Document:

Exhibit 10.2

 

SECOND MODIFICATION
AGREEMENT

 

THIS
SECOND MODIFICATION AGREEMENT, (this “Agreement”), made as of June 29, 2018 (the “Effective Date”),
by and among IPIC-GOLD CLASS ENTERTAINMENT LLC, a Delaware limited liability company (the “Borrower”),
IPIC GOLD CLASS HOLDINGS LLC, a Delaware limited liability company (“Holdings”), IPIC TEXAS, LLC,
a Texas limited liability company (“IPIC Texas”), IPIC MEDIA, LLC, a Florida limited liability company
(“IPIC Media”), DELRAY BEACH HOLDINGS, LLC, a Florida limited liability company (“DB Holdings”),
BAY COLONY REALTY, LLC, a Florida limited liability company (“Bay Colony”, together with Borrower, Holdings,
IPIC Texas, IPIC Media and DB Holdings, collectively, the “Borrower Parties”) and THE TEACHERS’ RETIREMENT
SYSTEM OF ALABAMA, a body corporate of the State of Alabama created under Section 16-25-1 et. seq., Code of Alabama
(1975), as amended (the “TRS”), and THE EMPLOYEES’ RETIREMENT SYSTEM OF ALABAMA, a body corporate of the
State of Alabama created under Section 36-27-1 et. seq., Code of Alabama (1975), as amended (the “ERS”)
(the TRS and the ERS are sometimes herein referred to individually as a “Lender” and collectively as the “Lenders”).

 

RECITALS:

 

A. Borrower
Parties and Lenders are party to that certain Second Amended and Restated Master Loan and Security Agreement dated February 1,
2018, as amended by Modification Agreement dated June 22, 2018 (as previously or hereafter amended, the “Loan Agreement”),
pursuant to which, Lenders have agreed to extend to Borrower a non-revolving credit facility in an aggregate
principal amount not to exceed $225,828,169.12 (the “Loan”) for the purpose of financing the costs of leasing,
constructing, furnishing, equipping, establishing and operating upscale cinema projects to be located at sites in the United States
of America in accordance with the terms of the Loan Agreement. Capitalized terms not otherwise defined herein shall have the
meanings given in the Loan Agreement.

 

B. The
Borrower Parties have requested that proceeds of the Loan be made available for Working Capital Expenses (as hereafter defined),
and, as a condition precedent to allowing proceeds of the Loan to be used for Working Capital Expenses, Lenders require that the
Loan Agreement be modified on the terms and conditions hereafter set forth.

 

AGREEMENT

 

NOW, THEREFORE,
in consideration of the foregoing Recitals and other good and valuable consideration, the parties hereto agree as follows:

 

1. Recitals. The Recitals herein are true and correct.

 

2. Tranche
3 Committed Amount Remaining Availability. Borrower Parties acknowledge and agree that as of June 27, 2018, $120,774,812.30
of the Tranche 3 Committed Amount has been Advanced, leaving $65,225,187.70 available for Advance subject to the terms and conditions
of the Loan Agreement, as modified hereby.

 

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3. Amendments
to Loan Agreement.

 

(a) Definitions.

 

		(i)	The definition of “Required Borrower’s Funds” is hereby deleted in its entirety.

 

		(ii)	The following definitions are hereby added to Section 1.1 of the Loan Agreement:

 

“Delray
Project” means the Project located in the development located at 59-61 SE 4th Avenue, Delray Beach, Florida.

 

“Irvine
Project” means the Project located at 2983 & 2981-E Michelson Drive, Irvine, California. 

 

“Mizner
Park Project” mean the renovations to the existing, operating Project located at 400 N. Federal Hwy., Boca Raton,
Florida 33432. 

 

“Remaining
Construction Projects” means, collectively, the following Projects: the Renovation Projects, the Mizner Park Project,
the Delray Project and the Irvine Project.

 

“Working
Capital Advance Request” shall have the meaning assigned to such term in Section 4.1(o) hereof.

 

“Working
Capital Expenses” means Borrower’s expenses related to day-to-day operations of Borrower, including, without
limitation, rent, payroll, inventory purchases, operational costs, annual routine and customary maintenance costs for each Project
in an aggregate amount of up to $50,000 (any maintenance costs for any Project in excess of such threshold must be approved in
writing by Agent Lender in its sole and absolute discretion), interest expense and construction costs associated with the Remaining
Construction Projects. Notwithstanding the foregoing, Working Capital Expenses do not include (i) any bonuses to employees
of Parent, Borrower or any Borrower Subsidiary or (ii) construction costs associated with any Project that is not a Remaining Construction
Project. 

 

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(b) Repayment
of Loan. Section 2.4(b)(3)(ii) of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu
thereof:

 

(ii) With
respect to the Tranche 3 Committed Amount, being that portion of the outstanding principal balance of the Loan to be Advanced to
Borrower in connection with a Remaining Construction Project or other Working Capital Expenses, interest shall be payable on Advances
of such Tranche 3 Committed Amount on a Project Tranche by Project Tranche basis as follows: (A) with respect to an Advance for
any Remaining Construction Project, on the first Scheduled Interest Payment Date following the earlier to occur of (1) the date
which is six (6) months following the opening or re-opening of a Remaining Construction Project, as applicable, or (2) the date
which is twenty-one (21) months following the initial Advance of the Project Tranche designated for such Remaining Construction
Project, as applicable, and on each Scheduled Interest Payment Date thereafter through and including the Scheduled Interest Payment
Date immediately preceding the Maturity Date, all accrued but unpaid interest on the outstanding principal balance of all
Advances of the Project Tranche designated for such Remaining construction Project shall be due and payable; and (B) with respect
to any Advance for Working Capital Expenses which is not used to construct a Remaining Construction Project, the first Scheduled
Interest Payment Date following such Advance for Working Capital Expenses, and on each Scheduled Interest Payment Date thereafter
through and including the Scheduled Interest Payment Date immediately preceding the Maturity Date, all accrued but unpaid
interest on the outstanding principal balance of all Advances of such Working Capital Expenses shall be due and payable. 

 

(c) Advances
for Project Costs and Working Capital Expenses. Section 3.2(a) of the Loan Agreement is hereby deleted in its entirety
and the following inserted in lieu thereof:

 

(a) Working
Capital Expenses. The parties hereto acknowledge and agree that the remaining proceeds from the Loan not yet Advanced are to
be used for Working Capital Expenses. 

 

(d) Project
Development Budget Review and Revision. Sections 3.3(b) and (c) of the Loan Agreement are hereby deleted in its entirety
and the following inserted in lieu thereof:

 

(b) Other
than the Remaining Construction Projects, proceeds from the Loan shall not be available for the construction of any proposed Project
without the express written consent of Agent Lender, which consent may be withheld in Agent Lender’s sole and absolute discretion.
Subject to the terms and conditions of this Agreement, the total amount of Loan proceeds required by the Project Development Budget
of each Remaining Construction Project may not exceed the lesser of (i) the Available Committed Amount or (ii) one hundred percent
(100%) of the total costs to develop such Remaining Construction Project and do all things necessary for the opening or re-opening,
as applicable, of such Remaining Construction Project, as set forth in the Project Development Budget for such Remaining Construction
Project.

 

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(c) Once
a Project Development Budget for a Remaining Construction Project is approved by Agent Lender, an amount equal to one hundred percent
(100%) of the total remaining costs to develop such Remaining Construction Project as shown on such Project Development Budget
shall constitute the “Project Tranche” applicable thereto. The parties anticipate that changes to Project Development
Budgets may be desired by Borrower in the course of developing the Remaining Construction Projects through reallocations among
line items, cost-savings or cost overruns. Such changes to Project Development Budgets may be made by Borrower with prior notice
to Agent Lender, but without Agent Lender approval or consent as provided in Section 4.1(f) hereof. Notwithstanding the foregoing,
any changes to the amount of a Project Tranche (either increases or decreases) shall be subject to Agent Lender’s prior written
consent, which consent shall not be unreasonably withheld as long as such changes will not result in a negative Remaining Construction
Project Reserve and Agent Lender reasonably believes the new proposed Project Tranche for the Project remains sufficient to permit
the completion of the Project without creating a negative Remaining Construction Project Reserve. In the event the Agent Lender
consents to any modification to a Project Tranche amount, the Remaining Construction Project Reserve will be adjusted upward or
downward accordingly; provided, at no time shall the Remaining Construction Project Reserve exceed the Available Committed Amount
(calculation of the Available Committed Amount shall not include the Interest Reserve). To the extent that Project Development
Budget changes by Borrower result in increased Project costs for which there is no Available Committed Amount sufficient to permit
such an increase in the Project Tranche, Borrower shall be responsible for paying the full amount of such Deficiency from Borrower’s
own funds, as hereinafter provided. To the extent an approved modification to an existing Project Tranche amount results in an
increase to the Remaining Construction Project Reserve with respect to Advances for a Remaining Construction Project, the amount
of such increase shall then be available for other Remaining Construction Projects, subject, however, to appropriate and acceptable
adjustments to the Project Development Budgets for such other Remaining Construction Projects.

 

(e) Tranche
3 Committed Amounts. Section 4.1(b) of the Loan Agreement is hereby deleted in its entirety and the following inserted
in lieu thereof:

 

(b) Tranche
3 Committed Amounts. With respect to Advances of the remaining Tranche 3 Committed Amount (other than in respect of the Village
Note Payoff Advance (which has been fully Advanced as of the date hereof and no further Advances are available related thereto)
and the Operating Expense Advance (which has been fully Advanced as of the date hereof and no further Advances are available related
thereto)), and subject to the Interest Reserve and Remaining Construction Project Reserve requirements set forth in this Agreement,
upon the Agent Lender’s receipt and approval, as and to the extent required by this Agreement, of (i) Project Specific Due
Diligence for a Remaining Construction Project (including, without limitation, the Project Development Budget for such Projects)
or (ii) a Working Capital Advance Request, the Lenders agree, on the terms and conditions and relying on the representations set
forth herein, to lend to the Borrower an amount not to exceed: 

 

(1) as
to each Remaining Construction Project, an amount equal to the Project Tranche for such Project calculated pursuant to Section
3.3(c) above; and

 

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(2) as
to Working Capital Expenses in the aggregate, the Tranche 3 Committed Amount less any Tranche 3 Committed Amount previously
advanced for any Existing Project, Planned Project, Future Project, the Village Note Payoff Advance, the Operating Expense Advance,
any Remaining Construction Project, or any other Working Capital Expenses.

 

(f) Remaining
Construction Project Advance Requests. Section 4.1(c) of the Loan Agreement is hereby deleted in its entirety and the following
inserted in lieu thereof:

 

(c) Subject
to compliance by Holdings, the Borrower and each Borrower Subsidiary with all of the provisions of this Agreement and so long as
no Default or Event of Default then exists, Loan proceeds applicable to each Remaining Construction Project shall be disbursed
by the Lenders making Advances in accordance with the following procedures:

 

(1) Not
less than five (5) Business Days before the date on which the Borrower desires an Advance for a Remaining Construction Project,
the Borrower shall submit to the Agent Lender a request for an Advance in the form attached hereto as Exhibit H. A separate
Advance request must be completed for each Project for which an Advance is requested. While Advances may be made simultaneously
to finance costs of more than one Project, Advances shall be made not more than once each calendar month, and the Borrower hereby
acknowledges and agrees that it must coordinate requests for multiple Projects such that the Lenders are not required to Advance
more than once per month. Notwithstanding anything to the contrary herein provided, no Advances shall be made during the last five
(5) Business Days in September of any year. Each request for an Advance shall identify the Remaining Construction Project for which
such Advance is made with specificity, must be signed by an Authorized Representative, must be submitted in compliance with the
provisions of Section 9.7 herein (with an e-mail transmission notification to each of hunter.harrell@rsa-al.gov, rachel.daniels@rsa-al.gov,
and steve.timms@rsa-al.gov (or such other e-mail addresses provided to Borrower by the Agent Lender) as to the incoming
Advance request), and must be accompanied by the following:

 

(i) a
copy of the Project Development Budget for such Project, together with a cost breakdown by line item showing the cost of Improvements
and any budgeted soft costs spent to the date of the requisition and showing the percentage of completion, certified by the Borrower
as correct;

 

(ii) AIA
Documents G702 and G703 and conditional lien waivers from the General Contractor and any Major Subcontractor (as hereinafter defined)
and invoices supporting all nonconstruction costs. As used herein “Major Subcontractor” means any subcontractor or
supplier of materials entering into contracts for services and/or supply of materials for the Project in an amount greater than
$50,000;

 

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(iii) unless
not available in a Project jurisdiction or otherwise waived by Agent Lender for a Project, an endorsement to the Title Policy which
brings the effective date of the Title Policy insuring the Mortgage forward to the date of such Advance, which shows no unapproved
title exceptions, which evidences to the Lenders’ satisfaction that there has been no change in the status of the title to
the Property or the Borrower’s interest therein or creation of any new encumbrances thereon, or occurrence of any event that
could in Lenders’ opinion impair the priority of the Lien of the Mortgage as of the time of each advance, and which increases
the amount of title insurance thereunder, and otherwise is in form and content acceptable to the Lenders;

 

(iv) Intentionally
Deleted;

 

(v) a
certificate of Borrower, Holdings and Borrower Subsidiaries to the effect that (1) the representations and warranties made by the
Borrower, Holdings and Borrower Subsidiaries in this Agreement and all other Loan Documents are true and correct on and as of the
date of the making of such request for an Advance with the same force and effect as if made on and as of such date, (2) no Default
or Event of Default has occurred and is continuing, (3) all completed construction is substantially in accordance with the Plans
and Specifications for such Project, (4) all construction and nonconstruction costs for the payment of which the Lenders have previously
made Advances (including Advances for the Project made the basis of the request and all prior Advances for any other Project) have
in fact been paid (except to the extent reasonable reserves have been established with respect to amounts due or to become due),
(5) as of the date of such Advance, to its knowledge, none of Holdings, Borrower or any Borrower Subsidiaries has any defenses,
equities or setoffs with respect to the Loan Obligations, (6) that the Project Development Budgets (as the same may have been amended
to the extent permitted herein and including any amendments thereto of which Borrower is then providing the required notice to
Agent Lender) for all other Remaining Construction Projects remain true, accurate and complete in all material respects and include
all costs required to develop and open the Projects to which they pertain; and (7) including such other certifications, representations
and warranties as Agent Lender may reasonably request; and

 

(vi) such
other items related to (i), (ii) and (iii) above as may be reasonably required by the Agent Lender in connection with any such
request for an Advance.

 

(g) Advance
Limitations. Section 4.1(h) of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu
thereof:

 

(h) The
Lenders reserve the right to limit the total amount advanced for any Remaining Construction Project at any time to an amount which,
when deducted from the Project Tranche designated and supported by the related Project Development Budget, leaves a balance equal
to one hundred percent (100%) of the sum of the cost of completion of all Improvements for such Project plus remaining nonconstruction
expenses for such Project necessary for completion, as reasonably determined by the Agent Lender from time to time.

 

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(h) Working
Capital Advance Requests.  The following is hereby added as Section 4.1(o) to the Loan Agreement:

 

(o) Subject
to compliance by Holdings, the Borrower and each Borrower Subsidiary with all of the provisions of this Agreement and so long as
no Default or Event of Default then exists, Loan proceeds applicable for Working Capital Expenses (other than Working Capital Expenses
related to Remaining Construction Projects, which shall be subject to the provisions of Section 4.1(c)) shall be disbursed by the
Lenders making Advances in accordance with the following procedures:

 

(1)
Not less than five (5) Business Days before the date on which the Borrower desires an Advance for applicable Working Capital
Expenses, the Borrower shall submit to the Agent Lender a request (each, a “Working Capital Advance
Request”) for an Advance in the form attached hereto as Exhibit R. A separate Advance request must be
completed for all Working Capital Expenses for which an Advance is requested. Advances for Working Capital Expenses shall be
made not more than once each calendar month, and the Borrower hereby acknowledges and agrees that it must coordinate requests
for Remaining Construction Projects such that the Lenders are not required to Advance more than once per month.
Notwithstanding anything to the contrary herein provided, no Advances shall be made during the last five (5) Business Days in
September of any year. Each request for an Advance must be signed by an Authorized Representative, must be submitted in
compliance with the provisions of Section 9.7 herein (with an e-mail transmission notification to each of
hunter.harrell@rsa-al.gov and rachel.daniels@rsa-al.gov (or such other e-mail addresses provided to Borrower by the Agent
Lender) as to the incoming Advance request)), and must be accompanied by the following:

 

(i) a
certificate of Borrower, Holdings and Borrower Subsidiaries to the effect that (1) the representations and warranties made by the
Borrower, Holdings and Borrower Subsidiaries in this Agreement and all other Loan Documents are true and correct on and as of the
date of the making of such request for an Advance with the same force and effect as if made on and as of such date, (2) no Default
or Event of Default has occurred and is continuing, (3) all construction and nonconstruction costs for the payment of which the
Lenders have previously made Advances (including Advances for Working Capital Expenses, Remaining Construction Projects and all
prior Advances for any other Project, Working Capital Expenses or Remaining Construction Projects) have in fact been paid (except
to the extent reasonable reserves have been established with respect to amounts due or to become due), (4) as of the date of such
Advance, to its knowledge, none of Holdings, Borrower or any Borrower Subsidiaries has any defenses, equities or setoffs with respect
to the Loan Obligations; and (5) including such other certifications, representations and warranties as Agent Lender may reasonably
request; and

 

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(ii) if
requested by Agent Lender, evidence, as reasonably required by Lender, of the Working Capital Expenses for which any subject Advance
is being requested.

 

(i) Working
Capital Expense Request Form. The Working Capital Expense Request Form attached as Schedule 1 hereto, is hereby
added as Exhibit R to the Loan Agreement and made a part thereof.

 

(j) Direct
Advances. Section 4.2 of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu thereof:

 

4.2 Direct
Advances. After the occurrence of an Event of Default, the Lenders may from time to time make Advances for any other Working
Capital Expenses, regardless of whether the Borrower has submitted a requisition therefor. Such Advances may be made directly to
parties to whom such amounts are due or to the Lenders to reimburse the Lenders for sums due to them. All such Advances to parties
other than the Borrower shall be deemed Advances to the Borrower hereunder and shall be secured by the Collateral to the same extent
as if they were made directly to the Borrower.

 

(k) Required
Borrower Funds. Section 4.4 of the Loan Agreement is hereby deleted in its entirety.

 

(l) Lessor
Contributions. Section 4.5(e) of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu
thereof:

 

(e) Borrower
may elect during the Commitment Period and so long as no Default or Event of Default then exists to apply any Lessor Contributions
toward the payment of Total Approved Project Costs To Date (as defined in Section 4.1(m)(1) herein). Notwithstanding that such
use of Lessor Contributions may be applied in lieu of Advances of the Loan to pay Total Approved Project Costs To Date, nothing
herein shall be deemed to limit or modify the Borrower’s obligation to the Lenders to comply with all obligations to provide
Project Specific Due Diligence for the Project to be financed with such Lessor Contributions as set forth in Section 3.2(d), including
but not limited to confirmation that the Lenders’ lien on and security interest in such Project and related Collateral has
attached and is perfected on a first priority basis.

 

(m) Interest
Reserve. The following is hereby added as Section 4.6 of the Loan Agreement and made a part thereof:

 

4.6 Interest
Reserve. The Tranche 3 Committed Amount will include an interest reserve in the amount of $11,356,647.89, which, subject to
the terms of this Agreement, shall be reserved solely for the payment of interest under the Loan as it becomes due (the “Interest
Reserve”). The Interest Reserve will not be included in the computation of the undisbursed portion of the Tranche 3 Committed
Amount. 

 

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(n) Remaining
Construction Project Reserve. The following is hereby added as Section 4.7 of the Loan Agreement and made a part thereof:

 

4.7 Remaining
Construction Project Reserve. The Tranche 3 Committed Amount will include a construction reserve in an amount being (collectively,
the “Remaining Construction Project Reserve”): (i) the aggregate of the Project Development Budgets for the
Remaining Construction Projects plus (ii) a contingency reserve equal to ten percent (10%) of the aggregate of the Project
Development Budgets for the Remaining Construction Projects (excluding the Project Development Budgets for the Pasadena Renovation
Project and the Renovation Project to the Existing Scottsdale Project) (the “Contingency Reserve”) plus
any sums not identified in any Project Development Budget for such Remaining Construction Projects (as the same may be amended
as permitted herein) but which are reasonably identified by the Agent Lender as amounts required to complete the development of
any Remaining Construction Projects (i.e., any “overrun” amounts). Funds in the Remaining Construction Project Reserve
shall be used for Advances related solely to the construction of the Remaining Construction Projects in accordance with the approved
Project Development Budgets therefor, and shall not be available for Advances for Working Capital Expenses that are not related
to the construction of such Remaining Construction Projects. So long as the cost of any Remaining Construction Project has not
exceeded the aggregate of the Project Development Budget for such Remaining Construction Project plus the Contingency Reserve
allocated thereto, as determined by Agent Lender in its discretion, and no other Default or Event of Default has occurred or is
occurring, funds in the Contingency Reserve shall be available for release from the Contingency Reserve upon satisfaction of the
following conditions: (A) upon completion of a Renovation Project (other than the Pasadena Renovation Project and the Renovation
Project to the Existing Scottsdale Project) and receipt by Agent Lender of a certificate for such Renovation Project in accordance
with Section 6.23 of this Agreement, to the extent there are any funds remaining in the Contingency Reserve allocable to such Renovation
Project, such funds shall be made available for Advances for any Working Capital Expenses so long as Borrower is in compliance
with all other terms and conditions of this Agreement; and (B) upon completion of all other Remaining Construction Projects
and receipt by Lender of a certificate for each one of such Remaining Construction Projects in accordance with Section 6.23 of
this Agreement, to the extent there are any funds remaining in the Contingency Reserve, such funds, together with any other funds
remaining in the Remaining Construction Project Reserve shall be made available for Advances for any Working Capital Expenses so
long as Borrower is in compliance with all other terms and conditions of this Agreement. 

 

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(o) Remaining
Construction Projects Budgets. For purposes of calculating the aggregate of the Project Development Budges for the Remaining
Construction Projects as set forth in Section 4.7 of the Loan Agreement, such aggregate amount shall be calculated by Agent Lender,
in its sole and absolute discretion, based upon the Project Development Budges for the Remaining Construction Projects attached
as Schedule 3 hereto and made a part hereof.

 

(p) Construction
of Improvements. Section 6.23 of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu
thereof:

 

Construct
Improvements and Complete the Projects. Commence construction, reconfiguration and/or renovation, as applicable, of each of
the Remaining Construction Projects within sixty (60) days following the initial Advance of the corresponding Project Tranche,
but in any event to commence construction of each of such Projects no later than the expiration of the Commitment Period; cause
each set of Improvements to be constructed substantially in accordance with the Plans and Specifications therefor, and in compliance
with all applicable restrictive covenants, zoning ordinances, setback requirements, building codes and governmental regulations,
and so as not to encroach upon or overhang into any easement or right-of-way; cause such construction to proceed continuously and
permit no cessation of work; and complete each of such Projects and obtain all required Permits and a certificate of occupancy
or other final governmental approval of such Improvements for their intended use on or before the Scheduled Completion Date therefor,
time being of the essence.

 

The completion
of each of the Remaining Construction Projects and the payment of all costs and expenses incidental thereto shall be evidenced
by the Borrower’s delivery, within ninety (90) days of the Scheduled Completion Date for each applicable Project, to the
Agent Lender of a certificate signed by the Borrower stating that:

 

(1) the
acquisition, construction, installation and equipping of such Project has been completed in all material respects substantially
in accordance with the Plans and Specifications;

 

(2) the
Borrower shall have received and made all Permits, approvals, consents, licenses (including environmental permits) and authorizations
of, and registrations, filings and recordings with, and declarations to, and other actions by governmental authorities, the lack
of which if not issued, granted or otherwise in existence, would materially impair commencement of operation of the Project;

 

(3) all
amounts due for labor, materials, supplies and other costs incurred in connection with the acquisition, construction, installation
and equipping of the Project have been paid except for amounts which the Borrower is entitled to retain pursuant to its respective
purchase orders or for amounts being disputed by the Borrower in good faith as being due and payable, which amounts shall be set
forth in the certificate and held in the disbursement account established for such Project until payment is due.

 

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(q) Use
of Proceeds. Section 6.24 of the Loan Agreement is hereby deleted in its entirety and the following inserted in lieu thereof:

 

6.24 Use
of Proceeds. Use the Advances under the Loan (if applicable) (other than (i) the Village Note Payoff Advance, which shall be
used for the purposes described in Section 2.10 and (ii) the Operating Expense Advance, which was used solely for the purposes
set forth in the Fourth Modification) solely and exclusively for Working Capital Expenses. The Borrower shall not commingle any
of the Advances or any of the funds of the Borrower which are to be invested in the Remaining Construction Projects or used for
other Working Capital Expenses with the funds of any other entity or Person or use any of the Advances for any uses except as permitted
by this Agreement. The Lenders reserve the right, at any time, to require satisfactory proof as to the disposition made of any
of the proceeds of the Loan. Nothing contained herein, however, shall be construed to require the Lenders to follow the disposition,
or to monitor the proper application; of any funds advanced by the Lenders. Borrower shall also use Excess Cash Flow and Lessor
Contributions only for such purposes as permitted herein. Other than the Remaining Construction Projects, no proceeds of the Loan
shall be available for Advances on any construction of any other Projects without Agent Lender’s express written consent,
which consent may be withheld in Agent Lender’s sole and absolute discretion. 

 

(r) Advance
Date Certification Form. Exhibit H of the Loan Agreement is hereby deleted in its entirety and the Advance Request
Form attached as Schedule 2 to this Agreement is hereby inserted in lieu thereof.

 

(s) Limited
Waiver of EBITDA Requirement. Lenders acknowledge and agree that with respect to Advances for Working Capital Expenses,
so long as (i) no Material Adverse Effect occurs prior to any Advance for any Working Capital Expenses, and (ii) no Default or
Event of Default occurs prior to any Advance for any Working Capital Expenses, the EBITDA Requirement set forth in Section 6.30
of the Loan Agreement shall be waived (the “Limited EBITDA Waiver”). Borrower acknowledges and agrees that the
Limited EBITDA Waiver is a limited waiver and, unless otherwise agreed by Lenders in writing, hereafter, any Advance of the Tranche
3 Committed Amount that is for construction of a Project that is not a Remaining Construction Project, will be subject to the EBITDA
Requirement. Borrower acknowledges and agrees that the Limited EBITDA Waiver shall not apply to, or in any way modify or otherwise
affect, the method of calculation of Net Income in conjunction with any other terms and conditions set forth in the Loan Agreement,
including, without limitation, the determination of Excess Cash Flow thereunder.

 

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4. Release
of Lenders.  For and in consideration of Lenders’ agreement to enter into and execute this Agreement, and without
any contingency, precondition, or condition subsequent, each of the Borrower Parties, for himself/herself/itself and his/her/its
heirs, executors, trustees, successors and assigns, does hereby fully and forever release, relinquish, discharge, settle and compromise
any and all claims, cross-claims, counterclaims, causes, damages and actions of every kind and character, and all suits, costs,
damages, expenses, compensation and liabilities of every kind, character and description, whether direct or indirect, known or
unknown, disclosed or hidden, in law or in equity, which he/she/it had or will have against Lenders, and/or any of Lenders’
affiliates, agents, representatives, officers, employees or contractors on account of, arising, or resulting from, or in any manner
incidental to, any and every thing or event occurring or failing to occur at any time in the past up to and including the date
hereof, including, without limitation, any claims relating to the Note, the Loan Agreement, the Mortgages or any other Loan Documents,
any act or event relating to Lenders’ (or its designees’) possession or use of any collateral securing the Note at any time,
the indebtedness evidenced by the Note, any act or event relating to the Lenders’ administration of the Loan Agreement, the
Note or any other Loan Documents.

 

5. Authorization.
Borrower Parties represent and warrant to Lenders that each of them has full power and authority to enter into this Agreement;
that the execution and delivery of this Agreement have been authorized by all requisite action; and that this Agreement constitutes
the valid and legally binding obligation of Borrower Parties enforceable in accordance with its terms. This Agreement is not intended
to be, nor shall it be construed to create, a novation or accord and satisfaction, and the Loan Agreement and the indebtedness
represented thereby and by the Note shall continue in full force and effect.

 

6. Ratification.
Except as herein amended, the Loan Agreement is hereby ratified and affirmed. Execution of this Agreement shall not alter or diminish
any rights of Lenders or obligations of Borrower Parties under any other note, instrument, or obligation secured by or entitled
to the benefits of the Loan Agreement or the Note, including, without limitation, any of the other Loan Documents.

 

7. No
Offsets or Defenses. Borrower Parties confirm that they have no offsets or defenses with respect to their obligations pursuant
to the Loan Agreement and Note or any of the other Loan Documents.

 

8. Events
of Default. Borrower Parties represent and warrant that, as of the Effective Date, there are no Events of Default under
the Loan Agreement, Note or any of the other Loan Documents.

 

9. No
Novation or Modification of Loan Documents, etc. Borrower Parties acknowledge and agree that (a) this Agreement is not
intended to be, and shall not be deemed or construed to be, a novation; (b) except as expressly provided in this Agreement or any
other written agreements with respect to the Loan Documents, no other modifications, amendments, or waivers of other Loan Documents
are implied or intended; and (c) Lender reserves all available rights and remedies, at law, in equity and under any the Loan Documents.

 

10. Expenses.
Borrower Parties agree to pay to Lenders all expenses, including Lenders’ attorney’s fees, incurred by Lenders in connection
with the negotiation and preparation of this Agreement.

 

    -12-

     

    

 

11. Counterparts.
This Agreement may be executed in two or more counterparts, each of which when executed and delivered shall constitute an original,
but all such counterparts together shall be deemed to be one and the same instrument.

 

12. Severability;
Complete Agreement. If any provisions of this Agreement or the application thereof to any person or circumstance shall
be invalid or unenforceable to any extent, the remainder of this Agreement and the application of such provisions to other persons
or circumstances shall not be affected thereby and shall be enforced to the greatest extent permitted by law. The Loan Agreement
and the Note, together with the other Loan Documents, as amended, constitute the full and complete agreement of the Borrower Partiers
and Lenders with respect to the indebtedness evidenced by the Note and Loan Agreement.

 

13. Successors
and Assigns. This Agreement shall inure to the benefit of and be binding upon the parties hereto, and their respective
successors and assigns.

 

14. Waiver
of Jury Trial. THE BORROWER PARTIES AND LENDERS HEREBY WAIVE ANY RIGHT THAT ANY OF THEM MAY HAVE TO A TRIAL BY JURY ON ANY
CLAIM, COUNTERCLAIM, SETOFF, DEMAND, ACTION OR CAUSE OF ACTION (A) ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT, THE
OTHER LOAN DOCUMENTS, OR THE LOAN, OR (B) IN ANY WAY CONNECTED WITH OR PERTAINING OR RELATED TO OR INCIDENTAL TO ANY DEALINGS OF
THE LENDERS AND ANY BORROWER PARTY WITH RESPECT TO THE LOAN DOCUMENTS OR IN CONNECTION WITH THIS AGREEMENT OR THE EXERCISE OF ANY
PARTY’S RIGHTS AND REMEDIES UNDER THIS AGREEMENT, OR OTHERWISE, OR THE CONDUCT OR THE RELATIONSHIP OF THE PARTIES HERETO, IN ALL
OF THE FOREGOING CASES WHETHER NOW EXISTING OR HEREAFTER ARISING AND WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE. THE BORROWER
PARTIES AND LENDERS AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS AGREEMENT WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING,
VOLUNTARY, AND BARGAINED AGREEMENT OF THE BORROWER PARTIES AND LENDERS IRREVOCABLY TO WAIVE THEIR RIGHTS TO TRIAL BY JURY AS AN
INDUCEMENT OF THE PARTIES TO ENTER INTO THIS AGREEMENT, AND THAT, TO THE EXTENT PERMITTED BY APPLICABLE LAW, ANY DISPUTE OR CONTROVERSY
WHATSOEVER (WHETHER OR NOT MODIFIED HEREIN) BETWEEN THE BORROWER PARTIES AND THE LENDERS SHALL INSTEAD BE TRIED IN A COURT OF COMPETENT
JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.

 

[Remainder of Page Intentionally
Left Blank]

 

    -13-

     

    

 

IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the year and date first
above written.

 

	 	BORROWER
    PARTIES:
	 	 	 
	 	IPIC-GOLD CLASS ENTERTAINMENT, LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

 

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of IPIC-GOLD CLASS ENTERTAINMENT, LLC, a Delaware limited liability company, is signed to the foregoing instrument, and
who is known to me, acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer
and with full authority, executed the same voluntarily for and as the act of said limited liability company, on the day the same
bears date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

    -14-

     

    

 

	 	IPIC GOLD CLASS HOLDINGS LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

 

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of IPIC-GOLD CLASS HOLDINGS LLC, a Delaware limited liability company, is signed to the foregoing instrument, and who is
known to me, acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer and
with full authority, executed the same voluntarily for and as the act of said limited liability company, on the day the same bears
date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

    -15-

     

    

 

	 	IPIC-GOLD CLASS TEXAS, LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

 

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of IPIC-GOLD CLASS TEXAS, LLC, a Delaware limited liability company, is signed to the foregoing instrument, and who is known
to me, acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer and with
full authority, executed the same voluntarily for and as the act of said limited liability company, on the day the same bears date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

    -16-

     

    

 

	 	IPIC MEDIA, LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

 

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of IPIC MEDIA, LLC, a Delaware limited liability company, is signed to the foregoing instrument, and who is known to me,
acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer and with full authority,
executed the same voluntarily for and as the act of said limited liability company, on the day the same bears date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

    -17-

     

    

 

	 	DELRAY BEACH HOLDINGS, LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

 

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of DELRAY BEACH HOLDINGS, LLC, a Delaware limited liability company, is signed to the foregoing instrument, and who is known
to me, acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer and with
full authority, executed the same voluntarily for and as the act of said limited liability company, on the day the same bears date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

    -18-

     

    

 

	 	BAY COLONY REALTY, LLC
	 	 	 
	 	By:	/s/ Hamid Hashemi
	 	Print Name: Hamid Hashemi
	 	Title: Managing Member

  

STATE OF FLORIDA

COUNTY OF PALM BEACH

 

I,
the undersigned, a Notary Public in and for said County, in said State, hereby certify that HAMID HASHEMI, whose name as Managing
Member of BAY COLONY REALTY, LLC, a Delaware limited liability company, is signed to the foregoing instrument, and who is known
to me, acknowledged before me on this day that, being informed of the contents of the instrument, he, as such officer and with
full authority, executed the same voluntarily for and as the act of said limited liability company, on the day the same bears date.

 

Given
under my hand and seal this 29th day of June, 2018.

 

	 	/s/ Roberta L. Ryncarz
	 	Notary Public
	 	My commission expires: April 1, 2020

 

 

    -19-

     

    

 

	 	LENDERS:
	 	 	 
	 	THE TEACHERS’ RETIREMENT SYSTEM OF ALABAMA
	 	 	 
	 	By:	/s/ David G. Bronner
	 	Print Name: David G. Bronner
	 	Title: CEO

 

STATE OF ALABAMA

COUNTY OF MONTGOMERY

 

I, the undersigned,
a Notary Public in and for said County, in said State, hereby certify that David G. Bronner, whose name as CEO of the Teachers’
Retirement System of Alabama is signed to the foregoing Agreement, and who is known to me, acknowledged before me on this day that,
being informed of the contents of the Agreement, he, as such officer and with full authority, executed the same voluntarily for
and as the act of said body corporate of the State of Alabama acting in its capacity as aforesaid.

 

Given under my hand and official
seal this 29th day of June, 2018.

 

	 	/s/ Sandra C. Bigger
	 	Notary Public
	 	My commission expires: July 1, 2018

 

    -20-

     

    

 

	 	THE EMPLOYEES’ RETIREMENT SYSTEM OF ALABAMA
	 	 	 
	 	By:	/s/ David G. Bronner
	 	Print Name: David G. Bronner
	 	Title: CEO

  

STATE OF ALABAMA

COUNTY OF MONTGOMERY

 

I, the undersigned,
a Notary Public in and for said County, in said State, hereby certify that David G. Bronner, whose name as CEO of the Employees’
Retirement System of Alabama is signed to the foregoing Agreement, and who is known to me, acknowledged before me on this day that,
being informed of the contents of the Agreement, he, as such officer and with full authority, executed the same voluntarily for
and as the act of said body corporate of the State of Alabama acting in its capacity as aforesaid.

 

Given under my hand and official
seal this 29th day of June, 2018.

 

	 	/s/ Sandra C. Bigger
	 	Notary Public
	 	My commission expires: July 1, 2018

 

    -21-

     

    

 

Schedule 1

 

Working Capital Advance
Request Form (non-Remaining Construction Project Advances)

 

Complete Advance Request
will include the following certification by Borrower.

 

	Date:	 	

 

		To:	THE TEACHERS’ RETIREMENT SYSTEM OF ALABAMA

 

135 South Union Street

Montgomery, Alabama
36130-4104

Attention: Private Placement
Dept.

 

Pursuant to that certain
Second Amended and Restated Master Loan and Security Agreement dated as of February 1, 2018, as amended by Modification Agreement
dated June ____, 2018, as amended by Second Modification Agreement dated June ___, 2018 (as amended from time to time, the “Loan
Agreement”) among IPIC-GOLD CLASS ENTERTAINMENT, LLC (the “Borrower”), IPIC GOLD CLASS HOLDING LLC,
a Delaware limited liability company (“Holdings”), the Borrower Subsidiaries party thereto and THE TEACHERS’
RETIREMENT SYSTEM OF ALABAMA (the “TRS” or “Agent Lender”), and THE EMPLOYEES’ RETIREMENT
SYSTEM OF ALABAMA (the “ERS”) (the TRS and the ERS are sometimes herein referred to individually as a “Lender”
and collectively as the “Lenders”), Borrower submits this Working Capital Advance Request pursuant to Section 4.1(o)
of the Loan Agreement (this “Request for Advance”). Capitalized terms used herein without definition shall
have the meanings ascribed to such terms in the Loan Agreement.

 

1. The
total amount of this Working Capital Advance Request is $__________________, which Advance should be paid into the following account:

 

Account Name: Ipic Gold Class Entertainment
LLC

433 Plaza Real, Suite 335

Boca Raton, FL 33432

Master/Depository Account

Bank Name: [____________]

Routing Transit Number: [____________]

Account Number:
[____________]

 

2. Upon
making the above requested Advance for Working Capital Expenses, the total Advances (inclusive of the requested Advance) by Lenders
of the Loan to date are:

 

(a) Working
Capital Expense Advances (non-Remaining Construction Project Advances: $____________

 

    -22-

     

    

 

(b) Working
Capital Expense Advances (Remaining Construction Project Advances: $__________

 

(c) Other
Project Advances: $_____________

 

(d) Operating
Expense Advances: $4,000,000

 

(e) Village Note Payoff
Advance: $18,000,000

 

3. The
undersigned represents and warrants to Lenders that the undersigned or other appropriate representations of Borrower have reviewed
the provisions of the Loan Agreement and that a review of the activities of Borrower during the period from the date of the last
Request for Advance through the date of this Request for Advance has been made by or under the supervision of the undersigned or
other appropriate representations of Borrower with a view to determining whether Borrower has kept, observed, performed and fulfilled
all of its obligations under the Loan Agreement. Borrower hereby represents and warrants to Lenders, knowing that Lenders will
rely on such representations and warranties as a condition to making any Advance requested hereby that:

 

(a) The
representations and warranties made by the Borrower in the Loan Agreement and all other Loan Documents are true and correct on
and as of the date hereof with the same force and effect as if made on and as of the date hereof;

 

(b) No
Default or Event of Default has occurred and/or is continuing;

 

(c) As
of the date of such Advance, the Borrower has no defenses, equities or setoffs with respect to the Loan Obligations;

 

4. Borrower
certifies that all information set forth in this Request for Advance is true, complete, and accurate.

 

[Remainder of Page Intentionally
Left Blank]

 

    -23-

     

    

 

Certified as true and
correct and executed this ______ day of __________________, 20___ by an Authorized Representative of Borrower.

 

	 	IPIC-GOLD CLASS ENTERTAINMENT, LLC
	 	 
	 	By:	 
	 	Print Name:	        
	 	Its:	 

 

    -24-

     

    

 

Schedule 2

 

Remaining Construction
Project Advance Request Form

 

 

Complete Advance Request
will include the following certification by Borrower with noted attachments and the attached Advance Request spreadsheets.

 

	Date:	 	 
	 	 	 
	IGCE Project

Reference/Location:	 	 
	 	 	 

 

		To:	THE TEACHERS’ RETIREMENT SYSTEM OF ALABAMA

 

135 South Union Street

Montgomery, Alabama
36130-4104

Attention: Private Placement
Dept.

 

Pursuant to that certain
Second Amended and Restated Master Loan and Security Agreement dated as of February 1, 2018, as amended by Modification Agreement
dated June ____, 2018, as amended by Second Modification Agreement dated June ___, 2018 (as amended from time to time, the “Loan
Agreement”) among IPIC-GOLD CLASS ENTERTAINMENT, LLC (the “Borrower”), IPIC GOLD CLASS HOLDING LLC,
a Delaware limited liability company (“Holdings”), the Borrower Subsidiaries party thereto and THE TEACHERS’
RETIREMENT SYSTEM OF ALABAMA (the “TRS” or “Agent Lender”), and THE EMPLOYEES’ RETIREMENT
SYSTEM OF ALABAMA (the “ERS”) (the TRS and the ERS are sometimes herein referred to individually as a “Lender”
and collectively as the “Lenders”), Borrower submits this Request for Advance pursuant to Section 4.1(b) of the Loan
Agreement (this “Request for Advance”). Capitalized terms used herein without definition shall have the meanings
ascribed to such terms in the Loan Agreement.

 

5. This
Request for Advance requests an Advance of the Loan under the Loan Agreement to fund development costs set forth in the Project
Development Budget for the Project identified above for which a Project Tranche of $__________ has been allocated pursuant to Section
3.3(c) of the Loan Agreement.

 

6. Attached
hereto as Schedule 1 is the Advance request calculation (the “Advance Request Calculation”) supporting this
Request for Advance, the line items of which correlate with the applicable Project Development Budget that has been approved by
the Agent Lender for the Project. Such Advance Request Calculation includes a breakdown by line item of amounts requested herein
in addition to a breakdown of the total Loan amounts previously advanced for the Project to date (the “Prior Advances”).
Said Project Development Budget continues to reflect accurate costs to complete and open or re-open, as applicable, the Project.
Attached as Schedule 2 is Borrower’s Project cost summary to date, which further supports the calculations set forth
in the Advance Request Calculation.

 

    -25-

     

    

 

7. The
total Advances for the Project being requested by this Request for Advance is $_________, which Advances should be paid into the
following account:

 

Account Name: Ipic Gold Class Entertainment
LLC

433 Plaza Real, Suite 335

Boca Raton, FL 33432

Master/Depository Account

Bank Name: [____________]

Routing Transit Number: [____________]

Account Number: [____________]

 

Upon making the above requested Advances, the total
Advances (inclusive of the requested Advances) to date are:

 

(a) Working
Capital Expense Advances (non-Remaining Construction Project Advances: $____________

 

(b) Working
Capital Expense Advances (Remaining Construction Project Advances: $__________

 

(c) Other
Project Advances: $_____________

 

(d) Operating
Expense Advances: $4,000,000

 

(e) Village Note Payoff
Advance: $18,000,000

 

8. Contemporaneously
herewith, in addition to the Project Development Budget, Borrower is submitting or has submitted all information required by Article
IV of the Loan Agreement for Advances as indicated below or, if not submitted, Borrower has indicated the status thereof below:

 

	 	______	(a)	AIA Documents G702 and G703.

 

	 	______	(b)	Conditional Lien Waiver from the General Contractor.

 

	 	______	(c)	Conditional Lien Waivers from all Major Subcontractors.

 

	 	______	(d)	Title Policy endorsement.

 

	 	______	(f)	Advance Request Calculation as Schedule 1 (as noted above).

 

	 	______	(g)	Project cost summary to date as Schedule 2 (as noted above).

 

	 	______	(h)	Any other items reasonably requested by Agent Lender to date in connection with this Advance or
Prior Advances for the Project.

 

    -26-

     

    

 

9. After
the amounts requested herein are advanced by Lenders, the total amounts expended for the Project will be as follows:

 

(a) Total
Approved Project Costs to Date for THIS PROJECT pursuant to Section 4.1(m)(1) of the Loan Agreement: $___________.

 

(b) Total
Amounts expended to date for THIS PROJECT:

 

	 	Advances of Loan Proceeds	 	$	 	 
	 	Excess Cash Flow	 	$	 	 
	 	 	 	 	 	 
	 	TOTAL:	 	$	 	 

 

10. After
the amounts requested herein plus any other amounts for other Projects for which Advances are being simultaneously requested
are advanced by Lenders, the total amounts expended for all Projects and Working Capital Expenses will be as follows:

 

(a) Total
Approved Project Costs to Date for ALL PROJECTS AND WORKING CAPITAL EXPENSES: $___________

 

(b) Total
Amounts expended to date for ALL PROJECTS AND OTHER WORKING CAPITAL EXPENSES:

 

	 	Required Borrower Funds	 	$	 	 
	 	Advances of Loan Proceeds	 	$	 	 
	 	Excess Cash Flow	 	$	 	 
	 	 	 	 	 	 
	 	TOTAL:	 	$	 	 

 

11. As
of the date hereof, the Disbursement Account (as more particularly provided in Section 4.3) has _____ or has not _______ (check
one) been established. If the same has been established:

 

(a) The
Disbursement Account is maintained at __________________________, and the Disbursement Account number is ________________________.

 

(b) The
account control agreement required by Section 4.3 of the Loan Agreement has been obtained and provided to Agent Lender and is dated
____________________.

 

    -27-

     

    

 

12. As
of the date hereof, the Excess Cash Flow Account, the Lessor Contribution Account and the Operating Accounts (as more particularly
provided in Sections 4.5 (b), (c) and(d)) have _____ or have not _______ (check one) been established. If the same has been established:

 

(a) The
Excess Cash Flow Account is maintained at __________________________, and the Excess Cash Flow Account number is ________________________.

 

(b) The
account control agreement required by the Loan Agreement for the Excess Cash Flow Account has been obtained and provided to Agent
Lender and is dated ____________________.

 

(c) The
Lessor Contribution Account is maintained at __________________________, and the Lessor Contribution Account number is ________________________.

 

(d) The
account control agreement required by the Loan Agreement with respect to the Lessor Contribution Account has been obtained and
provided to Agent Lender and is dated ____________________.

 

(e) The
Operating Account is maintained at __________________________, and the Operating Account number is ________________________.

 

(f) The
account control agreement required by the Loan Agreement with respect to the Operating Account has been obtained and provided to
Agent Lender and is dated ____________________.

 

13. The
undersigned represents and warrants to Lenders that the undersigned or other appropriate representations of Borrower have reviewed
the provisions of the Loan Agreement and that a review of the activities of Borrower during the period from the date of the last
Request for Advance through the date of this Request for Advance has been made by or under the supervision of the undersigned or
other appropriate representations of Borrower with a view to determining whether Borrower has kept, observed, performed and fulfilled
all of its obligations under the Loan Agreement. Borrower hereby represents and warrants to Lenders, knowing that Lenders will
rely on such representations and warranties as a condition to making any Advance requested hereby that:

 

(a) The
representations and warranties made by the Borrower in the Loan Agreement and all other Loan Documents are true and correct on
and as of the date hereof with the same force and effect as if made on and as of the date hereof;

 

(b) No
Default or Event of Default has occurred and/or is continuing;

 

(c) All
completed construction for each Project is substantially in accordance with the Plans and Specifications for such Project and materially
comply with all governmental laws, ordinances and requirements;

 

(d) All
construction and nonconstruction costs for the payment of which the Lenders have previously made Advances for the Project have
in fact been paid or such funds remain available pending payment in the Disbursement Account;

 

(e) As
of the date of such Advance, the Borrower has no defenses, equities or setoffs with respect to the Loan Obligations;

 

(f) The
Project Development Budget for the Project and all other Projects previously approved by the Lenders remain true, accurate and
complete in all material respects and include all costs required to develop the Projects.

 

14. Borrower
certifies that all information set forth in this Request for Advance is true, complete, and accurate.

 

[Remainder of Page Intentionally
Left Blank]

 

    -28-

     

    

 

Certified as true and
correct and executed this ______ day of __________________, 20___ by an Authorized Representative of Borrower.

 

	 	IPIC-GOLD CLASS ENTERTAINMENT, LLC
	 	 	 
	 	By:	            
	 	Print Name:	 
	 	Its:	 

 

		*	Attach Advance Request Calculation and Project Cost
Summary with Request as Schedule 1.

 

		*	Attach other supporting information as listed for Advance
request.

 

    -29-

     

    

 

Schedule 3

 

Remaining Construction Project Budgets

 

See Attached

 

    -30-

     

    

 

Pasadena, CA

August 22, 2017

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	12,667 SF	 
	 	 	Restaurant	 	 	 	 
	 	 	TOTAL	 	 	12,667 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per 
 Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	0	 	 	$	0.00	 
	GC work	 	$	225,119	 	 	$	17.77	 
	Millwork	 	 	Included	 	 	 	Included	 
	Permits & Fees	 	$	0	 	 	$	0.00	 
	TOTAL TENANT CONSTRUCTION	 	$	225,119	 	 	$	17.77	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	$	0	 	 	$	0.00	 
	Auditoriums	 	$	829,577	 	 	$	65.49	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	0	 	 	$	0.00	 
	Furniture, Smallwares and other	 	$	0	 	 	$	0.00	 
	Signage	 	$	0	 	 	$	0.00	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	829,577	 	 	$	65.49	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	0	 	 	$	0.00	 
	Contingency	 	$	100,058	 	 	$	7.90	 
	Administration	 	$	0	 	 	$	0.00	 
	SUBTOTAL OTHER COSTS	 	$	100,058	 	 	$	7.90	 
	 	 	 	 	 	 	 	 	 
	TOTAL PROJECT BUDGET	 	$	1,154,754	 	 	$	91.16	 

  

    -31-

     

    

 

Redmond, WA Theater Remodel

November 21, 2017

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	19,978 SF	 
	 	 	Restaurant	 	 	 	 
	 	 	TOTAL	 	 	19,978 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per 
 Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	0	 	 	$	0.00	 
	GC work	 	$	825,550	 	 	$	41.32	 
	Millwork	 	 	Included	 	 	 	Included	 
	Permits & Fees	 	$	139,846	 	 	$	7.00	 
	TOTAL TENANT CONSTRUCTION	 	$	965,396	 	 	$	48.32	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	$	0	 	 	$	0.00	 
	Auditoriums	 	$	1,362,690	 	 	$	68.21	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	0	 	 	$	0.00	 
	Furniture, Smallwares and other	 	$	0	 	 	$	0.00	 
	Signage	 	$	0	 	 	$	0.00	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	1,362,690	 	 	$	68.21	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	0	 	 	$	0.00	 
	Contingency	 	$	232,809	 	 	$	11.65	 
	Pre-Paid License / fees	 	$	82,555	 	 	$	4.13	 
	SUBTOTAL OTHER COSTS	 	$	315,364	 	 	$	15.79	 
	 	 	 	 	 	 	 	 	 
	PROJECT BUDGET	 	$	2,643,449	 	 	$	132.32	 

  

    -32-

     

    

 

Fairview Theater Remodel 2018

Revised 11/28/2017

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	29,394 SF	 
	 	 	Restaurant	 	 	 	 
	 	 	TOTAL	 	 	29,394 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	0	 	 	$	0.00	 
	GC work	 	$	688,076	 	 	$	23.41	 
	Millwork	 	 	Included	 	 	 	Included	 
	Permits & Fees	 	$	205,758	 	 	$	7.00	 
	TOTAL TENANT CONSTRUCTION	 	$	893,834	 	 	$	30.41	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	$	0	 	 	$	0.00	 
	Auditoriums	 	$	1,675,358	 	 	$	57.00	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	0	 	 	$	0.00	 
	Furniture, Smallwares and other	 	$	0	 	 	$	0.00	 
	Signage	 	$	0	 	 	$	0.00	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	1,675,358	 	 	$	57.00	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	0	 	 	$	0.00	 
	Contingency	 	$	256,919	 	 	$	8.74	 
	Pre-Paid License / fees 	 	$	56,766	 	 	$	1.93	 
	SUBTOTAL
OTHER COSTS
	 	$	313,686	 	 	$	10.67	 
	 	 	 	 	 	 	 	 	 
	PROJECT BUDGET	 	$	2,882,878	 	 	$	98.08	 

 

    -33-

     

    

 

Austin Theater Remodel 2018

Revised 02/19/18

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	26,776 SF	 
	 	 	Restaurant	 	 	 	 
	 	 	TOTAL	 	 	26,776 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	0	 	 	$	0.00	 
	GC work	 	$	652,125	 	 	$	24.35	 
	Millwork	 	 	Included	 	 	 	Included	 
	Permits & Fees	 	$	107,104	 	 	$	4.00	 
	TOTAL TENANT CONSTRUCTION	 	$	759,229	 	 	$	28.35	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	$	0	 	 	$	0.00	 
	Auditoriums	 	$	1,646,765	 	 	$	61.50	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	0	 	 	$	0.00	 
	Furniture, Smallwares and other	 	$	180,000	 	 	$	6.72	 
	Signage	 	$	0	 	 	$	0.00	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	1,826,765	 	 	$	68.22	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	0	 	 	$	0.00	 
	Contingency	 	$	245,979	 	 	$	9.19	 
	Pre-Paid License / fees	 	$	53,800	 	 	$	2.01	 
	SUBTOTAL OTHER COSTS	 	$	299,780	 	 	$	11.20	 
	 	 	 	 	 	 	 	 	 
	PROJECT BUDGET	 	$	2,885,774	 	 	$	107.77	 

 

    -34-

     

    

 

Scottsdale,
AZ Theater Remodel

December 12, 2017

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	25,975 SF	 
	 	 	Restaurant	 	 	 	 
	 	 	TOTAL	 	 	25,975 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per 
 Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	0	 	 	$	0.00	 
	GC work	 	$	851,602	 	 	$	32.79	 
	Millwork	 	$	0	 	 	 	Included	 
	Permits & Fees	 	$	155,850	 	 	$	6.00	 
	TOTAL TENANT CONSTRUCTION	 	$	1,007,452	 	 	$	38.79	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	$	0	 	 	$	0.00	 
	Auditoriums	 	$	1,566,259	 	 	$	60.30	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	0	 	 	$	0.00	 
	Furniture, Smallwares and other	 	$	0	 	 	$	0.00	 
	Signage	 	$	0	 	 	$	0.00	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	1,566,259	 	 	$	60.30	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	171,300	 	 	$	6.59	 
	Contingency	 	$	205,897	 	 	$	7.93	 
	Administration	 	$	0	 	 	$	0.00	 
	SUBTOTAL OTHER COSTS	 	$	377,197	 	 	$	14.52	 
	 	 	 	 	 	 	 	 	 
	TOTAL PROJECT BUDGET	 	$	2,950,907	 	 	$	113.61	 

 

    -35-

     

    

 

4th & 5th DELRAY - THEATER

May 9, 2017

 

	 	 	May 9, 2017	 
	 	 	Rentable SF =	 	 	44,950 SF	 
	Budget Categories	 	Total	 	 	Per SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	 	7,471,589	 	 	 	166.22	 
	Permits & Fees	 	 	632,175	 	 	 	14.06	 
	TOTAL TENANT CONSTRUCTION	 	$	8,103,764	 	 	$	180.28	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package I Displays	 	 	368,176	 	 	 	8.19	 
	Auditoriums	 	 	2,697,371	 	 	 	60.01	 
	Projection Booth	 	 	1,124,878	 	 	 	25.03	 
	Restaurant, Bar and Concession Equipment	 	 	1,545,000	 	 	 	34.37	 
	Furniture, Smallwares and other	 	 	549,487	 	 	 	12.22	 
	Signage	 	 	227,370	 	 	 	5.06	 
	IT	 	 	480,213	 	 	 	10.68	 
	TOTAL FF&E	 	$	6,992,496	 	 	$	155.56	 
	 	 	 	 	 	 	 	 	 
	PRE-OPENING AND SOFT COSTS	 	 	 	 	 	 	 	 
	Pre-Opening Unit Labor	 	 	500,000	 	 	 	11.12	 
	Pre-Opening Training Labor	 	 	140,000	 	 	 	3.11	 
	Pre-Opening Inventory	 	 	150,000	 	 	 	3.34	 
	Pre-Opening Marketing	 	 	400,000	 	 	 	8.90	 
	Soft Costs	 	 	160,000	 	 	 	3.56	 
	Pre-Paid License / fees	 	 	106,500	 	 	 	2.37	 
	TOTAL PRE-OPENING AND SOFT COSTS	 	$	1,456,500	 	 	$	32.40	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	 	150,000	 	 	 	3.34	 
	Legal - Lease and Licensing	 	 	50,000	 	 	 	1.11	 
	Contingency	 	 	1,312,299	 	 	 	29.19	 
	SUBTOTAL OTHER COSTS	 	$	1,512,299	 	 	$	33.64	 
	 	 	 	 	 	 	 	 	 
	TOTAL PROJECT BUDGET	 	$	18,065,060	 	 	$	401.69	 
	 	 	 	 	 	 	 	 	 
	LandLord Contribution	 	$	5,234,133	 	 	$	116.44	 
	Total Project Cost	 	$	12,830,927	 	 	$	285.45	 

  

    -36-

     

    

 

Boca
Raton - 2019 Theater & Tanzy Remodel

June
27, 2018

 

	 	 	 	 	 	Leasable SF	 
	 	 	Theater	 	 	38,310 SF	 
	 	 	Restaurant	 	 	9,633 SF	 
	 	 	TOTAL	 	 	47,943 SF	 
	Budget Categories	 	Total Cost	 	 	Cost Per 
 Leasable SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	$	186,417	 	 	$	3.89	 
	GC work	 	$	925,505	 	 	$	19.30	 
	Millwork	 	 	Included	 	 	 	Included	 
	Permits & Fees	 	$	315,420	 	 	$	6.58	 
	TOTAL TENANT CONSTRUCTION	 	$	1,427,342	 	 	$	29.77	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package I Displays	 	$	11,449	 	 	$	0.24	 
	Auditoriums	 	$	1,839,489	 	 	$	38.37	 
	Projection Booth	 	$	0	 	 	$	0.00	 
	Restaurant, Bar and Concession Equipment	 	$	214,000	 	 	$	4.46	 
	Furniture, Smallwares and other	 	$	263,124	 	 	$	5.49	 
	Signage	 	$	5,700	 	 	$	0.12	 
	IT	 	$	0	 	 	$	0.00	 
	TOTAL FF&E	 	$	2,333,762	 	 	$	48.68	 
	 	 	 	 	 	 	 	 	 
	NON-FINANCEABLE SOFT COSTS	 	 	 	 	 	 	 	 
	Pre-Opening Unit Labor	 	$	47,685	 	 	$	0.99	 
	Pre-Opening Training Labor	 	$	0	 	 	$	0.00	 
	Pre-Opening Inventory	 	$	0	 	 	$	0.00	 
	Pre-Opening Marketing	 	$	0	 	 	$	0.00	 
	Soft Costs	 	$	0	 	 	$	0.00	 
	Pre-Paid License I fees	 	$	0	 	 	$	0.00	 
	TOTAL SOFT COSTS	 	$	47,685	 	 	$	0.99	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	$	0	 	 	$	0.00	 
	Legal - Lease and Licensing	 	$	0	 	 	$	0.00	 
	Contingency	 	$	340,286	 	 	$	7.10	 
	Administration	 	$	0	 	 	$	0.00	 
	SUBTOTAL OTHER COSTS	 	$	340,286	 	 	$	7.10	 
	 	 	 	 	 	 	 	 	 
	TOTAL
PROJECT BUDGET
	 	$	4,149,075	 	 	$	86.54	 

 

    -37-

     

    

 

Budget Summary

Irvine, CA - Park Place

 

 

	 	Updated	 	3/21/2018	 
	 	Total Buildable SF	 	 	27,589	 
	 	# of Theaters	 	 	6	 
	 	Restaurant SF	 	 	4,400	 
	 	Theater SF	 	 	23,189	 

 

 

		 	 	 	 	Cost per SF	 
	TENANT CONSTRUCTION	 	 	 	 	 	 
	Tenant Construction	 	 	5,972,632	 	 	 	216.49	 
	Shell Construction incl. Demo, Seismic Upgrade, Façade, Mezzanine	 	 	2,910,088	 	 	 	105.48	 
	Webcam Monitoring During Const.	 	 	15,000	 	 	 	0.54	 
	Perm its & Fees	 	 	659,013	 	 	 	23.89	 
	TOTAL TENANT CONSTRUCTION	 	$	9,556,733	 	 	$	346.40	 
	 	 	 	 	 	 	 	 	 
	FURNITURE, FIXTURES, & EQUIPMENT	 	 	 	 	 	 	 	 
	AV Package / Displays	 	 	179,762	 	 	 	6.52	 
	Auditoriums	 	 	1,944,937	 	 	 	70.50	 
	Projection Booth	 	 	557,881	 	 	 	20.22	 
	Restaurant, Bar and Concession Equipment	 	 	811,046	 	 	 	29.40	 
	Furniture, Smallwares and Other	 	 	610,253	 	 	 	22.12	 
	Signage	 	 	204,215	 	 	 	7.40	 
	IT	 	 	407,249	 	 	 	14.76	 
	TOTAL FF&E	 	$	4,715,344	 	 	$	170.91	 
	 	 	 	 	 	 	 	 	 
	PRE-OPENING	 	 	 	 	 	 	 	 
	Pre-Opening Unit Labor	 	 	313,000	 	 	 	11.35	 
	Pre-Opening Training Labor	 	 	132,040	 	 	 	4.79	 
	Pre-Opening Inventory	 	 	75,000	 	 	 	2.72	 
	Pre-Opening Marketing	 	 	315,000	 	 	 	11.42	 
	Soft Costs	 	 	343,845	 	 	 	12.46	 
	Pre-Paid License /fees	 	 	22,000	 	 	 	0.80	 
	TOTAL PRE-OPENING	 	$	1,200,885	 	 	$	43.53	 
	 	 	 	 	 	 	 	 	 
	OTHER COSTS	 	 	 	 	 	 	 	 
	Loan Closing	 	 	65,000	 	 	 	2.36	 
	Other Legal	 	 	205,950	 	 	 	7.46	 
	Contingency	 	 	1,427,208	 	 	 	51.73	 
	SUBTOTAL OTHER COSTS	 	$	1,698,158	 	 	$	61.55	 
	 	 	 	 	 	 	 	 	 
	TOTAL PROJECT BUDGET	 	$	17,171,120	 	 	$	622	 
	 	 	 	 	 	 	 	 	 
	LandLord Contribution	 	$	4,800,000	 	 	$	173.98	 
	Total Project Cost	 	$	12,371,120	 	 	$	448.41	 

 

    -38-test.htm

 

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

 

 

 

 

 

JOINT VENTURE AND LICENSE OPTION AGREEMENT

 

 

BY AND BETWEEN

 

 

TG THERAPEUTICS, INC.

 

 

AND

 

 

NOVIMMUNE S.A.

 

 

 

 

 

 

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

 

 

This JOINT VENTURE
AND LICENSE OPTION AGREEMENT (the “Agreement”) is
entered into on June 18, 2018 (the “Effective Date”)
between Novimmune SA, a
Swiss company having an address at 14 ch. des Aulx, 1228
Plan-Les-Ouates, Geneva, Switzerland (“NOVIMMUNE”) and
TG Therapeutics, Inc., a
Delaware corporation, with a place of business at 2 Gansevoort
Street | 9th Floor, New York,
NY, USA (“TGTX”).  Novimmune and TGTX are
sometimes referred to herein individually as a “Party”
and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, NOVIMMUNE
is a pharmaceutical company focused on the discovery and
development of antibody-based drugs for the treatment of
inflammatory diseases, immune-related disorders and
cancer.

 

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

 

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

 

WHEREAS, TGTX will
be responsible for the manufacture or will have manufactured
clinical and commercial supplies of the Finished Product, in
addition to the *g of
ready-to-be-labelled Product initially supplied by NOVIMMUNE (the
“Novimmune Initial Drug Supply”) for use by TGTX
according to the Development Plan, as described below;

 

WHEREAS, TGTX will
be responsible for the development and commercialization of the
Product in the Territory (see section 1.89) and the Parties shall
share equally (subject to adjustment as more fully described in
this Agreement) in the costs and expense of and in the profits
resulting from marketing and sales of the Product in the Territory
in accordance with the terms set forth below; and

 

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

 

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

 

 

 
* Confidential material
redacted and filed separately with the Commission

 

 

 

 

 

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

 

ARTICLE
I.                      ARTICLE
1

 

 

SECTION
1.01                                DEFINITIONS

 

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

 

1.1  

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

 

1.2  

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

 

1.3  

“Alliance
Representative” has the meaning set forth in Section
2.4.

 

1.4  

“Bulk
API” means the Product in bulk form.

 

1.5  

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

 

1.6  

“Cause”
means, for purposes of Section 13.2(b), any failure of TGTX,
following good-faith efforts, to get clearance from the appropriate
Regulatory Authority to commence Phase 1 Clinical Trials under an
active IND or CTA or any unfavorable result (interim or final) from
a Clinical Trial (or non-clinical toxicology study) that, as
reasonably determined by TGTX, causes material concerns regarding
the tolerability, safety or effectiveness of the
Product.

 

1.7  

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

 

1.8  

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

 

1.9  

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

 

1.10  

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

 

 

 

 

1.11  

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

 

1.12  

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

 

1.13  

“Combination”
shall mean a co-administration of Product combined with any other
active pharmaceutical ingredient.

 

1.14  

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

 

1.15  

“Confidential
Information” means, with respect to a Party, all confidential
Information of such Party that is disclosed to the other Party
under this Agreement, which may include, but is not limited to
specifications, know-how, trade secrets, legal information,
technical information, drawings, models, business information,
inventions, discoveries, methods, procedures, formulae, protocols,
techniques, data, and unpublished patent applications, in each case
whether disclosed in oral, written, graphic, or electronic
form.  All Confidential Information disclosed by either
Party pursuant to the Mutual Confidential Disclosure Agreement
between the Parties dated February 15, 2018 shall be deemed to be
such Party’s Confidential Information disclosed
hereunder.

 

1.16  

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

 

1.17  

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

 

1.18  

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

 

1.19  

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

 

1.20  

“Development
Expenses” means (i) any amounts payable by a Party for the
Development or Manufacturing of Finished Product (excluding the
cost of the NOVIMMUNE Initial Drug Supply), (ii) any amounts
payable by a Party for obligation to a third party for non-clinical
studies and Clinical Trials, (iii) the cost of supply of Finished
Product or bulk API used for the Development of the Product as well
as the freight, postage, shipping, transportation, insurance,
warehousing and handling charges paid  with regard to
such Finished Product or Bulk API.

 

1.21  

“Development
Plan” means the plan for Development in the
Territory.  The initial Development Plan is attached
hereto as Exhibit D and covers through the completion of the Phase
I clinical study.  Exhibit D may be from time to time
added or modified by the Joint Steering Committee (JSC), as per
section 2.2.

 

 

 

 

1.22  

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

 

1.23  

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

 

1.24  

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

 

1.25  

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

 

1.26  

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

 

1.27  

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

 

1.28
 

“Field" means
the prevention, diagnosis, treatment or amelioration of any disease
or condition in humans or animals.

 

1.29  

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

 

1.30  

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

 

1.31  

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

 

1.32  

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

 

1.33  

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

 

1.34  

“Biosimilar
Product” means a biologic product that (i) is highly similar
to the active ingredient in the Product where the Product is the
reference-listed biologic, and (ii) is approved by a Governmental
Authority pursuant to a Biosimilar License Application an
application under 42 U.S.C. §262(k), or similar
application.

 

1.35  

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

 

 

 

 

1.36  

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

 

1.37  

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

 

1.38  

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

 

1.39  

“IND”
means (a) an Investigational New Drug application as defined in the
FD&C Act and applicable regulations promulgated thereunder by
the FDA or any successor application or procedure required to
initiate clinical testing of a Product in humans in the Territory;
and (b) all supplements and amendments to the
foregoing.

 

1.40  

“IND/CTA
Filing Conditions” means the delivery to TGTX by Novimmune of
all the data and reports necessary and required to file an IND in
the United States, with the exception of the Investigator’s
Brochure.  The Parties will work together diligently to
ensure that all such data and reports are indeed delivered to TGTX,
including a reasonable search by Novimmune of specific items
believed to be in the possession of Novimmune at the request of
TGTX.

 

1.41  

“IND/CTA
Filing Deadline” means the date that is the greater of twelve
months from the Effective date or six months from the delivery of
the thirteen week toxicity report, subject to a reasonable
extension of up to an additional twelve months in the discretion of
the JSC.

 

1.42  

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

 

1.43  

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

 

1.44  

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

 

1.45  

 “Joint
Steering Committee” or “JSC” means the committee
formed by the Parties as described in Section
2.2.

 

1.46  

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

 

1.47  

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

 

1.48  

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

 

1.49  

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

 

 

 

 

1.50  

“Major
Market(s)”: shall mean any of the following countries or
groups of countries: (i) the *; (ii) *; (iii) *, *, *, *,
and the * (each, a “
* ”); (iv) *; and (v)
*, * or * (each, a “
* ”).

 

1.51  

“Manufacturing
Costs” shall mean Manufacturing Development Expenses plus any
costs incurred by TGTX to supply clinical trial material and
commercial supply (excluding the cost of the Novimmune Initial Drug
Supply).

 

1.52  

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

 

1.53  

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

 

1.54  

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

 

1.55  

“Minimum
Phase 1 Patients” shall mean the lesser of (i) * patients
enrolled into the Phase I Clinical Trial or (ii) the maximum number
of patients that are enrolled at the time the quantity of
ready-to-be-labeled Product that NOVIMMUNE has supplied runs
out.

 

1.56  

“BLA”
means a “Biologics License Application” (as more fully
defined in 21 C.F.R. 601 et
seq.) filed with the FDA or the equivalent application filed
with any other Regulatory Authority to obtain Regulatory Approval
for a Product in a country or jurisdiction in the
Territory.

 

1.57  

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

 

(a)  

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

 

(b)  

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

 

(c)  

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

 

(d)  

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

 

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

 

Further, the
Parties agree to negotiate in good faith for an equitable
determination of the Net Sales of the Product in the event TGTX or
its Affiliates or its Subcontractors sells the Product in such a
manner that gross sales of the Product are not readily identifiable
(e.g., for Product to be
sold as a Combination product or bundling with other
products).  In addition, for purposes of this Agreement,
“sale” shall mean any transfer or other distribution or
disposition, but shall not include transfers or other distributions
or dispositions of Product at no charge for academic research,
preclinical, clinical, or regulatory purposes (including the use of
a Product in Clinical Trials) or in connection with patient
assistance programs or other charitable purposes or to physicians
or hospitals for promotional purposes (including free samples to a
level and in an amount which is customary in the industry and/or
which is reasonably proportional to the market for such
Product).

 

 

 

1.58  

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

 

1.59  

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

 

1.60  

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

 

1.61  

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

 

1.62  

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

 

1.63  

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

 

1.64  

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

 

1.65  

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

 

1.66  

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

 

1.67  

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

 

1.68  

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

 

1.69
 

“Product”
means a pharmaceutical preparation in any formulation that contains
the anti-CD47/anti-CD19 bispecific antibody, NI-1701 (whose
sequence is depicted in Exhibit C), or any antibody sequence that
shares at least * % or greater
sequence identity to all the complementarity determining regions
(CDRs) in the sequence in Exhibit C, as an active
ingredient.

 

 

 

 

1.70  

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

 

1.71  

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

 

1.72  

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

 

1.73  

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

 

1.74  

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

 

1.75  

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

 

1.76  

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

 

1.77  

“NOVIMMUNE
License Option” means the one time option that NOVIMMUNE has
to supplant this Agreement with a Licensing Agreement in favor of
TGTX in a form as substantially shown in Exhibit F (attached
hereto), and as further described in Section 6.3,
below.

 

1.78  

“NOVIMMUNE
Product Patent” means any Patent, including NOVIMMUNE’S
interest in any Joint Patent, that (a) is Controlled by NOVIMMUNE
or its Affiliates at any time during the Term, and (b) specifically
claims the Product or its specific manufacture or specific use. The
list of NOVIMMUNE Product Patents as of the Effective Date is
attached hereto as Exhibit B(1), and shall be from time to time
amended and updated during the Term to incorporate the then-current
NOVIMMUNE Product Patents.

 

1.79  

“NOVIMMUNE
Platform Patent” means any Patent, including
NOVIMMUNE’S interest in any Joint Patent, that (a) is
Controlled by NOVIMMUNE or its Affiliates at any time during the
Term, and (b) generically claims the Product or its manufacture or
use, or any other invention that is otherwise necessary for the
Development, Finished Manufacture or Commercialization of the
Product. The list of NOVIMMUNE Platform Patents as of the Effective
Date is attached hereto as Exhibit B(2), and shall be from time to
time amended and updated during the Term to incorporate the
then-current NOVIMMUNE Platform Patents.

 

1.80  

“NOVIMMUNE
Technology” means the NOVIMMUNE Platform Patents and
NOVIMMUNE Know-How.

 

1.81  

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

 

1.82  

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

 

 

 

 

1.83  

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

 

1.84  

“Territory”
means worldwide.

 

1.85  

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

 

1.86  

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

 

1.87  

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

 

1.88  

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

 

1.89  

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

 

1.90  

“TGTX License
Option” means the one time option that TGTX has to supplant
this Agreement with a Licensing Agreement in favor of TGTX in a
form as substantially shown in Exhibit F (attached hereto), and as
further described in Section 6.2, below.

 

1.91  

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

 

1.92  

“Valid
Claim” means (a) any claim of an issued unexpired patent that
(i) has not been permanently revoked, held invalid, or declared
unpatentable or unenforceable in a decision of a court or other
body of competent jurisdiction that is unappealable or unappealed
within the time allowed for appeal, and (ii) is not lost through an
interference proceeding that is unappealable or unappealed within
the time allowed for appeal; or (b) provided there is no Biosimilar
Product available in the market, a claim of a pending Patent
application, which claim has not been abandoned or finally
disallowed without the possibility of appeal or which has not been
pending for more than * years from its
filing date.

 

 

 

 

* Confidential material redacted and filed separately with
the Commission.

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
II.                                ARTICLE
2

 

 

SECTION
2.01                                MANAGEMENT

 

Collaboration Overview.  The
Parties desire and intend to form this JV to collaborate with
respect to the Development and Commercialization of the Product as
a single agent and/or as a Combination in the Territory, as and to
the extent set forth in this Agreement in two steps: (i) the First
Step shall be from the date hereof up to the start of a Phase III
Clinical Trial, i.e. first patient dosed, and (ii) the Second Step
being the continuation of the JV, unless and until one of the
Parties exercises its License Option (as set forth  in
Article 6).  During the First Step, TGTX shall carry-out
the activities set forth in Exhibit D at its own cost and expense
under the supervision and guidance of the JSC.  Following
the completion of the First Step and prior to either Party
exercising its License Option, the Parties shall participate in the
joint development of the Product as set forth in this Agreement,
including sharing of Development and Commercial Expenses incurred
in connection with the performance of the Development Plan in
accordance with Article 3.

 

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

 

2.1  

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

 

2.2  

Joint
Steering Committee.

 

(a)  

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

 

(i)  

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

 

(ii)  

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

 

(iii)  

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

 

(iv)  

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

 

(v)  

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

 

(vi)  

to inform the other
Party of up-coming material internal events and decisions related
to the Product and its Development;

 

(vii)  

to discuss material
submissions to FDA and any other Regulatory
Authorities;

 

(viii)  

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

 

(ix)  

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

 

(x)  

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

 

 

 

 

(xi)  

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

 

(b)  

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

 

(c)  

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

 

2.3  

JSC Meetings, Decisions and
Actions.

 

(a)  

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

 

(b)  

Decision Making.  Except as
expressly provided in this Section 2.3, actions to be taken by the
JSC shall be taken only following * vote during the Second Step,
with each Party having * ( * ) vote, with the caveat that during
the First Step, in the event of disagreement, * shall have the
final decision.

 

(c)  

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

 

(d)  

Location of in-person
meetings.  Meetings to be held in person shall be
held either (i) in a US city which is hosting a medical conference
that the Parties are otherwise attending or (ii) alternating
between home cities of each of the Parties.

 

2.4  

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

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
III.                                ARTICLE
3

 

 

SECTION
3.01                                CLINICAL
AND NON-CLINICAL PRODUCT DEVELOPMENT

 

Overview. TGTX shall Develop the Product
in the Territory as provided in this Article 3 and in accordance
with the then-current Development Plan.  The initial
Development Plan sets forth the Development activities to be
performed by TGTX under this Agreement during the First Step and,
for which the Development plan up to the end of Phase I is attached
hereto as Exhibit D.  Within * days following the
completion of Phase I, TGTX shall provide the JSC with an updated
Development Plan and any future updates thereof shall be submitted
to the JSC for review and approval in accordance with Article
2.

 

3.1  

Development Plan.  The initial
Development Plan through end of Phase I has been agreed upon by the
Parties and is attached hereto as Exhibit D and incorporated herein
by reference.  TGTX will be responsible for conducting
the activities in the Development Plan. Upon the completion of
Phase I, the Development Plan will be updated and presented to the
JSC and shall contain the following information for the Product, to
the extent such information is available:

 

(a)  

the proposed
overall plan for further Development for the Product to support
Regulatory Approval in the *, * and *;

 

(b)  

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

 

(c)  

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

 

(d)  

TGTX forecast for
clinical supply of such Finished Product and/or Bulk
API.

 

3.2  

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

 

3.3  

Development
Expenses.

 

(a)  

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

 

(i)  

During the First
Step, all expenses and activities are the responsibility of
*, as
per the Development Plan described in Exhibit D, and subsequent
activities required to complete the First Step;

 

(ii)  

After the First
Step, total Development Expenses shall be borne based on each
Parties P/L Share Percentage;

 

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

 

TGTX: *
%

 

NOVIMMUNE: *
%

 

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

 

 

 

 

(iii)  

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

 

(iv)  

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

 

(v)  

Within * ( * )
Business Days following the end of each calendar quarter, * shall
submit to * a written report setting forth in reasonable detail the
calculation of all Development Expenses for the Product, and the
calculation of any net amount owed by NOVIMMUNE to TGTX or by TGTX
to NOVIMMUNE, as the case may be, in order to ensure the
appropriate sharing of Development Expenses in accordance with the
provisions of Section 3.3(a) (ii).  The net amount
payable shall be paid to the other Party, as the case may be,
within * ( * ) days following the receipt of the written report;
provided, that, in the event of a dispute, any amounts not in
dispute shall be paid and the disputing Party shall provide written
notice without undue delay after receipt of the written report in
question to the other, specifying such dispute and explaining the
basis of the dispute.  The Parties shall promptly
thereafter meet and negotiate in good faith a resolution to such
dispute and, promptly upon resolution of such dispute, the
applicable Party shall make the agreed-upon payment.  If
such dispute is not resolved within * ( * ) days after
delivery of a notice of dispute with respect thereto to the other
Party, the disputing Party may audit the other Party in accordance
with the provisions of Section 8.7.  For clarity, nothing
in this Section 3.3(a) (v) shall serve to limit a Party’s
ability to seek recourse for billing errors discovered after
payment is made.

 

(vi)  

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

 

(vii)  

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

 

(b)  

Any reimbursement
payments made pursuant to this Section 3.3 shall be subject to the
general payment procedures set forth in Sections 8.5 and
8.6.

 

 

 

 

3.4  

Performance;
Diligence.

 

(a)  

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

 

(b)  

Without limiting
the generality of Section 3.4(a), TGTX shall devote Diligent
Efforts to obtaining Regulatory Approval of the Product in the
Territory.

 

(c)  

TGTX shall conduct
its Development activities under this Agreement in a good
scientific manner and in compliance with all applicable Laws,
including without limitation applicable GCP, GLP, and
GMP.

 

3.5  

Records, Reports and
Information.  Each Party shall maintain complete,
current and accurate records of all work conducted by it under the
Development Plan and all data and other Information resulting from
such work.  Such records shall fully and properly reflect
all work done and results achieved in the performance of the
Development Plan in sufficient detail and in a good scientific
manner appropriate for patent and regulatory
purposes.  Each Party shall have the right to review such
records maintained by the other Party at reasonable times, upon
written request.  Each Party shall provide written
reports in English to the JSC on its Development and regulatory
activities with the Product pursuant to the Development Plan on a *
basis at the end of each calendar * , at a level of
detail reasonably sufficient to enable the other Party to determine
the reporting Party’s compliance with its Diligent Efforts
obligation pursuant to Section 3.4.

 

3.6  

Manufacturing
Development.

 

(a)  

Duties. * shall be responsible for the
Manufacturing Development for the Bulk API and Finished Product,
(except with regard to the Novimmune Initial Drug Supply), itself
or through a Third Party contract manufacturer.

 

(b)  

Comparator Drugs.  * shall be
responsible for procuring all comparator drugs or placebos
necessary for conducting non-clinical studies and Clinical Trials
and the cost of these agents up to the end of the First Step. After
which, the costs and expenses related to the Comparator Drugs or
placebos for the Development shall be included in the Development
Expenses.

 

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
IV.                                ARTICLE
4

 

 

SECTION
4.01                                REGULATORY
MATTERS

 

4.1  

Transfer
of Data and Regulatory Materials.

 

(a)  

Existing Data.  Within
*  ( * ) of
the Effective Date, NOVIMMUNE shall provide copies of all
preclinical, non-clinical data and manufacturing reports (Exhibit
G), for Product as a single agent, relevant to an IND or CTA
submission.  * shall have the full right, without any
additional consideration, to use any and all such data and reports
to support collaborations on their bispecific antibody platform
using their anti-CD47 platform arm. * shall have the full right on
behalf of JV, without any additional consideration, to use any and
all such data and reports in connection with the Development and/or
Commercialization of the Product in the Territory, including the
incorporation of such data or reports in any regulatory
submissions, including MAA and BLA submissions.

 

(b)  

Future Data.  Novimmune shall,
in a timely manner and compliant with requirements of the FDA, the
EMA, and any other applicable Regulatory Authority, provide to TGTX
copies of all preclinical, non-clinical, analytical, manufacturing,
and clinical data relating to the Product either as single agent or
in Combination, generated by or on behalf of Novimmune that is
related to the Product.  TGTX shall provide to Novimmune
all completed clinical study reports and Novimmune shall have the
right to use these reports solely for the purposes of decision
making on Novimmune other programs.  Novimmune will treat
these reports as TGTX Confidential Information.  TGTX
shall have the full right, without any additional consideration, to
use any and all such data and reports in connection with the
Development and/or the Commercialization of the Product in the
Territory, including the incorporation of such data or reports in
any regulatory submissions including MAA and/or BLA
submissions.

 

4.2  

Regulatory
Submissions and Approvals.

 

(a)  

In General.  The Parties
intend to seek Regulatory Approval in the first instance in
the  * , * and  * thereafter the remainder of
the Territory wherein the JSC determines it is worthwhile to
Develop and Commercialize the Product. Subject to the terms of this
Article 4:

 

(i)  

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

 

(1)  

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

 

(2)  

* shall have primary
responsibility for providing the content of Regulatory Materials
relating to clinical data supporting Regulatory
Approval;

 

(ii)  

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

 

(b)  

Costs and Expenses.  Until
completion of the First Step, all expenses associated with
preparation, submission and maintenance of regulatory materials for
the Territory will be borne by  *. Following the First
Step, any Development Expenses to the extent required for the
Parties to prepare, submit and maintain all Regulatory Materials in
the Territory shall be treated as Development Expenses
and  * in accordance with Section
3.3.

 

 

 

 

4.3  

Rights of Reference to Regulatory
Materials.   Each Party hereby grants to the
other Party a right of reference to all Regulatory Materials filed
by such Party for Product as follows:  The right of
reference granted to  * herein shall be solely for the
purpose of  * obtaining Regulatory Approval for the
Product in the Territory.

 

4.4  

Reporting
and Review.

 

(a)  

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

 

(b)  

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

 

4.5  

Regulatory
Inspection or Audit.

 

(a)  

Audit
of TGTX.

 

(i)  

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

 

(b)  

Audit
of NOVIMMUNE.

 

(ii)  

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

 

 

 

 

(c)  

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

 

4.6  

Recalls and Voluntary
Withdrawals.   JSC shall assign
responsibility to  * for providing its internal standard
operating procedures (“SOPs”) for conducting any
recall, field alert, product withdrawal or other field action
relating to the finished product reasonably in advance of the First
Commercial Sale of any Product in the Territory to the other
party.  If either Party becomes aware of information
relating to any Product that indicates that a unit or batch of
Finished Product or Bulk API may not conform to the specifications
therefor, or that potential adulteration, misbranding, or other
issues have arisen that relate to the safety or efficacy of the
Product, it shall promptly so notify the other
Party.  The JSC shall meet to discuss such circumstances
and to consider and decide appropriate courses of action, which
shall be consistent with the internal SOP
of  *,     * shall have the
right and responsibility to control any product recall, field
correction, or withdrawal of any Product in the Territory that is
required by Regulatory Authorities in the Territory, and the
allocation of reasonable expenses incurred in connection with such
recall between the Parties shall be made as follows: (i) if the
recall is primarily due to a failure by  * to comply with
its obligation under this Agreement or the commercial supply
agreement, including with respect to the labeling, possession,
storage or distribution of the finished product, then  *
shall bear all such expenses, and (ii) otherwise, such expenses
shall be treated as Commercial Expenses.  In addition, *
shall have the right, at its discretion, to conduct any product
recall, field correction or withdrawal of any Product in the
Territory that is not so required by such Regulatory Authorities
but that * deems to be
appropriate, and the allocation of expenses incurred in connection
with such recall between the Parties shall be as set forth in the
immediately preceding sentence.  * shall maintain
complete and accurate records of any recall in the Territory for
such periods as may be required by applicable Laws, but in no event
for less than  * ( * ) *.

 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
V.                                ARTICLE
5

 

 

SECTION
5.01                                COMMERCIALIZATION

 

 

5.1  

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

 

5.2  

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

 

5.3  

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

 

5.4  

Sales and Distribution.  * shall be solely responsible for
handling all returns, order processing, invoicing and collection,
distribution, and inventory and receivables for the Product
throughout the Territory.  * shall have the right and
responsibility for establishing and modifying the terms and
conditions with respect to the sale of the Product throughout the
Territory, including any terms and conditions relating to or
affecting the price at which the Product shall be sold, discounts
available to any third party payers (including, without limitation,
managed care providers, indemnity plans, unions, self-insured
entities, and government payer, insurance or contracting programs
such as Medicare, Medicaid, or the U.S. Dept. of Veterans Affairs),
any discount attributable to payments on receivables, distribution
of the Product, and credits, price adjustments, or other discounts
and allowances to be granted or refused provided that NOVIMMUNE had
the opportunity to review and comment on such modifications, within
a period of  * days, thereof, and TGTX shall consider
NOVIMMUNE’S comments in good faith.

 

5.5  

TGTX
Performance; Diligence.

 

(a)  

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

 

 

 

 

(b)  

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

 

(c)  

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

 

5.6  

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

 

 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
VI.                                ARTICLE
6

 

 

SECTION
6.01                                LICENSE
AND LICENSE OPTIONS

 

 

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

 

6.1  

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

 

6.2  

TGTX License Option.  Any time
prior to the start of *, TGTX shall have
the exclusive right to convert this Agreement into a License
Agreement. If TGTX exercises this Option, then both Parties will
automatically enter into a licensing agreement under the same terms
and conditions as set forth in Exhibit F, provided however that the
terms of Section 6 of the form of Licensing Agreement shall remain
unchanged unless mutually agreed by the
Parties.

 

6.3  

Novimmune License
Option.  Within  * ( * ) days of the
start of a Phase III Clinical Trial where the Product is used
either as a single agent or in Combination with another active
pharmaceutical ingredient, NOVIMMUNE shall have the exclusive right
to convert this Agreement into a License Agreement.  If
NOVIMMUNE exercises this Option, then the Parties will
automatically enter into a licensing agreement under the same terms
and conditions as set forth in Exhibit F, provided however that the
terms of Section 6 of the form of Licensing Agreement shall remain
unchanged unless mutually agreed by the
Parties.

 

6.4  

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

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
VII.                                ARTICLE
7

 

 

SECTION
7.01                                MANUFACTURE
AND SUPPLY

 

7.1  

Roles
of the Parties.

 

NOVIMMUNE shall
supply  * g of
ready-to-be-labeled Product to the JV to support the Phase I
Clinical Trial ("Novimmune Initial Drug Supply”) within a
maximum of  * months after of the Effective Date. TGTX
and NOVIMMUNE shall work together to secure a manufacturing slot
with * in * (or the next available date), at  *
expense.  If Novimmune secures the manufacturing slot,
then on receipt of an invoice from  *, * shall
invoice  * and  * shall pay  * in
full for any payment in connection therewith within  * (
* ) business days from receipt of an invoice from  * for
such payment.  Thereafter  *, at  *
expense, shall be responsible to supply, or cause to be supplied
through its Third Party contract manufacturers, in a timely manner
consistent with a relevant supply agreement between the parties,
JV’s entire requirements of Bulk API and Finished Product, in
addition to the Product supplied by NOVIMMUNE, for the Development
and Commercialization of the Product as a single agent by the
Parties in or for the Territory in accordance with this Article
7.

 

7.2  

Clinical Supply.  In addition
to the NOVIMMUNE Initial Drug Supply to be used in the Phase I
Clinical Trial, TGTX by itself or through its Third Party contract
manufacturers, will use Diligent Efforts to supply all remaining
Product required to complete Phase I and Phase II Clinical Trials.
After completion of the First Step, the JV will be responsible for
supplying all quantities of Finished Product or Bulk API required
by TGTX to Develop the Product in the Territory pursuant to the
Development Plan.  Such quantities of Finished Product,
and the schedule for such supply, shall be confirmed and if
necessary updated by the JSC in a manner consistent with the
Development Plan.

 

7.3  

Manufacturer
Source.

 

(a)  

The Parties shall
establish an appropriate facility or contract manufacturing
organization for handling Finished Manufacture as
follows:  * shall be responsible for selecting
manufacturer(s) to supply the Finished Product required to complete
the Phase I and Phase II Clinical Trials, in addition to the
quantity of ready-to-be-labeled Product supplied by NOVIMMUNE. This
will involve negotiating the applicable supply agreement, and
effecting the technology transfer as necessary to establish and
qualify Bulk API and Finished Product
manufacturers.

 

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
VIII.                                ARTICLE
8

 

 

SECTION
8.01                                COMPENSATION

 

8.1  

 Initiation
Fee.

 

(a)  

As initiation fee
for the JV, concomitantly with the delivery of the preclinical,
non-clinical and manufacturing reports (Exhibit G) as per Section
4.1, TGTX shall pay to NOVIMMUNE a fee of Three Million US Dollars
($3,000,000) in its equivalent of TGTX shares (the
“Initiation Fee”).  In addition, NOVIMMUNE
shall supply TGTX with the Novimmune Initial Drug Supply within a
maximum of * ( * ) months as of the Effective
Date.

 

(b)  

Furthermore,
within  * (  * ) days following
written notification by TGTX (the “Notification Date”)
that the  *  patient has entered into the Phase
I Clinical Trial or at a time that the quantity of
ready-to-be-labeled Product that NOVIMMUNE has supplied runs out,
whichever is the earliest, TGTX shall pay to NOVIMMUNE an
additional collaboration fee of  * US Dollars ($ * ) in
its equivalent in TGTX shares (the “Milestone
Payment”), provided that this Agreement has not been
terminated pursuant to Section 13.

 

(c)  

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

 

(d)  

For payments made
in TGTX Shares pursuant to this Section 8.1, the number of shares
of Common Stock of TGTX owed shall equal a fraction where the
numerator is the  * and the denominator is
the  *.  For purposes of this Section 8.1, the
“ * ” means the  * (or, * ) for
the  * ( * ) trading days prior to the Effective Date (in
the case of the Initiation Fee) or the Notification Date (in the
case of the Milestone Payment); provided, however, that in the
event that TGTX effects a stock split, combination or stock
dividend at any time during such  * trading days or
subsequent thereto and prior to the issuance of the TGTX Shares,
the number of shares of TGTX Common Stock issuable shall be
appropriately adjusted to give effect to such
action.  TGTX shall issue to Novimmune certificates
representing the TGTX Shares as required by Sections 8.1(a) and
(b).  Within  * (  * ) business days
of the issuance of such certificates for the TGTX shares, TGTX
shall file a resale registration statement covering such shares and
shall use Diligent Efforts to make such resale registration
statement effective as quickly as possible.  TGTX
covenants to use Diligent Efforts to keep such registration
statement continuously effective until such time as such shares can
be sold without restriction under Rule 144.

 

8.2  

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

 

 

 

 

8.3  

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

 

8.4  

Taxes.

 

(a)  

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

 

(b)  

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

 

(c)  

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

 

(d)  

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

 

8.5  

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

 

8.6  

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

 

8.7  

Records; Audits.  Each Party
shall maintain complete and accurate records in sufficient detail
to permit the other Party to confirm the accuracy of the
calculation of payments to the other Party under this
Agreement.  Upon reasonable prior notice, such records
shall be available during regular business hours of audited Party
for a period of  * ( * ) years from
the creation of individual records for examination at auditing
Party’s expense, and not more often than once each Fiscal
Year, by an independent certified public accountant selected by
auditing Party and reasonably acceptable to audited Party, for the
sole purpose of verifying the accuracy of the financial reports
furnished pursuant to this Agreement.  Any such auditor
shall not disclose audited Party’s Confidential Information,
except to the extent such disclosure is necessary to verify the
accuracy of the financial reports furnished by audited Party or the
amount of payments due by audited Party under this
Agreement.  Any amounts shown to be owed but unpaid shall
be paid within  * ( * ) days from the accountant’s
report, plus interest (as set forth in Section 8.6) from the
original due date.  Any amounts determined to be overpaid
shall be refunded within  * ( * ) days from the
accountant’s report.  The auditing Party shall bear
the full cost of such audit unless such audit discloses an
underpayment of the amount actually owed during the applicable
Fiscal Year of more than  * %, in which case audited
Party shall bear the full cost of such audit.

 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

 

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

 

ARTICLE
IX.                                ARTICLE
9

 

 

                        
SECTION
9.01                                INTELLECTUAL
PROPERTY MATTERS

 

9.1  

Ownership of Inventions and Know
How.  Any new information, discovery, or invention
observed, conceived or made pertaining to the Product, its
manufacture, or use during the term of this Agreement will be owned
either solely by one Party (“Sole Know-How” or
“Sole Invention”) or jointly by both Parties
(“Joint Know-How” or “Joint Invention”)
according to a proper determination of inventorship based on U.S.
patent laws.  Sole or Joint ownership flows to the Party
that employs, or otherwise contracts with, a properly named
inventor or co-inventor.

 

Sole Know-How and
Sole inventions owned by TGTX and TGTX’s interest in all
Joint Know-How and Inventions shall be included in the TGTX
Technology.  Sole Know-How and Sole Inventions owned by
NOVIMMUNE and NOVIMMUNE’S interest in all Joint Know-How and
Inventions shall be included in the NOVIMMUNE Know-How, NOVIMMUNE
Product Patent, or NOVIMMUNE Platform Patent, as the case might be,
except that NOVIMMUNE”s interest in a Joint Invention shall
be designated as a NOVIMMUNE Product Patent or as a NOVIMMUNE
Platform Patent according to the claimed subject matter, provided
that if the claimed subject matter includes a claim specifically
directed to the Product, NOVIMMUNE’s interest in a Joint
Invention shall be included in the NOVIMMUNE Product Patent
regardless of the presence in the same patent or patent application
of claimed subject matter providing generic Product
coverage.

 

9.2  

Disclosure of
Inventions.  Each Party shall promptly disclose to
the other any invention disclosures, or other similar documents,
submitted to it by its employees, agents or independent contractors
describing inventions that may be either Sole Inventions or Joint
Inventions, and all Information relating to such
inventions.  Any Novimmune Know-How, TGTX Know-How,
Novimmune Product Patents or TGTX Patents generated or discovered
during the term of this Agreement shall * in this
Agreement.

 

9.3  

Prosecution
of Patents.

 

(a)  

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

 

 

 

 

(b)  

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

 

(c)  

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

 

(d)  

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

 

9.4  

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

 

9.5  

Infringement
of Patents by Third Parties.

 

(a)  

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

 

(b) Infringement
of Patents in the Territory.

 

(i)  

If a Party becomes
aware that a Third Party infringes any NOVIMMUNE Product Patent,
TGTX Patent, or Joint Patent in the Territory by making, using,
importing, offering for sale or selling the Product or any similar
anti-CD47/anti-CD19 bispecific antibody covered by any of such
Patents (such activities, “Product Infringement”), then
such Party shall so notify the other Party as provided in Section
9.5(a), which such notice shall include all Information available
to the notifying Party regarding such alleged
infringement.

 

 

 

 

(ii)  

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

 

(iii)  

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

 

(c)  

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

 

9.6  

Infringement
of Third Party Rights in the Territory.

 

(a)  

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

 

(b)  

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

 

 

 

 

(c)  

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

 

(d)  

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

 

9.7  

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

 

9.8  

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

 

9.9  

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

 

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
X.                                ARTICLE
10

 

 

SECTION
10.01                                REPRESENTATIONS
AND WARRANTIES

 

 

10.1  

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

 

a.  

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

 

b.  

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

 

c.  

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

 

d.  

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

 

10.2  

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

 

a.  

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

 

b.  

Sufficiency
of License Grants.

 

i.  

Except as set forth
on Schedule 10.2(b)(i) hereto, to NOVIMMUNE’s best knowledge
at the Effective Date the NOVIMMUNE Product Patents and NOVIMMUNE
Platform Patents are not subject to any encumbrance, lien or claim
or ownership by any Third Party that is inconsistent with the
rights and (sub)licenses granted to TGTX
hereunder;

 

ii.  

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

 

iii.  

No claim or
litigation has been brought or, to NOVIMMUNE’s best knowledge
at the Effective Date, is threatened to be brought, by any person
or entity alleging that (A) any of the NOVIMMUNE Product Patents or
NOVIMMUNE Platform Patents in the Territory is invalid or
unenforceable, or (B) practice of any of the NOVIMMUNE Product
Patents or NOVIMMUNE Platform Patents for making, using or selling
a Product in the Territory infringes or otherwise conflicts or
interferes with any intellectual property or proprietary right of
any Third Party;

 

 

 

 

iv.  

To
NOVIMMUNE’s best knowledge at the Effective Date, no Third
Party has infringed or misappropriated any NOVIMMUNE Product
Patents or NOVIMMUNE Platform Patents by making, using, importing,
offering for sale or selling the Product and, as of the Effective
Date, there is no actual or threatened infringement or
misappropriation of the NOVIMMUNE Product Patents or NOVIMMUNE
Platform Patents by any Third Party by making, using, importing,
offering for sale or selling the Product;

 

v.  

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

 

vi.  

This Agreement is
consistent with all Novimmune’s Third Party license
agreements in all respects and does not conflict with, violate,
breach or otherwise give rise to a default by NOVIMMUNE under, any
term of any of Novimumme’s Third Party license
agreements;

 

vii.  

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

 

c.  

Supply of Finished Product by
NOVIMMUNE.  The ready-to-be-labelled Product
supplied by NOVIMMUNE to TGTX pursuant to this Agreement
(“Novimmune Initial Drug Supply”) shall be
manufactured, handled and stored by NOVIMMUNE or its Third Party
contract manufacture(s) in compliance with applicable Laws and
regulations, including without limitation, GMP
requirements.

 

10.3  

Additional
Representations of TGTX.

 

a.  

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

 

b.  

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

 

10.4  

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

 

10.5  

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

 

 

 

 

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

 

ARTICLE
XI.                                ARTICLE
11

 

 

SECTION
11.01                                INDEMNIFICATION

 

11.1  

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

 

11.2  

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

 

11.3  

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

 

11.4  

Insurance. Each Party shall procure and
maintain insurance adequate to cover its obligations hereunder and
which are consistent with normal business practices of prudent
companies similarly situated at all times during which any Product
is being clinically tested in human subjects or commercially
distributed or sold.  During the First Step, TGTX shall
procure and maintain clinical trial insurance according to the laws
and regulations of each country in which the Phase I and Phase II
Clinical Trials are performed. It is understood that such insurance
shall not be construed to create a limit of either Party’s
liability with respect to its indemnification obligations under
this Article 11.  Each Party shall provide the other with
written evidence of such insurance upon request.  Each
Party shall provide the other with written notice at least 
*
(  * ) days prior to the cancellation, non-renewal or
material change in such insurance or self-insurance which
materially adversely affects the rights of the other Party
hereunder.

 

 

 

* Confidential material redacted and filed separately with
the Commission. 

 

 

 

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

 

ARTICLE
XII.                                ARTICLE
12

 

 

SECTION
12.01                                CONFIDENTIALITY

 

12.1  

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

 

(a)  

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

 

(b)  

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

 

(c)  

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

 

(d)  

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

 

(e)  

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

 

12.2  

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

 

(a)  

filing or
prosecuting Patents as permitted in this
Agreement;

 

(b)  

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

 

(c)  

prosecuting or
defending litigation or other proceedings or regulatory
actions;

 

(d)  

complying with
applicable Laws;

 

(e)  

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

 

(f)  

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

 

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

 

 

 

 

12.3  

Publicity;
Terms of Agreement.

 

(a)  

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

 

(b)  

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

 

(c)  

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

 

12.4  

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

 

12.5  

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

 

 

*
Confidential material redacted and filed separately with the
Commission. 
 

*
Confidential material redacted and filed separately with the
Commission. 
 

*
Confidential material redacted and filed separately with the
Commission. 

 

 

 

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

 

ARTICLE
XIII.                                ARTICLE
13

 

 

SECTION
13.01                                TERM
AND TERMINATION

 

13.1  

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

 

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

 

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

 

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

 

13.2  

Termination.

 

(a)  

Early Withdrawal by TGTX without any cause.  TGTX shall have no right to
terminate this Agreement until the enrollment  of the
Minimum Phase 1 Patients in the Phase I Dose Escalation study (see
Exhibit D). Thereafter, TGTX shall have the right to terminate this
Agreement, in its entirety, upon written notice to NOVIMMUNE by at
least  * written (  * ) notice prior
to the effective date of termination.  If TGTX terminates
this Agreement pursuant to this Section 13.2(a),
then:

 

(i)  

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

 

(ii)  

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

 

(iii)  

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

 

(iv)  

If TGTX terminates
prior to enrollment of the Minimum Phase 1 Patients then TGTX shall
pay NOVIMMUNE an amount equal to  * % of the Milestone
Payment.

 

(v)  

TGTX shall be
responsible for any cancellation fees payable to *, incurred on
termination of this Agreement.

 

(b)  

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

 

(i)  

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

 

(ii)  

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

 

(iii)  

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

 

(iv)  

TGTX shall be
responsible for any cancellation fees payable to *, incurred on
termination of this Agreement.

 

 

 

 

(c)  

Termination
for Breach.

 

(i)  

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

 

(ii)  

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

 

(iii)  

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

 

(d)  

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

 

13.3  

NOVIMMUNE Termination for TGTX Failure to File
IND/CTA: Notwithstanding Section 13.2(b) above if the
IND/CTA Filing Conditions are met and TGTX fails to file an IND or
CTA in a Major Market on or before the applicable IND/CTA Filing
Deadline (other than for reasons beyond the reasonable control of
TGTX, such as the requirements of the applicable Regulatory
Authority), NOVIMMUNE may terminate this Agreement on  *
(  * ) days’ written notice to TGTX unless TGTX
makes such filing, or is determined by the JSC to be actively in
the process of making such filing before the end of  *
(  * ) days’ written notice to
TGTX.  Notwithstanding the foregoing, if TGTX decides to
conduct the first Phase 1 study outside of the United States or in
a Major Market, then this condition shall be satisfied by the
enrollment of the first patient in such study.

 

13.4  

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

 

13.5  

Effect of Termination of the
Agreement.  Upon termination by NOVIMMUNE of the
Agreement under Section 13.2(c), Section 13.3, Section 13.4 or
Section 13.5, or upon termination by TGTX under Section 13.2(a) and
13.2(b), the following shall apply (in addition to any other rights
and obligations under Section 13.7 or 13.8 or otherwise under this
Agreement with respect to such termination) with respect to the
affected territory or territories:

 

 

 

 

a.  

Intellectual
Property.  NOVIMMUNE shall have the right,
exercisable upon written notice by NOVIMMUNE to TGTX given
within  *1 (  * ) days after the
effective date of such termination, to obtain, and effective upon
such notice, TGTX shall, and it hereby does, grant to NOVIMMUNE, a
perpetual, non-exclusive, worldwide, royalty-bearing license, with
the right to sublicense, under TGTX Intellectual Property Rights
(which, for purposes of this Section 13.5(a) shall not include the
Joint Patents or the Joint Know-How, but see below) solely to
develop, make, have made, use, sell, offer for sale, have sold and
import the Products in the Field of Use, subject to the terms and
conditions set forth below in subparagraph (c).  TGTX
shall provide to NOVIMMUNE when enforcing any such rights under
this Section 13.5(a) reasonable assistance in such enforcement, at
NOVIMMUNE’S request and cost, including joining such action
as a party plaintiff if required by applicable Law to pursue such
action.  In consideration for such non-exclusive license,
NOVIMMUNE shall pay to TGTX a royalty that is  * % of the
royalty amounts set forth in Exhibit F.  The royalty will be
paid out of NOVIMMUNE’S gross profits following the first
commercial sale of the Product, and which gross profits will be
based on all amounts paid to NOVIMMUNE from its sublicensing or
from sales directly or indirectly in the particular country or
Territory.  The term of such royalty will expire on the
expiration of the last to expire issued Valid Claim within the TGTX
Patents or Joint Patents covering the Product in the particular
country or Territory.

 

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

 

b.  

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

 

c.  

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

 

d.  

Remaining
Inventories.  NOVIMMUNE shall have the right to
purchase from TGTX all of the inventory of ready-to-be-labelled and
Finished Product held by TGTX for such terminated country(ies) as
of the effective date of termination of this Agreement at a price
equal to TGTX’s cost to acquire or manufacture such inventory
for such terminated country(ies).  NOVIMMUNE shall notify
TGTX within  2 (  * )
days after the date of termination of the Agreement whether
NOVIMMUNE elects to exercise such right.  If NOVIMMUNE
does not exercise such right, then TGTX shall have the right to
sell in such terminated country(ies) of the Territory any such
remaining inventory over a period of no greater than  *
(  * ) months after the effective date of termination of
this Agreement provided TGTX  makes appropriate payment
to NOVIMMUNE under similar terms of the prevailing
P/L  arrangements.

 

 

 

 

e.  

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

 

f.  

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

 

13.6  

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

 

13.7  

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

 

13.8  

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

 

  

* Confidential material redacted and filed separately with
the Commission. 

 

* Confidential material redacted and filed separately with
the Commission. 

  

* Confidential material redacted and filed separately with
the Commission. 

 
1 Confidential
material redacted and filed separately with the
Commission. 

 
2 Confidential
material redacted and filed separately with the
Commission. 

 

 

 

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

 

ARTICLE
XIV.                                ARTICLE
14

 

 

SECTION
14.01                                DISPUTE
RESOLUTION

 

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

 

14.2 Disputes.

 

(a)  

The Parties
recognize that disputes as to certain matters may from time to time
arise during the Term which relate to either Party’s rights
or obligations hereunder.  It is the objective of the
Parties to establish procedures to facilitate the resolution of
disputes arising under this Agreement in an expedient manner by
mutual cooperation and without resort to litigation.  To
accomplish this objective, the Parties agree to follow the
procedures set forth in this Section 14.2 to resolve any
controversy or claim arising out of, relating to or in connection
with any provision of this Agreement, if and when a dispute arises
under this Agreement.  With respect to all disputes
arising between the Parties (other than those matters delegated to
the JSC, which shall be governed in accordance with Section
2.3(c)), including, without limitation, any alleged failure to
perform, or breach, of this Agreement, or any issue relating to the
interpretation or application of this Agreement, if the Parties are
unable to resolve such dispute within sixty (60) days after such
dispute is first identified by either Party in writing to the
other, the Parties shall refer such dispute to the senior executive
officers for each Party for attempted resolution by good faith
negotiations within  3 (  * )
days after such notice is received.  If the senior
executive officers designated by the Parties are not able to
resolve such dispute within such  * (  * ) day
period, either Party may submit such dispute in accordance with
Section 14.2(b).

 

(b)  

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

 

(c)  

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

 

 

  

3 Confidential
material redacted and filed separately with the
Commission. 

 

 

 

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

 

ARTICLE
XV.                                ARTICLE
15

 

 

SECTION
15.01                                MISCELLANEOUS

 

15.1  

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

 

15.2  

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

 

15.3  

Notices.  Any notice required
or permitted to be given under this Agreement shall be in writing,
shall specifically refer to this Agreement, and shall be addressed
to the appropriate Party at the address specified below or such
other address as may be specified by such Party in writing in
accordance with this Section 15.3, and shall be deemed to have been
given for all purposes (a) when received, if hand-delivered sent by
a reputable overnight delivery service, or by by e-mail, or (b)
4
(  * ) days after mailing, if mailed by first class
certified or registered mail, postage prepaid, return receipt
requested.

 

	
If to
NOVIMMUNE:

	
 

	
NOVIMMUNE,
S.A.

14 ch. des
Aulx,

1228
Plan-Les-Ouates,

Geneva,Switzerland

Attn: Eduard E.
Holdener

-Email:
Legal@novimmune.com

	
 

	
 

	
 

	
If to
TGTX:

	
 

 

	
 

TG Therapeutics
Inc.

2 Gansevoort Street
| 9th
Floor

New York, New York
10014

Attn: Michael S.
Weiss

 

 

15.4  

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

 

15.5  

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

 

15.6  

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

 

 

 

 

15.7  

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

 

15.8  

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

 

15.9  

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

 

15.10  

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

 

15.11  

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

 

15.12  

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

 

{Signature page
follows.}

 

 
4 Confidential
material redacted and filed separately with the
Commission. 

 

 

 

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

 

 

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

 

 

	
TG THERAPEUTICS,
INC.

	
 

	
NOVIMMUNE
SA

	
 

	
 

	
 

	
 

	
 

	
 

	
By:

	
 

	
 

	
By:

	
 

	
 

	
 

	
 

	
Name: Michael S.
Weiss

	
 

	
Name: Eduard E.
Holdener

	
 

	
 

	
 

	
Title: Chairman and
CEO

	
 

	
Title:  Chairman
and CEO

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
By:

	
 

	
 

	
 

	
 

	
 

	
 

	
Name:

	
 

	
 

	
 

	
 

	
 

	
Title:

 

 

 

 

 

 

 

 

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

 

 

Exhibits

 

Exhibit
A: Press release of Joint Venture announcement

 

	
Novimmune
SA

 

14 Chemin des
Aulx

1228
Plan-Les-Ouates

Geneva,
Switzerland

 

+41 22 839 71
41 Tel

+41 22 839 71
43 Fax

 

www.novimmune.com

 

 

[Missing Graphic Reference]

 

 

MEDIA
INFORMATION

 

 

Novimmune
SA and TG Therapeutics collaborate on novel treatment for
hematological malignancies

 

 

Geneva, Switzerland – XXXXX, 2018
– Novimmune SA, a privately held Swiss biopharmaceutical
company and TG Therapeutics (New York, USA), announced today that
they have entered into an exclusive global agreement to collaborate
on the development and commercialization of Novimmune’s
Anti-CD47/ Anti-CD19 bispecific antibody, NI-1701. The companies
will jointly develop the product on a global basis to treat B cell
malignancies. 

 

NI-1701, a
fully-human IgG1 bispecific antibody, is based on Novimmune’s
κλ body format and is designed to kill B cell tumors by
engaging phagocytes. The novel compound is the first anti-CD47
bispecific antibody world wide that will go into clinical
trials.

 

 

TG
Therapeutics will make up-front licensing payments and
milestone payments based on early clinical development. They will
cover the costs of clinical development of the products through
phase II. Both TG Therapeutics and Novimmune will then each
have various options to continue the development of the
molecule.

 

“We are
delighted to see our first bispecific antibody move forward into
the clinic with an experienced partner in the field of
hematological malignancies, and to provide proof of principle for
our completely novel approach”, said Chairman and Chief
Executive Eduard Holdener. We are excited about the potential
benefit that this new approach could bring to B cell lymphoma
patients.

 

 

 

 

About
Novimmune

 

Novimmune SA is a
privately held, Swiss biopharmaceutical company focused on the
discovery and development of antibody-based drugs for the targeted
treatment of inflammatory diseases, immune-related disorders, and
cancer. The company is headquartered in Geneva and runs a Clinical
and Commercial Development Center in Basel. The company currently
employs 130 people. More information is available on the company
website at www.novimmune.com.

 

 

Contact:

 

Eduard Holdener

 

+41 22 839 71 41

 

eholdener@novimmune.com

 

 

   
    About TG Therapeutics

 

TG Therapeutics is a biopharmaceutical
company focused on the acquisition, development and
commercialization of novel treatments for B-cell malignancies and
autoimmune diseases. Currently, the company is developing two
therapies targeting hematological malignancies and autoimmune
diseases. Ublituximab (TG-1101) is a novel,
glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing umbralisib
(TGR-1202), an orally available PI3K delta inhibitor for various
hematologic malignancies (www.tgtxinc.com)

 

 

Contact:

 

xxxxxxxxxxx

 

 

 

 

 

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

 

 

Exhibit
B: Novimmune Patents

 

B(1)           Product
Patents

 

CD47
mAbs & CD47 x CD19 bispecifics (NI-1701):

 

(*5 Ref. No. * // NovImmune Ref. No. *) is
directed to fully human antibodies that recognize CD47. This family
discloses the nucleic acid and amino acid sequences for a variety
of fully human anti-CD47 monoclonal antibodies and bispecifics that
bind CD47 and a second antigen developed by
NovImmune.  Specific CD19 sequences are disclosed in this
application.  The earliest cases in this family
include:

 

·  

U.S. Nonprovisional
Application No. * , filed * , * and claiming priority to a
provisional application filed * , *;

 

·  

National Stage
Applications based on PCT Application No. * , filed * , * and
claiming priority to a provisional application filed * ,
*

 

o  

This family is
filed in * , * , * , * , *

 

B(2)           Platform
Patents

 

(* Ref. No. * // NovImmune Ref. No. * )
* . The
cases in this family include:

 

·  

U.S. Nonprovisional
Application No. * , filed * , * and claiming priority to a
provisional application filed * , * ; and

 

·  

National Stage
Applications based on PCT Application No. * , filed * , * and
claiming priority to a provisional application filed * ,
*

 

o  

Pending in the * ;
Granted in * , * , * , * , * , * , and *

 

 

 (* Ref.
No. * // *
Ref. No. * ) * .  The cases in this
family include:

 

·  

U.S. Nonprovisional
Application No. * filed * , * and a provisional application filed *
, * ; and

 

 

·  

National Stage
Applications based on National Stage Applications based on PCT
Application No. * , filed * , *  and a provisional
application filed * , *

 

o  

Pending in * , * ,
* , * , *  (all cases in substantive
examination)

 

(* Ref.
No. * // *
Ref. No. * ) * . This family includes:

 

·  

U.S. Application
No. * and * , claiming priority to a provisional filed * ,
*

 

 

 
5 Confidential
material redacted and filed separately with the
Commission. 

 

 

 

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

 

 

Exhibit C:6 NI-1701 Sequence7

 

 

*

 

 

 

 
6 Confidential
material redacted and filed separately with the
Commission. 

 

7 Includes
Confidential Material redacted in the publicly-filed copy of the
Agreement.
 

 

 

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

 

 

Exhibit
D: Phase 1 clinical trial Plan

 

*

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

Exhibit
E:  Licensing Agreement

 

 

LICENSING
AGREEMENT

 

 

 

BY AND BETWEEN

 

 

 

TG
THERAPEUTICS, INC.

 

 

 

AND

 

 

 

NOVIMMUNE
S A

 

 

 

 

 

 

 

 

 

 

 

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

 

 

This Licensing
Agreement is made and entered into on [   ] (the
“Effective
Date”) by and between

 

Novimmune  S.A., a Swiss
corporation having its principal place of business at 14 ch. des
Aulx, 1228 Plan-Les-Ouates, Geneva, Switzerland
(“NOVIMMUNE”).

 

On the one
hand,

 

And

 

TG Therapeutics, Inc., a Delaware
corporation, with a place of business at 2 Gansevoort Street | 9th Floor, New York,
NY (“TGTX”).

 

On the other
hand;

 

WITNESSETH:

 

WHEREAS, Novimmune is a pharmaceutical
company focused on the development of novel CD47/CD19 bi-specific
antibodies for the treatment of various B-cell proliferative
diseases;

 

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

 

WHEREAS, Novimmune and TGTX are parties
to that certain Joint Venture and License Option Agreement, dated
[   ] May, 2018 (the “JV
Agreement”).

 

WHEREAS, The development of the Product
has, to date, progressed satisfactorily to each Party to the JV
Agreement, and each Party has upheld the responsibilities delegated
to such Party dictated in the JV Agreement;

 

WHEREAS, The JV Agreement affords
[TGTX/Novimmune] the option to convert the JV into an exclusive
license to the Product under the terms of Article 6.2 and
Exhibit F of such
JV Agreement;

 

WHEREAS, [TGTX/Novimmune] pursuant to
the JV Agreement wishes to exercise its option to in license to
TGTX all the proprietary rights in and to the compound known as
“NI-1701”and Novimmune agrees to out license
“NI-1701” to TGTX in order to develop, manufacture and
commercialize Products (as hereinafter defined); and

 

WHEREAS, both TGTX and Novimmune,
pursuant to the JV
Agreement wish to enter into
this definitive Agreement, which provides TGTX with an exclusive
license to develop, manufacture and commercialize Products (as
hereinafter defined) in the Field of Use (as hereinafter defined)
and in the Territory (as hereinafter defined), under the terms and
conditions set forth below;

 

 NOW, THEREFORE, in consideration of the
foregoing and the covenants and obligations set forth herein,
including the exhibits or appendices hereto, and intending to be
legally bound, TGTX and Novimmune hereby agree as
follows:

 

 

 

 

1  DEFINITIONS
AND INTERPRETATIONS

 

Terms, when used
with initial capital letters, shall have the meanings set forth
below or at their first use when used in this
Agreement:

 

1.1           “Agreement”:
shall mean this License Agreement

 

1.2           “API”:
shall mean an active pharmaceutical ingredient.

 

1.3           “BLA”:
shall mean a “Biologics License Application” (as more
fully defined in 21 C.F.R. 601 et
seq.) filed with the FDA or the equivalent application filed
with any other Regulatory Authority to obtain marketing approval
for a Product in a country or jurisdiction in the
Territory.

 

1.4           “Biosimilar
Product” means a biologic product that (i) is highly
similar to the active ingredient in the Product where the Product
is the reference-listed biologic, and (ii) is approved by a
Governmental Authority pursuant to a Biosimilar License
Application, an application under 42 U.S.C. §262(k), or
similar application.

 

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

 

1.6           “Change
of Control Transaction”: shall have the meaning
ascribed to this term in Article 16.

 

1.7           “Cause”
means, for purposes of Section 11.1, any unfavorable result from a
pre-clinical or clinical trial that, as reasonably determined by
TGTX, causes material concerns regarding the tolerability, safety
or effectiveness of the Product.

 

1.8           “Combination”
shall mean a co-administration of Product together with any other
product.

 

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

 

1.10           “Compound”:
shall mean NI-1701 as described herein and as used in
Product.

 

 

 

 

1.11           “Confidential
Information”: means, with respect to a Party, all
confidential information of such Party that is disclosed to the
other Party under this Agreement, which may include specifications,
know-how, trade secrets, legal information, technical information,
drawings, models, business information, inventions, discoveries,
methods, procedures, formulae, protocols, techniques, data, and
unpublished patent applications, in each case whether disclosed in
oral, written, graphic, or electronic form.  All Confidential
Information disclosed by either Party pursuant to the Mutual
Confidential Disclosure Agreement between the Parties dated
15th
February 2018 shall be deemed to be such Party’s Confidential
Information disclosed hereunder.

 

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

 

1.13           “Data”:
shall mean any and all scientific and research data, technical
data, test and development data, pre-clinical and clinical data
(including pharmacological, biological, chemical, biochemical,
toxicological, pre-clinical and clinical test data, analytical and
quality control data, stability data, results of studies and
patient lists), formulations, processes, protocols, regulatory
files and the like which are developed by either Party in
connection with the Compound or the Product.

 

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

 

1.15           “Development
Plan”: shall mean plans for development of the Product
as outlined in Exhibit D which shall be provided by TGTX and
updated and amended pursuant to Section 3.

 

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

 

1.17           “Diligence
Failure”: shall mean TGTX does not correct a
failure to use Diligent Efforts within the applicable period
specified in, or determined in accordance with Section
3.2.5(b).

 

1.18           “EMA”:
shall mean the European Medicines Agency or any successor agency
thereto.

 

1.19           “FDA”:
shall mean the United States Food and Drug Administration, or a
successor federal agency thereto.

 

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

 

 

 

 

1.21           “Field
of Use”: shall mean the use of Compound or Products in
the Field as defined herein.

 

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

 

1.23           “First
Commercial Sale”: shall mean the first commercial sale
by TGTX, its Affiliates and/or Sublicensees to a Third Party of a
Product for value in any country in the Territory following receipt
of approval to market such Product from the relevant Regulatory
Authority in the applicable country.

 

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

 

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

 

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

 

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

 

1.28           “IND”:
shall mean (a) an Investigational New Drug application as defined
in the FD&C Act and applicable regulations promulgated
thereunder by the FDA or any successor application or procedure
required to initiate clinical testing of a Product in humans in the
Territory; and (b) all supplements and amendments to the
foregoing.

 

1.29           “Indication”:
means any indication for which (a) a Product is developed pursuant
to an IND or CTA (or if no such filing is required, pursuant to the
applicable clinical trial protocol), (b) a BLA for a Product is
submitted, or (c) a BLA for a Product is approved by a Regulatory
Authority.

 

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

 

1.31           “Joint
Inventions”: Any new invention pertaining to the
Compound, Product, or their uses made jointly by the
Parties.

 

 

 

 

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

 

1.33           “Joint
Patents”: shall mean any and all patents and patent
applications claiming any Joint Invention, together with any and
all patents issued on any such applications as well as any
divisional, continuation, continuation-in-part, substitution
applications, re-issue, re-examination, renewal and extended
patents (including supplementary protection certificates (SPC)) of
any of the foregoing.

 

1.34           “Know-How”:
shall mean any and all technical information, test and development
data and results, formulations, processes, ideas, protocols,
regulatory files, preclinical and clinical data (including, without
limitation, Data) and the like relating to the use, manufacture,
Development, or Commercialization of the Compound or the
Product.

 

1.35           “Launch”:
shall mean the First Commercial Sale in a country.

 

1.36           “Major
Market(s)”: shall mean any of the following countries
or groups of countries: (i) 8 ; (ii) * ; (iii) * , * , * , * ,
and the *  (each, a “ * ”); (iv) * ; and (v) * , * or *
(each, a “ *
”).

 

1.37           “Net
Sales”: shall mean, with respect to a particular time
period, the total amounts received or invoiced by TGTX, its
Affiliates, and sublicensees (subject to the provisions set forth
in Section 6) for sales of Product made during such time period to
unaffiliated Third Parties, less the following deductions to the
extent actually allowed or incurred with respect to such
sales:

 

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

 

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

 

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

 

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

 

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

 

 

 

 

For the purposes of
determining royalty rates and the royalties payable on
Combinations, Net Sales of Product shall be calculated 9 , * , * , * , and * , * ,
*  ( * ) *  ( * ) * .  In the event that such average
selling price cannot be determined for both Product and all other
active ingredient(s) and component(s) included in the Combination
Product, Net Sales for purposes of determining payments under this
Agreement shall be calculated by * , and * (s) * (s) * , as
determined by TGTX using its standard accounting procedures
consistently applied.  In the event that the standard
fully-absorbed cost of the Product and/or the other active
ingredient(s) or component(s) included in such Combination cannot
be determined, for the purposes of determining royalties payable
hereunder, the Parties shall negotiate in good faith to determine
an appropriate commercial value for all the components in the
Combination and calculate Net Sales of such Combination
accordingly.

 

Further, the
Parties agree to negotiate in good faith for an equitable
determination of the Net Sales of the Product in the event TGTX and
its Affiliates sells the Product in such a manner that gross sales
of the Product are not readily identifiable.  In
addition, for purposes of this Agreement, “sale” shall
mean any transfer or other distribution or disposition, but shall
not include transfers or other distributions or dispositions of
Product at no charge for academic research, preclinical, clinical,
or regulatory purposes (including the use of a Product in Clinical
Trials) or in connection with patient assistance programs or other
charitable purposes or to physicians or hospitals for promotional
purposes (including free samples to a level and in an amount which
is customary in the industry and/or which is reasonably
proportional to the market for such Product).

 

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

 

1.39           “Novimmune
Platform Patent(s)”: shall mean any Patent, including
Novimmune’s interest in any Joint Patent, that (a) is
Controlled by Novimmune or its Affiliates on the Effective Date and
during the Term, and (b) generically claims the Compound or the
Product or its manufacture or its use, or any other invention that
is otherwise necessary for the Development, manufacture, use or
Commercialization of the Compound or the Product in the Field of
Use including the patents listed in Exhibit B which shall be from
time to time amended and updated during the Term to incorporate the
then-current Novimmune Patents.

 

1.40           “Novimmune
Product Patent(s)”: shall mean any Patent, including
Novimmune’s interest in any Joint Patent, that (a) is
Controlled by Novimmune or its Affiliates on the Effective Date and
during the Term, and (b) specifically claims the Compound or the
Product or its specific manufacture or its specific use, including
the patents listed in Exhibit B which shall be from time to time
amended and updated during the Term to incorporate the then-current
Novimmune Patents.

 

1.41           “Party”:
shall mean either TGTX or Novimmune, as the context requires, or
both TGTX and Novimmune when used in the plural form

 

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

 

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

 

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

 

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

 

1.46           “Product(s)”:
shall have the meaning set forth in Section 1.71 of the JV
Agreement.

 

 

 

 

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

 

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

 

1.49           “Royalties”:
shall mean the royalties to be paid by TGTX to Novimmune on the
basis of Net Sales pursuant to Section 4.3.3 hereof

 

1.50           “Royalty
Term”: shall mean, on a country-by-country basis, the
period beginning upon the First Commercial Sale of a Product in a
country and ending on the later of (i) on the expiration of
the10 within the Licensed Patents
covering the sale of the Product in such country, or (ii) expiry of
any other * with respect to the Product in a country, including
patent term extensions, marketing exclusivity or any other
non-patent exclusivity.

 

1.51           “Sole
Inventions”: Any new invention pertaining to the
Compound, Product, or their uses made solely by one of the
Parties.

 

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

 

1.53           “Sublicensee(s)”:
shall mean any Third Party to whom TGTX, or any of its Affiliates,
has sublicensed any of TGTX’s rights under the license
granted to TGTX pursuant to Section 2.1

 

1.54           “Technology
Transfer Plan”: shall have the meaning ascribed to
this term in Section 3.1.1.

 

1.55           “Territory”:
shall mean the entire world.

 

1.56           “TGTX
Exercise Fee”: shall have the meaning ascribed to this
term in Section 6.2.

 

1.57           
“TGTX Intellectual Property
Rights”: shall mean all TGTX Patents and TGTX
Know-How.

 

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

 

1.59           “TGTX
Patent(s)”: shall mean any Patent, including
TGTX’s interest in any Joint Patent, that (a) is Controlled
by TGTX or its Affiliates on the Effective Date and during the
Term, and (b) claims the Product or its manufacture or its use, or
any other invention that is otherwise necessary or useful for the
Development, manufacture, use or Commercialization of the Compound
or the Product in the Field of Use, including the patents listed in
Exhibit [  ], which shall be from time to time amended
and updated during the Term to incorporate the then-current TGTX
Patents.

 

 

 

 

1.60           “Third
Party”: shall mean any entity other than TGTX or
Novimmune or an Affiliate of TGTX or Novimmune.

 

1.61           “Valid
Claim” shall mean (a) any claim of an issued
unexpired patent that (i) has not been permanently revoked, held
invalid, or declared unpatentable or unenforceable in a decision of
a court or other body of competent jurisdiction that is
unappealable or unappealed within the time allowed for appeal, and
(ii) is not lost through an interference proceeding that is
unappealable or unappealed within the time allowed for appeal; or
(b) provided there is no Biosimilar Product available in the
market, a claim of a patent application, which claim has not been
abandoned or finally disallowed without the possibility of appeal
and provided that such patent application has not been pending
before an examining authority for more than 11  ( * ) years from its
filing date.

 

2
LICENSE

 

2.1 Subject to the terms and conditions
of this Agreement, Novimmune grants to TGTX an exclusive license
under the Novimmune Product Patents and a non-exclusive license
under the Novimmune Platform Patents and Novimmune Know-How, to
develop, have developed, make, have made, use, have used, sell,
have sold, offer for sale, register, have registered,
Commercialize, and have Commercialized and import the Compound or
the Product for any Indication in the Field of Use in the
Territory.  For avoidance of doubt, Novimmune does not
grant to TGTX any right or license with respect to any API other
than the Compound, as defined herein above.

 

2.2 The license granted to TGTX by
Novimmune under Section 2.1 includes the right for TGTX to grant
sublicenses (across multiple tiers) to its Affiliates and to Third
Parties for the development, manufacture, sale and/or
commercialization of the Compound or the Product.  All
sublicenses granted by TGTX shall be subject to the terms and
conditions of this Agreement and TGTX shall enter into a written
sublicense agreement with each Sublicensee which will contain terms
and conditions fully consistent with the terms and conditions
contained in this Agreement. TGTX shall
use Diligent Efforts to include in any Commercial Sublicense
Agreement express permission to assign all of the rights and
obligations under such agreement to Novimmune without consent from
the Sublicensee.  TGTX
shall provide to Novimmune a true and complete copy of each
Commercial Sublicense Agreement entered into by TGTX or any of its
Affiliates and any Sublicensee, and of each amendment to any such
Commercial Sublicense Agreement, in each case, within * (* ) days
after execution of such Commercial Sublicense Agreement or
amendment.  For the purpose of this Section 2.2, the term
“Commercial Sublicense
Agreement” shall mean any agreement executed by TGTX
or any of its Affiliates under which any of TGTX’s rights
under the license granted to TGTX pursuant to Section 2.1 are
sublicensed; provided,
however, that the term Commercial Sublicense Agreement shall
exclude any agreement between TGTX or its Affiliate and a
Subcontractor. In addition, TGTX shall notify Novimmune in writing
of the termination of any Commercial Sublicense Agreement within *
( * ) days after such termination. If TGTX determines that there is
a reasonable likelihood of its execution of a Commercial Sublicense
Agreement or an amendment to, or termination of, an existing
Commercial Sublicense Agreement, TGTX shall use reasonable efforts
to provide notice thereof to Novimmune, which notice shall be
provided solely for Novimmune’ information and planning
purposes. No sublicense hereunder shall limit or affect the
obligations of TGTX under this Agreement, and TGTX shall remain
fully responsible for each Affiliate’s or Sublicensee’s
compliance with the applicable terms and conditions of this
Agreement. TGTX agrees to take Diligent Efforts to enforce the
terms of each Commercial Sublicense Agreement against the relevant
Sublicensee in the event of a material breach
thereof.  Notwithstanding anything else to the contrary
contained in this Agreement, all Commercial Sublicense Agreements
shall survive any termination of this Agreement by Novimmune, so
long as such Sublicensee is not in breach of the Commercial
Sublicense Agreement.

 

2.3 TGTX may subcontract certain
activities to Subcontractors who will conduct such activities, or a
portion thereof, on behalf of TGTX.  TGTX’s
execution of a subcontracting agreement with any Subcontractor
shall not relieve TGTX of any of its obligations under this
Agreement.  TGTX shall remain directly liable to
Novimmune for any performance or non-performance of a Subcontractor
that would be a breach of this Agreement if performed or omitted by
TGTX, and TGTX shall be deemed to be in breach of this Agreement as
a result of such performance or non-performance of such
Subcontractor.  TGTX
shall use reasonable efforts to include in any agreement with a
Subcontractor express permission to assign all of the rights and
obligations under such agreement to Novimmune without consent from
the Subcontractor.

 

2.4 Except as expressly provided in this
Agreement, no license or other right is or shall be created or
granted hereunder by implication, estoppel or
otherwise.

 

 

 

 

3
DEVELOPMENT PLAN

 

3.1. Obligations of Novimmune

 

3.1.1 As soon as possible after the
Effective Date, Novimmune shall transfer to TGTX, all Novimmune
Know-How that is necessary for TGTX to continue the development and
manufacture of the Compound and the Products in accordance with the
Development Plan and transfer the relevant information and
materials.

 

3.1.2 At no cost to TGTX, Novimmune
shall provide a reasonable amount of technical, scientific and
intellectual property support to the Development Plan, as requested
by TGTX, during the first 12  (* ) month period beginning
on the Effective Date unless the costs associated with such support
has been already shared by both Parties pursuant to the JV
Agreement.

 

3.2 Obligations of *

 

3.2.1 TGTX shall undertake Diligent
Efforts to Develop, register and Commercialize the Product in the
Field of Use in at least one Major Market and in such other markets
as TGTX deems commercially reasonable. TGTX shall use Diligent
Efforts to maximize Net Sales and shall not take any action with
the intent of reducing or avoiding the milestone payments or any
royalties hereunder.  From and after the Effective Date,
13 shall be solely responsible for
all the costs relating to the Development, registration and
Commercialization of the Product in the Field of Use. * shall
solely assume the managing and the financing of the Development
Plan, with the objective of verifying the safety, potency and
efficacy of the Product and, if the results of clinical development
are positive, filing applications for BLA approval in an
expeditious manner, within the limits of the demands of the
Regulatory Authorities and consistent with Diligent Efforts, as
more fully described below in this Section 3.2.2 TGTX shall retain final decision
making authority on all Development, Commercialization, marketing,
manufacturing and regulatory matters relating to the
Product.

 

3.2.3 TGTX shall conduct the activities
set forth in the Development Plan in accordance with all applicable
Laws and current good manufacturing practice (cGMP), current good
laboratory practice (cGLP) and current good clinical practice
(cGCP), where applicable.

 

3.2.4 The Development Plan will be
updated from time to time in accordance herewith and such updates
shall be attached hereto as Exhibit D. The Development Plan
indicates in reasonable details TGTX’s plans for the
Development of Product in the Field of Use, including regulatory
and registration strategy consistent with Diligent Efforts. Without
limiting the generality of any of the foregoing obligations in this
Section 3.2.3, TGTX shall use Diligent Efforts to Develop the
Product. TGTX may reasonably revise and amend the Development Plan
from time to time upon as much advance notice to Novimmune as is
practicable under the circumstances, so long as such amended
Development Plan meets the criteria described above.

 

3.2.5 If at any time TGTX definitively
and formally suspends its research or development efforts for the
Product, TGTX shall provide Novimmune notification of such
suspension, giving reasons and a statement of its intended
actions.

 

3.2.6 TGTX shall be obligated to make
Diligent Efforts to Develop, itself or through Affiliates,
subcontractors and/or Sublicensees, at least * ( * ) Product in one
Major Market.  If Novimmune considers that TGTX has
failed to exercise Diligent Efforts, then Novimmune shall notify
TGTX in writing within * ( * ) days of appearance of such potential
failure thereof stating in reasonable detail the particular alleged
failure.

 

(a) If TGTX
disagrees with Novimmune’s claim that TGTX has failed to
exercise Diligent Efforts, TGTX shall so notify Novimmune in
writing within * (* ) days after receipt of Novimmune’s
notice, in which event the Parties shall promptly refer the matter
to a Third Party expert in drug development, completely
unaffiliated and independent of the Parties and jointly selected by
the Parties, to determine whether a failure by TGTX to use Diligent
Efforts occurred, or if the related problem was due to some other
cause. Neither Party shall unreasonably withhold or delay its
approval of such expert. The Parties shall initially share equally
the fees and costs of such expert, but promptly after such expert
makes a determination regarding the matter, the non-prevailing
Party shall reimburse the prevailing Party for the share of such
fees and costs borne by the prevailing Party. Should it be
determined by the expert that such failure resulted from
TGTX’s failure to use Diligent Efforts to Develop the
Product, then the expert shall determine what corrective action by
TGTX would best meet the standard of Diligent Efforts and a
timeframe for the completion of such corrective action by TGTX. The
determination of such expert shall be final and binding on the
Parties.

 

 

 

 

(b) If TGTX does
not correct such alleged failure either: (i) within 14 ( * ) days after notice of such
alleged failure from Novimmune; or (ii) if TGTX disputes
Novimmune’s allegation of failure to use Diligent Efforts in
accordance with the preceding paragraph (a), within the period
specified by the expert; then, in each case, Novimmune shall have
the right to terminate this Agreement in accordance with Section
12.3.

 

3.2.7 TGTX shall maintain reasonable
records of its work, including research, development, clinical,
manufacturing and commercialization activities with respect to the
Product conducted by TGTX under this Agreement, together with all
results, data and developments made or generated in connection with
any of the foregoing. Such records shall fully and properly reflect
all work done and results achieved in the performance of this
Agreement in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes.

 

3.2.8 During the Term, TGTX shall use
commercially reasonable efforts to keep Novimmune regularly
informed of TGTX’s worldwide Product development through
periodic reports, including through the issuance of annual and
quarterly reports pursuant to the Securites and Exchange Act of
1934.  In addition, throughout the Term, TGTX shall
notify Novimmune promptly of the occurrence of the following with
respect to a Product: (i) initiation of any material Phase II
Clinical Trial in a Major Market; (ii) initiation of any Phase III
Clinical Trial in a Major Market; (iii) BLA filing and acceptance
in any Major Market; (iv) BLA approval in any Major Market; and (v)
First Commercial Sale in any Major Market. TGTX shall also respond
to reasonable (i.e., not
unduly frequent or burdensome) informal requests from Novimmune for
additional information regarding the development of the Product
from time to time; provided however, to the extent, TGTX makes a
public announcement with respect to the foregoing (i) – (v),
such public announcement shall serve as notice.

 

3.2.9 Novimmune agrees that the results
of the Development Plan cannot be accurately predicted, that
TGTX’s obligation with respect to the Development Plan is not
an obligation to obtain a particular result and that TGTX does not
warrant or guarantee that the Development Plan will yield any
useful or anticipated results.

 

4
CONSIDERATION

 

4.1 As consideration for the exclusive
license rights provided in Section 2.1, TGTX shall pay to Novimmune
the amounts set forth in this Article 4.

 

4.2
Exercise Fee

 

Upon the Effective
Date of this Agreement, TGTX shall pay to Novimmune a fully earned,
non-refundable, one-time, up-front license fee equal to the sum of
15 ($ * ) [or * ($ * ), if Novimmune
exercises their put option under the provisions of the JV
Agreement] (the “Exercise
Fee”), which shall be payable in cash and/or shares of
TGTX Common Stock (the “TGTX
Shares”) at the discretion of TGTX.

 

Upon signature of
this Agreement, Novimmune shall provide an original invoice for the
TGTX Exercise Fee to TGTX, who shall pay the cash portion of the
Exercise Fee within * ( * ) days of receipt of such
invoice.

 

For payments made
in TGTX Shares pursuant to this Section 4, such portion of the
Exercise Fee shall be made through the issuance of that number of
shares of Common Stock of TGTX as shall equal a fraction where the
numerator is * and the denominator is the * . For purposes of this
Section 4, the “ * ” means the *  (or, * , *
) for the *  ( * ) trading days prior to the Effective
Date; provided, however, that in the event that TGTX effects a
stock split, combination or stock dividend at any time during such
* trading days or subsequent thereto and prior to the issuance of
the TGTX Shares, the number of shares of TGTX Common Stock issuable
shall be appropriately adjusted to give effect to such action.
Within * ( * ) business days of the Effective Date, TGTX shall
issue to Novimmune certificates representing the TGTX Shares and
within * ( * ) business days of the issuance of such certificates
for the TGTX shares, TGTX shall file a resale registration
statement covering such shares and shall use Diligent Efforts to
make such resale registration statement effective as quickly as
possible.  TGTX covenants to use Diligent Efforts to keep
such registration statement continuously effective until such time
as such shares can be sold without restriction under Rule
144.

 

 

 

 

4.3
Milestones and Royalties

 

4.3.1
BLA Acceptance Payment

 

(a) BLA acceptance payment: Whether such
event is achieved by TGTX, its Affiliates, its Sublicensees or any
Third Party acting on behalf of TGTX, its Affiliates or its
Sublicensees, TGTX shall pay Novimmune a fully
earned, non-refundable, one-time, payment in each of the
territories listed below upon the acceptance of the first BLA in
each such territory:

 

	
 *

	
 $*

	
 *

	
 $*

	
 *

	
 $*

 

4.3.2 Approval and Sales
Milestone:

 

(a) Sales Milestones.  TGTX shall
pay the sales milestone payments set forth below (which, when paid,
shall be considered fully earned and non-refundable) based on
cumulative net sales of Product (each, a “Sales Milestone
Payment”).  The Sales Milestone Payments
shall be paid only once for each of the events set forth in this
Section 4.3.2(a), whether such milestone event is achieved by TGTX,
its Affiliates, its Sublicensees, or any Third Party acting on
behalf of TGTX, its Affiliates, or its Sublicensees.  No
payment shall be due for any milestone event which is not
achieved.

 

	
 Sales
Milestones:

	
  $*

	
 

	
  $*

	
 

	
  $*

 

(b) Approval Milestones.  Whether
such event is achieved by TGTX, its Affiliates, its Sublicensees or
any Third Party acting on behalf of TGTX, its Affiliates or its
Sublicensees, TGTX shall pay Novimmune a fully
earned, non-refundable, one-time, milestone payment in each of the
territories listed below upon the approval of the first BLA in each
such territory:

	
 Approval
Milestone:

	
  $*

	
 

	
  $*

	
 

	
  $*

 

Any milestone
payments owed under Sections 4.3.1 and 4.3.2 may be paid on cash
and/or TGTX Shares, or a combination of both, at the discretion of
TGTX.  TGTX shall provide Novimmune with written notice
within 17  ( * ) working days of the
occurrence of any of the foregoing milestone events and the
relevant milestone payment is payable by TGTX to Novimmune within *
( * ) days of receipt of a corresponding invoice issued by
Novimmune. If TGTX determines that there is a reasonable likelihood
of a particular milestone event being achieved on or about a
particular date, TGTX shall use reasonable efforts to provide
advance notice thereof to Novimmune, which notice shall be provided
solely for Novimmune’ planning purposes and shall not be
construed as a representation, warranty or covenant by TGTX that
such milestone event will occur when anticipated or at
all.

 

 

 

 

4.3.3 Royalties on Net Sales.  TGTX
shall pay to Novimmune royalties based on the aggregate annual Net
Sales of each Product(s) sold in the Territory at the rate shown in
the table below during the Royalty Term for each
country.

 

	
Sales
Royalties

	
 

*

	
 

	
 

* %

	
*

	
 

	
* %

	
*

	
 

	
* %

 

4.3.4
Royalty Stacking:

 

(a) Required Third Party
License(s).  Subject to the limitation set forth
in clause (b) below, if one or more licenses to patent rights owned
or controlled by one or more Third Parties are necessary, as
reasonably determined by TGTX and Novimmune jointly, for TGTX to
have freedom to operate under the Novimmune Product Patents to
Commercialize the Product in the Field and in the Territory, TGTX
may obtain such one or more Third Party licenses under such patent
rights and to deduct from any royalty payments due to NOVIMMUNE
hereunder an amount equal to * percent ( * %) of any royalties paid
by TGTX to such one or more Third Parties.

 

(b) Royalty Floor.  The
deductions in the foregoing clause (a) shall be limited in their
cumulative application so that no royalty payments due to NOVIMMUNE
hereunder shall be reduced by more than * percent ( *
%).

 

4.3.5
Additional Royalty Payments:

 

At TGTX’s
discretion, TGTX shall negotiate a license with * to manufacture
the Product.  It is acknowledged that TGTX may be
required to pay * for the use of their 18 cell line, media and feeds
and manufacturing process, and also a technology transfer fee (to
be directly negotiated with *) if the * cell line and process is
transferred to a third party CMO.

 

TGTX shall pay
Novimmune for the use of their * cell line, if available, and if
required, an additional Royalty payment of * %.

 

 

 

 

4.4 Payments

 

4.4.1 Timing of Royalty Payments:

 

(a) Royalties on Net Sales pursuant to
Section 4.3.3 shall be paid by TGTX to Novimmune * within * ( * )
days after the end of calendar * in which such Net Sales are made
(as determined by the date of invoice or billing). Simultaneously
with such payment, TGTX shall provide a report to Novimmune of its
calculation of such Royalties, in sufficient detail, including the
amounts of gross revenues and applicable deductions (the “ *
Royalty Report”).  Such Royalties shall be subject
to a true-up adjustment to take into account deductions under the
definition of Net Sales either (A) allowed during a calendar * that
were not accrued during such calendar * , or (B) accrued during a
calendar * but not taken or later subject to a reversal following
the end of such calendar *  (each of (A) and (B), a
“True-up Adjustment”).  Each * Royalty Report
provided by TGTX shall set forth the amount of any True-up
Adjustment applicable to any prior calendar * .

 

4.4.2 All payments to Novimmune
hereunder shall be made using the bank details provided by
Novimmune. All payments to Novimmune shall be made in US dollars.
If Net Sales are made in another currency other than US dollars,
TGTX shall convert them into US dollars for the purpose of the
calculation of Royalties by applying the average interbank exchange
rate as published by (OANDA/US treasury) for the last day of each
month within the calendar * for which payment to Novimmune is due.
All costs associated with making payments to Novimmune, including
the cost of wire transfers, shall be paid by * .

 

4.4.3 TGTX shall (and shall require its
Affiliates to) prepare and maintain complete and accurate books and
records regarding Net Sales (including gross sales and applicable
deductions from gross sales), Royalties due hereunder. Novimmune
shall have the right to have such books and records reasonably
inspected by an independent certified auditor selected by Novimmune
and accepted by TGTX, whose acceptance shall not be unreasonably
withheld, to confirm Net Sales (including gross sales and
applicable deductions from gross sales), Royalties due hereunder.
Such auditor will execute a written confidentiality agreement with
TGTX and will disclose to Novimmune only such information as is
reasonably necessary to provide Novimmune with information
regarding any actual discrepancies between the amounts reported or
paid and the amounts payable under this Agreement. Such auditor
will send a copy of its report to TGTX within 19 ( * ) days of delivery of such report
to Novimmune. Such report will include the methodology and
calculations used to determine the results. Prompt adjustments
shall be made by the Parties to reflect the results of such audit.
Records to be available under an inspection shall include all
relevant documents pertaining to payments specified above.
Novimmune shall bear the fees and expenses of such inspection,
provided that, if an underpayment of more than * percent ( * %) of
the payments due for any calendar year is discovered in any
inspection, then TGTX and or its affiliates shall bear all fees and
expenses of that inspection within * ( * ) days after receipt of
invoice from Novimmune.

 

4.4.4 Without limiting any other rights
or remedies available to Novimmune, TGTX shall pay Novimmune
interest on any payments that are not paid on or before * days from
the due date at the British Bankers Association’s one month
LIBOR Rate for United States Dollar deposits calculated from the
due date to the date paid in full.

 

4.4.5 In the event TGTX fails to pay
overdue amounts to Novimmune within the due date under this Section
4.4, Novimmune shall have the right to terminate this Agreement
upon * ( * ) days’ prior written notice to TGTX pursuant to
Section 8.4, unless TGTX has cured such failure to pay by the end
of such *  ( * ) day period.

 

4.4.6 TGTX shall make payments to
Novimmune under this Agreement withholding any taxes that may be
due with respect to such payments to the extent that such
withholding is required by applicable law. If any taxes are
required to be withheld by TGTX, then TGTX shall (a) deduct such
taxes from the payment made to Novimmune, (b) timely pay the taxes
to the proper taxing authority, and (c) send proof of such tax
payments to Novimmune and certify receipt of such payment by the
applicable tax authority within * ( * ) days following such tax
payment

 

 

 

 

5
INTELLECTUAL PROPERTY

 

5.1 Ownership of Intellectual Property Rights and
Inventions

 

5.1.1 Ownership of
Inventions.

 

The Novimmune
Product Patents and Novimmune Platform Patents shall at all times
be and remain the sole property of Novimmune, subject to any
limitation on the transfer of such rights contained
herein.

 

Inventorship shall
be determined in accordance with U.S. patent laws.  Sole
Inventions owned by TGTX and TGTX’s interest in all Joint
Inventions shall be included in the TGTX Intellectual Property
Rights.  Sole Inventions owned by Novimmune and
Novimmune’s interest in all Joint Inventions shall be
included in the Novimmune Product Patents or Novimmune Platform
Patents, as determined by the claimed subject matter; provided that
if the claimed subject matter includes a claim specifically
directed to the Product, NOVIMMUNE’s interest in all Joint
Inventions shall be included in the NOVIMMUNE Product Patent
regardless of the existence the same patent or
application  of claimed subject matter providing generic
Product coverage.

 

5.1.2 Disclosure of
Inventions.  Each Party shall promptly disclose to
the other any invention disclosures, or other similar documents,
submitted to it by its employees, agents or independent contractors
describing inventions that may be either Sole Inventions or Joint
Inventions, and all Information relating to such
inventions.  Either Party’s Sole Inventions and
Joint Inventions required for the development or commercialization
of the Product, shall automatically be included in this Agreement
and available for use by the Commercializing Party.

 

5.1.3 Prosecution of
Patents.

 

a.  

Novimmune Patents Other than Joint
Patents.  Except as otherwise provided in this
Section 5.1.3(a), Novimmune shall have the sole right, authority
and obligation to file, prosecute and maintain the Novimmune
Product Patents and Novimmune Platform Patents (other than Joint
Patents which shall be prosecuted and maintained in accordance with
Section 5.1.3(b)) in the Territory and on a worldwide
basis.  Novimmune shall provide TGTX reasonable
opportunity to review and comment on such prosecution efforts
regarding such Novimmune Product Patents in the
Territory.  Novimmune shall provide TGTX with a copy of
material communications from any patent authority in the Territory
regarding such Novimmune Product Patents, and shall provide TGTX
with drafts of any material filings or responses to be made to such
patent authorities a reasonable amount of time in advance of
submitting such filings or responses.  Notwithstanding
the foregoing, if Novimmune desires to abandon or not maintain any
Patent within such Novimmune Product Patents in the Territory, then
Novimmune shall provide TGTX with 20 ( * ) days prior written notice of
such desire (or such longer period of time as reasonably necessary
to allow TGTX to assume such responsibilities) and, if TGTX so
requests, shall provide TGTX with the opportunity to prosecute and
maintain such Patent in the Territory in place of
Novimmune.  If TGTX desires Novimmune to file, in the
Territory, a patent application that claims priority from a Patent
within the Novimmune Product Patents, other than a Joint Patent, in
the Territory, TGTX shall provide written notice to Novimmune
requesting that Novimmune file such patent application in the
Territory.  If TGTX provides such written notice to
Novimmune, Novimmune shall either (i) file and prosecute such
patent application and maintain any patent issuing thereon in the
Territory or (ii) notify TGTX that Novimmune does not desire to
file such patent application and provide TGTX with the opportunity
to file and prosecute such patent application and maintain any
patent issuing thereon in the Territory in place of
Novimmune.  Any patent controlled by or taken over by
TGTX under this Section 5.1.3(a) shall henceforth be automatically
assigned by NOVIMMUNE in favor of TGTX.

 

 

 

 

c.

Joint Patents.  Except as
otherwise provided in this Section 5.1.3 (b), TGTX shall be
entrusted with the right and authority, to prosecute and maintain
the Joint Patents on a worldwide basis at its sole discretion
herein referred to as an “Entrusted Party” (subject to
this Section 5.1.3 (b)).  The Entrusted Party shall
provide the other party reasonable opportunity to review and
comment on such prosecution efforts regarding such Joint
Patents.  The Entrusted Party shall provide the other
party with a copy of material communications from any patent
authority regarding such Joint Patents, and shall provide the other
party with drafts of any material filings or responses to be made
to such patent authorities a reasonable amount of time in advance
of submitting such filings or responses.  If one Party
determines in its sole discretion to abandon or not maintain any
Patent within the Joint Patents anywhere in the world, then such
Party shall provide the other Party with 21 ( * ) days’ prior written
notice of such determination (or such longer period of time
reasonably necessary to allow  the other party to assume
such responsibilities) and shall provide the other Party with the
opportunity to prosecute and maintain such Patent at the other
Party’s sole expense, and if the other Party so requests, the
one Party shall assign such Patent to the other Party (if the other
Party is Novimmune, such Patent shall be included in the Novimmune
Product Patents or if the other Party is TGTX, in which case such
patent will be included in the TGTX Patents).  If the other
Party desires to file, in a particular jurisdiction, a patent
application that claims priority from a Patent within the Joint
Patents, the other Party shall provide written notice to the
Entrusted Party of such desire.  Within * ( * ) days of
such written notice, the Entrusted Party shall provide written
notice to the First Party as to whether the Entrusted Party agrees
to file a patent application in such jurisdiction or
not.  In the event the Entrusted Party agrees to such a
filing, the Entrusted Party shall file such patent application in
such jurisdiction.  In the event the Entrusted Party does
not desire to file in such jurisdiction, the Entrusted Party shall
(i) provide the other Party with the opportunity to file and
prosecute such patent application and maintain any patent issuing
therefrom, and (ii) assign such patent application or a right to
file such patent application to the other Party; and the other
Party may file such patent application in such jurisdiction at its
sole expense (in which case such Patent shall be included in the
respective Party’s Patents).

 

d.

Cooperation in
Prosecution.  Each Party shall provide the other
Party all reasonable assistance and cooperation in the Patent
prosecution efforts provided above in this Section 5.1.3, including
providing any necessary powers of attorney and executing any other
required documents or instruments for such
prosecution.

 

e.

Costs of
Prosecution.  The costs to prosecute
and maintain the Novimmune Product Patents related to the Product
shall be borne by Novimmune.  The costs to prosecute and
maintain the Joint Patents related to the Product shall be borne
equally by Novimmune and TGTX.  The costs to prosecute
and maintain the TGTX Patents related to the Product shall be borne
by TGTX.  A Party taking over responsibility for a
particular patent or patent application under this Section 5 shall
be responsible for costs associated with same.

 

5.1.4 Infringement of Patents by Third
Parties.

 

(a)  

Notification. Each Party shall promptly notify
the other Party in writing of any existing or threatened
infringement of the Novimmune Product Patents, Joint Patents or
TGTX Patents of which it becomes aware, and shall provide evidence
in such Party’s possession demonstrating such
infringement.  The
Party that is commercializing the Product shall be deemed the
“Commercializing Party.”

 

 

(b)
Infringement of Patents in the Territory.

 

i.  

If a Party becomes
aware that a Third Party infringes any Novimmune Product Patent,
TGTX Patent, or Joint Patent in the Territory by making, using,
importing, offering for sale or selling the Product or any similar
CD47/CD19 bi-specific antibody covered by any of such Patents (such
activities, “Product
Infringement”), then such Party shall so notify the
other Party as provided in Section 5.1.4 (a), which such notice shall
include all information  available to the notifying Party
regarding such alleged infringement.

 

 

 

 

.

In the Territory,
TGTX shall have the first right, but not the obligation, to bring
an appropriate suit or other action against any person or entity
engaged in such Product Infringement, subject to Section
5.1.4 (b)(iii) below,
the cost and expense will be borne by TGTX.  TGTX shall
have a period of 22 ( * ) days (or shorter period,
if required by the nature of possible proceeding) after
notification by Novimmune or providing notification to Novimmune
pursuant to Section 5.1.4 (a), to elect to so enforce such
Patent.  In the event TGTX does not so elect, it shall so
notify Novimmune in writing during such 23 ( * ) day time period (or the
above-mentioned shorter period), and Novimmune shall have the
right, but not the obligation, to commence a suit or take action to
enforce the applicable Patent against such Third Party perpetrating
such Product Infringement at its sole cost and expense (except as
otherwise expressly provided in this Section 5.1.4 (b)(ii)).  Each Party
shall provide to the Party enforcing any such rights under this
Section 5.1.4 (b)(ii)
reasonable assistance in such enforcement, at such enforcing
Party’s request, including joining such action as a party
plaintiff if required by applicable Law to pursue such
action.  The enforcing Party shall keep the other Party
regularly informed of the status and progress of such enforcement
efforts, and shall reasonably consider the other Party’s
comments on any such efforts.  Any recoveries obtained
from a suit or an action commenced by TGTX hereunder shall first be
applied to the recovery of expenses incurred by TGTX or Novimmune
(if any) in bringing the suit or action and the remaining amounts,
if any, shall be deemed additional Net Sales; provided, further,
however, if Novimmune proceeds with the enforcement after TGTX
decides not to move forward, then any amounts recovered shall
belong solely to Novimmune.

 

.

The Party not
bringing an action with respect to Product Infringement in the
Territory under Section 5.1.4 (b) shall be entitled to separate
representation in such matter by counsel of its own choice and at
its own expense, but such Party shall at all times cooperate fully
with the Party bringing such action. Additionally, the Party not
bringing an action under this Section 5.1.4 (b) may have an opportunity to
participate in such action to the extent that the Parties may
mutually agree at the time the other Party elects to bring an
action hereunder.

 

(c)  

Settlement. TGTX shall not settle any claim,
suit or action that it brings under this Section 5.1.4 involving Novimmune Product
Patents (excluding Joint Patents) in any manner that would have a
materially adverse impact on Novimmune Patents anywhere in the
world, or that would materially limit or restrict the ability of
either Party to manufacture, use, sell, offer for sale or import
the Product anywhere in the world, without the prior written
consent of Novimmune.  Novimmune shall not settle any
claim, suit or action that it brings under this Section
5.1.4 involving TGTX
Patents (excluding Joint Patents) in any manner that would
negatively impact the TGTX Patents or that would limit or restrict
the ability of either Party to manufacture, use, sell, offer for
sale or import the Product anywhere in the world, without the prior
written consent of TGTX.  Neither Party shall settle any
claim, suit or action that it brings under this Section
5.1.4 involving Joint
Patents in any manner that would negatively impact the Joint
Patents or that would limit or restrict the ability of either Party
to manufacture, use, sell, offer for sale or import the Product
anywhere in the world, without the prior written consent of such
other Party.

 

(d)  

Reserved

 

6
REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS

 

6.1 Each Party represents, warrants and
covenants to the other that:

 

 

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

 

 

(ii) As of the
Effective Date, (i) it has the corporate power and authority and
the legal right to enter into this Agreement and perform its
obligations hereunder; (ii) it has taken all necessary corporate
action on its part required to authorize the execution and delivery
of the Agreement and the performance of its obligations hereunder;
and (iii) the Agreement has been duly executed and delivered on
behalf of such Party, and constitutes a legal, valid, and binding
obligation of such Party that is enforceable against it in
accordance with its terms. The execution, delivery and performance
of this Agreement by it does not conflict with any agreement or
instrument, oral or written, to which it is a party or by which it
may be bound;

 

 

(iii) It has not
granted, and shall not grant, any right to any Third Party which
would conflict with the rights granted to the other Party
hereunder; and

 

 

(iv) It is not a
party to any agreement that would prevent it from granting the
rights granted to the other Party under this Agreement or
performing its obligations under this Agreement.  The
execution, delivery and performance of this Agreement shall not
violate, conflict with or constitute a default under any agreement
(including its corporate charter or other organizational documents)
to which it is a party or to which it may be bound, or to its best
knowledge, any applicable Laws or order of any court or other
tribunal.

 

 

 

6.2 Novimmune represents and warrants
and covenants to TGTX that as of the Effective Date:

 

 

(i) All rights
pertaining to the Novimmune Product Patents and Novimmune Platform
Patents are owned by Novimmune;

 

 

(ii) The Novimmune
Product Patents and Novimmune Platform Patents are not subject to
any encumbrance, lien or claim or ownership by any Third Party that
is inconsistent with the rights and licenses granted to TGTX
hereunder;

 

 

(iii) Novimmune
owns or possesses adequate right, title and interest in the
Novimmune Product Patents and Novimmune Platform Patents to grant
the license thereto to TGTX as provided in this
Agreement;

 

 

(iv) No claim or
litigation has been brought, or is threatened to be brought, by any
person or entity (A) alleging that any of the Novimmune Product
Patents or Novimmune Platform Patents in the Territory is invalid
or unenforceable, or (B) alleging that use of the Novimmune Product
Patents or Novimmune Platform Patents in the Territory infringes or
otherwise conflicts or interferes with any intellectual property or
proprietary right of any Third Party;

 

 

(v)  No
Third Party has infringed or misappropriated any Novimmune Product
Patents by making, using, importing, offering for sale or selling
the Compound or the Product and, as of the Effective Date, there is
no actual or threatened infringement or misappropriation of the
Novimmune Know How by any Third Party by making, using, importing,
offering for sale or selling the Compound or the
Product;

 

 

(vi) To
Novimmune’s knowledge, neither A) TGTX’s exercise of
its rights hereunder with respect to the Novimmune Product Patents
or Novimmune Platform Patents, nor (B) TGTX’s Development or
Commercialization of the Product in the Territory, shall infringe
any valid and enforceable Patent of any Third
Party;

 

 

(vii)  This
Agreement is consistent with all Novimmune’s Third Party
license agreements in all respects and does not conflict with,
violate, breach or otherwise give rise to a default by Novimmune
under, any term of any Novimmune Third Party license
agreement;

 

 

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

 

 

(ix) Novimmune has
not received any written notice from any Third Party claiming that
the manufacture, use, sale, or importation of the Compound or
Product by Novimmune prior to the Effective Date infringed any
patent owned or controlled by any Third Party;

 

 

(x) Novimmune has
not granted any license or other right to any Third Party regarding
the Compound or the Product and/or the Novimmune Product Patents;
and

 

 

(xi) Novimmune has
not received any grant from or entered into any agreement with any
government and/or any of its subdivisions or federal governmental
bodies, or any other governmental bodies, regarding the Compound or
the Product and/or the Novimmune Product
Patents.

 

 

(xii) Novimmune has
ended its CD47/CD19 bispecific antibody program and will not engage
in a future program that will produce bispecific antibodies that
target CD47/CD19.

 

 

 

6.3  

Representations,
Warranties, and Covenants of TGTX.

6.3.1 TGTX agrees that all of its
activities, and the activities of its Affiliates related to its use
of the Novimmune Product and Platform Patents and Novimmune
Know-How and all Development and Commercialization of the Product
including the transport, storage, sale and promotion thereof,
pursuant to this Agreement shall comply with all applicable legal
and regulatory requirements. TGTX and its Affiliates shall not
engage in any activities that use the Novimmune Product and
Platform Patents and/or Novimmune Know-How in a manner that is
outside the scope of the license rights granted to TGTX hereunder.
TGTX represents and warrants that it will comply with the U.K.
Bribery Act, the United States Foreign Corrupt Practices Act and
any and all other applicable Laws prohibiting corruption or bribery
(collectively referred to as the “Anti-Corruption
Laws”).

 

6.3.2 TGTX represents, warrants, and
covenants that (i) the issuance of the Shares has been duly
authorized by all necessary corporate action; (ii) upon issuance,
the Shares will be validly issued, fully paid and nonassessable,
free and clear of all liens, encumbrances, restrictions (including
under the Securities Act), charges, security interests, rights of
first refusal and preemptive rights; and (iii) TGTX shall reserve
from its authorized and unissued shares of Common Stock, a
sufficient number of shares of Common Stock to issue Novimmune the
shares in accordance with Article 6 hereof.

 

6.4 No
Other Representations or Warranties: Except as expressly set
forth in this Agreement, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE
OR TRADE PRACTICES

 

7
INDEMNIFICATION AND INSURANCE

 

7.1 TGTX shall indemnify, defend, and
hold harmless Novimmune and its Affiliates and their respective
directors, officers, employees and agents (each, a “Novimmune Indemnitee”) from
and against any and all claims, suits, actions, demands,
liabilities, expenses and/or loss, including reasonable legal
expense and attorneys’ fees (collectively, “Losses”), to which any
Novimmune Indemnitee may become subject as a result of any claim,
demand, action or other proceeding (each, a “Claim”) by any Third Party
to the extent such Losses arise out of or result from (a) any
breach by TGTX of its representations, warranties, covenants or
obligations in this Agreement or (b) the gross negligence or
willful misconduct of TGTX and its Affiliates or Sublicensees;
except, in each case, to the extent such claim is caused by a
breach of this Agreement by Novimmune or the gross negligence or
willful misconduct of Novimmune.

 

7.2  Novimmune shall
indemnify, defend, and hold harmless TGTX and its Affiliates and
their respective directors, officers, employees and agents (each, a
“TGTX
Indemnitee”) from and against any and all Losses to
which any TGTX Indemnitee may become subject as a result of any
Claim by a Third Party to the extent such Losses arise out of or
result from (a) any breach by Novimmune of its representations,
warranties, covenants or obligations in this Agreement, or (b) the
gross negligence or willful misconduct of Novimmune or its
Affiliates; except, in each case, to the extent such claim is
caused by a breach of this Agreement by TGTX or the gross
negligence or willful misconduct of TGTX.

 

7.3  For purposes of Sections
7.1 and 7.2, the Novimmune Indemnitee or TGTX Indemnitee (the
“Indemnified
Party”) shall give prompt written notice to the other
Party (the “Indemnifying
Party”) of any claims, suits or proceedings by Third
Parties which may give rise to any claim for which indemnification
may be required under Section 7.1 or 7.2; provided, however, that failure to give
such notice shall not relieve the Indemnifying Party of its
obligation to provide indemnification hereunder except, if and to
the extent that such failure materially and adversely affects the
ability of the Indemnifying Party to defend the applicable claim,
suit or proceeding. The Indemnifying Party shall be entitled to
assume the defence and control of any such claim at its own cost
and expense; provided, however, that the Indemnified Party shall
have the right to be represented by its own counsel at its own cost
in such matters. Neither the Indemnifying Party nor the Indemnified
Party shall settle or dispose of any such matter in any manner
which would adversely affect the rights or interests of the other
Party (including the obligation to indemnify hereunder) without the
prior written consent of the other Party, which shall not be
unreasonably withheld or delayed. Each Party shall reasonably
cooperate with the other Party and its counsel in the course of the
defence of any such suit, claim or demand, such cooperation to
include without limitation using reasonable efforts to provide or
make available documents, information and witnesses.

 

7.4 At and during such time as TGTX, its
Affiliates, or its Sublicensees, begins clinical testing, sale or
distribution of Products, TGTX shall (and shall require its
Affiliates and Sublicensees to) at its sole expense, procure and
maintain commercially reasonable insurance policies as would be
maintained by similarly situated pharmaceutical companies
consistent with the current industry standards for similar
products, and compliant with any applicable law or
regulation.

 

7.5 EXCEPT WITH RESPECT TO A BREACH OF
SECTION 10 HEREOF, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR
INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE OR SPECIAL DAMAGES OF
THE OTHER PARTY ARISING OUT OF OR RELATED TO THIS AGREEMENT,
HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY EVEN IF ADVISED OF
THE POSSIBILITY OF SUCH DAMAGES.

 

 

 

 

8
CONFIDENTIALITY

 

8.1 Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing by the
Parties, each Party agrees that, for the Term and until the later
of (i) the 24 ( * ) anniversary of the Effective
Date, or (ii) *  ( * ) years after the
expiration or termination of the Term, it shall keep confidential
and shall not publish or otherwise disclose, and shall not use for
any purpose other than as provided for in this
Agreement, any
Confidential Information furnished to it by the other Party
pursuant to this Agreement except for that portion of such
information or materials that the receiving Party can demonstrate
by competent written proof:

 

(a)  

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

(b)  

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

(c)  

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

(d)  

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

(e)  

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

 

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

 

(a)  

filing or
prosecuting Patents as permitted in this
Agreement;

(b)  

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

(c)  

prosecuting or
defending litigation or other proceedings or regulatory
actions;

(d)  

complying with
applicable Laws;

(e)  

disclosure to its
employees, agents, and consultants, and any Third Parties 
(and potential licensees and) with which a Party is Developing or
Commercializing the Product) only on a need-to-know basis and
solely as necessary in connection with the performance of this
Agreement, provided that in each case the recipient of such
Confidential Information must agree to be bound by similar
obligations of confidentiality and non-use at least as equivalent
in scope as those set forth in this Article 10 prior to any
such disclosure; and

(f)  

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

 

8.3 The Parties agree that the terms of
this Agreement shall be treated as Confidential Information by both
Parties.

 

8.4 The Parties acknowledge that each
Party may desire or be required to issue press releases or to make
other public disclosures relating to this Agreement or its terms.
The Parties agree to consult with each other reasonably and in good
faith with respect to the text and timing of such press releases or
other public disclosures prior to the issuance thereof, provided
that a Party may not unreasonably withhold consent to such
releases, and that either Party may issue such press releases as it
determines, based on advice of counsel, are reasonably necessary to
comply with laws or regulations. In addition, following an initial
press release announcing this Agreement, each Party shall be free
to disclose, without the other Party’s prior written consent,
the existence of this Agreement, the identity of the other Party
and those terms of this Agreement which have already been publicly
disclosed in accordance herewith.

 

8.5 Subject to Section 8.4, TGTX shall
not use the name “Novimmune” nor any variation or
adaptation thereof, nor any trademark, tradename or other
designation owned by Novimmune or its Affiliates, nor the names of
any of its officers, employees or agents, for any purpose without
the prior written consent of the other Party in each instance,
except that TGTX may state that it has licensed from Novimmune one
or more of the patents and/or applications within the Novimmune
Patents, and TGTX may use Novimmune’s logo on TGTX’s
corporate website and corporate presentation materials for such
purpose, subject to Novimmune’s prior review and approval
(not to be unreasonably withheld) of TGTX’s proposed use
thereof.

 

8.6 Subject to Section 8.4, Novimmune
shall not use the name of “TGTX” or its Affiliates nor
any variation or adaptation thereof, nor any trademark, tradename
or other designation owned by TGTX or its Affiliates, nor the names
of any of its officers, employees or agents, for any purpose
without the prior written consent of the other Party in each
instance, except that Novimmune may state that it has licensed to
TGTX one or more of the patents and/or applications within the
Novimmune Patents, and Novimmune may use TGTX’s logo on
Novimmune’s corporate website and corporate presentation
materials for such purpose, subject to TGTX’s prior review
and approval (not to be unreasonably withheld) of Novimmune’s
proposed use thereof.

 

 

 

 

8.7 Each Party recognizes that the
publication by TGTX of Data and other information regarding
Compounds and Products, such as by public oral presentation,
manuscript or abstract, may be beneficial to both Parties provided
such publications are subject to reasonable controls to protect
Confidential Information. Accordingly, Novimmune shall have the
right to review and comment on any material proposed for public
oral presentation or publication by TGTX that includes Data or
other results of preclinical or clinical development of the
Compound or any Product and/or includes Confidential Information of
Novimmune. Before any such material is submitted for publication,
TGTX shall use reasonable efforts to deliver a complete copy to
Novimmune at least 25 ( * ) days prior to submitting the
material to a publisher or initiating any other disclosure.
Novimmune shall review any such material and give its comments to
TGTX within ten ( * ) * of the delivery of such material to
Novimmune. With respect to public oral presentation materials and
abstracts, Novimmune shall make reasonable efforts to expedite
review of such materials and abstracts, and shall return such items
as soon as practicable to TGTX with appropriate comments, if any,
but in no event later than ten ( * ) * from the date of delivery to
Novimmune. TGTX shall comply with Novimmune’s request to
delete references to Novimmune’s Confidential Information in
any such material. In addition, if any such publication contains
patentable subject matter, then at Novimmune’s request, TGTX
shall either delete the patentable subject matter from such
publication or delay any submission for publication or other public
disclosure for a period of up to an additional *  ( * )
days so that appropriate patent applications may be prepared and
filed.

 

8.8  Subject to Section 8.7,
TGTX and its contractors, including without limitation clinical
research organizations, shall have the right to publish results of
all clinical trials of the Compound or any Product on TGTX’s
clinical trial register, and such publication will not be a breach
of the confidentiality obligations provided in this Article
8.

 

8.9 All obligations of confidentiality and
non-use imposed under this Article 8 shall expire 26 ( * ) years after the date of
termination or expiration of this Agreement.

 

 

9
EXPIRY OF THE AGREEMENT; CONSEQUENCES OF EXPIRY

 

9.1 Unless terminated earlier pursuant
to Article 10 or other mutual written agreement, this Agreement
shall commence upon the Effective Date and shall expire, on a
country-by-country basis on the expiration of the Royalty Term (the
“Royalty
Term”).

 

 

10
TERMINATION

 

10.1 TGTX Termination with Cause: TGTX
may terminate this Agreement at any time for Cause upon
*  ( * ) days’ prior written notice to
Novimmune.

 

10.2 TGTX Termination: TGTX may terminate
this Agreement at any time for any reason upon *  ( * )
days’ prior written notice to Novimmune.

 

10.3 Novimmune Termination for TGTX Diligence
Failure: If TGTX does not correct a failure to use Diligent
Efforts within the applicable period specified in, or determined in
accordance with, Section 3.2.5 (b) (a “Diligence
Failure”), Novimmune shall have the right to terminate
this Agreement on * ( * ) days’ written notice to TGTX unless
TGTX cures such Diligence Failure before the end of such * ( * )
day period.

 

10.4 Termination for Material Breach:
Each Party shall have the right to terminate this Agreement upon *
( * ) days’ (or * ( * ) days’ in the case of failure to
make payment of amounts due hereunder) prior written notice to the
other Party in the event of the material breach of any term or
condition of this Agreement by the other Party, unless the
breaching Party has cured such breach by the end of the applicable
cure period; provided,
however, that:

 

(a) this Section 10.4 shall not apply to
any Diligence Failure by TGTX (in which case, Novimmune’s
termination right shall be as set forth in Section 10.3);
and

 

(b) any right to terminate under this
Section 10.4 shall be stayed and the cure period shall be stopped
in the event that, during any cure period, the Party alleged to
have been in material breach shall have initiated dispute
resolution in accordance with Article 19 with respect to the
alleged breach, which stay and stopping shall last so long as the
dispute resolution proceedings are ongoing.

 

 

 

 

11
CONSEQUENCES OF TERMINATION

 

11.1 In the event of

 

(A) termination of this Agreement by
TGTX pursuant to Section 10.1 or 10.2:

 

(a) The license
granted by Novimmune to TGTX under Section 2.1 shall terminate and
revert to Novimmune on the effective date of
termination.

 

(b) Novimmune shall
have the right, exercisable upon written notice by Novimmune to
TGTX given within 27 ( * ) days after the effective
date of such termination, to obtain, and effective upon such
notice, TGTX shall, and it hereby does, grant to Novimmune, a
perpetual, non-exclusive, worldwide, royalty-bearing license, with
the right to sublicense, under TGTX Intellectual Property Rights
(which, for purposes of this Section 11.1(A)(b) shall not include
the Joint Patents or the Joint Know-How) solely to develop, make,
have made, use, sell, offer for sale, have sold and import the
Compound and Products in the Field of Use, subject to the terms and
conditions set forth below in subparagraph (c).  In
consideration for such exclusive license, Novimmune shall pay to
TGTX a royalty that is * % of the royalty amounts set forth in
section 4.3.3 herein.

 

TGTX shall provide
to Novimmune when enforcing any such rights under this Section
11.1(A)(b) reasonable assistance in such enforcement, at
Novimmune’s request and cost, including joining such action
as a party plaintiff if required by applicable Law to pursue such
action.

 

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

 

(c)  TGTX
shall:

 

(i) at no cost to
Novimmune transfer to Novimmune as soon as reasonably practicable
all Data and information in TGTX’s or its Affiliates’
Control and possession relating to the Compound or Products as may
be necessary to enable Novimmune to practice such
license,

 

(ii) at no cost to
Novimmune transfer and assign to Novimmune all of its right, title
and interest in and to all INDs, BLAs, drug dossiers and master
files with respect to any and all Products and all regulatory
approvals with respect to any and all Products, and

 

(iii) Take such
other commercially reasonable actions and shall execute such other
instruments, assignments and documents as may be necessary to
effect the transfer of rights under this subparagraph (c) to
Novimmune, including without limitation assignments of any
contracts, including sublicensing agreements, related to the
Development and Commercialization of any Product or New Product,
unless such assignment is prohibited by a contract and the
applicable consent cannot be reasonably procured at reasonable
cost.  TGTX will use reasonable commercial efforts to
obtain the consent of any third-party to any contract or agreement
related to the Development or Commercialization of the Product or a
New Product, which consent is required for the assignment of any
such contract or agreement from TGTX to Novimmune, provided,
however, that any cash payment required by TGTX in order to procure
any such consent shall be deemed not commercially
reasonable.  Prior to receipt of such consent, TGTX shall
make available to Novimmune all rights and other benefits of such
contracts, on a subcontract or sublease basis or in some other
appropriate manner to the fullest extent reasonably practicable and
permitted by the terms of the contract or otherwise consented to by
the other party to such contract, and Novimmune shall be considered
an independent subcontractor or sublessee of TGTX, with respect to
all matters concerning such contracts.

 

(B) termination of this Agreement by
TGTX pursuant to Section 10.4:

 

(a) the license
granted by Novimmune to TGTX pursuant to Section 2.1 remains in
full force and effect in accordance with its terms and until such
time on a country-by-country basis (i.e. partial) as the expiration
of the Royalty Term or Entire territory , subject to TGTX’s
compliance with Article 4;

 

(b) all
notification and reporting rights of Novimmune shall terminate and
be of no further force or effect;

 

 

 

 

(c) pending the
outcome of arbitration proceedings pursuant to Article 17, TGTX
shall have the right to pay all amounts that become due under
Article 4 after such termination into an escrow account with a
reputable bank, and to the extent the arbitrators award damages to
TGTX, the arbitrators shall be authorized, in their discretion, (i)
to cause the release to TGTX of all or any part of the escrowed
funds in partial or full satisfaction of such award, and/or (ii) to
adjust the amounts payable by TGTX to Novimmune under this
Agreement to compensate TGTX for damages suffered by TGTX as a
result of Novimmune’ material breach.

 

(C)

 termination of this Agreement by
Novimmune pursuant to Section  10.3, or termination of
this Agreement by Novimmune pursuant to Section 10.4 (subject to
paragraph (b) thereof):

 

(a) The license
granted by Novimmune to TGTX under Section 2.1 shall terminate and
revert to Novimmune on the effective date of
termination.

 

(b) Novimmune shall
have the right, exercisable upon written notice by Novimmune to
TGTX given within 28 ( * ) days after the effective date
of such termination, to obtain, and effective upon such notice,
TGTX shall, and it hereby does, grant to Novimmune, a perpetual,
non-exclusive, worldwide, royalty-bearing license, with the right
to sublicense, under TGTX Intellectual Property Rights (which, for
purposes of this Section 11.1(C)(b) shall not include the Joint
Patents or the Joint Know-How) solely to develop, make, have made,
use, sell, offer for sale, have sold and import the Compound and
Products in the Field of Use, subject to the terms and conditions
set forth below in subparagraph (c).  TGTX shall provide
to Novimmune when enforcing any such rights under this Section
11.1(C)(b) reasonable assistance in such enforcement, at
Novimmune’s request and cost, including joining such action
as a party plaintiff if required by applicable Law to pursue such
action.  In consideration for such license, Novimmune
shall pay to TGTX a royalty based on the fair market value of such
license.  The royalty will be negotiated in good faith by the
Parties within * ( * ) days following the effective date of the
termination.  If the Parties cannot agree on the terms of
the royalty, the parties will select a disinterested Third Party to
determine the fair market value of the license (the
“Appraiser”).  Once the Appraiser is selected, the
Appraiser shall be instructed to furnish a written appraisal within
* ( * ) days of it selection.  TGTX shall bear the
Appraiser’s reasonable costs and expenses.  The fair
market value royalty will be paid out of Novimmune’s gross
profits following the first commercial sale of the Product, and
which gross profits will be based on all amounts paid to Novimmune
from its sublicensing or from sales directly or indirectly in the
particular country or Territory.  The term of such
royalty will expire on the expiration of the * .

 

TGTX shall, and it
hereby does, upon such Termination grant to Novimmune, (i) a
perpetual, exclusive, worldwide, royalty-free license, with the
right to sublicense, under the Joint Patents; and (ii) a perpetual,
exclusive, royalty-free license to the Joint Know-How, in each case
solely to develop, make, have made, use, sell, offer for sale, have
sold and import the Compound and Products in the Field of Use,
subject to the terms and conditions set forth below in subparagraph
(c).  TGTX shall provide to Novimmune when enforcing any
such rights under this Section 11.1(C)(b) reasonable assistance in
such enforcement, at Novimmune’s request and cost, including
joining such action as a party plaintiff if required by applicable
Law to pursue such action.

 

(c)  TGTX
shall:

 

(i) at no cost to
Novimmune , transfer to Novimmune as soon as reasonably practicable
all Data and information in TGTX’s or its Affiliates’
Control and possession relating to the Compound or Products as may
be necessary to enable Novimmune to practice such license; (ii) at
no cost to Novimmune,  transfer and assign to Novimmune
all of its right, title and interest in and to all INDs, BLAs, drug
dossiers and master files with respect to any and all Products and
all regulatory approvals with respect to any and all Products; and
(iii) Take such other commercially reasonable actions and shall
execute such other instruments, assignments and documents as may be
necessary to effect the transfer of rights under this subparagraph
(c) to Novimmune, including without limitation assignments of any
contracts, including sublicensing agreements, related to the
Development and Commercialization of any Product or New Product,
unless such assignment is prohibited by a contract and the
applicable consent cannot be reasonably procured at reasonable
cost.  TGTX shall use reasonable commercial efforts to
obtain the consent of any third-party to any contract or agreement
related to the Development or Commercialization of the Product or a
New Product, which consent is required for the assignment of any
such contract or agreement from TGTX to Novimmune, provided,
however, that any cash payment required by TGTX in order to procure
any such consent shall be deemed not commercially
reasonable.  Prior to receipt of such consent, TGTX shall
make available to Novimmune all rights and other benefits of such
contracts, on a subcontract or sublease basis or in some other
appropriate manner to the fullest extent reasonably practicable and
permitted by the terms of the contract or as consented to by the
other party to the contract, and Novimmune shall be considered an
independent subcontractor or sublicensee of TGTX, with respect to
all matters concerning such contracts.

 

(d) pending the
outcome of arbitration proceedings pursuant to Article 19, TGTX
shall pay all amounts that become due under Article 6 after such
termination into an escrow account with a reputable bank, and to
the extent the arbitrators award damages to Novimmune, the
arbitrators shall be authorized, in their discretion, (i) to cause
the release to Novimmune of all or any part of the escrowed funds
in partial or full satisfaction of such award, and/or (ii) to
adjust the amounts payable to Novimmune under this Agreement to
compensate Novimmune for damages suffered by Novimmune as a result
of TGTX’s material breach.

 

11.2 Any termination of this Agreement
shall be without prejudice to any rights or obligations which have
accrued to any Party prior to such termination. Without limiting
the generality of the foregoing, termination of this Agreement
shall not preclude either Party from claiming any other damages,
compensation or relief that it may be entitled to
hereunder.

 

 

 

 

12  SURVIVING
PROVISIONS

 

Sections 4.4 and
Articles 1, 8, 9, 10, 13, 14, 15, 17, 18, 19 and 21 shall survive
termination or expiration of this Agreement.

 

13   NOTICES

 

Notices required or
permitted to be made or given to either Party hereto pursuant to
this Agreement shall be sufficiently made or given on the date of
mailing if sent to such Party by certified or registered mail,
postage prepaid, addressed to it at its address set forth or to
such other address as it shall designate in the course of this
Agreement by written notice to the other Party as
follows:

 

 

	
If to Novimmune:

	
 

	
If to TGTX:

	
Novimmune

 

Attention:

Novimmune 14 ch.
des Aulx, 1228 Plan-Les-Ouates, Geneva,Switzerland

Email-
Legal@Novimmune.com

	
 

	
 

TGTX

 

Attention:  Hari
Miskin

TG Therapeutics,
Inc.

2 Gansevoort Street
| 9th Floor

New York, NY
10014

U.S.A.

Email –
hm@tgtxinc.com

 

 

14
INDEPENDENT CONTRACTOR

 

The relationship of
TGTX and Novimmune under this Agreement is intended to be that of
an independent contractor. Nothing contained in this Agreement is
intended or is to be construed so as to constitute the Parties as
partners or joint ventures or either Party as an agent or employee
of the other. Neither Party has any express or implied right or
authority under this Agreement to assume or create any obligations
on behalf of or in the name of the other, or to bind the other
Party to any contract, agreement or undertaking with any Third
Party.

 

15
COMPLETE AGREEMENT

 

The Parties hereto
acknowledge that this Agreement sets forth the entire agreement and
understanding of the Parties, and supersedes all prior written or
oral agreements or understandings with respect to the subject
matter hereof, including JV Agreement, but excluding:

 

 (a) that
certain Confidentiality Agreement between the Parties dated
15th
February 2018 (the “Original
Confidentiality Agreement”), which shall remain in
full force and effect in accordance with its terms; provided, however, that all
“Confidential Information” (as defined by the Original
Confidentiality Agreement) of Novimmune relating to its CD47/CD19
bi-specific antibody programs, shall be deemed Confidential
Information for purposes of this Agreement; and

 

(b) In the event of
any conflict between the provisions of this Agreement and the
provisions of the Original Confidentiality Agreement, this
Agreement shall control. No modification of this Agreement shall be
deemed to be valid unless in writing and signed by both
Parties

 

 

 

 

16
ASSIGNMENT

 

Except as expressly
provided hereunder, neither this Agreement nor any rights or
obligations hereunder may be assigned or otherwise transferred by
either Party without the prior written consent of the other Party
(which consent shall not be unreasonably withheld); provided, however, that either Party
may assign this Agreement and its rights and obligations hereunder
without the other Party’s consent: (a) in connection with the
transfer or sale of all or substantially all of the business of
such Party to which this Agreement relates to a Third Party,
whether by merger, sale of stock, sale of assets or otherwise
(each, a “Change of Control
Transaction”), provided that in the event of a Change
of Control Transaction in which the acquiring party is a Third
Party, intellectual property rights of the acquiring party to such
Change of Control Transaction that exist prior to the effective
time of such Change of Control Transaction shall not be included in
the technology licensed hereunder or otherwise subject to this
Agreement; or (b) to an Affiliate, provided that no such assignment
to an Affiliate shall relieve the assigning Party of its
obligations hereunder. The rights and obligations of the Parties
under this Agreement shall be binding upon and inure to the benefit
of the successors and permitted assigns of the Parties. Any
assignment not in accordance with this Agreement shall be
void.

 

17
GOVERNING LAW AND DISPUTE RESOLUTION

 

17.1  

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

 

17.2  

 Disputes.

 

(a)  

The Parties
recognize that disputes as to certain matters may from time to time
arise during the Term which relate to either Party’s rights
or obligations hereunder.  It is the objective of the Parties
to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual
cooperation and without resort to litigation.  To accomplish
this objective, the Parties agree to follow the procedures set
forth in this Section 17.2 to resolve any controversy or claim
arising out of, relating to or in connection with any provision of
this Agreement, if and when a dispute arises under this
Agreement.  With respect to all disputes arising between the
Parties, including, without limitation, any alleged failure to
perform, or breach, of this Agreement, or any issue relating to the
interpretation or application of this Agreement, if the Parties are
unable to resolve such dispute within 29 ( * ) days after such dispute is
first identified by either Party in writing to the other, the
Parties shall refer such dispute to the senior executive officers
for each Party for attempted resolution by good faith negotiations
within * ( * ) days after such notice is received.  If the
senior executive officers designated by the Parties are not able to
resolve such dispute within such * ( * ) day period, either Party
may submit such dispute in accordance with
Section 17.2(b).

(b)  

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

(c)  

Notwithstanding
anything to the contrary in this Article 19, either Party may
seek injunctive relief in any court in any jurisdiction where
appropriate.

 

 

 

18  FORCE
MAJEURE

 

18.1 Neither Party shall be liable for a
failure to comply with a provision herein, if it is prevented from
performing the said provision because of force majeure, this notion
being defined as an event beyond the control of the Parties and
independent from their will including, but not limited to, strikes
or other labor trouble, war, insurrection, fire, flood, explosion,
extreme weather and storms, discontinuity in supply of power, court
order or governmental interference

 

18.2 Despite the event of force majeure,
either Party hereto shall undertake reasonable efforts to comply to
the extent possible with its obligations towards the other Party,
pursuant to this Agreement.

 

18.3 The Party invoking an event of
force majeure shall notify it forthwith to the other Party, and
must specify which one or ones of its obligations it is being
prevented from complying with, and the nature of force majeure, and
must give an estimate of the period during which it is likely that
it shall be prevented from complying with the said obligation or
obligations

 

19
MISCELLANEOUS

 

19.1 If any provision of this Agreement
should be or become fully or partly invalid or unenforceable for
any reason whatsoever or should violate any applicable law, this
Agreement is to be considered divisible as to such provision and
such provision is to be deemed deleted from this Agreement, and the
remainder of this Agreement shall be valid and binding as if such
provision were not included therein. There shall be substituted for
any such provision deemed to be deleted a suitable provision which,
as far as is legally possible, comes nearest to the sense and
purpose of the stricken provision

 

19.2 Failure by any Party to enforce any
term or provision of this Agreement in any specific instance or
instances hereunder shall not constitute a waiver by such Party of
any such term or provision, and such Party may enforce such term or
provision in any subsequent instance without any limitation or
penalty whatsoever.

 

19.3 This Agreement is neither expressly
nor impliedly made for the benefit of any entity other than the
Parties.

 

19.4 The headings set forth in this
Agreement are for convenience only and do not qualify or affect the
terms or conditions of this Agreement. Ambiguities and
uncertainties in this Agreement, if any, shall not be interpreted
against either Party, irrespective of which Party may be deemed to
have caused the ambiguity or uncertainty to exist. This Agreement
has been prepared in the English language, and the English language
shall control its interpretation. In addition, all notices required
or permitted to be given hereunder, and all written, electronic,
oral or other communications between the Parties regarding this
Agreement shall be in the English language.

 

19.5 No waiver of any right or remedy
hereunder shall be effective unless provided in writing executed by
the waiving Party.

 

19.6 The agreement survives in case
either Party is acquired or goes bankrupt.

 

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

 

 

 

 

IN WITNESS WHEREOF,
the Parties have caused this Agreement to be executed by their duly
authorized representatives as of the Effective Date

 

 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
TG
THERAPEUTICS, INC.

	
 

	
NOVIMMUNE
SA

	
 

	
 

	

 

 

	
 

	
 

	
 

	
 

	
 

	
 

	
Name:

	
 

	
 

	
 

	
Name:

	
 

	
 

	
Title

	
 

	
 

	
 

	
 

	
 

	
Title:

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Date:

	
 

	
 

	
 

	
 

	
 

	
Date:

	
 

	
 

 

 

 

  

 

 

 

8 Confidential
material redacted and filed separately with the
Commission. 

 

9 Confidential
material redacted and filed separately with the
Commission. 
 

10 Confidential
material redacted and filed separately with the
Commission. 
 

11 Confidential
material redacted and filed separately with the
Commission. 
 

12 Confidential
material redacted and filed separately with the
Commission. 
 

13 Confidential
material redacted and filed separately with the
Commission. 
 

14 Confidential
material redacted and filed separately with the
Commission. 
 

15 Confidential
material redacted and filed separately with the
Commission. 
 

16 Confidential
material redacted and filed separately with the
Commission.   

 

17 Confidential
material redacted and filed separately with the
Commission. 

 

18 Confidential
material redacted and filed separately with the
Commission. 
 

19 Confidential
material redacted and filed separately with the
Commission. 
 

20 Confidential
material redacted and filed separately with the
Commission. 
 

21 Confidential
material redacted and filed separately with the
Commission. 
 

22 Confidential
material redacted and filed separately with the
Commission. 
 

23 Confidential
material redacted and filed separately with the
Commission. 
 

24 Confidential
material redacted and filed separately with the
Commission. 
 

25 Confidential
material redacted and filed separately with the
Commission. 
 

26 Confidential
material redacted and filed separately with the
Commission. 
 

27 Confidential
material redacted and filed separately with the
Commission. 
 

28 Confidential
material redacted and filed separately with the
Commission. 
 

29 Confidential
material redacted and filed separately with the
Commission. 
 

 

 

 

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

 

 

Exhibit
G

 

NI-1701
Study Reports & Mapping

 

 

 

30

 

 

 

 

 
30 Confidential
material redacted and filed separately with the
Commission.

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