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.


 




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(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.


 




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(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 -