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 -