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

 

Exhibit No. 10.1

 

 

 

JOINT VENTURE AND LICENSE OPTION AGREEMENT

 

BY AND BETWEEN

 

TG THERAPEUTICS, INC.

 

AND

 

RHIZEN PHARMACEUTICALS S A

  

 

 

 

 

 

This JOINT VENTURE AND LICENSE OPTION AGREEMENT (the “Agreement”) is entered
into on August 15, 2012 (the “Effective Date”) between Rhizen Pharmaceuticals S
A, a company incorporated under the laws of Switzerland, with a place of
business at Fritz-Courvoisier 40, CH-2300 La Chaux-de-Fonds, Switzerland
(“Rhizen”), and TG Therapeutics, Inc., a Delaware corporation, with a place of
business at 787 Seventh Avenue, New York, NY (“TGTX”). Rhizen and TGTX are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties”.

 

RECITALS

 

WHEREAS, Rhizen is a pharmaceutical company focused on the development of novel
inhibitors of PI3Kδ for the treatment of various B-cell proliferative diseases;

 

WHEREAS, TGTX is a biopharmaceutical company engaged in the development,
manufacturing and marketing of pharmaceutical products directed toward the
treatment of B-cell proliferative diseases;

 

WHEREAS, pursuant to that executed letter of intent between TGTX and Rhizen,
dated May 31, 2012, the Parties expressed desire to form a joint venture to
facilitate development of the PI3Kδ Products (as hereinafter defined) as a
single agent and in Combination (as defined below) with the option to convert to
a license;

 

WHEREAS, Rhizen and TGTX desire to establish a contractual Joint Venture (“JV”)
with an aim for broad collaboration under this Agreement for the joint
development and commercialization of the Product (as defined below) on a
worldwide basis, other than India, for the treatment of B-cell proliferative
diseases and such other indications as the Parties may jointly or unilaterally
develop with TGTX serving as the primary responsible Party for the clinical
development and commercialization and Rhizen serving as the primary responsible
Party for the non-clinical and CMC aspects of the program;

 

WHEREAS, the Parties desire that Rhizen manufacture or have manufactured
clinical and commercial supplies of the Finished Product (as hereinafter
defined) for use by both Parties hereunder;

 

WHEREAS, TGTX will be responsible for the clinical development and
commercialization of the Product in the Territory and the Parties shall share
equally (subject to adjustment as more fully described in this Agreement) in the
costs and efforts for the purpose of and in the profits resulting from marketing
and sales of the Product in the Territory in accordance with the terms set forth
below; and

 

WHEREAS, Rhizen desires to grant to TGTX exclusive rights to the Products and
certain backup compounds in the Territory for the joint development and
commercialization of the Product, under this Agreement, and TGTX desires to
obtain such rights for the joint development and commercialization of the
Product in each case on the terms set forth below;

 

NOW THEREFORE, in consideration of the foregoing premises and mutual promises,
covenants and conditions contained in this Agreement, the Parties agree as
follows:

 

 

 

   

ARTICLE 1

 

  

DEFINITIONS

 

  

The terms in this Agreement with initial letters capitalized, whether used in
the singular or the plural, shall have the meaning set forth below or, if not
listed below, the meaning designated in places throughout this Agreement.

 

1.1“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.

 

1.2“Affiliate” means, with respect to a particular Party, a person, corporation,
partnership, or other entity that controls, is controlled by or is under common
control with such Party. For the purposes of this definition, the word “control”
(including, with correlative meaning, the terms “controlled by” or “under the
common control with”) means the actual power, either directly or indirectly
through one or more intermediaries, to direct or cause the direction of the
management and policies of such entity, whether by the ownership of fifty
percent (50%) or more of the voting stock of such entity, or by contract or
otherwise.

 

1.3“Alliance Representative” has the meaning set forth in Section 24.

 

1.4“Backup Compound” means any two (2) compounds other than RP5264 as provided
in Exhibit G Controlled by Rhizen as of the Effective Date and/or developed
during the Term, which (i) falls within the chemical genus provided in Exhibit
B, and (ii) has targeted nanomolar potency (≤ 50 nM) in an in vitro enzyme assay
against the PI3Kδ target and targeted specificity of no less than 20x compared
to the PI3K α, β, and γ isoforms. However, this targeted specificity will not be
used to exclude consideration of individual backup compounds by JSC, or to limit
the ability of JSC to select particular backup candidates for further
development provided that targeted PI3Kδ specificity is no less than 8x compared
to PI3K α, β, and γ isoform. The initial list of the Backup Compounds is
attached hereto as Exhibit G and shall be updated from time to time by Rhizen
and provided to JSC promptly. The list of the Backup Compounds thus updated
shall include any compound which falls in the above definition which are
discovered or developed by Rhizen during the Term.

 

1.5“Bulk API” means any of the Compounds in bulk form.

 

1.6“Business Day” means any day other than (i) Saturday or Sunday or (ii) any
other day on which banks in New York, New York, United States, Switzerland, or
Mumbai, India are permitted or required to be closed.

 

1.7“Cause” means, for purposes of Section 13.(b), any unfavorable result from a
pre-clinical or Clinical Trial that, as reasonably determined by TGTX, causes
material concerns regarding the tolerability, safety or effectiveness of the
Product.

 

 

 

 

1.8“Change of Control” means (i) the acquisition, directly or indirectly, by any
person, entity or “group” (within meaning of Section 13(d)(3) or 14(d)(2) of the
Securities Exchange Act of 1934, as amended) by means of a transaction or series
of related transactions, of (a) beneficial ownership of fifty percent (50%) or
more of the outstanding voting securities of a Party (or the surviving entity,
as applicable, whether by merger, consolidation, reorganization, tender offer or
other similar means), or (b) all, or substantially all, of the assets of a
Party; or (ii) any consolidation or merger of a Party with or into any Third
Party, or any other corporate reorganization involving a Third Party, in which
those persons or entities that are stockholders of the Party immediately prior
to such consolidation, merger or reorganization (or prior to any series of
related transactions leading up to such event) own fifty (50%) or less of the
surviving entity’s voting power immediately after such consolidation, merger or
reorganization

 

1.9“Claims” has the meaning set forth in Section 11.1.

 

1.10           “Clinical Trial” means, collectively, any Phase I Clinical Trial,
Phase II Clinical Trial, Phase III Clinical Trial, or Phase IV Clinical Trial,
as applicable.

 

1.11           “CTA” means an application for Clinical Trial Authorization filed
with a Regulatory Authority in the Territory to undertake clinical trials of an
investigational new drug, the filing of which is necessary to commence or
conduct clinical testing of a pharmaceutical product in humans in the Territory
outside the U.S.

 

1.12           “Commercial Expenses” means those expenses incurred for the
purpose of the Commercialization of the Finished Product which are consistent
with the budget set forth in the Commercialization Plan and are specifically
attributable to the Commercialization of Finished Products, and shall consist of
(i) Cost of Goods Sold, (ii) Pre-Marketing Expenses, (iii) Marketing Expenses,
(iv) Distribution Expenses, (v) Clinical Phase IV and Related Expenses, (vi)
Regulatory Expenses, (vii) the Launch Expenses, (viii) Medical Science Liaison
Expenses, and (ix) amounts paid to Third Party licensors as described in Section
8.4 (as such terms are defined in Exhibit H). Commercial Expenses shall exclude
Development Expenses, even if incurred after the first commercial launch of a
Finished Product, and shall exclude any costs that are deductible from Net Sales
under the definition thereof (e.g., distributor fees). For avoidance of doubt,
any cost deducted in the calculation of Net Sales shall not be included in the
calculation of the Commercial Expenses.

 

1.13           “Commercialization”, with a correlative meaning for
“Commercialize”, means all activities undertaken before and after obtaining
Regulatory Approval relating specifically to the pre-marketing, launch,
promotion, marketing, sale, and distribution of a pharmaceutical product,
including: (a) strategic marketing, sales force detailing, advertising, medical
education and liaison, and market and product support; and (b) any Phase IV
Clinical Trials, and (c) all customer support and Product distribution,
invoicing and sales activities.

 

1.14           “Combination” shall mean a Co-administration of Product combining
a PI3K δ inhibitor together with any other active pharmaceutical ingredient.

 

1.15           “Commercialization Plan” has the meaning set forth in Section
5.2(b).

 

1.16           “Confidential Information” means, with respect to a Party, all
confidential Information of such Party that is disclosed to the other Party
under this Agreement, which may include specifications, know-how, trade secrets,
legal information, technical information, drawings, models, business
information, inventions, discoveries, methods, procedures, formulae, protocols,
techniques, data, and unpublished patent applications, in the each case whether
disclosed in oral, written, graphic, or electronic form. All Confidential
Information disclosed by either Party pursuant to the Mutual Confidential
Disclosure Agreement between the Parties dated April 27, 2012 shall be deemed to
be such Party’s Confidential Information disclosed hereunder.

 

 

 

 

1.17           “Control” means, with respect to any material, Information, or
intellectual property right, that a Party owns or has a license to such
material, Information, or intellectual property right and has the ability to
grant to the other Party access, a license, or a sublicense (as applicable) to
such material, Information, or intellectual property right on the terms and
conditions set forth herein without violating the terms of any agreement or
other arrangement with any Third Party existing at the time such Party would be
first required hereunder to grant to the other Party such access, license, or
sublicense.

 

1.18           “Detail” or “Detailing” means, with respect to the Product, the
communication by a Sales Representative during a sales call (a) involving
face-to-face contact, (b) describing in a fair and balanced manner the
Regulatory Authority-approved indicated uses and other relevant characteristics
of the Product, (c) using promotional materials in an effort to increase the
prescribing and/or hospital ordering preferences of the Product for its approved
indicated uses, and (d) made at such medical professional’s office, in a
hospital, at marketing meetings sponsored by a Party for the Product or other
appropriate venues conducive to pharmaceutical product informational
communication where the principal objective is to place an emphasis, either
primary or secondary, on the Product with such medical professional.

 

1.19           “Develop” or “Development” means all activities relating to
preparing and conducting preclinical testing, toxicology testing, human clinical
studies, regulatory affairs for obtaining the Regulatory Approvals, formulation
development, process development for manufacture and associated validation,
quality assurance and quality control activities (including qualification lots).
Development shall exclude all Phase IV Clinical Trials.

 

1.20           “Development Budget” means the budget of Development Expenses
expected to be incurred by the Parties in connection with the performance of the
Development Plan.

 

1.21           “Development Expenses” means (i) any amounts payable by a Party
for obligations to a Third Party for the Development performed on or after the
completion of the Early Development Period, which expenses are generally
consistent with the Development Plan, (ii) Manufacturing Development Expenses
incurred by either Party on or after the completion of the Early Development
Period, (iv) any amounts payable by a party for obligation to a third party for
Clinical Trials (v) the cost of supply of Finished Product or bulk API used for
the Development of the Product as well as the freight, postage, shipping,
transportation, insurance, warehousing and handling charges paid with regard to
such Finished Product or Bulk API.

 

1.22           “Development Plan” means the plan for Development in the
Territory. The initial Development Plan is attached hereto as Exhibit D and
covers through the completion of the Early Development Period. Exhibit D may be
from time to time added or modified by the JSC.

 

1.23           “Diligent Efforts” means, with respect to a Party’s obligation
under this Agreement to Develop or Commercialize a Product, the level of efforts
and resources required to carry out such obligation in a sustained manner
consistent with the efforts and resources a similarly situated biopharmaceutical
company devotes to a product of similar market potential, profit potential or
strategic value within its portfolio, based on conditions then prevailing i.e.
it shall mean the efforts required in order to carry out a task or objective in
a diligent and sustained manner without undue interruption, pause or delay,
which level is at least commensurate with the level of efforts that a
pharmaceutical company would devote to a product of similar potential and having
similar commercial and scientific advantages and disadvantages as compared to
the Product hereunder. Diligent Efforts requires (without limitation) that the
Party exerting such efforts (i) promptly assign responsibility for its
obligations to specific employee(s) or contractor(s) who are held accountable
for progress and monitor such progress, on an ongoing basis, (ii) set and
continue to seek to achieve specific and meaningful objectives for carrying out
such obligations, and (iii) consistently make and implement decisions and
allocate resources designed to advance progress with respect to such objectives,
in each case in a diligent manner.

 

 

 

 

1.24           “Dollar” means a U.S. dollar, and “$” shall be interpreted
accordingly.

 

1.25           “Early Development Period” shall be the time period from the
Effective Date of this agreement to the occurrence of the * Patient Event.

 

1.26           “EMA” means the European Medicines Agency, or any successor
thereto, which is responsible for coordinating the centralized system for
Regulatory Approval of pharmaceutical products in the European Union and the
European Economic Area and recommending to the European Commission (the “EC”)
that the EC grant Regulatory Approval of certain pharmaceutical products in the
EU and EEA under such centralized system.

 

1.27           “European Union” or “EU” means all of the European Union member
states as of the applicable time during the Term.

 

1.28           “FDA” means the U.S. Food and Drug Administration or its
successor.

 

1.29           “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as
amended.

 

1.30           “Field” means the prevention, treatment or amelioration of any
disease or condition in humans.

 

1.31           “Finished Manufacture” means the manufacture (and all reasonably
necessary testing, including release and, as appropriate, stability testing) of
Finished Product from Bulk API.

 

1.32           “Finished Product” means a Product that has been filled into
vials, syringes or capsules or manufactured into other pharmaceutical
presentations for administration, such as tablets or pills; finished and labeled
for use in clinical trials or for commercial purposes in accordance with the
applicable specifications and legal requirements.

 

1.33           “Financial Force Majeure” shall mean any situation outside of
either Party’s control that causes either Party to be unable to raise capital to
continue the Development of the Product for some period of time, including
without limitation, poor financing environment for biotech companies, product
failure or delay or any similar factors forcing a delay in appropriate financing
for either Party.

 

1.34           “First Commercial Sale” means, with respect to a particular
country, the first sale to a Third Party of the Product in such country after
Regulatory Approval has been obtained in such country.

 

1.35           “Fiscal Year” means the twelve (12)-month period commencing on
January 1 of a given year and ending on December 31 of the following year.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

1.36         “*Patient Event” shall mean the occurrence of the completion of
administration of Product to * patient in a Phase II trial (end of Early
Development Period) conducted by TGTX following establishment of optimal dosing
for either single agent or Combination administration.

  

1.37         “Generic Product” means a drug product that (i) contains the same
active ingredient as the Product where the Product is the reference-listed drug,
and (ii) is approved by a Governmental Authority pursuant to an Abbreviated New
Drug Application, an application under 21. U.S.C. §355(b) (2), or similar
application.

 

1.38         “Good Clinical Practices” or “GCP” means the then-current good
clinical practice standards, practices and procedures promulgated or endorsed by
the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good
Clinical Practice: Consolidated Guidance,” including related regulatory
requirements imposed by the FDA, and comparable regulatory standards, practices
and procedures in jurisdictions outside the U.S., in each case as they may be
updated from time to time.

 

1.39         “Good Laboratory Practices” or “GLP” means the then-current good
laboratory practice standards promulgated or endorsed by the FDA as defined in
21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside
the U.S., in each case as they may be updated from time to time.

 

1.40         “Good Manufacturing Practices” or “GMP” means the then-current good
manufacturing practices required by the FDA, as set forth in the FD&C Act and
the regulations promulgated thereunder, for the manufacture and testing of
pharmaceutical materials, and comparable Laws applicable to the manufacture and
testing of pharmaceutical materials in jurisdictions outside the U.S., including
without limitation 21 CFR 211 (Current Good Manufacturing Practice for Finished
Pharmaceuticals) and the guideline promulgated by the International Conference
on Harmonization designated ICH Q7A, entitled “Q7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients” and associated guidelines and
regulations, in each case as they may be updated from time to time.

 

1.41         “Governmental Authority” means any multi-national, federal, state,
local, municipal or other government authority of any nature (including any
governmental division, subdivision, department, agency, bureau, branch, office,
commission, council, court or other tribunal).

 

1.42         “IND” means (a) an Investigational New Drug application as defined
in the FD&C Act and applicable regulations promulgated thereunder by the FDA 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.

 

1.43         “IND/CTA Filing Conditions” means all mandatory preclinical
enabling studies have been completed and the JSC determines that the data are
sufficient for IND/CTA submission..

 

1.44         “IND/CTA Filing Deadline” means deadline determined by the JSC for
the submission of the IND/CTA once the “IND/CTA Filing Conditions” are
determined by the JSC to have been met.

 

1.45         “Information” means any data, results, technology, business
information, and information of any type whatsoever, in any tangible or
intangible form, including, without limitation, know-how, trade secrets,
practices, techniques, methods, processes, inventions, developments,
specifications, formulations, formulae, materials or compositions of matter of
any type or kind (patentable or otherwise), software, algorithms, marketing
reports, expertise, technology, test data (including pharmacological,
biological, chemical, biochemical, toxicological, preclinical and clinical test
data), analytical and quality control data, stability data, other study data and
procedures.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

1.46         “Internal Expenses” means any costs for employees, overhead, or
other internal handling incurred by a Party.

 

1.47         “Joint Know-How”: shall mean all Know-How developed or acquired by
either Party in performing its obligations pursuant to this Agreement that is
necessary or useful for the Development, manufacture or Commercialization of the
Product.

 

1.48         “Joint Steering Committee” or “JSC” means the committee formed by
the Parties as described in Section 2.3(a).

 

1.49         “Joint Inventions” has the meaning set forth in Section 9.1.

 

1.50         “Joint Patent” has the meaning set forth in Section 9.3(c).

 

1.51         “Laws” means all relevant laws, statutes, rules, regulations,
guidelines having the binding effect of law, ordinances and other pronouncements
having the effect of law of any federal, national, multinational, state,
provincial, county, city or other political subdivision, domestic or foreign.

 

1.52         “License Options” shall collectively refer to the TGTX License
Option and to the Rhizen License Option.

 

1.53         “Major Market(s)”: shall mean any of the following countries or
groups of countries: (i) the United States of America; (ii) Canada; (iii)
France, Germany, Italy, Spain, and the United Kingdom (each, a “Major European
Market”); (iv) Japan; and (v) Russia, Brazil or China (each, a “Major BRIC
Market”).

 

1.54         “Manufacturing Costs” has the meaning set forth in Exhibit H.

 

1.55         “Manufacturing Development” means any of the following with respect
to Bulk API or Finished Product: manufacturing process development and
validation, process improvements, associated analytical development and
validation and the manufacture and testing of clinical and stability or
consistency lots (including process development, qualification, QA, and test
batches).

 

1.56         “Manufacturing Development Expenses” means any costs incurred by a
Party to a Third Party after the Effective Date for the Manufacturing
Development.

 

1.57         “Marketing Authorization Application” or “MAA” means an application
for Regulatory Approval (but excluding Pricing Approval) in any particular
jurisdiction other than the U.S.

 

1.58         “NDA” means a “New Drug Application” (as more fully defined in 21
C.F.R. 314.5 et seq.) filed with the FDA or the equivalent application filed
with any other Regulatory Authority to obtain Regulatory Aproval for a Product
in a country or jurisdiction in the Territory.

 

1.59         “Net Sales” means, with respect to a particular time period, the
total amounts received or invoiced by TGTX and its Affiliates and Subcontractors
for sales of Finished Product made during such time period to unaffiliated Third
Parties, less the following deductions to the extent actually allowed or
incurred with respect to such sales:

 

 

 

 

(a)discounts, including cash, trade, and quantity discounts, retroactive price
reductions, charge-back payments, and rebates actually granted or administrative
fees actually paid to trade customers, patients (including those in the form of
a coupon or voucher), managed health care organizations, pharmaceutical benefit
managers, group purchasing organizations, federal, state, or local government
and the agencies, purchasers and reimbursers of managed health organizations,
pharmaceutical benefit managers, group purchasing organizations, or federal,
state or local government;;

 

(b)credits or allowances actually granted upon prompt payment or losses actually
incurred as a result of damaged goods, rejections or returns of such Product,
including in connection with recalls, and all other reasonable and customary
allowances and adjustments actually credited to customers.

 

(c)packaging, freight, postage, shipping, transportation, warehousing, handling
and insurance charges, credit card processing fees and any customary payments
with respect to the Products actually made to wholesalers or other distributors,
in each case actually allowed or paid for distribution and delivery of Product,
to the extent billed or recognized; and

 

(d)taxes, including sales taxes, excise taxes, value-added taxes, and other
taxes (other than income taxes), duties, tariffs or other governmental charges
levied on the sale of such Product, including, without limitation, value-added
and sales taxes.

 

Notwithstanding the foregoing, amounts received or invoiced by TGTX and its
Affiliates, and subcontractors for the sale of Finished Product among TGTX its
Affiliates and Subcontractors shall not be included in the computation of Net
Sales hereunder. In any event, any amounts received or invoiced by TGTX and its
Affiliates, or their Subcontractors shall be accounted for only once. Net Sales
shall be accounted for in accordance with US Generally Accepted Accounting
Principles (“GAAP”) consistently applied. Net Sales shall exclude any samples of
Product transferred or disposed of at no cost for promotional or educational
purposes, and the cost for such samples transferred or disposed of shall be
deemed to be included in the Commercial Expenses.

  

Further, the Parties agree to negotiate in good faith for an equitable
determination of the Net Sales of the Product in the event TGTX or its
Affiliates or its Subcontractors sells the Product in such a manner that gross
sales of the Product are not readily identifiable (e.g., for Product to be sold
as a combination product or bundling with other products). In addition, 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).

 

1.60“Notice to Rhizen” has the meaning set forth in Section 6.5.

 

1.61“Notice to TGTX” has the meaning set forth in Section 6.5.

 

1.62        “Patents” means (a) pending patent applications, including
provisional patents, issued patents, utility models and designs; and (b)
extensions, reissues, substitutions, confirmations, registrations, validations,
re-examinations, additions, continuations, continued prosecution applications,
requests for continued examination, continuations-in-part, or divisions of or to
any patents, patent applications, utility models or designs.

 

 

 

 

1.63“Patent Term Extension” means any term extensions, supplementary protection
certificates and equivalents thereof offering patent protection beyond the
initial term with respect to any issued patents.

 

1.64         “Patient” means any subject enrolled into any Phase I, II, or III
Clinical Trial and administered at least one dose of the Product.

 

1.65         “Phase I Clinical Trial” means a small scale trial of a
pharmaceutical product on subjects that generally provides for the first
introduction into humans of such product with the primary purpose of determining
safety, metabolism and pharmacokinetic properties, clinical pharmacology and any
other properties of such product as per the study protocol design, as required
by 21 C.F.R. 312(a) or a similar study in other countries.

 

1.66         “Phase II Clinical Trial” means a small scale clinical trial of a
pharmaceutical product on patients, including possibly pharmacokinetic studies,
the principal purposes of which are to make a preliminary determination that
such product is safe for its intended use and to obtain sufficient information
about such product’s efficacy to permit the design of further clinical trials,
as required by 21 C.F.R. 312(b) or a similar study in other countries.

 

1.67         “Phase III Clinical Trial” means one or more clinical trials on
sufficient numbers of patients, which trial(s) are designed to (a) establish
that a drug is safe and efficacious for its intended use; (b) define warnings,
precautions and adverse reactions that are associated with the drug in the
dosage range to be prescribed; and (c) support Regulatory Approval of such drug,
as required by 21 C.F.R. 312(c) or a similar study in other countries.

 

1.68         “Phase IV Clinical Trial” means a clinical trial of a Product,
possibly including pharmacokinetic studies, which trial is (a) not required in
order to obtain Regulatory Approval; (b) required by the Regulatory Authority as
mandatory to be conducted on or after the Regulatory Approval, and (c) conducted
voluntarily by a Party to enhance marketing or scientific knowledge of the
Product (e.g., providing additional drug profile, safety data or marketing
support information, or supporting expansion of Product Labeling) or conducted
due to a request or requirement of a Regulatory Authority.

 

1.69          “PI3Kδ Product” means Rhizen’s proprietary PI3Kδ inhibitor
designated as RP-5264 with the chemical structure attached hereto as Exhibit C
and any Two (2) Backup Compounds.

 

1.70          “PI3Kδ Inhibitor” shall mean a compound that binds to, and
selectively and specifically inhibits PI3Kδ isoform with no less than 20x
compared to PI3K α, β, and γ isoform.

 

1.71         “Pivotal Data” shall mean results from any Phase II Clinical Trial
or Phase III Clinical Trial that is designed to form the primary basis to
support Regulatory Approval for the Product.

 

1.72         “Pivotal Trial” shall mean any Phase II Clinical Trial or Phase III
Clinical Trial designed to yield Pivotal Data.

 

1.73         “P/L Share Percentage” shall be the percentage that each Party
contributes to Development Expenses and Commercial Expenses and shares in
Product Profit/Loss, pursuant to Section 3.4(a) and Section 8.2.

 

1.74         “Pricing Approval” means such approval, agreement, determination or
governmental decision establishing prices for the Product that can be charged to
consumers and shall be reimbursed by Governmental Authorities in regulatory
jurisdictions where the Governmental Authorities or Regulatory Authorities
approve or determine pricing of pharmaceutical products for reimbursement or
otherwise.

 

 

 

 

1.75         “Product” means a pharmaceutical preparation in any formulation
that contains the PI3Kδ Product(s) as an active ingredient.

 

1.76         “Product Assets” has the meaning set forth in Section 6.5.

 

1.77         “Product Infringement” has the meaning set forth in Section 9.5(b).

 

1.78         “Product Labeling” means (a) the full prescribing information for
the Product approved by the applicable Regulatory Authority, and (b) all labels
and other written, printed or graphic information included in or placed upon any
container, wrapper or package insert used with or for the Product.

 

1.79         “Product Profit/Loss” means the profits or losses resulting from
the Commercialization of the Product in the Territory and shall be equal to Net
Sales of the Product in the Territory less Commercial Expenses. For avoidance of
doubt, any cost deducted in the calculation of Net Sales shall not be included
in the calculation of the Commercial Expenses.

 

1.80         “Regulatory Approvals” means all approvals (including without
limitation supplements, amendments, and Pricing Approvals), licenses,
registrations or authorizations of any national, supra-national, regional, state
or local regulatory agency, department, bureau, commission, council or other
governmental entity, necessary for the manufacture, storage, import , transport,
distribution, marketing, use or sale of a pharmaceutical product in a given
regulatory jurisdiction.

 

1.81         “Regulatory Authority” means, in a particular country or
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or jurisdiction, including without
limitation, in the U.S., the FDA and any other applicable Governmental Authority
in the U.S. having jurisdiction over the Product, and, in the European Union,
the EMA and any other applicable Governmental Authority having jurisdiction over
the Product.

 

1.82         “Regulatory Materials” means regulatory applications, submissions,
notifications, registrations, Regulatory Approvals or other submissions made to
or with a Regulatory Authority that are necessary or reasonably desirable in
order to develop, manufacture, market, sell or otherwise commercialize the
Product in a particular country, territory or possession. Regulatory Materials
include, without limitation, INDs, CTAs and MAAs, NDAs, and amendments and
supplements for any of the foregoing, and applications for Pricing Approvals.

 

1.83         “Response Period” has the meaning set forth in Section 6.5.

 

1.84         “Rhizen Know-How”: shall mean (i) all Know-How that is Controlled
by Rhizen or its Affiliates on the Effective Date and during the Term, and (ii)
Rhizen’s interest in any Joint Know-How, in each case that is necessary or
useful for the Development, manufacture or Commercialization of the Product. For
clarity, Rhizen Know-How excludes the Rhizen Patents.

 

1.85         “Rhizen License Option” means the one time option that Rhizen has
to convert this Agreement into a Licensing Agreement pursuant to the terms
contained on Exhibit F (as defined below).

 

 

 

 

1.86         “Rhizen Patent” means any Patent, including Rhizen’s interest in
any Joint Patent, that (a) is Controlled by Rhizen or its Affiliates at any time
during the Term, and (b) claims the Product or its manufacture or use, or any
other invention that is otherwise necessary or useful for the Development,
Finished Manufacture or Commercialization of the Product. The list of Rhizen
Patents as of the Effective Date is attached hereto as Exhibit B, and shall be
from time to time amended and updated during the Term to incorporate the
then-current Rhizen Patents.

 

1.87         “Rhizen Technology” means the Rhizen Patents and Rhizen Know-How.

 

1.88         “Right of First Refusal” has the meaning set forth in Section 6.5.

 

1.89         “Sales Representative” means a pharmaceutical sales representative
conducting Detailing and other promotional efforts with respect to the Product,
including through a contract sales organizations.

 

1.90         “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.

 

1.91         “Subcontractor”: means a Third Party service provider engaged by
TGTX to perform contract services on behalf of TGTX or its Affiliates, where
TGTX retains a meaningful participatory role in the overall development and
commercialization of the Product (e.g., contract research or development
organizations, clinical sites performing clinical trials, universities and
scientific institutes, distributors in certain countries in the Territory, or
contract manufacturing organizations).

 

1.92         “Sole Inventions” has the meaning set forth in Section 9.1.

 

1.93         “Territory” means worldwide except India, its territories and
possessions, as adjusted from time to time pursuant to Section 3.5.

 

1.94         “TGTX Know-How”: shall mean (i) all Know-How that is Controlled by
TGTX or its Affiliates on the Effective Date and during the Term, and (ii)
TGTX’s interest in the Joint Know-How, in each case that is necessary or useful
for the Development, manufacture or Commercialization of the Product. For
clarity, TGTX Know-How excludes TGTX Patents.

 

1.95         “TGTX Patent” means any Patent, including TGTX’s interest in any
Joint Patent, that (a) is Controlled by TGTX or its Affiliates at any time
during the Term, and (b) claims the Product or its manufacture or use , or any
invention that is otherwise necessary or useful for the Development, Finished
Manufacture or Commercialization of the Product. The list of TGTX Patents as of
the Effective Date is attached hereto as Exhibit B, and shall be from time to
time amended and updated during the Term to incorporate the then-current TGTX
Patents.

 

1.96         “TGTX Technology” means the TGTX Patents and TGTX Know-How.

 

1.97         “Term” means the term of this Agreement, as determined in
accordance with Article 13.

 

1.98         “Third Party” means any entity other than Rhizen or TGTX or an
Affiliate of either of them.

 

 

 

 

1.99         “TGTX License Option” means the one time option that TGTX has to
convert this Agreement into a Licensing Agreement pursuant to the terms
contained on Exhibit F (as defined below).

 

1.100         “U.S.” means the United States of America and its possessions and
territories.

 

1.101         “Valid Claim” means (a) any claim of an issued unexpired patent
that (i) 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, and (ii) is not lost through an interference proceeding that
is unappealable or unappealed within the time allowed for appeal; or (b)
provided there is no Generic Product available in the market, a claim of a
pending Patent application, which claim has not been abandoned or finally
disallowed without the possibility of appeal.

 

 

 

  

ARTICLE 2

 

 

MANAGEMENT

 

  

Collaboration Overview. The Parties desire and intend to form a contractual JV
to collaborate with respect to the Development and Commercialization of the
Product as a single agent or Combination in the Territory, as and to the extent
set forth in this Agreement. There shall be two periods to the JV; the first
shall be the Early Development Period and the second being Continuation of JV
with an option to license (“Post Early Development Period”). During the Early
Development Period each party shall carry-out the activities set forth on
Exhibit D at their own cost and expense under the supervision and guidance of
the JSC. Following the completion of the Early Development Period (i.e.
beginning of Post Early Development Period), the Parties shall continue to
participate in the joint development of the Product with respect to specific
functions, as set forth in this Agreement including sharing of Development and
Commercial Expenses incurred in connection with the performance of the
Development Plan, as set forth in, and in accordance with, Article 3 unless
either party exercises its License Options (as set forth in, and in accordance
with Article 6) .

 

As an alternative to the continuation of JV post TGTX option both parties agree
to consider a 50:50 split in territories for continued development of PI3K δ
products. If an agreement cannot be reached on a territorial split, then the
50:50 cost/profit split will be maintained on a global basis as otherwise
contemplated herein including the development expenses referred to in Section
3.4.

 

TGTX shall be responsible for obtaining and maintaining Regulatory Approval of
the Product in the Territory. TGTX also shall be responsible for Commercializing
the Product in the Territory and share Product Profits/Losses based on each
Party’s P/L Share Percentage..

 

Each Party agrees and acknowledges that, as a JV they would be conducting joint
research efforts post Effective Date as assigned by the JSC, for example, but
not limited to, external studies such as efficacy on primary patient cells etc.
and studies such as improvement of API and formulation post IND submission etc;
both the parties shall share such expenses under development cost.

 

2.1Commitment to Development and Commercialization. Each Party agrees and
acknowledges that, by entering into this Agreement, it shall fund, as and to the
extent set forth in this Agreement, the Development Expenses and Commercial
Expenses, and shall use Diligent Efforts to conduct the activities assigned to
such Party in this Agreement and in the Development Plan, with the JSC
overseeing the implementation of such plan.

 

2.2Joint Steering Committee.

 

(a)Formation and Role. The Parties hereby establish a Joint Steering Committee
(sometimes referred to hereinafter as “JSC”) that shall monitor and coordinate
communication regarding the Parties’ performance under this Agreement to
Develop, obtain Regulatory Approval for and Commercialize the Product. The role
of the JSC shall be:

 

(i)to discuss and agree upon the Development Plan and Commercialization Plan,
and any proposed changes or amendments thereto that are not inconsistent with
this Agreement;

 

 

 

 

(ii)to review the overall strategy for Developing and seeking Regulatory
Approval for, manufacturing of, and Commercializing the Product in the
Territory;

 

(iii)to facilitate the exchange of information between the Parties with respect
to the activities hereunder for the Territory and to establish procedures for
the efficient sharing of information and materials necessary for each Party’s
Development, Product Development and Commercialization of the Product hereunder,
consistent with this Agreement;

 

(iv)to review the plan and the summary budget for the Development with respect
to the applicable countries in the Territory and provide comments regarding the
content and implementation of such plans;

 

(v)to monitor the Parties’ performance against the then-current Development Plan
and Commercialization Plans;

 

(vi)to inform the other party of up-coming material internal events and
decisions related to each such party’s obligations hereunder and communicate to
the other party on the results of such events and decisions taken;

 

(vii)to discuss material submissions to FDA and other Regulatory Authorities;

 

(viii)to create subcommittees as the JSC may find necessary or desirable from
time to time for implementation of the Development and Commercialization
hereunder;

 

(ix)to oversee the activities of subcommittees created under this Agreement, and
to seek to resolve any issues that such subcommittees cannot resolve;

 

(x)to provide a forum to evaluate strategies for obtaining, maintaining and
enforcing patent and trademark protection for the Product in the Territory; and

 

(xi)to perform such other functions as appropriate to further the purposes of
this Agreement, as determined by the Parties.

 

(b)Powers. The JSC shall have only the powers assigned expressly to it in this
Article 2 and elsewhere in this Agreement. The JSC shall not have any power to
amend, modify or waive compliance with this Agreement.

 

(c)JSC Membership. Each Party shall have an equal number of representatives on
the JSC, who initially shall be the eight (8) individuals as set forth in
Exhibit E. The JSC may change its size from time to time by mutual consent of
the Parties, provided that the JSC shall at all times consist of an equal number
of representatives of each of Party. Either Party may designate substitutes for
its representatives if one (1) or more of such Party’s designated
representatives are unable to be present at a meeting. From time to time each
Party may replace its representatives by written notice to the other Party
specifying the prior representative(s) and their replacement(s). TGTX shall
select one (1) of its representatives as the initial chairperson of the JSC. The
chairperson shall be responsible for (i) calling meetings, and (ii) preparing
and circulating an agenda for the upcoming meeting, but shall have no special
authority over the other members of the JSC, and shall have no additional voting
rights.

 

 

 

 

2.3JSC Meetings, Decisions and Actions.

 

(a)Meetings. The JSC shall hold at least four (4) meetings per year (at least
one (1) of which shall be held in person) on such dates at such times each year
as it elects. Meetings of the JSC shall be effective only if at least two (2)
representatives of each Party are present or participating. Each Party shall
bear the expense of its respective members’ participation in JSC meetings. The
Chairperson of the JSC shall be responsible for preparing and issuing minutes of
each such meeting within fifteen (15) days thereafter. Such minutes shall not be
finalized until each Party reviews and confirms the accuracy of such minutes in
writing; provided that any minutes shall be deemed approved unless a member of
the JSC objects to the accuracy of such minutes within thirty (30) days after
the circulation of the minutes by the Chairperson. With the prior consent of
both Parties’ representatives (such consent not to be unreasonably withheld or
delayed), other representatives of each Party or Third Parties involved with the
Products may attend meetings as nonvoting participants, subject to appropriate
agreements of confidentiality. All final JSC minutes must be signed by both
Parties.

 

(b)Decision Making. Except as expressly provided in this Section 2.3, actions to
be taken by the JSC shall be taken only following unanimous vote, with each
Party having one (1) vote.

 

(c)Disputes. If the members of the JSC cannot reach a unanimous decision with
respect to matters delegated to it under this Article 2 for a period in excess
of Fifteen (15) Business Days from the discussion at the JSC, unless the Parties
agree to prolong such time period, the matter shall be referred to two
appropriately qualified senior executive officers of the Parties, who shall
attempt resolution by good faith negotiations for at least thirty (30) days
after such referral. If the senior executive officers designated by the Parties
are not able to resolve such dispute within such thirty (30) day period, then
such dispute shall be finally decided by an independent advisory board to the
JSC, the members of which shall be agreed upon by both Parties at the time of
the dispute. Notwithstanding anything else to the contrary herein, any decision
with respect to the Development Plan or the Commercialization Plan that
disproportionately allocates a burden to or disproportionately limits the
profits of one Party relative to the other Party (e.g., one Party is required to
bear more than 50% of the cost) shall not be made without the consent of the
disproportionately burdened Party.

 

(d)Location of in-person meetings. Meetings to be held in person shall be held
either (i) in a US city which is hosting a medical conference that the Parties
are otherwise attending or (ii) at a mutually agreeable city that is located
approximately equidistant from each Parties principal place of business. The
Parties hereby designate Zurich, Switzerland as a mutually acceptable city, if
another more convenient location cannot be agreed upon for an in person meeting.

 

2.4Alliance Representative. Each Party has designated on Exhibit E an
appropriate employee to facilitate communication and coordination of the
Parties’ activities under this Agreement relating to the Product and to provide
support and guidance to the JSC (each, an “Alliance Representative”). From time
to time each Party may replace its Alliance Representative by prior written
notice to the other Party specifying the replacement.

 

 

 

  

ARTICLE 3

 

  

CLINICAL AND NON-CLINICAL PRODUCT DEVELOPMENT

 

  

3.1Overview. The Parties shall Develop the Product in the Territory as provided
in this Article 3 and in accordance with the then-current Development Plan. The
initial Development Plan sets forth the Development activities to be performed
by each Party under this Agreement during the Early Development Period and is
attached hereto as Exhibit D. Within 90 days following the completion of the
Early Development Period, either party shall provide the JSC with an updated
Development Plan and any future updates thereof shall be submitted to the JSC
for review and approval in accordance with Article 2. Without limiting the
generality of the foregoing, the Parties shall have the following Development
obligations for the Product:

 

(a)Rhizen shall be responsible for all ongoing non-clinical, Manufacturing
Development, preclinical and other activities regarding the Product that are
listed on Exhibit D and shall provide TGTX the data obtained therein as provided
in Section 4.1; and

 

(b)TGTX shall be responsible for implementing the clinical trials of the Product
for Regulatory Approval listed in Exhibit D and pursuant to the Development
Plan.

 

3.2Development Plan. The initial Development Plan through the Early Development
Period has been agreed upon by the Parties and is attached hereto as Exhibit D
and incorporated herein by reference. Each party will be responsible for
conducting those activities in the development plan that are assigned to such
party under the development plan. Upon the completion of the Early Development
Period, the Development Plan will be updated by the JSC and shall contain the
following information for the Product, to the extent such information is
available:

 

(a)the proposed overall plan for Development for the Product to support
Regulatory Approval in the U.S. ;

 

(b)the Development Budget, which shall include a two (2)-year rolling budget of
Development Expenses (including a detailed budget for the first year thereof and
an estimated budget for the subsequent year based on the then-current
Development Plan);

 

(c)scope and target timelines for the Parties’ performance of all studies and
activities within the Development, including without limitation, clinical trial
protocols, additional preclinical tests (including any and all carcinogenicity
and toxicology studies), Finished Product stability studies, enrollment numbers
and submission dates; and

 

(d)the Parties’ forecasts of their respective needs for preclinical or clinical
supply of such Finished Product and/or Bulk API.

 

3.3Updates to Development Plan and Development Budget. The JSC shall review the
development plan on an ongoing basis and may update the development plan as the
JSC determines consistent with article 2 hereof. As early as necessary in each
year beginning with the first full Fiscal Year after the completion of the Early
Development Period, the JSC shall update and prepare the Development Plan and
Development Budget for the Product for the following Fiscal Year to take into
account completion, commencement or cessation of Development activities not
contemplated by the then-current Development Plan, and submit such proposed
Development Plan to the JSC no later than November 1 of such year. The JSC shall
endeavor to finalize the updated U.S. Development Plan by December 15 of each
year. As necessary throughout the Fiscal Year, the JSC shall review the
Development Plan and any changes thereto proposed by either Party through the
JSC, and the JSC shall be decide on such changes as set forth in Article 2
hereof.

 

 

 

 

3.4Development Expenses.

 

(a)The Parties shall share any and all Development Expenses as follows:

 

(i)During the Early Development Period, each party shall bear the expenses of
the Development activities delegated to them on Exhibit D;

 

(ii)Following the Early Development Period, total Development Expenses shall be
borne based on each Parties P/L Share Percentage;

 

The initial P/L Share Percentages of the Parties are as follows:

 

TGTX: *%

 

Rhizen: *%

 

If either party fails to pay their proportionate share of Development Expenses
and Commercial Expenses prior to First Commercial Sale, then the P/L Share
Percentages shall be adjusted as set forth herein in Sections 3.4(a)(vi). The
adjustment of such Party’s P/L Share Percentages shall be the sole remedy for
such failure.

 

(iii)Each Party shall calculate and maintain records of all relevant Development
Expenses incurred by it for the Development of the Product, in accordance with
procedures to be agreed upon between the Parties. The Parties understand and
agree that Internal Expenses shall not be shared, subject to Section 3.4(a)(iv).

 

(iv)Within ten (10) Business Days following the end of each calendar quarter,
TGTX shall submit to Rhizen a written report setting forth in reasonable detail
the Development Expenses it has incurred in such calendar quarter. Within ten
(10) Business Days following the end of each calendar quarter, Rhizen shall
submit to TGTX a written report setting forth in reasonable detail the
Development Expenses it has incurred in such calendar quarter.

 

(v)Within twenty (20) Business Days following the end of each calendar quarter,
TGTX shall submit to Rhizen a written report setting forth in reasonable detail
the calculation of all Development Expenses for the Product, and the calculation
of any net amount owed by Rhizen to TGTX or by TGTX to Rhizen, as the case may
be, in order to ensure the appropriate sharing of Development Expenses in
accordance with the provisions of Section 3.4(a). The net amount payable shall
be paid to the other Party, as the case may be, within thirty (30) days
following the receipt of the written report; provided, that, in the event of a
dispute, any amounts not in dispute shall be paid and the disputing Party shall
provide written notice without undue delay after receipt of the written report
in question to the other, specifying such dispute and explaining the basis of
the dispute. The Parties shall promptly thereafter meet and negotiate in good
faith a resolution to such dispute and, promptly upon resolution of such
dispute, the applicable Party shall make the agreed-upon payment. If such
dispute is not resolved within forty-five (45) days after delivery of a notice
of dispute with respect thereto to the other Party, the disputing Party may
audit the other Party in accordance with the provisions of Section 8.9. For
clarity, nothing in this Section 3.4(a) (v) shall serve to limit a Party’s
ability to seek recourse for billing errors discovered after payment is made.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

(vi)If hereunder, either Party fails to contribute their portion of the
Development Expenses or Commercial Expenses, such Party’s P/L Share Percentage
shall be reduced pro rata to the extent of the Development Expenses or
Commercial Expenses that they do not fund as a percentage of the cumulative
Development Expenses and Commercial Expenses to date, however, in no event shall
Rhizen’s P/L Share Percentage be reduced below *%. In the event of failure to
pay allocated Development Expenses or Commercial Expenses on time as set forth
above, each party shall be afforded six (6) months to make a catch-up payment.
However, upon receipt of Pivotal Data for the Product and any time thereafter,
no catch-up payments will be allowed by either Party.

 

(vii)The Parties acknowledge and agree that Internal Expenses shall not be
reimbursed or shared except as set forth in this Section 3.4(a)(vi). However, in
connection with the Development, either Party may refer to the JSC to provide
certain specified Development activities using internal resources as opposed to
out-sourcing such activity to a Third Party and to include such Internal
Expenses as the Development Expenses to be shared hereunder. Any such referral
shall include a sufficiently detailed description of the proposed Development
activities, the associated Internal Expenses, and, where possible, the costs and
expenses to be paid to Third Party contractors if the same Development
activities were contracted out to them. If the JSC approves (which approval
shall not be unreasonably withheld) such Internal Expenses as the Development
Expenses, then the proposing Party shall obtain reimbursement as the Development
Expenses for the Internal Expenses actually incurred (in an amount not to exceed
any approved amount) in performing such Development activities for the Product.

 

(b)Any reimbursement payments made pursuant to this Section 3.4 shall be subject
to the general payment procedures set forth in Sections 8.5 through 8.8,
inclusive.

 

3.5Performance; Diligence.

 

(a)Each Party shall devote Diligent Efforts to the Development of the Product
consistent with the then-current Development Plan and in accordance with this
Agreement.

 

(b)Without limiting the generality of Section 3.5(a), TGTX shall devote Diligent
Efforts to obtaining Regulatory Approval of the Product in the Territory.

 

 

* Confidential material redacted and filed separately with the Commission.

  

 

 

 

(c)Rhizen shall use Diligent Efforts to ensure their Development and
Commercialization activities in India are not detrimental in any way, or
negatively impact Development and Commercialization of the Product outside
India. Each Party shall conduct its Development activities under this Agreement
in good scientific manner and in compliance with all applicable Laws, including
without limitation applicable GCP, GLP, and GMP.

 

3.6Records, Reports and Information. Each Party shall maintain complete, current
and accurate records of all work conducted by it under the Development Plan and
all data and other Information resulting from such work. Such records shall
fully and properly reflect all work done and results achieved in the performance
of the Development Plan in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes. Each Party shall have the right
to review such records maintained by the other Party at reasonable times, upon
written request. Each Party shall provide written reports in English to the JSC
on its Development and regulatory activities with the Product pursuant to the
Development Plan on a quarterly basis at the end of each calendar quarter, at a
level of detail reasonably sufficient to enable the other Party to determine the
reporting Party’s compliance with its Diligent Efforts obligation pursuant to
Section 3.5.

 

3.7Inclusion of Backup Compounds. If, during the Term, Rhizen develops potential
Backup Compounds (as defined herein above), then the JSC shall have the right to
include such Backup Compounds in the definition of Product for the purposes of
this Agreement. During the Term, Rhizen shall provide the JSC on an annual basis
a report stating the results of any pre-clinical studies conducted for such a
Backup Compound, if any, as well as all other material results and data with
respect to such potential Backup Compound(s), if any, for JSC’s evaluation. This
Section 3.7 shall apply on a Backup Compound-by-Backup Compound basis.

 

3.8Manufacturing Development.

 

(a)Duties. Rhizen shall be responsible for the Manufacturing Development for the
Bulk API and Finished Product, itself or through a Third Party contract
manufacturer. Notwithstanding the foregoing, TGTX shall have the right to
conduct any aspect of the Manufacturing Development, including obtaining
pre-clinical, clinical or commercial supply from a Third-party, if it can do so
at a price that is less than that obtained by Rhizen or if an alternate
manufacturing source is required due to regulatory or technical reasons. Rhizen
shall reasonably cooperate with TGTX for such purposes, which cooperation shall
include the transfer to TGTX of technology Controlled by Rhizen relating to
activities that were conducted by Rhizen as of the Effective Date and
thereafter, if any, with respect to any such Finished Manufacture.

 

(b)Costs. Manufacturing Development Expenses are included in Development
Expenses and, as a result, following the Early Development Period, shall be
shared pursuant to Section 3.4. Additionally, despite the fact that
Manufacturing Development Expenses are to be borne by Rhizen during the Early
Development Period, if drug supply is required to be supplied to a clinical
trial participant(s) after the completion of the Clinical Trial conducted during
the Early Development Period, then the parties shall share those expenses
pursuant to 3.4.

 

(c)Comparator Drugs. Each Party conducting pre-clinical and clinical trials for
the Product shall be responsible for procuring all of its requirements of all
comparator drugs or placebos necessary for conducting such trials. The costs and
expenses incurred by either Party for procuring the comparator drugs or placebos
for the Development shall be included in the Development Expenses.

 

 

 

 

   

ARTICLE 4

 

  

REGULATORY MATTERS

 

  

4.1Transfer of Data and Regulatory Materials.

 

(a)Existing Data. To the extent not already provided, within reasonable time
frame and as decided by JSC, either party shall provide copies of all
preclinical and non-clinical data, for Product either as single agent or in
combination, relevant to an IND or CTA submission. TGTX shall have the full
right on behalf of JV, without any additional consideration, to use any and all
such data and reports supplied by Rhizen under this Section 4.1(a) in connection
with the Development and/or Commercialization of the Product in the Territory,
including the incorporation of such data or reports in any regulatory
submissions, including MAA and NDA submissions.

 

(b)Future Data. Either Party shall, in a timely manner and compliant with
requirements of the FDA, the EMEA, and any other applicable Regulatory
Authority, provide copies of all preclinical, non-clinical, analytical,
manufacturing, and clinical data relating to the Product either as single agent
or in combination, generated by or on behalf of the JV in connection with the
performance of the Development Plan and relevant to any regulatory submission;
provided, that information regarding adverse events and serious adverse events
shall be provided as set forth in Section 4.5. If the receiving Party requests
that copies of such data be provided in compliance with requirements of other
Regulatory Authorities, the disclosing Party shall reasonably consider such
request. Rhizen shall have the full right, without any additional consideration,
to use any and all such data and reports in connection with the Development of
the Product in India and, TGTX on behalf of the JV shall have the full right,
without any additional consideration, to use any and all such data and reports
in connection with the Development and/or the Commercialization of the Product
in the Territory, including the incorporation of such data or reports in any
regulatory submissions including MAA and/or NDA submissions.

 

(c)Clarification. All preclinical, non-clinical, analytical, manufacturing, and
clinical data and associated reports disclosed by one Party to the other under
this Agreement shall be deemed Confidential Information of the disclosing Party.
Except as otherwise provided in this Section 4.1, the receiving Party may use
such data solely for the purpose of developing the Product, seeking and
obtaining Regulatory Approval and Commercializing the Product as permitted in
this Agreement, subject to Article 12.

 

4.2Regulatory Submissions and Approvals.

 

(a)In General. The Parties intend to seek Regulatory Approval in the first
instance in the U.S. and EU and thereafter the remainder of the Territory
wherein the JSC determines it is worthwhile to Develop and Commercialize the
Product. The Parties also intend that each Party with responsibility for
generating data will cooperate fully with the other Party to make that data
available for preparation and submission of Regulatory Materials. Subject to the
terms of this Article 4:

 

(i)TGTX, in consultation with JSC, shall be responsible for assembling,
submitting and maintaining any source regulatory submission components and
compiled submissions of the Regulatory Materials to be used in support of
Regulatory Approval for the Product in the Territory in accordance with such
regulatory strategy, including without limitation NDAs, MAAs and associated
documents;

 

 

 

 

(1)Rhizen shall have primary responsibility for providing components of
Regulatory Materials relating to Bulk API and Finished Product in support of
Regulatory Approval;

 

(2)TGTX shall have primary responsibility for providing the content of
Regulatory Materials relating to clinical data supporting Regulatory Approval;

 

(ii)TGTX, in consultation with JSC, shall be primarily responsible for preparing
and submitting to Regulatory Authorities INDs, CTAs and all associated
submissions (e.g., IMPDs, safety alerts, protocol submissions, etc.) for the
Product and for carrying out clinical protocols in support of Regulatory
Approval in the Territory under said INDs and CTAs in both the U.S. and EU in
accordance with such regulatory strategy.

 

(b)Costs and Expenses. Until completion of Early Development Period, all
expenses associated with preparation, submission and maintenance of regulatory
materials for the Territory will be borne by TGTX. Following the Early
Development Period, any Development Expenses to the extent required for the
Parties to prepare, submit and maintain all Regulatory Materials in the
Territory shall be treated as Development Expenses and shared by the Parties in
accordance with Section 3.4.

 

(c)Rights of Reference to Regulatory Materials. Each Party hereby grants to the
other Party a right of reference to all Regulatory Materials filed by such Party
for Product as follows: The right of reference granted to TGTX herein shall be
solely for the purpose of TGTX obtaining Regulatory Approval for the Product in
the Territory. The right of reference granted to Rhizen herein shall be solely
for the purpose of obtaining Regulatory Approval for the Product in India. Each
Party shall refer the Regulatory Materials filed by the other Party for Product
as feasible (e.g., for avoiding redundancy of work as far as possible).

 

4.3Reporting and Review.

 

(a)Each Party shall provide the other Party, in a timely manner, with copies of
all Regulatory Approvals it receives for the Product.

 

(b)Each Party shall provide the other Party, in a timely manner, with copies of
any notices of non-compliance with Laws in connection with the Product or its
activities related to the Product (e.g., warning letters or other notices of
alleged non-compliance), audit notices, notices of initiation by Regulatory
Authorities of investigations, inspections, detentions, seizures or injunctions
concerning the Product (or its manufacture, distribution, or facilities
connected thereto), notice of violation letters (i.e., an untitled letter),
warning letters, service of process or other inquiries and copies of any
communication in response to the Regulatory Authority.

 

4.4Communications. Except as may be required by Laws, only the Party that holds
the IND, CTA, NDA, MAA, etc. in a particular country or territory shall
communicate regarding the Product with any Regulatory Authority having
jurisdiction in such country or territory. If the Party not holding the IND,
CTA, NDA, MAA, etc. is required to make such a communication by a Regulatory
Authority in the Territory, then such Party shall provide immediately to the
other Party notice of such order.

 

 

 

 

4.5Adverse Event Reporting and Safety Data Exchange. The Parties agree that TGTX
shall be responsible for the establishment of the global safety database for the
Product in the Territory and the monitoring of all clinical experiences and
submission of all required reports throughout clinical Development and
Commercialization of the Product in the Territory, and that Rhizen shall have
primary responsibility for the monitoring of all clinical experiences and
submission of all required reports concerning the Product in India. In each
Party’s respective territory, such Party will be obligated, as part of their
monitoring of all clinical experiences, to obtain follow-up information on any
incomplete safety reports generated throughout the non-clinical and clinical
Development and Commercialization of the Product.

 

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 Application,
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 4.5 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. Pursuant to Section 5.1, TGTX shall have sole responsibility for
Commercialization of the Product in the Territory, and as such, prior to
Commercialization of the Product, TGTX shall be solely responsible for the
review and approval of safety information for inclusion in the Product Labeling
in the Territory.

 

4.6Regulatory Inspection or Audit.

 

(a)Audit of TGTX.

 

(i)If a Regulatory Authority desires to conduct an inspection or audit of TGTX’s
facility, or a facility under contract with TGTX, with regard to Bulk API or the
Finished Product, TGTX shall promptly notify Rhizen and permit and cooperate
with such inspection or audit, and shall cause the contract facility to permit
and cooperate with such Regulatory Authority during such inspection or audit.
Rhizen shall have the right to have a representative observe such inspection or
audit and Rhizen shall, if requested by TGTX, assist TGTX in preparing for,
facilitating or enabling such inspection or audit. Following receipt of the
inspection or audit observations of such Regulatory Authority (a copy of which
TGTX shall immediately provide to Rhizen), TGTX shall prepare a draft response
to any such observations in English, in consultation with Rhizen, and TGTX shall
prepare and file the final response with such Regulatory Authority, and shall
provide a copy of such response to Rhizen.

 

 

 

 

(b)Audit of Rhizen.

 

(ii)If a Regulatory Authority desires to conduct an inspection or audit of
Rhizen’s facility, or a facility under contract with Rhizen, with regard to the
Bulk API or Finished Product, Rhizen shall promptly notify TGTX and permit and
cooperate with such inspection or audit, and shall cause the contract facility
to permit and cooperate with such Regulatory Authority during such inspection or
audit. TGTX shall have the right to have a representative observe such
inspection or audit and TGTX shall, if requested by Rhizen, assist Rhizen in
preparing for, facilitating or enabling such inspection or audit. Following
receipt of the inspection or audit observations of such Regulatory Authority (a
copy of which Rhizen shall immediately provide to TGTX), Rhizen shall prepare a
draft response to any such observations in English, in consultation with TGTX,
and Rhizen shall prepare and file the final response with such Regulatory
Authority, and shall provide a copy of such response to TGTX provided, however,
if it is a Regulatory Authority in the Territory and the audit is specific to
the Product or the Bulk API, then TGTX shall prepare, with the assistance of
Rhizen, and file the final response and provide a copy to Rhizen.

 

(c)Audit Procedures. In any event, each Party shall notify the other Party
within forty-eight (48) hours of receipt of notification from a Regulatory
Authority of the intention of such Regulatory Authority to audit or inspect
facilities being used to conduct manufacture of Bulk API or Finished Manufacture
of the Finished Product. Each Party shall also provide the other Party with
copies of any written communications received from Regulatory Authorities with
respect to such facilities within seventy-two (72) hours of receipt.

 

4.7Recalls and Voluntary Withdrawals. JSC shall assign responsibility to TGTX
for providing its internal standard operating procedures (“SOPs”) for conducting
any recall, field alert, product withdrawal or other field action relating to
the finished product reasonably in advance of the First Commercial Sale of any
Product in the Territory to the other party. If either Party becomes aware of
information relating to any Product that indicates that a unit or batch of
Finished Product or Bulk API may not conform to the specifications therefor, or
that potential adulteration, misbranding, or other issues have arisen that
relate to the safety or efficacy of the Product, it shall promptly so notify the
other Party. The JSC shall meet to discuss such circumstances and to consider
and decide appropriate courses of action, which shall be consistent with the
internal SOP of TGTX, TGTX shall have the right and responsibility to control
any product recall, field correction, or withdrawal of any Product in the
Territory that is required by Regulatory Authorities in the Territory, and the
allocation of reasonable expenses incurred in connection with such recall
between the Parties shall be made as follows: (i) if the recall is primarily due
to failure by Rhizen or its contract manufacturer to manufacture the finished
product in accordance with the agreed upon specification and applicable laws,
then Rhizen shall bear all such expenses, (ii) if the recall is primarily due to
a failure by TGTX to comply with its obligation under this agreement or the
commercial supply agreement, including with respect to the labeling, possession,
storage or distribution of the finished product, then TGTX shall bear all such
expenses, and (iii) otherwise, such expenses shall be treated as Commercial
Expenses. In addition, TGTX shall have the right, at its discretion, to conduct
any product recall, field correction or withdrawal of any Product in the
Territory that is not so required by such Regulatory Authorities but that TGTX
deems to be appropriate, and the allocation of expenses incurred in connection
with such recall between the Parties shall be as set forth in the immediately
preceding sentence. TGTX shall maintain complete and accurate records of any
recall in the Territory for such periods as may be required by applicable Laws,
but in no event for less than three (3) years. If the parties are unable to
agree on which party is responsible for the cost of the recall pursuant to this
section 4.7, the parties agree to submit a sample of the finished product to an
independent third party analyst to determine the cause of the defect. The cost
of the report of the independent analyst will be paid by the party against which
the report is unfavorable.

 

 

 

  

ARTICLE 5

 

  

COMMERCIALIZATION

 

  

5.1Commercialization in the Territory. TGTX shall have the sole right and
responsibility for Commercializing the Product in the Territory, as provided in
this Article 5. TGTX shall book all sales of the Product in the Territory. The
Parties shall share equally all Commercial Expenses incurred by the Parties in
connection with such Commercialization in accordance with the procedures
described in Section 8. TGTX shall use diligent efforts to minimize Commercial
Expenses.

 

5.2Commercialization Plans. The strategy for the commercial launch of the
Product in the Territory shall be described in a comprehensive plan that
describes the pre-launch, launch and subsequent Commercialization activities and
budget for the Product (including, if available, advertising, education,
planning, marketing, sales force training and allocation, distribution, pricing,
and reimbursement) (the “Commercialization Plan”). TGTX shall present an initial
Commercialization Plan to the JSC at least twelve (12) months prior to the then
current date of expected Regulatory Approval for such Product in the Territory
(the “Approval Date”). The initial Commercialization Plan and subsequent
revisions thereto, which revisions shall be reviewed and approved by the JSC
from time to time, shall contain such information as the JSC believes necessary
for the successful commercial launch of such Product and shall generally conform
to the level of detail utilized by the Parties in preparation of their own
product commercialization plans. The Commercialization Plan shall be deemed
Confidential Information of both Parties, and each Party shall use such
Commercialization Plan only to the extent necessary to carry out its
Commercialization activities for the Product. From time to time as reasonably
necessary during the term of Commercialization of a Product in the Territory,
the JSC shall update the Commercialization Plan subject to the provisions of
article 2 and 3 hereof .

 

5.3Pricing Approvals; Pricing. TGTX shall have the responsibility to determine
all pricing of the Product in the Territory provided Rhizen has an opportunity
to review and comment upon TGTX’s proposed price of the Product or any material
modification thereof and shall consider Rhizen’s comments in good faith. TGTX
shall use its Diligent Efforts to maximize Net Sales in the aggregate and with
respect to each individual sale. Any discounts on sales where the Product is
bundled with other products will be apportioned among all of the products in the
bundle such that the discount on the Product is not more than the average
discount provided to all the products. Both the parties shall keep reasonably
informed on an ongoing basis of current Product pricing by regular reports to
the JSC no less frequently than such committee is required to meet pursuant to
Section 2.3.

 

5.4Sales and Distribution. TGTX shall be solely responsible for handling all
returns, order processing, invoicing and collection, distribution, and inventory
and receivables for the Product throughout the Territory. Rhizen may not accept
orders for the Product or make sales for its own account or for TGTX’s account.
If Rhizen receives any order for the Product, it shall refer such orders to TGTX
for acceptance or rejection. TGTX shall have the right and responsibility for
establishing and modifying the terms and conditions with respect to the sale of
the Product throughout the Territory, including any terms and conditions
relating to or affecting the price at which the Product shall be sold, discounts
available to any third party payers (including, without limitation, managed care
providers, indemnity plans, unions, self-insured entities, and government payer,
insurance or contracting programs such as Medicare, Medicaid, or the U.S. Dept.
of Veterans Affairs), any discount attributable to payments on receivables,
distribution of the Product, and credits, price adjustments, or other discounts
and allowances to be granted or refused provided that Rhizen had the opportunity
to review and comment on such modifications thereof and TGTX shall consider
Rhizen’s comments in good faith.

 

 

 

 

5.5TGTX Performance; Diligence.

 

(a)Level of Efforts in the Territory. TGTX shall devote Diligent Efforts to
obtaining Regulatory Approval and thereafter Commercializing the Product in the
Territory. Without limiting the generality of the foregoing, TGTX shall devote
Diligent Efforts to Commercialize the Product in the Territory in accordance
with the Commercialization Plan.

 

(b)Time to Launch Product. In addition to the requirements under Section 5.5(a),
TGTX shall achieve First Commercial Sale of each Product: within a reasonable
time after, but in no event more than 12 months after, the date on which Pricing
Approval is granted for such Product in the U.S. and EU, provided that such
Pricing Approval is deemed by TGTX, in consultation with the JSC, to be
sufficiently profitable for Commercialization in such country. If, however,
despite using diligent efforts it becomes difficult for TGTX to comply with the
above-mentioned time limitations, then TGTX shall, without delay, inform Rhizen
of the fact and explain the cause of such delay, and, such time limitations
shall be extended to a reasonable extent as agreed between the Parties.

 

(c)Territory Reports. Following First Commercial Sale, TGTX shall present a
written report to Rhizen at least semi-annually (and no later than June 30th and
December 31st of each year) summarizing TGTX’s overall Commercialization
activities undertaken with respect to the Product in or for the Territory
pursuant to this Agreement, covering subject matter at a level of detail
reasonably sufficient to enable Rhizen to determine TGTX’s compliance with its
Diligent Efforts obligation pursuant to this Section 5.5.

 

5.6Compliance. Each Party shall comply with all applicable Laws relating to
activities performed or to be performed by such Party (or its Affiliates,
contractor(s) or sublicensee(s)) under or in relation to the Commercialization
of the Product pursuant to this Agreement. Each Party represents, warrants and
covenants to the other Party that, as of the Effective Date and during the Term,
such Party and its Affiliates have adequate procedures in place: (i) to ensure
their compliance with such Laws; (ii) to bring any noncompliance therewith by
any of the foregoing entities to its attention; and (iii) to promptly remedy any
such noncompliance. TGTX shall be responsible for ensuring that all government
reporting, sales, marketing and promotional practices with respect to the
Product comply with applicable Laws. All promotional materials and labeling used
by or on behalf of TGTX for the Product shall comply with applicable Laws and
regulations.

 

 

 

 

ARTICLE 6

 

 

LICENSE AND LICENSE OPTIONS

 

  

Licenses to TGTX under Rhizen Technology. Subject to the terms and conditions of
this Agreement, Rhizen hereby grants TGTX an exclusive license under the Rhizen
Technology without the right to sublicense except as expressly permitted by
Section 6.4 hereof, to Develop, use, sell and offer for sale, and import the
Product in the Territory, in accordance with this Agreement. Rhizen retains the
exclusive right to manufacture the Product, including the Bulk API and Finished
Product in the Territory.

 

6.1No Implied Licenses. Except as explicitly set forth in this Agreement,
neither Party grants any license, express or implied, under its intellectual
property rights to the other Party.

 

6.2TGTX License Option. Within sixty (60) days following dosing the * Patient in
one or more Phase II Clinical Trial(s) TGTX will have the exclusive right to
convert this Agreement into a License Agreement. If TGTX exercises this Option,
then both the parties will enter into a mutually agreed upon licensing agreement
under substantially the same the terms and conditions as set forth in Exhibit F,
provided however that the terms of Section 6 of the form of Licensing Agreement
shall remain unchanged unless mutually agreed by the Parties.

 

6.3Rhizen License Option. Within sixty (60) days of commencement of a Phase III
clinical trial where the Product is used either as a single agent or in
Combination with another active pharmaceutical ingredient, Rhizen shall have the
exclusive right to convert this Agreement into a License Agreement. If Rhizen
exercises this Option, then both the parties will enter into a mutually agreed
upon licensing agreement under substantially the same the terms and conditions
as set forth in Exhibit F, provided however that the terms of Section 6 of the
form of Licensing Agreement shall remain unchanged unless mutually agreed by the
Parties.

 

6.4Sublicensing and Subcontracting: The license granted to TGTX by Rhizen
hereunder includes the right for TGTX to grant sublicenses to its Affiliates and
to Subcontractors in connection with such Subcontractors’ performance of
subcontracted activities, provided that such subcontracted activities shall be
subject to and subordinate to the terms and conditions of this Agreement. TGTX’s
execution of a subcontracting agreement with any Subcontractor shall not relieve
TGTX of any of its obligations under this Agreement. TGTX shall remain directly
liable to Rhizen for any performance or non-performance of a Subcontractor that
would be a breach of this Agreement if performed or omitted by TGTX, and TGTX
shall be deemed to be in breach of this Agreement as a result of such
performance or non-performance of such Subcontractor. TGTX shall use Diligent
Efforts to include in any agreement with a Subcontractor express permission to
assign all of the rights and obligations under such agreement to Rhizen without
consent from the Subcontractor. TGTX agrees to take Diligent Efforts to enforce
the terms of each subcontractor agreement to prevent a breach of any such
agreement that would constitute a breach of this Agreement if performed or
omitted by TGTX. Any sublicensing under the license granted to TGTX hereunder to
any Third Party that is not a Subcontractor is expressly prohibited unless
permitted by the JSC (i) following the expiration of the option rights pursuant
to Sections 6.2 and 6.3 hereof and (ii) an agreement of the parties on the
equitable sharing of any resulting revenues.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

6.5Change of Control. In the event that TGTX receives a bonafide, good faith
offer from a Third Party to either (i) enter into a transaction that would
result in a direct or indirect Change of Control of TGTX or (ii) pursuant to
which the Third Party would purchase the assets of TGTX related to the Product
(the “Product Assets”) and TGTX wishes to accept such Third Party offer, TGTX
shall first afford to Rhizen a right of first refusal (the “Right of First
Refusal”) to purchase TGTX or the Product Assets, as applicable, on the same
terms as those offered by the Third Party. TGTX shall notify Rhizen in writing
of the contemplated transaction (the “Notice to Rhizen”). Upon delivery of the
Notice to Rhizen, Rhizen shall have 10 Business Days (the “Response Period”) to
elect to purchase TGTX or the Product Assets, as applicable, by delivering a
written notice to TGTX stating that it offers to purchase TGTX or the Product
Assets, as applicable, on the terms offered by the Third Party (the “Notice To
TGTX”). The Notice to TGTX shall be binding upon delivery and irrevocable by
Rhizen, subject to execution of reasonably acceptable definitive agreements. If
Rhizen does not deliver the Notice To TGTX within the Response Period, then
Rhizen shall be deemed to have waived its rights under the Right of First
Refusal and TGTX shall thereafter be free to enter the transaction with the
Third Party. Each party shall take all actions as may be reasonably necessary to
consummate a sale contemplated by this Section 6.5 including, without
limitation, entering into agreements and delivering certificates and instruments
and consents as may be deemed necessary or appropriate.

 

 

 

  

ARTICLE 7

 

 

MANUFACTURE AND SUPPLY

 

  

7.1Roles of the Parties.

 

a. Rhizen shall use diligent efforts to supply, or cause to be supplied through
its Third Party contract manufacturers, in a timely manner consistent with
relevant supply agreement between the parties, JV’s entire requirements of Bulk
API and Finished Product for the Development and Commercialization of the
Product, as a single agent, by the Parties in or for the Territory, in
accordance with this Article 7. Except with respect to the clinical supply
discussed in section 7.1(c) below, from the Effective Date through the end of
the Early Development Period, Rhizen shall supply all of JV’s Finished Product
requirements for any pre-clinical, Phase I and Phase II Clinical Trials as a
single agent at Rhizen’s own expense. In addition, Rhizen will supply itself all
of its requirements of Bulk API and/or Finished Product to complete its
obligations during the Early Development Period as a single agent.

 

b. Rhizen shall use Diligent Efforts to supply, or cause to be supplied through
its Third Party contract manufacturers, in a timely manner, consistent with
relevant supply agreement between the parties, JV’s entire requirements of Bulk
API and Finished Product for the Development and Commercialization of the
Product, in a Combination, by the Parties in or for the Territory, in accordance
with this Article 7. Except with respect to the clinical supply discussed in
section 7.1(c) below, from the Effective Date through the end of the Early
Development Period, Rhizen shall supply all of JV’s Finished Product
requirements for any pre-clinical, Phase I or Phase II Clinical Trial involving
the Product in a Combination at Rhizen’s own expense if such Combination
includes *. For the sake of clarity, this Section 7.1(b) only applies in the
event that a Combination product incorporates the Compound with *.

 

c. Rhizen shall use Diligent Efforts to supply, or cause to be supplied through
its Third Party contract manufacturers, in a timely manner, consistent with
relevant supply agreement between the parties, JV’s entire requirements of Bulk
API and Finished Product for the Development and Commercialization of the
Product as a single agent if drug supply is required to be supplied to a
clinical trial participant(s) after the completion of the Clinical Trial
conducted during the Early Development Period. The parties shall share these
expenses pursuant to section 3.4.

 

d. TGTX shall use Diligent Efforts to supply, or cause to be supplied through
its Third Party contract manufacturers, in a timely manner, consistent with
relevant supply agreement between the parties, JV’s entire requirements of any
bulk active ingredient or finished product other than the Bulk API or Finished
Product required for the Development and Commercialization of the Product in a
Combination by the Parties in or for the Territory if such Combination includes
solely *. For the sake of clarity, this Section 7.1(d) only applies in the event
that a Combination product incorporates solely * with the Compound.

  

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

e. JSC shall assign the responsibity to either Party to cause to be supplied
through any Third Party contract manufacturers, in a timely manner, consistent
with relevant supply agreement between the parties, JV’s entire requirements of
the Bulk API and Finished Product and any other compound that is required for
any pre-clinical, Phase I or Phase II Clinical Trial involving the Product in a
Combination with a compound other than * (or involving a Combination with * and
yet another compound or compounds) and the Parties shall share these expenses
pursuant to Section 3.4.

 

f. The Parties each covenant and agree that all supply agreements executed
regarding the provision of any product or material pursuant to this Agreement,
shall contain customary representations and warranties regarding the manufacture
of such products and materials, including, but not limited to, that all
materials shall be manufactured, handled and stored: (i) in accordance with the
agreed upon specification and (ii) in compliance with applicabale Laws and
regulations, including, without limitation, the GMP requirements.

 

7.2Preclinical and Clinical Supply. Rhizen shall, by itself or through its Third
Party contract manufacturers, use Diligent Efforts to supply to TGTX all
quantities of Finished Product or Bulk API reasonably required by TGTX to
Develop the Product in the Territory pursuant to the Development Plan. Such
quantities of Finished Product, and the schedule for such supply, shall be
confirmed and if necessary updated by the JSC in a manner consistent with the
Development Plan. Such supply shall be governed by the clinical supply agreement
that the Parties shall negotiate in good faith promptly within one hundred
eighty (180) days following the Effective Date. The clinical supply agreement
shall, in addition to other terms and conditions agreed upon by the Parties,
provide for the following:

 

(a)Rhizen shall, before entering into negotiation for an agreement with a Third
Party contract manufacturer of Bulk API or Finished Product for supply to TGTX
hereunder, notify TGTX of the fact. Thereafter, TGTX shall have the right to
provide reasonable input regarding the terms of such agreement (as well as any
amendments thereof), review and comment on agreement drafts and forms, consult
with Rhizen regarding the negotiation of such agreement, and participate in
person in the negotiation of such agreement, as the Parties may agree, it being
understood that Rhizen shall retain the final authority over the terms and
conditions of any such agreement with such Third Party contractor. TGTX shall
also have the right to conduct a general GMP/regulatory inspection of any
manufacturing, packaging, labeling or storage facility in advance of the
conclusion of any agreement.

 

(b)From time to time, TGTX shall submit to Rhizen purchase orders for quantities
of Finished Product or Bulk API for such use consistent, as far as reasonably
practicable, with such confirmed, or, if applicable, updated quantity and
schedule which confirmation or update shall be consistent, as much as reasonably
possible, with the then-current Development Plan and Rhizen shall supply or have
supplied to TGTX such quantities of Finished Product. It shall not be a breach
of this Agreement by Rhizen if it is unable to supply such quantities of
Finished Product or Bulk API to the extent the quantities ordered were in excess
of 120% of the quantities forecasted in the then-current Development Plan. All
shipments to TGTX of Finished Product shall be made “Delivered Duty Paid”
(Incoterms 2010) to a secondary packager or distribution center of TGTX’s
choice.

 

(c)The cost for supplies from Rhizen of Finished Product or Bulk API for
Development of the Product shall be equal to the actual external costs for such
Finished Product or Bulk API plus the freight, postage, shipping,
transportation, insurance, warehousing and handling charges actually allowed or
paid by Rhizen or TGTX with regard to such Bulk API or Finished Product shall be
included in the Development Expenses; provided, however, that following the
exercise of either of the License Options, such amounts shall be invoiced and
paid for by TGTX.

  

 

* Confidential material redacted and filed separately with the Commission.

  

 

 

 

 

(d)All Finished Product or Bulk API supplied by Rhizen to TGTX shall, when
delivered, have been manufactured, handled and stored by Rhizen or its Third
Party contract manufacturer(s) in compliance with all agreed-upon specifications
and applicable Laws, including without limitation then-current GMP requirements.

 

(e)For the purpose of this Section 7.2, both Parties shall abide by the
above-mentioned (a) to (d) prior to the conclusion of a clinical supply
agreement.

 

7.3GLOBAL MATERIAL & SUPPLY RIGHTS: Rhizen shall retain rights for manufacturing
and supply of API and formulations for global development and commercialization
either as a JV entity or as a Licensor; provided however, that Rhizen’s price is
cost competitive (as described in 7.4(b)) and prior to the First Commercial
Sale, the Parties shall timely negotiate in good faith and enter into a
manufacturing and supply agreement. Such Commercial Supply Agreement shall
contain customary terms governing such manufacturing and supply relationships,
and shall provide as follows:

 

(a)Rhizen shall establish, by itself or through agreements with Third Parties,
an appropriate manufacturing facility or contract manufacturer for the
commercial Finished Product manufacture in a timely manner to ensure that Rhizen
meets its obligation to supply quantities of Finished Product ordered by TGTX
under the Commercial Supply Agreement. As further detailed in the Commercial
Supply Agreement, upon the material and uncured breach by Rhizen of its defined
supply obligations as set forth in the Commercial Supply Agreement, TGTX shall
have the right to obtain transfer and Rhizen shall have the obligation to give
transfer free of charge unless other wise determined by JSC to TGTX, without
undue delay, of any and all manufacturing technology necessary to enable it to
manufacture or have manufactured Finished Product to meet its requirements under
this agrrement. As further detailed in the Commercial Supply Agreement, if such
transfer occurs, Rhizen would grant, without prejudice to any other remedies
that are available to TGTX, to TGTX any additional licenses necessary to enable
TGTX to exercise the foregoing manufacturing right without requiring TGTX to pay
any additional consideration for such licenses unless otherwise determine by
JSC.

 

(b)Rhizen shall be responsible for the Finished Manufacture, testing (including
stability testing) and final release of the Finished Product for
Commercialization in the Territory. With regard to the Finished Product
manufactured by or on behalf of Rhizen and used or sold for Commercialization in
the Territory, the Manufacturing Cost incurred by Rhizen for the Finished
Manufacture of the Finished Product thus used or sold in the Territory
hereunder, as well as the freight, postage, shipping, transportation, insurance,
warehousing and handling charges actually allowed or paid by Rhizen with regard
to such Finished Product shall be included in the Cost of Goods Sold in the
calculation of the Product Profit/Loss.

 

7.4Manufacturer Source.

 

(a)The Parties shall establish an appropriate facility or contract manufacturing
organization for handling Finished Manufacture as follows: Rhizen shall be
responsible for screening potential manufacturers, negotiating the applicable
supply agreement, and effecting the technology transfer as necessary to
establish and qualify Bulk API and Finished Product manufacturers, whether those
are Rhizen, its Affiliates, or Third Parties; provided, that, TGTX shall have
the right to provide input regarding the terms of such agreements (as well as
any amendments thereof), review and comment on agreement drafts and forms,
consult with Rhizen regarding the negotiation of such agreements between Rhizen
and Third Party contract manufacturers, and conduct a general GMP/regulatory
inspection of the proposed manufacturing facilities as the Parties may agree, it
being understood that Rhizen shall retain the final authority over the terms and
conditions of any such agreements with such Third Party contractors unless
either of the License Options are exercised, in which case, TGTX would have
final authority. In case the manufacturing sources are not the Parties or their
Affiliates but rather are Third Party contractors, then the reasonable costs
incurred by the Parties in connection with the establishment of such
manufacturing sources shall be treated as Commercial Expenses.

 

 

 

 

(b)Notwithstanding 7.4(a), Rhizen shall be responsible for using Diligent
Efforts to minimize the Manufacturing Cost of the Finished Product. In order to
ensure a competitive rate of Manufacturing Cost is obtained, the facility or
contract manufacturer used by Rhizen to produce the Finished Product must
provide manufacturing services at a Manufacturing Cost within *% of a
Manufacturing Cost of an alternative contract manufacturing organization of
equal repute and quality, where the comparative manufacturing cost are measured
as an average of such cost over the immediately preceding Twelve (12) month
period. In the event that Rhizen does not provide manufacturing services at the
cost required in this Section 7.4(b), then TGTX shall have the right to directly
procure manufacturing services in its discretion.

 

 

* Confidential material redacted and filed separately with the Commission.

  

 

 

   

ARTICLE 8

 

  

COMPENSATION

 

  

8.1Initiation Fee.

 

(a)No later than ten (10) days after the Effective Date, TGTX shall pay to
Rhizen a fee of One Million Dollars ($1,000,000) as initiation of the JV, by
wire transfer of immediately available funds into an account designated by
Rhizen in writing.

 

  (b) In addition, within thirty (30) days following notification by TGTX to
Rhizen that the *(*) patient has been dosed in one or more Phase 1 Clinical
Trials, TGTX shall pay to Rhizen an additional collaboration fee of * Dollars
($*) (the “Milestone Payment”) by wire transfer of immediately available funds
into an account designated by Rhizen in writing, provided that this Agreement
has not been terminated pursuant to Section 13.

 

(c)Such collaboration fees once paid shall be fully earned, non-refundable and
non-creditable against any other payments due hereunder.

 

8.2Sharing of Commercial Expenses and Product Profit/Loss. During the Term but
post Early Development Period, assuming none of the License Options have been
exercised, the Parties shall share Product Profit/Loss for each Finished Product
based on their respective P/L Sharing Percentage. Within twenty (20) Business
Days of the end of each calendar quarter following the First Commercial Sale of
the Finished Product, TGTX shall report to the JSC its revenues and Commercial
Expense items (with appropriate supporting information) involved in the
computation of Product Profit/Loss and accrued during such quarter with respect
to each such Finished Product (the “Quarterly P/L Report”). Similarly, Rhizen
shall report to the JSC its Commercial Expense items (including appropriate
supporting information). Such Quarterly P/L reports shall be in such form as the
Parties may agree from time to time. In addition, TGTX shall provide Rhizen with
a monthly statement of the amount of gross sales of Product by country in the
Territory. The Parties shall calculate and share such Product Profit/Losses
based on each Party’s respective P/L Sharing Percentage on a calendar quarterly
basis and shall make reconciliation, if necessary, for this purpose of sharing
such Product Profit/Losses, within twenty (20) Business Days after TGTX provides
its quarterly report to the JSC. For the avoidance of doubt, if Commercial
Expenses exceed Net Sales, then each party shall reimburse the other party for
such Commercial Expenses such that each party’s share of the Commercial Expenses
is equal to its P/L Sharing Percentage. If either Party fails to contribute
their portion of the Product Profit/Loss and Commercial Expenses, such Party’s
P/L Share Percentage shall be reduced pro rata to the extent of the Product
Profit/Loss and Commercial Expenses that they do not fund as a percentage of the
total accumulated Commercial Expenses and Product Profit/Loss to date, however,
in no event shall Rhizen’s P/L Share Percentage be reduced below *%. Such
adjustment to a party’s P/L share % shall be the sole remedy hereunder for such
failure. Additionally, with regard to Commercial Expenses incurred by either
Party before the First Commercial Sale, such expenses shall be included in
Development Expenses and shared pursuant to Section 3.4. Alternately, both
Parties may devise a feasible legal structure to address Product Profit/Loss for
simplified obligations with regard to maintenance of financial records and
audits of either party, including tax benefits, if any, and if agreed to by both
Parties.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

 

8.3The Quarterly P/L Report will be subject to a true-up adjustment to take into
account deductions under the definition of Net Sales either (a) allowed during a
calendar quarter that were not accrued during such calendar quarter, or (b)
accrued during a calendar quarter but not taken or later subject to a reversal
following the end of such calendar quarter (each of (a) and (b), a “True-up
Adjustment”). Each Quarterly P/L Report provided by TGTX shall set forth the
amount of any True-up Adjustment applicable to any prior calendar quarter.

 

8.4Taxes.

 

(a)Cooperation and Coordination. The Parties acknowledge and agree that it is
their mutual objective and intent to minimize, to the extent feasible and legal,
taxes payable with respect to their collaborative efforts under this Agreement
and that they shall use all commercially reasonable efforts to cooperate and
coordinate with each other to achieve such objective.

 

(b)Payment of Tax. A Party receiving a payment pursuant to this Article 8 shall
pay any and all taxes levied on such payment. If applicable Law requires that
taxes be deducted and withheld from a payment made pursuant to this Article 8,
the remitting Party shall promptly notify the other Party and provide all
relevant information available to it and (i) deduct those taxes from the
payment; (ii) pay the taxes to the proper taxing authority; and (iii) send
evidence of the obligation together with proof of payment to the other Party
within sixty (60) days following that payment.

 

(c)Tax Residence Certificate. A Party (including any entity to which this
Agreement may be assigned, as permitted under Section 15.5) receiving a payment
pursuant to this Article 8 shall provide the remitting Party appropriate
certification from relevant revenue authorities that such Party is a tax
resident of that jurisdiction (a “Tax Residence Certificate”), if such receiving
Party wishes to claim the benefits of an income tax treaty to which that
jurisdiction is a party. Upon the receipt thereof, any deduction and withholding
of taxes shall be made at the appropriate treaty tax rate.

 

(d)Assessment. Either Party may, at its own expense, protest any assessment,
proposed assessment, or other claim by any Governmental Authority for any
additional amount of taxes, interest or penalties or seek a refund of such
amounts paid if permitted to do so by applicable Law. The Parties shall
cooperate with each other in any protest by providing records and such
additional information as may reasonably be necessary for a Party to pursue such
protest.

 

8.5Foreign Exchange. The rate of exchange to be used in computing the amount of
currency equivalent in Dollars owed to a Party under this Agreement shall be
made at the period-end rate of exchange quoted on the last day of the applicable
calendar quarter by Citibank in New York City.

 

8.6Late Payments. If a Party does not receive payment of any sum due to it on or
before the due date, simple interest shall thereafter accrue on the sum due to
such Party until the date of payment at the per annum rate of 3% over the
then-current LIBOR, or the maximum rate allowable by applicable Law, whichever
is lower.

 

 

 

 

8.7Records; Audits. Each Party shall maintain complete and accurate records in
sufficient detail to permit the other Party to confirm the accuracy of the
calculation of payments to the other Party under this Agreement. Upon reasonable
prior notice, such records shall be available during regular business hours of
audited Party for a period of three (3) years from the creation of individual
records for examination at auditing Party’s expense, and not more often than
once each Fiscal Year, by an independent certified public accountant selected by
auditing Party and reasonably acceptable to audited Party, for the sole purpose
of verifying the accuracy of the financial reports furnished pursuant to this
Agreement. Any such auditor shall not disclose audited Party’s Confidential
Information, except to the extent such disclosure is necessary to verify the
accuracy of the financial reports furnished by audited Party or the amount of
payments due by audited Party under this Agreement. Any amounts shown to be owed
but unpaid shall be paid within thirty (30) days from the accountant’s report,
plus interest (as set forth in Section 8.7 ) from the original due date. Any
amounts determined to be overpaid shall be refunded within thirty (30) days from
the accountant’s report. The auditing Party shall bear the full cost of such
audit unless such audit discloses an underpayment of the amount actually owed
during the applicable Fiscal Year of more than 5%, in which case audited Party
shall bear the full cost of such audit.

 

 

 

  

ARTICLE 9

 

  

INTELLECTUAL PROPERTY MATTERS

 

  

9.1Ownership of Inventions and Know How. Any new invention pertaining to the
Product made alone or jointly by the parties will be owned by both parties
(“Joint Inventions”), unless otherwise determined by the JSC to be owned by
solely by one Party (a “Sole Invention”).

 

Further, the JSC shall determine:

 

a) If either party is eligible for any payment or consideration in lieu of the
invention and/or royalty; or

 

b) If the licensing of such Joint Inventions by either Party to a Third Party
could have a material adverse effect on the Product or the Development or
Commercialization of the Product, then such Party will not be able to consummate
such Third Party licensing.

 

Inventorship shall be determined by the JSC in accordance with U.S. patent Laws.
Sole inventions owned by TGTX and TGTX’s interest in all Joint Inventions shall
be included in the TGTX Technology. Sole Inventions owned by Rhizen and Rhizen’s
interest in all Joint Inventions shall be included in the Rhizen Technology.

 

Joint Know-How shall be owned jointly by the Parties.

 

9.2Disclosure of Inventions. Each Party shall promptly disclose to the other any
invention disclosures, or other similar documents, submitted to it by its
employees, agents or independent contractors describing inventions that may be
either Sole Inventions or Joint Inventions, and all Information relating to such
inventions. Sole Inventions and Joint Inventions required or deemed useful by
the JSC for the Development or Commercialization of the Product, shall
automatically be included in this Agreement and available for use by the Parties
in the Territory, and by Rhizen outside the Territory.

 

9.3Prosecution of Patents.

 

(a)Rhizen Patents Other than Joint Patents. Except as otherwise provided in this
Section 9.3(a), Rhizen shall have the sole right, authority and obligation to
file, prosecute and maintain the Rhizen Patents (other than Joint Patents which
shall be prosecuted and maintained in accordance with Section 9.3(b)) on a
worldwide basis. Rhizen shall provide TGTX reasonable opportunity to review and
comment on such prosecution efforts regarding such Rhizen Patents in the
Territory. Rhizen shall provide TGTX with a copy of material communications from
any patent authority in the Territory regarding such Rhizen Patents, and shall
provide TGTX with drafts of any material filings or responses to be made to such
patent authorities a reasonable amount of time in advance of submitting such
filings or responses. Notwithstanding the foregoing, if Rhizen desires to
abandon or not maintain any Patent within such Rhizen Patents in the Territory,
then Rhizen shall provide TGTX with thirty (30) days prior written notice of
such desire (or such longer period of time as reasonably necessary to allow TGTX
to assume such responsibilities) and, if TGTX so requests, shall provide TGTX
with the opportunity to prosecute and maintain such Patent in the Territory in
place of Rhizen. If TGTX desires Rhizen to file, in the Territory, a patent
application that claims priority from a Patent within the Rhizen Patents, other
than a Joint Patent, in the Territory, TGTX shall provide written notice to
Rhizen requesting that Rhizen file such patent application in the Territory. If
TGTX provides such written notice to Rhizen, Rhizen shall either (i) file and
prosecute such patent application and maintain any patent issuing thereon in the
Territory or (ii) notify TGTX that Rhizen does not desire to file such patent
application and provide TGTX with the opportunity to file and prosecute such
patent application and maintain any patent issuing thereon in the Territory in
place of Rhizen

 

 

 

 

(b)Joint Patents. Except as otherwise provided in this Section 9.3(b), the JSC
shall entrust one party the right and authority, to prosecute and maintain the
Joint Patents on a worldwide basis at its sole discretion herein referred to as
an “Entrusted Party” (subject to this Section 9.3(b)). The Entrusted Party shall
provide the other party reasonable opportunity to review and comment on such
prosecution efforts regarding such Joint Patents. The Entrusted Party shall
provide the other party with a copy of material communications from any patent
authority regarding such Joint Patents, and shall provide the other party with
drafts of any material filings or responses to be made to such patent
authorities a reasonable amount of time in advance of submitting such filings or
responses. If one Party( the “First Party”) determines in its sole discretion to
abandon or not maintain any Patent within the Joint Patents anywhere in the
world, then the First Party shall provide the other party (the “Second Party”)
with thirty (30) days’ prior written notice of such determination (or such
longer period of time reasonably necessary to allow the other party to assume
such responsibilities) and shall provide the Second Party with the opportunity
to prosecute and maintain such Patent in place of the First Party at such Second
Party’s sole expense, and if the Second Party so requests, the First Party shall
assign such Patent to the Second Party (if the Second Party is Rhizen in which
case such Patent shall be included in the Rhizen Patents or if the Second Party
is TGTX, in which case such patent shall be included in the TGTX patents). If
one (the “First Party”) party desires the other party (the “Second Party”) to
file, in a particular jurisdiction, a patent application that claims priority
from a Patent within the Joint Patents, the First Party shall provide written
notice to the Second Party expressing its desire to file such patent application
in such jurisdiction. If the First Party provides such written notice to the
Second Party , the Second Party shall either (i) express its agreement in
writing to the First Party and the Entrusted Party shall file and prosecute such
patent application and maintain any patent issuing thereon in such jurisdiction
at its expense, or (ii) notify the First party that the Second Party does not
desire to file such patent application and provide the First Party with the
opportunity to file and prosecute such patent application and maintain any
patent issuing thereon at it’s sole expense in place of the Second Party , in
which case the Second Party shall assign such patent application  to the First
Party (and in which case such Patent shall be included in the respective party’s
Patents).

 

(c)Cooperation in Prosecution. Each Party shall provide the other Party all
reasonable assistance and cooperation in the Patent prosecution efforts of the
Rhizen Patents and Joint Patents including providing any necessary powers of
attorney and executing any other required documents or instruments for such
prosecution.

 

(d)Costs of Prosecution. The costs to prosecute and maintain the Patents related
to the Product shall be considered Development Expenses and shared according to
Section 3.4; provided , however, if either of the License Options are exercised
then the cost of prosecution of any Rhizen Patent, shall be borne by Rhizen.

 

 

 

 

9.4Patent Term Extensions in the Territory. Each Party shall discuss and
recommend to the JSC for which, if any, of the Rhizen Patents, TGTX Patents, and
Joint Patents the Parties should seek Patent Term Extensions in the Territory,
following which the JSC shall recommend to either of the parties which of the
Rhizen Patents, TGTX Patents, or Joint Patents should be the subject of such
Patent Term Extension application; provided, however, that JSC shall have the
final decision-making authority with respect to applying for any such Patent
Term Extensions in the Territory. Each party shall cooperate fully with the
other in making such filings or actions, for example and without limitation,
making available all required regulatory data and information and executing any
required authorizations to apply for such Patent Term Extension. All activities
and expenses thereof of the Parties pursuant to this Section 9.4 for the
Territory shall be deemed Development Expenses, unless either of the License
Options have been exercised then such expenses shall be borne solely by TGTX.

 

9.5Infringement of Patents by Third Parties.

 

(a)Notification. Each Party shall promptly notify the other Party in writing of
any existing or threatened infringement of the Rhizen Patents, Joint Patents or
TGTX Patents of which it becomes aware, and shall provide evidence in such
Party’s possession demonstrating such infringement.

 

(b)Infringement of Patents in the Territory.

 

(i)If a Party becomes aware that a Third Party infringes any Rhizen Patent, TGTX
Patent, or Joint Patent in the Territory by making, using, importing, offering
for sale or selling the Product or any similar PI3K selective inhibitor covered
by any of such Patents (such activities, “Product Infringement”), then such
Party shall so notify the other Party as provided in Section 9.5(a), which such
notice shall include all Information available to the notifying Party regarding
such alleged infringement.

 

(ii)In the Territory, TGTX shall have the first right, but not the obligation,
to bring an appropriate suit or other action against any person or entity
engaged in such Product Infringement, subject to Section 9.5(b)(iii) below, the
cost and expense of which will be included in Commercial Expenses (except as
otherwise expressly provided in this Section 9.5(b)(ii)); provided, however, if
either of the License Options is exercised then the cost and expense will be
borne by TGTX. TGTX shall have a period of sixty (60) days (or shorter period,
if required by the nature of the proceeding) after notification by Rhizen or
providing notification to Rhizen pursuant to section 9.5(a), to elect to so
enforce such Patent. In the event TGTX does not so elect, it shall so notify
Rhizen in writing during such sixty (60) day time period (or the above-mentioned
shorter period), and Rhizen shall have the right, but not the obligation, to
commence a suit or take action to enforce the applicable Patent against such
Third Party perpetrating such Product Infringement at its sole cost and expense
(except as otherwise expressly provided in this Section 9.5(b)(ii). Each Party
shall provide to the Party enforcing any such rights under this Section
9.5(b)(ii) reasonable assistance in such enforcement, at such enforcing Party’s
request, including joining such action as a party plaintiff if required by
applicable Law to pursue such action. The enforcing Party shall keep the other
Party regularly informed of the status and progress of such enforcement efforts,
and shall reasonably consider the other Party’s comments on any such efforts.
Any recoveries obtained from a suit or an action commenced by TGTX hereunder
shall first be applied to the recovery of expenses incurred by TGTX and Rhizen
in bringing the suit or action; and the remaining amounts, if any, shall be
shared by the Parties according to Section 8.2; provided, however, if either
License Option is exercised, then any recoveries obtained from a suit or an
action commenced by TGTX hereunder shall first be applied to the recovery of
expenses incurred by TGTX in bringing the suit or action and the remaining
amounts, if any, shall be deemed additional Net Sales; provided, further,
however, if Rhizen proceeds with the enforcement after TGTX decides not to move
forward, then any amounts recovered shall belong solely to Rhizen.

 

 

 

 

(iii)The Party not bringing an action with respect to Product Infringement in
the Territory under Section 9.5(b) shall be entitled to separate representation
in such matter by counsel of its own choice and at its own expense, but such
Party shall at all times cooperate fully with the Party bringing such action.
Additionally, the Party not bringing an action under this Section 9.5(b) may
have an opportunity to participate in such action to the extent that the Parties
may mutually agree at the time the other Party elects to bring an action
hereunder.

 

(c)Settlement. TGTX shall not settle any claim, suit or action that it brings
under this Section 9.5 involving Rhizen Patents (excluding Joint Patents) in any
manner that would negatively impact Rhizen Patents anywhere in the world, or
that would limit or restrict the ability of either Party to manufacture, use,
sell, offer for sale or import the Product anywhere in the world, without the
prior written consent of Rhizen. Rhizen shall not settle any claim, suit or
action that it brings under this Section 9.5 involving TGTX Patents (excluding
Joint Patents) in any manner that would negatively impact the TGTX Patents or
that would limit or restrict the ability of either Party to manufacture, use,
sell, offer for sale or import the Product anywhere in the world, without the
prior written consent of TGTX. Neither Party shall settle any claim, suit or
action that it brings under this Section 9.5 involving Joint Patents in any
manner that would negatively impact the Joint Patents or that would limit or
restrict the ability of either Party to manufacture, use, sell, offer for sale
or import the Product anywhere in the world, without the prior written consent
of such other Party.

 

9.6Infringement of Third Party Rights in the Territory.

 

(a)Notice. If any Product manufactured, used or sold by either Party, its
Affiliates, licensees or sublicensees becomes the subject of a Third Party’s
claim or assertion of infringement of a Patent granted by a jurisdiction within
the Territory relating to the manufacture, use, sale, offer for sale or
importation of the Product, the Party first having notice of the claim or
assertion shall promptly notify the JSC, and the Parties shall promptly meet to
consider the claim or assertion and the appropriate course of action for an
approval by the JSC.

 

(b)Defense. The Parties, working through the JSC, shall cooperate to defend any
such claims under the strategy, terms and conditions as may be authorized by the
JSC. Unless otherwise agreed, TGTX shall be the leading Party for such defense.
The Parties shall make decisions with regard to such actions covered by this
Section 9.6 jointly through the JSC in accordance with the provisions of
Sections 2.3 , provided that any unresolved disputes shall not be subject to
settlement by expedited arbitration and, in the case of any unresolved dispute,
each Party named as a defendant in such action shall be entitled upon written
notice to defend itself in such matter independently by counsel of its own
choice and at its own expense; provided, that each Party shall inform the other
Party of the progress of such defense and, if reasonably requested by the other
Party, shall reasonably cooperate with the other Party. For so long as the
Parties continue to pursue such matter jointly through the JSC, all costs and
expenses of any defense actions under this Section 9.6(b) shall be considered
Commercial Expenses and shared as in Section 8.2. In any action pursued jointly
by the Parties through the JSC, the non-leading Party shall reasonably cooperate
with the leading Party, including if required to conduct such defense,
furnishing a power of attorney. The non-leading Party shall have the right to
confer, through the JSC, with the leading Party in any such defense and the
leading Party shall consider in good faith such input from the non-leading
Party.

 

 

 

 

(c)Settlement. Neither Party shall enter into any settlement of any claim
described in this Section 9.6 that affects the other Party’s rights or interests
without such other Party’s written consent, which consent shall not be
unreasonably withheld or delayed.

 

(d)Settlement Payment. Any amounts that either Party becomes obligated to pay as
a result of any settlement of or decision rendered in any defense pursuant to
this Section 9.6 with respect to the manufacture, use, sale, offer for sale or
import of the Product in or for the Territory shall be shared as provided in
Section 8.2.

 

9.7Patent Oppositions and Other Proceedings. If either Party desires to bring an
opposition, action for declaratory judgment, nullity action, interference,
declaration for non-infringement, reexamination or other attack upon the
validity, title or enforceability of a Patent owned or controlled by a Third
Party that covers, in the Territory, the Product, or the manufacture, use, sale,
offer for sale or importation of the Product (except insofar as such action is a
counterclaim to or defense of, or accompanies a defense of, a Third Party’s
claim or assertion of infringement under Section 9.6, in which case the
provisions of Section 9.6 shall govern), such Party shall so notify the JSC and
the Parties shall promptly confer to determine whether to bring such action or
the manner in which to settle such action for the approval by the JSC. The
Parties working jointly through the JSC shall cooperate to assert any such
claims under the strategy, terms and conditions as may be authorized by the JSC.
Unless otherwise agreed, the JSC shall designate TGTX as the leading Party for
such claims. The Parties shall make decisions jointly through the JSC in
accordance with the provisions of Sections 2.3. For so long as the Parties
continue to pursue such matter jointly through the JSC, all costs and expenses
of any actions or settlement efforts under this Section 9.7 shall be shared
pursuant to Section 8.2. In any action pursued jointly by the Parties through
the JSC, the non-leading Party shall cooperate fully with the leading Party,
including, if required, to conduct such defense, furnishing a power of attorney.
The non-leading Party shall have the right to confer with the leading Party, and
the leading Party shall consider in good faith input from the non-leading Party.
Any awards or amounts received in bringing any such action, if any, shall be
first allocated to reimburse the Parties’ respective expenses in such action,
and any remaining amounts shall be shared pursuant to Section 8.2; provided,
however, if either of the License Options is exercised then the entire cost of
the action shall be borne by TGTX, who shall have the final decision making
authority over such action, and any awards or amounts received in bringing such
action shall first be allocated to reimburse TGTX for their expenses in such
action and any remaining amounts shall be deemed additional Net Sales.

 

9.8Parties’ Patent Rights. If a Rhizen Patent, Joint Patent or TGTX Patent
becomes the subject of any proceeding commenced by a Third Party within the
Territory in connection with an opposition, reexamination request, action for
declaratory judgment, nullity action, interference or other attack upon the
validity, title or enforceability thereof (except insofar as such action is a
counterclaim to or defense of, or accompanies a defense of, an action for
infringement against a Third Party under Section 9.5, in which case the
provisions of Section 9.5 shall govern), then the Party owning or otherwise
Controlling such Patent shall promptly notify the other Party of such effect and
discuss with the other Party how to defend such proceedings. The Party owning or
otherwise Controlling such Patent shall, in close communication and discussion
with the other Party, control such defense and shall solely bear the costs of
such defense; provided that if such action relates to a Joint Patent, the
Parties shall confer and determine which Party shall control such action and
bear the associated costs. The controlling Party shall permit the
non-controlling Party to participate in the proceeding to the extent permissible
under applicable Law, and to be represented by its own counsel in such
proceeding, at the non-controlling Party’s expense. Any awards or amounts
received in defending any such Third-Party action, if any, shall be first
allocated to reimburse the Controlling Party’s expenses in such action, and any
remaining amounts shall be shared pursuant to Section 8.2; provided, however, if
either of the License Options have been exercised, then TGTX shall bear the
expense and any remaining amounts shall first be used to reimburse TGTX’s
expenses and any remainder shall be deemed additional Net Sales.

 

 

 

 

9.9Orange Book Listing, Compendial Listing. Rhizen shall allow TGTX to file
appropriate information with the Regulatory Authority in the Territory listing
any Rhizen Patents in the Orange Book or equivalent in the US and EU and each
other country of the Territory, that JV deems appropriate, if any, as a Patent
related to the Product and the Parties shall use Diligent Efforts to obtain and
maintain such listing.

 

9.10Rights to Intellectual Property in India.

 

(a)TGTX hereby grants Rhizen a perpetual, exclusive, royalty-free license, with
the right to sublicense, to the Joint Patents and a perpetual, non-exclusive,
royalty-free license to the Joint Know-How to make, have made, use, sell, offer
for sale, and import the Product outside the Territory.  Outside the Territory,
Rhizen shall have the right, but not the obligation, at Rhizen’s sole expense,
to bring an appropriate suit or other action against any person or entity
engaged in Product Infringement of the Joint Patents. TGTX shall provide to
Rhizen when enforcing any such rights under this Section 9.10 reasonable
assistance in such enforcement, at Rhizen’s request and cost, including joining
such action as a party plaintiff if required by applicable Law to pursue such
action.

 

(b)The Parties agree that in the event Rhizen desires to use the TGTX
Technology, other than the Joint Patents and the Joint Know-How, for any purpose
outside of the Territory, then Rhizen shall pay such fair market value royalties
and/or fees to TGTX that the Parties determine by future written agreement. Each
Party agrees to negotiate in good faith to execute an agreement regarding the
subject matter of this paragraph.

  

(c)For the purpose of this Section 9.10, TGTX Technology shall exclude any
rights related to *.

 

 

* Confidential material redacted and filed separately with the Commission.

 

 

 

  

ARTICLE 10

 

  

REPRESENTATIONS AND WARRANTIES

 

  

10.1        Mutual Representations and Warranties. Each Party hereby represents,
warrants, and covenants (as applicable) to the other Party as follows:

 

a.Corporate Existence and Power. It is a company or corporation duly organized,
validly existing, and in good standing under the Laws of the jurisdiction in
which it is incorporated, and has full corporate power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as contemplated in this Agreement,
including, without limitation, the right to grant the licenses granted by it
hereunder.

 

b.Authority and Binding Agreement. As of the Effective Date, (i) it has the
corporate power and authority and the legal right to enter into this Agreement
and perform its obligations hereunder; (ii) it has taken all necessary corporate
action on its part required to authorize the execution and delivery of the
Agreement and the performance of its obligations hereunder; and (iii) the
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, and binding obligation of such Party that is
enforceable against it in accordance with its terms.

 

c.No Conflict. It is not a party to any agreement that would prevent it from
granting the rights granted to the other Party under this Agreement or
performing its obligations under this Agreement. The execution, delivery and
performance of this Agreement shall not violate, conflict with or constitute a
default under any agreement (including its corporate charter or other
organizational documents) to which it is a party or to which it may be bound, or
to its best knowledge, any applicable Laws or order of any court or other
tribunal.

 

d.No Debarment. In the course of the Development and Commercialization of the
Product, each Party has not used and shall not use, during the term of this
Agreement, any employee or consultant who has been debarred by any Regulatory
Authority, or is the subject of debarment proceedings by a Regulatory Authority.

 

10.2        Additional Representations, Warranties and Covenants of Rhizen.
Rhizen represents, warrants and covenants (as applicable) to TGTX as follows, as
of the Effective Date:

 

a.Regulatory Materials and Studies. To the best of Rhizen’s knowledge, all
Regulatory Materials Controlled by Rhizen in existence as of the Effective Date
and to which TGTX has rights of use or reference hereunder (collectively,
“Rhizen Regulatory Materials”), including the Regulatory Materials described in
Section 4.1(a), have been prepared, maintained and retained in accordance with
applicable Laws. All preclinical studies conducted with respect to the Product
in connection with the preparation of the Rhizen Regulatory Materials, including
such studies from which the data described in Section 4.1(a) are derived, have
been conducted substantially in accordance with applicable Laws by persons with
appropriate education, knowledge and experience. Rhizen has not been debarred
and is not subject to debarment, in each case pursuant to Section 306 of the
FD&C Act or any similar law or regulation in any jurisdiction outside the United
States.

 

 

 

 

b.Sufficiency of License Grants.

 

i.Except as set forth on Schedule 10.2(b)(i) hereto, the Rhizen Patents are not
subject to any encumbrance, lien or claim or ownership by any Third Party that
is inconsistent with the rights and (sub)licenses granted to TGTX hereunder;

 

ii.Except as set forth on Schedule 10.2(b)(ii) hereto, Rhizen owns or possesses
adequate right, title and interest in any Rhizen Patents to grant the license
thereto to TGTX as provided in Article 6;

 

iii.No claim or litigation has been brought or, to the knowledge of Rhizen, is
threatened to be brought, by any person or entity alleging that (A) any of the
Rhizen Patents in the Territory is invalid or unenforceable, or (B) practice of
any of the Rhizen Technology in the Territory infringes or otherwise conflicts
or interferes with any intellectual property or proprietary right of any Third
Party;

 

iv.To the knowledge of Rhizen, prior to the Effective Date, no Third Party has
infringed or misappropriated any Rhizen Technology by making, using, importing,
offering for sale or selling the Product and, as of the Effective Date, there is
no actual or threatened infringement or misappropriation of the Rhizen
Technology by any Third Party by making, using, importing, offering for sale or
selling the Product;

 

v.Except as set forth on Schedule 10.2(b)(v), to the knowledge of Rhizen,
neither (A) TGTX’s exercise of its rights hereunder with respect to the Rhizen
Technology, nor (B) Rhizen’s or TGTX’s Development or Commercialization of the
Product in the Territory, shall infringe any valid and enforceable Patent or
other intellectual property right or other proprietary right of any Third Party;

 

vi.This Agreement is consistent with all of the Third Party License Agreements
in all respects and does not conflict with, violate, breach or otherwise give
rise to a default by Rhizen under, any term of each of the Third Party License
Agreement;

 

vii.Rhizen has obtained any and all consents, if any, required from Third
Parties for Rhizen to enter into this Agreement and to grant to TGTX the
licenses and other rights provided herein and has provided a copy of such
consents to TGTX;

 

viii.Rhizen owns or possesses adequate right, title and interest in the Rhizen
Know-How to grant the license thereto to TGTX as provided in Article 6;

 

c.Supply of Bulk API or Finished Product by Rhizen. All Bulk API or the Finished
Product supplied by Rhizen to TGTX pursuant to this Agreement shall be
manufactured, handled and stored by Rhizen or its Third Party contract
manufacture(s): (i) in accordance with the agreed upon specification and (ii) in
compliance with applicable Laws and regulations, including without limitation,
the GMP requirements.

 

d.Listing of Backup Compounds. The list set forth on Exhibit G includes all
Backup Compounds as of the Effective Date.

 

10.3Additional Representations of TGTX.

 

a.TGTX represents and warrants that it will comply with the U.K. Bribery Act,
the United States Foreign Corrupt Practices Act and any and all other Applicable
Laws prohibiting corruption or bribery (collectively referred to as the
“Anti-Corruption Laws”); and

 

 

 

 

b.TGTX agrees, represents and warrants that (i) it (and its Affiliates) shall
transport, store, distribute, sell and promote the Product in compliance with
all applicable Laws, and (ii) any calculated prices or other data or information
that used by TGTX for reporting purposes pursuant to the rules and regulations
of any federal or state government programs, shall be current, accurate and
complete and shall comply with applicable Laws.

 

10.4        Disclaimer. TGTX understands that the Product is the subject of
ongoing clinical research and development and that Rhizen cannot assure the
safety or usefulness of the Product. In addition, Rhizen makes no warranties
except as set forth in this Agreement concerning the Rhizen Technology.

 

10.5        No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED
IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS
OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A
PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW
OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

 

 

 

ARTICLE 11

 

  

INDEMNIFICATION

 

  

11.1        Indemnification by each Party. Each Party hereby agrees to defend,
indemnify, and hold the other Party and its officers, directors, employees, and
agents harmless from and against any and all Third Party claims, suits,
proceedings, damages, expenses (including court costs and reasonable attorneys’
fees and expenses), and recoveries, including product liability claims
(collectively, “Claims”) to the extent that such Claims arise out of, are based
on, or result from (a) a breach by the indemnifying Party of its
representations, warranties, and obligations under the Agreement; or (b) the
willful misconduct or grossly negligent acts of the indemnifying Party or its
Affiliates, or the officers, directors, employees, or agents of such
indemnifying Party or its Affiliates. The foregoing indemnity obligation shall
not apply to the extent that any Claim arises from, is based on, or results from
(i) a breach of any of the representations, warranties, and obligations under
the Agreement by the Party seeking indemnity; or (ii) the willful misconduct or
grossly negligent acts of the Party seeking indemnity or its Affiliates, or the
officers, directors, employees, or agents of such Party. The foregoing indemnity
obligation shall not apply if the applicable indemnitees fail to comply with the
indemnification procedures set forth in Section 11.2. Expenses relating to any
other Claims resulting directly or indirectly from the manufacture, use,
handling, storage, sale or other disposition of the Product in the U.S. shall be
shared equally by the Parties at the time such expenses are required to be paid.

 

11.2        Indemnification Procedures. The Party claiming indemnity under this
Article 11 (the “Indemnified Party”) shall give written notice to the Party from
whom indemnity is being sought (the “Indemnifying Party”) promptly after
learning of such Claim. In the event of a claim relating to the U.S., the
Parties shall confer as to whether such claim would result in indemnification
under Section 11.1 and in any event how to respond to the claim. The Indemnified
Party shall provide the Indemnifying Party with reasonable assistance, at the
Indemnifying Party’s expense, in connection with the defense of the Claim for
which indemnity is being sought. The Indemnified Party may participate in and
monitor such defense with counsel of its own choosing at its sole expense;
provided, however, the Indemnifying Party shall have the right to assume and
conduct the defense of the Claim with counsel of its choice. The Indemnifying
Party shall not settle any claim without the prior written consent of the
Indemnified Party, such consent not to be unreasonably withheld, unless the
settlement involves only the payment of money. So long as the Indemnifying Party
is actively defending the Claim in good faith, the Indemnified Party shall not
settle any such Claim without the prior written consent of the Indemnifying
Party. If the Indemnifying Party does not assume and conduct the defense of the
Claim as provided above, (a) the Indemnified Party may defend against, and
consent to the entry of any judgment or enter into any settlement with respect
to the claim in any manner the Indemnified Party may deem reasonably appropriate
(and the Indemnified Party need not consult with, or obtain any consent from,
the Indemnifying Party in connection therewith), and (b) the Indemnifying Party
shall remain responsible to indemnify the Indemnified Party as provided in this
Article 11.

 

11.3        Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING,
NOTHING IN THIS SECTION 11.3 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE
DAMAGES AVAILABLE FOR A PARTY’S BREACH OF THE CONFIDENTIALITY OBLIGATIONS IN
ARTICLE 12.

 

 

 

 

11.4        Insurance. Each Party shall procure and maintain insurance,
including product liability and other appropriate insurance, adequate to cover
its obligations hereunder and which are consistent with normal business
practices of prudent companies similarly situated at all times during which any
Product is being clinically tested in human subjects or commercially distributed
or sold. It is understood that such insurance shall not be construed to create a
limit of either Party’s liability with respect to its indemnification
obligations under this Article 11. Each Party shall provide the other with
written evidence of such insurance upon request. Each Party shall provide the
other with written notice at least thirty (30) days prior to the cancellation,
non-renewal or material change in such insurance or self-insurance which
materially adversely affects the rights of the other Party hereunder.

 

 

 

  

ARTICLE 12

 

 

CONFIDENTIALITY

 

  

12.1           Confidentiality. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing by the Parties, each Party agrees
that, for the Term and until the later of (i) the tenth (10th) anniversary of
the Effective Date, or (ii) five (5) years after the expiration or termination
of the Term, it shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as provided for in this
Agreement any Confidential Information furnished to it by the other Party
pursuant to this Agreement except for that portion of such information or
materials that the receiving Party can demonstrate by competent written proof:

 

(a)was already known to the receiving Party or its Affiliate, other than under
an obligation of confidentiality to the disclosing party ,at the time of
disclosure by the other Party as evidenced by written documentation;

 

(b)was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the receiving Party;

 

(c)became generally available to the public or otherwise part of the public
domain after it disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement;

 

(d)was disclosed to the receiving Party or its Affiliate by a Third Party
without obligations of confidentiality with respect thereto; or

 

(e)was independently discovered or developed by the receiving Party or its
Affiliate without the aid, application, or use of Confidential Information of
the other Party as evidenced by written documentation; provided, however, that
this exception shall not apply to information or materials consisting of data
and results generated or resulting from Development activities with respect to
the Product, which information and materials shall be deemed Confidential
Information of the Party who has developed such information or materials
regardless of whether such information and materials were independently
discovered or developed by the receiving Party or its Affiliate.

 

12.2        Authorized Disclosure. Each Party may disclose Confidential
Information belonging to the other Party to the extent such disclosure is
reasonably necessary in the following situations:

 

(a)filing or prosecuting Patents as permitted in this Agreement;

 

(b)regulatory submissions and other filings with Governmental Authorities,
including filings with the Securities and Exchange Commission;

 

(c)prosecuting or defending litigation or other proceedings or regulatory
actions;

 

(d)complying with applicable Laws;

 

(e)disclosure to its employees, agents, and consultants, and any Third Parties
(and potential licensees and) with which a Party is Developing or
Commercializing the Product) only on a need-to-know basis and solely as
necessary in connection with the performance of this Agreement, provided that in
each case the recipient of such Confidential Information must agree to be bound
by similar obligations of confidentiality and non-use at least as equivalent in
scope as those set forth in this Article 12 prior to any such disclosure; and

 

 

 

 

(f)disclosure of the material financial terms of this Agreement to any bona fide
potential investor, investment banker, acquiror, merger partner, or other
potential financial partner; provided that in connection with such disclosure,
the disclosing Party shall use all reasonable efforts to inform each recipient
of the confidential nature of such Confidential Information and shall cause each
recipient of such Confidential Information to treat such Confidential
Information as confidential.

 

Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to clause (a)
through (d) of this Section 12.2, it shall, except where prohibited by
applicable Law, give reasonable advance notice to the other Party of such
disclosure and use reasonable efforts to secure confidential treatment of such
information. In any event, the Parties agree to take all reasonable action to
avoid disclosure of Confidential Information hereunder.

 

12.3        Publicity; Terms of Agreement.

 

(a)The Parties agree that the material terms of this Agreement are included
within the Confidential Information of both Parties, subject to the special
authorized disclosure provisions set forth below in this Section 12.3. The
Parties have agreed to make a joint public announcement of the execution of this
Agreement substantially in the form of the press release attached as Exhibit A
on or after the Effective Date.

 

(b)After release of such press release, if either Party desires to make a public
announcement concerning the material terms of this Agreement, such Party shall
give reasonable prior advance notice of the proposed text of such announcement
to the other Party for its prior review and approval (except as otherwise
provided herein), such approval not to be unreasonably withheld. A Party
commenting on such a proposed press release shall provide its comments, if any,
within five (5) Business Days after receiving the press release for review.
Neither Party shall be required to seek the permission of the other Party to
repeat any information regarding the terms of this Agreement that has already
been publicly disclosed or previously agreed to by such Party, or by the other
Party, in accordance with this Section 12.3.

 

(c)The Parties acknowledge that TGTX will be obligated to file a copy of this
Agreement with the U.S. Securities and Exchange Commission (the “SEC”). TGTX
shall be entitled to make such a required filing, provided that it requests
confidential treatment of certain commercial terms and sensitive technical terms
hereof to the extent such confidential treatment is reasonably available to
TGTX. In the event of any such filing, TGTX shall provide Rhizen with a copy of
the Agreement marked to show provisions for which TGTX intends to seek
confidential treatment and shall reasonably consider and incorporate Rhizen’s
comments thereon to the extent consistent with the legal requirements governing
redaction of information from material agreements that must be publicly filed.
Rhizen shall promptly provide any such comments. Rhizen recognizes that U.S.
Laws and SEC policies and regulations to which TGTX is and may become subject
may require TGTX to publicly disclose certain terms of this Agreement that
Rhizen may prefer not be disclosed, and that TGTX is, after completing the above
mentioned procedures, entitled hereunder to make such required disclosures to
the extent legally required.

 

 

 

 

12.4           Publications. Neither Party may publish peer reviewed
manuscripts, or give other forms of public disclosure such as abstracts and
presentations, of results of studies carried out under this Agreement with
respect to the Territory, without the opportunity for prior review by the other
Party. Each Party shall provide the other Party the opportunity to review and
comment on any proposed manuscripts or presentations which relate to any Product
at least thirty (30) days prior to their intended submission for publication or
presentation. Each Party shall consider the comments of the other Party and
shall remove any and all of the other Party’s Confidential Information at the
request of such other Party. A Party seeking publication shall also provide the
other Party a copy of the manuscript at the time of the submission. Neither
Party shall have the right to publish or present the other Party’s Confidential
Information without the other Party’s prior written consent, except as expressly
permitted in this Agreement.

 

12.5           Injunction. Each Party shall be entitled, in addition to any
other right or remedy it may have, at Law or in equity, to seek an injunction in
any court of competent jurisdiction, enjoining or restraining the other Party or
its Affiliates from any violation or threatened violation of this Article 12.

 

 

 

  

ARTICLE 13

 

  

TERM AND TERMINATION

 

  

13.1           Term. This Agreement shall become effective on the Effective Date
and, unless earlier terminated pursuant to this Article 13, shall remain in
effect in the Territory until the earlier to occur of:

 

(i) the exercise of the TGTX License Option and the effective date of the
License Agreement between the Parties with respect thereto;

 

(ii) the exercise of the Rhizen License Option and the effective date of the
License Agreement between the Parties with respect thereto; and

 

(iii) the later to occur of (A) the expiration of the last applicable patent of
the Joint Patents, the Rhizen Patents or TGTX Patents, or (B) the expiry of any
other exclusivity right with respect to the Product in a country, including
patent term extensions, marketing exclusivity or any other non-patent
exlusivity.

 

13.2        Termination.

 

(a)Early Withdrawal by TGTX without any cause. TGTX shall have the right to
terminate this Agreement, in its entirety, upon written notice to Rhizen by at
least six (6) months’ written notice prior to the effective date of termination.
If TGTX terminates this Agreement pursuant to this Section 13.2(a), then:

 

(i)TGTX shall not, during the applicable notice period, take any action that
could adversely affect or impair the further Development and Commercialization
of the Product.

 

(ii)The JSC shall coordinate the wind-down of TGTX’s efforts under this
Agreement.

 

(iii)TGTX shall not be responsible for any payments that become due to Rhizen
pursuant to this Agreement that are incurred or accrued during the applicable
notice period, other than those that relate to reimbursement of Development and
Commercial Expenses based on the P/L Sharing Percentage in effect at the time of
termination, subject to determination by the JSC.

 

(iv)Provided TGTX terminates both (1) prior to enrollment of * patient as
described in Section 8.1(b) and (2) after the filing of an IND or CTA with a
Regulatory Agency, then TGTX shall pay Rhizen an amount equal to *% of the
Milestone Payment. For the sake of clarity, if either condition of the proviso
of the preceding sentence is not satisfied, then TGTX will have no obligation to
make any cash payment to Rhizen upon termination of this Agreement pursuant to
this Section 13.2(a) (except for any cost sharing pursuant to Section
13.2(a(iii)).

 

(b)Withdrawal by TGTX with cause. TGTX shall have the right to terminate this
Agreement, in its entirety, for Cause upon written notice to Rhizen by at least
six (6) months’ written notice prior to the effective date of termination. If
TGTX terminates this Agreement pursuant to this Section 13.2(b), then:

 

 

* Confidential material redacted and filed separately with the Commission.

  

 

 

  

(i)TGTX shall not, during the applicable notice period, take any action that
could adversely affect or impair the further Development and Commercialization
of the Product.

 

(ii)The JSC shall coordinate the wind-down of TGTX’s efforts under this
Agreement.

 

(iii)TGTX shall not be responsible for any payments that become due to Rhizen
pursuant to this Agreement that were incurred or accrued during the applicable
notice period, other than those that relate to reimbursement of Development and
Commercial Expenses based on the P/L Sharing Percentage in effect at the time of
termination, subject to determination by the JSC.

 

  (iv) Provided TGTX terminates both (1) prior to enrollment of * patient as
described in Section 8.1(b) and (2) after the filing of an IND or CTA with a
Regulatory Agency, then TGTX shall pay Rhizen an amount equal to *% of the
Milestone Payment. For the sake of clarity, if either condition of the proviso
of the preceding sentence is not satisfied, then TGTX will have no obligation to
make any cash payment to Rhizen upon termination of this Agreement pursuant to
this Section 13.2(b) (except for any cost sharing pursuant to Section
13.2(b(iii)).

 

(c)Termination for Breach.

 

(i)Rhizen shall have the right to terminate this Agreement upon written notice
to TGTX if TGTX, after receiving written notice identifying such material breach
by TGTX, fails to cure such material breach within ninety (90) days from the
date of such notice ; provided, that if such breach cannot be remedied within
such 90-day period (including a breach caused by a Financial Force Majeure) and
TGTX has provided Rhizen with a written plan, reasonably acceptable to Rhizen,
setting forth the activities to be performed by TGTX to remedy such breach, then
Rhizen may not terminate this Agreement during such time as TGTX is diligently
pursuing the performance of the activities described in the plan; and provided,
further, that if such material breach relates solely to a particular country in
the Territory, then Rhizen may terminate this Agreement only with respect to the
applicable country but may not terminate this Agreement with respect to any
other countries. Additionally, all the timeframes for curing a breach shall be
stayed pending resolution of any disputes related to such purported breach.

 

(ii)TGTX shall have the right to terminate this Agreement upon written notice to
Rhizen if Rhizen, after receiving written notice identifying a material breach
by Rhizen of its obligations under this Agreement, fails to cure such material
breach within ninety (90) days from the date of such notice; provided, that if
such breach cannot be remedied within such 90-day period (including a breach
caused by a Financial Force Majeure) and Rhizen has provided TGTX with a written
plan, reasonably acceptable to TGTX, setting forth the activities to be
performed by Rhizen to remedy such breach, then TGTX may not terminate this
Agreement during such time as Rhizen is diligently pursuing the performance of
the activities described in the plan; and provided, further, that if such
material breach relates solely to a particular country in the Territory, then
TGTX may terminate this Agreement only with respect to the applicable country
but may not terminate this Agreement with respect to any other countries.
Additionally, all the timeframes for curing a breach shall be stayed pending
resolution of any disputes related to such purported breach.

 

 

* Confidential material redacted and filed separately with the Commission.

  

 

 

 

(iii)For clarity, if a Party elects not to exercise its rights to terminate this
Agreement pursuant to this Section 13.2(c) for the other Party’s uncured
material breach or pursuant to Section 13.5, but instead elects to allow this
Agreement to continue in effect, then the breaching Party shall continue to be
liable to the other Party for any breach of representations, warranties,
obligations or agreements made in this Agreement by such breaching Party, and
the non-breaching Party shall be entitled to pursue legal and equitable remedies
arising from such breach that are available to it.

 

(d)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.

 

13.3           Other Remedies for Rhizen Breach. In addition to the termination
remedy described in Sections 13.2(c), TGTX shall have certain other remedies for
the material breaches of this Agreement (including a Rhizen failure to comply
with Section 13.5) by Rhizen (which in all events shall be (i) in addition to,
and not in lieu of, any other remedies available to TGTX under this Agreement or
applicable law, and (ii) subject to the notice and cure provisions of Section
13.2(c)), specified as follows:.

 

(a)Continuing Rights of TGTX. If TGTX otherwise has the right to terminate the
entire Agreement pursuant to Section 13.2(c)(ii) due to a material breach by
Rhizen, TGTX shall have, in addition to its other remedies, the right to elect
in writing to continue the Agreement pursuant to Section 13.2(c)(iii) to retain:
(i) its rights and obligations to the Backup Compounds pursuant to the terms of
Section 3.7, and (ii) all other rights and obligations granted under this
Agreement to TGTX, including, but not limited to, all Patent rights and
licenses.  If TGTX exercises such right, then the Agreement shall remain in
effect with respect to the Backup Compound and all other rights and obligations
of the Parties shall remain in full force and effect under the Agreement.  If
TGTX does not exercise such right, then the Agreement shall be deemed
terminated.

 

13.4           Rhizen Termination for TGTX Failure to File IND/CTA:
Notwithstanding Section 13.2(b) above if the IND/CTA Filing Conditions are met
and TGTX fails to file an IND or CTA in a Major Market on or before the
applicable IND/CTA Filing Deadline (other than for reasons beyond the reasonable
control of TGTX, such as the requirements of the applicable Regulatory
Authority), Rhizen may terminate this Agreement on sixty(60) days’ written
notice to TGTX unless TGTX makes such filing, or is determined by the JSC to be
actively in the process of making such filing before the end of sixty (60) days’
written notice to TGTX.

 

13.5           Termination for Diligence Failure: Notwithstanding Section
13.2(b) above, if a party does not correct a failure to use Diligent Efforts
within the applicable period specified in, or determined in accordance with this
Agreement (a “Diligence Failure”), the non-breaching party shall have the right
to terminate this Agreement on sixty (60) days’ written notice to the breaching
party unless the breaching party cures such Diligence Failure before the end of
such sixty (60) day period, or is determined by the JSC to be actively in the
process of curing such Diligence Failure before the end of such sixty (60) day
period.

 

 

 

 

13.6                Effect of Termination of the Agreement. Upon termination by
Rhizen of the Agreement under Section 13.2(c), Section 13.4 or Section 13.5, or
upon termination by TGTX under Section 13.2(a) and 13.2(b), the following shall
apply (in addition to any other rights and obligations under Section 13.7 or
13.8 or otherwise under this Agreement with respect to such termination) with
respect to the affected territory or territories:

 

a.Intellectual Property. Rhizen shall have the right, exercisable upon written
notice by Rhizen to TGTX given within sixty (60) days after the effective date
of such termination, to obtain, and effective upon such notice, TGTX shall, and
it hereby does, grant to Rhizen, a perpetual, exclusive, worldwide,
royalty-bearing license, with the right to sublicense, under TGTX Intellectual
Property Rights (which, for purposes of this Section 13.6 shall not include the
Joint Patents or the Joint Know-How) solely to develop, make, have made, use,
sell, offer for sale, have sold and import the Compound and Products in the
Field of Use, subject to the terms and conditions set forth below in
subparagraph (c). TGTX shall provide to Rhizen when enforcing any such rights
under this Section 13.6(a) reasonable assistance in such enforcement, at
Rhizen’s request and cost, including joining such action as a party plaintiff if
required by applicable Law to pursue such action. In consideration for such
exclusive license, Rhizen shall pay to TGTX a royalty based on the fair market
value of such license.  The royalty will be negotiated in good faith by the
Parties within fifteen (15) days following the effective date of the
termination. If the Parties cannot agree on the terms of the royalty, the
parties will select a disinterested Third Party to determine the fair market
value of the license (the “Appraiser”).  Once the Appraiser is selected, the
Appraiser shall be instructed to furnish a written appraisal within sixty (60)
days of it selection. TGTX shall bear the Appraiser’s reasonable costs and
expenses.  The fair market value royalty will be paid out of Rhizen’s gross
profits following the first commercial sale of the Product, and which gross
profits will be based on all amounts paid to Rhizen from its sublicensing or
from sales directly or indirectly in the particular country or Territory. The
term of such royalty will expire on the expiration of the last to expire issued
Valid Claim within the TGTX Patents covering the Product in the particular
country or Territory.

 

TGTX shall, and it hereby does, upon such Termination grant to Rhizen, (i) a
perpetual, exclusive, worldwide, royalty-free license, with the right to
sublicense, under the Joint Patents; and (ii) a perpetual, non-exclusive,
royalty-free license to the Joint Know-How, in each case solely to develop,
make, have made, use, sell, offer for sale, have sold and import the Compound
and Products in the Field of Use. TGTX shall provide to Rhizen when enforcing
any such rights under this Section 13.6(a) reasonable assistance in such
enforcement, at Rhizen’s request and cost, including joining such action as a
party plaintiff if required by applicable Law to pursue such action.

 

b.Regulatory Materials. TGTX shall transfer and assign to Rhizen all Regulatory
Materials and Regulatory Approvals for Product for the terminated country(ies)
of the Territory , and shall grant Rhizen a right of reference to all Regulatory
Materials filed by TGTX in the Territory solely for the purpose of Rhizen
obtaining Regulatory Approval for the Product in such terminated country(ies).
For avoidance of doubt , Rhizen shall have right to transfer and assign the
rights to any of its licensing partner for the terminated country(ies) of the
Territory.

 

 

 

 

c.Transition Assistance. TGTX shall, for a reasonable period of time, provide
such assistance, at no cost to Rhizen, to transfer or transition to Rhizen all
other technology or know-how, including Information generated from the Clinical
Trials or other Development activities, or then-existing commercial
arrangements, that is, or are, reasonably necessary or useful for Rhizen to
commence or continue Developing, conducting Finished Manufacturing of or
Commercializing the Product in or for the terminated country(ies) of the
Territory, to the extent TGTX is then performing or having performed such
activities. TGTX shall take such other commercially reasonable actions and shall
execute such other instruments, assignments and documents as may be necessary to
effect the transition of the Development and Commercialization of the Product to
Rhizen, including without limitation assignments of any contracts, including
subcontracting agreements, related to the Development and Commercialization of
the Product, unless such assignment is prohibited by a contract and the
applicable consent cannot be reasonably procured at reasonable cost.  TGTX will
use commercially reasonable efforts to obtain the consent of any third-party to
any contract or agreement related to the Development or Commercialization of the
Product, which consent is required for the assignment of any such contract or
agreement from TGTX to Rhizen, provided, however, that any cash payment required
by TGTX in order to procure any such consent shall be deemed not commercially
reasonable.  Prior to receipt of such consent, TGTX shall make available to
Rhizen all rights and other benefits of such contracts, on a subcontract or
sublease basis or in some other appropriate manner to the fullest extent
reasonably practicable, and Rhizen shall be considered an independent
subcontractor or sublessee of TGTX, with respect to all matters concerning such
contracts.

 

d.Remaining Inventories. Rhizen shall have the right to purchase from TGTX all
of the inventory of Finished Product held by TGTX for such terminated
country(ies) as of the effective date of termination of this Agreement at a
price equal to TGTX’s cost to acquire or manufacture such inventory for such
terminated country(ies). Rhizen shall notify TGTX within thirty (30) days after
the date of termination of the Agreement whether Rhizen elects to exercise such
right. If Rhizen does not exercise such right, then TGTX shall have the right to
sell in such terminated country(ies) of the Territory any such remaining
inventory over a period of no greater than six (6) months after the effective
date of termination of this Agreement provided TGTX makes appropriate payment to
Rhizen under similar terms of the prevailing P/L arrangements.

 

f.Termination of Licenses. For clarity, upon any termination of this Agreement
under Section 13.2, the licenses granted to TGTX under this Agreement for such
terminated country(ies) shall terminate.

 

g.Clinical Trials. In the event that any clinical trial of the Product being
conducted by or on behalf of TGTX is on-going as of the effective date of any
termination of this Agreement, then upon written request of Rhizen, TGTX shall
cooperate to transfer responsibility for such clinical trial to Rhizen or its
designee as expeditiously as possible in an orderly manner and in compliance
with Law and common standards of industry practice, and cooperate to facilitate
the transfer to Rhizen of, as applicable, regulatory filings, CRO contracts,
site agreements and the like as expeditiously as possible, provided that the
costs of conducting such clinical trial up to the effective date of termination
of this Agreement shall be considered Development Costs. In the event that
Rhizen does not request to transfer responsibility for the conduct of such
on-going clinical trial, then TGTX shall wind down such on-going clinical trial
as expeditiously as possible, consistent with TGTX’s ethical and regulatory
obligations and in compliance with Law and standards of industry practice,
provided that all costs of TGTX in winding-down such clinical trial shall be
considered Development Costs; provided, however, if the Agreement was terminated
by Rhizen pursuant to Section 13.2(c)(i), Section 13.4, or Section 13.5, or upon
termination by TGTX under Section 13.2(a), TGTX shall be responsible for such
costs. However, if the Agreement was terminated by TGTX pursuant to Section
13.2(c)(ii) or Section 13.5, Rhizen shall be responsible for such costs.

 

 

 

 

13.7           Other Remedies. Other than as explicitly stated otherwise in this
Article 13, termination or expiration of this Agreement for any reason shall not
release any Party from any liability or obligation that already has accrued
prior to such expiration or termination, nor affect the survival of any
provision hereof to the extent it is expressly stated to survive such
termination. Termination or expiration of this Agreement for any reason shall
not constitute a waiver or release of, or otherwise be deemed to prejudice or
adversely affect, any rights, remedies or claims, whether for damages or
otherwise, that a Party may have hereunder or that may arise out of or in
connection with such termination or expiration.

 

13.8           Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by Rhizen are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that TGTX, as licensee of such rights under this
Agreement, shall retain and 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 of the commencement of a bankruptcy proceeding by or against
Rhizen, TGTX shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in TGTX’s possession, shall be
promptly delivered to it (a) upon any such commencement of a bankruptcy
proceeding upon TGTX’s written request therefor, unless Rhizen elects to
continue to perform all of its obligations under this Agreement or (b) if not
delivered under clause (a), following the rejection of this Agreement by or on
behalf of Rhizen upon written request therefor by TGTX.-

 

13.9           Survival. The following provisions shall survive any expiration
or termination of this Agreement for the period of time specified therein (or,
if no such period is specified, indefinitely): Articles 1, 10, 11, 12, 14, and
15, and Sections 4.7, 9.1, 9.8 (to the extent that TGTX uses a Product Trademark
after such expiration or termination), 13.4, 13.3, 13.6, 13.7, and 13.8.

 

 

 

  

ARTICLE 14

 

  

DISPUTE RESOLUTION

 

  

14.1         English Language; Governing Law. This Agreement was prepared in the
English language, which language shall govern the interpretation of, and any
dispute regarding, the terms of this Agreement. This Agreement and all disputes
arising out of or related to this Agreement or any breach hereof shall be
governed by and construed under the Laws of the State of New York without giving
effect to any choice of law principles that would require the application of the
Laws of a different state.

 

14.2        Disputes.

 

(a)The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Party’s rights or obligations
hereunder. It is the objective of the Parties to establish procedures to
facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual cooperation and without resort to litigation. To
accomplish this objective, the Parties agree to follow the procedures set forth
in this Section 14.2 to resolve any controversy or claim arising out of,
relating to or in connection with any provision of this Agreement, if and when a
dispute arises under this Agreement. With respect to all disputes arising
between the Parties (other than those matters delegated to the JSC, which shall
be governed in accordance with Section 2.3(c)), including, without limitation,
any alleged failure to perform, or breach, of this Agreement, or any issue
relating to the interpretation or application of this Agreement, if the Parties
are unable to resolve such dispute within sixty (60) days after such dispute is
first identified by either Party in writing to the other, the Parties shall
refer such dispute to the senior executive officers for each Party for attempted
resolution by good faith negotiations within thirty (30) days after such notice
is received. If the senior executive officers designated by the Parties are not
able to resolve such dispute within such thirty (30) day period, either Party
may submit such dispute in accordance with Section 14.2(b).

 

(b)Arbitration. Any dispute arising out of or relating to this Agreement,
including the breach, termination or validity thereof, which has not been
resolved by the executives of the Parties as provided herein will be finally
resolved by arbitration in accordance with the CPR Rules for Non-Administered
Arbitration then currently in effect, by three arbitrators of whom each party
will appoint one in accordance with the ‘screened’ appointment procedure
provided in Rule 5.4, provided, however, that if one party fails to participate
in either the negotiation or mediation as agreed herein, the other party can
commence arbitration prior to the expiration of the time periods set forth
above. The arbitration will be governed by the Federal Arbitration Act, 9 U.S.C.
§§1 et seq., and judgment upon the award rendered by the arbitrator(s) may be
entered by any court having jurisdiction thereof. The place of arbitration will
be New York, NY. The award may be made a judgment by any court of competent
jurisdiction pursuant to the New York Convention, 9 U.S.C. § 201 et seq., and
for this purpose the Party against whom the award is made will agree to the
personal jurisdiction of the court in which recognition is sought and will not
raise any argument of forum non conveniens.

 

(c)Notwithstanding anything to the contrary in this Article 14, either Party may
seek injunctive relief in any court in any jurisdiction where appropriate.

 

 

 

  

ARTICLE 15

 

  

MISCELLANEOUS

 

  

15.1           Entire Agreement; Amendment. This Agreement, including the
Exhibits hereto, sets forth the complete, final and exclusive agreement and all
the covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto with respect to the subject matter
hereof and supersedes, as of the Effective Date, all prior agreements and
understandings between the Parties with respect to the subject matter hereof.
There are no covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties other
than as are set forth herein and therein. No subsequent alteration, amendment,
change or addition to this Agreement shall be binding upon the Parties unless
reduced to writing and signed by an authorized officer of each Party.

 

15.2           Force Majeure. Both Parties shall be excused from the performance
of their obligations under this Agreement to the extent that such performance is
prevented by force majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse shall be continued so long as
the condition constituting force majeure continues and the nonperforming Party
takes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the
Parties, including without limitation, an act of God, war, civil commotion,
terrorist act, labor strike or lock-out, epidemic, failure or default of public
utilities or common carriers, destruction of production facilities or materials
by fire, earthquake, storm or like catastrophe, and failure of plant or
machinery (provided that such failure could not have been prevented by the
exercise of skill, diligence, and prudence that would be reasonably and
ordinarily expected from a skilled and experienced person engaged in the same
type of undertaking under the same or similar circumstances). Notwithstanding
the foregoing, a Party shall not be excused from making payments owed hereunder
because of a force majeure affecting such Party, except in the case of a
Financial Force Majeure. Nevertheless, any failure to make a payment as a result
of a Financial Force Majeure will trigger a reduction in a Party’s P/L Share
Percentage in accordance with Sections 3.4 and 8.2 hereof.

 

15.3           Notices. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this Agreement, and
shall be addressed to the appropriate Party at the address specified below or
such other address as may be specified by such Party in writing in accordance
with this Section 15.3, and shall be deemed to have been given for all purposes
(a) when received, if hand-delivered sent by a reputable overnight delivery
service, or by facsimile (with electronic confirmation of receipt) or by e-mail,
or (b) seven (7) days after mailing, if mailed by first class certified or
registered mail, postage prepaid, return receipt requested.

 

If to Rhizen:  

Rhizen Pharmaceuticals, S.A.

Fritz-Couveoriser 40

CH-2300 La Chaux-de-Fonds

Switzerland

Attn: Swaroop Vakkalanka

 

 

 

 

If to TGTX:  

TG Therapeutics Inc.

787 Seventh Avenue 48th Floor

New York, New York 10019

Attn: Michael S. Weiss

 

15.4           No Strict Construction; Headings. This Agreement has been
prepared jointly and shall not be strictly construed against either Party.
Ambiguities, if any, in this Agreement shall not be construed against any Party,
irrespective of which Party may be deemed to have authored the ambiguous
provision. The headings of each Article and Section in this Agreement have been
inserted for convenience of reference only and are not intended to limit or
expand on the meaning of the language contained in the particular Article or
Section.

 

15.5           Assignment. Neither Party may assign or transfer this Agreement
or any rights or obligations hereunder without the prior written consent of the
other, except that a Party may make such an assignment without the other Party’s
consent to Affiliates or to a successor to substantially all of the business of
such Party, whether in a merger, sale of stock, sale of assets or other
transaction. Any permitted assignment shall be binding on the successors of the
assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 15.5 shall be null, void and of no legal
effect.

 

15.6           Performance by Affiliates. Each Party may discharge any
obligations and exercise any right hereunder through any of its Affiliates. Each
Party hereby guarantees the performance by its Affiliates of such Party’s
obligations under this Agreement, and shall cause its Affiliates to comply with
the provisions of this Agreement in connection with such performance. Any breach
by a Party’s Affiliate of any of such Party’s obligations under this Agreement
shall be deemed a breach by such Party, and the other Party may proceed directly
against such Party without any obligation to first proceed against such Party’s
Affiliate.

 

15.7           Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.

 

15.8           Severability. If any one or more of the provisions of this
Agreement is held to be invalid or unenforceable by any court of competent
jurisdiction from which no appeal can be or is taken, the provision shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized.

 

15.9           No Waiver. Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of such Party’s rights to the future enforcement of its
rights under this Agreement, except with respect to an express written and
signed waiver relating to a particular matter for a particular period of time.

 

15.10         Independent Contractors. Each Party shall act solely as an
independent contractor, and nothing in this Agreement shall be construed to give
either Party the power or authority to act for, bind, or commit the other Party
in any way. Nothing herein shall be construed to create the relationship of
partners, principal and agent, or joint-venture partners between the Parties.

 

 

 

 

15.11         Counterparts. This Agreement may be executed in one (1) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement shall be
binding upon the delivery by each Party of an executed signature page to the
other Party by facsimile transmission. If signature pages are so delivered by
facsimile transmission, each Party shall also immediately deliver an executed
original counterpart of this Agreement to the other Party by courier delivery
service.

 

15.12         Construction. Except where the 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, and the word “or” is
used in the inclusive sense (and/or). The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit
the scope or intent of this Agreement or the intent of any provision contained
in this Agreement. The term “including” as used herein means including, without
limiting the generality of any description preceding such term. References to
“Article,” “Section” or “Exhibit” are references to the numbered sections of
this Agreement and the exhibits attached to this Agreement, unless expressly
stated otherwise.

 

{Signature page follows.}

 

 

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their duly authorized officers as of the Effective Date.

 

TG THERAPEUTICS, INC.   RHIZEN PHARMACEUTICALS, LTD       By: /s/ Michael S.
Weiss   By: /s/ Swaroop Vakkalanka           Name: Michael S. Weiss   Name:
Swaroop Vakkalanka           Title: Chairman and CEO   Title: President