with at least thirty (30) days advance notice of any meeting
with any Regulatory Authority regarding any Marketing Authorization for any
Product in the LICENSOR Commercialization Territory and LICENSOR may elect to
send one (1) person reasonably acceptable to TG to participate as an observer
(at LICENSOR’ sole cost and expense) in such meeting.

 

4.4.2           Access; Notice of Meetings. TG shall use reasonable efforts to
provide LICENSOR with at least thirty (30) days’ advance notice of any meeting
with any Regulatory Authority in the LICENSOR Commercialization Territory
regarding any Drug Approval Application for Products and/or any such audit or
inspection conducted by any Regulatory Authority at any site at which Clinical
Trials with respect to Products are being conducted and LICENSOR may elect to
send representatives reasonably acceptable to TG to participate as an observer
in such meeting at LICENSOR’ sole cost and expense.

 

5.          COMMERCIALIZATION OF PRODUCTS

 

For the sake of clarity, in this Section 5, TG means TG, and where applicable,
its Affiliates, Sublicensees and Distributors.

 

5.1           Commercialization Plan.

 

The initial Commercialization Plan shall be prepared by TG and submitted to
LICENSOR for information with the Anticipated Approval Notice and attached
hereto as Schedule 2. On and after such date and continuing for the remainder of
the Term, additional Commercialization Plans and/or amendments, modifications
and/or updates to the Commercialization Plan, shall be prepared by TG and
submitted to LICENSOR for its review within thirty (30) days of the end of each
Calendar Year.

 

26

 

 

5.2           Responsibility for Commercialization of Products.

 

Subject to Section 5.11 below, TG shall have the primary right and
responsibility for, and shall have primary control and authority over, at its
sole cost and expense, (a) all aspects of the Commercialization of Products in
the Field in the Territory including the sole responsibility for booking sales
of Product and for all returns, charge-backs and rebates with respect to
Products; and (b) the conduct of all pre-marketing, marketing, Branding,
promotion, sales, distribution, import and export activities (including securing
pricing, reimbursement, sales and marketing and conducting any post-marketing
trials or post-marketing safety surveillance and maintaining databases)
applicable to the Commercialization of Products in the Field and in the
Territory.

 

5.3           Commercialization Diligence.

 

TG shall use Commercially Reasonable Efforts during the Term to Commercialize
Products for all approved Indications in the Field and in the Territory. Without
limiting the foregoing, (a) commencing no later than ninety (90) days prior to
the estimated date of First Commercial Sale of the Product, TG shall conduct
pre-marketing activities in the Territory with respect to the Product and (b)
following receipt of Marketing Authorization with respect to the Product in the
Territory, TG shall initiate and conduct such promotional activities determined
by TG as may be required to develop a commercial market for, launch and
Commercialize the Product (including through direct conduct with key opinion
leaders) in the Territory. Without limiting the foregoing, TG’s efforts
described in this Section 5.3 shall comply with the diligence obligations set
forth in the Hadam License Agreement. In addition, TG, shall establish and
maintain a well trained sales force for the Product,( together with a
well-trained support staff) adequate to service all the customers of TG and to
keep the sales force knowledgeable and fully informed as to the Product;
maintain an effective distribution system for the Product in the Territory;
transport and store the Product to preserve its quality in accordance with
pre-determined QA requirements; obtain and maintain all licenses, approvals and
permits in the Territory necessary for TG to perform its obligations under this
Agreement; establish and maintain suitable systems and records to enable a
recall of Product in a timely, efficient and accurate manner and otherwise in
accordance with applicable laws and regulations in the Territory; abide by all
applicable rules and regulations relating to sales, marketing and reimbursement;
ensure that no Product shipped by TG is adulterated or misbranded; maintain
adequate control over the physical security of the Product; Cause all
Affiliates, sublicensees and subcontractors of TG to comply with the above.

 

5.4           Failure to Satisfy Commercialization Diligence Obligations.

 

LICENSOR shall have the right, in its sole discretion, to provide TG with
written notice if it reasonably believes TG has failed to satisfy its
Commercialization diligence obligations under this Agreement (a “TG Diligence
Failure”). Such written notice (a “Diligence Failure Notice”) shall set forth in
reasonable detail the nature of the alleged failure and shall request written
justification, in the form of detailed reasons that would support the
proposition that TG has satisfied such diligence obligations. TG shall provide
such written justification to LICENSOR within thirty (30) days after receipt of
such Diligence Failure Notice and shall identify any Commercially Reasonable
Justifications (as defined below) applicable thereto. If TG fails to provide
LICENSOR with a Commercially Reasonable Justification within such thirty (30)
day period TG shall have an additional (90) day period to cure such failure.
During that period a penalty equal to the * shall accrue on a monthly basis, to
the benefit of LICENSOR. Should TG’s failure continue within this additional
period, TG shall continue to pay the penalty abovementioned and LICENSOR
reserves the right in its discretion to, in addition to all damages caused in
relation thereof, convert the licenses and rights granted under any or all of
Section 2.1 from exclusive licenses to non-exclusive licenses only as such
licenses and rights apply to such Product. Should TG’s failure continue within
an additional hundred eighty (180) day period, TG shall continue to pay the
penalty abovementioned and LICENSOR reserves the right in its discretion to, in
addition to any other remedies it may have all damages caused in relation
thereof, terminate any or all of the licenses and rights granted under Section
2.1 hereof with respect to the Product that is the subject of the Diligence
Failure Notice termination or conversion, as the case may be, shall be at the
discretion of LICENSOR and be effective immediately upon issuance by LICENSOR of
written notice to TG specifying the remedy that LICENSOR is electing to exercise
under this Section 5.4.

 

 

*Confidential material redacted and filed separately with the Commission.

 

27

 

 

For purposes of this Section 5.4, “Commercially Reasonable Justification” means
the existence or occurrence of one or more of the following events or
justifications: (i) the occurrence of an event of Force Majeure; (ii) the
adoption by a Regulatory Authority of any one or more regulations that become
effective after the Effective Date and that materially affect the Development or
clinical testing of the Product or the process for obtaining any Regulatory
Approval for the Product; and (iii) the occurrence of any event, condition or
circumstance (including an event, condition or circumstance related to the
manufacture or supply of the Product (or any material component thereof) for
clinical studies or a regulatory action by any Regulatory Authority) with
respect to the Product (or any material component thereof) that (A) involves the
safety, toxicity, efficacy or pharmacokinetics of the Product or (B) prevents
the use of the Product in humans (including, without limitation, as a result of
patent or other blocking rights) and, in the case of clauses (A) or (B) above,
is not attributable to (1) a breach by TG of any obligation under this
Agreement, (2) the failure of TG to comply with any protocol, development plan
or Applicable Laws with respect to the development of the Product, or (3) any
grossly negligent or willful act or omission of TG; or (C) that the TG Diligence
Failure is caused by TG’s failure to take actions that would be in excess of
Commercially Reasonable Efforts; provided, that, in any such case, TG shall use
Commercially Reasonable Efforts to mitigate the effect and duration of any such
acceptable delay with respect to the Product that is the subject of the
Diligence Failure Notice.

 

5.5           Failure to achieve Sales Targets

 

5.5.1           Initial Period. For the * following the date of First Commercial
Sale (the "Initial Period") TG shall achieve the Sales Target. If TG fails to
achieve * percent (*%) of the Sales Target by completion of the Initial Period,
TG shall, within * (*)*, pay to LICENSORS a sum equal to *. For purposes of this
Agreement, “Commercial Years” means the period commencing on the date of First
Commercial Sale of a Product and ending on the anniversary thereof and
thereafter each successive period of twelve (12) months.

 

5.5.2           Subsequent Periods. For Commercial Years subsequent to the
Initial Period TG shall achieve the Sales Target. If TG fails to achieve *
percent (*%) of the Sales Target for any Commercial Year subject to the Initial
Period, TG shall, within * (*)* pay to LICENSOR a sum equal to *.

 

 

*Confidential material redacted and filed separately with the Commission.

 

28

 

 

In addition to the above, if TG fails to achieve * (*%) of the Sales Target for
* (*) * Commercial Years, LICENSOR shall have the right to terminate this
Agreement with respect to countries within the Territory *. In the case where
LICENSOR exercises its rights to terminate this Agreement, LICENSOR shall
provide six (6) months prior notice of termination and purchase back any Product
stock held by TG valued at the commercial price. If during the above mentioned 6
month period, TG achieves * for such six-month period, then TG shall be deemed
to have cured the breach and the termination shall be null and void.

 

5.6           Compliance.

 

TG shall use its Commercially Reasonable Efforts to Commercialize the Products
in compliance in all material respects with all Applicable Laws.

 

5.7            No Unauthorized Sales.

 

TG shall not, and shall not permit its Affiliates and not permit Sublicensees or
Distributors to, distribute, market, promote, offer for sale or sell the Product
to any Third Party in any country that TG, or its Affiliates, Sublicensees or
Distributors, as applicable, reasonably believes is reasonably likely to engage
in an unauthorized distribution, marketing, promotion, or sale of the Product
outside the country of purchase.

 

5.8           Records; Reports.

 

TG shall (a) maintain records of its Commercialization activities under this
Article 5 in sufficient detail, which shall fully and properly reflect all work
done and results achieved in the Commercialization of Products and (b) following
the commencement of Commercialization of the Products provide LICENSOR with
annual written reports (each, a “Commercialization Report”) which shall (i)
summarize TG’s efforts to Commercialize Products, (ii) identify the Regulatory
Filings and Drug Approval Applications with respect to such Product that TG or
any of its Affiliates or Sublicensees have filed, sought or obtained in the
prior twelve (12) month period or reasonably expect to make, seek or attempt to
obtain in the following twelve (12) month period and (iii) summarize all
Clinical Data generated by TG with respect to Products. Commencing no later than
ninety (90) days from the date of receipt by TG of the first Marketing
Authorization for each Product and on each anniversary thereof until the
expiration of the Royalty Term applicable to such Product, each such
Commercialization Report shall also include (i) an outline of the key sales and
marketing activities that TG reasonably expects to conduct with respect to
Product in the Territory, (ii) a non-binding estimate of projected sales of
Product in the Territory for the subsequent three (3) Calendar Year period and
(iii) such additional information that it has in its possession as may be
reasonably requested by LICENSOR regarding the Commercialization of any Product,
which request shall not be made more than once each Calendar Year. The
Commercialization Plan and Commercialization Report can be provided as one
document.

 

5.9           Supply of Product for Commercialization.

 

LICENSOR’s and TG’s rights and responsibilities pertaining the supply of the
Compound for the Commercialization shall be governed by Section 6 below.

 

 

*Confidential material redacted and filed separately with the Commission.

 

29

 

 

5.10         Product Recalls.

 

In the event that any Regulatory Authority issues or requests a recall or takes
similar action in connection with a Product in the Territory, or in the event TG
reasonably believes that an event, incident or circumstance has occurred that
may result in the need for a recall, market withdrawal or other corrective
action regarding a Product in the Territory (each, a “Recall”), TG shall
promptly advise LICENSOR thereof by e-mail, telephone or facsimile. Following
such notification, TG shall have the sole right to decide, and have control of,
whether to conduct a recall or market withdrawal (except in the event of a
recall or market withdrawal mandated by a Regulatory Authority, in which case it
shall be required) or to take other corrective action in the Territory and the
manner in which any such recall, market withdrawal or corrective action shall be
conducted; provided, that, TG shall keep LICENSOR reasonably informed regarding
any such Recall. All expenses incurred by TG in connection with any such Recall
(including, without limitation, expenses for notification, destruction and
return of the affected Product and any refund to customers of amounts paid for
such Product) shall be the sole responsibility of TG.

 

5.11         Grant of Commercialization Option to LICENSOR.

 

5.11.1    Exercise of Commercialization Option.

 

(a)          Notice of Anticipated Regulatory Approval. TG shall give LICENSOR
written notice at least one hundred twenty (120) days prior to the anticipated
date of receipt of Marketing Authorization for a Product for the first
Indication by the EMA or the applicable Regulatory Authority in the LICENSOR
Commercialization Territory (the “Anticipated Approval Notice”).

 

(b)          Exercise of Commercialization Option. Commencing on the date of
receipt by LICENSOR of the Anticipated Approval Notice and continuing for a
period of ninety (90) days (such period, the “Product Candidate Option Period”),
LICENSOR shall have the exclusive option (the “LICENSOR Commercialization
Option”), in its sole discretion, to have the exclusive right to Commercialize
any Product in the LICENSOR Commercialization Territory by providing written
notice to TG, which notice shall identify the Product (each, such Product, a
“LICENSOR Commercialized Product”). If LICENSOR exercises the Commercialization
Option with respect to any Product:

 

(i)          the Parties shall, within ninety (90) days of the date of such
exercise, negotiate and execute a Commercialization and License Agreement for
such LICENSOR Commercialized Product which Commercialization Agreement shall, to
the extent possible, be in substantially the same form as this Agreement;

 

(ii)         the license granted to TG pursuant to Section 2.1.1 shall be deemed
to have been amended such that LICENSOR shall retain the exclusive right under
the Licensed Technology and/or Licensed Patent Rights, including the right to
grant sublicenses to its Affiliates, to Commercialize, use, have used,
Manufacture, have Manufactured, supply, sell, offer to sell, import, have
imported, market, and otherwise Commercialize the LICENSOR Commercialized
Product in the Field and in the Commercialization Territory;

 

30

 

 

(iii)        the definition of Territory for purposes of this Agreement shall be
deemed to have been amended to specifically exclude the countries within the
LICENSOR Commercialization Territory; and

 

(iv)        TG shall be deemed to have automatically granted to LICENSOR an
exclusive (including with respect to TG and its Affiliates), mirror
royalty-bearing license or sublicense with respect to TG Materials, TG
Confidential Information, and all Technology Patent Rights Controlled by TG
(including the right to grant sublicenses under the such Technology and Patent
Rights) to Commercialize, use, have used, supply, sell, offer to sell, import,
have imported, market, and otherwise Commercialize the LICENSOR Commercialized
Product in the Field and in the LICENSOR Commercialization Territory. For the
avoidance of doubt, the Royalty rate due by LICENSOR to TG shall be equal to the
amount due by TG to LICENSORS on sales recorded in France and Belgium.

 

(c)        Cooperation; Failure to Reach Agreement. In connection with
LICENSOR’S consideration of the exercise of a LICENSOR’s Commercialization
Option with respect to each Product, TG shall provide LICENSOR with any
information Controlled by TG and reasonably requested by LICENSOR that is
necessary or useful to LICENSOR in determining whether to exercise such LICENSOR
Commercialization Option.

 

6.          SUPPLY OF THE COMPOUND

 

6.1           Supply of LFB-R603 for Development and Commercialization.

 

(a)          Where the cell culture Manufacturing capacity requested for
Manufacturing and supply of LFB R603 for Clinical Trials is less than or equal
to 1 000 liter per batch, LICENSOR shall have the exclusive right and
responsibility to provide, directly or indirectly, Manufacturing services to TG
and Manufacture supply of LFB-R603 as required for the Development and
Commercialization of LFB-R603 . In this case, LICENSOR will be responsible for
all aspects of Manufacturing and facilities and TG shall be responsible for
Process Development (alone or with LICENSOR through the Development Services and
Manufacturing Agreement).

 

LICENSOR shall use its Commercially Reasonable Effort to provide Manufacturing
services to TG and Manufacture supply of LFB-R603 as required for the
Development and Commercialization of LFB-R603 when and as required by TG and
shall take such actions as shall be reasonably required to provide TG with
supplies of LFB R603 for analytical development, non-clinical toxicology,
pre-clinical activities and clinical activities. * and shall be pursuant to the
Development Services and Manufacturing Agreement.

 

31

 

 

LICENSOR shall provide a preliminary pharmaceutical development plan including
major milestones and provisional budget within sixty (60) days following the
execution of the agreement, and a detailed pharmaceutical development plan,
which shall be an appendix of the Development Services and Manufacturing
Agreement, within six (6) months following the execution of this Agreement.

 

(b)          Where the cell culture Manufacturing capacity requested for
Manufacturing and supply of LFB R603 for Clinical Trials is higher than *,
LICENSOR shall no longer have the exclusive right and responsibility to
Manufacture directly or indirectly LFB R603 for Clinical and Commercialization
under. In this case, if LICENSOR is not appointed by TG for Manufacturing and
supply of LFB R603, TG shall pay to LICENSOR the extra-royalty under section
7.3.4

 

For the sake of clarity, if LICENSOR provides, directly or indirectly, the
supply of LFB R603 for Pivotal Clinical Trials, LICENSOR or its Affiliates shall
have the exclusive right and responsibility to provide Manufacturing services to
TG and Manufacture and supply LFB R603 as required for the Commercialization in
the Territory. In such case the extra-royalty under Section 7.3.4 shall not
apply

 

6.2           Supply of TG20 for Development and Commercialization.

 

LICENSOR and/ or its Affiliates shall have the exclusive right and
responsibility to provide Manufacturing services to TG and Manufacture supply of
TG20. LICENSOR shall provide a preliminary pharmaceutical development plan
including major milestones and provisional budget within sixty (60) days
following the execution of the agreement, and a detailed pharmaceutical
development plan, which shall be an appendix of the Development Services and
Manufacturing Agreement, within six (6) months following the execution of this
Agreement. LICENSOR will be responsible for all aspects of manufacturing and
facilities, including any additional capacity required at its own expense and TG
shall be responsible for Process Development (alone or with LICENSOR through the
Development Services and Manufacturing Agreement). Since LICENSOR and/or its
Affiliates shall be a sole supplier of TG20 for the foreseeable future, LICENSOR
shall use its Commercially Reasonable effort to provide Manufacturing services
to TG and Manufacture supply of TG20 as required for the Development and
Commercialization of TG 20 when and as required by TG and shall take such
actions as shall be reasonably required to provide TG with supplies of TG20 for
analytical development, non-clinical toxicology, pre-clinical activities and
clinical activities. All supplies of Compound and Product for Clinical Trials
supplied by LICENSOR shall be billed to TG at *.

 

 

*Confidential material redacted and filed separately with the Commission.

 

32

 

 

Prior to commencing Phase 3 Clinical Trials, parties will enter into a
Commercial Supply Agreement, which shall be attached in Exhibit B as soon as it
is executed by the Parties and which shall include such customary terms of such
agreements and shall include the payment by TG to LICENSOR * percent (*%). As
part of such commercial supply agreement, LICENSOR and TG shall establish the
Joint Pharmaceutical, development and manufacturing Committee to serve as a
forum for information, coordination communication and forecasting of supply
needs between the Parties with respect to the Manufacturing of the Products by
the LICENSORS and Commercialization by TG of the Compound and/or Products in the
Territory

 

6.3           Contractual conditions for Process Development Services and supply
of Compounds for Development.

 

For each Product, Process Development Services and Supply of Compounds for
Development shall be performed in accordance with the terms set forth in the
Development Services and Manufacturing Agreement.

 

7.          PAYMENTS

 

7.1           Issuance of Equity.

 

In consideration for the rights granted to TG hereunder, TG hereby agrees to
issue to LICENSOR, on the date hereof, the shares listed on Schedule8., on the
terms and subject to the conditions set forth in the stock purchase agreement
attached hereto as Exhibit C (the “Stock Purchase Agreement”). Such Stock
Purchase Agreement contains a right of LICENSOR to appoint one (1) member to the
Board of Directors of TG.

 

7.2           Milestone Payments.

 

7.2.1           Development and Regulatory Milestones. TG shall make the
following non-refundable, non-creditable payments to LICENSOR upon the
occurrence of each of the following milestone events for the first Product that
achieves the corresponding milestone event (unless otherwise provided below):

 

   Milestone Event   Milestone
Payment  1.  Completion of the first Phase 3 Clinical Trial for a Product   $* 
2.  the earliest of the completion of the first Pivotal Clinical Trial and/or of
the  second Phase 3 Clinical Trial for a Product   $*  3.  Acceptance of the
first Drug Approval Application for a Product by the FDA   $*  4.  Receipt of
the first Marketing Authorization for a Product by the FDA   $*  5.  Acceptance
of the first Drug Approval Application for a Product by the EMA or the
applicable Regulatory Authorities in any Major Market Country   $*  6.  Receipt
of the first Marketing Authorization for a Product by the EMA or the applicable
Regulatory Authorities in any Major Market Country   $*             

 

 

*Confidential material redacted and filed separately with the Commission.

 

33

 

 

 

7.2.2      Notice and Payment of Milestones.

 

(a)          Notice of Milestone Events. TG shall provide LICENSOR with prompt
written notice upon the occurrence of each milestone event set forth in Section
7.2.1. In the event that, notwithstanding the fact that TG has not given such a
notice, LICENSOR believes any such milestone event has occurred, it shall so
notify TG in writing and shall provide to TG data, documentation or other
information that supports its belief.  Any dispute under this Section 7.2.2(a)
that relates to whether or not a milestone event has occurred shall be resolved
in accordance with Section 14.1.

 

(b)          Single Milestone Payments. TG shall make a milestone payment
corresponding to each of the foregoing milestone events only once under Section
7.2.1, regardless of (i) the number of Products that achieve such milestone
event and (ii) the number of times such milestone event occurs with respect to a
Product. For the sake of clarity, each milestone event shall only trigger one
milestone payment.

 

7.3           Payment of Royalties; Royalty Rates; Sublicense Royalties;
Accounting and Records.

 

7.3.1      Payment of Royalties. Subject to the remainder of this Section 7.3,
TG shall pay LICENSOR a non-refundable, non-creditable royalty at royalty rate
equal to * percent (*%) of the Annual Net Sales of each Product in each Calendar
Year (or partial Calendar Year) commencing with the First Commercial Sale of
such Product in any country in the Territory and ending upon the last day of the
last Royalty Term for such Product in such country. For purposes of clarity,
Annual Net Sales shall be determined separately for each separate Product that
is sold in a given Calendar Year.

 

7.3.2      Sublicense Royalties. Notwithstanding the foregoing, if TG
sublicenses any of the Products in any country of the Territory, then in such
Territory for such Product, the TG shall pay to LICENSOR Sublicense Royalties in
lieu of the royalties set forth above.

 

 

*Confidential material redacted and filed separately with the Commission.

 

34

 

 

7.3.3       Adjustments to Royalties for Generic Products. In the event that a
Third Party sells a Generic Product (as defined below) in a country in which a
Product is then being sold and such Generic Product is not covered by a Valid
Claim under the Licensed Patent Rights or TG Program Patent Rights in such
country, then during the period in which sales of the Generic Product by such
Third Party are equal to at least * percent (*%) of TG’s volume-based market
share of the Product in such country (as measured by prescriptions or other
similar information available in such country), the royalty rate applicable to
Net Sales of the Product in such country shall be reduced to * percent (*%). 
Notwithstanding the foregoing, TG’s right to reduce its royalty obligation under
this Section 7.3.3(1) shall expire on the first day of the Calendar Quarter
immediately following the Calendar Quarter in which sales of such Generic
Product account for less than * percent (*%) of TG’s volume-based market share
of the Product in such country (as measured by prescriptions or other similar
information available in such country). For purposes of this Section 7.3.3), a
“Generic Product” means a biosimilar product with the same amino acid sequence
as the Compound.

 

7.3.4       Adjustment to Royalties and to Sublicense Royalties for loss of
Manufacturing under section 6.2

 

In the event that LICENSOR loses its exclusive right of Manufacturing under
section 6.2 (b), TG shall pay to LICENSOR an additional royalty of: * percent
(*%) of Net Sales, *.

 

7.3.5       Payment Dates and Reports.

 

(a)          Royalty Payments. Royalty payments shall be made by TG with respect
to each Product within thirty (30) days after the end of each Calendar Quarter
in which sales of such Product occur, commencing with the Calendar Quarter in
which the First Commercial Sale of such Product occurs. TG shall also provide,
at the same time each such payment is made, a report showing: (a) the Net Sales
of each Product by type of Product and country in the Territory and, if
applicable, by Combination Product; (b) the total amount of deductions from
gross sales to determine Net Sales; (c) the applicable royalty rate for Product
in each country in the Territory after applying any reductions set forth above;
and (d) a calculation of the amount of royalty due to LICENSOR.

 

(b)          Sublicensee Royalty. Sublicense Income Payments shall be made by TG
to LICENSOR with respect to all Sublicense Income, within thirty (30) days of
the end of each Calendar Quarter in which such Sublicense Income is received by
TG. TG shall also provide, at the same time each such Sublicense Income is made,
a report showing: (a) a detailed accounting of all Sublicense Income received
during the applicable Calendar Quarter; (a) the Net Sales of each Product by
type of Product and country in each country covered by the Sublicense Agreement;
(b) the total amount of deductions from gross sales to determine Net Sales; (c)
the amount of the royalty payment that would be payable in such country based
upon a royalty rate of * percent (*%); and (d) a calculation of the aggregate *
payable to LICENSOR in U.S. Dollars. If no amounts are due to LICENSOR for a
particular Calendar Quarter, the report shall so state.

 

(c)          Royalties on Licensed Trademarks. The above mentioned Royalty
payments and Sublicense Royalties percentages includes a * percent (*%) royalty
in consideration of the grant of the license to the Licensed Trademarks.

 

 

*Confidential material redacted and filed separately with the Commission.

 

35

 

 

(d)          Payment in Common Stock. In the event that on the date on which TG
owes a milestone payment to LICENSOR pursuant to Section 7.2.1, above, TG is
publicly traded on a stock exchange then, subject to LICENSOR’s prior approval
not to be unreasonably withheld, such milestone payment may be made through the
issuance of that number of shares of Common Stock of TG as shall equal the
amount of the milestone payment due and payable divided by the Average Closing
Price. For purposes of this Section 7.3.5(c), the “Average Closing Price” means
the average of the closing prices of TG Common Stock on The NASDAQ Global Market
(or, if Common Stock of TG is not listed on the NASDAQ Global Market, the
principal exchange or interdealer quotation system on which the TG Common Stock
is listed) for the thirty (30) trading days prior to the public announcement of
the occurrence of the milestone event with respect to which the milestone
payment is being made, pursuant to the terms, and subject to the conditions, set
forth in the Stock Purchase Agreement.

 

7.3.6       Records; Audit Rights. TG and its Affiliates, Sublicensees and
Distributors shall keep and maintain for three (3) years from the date of each
payment of royalties and/or Sublicense Royalties hereunder complete and accurate
records of gross sales and Net Sales by TG and its Affiliates, Sublicensees and
Distributors of each Product, in sufficient detail to allow royalties and/or
Sublicense Royalties to be accurately determined. LICENSOR shall have the right
for a period of three (3) years after receiving any such royalty payment to
appoint at its expense an independent certified public accountant reasonably
acceptable to TG to audit the relevant records of TG and its Affiliates,
Sublicensees and Distributors to verify that the amount of each such payment was
correctly determined; provided, that, (a) if requested by TG, LICENSOR shall
cause the independent certified public accountant to enter into a
confidentiality agreement reasonably acceptable to TG and (b) such independent
certified public accountant may only disclose to LICENSOR whether the royalties
and/or Sublicense Royalties paid are correct and the details with respect to any
discrepancies. TG and its Affiliates, Sublicensees and Distributors shall each
make its records available for audit by such independent certified public
accountant during regular business hours at such place or places where such
records are customarily kept, upon thirty (30) days written notice from
LICENSOR. Such audit right shall not be exercised by LICENSOR more than once in
any Calendar Year or more than once with respect to sales of a particular
Product in a particular period. All records made available for audit shall be
deemed to be Confidential Information of TG. The results of each audit, if any,
shall be binding on both Parties absent manifest error. In the event there was
an underpayment of royalties by TG hereunder, TG shall promptly (but in any
event no later than thirty (30) days after TG’s receipt of the report so
concluding) make payment to LICENSOR of any shortfall. LICENSOR shall bear the
full cost of such audit unless such audit discloses an underpayment by TG of
five percent (5%) or more of the aggregate amount of royalties and/or Sublicense
Royalties payable in any Calendar Year, in which case TG shall reimburse
LICENSOR for all costs incurred by LICENSOR in connection with such audit.

 

7.3.7       Overdue Payments. All royalty payments not made within the time
period set forth in Section 7.3.5, and all milestone payments not made within
the time period specified in Section 7.2.1, shall bear interest at the rate of *
percent (*%) * until paid in full or, if less, the maximum interest rate
permitted by Applicable Laws. Any such overdue royalty or milestone payment
shall, when made, be accompanied by, and credited first to, all interest so
accrued.

 

 

*Confidential material redacted and filed separately with the Commission.

 

36

 

 

7.3.8       Payments; Withholding Tax; Currency Restrictions.

 

(a)          Payments in United States Dollars. Except as set forth in Section
6.3.7(b) below, all payments made by TG under this Article 6 shall be made by
wire transfer in United States Dollars in accordance with wire transfer
instructions provided to TG in writing from time to time by LICENSOR. If in any
Calendar Quarter, Net Sales are made in any currency other than United States
Dollars, such Net Sales shall be converted into United States Dollars as
follows:

 

(A/B), where

 

A = foreign “Net Sales” (as defined above) in such Calendar Quarter expressed in
such foreign currency; and

 

B = foreign exchange conversion rate, expressed in local currency of the foreign
country per United States Dollar (using, as the applicable foreign exchange
rate, the spot purchase rate published in the Financial Times on the last
Business Day of each Calendar Quarter in which any payment is due and payable or
any other mutually agreed upon source, for such Calendar Quarter).

 

(b)          Tax Withholding. If Applicable Laws require withholding of income
or other taxes imposed upon any payments made by TG to LICENSOR under this
Agreement, TG shall (i) make such withholding payments as may be required, (ii)
subtract such withholding payments from such payments to be made to LICENSOR,
(iii) submit appropriate proof of payment of the withholding taxes to LICENSOR
within a reasonable period of time, and (iv) promptly provide LICENSOR with all
official receipts with respect thereto.

 

(c)          Currency Restrictions. If any restrictions on the transfer of
currency exist in any country in which Products are sold that prevent TG from
making royalty payments thereon in United States Dollars, TG shall make royalty
payments on the sales in such country in the local currency by deposit in a
local bank or other depository designated in writing by LICENSOR (or, in the
absence of such designation, at a local bank or other depository selected by TG
and identified by TG by written notice to LICENSOR).

 

8.          TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY

 

8.1         Confidentiality.

 

8.1.1           Confidentiality Obligations. LICENSOR and TG each recognize that
the other Party’s Confidential Information and Proprietary Materials constitute
highly valuable assets of such other Party. LICENSOR and TG each agrees that,
(a) subject to Section 8.1.2, during the Term and for an additional ten (10)
years after termination or expiration of this Agreement it will not disclose,
and will cause its Affiliates, Sublicensees (with respect to TG) and
Distributors or Sublicensees (with respect to LICENSOR) not to disclose whether
directly or indirectly, in any manner whatsoever, any Confidential Information
or Proprietary Materials of the other Party and (b) it will not use, and will
cause its Affiliates, Sublicensees (with respect to TG) and Distributors or
Sublicensees (with respect to LICENSOR) not to use, any Confidential Information
or Proprietary Materials of the other Party, without the prior written consent
of the Disclosing Party, except as expressly permitted hereunder.

 

37

 

 

8.1.2           Limited Disclosure. LICENSOR and TG each agrees that disclosure
of its Confidential Information or any transfer of its Proprietary Materials may
be made by the other Party on a need-to-know basis to any employee, consultant
or Affiliate of such other Party or, to the extent the other Party is TG, to any
Third Party subcontractor engaged by TG pursuant to Section 2.2, in each case
solely to the extent reasonably necessary to enable such other Party to exercise
its rights or to carry out its responsibilities under this Agreement; provided,
that, any such disclosure or transfer shall only be made to Persons who are
bound by written obligations comparable in scope to the obligations described in
Section 8.1.3. LICENSOR and TG each further agrees that the other Party may
disclose its Confidential Information (a) on a need-to-know basis to such other
Party’s legal and financial advisors, (b) as reasonably necessary in connection
with an actual or potential (i) permitted sublicense of such Party’s rights
hereunder, (ii) debt or equity financing of such other Party or (iii)
acquisition, consolidation, share exchange or other similar transaction
involving such Party and any Third Party, (c) to the extent the other Party is
TG, to any Third Party that is or may be engaged by TG to perform services in
connection with the Commercialization of Products as necessary to enable such
Third Party to perform such services, (d) as reasonably necessary to make
Regulatory Filings with respect to Products under this Agreement or to respond
to any inquiry made by any Regulatory Authority with respect to Products and to
prosecute or maintain Patent Rights, or to file, prosecute or defend litigation
related to Patent Rights, in accordance with this Agreement; (e) as required by
Applicable Laws (which shall be determined by the Disclosing Party in its
reasonable discretion); provided, that, in the case of any disclosure under this
clause (e), the Disclosing Party shall (i) if practicable, provide the other
Party with reasonable advance notice of and an opportunity to comment on any
such required disclosure and (ii) if requested by the other Party, cooperate in
all reasonable respects with the other Party’s efforts to obtain confidential
treatment or a protective order with respect to any such disclosure, at the
other Party’s expense.

 

8.1.3           Employees and Consultants. LICENSOR and TG each hereby covenants
and agrees that all of its employees and consultants, and all of the employees
and consultants of its Affiliates, who have access to Confidential Information
or Proprietary Materials of the other Party will, prior to having such access,
be bound by written obligations to maintain such Confidential Information or
Proprietary Materials in confidence that are no less stringent than those
confidentiality and non-use provisions contained in this Agreement. Each Party
agrees to use, and to cause its Affiliates to use, reasonable efforts to enforce
such obligations and to prohibit its employees and consultants from using such
information except as expressly permitted hereunder. Each Party will be liable
to the other Party for any disclosure or misuse by its employees of Confidential
Information or Proprietary Materials of the other Party.

 

38

 

 

8.2           Publicity.

 

Notwithstanding anything to the contrary in Section 8.1, the Parties, upon the
execution of this Agreement, shall jointly issue a press release with respect to
this Agreement to be reasonably agreed by the Parties in substantially the form
attached hereto as Schedule 6, and either Party may make subsequent public
disclosure of the contents of such press release without further approval of the
other Party. Subject to the foregoing, except as required by Applicable Laws
(including those relating to disclosure of material information to investors),
neither Party shall issue a press or news release or make any similar public
announcement (it being understood that publication in scientific journals,
presentation at scientific conferences and meetings and the like are intended to
be covered by Section 8.4 and not subject to this Section 8.2) related to the
terms or existence of this Agreement or the conduct of the Development Program
or the Commercialization of Products without the prior written consent of the
other Party; provided, however, that either Party may make such a disclosure (a)
to the extent required by Applicable Laws (including the requirements of any
nationally recognized securities exchange, quotation system or over-the-counter
market on which such Party has its securities listed or traded), or (b) to any
investors, prospective investors, lenders and other potential financing sources
who are obligated to keep such information confidential. In the event that such
disclosure is required as aforesaid, the disclosing Party shall make reasonable
efforts to provide the other Party with notice beforehand and to coordinate with
the other Party with respect to the wording and timing of any such disclosure.
Once any press release or any other written statement is approved for disclosure
by both Parties, either Party may make subsequent public disclosure of the
contents of such statement without the further approval of the other Party.

 

8.3           No Use of Name.

Neither Party shall use the name of the other Party in any Promotional Materials
or advertising without the prior express written permission of the other Party.

 

8.4           Publications and Presentations.

Following the date hereof, LICENSOR shall not publish or present any results
(the “Results”) of the Development Program, without the prior written consent of
TG, such consent not to be unreasonably withheld.

 

9.          INTELLECTUAL PROPERTY RIGHTS

 

9.1           LICENSOR Intellectual Property Rights.

LICENSOR shall have ownership of all right, title and interest, or license to,
on a worldwide basis in and to any and all Licensed Technology and Licensed
Patent Rights.

 

9.2           Improvement

 

9.2.1TG agrees to notify LICENSOR of each Product Improvement TG, its Affiliates
or its Sublicensees has developed, conceived or acquired during the Term of this
Agreement. TG shall, upon request of LICENSOR, provide to LICENSOR all data and
specifications concerning such Product Improvement. All Product Improvements
shall be deemed to be considered as a “Joint Improvement”.

 

39

 

 

9.2.2All LICENSOR Improvement shall be the exclusive and sole property of
LICENSOR and shall become Background Patent Right or Licensed Patent Rights, as
the case may be.

 

9.3           Joint Improvement

 

9.3.1Subject to any other provision to the contrary that may be contained in
LICENSOR’s Licenses as defined in Section 2.1.1, any Joint Improvement shall be
jointly owned by TG and LICENSOR.

 

9.3.2TG shall have the exclusive, fully paid-up, irrevocable, transferable right
to Use such Joint Improvements in order to Develop the Compounds or Products as
part of the Development Program and to Commercialize, use, have used,
Manufacture, have Manufactured, supply, sell, offer to sell, import, have
imported, market, and otherwise Commercialize Products in the Field, within the
Territory with the right to sublicense .

 

9.3.3Each Party have the exclusive, fully paid-up, irrevocable, transferable
right to Use such Joint Improvements in order to develop and to commercialize
have used, Manufacture, have Manufactured, supply, sell, offer to sell, import,
have imported, market, any product other than the Product and Compound.

 

9.3.4Each Party shall reasonably assist the other in preparing, prosecuting and
maintaining Patent Rights for Joint Improvements pursuant to section 9.4; 9.5
and 10.

  

9.4           Patent Coordinators.

 

Each Party shall, by written notice to the other Party, appoint a patent
coordinator reasonably acceptable to the other Party (each, a “Patent
Coordinator”) to serve as such Party’s primary liaison with the other Party on
matters relating to the filing, prosecution, maintenance and enforcement of
Patent Rights. Each Party may replace its Patent Coordinator at any time by
notice in writing to the other Party. The initial Patent Coordinators shall be:

 

For LICENSOR: Nicolas MARRO     For TG: Lauren Friedberg

  

40

 

 

9.5           Notice; Inventorship.

 

The Parties hereby agrees to promptly notify to the other Party, through the
Patent Coordinators, of the conception or reduction to practice of any Program
Technology or Joint-Improvement and to promptly execute any documents that may
be necessary to perfect LICENSOR’s rights in and to such Program Technology or
Joint-Improvement. The Patent Coordinators shall determine inventorship of
Program Technology or Joint-Improvement under U.S. patent law. In case of a
dispute between the Patent Coordinators over inventorship and, as a result,
whether any particular Technology is LICENSOR Technology or Joint Improvement,,
such dispute shall be resolved according to U.S. patent law by patent counsel
selected by the Patent Coordinators who (and whose firm) is not at the time of
the dispute, and was not at any time during the five (5) years prior to such
dispute, performing services for either of the Parties. Expenses of such patent
counsel shall be shared equally by the Parties.

 

10.         FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

 

10.1         Patent Filing, Prosecution and Maintenance.

 

10.1.1           LICENSOR Prosecution Rights. LICENSOR shall have the sole right
and responsibility to prepare and file applications with respect to, and
prosecute and maintain, at its sole cost, expense and discretion, and using
patent counsel or agents of its choice, all Licensed Patent Rights (including
all Joint Patent Rights that are Licensed Patent Rights) throughout the
Territory. TG shall cooperate with and assist LICENSOR in all reasonable
respects, in connection with LICENSOR’s preparation, filing, prosecution and
maintenance of Licensed Patent Rights.

 

10.1.2            TG Prosecution Rights. TG shall have the sole right and
responsibility to prepare and file applications with respect to, and prosecute
and maintain, at its sole cost, expense and discretion, and using patent counsel
or agents of its choice, all TG Program Patent Rights throughout the Territory.
LICENSOR shall cooperate with and assist TG in all reasonable respects, in
connection with TG’s preparation, filing, prosecution and maintenance of TG
Program Patent Rights.

 

10.1.3           Joint Patent Rights. Subject to Section 10.1.1, within ten (10)
Business Days after it is determined pursuant to Section 9.5 that any particular
Program Technology is Joint Improvement, the Parties will determine which Party
will undertake the prosecution of such Joint Patent Rights based on the
respective expertise of the Parties and the rights of the Parties under this
Agreement. If the Parties fail to agree within such ten (10) Business Day
period, then prosecution of such Patent Rights shall be jointly controlled by
the Parties, using patent counsel agreed upon by the Patent Coordinators. All
patent costs and expenses incurred by a Party or jointly by the Parties in
connection with the preparation, filing, prosecution and maintenance of Joint
Patent Rights in the Territory that cover any Product for use in the Field shall
be shared equally by the Parties. Provided however that, if a Party refuses,
declines or fails to assume its obligations under this section 11.1.2, it shall
advise the other Party and said other Party shall have the right, at its own
expense, to prepare, prosecute and maintain Patent Rights for Joint
Improvements. In such a case, upon request of the non-defaulting Party, the
Party that refuses, declines or fails to file, prosecute or maintain any such
Patent Rights for Joint Improvements shall assign all its co-ownership rights to
the other Party.

 

41

 

 

10.1.4    Information and Cooperation. The Parties hereby agree to cooperate
with each other in connection with the filing, prosecution and maintenance of
Patent Rights under this Agreement, including through the prompt execution and
delivery of documents and instruments as may reasonably be required in
connection therewith. Without limiting the foregoing, each Party responsible for
the filing, prosecution and/or maintenance of Patent Rights under Sections
10.1.1 and/or 10.1.2 above (a “Filing Party”) shall (a) promptly provide the
other Party with copies of all patent applications filed hereunder and other
material submissions and correspondence with applicable patent offices, in
sufficient time to allow for review and comment by the other Party; (b) provide
the other Party and its patent counsel with an opportunity to consult with the
Party and its patent counsel regarding the filing and contents of any such
application, amendment, submission or response; and (c) take into consideration
in good faith the advice and suggestions of the other Party and its patent
counsel in connection with such filing.

 

10.1.5    Interference, Opposition, Reexamination and Reissue.

 

(a)          Notice. Not more than thirty (30) days following the discovery by
either Party of any request for, or the filing or declaration of, any
interference, opposition, or reexamination proceeding with respect to any
Licensed Patent Rights in the Territory, the discovering or determining Party
shall notify the other Party of such event.

 

(b)          Primary Responsibility and Cooperation. LICENSOR shall have primary
responsibility, at its own expense, with respect to the course of action taken
to defend or prosecute any such interference, opposition, reexamination or
reissue, except that the Parties shall share equally the reasonable fees and
expenses incurred under this Section 10.1.4(b) with respect to Joint Patent
Rights. The Parties shall cooperate fully with each other and each shall provide
to the other any information or assistance that the other may reasonably request
with respect to any course of action taken under this Section 10.1.4. LICENSOR
shall (a) keep TG reasonably informed of all developments in such interference,
opposition, reexamination or reissue in the Territory, including to the extent
permissible, the status of any settlement negotiations and the terms of any
offer related thereto and (b) provide to TG copies of all submissions or
agreements arising in connection with such proceeding sufficiently in advance of
their filing or due date so as to give TG sufficient time to comment thereon,
and LICENSOR shall give good faith consideration to TG’s comments, with due
regard to the other Party’s rights and commercial interests under this
Agreement. Neither Party shall enter into any settlement or consent decree
regarding Joint Patent Rights, or assent to the grant of any reissued or
reexamined patent within the Joint Patent Rights, without the prior written
consent of the other Party, which shall not be unreasonably withheld or delayed.

 

10.1.6   Decision Not to File; Abandonment. LICENSOR shall notify TG in the
event LICENSOR decides at any time to abandon or discontinue prosecution of any
one or more of the patents or patent applications included in the Licensed
Patent Rights and in the Territory. Such notification will be given as early as
possible which in no event will be less than fifteen (15) days prior to the date
on which said patent(s) or patent application(s) will become abandoned. TG shall
have the option, exercisable upon written notification to LICENSOR, to assume
full responsibility, at its discretion for the prosecution of the affected
patent(s) or patent application(s), which shall be conducted in the name of TG.

 

42

 

 

10.2         Enforcement and Defense.

 

10.2.1    Third Party Infringement.

 

(a)          In General.

 

(i)          Notice. In the event either Party becomes aware of (i) any
suspected infringement or misappropriation of any Licensed Patent Rights, Joint
Patent Rights that covers the development or commercialization of a Compound or
Product in the Field in the Territory, or (ii) the submission by any Third Party
of an abbreviated NDA under the Hatch-Waxman Act for a product in the Field that
comprises the Compound (each, an “Infringement”), that Party shall promptly
notify the other Party and provide it with all details of such Infringement of
which it is aware (each, an “Infringement Notice”). The Patent Coordinators
shall promptly meet to discuss the Infringement and the strategy for patent
enforcement with respect to such Infringement.

 

(ii)         LICENSOR Right to Enforce. LICENSOR shall have the first right, but
not the obligation, to address any such Infringement in the Territory by taking
reasonable steps, which may include the institution of legal proceedings or
other actions (each, an “Action”), and to compromise or settle such Action;
provided, that, (A) LICENSOR shall keep TG reasonably informed about such
Action, (B) TG shall provide reasonable cooperation to LICENSOR in connection
with such Action, (C) LICENSOR shall not take any position with respect to, or
compromise or settle, such Action in any way that would be reasonably likely to
directly and adversely affect the scope, validity or enforceability of the
Licensed Patent Rights without the prior consent of TG, which consent shall not
be unreasonably withheld, and (D) if LICENSOR does not intend to prosecute or
defend an Infringement, or determines to cease to pursue such an Action, it
shall promptly inform TG and Section 10.2.1(a)(iii) shall apply. LICENSOR shall
incur no liability to TG as a consequence of such Action or any unfavorable
decision resulting therefrom, including any decision holding any such claim
invalid, not infringed or unenforceable. All costs, including, without
limitation, attorneys’ fees, relating to such legal proceedings or other action
shall be borne by LICENSOR.

 

(iii)        TG Right to Enforce. If (A) LICENSOR informs TG that LICENSOR does
not intend to prosecute an Action in respect of any Licensed Patent Rights or
Joint Patent Rights pursuant to Section 10.2.1(a)(ii), (B) within sixty (60)
days after the Infringement Notice, LICENSOR has not commenced any Action, or
(C) if LICENSOR determine to cease to pursue any such Action with respect to
such Infringement, then TG shall have the right, at its own expense, upon notice
to LICENSOR to take appropriate action to address such Infringement, including
by initiating its own Action or taking over prosecution of any Action initiated
by LICENSOR; provided, that, in such event, (1) TG shall keep LICENSOR
reasonably informed about such Action and shall consult with LICENSOR before
taking any major steps during the conduct of such Action, (2) LICENSOR shall
provide reasonable cooperation to TG in connection with such Action, and (3) TG
shall not take any position with respect to, or compromise or settle, such
Action in any way that is reasonably likely to directly and adversely affect the
scope, validity or enforceability of the Licensed Patent Rights without
LICENSOR’ prior written consent, which consent shall not be unreasonably
withheld. LICENSOR shall incur no liability to LICENSOR as a consequence of such
Action or any unfavorable decision resulting therefrom, including any decision
holding any such claim invalid, not infringed or unenforceable. All costs,
including, without limitation, attorneys’ fees, relating to such legal
proceedings or other action shall be borne by TG.

 

43

 

 

(iv)        Joint Patent Rights. In the event of an Infringement of a Joint
Patent Right, the Parties shall enter into good faith discussions as to whether
and how to eliminate the Infringement. Subject to the foregoing, (A) TG shall
have the first right and option to eliminate such Infringement by reasonable
steps, which may include the institution of legal proceedings or other action
and (B) all costs, including without limitation attorneys’ fees, relating to
such legal proceedings or other action shall be borne by TG. If TG does not take
or initiate commercially reasonable steps to eliminate the Infringement within
one hundred twenty (120) days from any Infringement Notice (or twenty (20) days
in the case of an Infringement resulting from the submission by any Third Party
of an abbreviated new drug application under the Hatch-Waxman Act), then
LICENSOR shall have the right an option to do so at its expense.

 

(b)         Right to Representation. Each Party shall have the right to
participate and be represented by counsel that it selects, in any Action
instituted under Section 10.2.1(a)(ii), (iii) or (iv) by the other Party. If a
Party with the right to initiate an Action under Section 10.2.1(a) to eliminate
an Infringement lacks standing to do so and the other Party has standing to
initiate such Action, then the Party with the right to initiate an Action under
Section 10.2.1(a) may name the other Party as plaintiff in such Action or may
require the Party with standing to initiate such Action at the expense of the
other Party.

 

(c)         Cooperation. In any Action instituted under this Section 10.2.1, the
Parties shall cooperate with and assist each other in all reasonable respects.
Upon the reasonable request of the Party instituting such Action, the other
Party shall join such Action and shall be represented using counsel of its own
choice, at the requesting Party’s expense.

 

(d)         Allocation of Proceeds. Any amounts recovered by either Party
pursuant to Actions under Sections 10.2.1(a)(ii), (iii) or (iv) with respect to
any Infringement, whether by settlement or judgment, shall, after reimbursing TG
and LICENSOR for their respective reasonable out-of-pocket expenses incurred in
pursuing such Action and obtaining such recovery (which amounts shall be
allocated pro rata if insufficient to cover the totality of such expenses) be
retained by or paid to TG and treated as Net Sales of the Product affected by
the Infringement for purposes of this Agreement, such that TG shall pay to
LICENSOR the applicable royalty due on such Net Sales pursuant to Section 7.3.1.

 

10.2.2     Defense of Claims.

 

(a)          Notice. In the event that any action, suit or proceeding is brought
against either Party or any Affiliate of either Party or any Sublicensee or
Distributor of TG alleging the infringement of the Technology or Patent Rights
of a Third Party by reason of or the Development or Commercialization, including
the Manufacture, use or sale, of any Compound or Product, by or on behalf of TG,
its Affiliates, Sublicensees or Distributors, such Party shall notify the other
Party within five (5) days of the earlier of (i) receipt of service of process
in such action, suit or proceeding, or (ii) the date such Party becomes aware
that such action, suit or proceeding has been instituted and the Patent
Coordinators shall meet as soon as possible to discuss the overall strategy for
defense of such matter.

 

44

 

 

(b)          Prosecution of Infringement claims in the Territory. Except as
unanimously agreed by the Patent Coordinators and subject to Article 14, (i)
LICENSOR shall have the primary right but not the obligation to institute and
control such action, suit or proceeding in its own name and at its sole expense
and in such case, LICENSOR and/or any of its Affiliates shall have the right to
separate counsel at its own expense in any such action, suit or proceeding and,
TG shall cooperate with LICENSOR in all reasonable respects in any such action,
suit or proceeding ; (ii) in the event LICENSOR waives its primary right as
defined in (i) the Parties may elect, without being obliged, to jointly commence
an action, an in this respect shall be represented by a counsel jointly chosen
by the Parties, decide on a course of action, and share equally in the costs and
expenses, and in the amounts recovered in accordance with, subject to and within
the limits set out in LICENSOR’s Licenses or (iii) Upon LICENSOR’s request TG
may defend any action, suit or proceeding in its own name and at its sole
expense and in such case TG and/or any of its Affiliates shall have the right to
separate counsel at its own expense in any such action, suit or proceeding and
LICENSOR shall cooperate with TG in all reasonable respects in any such action,
suit or proceeding .

 

(c)          Cooperation. Each Party shall promptly furnish the other Party with
a copy of each communication relating to the alleged infringement that is
received by such Party including all documents filed in any litigation. In no
event shall either Party settle or otherwise resolve any such action, suit or
proceeding brought against the other Party or any of its Affiliates or
sublicensees without the other Party’s prior written consent.

 

10.2.3    Patent Term Restoration. The Parties hereto shall cooperate with each
other in obtaining patent term restoration or supplemental protection
certificates or their equivalents in any country in the Territory where
applicable to Licensed Patent Rights. Such cooperation shall include diligently
and timely conferring and coordinating with respect to such matters to ensure
compliance with applicable filing deadlines, and agreeing on procedures to be
followed by the Parties to ensure such compliance. In the event that elections
with respect to obtaining such patent term restoration are to be made, LICENSOR
shall have the right to make the election with respect to Licensed Patent
Rights.

 

10.3         Trademark Prosecution and Registration.

 

LICENSOR shall control the registration of the Licensed Trademark, to be used
with Products in the Territory. LICENSOR shall have the primary right and
obligation to take any actions as are required to continue and maintain in full
force and effect and enforce and defend all Licensed Trademarks and
registrations thereof, against infringement and misappropriation in the
Territory, and shall be solely responsible for all expenses incurred in
connection therewith. Upon LICENSOR’s request TG may have the right to take any
actions as are required to continue and maintain in full force and effect and
enforce and defend all Licensed Trademarks and registrations thereof, against
infringement and misappropriation in the Territory, and shall be solely
responsible for all expenses incurred in connection therewith.

 

45

 

 

11.         TERM AND TERMINATION

 

11.1         Term.

 

This Agreement shall commence on the Effective Date and shall continue in full
force and effect, unless otherwise terminated pursuant to Section 11.2, (a)
until such time as TG is no longer Developing at least one (1) Compound and/or
at least one (1) Product or (b) if, as of the time TG is no longer Developing at
least one (1) Compound and/or at least one (1) Product, TG is Commercializing a
Product, until the later of (i) the expiration of all applicable Royalty Terms
with respect to Products and (ii) the expiration of all obligations of TG to pay
Sublicense Royalties to LICENSOR under this Agreement (the “Term”). Upon the
expiration of this Agreement as set forth in this Section 11.1, the license
rights granted hereunder shall be converted to perpetual and fully paid-up
licenses on Licensed Technology and Licensed Patent Rights, with the right to
grant unlimited sublicenses. However, TG shall continue to pay to LICENSOR
royalties on the use of Licensed Trademarks as defined in section 7.3.4. c.).

 

11.2         Termination.

 

This Agreement may be terminated by either Party as follows:

 

11.2.1     Unilateral Right to Terminate Agreement.

 

(a)          LICENSOR Rights to Terminate for Challenge.  Except to the extent
the following is unenforceable under the Applicable Laws of a particular
jurisdiction where a patent application within the Licensed Patent Rights is
pending or a patent within the Licensed Patent Rights is issued, LICENSOR may
terminate this Agreement immediately upon written notice to TG in the event that
TG or any of its Affiliates or Sublicenses Challenges any Licensed Patent Rights
or assists a Third Party in initiating a Challenge of any Licensed Patent
Rights.

 

11.2.2     Termination for Breach. Either Party may terminate this Agreement,
effective immediately upon written notice to the other Party, for a material
breach (including TG’s failure to meet its diligence requirements and
responsibilities as set forth in Section 3; 4 and 5) by the other Party of any
term of this Agreement that remains uncured ninety (90) days (sixty (60) days in
the event that the breach is a failure of a Party to make any payment required
hereunder) after the non-breaching Party first gives written notice to the other
Party of such breach and its intent to terminate this Agreement if such breach
is not cured. For purposes of clarity, the obligation of the breaching Party to
cure any such breach shall be stayed for any time period during which such
breach is the subject of a dispute resolution proceeding pursuant to Section
14.1; provided, that, the obligation of the breaching Party to cure such breach
such breach shall resume commencing on the date of any final resolution of such
proceeding.

 

11.2.3     Termination for Insolvency. In the event that either Party makes an
assignment for the benefit of creditors, appoints or suffers appointment of a
receiver or trustee over all or substantially all of its property, files a
petition under any bankruptcy or insolvency act or has any such petition filed
against it which is not discharged within sixty (60) days of the filing thereof,
then the other Party may terminate this Agreement effective immediately upon
written notice to such Party.

 

11.3         Consequences of Termination of Agreement.

 

In the event of the termination of this Agreement pursuant to Section 11.2, the
following provisions shall apply, as applicable.

 

46

 

 

 

11.3.1    Termination by LICENSOR. If this Agreement is terminated by LICENSOR
pursuant to Section 11.2.1, 11.2.2 or 11.2.3:

 

(a)          All licenses and rights granted by LICENSOR to TG, including all
licenses granted to TG pursuant to Section 2.1, shall immediately terminate.

 

(b)          TG shall cease to use any and all Licensed Trademarks, any
Marketing Authorization obtained in accordance with the AGREEMENT and shall
further promptly transfer such Marketing Authorizations and/or orphan drug
designations to LICENSOR at no cost for LICENSOR.

 

(c)          TG shall cease to conduct any activity related to the Development
and Commercialization of the Product.

 

(d)          Upon request of LICENSOR, TG shall promptly, and in any event
within sixty (90) days after LICENSOR’s request (which request may specify any
or all of the actions in clauses (A) through (H): (A) transfer to LICENSOR all
of its right, title and interest in all Drug Approval Applications and then in
its name applicable to the Product, if any, and all Confidential Information
Controlled by TG as of the date of termination relied on by such Drug Approval
Applications; (B) notify the applicable Regulatory Authorities and take any
other action reasonably necessary to effect such transfer; (C) provide LICENSOR
with copies all correspondence between TG and such Regulatory Authorities
relating to such Drug Approval Applications; (D) unless expressly prohibited by
any Regulatory Authority, transfer sponsorship and control to LICENSOR of all
Clinical Trials of the Product being conducted as of the effective date of
termination and continue to conduct such Clinical Trials after the effective
date of termination to enable such transfer to be completed without interruption
of any such Clinical Trial for up to twelve (12) months from the effective date
of termination, except for termination for breach of TG, the fully burdened cost
of such continuation to be paid for by LICENSOR (E) cooperate with LICENSOR,
cause its Affiliates to cooperate with LICENSOR and use commercially reasonable
efforts to require any Third Party with which TG has an agreement with respect
to the conduct of Clinical Trials for the Product (including agreements with
contract research organizations, clinical sites and investigators), to cooperate
with LICENSOR in order to accomplish the transfer to LICENSOR of similar rights
as held by TG under its agreements with such Third Parties; (F) provide LICENSOR
with copies of all reports and Clinical Data generated or obtained by TG or its
Affiliates, and all Promotional Materials used by TG, pursuant to this Agreement
that relate to the Product that have not previously been provided to LICENSOR
and provide LICENSOR with a right of access, a right of reference and a right to
use and incorporate all Clinical Data, results and information in all Drug
Approval Applications then in its name applicable to the commercialization of
Product and all material aspects of Confidential Information Controlled by it as
of the date relating to such Drug Approval Applications for LICENSOR to use to
seek Regulatory Approvals; (G) provide LICENSOR at cost with all supplies of
Compounds an Products in the possession of TG or any Affiliate or contractor of
TG; and (H) provide LICENSOR with copies of all reports and data generated or
obtained by TG or its Affiliates pursuant to this Agreement that relate to any
Product that have not previously been provided to LICENSOR; (I) enter into
negotiations with LICENSOR and agree upon and implement a plan for the orderly
transition of Development and Commercialization from TG to LICENSOR in a manner
consistent with Applicable Laws and standards of ethical conduct of human
Clinical Trials and will seek to replace all TG personnel engaged in any
Development or Commercialization activities, in each case, as promptly as
practicable. In connection therewith, TG shall be deemed to have granted to
LICENSOR an exclusive, fully-paid, royalty-free, irrevocable license, with the
right to grant sublicenses under TG’s interest in Joint Improvements and Joint
Patent Rights, for the sole purpose of using, making, having made, offering for
sale, selling, having sold, importing and exporting any Products being Developed
and/or Commercialized by TG as of the effective date of such termination in the
Field and in the Territory.

 

47

 

 

(e)          Each Party shall promptly return all Confidential Information and
Proprietary Materials of the other Party that are not subject to a continuing
license hereunder; provided, that, each Party may retain one copy of the
Confidential Information of the other Party in its archives solely for the
purpose of establishing the contents thereof and ensuring compliance with its
obligations hereunder.

 

(f)          TG shall promptly return to LICENSOR all raw data and results
generated in each such Clinical Trial

 

11.3.2    Termination by TG. If this Agreement is terminated by TG pursuant to
Section, 11.2.2 or 11.2.3:

 

(a)          At TG’s election, all licenses granted by LICENSOR to TG pursuant
to Section 2.1 shall survive such termination, in each case subject to TG’s
continued payment of all milestone, royalty, Sublicense Royalties and other
payments under and in accordance with this Agreement with respect thereto.

 

(b)          Each Party shall promptly return all Confidential Information and
Proprietary Materials of the other Party that are not subject to a continuing
license hereunder; provided, that, each Party may retain one copy of the
Confidential Information of the other Party in its archives solely for the
purpose of establishing the contents thereof and ensuring compliance with its
obligations hereunder.

 

(c)          TG shall promptly return to LICENSOR all raw data and results
generated in each such Clinical Trial

 

11.4       Surviving Provisions.

 

Termination or expiration of this Agreement for any reason shall be without
prejudice to:

 

(a)          Survival of rights specifically stated in this Agreement to
survive, including without limitation as set forth in Section 11.3;

 

(b)          the rights and obligations of the Parties provided in Sections 8,
9, 10, 12, 13, 14.1 and 14.2 (including all other Sections or Articles
referenced in any such Section or Article), all of which shall survive such
termination except as provided in this Article 10; and

 

(c)          any other rights or remedies provided at law or equity which either
Party may otherwise have.

 

48

 

  

12.     REPRESENTATIONS AND WARRANTIES

 

12.1       Mutual Representations and Warranties.

 

LICENSOR and TG each hereby represents and warrants to the other, as of the
Effective Date, as follows:

 

12.1.1           Organization. It is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction of its
organization, and has all requisite power and authority, corporate or otherwise,
to execute, deliver and perform this Agreement.

 

12.1.2           Authorization. The execution and delivery of this Agreement and
the performance by it of the transactions contemplated hereby have been duly
authorized by all necessary corporate action and will not violate (a) such
Party’s certificate of incorporation or bylaws (or equivalent charter or
organizational documents), (b) any agreement, instrument or contractual
obligation to which such Party is bound in any material respect, (c) any
requirement of any Applicable Laws, or (d) any order, writ, judgment,
injunction, decree, determination or award of any court or governmental agency
presently in effect applicable to such Party.

 

12.1.3           Binding Agreement. This Agreement is a legal, valid and binding
obligation of such Party enforceable against it in accordance with its terms and
conditions.

 

12.1.4           No Inconsistent Obligation. It is not under any obligation,
contractual or otherwise, to any Person that conflicts with or is inconsistent
in any respect with the terms of this Agreement or that would impede the
diligent and complete fulfillment of its obligations hereunder.

 

12.1.5           No Government Authorization Required. No government
authorization, consent, approval, license, exemption of or filing or
registration with any court or governmental department, commission, board,
bureau, agency or instrumentality, domestic or foreign, under any Applicable
Laws currently in effect, is or will be necessary for, or in connection with,
the transactions contemplated by this Agreement, or for the performance by it of
its obligations under this Agreement.

 

12.1.6           TG represents and warrants that it has all necessary financial
and human resources to enter and perform all its commitments and obligations
contained in the Agreement.

 

12.2       Additional Representations of LICENSOR.

 

LICENSOR further represents and warrants to TG, as of the Effective Date, as
follows:

 

12.2.1           Validity of Patent Rights. All Licensed Patent Rights listed on
Schedule 4 are existing and, to LICENSOR’ Knowledge, no issued patents which are
part of the Licensed Patent Rights listed on Schedule 4 are invalid or
unenforceable.

 

49

 

 

12.2.2           No Claims. There are no claims, judgments or settlements
against LICENSOR pending, or to LICENSOR’ Knowledge, threatened, that invalidate
or seek to invalidate the Licensed Patent Rights. There is no litigation pending
against LICENSOR or any Affiliate of LICENSOR that alleges that any of LICENSOR’
activities relating to the Compound have violated, or by Developing the Compound
would violate, any of the intellectual property rights of any Third Party (nor
has it received any written communication threatening such litigation). To
LICENSOR’ Knowledge, no litigation has been threatened against LICENSOR or any
Affiliate of LICENSOR which alleges that any of its activities relating to the
Compound have violated, or by Developing the Compound would violate, any of the
intellectual property rights of any Third Party.

 

12.2.3           No License. LICENSOR has not previously entered into any
agreement pursuant to which it granted a license with respect to the Compound,
or Product or under the Licensed Patent Rights or Licensed Technology to any
Affiliate or Third Party, which license grant remains in effect or which
agreement has surviving license rights, or other surviving terms, that are
inconsistent with the rights and licenses granted to TG under this Agreement.

 

12.2.4           Third Party Patents. Except the patents disclosed in the
dataroom and to LICENSOR’ Knowledge, no Patent Rights owned or controlled by any
Third Party would be infringed by the Development, Manufacture, use of
Commercialization by or on behalf of TG of the Compound or any Product pursuant
to this Agreement.

 

12.2.5           No Interference. To LICENSOR’ Knowledge, (a) the Licensed
Patent Rights are not the subject of any interference proceeding and (b) there
is no pending or threatened action, suit, proceeding or claim by any Third Party
challenging LICENSOR’ ownership rights in, or the validity or scope of, the
Licensed Patent Rights.

 

12.3       Additional Representations of TG.

 

TG further represents and warrants to LICENSOR, as of the Effective Date, as
follows:

 

12.3.1           No Claims. There is no litigation pending against TG or any
Affiliate of TG that relates, directly or indirectly, to the subject matter of
this Agreement and that alleges that any of TG’s activities to be conducted
relating to the Development of the Compound would violate any of the
intellectual property rights of any Third Party (nor has it received any written
communication threatening such litigation).

 

12.3.2           Compliance with Applicable Laws.  TG is in compliance with all
Applicable Laws, and is not in default under or in violation of any Applicable
Laws, that, in any case, would reasonably be expected to adversely affect the
ability of TG to comply with and perform its obligations under this Agreement.

 

12.3.3           Electronic Dataroom. TG represents and warrants that it has
been granted access to an electronic dataroom organized by LICENSOR and
therefore has a clear and perfect knowledge and a good understanding of all
documents, information and data contained in such electronic dataroom, and their
consequences on rights granted by LICENCOR under the Agreement. Within thirty
(30) days of the date hereof, LICENSOR will use Commercially Reasonable Efforts
to transfer a copy of the contents of the electronic dataroom in their original
format to TG and will transfer such other manifestations of the Licensed
Technology useful or necessary for TG to Develop and Commercialize the Products,
including without limitation raw data and results generated in each clinical
trial and pre-clinical studies  previously conducted and batch reports from
manufacturing runs through the date hereof, to the extent not included in the
dataroom.  On and after the date hereof, LICENSOR will use Commercially
Reasonable Efforts to forward such manifestations of the Licensed Technology
that it has in its possession to TG on a regular basis or upon request.

 

50

 

 

 

13.         INDEMNIFICATION; INSURANCE

 

13.1         Indemnification of LICENSOR by TG.

 

TG shall indemnify, defend and hold harmless LICENSOR, its Affiliates, their
respective directors, officers, employees and agents, and their respective
successors, heirs and assigns (collectively, the “LICENSOR Indemnities”),
against all liabilities, damages, losses and expenses (including, without
limitation, reasonable attorneys’ fees and expenses of litigation)
(collectively, “Losses”) incurred by or imposed upon LICENSOR Indemnities, or
any of them, as a direct result of claims, suits, actions, demands or judgments
of Third Parties, including, without limitation, personal injury and product
liability claims (collectively, “Claims”), arising out of (a) the Development,
testing, sale, offer for sale, or Commercialization by TG or any of its
Affiliates, Sublicensees or Distributors of any Product; (b) any breach of this
Agreement by TG or any of its Affiliates, Sublicensees, Distributors or agents;
and (c) the gross negligence or willful misconduct of any TG Indemnity or
Sublicensee of TG; excluding, in each of (a), (b) and (c) above, any Claim or
Loss with respect to which LICENSOR has an obligation to indemnify TG
Indemnities pursuant to Section 13.2, as to which Claim or Loss each Party will
indemnify the other to the extent of their respective liability for such Loss
(unless such Claim or Loss is otherwise expressly excluded from a Party’s
indemnification obligations under this Agreement).

 

13.2         Indemnification of TG by LICENSOR.

 

LICENSOR shall indemnify, defend and hold harmless TG, its Affiliates, their
respective directors, officers, employees and agents, and their respective
successors, heirs and assigns (collectively, the “TG Indemnities”), against all
Losses incurred by or imposed upon the TG Indemnities, or any of them, as a
direct result of Claims arising out of (a) the commercialization by LICENSOR of
any LICENSOR Commercialization Product in the LICENSOR Commercialization
Territory following exercise of LICENSOR commercialization option (b) any breach
of this Agreement by LICENSOR or any of its Affiliates, (sub)licensees,
distributors or agents; or (b) the gross negligence or willful misconduct of any
LICENSOR Indemnity or (sub)licensee of LICENSOR; excluding, in the case of
clauses (a) and (b) above, any Claim or Loss with respect to which TG or any of
its Affiliates has an obligation to indemnify LICENSOR pursuant to Section 13.1,
as to which Claim or Loss each Party will indemnify the other to the extent of
their respective liability for such Loss.

 

51

 

 

13.3         Conditions to Indemnification.

 

A Person seeking modification under this Article 13 (the “Indemnified Party”) in
respect of a Claim shall give prompt notice of such Claim to the Party from
which indemnification is sought (the “Indemnifying Party”); provided, that, the
Indemnifying Party is not contesting its obligation under this Section 13, shall
permit the Indemnifying Party to control any litigation relating to such Claim
and the disposition of such Claim; provided, that, the Indemnifying Party shall
(a) act reasonably and in good faith with respect to all matters relating to the
settlement or disposition of such Claim as the settlement or disposition relates
to such Indemnified Party and (b) not settle or otherwise resolve such claim
without the prior written consent of such Indemnified Party (which consent shall
not be unreasonably withheld, conditioned or delayed). Each Indemnified Party
shall cooperate with the Indemnifying Party in its defense of any such Claim in
all reasonable respects and shall have the right to be present in person or
through counsel at all legal proceedings with respect to such Claim.

 

13.4         Insurance.

 

Not later than thirty (30) days before the date on which TG or any Affiliate or
Sublicensee of TG shall, on a commercial basis, make, use, or sell any Products,
and at all times thereafter until the expiration of all applicable statutes of
limitation pertaining to any such manufacture, marketing, possession, use, sale
of other disposition of any Products, TG will, at its expense, and LICENSOR
will, at its expense, with respect to Products, obtain and maintain in full
force and effect, comprehensive general liability insurance, including product
liability insurance and Clinical Trial insurance in such amounts as each such
Party customarily maintains with respect to the development, manufacture and
sale of its other products. Notwithstanding the foregoing, either Party may
elect to self-insure with respect to any insurance coverage it is required to
obtain hereunder as part of a comprehensive self-insurance program adopted by
such Party. For the avoidance of doubt, all insurance obligations and associated
costs for any sale and development of Product within the Territory and over
which LICENSOR has little or no control, shall be borne solely by TG.

 

13.5         Warranty Disclaimer.

 

EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES
ANY WARRANTY WITH RESPECT TO ANY KNOW-HOW, GOODS, SERVICES, RIGHTS OR OTHER
SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.

 

13.6         No Warranty of Success.

 

Nothing contained in this Agreement shall be construed as a warranty, either
express or implied, on the part of either Party that (a) the Development Program
will yield a Product or otherwise be successful or meet its goals, time lines or
budgets, or (b) the outcome of the Development Program will be commercially
exploitable in any respect.

 

13.7         Limited Liability.

 

EXCEPT AS SET FORTH UNDER SECTIONS 13.1 OR 13.2, NEITHER PARTY SHALL BE LIABLE
TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR (I) ANY SPECIAL, PUNITIVE,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION,
LOST PROFITS OR LOST REVENUES, OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS,
KNOW-HOW OR SERVICES, WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY.

 

52

 

 

14.    MISCELLANEOUS

 

14.1         Disputes; Consent to Jurisdiction.

 

The Parties shall use reasonable efforts to settle any Disputed Matter arising
from or related to this Agreement or the breach thereof (each, a “Dispute”) by
promptly referring any such dispute to the Executive Officer of each Party. If
the Executive Officers are unable to resolve any Dispute within thirty (30) days
of the date on which the Dispute was referred to them for resolution, the
Dispute shall be subject to the sole jurisdiction of, and venue in, the U.S.
federal courts of competent jurisdiction located within Boston, Massachusetts,
USA (if available), and otherwise the state courts of competent jurisdiction
located within Boston, Massachusetts, USA. TG and LICENSOR each irrevocably
consent to the jurisdiction of such courts, irrevocably waive any objection
based on inconvenience of forum, and agree that process may be served in the
manner provided herein for giving notices or otherwise as allowed by
Massachusetts or applicable federal law. Notwithstanding the foregoing, either
Party shall have the right, without waiving any right or remedy available to
such Party under this Agreement or otherwise, to seek and obtain from any court
of competent jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party.

 

14.2         Notices.

 

All notices and communications shall be in writing and delivered personally or
by internationally-recognized overnight express courier providing evidence of
delivery or mailed via certified mail, return receipt requested, addressed as
follows, or to such other address as may be designated from time to time:

 

If to LICENSOR:GTC Biotherapeutics, Inc.

175 Crossing Boulevard

Framingham, MA 01701

Attention: _______________

Tel.: 508-620-9700

Fax: ___________________

 

LFB Biotechnologies S.A.S.

3 avenue des Tropiques

B.P. 305-Les Ulis- 91958

Courtaboeuf Cedex, France

Attention: _______________

Tel.: ____________________

Fax: ____________________

 

53

 

 

LFB/GTC LLC

175 Crossing Boulevard

Framingham, Massachusetts 01701

Attention: ________________

Tel. ______________________

Fax: ______________________

 

With a copy to:

 

Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.

One Financial Center

Boston, MA 02111

Attention: Brian P. Keane, Esq.

Tel.: 617-542-6000

Fax: 617-542-2241

 

If to TG:TG Therapeutics, Inc.

787 Seventh Avenue

48th Floor

New York, NY 10019

Attn: __________________

Tel: ___________________

Fax: ___________________

 

With a copy to:

______________________

______________________

______________________

Attention: ______________

Tel: ___________________

Fax: __________________

 

Except as otherwise expressly provided in this Agreement or mutually agreed in
writing, any notice, communication or document (excluding payment) required to
be given or made shall be deemed given or made and effective upon actual receipt
or, if earlier, (a) three (3) Business Days after deposit with an
internationally-recognized overnight express courier with charges prepaid, or
(b) five (5) Business Days after mailed by certified, registered or regular
mail, postage prepaid, in each case addressed to a Parties at its address stated
above or to such other address as such Party may designate by written notice
given in accordance with this Section 14.2.

 

14.3         Governing Law.

 

This Agreement shall be governed by and construed in accordance with the laws of
the State of Delaware, without regard to the application of principles of
conflicts of law.

 

54

 

 

14.4         Competition Law.

 

LICENSOR and TG agree that nothing in this Agreement shall be interpreted in a
way that conflicts with EC Block Exemption No: 418/85 on research and
development agreements, or EC Block Exemption No: 240/96 on technology transfer
agreements, as issued by the European Commission (as these may be amended or
replaced from time to time).

 

14.5         Binding Effect.

 

This Agreement shall be binding upon and inure to the benefit of the Parties and
their respective legal representatives, successors and permitted assigns.

 

14.6         Headings.

 

Section and subsection headings are inserted for convenience of reference only
and do not form a part of this Agreement.

 

14.7         Counterparts.

 

This Agreement may be executed simultaneously in two or more counterparts, each
of which shall be deemed an original and both of which, together, shall
constitute a single agreement.

 

14.8         Amendment; Waiver.

 

This Agreement may be amended, modified, superseded or canceled, and any of the
terms of this Agreement may be waived, only by a written instrument executed by
each Party or, in the case of waiver, by the Party or Parties waiving
compliance. The delay or failure of either Party at any time or times to require
performance of any provisions shall in no manner affect the rights at a later
time to enforce the same. No waiver by either Party of any condition or of the
breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of
such term or any other term of this Agreement.

 

14.9         No Third Party Beneficiaries.

 

Except as set forth in Sections 13.1 and 13.2, no Third Party (including,
without limitation, employees of either Party) shall have or acquire any rights
by reason of this Agreement.

 

14.10      Section 365(n).

 

All licenses granted under this Agreement are deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual
property” as defined in Section 101 of such Code. The Parties agree that TG may
fully exercise all of its rights and elections under the U.S. Bankruptcy Code
and any foreign equivalent thereto in any country having jurisdiction over a
Party or its assets. The Parties further agree that, in the event TG elects to
retain its rights as a licensee under such Code, TG shall be entitled to
complete access to any technology licensed to it hereunder and all embodiments
of such technology. Such embodiments of the technology shall be delivered to the
TG not later than the commencement of bankruptcy proceedings against LICENSOR,
upon written request, unless LICENSOR elects to perform its obligations under
the Agreement, or if not so delivered, upon the rejection of this Agreement by
or on behalf of LICENSOR, upon written request.

 

55

 

 

14.11         Purposes and Scope.

 

The Parties hereto understand and agree that this relationship is limited to the
activities, rights and obligations as set forth in this Agreement. Nothing in
this Agreement shall be construed (a) to create or imply a general partnership
between the Parties, (b) to make either Party the agent of the other for any
purpose, (c) to alter, amend, supersede or vitiate any other arrangements
between the Parties with respect to any subject matters not covered hereunder,
(d) to give either Party the right to bind the other, (e) to create any duties
or obligations between the Parties except as expressly set forth herein, or (f)
to grant any direct or implied licenses or any other right other than as
expressly set forth herein.

 

14.12         Assignment and Successors.

 

Neither this Agreement nor any obligation of a Party hereunder may be assigned
by either Party without the consent of the other which shall not be unreasonably
withheld, except that each Party may assign this Agreement and the rights,
obligations and interests of such Party, (a) in whole or in part, to any of its
Affiliates, or (b) in whole, but not in part, to any purchaser of all of its
assets or all of its assets to which this Agreement relates or shares
representing a majority of its common stock voting rights or to any successor
corporation resulting from any merger, consolidation, share exchange or other
similar transaction.

 

Notwithstanding the foregoing, by signing the Agreement, TG is deemed to consent
that LFB BIOTECHNOLOGIES, GTC and/ or LFB / GTC LLC may, at any time, assign
their rights and obligations under the Agreement to any of them or to any of
their Affiliates.

 

14.13         Force Majeure.

 

Neither TG nor LICENSOR shall be liable for failure of or delay in performing
obligations set forth in this Agreement, and neither shall be deemed in breach
of its obligations, if such failure or delay is due to a Force Majeure. In event
of such Force Majeure, the Party affected shall use reasonable efforts to cure
or overcome the same and resume performance of its obligations hereunder.

 

14.14         Interpretation.

 

The Parties hereto acknowledge and agree that: (a) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (b) the rule of construction to the effect that any
ambiguities are resolved against the drafting Party shall not be employed in the
interpretation of this Agreement; and (c) the terms and provisions of this
Agreement shall be construed fairly as to each Party and not in a favor of or
against either Party, regardless of which Party was generally responsible for
the preparation of this Agreement. In addition, unless a context otherwise
requires, wherever used, the singular shall include the plural, the plural the
singular, the use of any gender shall be applicable to all genders, the word
“or” is used in the inclusive sense (and/or) and the word “including” is used
without limitation and means “including without limitation”.

 

56

 

 

14.15         Integration; Severability.

 

This Agreement, and when executed, the Development Services and Manufacturing
Agreement, the Commercial Supply Agreement(s) and the Stock Purchase Agreement
set forth the entire agreement with respect to the subject matter hereof and
thereof and supersede all other agreements and understandings between the
Parties with respect to such subject matter. If any provision of this Agreement
is or becomes invalid or is ruled invalid by any court of competent jurisdiction
or is deemed unenforceable, it is the intention of the Parties that the
remainder of this Agreement shall not be affected.

 

14.16         Further Assurances.

 

Each of LICENSOR and TG agrees to duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done
such further acts and things, including, without limitation, the filing of such
additional assignments, agreements, documents and instruments, as the other
Party may at any time and from time to time reasonably request in connection
with this Agreement or to carry out more effectively the provisions and purposes
of, or to better assure and confirm unto such other Party its rights and
remedies under, this Agreement.

 

[Remainder of page intentionally left blank.]

 

57

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

  GTC BIOTHERAPEUTICS, INC.         By: /s/ William K. Heiden   Name: William K.
Heiden   Title: CEO         LFB BIOTECHNOLOGIES S.A.S.         By: /s/ Denis
Soubeyran   Name: Denis Soubeyran   Title:           LFB/GTC LLC         By: /s/
Denis Soubeyran   Name: Denis Soubeyran   Title:         TG THERAPEUTICS, INC.  
      By: /s/ Michael S. Weiss   Name: Michael S. Weiss   Title: CEO and
President

 

 

58