Untitled Document





 






 






 


 


 



LICENSE AGREEMENT

 


BY AND
BETWEEN

 


Jiangsu
Hengrui Medicine Co.

 


AND

 


TG
Therapeutics, Inc.

 

 

 

 

 




 









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










 



LICENSE AGREEMENT

 


THIS LICENSE AGREEMENT (the
“Agreement”) is
dated as of January 8, 2018 (the “Effective Date”) by and between
Jiangsu Hengrui Medicine Co., a Chinese corporation having its
place of business at No.7 Kunlunshan Road, Lianyungang Eco &
Tech Development Zone, Jiangsu Province, China 222047 (including
its successors and permitted assigns, “Licensor”), and TG Therapeutics,
Inc., a Delaware corporation with its place of business at 2
Gansevoort St., New York, New York 10014 (including its successors
and permitted assigns, “TGTX”). TGTX, on the one hand, and
Licensor, on the other hand, shall each be referred to herein as a
“Party” or,
collectively, as the “Parties.”

 



RECITALS:

 


WHEREAS, TGTX is engaged in the
research, development, manufacturing and commercialization of
pharmaceutical products, and TGTX is interested in developing and
commercializing products containing or comprising the Compounds;
and

 


WHEREAS, TGTX desires to license from
Licensor and Licensor wishes to license to TGTX, on an exclusive
basis, the right to use, develop and commercialize Licensor
Technology in and for a defined field of use.

 


NOW, THEREFORE, in consideration of the
foregoing and of the various promises and undertakings set forth
herein, the Parties agree as follows:

 

        


 ARTICLE I.




DEFINITIONS

 


Unless
otherwise specifically provided herein, the following terms shall
have the following meanings:

 

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

 

1.2. “Affiliate”
means, with respect to either Party, a
Person that controls, is controlled by or is under common control
with a Party, but only for so long as such control exists. For the
purposes of this Section 1.2, the word
“control” (including, with correlative meaning, the
terms “controlled
by” or
“under
common control with”)
means the actual power, either directly or indirectly through one
or more intermediaries, to direct the management and policies of
such Person by the ownership of at least fifty percent (50%) of the
voting securities of such Person.

 

1.3.  “Calendar
Quarter” means each three
month period commencing January 1, April 1, July 1
or October 1, provided however that (a) the first
Calendar Quarter of the Term shall extend from the Effective Date
to the end of the first full Calendar Quarter thereafter, and
(b) the last Calendar Quarter of the Term shall end upon the
termination or expiration of this Agreement.

 

1.4. “Calendar
Year” means the period
beginning on the 1st
of January and ending on the
31st
of December of the same year, provided
however that (a) the first Calendar Year of the Term shall
commence on the Effective Date and end on December 31 of the
same calendar year as the Effective Date, and (b) the last
Calendar Year of the Term shall commence on January 1 of the
Calendar Year in which this Agreement terminates or expires and end
on the date of termination or expiration of this
Agreement.

 

1.5. “Change
of Control” means, with
respect to a 
Party,
(a) a merger or consolidation of such Party with a Third Party that results in the voting securities
of such Party outstanding
immediately prior thereto, or
any securities into which such voting securities have been
converted or exchanged, ceasing
to represent more than 50% of
the combined voting power of the surviving entity
or the parent of the surviving entity
immediately after such merger or consolidation, or (b) a
transaction or series of
related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of
more than 50% of the combined voting
power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s business to which the subject matter
of this Agreement
relates.

 

1.6. “
* ” means the * of * and its
possessions.

 

1.7. “Combination
Product” means a product
(a) containing a Licensed Product together with one or more other
active ingredients, or (b) with one or more products, devices,
pieces of equipment or components, but sold for an integrated price
(e.g., with the purchase of one product the customer gets a coupon
for the other) or for a single price.

 



 







 





 

1.8. “Commercialization”
or “Commercialize”
means any and all activities
undertaken at any time for a particular Licensed Product and that
relate to the manufacturing, marketing, promoting, distributing,
importing or exporting for sale, offering for sale, and selling of
the Licensed Product, and interacting with Regulatory Authorities
regarding the foregoing.

 

1.9. “Commercially
Reasonable Efforts” means, with respect to the efforts to be expended
by a Party or such Party’s applicable Affiliate with respect
to any objective, such reasonable, diligent, and good faith efforts
normally used to accomplish a similar objective under similar
circumstances by a similarly-situated company. Commercially
Reasonable Efforts will not mean that a Party commits that it or
such Party’s applicable Affiliate will actually accomplish
the applicable task.

 

1.10.  “Compounds”
means Licensor’s proprietary Bruton’s Tyrosine
Kinase (BTK) inhibitors set forth
on Schedule 1
and any other *, *, *, *, *, *, * and
*.

 

1.11. “Control”
means, with respect to (a) Patent Rights, (b) Know-How or
(c) biological, chemical or physical material, that a Party or
one of its Affiliates owns or has a license or sublicense to such
Patent Rights, Know-How or material (or in the case of material,
has the right to physical possession of such material) and has the
ability to grant a license or sublicense to, or assign its right,
title and interest in and to, such Patent Rights, Know-How or
material as provided for in this Agreement without violating the
terms of any agreement or other arrangement with any Third
Party. Notwithstanding anything in this Agreement to the
contrary, a Party will be deemed to not Control any Patents,
Know-How or material that are owned or controlled by a Third Party
described in the definition of “Change of Control,” or
such Third Party’s Affiliates (other than an Affiliate of
such Party prior to the Change of Control), (a) prior to the
closing of such Change of Control, except to the extent that any
such Patents or Know-How were developed prior to such Change of
Control through the use of such Party’s technology, or
(b) after such Change of Control to the extent that such
Patents or Know-How are developed or conceived by such Third Party
or its Affiliates (other than such Party) after such Change of
Control without using or incorporating such Party’s
technology.

 

1.12. “Covered”
means, with respect to a Licensed
Product, that the manufacturing, importing, using, selling, or
offering for sale of such Licensed Product would, but for ownership
of or a license granted hereunder under Licensor Patents, infringe
a Valid Claim of Licensor Patents in the country in which the
activity occurs.

 

1.13. “Development”
or “Develop” means,
with respect to a Licensed Product, the performance of all
preclinical and clinical development (including, without
limitation, toxicology, pharmacology, test method development and
stability testing, process development, formulation development,
quality control development, statistical analysis), clinical
trials, and manufacturing and regulatory activities that are
required to obtain Regulatory Approval of such Licensed
Product.

 

1.14. “EMA”
means the European Medicines Agency or
any successor agency.

 

1.15. “European
Commission” means the
authority within the European Union that has the legal authority to
grant Regulatory Approvals in the European Union based on input
received from the EMA or other competent Regulatory
Authorities.

 

1.16. “FDA”
means the United States Food and Drug
Administration, or a successor federal agency
thereto.

 

1.17. “Field”
means prophylactic, palliative,
therapeutic or diagnostic uses of a Licensed Product as monotherapy
or in combination with ublituximab (TG-1101, an anti-CD20
mAb), in
combination with umbralisib (TGR-1202, a PI3Kd inhibitor), or in
combination with ublituximab (TG-1101) and umbralisib (TGR-1202) in
connection with Hematologic Malignancies. “Hematologic
Malignancies” are forms of cancer that begin in the
cells of blood-forming tissue,
such as the bone marrow, or in the cells of the immune system.
Non-limiting examples of such malignancies include acute and
chronic leukemias, such as Chronic Lymphocytic leukemia
(“CLL”), Small Lymphocytic lymphoma
(“SLL”), Mantle Cell lymphoma (“MCL”),
Multiple myeloma (“MM”), Myelodysplastic syndromes
(“MS”); Hodgkin lymphoma (“HL”), including
classical Hodgkin lymphoma (cHL) and Nodular lymphocyte-predominant
Hodgkin lymphoma (NLPHL); Non-Hodgkin lymphomas (NHL) including
B-cell lymphoma and NK/T-cell lymphoma; precursor B/T lymphoblastic
lymphoma; and Waldenstrom macroglobulinemia (WM), in all cases, in
humans or animals.

 

1.18. “First
Commercial Sale” means,
with respect to a Licensed Product in any country, the first
commercial transfer or disposition for value of such Licensed
Product in such country to a Third Party by TGTX, an Affiliate of
TGTX or a Sublicensee after Regulatory Approval has been obtained
in such country.

 

1.19. “GAAP”
means United States generally accepted accounting
principles.

 



 







 





 

1.20. “Governmental
Body” means any:
(a) nation, principality, state, commonwealth, province,
territory, county, municipality, district or other jurisdiction of
any nature; (b) federal, state, local, municipal, foreign or
other government; (c) governmental or quasi-governmental
authority of any nature (including any governmental division,
subdivision, department, agency, bureau, branch, office,
commission, council, board, instrumentality, officer, official,
representative, organization, unit, body or entity and any court or
other tribunal); (d) multi-national or supranational
organization or body; or (e) individual, entity, or body
exercising, or entitled to exercise, any executive, legislative,
judicial, administrative, regulatory, police, military or taxing
authority or power of any nature.

 

1.21. “Know-How”
means any scientific or technical
information, results and data of any type whatsoever, in any
tangible or intangible form whatsoever, that is not in the public
domain or otherwise publicly known, including, without limitation,
discoveries, inventions, trade secrets, databases, practices,
protocols, regulatory filings, methods, processes, techniques,
software, works of authorship, plans, concepts, ideas, biological
and other materials, reagents, specifications, formulations,
formulae, data (including, but not limited to, pharmacological,
biological, chemical, toxicological, clinical and analytical
information, quality control, trial and stability data), case
reports forms, data analyses, reports, studies and procedures,
designs for experiments and tests and results of experimentation
and testing (including results of research or development),
summaries and information contained in submissions to and
information from ethical committees, the FDA or other Regulatory
Authorities, and manufacturing process and development information,
results and data, whether or not patentable, all to the extent not
claimed or disclosed in a patent or pending patent application. The
fact that an item is known to the public shall not be taken to
exclude the possibility that a compilation including the item,
and/or a development relating to the item, is (and remains) not
known to the public. “Know-How” includes any rights
including copyright, moral, trade-secret, database or design rights
protecting such Know-How. “Know-How” excludes Patent
Rights.

 

1.22. “Indication”
means a generally acknowledged disease
or condition, a significant manifestation of a disease or
condition, or symptoms associated with a disease or condition or a
risk for a disease or condition, which a Licensed Product is
intended to address.

 

1.23. “Law”
or “Laws”
means all applicable laws, statutes,
rules, regulations, ordinances and other pronouncements having the
binding effect of law of any Governmental Body.

 

1.24. “Licensed
Product” means any
pharmaceutical product, in any dosage form, preparation,
composition, formulation, presentation or package configuration,
that is Commercialized or undergoing research or preclinical or
clinical Development that contains or comprises, in part or in
whole, a Compound. For clarity: if a product is described by the
foregoing sentence it is a “Licensed Product” for all
purposes hereof whether or not it is Covered and whether or not the
manufacturing, importing, using, selling, or offering for sale of
such product would, but for a license granted under this Agreement
under the Licensor Technology, infringe any Licensor Patents in the
country in which the activity occurs.

 

1.25. “Licensor
Know-How” means any and
all Know-How that (a) is Controlled by Licensor or any of its
Affiliates as of the Effective Date or at any time thereafter
during the Term and (b) pertains directly and particularly to the
Compounds and (c) is from time to time expressly identified in
writing by Licensor to TGTX as constituting Licensor Know-How. The
Licensor Know-How shall include, but not be limited to, the
Know-How listed on Schedule 2
hereto.

 

1.26. “Licensor
Patents” means all Patent
Rights that are Controlled by Licensor or any of its Affiliates as
of the Effective Date or at any time thereafter during the Term and
that pertain directly and particularly to the Compounds, which are
set forth on Schedule 3
hereto, as updated from time to
time.

 

1.27. “Licensor
Technology” means the
Licensor Patents and the Licensor Know-How.

 

1.28. “Major
Market” means any of the
(a) * , (b) the *
, or (c) *.

 

1.29. “NDA”
means a New Drug Application submitted
pursuant to the requirements of the FDA, as more fully defined in
21 U.S. CFR § 314.3 et seq., a Biologics License
Application submitted pursuant to the requirements of the FDA, as
more fully defined in 21 U.S. CFR § 601, and any
equivalent application submitted in any country, including a
European Marketing Authorization Application, together, in each
case, with all additions, deletions or supplements
thereto.

 

1.30. “NDA
Approval” means the
receipt of notice from the relevant US Regulatory Authority that an
NDA for a Licensed Product has met all the criteria for marketing
approval.

 



 







 





 

1.31. “Net
Sales” means the gross
amount invoiced or otherwise charged by TGTX, its Affiliates and
Sublicensees to Third Parties for a Licensed Product,
less:

 



(a) 

Normal and
customary trade, quantity, cash and discounts and credits allowed
and taken;





 



(b) 

Discounts, refunds,
rebates, chargebacks, retroactive price adjustments, and any other
allowances given and taken which effectively reduce the net selling
price (other than such which have already diminished the gross
amount invoiced such as those outlined in Section 1.29(a) above),
including, without limitation, Medicaid rebates, institutional
rebates or volume discounts;





 



(c) 

Product returns and
allowances;





 



(d) 

Administrative fees
paid to government related group purchasing organizations (e.g.,
Medicare) and government-mandated rebates;





 



(e) 

Shipping, handling,
freight, postage, insurance and transportation charges, but all
only to the extent included as a separate line item in the gross
amount invoiced;





 



(f) 

Any
tax, tariff or duties imposed on the production, sale, delivery or
use of the Licensed Product, including, without limitation, sales,
use, excise or value added taxes and customs and duties, but all
only to the extent included as a separate line item (e.g.,
“taxes”) in the gross amount invoiced; and





 



(g) 

Bad
debt actually written off during the accounting period (provided,
that any bad debt write-off so taken which is later reversed shall
be added back to Net Sales in the accounting period in which the
reversal occurs).





 


Notwithstanding the
foregoing, amounts invoiced by TGTX and its Affiliates and
Sublicensees for sales of Licensed Products among TGTX and its
Sublicensees and their respective Affiliates for resale shall not
be included in the computation of Net Sales.

 


For
purposes of determining royalties and sales milestones payable on
Combination Products, Net Sales will be calculated as follows, in
each calendar quarter:


 


           
(i)            
If all
therapeutically active pharmaceutical ingredients comprising the
Combination Product are marketed and sold separately in
commercially relevant quantities in a calendar quarter and the Net
Selling Price (as defined below) for each such therapeutically
active pharmaceutical ingredients can be separately determined for
such quarter, Net Sales of each Combination Product for determining
the royalty payment and sales milestones payable with respect to
such Combination Product shall be calculated by * the * of the * by * by the * of * ( * /( *
+ * )), in which * is the * of the single therapeutically
active pharmaceutical ingredient in the Licensed Product contained
in the Combination Product sold during the relevant payment period
and * is the * of the other
single therapeutically active pharmaceutical ingredient contained
in the Combination Product sold during such payment period.
“Net Selling Price” means the gross price at which a
product is sold to a third party after discounts, deductions,
credits, taxes and allowances


 


(ii)           If
: (a) neither of the therapeutically active pharmaceutical
ingredients of a Combination Product are sold separately in
commercially relevant quantities during a particular payment
period, or (b) a Combination Product has * ( * )
or more therapeutically active pharmaceutical ingredients in
addition to the Licensed Product, then, in any such case, the
Parties will meet and negotiate an appropriate method for
determining the * resulting from sales of such Combination Product,
taking into account the contribution each therapeutically active
pharmaceutical ingredient makes to the total selling price of such
Combination Product, based on the principle behind the formulas
above and with reference to a mutually agreed sampled median of
comparable branded, non-generic or non-biosimilar products
comprised of BTK (e.g.,
* ), * (e.g., *
) 
( * 
) / * 
( * 
), * and ( * ), or * (e.g., * ) agent as a monotherapy for use in the
Field.

 

1.32.  “Non-Hematology
Malignancy Indications” means any Indication that is
not covered in the Field.

 

1.33. “Patent
Right” means: (a) an
issued or granted patent, including any extension, supplemental
protection certificate, registration, confirmation, reissue,
reexamination, extension or renewal thereof; (b) a pending
patent application, including any continuation, divisional,
continuation-in-part, substitute or provisional application
thereof; and (c) all counterparts or foreign equivalents of
any of the foregoing issued by or filed in any country or other
jurisdiction; provided, however, that, with respect to items (b)
and (c), no patent application shall be considered pending after a
period of seven years from its effective filing
date.

 

1.34. “Person”
means any natural person, corporation,
firm, business trust, joint venture, association, organization,
company, partnership or other business entity, or any government or
agency or political subdivision thereof.

 

1.35. “Pivotal
Trial” means
any clinical trial designed and executed to obtain
statistically significant evidence that the Licensed Product is
safe and efficacious and is intended to be or is in fact used as
one of the, or the sole, adequate and well-controlled trial(s) for
registration in any jurisdiction.

 



 







 





 

1.36.  “Phase
2 Clinical Trial” means any human clinical trial conducted in
patients that is intended to provide preliminary evidence
suggesting effectiveness of the drug, including clinical trials
described in 21 C.F.R. §312.21(b), or, with respect to a
jurisdiction other than the United States, a similar clinical
trial.

 

1.37. “Regulatory
Authority” means
(a) the FDA, (b) the EMA or the European Commission, or
(c) any regulatory body with similar regulatory authority over
pharmaceutical or biotechnology products in any other jurisdiction
anywhere in the world.

 

1.38. “Regulatory
Approval” means any and
all approvals, licenses, registrations, or authorizations of the
relevant Regulatory Authority, necessary for the Development,
manufacture, use, storage, import, transport and Commercialization
of a given Licensed Product in a particular country or
jurisdiction. For the avoidance of doubt, Regulatory Approval
outside of the United States shall include any pricing or marketing
approval needed prior to the sale of a Licensed Product in the
Field.

 

1.39. “Royalty
Term” means, on a
Licensed Product-by-Licensed Product and country-by-country basis,
the period from the First Commercial Sale of a given Licensed
Product in such country until the later of (1) expiry of the
* containing a Valid Claim that Covers
such Licensed Product in such country or (2) * ( * ) years from
such First Commercial Sale of such Licensed Product in such
country.

 

1.40. “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.

 

1.41. “Share
Value” as of a particular
date means the closing sale price of the Shares on the
Share’s principal United States securities exchange on such
date, or other major securities
exchange where TGTX is listed for trading.

 

1.42. “Shares”
means shares of TGTX’s common stock, par value $0.001 per
share, as constituted on the Effective Date; the meaning of such
term shall be adjusted appropriately to reflect the occurrence of
any stock split, reverse stock split, recapitalization,
reorganization or other such event.

 

1.43. “Sublicensee”
means a Person, other than TGTX or its
Affiliate, to which TGTX or its Affiliate has, pursuant to
Section 2.2, granted a license, sublicense, or other similar
rights via sale or divestment, to Develop and/or Commercialize
Licensed Products under any of the license rights granted under
Section 2.1. “Sublicense” shall be construed
accordingly.

 

1.44. “Sublicense
Income” shall mean all
upfront, realized contingent, and milestone payments received by
TGTX or its Affiliate from Sublicensees,
excluding:

 

(a) the
portion of amounts received by TGTX or its Affiliate from such
Sublicensee as the purchase price for TGTX's or its
Affiliate’s debt or equity securities; provided that any
amount paid above the fair market value for such securities (which
shall be the Share Value, if applicable, but calculated as a * -day
volume weighted average price following an announcement of the
securities purchase) shall be part of Sublicense Income,
and

 

(b) the
portion of amounts received by TGTX or its Affiliate to fund the
direct cost of research or development activities to be performed
in connection with the relevant Sublicense, or services or goods
obtained for use in connection with the relevant
Sublicense.

 


For
sake of clarity, Sublicense Income shall exclude any royalty
payments made by a Sublicensee to TGTX or its Affiliate, a portion
of which will be payable to Licensor as provided in Section
5.4.

 

1.45.  “Third
Party” means any Person
other than Licensor, TGTX or Affiliates of either of them, or any
Sublicensees.

 

1.46. “Third
Party Action” means any
claim or action made by a Third Party against a Party that claims
that a Licensed Product, or its use, Development, manufacture or
sale infringes such Third Party’s intellectual property
rights.

 

1.47. “United
States” or
“US”
means the United States of America and
its territories and possessions.

 

1.48. “Valid
Claim” means a claim of
an issued and unexpired patent which has not lapsed or been
revoked, abandoned or held unenforceable or invalid by a final
decision of a court or governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been disclaimed, denied or admitted
to be invalid or unenforceable through reissue, reexamination or
disclaimer or otherwise.

 



 







 





 

1.49. The
definition of each of the following terms is set forth in the
section of the Agreement indicated below:

 


“Action” has the meaning set
forth in Section 6.5(b).

 


“BTK Inhibitor Program” has
the meaning set forth in Section 8.2(f).

 


“Claim” has the meaning set
forth in Section 9.1.

 


“Confidential Information”
has the meaning set forth in Section 7.1.

 


“Controlling Party” has the
meaning set forth in Section 6.6(c).

 


“Development Program” has
the meaning set forth in Section 3.1.

 


“Disclosing Party” has the
meaning set forth in Section 7.1.

 


“Indemnified Party” has the
meaning set forth in Section 9.4.

 


“Indemnifying Party” has the
meaning set forth in Section 9.4.

 


“Licensor Indemnitees” has
the meaning set forth in Section 9.1.

 


“Receiving Party” has the
meaning set forth in Section 7.1.

 


“Superiority”
has the meaning set forth in Section 5.2(a).

 


“Term” has the meaning set
forth in Section 10.1.

 


“TGTX Indemnitees” has the
meaning set forth in Section 9.2.

 



 







 






 

 



ARTICLE II.

 



LICENSES AND OTHER RIGHTS

 

2.1. Grant
of License to TGTX. Subject to
the terms and conditions of this Agreement, Licensor hereby grants
to TGTX, and TGTX hereby accepts, an exclusive (even as to
Licensor, except as provided in Section 2.3), royalty-bearing right
and license (with the right to sublicense, and to further
sublicense, subject to the provisions of Section 2.2) under the
Licensor Technology to research, Develop, manufacture, have
manufactured, use, import and Commercialize and have Commercialized
the Licensed Products, in all cases, solely in and for the Field
and in and for all the countries of the world, except for those
listed on Exhibit A (the “Territory”). Licensor and its Affiliates grant no
licenses or rights to use other than as expressly set forth
herein.

 

2.2. Grant
of Sublicenses by TGTX. TGTX
shall have the right, in its sole discretion, to grant Sublicenses,
in whole or in part, under the license granted in Section 2.1 to
any of its Affiliates or Third Parties, excluding biotech or
pharmaceutical companies that are headquartered, or have their
principal operations, in * ; provided, however, that (1) the
granting by TGTX of a Sublicense shall not relieve TGTX of any of
its obligations hereunder;(2) TGTX’s right to grant a Person
a Sublicense shall be subject to TGTX including within such
Sublicense express provisions binding the Sublicensee to all of the
duties, obligations, restrictions and acknowledgements hereunder of
TGTX (with Licensor being an express third-party beneficiary
thereof), and stating that the Sublicense shall (except as
otherwise expressly provided in Section 10.3 or 10.4(c))
automatically terminate upon the expiration or earlier termination
of this Agreement; (3) TGTX, within * ( * ) days of the granting of
each Sublicense, shall notify Licensor of such grant and the name
and address of each such Sublicensee; and (4) the Sublicense shall
be at *. Notwithstanding the foregoing sentence, it is not required
that a Sublicense include provisions for the Sublicensee to pay
Royalties or make milestone payments directly to Licensor or to
provide royalty reports directly to Licensor. TGTX shall ensure
that all of its Sublicensees shall comply with the terms and
conditions of this Agreement (as applicable to them) and TGTX shall
be and remain fully responsible for the compliance by such
Sublicensees with the terms and conditions of this Agreement (as
applicable to them) as if such Sublicensees were TGTX hereunder.
Except for Sublicenses as expressly allowed herein, TGTX
acknowledges that it has no right to, and agrees not to purport to,
grant to anyone a sublicense under the Licensor
Technology.

 

2.3. Retained
Rights; No Implied Licenses.
Licensor hereby retains the right to use, itself and with or
through its Affiliates and Third Parties, the Licensor Technology
for: (A)(i) any and all uses outside of the Field throughout the
world and (ii) for any and all uses within the Field outside of the
Territory and (B) to manufacture and conduct development
(including, but subject to TGTX’s consent, clinical
development) of the Licensed Product within the Territory. Except
as expressly set forth herein, no rights are granted by Licensor to
TGTX hereunder, whether by necessity, implication or otherwise.
Notwithstanding any of the foregoing, Licensor is obliged to give
TGTX * ( * ) days advance written notice prior to engaging in
activities falling within the scope of this clause (B)
above.

 

2.4. Right
of First Offer for Uses outside the Field. Prior to agreeing to a license, sale or other
disposition of the right to commercialize the Licensed Product for
uses outside of the Field and within the Territory, Licensor shall
notify TGTX in writing of such pending agreement. For clarity,
Licensor reserves the right to enter into such an agreement with a
Licensor Affiliate or a Third Party on any terms that Licensor
determines to be acceptable.

 

2.5. Right
of First Refusal for Combination Development. Prior to undertaking any Hematologic Malignancy
combination clinical trial with a Licensed Product in the Territory
and outside the Field, Licensor shall (i) notify TGTX in writing of
its intent to undertake such combination and (ii) for a period of *
(* ) days after TGTX’s receipt of such notice, TGTX shall
have the right to pursue such combination subject to the terms of
Section 5.2(b). If
TGTX fails to notify Licensor of its intent to pursue such
combination and make the appropriate milestone payment as specified
in Section 5.2(b) within such *day period, Licensor shall be free to
pursue such combination at its sole expense. For sake of clarity,
in the event that TGTX makes any payment under Section
5.2(b) for
combination of a Licensed Product with any specific agent, then any
combination with that class of agent will be added to the Field,
and Licensor shall no longer have the right to pursue combinations
of any Licensed Product with that class of agents in the Territory.
Further, in the event that TGTX makes the All Combinations Payment
(as defined in Section 5.2(b)),
the Field will be expanded to encompass all combinations within
Hematologic Malignancy Indications and Licensor may not undertake
any combination clinical trial within the Territory and within the
Field.

 

2.6. Exclusivity.
During the Term, neither Party shall Develop beyond Phase 2 or
Commercialize a product comprising a BTK inhibitor for use in the
Field and in the Territory other than the Licensed Product (a
“Distracting
Product”); provided, however, that nothing in this
Agreement shall in anyway prevent, impact, or otherwise affect
either Party’s right to conduct clinical trials with any
agents owned by third parties and to seek approval for combinations
with approved agents, including approved BTK inhibitor
..

 



 







 





 

2.7. Acquisition
of Distracting Product. Notwithstanding the provisions of
Section 2.6, if a Party or any of its Affiliates (such Party, the
“Distracted
Party”) acquires rights to Develop or Commercialize a
Distracting Product in the Field and in the Territory as the result
of a merger, acquisition (including by license) or combination with
or of a Third Party other than a Change of Control (each, an
“Acquisition
Transaction”) and, on the date of the completion of
such Acquisition Transaction, such Distracting Product is being
researched, developed or commercialized and such activities would,
but for the provisions of this Section 2.7, constitute a
breach of Section 2.6, then the Distracted Party or such
Affiliate will, within * (
* ) days after the
completion of such Acquisition Transaction notify the other Party
of such acquisition and either:

 




(a)

request that such
Distracting Product be included in this Agreement on terms to be
negotiated, in which case, the Parties will discuss the matter in
good faith for a period of no less than * ( *
) days (or such longer period as may be agreed to by the
Parties) and, if unable to reach agreement on the terms on which
such Distracting Product would be included hereunder within such
period, the Distracted Party will elect to take the action
specified in either clause (b) or (c) below;provided that the time periods
specified in such clauses will be tolled for so long as the Parties
are engaged in discussion under this clause (a);





 




(b)

notify the other
Party that the Distracted Party or its Affiliate will Divest its
rights to such Distracting Product, in which case, within * (
* ) days after the
completion of the Acquisition Transaction, the Distracted Party or
its Affiliate will divest such Distracting Product; or





 




(c)

notify the other
Party in writing that it is ceasing all such research, development
and commercialization activities with respect to the Distracting
Product, in which case, within * ( * ) days thereafter the
Distracted Party and its Affiliates will cease all such
activities.






 


During
the discussion period under clause (a), prior to the time of
divestiture pursuant to clause (b) or prior to the termination of
activities pursuant to clause (c), as applicable, the Distracted
Party and its Affiliates will use Commercially Reasonable Efforts
to segregate all Development and Commercialization activities
relating to the Distracting Product from Development and
Commercialization with respect to the Licensed Product, including
using Commercially Reasonable Efforts to ensure that (i) no
personnel involved in performing the research, development or
commercialization of such Distracting Product have access to
non-public plans or information relating to the Development or
Commercialization of the Licensed Product and (ii) no
personnel involved in performing the Development or
Commercialization of the Licensed Product have access to non-public
plans or information relating to the Development or
Commercialization of such Distracting Product.


 

2.8. Change
of Control. If there is a Change of Control involving a
Party (where such Party is the acquired entity), the obligations of
Section 2.6 will not apply to any program or product that exists
prior to the closing of such Change of Control and that is
Controlled by the relevant acquirer or its Affiliates;provided that, at the acquired
Party’s election to be made in writing prior to the closing
of such Change of Control either (A) the license and rights granted
to TGTX within this agreement will terminate effective upon the
closing of such Change of Control and, to the extent requested by
Licensor, TGTX will transfer and assign to the Licensor all
clinical data, filings, contacts, including sublicense agreements,
and regulatory approvals associated with the Licensed Product and
Compound within a * ( * ) days or (B)(i) the acquired Party
and the acquirer and its Affiliates will fulfill TGTX obligations
under Diligence by TGTX of Section 3.1, (ii) the acquirer and its
Affiliates establish and enforce internal processes, policies,
procedures and systems to segregate information relating to any
such program or product from any Confidential Information related
to the Licensed Product, (iii) the acquirer and its Affiliates
will not use, directly or indirectly, any Patent Rights, Know-How
or Confidential Information of the acquired Party (including any
Patent Rights, Know-How or Confidential Information licensed or
acquired from the other Party under this Agreement) in connection
with such program or product, and (iv) no personnel who were
employees or consultants of the acquired Party or its Affiliates at
the closing of such Change of Control will participate in the
development or commercialization of such program.

 

2.9. Grantback
of Rights. Subject to the terms
and conditions of this Agreement, during the Term of this
Agreement, TGTX hereby grants to Licensor, and Licensor hereby
accepts, a non-exclusive, royalty-free license (with the right to
sublicense through multiple tiers) under any intellectual property
rights owned or controlled by TGTX, which relate specifically to
improvements to Licensed Product (e.g., formulation, process
optimization) solely as, and only to an extent that, such
intellectual property rights are used by TGTX to Develop a Licensed
Product in the Territory, for use by Licensor solely to research,
Develop, manufacture, have manufactured, use, import and
Commercialize and have Commercialized the Licensed Product, in all
cases, solely outside the Territory. TGTX and its Affiliates grant
no licenses or rights to use other than as expressly set forth
herein. Likewise, if in the course of Licensor’s Development
activities, Licensor creates intellectual property rights, which
relate specifically to improvements to Licensed Product (e.g.,
formulation, process optimization), such intellectual property
rights shall automatically be included under Licensor Technology
and become subject to the rights and license granted to TGTX under
the terms of this Agreement.

 

2.10. Licensor
Right of First Offer for Ublituximab * Rights. Prior to agreeing to a license, sale or other
disposition of the right to develop and commercialize ublituximab
(TG-1101, an anti-CD20 mAb) within * , TGTX shall notify Licensor
in writing of such pending agreement. For clarity, TGTX reserves
the right to enter into such an agreement with an Affiliate of TGTX
or a Third Party on any terms that TGTX determines to be
acceptable.

 



 







 





 



ARTICLE III.

 



DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION

 

3.1. Diligence
by TGTX. TGTX shall use
Commercially Reasonable Efforts to Develop and to Commercialize at
least one Licensed Product in the Territory and for the Field in
each Major Market. In connection therewith, TGTX shall formulate
and execute a development program to Develop one or more Licensed
Products in the Territory and for the Field in each Major Market
(the “Development
Program”). TGTX shall
deliver to Licensor a development plan (Development Plan)
within * ( *
) days of the Effective Date detailing
the actions to be undertaken by TGTX for such Development Program.
In particular, under Commercially Reasonable Efforts and good
faith, TGTX shall:

 




a)

File IND in the US by the end of
*








b)

Initiate a * in the US by the end of *










 



TGTX may accomplish such milestones itself or through its Affiliate
or Sublicensees. TGTX or its Affiliate shall have an option of
satisfying its diligence obligations hereunder in *
, * , or both, at its sole discretion, by (i)
initiating discussions with one or more potential Sublicensees in
either or both of those Major Market by the end of 2019, or (ii)
pursuing a Development Program in the US, which is sufficient to
satisfy regulatory requirements in * , * , or
both.

 

3.2. No
Guaranty of Favorable Results.
Licensor does not warrant that the Development Program,
TGTX’s other preclinical studies and evaluation (if any)
and/or TGTX’s clinical studies (if any) will produce any
particular results or any favorable results.

 

3.3. TGTX
Responsibility and Authority for Development. TGTX shall have the exclusive right, and sole
responsibility and decision-making authority, to research and
Develop any Licensed Products in the Territory and for the Field
and to conduct (either itself or through its Affiliate, agents,
subcontractors and/or Sublicensees) all clinical trials and
non-clinical studies TGTX believes appropriate to obtain Regulatory
Approval for Licensed Products in the Territory and for the
Field.

 

3.4. Commercialization.
Subject to the terms of this Agreement, TGTX shall have the
exclusive right, and sole responsibility and decision-making
authority, to Commercialize any Licensed Products in the Territory
and for the Field itself, through its Affiliate, or through one or
more Sublicensees or other Third Parties selected by TGTX and shall
have the sole decision-making authority and responsibility in all
matters relating to the Commercialization of Licensed
Products.

 

3.5. Manufacturing.
TGTX shall have the exclusive right, and sole responsibility and
decision-making authority, to manufacture, at the clinical and/or
commercial stage, any Licensed Product itself or through one or
more Sublicensees or vendors selected by TGTX.

 

3.6. Reporting
to Licensor. TGTX shall, at
least *, participate in a telephone or video conference with
Licensor to provide to Licensor an oral update report (followed by
transmittal to Licensor of written minutes) regarding the progress
of all research and Development efforts toward Licensed Products
and regarding the progress of Commercialization of Licensed
Products. Additionally, TGTX shall share with Licensor a
confidential copy of TGTX’s annual report to the FDA of its
clinical development efforts in connection with Licensed
Products.

 

3.7. Right
to Subcontract of TGTX. Subject
to any required compliance with Section 2.2, TGTX may exercise any
of the rights or obligations that TGTX may have under this
Agreement (including, without limitation, any of the rights
licensed in Section 2.1 hereof) by Sublicensing, but any Sublicense
granted or entered into by TGTX as contemplated by this Section 3.7
or any Sublicensee’s exercise or performance of all or any
portion of the rights or obligations that TGTX may have under this
Agreement shall not relieve TGTX from any of its obligations under
this Agreement.

 

3.8. Compliance
with Law. TGTX undertakes and agrees that the conduct of the
Development of Licensed Products hereunder, the use of the Licensor
Technology, and all Development, manufacture and Commercialization
of Licensed Products by it and its Affiliates and Sublicensees
shall comply in all material respects with all applicable
international, federal, state and local laws, rules and
regulations, including, but not limited to, environmental,
occupational safety/health, safety and import/export restrictions,
laws, rules and regulations.

 

3.9. Costs
and Expenses. As between Licensor and TGTX, * shall be
solely responsible for all costs and expenses related to
Development, manufacture and Commercialization of the Licensed
Products for the Field in the Territory, including without
limitation costs and expenses associated with all preclinical
activities and clinical trials, and all regulatory filings and
proceedings relating to Licensed Product for the Field and in the
Territory.

 

3.10. .Patent
Marking. TGTX agrees that with
respect to each unit or package of Licensed Products sold in a
given country, TGTX shall comply with the customary patent marking
laws and practices of such country as to the applicable Licensor
Patents.

 

3.11. Trademarks.
As between Licensor and TGTX, * shall have the sole authority to select trademarks
for Licensed Products and shall own all such trademarks in the
Territory for the Field. Licensor does not grant TGTX the right to
use any trademarks of Licensor or its
Affiliates.

 



 







 





 



ARTICLE IV.

 



REGULATORY MATTERS

 

4.1. Regulatory
Filings. TGTX (or its
applicable Affiliate) shall (a) have the sole right and
responsibility, at its sole cost and expense, for preparing and
filing all Regulatory Approval applications required to Develop
Licensed Products and Commercialize Licensed Products in the
Territory in the Field in its own name; (b) all Regulatory
Approvals for Licensed Products shall be solely owned by TGTX; and
(c) TGTX shall have the sole right and responsibility for (i)
maintaining all Regulatory Approvals and (ii) reporting to any
Regulatory Authority within the Territory all Adverse Events and
Serious Adverse Events related to any Licensed Product if and to
the extent required by applicable Laws. To maximize market
protection of any Licensed Product, TGTX may file for any orphan
drug designations within the Field as appropriate within requisite
timeframes prior to the submission of any Regulatory Approval
application.

 

4.2. Right
of Reference. Each Party hereby grants to the other
Party, and at the request of the other Party will grant to the
other Party’s Sublicensees, a “Right of
Reference,” as that term is defined in 21 C.F.R. §
314.3(b) (or any successor rule or analogous Law recognized outside
of the United States), to, and a right to copy, access, and
otherwise use, all information and data (including all chemistry,
manufacturing and controls information as well as data made,
collected or otherwise generated in the conduct of any clinical
studies for Licensed Products) included in or used in support of
any regulatory filing, Regulatory Approval, drug master file or
other regulatory documentation (including orphan drug applications
and designations) owned or controlled by such Party, and such Party
shall provide a signed statement to this effect, if requested by
the other Party, in accordance with 21 C.F.R. § 314.50(g)(3)
(or any successor or analogous Law outside of the United States).
In addition, upon request of either Party (on behalf of itself or a
Sublicensee), the other Party shall obtain and provide to the
requesting Party certificates or other formal or official
attestations concerning the regulatory status of the Licensed
Products (e.g.,
Certificates of Free Sale, Certificates for Export, Certificates to
Foreign Governments). Notwithstanding anything to the contrary in
this Agreement, neither Party shall withdraw or inactivate any
regulatory filing that the other Party references or otherwise uses
pursuant to this Section 4.2

 

4.3. Communications
with Authorities. TGTX (or one
of its Affiliates or Sublicensees) shall be responsible for and act
as the sole point of contact for communications with Regulatory
Authorities in the Territory in connection with the Development,
Commercialization, and manufacturing of Licensed Products for uses
in the Field. At the request of TGTX, Licensor shall make available
to TGTX, free of charge, a qualified representative or
representatives who shall, together with the representatives of
TGTX, prepare for and/or participate in and contribute to meetings
with the Regulatory Authorities with respect to regulatory matters
relating solely to the Licensor Technology. TGTX shall pay for any
out-of-pocket expenses incurred by Licensor in assisting TGTX under
this Section 4.2.

 

4.4. Adverse
Event Reporting. TGTX agrees to
comply with any and all Laws that are applicable to it as of the
Effective Date and thereafter during the Term in connection with
Licensed Product safety data collection and reporting (and, if
applicable, recalls). The Parties hereby agree to report to each
other all Adverse Events and/or Serious Adverse Events with respect
to the Licensed Product (whether occurring in any Clinical Trial
conducted with regard to the Licensed Product or in connection with
the Commercialization of the Licensed 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 Licensed Product under its own Regulatory Approval, then the
other Party shall report such events no later than * ( * ) business
days for a Serious Adverse Event, and quarterly for Adverse Events,
which report shall, in each case, include the circumstances and
nature of such Serious Adverse Event or Adverse Event as required
for reporting under applicable Laws. In addition, to the extent
requested by either Party, the other Party shall promptly provide
to the requesting Party any other information or materials that the
requesting Party may require to provide to any Regulatory Authority
with respect to any such Adverse Event or Serious Adverse Event.
All disclosures made under this Section 4.3 shall be deemed
Confidential Information of the disclosing Party; provided, that,
the Party receiving such disclosures may, upon written notice to
the disclosing Party, report the occurrence, circumstances and
nature of such Adverse Event and/or Serious Adverse Event to any
Regulatory Authority solely insofar as such reporting is required
to comply with applicable Laws.

 



 







 





 

4.5. Clinical
Development Coordination and Governance. In the spirit of a productive, mutually beneficial
alliance management, TGTX and Hengrui agree to share their clinical
development plans and results related to hematology malignancy
within their respective territories with each other at least * via
a Joint Steering Committee (“JSC”). The Parties shall establish the JSC within * (
* ) calendar days after the Effective Date. The JSC shall perform
the following functions:

 


(a)
Review and discuss the overall strategy for developing,
manufacturing and commercializing the Licensed Products in the
Territory. For clarity, * shall have final authority over clinical
development to be conducted by it or its Sublicensee(s) within the
Field and in the Territory;

 


(b)
Review and discuss any proposed hematology malignancy studies to be
conducted with the Licensed Products to prevent or manage
logistical confusion or conflict and potential adverse impact on
the other Parties’ efforts to Develop and Commercialize the
Licensed Products in its territory. For clarity, * shall have final
authority over clinical development in its
territories;

 


(c)
Facilitate the exchange of information between the Parties under
this Agreement regarding the development, manufacturing and
commercialization of the Licensed Products and establishing
procedures for the efficient sharing of information and materials
and Know-How reasonably necessary or useful for the development,
manufacture or commercialization of the Licensed
Products;

 


(d)
Review and discuss the contents of all submissions to regulatory
authorities and governmental authorities relating to the use of the
Licensed Products within the Field;

 


(e) Resolve any disputes or other matters referred
to the JSCJSC. TGTX and Hengrui shall each designate * ( * )
representatives of appropriate seniority and experience to serve on
the JSC by written notice to the other party. Replacements and
substitutes should be specified by written notice. The JSC should
be chaired by a representative of *, who is responsible for (i)
calling meetings, (ii) preparing and issuing minutes within * weeks
thereafter, and (iii) preparing and circulating an agenda for the
upcoming meeting, provided that the chairperson shall consider
including any agenda items proposed by either TGTX or Hengrui no
less than * prior to the next scheduled JSC meeting. Meeting can
take the form of in-person meeting or
teleconference.

 

4.6. Ex-Territory
Sales. Subject to applicable
Law, neither
Party shall engage in any advertising or promotional activities
relating to any Licensed Product directed primarily to customers or
other buyers or users of such Licensed Product located outside its
territory or accept orders for Licensed Products from or sell
Licensed Products into such other Party’s territory for its
own account, and if a Party receives any order for any Licensed
Product in the other Party’s territory, it shall refer such
orders to the other Party.

 

4.7. Export
Monitoring. Each Party and its
Sublicensees will use Commercially Reasonable Efforts to monitor
and prevent exports of Licensed Products from its own territory for
Commercialization in the other Party’s territory using
methods permitted under applicable Law that are commonly used in
the industry for such purpose (if any), and shall promptly inform
the other Party of any such exports of Licensed Products from its
territory, and any actions taken to prevent such exports. Each
Party agrees to take reasonable actions requested in writing by the
other Party that are consistent with Law to prevent exports of
Licensed Products from its territory for Commercialization in the
other Party’s territory.

 



 







 





 



ARTICLE V.

 



Financial Provisions

 

5.1. Upfront
Fee. TGTX becomes obligated on
the Effective Date to pay Licensor a one-time, non-refundable
payment of * dollars ($ * ) in partial consideration of the rights
granted to TGTX under this Agreement. Such payment shall be payable
in * ( * ) equal installments of * dollars ($ * ), the first of
which is due within * ( * ) business days of the Effective Date,
and the second of which is due * ( * ) days after the Effective
Date. TGTX shall have the right to elect to pay such payments up to
* % in Shares, with any remainder of such milestone payment not
paid in Shares payable in cash. The number of Shares payable shall
be equal to a fraction where the numerator is the amount of such
milestone elected to be paid in Shares and the denominator is the
Share Value calculated as * volume weighted average price (VWAP)
prior to the Effective Date for both the first and the second
installments. For payment made in Shares, TGTX shall deliver to
Licensor a stock certificate representing the portion of such
payment elected to be paid in Shares. Such stock certificate shall
be unlegended except for a standard securities-law restrictive
legend. For clarity, non-publicly traded Shares cannot be used
hereunder for payment of the upfront fee, or milestone or royalty
payments.

 

5.2. Development
and Commercial Milestone Payments. As further partial consideration for
Licensor’s grant of the rights and licenses to TGTX
hereunder, TGTX shall pay to Licensor the following one-time,
non-refundable milestone payments (a) with regard to each Licensed
Product to achieve the respective milestone events in Section
5.2(a), assuming that both * and * move forward in development, and
(b) upon achievement of each respective approval and sales
milestone event in Section 5.2(b)
by TGTX or its Affiliates or
Sublicensees. TGTX shall promptly, but in no event later than * ( *
) days following TGTX or its Affiliate’s receipt of actual
knowledge of each achievement of a milestone event, notify Licensor
in writing of the achievement of such milestone event and, unless
otherwise specified, shall pay the relevant milestone payment
within * ( * ) days thereafter. TGTX shall have the right to elect
to pay all clinical development milestones payments in this Section
5.2 up to * % in Shares, with the remainder of such milestone
payment to be paid in cash. The number of Shares payable shall be
equal to a fraction where the numerator is the amount of such
milestone elected to be paid in Shares and the denominator is the
Share Value calculated as * ( * ) day VWAP prior to the date such
milestone is achieved. For payments made in Shares, TGTX shall
deliver to Licensor a stock certificate representing the Shares on
the date such notice of achievement is delivered or within * ( * )
business days thereafter; such stock certificate shall be
unlegended except for a standard securities-law restrictive
legend.

 

(a) Clinical Development
Payments.

 


	
 
Milestone
Event

 

	
 
Milestone
Payment

 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 







 


For the
purposes of this provision, “Superiority” will have been
demonstrated if, *. TGTX shall have the right to elect to pay all
milestones payments in this section 5.2(a) up to * % in Shares, with the remainder
of such milestone payment to be paid in cash. The number of Shares
payable shall be equal to a fraction where the numerator is the
amount of such milestone elected to be paid in Shares and the
denominator is the Share Value calculated as * ( * ) day VWAP prior
to the date such notice of achievement is delivered. For payments
made in Shares, TGTX shall deliver to Licensor a stock certificate
representing the Shares on the date such notice of achievement is
delivered or within * ( * ) business days thereafter; such stock
certificate shall be unlegended except for a standard
securities-law restrictive legend.

 

(b) Combination Development
Payments. As further partial
consideration for Licensor’s grant of the rights and licenses
to TGTX hereunder, TGTX shall pay to Licensor a one-time,
non-refundable milestone payment of * dollars ($ * ) * or *, in the
case that a * is unnecessary, evaluating the combination of a
Licensed Product with any and each molecule other than ublituximab
(TG-1101) and/or umbralisib (TGR-1202). For sake of clarity, a
milestone payment will be payable only once for each new agent
evaluated in combination with a * provided such combination is
evaluated in a * or * , in the case that a * is unnecessary.
Further, at any time prior to the initiation of the first * for a *
, TGTX may elect to pay to Licensor a one-time, non-refundable
milestone payment of * ($ * ) (the “All Combinations
Payment”) to expand the
Field in the Territory to include the use of the Licensed Products
to treat all hematologic malignancy indications in the
Territory. In the event TGTX elects to make the All Combinations
Payment, TGTX will owe no further payments under this Section
5.2(b) for any combination Clinical Trial undertaken of any Phase
with any agent. Hengrui shall have the right to elect to receive
all milestones payments in this Section 5.2(b)
up to * % in Shares, with the
remainder of such milestone payment to be paid in cash. The number
of Shares payable shall be equal to a fraction where the numerator
is the amount of such milestone elected to be paid in Shares and
the denominator is the Share Value calculated as * VWAP of the date
such notice of achievement is delivered. For payments made in
Shares, TGTX shall deliver to Licensor a stock certificate
representing the Shares on the date such notice of achievement is
delivered or within * ( * ) business days thereafter; such stock
certificate shall be unlegended except for a standard
securities-law restrictive legend.

 



 







 





(c) Approval
and Sales based Milestones. All
milestone and other payments made under this section 5.2(c), if
such Milestone Event is achieved, shall be payable in
cash.

 


	
 
Milestone
Event

 

	
 
Milestone
Payment

 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 


	
  * 

	
 $* 







 

5.3. Sublicense
Payments. TGTX shall pay to
Licensor the following percentages of any Sublicense Income
actually received by TGTX from a Sublicensee:

 

(a) *
percent (* %) of such Sublicense Income if the Sublicense agreement
pursuant to which such Sublicense Income was received was entered
into within * ( * ) year following the Effective Date or prior to
completing a * or * , in the case that a * is unnecessary;
or

 

(b) *
percent (* %) of such Sublicense Income if the Sublicense agreement
pursuant to which such Sublicense Income was received was entered
into more than * ( * ) year following the Effective Date and after
completing a * or *, in the case that a * is
unnecessary.

 


Sublicense payments
made under this Section 5.3 shall be
payable only in cash and for amounts actually received by TGTX or
its Affiliates from a Sublicensee. TGTX shall promptly, but in no
event later than * ( * ) days following receipt of any payment
which qualifies as Sublicense Income, notify Licensor in writing of
such payment and shall pay the applicable percentage to Licensor
within * ( * ) days thereafter.

 

5.4. Royalty,
Etc. Payments for Licensed Products.

 

(a) With
respect to Net Sales of all Licensed Products during the applicable
Royalty Term: as further consideration for Licensor’s grant
of the rights and licenses to TGTX hereunder, TGTX shall pay to
Licensor royalties based on the aggregate annual Net Sales of all
such Licensed Products by TGTX and its Affiliates and Sublicensees
within the Territory (but excluding Net Sales of a given Licensed
Product after its applicable Royalty Term) at the rate shown in the
table below (which rates and amounts shall not be subject to
offset, credit, or reduction):

 


	


Net Sales

	


Royalty Rate


	

*

	

*
%


	

*

	

*
%


	

*

	

*
%







 

 

(b) In
establishing the royalty/payment in the nature of royalties
structure hereunder, the Parties recognize, and TGTX acknowledges,
the substantial value of the various obligations being undertaken
by Licensor under this Agreement, in addition to the grant of the
license under the Licensor Patents, to enable the rapid and
effective market introduction of the Licensed Products. The Parties
have agreed to the payment structure set forth herein as a
convenient and fair mechanism to compensate Licensor for these
obligations.

 

(c) On
a Licensed Product by Licensed Product and country-by-country
basis, upon expiration of the Royalty Term for a Licensed Product
in a country, the rights, licenses and sublicenses granted to TGTX
hereunder with respect to such Licensed Product in such country
shall continue in effect but become fully paid-up, royalty-free,
transferable (to the extent not transferable previously), perpetual
and irrevocable.

 

(d) Subject
to the limitation set forth in clause (f) below, if a license to
patent rights owned or controlled by a Third Party is necessary, as
reasonably determined by TGTX, for TGTX to have freedom to operate
under the Licensor Patents to Commercialize the Licensed Product as
a monotherapy in the Field and in the Territory, TGTX may obtain
such a Third Party license under such patent rights and to
deduct from any royalty payments due
to the Licensor hereunder an amount equal to * percent ( * %) of any royalty paid by TGTX to such Third
Party.

 

(e) The
royalty rates specified in Section 5.4(a) shall be reduced to *
percent ( * %) on a country-by-country basis if and when one or
more Generic Products achieve * percent market share (by
prescription units) in such country, relative to all approved
monotherapy products containing Compound indicated for hematologic
malignancy. For purposes of this Section, “Generic
Product” means a pharmaceutical product that contains the
Compound as monotherapy and that is
sold in the same country as a Licensed Product by a Third Party
that is not a Sublicensee, one of TGTX’s Affiliates, or a
Third Party that is otherwise acting on TGTX’s behalf in
conducting such sales.

 

(f) The
deduction in the foregoing clause (d) shall be limited in its
cumulative application so that no royalty payment hereunder shall
be reduced by more than * percent ( * %).

 



 







 





 

5.5. Timing
of Payment. Royalties/payments
in the nature of royalties payable under Section 5.4 shall be
payable on actual Net Sales and shall accrue at the time provided
therefor by US GAAP. Royalty/payment in the nature of royalties
obligations that have accrued during a particular Calendar Quarter
shall be paid, on a Calendar Quarter basis, within *
( * ) days after the end of each Calendar Quarter
during which the royalty/payment in the nature of royalties
obligation accrued;provided that within * ( * ) days
after the conclusion of each Calendar Year TGTX shall provide
notice to Licensor of any adjustments necessary to account for any
royalties/payment in the nature of royalties which were overpaid or
underpaid for such prior Calendar Year’s Calendar Quarters,
and the Parties shall promptly true-up based on such adjustments,
provided however, the lapse of such * -day period shall not impact the right of TGTX to
credit any over-payments discovered during an audit against future
royalties due under Section 5.7 hereof.

 

5.6. Royalty
(Etc.) Reports and Records Retention. Within * ( * ) days
after the end of each Calendar Quarter during which Licensed
Products have been sold, TGTX shall deliver to Licensor, together
with the applicable royalty/payment in the nature of royalties
payment due, a written report, on a Licensed Product-by-Licensed
Product and country-by-country basis, of (a) gross invoiced (or
otherwise charged) amounts of sales, by TGTX and its Affiliates and
Sublicensees, of Licensed Products subject to royalty payments for
such Calendar Quarter, (b) amounts deducted by category (following
the definition of Net Sales) from such gross invoiced amounts to
calculate Net Sales, (c) Net Sales subject to royalty or
royalty/payment in the nature of royalties payments for such
Calendar Quarter and Calendar Year to date and (d) the
corresponding royalty or royalty/payment in the nature of
royalties. Such report shall be deemed “Confidential
Information” of TGTX subject to the obligations of Article
VII of this Agreement. For * years after each sale of a Licensed Product
(whether Covered or not), TGTX shall keep (and shall ensure that
its Affiliates and Sublicensees shall keep) complete and accurate
records of such sale in sufficient detail to confirm the accuracy
of the royalty or royalty/payment in the nature of royalties
calculations hereunder.

 

5.7. Audits.

 

(a) From
the First Commercial Sale (of the first Licensed Product to have a
First Commercial Sale) until * Calendar Year after the conclusion of the final
Royalty Term, upon the written request of Licensor, and not more
than * in each *
, TGTX shall permit, and shall cause
its Affiliates and Sublicensees to permit, an independent certified
public accounting firm of nationally recognized standing selected
by Licensor (who has not been engaged by Licensor to provide
services in any other capacity at any time during the *
period before such selection), and
reasonably acceptable to TGTX or such Affiliate or Sublicensee, to
have access to and to review, during normal business hours upon
reasonable prior written notice, the applicable records of TGTX and
its Affiliates or Sublicensees to verify the accuracy of the
royalty and payment in the nature of royalties reports and payments
under this Article V. Such review may cover: (i) the records for
sales made in any Calendar Year ending not more than *
( * ) years before the date of such request, and (ii)
only those periods that have not been subject to a prior
audit.

 

(b) If
such accounting firm concludes that additional royalties and/or
royalties/payment in the nature of royalties were owed during such
period, TGTX shall pay the additional royalties and/or
royalties/payment in the nature of royalties within *
( * ) days after the date such public accounting firm
delivers to TGTX such accounting firm’s written report. If
such accounting firm concludes that an overpayment was made, such
overpayment shall be fully creditable against amounts payable in
subsequent payment periods or at TGTX’s request, shall be
reimbursed to TGTX within * ( * ) days
after the date such public accounting firm delivers such report to
TGTX. If TGTX disagrees with such calculation, TGTX may contest
such calculation in writing – at which point the parties will
work in good faith to submit the matter to a mediator for
resolution. If the parties are unable to reach an agreement via
mediation, then TGTX or Licensor may initiate a court action to
seek to recover the additional payment or to increase the amount of
credit or reimbursement. Licensor shall pay for the cost of any
audit by Licensor, unless TGTX has underpaid Licensor by five
percent (* %) or more for a
specific royalty period, in which case TGTX shall pay for the
reasonable costs of audit.

 

(c) Each
Party shall treat all information that it receives under this
Section 5.7 in accordance with the confidentiality provisions of
Article VII of this Agreement, and shall cause its accounting firm
to enter into an acceptable confidentiality agreement with the
audited Party obligating such firm to retain all such financial
information in confidence pursuant to such confidentiality
agreement, except to the extent necessary for a Party to enforce
its rights under the Agreement.

 

5.8. Mode
of Payment and Currency. All
payments to Licensor under this Agreement, except for payments made
in Shares, whether or not in respect of Net Sales or milestone
events, shall be made by deposit of US Dollars in the requisite
amount to such bank account as Licensor may from time to time
designate by advance written notice to TGTX. Conversion of sales or
expenses recorded in local currencies to Dollars will be performed
in a manner consistent with TGTX’s normal practices used to
prepare its audited financial statements for external reporting
purposes, provided that such practices use a widely accepted source
of published exchange rates. Based on the resulting Net Sales in US
Dollars, the then applicable royalties/payment in the nature of
royalties shall be calculated.

 

5.9. Late
Payments. If a Party does not
receive payment of any sum due to it on or before the due date
therefor, simple interest shall thereafter accrue on the sum due to
such Party from the due date until the date of payment at a rate
equal to the lesser of (a) US dollar one-month LIBOR, or its
official successor, plus * basis points, or (b) the maximum rate permissible
under applicable Law. Accrual and payment of interest shall not be
deemed to excuse or cure breaches of contract arising from late
payment or nonpayment.

 



 







 





 

5.10. Taxes.
All amounts due hereunder exclude all
applicable sales, use, and other taxes and duties, and TGTX shall
be responsible for payment of all such taxes (other than taxes
based on Licensor’s income) and duties and any related
penalties and interest, arising from the payment of amounts due
under this Agreement. The Parties agree to cooperate with one
another and use Commercially Reasonable Efforts to avoid or reduce
tax withholding or similar obligations in respect of royalties,
payments in the nature of royalties, milestone payments, and other
payments made by TGTX to Licensor under this Agreement. To the
extent TGTX is required to withhold taxes on any payment to
Licensor, TGTX shall pay the amounts of such taxes to the proper
governmental authority in a timely manner and promptly transmit to
Licensor official receipts issued by the appropriate taxing
authority and/or an official tax certificate, or such other
evidence as Licensor may reasonably request, to establish that such
taxes have been paid. Licensor shall provide TGTX any tax forms
that may be reasonably necessary in order for TGTX to not withhold
tax or to withhold tax at a reduced rate under an applicable
bilateral income tax treaty. Licensor shall use Commercially
Reasonable Efforts to provide any such tax forms to TGTX at
least * ( * ) days before the due date for any payment for
which Licensor desires that TGTX apply a reduced withholding rate.
Each Party shall provide the others with reasonable assistance to
enable the recovery, as permitted by applicable law, of withholding
taxes, value added taxes, or similar obligations resulting from
payments made under this Agreement, such recovery to be for the
benefit of the Party bearing such withholding tax or value added
tax. Licensor shall indemnify and hold TGTX harmless from and
against any penalties, interest or other tax liability arising from
any failure by TGTX (at the express request of Licensor) to
withhold or by reduction (at the express request of Licensor) in
its withholding.

 



ARTICLE VI.

 



Inventions and Patents

 


6.1. Patent
Prosecution and Maintenance.

 

(a) Licensor
Patents. Licensor shall have
the first right to file, prosecute and maintain Licensor Patents in
Licensor’s name and at Licensor’s expense. TGTX and
Licensor agree to consult on a reasonable list of countries in
which Licensor shall file, prosecute and maintain Licensor
Patents.

 

(b) Liaising.
Licensor shall keep TGTX promptly and
regularly informed of the course of the filing and prosecution of
Licensor Patents or related proceedings (e.g. interferences,
oppositions, reexaminations, reissues, revocations or
nullifications) in a timely manner, and to take into consideration
the advice and recommendations of TGTX, however, Licensor shall
make all decisions relating thereto.

 

(c) Election
Not to File/Prosecute/Maintain Licensor Patents. TGTX acknowledges and agrees that Licensor shall
not be required to file, prosecute or maintain Patent Rights for
the Licensor Patents, provided, however, if Licensor decides to not
pursue or maintain any such Patent Rights then Licensor shall
provide TGTX with at least * ( * )
days’ notice before discontinuing the filing, prosecution or
maintenance of such Patent Rights so that TGTX may assume
responsibility for such activities in Licensor’s name but at
TGTX’s expense. In such event, TGTX will no longer owe any
royalty obligation on account of such (country-level) Patent Rights
assumed by TGTX.

 

6.2. Certification
under Drug Price Competition and Patent Restoration Act.
Each of Licensor and TGTX shall
immediately give written notice to the other of any certification
of which they become aware filed pursuant to 21 U.S.C. Section
355(b)(2)(A) (or any amendment or successor statute thereto)
claiming that any Licensor Patents covering a Compound or a
Licensed Product, or the manufacture or use of each of the
foregoing, are invalid or unenforceable, or that infringement will
not arise from the manufacture, use or sale in the US of a Licensed
Product by a Third Party.

 

6.3. Listing
of Patents. TGTX shall have the
sole right to determine which of the Licensor Patents, if any,
shall be listed for inclusion in the Approved Drug Products with
Therapeutic Equivalence Evaluations publication pursuant to 21
U.S.C. Section 355, or any successor Law in the United States,
together with any comparable Laws in any other country in the
Territory and pertaining to uses within the Field. Licensor will
co-operate with TGTX to list any of said Licensor
Patents.

 



 







 





 


6.4. Enforcement
of Patents.

 

(a) Notice.
If either Licensor or TGTX believes
that a Licensor Patent is being infringed in the Field, or that
Licensor Know-How has been misappropriated in the Field, by a Third
Party or if a Third Party claims that any Licensor Patent is
invalid or unenforceable, the Party possessing such knowledge or
belief shall notify the other and provide it with details of such
infringement, misappropriation or claim that are known by such
Party.

 

(b) Right
to Bring an Action for Licensor’s Patents.
If such infringement, misappropriation
or claim is in one or more of the Major Markets in respect of
Licensor Patents, Licensor shall have the right to attempt to
resolve such infringement, misappropriation or claim, including by
filing an infringement suit, defending against or bringing a
declaratory judgment action as to such claim or taking other
similar action (each, “initiation” of an
“Action”) and (subject to Section 6.5(e)) to
compromise or settle such infringement or claim. *
may, in its sole discretion and at its
expense, join in any such Action and in such case shall reasonably
cooperate with Licensor. If Licensor does not intend to initiate an
Action, Licensor shall promptly inform TGTX. If Licensor does not
initiate an Action with respect to such an infringement or claim
within * ( *
) days following notice
thereof, * shall have the right
to attempt to resolve such infringement, misappropriation or claim,
including by initiating an Action, and (subject to Section 6.5(e))
to compromise or settle such infringement, misappropriation or
claim. At TGTX’s request, Licensor shall immediately provide
TGTX with all relevant documentation (as may be requested by TGTX)
evidencing that TGTX is validly empowered by the Licensor to
initiate an Action. Licensor shall be under the obligation to join
TGTX in its Action if TGTX determines that this is necessary to
demonstrate “standing to sue.” The Party initiating
such Action shall have the sole and exclusive right to select
counsel for any suit initiated by it pursuant to this Section 6.5.
If a Party initiates an Action but then elects not to pursue the
Action, the other Party shall have the right (but not the
obligation) to take over the Action, in which case the second Party
shall be deemed to have been the initiating
Party.

 

(c) Costs
of an Action. Subject to the
respective indemnity obligations of the Parties set forth in
Article IX and subject to Section 6.5(f), each Party involved in an
Action under Section 6.5(b) shall pay its own costs and expenses
incurred in connection with such Action.

 

(d) Settlement.
No Party shall settle or otherwise compromise (or resolve by
consent to the entry of judgment upon) any Action by admitting that
any Licensor Patent is to any extent invalid or unenforceable, or
that any Licensor Know-How is not protected or has not been
misappropriated, without the other Party’s prior written
consent, and, in the case of Licensor, Licensor may not settle or
otherwise compromise (or resolve by consent to the entry of
judgment upon) an Action in a way that adversely affects or would
be reasonably expected to adversely affect any of TGTX’s
rights or benefits hereunder with respect to any Licensor
Technology or any Licensed Product, without TGTX’s prior
written consent.

 

(e) Reasonable
Assistance. Each Party (if it
is not the Party enforcing or defending Licensor’s Patent
Rights) shall provide reasonable assistance to the other Party,
including providing access to relevant documents and other evidence
and making its employees and consultants available, subject to the
other Party’s reimbursement of any reasonable out-of-pocket
expenses incurred on an on-going basis by the non-enforcing or
non-defending Party in providing such
assistance.

 

(f) Distribution
of Amounts Recovered. Any
amounts recovered by the Party initiating an Action pursuant to
this Section 6.5, whether by settlement or judgment, shall be
allocated in the following order: (i) to reimburse the Party
initiating such Action for any costs incurred; (ii) to reimburse
the Party not initiating such Action for its costs incurred in such
Action, if it joins (as opposed to taking over) such Action; and
(iii) the remaining amount of such recovery shall (A) if Licensor
initiated the Action, the remainder shall be allocated to TGTX and
the portion thereof attributable to “lost sales” shall
be deemed to be Net Sales for the Calendar Quarter in which the
amount is actually received by TGTX and TGTX shall pay to Licensor
a royalty on such portion based on the royalty rates set forth in
Section 5.4(a), and the portion thereof not attributable to
“lost sales” shall be allocated to * % to Licensor and
* % to TGTX (B) if Licensor failed to initiate and TGTX initiated
the Action, the remainder shall be allocated to TGTX and the
portion thereof attributable to “lost sales” shall be
deemed to be Net Sales for the Calendar Quarter in which the amount
is actually received by TGTX and TGTX shall pay to Licensor a
royalty on such portion based on the royalty rates set forth in
Section 5.4(a), and the portion thereof not attributable to
“lost sales” shall be allocated to
TGTX.

 

6.5. Third
Party Actions Claiming Infringement.

 

(a) Notice.
If either Licensor or TGTX becomes aware of any Third Party Action,
such Party shall promptly notify the other of all details regarding
such claim or action that is reasonably available to such
Party.

 

(b) Right
to Defend. TGTX shall have the
right, at its sole expense, but not the obligation, to defend a
Third Party Action described in Section 6.6(a) and (subject to Section 6.6(f)) to compromise or
settle such Third Party Action. If TGTX declines or fails to assert
its intention to defend such Third Party Action within *
( * ) days of receipt/sending of notice under Section
6.6(a), then Licensor shall have the right, at its sole expense, to
defend such Third Party Action and (subject to Section 6.6(f)) to
compromise or settle such Third Party Action. The Party defending
such Third Party Action shall have the sole and exclusive right to
select counsel for such Third Party Action.

 

(c) Consultation.
The Party defending a Third Party
Action pursuant to Section 6.6(b) shall be the “Controlling
Party”. The Controlling
Party shall consult with the non-Controlling Party, pursuant to an
appropriate joint defense or common interest agreement, on all
material aspects of the defense. The non-Controlling Party shall
have a reasonable opportunity for meaningful participation in
decision-making and formulation of defense strategy. The Parties
shall reasonably cooperate with each other in all such actions or
proceedings. The non-Controlling Party will be entitled to join the
Third Party Action and be represented by independent counsel of its
own choice at its own expense.

 



 







 





 

(d) Appeal.
In the event that a judgment in a Third Party Action is entered
against either Party and an appeal is available, the Controlling
Party shall have the first right, but not the obligation, to file
such appeal. In the event the Controlling Party does not desire to
file such an appeal, it will promptly, in a reasonable time period
(i.e., with sufficient time for the non-Controlling Party to take
whatever action may be necessary) before the date on which such
right to appeal will lapse or otherwise diminish, permit the
non-Controlling Party to pursue such appeal at such non-Controlling
Party’s own cost and expense. If applicable Law requires the
other Party’s involvement in an appeal, the other Party shall
be a nominal party in the appeal and shall provide reasonable
cooperation to such Party at such Party’s
expense.

 

(e) Costs
of an Action. Subject to the
respective indemnity obligations of the Parties set forth in
Article IX, the Controlling Party shall pay all costs and expenses
associated with such Third Party Action other than the expenses of
the other Party if the other Party elects to join such Third Party
Action (as provided in the last sentence of Section
6.6(c)).

 

(f) No
Settlement without Consent. Neither Licensor or TGTX shall settle or otherwise
compromise (or resolve by consent to the entry of judgment upon)
any Third Party Action by admitting that any Licensor Patent is to
any extent invalid or unenforceable or that any Licensed Product,
or its use, Development, importation, manufacture or sale infringes
such Third Party’s intellectual property rights, in each case
without the other Party’s prior written consent, and, in the
case of Licensor, Licensor may not settle or otherwise compromise
(or resolve by consent to the entry of judgment upon) a Third Party
Action in a way that adversely affects or would be reasonably
expected to adversely affect TGTX’s rights and benefits
hereunder with respect to any Licensor Technology or any Licensed
Product, without TGTX’s prior written
consent.

 



ARTICLE VII.

 



CONFIDENTIALITY

 

7.1. Definitions.
The Parties recognize that disclosures of Confidential Information
between them before the Effective Date were subject to the
Confidential Disclosure Agreement between them dated February 22,
2016. TGTX and Licensor each recognizes that during the Term, it
may be necessary for a Party (the “Disclosing
Party”) to provide
Confidential Information (as defined herein) to another Party (the
“Receiving
Party”) that is highly
valuable, the disclosure of which would be highly prejudicial to
such Party. The disclosure and use of Confidential Information
shall be governed by the provisions of this Article VII. Neither
TGTX nor Licensor shall use the other’s Confidential
Information except as expressly permitted in this Agreement. For
purposes of this Agreement, “Confidential
Information” means all
information (including information relating to the business,
operations and products of a Party or any of its Affiliates)
disclosed by the Disclosing Party to the Receiving Party and which
reasonably ought to have been understood to be confidential and/or
non-public information at the time disclosed to the Receiving
Party, or which is designated in writing by the Disclosing Party as
“Confidential” (or equivalent), or which when disclosed
orally to the Receiving Party is declared to be confidential by the
Disclosing Party and is so confirmed in a writing delivered to the
Receiving Party within * ( * ) days
after such oral disclosure, including but not limited to any
technical information, Know-How, trade secrets, or inventions
(whether patentable or not), that such Party discloses to another
Party under this Agreement, or otherwise becomes known to another
Party by virtue of or that relates to this
Agreement.

 

7.2. Obligation.
Licensor and TGTX agree that they will disclose the other
Party’s Confidential Information to its own (or its
respective Affiliate’s, or with respect to TGTX, its
Sublicensees’) officers, employees, consultants and agents
only if and to the extent necessary to carry out their respective
responsibilities under this Agreement or in accordance with the
exercise of their rights under this Agreement, and such disclosure
shall be limited to the maximum extent possible consistent with
such responsibilities and rights. Except as set forth in the
foregoing sentence, no Party shall disclose Confidential
Information of the other to any Third Party without the
other’s prior written consent. In all events, however, any
and all disclosure to a Third Party (or to any such Affiliate or
Sublicensee) shall be pursuant to the terms of a
non-disclosure/nonuse agreement no less restrictive than this
Article VII. The Party which disclosed Confidential Information of
the other to any Third Party (or to any such Affiliate or
Sublicensee) shall be responsible and liable for any disclosure or
use by such Third Party, Affiliate or Sublicensee (or its
disclosees) which would have violated this Agreement if committed
by the Party itself. No Party shall use Confidential Information of
the other except as expressly allowed by and for the purposes of
this Agreement. Each Party shall take such action to preserve the
confidentiality of each other’s Confidential Information as
it would customarily take to preserve the confidentiality of its
own Confidential Information (but in no event less than a
reasonable standard of care). Upon expiration or termination of
this Agreement, each Party, upon the other’s request, shall
return or destroy (at Disclosing Party’s discretion) all the
Confidential Information disclosed to the other Party pursuant to
this Agreement, including all copies and extracts of documents,
within * ( *
) days after the request, except for
one archival copy (and such electronic copies that exist as part of
the Party’s computer systems, network storage systems and
electronic backup systems) of such materials solely to be able to
monitor its obligations that survive under this
Agreement.

 



 







 





7.3. Exceptions.
The non-use and non-disclosure obligations set forth in this
Article VII shall not apply to any Confidential Information, or
portion thereof, that the Receiving Party can demonstrate by
competent evidence:

 

(a) at
the time of disclosure is in the public domain;

 

(b) after
disclosure, becomes part of the public domain, by publication or
otherwise, through no fault of the Receiving Party or its
disclosees;

 

(c) is
made available to the Receiving Party by an independent Third Party
without obligation of confidentiality;provided, however, that to
the Receiving Party’s knowledge, such information was not
obtained by said Third Party, directly or indirectly, from the
Disclosing Party hereunder; or

 



In addition, the Receiving Party may disclose information that is
required to be disclosed by law, by a valid order of a court or by
order or regulation of a governmental agency including but not
limited to, regulations of the SEC or in the course of arbitration
or litigation; provided, however, that in all cases the Receiving
Party shall give the other party prompt notice of the pending
disclosure and make a reasonable effort to obtain, or to assist the
Disclosing Party in obtaining, a protective order or
confidential-treatment order preventing or limiting (to the
greatest possible extent and for the longest possible period) the
disclosure and/or requiring that the Confidential Information so
disclosed be used only for the purposes for which the law or
regulation required, or for which the order was
issued.

 

7.4. Third
Party Information. The Parties
acknowledge that the defined term “Confidential
Information” shall include not only a Disclosing
Party’s own Confidential Information but also Confidential
Information of a Third Party which is in the possession of a
Disclosing Party. TGTX and Licensor agree not to disclose to the
other any Confidential Information of a Third Party which is in the
possession of such Party, unless the other has given an express
prior written consent (which specifies the owner of such
Confidential Information) to receive such particular Confidential
Information.

 

7.5. Press
Releases and Disclosure. The
Parties acknowledge that each Party may desire or be required to
issue a press release or to make other public disclosures relating
to the execution of this Agreement and its terms. The Parties agree
to consult with each other reasonably and in good faith with
respect to the text and timing of such a press release or other
public disclosure prior to the issuance thereof, provided that a
Party may not unreasonably withhold consent to such release, and
that either Party may issue such press release as it determines,
based on advice of counsel, are reasonably necessary to comply with
laws or regulations. (Provided, that no Party shall use the
trademark or logo of the other Party, its Affiliates or their
respective employee(s) in any publicity, promotion, news release or
public disclosure relating to this Agreement or its subject matter,
except as may be required by Law or required by the rules of an
applicable * or * national securities exchange or except with the
prior express written permission of such other Party, such
permission not to be unreasonably withheld.) Notwithstanding the
above, once a public disclosure has been made, either Party shall
be free to disclose to third parties any information contained in
said public disclosure, without further
pre-review.

 



ARTICLE VIII.

 



REPRESENTATIONS, WARRANTIES AND COVENANTS

 

8.1. Representations
and Warranties. (a) TGTX
represents and warrants to Licensor, and (b) Licensor represents
and warrants to TGTX, in each case as of the Effective
Date:

 

(a) Such
Party is a corporation duly organized and validly existing under
the Laws of the jurisdiction of its incorporation;

 

(b) Such
Party has all right, power and authority to enter into this
Agreement, and to perform its obligations under this
Agreement;

 

(c) Such
Party has taken all action necessary to authorize the execution and
delivery of this Agreement and the performance of its obligations
under this Agreement;

 

(d) This
Agreement is a legal and valid obligation of such Party, binding
upon such Party and enforceable against such Party in accordance
with the terms of this Agreement, except as enforcement may be
limited by applicable bankruptcy, fraudulent conveyance,
insolvency, reorganization, moratorium and other Laws relating to
or affecting creditors’ rights generally and by general
equitable principles;

 

(e) To
the best of such party’s knowledge, the execution, delivery
and performance of this Agreement by such Party does not and will
not conflict with, breach or create in any Third Party the right to
accelerate, terminate or modify any agreement or instrument to
which such Party is a party or by which such Party is
bound;

 

(f) To
the best of such party’s actual knowledge, all consents,
approvals and authorizations from all governmental authorities or
other Third Parties required to be obtained by such Party in
connection with the execution and delivery of this Agreement have
been obtained; and the execution, delivery and performance of this
Agreement by such Party does not and will not violate any Law of
any Governmental Body having authority over such
Party;

 

(g) No
person or entity has or will have, as a result of the execution and
delivery of or as a result of the transactions contemplated by this
Agreement, any right, interest or valid claim against or upon such
Party for any commission, fee or other compensation as a finder or
broker because of any act by such Party or its Affiliates, agents
or Sublicensees; and

 

(h) To
the best of such party’s actual knowledge, no agreement
between it and any Third Party is in conflict with the rights
granted to any other party pursuant to this Agreement.

 



 







 





 

8.2. Additional
Representations and Warranties of Licensor. Licensor represents and warrants to TGTX as of the
Effective Date that:

 

(a) No
consent by any Third Party or Governmental Body is required with
respect to the execution and delivery of this Agreement by Licensor
or the consummation by Licensor of the transactions contemplated
hereby;

 

(b) To
the best of Licensor’s actual knowledge, no valid claims have
been asserted or threatened by any Person (i) challenging the
validity, effective status, or ownership of Licensor Technology,
and/or (ii) to the effect that the use, reproduction, modification,
manufacturing, distribution, licensing, sublicensing, sale or any
other exercise of rights in any of Licensor Technology infringes or
will infringe on any intellectual property right of any Person; and
no such claims have been asserted or are threatened;

 

(c) The
Licensor Patents are subsisting and are not the subject of any
litigation procedure, discovery process, interference, reissue,
reexamination, opposition, appeal proceedings or any other legal
dispute;

 

(d) The
Licensor Patents constitute all Patent Rights owned or Controlled
by Licensor that pertain directly and particularly to the research,
Development, manufacture, use and Commercialization of the Licensed
Products in the Field and in the Territory as currently
envisioned;

 

(e) To
the best of Licensor’s actual knowledge, no Third Party has
filed, pursued or maintained or threatened in writing to file,
pursue or maintain any claim, lawsuit, charge, complaint or other
action alleging that any Licensor Technology is invalid or
unenforceable; and

 

(f) Licensor
has ceased its research and development activities to discover
compounds under a BTK Inhibitor Program (as defined herein) and
will not initiate research and development activities aimed at
discovering compounds under a BTK Inhibitor Program prior to the *
( * ) anniversary of the Effective Date. For the purposes of this
provision, a “BTK Inhibitor
Program” is one that
seeks to discover a selective compound that *, and which may be
suitable for treating hematological malignancies and/or autoimmune
indications.

 

8.3. Disclaimer.
Notwithstanding the representations and warranties set forth in
this Article VIII, TGTX acknowledges and accepts the risks inherent
in attempting to Develop and Commercialize any pharmaceutical
product. There is no implied representation that the Compounds can
be successfully Developed or Commercialized. The representations
and warranties set forth in
this Article VIII are provided in lieu of, and EACH PARTY HEREBY
DISCLAIMS, all other
warranties, express and implied, relating to the subject matter of
this Agreement, the Licensor Technology, the Compounds and/or the
Licensed Products, including but not limited to the implied
warranties of merchantability and fitness for a particular purpose,
title and non-infringement of Third Party rights. Each Party’s representations
and warranties under this Agreement are solely for the benefit of
the other Party and may be asserted only by the other Party and not
by any Affiliate, Sublicensee or any customer of the other Party,
its Affiliates or Sublicensees. Each Party, its Affiliates and
Sublicensees shall be solely responsible for all representations
and warranties that it, its Affiliates or Sublicensees make to any
customer, Affiliates or Sublicensees.

 



ARTICLE IX.

 



INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

 

9.1. Indemnification
by TGTX. TGTX shall indemnify,
defend and hold Licensor and its Affiliates, and each of their
respective employees, officers, directors and agents (the
“Licensor
Indemnitees”) harmless
from and against any and all actions, judgments, settlements,
liabilities, damages, penalties, fines, losses, costs and expenses
(including reasonable attorneys’ fees and expenses) to the
extent arising out of any Third Party claim, demand, action or
other proceeding (each, a “Claim”) related to (a) TGTX’s performance
of its obligations or exercise (by it or its Affiliates or
Sublicensees) of its rights under this Agreement, including without
limitation, product liability claims; or (b) breach by TGTX of its
representations and warranties set forth in Article VIII; provided,
however, that TGTX’s obligations pursuant to this Section 9.1
shall not apply (x) to the extent such claims or suits result from
the gross negligence or willful misconduct of any of the Licensor
Indemnitees, or (y) with respect to claims or suits arising out of
breach by Licensor of this Agreement, including without limitation
of its or their representations and warranties set forth in Article
VIII.

 


9.2. Indemnification
by Licensor. Licensor shall
indemnify, defend and hold TGTX and its Affiliates and each of
their respective agents, employees, officers and directors (the
“TGTX
Indemnitees”) harmless
from and against any and all actions, judgments, settlements,
liabilities, damages, penalties, fines, losses, costs and expenses
(including reasonable attorneys’ fees and expenses) to the
extent arising out of any and all Claims related to (a)
Licensor’s performance of its obligations or exercise (by it
or its Affiliates) of its or their rights under this Agreement; or
(b) breach by Licensor of its representations and warranties set
forth in Article VIII; provided, however, that Licensor’s
obligations pursuant to this Section 9.2 shall not apply (x) to the
extent that such claims or suits result from the gross negligence
or willful misconduct of any of the TGTX Indemnitees or (y) with
respect to claims or suits arising out of a breach by TGTX of this
Agreement, including without limitation its representations and
warranties set forth in Article VIII.

 



 







 





 

9.3. No
Consequential, Etc., Damages.
EXCEPT FOR DAMAGES FOR WHICH A PARTY IS RESPONSIBLE PURSUANT TO ITS
INDEMNIFICATION OBLIGATIONS SET FORTH IN ARTICLE IX, EACH PARTY
SPECIFICALLY DISCLAIMS ALL LIABILITY FOR AND SHALL IN NO EVENT BE
LIABLE TO ANY OTHER PARTY OR TO ANY OTHER PARTY’S AFFILIATES
FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES,
EXPENSES, LOST PROFITS, LOST SAVINGS, INTERRUPTIONS OF BUSINESS OR
OTHER DAMAGES OF ANY KIND OR CHARACTER WHATSOEVER ARISING OUT OF OR
RELATED TO THIS AGREEMENT OR THE DEVELOPMENT PROGRAM OR THE
LICENSED TECHNOLOGY OR RESULTING FROM THE MANUFACTURE, HANDLING,
MARKETING, SALE, DISTRIBUTION OR USE OF LICENSED PRODUCTS,
REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT, STRICT
LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY WAS ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.


 

9.4. Procedure.

 


(a)           The
Party or other Person intending to claim indemnification under this
Article IX (an “Indemnified
Party”) shall promptly
notify the opposed Party (the “Indemnifying
Party”) of any Claim in
respect of which the Indemnified Party intends to claim such
indemnification (provided, that no delay or deficiency on the part
of the Indemnified Party in so notifying the Indemnifying Party
will relieve the Indemnifying Party of any liability or obligation
under this Agreement except to the extent the Indemnifying Party
has suffered actual prejudice directly caused by the delay or other
deficiency), and the Indemnifying Party shall assume the defense
thereof (with counsel selected by the Indemnifying Party and
reasonably satisfactory to the Indemnified Party) whether or not
such Claim is rightfully brought; provided, however, that an
Indemnified Party shall have the right to retain its own counsel
and to participate in the defense thereof, with the fees and
expenses to be paid by the Indemnified Party unless the
Indemnifying Party does not assume the defense or unless a
representation of both the Indemnified Party and the Indemnifying
Party by the same counsel would be inappropriate due to the actual
or potential differing interests between them, in which case the
reasonable fees and expenses of counsel retained by the Indemnified
Party shall be paid by the Indemnifying Party. (Provided, that in
no event shall the Indemnifying Party be required to pay for more
than one separate counsel no matter the number or circumstances of
all Indemnified Parties.)

 


(b)           If
the Indemnifying Party shall fail to timely assume the defense of
and reasonably defend such Claim, the Indemnified Party shall have
the right to retain or assume control of such defense and the
Indemnifying Party shall pay (as incurred and on demand) the fees
and expenses of counsel retained by the Indemnified
Party.

 


(c)           The
Indemnifying Party shall not be liable for the indemnification of
any Claim settled (or resolved by consent to the entry of judgment)
without the written consent of the Indemnifying Party. Also, if the
Indemnifying Party shall control the defense of any such Claim, the
Indemnifying Party shall have the right to settle such Claim;
provided, that the Indemnifying Party shall obtain the prior
written consent (which shall not be unreasonably withheld or
delayed) of the Indemnified Party before entering into any
settlement of (or resolving by consent to the entry of judgment
upon) such Claim unless (i) there is no finding or admission of any
violation of law or any violation of the rights of any person by an
Indemnified Party, no requirement that the Indemnified Party admit
negligence, fault or culpability, and no adverse effect on any
other claims that may be made by or against the Indemnified Party
and (ii) the sole relief provided is monetary damages that are paid
in full by the Indemnifying Party and such settlement does not
require the Indemnified Party to take (or refrain from taking) any
action.

 


(d)           The
Indemnified Party, and its employees and agents, shall cooperate
fully with the Indemnifying Party and its legal representatives in
the investigations of any Claim.

 


(e)           Regardless
of who controls the defense, each Party hereto shall reasonably
cooperate in the defense as may be requested.

 

9.5. Expenses.
As the Parties intend complete indemnification, all costs and
expenses of enforcing any provision of this Article IX shall also
be reimbursed by the Indemnifying Party..

 

9.6. Limitation
of Liability. EACH PARTY SHALL
HAVE NO REMEDY, AND EACH PARTY SHALL HAVE NO LIABILITY, OTHER THAN
AS EXPRESSLY SET FORTH IN THIS AGREEMENT. EXCEPT WITH RESPECT TO
THE INDEMNIFICATION SPECIFICALLY PROVIDED IN ARTICLE IX OR CLAIMS
FOR NON-PAYMENT. NO ACTION, REGARDLESS OF FORM, ARISING OUT OF OR
RELATED TO THIS AGREEMENT MAY BE BROUGHT BY EITHER PARTY MORE
THAN * YEARS AFTER SUCH PARTY
HAS KNOWLEDGE OF THE OCCURRENCE THAT GAVE RISE TO THE CAUSE OF
ACTION OR AFTER EXPIRATION OF THE APPLICABLE STATUTORY LIMITATIONS
PERIOD, WHICHEVER IS SOONER.

 

9.7. Insurance.
During the Term and for three years
thereafter, TGTX shall obtain and maintain, at its own cost and
expense, product liability insurance in amounts, that are
reasonable and customary in the United States pharmaceutical and
biotechnology industry for companies engaged in comparable
activities, with Licensor identified as an additional named
insured. It is understood and agreed that this insurance shall not
be construed to limit TGTX’s liability with respect to its
indemnification obligations hereunder. TGTX shall upon request
provide to Licensor upon request a certificate evidencing the
insurance TGTX is required to obtain and keep in force under this
Section 9.7.

 



 







 





 



ARTICLE X.

 



TERM AND TERMINATION

 

10.1. Term
and Expiration. The term of
this Agreement shall commence on the Effective Date and, unless
earlier terminated as provided in this Article X, shall continue in
full force and effect, on a country-by-country and Licensed
Product-by-Licensed Product basis until the Royalty Term in such
country with respect to such Licensed Product expires, at which
time this Agreement shall expire in its entirety with respect to
such Licensed Product in such country. (The “Term”
shall mean the period from the
Effective Date until the earlier of termination of this Agreement
as provided in this Article X or expiration of this Agreement upon
the expiration of the last-to-expire Royalty Term.) The Parties
confirm that subject to the foregoing sentence, this Agreement
shall not be terminated or invalidated by any future determination
that any or all of the Licensor Patents have expired or been
invalidated.

 


10.2. Termination
upon Material Breach. If a
Party breaches any of its material obligations under this
Agreement, the Party not in default may give to the breaching Party
a written notice specifying the nature of the default, requiring it
to cure such breach, and, if desired, stating its intention to
terminate this Agreement if such breach is not cured. If such
breach is not capable of being cured, or is capable of being cured
but nonetheless has not within * ( * ) days
after the receipt of such notice been cured, then the Party not in
default shall (in addition to and not in lieu of all other
available rights and remedies) be entitled to at its option either
(a) terminate this Agreement immediately by written notice to the
other Party, or (b) continue this Agreement in full force and
effect and seek any legal or equitable remedies that the
non-breaching Party may have. In case of a breach of an obligation
to pay money, which obligation to pay is not disputed in good
faith, the cure period shall be * ( * ) days
instead of * ( *
) days. The Parties agree that any
failure by TGTX to pay when due * percent (* %)
of such portion of any amount of money owing from TGTX to Licensor
as is not disputed in good faith by TGTX (subject to the *
( * ) day cure period) shall conclusively be deemed to
constitute a “material” breach. Notwithstanding the
foregoing provisions, in the event of a good-faith dispute as to
whether any alleged breach is in fact a breach, termination under
this Section 10.2 in respect of such alleged breach shall not take
effect unless and until (y) such dispute is resolved (according to
the procedure described in 11.2) in favor of the Party alleging the
breach or (z) the breaching Party’s denial that the alleged
breach is in fact a breach ceases to be in good
faith.

 

10.3. Termination
for Bankruptcy. Licensor may terminate this Agreement immediately upon
written notice to TGTX in the event that TGTX has a petition in
bankruptcy filed against it that is not dismissed within *
( * ) days of such filing, files a petition in
bankruptcy, or makes an assignment for the benefit of creditors. If
TGTX has before such filing or such assignment entered into a
written Sublicense which complies with Section 2.2, then the
Sublicensee thereunder shall have the right to, by but only by
delivering to Licensor within * ( * ) days
after such termination a written election to do so and a written
assumption of all of TGTX’s past and future obligations,
liabilities and duties under this Agreement, convert its Sublicense
into a direct of license from Licensor of the same technology, for
the same field and for the same territory, as had been provided for
in the Sublicense and otherwise on the same terms and conditions as
are set forth in this Agreement as if such Sublicensee were TGTX
hereunder. TGTX may terminate this Agreement immediately upon
written notice to Licensor in the event that Licensor has a
petition in bankruptcy filed against it that is not dismissed
within * ( *
) days of such filing, files a
petition in bankruptcy, or makes an assignment for the benefit of
creditors.

 

10.4. TGTX
Termination. TGTX may terminate
this Agreement at any time for any reason upon * ( * ) days’
prior written notice to Licensor, provided that (i) TGTX and
Hengrui attempted to resolve any issues in good faith, and (ii)
TGTX and Hengrui agree to consult with each other with regard to
public communications related to the termination of agreement. If
TGTX has the right to terminate this Agreement pursuant to Section
10.2 for an uncured material breach by the Licensor, TGTX shall,
within * ( * ) days after the end of the applicable cure period,
elect in writing to either (i) exercise such right of termination
with the effects set forth in Section 10.5 or (ii) waive such right
of termination and any other right to pursue damages or other
remedies in connection with such uncured material breach and
maintain this Agreement in full force and effect provided that the
then applicable royalty rates specified in Section 5.4, after
taking into account all clauses thereunder, shall be and remain
reduced by a further * % for the remainder of the term of this
Agreement despite the * percent (* %) floor set by clause (f) in
Section 5.4.

 


10.5. Effects
of Termination/Expiration.

 

(a) Articles
I (Definitions), VII (Confidentiality), IX (Indemnification;
Limitation of Liability; Insurance) and XI (Miscellaneous
Provisions) and Sections 5.6 (Royalty Reports and Records
Retention), 5.7 (Audits), 5.9 (Late Payments), 5.10 (Taxes)
and 10.5 (Effects of Termination/Expiration) hereof shall survive
the expiration or termination of this Agreement for any
reason.

 

(b) Termination
or expiration of this Agreement shall not relieve the Parties of
any liability that accrued hereunder before the effective date of
such termination or expiration. In addition, termination or
expiration of this Agreement shall not preclude either Party from
pursuing all rights and remedies it may have hereunder or at Law or
in equity with respect to any breach of this Agreement nor
prejudice either Party’s right to obtain performance of any
obligation.

 



 







 





 

(c) Upon
termination of this Agreement pursuant to Section 10.2 for an
uncured material breach by TGTX or pursuant to Section 10.3, all
licenses granted to TGTX hereunder shall terminate. If TGTX has
before termination entered into a written Sublicense which complies
with Section 2.2, then, if the Sublicensee thereunder is not then
in breach of such Sublicense, the Sublicensee shall have the right
to convert its Sublicense into a direct license from Licensor of
the same technology, for the same field and for the same territory,
as had been provided for in the Sublicense and otherwise on the
same terms and conditions as are set forth in this Agreement as if
such Sublicensee were TGTX hereunder. Such right of conversion
shall be exercisable by Sublicensee by delivering to Licensor
within * ( *
) days after such termination a
written election to so convert. In addition, upon any termination
of this Agreement pursuant to Section 10.2 for an uncured material
breach by TGTX or pursuant to Section 10.3, TGTX and Licensor agree
that TGTX shall: (i) assign to Licensor all Regulatory Approvals,
applications for Regulatory Approvals and all drug master files and
drug dossiers in the Territory, (ii) transfer to Licensor all
correspondence and files pertaining to such Regulatory Approvals,
applications for Regulatory Approvals and all drug master files and
drug dossiers in the Territory, (iii) transfer to Licensor all data
generated by TGTX, its Affiliates and Sublicensees in connection
with the Development of the Licensed Products (in written or
electronic form as Licensor may direct), (iv) grant, and hereby
does grant, to Licensor a non-exclusive, fully-paid, perpetual,
irrevocable license, with the right to sublicense through multiple
tiers, to all intellectual property developed by TGTX, its
Affiliates and Sublicenses in connection with the Development of
the Licensed Products, and (v) upon the request of Licensor, assign
to Licensor any contracts related to the Development, manufacture
or Commercialization of the Licensed Products in the Territory
under the following scenarios and conditions: (i) if at the time of
termination TGTX has met the diligence milestone set forth under
Section 3.1(a), the Licensor shall pay TGTX a royalty amounting
to * % of Net Sales in the
Territory on an annual basis until TGTX recovers *
% of the cost of development of the
Licensed Products; (ii) if at the time of termination TGTX has met
the diligence milestone set forth under Section 3.1(b), the
Licensor shall pay TGTX a royalty amounting to *
% of * in the Territory on an annual basis until TGTX
recovers * % of the cost of
development of the Licensed Products; or (iii) if at the time of
termination TGTX has dosed at least * in a Phase 3 clinical study or Pivotal Trial, the
Licensor shall pay TGTX a royalty amounting to *
% of Net Sales in the Territory on an
annual basis until TGTX recovers * % of the cost of development of the Licensed
Products. The cost of development of the Licensed Products shall
include all costs and expenses incurred by TGTX as of the time of
termination, as calculated in good faith by TGTX, subject to
Licensor’s right to an audit. Net Sales shall have the
meaning set forth under Section 1.31, except it shall apply to
sales of the License Products by Licensor, its Affiliates, or any
sublicensees. Licensor can, in its sole discretion, choose not to
assume Regulatory Approvals and filings, data, or intellectual
property generated by TGTX. In such event, TGTX will not be
entitled to any cost of development recovery.

 



 







 





 



ARTICLE XI.

 



MISCELLANEOUS PROVISIONS

 

11.1. Relationship
of the Parties. Nothing in this
Agreement is intended or shall be deemed to constitute a
partnership, agency, joint venture or employer-employee
relationship between the Parties. No Party shall have any right or
authority to commit or legally bind any other Party in any way
whatsoever including, without limitation, the making of any
agreement, representation or warranty and each Party agrees to not
purport to do so.

 

11.2. 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 11.2 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, 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 * ( * ) days after such dispute is first
identified by either Party in writing to the other, the Parties
shall refer such dispute to the Chief Executive Officers and/or
Chairman for each Party for attempted resolution by good faith
negotiations within * ( * ) days after such notice is received. If
the senior executive officers designated by the Parties are not
able to resolve such dispute within such * ( * ) day period, either
Party may submit such dispute in accordance with Section
11.2(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 11, either Party may seek
injunctive relief in any court in any jurisdiction where
appropriate.

 


11.3. Assignment.

 

(a) Any
assignment not in accordance with this Section 11.2 shall be
void.

 

(b) No
assignment shall relieve the assigning Party of any of its
responsibilities or obligations hereunder.

 

(c) Neither
Party may transfer or assign its rights or licenses or delegate its
obligations under this Agreement, in whole or in part, by operation
of law or otherwise, to any Third Party without the prior written
consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed;provided that,
notwithstanding the foregoing, either
Party may assign its rights or licenses and/or delegate its
obligations under this Agreement to an Affiliate or to a successor
to all or substantially all of its assets, whether by way of
merger, sale of all or substantially all of its assets, sale of
stock or otherwise, without the other Party’s prior written
consent. As a condition to any permitted assignment hereunder, the
assignee must expressly assume, in a writing delivered to the other
Party (and in a form reasonably acceptable to the other Party) all
of such assigning Party’s obligations under this Agreement,
whether arising before, at or after the
assignment.

 

11.4. 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.

 



 







 





 

11.5. Force
Majeure. No Party shall be
liable to any other Party or be deemed to have breached or
defaulted under this Agreement for failure or delay in the
performance of any of its obligations under this Agreement (other
than obligations for the payment of money) for the time and to the
extent such failure or delay is caused by or results from acts of
God, earthquake, riot, civil commotion, terrorism, war, strikes or
other labor disputes, fire, flood, failure or delay of
transportation, omissions or delays in acting by a governmental
authority, acts of a government or an agency thereof or judicial
orders or decrees or restrictions or any other like reason which is
beyond the control of the respective Party. The Party affected by
force majeure shall provide the other Party with full particulars
thereof as soon as it becomes aware of the same (including its best
estimate of the likely extent and duration of the interference with
its activities), and shall use Commercially Reasonable Efforts to
overcome the difficulties created thereby and to resume performance
of its obligations hereunder as soon as practicable, and the time
for performance shall be extended for a number of days equal to the
duration of the force majeure.

 

11.6. Entire
Agreement of the Parties; Amendments. This Agreement and the Schedules hereto constitute
and contain the entire understanding and agreement of the Parties
respecting the subject matter hereof and cancel and supersede any
and all prior or contemporaneous negotiations, correspondence,
understandings and agreements between the Parties, whether oral or
written, regarding such subject matter (provided, that any and all
previous nondisclosure/nonuse obligations are not superseded and
remain in full force and effect in addition to the
nondisclosure/nonuse provisions hereof). Each Party acknowledges
that it has not relied, in deciding whether to enter into this
Agreement on this Agreement’s expressly stated terms and
conditions, on any representations, warranties, agreements,
commitments or promises which are not expressly set forth within
this Agreement. No modification or amendment of any provision of
this Agreement shall be valid or effective unless made in a writing
referencing this Agreement and signed by a duly authorized officer
of each Party.

 

11.7. Governing
Law. This Agreement shall be
governed by and interpreted in accordance with the laws of the
State of New York, excluding application of any conflict of laws
principles.

 

11.8. Notices
and Deliveries. Any notice,
request, approval or consent required or permitted to be given
under this Agreement shall be in writing and shall be deemed to
have been sufficiently given if and only if delivered in person, by
email or by express courier service to the Party to which it is
directed at its physical or email address shown below or such other
physical or email address as such Party shall have last given by
such written notice to the other Party.

 


If to
TGTX, addressed to:

 


TG
Therapeutics, Inc.


   
           
              2
Gansevoort St., 9th Floor


New
York, NY 10014


Attention: Michael
S. Weiss, Executive Chairman, and Chief Executive
Officer


Email:
*

 


With a
copy to:

 


Foley
& Lardner LLP


3000 K
St., NW, Suite 600


Washington, DC
20007


U.S.A.


Attention: Ybet
Villacorta *

 


If to
Licensor, addressed to:

 


Jiangsu
Hengrui Medicine Co.


No.7
Kunlunshan Road, Lianyungang Eco & Tech Development
Zone,


Jiangsu
Province, China 222047


Attention: Lianshan
Zhang, Ph.D., President of Global R&D


     Paul
Lu, Ph.D., Global Business Development


Email:
*


 


With a
copy to :


 


Goodwin
Procter


100
Northern Avenue


Boston,
MA 02210


U.S.A.


Attention :
Christopher Denn *


 



 







 






 

11.9. Waiver.
No waiver of any provision of this
Agreement shall be valid or effective unless made in a writing
referencing this Agreement and signed by a duly authorized officer
of the waiving Party. A waiver by a Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or
construed to be a waiver of such term or condition for the future,
or of any other term or condition hereof.

 

11.10. Rights
and Remedies are Cumulative.
Except to the extent expressly set forth herein, all rights,
remedies, undertakings, obligations and agreements contained in or
available upon violation of this Agreement shall be cumulative and
none of them shall be in limitation of any other remedy or right
authorized in law or in equity, or any undertaking, obligation or
agreement of the applicable Party.

 

11.11. Severability.
This Agreement is severable. When
possible, each provision of this Agreement will be interpreted in
such manner as to be effective and valid under applicable Law, but
if any provision of this Agreement is held to be to any extent
prohibited by or invalid under applicable Law, such provision will
be ineffective only to the extent of such prohibition or
invalidity, without invalidating the remainder of this Agreement
(or of such provision). The Parties shall make a good faith effort
to replace the invalid or unenforceable provision with a valid one
which in its economic effect is most consistent with the invalid or
unenforceable provision.

 

11.12. Third
Party Beneficiaries. Except for
the rights of Indemnified Parties pursuant to Article IX hereof and
the rights of Sublicensees set forth in Sections 10.2 and 10.4(c),
the terms and provisions of this Agreement are intended solely for
the benefit of each Party hereto and their respective successors or
permitted assigns and it is not the intention of the Parties to
confer third-party beneficiary rights upon any other person,
including without limitation Sublicensees. The enforcement of any
obligation of Licensor under this Agreement shall only be pursued
by TGTX or such Indemnified Party, and not Sublicensees (except as
set forth in Sections 10.2 and 10.4(c)).

 

11.13. No
Implied License. No right or
license is granted to TGTX hereunder by implication, estoppel, or
otherwise to any know-how, patent or other intellectual property
right owned or controlled by Licensor or its Affiliates, except by
an express license granted hereunder. No right or license is
granted to Licensor hereunder by implication, estoppel, or
otherwise to any know-how, patent or other intellectual property
right owned or controlled by TGTX or its Affiliates, except by an
express license granted hereunder.

 

11.14. No
Right of Set-Off. Except as
expressly provided in Section 5.7(b) of this Agreement, TGTX shall
not have a right to set-off any royalties, milestones or other
amount due to Licensor under this Agreement against any damages
incurred by TGTX for a breach by Licensor of this
Agreement.

 

11.15. Equitable
Relief. Each Party recognizes that the covenants and
agreements herein and their continued performance as set forth in
this Agreement are necessary and critical to protect the legitimate
interests of the other Party, that the other Party would not have
entered into this Agreement in the absence of such covenants and
agreements and the assurance of continued performance as set forth
in this Agreement, and that a Party’s breach or threatened
breach of such covenants and agreements may cause the opposed Party
irreparable harm and significant injury, the amount of which will
be extremely difficult to estimate and ascertain, thus potentially
making any remedy at law or in damages inadequate. Therefore, each
Party agrees that an opposed Party shall be entitled to seek
specific performance, an order restraining any breach or threatened
breach of Article VII and all other provisions of this Agreement,
and any other equitable relief (including but not limited to
temporary, preliminary and/or permanent injunctive relief). This
right shall be in addition to and not exclusive of any other remedy
available to such other Party at law or in
equity.

 

11.16. Interpretation.
The language used in this Agreement is
the language chosen by the Parties to express their mutual intent,
and no provision of this Agreement shall be interpreted for or
against a Party because that Party or its attorney drafted the
provision.

 

11.17. Use
of Name. Neither Party shall be permitted to use the name,
or any proprietary trademarks, trade names, trade dress or logos
(“Marks”) of the
other Party, or its Affiliates, or its Sublicensees, in any
publicity, promotion, news release or public disclosure relating to
this Agreement or its subject matter, without the prior express
written permission of the other Party. Counterparts.
This Agreement may be executed in
counterparts, each of which will be deemed an original, and all of
which together will be deemed to be one and the same instrument. A
facsimile or a portable document format (.pdf) copy of this
Agreement, including the signature pages, will be deemed an
original.

 


 

 


[the remainder of this page has
been left blank intentionally]

 



 







 





 


IN WITNESS WHEREOF, the Parties have
caused this License Agreement to be executed and delivered by their
respective duly authorized officers as of the day and year first
above written.

 






 


 



JIANGSU HENGRUI MEDICINE CO.

 


 

 


By:
_/s/ Piaoyang
Sun________________

 

Name: Piaoyang
Sun









Title:
Chairman

 


 

 



TG THERAPEUTICS, INC.


 

 


 

 


By:
_/s/ Michael S.
Weiss_____________

 

Name: Michael S.
Weiss


 


Title:
Executive Chairman, President and Chief Executive
Officer


 


 




 









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






 



Exhibit A

 

 


*

 


 

 


 

 


 

 




 









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










 



Schedule 1

 



Compounds

 


 

 


* ( *
)


 

 


 

 


*

 


 

 


 

 


* ( *
)


 

 


 

 


*

 




 









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






 



Schedule 2

 



Licensor Know-How includes, but is not limited to, the information
disclosed in the documents available in a data room, which is
accessible via the following link:

 


*

 


 

 


 

 


 




 









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






 



Schedule 3



Licensor Patent Rights and Status as of Effective Date

 


	


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* (
* )


	


Country:

	


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