Document:

Exhibit 10.2

 

LICENSE AGREEMENT 

effective February 26, 2016

between

ALBA THERAPEUTICS CORPORATION

and

INNOVATE BIOPHARMACEUTICALS, INC.

 

     

     

    

 

TABLE OF CONTENTS

 

	ARTICLE 1. BACKGROUND	1
	ARTICLE 2. DEFINITIONS	1
	ARTICLE 3. GRANT OF LICENSE; Assignment of Contracts; OPTION	3
	ARTICLE 4. COMPANY RESPONSIBILITIES	5
	ARTICLE 5. CONSIDERATION: PAYMENTS	6
	ARTICLE 6. DATA	8
	ARTICLE 7. PATENT PROSECUTION	8
	ARTICLE 8. CONFIDENTIALITY	8
	ARTICLE 9. [INTENTIONALLY OMITTED]	10
	ARTICLE 10. INFRINGEMENT	10
	ARTICLE 11. TERM AND TERMINATION	11
	ARTICLE 12. ASSIGNABILITY	12
	ARTICLE 13. APPLICABLE LAW; WAIVER	12
	ARTICLE 14. INTEGRATION AND INTERPRETATION	13
	ARTICLE 15. REPRESENTATIONS AND WARRANTIES	13
	ARTICLE 16. CLAIMS, INDEMNIFICATION AND INSURANCE	14
	ARTICLE 17. ADVERTISING AND PUBLICITY	15
	ARTICLE 18. DISPUTE RESOLUTION	15
	ARTICLE 19. MISCELLANEOUS	16

 

	EXHIBIT A	COPYRIGHTS
	EXHIBIT A-1	INVENTORY
	EXHIBIT B	LICENSED PATENTS
	EXHIBIT C	UMD SUBLICENSE
	EXHIBIT D  	TRANSFERRED CONTRACTS
	EXHIBIT E  	DEVELOPMENT PLAN

 

    	 	 -i-	 

     

    

 

LICENSE AGREEMENT

 

This License Agreement
(“Agreement”) effective as of February 26, 2016 (“Effective Date”) is made by and between
Alba Therapeutics Corporation, a Delaware corporation (“Alba”), having an address at 100 International Drive,
23rd Floor, Baltimore, MD 21202, and Innovate Biopharmaceuticals, Inc., a Delaware corporation, having an address at 8601 Six Forks
Road, Suite 400, Raleigh, NC 27615 (“Company”).

 

ARTICLE
1. BACKGROUND

 

1.01       Alba
and Company are parties to an Option Agreement, dated October 7, 2015, as amended, in which Alba granted an exclusive option to
Company for the purchase of Alba’s assets relating to Larazotide acetate and related compounds, which option was exercised
by Company on January 15, 2016.

 

1.02       In
lieu of entering into an asset purchase agreement, Alba and Company elected to enter into a license arrangement with respect to
Alba’s Assets (as defined below) and an accompanying sublicense arrangement (in the form of Exhibit C) with respect to that
certain Restated Master License Agreement, dated as of July 1, 2005, by and between Alba and the University of Maryland, Baltimore.

 

1.03       In
furtherance of such license arrangement and a potential eventual asset transfer, Alba desires to grant, and the Company desires
to accept, an exclusive license to the Assets, upon the terms and subject to the conditions set forth in this Agreement.

 

1.04       Subject
to certain conditions set forth herein, upon completion by the Company of certain clinical milestones Alba desires to sell, and
the Company desires to purchase, the Assets pursuant to an asset purchase agreement incorporating terms mutually agreed upon herein.

 

ARTICLE
2. DEFINITIONS

 

In this Agreement, the
following terms have the meanings set forth in this Article.

 

2.01       “Affiliate”:
Any entity that directly or indirectly controls, is controlled by, or is under common control with Company. “Control”
means the right to exercise more than 50% of the voting rights of a controlled corporation, limited liability company, or partnership,
or the power to direct or cause the direction of the management or policies of any other controlled entity.

 

2.02       “Assets”:
Intellectual Property and all other assets owned or controlled by Alba primarily related to the Licensed Product, including, without
limitation, all inventory (including inventory identified on Exhibit A-1), contracts, books, records, files, regulatory filings
and data related to the Licensed Product.

 

2.03       “CeD
PRO Instrument”: The Celiac Disease Patient Reported Outcome Instrument developed by Alba, including User Manual and
Evidence Dossier, and any translations of the foregoing.

 

2.04       “Commercially
Reasonably Efforts”: With respect to the performance of development, manufacturing or commercialization activities with
respect to the Licensed Products by Company or its Affiliates, the expenditure of efforts and resources consistent with the usual
and commercially reasonable practice of Company in the exercise of its reasonable business discretion (but no less efforts and
resources than a similarly-situated company would reasonably be expected to expend), with respect to development, manufacturing
or commercialization of other products that are of similar market potential at a similar stage in their development or product
life.

 

    	 	1	 

     

    

 

2.05       “Confidential
Information”: Information relating to the subject matter of the Licensed Product or Patent Rights which has not been
made public and includes, without limitation, any documents, drawings, sketches, models, designs, data, memoranda, tapes, records,
formulae and algorithms, given orally, in hard copy form, or in electronic form, which Company receives from Alba, or Alba receives
from Company.

 

2.06       “Copyrights
& Trademarks”: The copyrights and trademarks listed on Exhibit A hereto.

 

2.07      
“First Commercial Sale”: The initial transfer of a Licensed Product for compensation by Company, an Affiliate
or a Sublicensee to a Third Party. First Commercial Sale shall not include any transfer or disposition of a sample or for charitable
purposes (including, without limitation, pursuant to an early access, compassionate use, named patient, indigent access or patient
assistance program), or for preclinical, clinical or regulatory purposes.

 

2.08       “Improvement”:
An invention or discovery by Company directly related to the Patent Rights in the Licensed Field which is or may be patentable
or otherwise protected under law, and is reasonably necessary for the practice of the Patent Rights by Alba or a third party.

 

2.09       “Intellectual
Property”: Patent Rights, Copyrights & Trademarks and Know-How.

 

2.10       “Know-How”:
All data, results, improvements, processes, methods, protocols, formulas, inventions, trade-secrets and other information, patentable
or otherwise, which may include (but is not limited to) scientific, research and development, manufacturing know-how, pre-clinical,
clinical, regulatory, manufacturing, safety, marketing, financial and commercial information or data which is owned or controlled
by Alba and are necessary or useful to the research, development and/or commercialization of the Licensed Product.

 

2.11       “Licensed
Field”: All fields.

 

2.12       “Licensed
Product(s)”: Any pharmaceutical composition containing, consisting of, or comprising: (i) [***];
(ii) larazotide, including any salt or ester thereof including larazotide acetate; and (iii) to the extent not contemplated by
the preceding clauses (i)-(ii), a compound for treating or preventing a condition, including but not limited to Celiac Disease,
or its use in treatment or prevention of a condition, including but not limited to Celiac Disease, where the compound or method
of use is covered by an issued Licensed Patent

 

2.13       “MAA”:
A marketing authorization application filed with the European Medicines Agency or any successor agency thereto (“EMA”)
to obtain regulatory approval for a new drug under the centralized EMA filing procedure or, if the centralized EMA filing procedure
is not used, filed to obtain regulatory approval for a new drug using applicable procedures in accordance with applicable law in
any European Union country.

 

 

[***] Confidential treatment
requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

 

    	 	2	 

     

    

 

2.14       “NDA”:
A New Drug Application for purposes of the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and
the rules, regulations, guidelines, guidances and requirements promulgated thereunder, as may be in effect.

 

2.15       “Net
Sales”: The gross sales revenues and fees invoiced by Company, an Affiliate or a Sublicensee to independent Third Party
purchasers who are not Affiliates, for the sale of Licensed Products, less the sum of the following: (a) credits, allowances, discounts
and rebates to, and charge backs from the account of, such Third Party purchasers for spoiled, damaged, out-dated, rejected or
returned Licensed Products; (b) actual freight and insurance costs incurred in transporting such Licensed Products to such Third
Party purchasers; (c) cash, quantity and trade discounts and other price reductions; (d) sales, use, value-added and other direct
taxes incurred (which term shall include any annual fees due under Section 9008 of the United States Patient Protection and Affordable
Care Act of 2010 allocable to such Licensed Product); (e) customs duties, surcharges and other governmental charges incurred in
connection with the exportation or importation of such Licensed Products; and (f) the cost to Third Party purchasers of the devices
for dispensing or administering such Licensed Products, as well as diluents or similar materials which accompany such Licensed
Products as they are sold.

 

Net Sales do not include
any resales of Licensed Product after its sale by Company, an Affiliate or a Sublicensee to a Third Party purchaser. In computing
Net Sales, (1) no deductions from gross revenues and fees will be made for commissions paid to individuals, whether they be with
independent sales agencies or regularly employed on the payroll by Company, its Affiliate(s) or Sublicensee(s), or for cost of
collections, and (2) Licensed Products will be considered sold when invoiced.

 

2.16      
“Patent Rights”: Alba’s interest in the patents and patent applications related to the Licensed Product,
as further itemized in Exhibit B, including (i) patents and patents that may issue from the applications, (ii) all continuations,
continuations-in-part, divisions, reissues, re-examinations or extensions of the foregoing, and (iii) and foreign counterparts
of any of the foregoing.

 

2.17       “Phase
3 Trial”: A controlled clinical study of a Licensed Product that is prospectively designed to demonstrate with statistical
significance the efficacy and safety of the Licensed Product for use in a particular indication and that is sufficient to obtain
regulatory approval by the FDA to market the Licensed Product in such indication.

 

2.18      
“Sublicensee”: A person or entity, including an Affiliate, to which Company sublicenses all or some of the Patent
Rights or Assets.

 

2.19       “Third
Party”: Any entity or person other than Alba, Company, an Affiliate or a Sublicensee.

 

2.20       “Transferred
IND” shall mean the Investigational New Drug Application (IND# 70,568) for larazotide acetate submitted on September
11, 2005 (Serial Number 0000).

 

ARTICLE
3. GRANT OF LICENSE; Assignment of Contracts; OPTION

 

3.01       Alba
hereby grants to Company, and Company accepts, an exclusive worldwide license under the Assets, including the Patent Rights, to
conduct research and development and to make, have made, use, lease, offer to sell, sell and import the Licensed Products within
the Licensed Field, anywhere in the world, for the term of this Agreement; provided, however, that with respect to the CeD PRO
Instrument, such license shall be exclusive, subject only to licenses granted prior to the Effective Date which licenses are included
in the Transferred Contracts.

 

    	 	3	 

     

    

 

3.02       During
the term of this Agreement, Company may transfer its rights to an Affiliate consistent with this Agreement, provided Company is
responsible for the obligations of its Affiliate relevant to this Agreement, including the payment of milestones, whether or not
paid to Company by its Affiliate.

 

3.03       During
the term of this Agreement, Company may grant sublicenses consistent with this Agreement, provided Company is responsible for the
obligations of its Sublicensees relevant to this Agreement, including the payment of milestones, whether or not paid to Company
by its Sublicensees, and provided further that in no event shall Company grant such a sublicense without first obtaining Alba’s
written consent, which consent shall not be unreasonably withheld. For clarification, no consent requirement shall be applicable
after execution of the Asset Purchase Agreement.

 

3.04       Company
will identify its Affiliates and its Sublicensees under this Agreement to Alba by name, address and field of sublicense (both as
to geography and subject matter), and any other reasonable information necessary for Alba to conduct a meaningful audit under Section
9.01 below, except that Company reserves the right to redact any and all Confidential Information that is nonessential to any such
Alba audit.

 

3.05       Alba
hereby assigns to Company, and Company hereby assumes, Alba’s rights and all obligations first arising after the Effective
Date under (i) the contracts identified on Exhibit D attached hereto (the “Transferred Contracts”) and (ii)
the Transferred IND, and Alba shall have no liability thereunder for obligations first arising from and after the Effective Date,
and the Company hereby agrees to indemnify Alba against any and all such liabilities thereunder; provided that, in the event this
Agreement terminates for any reason, Company shall execute any and all documents necessary to assign back to Alba, and Alba shall
assume back from Company, Alba’s rights and obligations under the Transferred Contracts and the Transferred IND. Company
shall not transfer, assign, modify, sublicense or terminate the Transferred Contracts or the Transferred IND without first obtaining
Alba’s written consent, which consent shall not be unreasonably withheld; provided, however, that Company may assign the
Transferred Contracts and the Transferred IND in connection with an assignment of this Agreement pursuant to Article 12; and provided
further that such assignments be subject to Alba’s reversion rights as set forth in the immediately preceding sentence.

 

3.06       (a)         Upon payment
by Company of the first Milestone Payment (as defined in Section 5.01(b) below), and provided that Company has delivered to Alba
reasonable evidence of sufficient financial resources necessary to complete Company’s Phase 3 Trial in accordance with the
Development Plan (as defined below), Company shall have an exclusive option to purchase (the “Company Option to Purchase”)
the Assets from Alba pursuant to the terms of a customary asset purchase agreement (an “Asset Purchase Agreement”),
exercisable by Company’s delivery to Alba, on or before the first (1st) anniversary of such first Milestone Payment, of a
written notice informing Alba that Company is exercising its Company Option to Purchase (such notice, the “Company Exercise
Notice”).

 

(b)      
During the term of this Agreement, Alba shall have the right to sell (the “Alba Option to
Sell”) the Assets to Company pursuant to the terms of an Asset Purchase Agreement, exercisable by Alba’s delivery
to Company of a written notice informing the Company that Alba is exercising its Alba Option to Sell (such notice, the “Alba
Exercise Notice”).

 

(c)       Upon
either delivery by Company of the Company Exercise Notice or by Alba of the Alba Exercise Notice, Company and Alba agree to negotiate
in good faith and execute an Asset Purchase Agreement within ninety (90) days following such delivery (the “Negotiation
Period”). Should the Parties fail to enter into an Asset Purchase Agreement before the end of the Negotiation Period
following Company’s delivery of the Company Exercise Notice, this License Agreement will remain in effect. 

 

    	 	4	 

     

    

 

(d)       Notwithstanding the forgoing, such Asset Purchase Agreement shall include at least the following
provisions:

 

1.       a
purchase price payable by Company to Alba for the purchase of the Assets that consists [***].

 

2.       indemnification
provisions substantially similar to the indemnification provisions set forth in this Agreement, subject to appropriate escrows,
baskets and caps consistent with an asset purchase transaction;

 

3.       the
same diligence requirements set forth in this Agreement;

 

4.       reporting
provisions whereby Company shall provide reasonable updates regarding product development, clinical and regulatory matters sufficient
to enable Alba to satisfy its obligations to its stockholders; and

 

5.       for
[***] ([***]) years following the effective date of the Asset Purchase Agreement, a covenant whereby Alba agrees it shall not directly
or indirectly develop or commercialize any product that competes against the Licensed Product.

 

ARTICLE
4. COMPANY RESPONSIBILITIES

 

4.01       Company
will use its Commercially Reasonable Efforts to bring one or more Licensed Products to market in accordance with the Development
Plan (as defined below), subject in all cases to the following:

 

(a)       Company
has delivered to Alba prior to execution of this Agreement a confidential development plan (the “Development Plan”)
with respect to the development, manufacture and commercialization of the Licensed Product, a copy of which is attached hereto
as Exhibit E. The Development Plan, and any reports or other information related thereto delivered by Company to Alba pursuant
to Section 5.02(b) below, will be treated as Confidential Information by Alba.

 

(b)       To
the extent that the Company’s responsibility for any aspect of the Development Plan is made the responsibility of an Affiliate
or Sublicensee, Company retains its obligations to Alba as to this Article as if Company is solely responsible for that aspect.

 

4.02       Company
agrees that any Licensed Products for use or sale in the United States will be manufactured substantially in the United States
in accordance with the requirements of 35 U.S.C. Section 204 and 37 CFR 401.14(a)(i). In the event Company determines that compliance
with this obligation is commercially impracticable, Company agrees that it will apply for a waiver of such obligation from the
United States Government. In agreements with Affiliates and Sublicensees, Company will pass through this obligation. Company will
use its best efforts to enforce this obligation and will promptly advise Alba of any known violations, or charges of violations,
of this obligation.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	5	 

     

    

 

 

4.03       The
use and disclosure of technical information acquired pursuant to this Agreement and the exercise of Patent Rights granted by this
Agreement are subject to the export, assets, and financial control regulations of the United States of America, including, without
limitation, restrictions under regulations of the United States that may be applicable to direct or indirect re-exportation of
such technical information or of equipment, products, or services directly produced by use of such technical information. Company
is responsible for taking any steps necessary to comply with such regulations.

 

ARTICLE
5. CONSIDERATION: PAYMENTS

 

In consideration of the
license granted to Company:

 

5.01       (a)         At execution
of this Agreement, Company will pay to Alba a one-time, non-refundable license fee of Four Hundred Thousand Dollars ($400,000.00).

 

(b)       In
addition, Company shall make each of the following payments to Alba (each, a “Milestone Payment”) upon the occurrence
of each of the following corresponding events (each, a “Milestone Trigger”):

 

	 	 	Milestone Payment	 	Milestone Trigger
	 	 	 	 	 
	1.	 	$[***]	 	Dosing of first patient in first Phase 3 Trial
	 	 	 	 	 
	2.	 	$[***]	 	First Acceptance of an NDA or MAA for a Licensed  Product
	 	 	 	 	 
	3.	 	$[***]	 	First Approval of an NDA or MMA for a Licensed Product
	 	 	 	 	 
	4.	 	$2,500,000.00	 	First Commercial Sale for a Licensed Product
	 	 	 	 	 
	5.	 	$[***]	 	First instance of annual Net Sales of Licensed Products in any calendar year exceeding $100,000,000.00
	 	 	 	 	 
	6.	 	$[***]	 	First instance of annual Net Sales of Licensed Products in any calendar year exceeding $500,000,000.00
	 	 	 	 	 
	7.	 	$[***]	 	First instance of annual Net Sales of Licensed Products in any calendar year exceeding $1,000,000,000.00
	 	 	 	 	 
	8.	 	$[***]	 	First instance of annual Net Sales of Licensed Products in any calendar year exceeding $1,500,000,000.00

 

(c)       For
the avoidance of doubt, if Company achieves more than one of the Milestone Triggers in the same calendar year, then Company shall,
at the time prescribed in this Article 5, pay to Alba the applicable Milestone Payments for all of such Milestone Triggers achieved
in such calendar year. For example, if Net Sales for a calendar year are $500,000,000.00 and Company has not previously paid to
Alba the Milestone Payment applicable to Milestone Trigger 5 (but has previously paid to Alba the Milestone Payments applicable
to Milestone Triggers 1, 2, 3 and 4), then Company shall pay $[***] to Alba (the sum of the Milestone Payments applicable to Milestone
Triggers 5 and 6). 

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	6	 

     

    

 

5.02       From
and after the Effective Date:

 

(a)       Company
shall use its Commercially Reasonable Efforts to cause each Milestone Trigger to occur as promptly as practicable and shall not
take any action or omit to take any action with the intent of circumventing or delaying any Milestone Trigger or Company’s
obligations set forth in this Article V.

 

(b)       No
later than forty five (45) days after the end of each calendar quarter (until Milestone Payment #3 has been made), Company shall
provide Alba with a written report for such calendar quarter (each, a “Milestone Report”), in each case, setting
forth in reasonable detail all material development, manufacturing and commercialization activities undertaken by or on behalf
of Company, during such quarter with respect to the Licensed Product, as well as summary results of all pre-clinical or clinical
studies related to Licensed Product completed during such quarter, including a review of activities as measured against the Development
Plan, and shall otherwise keep Alba reasonably informed as to its activities and the status of its efforts with respect to the
achievement of the Milestone Triggers, including, until the occurrence of the first Milestone Trigger, updates on Company’s
efforts to raise the capital necessary to accomplish the Development Plan. Company shall actively engage with Alba (including by
making available Company’s most senior research and development employee) to answer any questions regarding any Milestone
Report and to provide such additional information and documents as Alba may reasonably request with respect thereto.

 

(c)       If
a Milestone Trigger has been achieved during a calendar quarter, the Milestone Report for such calendar quarter shall indicate
such achievement.

 

(d)       Without
limiting clause (b) above, Company shall (until all of the Milestone Payments have been made), upon at least ten (10) business
days’ prior notice, permit an independent third party accounting firm reasonably acceptable to both parties reasonable access
during normal business hours to examine such records at the facilities where such records are customarily kept, as may be necessary
for the sole purpose of verifying the calculation and reporting of Net Sales. Such examination shall occur no more frequently than
once each calendar year and shall be paid for by Alba, unless the auditor determines that Company undercalculated Net Sales by
more than $[***], in which case such
examination shall be paid for by Company. The independent accounting firm may only disclose to Alba (i) whether a Milestone Trigger
has been achieved or (ii) that Company undercalculated Net Sales.

 

5.03       
Company shall pay each Milestone Payment with respect to a Development Milestone Trigger to Alba within thirty (30) days after
providing to Alba notice of the achievement of the applicable Milestone Trigger (whether in a Milestone Report or otherwise). Interest
is due on any Milestone Payment payable to Alba under this Agreement. The interest rate is the prime rate plus [***] percent simple
interest per annum accruing from the due date.

 

 

[***] Confidential treatment
requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

  

    	 	7	 

     

    

 

ARTICLE
6. DATA

 

6.01       Nothing
herein shall be construed to require either party to disclose or deliver to the other party any information or communication that
is considered by the disclosing party to be protected by the attorney-client privilege, or is considered by the disclosing party
to be attorney work product, without the express written consent of the disclosing party. In no event shall this clause be deemed
to permit (i) Alba to withhold any pre-clinical or clinical data or (ii) Company to withhold any data or information required to
be included in any Milestone Report prepared for, and delivered to, Alba pursuant to Section 5.02(b) above.

 

ARTICLE
7. PATENT PROSECUTION

 

7.01       Company,
at company’s expense shall file, prosecute and maintain all patents and patent applications specified in Exhibit B. Company
shall have control over all patent matters, provided however, that Company shall allow Alba an opportunity to comment and advise
Company on decisions that diminish or limit the scope of any patent or application. If Company elects to abandon any patent application
(except for purposes of filing a continuation application) or patent in any country, Company shall notify Alba in writing at least
thirty (30) days prior to any filing or payment due date or any other deadline that requires action to avoid loss of rights and
thereafter, Alba shall have the right to control the filing, prosecution, and/or maintenance of such patent application or patent
in such country at its own expense. By written notification to Alba at least thirty (30) days in advance of any filing or response
deadline, or fee due date, company may elect not to have a particular patent application maintained in any particular country or
not to pay expenses associated with filing, prosecuting or maintaining a particular patent application or patent, provided that
company pays for all costs incurred up to Alba’s receipt of such notification. Upon such notification, Alba may file, prosecute
and/or maintain such patent applications or patent in such country at its own expense and for its own benefit, and any rights or
license granted hereunder held by company, an affiliate or sublicensee relating to such patent application or patent in such country
shall terminate.

 

ARTICLE
8. CONFIDENTIALITY

 

8.01       Knowingly
or inadvertently, either party may disclose to the other certain Confidential Information. Disclosures by Alba are deemed to refer
to disclosures by any Alba officers, directors, employees, consultants or agents. Disclosures by Company are deemed to refer to
disclosures by Company officers, directors, employees, consultants or agents. Confidential Information may be disclosed only in
accordance with the provisions of this Article.

 

8.02       Except
as hereafter specifically authorized in writing by the disclosing party, the receiving party will not disclose or use the Confidential
Information for a period of [***] years
after the date of receipt of Confidential Information.

 

8.03       These
obligations of non-disclosure and nonuse do not apply to any Confidential Information which the receiving party can demonstrate
by reliable written evidence:

 

(a)       was
generally available to the public at the time of disclosure to the receiving party; or

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	8	 

     

    

  

(b)       was
already in the possession of the receiving party at the time of the disclosure, other than pursuant to a confidential disclosure
agreement between the parties and not due to any unauthorized act by the receiving party; or

 

(c)       was
developed by the receiving party prior to the disclosure; or

 

(d)       the
receiving party is required by law to disclose.

 

8.04       These
obligations of non-disclosure and nonuse will not continue to apply to any Confidential Information which the receiving party can
demonstrate by reliable written evidence:

 

(a)       has
become generally available to the public other than through a breach of this Agreement by the receiving party after disclosure;

 

(b)       has
been acquired by the receiving party on a nonconfidential basis from any third party having a lawful right to disclose it to the
receiving party; or

 

(c)       corresponds
to information developed by the receiving party independent of and with no reliance upon the disclosing party’s Confidential
Information.

 

8.05       Each
party will use that level of care to prevent the use or disclosure of the other party’s Confidential Information as it exercises
in protecting its own Confidential Information, which in no event will be less than a reasonable standard of care.

 

8.06       All
Confidential Information will be clearly marked as confidential by the disclosing party and, if not in written or tangible form
when disclosed, will be indicated as confidential upon disclosure and then summarized in writing and so marked as confidential
within 30 days after disclosure to the receiving party.

 

8.07       Notwithstanding
the foregoing, Company, its Affiliates and its Sublicensees are permitted to disclose and use the Confidential Information to the
extent reasonably necessary to exercise Company’s license or sublicenses hereunder, or to comply with Federal reporting requirements,
provided that any disclosure is made subject to written confidentiality restrictions consistent with those accepted by Company
in this Agreement. During the Term and after execution of the Asset Purchase Agreement, any Confidential Information related to
Licensed Product shall be deemed to constitute Confidential Information of Company.

 

8.08       Upon
termination of this Agreement (unless terminated by virtue of execution of the Asset Purchase Agreement), (i) Company will return
to Alba all material which is Confidential Information of Alba, together with all copies and other forms of reproduction, except
that a single archive copy may be kept in Company’s legal files, and (ii) Alba will return to Company all material which
is Confidential Information of Company, together with all copies and other forms of reproduction, except that a single archive
copy may be kept in Alba’s legal files. Each party agrees that termination of this Agreement does not alter the [***] year
obligation of confidentiality set forth in Section 8.02.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	9	 

     

    

 

ARTICLE
9. [INTENTIONALLY OMITTED]

 

ARTICLE
10. INFRINGEMENT

 

10.01     Alba
and Company agree to notify each other promptly of each infringement or possible infringement of the Patent Rights of which either
party becomes aware.

 

10.02     Company
may (a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the
Patent Rights licensed to Company; (b) in any such suit, enjoin infringement and collect for its use damages, profits, and awards
of whatever nature recoverable for such infringement; and (c) settle any claim or suit for infringement of the Patent Rights. Company
may not compel Alba to initiate or join in any such suit for patent infringement. Company may request Alba to initiate or join
in any such suit if necessary to avoid dismissal of the suit. If Alba is made a party to any such suit, Company will reimburse
and indemnify Alba for any costs, expenses, or fees which Alba incurs as a result of its joinder. In all cases, Company agrees
to keep Alba reasonably apprised of the status and progress of any litigation.

 

10.03      If
an infringement action or a declaratory judgment action alleging invalidity or non-infringement of any of the Patent Rights is
brought against Company or raised by way of counterclaim or affirmative defense in an infringement suit brought by Company under
Section 10.02, Company may (a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid
claims in the Patent Rights; (b) in any such suit, ultimately enjoin infringement and collect for its use, damages, profits, and
awards of whatever nature recoverable for such infringement; and (c) settle any claim or suit for damages or a declaratory judgment
involving the Patent Rights, including the granting of further licenses on sublicenses, provided that Company does not admit Alba’s
infringement or concede invalidation of any Patent Rights, without Alba’s prior written consent, respectively. Alba consent
will not be unreasonably withheld. Company may not compel Alba to initiate or join in any such suit. Company may request Alba to
initiate or join in any such suit if necessary to avoid dismissal of the suit. If Alba is made a party to any such suit, Company
will reimburse and indemnify Alba for any costs, expenses, or fees which it incurs as a result of its joinder. In all cases, Company
agrees to keep Alba reasonably apprised of the status and progress of any litigation.

 

10.04     Company
will not settle any action described in Section 10.02 or 10.03 without first notifying Alba. In any action under Sections 10.02
or 10.03, the expenses of Company and Alba, including costs, fees, attorney fees, and disbursements, will be paid by Company.

 

10.05     Alba
will cooperate reasonably with Company in connection with any action under Sections 10.02 or 10.03. Alba agrees to provide prompt
access to all necessary documents and to render reasonable assistance in response to requests by Company.

 

10.06     Alba
has a continuing right to intervene in a suit initiated by Company under Section 10.02 or in a declaratory judgment action involving
the Patent Rights brought against Company under Section 10.03. In either case, if Alba chooses to intervene, Alba will be responsible
for its litigation expenses and will be entitled to all recoveries which it obtains for itself as a result of its intervention.

 

10.07      If
Company desires to initiate a suit for patent infringement under Section 10.02, Company will notify Alba in writing within 90 days
after giving or receiving notice of infringement under Section 10.01. If Company fails to notify Alba of its intent to initiate
suit within the 90 day period or if Company notifies Alba that it does not intend to initiate suit, Alba may initiate suit at its
own expense. In such case, Alba is entitled to all recoveries from such action.

 

    	 	10	 

     

    

 

10.08     If
an infringement action or a declaratory judgment action alleging invalidity or non-infringement of any of the Patent Rights is
brought against Company or raised by way of counterclaim or affirmative defense in an infringement suit brought by Company as described
in Section 10.02, Company will notify Alba whether Company intends to respond in opposition to such legal action within 15 days
after Company’s receipt of notice of the filing of such action. If Company fails to notify Alba of its intent to respond
in opposition to such legal action within the 15 day period, or if Company notifies Alba that it does not intend to oppose the
action, Alba may respond to the legal action at Alba’s expense. In such case, Alba is entitled to all recoveries from such
action.

 

10.09     Company
will cooperate reasonably with Alba in connection with any action described in Sections 10.07 or 10.08. Company agrees to provide
prompt access to all necessary documents and to render reasonable assistance in response to requests by Alba.

 

ARTICLE
11. TERM AND TERMINATION

 

11.01     Unless
sooner terminated in accordance with any of the succeeding provisions of this Article 11, this Agreement will continue in full
force and effect. Upon payment of Milestone Payment 4, the licenses granted herein shall thereafter be perpetual and irrevocable.
Upon payment of Milestone Payment 8, the licenses granted herein shall thereafter be perpetual, irrevocable and royalty free.

 

11.02     Should
Company fail to pay Alba any sum due and payable under this Agreement prior to and including Milestone Payment 4, Alba may terminate
this Agreement on thirty (30) days written notice, unless Company pays Alba within the thirty (30) day period all delinquent sums
together with interest due and unpaid. Upon expiration of the thirty (30) day period, if Company has not paid all sums and interest
due and payable, the parties will enter into a thirty (30) day Cure Period during which time, both parties will attempt to resolve
the non-payment. If no resolution is reached at the end of the Cure Period, then the rights, privileges, and licenses granted under
this Agreement will terminate.

 

11.03     Prior
to the First Commercial Sale of a Licensed Product to a Third Party, Company is considered diligent with regard to development
of a Licensed Product as long as Company updates and reports progress against the Development Plan in its Milestone Reports and
as long as Company continues to use Commercially Reasonable Efforts pursuant to Section 4.01 above to accomplish the Development
Plan as it relates to Licensed Products.

 

11.04     If
Alba reasonably believes that Company is not diligent in development of Licensed Product based upon the criteria set forth in Section
11.03, then Alba may assert a breach and its termination rights under Section 11.05 below and invoke the dispute resolution procedures
in Section 18.

 

11.05     In
the event that prior to the First Commercial Sale of a Licensed Product to a Third Party Company, an Affiliate or a Sublicensee
breaches Sections 3.02, 3.03, 3.04, 4.01, 5.02, 5.03, 10.04(a), 12.01, 15.02, 16.01 or 16.02, Alba may terminate this Agreement
upon 90 days written notice to Company. However, if the breach is corrected within the 90-day period and Alba is reimbursed for
all damages directly resulting from the breach, this Agreement will continue in full force and effect and Alba will so notify Company
in writing.

 

11.06     Expiration
or termination of this Agreement does not relieve either party of any obligation for payment and reporting which arises before
expiration or termination including obligations under Articles 5 and 7 (but only for expenses incurred before termination). Articles
2, 10, 13, 14, 15, 16, 17, and 18 and Sections 6.03, 11.07, 11.08 and 19.09 will survive expiration or termination. Article 8 and
Sections 19.02 will survive expiration or termination and will expire in accordance with their terms. Other sections of this Agreement
will be effective after expiration or termination where that intent is clear from the content of those sections

 

    	 	11	 

     

    

 

11.07     Upon
termination of this entire Agreement pursuant to Section 11.05, any Sublicensee not in default may seek a license directly from
Alba to practice Patent Rights within the licensed field set out in its sublicense and upon the consideration stated in its sublicense
to the extent such consideration has not previously been paid to Company. Alba will permit a Sublicensee not in default to continue
use of Patent Rights for a period of up to 60 days (the “Continuation Term”) after termination of this Agreement
while Alba and the Sublicensee negotiate, such license to be consistent with the terms of this Agreement subject to appropriate
amendments of Article 5 and relevant definitions to substitute the consideration and field of use provisions from the sublicense.
Should Alba and the Sublicensee fail to agree upon an amendment within the Continuation Term, they will submit the definition and
consideration provisions in dispute between them to commercial arbitration for resolution, and include the resulting provisions
in a license. Prior to the Continuation Term, and in consideration of the opportunity to enter into a license agreement with Alba,
a Sublicensee seeking a license from Alba must tender to Alba a written agreement to pay running royalties and milestone payments
to Alba with respect to Net Sales during the Continuation Term and any subsequent period of arbitration upon the terms that running
royalties and milestones due Alba from the Company would be calculated in this Agreement, or to pay running royalty and milestone
payments at the rate provided in the sublicense, whichever is greater.

 

11.08     Upon
the termination of this Agreement (unless terminated by virtue of execution of the Asset Purchase Agreement), and notwithstanding
anything to the contrary in Section 8.09 above, at Alba’s request, Company will (a) execute a document acknowledging the
license rights that have expired or terminated (b) execute any and all documents necessary to assign all Company Improvements to
Alba and (c) make a good faith effort to transfer to Alba any other data, information or results, relating to the Licensed Products,
obtained by Company during the term of this Agreement, whether or not the same constitutes Company Confidential Information.

 

ARTICLE
12. ASSIGNABILITY

 

12.01      Company
may assign this Agreement to an Affiliate or to a successor to all or substantially all of Company’s assets or business related
to Licensed Product. Company may not otherwise assign or transfer this Agreement without the prior written consent of Alba, which
will not be unreasonably withheld.

 

12.02      Alba
may assign this Agreement to a successor-in-interest but Alba may not otherwise assign or transfer this Agreement without the prior
written consent of Company, which will not be unreasonably withheld.

 

ARTICLE
13. APPLICABLE LAW; WAIVER

 

13.01      This
Agreement is made and construed in accordance with the laws of the State of Delaware without regard to choice of law issues, except
that all questions concerning the construction or effect of patents will be decided in accordance with the laws of the country
in which the particular patent concerned has been granted.

 

13.02     Each
Party submits itself to the jurisdiction and venue of any state of federal court located in the State of Delaware.

 

    	 	12	 

     

    

 

 

13.03     Alba
and Company waive their rights to trial by jury as to any litigation between them relating to this Agreement.

 

ARTICLE
14. INTEGRATION AND INTERPRETATION

 

14.01     This
Agreement, together with any Exhibits specifically referenced and attached, embodies the entire understanding between Company and
Alba with respect to the subject matter hereof. There are no contracts, understandings, conditions, warranties or representations,
oral or written, express or implied, with reference to the subject matter of this Agreement that arc not merged in this Agreement.

 

14.02     This
Agreement is negotiated as an arm’s-length business transaction. Draftsmanship will not be taken into account in construing
the Agreement.

 

14.03     If
any condition or provision in any Article of this Agreement is held to be invalid or illegal or contrary to public policy by a
court of competent jurisdiction from which there is no appeal, this Agreement will be construed as though the provision or condition
did not appear. The remaining provisions of this Agreement will continue in full force and effect.

 

ARTICLE
15. REPRESENTATIONS AND WARRANTIES

 

15.01     Alba
hereby represents that, as of the date of execution by the officer (a) Alba has full right, title, and interest in and to the Patent
Rights identified in Exhibit B (unless otherwise noted as co-owned on Exhibit B); (b) to the knowledge of the executing Alba officer,
the Patent Rights identified in Exhibit B are not the subject matter of any currently pending claims, actions or litigation involving
Alba, and Alba has not been informed of any related matters or litigation contemplated either by Alba or any Third Party; (c) Alba
is unaware that any person disputes inventorship or ownership of Patent Rights as described in this Agreement; (d) to the knowledge
of the executing Alba officer, the Transferred Contracts are in full force and effect, binding and enforceable upon Alba and the
other parties thereto; (e) Alba and each other party to Transferred Contracts are in material compliance therewith; (f) to the
knowledge of the executing Alba officer, Alba all pre-clinical studies conducted by or on behalf of Alba with respect to Licensed
Product were conducted in compliance with all applicable laws and standards applicable to pharmaceutical development; (g) to the
knowledge of the executing Alba officer, Alba has disclosed to Company prior to the Effective Date all preclinical and clinical
data related to Licensed Product known to Alba; and (h) to the knowledge of the executing Alba officer, neither Alba nor any of
its Affiliates nor any Third Party owns or controls any intellectual property related to Licensed Products which is not licensed
to Company hereunder or under the accompanying Sublicense with the University of Maryland. Alba warrants that the officer of Alba
executing this Agreement is authorized to do so on behalf of Alba. Alba EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT, AND PATENT VALIDITY, WITH RESPECT TO PATENT RIGHTS. ALBA EXPRESSLY DISCLAIMS ANY RELIANCE ON ANY AND
ALL OF ALBA’S CLINICAL OR TOXOCOLOGY TRIAL DATA AND RESULTS, AND COMPANY HEREBY ACKNOWLEDGES THAT ALBA SHALL HAVE NO LIABILITY
FOR COMPANY’S DECISION TO ADVANCE THE LICENSED PRODUCT IN RELIANCE ON SUCH DATA AND RESULTS.

 

15.02     Company
hereby represents and warrants to Alba that: (a) Company has full legal right, power and authority to execute, deliver and perform
its obligations under this Agreement; (b) the execution, delivery and performance by Company of this Agreement do not contravene
or constitute a default under any provision of applicable law or of any agreement, judgment, injunction, order, decree, or other
instrument binding upon Company; and (c) the officer of the Company executing this Agreement has been authorized by the Company’s
board of directors or governing body to execute this Agreement as the act of the Company.

 

    	 	13	 

     

    

 

ARTICLE
16. CLAIMS, INDEMNIFICATION AND INSURANCE

 

16.01     Company
warrants and represents that it maintains comprehensive liability insurance coverage for itself, its officers, employees and agents,
in the minimum amounts of $[***] per claim and $[***] aggregate (inclusive of umbrella coverage), applicable to bodily injury and
property damage. Prior to the initiation of any human trials in any geographical location with any products, processes, or protocols
developed either by Company, its Affiliates, or Sublicensees or their officers, servants, or agents, or by Third Parties acting
on behalf of or under authorization from Company, its Affiliates or Sublicensees, using licensed Patent Rights, the Company will
establish and maintain Product & Clinical Trials Liability insurance coverage in the amount of $[***] per claim and $[***]
aggregate. Company warrants that its liability insurance will cover contractually assumed obligation for product liability claims
referred to in Section 16.03, when/if human clinical trials are commenced. Alba acknowledges that Company’s liability insurance
will not cover indemnity claims related to patent infringement referred to in Section 16.03. A certificate evidencing the required
insurance coverage will be delivered to Alba: (i) at or before execution of this Agreement; (ii) each time there is a change in
Company’s insurance coverage; and (iii) each time Company’s insurance coverage is renewed. Company agrees to require
its insurance carrier(s) to notify Alba within 15 days prior to cancellation of Company’s insurance coverage, except in the
case of cancellation for nonpayment of premium, where 10 days advance notice will be provided. If Company does not secure liability
insurance written on an occurrence basis, but instead secures liability insurance written on a claims-made basis, Company warrants
that it will purchase extending reported coverage or otherwise provide insurance satisfying its obligations hereunder for a period
of not less than [***] years following termination of this Agreement. 

 

16.02     (a)         Company
will defend, indemnify, and hold harmless Alba, Alba Personnel and Alba Affiliates, and their, officers, employees, and agents
(each individually an “Alba Party” and all, collectively “Alba Parties”), against any and
all claims, costs or liabilities, including attorney’s fees and court costs at trial and appellate levels, for any loss,
damage, personal injury, or loss of life:

 

1.       caused
by the actions of Company, its Affiliates, or Sublicensees, or their officers, servants, or agents, or Third Parties acting on
behalf of or under authorization from Company, its Affiliates or Sublicensees, in the performance of this Agreement;

 

2.       arising
out of use of licensed Patent Rights by Company, its Affiliates, or Sublicensees or their officers, servants, or agents, or by
any Third Party acting on behalf of or under authorization from Company, its Affiliates, or Sublicensees; or

 

3.       arising
out of use by a Third Party of products, processes, or protocols developed either by Company, its Affiliates, or Sublicensees or
their officers, servants, or agents, or by Third Parties acting on behalf of or under authorization from Company, its Affiliates
or Sublicensees, using licensed Patent Rights, provided such use was consistent with any instructions, protocols or supervision
provided by Company.

 

(b)       Alba
will defend, indemnify, and hold harmless Company, Company Personnel and Company Affiliates, and their officers, employees, and
agents (each individually a “Company Party” and all, collectively “Company Parties”), against
any and all claims, costs or liabilities, including attorney’s fees and court costs at trial and appellate levels, for any
loss, damage, personal injury, or loss of life:

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	14	 

     

    

 

1.       caused
by the actions of Alba or its Affiliates or their officers, servants, or agents, or Third Parties acting on behalf of or under
authorization from Alba or its Affiliates or Sublicensees;

 

2.       arising
out of use of licensed Patent Rights by Alba, its Affiliates or their officers, servants, or agents, or by any Third Party acting
on behalf of or under authorization from Alba or its Affiliates;

 

3.       arising
out of use, prior to the Effective Date, by a Third Party of products, processes, or protocols developed either by Alba or its
Affiliates or their officers, servants, or agents, or by Third Parties acting on behalf of or under authorization from Alba or
its Affiliates, using licensed Patent Rights, provided such use was prior to the Effective Date and consistent with any instructions,
protocols or supervision provided by Alba.

 

(c)       Company’s
agreement to defend, indemnify and hold harmless a Alba Party is conditioned upon and Alba’s agreement to defend, indemnify
and hold harmless a Company Party is conditioned upon:

 

1.       Alba
or Company promptly notifying the other in writing after it receives notice of a claim, and

 

2.       the
Alba Party or Company Party seeking indemnification fully cooperating with Alba and the Company in the defense of the claim.

 

(d)       Company’s
agreement to defend, indemnify and hold harmless a Alba Party will not apply to any claim, cost, or liability attributable to the
negligent act or willful misconduct of the Alba Party or a Third Party acting outside the direction or control of Company. Alba’s
agreement to defend, indemnify and hold harmless a Company Party will not apply to any claim, cost, or liability attributable to
the negligent act or willful misconduct of the Company Party or a Third Party acting outside the direction or control of Alba.

 

16.03       Alba
and Company further agree that nothing in this Agreement will be interpreted as a denial to either party of any remedy or defense
available to it under the laws of the State of Delaware.

 

ARTICLE
17. ADVERTISING AND PUBLICITY

 

17.01       Neither
party will use the name of the other or any of its employees or personnel, or any adaptation thereof, in any advertising, promotional,
or sales literature without prior written consent obtained from the other party. Either party may publicize the fact that the parties
have made this Agreement.

 

ARTICLE
18. DISPUTE RESOLUTION

 

If a dispute between the
parties related to this Agreement arises, either party, by notice to the other party, may have the dispute referred to the parties’
respective officers designated below, or their successors, for attempted resolution by good faith negotiations within 30 days after
the notice is received. The designated officers are as follows:

 

    	 	15	 

     

    

 

	For Company:	Chief Executive Officer
	For Alba:	Chief Executive Officer

 

In the event the designated
officers are not able to resolve the dispute within this 30 day period, or any agreed extension, they will confer in good faith
with respect to the possibility of resolving the matter through mediation with a mutually acceptable Third Party or a national
mediation organization. The parties agree that they will participate in any mediation sessions in good faith in an effort to resolve
the dispute in an informal and inexpensive manner. All expenses of the mediator will be shared equally by the parties. Any applicable
statute of limitations will be tolled during the pendency of a mediation initiated under this Agreement. Evidence of anything said
or any admission made in the course of any mediation will not be admissible in evidence in any civil action between the parties.
In addition, no document prepared for the purpose of, or in the course of, or pursuant to, the mediation, or copy thereof, will
be admissible in evidence in any civil action between the parties. However, the admissibility of evidence will not be limited if
all parties who participated in the mediation consent to disclosure of the evidence.

 

ARTICLE
19. MISCELLANEOUS

 

19.01     No
license or right is granted by implication or otherwise with respect to any patent application or patent owned by either party,
unless specifically set forth in this Agreement.

 

19.02     Neither
party is liable for failure or delay in performing any of its obligations under this Agreement if the failure or delay is required
in order to comply with any governmental regulation, request or order, or necessitated by other circumstances beyond the reasonable
control of the party so failing or delaying, including but not limited to Acts of God, war (declared or undeclared), insurrection,
fire, flood, accident, labor strikes, work stoppage or slowdown (whether or not such labor event is within the reasonable control
of the parties), or inability to obtain raw materials, supplies, power or equipment necessary to enable a party to perform its
obligations. Each party will: (a) promptly notify the other party in writing of an event of force majeure, the expected duration
of the event and its anticipated effect on the ability of the party to perform its obligations; and (b) make reasonable efforts
to remedy the event of force majeure.

 

19.03     All
notices, consents and other communications required or allowed under this Agreement must be in writing and are effective upon receipt:
(a) when delivered by hand; or (b) when received by the addressee after being mailed by registered or certified mail (air mail
if mailed overseas), return receipt requested; or (c) when received by the addressee, by delivery service (return receipt requested),
in each case addressed to the party at its address set forth below (or to another address that a party may later designate by notice
to the other party):

 

	If to Alba:	
        Alba Therapeutics Corporation

        100 International Drive, 23rd Floor

        Baltimore, MD 21202

	 	 
	Copy to:	
        Morgan, Lewis & Bockius LLP

        One Federal Street

        Boston, MA 02110

        Attn: and Mark Hayman, Esq.

 

	If to Company:	
        Innovate Biopharmaceuticals, Inc.

        8601 Six Forks Road

        Suite 400

        Raleigh, NC 27615

 

    	 	16	 

     

    

 

	Copy to:	
        Hutchison PLLC

        3110 Edwards Mill Road, Suite 300

        Raleigh, NC 27612

        Attn: Bill Wofford, Esq.

 

19.04     This
Agreement, including Exhibits, may not be amended, nor may any right or remedy of either party be waived, unless the amendment
or waiver is in writing and signed by a duly authorized representative of each party.

 

19.05     A
failure or delay by a party in exercising any of its rights or remedies under this Agreement does not constitute a waiver of the
rights or remedies, nor does any single or partial exercise of any right or remedy preclude any other or further exercise thereof
or the exercise of any other right or remedy. The rights and remedies of the parties provided in this Agreement are cumulative
and not exclusive of any rights or remedies provided by law.

 

19.06     Alba
and Company are not (and nothing in this Agreement may be construed to constitute them as) partners, joint venturers, agents, representatives
or employees of the other, nor is there any status or relationship between them other than that of independent contractors. Neither
party has any responsibility nor liability for the actions of the other party except as specifically provided in this Agreement.
Neither party has any right or authority to bind or obligate the other party in any manner or make any representation or warranty
on behalf of the other party.

 

19.07     Unless
otherwise provided, all costs and expenses incurred in connection with this Agreement will be paid by the party which incurs the
cost or expense, and the other party has no liability for such cost or expense.

 

19.08     This
Agreement is not intended to create, and does not create, enforceable legal rights as a third party beneficiary or through any
other legal theory on the part of any Section 16.02.

 

19.09     This
Agreement is signed in duplicate originals. The headings used in this Agreement are for convenience of reference only and do not
affect the meaning or construction of this Agreement.

 

19.10     Further
Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and
do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments,
as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively
the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
Without limiting the generality of the foregoing, in the

 

[signature page to follow]

 

    	 	17	 

     

    

 

The parties have caused this Agreement to be
executed by their duly authorized representatives on the dates indicated below.

 

	 	Company:
	 	 
	 	Innovate Biopharmaceuticals, Inc.
	 	 	 
	 	By:	/s/ Jay P Madan
	 	Name: 	Jay P Madan
	 	Title:	President
	 	 	 
	 	Alba:
	 	 
	 	Alba Therapeutics Corporation
	 	 	 
	 	By:	/s/ Wendy Perrow
	 	Name: 	Wendy Perrow
	 	Title:	CEO

 

[Signature Page to License Agreement]

 

     

     

    

 

EXHIBIT A 

 

COPYRIGHTS & TRADEMARKS

 

		A.	Celiac Disease Patient Reported Outcome (CeD PRO) Instrument

 

		1.	Certificate of Registration of the Celiac Disease PRO Questionnaire, Registration Number TXu-780-192, effected date of registration
October 13, 2011

 

		2.	Copyright Certificate of Registration No. TXu-780-192, letter regarding the Registration of Celiac Disease PRO Questionnaire,
dated February 21 2012

 

		B.	Trademark Status Chart

 

[***]

 

		C.	Wheat Character

 

[***]

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

     

     

    

 

EXHIBIT A-1

 

INVENTORY

 

[***] 

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

     

     

    

 

EXHIBIT B 

 

PATENT RIGHTS

 

(*co-owned with University of Maryland, Baltimore)

 

[***]

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

     

     

    

 

EXHIBIT C

 

FORM OF UMD SUBLICENSE

 

[Filed as Exhibit 10.1 to the Form 10-K
for the year ended December 31, 2017]

 

     

     

    

 

EXHIBIT D 

 

TRANSFERRED CONTRACTS

 

[***]

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

     

     

    

 

EXHIBIT E

 

DEVELOPMENT PLAN

 

[***] 

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.Exhibit 10.3

 

ASSET PURCHASE AGREEMENT

 

This Asset Purchase
Agreement (this “Agreement”) is made and entered into as of December 23rd, 2014 (“Effective
Date”) between Innovate Biopharmaceuticals Inc., a Delaware corporation, with offices at 8601 Six Forks Road,
Suite 400, Raleigh, North Carolina 27615, (“Innovate”) and Repligen
Corporation, a Delaware corporation with offices at 41 Seyon Street, Building 1, Suite 100, Waltham, MA 02453 (“Repligen”).
Repligen and Innovate shall also be referred to herein individually as “Party” and collectively as “Parties”.

 

Whereas,
Repligen owns certain assets (as more fully defined below, the “Assets”) relating to SecreFlo, a synthetic human
secretin, and its use to improve visualization of pancreatic duct abnormalities when used in combination with magnetic resonance
imaging; and

 

Whereas,
Innovate and Repligen desire to enter into this Agreement under which Innovate will acquire all of the Assets.

 

Now,
Therefore, in consideration of the foregoing and the mutual covenants and premises contained in this Agreement, the
receipt and sufficiency of which are hereby expressly acknowledged, the Parties hereto agree as follows:

 

		1.	DEFINITIONS.

 

In this Agreement, the
following words and expressions shall be construed as follows:

 

1.1       
“Affiliate” means any person, corporation, company, partnership, joint venture, firm or other entity which controls,
is controlled by or is under common control with a Party. For purposes of this Section 1.1, “control” will mean (i)
in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) (or such lesser percentage that
is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the stock or shares entitled to vote
for the election of directors and (ii) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

 

1.2       “Assets”
means (i) all clinical and non-clinical data, reports, know how, regulatory filings (including for orphan designation) and approvals
to the extent still valid and transferable, and all intangible property rights to the extent still valid and transferable, including
any domain names, trade secrets, formulae, processes, designs, manufacturing know how, and any other intellectual property, in
each case, as contained in the electronic data room maintained by Repligen and shared with Innovate, and (ii) laboratory notebooks
or files located on the premise at Repligen, in each of (i) and (ii), only to the extent related to synthetic human secretin and
Controlled by Repligen. The assets described in (i) shall be collectively referred to as the “Electronic Files”, and
the assets described (ii) shall be collectively referred to as the “Physical Files”.

 

     

     

    

1.3       
“Commercially Reasonable Efforts” means, in reference to a Party’s obligation to perform or achieve a specified
obligation or goal with respect to a particular product, efforts that are comparable in quality and scope to those efforts that
are generally used by such Party to perform or achieve a comparable obligation or goal with respect to a product in respect of
which such Party owes no royalties or similar third party payments, which has the same regulatory requirements or status (for example,
requires a prescription), is at a comparable stage of development or product life to the relevant product, and that has similar
market potential to the relevant product, taking into account relative safety and efficacy, product profile, the competitiveness
of the marketplace, the proprietary position of the product and relevant regulatory circumstances. Without limiting the foregoing,
Commercially Reasonable Efforts require that a Party: (i) devote appropriate resources and personnel with an appropriate level
of education, experience and training for the relevant obligation; (ii) promptly assign responsibility for the relevant obligation
to specific employees and/or contractors who are held accountable for progress and monitor such progress on an on-going basis,
(iii) set and consistently seek to achieve specific and meaningful objectives and timelines for carrying out such obligation, and
(iv) consistently make and implement decisions and allocate resources designed to advance progress with respect to relevant objectives
and timelines.

 

1.4       “Confidential
Information” has the meaning set forth in Section 9 of this Agreement.

 

1.5       “Control”
or “Controlled” means with respect to any Information and/or Patents, the possession by a Party of the ability
to assign or to grant a license or sublicense of such Information and/or Patents as provided herein without violating the terms
of any agreement or arrangement between such Party and any third party.

 

1.6       
“Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

 

1.7       “Executive
Officer” means, with respect to Repligen, its Chief Executive Officer, and with respect to Innovate, its Chief Executive
Officer.

 

1.8       
“First Commercial Sale” means, with respect to a particular Product in a particular country, the first arms-length
sale to a Third Party of such Product in such country after Regulatory Approval has been obtained in such country. First Commercial
Sale shall not include any transfer or disposition of a sample or for charitable purposes (including, without limitation, pursuant
to an early access, compassionate use, named patient, indigent access or patient assistance program), or for preclinical, clinical
or regulatory purposes.

 

1.9       
“Generic Competition” means, with respect to a particular Product, when there is one or more products being
sold that are Generic Products with respect to such Product. For clarity, [***].

 

1.10       “Generic
Product” means with respect to a particular Product, a diagnostic product that (a) contains as active ingredient secretin
(or any derivative or variant or similar form of such agent); (b) is approved for use in the United States pursuant to a regulatory
approval process governing approval of generic, interchangeable or biosimilar biologics based on the then-current standards for
regulatory approval in the United States, whether or not such regulatory approval was based in whole or part upon clinical data
generated by either Innovate or Repligen pursuant to this Agreement or was obtained using an abbreviated, expedited or other process;
and (c) is sold in the United States by any Third Party who has not obtained the right or access to such product (through (sub)license,
subcontract or chain of distribution) from Innovate or any of its Affiliates or licensees and did not purchase such product in
a chain of distribution that included Innovate or any of its Affiliates or licensees. For clarity, [***] shall not constitute Generic
Product.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 2 -	 

     

    

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

 

1.12      “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, improvements,
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.

 

1.13       “Laws”
means any law, statute, rule, regulation, ordinance or other pronouncement having the effect of law of any federal, national, multinational,
state, provincial, county, city or other political subdivision, domestic or foreign.

 

1.14       “Net
Sales” means, with respect to a particular time period, the total amounts invoiced by Innovate, its Affiliates and their
respective licensees for sales of Products made during such time period to unrelated Third Parties, less the following deductions
to the extent actually allowed or incurred with respect to such sales:

 

(a)       reasonable
and customary discounts, including cash and quantity discounts, charge-back payments, administrative fees incurred directly in
such discounting, and rebates actually granted to trade customers and distributors;

 

(b)       reasonable
and customary credits or allowances actually granted for damaged, outdated, spoiled, returned or rejected Products, including,
without limitation, in connection with recalls;

 

(c)      sales
and excise taxes, tariffs, duties or other governmental charges (other than income taxes) levied on, absorbed or otherwise imposed
on the manufacture or sales of Products;

 

(d)       freight,
insurance, data, administrative, inventory management and nursing charges or other fees related to handling and distribution of
Products (to the extent not paid by the Third Party customer);

 

    	 	- 3 -	 

     

    

(e)       credits
and allowances made for wastage replacement and indigent or similar programs; and

 

(f)       reasonable
allowances for bad debts as reconciled to actual experience at least annually.

 

Each of the deductions set forth above shall
be reasonable and customary, and in accordance with United States Generally Accepted Accounting Principles (GAAP). Notwithstanding
the foregoing, amounts billed by Innovate, its Affiliates, or their respective licensees for the sale of Products among Innovate,
its Affiliates or their respective licensees for resale shall not be included in the computation of Net Sales hereunder. For purposes
of determining Net Sales, the Products shall be deemed to be sold when shipped and a “sale” shall not include reasonable
transfers or dispositions as samples or for charitable purposes (including, without limitation, pursuant to an early access, compassionate
use, named patient, indigent access or patient assistance program), or transfers or dispositions for preclinical, clinical or regulatory
purposes.

 

1.15     
“Patents” means (a) pending provisional and non-provisional patent applications, issued patents, utility models
and designs; (b) continuations, continued prosecution applications, continuations-in-part, divisions, reissues, substitutions,
confirmations, registrations, validations, re-examinations, additions, extensions, renewals, supplementary protection certificates,
and term restorations of any of the foregoing and (c) any foreign equivalent or counterpart of any of the foregoing.

 

1.16     
“Pricing Approval” means such governmental approval, agreement, determination or decision establishing prices
for a Product that can be charged or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve
or determine the price or reimbursement of diagnostic products.

 

1.17      “Product”
means, on a country-by-country basis, synthetic human secretin or any formulation of synthetic human secretin for all diagnostic
uses, including without limitation, for use in pancreatic function testing and the visualization of pancreatic duct abnormalities
such as (by way of example) (a) stimulation of pancreatic secretions, including bicarbonate to aid in the diagnosis of exocrine
pancreas dysfunction, (b) stimulation of gastrin secretion to aid in the diagnosis of gastrinoma; (c) facilitation of identification
of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) and (d) secretin
enhanced magnetic resonance cholangiopancreatography (SMRCP). For the avoidance of doubt, any product that was licensed or acquired
by Innovate from a Third Party, or discovered by Innovate as part of an independent development program without access to, reliance
upon, or use of Repligen Confidential Information, Repligen Know-How, or Assets, in each case as (and to the extent) documented
in Innovate’s contemporaneous written business records, shall not be considered a Product.

 

1.18       “Regulatory
Approval” means all approvals, including Pricing Approvals and government reimbursement approval (in each case if applicable),
necessary for the commercial sale of a Product in a given country or regulatory jurisdiction.

 

1.19       “Regulatory
Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or jurisdiction.

 

    	 	- 4 -	 

     

    

1.20       “Regulatory
Exclusivity” means market exclusivity granted by a Governmental Authority designed to prevent the entry of generic product(s)
onto the market, including without limitation new chemical entity exclusivity, new use or indication exclusivity, new formulation
exclusivity, orphan drug exclusivity, pediatric exclusivity and 180-day generic product exclusivity, or any equivalent of the foregoing
in any country in the world.

 

1.21       
“Regulatory Materials” means regulatory applications, submissions, notifications, communications, correspondence,
registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority
in order to develop, manufacture, market, sell or otherwise commercialize a Product in a particular country or jurisdiction, specifically
including the filings made with FDA and listed on Exhibit A.

 

1.22       “Repligen
Know-How” means all Information or other materials in Repligen’s possession or Control, as of the Effective Date:
(a) relating to synthetic human secretin, or the manufacture or use thereof; or (b) that is necessary for the research, development,
manufacture or commercialization of products containing synthetic human secretin or any analogs or derivatives thereof.

 

1.23       
“Third Party” means any entity other than Repligen or Innovate or an Affiliate of Repligen or Innovate.

 

1.24       “U.S.”
means the United States of America.

 

		2.	RESERVED.

 

		3.	ASSIGNMENT OF TRANSFERRED ASSETS.

 

3.1         Assignment
of the Assets. Repligen hereby sells, assigns, transfers, conveys, and delivers to Innovate, and Innovate hereby purchases,
accepts, and acquires from Repligen, all of Repligen’s right, title and interest in and to the Assets. Repligen shall (i)
on or prior to the Effective Date, provide appropriate assistance to Innovate, at Innovate’s expense, to enable Innovate
to take the actions listed in Appendix A attached hereto (A) to prepare the assignment to Innovate of the Regulatory Filings
set forth on Exhibit A, on a form reasonably acceptable to Repligen and appropriate for recording such assignments with
the FDA and (B) record such assignment with the FDA on or after the Effective Date, and (ii) within 3 business days of the Effective
Date, provide Innovate with a CD, or other electronic mediums, containing the content of the Electronic Files. For a period of
one year after the Effective Date, Repligen shall, upon reasonable request by Innovate and at the expense of Innovate, take any
or all of the actions listed in Exhibit B attached hereto. Innovate does not assume, shall not take subject to, and shall
not be liable for any liabilities or obligations of any kind or nature, whether absolute, contingent, accrued, known or unknown,
of Repligen or any Affiliate of Repligen related to the ownership of the Assets prior to the Effective Date; and such liabilities
and obligations shall remain the responsibility of Repligen. Furthermore, Repligen shall continue to be responsible for all Third
Party agreements and obligations related to the Assets and not assigned to Innovate under this Agreement, and except as set forth
in the next sentence, Innovate shall have no responsibility or liability for such agreements and obligations. At Innovate’s
request and expense, Repligen will take reasonable actions to enforce such Third Party agreements and obligations.

 

    	 	- 5 -	 

     

    

3.2         No
Implied Licenses. No right or license under any Information or Patents of Innovate or the Repligen Know-How is granted or shall
be granted by implication or estoppel. All such rights or licenses are or shall be granted only as expressly provided in this Agreement.

 

		4.	PAYMENTS.

 

4.1         Upfront
Payment. Innovate shall pay to Repligen a non-refundable, non-creditable cash payment of [***] Dollars ($[***]) on the Effective
Date.

 

4.2         Royalty
Payments.

 

(a)       For
each Product, Innovate shall pay to Repligen non-refundable, non-creditable royalty payments during the applicable Royalty Term,
as calculated (i) by multiplying the applicable royalty rate set forth below by the corresponding amount of incremental Net Sales
of such Products in the applicable calendar year and (ii) by subsequently making all applicable adjustments in accordance with
Section 4.2(c).

 

	Annual Net Sales 	 	Royalty Rate 
	For that portion of annual Net Sales that is less than $[***]	 	[***]%
	For that portion of annual Net Sales that is equal to or greater than $[***] but less than or equal to $[***]	 	[***]%
	For that portion of annual Net Sales that is greater than $[***]	 	[***]%

 

(b)       Royalty
Term. Royalties shall be paid under this Section 4.2, on a country-by-country and Product-by-Product basis, during the period
of time beginning from the First Commercial Sale of such Product in such country until the later of: (i) the expiration of Regulatory
Exclusivity for such Product in such country or (ii) the expiration of the period of ten years following the First Commercial Sale
of such Product in any country (the “Royalty Term”).

 

(c)       Royalty
Adjustments. To the extent applicable, Innovate may apply the following adjustments to the royalty payments due to Repligen
under this Section 4.2(c).

 

(i)       Third
Party Intellectual Property. If Innovate, in its reasonable judgment, is required to obtain a license from any Third Party
under any intellectual property owned or controlled by such Third Party that would be infringed or misappropriated by the importation,
sale, manufacture or use of a Product, then, the royalty payment that would otherwise be due pursuant to this Section 4.2 shall
be reduced by [***] percent ([***]%) of the amount of the royalty payments made by Innovate to such Third Party; provided, however,
that the royalty payment that would otherwise be due pursuant to this Section 4.2 with respect to a particular calendar year shall
not be reduced by more than [***] percent ([***]%) by operation of this Section 4.2(c)(i).

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 6 -	 

     

    

(ii)       Generic
Competition. For each calendar year during the Royalty Term when Generic Competition exists in the United States, Innovate
may reduce the royalty rates to the following amounts if (a) the annual unit sales during such calendar year of the Product in
the United States is reduced, due to the entry of generic competition as demonstrated by Innovate to Repligen’s reasonable
satisfaction, by at least [***]% from the highest annual unit sales in all preceding calendar years in the United States commencing
in the calendar year of the First Commercial Sale of such Product and (b) to the extent Innovate has regulatory right under applicable
Law to enforce against Generic Competition entry in the United States, demonstrates that it has taken reasonable steps to enforce.

 

	Annual Net Sales 	 	Royalty Rate 
	For that portion of annual Net Sales that is less than $[***]	 	[***]%
	For that portion of annual Net Sales that is equal to or greater than $[***] but less than or equal to $[***]	 	[***]%
	For that portion of annual Net Sales that is greater than $[***]	 	[***]%

 

4.3        Royalty
Reports and Payments. Within thirty (30) days following the end of each calendar quarter, commencing with the calendar quarter
in which the First Commercial Sale of any Product occurs, Innovate shall provide Repligen with a report containing the following
information for the applicable calendar quarter, on a country-by-country and Product-by-Product basis: (i) the amount of gross
sales of Product, (ii) the calculation of Net Sales, and (iii) the calculation of the royalty payment due. Concurrent with the
delivery of the applicable quarterly report, Innovate shall pay in Dollars all amounts due to Repligen pursuant to Section 4.2
with respect to Net Sales by Innovate, its Affiliates and their respective sublicensees for such calendar quarter.

 

4.4        Payment
Method. All payments due to Repligen hereunder shall be made in Dollars by wire transfer of immediately available funds into
an account designated by Repligen.

 

4.5        Records;
Audits. Innovate and its Affiliates and sublicensees will maintain complete and accurate records in sufficient detail to permit
Repligen to confirm the accuracy of the calculation of royalty payments and the achievement of milestone events. Upon reasonable
prior notice, such records shall be available during regular business hours for a period of three (3) years from the end of the
calendar year to which they pertain for examination, and not more often than once each calendar year, by an independent certified
public accountant selected by Repligen and reasonably acceptable to Innovate, for the sole purpose of verifying the accuracy of
the previously unaudited financial reports furnished by Innovate pursuant to this Agreement. Any such auditor shall not disclose
Innovate’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial
reports furnished by Innovate or the amount of payments due by Innovate to Repligen under this Agreement. Any amounts shown to
be owed but unpaid shall be paid within thirty (30) days from the accountant’s report. Repligen shall bear the full cost
of such audit unless such audit discloses an underpayment by Innovate of more than [***] percent ([***]%) of the amount due, in
which case Innovate shall bear the reasonable cost of such audit.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 7 -	 

     

    

4.6        Taxes.

 

(a)       Taxes
on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly
or indirectly from the efforts of the Parties under this Agreement.

 

(b)       Tax
Cooperation. The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate tax withholding
or similar obligations in respect of royalties, and other payments made by Innovate to Repligen under this Agreement. To the extent
Innovate is required to deduct and withhold taxes on any payment to Repligen, Innovate shall pay the amounts of such taxes to the
proper Governmental Authority in a timely manner and promptly transmit to Repligen an official tax certificate or other evidence
of such withholding sufficient to enable Repligen to claim such payment of taxes. Repligen shall provide Innovate any tax forms
that may be reasonably necessary in order for Innovate not to withhold tax or to withhold tax at a reduced rate under an applicable
bilateral income tax treaty. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted
by applicable Laws, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement,
such recovery to be for the benefit of the Party bearing such withholding tax or value added tax.

 

		5.	REPRESENTATIONS AND WARRANTIES. 

 

5.1         Each
Party hereby represents and warrants to the other Party as of the Effective Date as follows:

 

(a)       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;

 

(b)       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;

 

    	 	- 8 -	 

     

    

(c)       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 the Agreement; and

 

(d)       It
has not retained any finder, broker, investment banker or the like with respect to the transactions contemplated by this Agreement.

 

5.2         Repligen
hereby represents, warrants and covenants that, as of the Effective Date:

 

(a)       It
has sufficient legal or beneficial title, ownership or license, free and clear from any mortgages, pledges, liens, security interests,
conditional and installment sale agreements, encumbrances, charges or claims of any kind, of the Assets to grant the assignments
to Innovate as purported to be granted pursuant to this Agreement. It is the sole owner of all right, title and interest in and
to (free and clear from any mortgages, pledges, liens, security interests, conditional and installment sale agreements, encumbrances,
charges or claims of any kind) Regulatory Filings listed on Exhibit A and the data specified therein and of the other Assets.
[***].

 

(b)       It
has not received any written notice from any Third Party asserting or alleging that any research or development of the Products
by Repligen prior to the Effective Date infringed or misappropriated the intellectual property rights (including any trade secrets)
of such Third Party. No part of the Assets was obtained in violation of any contractual or fiduciary obligation owed by Repligen
or its employees or agents to any Third Party.

 

(c)       To
Repligen’s knowledge, the research, development, manufacture and use prior to the Effective Date of Products by or on behalf
of Repligen has been carried out, without infringing any published patent applications (evaluating such patent applications as
though they were issued with the claims as published as of the Effective Date) or issued patents owned or Controlled by a Third
Party.

 

(d)       There
are no pending, and to Repligen’s knowledge no threatened, adverse actions, suits or proceedings against Repligen involving
(i) the Assets or (ii) the research, development, manufacture and use of the Products prior to the Effective Date.

 

(e)       To
Repligen’s knowledge, there are no activities by Third Parties that would constitute infringement or misappropriation of
the Repligen Know-How.

 

(f)       It
has not conveyed or licensed, and will not attempt to convey or license after the Effective Date, to a Third Party any right, title,
or interest in, to or under any of the Regulatory Filings set forth on Exhibit A or Repligen Know-How which conflicts with
any rights granted to Innovate under this Agreement.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 9 -	 

     

    

 

(g)       To
Repligen’s knowledge, no person, other than former or current employees of Repligen who are obligated in writing to assign
his/her inventions to Repligen, is an inventor of any of the inventions constituting part of the Assets.

 

(h)       The
development of Products has been conducted prior to the Effective Date by Repligen and its Affiliates and, to the knowledge of
Repligen, its independent contractors, in compliance in all material respects with all applicable Laws, including all public health,
environmental, and safety provisions thereof.

 

(i)       It
has disclosed to Innovate all material information known to Repligen with respect to the safety and efficacy of Products as determined
from nonclinical or clinical studies.

 

(j)       There
are no Patents Controlled by Repligen or its Affiliates that relate to Repligen’s synthetic human secretin program and there
are no inventions described in an invention disclosure form or draft patent application relating to synthetic human secretin in
Repligen’s or its Affiliates’ Control.

 

		6.	DILIGENCE.

 

6.1         Innovate
Diligence Obligations. Innovate shall, directly or indirectly through one or more sublicensees or assignees, use Commercially
Reasonable Efforts to commercialize at least one Product. Innovate shall provide written annual reports within 30 days of each
anniversary of the Effective Date to Repligen detailing progress made with Products during such preceding annual period including
progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing or assignment,
marketing and FDA minutes. Repligen shall have a period of forty five days from receipt of any such report to ask questions or
raise any objections to the matters set forth in the report. In the event Repligen does not provide written notice of objection
within such period, Repligen shall irrevocably waive its right to claim that Innovate is in breach of its obligation to use Commercially
Reasonable Efforts during the period covered by, and with respect to matters set forth in, the report. Moreover, Innovate will
provide Repligen an annual plan for its research, development and commercialization activities for the upcoming period of up to
12 months. If Repligen does not provide written notice of objection within 45 days of receipt of such plan, Repligen shall be deemed
to have accepted the plan and shall have no right to claim that Innovate is in breach of its obligation to use Commercially Reasonable
Efforts during the period covered by, and with respect to matters set forth in, the plan if Innovate substantially executes the
plan as presented. For clarity, Innovate shall have no obligation to commercialize more than one Product. Innovate’s obligations
under this Section 6.1 shall terminate upon the tenth (10th) anniversary of the Effective Date.

 

6.2         Impact
of Failed Diligence. If Innovate provides notice pursuant to the final sentence of Section 6.1 or is in breach of Section
6.1 prior to the completion of the first phase III or other registrational clinical trial involving the use of the Product and
fails to cure such breach within ninety (90) days of written notice by Repligen detailing the nature of such breach, then: [***]. For clarity, in lieu of the foregoing, Repligen will have the option to pursue claims under
Section 7 for an alleged breach by Innovate of its obligations under this Section 6.

  

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 10 -	 

     

    

		7.	INDEMNIFICATION.

 

7.1         Indemnification
by Repligen. Repligen shall defend, indemnify, and hold Innovate and its Affiliates and their respective officers, directors,
employees, and agents (the “Innovate Indemnitees”) harmless from and against any and all damages or other amounts
payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Innovate
Indemnitees; provided however, that the aggregate amount payable by Repligen in all instances under this Section 7.1 shall not
exceed the sum of [***] (collectively, “Innovate Damages”), all to the extent resulting from
any claims, suits, proceedings or causes of action brought by such Third Party against such Innovate Indemnitee (collectively,
“Innovate Claims”) that arise from or are based on: (a) a breach of any of Repligen’s representations,
warranties and obligations under this Agreement; or (b) the willful misconduct or negligent acts of Repligen, its Affiliates, or
the officers, directors, employees, or agents of Repligen or its Affiliates. The foregoing indemnity obligation shall not apply
to the extent that (i) the Innovate Indemnitees fail to comply with the indemnification procedures set forth in Section 7.4 and
Repligen’s defense of the Innovate Claims is prejudiced by such failure, or (ii) any of the Innovate Claims arises from,
is based on, or results from any activity set forth in Section 7.2(a), 7.2(b) or 7.2(c) for which Innovate is obligated to indemnify
the Repligen Indemnitees under Section 7.2.

 

7.2         Indemnification
by Innovate. Innovate shall defend, indemnify, and hold Repligen and its Affiliates and their respective officers, directors,
employees, and agents (the “Repligen Indemnitees”) harmless from and against any and all damages or other amounts
payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Repligen
Indemnitees (collectively, “Repligen Damages”), all to the extent resulting from any claims, suits, proceedings
or causes of action brought by such Third Party against such Repligen Indemnitee (collectively, “Repligen Claims”)
that arise from or are based on: (a) the research, development, manufacture, or commercialization of Products by or on behalf of
Innovate or its Affiliates or its or their licensees, or (b) a breach by Innovate of any of its representations, warranties and
obligations under this Agreement, or (c) the willful misconduct or negligent acts of Innovate, its Affiliates, or the officers,
directors, employees, or agents of Innovate or its Affiliates. The foregoing indemnity obligation shall not apply to the extent
that (i) the Repligen Indemnitees fail to comply with the indemnification procedures set forth in Section 7.4 and Innovate’s
defense of the Repligen Claims is prejudiced by such failure, or (ii) any of the Repligen Claims arises from, is based on, or results
from any activity set forth in Section 7.1(a) or 7.1(b) for which Repligen is obligated to indemnify the Innovate Indemnitees under
Section 7.1.

 

7.3         Indemnification
for Product Liability Claims.  Innovate shall defend, indemnify, and hold the Repligen Indemnitees harmless from and against
any and all Repligen Damages, all to the extent resulting from Repligen Claims that arise from or are based on: (a) death or injury
to person or property as a result of any actual or alleged defect in any Product; (b) inaccurate test results with respect to any
patient or reported in any clinical database, which inaccuracies are related to any use or misuse of the Product; (c)  any
actual or alleged warranty, recall or similar liability for any Product; or (d) any statutory liability of the Repligen Indemnitees
or any liability of the Repligen Indemnitees assessed with respect to any failure to warn arising out of any Product.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 11 -	 

     

    

7.4         Indemnification
Procedures. The Party claiming indemnity under this Article 7 (the “Indemnified Party”) shall give written
notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of
such Innovate Claims or Repligen Claims (as applicable) (each a “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, 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 or compromise 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, consent to the entry of any judgment, or
enter into any settlement with respect to such 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 7.

 

7.5         Limitation
of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR LOSS
OF PROFITS 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 7.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF ANY PARTY UNDER SECTION 7.1 OR 7.2 OR THE DAMAGES AND REMEDIES AVAILABLE WITH RESPECT TO MATTERS COVERED BY SECTIONS
4.5, 6.2 AND 12.13.

 

7.6         Exclusive
Remedies. Each of the Parties hereto acknowledges and agrees that following the Effective Date, except with respect to matters
covered by Sections 4.5, 6.2 and 12.13, the indemnification provisions of Section 7 shall be the sole and exclusive remedies of
the parties hereto. The provisions of this Section 7.6 will not prevent or limit a cause of action (i) under Section 12.13 to obtain
an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof,
(ii) under Section 6.2 to enforce, or seek damages for a breach of, Innovate’s obligations under Section 6.1, and (iii) under
Section 4.5 to enforce any decision or determination of the independent certified public accountant.

 

    	 	- 12 -	 

     

    

7.7         Insurance.

 

(a)       Innovate
shall procure and maintain insurance adequate to cover its activities with respect to the Assets and the Products 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 by or on behalf of Innovate.  Without limiting the foregoing, such insurance
policies following any Regulatory Approval of the Product shall include aggregate coverage amounts as provided on Exhibit C
attached hereto and shall name Repligen as an additional insured party.  If such insurance is written on a claims-made form,
it shall continue for [***] ([***]) years following termination of this Agreement.  During (i) the term of this Agreement
and (ii) in the case of insurance written on a claims-made form, [***] ([***])
years following termination of this Agreement, Innovate shall not permit such insurance to be reduced, expired, materially amended
or canceled during the period of such insurance.  It is understood that such insurance shall not be construed to create a
limit of Innovate’s liability with respect to its indemnification obligations under this Article 7.  Innovate shall
provide Repligen with written evidence of such insurance upon request. The insurance shall be valid in any location worldwide regarding
the activities performed by each of Innovate and Repligen hereunder (including worldwide jurisdictions) for any destination or
lawsuit.

 

(b)       If
Innovate is in breach of Section 7.7(a) and fails to cure such breach within ninety (90) days of written notice by Repligen detailing
the nature of such breach, then: Repligen will have the option to require Innovate to sell, assign, transfer, convey, and
deliver to Repligen, for $[***] in cash, all of the Assets, the Products and all materials related thereto then controlled by Innovate
or its Affiliates, and all data generated by or on behalf of Innovate in connection with the development of Products as defined
under Section 1.15 and all Regulatory Approvals and applications for Regulatory Approval of Products as defined under Section 1.15.
Any such transfer pursuant to Repligen’s exercise of such option shall be at Innovate’s cost and be completed within
thirty (30) days of Repligen’s written notice to Innovate that it has exercised such option.    

 

(c)       Innovate
shall use Commercially Reasonable Efforts that such insurance shall contain an explicit clause, stating that Innovate and its insurer
waive their rights of subrogation against Repligen and its directors, employees and/or any one on its behalf with respect to the
insurance.  The insurance shall be primary to any other insurance maintained by each of Innovate and Repligen and each Party
hereby waives any claim or demand as to participation in any such other insurance. 

 

(d)       Prior
to Innovate commencing any clinical trial involving the use of the Product, Innovate shall pay to Repligen cash payments in amounts
equal to the amounts Repligen will reasonably be required to pay to increase the aggregate coverage amount of Repligen’s
insurance covering the Product from [***] Dollars ($[***])
per year to $[***] per year (the “Increased Coverage Amount”).

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 13 -	 

     

    

(e)       On
the earlier of (i) the third anniversary of the Effective Date and (ii) prior to the First Commercial Sale, Innovate shall pay
to Repligen a one-time cash payment in an amount equal to the amount Repligen will reasonably be required to pay to procure and
maintain supplemental extended runoff insurance in an aggregate coverage amount of $[***] covering
the Product (the “Runoff Policy”). From and after the date on which Innovate pays such amount for Repligen to
procure the Runoff Policy, Repligen will be responsible for any and all annual premium amounts necessary to maintain the Increased
Coverage Amount.

 

		8.	INTELLECTUAL PROPERTY. 

 

8.1         Patent
Prosecution. Innovate shall have the sole right to file, prosecute, and maintain any Patents related to a Product and shall
use Commercially Reasonable Efforts to do so in order to support the development and commercialization of Products.

 

8.2         Trademarks.
Innovate shall have the right to brand the Products using the name SecreFlo, Innovate-related trademarks and any other trademarks
and trade names it determines appropriate for the Products, which may vary by country or within a country (“Product Marks”);
provided that Innovate shall not, and shall ensure that its Affiliates and licensees will not, make any use of the trademarks or
house marks of Repligen (including Repligen’s corporate name) or any trademark confusingly similar thereto. Innovate shall
own all rights in the Product Marks and shall register and maintain, at its own cost and expense, the Product Marks in the countries
and regions that it determines reasonably necessary.

 

		9.	TREATMENT OF CONFIDENTIAL INFORMATION.

 

For purposes of this Agreement,
“Confidential Information” shall mean all non-public scientific, technical, financial or business information
which is disclosed by or on behalf of either Party hereunder to the other Party hereunder before, on, or after the Effective Date,
whether in writing, or by oral or visual disclosure or presentation, and which is treated by the disclosing Party as confidential
or proprietary; provided, that from and after the Effective Date, all Repligen Know-How is deemed to be Confidential Information
of Innovate unless and until Repligen exercises its reversionary right set forth in Section 6.2(a). Notwithstanding the foregoing,
“Confidential Information” shall not include information that the receiving Party can demonstrate by competent evidence:

 

(a)       was
already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the disclosing
Party;

 

(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)       is
independently discovered or developed by the receiving Party without the use of Confidential Information of the disclosing Party;
or

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 14 -	 

     

    

(e)       is
disclosed to the receiving Party, on a non-confidential basis, by a Third Party who had no obligation to the disclosing Party not
to disclose such information to others.

 

Notwithstanding the foregoing,
the receiving Party shall not be prohibited from disclosing the disclosing Party’s Confidential Information to the extent
such information is required to be disclosed by court order or by applicable Law or government regulation; provided, however, that
in such event, the receiving Party shall give reasonable advance notice (except where impracticable) to the disclosing Party of
such required disclosure and, at the disclosing Party’s request and expense, shall cooperate with the disclosing Party’s
efforts to contest such disclosure, and/or to obtain a protective order or other confidential treatment of the Confidential Information
required to be disclosed.

 

    	 	- 15 -	 

     

    

The receiving Party agrees
that it will hold Confidential Information received from the disclosing Party in secrecy and confidence and will not disclose it
to any Third Party, or use it for any purpose, other than for the purpose of the performance of this Agreement. The receiving Party
further agrees that it will restrict disclosure of Confidential Information within its own organization and Affiliates to those
persons having a need to know it for the purpose of this Agreement, and that such persons will be advised of the obligation set
forth in this Agreement and obligated in like fashion. If the receiving Party learns of any disclosure by it or its employees,
agents, independent contractors, or Affiliates of any Confidential Information of the disclosing Party not in accordance with this
Section 9, the receiving Party shall promptly notify the disclosing Party of such unauthorized disclosure.

 

The above obligations
of the receiving Party with respect to its treatment of Confidential Information shall commence as of the Effective Date and continue
for a period of [***] ([***]) years following disclosure of such Confidential Information. This Agreement shall not be construed
as granting any license rights with respect to the Confidential Information. Except as otherwise required by applicable Laws and
regulations or rules of any securities exchange, the Parties hereby agree that any disclosure of the terms and conditions of this
Agreement shall be subject to the other Party’s prior written agreement; provided, however, that each Party may disclose
the terms and conditions of this Agreement to a prospective or actual investor or lender, acquirer, licensee or collaborator pursuant
to a written confidentiality agreement of the same or more restrictive provisions as those contained herein, and provided further
that if any such disclosure is required by laws, regulations or rules of a securities exchange, the Party required to make such
disclosure shall notify the other Party of any such disclosure and shall seek confidential treatment of portions of this Agreement
where reasonably available.

 

		10.	NOTICES.

 

10.1      All
notices and statements to either Party required under this Agreement shall be made in writing delivered via certified mail, return
receipt requested, courier, provided that evidence of delivery is made, or facsimile with confirmation of such transmission addressed
to such Party at the following addresses or faxed to the appropriate numbers set forth below (with the copies to other Parties
set forth below) or to such other address as may be designated from time to time:

  

	To Repligen:
	Repligen Corporation
	41 Seyon Street
	Building 1, Suite 100
	Waltham, MA 02453
	Attn: President
	Fax: (781) 250-0115
	 
	With a copy to:
	Goodwin Procter LLP
	Exchange Place

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 16 -	 

     

    

	Boston, MA 02109
	Attn: Arthur R. McGivern
	Fax: 617-523-1231
	 
	To Innovate:
	Innovate Biopharmaceuticals Inc.
	
        8601 Six Forks Road, Suite 400

        Raleigh, NC 27615

	Attn: President
	 
	With a copy to:
	Hutchison PLLC
	3110 Edwards Mill Road, Suite 300
	Raleigh, NC 27612
	Attn: William N. Wofford, Esq.
	Fax: (866) 479-7550

 

10.2       All
notices and statements provided to a Party hereunder shall be deemed to have been given as of the date received, or at the time
of delivery of a facsimile to the relevant facsimile number above.

 

10.3       Each
Party hereto may change its address and contact information set forth above for the purpose of this Agreement by providing written
notice to the other Party of the same from time to time.

 

		11.	DISPUTE RESOLUTION

 

11.1       Executive
Officers. Unless otherwise set forth in this Agreement, in the event of a dispute arising under this Agreement between the
Parties, the Parties shall refer such dispute to the respective Executive Officers, and such Executive Officers shall attempt in
good faith to resolve such dispute. Either Party may initiate such informal dispute resolution by sending written notice of the
dispute to the other Party, and, within twenty (20) days after such notice, such Executive Officers shall meet for attempted resolution
by good faith negotiations. If such Executive Officers are unable to resolve such dispute within thirty (30) days of their first
meeting for such negotiations, either Party may seek to have such dispute resolved in accordance with the following Sections 11.2
and 11.3.

 

11.2       Governing
Law. This Agreement shall be governed and interpreted in accordance with the laws of the State of Delaware, without regard
to conflict of law provisions.

 

    	 	- 17 -	 

     

    

11.3       Jurisdiction;
Venue. Any dispute arising under this Agreement, or other legal proceeding relating to this Agreement or the enforcement of
any provision of this Agreement must be brought or otherwise commenced solely and exclusively in courts of competent jurisdiction
located in the city of Wilmington, Delaware. Consistent with the preceding sentence, each of the Parties: (a) expressly and irrevocably
consents and submits to the jurisdiction of the courts of competent jurisdiction in the city of Wilmington, Delaware (and each
appellate court located in the State of Delaware) in connection with any such legal proceeding; (b) expressly agrees that the courts
of competent jurisdiction in the city of Wilmington, Delaware shall be deemed to be a convenient forum; and (c) expressly agrees
not to assert (by way of motion, as a defense or otherwise), in any such legal proceeding commenced in the courts of competent
jurisdiction in the city of Wilmington, Delaware, any claim that such Party is not subject personally to the jurisdiction of such
court, that such legal proceeding has been brought in an inconvenient forum, that the venue of such proceeding is improper or that
this Agreement or the subject matter of this Agreement may not be enforced in or by such court.

 

		12.	MISCELLANEOUS.

 

12.1       Acknowledgement.
Each Party acknowledges that it has negotiated and entered into this Agreement in good faith.

 

12.2       Severability.
If any provision of this Agreement is held by a court of competent jurisdiction to be invalid or unenforceable, it shall be modified,
if possible, to the minimum extent necessary to make it valid and enforceable or, if such modification is not possible, it shall
be stricken and the remaining provisions shall remain in full force and effect.

 

12.3       Interpretation.

 

(a)       The
English language of this Agreement shall govern any interpretation of or dispute regarding this Agreement.

 

(b)       Any
reference in this Agreement to a Section or Exhibit is a reference to the Sections and Exhibits of this Agreement unless the context
requires otherwise. Any reference to a Section shall be deemed to include a reference to any subsidiary Sections.

 

(c)       The
captions of the Sections are included for reference purposes only and are not intended to be a part of the Agreement or in any
way to define, limit or describe the scope or intent of the particular provision to which they refer.

 

(d)       Whenever
the context requires: the singular number shall include the plural and vice versa; the masculine gender shall include the feminine
and neuter gender; the feminine gender shall include the masculine and neuter gender; and the neuter gender shall include the feminine
and masculine gender.

 

(e)       The
Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall
not be applied in the construction or interpretation of this Agreement.

 

(f)       As
used in this agreement “include” and “including” and variations thereof shall not be deemed to be terms
of limitation, but rather shall be deemed to be followed by the words “without limitation.”

 

    	 	- 18 -	 

     

    

12.4       Assignment.
This Agreement shall not be assigned by either Party, without the prior written consent of the other Party; provided that either
Party may assign this Agreement without such consent: (i) to an Affiliate; (ii) in the event of a merger, consolidation or similar
reorganization with or into a Third Party, whether by acquisition, merger, sale of stock, change of control or otherwise, or (iii)
in the event of a sale of all or substantially all of the assets to which this Agreement relates, this Agreement shall be assigned
to or become the obligation and liability of the acquiring entity. Any purported assignment in violation of this Section 12.4 shall
be void.

 

12.5       Expenses.
Innovate shall reimburse Repligen for its documented out of pocket legal fees incurred in connection with negotiating and consummating
the transactions contemplated by this Agreement in an amount not to exceed $[***], subject to Innovate’s review of all invoices
for such fees, which shall be provided to Innovate by Repligen within 45 days of the Effective Date or the incurrence of such fees
by Repligen, and provided that all such fees shall be reasonable and customary for transactions of the type contemplated by this
Agreement. Except as otherwise expressly provided herein, all parties will be responsible for their own costs and expenses, including
counsel fees, incurred in connection with the transactions contemplated by this Agreement.

 

12.6       Force
Majeure. If the performance of this Agreement or any obligation hereunder (except for the payment of money) is prevented, restricted
or interfered with by reason of fire or other casualty or accident, strikes or labor disputes, inability to procure raw materials,
power or supplies, war, invasion, civil commotion or other violence, compliance with any order of any governmental authorities
or any other act or conditions whatsoever beyond the reasonable control of either Party hereto, the Party so affected upon giving
a prompt notice to the other Party shall be excused from such performance to the extent of such prevention, restriction or interference;
provided, however, that the Party so affected shall use commercially reasonable efforts to avoid or remove such causes of non-performance
and shall continue performance hereunder with the utmost dispatch whenever such causes are removed, to the extent commercially
reasonable.

 

12.7       Entirety
of Agreement. This Agreement contains the entire understanding of the Parties hereto with respect to the subject matter contained
herein. Without limiting the generality of the foregoing, that certain letter of intent between the Parties executed on or about
August 12, 2014 shall be of no further force and effect. There are no restrictions, promises, covenants or understandings other
than those expressly set forth herein, and no rights or duties on the part of either Party are to be implied or inferred beyond
those expressly herein provided for. The Parties may, from time to time during the term of this Agreement, amend, modify, vary,
waive or alter any of the provisions of this Agreement, but only by a written instrument that makes specific reference to this
Agreement which is duly executed by each Party, or in the case of waiver, by the Party or Parties waiving compliance.

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 19 -	 

     

    

12.8       Further
Assurances; Personnel. Each Party agrees to duly execute and deliver, or cause to be duly executed and delivered, such further
instruments and do and cause to be done such further acts and things, including, without limitation, the filing of such additional
assignments, agreements, documents and instruments, that may be necessary or as the other Party hereto may at any time and from
time to time reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes
of, or to better assure and confirm unto such other Party its rights and remedies under, this Agreement. Repligen acknowledges
that Innovate may elect to engage one or more former Repligen employees or consultants as employees or consultants to assist with
the development and commercialization of Products and Repligen hereby consents to such engagement and waives any covenants regarding
confidentiality, solicitation or competition that it may have against or otherwise with respect to such persons, solely to the
extent deemed necessary or helpful by Innovate to develop and commercialize Products.

 

12.9       No
Partnership. For the purposes of this Agreement and all obligations to be performed hereunder, each Party shall be, and shall
be deemed to be, an independent contractor and not an agent, partner, joint venturer or employee of the other Party. Neither Party
shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding
on the other Party, except as may be explicitly provided for herein or authorized in writing.

 

12.10    Use
of Other Party’s Name. Neither Party shall use the name, trademark, trade name or logo of the other Party or their respective
employee(s) in any publicity, promotion, press release or disclosure relating to this Agreement or its subject matter, without
the prior express written permission of the other Party, except as may be required by applicable Laws or regulations.

 

12.11    Waiver.
The waiver by either Party of any breach, default or omission in the performance or observance of any of the terms of this Agreement
by the other Party shall not be deemed to be a waiver of any other such breach, default or omission. Any waiver of this Agreement
must be in writing and signed by the waiving Party to be effective.

 

12.12    Counterparts.
This Agreement may be executed in counterparts, each of which shall be deemed an original, and all of such counterparts taken together
shall constitute one and the same instrument. Counterparts may be signed and delivered by facsimile, each of which shall be binding
when sent.

 

12.13    Specific
Performance. The Parties hereto acknowledge and agree that the Parties hereto would be irreparably damaged if any of the provisions
of this Agreement are not performed in accordance with their specific terms or are otherwise breached and that any nonperformance
or breach of this Agreement by any Party hereto could not be adequately compensated by monetary damages alone and that the Parties
hereto would not have any adequate remedy at law. Accordingly, such Party shall be entitled to enforce any provision of this Agreement
by a decree of specific performance and temporary, preliminary and permanent injunctive relief to prevent breaches or threatened
breaches of any of the provisions of this Agreement without posting any bond or other undertakings.

 

[SIGNATURE PAGE FOLLOWS]

 

    	 	- 20 -	 

     

    

In
Witness Whereof, the parties hereto, intending to be legally bound hereby, have duly executed this Asset Purchase Agreement
to be effective as of the Effective Date.

 

	Innovate Biopharmaceuticals Inc.	 	Repligen Corporation
	 	 	 
	By:	/s/ Jay P. Madan	 	By:	 /s/ Howard Benjamin
	 	 	 	 	 
	Name:	Jay P. Madan	 	Name:	 /s/ Howard Benjamin
	 	 	 	 	 
	Title:	President	 	Title:	 VP BD

 

    	 	- 21 -	 

     

    

EXHIBIT A

 

Regulatory Filings

 

[***]

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 22 -	 

     

    

EXHIBIT B

 

		1.	Reasonable access to the Physical Files during normal business hours at mutually agreeable times,
and at such time that Repligen is no longer required to maintain the Physical Files on premise under applicable Law, whether such
time is within one year of the Effective Date or thereafter, enable Innovate, at Innovate’s expense, to transfer the Physical
Files from Repligen’s premise to Innovate’s designated location.

 

		2.	Provide the appropriate release under any applicable contracts between Repligen and a Third Party
to enable Innovate to discuss with such Third Party matters pertaining to the research, development, manufacture or commercialization
of the Products

 

    	 	- 23 -	 

     

    

CONFIDENTIAL TREATMENT REQUESTED

 

EXHIBIT C

 

Insurance Requirements

 

		1.	Prior to the commencement of clinical work using the Product, Innovate shall maintain product liability
insurance in the aggregate amount of $[***] per year ($[***] per occurrence).

 

		2.	Upon the commencement of the first clinical trial using the Product, Innovate shall increase its
product liability insurance to an aggregate amount of $[***] per year ($[***] per occurrence).

 

		3.	Prior to the First Commercial Sale, Innovate shall increase its product liability insurance to
an aggregate amount of $[***] per year ($[***] per occurrence).

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 1 -	 

     

    

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix A

 

Critical Path Activities

 

[***]

 

 

[***] Confidential treatment requested pursuant
to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately
with the Commission.

 

    	 	- 2 -

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