Document:

Amph_Ex10_2

		

			Exhibit 10.2

		

		
			 
		

		
			Certain identified information has been omitted from this document because it is not material and would be competitively harmful if publicly disclosed, and has been marked with “[***]” to indicate where omissions have been made.
		

		
			 
		

		
			FIFTH AMENDMENT TO SUPPLY AGREEMENT
		

		
			This fifth amendment (“Fifth Amendment”) to the Supply Agreement by and between MannKind Corporation (“MannKind”) and Amphastar Pharmaceuticals, Inc.  (“Amphastar”), originally dated July 31, 2014 and as previously amended on October 31, 2014 (“First Amendment”), November 9, 2016 (“Second Amendment”), April 11, 2018 (“Third Amendment”), and December 24, 2018 (“Fourth Amendment”) (collectively, the “Agreement”), is hereby made as of the 2nd day of August,  2019, by and between MannKind on the one hand, and on the other hand, Amphastar.  
		

		
			RECITALS
		

		
			WHEREAS, MannKind and Amphastar entered into the Agreement pursuant to which Amphastar is to manufacture and supply the Product to MannKind, and MannKind is to purchase certain minimum quantities of the Product; and
		

		
			WHEREAS MannKind and Amphastar have determined it to be mutually beneficial to amend the Agreement as set forth herein.
		

		
			NOW, THEREFORE,  for good and valuable consideration, MannKind and Amphastar, hereby agree to amend the Agreement as follows:
		

			
	
			
				 1.
			Definitions.  Unless otherwise defined herein, each of the capitalized terms used in this Fifth Amendment shall have the definition and meaning ascribed to it in the Agreement.

			
	
			
				 2.
			Amendment Fees.  In order to compensate Amphastar and its subsidiaries for its unused manufacturing capacity related to 2019 production,  MannKind shall make the following payments (in U.S. dollars) to Amphastar France Pharmaceuticals S.A.S., as manufacturer of the API, no later than the dates specified below: 

			
					
						Amount

					
					
						Payment Due Date

				
	
					
						$1,500,000

					
					
						September 15, 2019

				
	
					
						$1,250,000

					
					
						December 15, 2019

				

		
			In the event that MannKind fails to make timely payment in full of the Amendment Fees specified in this Section 2, the terms and conditions of the Agreement, as amended by the Fourth Amendment, shall be in full force and effect from and after January 1, 2020; provided, however, that MannKind will still be required to immediately pay in full the Amendment Fees and purchase an additional [***] kg of Purchase Commitment Quantities to be added to the 2020 Purchase Commitment Quantities specified in the Fourth Amendment (i.e., the Purchase Commitment Quantities for 2020 shall become [***] kg).
		

			
	
			
				 3.
			Amendments to the Agreement. Subject to Section 2 of this Fifth Amendment,  the Agreement shall be, and hereby is, amended,  as follows:

		
			

		 

		

			
	
			
				 3.1
			Section 6.1 of the Agreement,  as amended by the First, Second, and Fourth Amendments, shall be amended and replaced in its entirety with the following:

		
			 
		

		
			“6.1Purchase Commitment and Purchase Price. MannKind shall purchase from Amphastar the minimum quantities of Product (the "Purchase Commitment Quantities") at the purchase price per gram (the "Purchase Price") in each calendar year as provided in the table set forth below. This annual Purchase Commitment Quantities will be divided into four (4) equal quarterly commitments (the "Quarterly Commitment') for purchase commitments in years 2022 - 2026. In the event that MannKind fails to meet the Quarterly Commitment in any given calendar quarter, MannKind shall pay Amphastar for the difference in the amount of the Quarterly Commitment and the actual amount purchased for the corresponding calendar quarter (such difference, the "Payment Commitment Difference"). Amphastar shall issue an invoice and MannKind shall pay the Payment Commitment Difference no later than fifteen (15) business days after the close of the corresponding calendar quarter. 
		

			
					
						Calendar Year

					
					
						Purchase Commitment Quantities (kg)

					
					
						Purchase Price (per gram)

					
					
						Delivery and Payment

				
	
					
						2014

					
					
						[***]

					
					
						EUR [***]

					
					
						Completed

				
	
					
						2015

					
					
						[***]

					
					
						EUR [***]

					
					
						Completed

				
	
					
						2016

					
					
						[***]

					
					
						EUR [***]

					
					
						 

				
	
					
						2017

					
					
						[***]

					
					
						EUR [***]

					
					
						Completed

				
	
					
						2018

					
					
						[***]

					
					
						EUR [***]

					
					
						Completed

				
	
					
						2019

					
					
						[***]

					
					
						EUR [***]

					
					
						Completed    

				
	
					
						2020

					
					
						[***]

					
					
						EUR [***]

					
					
						50% of the Purchase Commitment Quantities shall be purchased in each of the second Quarter and fourth Quarter. 

				
	
					
						2021

					
					
						[***]

					
					
						EUR [***]

					
					
						50% of the Purchase Commitment Quantities shall be purchased in each of the second Quarter and fourth Quarter.  

				
	
					
						2022

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be purchased on a Quarterly basis. 

				

		 

		

			2

		

	
					
						

					
						2023

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be purchased on a Quarterly basis.

				
	
					
						2024

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be purchased on a Quarterly basis.

				
	
					
						2025

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be purchased on a Quarterly basis.

				
	
					
						2026

					
					
						[***]

					
					
						EUR [***]

					
					
						25% of the Purchase Commitment Quantities shall be purchased on a Quarterly basis.

				

		
			 
		

		
			All amounts due under this § 6.1 shall be due and payable by MannKind to Amphastar in U.S. dollars, and the conversion of the Purchase Price from euros (EUR) to U.S. dollars shall be made using the exchange rate at the close (Eastern time) of the last business day immediately prior to the shipment date, as reported by the Bloomberg Currency Spot Exchange Rate (http://www.bloomberg.com/guote/EURUSD:CUR), and otherwise in accordance with § 6.2.
		

		
			 
		

		
			(a) The Purchase Price will be subject to an obligatory annual adjustment on January 1 of each calendar year equal to the percentage change in the [***] (the "Index"), where the annual adjustment is calculated using the historical twelve (12) month percentage change of the Index, as of December 1 of the immediate prior year; provided, however, that if the percentage change (either increase or decrease, as applicable) of the Index equals or exceeds [***] percent (i.e., +/- [***]%), the Purchase Price adjustment shall not be obligatory, but instead the Parties shall attempt in good faith to negotiate an adjusted Purchase Price based on such change, which attempted negotiations shall be concluded no later than February 15 of that calendar year.
		

		
			 
		

		
			(b) In addition to any adjustment to the Purchase Price pursuant to §6.1(a), if for causes beyond Amphastar's reasonable control (including market shortage, market embargo, etc.), Amphastar has incurred any price increase(s) in its aggregate material and service costs (such increased costs measured on a per gram basis of Product, the "Cost Excess") which are in excess of [***] percent ([***]%) of the Purchase Price in a given calendar year, then the Purchase Price for the next calendar year shall be increased by the percentage increase of the Cost Excess as compared to the aggregate costs for such materials and services during the prior calendar year.
		

		
			 
		

		
			(c) If Amphastar delivers any Product Purchase Commitment Quantities, as defined in the Firm Order Period through a Purchase Order accepted by Amphastar, beyond sixty (60) days after the committed delivery date, then such quantities shall be subject to a [***] percent ([***]%) discount off the Purchase Price.”
		

		
			 
		

			
	
			
				 3.2
			Section 6.2,  as amended by the Second Amendment, shall be amended and replaced with the following:

		
			

		 

		

			3

		

		

		
			 
		

		
			 
		

		
			“6.2Payment.    MannKind shall pay Amphastar for the Product within thirty (30) days from the shipment date of the Product.  Notwithstanding anything to the contrary, in no event shall any of the Quarterly payments set forth in the table above [Section 6.1 of the Agreement] be payable to Amphastar later than fifteen (15) days after the close of the corresponding Quarter.  Amphastar shall submit an invoice electronically to MannKind, Attention: Account Payable, ap@mannkindcorp.com. If any portion of an invoice is disputed then MannKind shall pay the undisputed amount and the Parties shall use good faith efforts to reconcile the disputed amount as soon as practicable.”    
		

			
	
			
				 3.3
			The following sentence in Section 5.1 of the Agreement,  as amended in the Second Amendment:

		
			“In calendar year 2017 and 2018, upon delivery to MannKind, Amphastar shall ensure that Product will have a remaining expiry date of not less than two (2) years. In calendar year 2019 and the remainder of the term of the Agreement, Amphastar shall ensure Product will have a remaining expiry date of not less than three (3) years.”   
		

		
			is amended and replaced in its entirety with the following:
		

		
			“In calendar years 2019, 2020, and 2021, upon delivery to MannKind, Amphastar shall ensure that Product will have a remaining expiry date of not less than three (3) years. In calendar years 2022 and 2023, upon delivery to MannKind, Amphastar shall ensure that Product will have a remaining expiry date of not less than two (2) years. In calendar year 2024 and the remainder of the term of the Agreement, Amphastar shall ensure Product will have a remaining expiry date of not less than three (3) years.”   
		

			
	
			
				 3.4
			Section 4.1 of the Agreement is amended and replaced in its entirety with the following:

		
			“4.1Raw Materials.  Amphastar shall be responsible for obtaining, and shall store at no cost to MannKind, any and all materials required for the manufacture of the Product, in reasonable quantities consistent with MannKind’s designated quantities and orders for the Product.  Amphastar shall use and rotate all stock of materials on a first in, first out basis.  Amphastar shall conduct on-site quality audits of its inclusion bodies supplier on a regular basis, but shall not be obligated to conduct more than one (1) such audit every calendar year.  Amphastar represents, and warrants that Amphastar’s long-term supply agreement with Merck Sharpe & Dohme B.V., combined with the alternate source described below, will provide Amphastar with a sufficient supply of inclusion bodies to support Amphastar’s obligations with respect to the Purchase Commitment Quantities and Purchase Price (without resorting to § 6.1(b)) under this Agreement and covenants that during the term of this Agreement Amphastar shall not unreasonably terminate its sources or amend such supply agreement in a manner that would adversely affect Amphastar’s ability to perform its obligations under this Agreement.  If during the term of this Agreement Amphastar intends to qualify an appropriate alternate source of inclusion bodies to supplement or replace its supply from Merck Sharpe & Dohme B.V. then Amphastar must notify MannKind in writing and Amphastar agrees that such change shall not 

		 

		

			4

		

adversely affect Amphastar’s ability to perform its obligations under this Agreement.  For the avoidance of doubt, the Parties agree that Amphastar had notified MannKind on April 24, 2018 that Amphastar intends to qualify an alternate source of inclusion bodies. Both parties shall cooperate diligently and in good faith to obtain any and all necessary approvals for the alternate source of inclusion bodies.  MannKind agrees that Amphastar’s use of an alternate source of inclusion bodies does not change the Purchase Commitments agreed upon in the table of Section 6.1.”
		

			
	
			
				 3.5
			Section 10.1 of the Agreement shall be extended until December 31, 2026.  All other terms and conditions in Section 10.1 shall remain in full force and effect.  

			
	
			
				 4.
			Final Agreement.  From and after the execution of this Fifth Amendment, all references in the Agreement (or in the Fifth Amendment) to “this Agreement,” “hereof,” “herein,” “hereto,” and similar words or phrases shall mean and refer to the Agreement as amended by this Fifth Amendment.  The Agreement as amended by this Fifth Amendment constitutes the entire agreement by and between the Parties as to the subject matter hereof.  Except as expressly modified by this Fifth Amendment, all other terms and conditions of the Agreement shall remain in full force and effect

		
			IN WITNESS WHEREOF, each of MannKind and Amphastar has caused this Fifth Amendment to be executed by their duly authorized officers.
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						MannKind Corporation

					
						 

					
					
						 

					
					
						Amphastar Pharmaceuticals, Inc.

					
						 

				
	
					
						By:

					
					
						/s/ Michael Castagna

					
					
						 

					
					
						By:

					
					
						/s/ Jason Shandell

				
	
					
						Name:

					
					
						Michael Castagna

					
					
						 

					
					
						Name:

					
					
						Jason Shandell

				
	
					
						Title:

					
					
						Chief Executive Officer

					
					
						 

					
					
						Title:

					
					
						President

				

		
			 
		

		
			 
		

		 

		

			5Blueprint

 Exhibit
10.1

Certain identified information has
been excluded from the document because it is both (i) not material
and (ii) would be competitively harmful if publicly
disclosed.

 

 

AMENDED AND RESTATED COLLABORATION AGREEMENT

 

THIS AMENDED AND RESTATED COLLABORATION
AGREEMENT (the “Agreement”) is dated as of June
19, 2019 by and between Checkpoint Therapeutics, Inc., a Delaware
corporation organized having its place of business at 2 Gansevoort
Street, New York, NY 10014 (“CTI”), and TG Therapeutics, Inc.
located at 2 Gansevoort Street, New York, NY 10014
(“TGTX”). CTI,
on the one hand, and TGTX, on the other hand, shall each be
referred to herein as a “Party” or, collectively, as the
“Parties.”

 

RECITALS:

 

WHEREAS, CTI is party to that certain
license agreement (the “License Agreement”) dated March
3, 2015 with Dana Farber Cancer Institute
(“DFCI”);

 

WHEREAS, DFCI is the owner of certain
rights in the DFCI Technology; and

 

WHEREAS, DFCI has licensed rights to the
DFCI Technology to CTI; and

 

WHEREAS, CTI is permitted to extend the
rights granted to it under the DFCI Technology to Affiliates (as
defined in the License Agreement); and

 

WHEREAS, CTI has developed and licensed
the rights to Additional PD-L1 Intellectual Property, including
rights under CTI Patents (as defined, below) and that certain
collaboration agreement (“Collaboration Agreement”)
dated January 22, 2019 with Adimab LLC (“Adimab”), a
true and correct copy of which is attached hereto as Exhibit A;
and

 

WHEREAS, TGTX, an Affiliate of CTI, is
engaged in the research, development, manufacturing and
commercialization of pharmaceutical products, and TGTX is
interested in developing and commercializing products based on the
DFCI Patents and Additional PD-L1 Intellectual Property (together,
the “Licensed Technology”); and

 

WHEREAS, the Parties signed a
Collaboration Agreement (the “Original Agreement”) on March 3,
2015 (the “Effective
Date”), and the Parties wish to amend such Original
Agreement as provided herein; and

 

WHEREAS, CTI desires to continue to
collaborate with TGTX and extend to TGTX the rights granted to it
under the Licensed Technology in order to benefit the public by
disseminating the results of its research via the commercial
development, manufacture, distribution and use of Licensed Products
(as defined below); and

 

WHEREAS, TGTX desires to continue to
collaborate with CTI and to exercise the rights granted to CTI, on
an exclusive basis, so that it can exclusively use, develop and
commercialize the Licensed Technology in and for a defined field of
use; and

 

WHEREAS, in the event TGTX is no longer
an Affiliate of CTI, TGTX and CTI intend for the rights extended to
TGTX hereunder to continue as a Sublicense (as defined in the
License Agreement) as permitted by Section 2.3 of the License
Agreement and Section 3.2(b)(ii) of the Collaboration Agreement
with Adimab.

 

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  “Affiliate”
means a Person or entity 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 1.1, 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 or entity, whether by the ownership of at least 50% of
the voting stock of such entity, or by contract or otherwise. TGTX
and CTI acknowledge and agree that TGTX is an Affiliate of
CTI.

 

1.2 "Antibody"
means any antibody, any gene expressing such an antibody, any
hybridoma producing such antibody, or any fragment, variant,
derivative or construct thereof, or antibody fusion protein
produced therefrom (including PEDgylated or multimeric versions
thereof, whether polyclonal, monoclonal, multi-specific antibodies
(e.g., bi-specific antibodies), human, humanized, chimeric, murine,
synthetic, or from any other source), including without limitation
(a) the full immunoglobin molecules (e.g., the IgG, IgM, IgE, IgA,
and IgD molecules), and (b) the antigen binding portions including
Fab, Fab', F(ab')2, Fv, dAb, and CDR fragments, chimeric
antibodies, diabodies, polypeptides, linear antibodies and
single-chain antibodies (scFv) that contain any portion of an
immunoglobulin that is sufficient to confer specific binding to an
antigen.

 

1.3 “Autoimmune
Diseases” means any disease which results from a loss
of immune tolerance to self-antigens, including without limitation
multiple sclerosis, rheumatoid arthritis, systemic lupus
erythematosus, sjogren syndrome, celiac disease, Graves’
disease, myasthenia gravis, Type I diabetes, idiopathic
thrombocytopenic purpura, pemphigus vulgaris, among others,
including any presentation or manifestation thereof.

 

1.4 “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.

 

1.5 “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.

 

1.6 “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.

 

1.7 “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.

 

1.8 “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.

 

1.9 “Controlled”
means, with respect to (a) DFCI Patents, (b) Know-How,
(c) Antibodies, (d) DFCI Materials, or (e) Additional PD-L1
Intellectual Property, that a Party or one of its Affiliates owns
or has a license or sublicense to such DFCI Patents, Know-How,
Antibodies, DFCI Material (or in the case of DFCI Material, has the
right to physical possession of such material), or Additional PD-L1
Intellectual Property, and has the ability to grant a license or
sublicense to, or assign its right, title and interest in and to,
such DFCI Patents, Know-How, Antibodies, DFCI Material, or
Additional PD-L1 Intellectual Property as provided for in this
Agreement without violating the terms of any agreement or other
arrangement with any Third Party.

 

1.10  “Covered”
means, with respect to a Licensed
Product, that the practicing, manufacturing, importing, using,
selling, or offering for sale of such Licensed Product would, but
for ownership of or a license granted hereunder under Additional
PD-L1 Intellectual Property or DFCI’s relevant DFCI Patents,
infringe a Valid Claim of Additional PD-L1 Intellectual Property or
DFCI’s relevant DFCI Patents in the country in which the
activity occurs (or, in the case of a Valid Claim that has not yet
issued, would infringe such Valid Claim if it were to
issue).

 

 

 

 

1.11 “Derivative"
means a DFCI Antibody that has (a) been modified via isotype
switching; (b) undergone a modification of effector function; (c)
been adapted to enable the antibody to carry payloads; (d) been
altered to change the expression characteristics, stability or
biological half-life of the antibody; or (e) been mutated using an
affinity maturation strategy designed to modify the affinity of
either the variable regions and/or the constant regions of the
antibody for any ligands, antigens or receptors. Derivatives may be
full length antibodies, monoclonal and polyclonal antibodies,
multispecific antibodies (e.g., bi-specific antibodies) and
antibody fragments (including Fab, Fab', F(ab')2, Fy fragments,
diabodies, linear antibodies and single-chain antibodies), in each
case, of any origin, whether human, humanized, chimeric or
otherwise.

 

1.12 “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.

 

1.13 DFCI
Antibodies" means the Antibodies supplied by or on behalf of
DFCI to CTI under this Agreement as identified in Schedule
4.

 

1.14 “DFCI
Know-How” means any and
all Know-How that (a) is Controlled by DFCI or any of its
Affiliates as of the Effective Date and (b) was developed in the
laboratory of Dr. Wayne Marasco in the performance of research
directly pertaining to the DFCI Patents and (c) is necessary for
CTI to research, Develop, manufacture, use, or Commercialize
Licensed Products. The DFCI Know-How is described in
Schedule
2 hereto.

 

1.15   [Reserved]

 

1.16 “DFCI
Patents” means (a) those
patents and patent applications set forth on Schedule 1
hereto; (b) any additions,
divisionals, continuations, conversion, supplemental examinations,
extensions, term restorations, registrations, reinstatements,
amendments, reissuances, corrections, substitutions,
re-examinations, registrations, revalidations, supplementary
protection certificates, renewals, and foreign counterparts of the
patents and patent applications mentioned in clause (a) above; (c)
all patents issuing from any of the patents and patent applications
mentioned in clause (a) or (b) above and any foreign counterparts
of any such patents and patent applications, and which shall
include, in any case, patents surviving post grant review
and inter
partes review.

 

1.17 “DFCI
Technology” means the
DFCI Patents, DFCI Know-How, DFCI Antibodies, Derivatives, and DFCI
Materials.

 

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

 

1.19 “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.

 

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

 

1.21 “Field”
means all prophylactic, palliative,
therapeutic or diagnostic uses in humans or animals for the
prevention, diagnosis and treatment of hematological malignancies,
including, without limitation, all Leukemia’s,
Lymphoma’s, Multiple Myeloma and Waldentroms Macroglobulemia,
but specifically excluding use in chimeric antigen receptor
technology. Additionally, upon exercise of the Autoimmune Option,
the Field shall include the prevention, diagnosis and treatment of
Autoimmune Diseases.

 

1.22 “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 the Field in
such country to a Third Party, by TGTX, by an Affiliate of TGTX or
by a Sublicensee after Regulatory Approval therefor has been
obtained in such country, for cash or non-cash consideration
to which a fair market value can be assigned for purposes of
determining Net Sales.

 

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

 

1.24 “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.

 

 

 

 

1.25 “Know-How”
means any scientific or technical
information, results and data of any type whatsoever, in any
intangible form whatsoever, that is not in the public domain or
otherwise publicly known and is not claimed or disclosed in a
patent or pending patent application, including practices,
protocols, regulatory filings, scientific techniques, works of
authorship, plans, data (including, but not limited to,
pharmacological, biological, chemical, toxicological, clinical and
analytical information, quality control, trial and stability data),
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. 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” excludes Additional PD-L1
Intellectual Property, DFCI Patents, DFCI Antibodies, and DFCI
Materials.

 

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

 

1.27 “Licensed
Product” means any
pharmaceutical product, in any dosage form, preparation,
composition, formulation, presentation or package configuration,
(a) that is Covered in whole or in part by a Valid Claim in the
DFCI Patents or Additional PD-L1 Intellectual Property, (b) that
incorporates, constitutes, or contains DFCI Antibodies or
Derivatives as an active ingredient, or (c) that shares at least [
* ]% of the amino acid sequence identity (combined or in the
aggregate) to all the complementarity determining regions (CDRs) of
any DFCI Antibodies or Derivatives and made using DFCI Technology
or Additional PD-L1 Intellectual Property.

 

1.28 “Licensed
Process” means processes
which, (a) in the course of being practiced, is Covered in
whole or in part by a Valid Claim in the Additional PD-L1
Intellectual Property or DFCI Patents, or (b) which incorporates or
uses DFCI Antibodies or Derivatives in whole or in
part.

 

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 income derived by TGTX
or its Affiliates or Sublicensees to unrelated Third Parties for a
Licensed Product in the Field in bona-fide arms-length
transactions, less the
following deductions, which may not exceed reasonable and customary
amounts in the country in which the transaction occurs:

 

(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, including, without limitation, Medicaid rebates,
institutional rebates or volume discounts;

 

(c) 

Product returns and
allowances;

 

(d) 

Administrative fees
paid to 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 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.

 

(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).

 

No
deduction shall be made for any item of cost incurred by TGTX, its
Affiliates or Sublicensees in Developing or Commercializing
Licensed Products except as permitted pursuant to clauses (a)
through (g) of the foregoing.

 

Net
Sales includes the fair market value of any non-cash consideration
from sale of Licensed Products received by TGTX, its Affiliates or
Sublicenses. Licensed Products are considered “sold”
when billed, invoiced, or payment is received, whichever occurs
first.

 

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 except where such
purchasing party is an end user or consumer of Licensed
Products.

 

 

 

 

Net
Sales of any Combination Product (as defined below) for the purpose
of calculating royalties due under this Agreement shall be
determined on a country-by-country basis as follows:  the Net
Sales of the Combination Product (prior to application of the
following adjustment) shall be multiplied by the fraction A/(A+B),
where A is the net selling price in such country of a Licensed
Product without the additional active ingredient in the Combination
Product, if sold separately for the same dosage as contained in the
Combination Product, and B is the net selling price in such country
of any other active ingredients (or delivery device) in the
combination if sold separately for the same dosage (or form) as
contained in the Combination Product.  All net selling prices
of the elements of such end-user product or service shall be
calculated as the average net selling price of the said elements
during the applicable accounting period for which the Net Sales are
being calculated.  In the event that, in any country, no
separate sale of either such above-designated Licensed Product
(containing only such Licensed Product and no other active
ingredients) or any one or more of the active ingredients included
in such Combination Product are made during the accounting period
in which the sale was made or if the net selling price for an
active ingredient cannot be determined for an accounting
period, Net Sales for
purposes of determining payments under this Agreement shall be
calculated by multiplying the sales price of the Combination
Product by the fraction C/(C+D) where C is the standard
fully-absorbed manufacturing cost of the Licensed Product portion
of the combination, and D is the standard fully-absorbed
manufacturing cost of the other active ingredients or components
included in the Combination Product, as determined by TGTX using
its standard accounting procedures consistently applied. In the
event that the standard fully-absorbed manufacturing cost of the
Licensed Product and/or the other active ingredients or components
included in such Combination Product cannot be determined, Net
Sales allocable to the Licensed Product in each such country shall
be determined by mutual agreement reached in good faith by the
parties prior to the end of the accounting period in question based
on an equitable method of determining same that takes into account,
on a country-by-country basis, all relevant factors (including
variations in potency, the relative contribution of each active
ingredient in the combination, and relative value to the end user
of each active ingredient).

 

1.32  “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.

 

1.33  “Phase I
Trial” means a
clinical trial of a Licensed Product in human patients designated
as a Phase I Trial and conducted primarily for the purpose of
determining the safety of and/or the metabolism and pharmacologic
actions of the Licensed Product in humans, as described under 21
CFR § 312.21(a) (as hereafter modified or amended) and any of
its foreign equivalents. For purposes of this definition, Phase I
Trial shall specifically exclude trials in healthy
volunteers.

 

1.34 “Phase II
Trial” means a clinical
trial of a Licensed Product, designated as a Phase II Trial and the
principal purpose of which is to make a preliminary determination
that such Licensed Product is safe and active in a patient
population for its intended use and is designed to obtain
sufficient information about such Licensed Product’s efficacy
to permit the design of a Phase III Trial(s), and generally
consistent with 21 CFR § 312.21(b). For purposes of this
definition, Phase II trial shall specifically exclude expansion
cohorts from Phase I Trial(s).

 

1.35 “Phase III
Trial” means a clinical trial of a
Licensed Product in human patients, which is designated as a Phase
III Trial or a pivotal trial and is designed (a) to establish
that the Licensed Product is safe and efficacious for its intended
use; (b) to define warnings, precautions and adverse reactions that
are associated with the Licensed Product in the dosage range to be
prescribed; and (c) to be, either by itself or together with
one or more other clinical trials having a comparable design and
size, the final human clinical trial in support of Regulatory
Approval of the Licensed Product, and (d) consistent with 21
CFR § 312.21(c) (as hereafter modified or amended) and any of
its foreign equivalents.

 

1.36 “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.

 

1.37 “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.

 

1.38 “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 (i) twelve (12) years
after First Commercial Sale of the applicable Licensed Product in
such country, or (ii) the expiry of the last-to-expire DFCI Patent
or Additional PDL-1 Intellectual Property containing a Valid Claim
to the Licensed Product in such country.

 

1.39  “Sublicensee”
means a Person, other than an
Affiliate of TGTX, to which TGTX (or its Affiliate) has, pursuant
to Section 2.3, granted sublicense rights under any of the
license rights granted under Section 2.1. “Sublicense”
shall be construed accordingly.

 

1.40  “Sublicense
Revenue" means any payments or other consideration that TGTX
actually receives from a Sublicensee as consideration for the grant
of a Sublicense, including, without limitation, milestone payments,
license fees, license maintenance fees and equity. Sublicense
Revenue excludes (i) purchases of equity or debt of TGTX, (ii)
payments made for TGTX’s performance of any research,
Development, or Commercialization of any Licensed Product, (iii)
(b) royalties on Net Sales (or, in the case of a profit sharing
deal structure, shares of net profits) which are covered in Section
5.9, and (iv) any payment or reimbursement of any costs or expenses
incurred by TGTX for filing, prosecution, maintenance, or defense
of any DFCI Patents or CTI Patents. In the event such consideration
received from a Sublicensee is not cash, Sublicense Revenue shall
be calculated by TGTX based on the fair market value of such
consideration, at the time of the transaction, assuming an
arm’s length transaction made in the ordinary course of
business.

 

1.41 “Tax”
or “Taxes”
means any federal, state, local or
foreign income, gross receipts, license, payroll, employment,
excise, severance, stamp, occupation, premium, windfall profits,
environmental, customs duties, capital stock, franchise, profits,
withholding, social security, unemployment, disability, real
property, personal property, sales, use, transfer, registration,
value added, alternative or add-on minimum, estimated, or other tax
of any kind whatsoever, including any interest, penalty, or
addition thereto, whether disputed or not.

 

 

 

 

1.42 “Third
Party” means any Person
other than Adimab, DFCI, CTI, TGTX, or Affiliates of either of
them, or any Sublicensees.

 

1.43 “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.

 

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

 

1.45 “Valid Claim” means (a) a claim of an issued and
unexpired patent that has not been held permanently revoked,
invalid or unenforceable by a patent office, court or other
governmental agency of competent jurisdiction in a final and
non-appealable judgment (or judgment from which no appeal was taken
within the allowable time period) and that is not admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise
(i.e. only to the extent the subject matter is disclaimed or is
sought to be deleted or amended through reissue or (b) a claim of a
pending patent application within DFCI Patents or Additional PD-L1
Intellectual Property that has not been abandoned, finally rejected
or expired without the possibility of appeal or refiling, provided
that (i) Valid Claim shall exclude any such pending claim in an
application that has not been granted within the latter of five (5)
years after the Effective Date or seven (7) years following the
earliest priority filing date for such application (unless and
until such claim is granted) and (ii) Valid Claim will exclude any
such pending claim that does not have a reasonable bona fide basis
for patentability, in either case of (i) or (ii), unless and until
such claim is granted. Notwithstanding the foregoing, in the event
that a claim in a pending patent application is involved in an
interference action declared by the US Patent and Trademark Office
or any analogous patentability determination by any other national
patent office, and, at the time such proceeding is filed or
initiated such claim is a Valid Claim, the time period set forth in
subsection (i) above will be stayed for the pendency of such
proceeding.

 

1.46 “CTI Patents” means (a) that patent applications set
forth as CTI Patents in Schedule 1 hereto; (b) any additions
divisionals, continuations, conversion, supplemental examinations,
extensions, term restorations, registrations, reinstatements,
amendments, reissuances, corrections, substitutions,
re-examinations, registrations, revalidations, supplementary
protection certificates, renewals, and foreign counterparts of the
patent application mentioned in clause (a) above; (c) all patents
issuing from the patent applications mentioned in clause (a) or (b)
above and any foreign counterparts of any such patents and patent
applications, and which shall include, in any case, patents
surviving post grant review and inter partes
review.

 

1.47 “Marketing
Approval” each means,
within any given country, approval to market a Licensed Product
legally as a drug or biologic, including approval of a Biologic
License Application (as defined in the U.S. Federal Food, Drug and
Cosmetics Act and the regulations promulgated thereunder (21 C.F.R.
§§ 600-680) in the United States, or approval of a
comparable filing in the United States or any other jurisdiction.
Pricing approval need not be obtained in order for Marketing
Approval to be achieved.

 

1.48 “Additional
PD-L1 Intellectual Property” means CTI Patents and any
patents licensed to CTI under the Collaboration Agreement with
Adimab (namely, Adimab Program Antibody Patents and Adimab Platform
Patents).

 

1.49  “Licensed
Patents”
means DFCI Patents, CTI Patents, Adimab Program Antibody Patents
and Adimab Platform Patents.

 

1.50  “Adimab Program Antibody
Patents” means (a) that
patent applications set forth in Schedule 1 hereto; (b) any
additions divisionals, continuations, conversion, supplemental
examinations, extensions, term restorations, registrations,
reinstatements, amendments, reissuances, corrections,
substitutions, re-examinations, registrations, revalidations,
supplementary protection certificates, renewals, and foreign
counterparts of the patent application mentioned in clause (a)
above; (c) all patents issuing from the patent applications
mentioned in clause (a) or (b) above and any foreign counterparts
of any such patents and patent applications, and which shall
include, in any case, patents surviving post grant review
and inter
partes review.

 

1.51 “Adimab Platform
Patents” means (a) that
patent applications set forth in Schedule 1 hereto; (b) any
additions divisionals, continuations, conversion, supplemental
examinations, extensions, term restorations, registrations,
reinstatements, amendments, reissuances, corrections,
substitutions, re-examinations, registrations, revalidations,
supplementary protection certificates, renewals, and foreign
counterparts of the patent application mentioned in clause (a)
above; (c) all patents issuing from the patent applications
mentioned in clause (a) or (b) above and any foreign counterparts
of any such patents and patent applications, and which shall
include, in any case, patents surviving post grant review
and inter
partes review.

 

1.52 CTI
Antibodies" means the Antibodies supplied by or on behalf of
CTI to TGTX under this Agreement as identified in Schedule
3.

 

 

 

 

  ARTICLE
II

 LICENSES
AND OTHER RIGHTS

 

2.1 Grant of License to
TGTX.

 

(a) Subject
to the terms and conditions of this Agreement, the Collaboration
Agreement with Adimab, the excluded rights under Section 3.2(b)(ii)
of the Collaboration Agreement with Adimab, the License Agreement,
and the reserved rights described in Section 2.4 and Section 2.5 of
the License Agreement, effective immediately at the time TGTX is no
longer deemed to be an Affiliate of CTI (following receipt by one
Party of a written notice from the other Party), CTI hereby grants
to TGTX, and TGTX hereby accepts, an exclusive, worldwide,
royalty-bearing right and license (with the right to sublicense,
subject to the provisions of Section 2.3) under the Additional
PD-L1 Intellectual Property and DFCI Patents to (i) research,
Develop, manufacture, have manufactured, use, import and
Commercialize and have Commercialized the Licensed Products, in and
for the Field and (ii) to practice and have practiced any Licensed
Processes, in and for the Field. CTI and its Affiliates grant no
licenses or rights by implication, estoppel or otherwise under any
other patent applications or patents owned in whole or in part by
CTI other than as expressly set forth herein.

 

(b)   Pursuant
to an obligation imposed on a sublicensee under Section 3.2(b)(iii)
of the Collaboration Agreement with Adimab, TGTX, by executing this Agreement,
explicitly agrees to
comply with all applicable terms of the Collaboration Agreement
with Adimab, including Section 9.3 (Commitments Regarding
Program-Benefited Antibodies) thereof.

 

2.2 Affiliates.
Effective immediately at the time TGTX is no longer deemed to be an
Affiliate of CTI (following receipt by one Party of a written
notice from the other Party), TGTX is entitled to extend its
licenses under this Article II to its Affiliates, consistent with
all of the terms and conditions of this Agreement. If TGTX does
extend its license and an Affiliate assumes obligations under the
Agreement, TGTX shall be responsible and liable for the acts or
omissions of the Affiliate in the exercise of rights under this
Agreement. If CTI has a claim arising under this Agreement against
an Affiliate, CTI may seek a remedy directly against TGTX and may,
but is not required to, seek a remedy against the Affiliate. Any
termination of the Agreement under Article X as to TGTX also
constitutes termination as to any Affiliates.

 

2.3 Grant of Sublicenses by
TGTX. Effective immediately at
the time TGTX is no longer deemed to be an Affiliate of CTI
(following receipt by one Party of a written notice from the other
Party), 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; provided, however, that the granting by TGTX of a
Sublicense shall not relieve TGTX of any of its obligations
hereunder; and provided, further, that TGTX’s right to grant
a Person a Sublicense shall be subject to TGTX including within
such Sublicense express provisions binding the Sublicensee to terms
and condition consistent with those contained herein. TGTX shall be
and remain fully responsible and primarily liable for the
compliance by Sublicensees with the terms and conditions of this
Agreement (as applicable to them) as if such Sublicensees were TGTX
hereunder. TGTX shall promptly provide a copy of each executed
sublicense agreement and any modifications of the sublicense
agreement (provided that such copy may be redacted to remove
commercially sensitive terms that are not necessary to confirm
compliance with the terms and conditions of this Agreement)
following execution of such agreement.

2.4 Delivery of DFCI Know-How, DFCI
Antibodies, and CTI Antibodies. Effective immediately at the time TGTX is
no longer deemed to be an Affiliate of CTI, CTI shall deliver to TGTX DFCI Know-How, DFCI
Antibodies, and CTI Antibodies within sixty (60) days of the
Effective Date of this Agreement.

 

2.5 Extension of
Rights. During such time as
TGTX is deemed an Affiliate of CTI, CTI extends to TGTX all of its
rights under the Collaboration Agreement with Adimab (except Adimab
Materials, Optioned Program Antibody Know-How and Program Antibody
Know-How), License Agreement (except CAIX) subject to the terms and
conditions of this Agreement, the Collaboration Agreement
with Adimab and the License Agreement,
provided that such rights shall be limited to the Field and shall
exclude the right to make and have made Licensed Products. TGTX
hereby assumes the obligations of CTI under the Collaboration
Agreement with Adimab and
License Agreement with respect to its exercise of rights
thereunder. Such extension of rights shall automatically terminate
at the time TGTX is no longer deemed to be an Affiliate of CTI. It
is the intention of TGTX and CTI for this Agreement to be
consistent with the Collaboration Agreement with Adimab
and the License Agreement. During the
term of this Agreement, if CTI shall default on any obligations
owed Adimab or DFCI then TGTX shall have the right to cure such
defaults and set any amounts incurred by TGTX in curing such
defaults against any future payments TGTX may owe to
CTI.

 

 

 

 

ARTICLE III

 RIGHTS,
DUTIES AND DILIGENCE

 

3.1 Diligence by TGTX.
TGTX shall use Commercially Reasonable
Efforts to Develop and to Commercialize Licensed Products targeting
PD-L1 and GITR in the Field. The Parties acknowledge that TGTX may
Develop and Commercialize Licensed Products that are a Combination
Product containing one or more DFCI Antibodies, CTI Antibodies, or
Derivatives thereof. Except as otherwise provided herein or agreed
upon in writing, CTI agrees that it will not make, use or sell
Licensed Products in the Field (“Exclusivity
Covenant”). In addition, TGTX shall have the option (the
“Autoimmune Option”) to include Autoimmune Diseases in
the Field by providing notice to CTI and making a $1,000,000
payment. Such Autoimmune Option can be exercised up to 7 years from
the date of the Original Agreement.

 

3.2 Projected
Milestone Dates. TGTX shall use its commercially reasonable
efforts to meet the following milestones (“Milestones”)
by the dates specified in this paragraph, subject to annual
adjustment as described below.

 

For
purposes of this Section 3.2, CTI will consider efforts of an
Affiliate or Sublicensee as efforts of TGTX.

 

(a) Milestone
Dates for a Licensed Product Targeting PD-L1

 

	

Milestone

	

Achievement Date

	

   [ * ] for first
PD-L1 Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first PD-L1 Licensed
Product

	

[ * ] Years from the Effective
Date

 

(b) Milestone
Dates for a Licensed Product Targeting GITR

 

	

Milestone

	

Achievement Date

	

   [ * ] for first
GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] years from the Effective
Date

	

   [ * ] for first GITR Licensed Product

	

[ * ] Years from the Effective
Date

 

 

3.3 Adjustments.
The parties acknowledge that since the program is in early
pre-clinical development that the dates included in the Milestone
table above are rough estimates to provide Adimab, DFCI and CTI a
preliminary projection of what can be achieved by what dates, the
accuracy of which the parties agree is impossible to predict and
will be based on many factors completely outside the control of
TGTX and its Diligence Efforts. On an annual basis, with its report
contained below, TGTX will, in good faith, update the dates in the
Milestones table above to provide CTI an updated assessment of the
timing of the upcoming milestones. Upon providing such update, the
table above shall be deemed amended notwithstanding Section 11.5
hereof.

 

3.4 Development
and Commercialization Reports. Within 50 days of the
Effective Date and at least 10 days before each anniversary of the
Effective Date, TGTX shall provide to CTI a written report
describing the efforts by TGTX, or any Affiliates or Sublicensees,
to bring one or more Licensed Products to the marketplace. The
report must be in sufficient detail to permit CTI to monitor
TGTX’ compliance with the due diligence provisions of this
Agreement.

 

TGTX
shall include at least the following in these reports: (a) a
summary of TGTX’ progress toward meeting the goals and
objectives that had been established for the previous year; (b) a
summary of TGTX’ goals and objectives for the ensuing year
for developing and commercializing Licensed Products, including an
identification of Licensed Products that TGTX intends to develop,
if any; and (c) to the extent not covered by the foregoing, a
summary of TGTX’ progress in meeting the Milestone timelines
above.

 

If
multiple technologies are covered by this Agreement, the progress
report must provide the information set forth above for each
Licensed Product.

 

 

 

 

3.5 Failure
to Perform. TGTX’s failure to use commercially
reasonable efforts to perform any due diligence requirement
provided in Section 3.1 through 3.4 is grounds for CTI to terminate
this Agreement according to Section 10.2(d); provided that CTI
shall only have the right to terminate this Agreement with respect
to the specific Licensed Product for which such failure is claimed
and the Agreement shall remain in full force and effect for the
remaining Licensed Products. In the alternative, CTI may terminate
the Exclusivity Covenant (if such failure occurs while TGTX is an
Affiliate of CTI) or convert the exclusive licenses granted under
this Agreement to a non-exclusive license (if such failure occurs
after the time TGTX ceases to be an Affiliate of CTI), as further
provided in Section 3.6, as to the specific Licensed Product for
which such failure is claimed.

 

3.6 Conversion
to Non-exclusive License. If (i) the Exclusivity Covenant is
terminated as provided in Section 3.5 or (ii) the exclusive license
granted under this Agreement is converted to a non-exclusive
license for any Licensed Product as provided in Section 3.5, this
Agreement is automatically amended as follows as it relates to such
Licensed Product; (a) the exclusive license of Section 2.1 becomes
a non-exclusive license, (b) TGTX loses the right to grant
sublicenses under Section 2.3; provided that any sublicense granted
prior to such conversion shall continue and not be affected by such
conversion, (c) the obligations of Sections 3.1 through 3.4
continue to apply, (d) the obligation under Section 3.10 no longer
applies, (e) TGTX has no further rights or obligations under
Article VI; provided that CTI shall keep TGTX apprised of any new
filings of patent applications and issuance of patents that fall
within the DFCI Patents, and (f) CTI has the sole right to pursue
apparent infringements and the terms of Article VI no longer
apply.

 

3.7 Costs
and Expenses. As between CTI and TGTX, (a) TGTX shall be
solely responsible for all costs and expenses related to
Development, and Commercialization of the Licensed Products,
including without limitation costs and expenses associated with all
preclinical activities and clinical trials, and all regulatory
filings and administrative proceedings relating to Licensed
Products in the Field and (b) CTI shall be the sole and exclusive
manufacturer of Licensed Products for TGTX and its Affiliates and
Sublicensees, such that TGTX and its Affiliates and Sublicensees
shall purchase all of its requirements of Licensed Products from
CTI and will not make or have made Licensed Products directly or
through its Affiliates or Sublicensees unless CTI is unable to
provide sufficient supplies at competitive prices, the terms of
which shall be negotiated in a manufacturing and supply agreement.
In such case, TGTX may manufacture Licensed Products provided TGTX
obtains all necessary licensing rights for such manufacture. TGTX
shall be solely responsible for the costs of such additional
licenses to manufacture Licensed Products. With the exception of
the above, CTI shall be solely responsible for all costs and
expenses related to CMC including without limitation, CMC
development and scale-up, CMC validation, analytical method
development and validation, stability testing, manufacturing,
finishing and release. TGTX shall reimburse CTI for CTI’s
out-of-pocket cost for Licensed Product used by TGTX for its
Development activities and shall pay CTI a manufacturing transfer
price for Commercial supplies equal to CTI’s out-of-pocket
cost of Licensed Product plus the lesser of: (a) 30% of such cost
and (b) 3% of Net Sales generated by the materials supplied The
Parties agree to execute a manufacturing and supply agreement
within a reasonable time after the execution of the Agreement on
these terms and including such other customary and reasonable
terms.

 

3.8 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 Additional
PD-L1 Intellectual Property and DFCI Patents.

 

3.9 Trademarks. As between TGTX and CTI, TGTX shall have the
sole authority to select trademarks for Licensed Products and shall
own all such trademarks. CTI does not grant TGTX the right to use
any trademarks of CTI, Adimab, DFCI or its respective
Affiliates.

 

3.10 U.S.
Manufacture. To the extent TGTX manufactures Licensed
Products (e.g. if TGTX and CTI agree that CTI will no longer be the
sole manufacturer of Licensed Products), TGTX shall manufacture
Licensed Products leased, used or sold in the United States
substantially in the United States as required by 35 U.S.C. 204 and
37 C.F.R. 401 et. seq., as amended. TGTX shall also require any
Affiliate(s) or Sublicensee(s) to comply with this U.S. manufacture
requirement. Notwithstanding the foregoing, if TGTX or its
Affiliate(s) or Sublicensee(s) determines that it is not
commercially feasible or reasonable to manufacture such Licensed
Products in the United States or determines that it is necessary to
have additional manufacturers outside the United States for back-up
supply or to supply Licensed Products outside the United States,
then CTI agrees to make reasonable efforts to assist TGTX, or its
Affiliate(s) or Sublicensee(s), as applicable, at TGTX’
expense, in obtaining any necessary permission from the appropriate
government authorities to manufacture such Licensed Products
outside the United States.

 

3.11 Other
Government Laws. TGTX shall comply with, and ensure that its
Affiliates and Sublicensees comply with, all government statutes
and regulations that relate to Licensed Products. These include but
are not limited to FDA statutes and regulations, the Export
Administration Act of 1979, as amended, codified in 50 App. U.S.C.
2041 et seq. and the regulations promulgated thereunder or other
applicable export statutes or regulations.

 

3.12 Publicity.
TGTX, its Affiliate and Sublicensees are not permitted to use the
names of CTI, DFCI, its related entities or its employees, or any
adaptations thereof, in any advertising, promotional or sales
literature, or in any securities report required by the Securities
and Exchange Commission (except as required by law), without the
prior written consent of CTI, Adimab and/or DFCI in each case.
However, TGTX may (a) refer to publications in the scientific
literature by employees of Adimab, DFCI, or CTI or (b) state that a
license from Adimab, DFCI, or CTI has been granted as provided in
this Agreement.

 

3.13 Other
Agreements. In the event that TGTX determines to conduct a
clinical trial of a Licensed Product in the Field in the United
States, TGTX shall consider in good faith and discuss with DFCI the
potential of engaging DFCI to serve as a clinical site for such
clinical trial; provided that (a) DFCI has the appropriate
expertise and patient population to conduct the clinical trial, and
(b) DFCI is economically competitive with other sites having
substantially similar expertise and patient populations to conduct
such clinical trial.

 

 

 

 

 

ARTICLE IV

 REGULATORY
MATTERS

 

4.1 Regulatory Filings.
As between CTI and TGTX, TGTX (or its
applicable Affiliate) shall own and maintain all regulatory filings
made after the Effective Date for Licensed Products and all
Regulatory Approvals for Licensed Products. Once per year,
representatives from CTI may visit TGTX and review all such
regulatory filings, provided such representatives do not have a
conflict of interest or involvement with any competitive companies
or technologies and agree to TGTX’s confidentiality
agreement.

 

ARTICLE
V

FINANCIAL
PROVISIONS

5.1 Upfront Fee. Upon the signing of the Original Agreement, TGTX
paid CTI an up-front, non-creditable, non-refundable fee in the
amount of Five Hundred Thousand Dollars ($500,000). Upon the
signing of this Agreement, TGTX shall pay CTI a non-creditable,
non-refundable fee in the amount of One Million Dollars
($1,000,000).

 

5.2 Maintenance
Fee. Within thirty (30) days
following the second anniversary of the Effective Date and each
anniversary thereafter, TGTX shall pay CTI an annual license
maintenance fee in the amount of [ * ] Dollars
($[ * ]). Such fees are
creditable against milestone payments due pursuant to Section 5.6,
royalties due pursuant to Section 5.7 or Sublicense Revenue Share
Payments (as defined in Section 5.9).

 

5.3 Reserved.

 

5.4 Milestone Payments.

 

(a) PD-L1-based
Milestones. As further partial
consideration for CTI’s grant of the rights to TGTX
hereunder, TGTX shall pay to CTI the following one-time, PD-L1
targeting product-based milestone payments with regard to each
Licensed Product targeting PD-L1 (as specifically set forth below).
TGTX will pay the relevant milestone payment within thirty (30)
days of such achievement.

 

	

PD-L1 Targeting Product-based Milestone Events

	

Milestone Payment

	
 
[ *
]*

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

 

* 

[ * ].

 

If
a later-stage PD-L1 targeting product-based clinical milestone
event is achieved for any Licensed Product targeting PD-L1 without
one or more earlier-stage clinical milestone events having been
achieved for that Licensed Product, then TGTX shall pay the PD-L1
Milestone Payment(s) for such previous clinical milestone event(s)
along with the payment for the most recently achieved milestone
event. If a milestone event related to [ * ] is achieved without
one or more of the clinical milestone events being achieved, then
TGTX shall pay the PD-L1 Milestone Payment(s) for such previous
clinical milestone event(s) along with the payment for the first
milestone event related to [ * ].

 

(b) GITR-based
Milestones. As further partial
consideration for CTI’s grant of the rights to TGTX
hereunder, TGTX shall pay to CTI the following one-time, GITR
targeting product-based milestone payments with regard to each
Licensed Product targeting GITR (as specifically set forth below).
TGTX will pay the relevant milestone payment within thirty (30)
days of such achievement.

 

	

GITR Targeting Product-based Milestone Events

	

Milestone Payment

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

	

[ *
]

	

$[ *
]

 

 

 

 

(c) Combination
Approval Milestones. If any of
the above milestones in (a) and (b) are triggered as a result of a
combination approval of two or more Licensed Products or
combination clinical trial of two or more Licensed Products, only
one milestone payment (the higher payment) shall be due to CTI as
if the combination was a single Licensed
Product.

 

(d) Aggregate
Net Sales Achievement Milestones: As further consideration for CTI’s grant of
the rights to TGTX hereunder, TGTX shall pay to CTI the following
one-time milestone payments upon first achievement of worldwide Net
Sales (as specifically set forth below) by TGTX and its Affiliates
and Sublicensees. TGTX will pay the relevant milestone payment
within 90 days of such achievement.

 

 

	

Aggregate Net Sales Achievement Milestones

	
 

	

The first time aggregate worldwide Net Sales for all Licensed
Products exceeds $[ * ] in any
Calendar Year

	

$[ *
]

	

The first time aggregate worldwide Net Sales for all Licensed
Products exceeds $[ * ] in any
Calendar Year

	

$[ *
]

	

The first time aggregate worldwide Net Sales for all Licensed
Products exceeds $[ * ] in any
Calendar Year

	

$[ *
]

	

The first time aggregate worldwide Net Sales for all Licensed
Products exceeds $[ * ] in any
Calendar Year

	

$[ *
]

 

5.5 Royalty, Etc. Payments for
Licensed Products.

 

(a) With
respect to Net Sales of all Licensed Products: As further
consideration for CTI’s grant of the rights to TGTX
hereunder, TGTX shall pay to CTI a royalty of on aggregate annual
worldwide Net Sales of all such Licensed Products by TGTX and its
Affiliates and Sublicensees (but excluding Net Sales of a given
Licensed Product after its applicable Royalty Term) at the
percentage rates set forth below:

 

	

Annual Worldwide Net Sales of All Licensed Products per Calendar
Year (US Dollars)

	

Incremental Royalty Rate

	

For Net
Sales of such Licensed Products from $0 up to and including
$[ * ]

	

[ * ]%

	

For
that portion of Net Sales of such Licensed Products that is greater
than $[ * ]

	

[ * ]%

 

(b) In
no event shall the manufacture of a Licensed Product give rise to a
royalty/payment in the nature of royalties obligation until the
particular unit of Licensed Product is sold; but if Net Sales of a
particular unit of Licensed Product might or might not be subject
to a royalty/payment in the nature of royalties payment (e.g.,
manufactured in Country A where the Royalty Term has expired but
sold in Country B where the Royalty Term has not expired), the sale
shall be deemed to be subject to a royalty/payment in the nature of
royalties payment. For clarity, TGTX’s obligation to pay
royalties to CTI under Section 5.7(a) is imposed only once with
respect to the same unit of Licensed Product regardless of the
number of DFCI Patents pertaining thereto or the number of times
such Licensed Product has been sold or transferred to a
Person.

 

(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,
and perpetual.

 

(d) Reserved.

 

(e) Reserved.

 

(f) In
the event that a Licensed Product in a country is not Covered by a
Valid Claim of a Licensed Patent, royalties with respect to such
Licensed Product in such country shall be reduced by [ *
] percent ([ * ]%) of the applicable royalty rate as set forth in
Section 5.5(a) and shall be due for the period commencing with the
First Commercial Sale of such Licensed Product in such country and
ending ten (10) years from date of such First Commercial
Sale.

 

(g) Notwithstanding
the above, in no event shall the royalty rates set forth in Section
5.7(a) be reduced under 5.7(d), (e), and (f) above by more
than [ * ]%
collectively.

 

5.6 Timing of Royalty
Payment. Royalties/payments in
the nature of royalties payable under Section 5.5 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 80 days after the end of
each Calendar Quarter during which the royalty/payment in the
nature of royalties obligation accrued; provided that within 40
days after the conclusion of each Calendar Year TGTX shall provide
notice to CTI 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 50-day period shall not impact
the right of TGTX to credit any over-payments discovered during an
audit against future royalties due under Section 5.5
hereof.

 

 

 

 

5.7 Sublicense
Revenue. TGTX shall pay to
CTI [ * ] percent
([ * ]%) of all Sublicense
Revenue received by TGTX (“Sublicense Revenue Share
Payments”).
Sublicense Revenue Share Payments
shall be paid, on a Calendar Quarter basis, within 80 days after
the end of each Calendar Quarter during which the respective
Sublicense Revenue is received.

 

5.8 Royalty Reports and Records
Retention. Within 50 days after
the end of each Calendar Quarter during which Licensed Products
have been sold, TGTX shall deliver to CTI, together with the
applicable royalty/payment in the nature of royalties payment due,
a written report, on a Licensed Product-by-Licensed Product (and
specifying non-Covered status, as applicable) and
country-by-country basis, of (a) (a)Number of Licensed Products
manufactured and sold by TGTX, and any Affiliates or Sublicensees,
in each country; (b) 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
(and, if non-Covered, subject to royalty/payment in the nature of
royalties payments for such Calendar Quarter), (c) amounts deducted
by category (following the definition of Net Sales) from such gross
invoiced amounts to calculate Net Sales, (d) Net Sales subject to
royalty or royalty/payment in the nature of royalties payments for
such Calendar Quarter and Calendar Year to date, and (e) the
corresponding royalty or royalty/payment in the nature of
royalties, and (f) the nature and amount of Sublicense Revenue
received by TGTX. Such report shall be deemed “Confidential
Information” of TGTX subject to the obligations of Article
VII of this Agreement. For three 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.

 

5.9 CTI
shall be solely responsible for paying directly to DFCI all
payments due to DFCI under Section 5 of the License Agreement that
arise out of the exercise of rights by TGTX under this Agreement,
including, without limitation, royalties on TGTX’s Net Sales.
Likewise, CTI shall be solely responsible for paying directly to
Adimab all payments due to Adimab under Section 4 of the
Collaboration Agreement with Adimab that arise out of the exercise
of rights by TGTX under this Agreement, including, without
limitation, royalties on TGTX’s Net Sales.

 

5.10 Reserved.

 

5.11 Books and
Audits.

 

            TGTX shall
keep, and shall require its Affiliates and Sublicensees to keep,
true books of account containing an accurate record (together with
supporting documentation) of all data necessary for determining the
amounts payable to CTI. TGTX shall keep it records at its principal
place of business or the principal place of business of the
appropriate division of TGTX to which this Agreement relates and
shall require its Affiliates and Sublicenses to keep their books
and records in the same manner.

 

(a) Commencing
on the earlier of (i) the First Commercial Sale (of the first
Licensed Product to have a First Commercial Sale) or (ii) receipt
of Sublicense Revenue, and continuing until one Calendar Year after
the conclusion of the final Royalty Term, upon the written request
of CTI, and not more than once in each Calendar Year, TGTX shall
permit, shall cause its Affiliates to permit, an independent
certified public accounting firm of nationally recognized standing
selected by CTI (who has not been engaged by CTI to provide
services in any other capacity at any time during the three-year
period before such selection), and reasonably acceptable to TGTX or
such Affiliate, to have access to and to review, during normal
business hours upon reasonable prior written notice, the applicable
records of TGTX and its Affiliates to verify the accuracy of the
royalty payments and Sublicense Revenue Share Payments. Such review
may cover: (i) the records for the Calendar Year ending not more
than three 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 amounts were owed
during such period, TGTX shall pay the additional royalties and/or
royalties/payment in the nature of royalties within 15 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. 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 may initiate a court action to seek to recover
the additional payment or to increase the amount of credit or
reimbursement. CTI shall pay for the cost of any audit by CTI,
unless TGTX has underpaid CTI by 5% or more for a specific royalty
period, in which case TGTX shall pay for the reasonable costs of
audit, as well as any additional sum that would have been payable
to CTI had the TGTX reported correctly, plus interest as set forth
in Section 4.14.

 

(c) Each
Party shall treat all information that it receives under this
Section 5.10 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.

 

 

 

 

5.12 Mode of Payment and
Currency. All payments to CTI
under this Agreement, whether or not in respect of Net Sales or
milestone events, shall be made by deposit of US Dollars in the
requisite amount to the following, which CTI may from time to time
amend by advance written notice to TGTX.

 

by
check:

 

Checkpoint
Therapeutics, Inc.

2
Gansevoort Street

New
York, NY 10014

 

    by
wire transfer:

 

[To be
provided]

 

 

            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.

 

5.13 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 plus 300 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.
Waiver or deferral by CTI of any payment owed under any paragraph
under this Article V may not be construed as a waiver or deferral
of any subsequent payment owed by TGTX to CTI.

 

5.14 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 CTI’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 CTI under this Agreement. To the extent TGTX is required to
withhold taxes on any payment to CTI, TGTX shall pay the amounts of
such taxes to the proper governmental authority in a timely manner
and promptly transmit to CTI official receipts issued by the
appropriate taxing authority and/or an official tax certificate, or
such other evidence as CTI may reasonably request, to establish
that such taxes have been paid. CTI 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. CTI shall use Commercially
Reasonable Efforts to provide any such tax forms to TGTX at least
45 days before the due date for any payment for which CTI 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. CTI
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 CTI) to withhold or by reduction
(at the express request of CTI) in its
withholding.

 

5.15 Currency
Conversion. If any currency conversion is required in
connection with any payment owed to CTI, the conversion will be
made at the buying rate for the transfer of such other currency as
quoted by the Wall Street Journal on the last business day of the
applicable accounting period in the case of any payment payable
with respect to a specified accounting period or, in the case of
any other payment, the last business day before the date the
payment is due.

 

 

 

 

 ARTICLE
VI

 PATENTS

 

6.1 Patent
Prosecution and Maintenance.

 

(a) DFCI
Patents and Additional PD-L1 Intellectual
Property. TGTX shall reimburse
CTI for [ *
]% of the patent expenses
incurred under the License Agreement and incurred for the filing,
maintenance and prosecution of patents included in
Additional PD-L1
Intellectual Property for which
CTI is responsible.

 

(b) New
or Revised Applications. CTI
will, upon learning from DFCI of an intention to file or revise one
or more patent applications which are DFCI Patents subject to the
License grant in Article II, promptly inform TGTX of such
intention, and will provide TGTX with the opportunity to comment on
the content of such DFCI patent application before CTI sends
comments to DFCI on such filing. CTI shall include any such
reasonable TGTX comments in the comments to be sent to DFCI. CTI
will inform TGTX of CTI’s intention to file or revise one or
more patent applications which are included in Additional PD-L1 Intellectual
Property for which CTI is
responsible subject to the
License grant in Article II and will provide TGTX with the
opportunity to comment on the content of such one or more patent
applications. CTI shall take into account any such reasonable TGTX
comments.

 

(c) Liaising.
CTI shall keep TGTX promptly and
regularly informed of the course of the filing and prosecution of
DFCI Patents and patents included in Additional PD-L1
Intellectual Property for which CTI is responsible or related proceedings (e.g., interferences,
oppositions, reexaminations, reissues, revocations or
nullifications) in a timely manner, and to reasonably take into
consideration the advice and recommendations of
TGTX.

 

(d) Election
Not to File/Prosecute/Maintain DFCI Patents and Patents Included
in Additional
PD-L1 Intellectual Property for which CTI is
Responsible. TGTX acknowledges and agrees that CTI and DFCI
shall not be required to file, prosecute or maintain patents
included in Additional PD-L1 Intellectual
Property for which CTI is
responsible and DFCI Patents, respectively, provided, however, if
DFCI decides to not pursue or maintain any such DFCI Patents then
CTI shall promptly notify TGTX so the Parties can determine if they
would like to assume responsibility for such activities in
DFCI’s name but at the Parties expense. The same notice
applies to any decision made by CTI to drop a case included
in Additional
PD-L1 Intellectual Property for which CTI is
responsible. In either event,
TGTX will no longer owe any royalty obligation on account of such
(country-level) DFCI Patents or patents included in
Additional PD-L1
Intellectual Property for which
CTI is responsible assumed by the Parties or TGTX, as the case
might be. Similarly, to the extent CTI does not want to continue
funding the patent costs of any portion of DFCI Patents, CTI will
notify TGTX and give TGTX an opportunity to assume responsibility
for such Patents at TGTX’s expense, in which case TGTX shall
owe DFCI directly the royalties due under the License Agreement and
shall no longer owe royalty obligation to CTI on account of such
(country-level) DFCI Patents assumed by TGTX. The Parties
acknowledge that if neither CTI nor TGTX continues funding patent
costs then such portion of DFCI Patents will no longer be included
as DFCI Patents. The same course of action will be followed by the
Parties in connection with patents included in Additional PD-L1 Intellectual
Property for which CTI is
responsible.

 

6.2 Certification under Drug Price
Competition and Patent Restoration Act. Each of TGTX and CTI shall provide within a
reasonable time 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 DFCI Patents covering 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.
To the extent a DFCI Patent and/or
a patent included in
Additional PD-L1 Intellectual Property is
applicable in support of a label associated with an approval to
market a Licensed Product, TGTX shall have the sole right to
determine which of such DFCI Patents and/or a patents included in Additional PD-L1
Intellectual Property, 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, any equivalent publication for biologics, or
any successor Law in the United States, together with any
comparable Laws in any other country. CTI will co-operate with TGTX
to list any of said DFCI Patents and patents included in Additional PD-L1
Intellectual Property.

 

 

 

 

6.4 Enforcement
of Patents.

 

(a) Notice.
If either TGTX or CTI believes that a
Licensed Patent is being infringed in the Field by a Third Party or
if a Third Party claims that any Licensed 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) Action
by DFCI.

 

(i) Procedure.
TGTX acknowledges that DFCI is
responsible for enforcing its DFCI Patents and prosecuting apparent
infringers when, in DFCI’s judgment, such action may be
reasonably necessary and justified. TGTX may request that CTI
request DFCI to take steps to protect the DFCI Patents from an
apparent infringement. However, TGTX recognizes that before DFCI
must respond to the request, TGTX shall supply CTI to provide to
DFCI (i) an opinion of qualified legal counsel demonstrating to
DFCI's reasonable satisfaction that an infringement of the DFCI
Patents exists in a particular country and (ii) with written
evidence demonstrating to DFCI’s reasonable satisfaction that
a Substantial Infringement of the DFCI Patents exists in a
particular country (“Substantial
Infringer”).

 

(ii) DFCI
has three months from the date of receiving satisfactory written
evidence from CTI of a Substantial Infringement to decide whether
it will seek to terminate the Substantial Infringement. DFCI shall
give CTI notice of its decision by the end of this three-month
period, which CTI shall promptly forward to TGTX. If DFCI notifies
CTI that it intends to prosecute the alleged infringer, then DFCI
has six (6) months from the date of its notice to CTI to either (a)
cause the Substantial Infringement to terminate or (b) initiate
legal proceedings against the infringer. If any such suit is
brought by DFCI in its own name, or jointly with CTI if required by
law, it will be at DFCI’s expense and on its own behalf, but
DFCI shall not be obligated to bring more than one such suit at a
time.

 

(iii) CTI’s
Right to Join. If CTI shall
exercise its rights to join any legal proceeding brought by DFCI
under Section 6.4 of the License Agreement, then TGTX shall have
the right to join CTI under the same terms and conditions of
paragraph 6.4(b)(iii) of the License Agreement.

 

(c) Action
by CTI and TGTX.

 

(i) Procedure.
If CTI has the right to prosecute a
Substantial Infringement under Section 6.4(c) of the License
Agreement, then CTI shall promptly notify TGTX, and it may initiate
a legal proceeding against the alleged infringer. If CTI decides
that it will not commence any legal proceeding with respect to the
Substantial Infringement, then such right to prosecute a
Substantial Infringement under Section 6.4(c) of the License
Agreement passes to TGTX hereunder.

 

(ii) TGTX’s
Right To Join. TGTX
independently has the right to join any legal proceeding brought by
CTI under this Section 6.4 and fund up to fifty percent of the cost
of the legal proceeding from the date of joining. If TGTX elects to
join as a party plaintiff pursuant to this Section 6.4, TGTX may
jointly participate in the action with CTI, but CTI’s counsel
will be lead counsel.

 

(iii) Reduction
of Royalties. If CTI initiates
legal proceedings under Section 6.4 of the License Agreement and
TGTX joins pursuant to this Section 6.4, then TGTX shall have the
same rights as CTI has under Section 6.4(c)(iii) of the License
Agreement. Additionally, if TGTX prosecutes pursuant Section 6.4(i)
of this Agreement after CTI decides not to prosecute and neither
DFCI nor CTI independently (except as a necessary party) join the
proceeding, then TGTX may deduct up to [ * ] percent ([ * ]%) of TGTX’s documented costs
and expenses of the proceeding (including reasonable attorney fees)
from running and minimum royalties payable to CTI under Section
5.7(a) of this Agreement from sales of Licensed Products covered by
the patent(s)-in suit. However, TGTX may not reduce CTI’s
royalty payments by more than fifty percent of the amount otherwise
due under Article V. If [ * ] percent ([ * ]%) of TGTX’s costs and
expenses exceed the amount of royalties deducted by TGTX for any
calendar year, TGTX may, to that extent, reduce the royalties due
to CTI in succeeding calendar quarters for so long as TGTX is
actively engaged in legal proceedings to terminate the Substantial
Infringement. However, TGTX may not reduce total royalties due to
CTI in a given calendar quarter by more than [ *
] percent ([ * ]%). TGTX’s right to reduce
royalty payments to CTI under this paragraph 6.4(c)(iii) applies
only for so long as the Substantial Infringement
continues.

 

(iv) Settlement.
Regardless of whether CTI or DFCI is
joined or joins any legal proceeding initiated by
TGTX,
TGTX acknowledges and agrees that no
settlement, consent judgment or other voluntary final disposition
of the legal proceeding may be entered into without the consent of
DFCI and CTI.

 

 

 

 

6.5 Cooperation.
If one party
initiates legal proceedings to enforce the DFCI Patents pursuant to
this Article VI, the other party shall cooperate with and supply
all assistance reasonably requested by the party initiating the
proceedings, at the initiating party’s request and
expense.

 

6.6 Distribution of Amounts Paid by
Third Parties. Any amounts
recovered by the Party initiating an Action pursuant to this
Section 6.6, whether by settlement or judgment, shall be allocated
in the following order: to reimburse the Parties for all
out-of-pocket costs and expenses incurred in connection therewith,
including attorneys’ fees. If such recovery is insufficient
to cover all such costs and expenses of both Parties, it will be
shared pro-rata in proportion to the relative amount of such costs
and expenses incurred by each Party. If after such reimbursement
any funds remain from such damages, the remaining amount of such
recovery shall be allocated as follows: the portion thereof
attributable to “lost sales” in the Field shall be
retained by TGTX and 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 CTI a royalty on such portion based on the
royalty rates set forth in Section 5.7(a), and the portion thereof
not attributable to “lost sales” and is not allocated
to DFCI under Section 6.6 of the License Agreement shall be
allocated 50%
to TGTX and 50% to CTI.

 

6.7 Declaratory Judgment
Actions. In the event that any
third party initiates a declaratory judgment action alleging the
invalidity or unenforceability of the Licensed Patents with respect
to claims relating to the Field, or if any third party brings an
infringement action against TGTX or its Affiliates or Sublicensees
because of the exercise of the rights granted TGTX under this
Agreement, then TGTX shall have the right to defend such action
under its own control and at its own expense; provided, however,
that TGTX acknowledges that DFCI has the right to assume control of
such defense, at its own expense, if such action is directed to a
DFCI Patent and DFCI in good-faith believes that assuming control
of such defense is beneficial to CTI and DFCI. TGTX shall NOT enter
into any settlement, consent judgment or other voluntary final
disposition of any action under this Section 6.7 without the
consent of the other party (the patent owner), which consent shall
not be unreasonably withheld unless the settlement includes any
express or implied admission of liability or wrongdoing on the
other party’s part, in which case the other party’s
right to grant or deny consent is absolute and at its sole
discretion. Any recovery shall be first applied to reimburse each
party pro rata for any out-of-pocket expenses it may have incurred
with respect to defense of such action, and the remainder shall be
retained entirely by the party controlling the action; provided,
however, that any recovery for infringement will be distributed as
described in Section 6.6.

 

 

ARTICLE VII

 CONFIDENTIALITY

 

7.1 Definitions. CTI and TGTX 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
Party 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 30 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. The Parties 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 60 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

 

(d) is
independently developed by an employee of the Receiving Party not
accessing or utilizing the Disclosing Party’s
information.

 

            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. The Parties 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 Release Announcing the
Execution of the License Agreement and Related Disclosures.
Either Party may make an initial press
release announcing the execution of this Agreement, including any
matter covered by this Agreement, and the Development or
Commercialization of Licensed Products, but such Party shall
provide the text of such planned disclosure to the other Party
sufficiently in advance of the scheduled disclosure to afford such
other Party a reasonable opportunity to review and comment upon the
proposed text and the timing of such disclosure, and shall consider
all reasonable comments of the other Party regarding such
disclosure. (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
US national securities exchange or except with the prior express
written permission of such other Party, such permission not to be
unreasonably withheld.)

 

 

 

 

ARTICLE VIII

 REPRESENTATIONS,
WARRANTIES AND COVENANTS

 

8.1 Representations and
Warranties. (a) TGTX represents
and warrants to CTI, and (b) CTI represents 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 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 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 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 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 Reserved.

 

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 Licensed Products can be successfully
Developed or Commercialized.

 

8.4 CTI
MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS
FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK,
SOFTWARE, NON-PUBLIC OR OTHER INFORMATION, DFCI MATERIALS, DFCI
ANTIBODIES, KNOW-HOW, OR TANGIBLE RESEARCH PROPERTY, LICENSED OR
OTHERWISE PROVIDED TO TGTX HEREUNDER AND HEREBY DISCLAIMS THE
SAME.

 

8.5 CTI
DOES NOT WARRANT THE VALIDITY OF THE LICENSED PATENTS LICENSED
HEREUNDER AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE
SCOPE OF THE LICENSED PATENTS OR THAT SUCH LICENSED PATENTS MAY BE
EXPLOITED BY TGTX, AFFILIATE OR SUBLICENSEE WITHOUT INFRINGING
OTHER PATENTS. CTI MAKES NO REPRESENTATION THAT DFCI ANTIBODIES,
CTI ANTIBODIES OR THE METHODS USED IN MAKING OR USING SUCH DFCI
ANTIBODIES OR CTI ANTIBODIES ARE FREE FROM LIABILITY FOR PATENT
INFRINGEMENT.

 

 

 

 

ARTICLE IX

 INDEMNIFICATION;
LIMITATION OF LIABILITY; INSURANCE

 

Indemnification and Defense.

 

9.1 TGTX
shall indemnify, defend and hold harmless (i) DFCI and its trustees
officers, medical and professional staff, employees, and agents and
their respective successors, heirs and assigns and (ii) CTI and its
directors, officers, employees, agents and contractors (the "CTI
Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorneys' fees and expenses of litigation)
incurred by or imposed upon the CTI Indemnitees, or any one of
them, in connection with any claims, suits, actions, demands or
judgments arising out any theory of
product liability ( including but not limited to action in the form
of tort, warranty, strict liability) concerning any product,
process or service relating to, or developed by TGTX, its
Affiliates or Sublicensees pursuant to (a) any right or license
granted under this Agreement or (b) arising out of any other
activities to be carried out by TGTX pursuant to this agreement.
TGTX's indemnification under Section 9.1 does not apply to any
liability, damage, loss or expense to the extent that it is
attributable to (x) the grossly negligent activities of the CTI
Indemnitees, or (y) the intentional wrongdoing or intentional
misconduct of the CTI Indemnitees TGTX shall, at its own expense,
provide attorneys reasonably acceptable to CTI to defend against
any actions brought or filed against any party indemnified
hereunder with respect to the subject of indemnity contained
herein, whether or not such actions are rightfully
brought.

 

9.2 CTI
shall indemnify, defend and hold harmless TGTX and its directors,
officers, employees, agents and contractors (the "TGTX
Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorneys' fees and expenses of litigation)
incurred by or imposed upon the TGTX Indemnitees, or any one of
them, in connection with any claims, suits, actions, demands or
judgments arising out any theory of
product liability ( including but not limited to action in the form
of tort, warranty, strict liability) concerning (a) any product,
process or service relating to, or developed by CTI, its Affiliates
or Sublicensees pursuant to the License Agreement or (b) any other
activities to be carried out by CTI pursuant to this agreement.
CTI's indemnification under Section 9.1 does not apply to any
liability, damage, loss or expense to the extent that it is
attributable to (x) the grossly negligent activities of the TGTX
Indemnitees, or (y) the intentional wrongdoing or intentional
misconduct of the TGTX Indemnitees. CTI shall, at its own expense,
provide attorneys reasonably acceptable to DFCI and TGTX to defend
against any actions brought or filed against any party indemnified
hereunder with respect to the subject of indemnity contained
herein, whether or not such actions are rightfully
brought.

 

9.3 If
any such action is commenced or claim made or threatened against a
DFCI Indemnitee or CTI Indemnitee (collectively,
“Indemnitees”) as to which the other Party (the
“Indemnifying Party”) is obligated to indemnify it
(them) or hold it (them) harmless, the Indemnitee shall promptly
notify Indemnifying Party of such event. Indemnifying Party shall
assume the defense of, and may settle, that part of any such claim
or action commenced or made against an Indemnitee which relates to
the Indemnifying Party’s indemnification and CTI may take
such other steps as may be necessary to protect it. Indemnifying
Party will not be liable to Indemnitees on account of any
settlement of any such claim or litigation affected without
Indemnifying Party’s consent. The right of Indemnifying Party
to assume the defense of any action is limited to that part of the
action commenced against Indemnitees that relates to Indemnifying
Party’s obligation of indemnification and holding
harmless.

 

9.4 TGTX
shall require any Affiliates or Sublicensee(s) to indemnify, hold
harmless and defend DFCI and CTI under the same terms set forth in
Sections 9.1 – 9.4.

 

9.5 Insurance.
At such time as any product, process or service relating to, or
developed pursuant to, this Agreement is being commercially
distributed or sold (other than for the purpose of obtaining
regulatory approvals) by TGTX or by a Sublicensee, Affiliate or
agent of TGTX, TGTX shall, at its sole cost and expense, procure
and maintain policies of commercial general liability insurance in
amounts not less than $2,000,000 per incident and $2,000,000 annual
aggregate and naming the Indemnitees as additional insureds. Such
commercial general liability insurance must provide (a) product
liability coverage and (b) contractual liability coverage for
TGTX's indemnification under Sections 9.1 through 9.5 of this
Agreement. If TGTX elects to self-insure all or part of the limits
described above (including deductibles or retentions which are in
excess of $250,000 annual aggregate), such self-insurance program
must be acceptable to the CTI, DFCI and the DFCI's associated Risk
Management Foundation. The minimum amounts of insurance coverage
required under these provisions may not be construed to create a
limit of TGTX's liability with respect to its indemnification
obligation under Sections 9.1 through 9.5 of this
Agreement.

 

9.6 TGTX
shall provide CTI with written evidence of such insurance upon
request of CTI. TGTX shall provide CTI with written notice at least
fifteen (15) days prior to the cancellation, non-renewal or
material change in such insurance; if TGTX does not obtain
replacement insurance providing comparable coverage within such
fifteen (15) day period, CTI has the right to terminate this
Agreement effective at the end of such fifteen (15) day period
without any notice or additional waiting periods.

 

9.7 TGTX
shall maintain such comprehensive general liability insurance
beyond the expiration or termination of this Agreement during (a)
the period that any product, process, or service, relating to, or
developed pursuant to, this Agreement is being commercially
distributed or sold (other than for the purpose of obtaining
regulatory approvals) by TGTX or by a Sublicensee, Affiliate or
agent of TGTX and (b) a reasonable period after the period referred
to in 9.8 (a) above which in no event shall be less than fifteen
(15) years.

 

9.8 TGTX
shall require any of its Affiliates or Sublicensee(s) to, maintain
insurance in favor of CTI, DFCI and the Indemnitees under the same
terms set forth in Sections 9.5 – 9.7 of this
Agreement.

 

 

 

 

 
ARTICLE
X

 TERM
AND TERMINATION

 

10.1 Term. 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 Licensed Patents have expired or been
invalidated.

 

10.2 Termination
by CTI. CTI has the right to immediately terminate this
Agreement, the extension of rights (if such termination occurs
while TGTX is an Affiliate of CTI), and all licenses granted
hereunder (if such failure occurs after the time TGTX ceases to be
an Affiliate of CTI), or at CTI’s option to convert the
exclusive license granted in Article 2.1 to a non-exclusive license
(if such failure occurs after the time TGTX ceases to be an
Affiliate of CTI) in accordance with Section 3.6, by providing TGTX
with written notice of such, upon the occurrence of any of the
following events.

 

(a) TGTX’s
Board of Director’s has agreed that TGTX will cease to carry
on its business with respect to Licensed Products.

 

(b) TGTX
fails to pay when due any undisputed royalty or other undisputed
payment that has become due and is payable under Article V of this
Agreement and has not cured the default by making the required
payment, together with interest due, within ninety days of
receiving a written notice of default from CTI requesting such
payment.

 

(c) An
officer of TGTX is convicted of a felony relating to the
manufacture, use, sale or importation of Licensed
Products.

 

(d) TGTX
materially breaches any other provision of this Agreement
(including but not limited to due diligence obligations under
Article III and insurance obligations under Section 9.7 –
Section 9.10), unless TGTX has cured the breach within ninety days
of receiving written notice from CTI specifying the nature of the
breach; provided, however, that the due diligence obligations shall
be determined on a Licensed Product by Licensed Product
basis.

 

10.3 Termination for
insolvency. TGTX or CTI may
terminate this Agreement immediately upon written notice, with no
further notice obligation or opportunity to cure, if TGTX or CTI
shall become insolvent, shall make an assignment for the benefit of
creditors, or shall have a petition in bankruptcy filed for or
against it (which is not dismissed within 60 days of such
filing).

 

10.4 Notwithstanding
Sections 10.2 and 10.3, in the event of a good-faith dispute as to
whether any alleged breach, default, failure or any other act or
omission gives rise to a right of termination under this Agreement,
is in fact a breach, default, failure or other act or omission that
gives rise to a right of termination under this Agreement,
termination of this Agreement in respect of such alleged breach,
default, failure or other act or omission shall not take effect
unless and until (y) such dispute is resolved in accordance with
Section 10.7 below in favor of the Party alleging such breach,
default, failure or other act or omission or (z) the
non-terminating Party’s denial that the alleged breach,
default, failure or other act or omissions is in fact a breach,
default, failure or other act or omission giving rise to a right of
termination hereunder ceases to be in good faith.

 

10.5 Termination by TGTX.
TGTX has the right to terminate this
Agreement without cause by giving CTI one hundred and eighty days
prior written notice in whole or on a Licensed Product by Licensed
Product basis. Any milestones achieved by TGTX during this one
hundred and eighty-day period will be due and payable to
CTI.

 

10.6 Effect
of Termination

 

(a) No
release. Upon termination of
this Agreement for any reason, nothing in this Agreement may be
construed to release either party from any obligation that matured
prior to the effective date of the termination.

 

(b) Survival.
The provisions of Section 6.1(a)
(patent expenses) Article V (Financial Provisions), Section 3.1.2
(Publicity –paragraph 10.6(c) (Inventory), Article IX
(Indemnification), Sections 9.7 – 9.10 (Insurance), Article
VIII (Representations and Warranties) and Section 10.7 (Dispute
Resolution) survive termination or expiration of this
Agreement.

 

(c) Inventory.
TGTX, any Affiliate(s) and any
Sublicensees whose sublicenses are not converted as provided in
paragraph 10.6(d) below, may, after the effective date of
termination, sell all Licensed Products that are in inventory as of
the date of written notice of termination, and complete and sell
Licensed Products which the licensed entity(ies) can reasonably
demonstrate were in the process of manufacture as of the date of
written notice of termination, provided that TGTX shall pay to CTI
the royalties thereon as required by Article V and shall submit the
reports required by Section 5.10 on the sales of Licensed
Products.

 

 

 

 

(d) Sublicenses.
Any Sublicenses will terminate
contemporaneously with this Agreement; provided, however, that any
Sublicenses that are not in default under the sublicense agreement
shall, upon DFCI’s and CTI’s written approval, survive
and remain in full force and effect so long as the Sublicensee
agrees to be bound by all of the provisions of this Agreement, if
not otherwise already provided for in the sublicense agreement.
Such approval by DFCI and CTI shall not be unreasonably withheld
and shall not require the payment of additional
consideration.

 

(e) If
(i) this Agreement is in effect at the time of the termination of
the License Agreement and (ii) TGTX is not an Affiliate of CTI at
such time then, upon the written approval by DFCI, this Agreement
survive and remain in full force and TGTX hereby agrees to be bound
by the terms of the License Agreement pursuant to Section 10.6(d)
of the License Agreement. If DFCI does not approve such survival,
then this Agreement shall terminate upon termination of the License
Agreement. Such approval by DFCI shall not be unreasonably withheld
and shall not require the payment of additional
consideration.

(f) Pursuant
to the License Agreement, TGTX is deemed an Affiliate of CTI, and
thus at the time the License Agreement is terminated, this
Agreement shall automatically terminate at such time; provided,
that pursuant to Section 2.5, TGTX shall have the right to cure any
breach and that CTI will not voluntarily terminate the License
Agreement with TGTX’s prior written
consent. 

 

10.7 Dispute
Resolution.

 

(a) Negotiation
between the Parties. The
parties shall first attempt to resolve any controversy that arises
from this Agreement, or claim for breach of the Agreement, by good
faith negotiations, first between their respective business
development representatives and then, if necessary, between senior
representatives for the Parties.

 

(b) Non-Binding
Mediation. If the controversy
or claim cannot be settled through good faith negotiation between
the parties, the parties agree first to try in good faith to settle
their dispute by non-binding mediation under the Mediation Rules of
the American Arbitration Association, before resorting to
arbitration, litigation or other dispute resolution
procedure.

 

 

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 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) TGTX
may not 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 CTI, which consent shall not be unreasonably withheld,
conditioned or delayed; provided that,
notwithstanding the foregoing, TGTX
may, without such consent, assign its rights or licenses and/or
delegate its obligations under this Agreement to (i) an Affiliate
or (ii) a Third Party in connection with a Sale Event (and for the
avoidance of doubt, at such time the extension of rights set forth
in Section 2.5 shall terminate and the licenses granted to TGTX in
Section 2 shall become effective). As a condition to any permitted
assignment hereunder, the assignee must expressly assume, in a
writing delivered to CTI and signed by a duly authorized officer of
the assignee (and in a form reasonably acceptable to CTI) all of
TGTX’s obligations under this Agreement, whether arising
before, at or after the assignment.

 

11.3 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.

 

 

 

 

11.4 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.

 

11.5 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.

 

11.6 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.

 

11.7 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
CTI, addressed to:

 

Checkpoint
Therapeutics, Inc.

2
Gansevoort Street, 9th Floor

New
York, NY 10014

Attention: James F.
Oliviero, CEO

Email:
jfo@checkpointtx.com

 

 

If to
TGTX, addressed to:

 

TG
Therapeutics, Inc.

2
Gansevoort Street, 9th Floor

New
York, NY 10014

Attention: Sean
Power, CFO

Email:
sp@tgtxinc.com

 

 

11.8 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.

 

11.9 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.

 

 

 

 

11.10 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.

 

11.11 Third Party
Beneficiaries. Except for the
rights of Indemnified Parties pursuant to Article IX hereof and the
rights of Sublicensees set forth in Sections 2.3 and 10.6(d), 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 CTI under this Agreement shall only be pursued by
TGTX or such Indemnified Party, and not Sublicensees (except as set
forth in Sections 2.3 and 10.6(d)).

 

11.12 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
CTI or its Affiliates, except by an express license granted
hereunder. No right or license is granted to CTI 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.

 

11.13 No Right of Set-Off.
Except as expressly provided in
Article 5 of this Agreement, TGTX shall not have a right to set-off
any royalties, milestones or other amount due to CTI under this
Agreement against any damages incurred by TGTX for a breach by CTI
of this Agreement.

 

11.14 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.

 

11.15 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.

 

11.16 Construction.
The words “include,”
“includes” and “including” shall be deemed
to be followed by the phrase “without limitation.” All
references herein to Articles, Sections and Schedules shall be
deemed references to Articles and Sections of, and Schedules to,
this Agreement unless the context shall otherwise
require.

 

11.17 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 Amended and Restated Collaboration Agreement to be
executed and delivered by their respective duly authorized officers
as of the day and year first above written.

 

CHECKPOINT THERAPEUTICS, INC.

 

 

 

By: /s/ James
Oliviero                         

Name:
James
Oliviero                         

 

Title:
CEO
               
                 
        

 

 

TG THERAPEUTICS, INC.

 

 

 

By: /s/ Michael S. Weiss
                       

Name:
Michael S. Weiss
                       

 

Title:
CEO

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