Document:

exv10w11

EXHIBIT 10.11

EXCLUSIVE LICENSE AGREEMENT NUMBER

Between

REVA Medical, Inc.

and

RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY

 

 

EXCLUSIVE LICENSE AGREEMENT NUMBER 2

THIS Exclusive License Agreement Number 2 (the “Agreement”) is made and is effective as of the
1st day of June 2010, (the “Effective Date”) by and between Rutgers, The State
University Of New Jersey, having its statewide Office of Technology Commercialization at ASB Annex
III, 3 Rutgers Plaza, New Brunswick, New Jersey 08901-8559, (hereinafter referred to as “Rutgers”),
and REVA Medical, Inc., a California corporation having a principal place of business at 5751
Copley Drive, Suite B, San Diego, CA 92111 (hereinafter referred to as “Licensee”).

RECITALS

WHEREAS, Certain inventions were made in the course of research at Rutgers under the direction of
Dr. Joachim Kohn and in the course of research at Licensee; and

WHEREAS, The development of the inventions was sponsored in part by the National Institutes of
Health under Grant GM39455, and in consequence this Agreement is subject to overriding obligations
to the federal government as set forth in 35 U.S.C. sections 200-212 and applicable governmental
regulations; and

WHEREAS, Licensee entered into that certain Exclusive License Agreement dated January 21, 2004, as
amended, (the “2004 License Agreement”) (License Number L04-062); and

WHEREAS, the 2004 License Agreement is superseded and replaced in its entirety by this Agreement;
and

WHEREAS, Licensee has maintained a sponsored research agreement (as later defined) with Rutgers
(Dr. Joachim Kohn and other Rutgers employees working under his direction) and intends to continue
this agreement, which contributes to the Rutgers’ Patent Rights; and

WHEREAS, Licensee intends to continue its contributions to the technology advancements with its
collaboration efforts through the sponsored research agreement and its other research efforts; such
contributions and collaborations by Licensee have previously, and may in the future, give rise to
Joint Improvements (as later defined) and Joint Inventions (as later defined); and

WHEREAS, as of the Effective Date Licensee is a “Small Business Firm” as defined (for grants) in 15
U.S.C. 632; and

WHEREAS, Licensee wishes to obtain certain rights from Rutgers for the commercial development,
manufacture, use, and sale of the Inventions (defined below), and
Rutgers is willing to grant such rights on the terms and conditions set forth in this

 

 

Agreement;
and

WHEREAS, Rutgers is desirous that the Inventions be developed and utilized to the fullest extent so
that the benefits can be enjoyed by the general public.

NOW THEREFORE, the parties agree as follows:

1. DEFINITIONS

All definitions below or elsewhere in this Agreement apply to both their singular and plural forms,
as the context may require. “Herein,” “hereunder,” and “hereof” and other similar expressions
refer to this Agreement. “Section” and “Article” refer to sections in this Agreement. The term
“including” means “including without limitation” and “Days” means “calendar days,” unless otherwise
stated.

	1.1.	 	“Affiliate(s)” means any corporation or other legal entity that directly or indirectly
controls, is controlled by, or is under common control with Licensee to the extent of at least
fifty percent (50%) of the outstanding stock or other voting rights entitled to elect
directors.

	1.2.	 	“Change of Control” means the acquisition by a third party or an Affiliate of more than fifty
percent (50%) of Licensee’s securities which are outstanding after the acquisition, or all or
substantially all of Licensee’s assets.

	1.3.	 	“Confidential Information” with respect to property owned or controlled by either party means
all data, information, and/or tangible material owned or controlled by either party and
provided to each other, its Affiliates or its sublicensee (“Sublicensee) directly or
indirectly from or through either party, its units, its employees, the Inventors, or its
consultants relating to the Inventions, Licensed Products, or this Agreement, including but
not limited to, all patent prosecution documents and all information received from Inventors.

	1.4.	 	“Coronary stent products” means Licensed Products in the Licensed Field that are polymer
stents used in coronary blood vessels.

	1.5.	 	“Improvement(s)” means any change, modification or enhancement of a technology and/or
invention that cannot be practiced without infringing a claim cited in an Invention described
in Exhibit A and/or that cannot be practiced without a license to the Inventions described in
Exhibit A.

	1.6.	 	“Invention(s)” collectively means, with respect to Licensed Polymers, any patent application,
disclosure and/or discovery that is patentable or non-patentable,
which is included in Exhibit A, and as subsequently amended, which was made in the course of
research at Rutgers under the direction of Dr. Joachim Kohn

 

 

	 	 	(hereinafter “Rutgers
Inventions”) or in the course of research by Licensee, including work for hire, and is
included on Exhibit A, and as subsequently amended (hereinafter “Licensee Inventions”), or
was made by Rutgers and Licensee and is included on Exhibit A and as subsequently amended
(hereinafter “Joint Inventions”). The parties represent that Exhibit A correctly lists all
applicable intellectual property of theirs as of the Effective Date of this Agreement that
is intended to be included in the scope of this Agreement.

	1.7.	 	“Inventor(s)” collectively means any person at Rutgers working under the direction of Dr.
Joachim Kohn (“Rutgers Inventor”) and/or at Licensee, including work for hire (“Licensee
Inventor”) who contributes to the claims of a patentable invention or non-patentable
technology. If both a Rutgers Inventor(s) and a Licensee Inventor(s) contribute to said
invention or non-patentable technology, they shall be termed “Joint Inventors,” as applicable.

	1.8.	 	“Licensed Fields” collectively means:

	 	(i)	 	For all licensed intellectual property that is owned by Rutgers, the Licensed
Field shall be defined as any product applications that work in or with the vasculature
(i.e., that which comprises all cardiovascular and peripheral vessels (arteries and
veins, capillaries to large vessels, and blood vessels to the heart and those vessels
on the surface of the heart such as coronary vessels)) which includes vessel lumens
and/or vessel exteriors and vessel replacements. Products applications in the Licensed
Field may include a therapeutic that is pharmaceutically and/or biologically active
and/or a passive agent as long as said therapeutic is acting and is intended to be used
in a site specific fashion only. Excluded from the Licensed Field are

	 	(a)	 	any systemic drug delivery devices and implants that are placed
into the blood stream predominantly for the purpose of the delivery of a
therapeutic to the patient’s entire system, and

	 	(b)	 	arterial and venous closure devices defined as any device whose
primary purpose and function is to close a catheter access puncture of a blood
vessel, and

	 	(c)	 	any device that resides within the chambers (atria or ventricles)
of the heart or within the muscle wall of the heart chambers.

	 	(ii)	 	For all Joint Inventions that were jointly invented by Rutgers and Licensee and
filed in 2007 or thereafter, and for all Licensee Inventions, subject to the terms of
this License Agreement, the Licensed Field shall be defined as product applications
that work in or with the vasculature (i.e., that which comprises all cardiovascular and
peripheral vessels (arteries and veins,
capillaries to large vessels, and blood vessels to the heart and those vessels on the
surface of the heart such as coronary vessels) which includes vessel lumens and/or
vessel exteriors and vessel replacements. Products

 

 

	 	 	 	applications in the Licensed Field
may include a therapeutic that is pharmaceutically and/or biologically active and/or a
passive agent as long as said therapeutic is acting and is intended to be used in a
site specific fashion only. Excluded from the Licensed Field are

	 	(a)	 	any systemic drug delivery devices and implants that are placed
into the blood stream predominantly for the purpose of the delivery of a
therapeutic to the patient’s entire system.

	1.9.	 	“Licensed Method(s)” means any process, method, or use that is covered by Rutgers’ Patent
Rights or use or practice of which would constitute, but for the license granted to Licensee
pursuant to this Agreement, an infringement of any issued or pending claim within Rutgers’
Patent Rights.

	1.10.	 	“Licensed Polymer(s)” means (should be numbered (i) through (iv))

	 	(i)	 	any polymer that the manufacture, use or sale of which is covered by at least
one Valid Claim; and

	 	(ii)	 	Including starting materials to the extent used by Licensee or a Sublicensee to
make polymers under this Agreement in the Licensed Field, which materials are covered
by the intellectual property listed on Exhibit A, as amended, and Improvements thereto
(for example monomers). Notwithstanding anything to the contrary in this Agreement,
Licensed Polymers shall not include starting materials sold or traded as product itself
(i.e., a monomer) if the starting material is not covered by a Valid Claim, but

	 	(iii)	 	excluding the following intellectual property licensed by Rutgers to a third
party for certain fields of use: Polyarylates polymerized from diphenol monomers
disclosed in US Patents Nos. ***
and US Application Publication *** .

	 	iv)	 	excluding materials, methods and intellectual property claimed in Exhibit A not
already excluded by subsection 1.10 (iii) above, and that have been previously licensed
by Rutgers exclusively to a third party for use outside the “Licensed Fields” as
defined in Section 1.8 above.

	1.11.	 	“Licensed Product(s)” means those products containing a Licensed Polymer including, without
limitation, those Licensed Polymers that

 

			
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	 	(i)	 	are covered by Rutgers’ Patent Rights in that their manufacture, use,
distribution or sale would constitute, but for the license granted to Licensee pursuant
to this Agreement, an infringement of any valid claim within Rutgers’ Patent Rights
and/or

	 	(ii)	 	are discovered, developed, made, or practiced using a Licensed Method.

	1.12.	 	“Major Market Countries” means Canada, France, Germany, Italy, Japan, the United States of
America and the United Kingdom.

	1.13.	 	“Net Sales” means the total of the gross consideration received for Licensed Products made,
used, leased, transferred, distributed, sold or otherwise disposed of by Licensee, its
Affiliates, and its Sublicensees, less the sum of the following actual and customary
deductions, returns, credits, rebates or allowances actually paid or given, including without
limitation, cash, trade, or quantity discounts; sales, production, value added or use taxes
imposed upon particular sales; chargeback payments and rebates granted to managed healthcare
organizations or to governments; and import/export duties; and transportation and insurance
charges. In the event Licensee or any of its Affiliates or Sublicensees makes a transfer of a
Licensed Product to a third party for other than monetary consideration or for less than fair
market value, such transfer shall be considered a sale hereunder to be calculated at a fair
market value for accounting and royalty purposes. Furthermore if Licensee, its Affiliates or
Sublicensees commercially use Licensed Product with no expectation of subsequent royalty
bearing transfer of such Licensed Product to an unaffiliated third party, such commercial use
shall be considered a sale hereunder to be calculated at a fair market value for royalty and
accounting purposes. Only one royalty shall be payable to Rutgers with respect to each
Licensed Product. Notwithstanding the foregoing, free sampling of Licensed Product in
reasonable and customary quantities, including development trials, evaluation and reasonable
marketing, as well as providing Licensed Product for compassionate use, shall not be subject
to payment of royalties to Rutgers.
	 
	 	 	A Licensed Product shall be deemed made, used, leased, transferred, sold, or otherwise
disposed of at the time Licensee bills, invoices, ships, or receives payment for such
Licensed Product or commercially uses such Licensed Product, whichever occurs first.

	1.14.	 	“Non-Coronary Stent Product” means a Licensed Product in the Licensed Field that is inserted
into any blood vessel that is not part of the coronary blood supply.
For the avoidance of doubt, any stent used in peripheral blood vessels or any stent used
within the vasculature of the brain is a “Non-Coronary Stent Product.”

	1.15.	 	“Non-Stent Product” means a Licensed Product in the Licensed Field that is not

 

 

	 	 	inserted into
the blood vessel with the intent to maintain the lumen of a blood vessel open. For the
avoidance of doubt, a product injected into the vasculature with the intent of blocking the
flow of blood in a target blood vessel will be a “Non-Stent Product.”
	 
	1.16.	 	“Rutgers’ Patent Rights” means the following patent applications, provisional patent
applications, and issued patents owned or controlled by Rutgers and/or Rutgers’ ownership
interest in jointly owned provisional patent applications and issued patents to the extent
they apply to Licensed Polymers:

	 	(i)	 	U.S. Patents and Patent Applications listed on Exhibit A, and as subsequently
amended; any divisionals, renewals, substitutions, continuations or
continuations-in-part to any such Patent Applications; U.S. Patent(s) that claim
priority to, or common priority with, any of the foregoing Patent Applications; and any
reissues, extensions (including governmental equivalents thereto) and reexaminations to
any of the foregoing Patents that are owned or controlled by Rutgers, and

	 	(ii)	 	any other pending, issued or hereafter filed, foreign counterpart of any
application from clause (i) above, all of the foregoing owned or controlled by Rutgers,
in Exhibit A, and

	 	(iii)	 	any disclosures, U.S. provisional patent applications, patent registrations,
utility models, registered or unregistered designs, in Exhibit A, and

	 	(iv)	 	Improvements with respect to subsections (i), (ii) and (iii) above to which
Licensee acquires or has otherwise licensed rights in accordance with this Agreement
except as set forth in Section 2.8, and

	 	(v)	 	for avoidance of doubt, with respect to such Improvements with respect to
subsections (i), (ii) and (iii) which constitute the Licensee Inventions or Joint
Inventions of Licensee under U.S. patent law, Licensee elects to have such Licensee’s
rights in such Improvements included in the Rutgers’ Patent Rights for purposes of this
Agreement. Further, other intellectual property which is added to Exhibit A, pursuant
to the terms of this Agreement, will be included in the definition of Rutgers’ Patent
Rights for purposes of this Agreement

	1.17.	 	“Rutgers’ Technology” means, to the extent they apply to Licensed Polymers, all information,
know-how, data rights, trade secrets, mask works, and physical objects to the extent
reasonably necessary or useful to practice the Inventions in the Licensed Field and any
non-patent intellectual property thereunder owned or controlled by Rutgers, which Rutgers has
the right to disclose and license to Licensee, except as set forth herein, without incurring
obligations, and which was
created and discovered by, or under the direction of, one or more of the Rutgers Inventors
prior to the Effective Date of this Agreement.

	1.18.	 	“Sponsored Research Agreement” means the agreement dated July 18, 2002 between Licensee and
Rutgers for the work performed by Professor Joachim

 

 

	 	 	Kohn and other Rutgers employees, and as
previously amended by Modification No.1 dated July 7, 2003, Modification No. 2 dated October
12, 2004, Modification No.3 dated February 28, 2005 and Modification No.4 dated July 25, 2005
and Modification No. 5 dated July 12, 2006 and Modification No. 6 dated May 29, 2007 and
Modification No. 7 dated March 4, 2008 and Modification No. 8 dated December 23, 2008 and
Modification No. 9 dated July 21, 2009.

	1.19.	 	“Territory” means worldwide.

	1.20.	 	“Valid Claim” means either (a) a claim of an issued and unexpired patent included within the
Rutgers Patent Rights, which has not been held permanently revoked, unenforceable or invalid
by a decision of a court or other governmental agency of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, and which has not been admitted to be
invalid or unenforceable through reissue or disclaimer or otherwise or (b) a claim of a
pending patent application included within the Rutgers Patent Rights, which claim was filed in
good faith, and has not been abandoned or finally disallowed without the possibility of appeal
or refiling of such application.

2. GRANTS

	2.1.	 	Subject to the limitations set forth in this Agreement, Rutgers hereby grants to Licensee an
exclusive license solely with respect to Licensed Polymers in the Licensed Field in the
Territory under Rutgers’ Patent Rights and a non-exclusive right to use the Rutgers’
Technology, in each case to make, have made, use, import, put into use, modify, distribute,
sell, offer for sale and have sold Licensed Products and to practice Licensed Method in the
Territory during the term of this Agreement. During the term of this Agreement, Licensee
shall also have the right to make Improvements as long as the Improvements are made with the
intent to incorporate into this Agreement.

	2.2.	 	As the Inventions were funded in part by the U.S. Government, the licenses granted hereunder
shall be subject to the overriding obligations to the U.S. Government set forth in 35 U.S.C.
200-212 and any future amendments thereto, and applicable governmental regulations, as well as
any other applicable governmental restrictions, if any, including, without limitation

	 	(i)	 	to the obligation to manufacture in the United States Licensed Product intended
for consumption in the United States unless a waiver is obtained, and

	 	(ii)	 	to the royalty free non-exclusive license thereunder to which the U.S.
Government is entitled.

 

 

	2.3.	 	Rutgers’ reserved rights:

	 	(i)	 	Rutgers expressly reserves the right to have the Inventions and associated
Rutgers Patent Rights licensed hereunder used for educational, non-commercial research
and other non-business purposes and to publish (excluding Licensee Confidential
Information) the results thereof.

	 	(ii)	 	Except as provided by Section 2.8, Licensee hereby grants to Rutgers an
exclusive, worldwide, license, with right of sublicense, to make, use and sell products
containing or covered by the claims of Inventions listed on Exhibit A, as amended and
Improvements thereto, discovered and/or developed by or on behalf of Licensee, its
Affiliates or its Sublicensees during the term of this Agreement for all fields of use
outside the Licensed Field. With respect to Rutgers Patent Rights, in the event that
Rutgers sublicenses these Rutgers Patent Rights to a third party outside the Licensed
Field after the Effective Date, the patent-related costs of the Rutgers Patent Rights
will be shared pro-rata with either Rutgers or the applicable Sublicensee.

	 	(iii)	 	If, pursuant to the rights granted in Section 2.3(ii), Rutgers licenses only
Inventions and/or Improvements constituting a Licensee Invention or otherwise solely
owned by Licensee, Rutgers shall pay Licensee *** percent (***%) of all income and
consideration Rutgers receives from such licenses. Rutgers shall make all such
payments, and provide reports and audit rights, consistent with Sections 5, 7 and 8,
parri passu. Notwithstanding the foregoing, Rutgers shall deduct all non-reimbursed
patent costs and other reasonable out of pocket costs it has incurred in regards to
such license prior to allocating income percentages. This provision shall survive
termination of the license.

	 	(iv)	 	As long as Licensee retains its exclusive grant of license rights from Rutgers
pursuant to the terms of this Agreement, neither Rutgers nor its (sub)licensees shall
have the right to practice the license rights to the Improvements granted pursuant to
this Section within the Licensed Field for commercial purposes.

	2.4.	 	To the extent Rutgers, principally through the Inventors, has provided Rutgers’ Technology to
Licensee, it is understood that at the time of disclosure to the Licensee some of the Rutgers’
Technology may have been made available to the public without restrictions.

	2.5.	 	Continuing Research by Rutgers and Licensee.

	 	(i)	 	Each Party will advise the other of Improvements to the Inventions made by the
Inventors during the term of this Agreement and will disclose them to the Rutgers
Office of Technology Commercialization. Each party shall further disclose to each
other any patent filings directly related to the Inventions that such party intends to
make.

 

			
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	 	(a)	 	Rutgers Inventions which are Improvements, to the extent such
Improvements were funded by Licensee pursuant to a Sponsored Research Agreement
between Licensee and Rutgers, will be included within the definition of
“Inventions” set forth in this Agreement.

	 	(b)	 	For avoidance of doubt, Licensee Inventions and all Joint
Inventions which are Improvements will be included within the definition of
“Inventions” set forth in this Agreement.

	 	(c)	 	A new Invention, which is not an Improvement, and which is within
the definition of the Licensed Polymer and is developed as part of the Sponsored
Research Agreement, and which is a Rutgers Invention or a Joint Invention, will
be included within the definition of “Inventions” set forth in this Agreement.

	 	(ii)	 	Each Party will advise the other, at their sole discretion, if they elect to
include in this Agreement a novel invention that consists of a new biodegradable
polymer that:

	 	(a)	 	is not an Improvement to an existing Invention on Exhibit A, and
	 
	 	(b)	 	that was developed separately from the Sponsored Research
Agreement, and
	 
	 	(c)	 	that is a sole Invention by Rutgers Inventors or by Licensee
Inventors.
Upon one Party providing written notice to the other party pursuant to this clause
(ii), the applicable invention shall be an “Invention” under this Agreement.

	 	(iii)	 	Exhibit A will be periodically amended to include Improvements, new
Inventions.

	 	(iv)	 	The provisions of this Agreement supersede the terms of intellectual property
as stated in the Sponsored Research Agreement.

	2.6.	 	Subject to Sections 2.3 and 2.8, Licensee shall hold all rights and interests in and to any
Improvements that Licensee, its Affiliates or its Sublicensees develop during the term of this
Agreement for the Licensed Field. The parties shall execute any and all documentation and
take any such actions at Licensee’s expense to achieve the intent of this Section 2.6 and
Sections 2.1, 2.3 and 2.8. For avoidance of doubt, with respect to such Improvements,
Licensee Inventions will be included in the Rutgers’ Patent Rights for purposes of this
Agreement.

	2.7.	 	Subject to Sections 2.2 and 2.3 Rutgers represents that as of the Effective Date of this
Agreement it has not entered into any agreements or other arrangements to license the Rutgers’
Patent Rights to any third party in the Licensed Field, and warrants that to the extent
Licensee is not in default of its obligations under this Agreement and retains an exclusive
license in the Licensed Field to such provisional patent or U.S. or foreign patent
applications corresponding thereto or patents issuing thereon, Rutgers shall not grant to a
third party a license of such

 

 

	 	 	applications or patents in the Licensed Field or for any other
polymer within the Licensed Field (for avoidance of doubt, as used solely in this instance
“Licensed Field” shall exclude the “solely with respect to Licensed Polymers” language
therein).

	2.8.	 	Notwithstanding anything in this Agreement to the contrary, after the effective date of a
Change of Control, all rights (including Rutgers Patent Rights and Rutgers Technology), title
and interests in any Improvements made by Licensee with no contribution by Rutgers after such
Change of Control, shall be owned exclusively by Licensee without any obligation to pay any
royalties or fees of any kind on such Improvements (or the use of the Improvements in any
products). For avoidance of doubt,

	 	(i)	 	after a Change of Control, such Improvements shall not constitute “Rutgers’
Patent Rights” or “Inventions” as such terms are defined in this Agreement, and

	 	(ii)	 	notwithstanding Sections 2.1, 2.3, 2.6 and 11, Licensee shall not be obligated
to license or assign such Improvements which are Licensee Inventions, or any rights
underlying such Improvements, or any information related to such Improvements, to
Rutgers or any third party and all rights granted to Rutgers hereunder with respect to
such Improvements shall terminate.

3. SUBLICENSES

	3.1.	 	Rutgers grants to Licensee the right to grant sublicenses to third parties under any or all
of the licenses granted in Article 2, provided Licensee has current exclusive rights thereto
under this Agreement at the time it exercises a right of sublicense. To the extent applicable,
any such sublicense shall include all of the rights of and obligations due to Rutgers (and to
the U.S. Government) that are contained in this Agreement. Upon any termination of this
Agreement, any sublicense agreements that have been properly entered into prior to the date of
such termination and that are in good standing shall be automatically assigned to Rutgers
after the date of such termination, such that the applicable Sublicensee shall continue to
receive a license under the Rutgers’ Patent Rights.

	3.2.	 	Within thirty (30) days after execution thereof, Licensee shall provide Rutgers with a copy
of each sublicense issued hereunder, and shall thereafter collect and guarantee payment of all
royalties and other obligations due Rutgers relating to the sublicenses and summarize and
deliver all reports due Rutgers relating to the sublicenses. Notwithstanding the foregoing,
if a Sublicensee breaches its obligation to pay royalties to Licensee pursuant to the terms of
the sublicense agreement, and Licensee timely terminates the applicable sublicense agreement,
then Licensee shall not be in breach of its obligation to pay royalties to Rutgers from such
Sublicensee’s Net Sales of Licensed Product.

 

 

	4.	 	LICENSE FEES AND MILESTONE AND OTHER PAYMENTS

	4.1.	 	Licensee shall pay to Rutgers $ *** on January 1, 2010 and on each following
annual anniversary thereafter, until a Licensed Product has commenced commercial sales in a
Major Market Country.

	4.2.	 	Licensee shall pay to Rutgers milestone payment fees on milestones achieved by REVA itself
(not Sublicensees) of:

	 	(i)	 	$ *** for the European Marketing Approval of each Coronary Stent Product, $
*** for the European Marketing Approval of each Non-Coronary Stent Product, and $
*** for the European Marketing Approval of any other product that is a Non-Stent
Product, up to a total aggregate over the lifetime of this Agreement of $ *** for
European Marketing Approvals, and,

	 	(ii)	 	$ *** for the Marketing Approval of each Coronary Stent Product in any
country other than the USA and Europe, $ *** for the Marketing Approval of each
Non-Coronary Stent Product in any country other than the USA and Europe, and $ ***
for the Marketing Approval of any other product that is a Non-Stent Product in any
country other than the USA and Europe, up to a total aggregate over the lifetime of
this Agreement of $ *** for all Marketing Approvals in countries that are outside of
Europe and the USA.

	 	(iii)	 	$*** for the Pre-Marketing Approval by USFDA of each Coronary Stent
Product, $ *** for the Pre-Marketing Approval by USFDA of each Non-Coronary Stent
Product by USFDA, and $ *** for each Non-Stent Product by USFDA, up to a total
aggregate over the lifetime of this Agreement of
$ *** for all Pre-Market Approvals (or equivalent regulatory approval) by USFDA.

	 	(iv)	 	These milestone payment fees under Sections (i) through (iii) shall be paid
to Rutgers within thirty (30) days after the occurrence of the event set forth on the
schedule above and shall not be refundable or creditable against royalties.

	4.3.	 	Licensee shall pay to Rutgers *** percent (***%) of milestone fees and ***% up to the
first $*** received (***% of all amounts received over $***) of license fees received in
consideration for the grant of a sublicense to Rutgers’ Patent Rights, Rutgers’ Technology or
Licensed Products licensed hereunder (“Rights”) received by Licensee or its Affiliates in
connection with all such sublicenses or

 

			
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	 	 	transfer of rights agreements. The applicable fee will
be made at the first to occur of the following:

	 	(i)	 	The first milestone payment received by Licensee under a sublicense or transfer
of rights agreement or

	 	(ii)	 	The first commercial sale of Licensed Product by a Sublicensee under a
sublicense or transfer of rights agreement or

	 	(iii)	 	30 days after receipt by Licensee if received after the occurrence of (i) or
(ii) above.

	4.4.	 	Neither milestone or license fees shall be paid on the following:

	 	(i)	 	royalties received pursuant to Section 5.1 herein, and

	 	(ii)	 	bona fide equity investments in Licensee, and

	 	(iii)	 	payments received and used for the direct cost of future Licensee research
expenses and reasonable operating expenses of Licensee related to the development of
the Licensed Products for which the payments are received (including without limitation
reimbursement for patent expenses), and

	 	(i)	 	payments received as installments in the sale of Licensee to a third party or
a part of a Change of Control (regardless of structure, and for avoidance of doubt,
whether structured as a sale of substantially all of the assets of Licensee or a sale
of substantially all of the stock of Licensee).

	4.5.	 	In sublicense or “transfer of rights” transaction agreements set forth above, where Licensee
equity is part of the transaction and the Sublicensee is purchasing Licensee’s equity at above
its fair market value, then Licensee will pay Rutgers *** percent (***%) of the
difference between the consideration received by License and the fair market value (as
determined by a mutually agreeable third party under confidentiality obligations at least as
protective of the parties as those set forth in this Agreement) of the equity acquired if such
difference is less than $***. If the difference between the consideration received
by Licensee for such equity and the fair market value (as determined by a
mutually agreeable third party under confidentiality obligations at least as protective of
the parties as those set forth in this Agreement) of the equity acquired exceeds $***, then
Licensee shall pay Rutgers *** percent (***%) of such difference.

	4.6.	 	Licensee shall pay Rutgers a one time fee of $*** at closing of the first Change of
Control of Licensee.

 

			
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5. ROYALTIES

	5.1.	 	Except as otherwise required by law, Licensee shall pay to Rutgers a royalty of ***
percent (***%) of Licensee’s Net Sales of each category of Licensed Products and
*** percent (***%) of Net Sales of Licensee’s Sublicensees. This obligation to pay
royalties shall survive termination (but not expiration) of this License.
	 
	 	 	Sales or other transfers among Licensee, its Affiliates and Sublicensees which would
otherwise be royalty bearing under this Agreement shall be disregarded for purposes of
computing royalties, to the extent that Licensed Products subject to such sale or transfer
are subsequently sold or transferred to a third party where a payment of royalty by such
third party pursuant to the terms of this Agreement with respect to such sale or transfer
will be required. Regardless of the number of Licensed Patents that cover a Licensed
Product, Licensee shall only pay one applicable royalty set forth in this Article 5.1, and
shall not pay multiple royalties for such overlapping coverage.
	 
	5.2.	 	Royalties payable to Rutgers shall be paid quarterly on or before the following dates of each
calendar year with respect to the immediately preceding calendar quarter:

	 	(i)	 	February 28th, and
	 
	 	(ii)	 	May 31st, and
	 
	 	(iii)	 	August 31st, and
	 
	 	(iv)	 	November 30th.

	 	 	Each such payment will be for unpaid royalties that accrued within Licensee’s most recently
completed calendar quarter plus any other undisputed unpaid royalties due, but not
previously paid for any reason.

	5.3.	 	For the term of this Agreement, with regard to Coronary Stent Products only Licensee shall
pay to Rutgers a minimum annual royalty beginning on the first
anniversary of the first commercial sale of a Coronary Stent Product according to the
following payment schedule:
	 
	 	 	Year one: $***
	 
	 	 	Year two: $***
	 
	 	 	Year three: $***

 

			
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	 	 	Year four: $***
	 
	 	 	Year five: $***
	 
	 	 	Year six: $***
	 
	 	 	In year seven and every year thereafter, Licensee shall pay an annual fee of
$***
	 
	 	 	For the term of this Agreement with regard to Non-Coronary Stent Products and Non-Stent
Products which for the purposes of this Section 5.3 only are combined into one category of
Licensed Products other than Coronary Stent Products, Licensee shall pay to Rutgers a
minimum annual royalty beginning on the first anniversary of the first commercial sale of a
Licensed Product, other than a Coronary Stent Product, according to the following payment
schedule.

	 	 	Year one: $***
	 
	 	 	Year two: $***
	 
	 	 	Year three: $***
	 
	 	 	Year four: $***
	 
	 	 	Year five: $***
	 
	 	 	Year six: $***
	 
	 	 	In year seven and every year thereafter, Licensee shall pay an annual minimum royalty
payment of $***.

	5.4.	 	This minimum annual royalty shall be paid to Rutgers by February 28 of each year and shall be
credited against the earned royalty due and owing for the
calendar year in which the minimum annual royalty is paid. The first minimum annual royalty
due shall be prorated by the fractional number of full months remaining in that calendar
year and shall be paid within forty-five days (45) of the date of first commercial sale of a
Licensed Product.

	5.5.	 	All amounts due Rutgers shall be payable in United States Dollars in New Brunswick, New
Jersey. When Licensed Products are sold for monies other than United States Dollars, the
earned royalties will first be determined in the foreign currency of the country in which such
Licensed Products were sold and then

 

			
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	 	 	converted into equivalent United States Dollars. The
exchange rate will be the average of the United States Dollar buying rate quoted in the Wall
Street Journal on the last business day of each month during the reporting period.
	 
	5.6.	 	Licensee shall be responsible for any and all taxes, fees, or other charges imposed by the
U.S. Government or any country outside the United States on the income for sales occurring in
any such country, excluding income taxes owing on Rutgers’ income.
	 
	5.7.	 	If at any time legal restrictions prevent the acquisition or prompt remittance of United
States Dollars by Licensee with respect to any country where a Licensed Product is sold,
Licensee shall pay royalties due to Rutgers from Licensee’s other sources of United States
Dollars.
	 
	5.8.	 	In the event that any patent or any claim thereof included within the Rutgers’ Patent Rights
shall be held invalid in a final decision by a court of competent jurisdiction and last resort
in any country and from which no appeal has or can be taken, all obligation to pay royalties
based on such patent or claim or any claim patently indistinct there from shall cease as of
the date of such final decision with respect to such country. Licensee shall not, however, be
relieved from paying any royalties that accrued before such decision or that are based on
another patent or claim not involved in such decision, or that are based on the Rutgers’
Technology.
	 
	5.9.	 	If a license to the Inventions has been granted to the U.S. Government, no running royalties
shall be payable hereunder on Licensed Products sold to the U.S. Government. Licensee, its
Affiliates and its Sublicensees shall reduce the amount charged for Licensed Products sold to
the U.S. Government by an amount equal to the royalty for such Licensed Products otherwise due
Rutgers as provided herein.
	 
	5.10.	 	If Licensee’s practice of a claim of an issued patent included in the Rutgers’ Patent Rights
infringes a third party’s patent rights (as documented by a written opinion of an outside
patent counsel selected by the parties, a copy of which is provided to Rutgers), and as a
result Licensee is obligated to pay running
royalties to such third party as a result of such infringement, then to the extent the sum
of the running royalties Licensee is obligated to pay Rutgers and said third party for such
infringement exceed ***% of Net Sales of Licensed Product, the running royalties
due Rutgers shall be reduced by *** percent (***%) of such excess, provided however, the
running royalty rate due Rutgers will not be reduced by more than one-half the rates
otherwise due to Rutgers, as stated above.

 

			
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6. DILIGENCE

	6.1.	 	Licensee, upon and after execution of this Agreement, shall use all reasonable efforts to
develop, test, obtain any required governmental approvals, manufacture, market and sell
Licensed Products in all countries of the Major Market Countries and any such other countries
mutually agreed to by the parties. Licensee shall use all commercially reasonable efforts to
obtain such Major Market Country approval within a reasonable time after execution of this
Agreement and supply (or have supplied) Licensed Product to such Major Market Countries in
quantities sufficient to meet the market demands.
	 
	6.2.	 	Licensee shall be entitled to exercise prudent and reasonable business judgment in meeting
its diligence obligations in Section 6.1, but at a minimum will exert at least the efforts
that it exerts for its own highly valuable potential products under development and existing
products being marketed and sold.
	 
	6.3.	 	Licensee shall meet the following key commercialization milestones within the time frames
indicated. If a substantial change in laws or regulations that directly affects the approval
process for a Licensed Product prevents Licensee from meeting the milestone dates in this
Section 6.3 Rutgers and Licensee agree to negotiate in good faith for a reasonable change in
the dates effected.

	 	(i)	 	In regard to a Coronary Stent Product,

	 	(a)	 	Licensee or its Sublicensees will initiate at least one clinical trial
for a Coronary Stent Product within eighteen (18) months of the Effective Date of
this Agreement in Major Market Country.
	 
	 	(b)	 	Licensee or its Sublicensees will submit a complete application to
either an appropriate regulatory body in the European Community or to the USFDA for
CE Market/PreMarket Approval for at least one Coronary Stent Product within
forty-eight (48) months of the Effective Date of this Agreement. Should applicable
regulatory requirements change subsequent to the Effective Date or should there
arise a technical complication requiring that Licensee (or Sublicensees) must
perform additional research and development work to satisfy the new requirements,
Licensee may request an extension at no cost to Licensee of up to eighteen (18)
months to complete this milestone. Permission for such an extension shall not be
unreasonably withheld by Rutgers as long as Licensee provides documentation showing
that the extension is necessary, as well as a reasonable revised timeline to the
submission required to satisfy this milestone. .
	 
	 	(c)	 	Licensee or its Sublicensees will commence commercial sales of at least

 

 

	 		 	one Coronary Stent Product in at least one Major Market Country within six (6)
months of obtaining regulatory approval for such product.

	 	(ii)	 	With regard to any Non-Stent Product,

	 	(a)	 	Licensee shall pay to Rutgers $*** upon execution of this
Agreement.
	 
	 	(b)	 	Licensee or its Sublicensees shall file with the USFDA or with
a comparable agency in another Major Market Country, product specific
applications to initiate human trials that are intended to lead to market
approval of a Licensed Product. Such filing shall occur no later than three
(3) years from the date of execution of this Agreement. If such filing does
not occur within three years, Licensee may elect to extend the filing period by
an additional year by payment of a $***
extension fee. If extended, and if such filing does not occur by the fourth
anniversary, Licensee may elect a further extension of the filing period to a
fifth year by payment of a $*** extension fee. If additional extensions are
required, Licensee may obtain them by paying $*** annually there
after if the necessary filing has not occurred prior to the date the extension
fee is due.
	 
	 	 	 	Should applicable regulatory requirements change subsequent to the Effective
Date or should there arise a technical complication requiring that Licensee (or
Sublicensees) must perform additional research and development work to satisfy
the new requirements, Licensee may request a one-time extension at no cost to
Licensee of up to eighteen (18) months to complete this milestone. Permission
for such an extension shall not be unreasonably withheld by Rutgers as long as
Licensee provides documentation showing that the extension is reasonably
necessary, as well as a reasonable revised timeline to the submission required
to satisfy this milestone.

For the avoidance of doubt, it is made explicit that the extension fees outlined above are
distinct from milestone, license or any other fees discussed in this Agreement.

7. PROGRESS AND PAYMENT REPORTS

	7.1.	 	Beginning six (6) months after the Effective Date, and semi-annually thereafter,

 

			
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	 	 	Licensee
shall submit to Rutgers a progress report covering Licensee’s activities related to the
research, development and testing of Licensed Products and the obtaining of governmental
approvals necessary for marketing. These progress
reports are Licensee’s Confidential Information and shall be made for each Licensed Product
in each country of the Territory.
	 
	7.2.	 	The progress reports submitted under Section 7.1 shall include sufficient information to
enable Rutgers to determine Licensee’s progress in fulfilling its obligations under Article 6,
including, but not limited to, the following topics:

	 	(i)	 	summary of work completed, including key scientific results and market
analysis;
	 
	 	(ii)	 	summary of work in progress, including product development and testing and
progress in obtaining government approvals;
	 
	 	(iii)	 	current schedule of anticipated events or milestones;
	 
	 	(iv)	 	market plans for introduction of Licensed Products in the Territory;
	 
	 	(v)	 	summary of resources (dollar value) spent in the reporting period for research,
development, and marketing of Licensed Products;
	 
	 	(vi)	 	activities in obtaining Sublicensees and activities of Sublicensees;
	 
	 	(vii)	 	certified financial statements as of the end of the previous calendar quarter;
and,
	 
	 	(viii)	 	A statement showing how amounts due were calculated.

	7.3.	 	Licensee shall have a continuing responsibility to keep Rutgers informed of the large/small
entity status (as defined by the United States Patent and Trademark Office) of itself and its
Sublicensees.
	 
	7.4.	 	Licensee shall report to Rutgers in its immediately subsequent progress and payment report
the date of first commercial sale of each Licensed Product in each country.
	 
	7.5.	 	After the first commercial sale of a Licensed Product anywhere in the world, Licensee will
make quarterly royalty reports to Rutgers on or before each February 28, May 31, August 31 and
November 30 of each year. Each such royalty report will cover Licensee’s most recently
completed calendar quarter and will show

	 	(i)	 	the units and gross consideration received and Net Sales of each type of
Licensed Product sold by Licensee, its Affiliates and sublicenses on which royalties
have not been paid, including a clear indication of how Net Sales were calculated;
	 
	 	(ii)	 	the royalties and fees, in U.S. dollars, payable hereunder and which patents
apply;
	 
	 	(iii)	 	the method used to calculate the royalty;
	 
	 	(iv)	 	the exchange rates used, if any; and

 

 

	 	(v)	 	any other information relating to the foregoing reasonably requested by
Rutgers.

	7.6.	 	If no sales of Licensed Products have been made during any reporting period, a
statement to this effect shall be made by Licensee.
	 
	7.7.	 	Licensee shall include a written statement with any additional payment or other consideration
made to Rutgers pursuant to the terms of this Agreement setting forth in reasonable detail the
basis for the payment and the manner in which the payment was calculated.

8. BOOKS AND RECORDS

	8.1.	 	Licensee shall keep and cause its Affiliates and require its Sublicensees to keep books and
records in accordance with generally accepted accounting principles accurately showing all
financial transactions and information relating to this Agreement. Such books and records
shall be preserved for at least five (5) years from the date of the entry to which they
pertain and shall be open to inspection by a nationally recognized accounting firm designated
by Rutgers no more than once a calendar year at reasonable times upon reasonable notice.
	 
	8.2.	 	The fees and expenses of Rutgers’ representatives performing such an examination shall be
borne by Rutgers. However, if an error in any payment of more than five percent (5%) of such
payment due is discovered, then the fees and expenses of these representatives shall be borne
by Licensee, and Licensee shall promptly reimburse Rutgers for reasonably documented audit
expenses as well as all overdue payments and late interest payments. Any information gathered
during such accounting shall be deemed Licensee’s Confidential Information, and the
independent accounting firm shall be bound to confidentiality terms substantially equivalent
to those contained in this Agreement.

9. TERM OF THE AGREEMENT

	9.1.	 	Unless otherwise terminated by operation of law or by acts of the parties in accordance with
the provisions of this Agreement, this Agreement shall be in force from the Effective Date and
shall remain in effect in each country of the Territory until the expiration of the
last-to-expire patent licensed under this Agreement in such country.
	 
	9.2.	 	Any termination or expiration of this Agreement shall not affect the rights and obligations
set forth in the following Sections and/or Articles:

	 	 	 	Article 1, Section 2.2, Section 2.3, Section 2.6, Section 2.8, Section 3.1,

 

 

	 	 	 	Section
5.5, Section 5.6, Section 5.7, Section 5.8, Section 5.9, Section 5.10, Article 8,
this Article 9, Section 10.1, Section 11.1, Article 12, Article 13, Article 17,
Article 18, Article 19, Article 20, Article 21, Article 22, Article 24, Article 25,
Article 26, Article 27.

	9.3.	 	Any termination or expiration under this Agreement shall not relieve a party of any
obligation or liability accrued hereunder prior to such termination or expiration or rescind
anything done by a party or any payments made to the other party hereunder prior to the time
such termination or expiration becomes effective, and such termination or expiration shall not
affect in any manner any rights of a party arising under this Agreement prior to such
termination or expiration. Solely upon expiration of this Agreement in any country, Rutgers
shall grant to Licensee the rights set forth in Section 2.1, solely with regard to the
Rutgers’ Technology on a perpetual, non-exclusive and fully-paid basis in such country.
	 
	9.4.	 	Except as expressly set forth in this Agreement, Licensee shall only have the right to
terminate this Agreement in its entirety , or to terminate with regard to its obligations
under the Agreement that relate to Coronary Stent Products, if specific circumstances obtain
as described below. In the event of such termination, Licensee shall give Rutgers one hundred
and twenty (120) days notice of intent to terminate. Licensee may not terminate Agreement
prior to initial commercial sales of a Coronary Stent Product. The circumstances that would
permit Licensee to terminate the Agreement are specified below:

	 	a.	 	If market conditions outside Licensee’s control related to commercial potential
for Coronary Stent Products deteriorate to the extent that continued marketing of such
Products is no longer commercially viable for Licensee. In these circumstances,
Licensee shall provide Rutgers with documentation of the market conditions adversely
affecting sales of Coronary Stent Products and how such conditions make it no longer
commercially reasonable for Licensee to continue to market said products. Market
conditions sufficient to justify termination would include, for example (but would not
be restricted to), the commercial development of a non-stent technology that
substantially reduces the demand for and/or the selling price of the Coronary Stent
Products to the extent that it is no longer commercially viable for Licensee to
continue to market such Products.
	 
	 	b.	 	The imposition of new regulations (outside Licensee’s control) that render
further marketing of Coronary Stent Products not commercially viable for Licensee.
Regulatory factors justifying termination of the License might include, but would not
be restricted to, regulations that so affect the manufacture of Coronary Stent Products
(including the polymer, the stent or

 

 

	 	 	 	any process related thereto) that it is no longer
commercially viable for Licensee to produce such Products (e.g. if a component of the
manufacturing process is banned from the market or otherwise becomes unavailable and
there is no suitable replacement). Another example of a regulation that would justify
termination of the Agreement is one that would result in the
Product being prohibited from use in human beings. . In these circumstances, Licensee
shall provide Rutgers with documentation regarding the applicable regulatory change and
the effect of such change on Licensee.

	 	 	Unless Licensee terminates the Agreement under the provisions of this Section 9.4, following
receipt of regulatory approval to market a Coronary Stent Product, Licensee will be bound by
the minimum royalty payments set forth in Section 5.3.
If Licensee terminates the Agreement in whole under the provisions of this Section 9.4,
Licensee will forfeit all rights to manufacture, sell, or distribute any Licensed Products
and Licensee will assign its interest in any and all joint patent rights included in Rutgers
Patent Rights to Rutgers. If Licensee only terminates the Agreement with respect to
Coronary Stent Products, then it shall only forfeit the rights to manufacture, sell or
distribute Coronary Stent Products and will assign to Rutgers its interest in any and all
applicable patent rights included in Rutgers Patent Rights.

10. TERMINATION FOR CAUSE BY EITHER PARTY

	10.1.	 	If one party should materially breach or materially fail to perform any provision of this
Agreement, then the other party may give written notice of such default (Notice of Default) to
the breaching party. The parties agree that failure to make any payment when due under the
terms of this Agreement or breach of any of the required obligations in Sections 6.1 through
6.3 of the Agreement shall be deemed, without limitation, a material breach or a material
failure under this Section. If the breaching party should fail to cure such default within
sixty (60) days of notice thereof, the non-breaching party shall have the right to terminate
this Agreement and the licenses herein by a second written notice (Notice of Termination) to
the breaching party. If a Notice of Termination is sent to the breaching party, this
Agreement shall automatically terminate on the effective date of such notice. Termination
shall not relieve the breaching party of its obligation to pay all amounts due to the
non-breaching party as of the effective date of termination and shall not impair any accrued
rights of the non-breaching party.
	 

11. DISPOSITION OF LICENSED PRODUCTS AND INFORMATION ON HAND UPON TERMINATION

 

 

	11.1.	 	Upon termination of this Agreement by either party:

	 	(i)	 	Licensee shall have the privilege of disposing of all previously made or
partially made Licensed Products (Licensee may complete partially made Licensed
Products), but no more, within a period of one hundred and eighty (180) days after the
initial notice of termination given pursuant to Sections 9.4, 10.1 or 11.1 hereunder,
provided, however, that the disposition of such Licensed Products shall be subject to
the terms of this
Agreement including, but not limited to, the payment of royalties at the rate and at
the time provided herein and the rendering of reports thereon; and,
	 
	 	(ii)	 	each party shall promptly return, and shall cause its Affiliates and require
its Sublicensees to return, all property belonging to the other party, including
without limitation in the case of Rutgers, Rutgers’ Technology and Rutgers’
Confidential Information, if any, that has been provided to Licensee or its Affiliates
or Sublicensees hereunder; and including without limitation in the case of Licensee,
Licensee Confidential Information. All copies and facsimiles thereof and derivatives
therefrom shall be returned (except that one copy of written material for record
purposes only, provided such material is not used for any other purpose and is not
disclosed to others).

12. USE OF NAMES, TRADEMARKS, AND CONFIDENTIAL INFORMATION

	12.1.	 	Nothing contained in this Agreement shall be construed as granting any right to a party, its
Affiliates or Sublicensees to use in advertising, publicity, or other promotional activities
or otherwise any name, trade name, trademark, or other designation of the other party or any
of its units (including contraction, abbreviation or simulation of any of the foregoing).
Unless required by law or consented to in advance in writing by an authorized representative
of Rutgers, the use by Licensee of the name, “Rutgers, The State University” or any campus or
unit of Rutgers is expressly prohibited.

	13.	 	 LIMITED WARRANTY

	13.1.	 	Rutgers represents to Licensee that as of the Effective Date it owns the Rutgers’ Patent
Rights and that Rutgers has the lawful right to grant the licenses in this Agreement to
Licensee. Licensee represents that it owns the Licensee Inventions, that it has the lawful
right to grant the licenses in this Agreement to Rutgers, and that it has consented to include
the Licensee Inventions as part of Exhibit A in this Agreement.

	13.2.	 	Rutgers represents that, as of the Effective Date, its Director of the Office of Technology
Commercialization: (a) has no actual knowledge of any third party intellectual property rights
which are infringed by the use of the Rutgers’ Patent

 

 

	 	 	Rights or Rutgers’ Technology; and (b)
has no actual knowledge of any action or suit that threatens the validity of the Rutgers’
Patent Rights or of any intellectual property rights owned by Rutgers as of the Effective Date
which would prevent Licensee from practicing the rights licensed to Licensee under this
Agreement. Rutgers shall not exercise any intellectual property rights owned by Rutgers as of
the Effective Date, or grant a license to any third party, which would prevent Licensee from
practicing, or conflict with, the rights licensed to Licensee under this Agreement.
	 
	13.3.	 	EXCEPT AS SET FORTH IN SECTION 13.1 AND 13.2, THIS LICENSE IS WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED
AND RUTGERS MAKES NO REPRESENTATION OR WARRANTY THAT THE LICENSED PRODUCTS OR LICENSED METHODS
WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
	 
	13.4.	 	IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, DIRECT, INDIRECT, SPECIAL OR
CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST PROFITS, RESULTING FROM THIS
AGREEMENT, INCLUDING THE MANUFACTURE, SALE, OR USE OF THE INVENTIONS OR LICENSED PRODUCTS OR
RUTGERS INTELLECTUAL PROPERTY OR LICENSEE INVENTIONS LICENSED HEREUNDER.
	 
	13.5.	 	Except as set forth in Sections 13.1 and 13.2, nothing in this Agreement shall be construed
as:

	 	(i)	 	a warranty or representation by Rutgers as to the validity or scope of any
Rutgers’ Patent Rights or a warranty or representation by Licensee as to the validity
or scope of any patent that may claim a Licensee Invention; or
	 
	 	(ii)	 	a warranty or representation that anything made, used, sold or otherwise
disposed of under any license granted in this Agreement is or will be free from
infringement of patents or other intellectual property rights of third parties; or
	 
	 	(iii)	 	an obligation to bring or prosecute actions or suits against third parties
except as provided in Article 16; or
	 
	 	(iv)	 	conferring by implication, estoppel or otherwise any license or rights under
any patents or other intellectual property of Rutgers or Licensee other than Rutgers’
Patent Rights and Rutgers’ Technology and Licensee Inventions; or
	 
	 	(v)	 	an obligation to furnish any know-how not provided in Rutgers intellectual
property licensed hereunder.

 

 

14. PATENT PROSECUTION AND MAINTENANCE

	14.1.	 	Rutgers shall diligently prosecute and maintain the United States pending patent
applications and issued patents comprising the Rutgers’ Patent Rights using counsel of its
choice. Rutgers’ counsel shall take instructions only from Rutgers. Prior to making filings,
and providing reasonable time for Licensee to comment and consult with Rutgers, Rutgers shall
keep Licensee informed and apprised of the continuing prosecution of Rutgers’ Patent Rights.
Licensee agrees to keep this documentation confidential.
	 
	14.2.	 	Rutgers shall give due consideration to amending any patent application to
include claims reasonably requested by Licensee to protect the Licensed Products
contemplated to be sold under this Agreement. If Rutgers elects not to file any patent
application included within the Rutgers’ Patent Rights in any country, or decides to abandon
any pending application or issued patent the Rutgers’ Patent Rights in any country, then
Rutgers shall provide reasonable advance written notice to Licensee, and Licensee shall have
the right at its sole expense to assume control of the preparation, filing, prosecution and
maintenance of such patent application or patent at its own expense (provided Rutgers shall
remain the owner thereof).
	 
	14.3.	 	All unreimbursed costs incurred by Rutgers after the Effective Date for preparing, filing,
prosecuting and maintaining the patent applications and/or patents included within the
Rutgers’ Patent Rights, including but not limited to patent applications and patents covered
by Rutgers’ Patent Rights and included pursuant to Section 14.4 shall be borne by Licensee.
Such costs shall be payable by Licensee within thirty (30) days of the billing date. If
Licensee fails to pay patent costs in a timely manner as required in this Section, Rutgers
may, at its discretion, require Licensee to pay estimated patent costs in advance as a
condition for maintaining this license. If Rutgers licenses the Rutgers’ Patent Rights to a
third party licensee(s), then Licensee and such third party licensee(s) shall each share in
such patent costs incurred after the dates of such third party license(s). In principle, such
sharing shall be pro rata, so long as the relative markets and scope of license of this
License and such third party license(s) are approximately the same; if not, Rutgers reserves
the right to make an equitable allocation of patents costs among licensees. Should a
situation arise, where protection of the patent rights licensed under this Agreement requires
seeking a declaratory judgment, filing an interference or other exceptional action with
potential high costs associated, Rutgers shall consult with Licensee to determine whether
Licensee wishes to Rutgers to pursue such action (at Licensee’ expense). Should Licensee
choose not to pursue such actions, Rutgers reserves the right, but is under no obligation to
pursue such action at its own expense.
	 
	14.4.	 	Rutgers shall, at the request of Licensee, file, prosecute, and maintain patent applications
and patents covered by Rutgers’ Patent Rights in foreign countries. Licensee consents to the
filing of all PCT and foreign patent applications that have already been filed as of the
Effective Date. Rutgers shall provide Licensee

 

 

	 	 	copies of all PCT and foreign patent
applications that have been filed within thirty (30) days after the Effective Date. Licensee
shall notify Rutgers within six (6) months of the filing of the corresponding United States
application of its decision to obtain all other foreign patents. This notice shall be in
writing and shall identify the countries desired. The absence of such a notice from Licensee
shall be considered by Rutgers to be an election not to request foreign rights.
	 
	14.5.	 	Licensee’s obligation to underwrite and to pay patent prosecution costs shall continue for
so long as this Agreement remains in effect, provided, however, that Licensee may terminate
its obligations with respect to any given patent
application or patent upon three (3) months’ prior written notice to Rutgers. Rutgers shall
use reasonable efforts to curtail future patent costs when such a notice is received from
Licensee. Licensee shall promptly pay patent costs which cannot be so curtailed.
Commencing on the effective date of such notice, Rutgers may continue prosecution and/or
maintenance of such application(s) or patent(s) at its sole discretion and expense, and
Licensee shall have no further right or licenses thereunder.
	 
	14.6.	 	Rutgers shall have the right to file patent applications at its own expense in any country
or countries in which Licensee has not elected to pay Rutgers’ prosecution and maintenance
costs for securing patent rights or in which Licensee’s license to the Rutgers’ Patent Rights
has terminated. So long as this Agreement remains in effect such applications and resultant
patents shall not be freely licensed by Rutgers to third parties within the Licensed Field.
If the Licensee’s license to the Rutgers’ Patent Rights has terminated such applications and
resultant patents shall not be subject to this Agreement and may be freely licensed by Rutgers
to third parties together with non-exclusive rights to the Rutgers’ Technology in such
countries. In the event Rutgers intends to exercise this right, it shall notify Licensee in
writing of its intent to do so and the countries where it intends to file patent applications.
Licensee shall then have thirty (30) days to maintain its license to such patent rights and
applications (“Prosecution Funding Right”) by notifying Rutgers in writing that it wishes to
again add such countries to this Agreement and to pay the applicable prosecution and
maintenance costs for doing so.

15. PATENT MARKING

	15.1.	 	Licensee shall mark all Licensed Products made, used, sold imported, exported, or otherwise
disposed of under the terms of this Agreement, and/or their containers, in accordance with the
applicable patent marking laws.

 

 

16. PATENT INFRINGEMENT

	16.1.	 	In the event that Licensee shall learn of the substantial infringement of any patent
licensed under this Agreement in the Licensed Field, Licensee shall notify Rutgers in writing
and shall provide Rutgers with reasonable evidence of such infringement. Both parties to this
Agreement agree that during the period and in a jurisdiction where Licensee has exclusive
rights under this Agreement, neither will notify a third party of the infringement of any of
Rutgers’ Patent Rights in the Licensed Field, without first obtaining consent of the other
Party, which consent shall not be unreasonably denied, provided that for purposes of this
Section, Licensee’s Sublicensees shall not be deemed to be “third parties” as that term used
herein. Both parties shall use their diligent efforts in cooperation with each other to
terminate such infringement without litigation.
	 
	16.2.	 	Licensee may request that Rutgers take legal action against the infringement of Rutgers’
Patent Rights in the Licensed Field. Such request shall be made in writing and shall include
reasonable evidence of such infringement and damages to Licensee. If the infringing activity
has not been abated within ninety (90) days following the effective date of such request,
Rutgers shall have the right to commence suit on its own account or refuse to commence such
suit. However, in the event Rutgers elects to bring suit in accordance with this paragraph,
Licensee may thereafter join such suit at its own expense. Rutgers shall give notice of its
election in writing to Licensee by the end of the one-hundredth (100th) day after receiving
notice of such request from Licensee. However, Licensee may thereafter bring suit for patent
infringement in its own name and if required for standing purposes in the name of Rutgers if
and only if Rutgers refuses to commence suit and if the infringement occurred during the
period and in a jurisdiction where Licensee had exclusive rights under this Agreement.
However, in the event Licensee elects to bring suit in accordance with this paragraph, Rutgers
may thereafter join such suit at its own expense. Such legal action as is decided upon shall
be at the expense of the party on account of whom suit is brought.
	 
	16.3.	 	Each party agrees to cooperate with the other in litigation proceedings instituted hereunder
but at the expense of the party on account of whom suit is brought for out-of-pocket expenses.
Such litigation shall be controlled by the party bringing the suit. Each party may be
represented by counsel of its choice at its own expense. Any recovery or damages or
settlement amounts derived from any such action shall first be applied to reimburse each party
for the total cost of such action, with the remainder to be allocated among the parties as
follows: the party bringing the action shall receive from the other party, and the other party
shall assign to the party bringing the action eighty percent (80%) of such remainder, and the
other party shall receive from the party bringing the action, and the party bringing the
action shall assign twenty percent (20%) of such remainder to the other party.

 

 

17. INDEMNIFICATION AND INSURANCE

	17.1.	 	To the maximum extent permitted by law, Licensee shall indemnify, hold harmless and defend
Rutgers, its governors, trustees, officers, employees, students, agents and the Inventors
(“Indemnified Parties”) against any and all third party claims, suits, losses, liabilities,
damages, costs, fees and expenses (including reasonable attorneys’ fees) (collectively,
“Claims”) resulting from or arising out of the exercise of the rights granted under this
license or any sublicense by Licensee, its Affiliates and Sublicensees. This indemnification
shall include, but is not limited to, any and all claims alleging products liability. Rutgers
shall remain liable for, and the foregoing indemnification obligation shall not include, any
claims of infringement arising out of the Inventions, the Rutgers’
Patent Rights or the Rutgers’ Technology and any claims arising out of the gross negligence,
to the extent negligence is applicable, or willful misconduct of Rutgers.
	 
	17.2.	 	Throughout the term of this Agreement, and to the extent applicable from and after the date
of first transfer of a Licensed Product and for the life of all Licensed Products used or
transferred, Licensee shall maintain commercially issued policies of insurance, or a program
of self-insurance if such program is approved in advance in writing by an authorized
representative of Rutgers, which provide coverage and limits as required by statute or as
necessary to prudently insure the activities and operations of Licensee. The commercial
general liability insurance policy, or liability self-insurance program, shall include the
interests of Rutgers as an additional insured and provide coverage limits of not less than
$5,000,000 combined single limits as respects premises, operations, contractual liability and,
if applicable, liability arising out of products and/or completed operations. Licensee shall
provide Rutgers with certificates of insurance for commercially insured policies, or a letter
from Licensee’s independent auditors stating its opinion as to the adequacy of any
self-insurance program.
	 
	17.3.	 	It is expressly agreed that the insurance or self-insurance are minimum requirements which
shall not in any way limit the liability of Licensee and shall be primary coverage. Any
insurance or self-insurance program maintained by Rutgers shall be excess and noncontributory.
	 
	17.4.	 	Rutgers shall promptly notify Licensee in writing of any claim or suit brought against
Rutgers in respect of which Rutgers intends to invoke the provisions of Article 17. Licensee
shall keep Rutgers informed on a current basis of its defense of any claims pursuant to
Article 17.

 

 

18. NOTICES

	18.1.	 	Any notice or payment required to be given to either party shall be deemed to have been
properly given and to be effective (a) on the date of delivery if delivered in person, (b)
five (5) days after mailing if mailed by first-class certified mail, postage paid and
deposited in the United States mail, to the respective addresses given below, or to such other
address as it shall designate by written notice given to the other party, (c) on the date of
delivery if delivered by express delivery service such as Federal Express or DHL or (d) or as
otherwise agreed upon in writing by the parties.

	 	 	 

	 	  In the case of Licensee:  

	REVA Medical, Inc.
	 

	 	5751 Copley Drive, Suite B

San Diego, CA 92111
	 

	 	Attention: President
	 

	 	Telefax No. (858) 966-3099
	 

	 	Telephone No (858) 966-3000
	 
	 	 
	 	  In the case of Rutgers:

	Rutgers, The State University
	 

	 	Office of Technology Commercialization
	 

	 	Attention: Director
	 

	 	ASB III, 3 Rutgers Plaza
	 

	 	New Brunswick, NJ 08901
	 

	 	Telefax No. (732) 932-0115
	 

	 	Telephone No (732) 932-0146

19. ASSIGNABILITY

	19.1.	 	Neither this Agreement nor any right or obligation hereunder is assignable in whole or part
by any party without the prior written consent of the other party. Notwithstanding the
foregoing, either party may assign this Agreement, without such consent, to a third party in
connection with a Change of Control of or by the assigning party. This Agreement shall inure
to the benefit of each of the party’s successors and assignees, provided that such successors
or assignees assume the party’s obligations under this Agreement.

20. LATE PAYMENTS

	20.1.	 	In the event any amounts due Rutgers hereunder, including but not limited to royalty
payments, fees and patent cost reimbursements, are not received when due, Licensee shall pay
to Rutgers interest charges at a rate of ten (10) percent per annum, compounded monthly, or
the highest rate permitted by law, if less than ten (10) percent. Such interest shall be
calculated from the date payment was due until actually received by Rutgers.

 

 

21. WAIVER

	21.1.	 	It is agreed that failure to enforce any provisions of this Agreement by a party shall not
be deemed a waiver of any breach or default hereunder by the other party. It is further agreed
that no express waiver by either party hereto of any breach or default of any of the covenants
or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar
breach or default.

22. FAILURE TO PERFORM

	22.1.	 	In the event of a failure of performance due under the terms of this Agreement and if it
becomes necessary for either party to undertake legal action against the other on account
thereof, then the prevailing party shall be entitled to reasonable
attorneys’ fees in addition to costs and necessary disbursements.

23. PRIOR AGREEMENTS

	23.1.	 	This Agreement supersedes and replaces in its entirety the 2004 License Agreement (as
amended) between the parties; provided that Section 2.6 and Articles 9, 14 and 21 of the 2004
License Agreement shall survive.

24. GOVERNING LAWS

	24.1.	 	THIS AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE
OF NEW JERSEY WITHOUT REGARD TO ITS CONFLICTS OF LAW PROVISIONS, but the scope and validity of
any patent or patent application shall be governed by the applicable laws of the country of
such patent or patent application.

25. FOREIGN GOVERNMENT APPROVAL OR REGISTRATION

	25.1.	 	If this Agreement or any associated transaction is required by the law of any nation to be
either approved or registered with any governmental agency, Licensee shall assume all legal
obligations to do so and the costs in connection therewith. Rutgers shall provide reasonable
assistance to Licensee regarding compliance with the same at Licensee’s cost.

26. EXPORT CONTROL LAWS

	26.1.	 	Licensee shall observe all applicable United States and foreign laws with respect to the
transfer of Licensed Products and related technical data to foreign

 

 

	 	 	countries, including,
without limitation, the International Traffic in Arms Regulations (ITAR) and the Export
Administration Regulations. Rutgers shall provide reasonable assistance to Licensee regarding
compliance with the same at Licensee’s cost.

27. CONFIDENTIALITY

	27.1.	 	Each receiving party (“Recipient”)

	 	(i)	 	shall not use any Confidential Information of the other party (“Discloser”)
except for the sole purpose of performing this Agreement,
	 
	 	(ii)	 	shall safeguard the same against disclosure to others with the same degree of
care as it exercises with its own information of a similar nature, but using at least
reasonable diligent efforts and
	 
	 	(iii)	 	shall not disclose or permit the disclosure of Discloser Confidential
Information to others (except to its employees, agents or consultants who are bound by
a like obligation of confidentiality) without the express written permission of
Discloser, except that Recipient shall not be prevented from using or disclosing any
Confidential Information:

	 	(a)	 	which Recipient can demonstrate by written records was previously
known to it; or
	 
	 	(b)	 	which is now, or becomes in the future, information generally
available to the public in the form supplied, other than through acts or
omissions of Recipient; or
	 
	 	(c)	 	which is lawfully obtained by Licensee from sources independent of
Discloser who were entitled to provide such information to Recipient; or
	 
	 	(d)	 	which is required by law to be disclosed by Recipient.

If Recipient learns or believes that any person who has had access to the Confidential Information
of Discloser has violated or intends to violate the confidentiality or use restrictions of this
Agreement, Recipient shall immediately notify Discloser and shall cooperate with Discloser in
seeking injunctive or other equitable relief against any such person. The obligations under this
Section 27.1 shall remain in effect during the term of this Agreement and for five (5) years from
the date of termination or expiration of this Agreement.

28. MISCELLANEOUS

	28.1.	 	The headings of the several articles are inserted for convenience of reference only and are
not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

 

	28.2.	 	This Agreement will not be binding upon the parties until it has been signed below on behalf
of each party by a duly authorized representative.
	 
	28.3.	 	No amendment or modification hereof (including without limitation adding additional
Inventions and patents to Exhibit A) shall be valid or binding upon the parties unless made in
writing and signed on behalf of each party by a duly authorized representative.
	 
	28.4.	 	This Agreement, including the Exhibits attached hereto, embody the sole, entire and final
understanding of the parties and shall supersede all previous and contemporaneous
communications, representations or understandings, either oral or written, between the parties
relating to the subject matter hereof.
	 
	28.5.	 	Licensee shall not enter into any agreements relating to this Agreement with Rutgers
Inventors or other Rutgers employees or students in contravention of the legal rights or
policies of Rutgers.
	 
	28.6.	 	In case any of the provisions contained in this Agreement shall be held to be invalid,
illegal or unenforceable in any respect,

	 	(i)	 	such invalidity, illegality or unenforceability shall not affect any other
provisions hereof,
	 
	 	(ii)	 	the particular provision, to the extent permitted by law, shall be reasonably
construed and equitably reformed to be valid and enforceable and if the provision at
issue is a commercial term, it shall be equitably reformed so as to maintain the
overall economic benefits of the Agreement as originally agreed upon by the parties,
and
	 
	 	(iii)	 	this Agreement shall be construed as if such invalid or illegal or
unenforceable provisions had never been contained herein.

	28.7.	 	Rutgers shall have the right to terminate this Agreement forthwith by giving written notice
of termination to Licensee at any time upon or after the filing by Licensee of a petition in
bankruptcy or insolvency, or upon or after any adjudication that Licensee is bankrupt or
insolvent, or upon or after the filing by Licensee of any petition or answer seeking judicial
reorganization, readjustment or arrangement of the business of Licensee under any law relating
to bankruptcy or insolvency, or upon or after the appointment of a receiver for all or
substantially all of the property of Licensee, or upon or after the making of any assignment
or attempted assignment for the benefit of creditors, or upon or after the institution of any
proceeding by Licensee or passage of any resolution by Licensee for the liquidation or winding
up of Licensee’s business or for termination of its corporate life.
	 
	28.8.	 	Neither party or its Affiliates shall originate any publicity, news release or other public
announcement, written or oral, relating to this Agreement or the existence

 

 

	 	 	of an arrangement
between the parties or the terms and conditions of this Agreement, except as required by law,
without the prior written approval of the other party, which approval shall not be
unreasonably withheld. Notwithstanding the foregoing, disclosures may be made by either party

	 	(i)	 	to its accountants, banks, financing sources, lawyers and other professional
advisors, provided that such parties undertake in writing to keep such information
confidential, or
	 
	 	(ii)	 	as required by applicable laws and regulations, including those of the U.S.
Securities and Exchange Commission, or
	 
	 	(iii)	 	to governmental agencies with respect to the tax treatment or tax structure
contemplated by this Agreement, or
	 
	 	(iv)	 	to actual or prospective Sublicensees or assignees.

	28.9.	 	This Agreement may be executed in any number of counterparts, each of which shall be deemed
an original, but all of which together shall constitute one and the same instrument.
	 
	28.10.	 	Nothing herein shall be deemed to constitute one party as the agent or representative of the
other party or both parties as joint ventures or partners. Each party as an independent
contractor.

 

 

IN WITNESS WHEREOF, both Rutgers and Licensee have executed this Agreement by their duly
authorized.

	 	 	 	 	 	 	 

	REVA Medical, Inc.	 	Rutgers, The State University of New Jersey,

Office of Technology Commercialization
	 
	 	 	 	 	 	 
	By

	 	/s/ Robert K. Schultz
	 	By
	 	/s/ Dipanjan Nag
	 

	 	 
	 	 	 	 
	 

	 	(Signature)	 	 

	 	(Signature)
	 

	 	Robert K. Schultz	 	 

	 	Dipanjan Nag
	 

	 	President	 	 

	 	Executive Director Office of Technology
Commercialization
	 
	 	 	 	 	 	 
	 

	 	 7-1-2010	 	 

	 	 7/8/10
	 

	 	(Date)	 	 

	 	(Date)

 

 

EXHIBIT A.

 

 

     

Exhibit A

This Exhibit A lists Inventions covering a wide range of polymer compositions. These Inventions are included in this Agreement only to the extent they apply to “Licensed Polymers”, as defined in Section 1.10 of this Agreement. Claims that are not applicable and claims that relate to uses
outside the Licensed Field as defined in Section 1.8 of this agreement are excluded. Exhibit A will be periodically updated by Rutgers and Licensee to include Improvements.

Exhibit A includes U.S. Patent Number(s) listed and any reissues, extensions (including governmental equivalents thereto), divisionals, renewals, substitutions, continuations, continuations-in-part, reexaminations, and any other pending, issued or hereafter filed, foreign counterpart of any
such applications corresponding to all of the foregoing, owned or controlled by Rutgers, and any disclosures, U.S. provisional patent applications, patent registrations, utility models, registered or unregistered designs, Improvements with respect Polycarbonates, and Rutgers Technology with
respect to Polycarbonates (information, know-how, data rights, trade secrets, mask works, and physical objects to the extent reasonably necessary or useful to practice the Inventions) that is patentable or non-patentable.

Legend: Fox: Fox Rothschild LLP; CRBCP: Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd.; KMOB: Knobbe, Martens, Olson & Bear, LLP.; RSU: Rutgers, The State University of New Jersey; Integra LS: ; N/A: Not Applicable; Inventors (RSU = Rutgers Inventors; REVA = Licensee Inventors, Joint =
Rutgers and Licensee Inventors); % REVA Patent Costs refers to current share of patent costs as Rutgers has other licensees for the same patents but different licensed fields or claims.

Designation: The following patents are subject to the license terms of Article 1.8(i).

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Fox	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	% REVA	 	 	 	 
	 	 	 	 	(70439, 74584)	 	 	 	 	 	 	 	Patent	 	Patent	 	Patent No. or	 	Patent	 	 	 	Patent Cost	 	Patent	 	 
	#	 	Fox short #	 	or CRBCP	 	RSU#	 	Type	 	Status	 	Application #	 	Filing Date	 	Publication No.	 	Expiry Date	 	Inventors	 	Sept.09	 	Assignee	 	Patent Title
	1

	 	***
	 	***
	 	88-0525-1
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Polyiminocarbonate synthesis
	2

	 	***
	 	***
	 	89-0530-1
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Synthesis of amino acid-derived bioerodible polymers
	3

	 	***
	 	***
	 	91-0304-1
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Polyiminocarbonate synthesis
	4

	 	***
	 	***
	 	89-0529-1
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Poly(N-substituted iminocarbonate)
	5

	 	***
	 	***
	 	92-0108-1
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Synthesis of Amino Acid-Derived Bioerodible Polymers
	6

	 	***
	 	***
	 	95-0410-DD1
	 	DIV
	 	Reissued as

RE 37,795
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Synthesis of tyrosine derived diphenol monomers
	7

	 	***
	 	***
	 	99-0095
	 	Reissue
	 	Reissue
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Synthesis of tyrosine derived diphenol monomers
	8

	 	***
	 	***
	 	92-1119-1
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Poly(N-phenyl urethane) from poly(N-substituted

iminocarbonate)
	9

	 	***
	 	***
	 	92-0624-1
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Polyiminocarbonate synthesis
	10

	 	***
	 	***
	 	95-0410-D
	 	CIP
	 	Reissued as

RE 37,160
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Synthesis of tyrosine derived diphenol monomers
	11

	 	***
	 	***
	 	99-0105
	 	Reissue
	 	Reissue
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Syntheses tyrosine-derived diphenol MMRS
	12

	 	***
	 	***
	 	95-0615-1
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Copolymers of tyrosine-based polycarbonate and
poly(alkylene oxide)
	13

	 	***
	 	***
	 	95-0615-1-CIP
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Copolymers of tyrosine-based polyarylates and
poly(alkylene oxides)
	14

	 	***
	 	***
	 	00-0116 (USDIV)
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Copolymers of tyrosine-based polyarylates and
poly(alkylene oxides)
	15

	 	***
	 	***
	 	RU 96-0606-1
	 	US np
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Monomers derived from hydroxy acids and polymers
prepared therefrom
	16

	 	***
	 	***
	 	97-0037 (USA)
	 	New
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Biodegradable, anionic polymers derived from the

amino acid L-tyrosine
	17

	 	***
	 	***
	 	03-075 (USA)
	 	DIV
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Radio-opaque polymer biomaterials
	18

	 	***
	 	***
	 	04-127 (US)
	 	CONT
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Radio-opaque polymer biomaterials (device claims)
	19

	 	***
	 	***
	 	03-075
	 	CONT
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Radio-opaque polymeric medical devices
	20

	 	***
	 	***
	 	98-0012A
	 	US np
	 	Issued
	 	***
	 	***
	 	***
	 	***
	 	RSU
	 	***
	% 	RSU
	 	Radio-opaque polymer biomaterials
	21

	 	***
	 	***
	 	04-165 (USA)
	 	New
	 	Pending
	 	***
	 	***
	 	***
	 	 	 	Joint
	 	***
	% 	RSU
	 	Inherently radiopaque polymeric products for

embolotherapy
	22

	 	***
	 	***
	 	RU 03-175

or 05-125
	 	New
	 	Pending
	 	***
	 	***
	 	***
	 	 	 	Joint
	 	***
	% 	RSU
	 	Radiopaque polymeric stents

 

 

     

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Fox	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	% REVA	 	 	 	 
	 	 	 	 	(70439, 74584)	 	 	 	 	 	 	 	Patent	 	Patent	 	Patent No. or	 	Patent	 	 	 	Patent Cost	 	Patent	 	 
	#	 	Fox short #	 	or CRBCP	 	RSU#	 	Type	 	Status	 	Application #	 	Filing Date	 	Publication No.	 	Expiry Date	 	Inventors	 	Sept.09	 	Assignee	 	Patent Title
	23

	 	***
	 	***
	 	04-118 (US)
	 	CONT
	 	Pending
	 	***
	 	***
	 	 	***	 	 	 	 	RSU
	 	***
	%  	RSU
	 	Radio-opaque polymer biomaterials
	24

	 	***
	 	***
	 	RU 08-025
	 	New
	 	Pending
	 	***
	 	***
	 	 	***	 	 	 	 	Joint
	 	***
	%  	RSU
	 	N-Methyl Substituted Amine (N-Substituted Monomers
and Polymers)
	25

	 	***
	 	***
	 	TBD
	 	prov
	 	Pending
	 	***
	 	***
	 	 	.	 	 	 	 	Rutgers
	 	***
	%  	Pending
	 	Imine Monomers And Polymers Thereof 
(Polyimide
Carbonates)
	26

	 	***
	 	***
	 	98-0012
	 	CONT
	 	Pending
	 	***
	 	***
	 	 	***	 	 	 	 	RSU
	 	***
	%  	RSU
	 	Radio-opaque polymer biomaterials
	27

	 	***
	 	***
	 	RU 08-037
	 	PCT (US designated)
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Rutgers
	 	***
	%  	Pending
	 	Bioresorbable Polymers Synthesized From Monomer

Analogs Of Natural Metabolites 
(based on Fox-201 provisional 61/097,494)
	28

	 	***
	 	***
	 	97-0037
	 	CONT of 6,120,491
	 	Pending
	 	***
	 	***
	 	 	***	 	 	 	 	RSU
	 	***
	%  	RSU
	 	Biodegradable, Anionic Polymers Derived From the

Amino Acid L-tyrosine
	29

	 	N/A
	 	N/A
	 	RU08-037
	 	Technology

Know-How
	 	Unfiled
	 	N/A
	 	N/A
	 	 	N/A	 	 	N/A
	 	RSU
	 	N/A
	 	RSU
	 	Tech Transfer on 01/15/2008: New Amino Acid Monomer
(i.e., tetra-iodinated monomers)

Designation: The following patents are subject to the license terms of Article 1.8(ii).

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Fox	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	(70439, 74584)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	% REVA	 	 	 	 
	 	 	 	 	or CRBCP	 	 	 	 	 	 	 	Patent	 	Patent	 	Patent No. or	 	Patent	 	 	 	Patent Cost	 	Patent	 	 
	#	 	Fox short #	 	or KMOB	 	RSU#	 	Type	 	Status	 	Application #	 	Filing Date	 	Publication No.	 	Expiry Date	 	Inventors	 	Sept.09	 	Assignee	 	Patent Title
	1

	 	N/A
	 	***
	 	REVA case
	 	New
	 	Issued
	 	***
	 	***
	 	 	***	 	 	***
	 	REVA
	 	***
	%  	REVA
	 	Inherently Radiopaque Bioresorbable Polymers For

Multiple Uses
	2

	 	N/A
	 	***
	 	REVA case
	 	New
	 	Pending
	 	***
	 	***
	 	 	***	 	 	 	 	REVA
	 	***
	%  	REVA
	 	N-Substituted Monomers and Polymers (Alkylated
Other)
	3

	 	***
	 	***
	 	TBD
	 	US
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Inherently Radio-Opaque Polymers For Medical
Devices (IRPLP’s)
(based on Fox-212 provisional 61/104,724)
	4

	 	***
	 	***
	 	TBD
	 	PCT
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Inherently Radio-Opaque Polymers For Medical
Devices (IRPLP’s)
(based on Fox-212 provisional 61/104,724)
	5

	 	***
	 	***
	 	TBD
	 	US
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Phase-Separated Biocompatible Polymer Compositions

For Medical Uses (FTTPs) 
(based on Fox-295 provisional 61/104,728)
	6

	 	***
	 	***
	 	TBD
	 	PCT
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Phase-Separated Biocompatible Polymer Compositions

For Medical Uses (FTTPs)

(based on Fox-295 provisional 61/104,728)
	7

	 	***
	 	***
	 	TBD
	 	prov
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Tyrosine-Derived Biocompatible Polymers for
 Medical
Devices (Flexi-Ty)
	8

	 	***
	 	***
	 	TBD
	 	prov
	 	Pending
	 	***
	 	***
	 	 	 	 	 	 	 	Joint
	 	***
	%  	Pending
	 	Compliant Biocompatible Polymer Compositions for
Medical Uses (Carbonate Monomers , Broader version
of Flexi-DAT (PolyT-T))

 

 

     

Legend: Fox: Fox Rothschild LLP; CRBCP: Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd.; KMOB: Knobbe, Martens, Olson & Bear, LLP.; RSU: Rutgers, The State University of New Jersey; Integra LS: ; N/A: Not Applicable; Inventors (RSU = Rutgers Inventors; REVA = Licensee
Inventors, Joint = Rutgers and Licensee Inventors); % REVA Patent Costs refers to current share of patent costs as Rutgers has other licensees for the same patents but different licensed fields or claims.

Designation: The following patents are subject to the license terms of Article 1.8(ii).

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Fox	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	(70439, 74584)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	% REVA	 	 	 	 
	 	 	 	 	or CRBCP	 	 	 	 	 	 	 	Patent	 	Patent	 	Patent No. or	 	Patent	 	 	 	Patent Cost	 	Patent	 	 
	#	 	Fox short #	 	or KMOB	 	RSU#	 	Type	 	Status	 	Application #	 	Filing Date	 	Publication No.	 	Expiry Date	 	Inventors	 	Sept.09	 	Assignee	 	Patent Title
	9

	 	***
	 	***
	 	TBD
	 	 	 	Develop PR
	 	Not yet filed
	 	 	 	 	 	 	 	 	 	Joint
	 	***
	%  	TBD
	 	Iodinated Benzyl Esters
	10

	 	***
	 	***
	 	TBD
	 	 	 	Unfiled
	 	Not yet filed
	 	 	 	 	 	 	 	 	 	Joint
	 	***
	%  	TBD
	 	N-Alkyl Supermonomers
	11

	 	 	 	Unassigned
	 	TBD
	 	 	 	Unfiled
	 	Not yet filed
	 	 	 	 	 	 	 	 	 	Joint
	 	***
	%  	TBD
	 	Fracture Toughened PL Carbonates (FTPLPs)

TBD: to Be Determined

	 	 	 	 	 	 	 	 	 

	REVA Medical, Inc.	 	Rutgers, The State University of New Jersey,	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Office of Technology Commercialization	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	By

	 	/s/ Robert Shultz
 

	 	By
	 	/s/ Yair Harel
 

	 	 
	 	 	(Signature)	 	 	 	(Signature)	 	 
	 
	 	 	 	 	 	 	 	 
	Robert Schultz, President & COO	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	7-25-10	 	7/23/10	 	 
	 	 	 	 	 
	(Date)	 	(Date)	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Exhibit A Version  1 (Original)exv10w12

EXHIBIT 10.12

ROYALTY AND LICENSE AGREEMENT

     This License Agreement (this “AGREEMENT”) is entered into and effective upon the date of last
signature herein (the “EFFECTIVE DATE”), by and between Integral LifeSciences Corporation, a
corporation organized under the laws of the State of Delaware, having a business office at 105
Morgan Lane, Plainsboro, New Jersey 08536 (hereinafter referred to as “INTEGRA”), and REVA Medical,
Inc., a corporation duly organized and existing under the laws of California, having its principal
office at 5751 Copley Drive, Suite B, San Diego, CA 92111 (hereinafter referred to as “REVA”).

WITNESSETH

     WHEREAS, concurrently with this AGREEMENT, INTEGRA and Rutgers, The State University of New
Jersey, having its statewide Office of Corporate Liaison and Technology Transfer at ASB Annex III,
3 Rutgers Plaza, New Brunswick, New Jersey 08901-8559 (“RUTGERS”) shall execute a certain License
Termination Agreement (“LICENSE TERMINATION AGREEMENT”), an executed copy of which is attached
hereto as Appendix A, terminating the Exclusive License Agreement between INTEGRA and RUTGERS dated
January 13, 1995. Pursuant to the LICENSE TERMINATION AGREEMENT certain inventions, technology,
and intellectual property thereunder, revert or are assigned to RUTGERS.

     WHEREAS, REVA desires that INTEGRA enter into the LICENSE TERMINATION AGREEMENT; and

     WHEREAS, INTEGRA has made certain inventions with regard to the manufacturing and production
of certain polycarbonates as more specifically set forth in Appendix B (to the extent that such
inventions have not reverted or been assigned to RUTGERS pursuant to the LICENSE TERMINATION
AGREEMENT, the “INTEGRA TECHNOLOGY”);

     WHEREAS, INTEGRA is the owner of certain “INTELLECTUAL PROPERTY” (as defined herein below)
arising out of or under the INTEGRA TECHNOLOGY and has the right to grant licenses under and to
such INTELLECTUAL PROPERTY;

     WHEREAS, REVA desire to license rights from INTEGRA with regard to the INTEGRA TECHNOLOGY and
the INTELLECTUAL PROPERTY thereunder, for certain royalty payments set forth herein;

     NOW THEREFORE, in consideration of the mutual promises and covenants set forth herein and for
good and valuable consideration, the adequacy and sufficiency of which is hereby acknowledged, the
parties hereby agree as follows:

ARTICLE I — DEFINITIONS

     All definitions below or elsewhere in this AGREEMENT apply to both their singular and plural
forms, as the context may require. “H/herein,” “hereunder,” and “hereof” and other similar
expressions refer to this AGREEMENT. “Article(s)” and “Section(s)” refer to a

 

 

section(s) in this AGREEMENT. “I/including” means “including without limitation.” “D/day(s)”
means “calendar day(s),” unless otherwise stated.

     1.1 “CONFIDENTIAL INFORMATION” means the proprietary or confidential information of a party
(each, a “DISCLOSER”) which is disclosed to the other party (each, a “RECIPIENT”) before or after
the EFFECTIVE DATE and (i) is identified as “confidential” by DISCLOSER in writing prior to
disclosure and (ii) relates to products, plans, designs, costs, prices, finances, marketing plans,
business opportunities, personnel, research, development, know-how, trade secrets, inventions,
blueprints, techniques, chemical or biological materials, drugs, devices, specimens, apparatus,
processes, algorithms, software programs, schematics, designs, contracts, customer lists,
procedures, formulae, patent applications and other information relating to DISCLOSER’s business,
services, processes or technology. CONFIDENTIAL INFORMATION shall not include information that:
(i) was known by RECIPIENT, or was publicly available, prior to disclosure by DISCLOSER to
RECIPIENT; (ii) become publicly available after disclosure by DISCLOSER to RECIPIENT through no act
of RECIPIENT; (iii) is hereafter rightfully furnished to RECIPIENT by a third party without
confidentiality restriction; or (iv) is disclosed with the prior written consent of DISCLOSER or as
expressly authorized under this AGREEMENT.

     1.2 “FIELD” shall mean the field of or related to products for blood vessels.

     1.3 “FIRST GENERATION MATERIAL” shall mean the family of desaminotyrosyl-L-tyrosine derived
polycarbonates which include poly(DTE-carbonate), poly(DTB-carbonate), poly(DTH-carbonate),
poly(DTO-carbonate) and poly(X%DTR-co-Y%DT-carbonate)s and tyrosine derived polycarbonates
containing the chain-terminating groups derived from acetic anhydride or the ethyl, butyl, hexyl,
or octyl esters of L-tyrosine or desamino tyrosine. FIRST GENERATION MATERIAL are further
described in subsections (a) and (d) of the definition of “POLYCARBONATES,” as set forth in
Appendix C.

     1.4 “INTELLECTUAL PROPERTY” means the PATENT RIGHTS and the TECHNICAL INFORMATION AND RIGHTS.

     1.5 “LICENSED PRODUCT” shall mean (i) any product or part thereof in the FIELD which is
covered in whole or claimed in at least one unexpired claim of PATENT RIGHTS or RUTGERS PATENT
RIGHTS in the country in which any such product or part thereof is made, used, or sold by LICENSEE
or its sublicensees; and (ii) any product made by any process which is covered in whole or claimed
in at least one unexpired claim of PATENT RIGHTS or RUTGERS PATENT RIGHTS in the country in which
any such process is used to make such product or part thereof by REVA.

     1.6 “PATENT RIGHTS” shall mean all of the following patent applications and patents, but only
to the extent that such have not reverted or been assigned to RUTGERS pursuant to the LICENSE
TERMINATION AGREEMENT, including, without limitation:

          (a) US Pat # 6,359,102, issued on March 19, 2002, entitled, “Biphasic polymerization process,”
EP0991693A1, issued on April 12, 2000, entitled, “Biphasic

2

 

polymerization process,” EP0991693B1, issued on September 3, 2003, entitled, “Biphasic
polymerization process,” and US Pat # 6620356, issued on September 16, 2003, entitled, “Porous
constructs fabricated by gas induced phase inversion,” together with all pending and issued foreign
counterparts of such application; and all pending and issued renewals, continuations,
continuations-in-part, divisions, patents of addition, reexaminations and/or reissues of such
application or foreign counterparts;

          (b) United States Patent Application 10/350,202 and any other pending, issued or hereafter
filed, U.S. or foreign patents applications owned by INTEGRA covering the INTEGRA TECHNOLOGY; and

          (c) Any United States or foreign patent application or patent that claims a right of priority
from any of the patents or patent applications in Section 1.6 (a) or (b).

     1.7 “RUTGERS PATENT RIGHTS” shall: (i) have the meaning set forth in the LICENSE TERMINATION
AGREEMENT for the term “Rutgers’ Patent Rights” and shall also include any additional patents,
patent applications, all pending and issued foreign counterparts of such applications; and all
pending and issued renewals, continuations, continuations-in-part, divisions, patent of addition,
reexaminations and/or reissues of such applications or foreign counterparts, to which rights have
reverted from, or been assigned by, INTEGRA to RUTGERS pursuant to the LICENSE TERMINATION
AGREEMENT; and (ii) include the U.S. Patent Application Numbers and provisional patents listed on
Appendix C and patents issuing thereon, the U.S. Patent Number(s) listed on Appendix C, and shall
also include any additional patents, patent applications, all pending and issued foreign
counterparts of such applications; and all pending and issued renewals, continuations,
continuations-in-part, divisions, patent of addition, reexaminations and/or reissues of such
applications or foreign counterparts.

     1.8 “SECOND GENERATION MATERIAL” shall mean FIRST GENERATION MATERIAL that are radiopaque
(using iodine and/or bromine) and/or PEGylated and are further described in subsections (a) and (d)
of the definition of “POLYCARBONATES,” as set forth in Appendix C.

     1.9 “TECHNICAL INFORMATION AND RIGHTS” shall mean copyrights, moral rights, data rights,
business processes, trade secrets, all technical information, know-how, formulations,
specifications, processes, techniques and data, and any other proprietary right arising or
enforceable under the laws of the United States, any other country, or any bilateral or
multilateral treaty that arises from a laboratory of INTEGRA or exists at the time of this
AGREEMENT which are not readily available to others through public means, (i) other than the PATENT
RIGHTS, and (ii) only to the extent that such information and/or rights have not reverted or been
assigned to RUTGERS pursuant to the LICENSE TERMINATION AGREEMENT.

     1.10 “TERRITORY” shall mean the entire world.

ARTICLE II  — THE LICENSE

     2.1 Subject to the terms and conditions of this AGREEMENT, INTEGRA hereby grants to REVA and
REVA hereby accepts from INTEGRA an exclusive right in the

3

 

TERRITORY in the FIELD, with right to sublicense as set forth in Section 2.2, (a) to the
INTELLECTUAL PROPERTY and (b) to make, have made, modify, distribute, lease, import, use, offer to
sell, have sold and otherwise dispose of LICENSED PRODUCTS and (c) to use, have used, perform and
have performed processes under the INTELLECTUAL PROPERTY.

     2.2 REVA shall have the exclusive right, at its sole discretion, to sublicense any of the
rights, privileges and licenses granted hereunder during the term of this AGREEMENT.

     2.3 All sublicenses granted by REVA of its rights hereunder shall be subject to terms
substantially similar to this AGREEMENT and if a sublicense allows sublicensee to sell the LICENSED
PRODUCTS, such sublicense shall provide for the payment of running royalties for the sale of such
LICENSED PRODUCTS hereunder at amounts equal to the amount specified for payments by REVA to
INTEGRA in Section 5.2 hereof. REVA agrees to forward to INTEGRA a copy of reports received by
REVA from its sublicensees under the sublicenses as shall be pertinent to a royalty accounting
regarding the sale of LICENSED PRODUCTS, if any, under sublicense agreements.

     2.4 The parties recognize and acknowledge that REVA’s reasonable efforts to develop and market
the LICENSED PRODUCTS may not result in the commercialization of the LICENSED PRODUCTS or profits
from such commercialization.

ARTICLE III - LICENSE RESTRICTIONS AND ENFORCEMENT

     3.1 No license or other right is granted, by either party to the other, by implication,
estoppel or otherwise, under any intellectual property now or hereafter owned or controlled by such
party except for the licenses and rights expressly granted in this AGREEMENT.

     3.2 At any time or from time to time on and after the EFFECTIVE DATE, each party shall, at the
request of the other party, (i) deliver to the requesting party such records, data or other
documents consistent with this AGREEMENT; (ii) execute, and deliver or cause to be delivered, all
such assignments or further instruments of transfer or license, and (iii) take or cause to be taken
all such other actions, as the requesting party may reasonably deem necessary or desirable in order
for the requesting party to obtain the full benefits of this AGREEMENT and the transactions
contemplated hereby.

ARTICLE IV - OWNERSHIP

     4.1 REVA shall retain all rights, title and interests in and to of all REVA’s intellectual
property, and any and all other tangible forms thereof.

     4.2 Except for the license grants set forth in Article II, INTEGRA shall retain all rights,
title and interests in and to all of INTEGRA’S INTELLECTUAL PROPERTY.

ARTICLE V - PAYMENTS

     5.1 In consideration of the license grants and for executing the LICENSE TERMINATION
AGREEMENT, among other good and valuable consideration, REVA shall

4

 

pay INTEGRA a royalty of: (i) *** U.S. Dollars ($***) per unit in the
United States and Japanese markets, and *** U.S. Dollars ($***) per unit in all other
territories, only on coronary stents made from FIRST GENERATION MATERIALS sold by REVA or a
sublicensee of REVA, as appropriate (but in no instances both REVA and sublicensee of REVA so to
create a “double royalty” for INTEGRA); and (ii) *** U.S. Dollars and *** Cents ($***) per unit
only on coronary stents made from SECOND GENERATION MATERIALS sold by REVA or a sublicensee of
REVA, as appropriate (but in no instances both REVA and sublicensee of REVA so to create a “double
royalty” for INTEGRA). Such royalties shall be payable as provided in Section 5.3.

     5.2 Payment of the royalties specified in Section 5.1, if any such royalty is due, for the
preceding calendar quarter shall be made by REVA to INTEGRA within thirty (30) days after March 31,
June 30, September 30 and December 31 of each year during the term of this AGREEMENT. After
termination or expiration of this AGREEMENT, a final payment shall be made by REVA covering the
last whole or partial calendar quarter. Each quarterly payment shall be accompanied by a written
statement of royalties due, as described in Section 6.2 hereunder.

     5.3 All monetary payments due hereunder are expressed in and shall be paid by check payable in
United States dollars, without deduction of exchange, collection or other charges, to INTEGRA.

     5.4 For converting into United States dollars any monetary payment accrued hereunder in the
currency of any other country, the rate of exchange for the purchase of United States dollars with
such currency quoted by The Chase Manhattan Bank, New York, New York, on the last business day of
the payment period in question shall be used.

     5.5 No multiple royalties shall be payable because any LICENSED PRODUCTS, their manufacture,
use, lease or sale are or shall be covered by more than one patent application, patent or
certificate of registration licensed under this AGREEMENT. For avoidance of doubt, REVA has no
obligations under this AGREEMENT to make any royalty, milestone or maintenance payments to INTEGRA,
except as explicitly set forth in Section 5.1.

ARTICLE VI - REPORTS AND RECORDS

     6.1 REVA shall keep and preserve, in accordance with generally accepted accounting principles
and procedures, complete and accurate books, records and accounts containing particulars that are
necessary for the purpose of showing the amounts payable to INTEGRA hereunder. Said books, records
and accounts shall be kept at REVA’s principle place of business or the principle place of business
of the appropriate division of REVA to which this AGREEMENT relates. No more than once per annum
said books and supporting data shall be open, upon reasonable notice at all reasonable times and
places during business hours for two (2) years following the end of the calendar year to which they
pertain, to the inspection of an independent auditor engaged at INTEGRA’S cost (that has signed a
confidentiality agreement at least as protective of REVA’s CONFIDENTIAL INFORMATION as Article XII)
mutually

 

			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment filed separately with the
Commission.

5

 

agreeable to the parties for the purpose of verifying REVA’s royalty statement or compliance
in other respects with this AGREEMENT.

     6.2 REVA shall, within thirty (30) days after March, 31, June 30, September 30 and December
31, of each year, deliver to INTEGRA true and accurate reports, giving such particulars of the
business conducted by REVA and its sublicensees during the preceding calendar quarter under this
AGREEMENT as shall be pertinent to a royalty accounting hereunder. These reports shall be duly
signed by an authorized signatory of REVA on behalf of REVA and shall include at least the
following:

          (a) number of LICENSED PRODUCTS which are coronary stents made from FIRST GENERATION MATERIALS
and the number of LICENSED PRODUCTS which are coronary stents made from SECOND GENERATION MATERIALS
manufactured and sold by REVA and its sublicensees;

          (b) total royalties due; and

          (c) names and addresses of all sublicensees of REVA.

     6.3 With each such report submitted, REVA shall pay to INTEGRA the royalties due and payable
under this AGREEMENT. If no royalties are due, REVA shall so report.

     6.4 REVA shall use the royalty reporting sheet attached hereto as Appendix D, or a substantial
equivalent, to fulfill the royalty and reporting requirements of this Article VI.

ARTICLE VII - PATENT PROSECUTION AND MAINTENANCE

     7.1 Responsibility for Patent Prosecution. Within thirty (30) days after the
EFFECTIVE DATE, INTEGRA shall deliver to REVA all relevant United States or foreign filings for any
PATENT RIGHTS which were filed on any date prior to thirty (30) days after the EFFECTIVE DATE.
Subject to this Article VII, REVA shall file, prosecute, and maintain the PATENT RIGHTS during the
term of this AGREEMENT. REVA shall keep INTEGRA advised of the continuing prosecution of the
PATENT RIGHTS. REVA shall provide INTEGRA with a copy of each relevant proposed United States and
foreign filing for the PATENT RIGHTS at least fifteen (15) days prior to the date of such filing so
that INTEGRA may be informed of the continuing prosecution and have an opportunity to review and
comment on such filings and upon the breadth and scope of the related patent applications of the
PATENT RIGHTS.

     7.2 Payments for Patent Filings. Payment of all fees and costs relating to the
filing, prosecution, maintenance and defense of PATENT RIGHTS shall be borne by REVA. In the event
INTEGRA has entered, or enters, into licenses with third parties outside the FIELD, INTEGRA shall
require said parties to pay a pro-rata share of said prior expenses to REVA.

     7.3 Abandonment by REVA. If REVA decides not to continue payment for prosecution of a
United States or foreign patent application to issuance or grant, or decides not to continue
payment for maintenance of any United States or foreign patent application or patent within the
PATENT RIGHTS, then (a) REVA shall timely notify INTEGRA in writing in order that INTEGRA may
continue said prosecution or maintenance of such intellectual property at

6

 

INTEGRA’S own expense, and (b) from and after the date of the written notice under (a), REVA
shall have no further obligation to pay any fees or costs relating to the filing, prosecution, or
maintenance of such patent application or patent of the PATENT RIGHTS, and REVA’s license with
regard to such patent application or patent shall cease become non-exclusive (but only for the
applicable country or countries in which REVA has decided not to continue prosecution or not to
maintain such patent application or patent of the PATENT RIGHTS).

ARTICLE VIII - INFRINGEMENT AND OTHER ACTIONS

     8.1 Notice. Each of the parties, as a notifying party, shall promptly provide to the
other party (a) written notice of any alleged infringement by a third party of any patent licensed
hereunder under PATENT RIGHTS, and (b) any available evidence of any infringement referenced in (a)
that is in such notifying party’s possession or control.

     8.2 Infringement. REVA, at its expense, may enforce the PATENT RIGHTS licensed
hereunder against infringement by third parties and is entitled to retain recovery from such
enforcement. INTEGRA hereby agrees that REVA may join INTEGRA as a party in any such action (with
INTEGRA having the right to participate in such action and to be represented, if it so desires and
at its own expense, by counsel of its own selection) and to give REVA reasonable assistance and any
needed authority to control, file and prosecute such action, without expense to INTEGRA. REVA
agrees to keep INTEGRA reasonably informed as to the status of any such action and to provide
copies to INTEGRA, upon request by INTEGRA, of any papers or information relevant to the
prosecution of any such action. REVA shall timely inform INTEGRA of any offer for settlement
presented by a third party for any such action and REVA shall consider INTEGRA’S input in deciding
whether or not to accept any such settlement offer. The total cost of any such action, commenced
or defended solely by REVA, shall be borne by REVA. After reimbursement of REVA’s reasonable legal
costs and expenses related to such recovery, REVA agrees to pay INTEGRA the royalty detailed in
Section 5.1 for any monetary recovery that is for sales of coronary stents which are LICENSED
PRODUCTS lost due to the infringement and a pro-rata portion of any related punitive or
consequential damages awarded REVA.

     8.3 Right to Withhold. If REVA undertakes to prosecute and/or defend any action
alleging infringement of, and/or any action challenging the validity of, any of the PATENT RIGHTS,
as provided in Section 8.2, REVA may withhold up to fifty percent (50%) of the payments otherwise
thereafter due INTEGRA under Article V hereunder and apply the same toward reimbursement of up to
one-half (1/2) of REVA’s expenses, including attorneys’ fees, in connection therewith.

     8.4 Cooperation. In any action brought by REVA under this Article VIII, INTEGRA
shall, at the request and expense of REVA, cooperate in all respects and, to the extent possible,
have its employees testify when requested and make available relevant records, papers, information,
samples and specimens.

     8.5 Licenses to Abate Third Party Infringement. REVA shall have the sole right in
accordance with the terms and conditions herein to sublicense any alleged infringer for the

7

 

FIELD to the INTELLECTUAL PROPERTY of no greater scope than set forth in Section 2.1. Any
royalties as part of such a sublicense shall be treated per Article V.

     8.6 Licenses to Abate Own Infringement. If a third party asserts that a patent or
other right owned by it is infringed by the manufacture, import, use, sale or offer for sale of any
LICENSED PRODUCT, the party first obtaining knowledge of such a claim shall immediately provide the
other party notice of such claim and the related facts in reasonable detail. Notwithstanding any
provision in this AGREEMENT to the contrary, except subject to the indemnification provisions of
Article XI, the defense of any such claim (including without limitation the institution and
prosecution of any counterclaims thereto) shall be controlled by REVA, and REVA shall have the
right to enter into settlements, stipulated judgments or other voluntary, final disposition
respecting such claim (and related counterclaims). If REVA should be of the reasonable opinion
that it cannot commercially reasonably make, use, sell, offer for sale, or import any of the
LICENSED PRODUCTS because the INTELLECTUAL PROPERTY or RUTGERS PATENT RIGHTS (or such other
intellectual property right licensed by REVA from RUTGERS) infringe a third party patent or other
intellectual property right, REVA shall obtain the consent from INTEGRA, which shall not be
unreasonably withheld, conditioned or delayed, if such party is willing to grant such license, to
credit fifty percent (50%) of any payment payable to the above-mentioned third party for such a
license against the amounts payable to INTEGRA hereunder on a going-forward basis, but in no event
will INTEGRA’S total payments received hereunder each calendar year be reduced by more than fifty
percent (50%). INTEGRA’S consent hereunder shall only be withheld on the basis of a bona fide
independent legal opinion that no such infringement exists. INTEGRA shall be required to provide
or withhold its consent within twenty (20) days of the date of such notice. No response from
INTEGRA within twenty (20) days shall be deemed to be consent.

 ARTICLE IX — REPRESENTATIONS AND WARRANTIES

     9.1 INTEGRA hereby represents and warrants as follows:

          (a) INTEGRA has full power and authority to enter into and perform this AGREEMENT;

          (b) Neither INTEGRA’S entering nor performing this AGREEMENT will violate any contractual
right of or breach any contractual obligation to any third party under any agreement or arrangement
between INTEGRA and such third party;

          (c) INTEGRA has received and currently holds valid and effective assignments of all inventors’
rights in and to the INTEGRA TECHNOLOGY and the INTELLECTUAL PROPERTY, and no other person may
claim rights to the INTEGRA TECHNOLOGY or the INTELLECTUAL PROPERTY;

          (d) There are no outstanding liens, encumbrances, third party rights, agreements or
understandings of any kind, either written, oral or implied, other than the LICENSE. TERMINATION
AGREEMENT, regarding the INTEGRA TECHNOLOGY or the INTELLECTUAL PROPERTY which are inconsistent or
in conflict with any provision of this AGREEMENT;

8

 

          (e) INTEGRA is the owner of, and has not, other than as set forth in the LICENSE TERMINATION
AGREEMENT, assigned any of its rights, title or interests in or to, and is not aware that any other
person or entity has assigned or licensed, or agreed to grant an assignment or license to any third
party any rights, title or interests in or to, the INTEGRA TECHNOLOGY or the INTELLECTUAL PROPERTY;

          (f) INTEGRA shall not assert against REVA and its sublicensees any of INTEGRA’S rights under
any intellectual property of any kind owned or licensed by INTEGRA for any activities by REVA or
its sublicensees related to the discovery, research, development, manufacture or commercialization
of LICENSED PRODUCTS or of any other products sold by REVA or its sublicensees in the FIELD;

          (g) INTEGRA has not received any notice of any potential or threatened claim of infringement
of third party patents and, (i) INTEGRA, is not aware of any facts which could give rise to any
claim of infringement of third party intellectual property relating to the use and practice of the
INTELLECTUAL PROPERTY or the INTEGRA TECHNOLOGY; and (ii) INTEGRA is not aware of any issued or
granted patent that would be infringed by the practice of the INTELLECTUAL PROPERTY as permitted
under the license rights granted in this AGREEMENT;

          (h) There are no court orders, judgments or decrees that impair or restrict the use, validity
or enforceability of the INTELLECTUAL PROPERTY and no action, suit, inquiry, proceeding or
investigation is currently pending before any court, administrative agency or other governmental
body in which such use, validity or enforceability is being challenged or questioned in any way,
either directly or indirectly, by way of claim, counterclaim or affirmative defense, it being
clearly acknowledged by REVA that such representation and warranty does not apply to any
proceedings before any patent office with respect to the prosecution and issuance of any patent;

          (i) To INTEGRA’S knowledge there is no actual infringement by any third party in the FIELD of
the licensed INTELLECTUAL PROPERTY; and

          (j) To INTEGRA’S knowledge, there are no publications, public uses or public sales or offers
for sale to any party other than REVA which would render any of the PATENT RIGHTS invalid.

     9.2 REVA hereby represents and warrants as follows:

          (a) REVA has full power and authority to enter into and perform this AGREEMENT; and

          (b) Neither REVA’s entering nor performing this AGREEMENT will violate any contractual right
of or breach any contractual obligation to any third party under any agreement or arrangement
between REVA and such third party.

     9.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, INTEGRA AND REVA AND THEIR
TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO

9

 

WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS CLAMS, ISSUED OR
PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.

ARTICLE X - LIMITATION OF LIABILITY

     10.1 EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS WITH REGARD TO INTELLECTUAL PROPERTY
INFRINGEMENT SET FORTH IN ARTICLE XI, OR A BREACH OF ARTICLE XII, CONFIDENTIAL INFORMATION, OR
ARTICLE XVIII, TERMINATION, TO THE MAXIMUM EXTENT PERMITTED BY LAW,

          (a) NEITHER PARTY WILL BE LIABLE FOR ANY DAMAGES WITH RESPECT TO ANY CLAIMS ARISING FROM OR
RELATING TO THIS AGREEMENT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT PRODUCT
LIABILITY OR ANY OTHER THEORY OF LIABILITY, FOR LOST PROFIT, OR OTHER SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF ANY CHARACTER, INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF
GOODWILL, WORK STOPPAGE, COMPUTER FAILURE OR MALFUNCTION, LOSS OF DATA, OR OTHER COMMERCIAL DAMAGES
OR LOSSES, EVEN IF THAT PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

          (b) NEITHER PARTY WILL BE LIABLE FOR ANY DAMAGES WITH RESPECT TO ANY CLAIMS ARISING FROM OR
RELATING TO THIS AGREEMENT, WHETHER IN CONTRACT (OTHER THAN FOR PAYMENT OF ROYALTIES), TORT
(INCLUDING NEGLIGENCE), STRICT PRODUCT LIABILITY OR ANY OTHER THEORY OF LIABILITY, THAT EXCEED THE
SUM OF THE AMOUNTS PAID BY REVA TO INTEGRA AND THE AMOUNTS OUTSTANDING OWED BY REVA TO INTEGRA
HEREUNDER PRIOR TO THE DATE OF THE EVENT GIVING RISE TO SUCH LIABILITY. THIS LIMITATION SHALL
APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.

ARTICLE XI - INDEMNIFICATION

     11.1 INTEGRA’S Indemnification. INTEGRA shall at all times during the term of this
AGREEMENT and thereafter, indemnify, defend and hold REVA, its trustees, directors, officers,
employees and affiliates (“REVA’s INDEMNITEES”), harmless against all third party claims,
proceedings, demands and liabilities of any kind whatsoever, including legal expenses and
reasonable attorneys’ fees, arising out of what is judicially determined to be a breach of any
representation or warranty as set forth in Section 9.1, and to pay all damages and costs awarded
against REVA or that arise out of settlement provided that REVA’s INDEMNITEES: (a) promptly notify
INTEGRA in writing of any such suit or proceeding, (b) provides INTEGRA with sole control over the
defense or settlement of such suit or proceeding, and (c) provide reasonable information and
assistance in the defense and/or settlement of any such claim or action. Notwithstanding the
foregoing, INTEGRA’S indemnification obligation with respect to claims arising from or relating to
breaches of representations or warranties that do not relate to INTEGRA’S infringement of a third
party’s intellectual property rights shall (x) exclude

10

 

damages of the type described in Section 10.1(a), and (y) be limited in amount to the sum of
the amounts paid or owed by REVA to INTEGRA hereunder. REVA will have the right to approve any
settlement or compromise that may adversely affect its rights. In the event that REVA disapproves
such settlement and compromise, REVA shall compensate INTEGRA for any additional damages,
liabilities, costs and expenses incurred by INTEGRA resulting from such disapproval.

     11.2 REVA’s Indemnification. REVA shall at all times during the term of this
AGREEMENT and thereafter, indemnify, defend and hold University and INTEGRA, its trustees,
directors, officers, employees and affiliates (“INTEGRA’s INDEMNITEES”), harmless against all third
party claims, proceedings, demands and liabilities of any kind whatsoever, including legal expenses
and reasonable attorneys’ fees, directly arising out of the death of or injury to any person or
persons or out of any damage to property, or directly resulting from the production, manufacture,
sale, use, lease, consumption or advertisement of the LICENSED PRODUCTS by REVA or sublicensees or
arising from any breach of any contractual obligation of REVA hereunder, and to pay all damages and
costs awarded against INTEGRA or that arise out of settlement provided that INTEGRA’S INDEMNITEES:
(a) promptly notify REVA in writing of any such suit or proceeding, (b) provide REVA with sole
control over the defense or settlement of such suit or proceeding, and (c) provide reasonable
information and assistance in the defense and/or settlement of any such claim or action. INTEGRA
will have the right to approve any settlement or compromise that may adversely affect its rights.
In the event that INTEGRA disapproves such settlement and compromise, INTEGRA shall compensate REVA
for any additional damages, liabilities, costs and expenses incurred by REVA resulting from such
disapproval.

ARTICLE XII - CONFIDENTIALITY

     12.1 Nondisclosure. RECIPIENT shall not, except as otherwise expressly provided
herein, disclose, disseminate or otherwise allow access to the CONFIDENTIAL INFORMATION of
DISCLOSER to anyone other than RECIPIENT’S employees that have a need to know such CONFIDENTIAL
INFORMATION to implement this AGREEMENT and who are bound by written confidentiality obligations
with provisions no less stringent than those contained in this ARTICLE XII. RECIPIENT shall
prevent unauthorized disclosure or use of the CONFIDENTIAL INFORMATION of DISCLOSER. DISCLOSER and
RECIPIENT shall execute any documents and otherwise shall take all necessary steps to ensure that
DISCLOSER and RECIPIENT shall each be able to enforce DISCLOSER’s rights hereunder against
RECIPIENT, its employees and all other third parties to whom RECIPIENT discloses DISCLOSER’s
CONFIDENTIAL INFORMATION, under the laws of each jurisdiction in which DISCLOSER’s CONFIDENTIAL
INFORMATION is disclosed by RECIPIENT. RECIPIENT shall be responsible for any breach of this
ARTICLE XII by RECIPIENT’S employees, contractors or agents.

     12.2 Ownership. Except as set forth in ARTICLE TV, RECIPIENT acknowledges and agrees
that DISCLOSER (or its licensors) owns all rights, title and interests, including intellectual
property rights in and to DISCLOSER’s CONFIDENTIAL INFORMATION.

11

 

     12.3 Notification. If RECIPIENT learns or believes that any person who has had access
to the CONFIDENTIAL INFORMATION of DISCLOSER has violated or intends to violate this AGREEMENT,
RECIPIENT shall immediately notify DISCLOSER and shall cooperate with DISCLOSER in seeking
injunctive or other equitable relief against any such person.

     12.4 Exceptions. RECIPIENT may disclose the CONFIDENTIAL INFORMATION of DISCLOSER, if
such disclosure is required by law, provided that RECIPIENT promptly notifies DISCLOSER to allow
intervention by DISCLOSER (prior to the disclosure), cooperates with DISCLOSER to contest or
minimize the disclosure (including application for a protective order) at DISCLOSER’s expense and
limits such disclosure to the party entitled to receive the CONFIDENTIAL INFORMATION and to the
scope of the legal requirement. Notwithstanding the foregoing, any CONFIDENTIAL INFORMATION
disclosed pursuant to this Section 12.4 shall otherwise continue to be treated as CONFIDENTIAL
INFORMATION hereunder.

     12.5 Confidentiality of AGREEMENT. Neither party will publicly disclose any term of
this AGREEMENT or announce the existence of this AGREEMENT without the prior written consent of the
other party, except that each party may reveal the terms of this AGREEMENT (a) to its accountants,
banks, financing sources, lawyers and other professional advisors, provided that such parties
undertake in writing to keep such information confidential, or (b) as required by applicable laws
and regulations including those of the U.S. Securities and Exchange Commission on the notification.
Each party may also disclose the tax treatment and tax structure of the transactions contemplated
by this AGREEMENT and all materials of any kind (including opinions or other tax analyses) that are
provided to it relating to such tax treatment and tax structure.

     12.6 Reproduction of CONFIDENTIAL INFORMATION. CONFIDENTIAL INFORMATION shall not be
reproduced except as reasonably required to implement this AGREEMENT. Any reproduction or
derivative of any CONFIDENTIAL INFORMATION of DISCLOSER by RECIPIENT shall remain the property of
DISCLOSER and shall contain all confidential or proprietary notices or legends which appear on the
original.

ARTICLE XIII - EXPORT CONTROLS

     13.1 It is understood that INTEGRA is subject to United States laws and regulations
controlling the export of technical data, computer software, laboratory prototypes and other
commodities (including the Arms Export Control Act, as amended and the Export Administration Act of
1979). The transfer of certain technical data and commodities may require a license from the
cognizant agency of the United States Government and/or written assurances by REVA that REVA shall
not export data or commodities to certain foreign countries without prior approval of such agency.
INTEGRA shall assist REVA to comply with the United States export laws and regulations set forth in
this Section 13.1.

ARTICLE XIV - NON-USE OF NAMES

     14.1 REVA shall not use the names or trademarks of INTEGRA, or any of its employees, or any
adaptation thereof, in any advertising, promotional or sales literature without

12

 

prior written consent obtained from INTEGRA, in each case, except that REVA may, without prior
written consent, state that it is licensed by INTEGRA, under one or more of the patents and/or
applications comprising the PATENT RIGHTS.

ARTICLE XV - PAYMENTS. NOTICES AND OTHER COMMUNICATIONS

     15.1 Any payment, notice or other communication pursuant to this AGREEMENT shall be
sufficiently made or given on the date of mailing if sent to such party by certified or registered
first class mail, postage prepaid, addressed to it at its address below or as it shall designate by
written notice given to the other party as follows:

In the case of INTEGRA:

To the Attention of: General Counsel

Integra LifeSciences Corporation

105 Morgan Lane

Plainsboro, New Jersey 08536

In the case of REVA:

To the Attention of: Robert Schultz, President

REVA Medical, Inc.

5751 Copley Drive, Suite B

San Diego, CA 92111

ARTICLE XVI - ASSIGNMENT

     16.1 Neither this AGREEMENT nor any right or obligation hereunder is assignable in whole or in
part by any party without the prior written consent of the other party. Notwithstanding the
foregoing, either party may assign this AGREEMENT, without such consent to a third party in
connection with any merger, acquisition, consolidation, reorganization (in which a change of
control occurs), CHANGE OF CONTROL of or by the assigning party, or sale of all, substantially all
or a majority of such parties’ assets or voting securities. A “CHANGE OF CONTROL” occurs when over
fifty percent (50%) of a party’s then outstanding securities are acquired by a third party. This
AGREEMENT shall inure to the benefit of each of the party’s successors and assignees provided that
such successors or assignees assume the party’s obligations under this AGREEMENT.

ARTICLE XVII - DISPUTE RESOLUTION

     17.1 This AGREEMENT is entered into in and shall be governed, construed and enforced in all
respects solely and exclusively under the laws of the State of California, USA without giving
effect to any law which would result in the application of a different body of law.

     17.2 Any and all claims, disputes or controversies arising under, out of, or in connection
with this AGREEMENT, including any dispute relating to patent validity or

13

 

infringement, which the parties shall be unable to resolve within sixty (60) days, shall be
mediated in good faith. The party raising such dispute shall promptly advise the other party of
such claim, dispute or controversy in a writing which describes in reasonable detail the nature of
such dispute. By not later than five (5) business days after the recipient has received such
notice of dispute, each party shall have selected for itself a representative who shall have the
authority to bind such party, and shall additionally have advised the other party in writing of the
name and title of such representative. By not later than ten (10) business days after the date of
such notice of dispute, the party against whom the dispute shall be raised shall select a mediation
firm in San Diego, California and such representatives shall schedule a date with such firm for a
mediation hearing. The parties shall enter into good faith mediation and shall share the costs
equally.

     17.3 If the representatives of the parties have not been able to resolve a dispute within
fifteen (15) business days after a mediation hearing, as set forth in Section 17.2, the parties
shall have the right to pursue any other remedies legally available to resolve such dispute solely
and exclusively in, and the parties hereby irrevocably consent to the exclusive jurisdiction and
proper venue of, the state and federal courts located in the County of San Diego, State of
California, USA, and waive any objections thereto based on any ground including improper venue or
Forum Non-Conveniens. The parties agree that service of process may be effected in accordance with
Article XV. Any decision rendered by such court shall be binding, final and conclusive upon the
parties, and a judgment thereon may be entered in, and enforced by, any court having jurisdiction
over the party against which an award is entered or the location of such party’s assets.

     17.4 Notwithstanding anything to the contrary herein, each party shall be entitled to seek
injunctive or other equitable relief, wherever such party deems appropriate in any jurisdiction, in
order to preserve or enforce such party’s rights for any breach or threatened breach of the other
party of Articles II, IV or XII. Each party agrees that: (i) Articles II, IV and XII are
necessary and reasonable to protect the other party and its business, (ii) any violation of these
provisions could cause irreparable injury to the other party for which money damages would be
inadequate, and (iii) as a result, the other party will be entitled to seek and obtain injunctive
relief against the breach or threatened breach of the provisions of Articles II, IV or XII without
the necessity of posting bond or proving actual damages. The parties agree that the remedies set
forth in this Section 17.4 are in addition to and in no way preclude any other remedies or actions
that may be available at law or under this AGREEMENT.

ARTICLE XVIII - TERM AND TERMINATION

     18.1 Unless earlier terminated as hereinafter provided, this AGREEMENT shall continue until
the later of the end of the life of the last to expire patent of the PATENT RIGHTS and the end of
the life of the last to expire patent of the RUTGERS PATENT RIGHTS. The term of the license for
TECHNICAL INFORMATION AND RIGHTS set forth in Section 2.1 shall last until the later of the end of
the life of the last to expire patent of the PATENT RIGHTS, the end of the life of the last to
expire patent of the RUTGERS PATENT RIGHTS and fifteen (15) years from the EFFECTIVE DATE.

     18.2 If REVA shall cease to carry on its business, this AGREEMENT shall terminate upon notice
by INTEGRA.

14

 

     18.3 Upon any default by REVA of its obligation to pay INTEGRA the royalties set forth in
ARTICLE V, INTEGRA shall have the right to terminate this AGREEMENT and the rights, privileges and
license granted hereunder effective on three (3) months notice to REVA. Such termination shall
become automatically effective unless REVA shall have cured any such default prior to the
expiration of the three (3) month period.

     18.4 Upon termination or expiration of this AGREEMENT for any reason, nothing herein shall be
construed to release either party from any obligation that matured prior to the effective date of
such termination; and Articles I, IV, VI, IX — XV, XVII and XIX and Section 18.4 shall survive any
such termination by their terms. REVA and any sublicensee thereof may, however, after the
effective date of such termination, sell all LICENSED PRODUCTS, and complete LICENSED PRODUCTS in
the process of manufacture at the time of such termination and sell the same, provided that REVA
shall make the payments to INTEGRA as required by Article V and shall submit the reports required
by Article VI hereof. Except as necessary to carry out the terms of this Section 18.4, upon
termination each party shall immediately return the other party’s CONFIDENTIAL INFORMATION, and any
copies thereof in any form, or certify the destruction of the same.

ARTICLE XIX - MISCELLANEOUS PROVISIONS

     19.1 Entire Agreement. This AGREEMENT, including Appendices A, B, C and D embodies
the sole, final and entire understanding of the parties and shall supersede all previous
communications, representations, or undertakings, either verbal or written, between the parties
relating to the subject matter hereof.

     19.2 Amendment. This AGREEMENT may be amended only by a written agreement embodying
the full terms of the amendment signed by authorized representatives of both parties.

     19.3 Severability. If one or more provisions in this AGREEMENT are ruled entirely or
partly invalid or unenforceable by any court or governmental authority of competent jurisdiction,
then: (i) the validity and enforceability of all provisions not ruled to be invalid or
unenforceable shall remain unaffected; (ii) the effect of such ruling shall be limited to the body
making the ruling; (iii) the provision(s) held wholly or partly invalid or unenforceable shall be
deemed amended, and the parties shall reform the provision(s) to the minimum extent necessary to
render them valid and enforceable in conformity with the parties’ intent as manifested herein; and
(iv) if the ruling, or the controlling principle of law or equity leading to the ruling, is
subsequently overruled, modified, or amended, then the provision(s) in question, as originally set
forth in this AGREEMENT, shall be deemed valid and enforceable to the maximum extent permitted by
the new controlling principle of law or equity.

     19.4 No Strict Construction. The language used in this AGREEMENT shall be deemed to
be the language chosen by both parties hereto to express their mutual intent and no rule of strict
construction against either party shall apply to any term or condition of this AGREEMENT.

15

 

     19.5 Relationship of Parties. The parties are independent contractors. Nothing
contained in this AGREEMENT shall be construed as creating a partnership, joint venture, agency or
an association of any kind.

     19.6 No Waiver. The failure of one party hereto to enforce at any time any of the
provisions of this AGREEMENT, or any rights in respect thereto, or to exercise any election herein
provided, shall in no way be considered to be a waiver of such provision, rights or elections or in
any way to affect the validity of this AGREEMENT, or excuse a similar subsequent failure to perform
any such term or condition by the other party. Any waiver must be in writing.

     19.7 Interpretation. The headings of sections contained herein are inserted for
convenience of reference only, and are not intended to be a part of or to affect the meaning or
interpretation of this AGREEMENT.

     19.8 Counterparts. This AGREEMENT may be executed in two counterparts, each of which
will be deemed an original, but together will constitute one and the same instrument. A party may
deliver this AGREEMENT by transmitting a facsimile of this AGREEMENT signed by such party to the
other party, which facsimile signature shall be deemed an original for all purposes.

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]

16

 

     IN WITNESS WHEREOF, the parties hereto, intending to be legally bound hereby, have each caused
a duly authorized representative to execute this AGREEMENT on the day and year set forth below.

	 	 	 	 	 
	REVA MEDICAL, INC.

(REVA)

 	 
	By:  	/s/ Robert K. Schultz
 	 
	 	Name:Robert K. Schultz
 	 
	 	Title: President
 	 
	 	Date: 1/30/04
 	 

	 	 	 	 	 
	INTEGRA LIFESCIENCES CORPORATION

(INTEGRA)

 	 
	By:  	/s/ Stuart Essig
 	 
	 	Name:Stuart
Essig	 
	 	Title: CEO	 
	 	Date: 1/25/04	 

17

 

Appendix A

LICENSE TERMINATION AGREEMENT

Appendix A - 1

 

AGREEMENT

     This Agreement (the “Agreement”) is made as of the                      day of                     , 2004, by and
between Rutgers, The State University of New Jersey, having its statewide administrative offices at
New Brunswick, New Jersey (hereafter referred to as “Rutgers”), and Integra LifeSciences
Corporation, a corporation organized under the laws of the State of Delaware, having a business
office at 311 Enterprise Drive, Plainsboro, New Jersey 08536 (hereinafter referred to as
“Integra”).

Recitals

     WHEREAS, Rutgers and Integra are parties to an Exclusive License Agreement made effective as
of the 31st day of December, 1994, and amended from time to time thereafter (the Exclusive License
Agreement and amendments hereinafter referred to collectively as the “License Agreement”); and

     WHEREAS, Rutgers and Integra wish to terminate the License Agreement and enter a new and
different contractual relationship;

     NOW, THEREFORE, the parties agree as follows:

     1. Definitions.

          1.1 The defined terms in the License Agreement shall have the same meanings when they are used
in this Agreement.

          1.2 “First Generation Polycarbonates” shall mean Licensed Products in the “Licensed Field,” as
those terms are defined in the License Agreement, covered by the patents or patent applications
identified in Schedule B attached hereto. First Generation Polycarbonates shall not include Second
Generation Polycarbonates.

          1.3 “Integra Process Patents” shall mean United States Patent Numbers 6,120,491, 6,359,102 and
6,620,356 and patents issuing on United States Patent Application Number 10/350,202, together with
all issued foreign counterparts of such patents and patent application, and all issued renewals,
continuations, divisions, patents of addition, reexaminations and/or reissues of such patents or
foreign counterparts.

          1.4 “Second Generation Polycarbonates” shall mean polycarbonates containing sulfur,
phosphorus, chlorine, bromine, boron or iodine atoms or repeat units other than a
desaminotyrosyl-tyrosine alkyl ester and desaminotyrosyl-tyrosine.

          1.5 “Master File” shall mean United States Food and Drug Administration (“FDA”) designated
file MAF-1140 Tyrosine-Derived Polycarbonates, and all amendments and addendums to date, and all
FDA communications of any kind relevant to the same.

          1.6 “End Product” shall mean a product incorporating (i) the First Generation Polycarbonates
in finished product form or (ii) any material whose manufacture would, but for

 

the license granted Rutgers under this Agreement, violate one or more claims of the Integra
Process Patents.

          1.7 “Net Sales” means the total of the gross invoice prices of End Product sold or transferred
by Rutgers, its Affiliates, and its licensees and sublicensees plus rebates and allowances received
by Rutgers, its Affiliates or licensees or sublicensees of amounts that have been deducted from
gross sales less the sum of the following actual and customary deductions (net of rebates or
allowances of such deductions received) included on the invoice and actually paid: cash, trade, or
quantity discounts; sales, use, tariff, or other excise taxes imposed upon particular sales;
import/export duties; and transportation charges. Sales among Rutgers, its Affiliates and its
licensees or sublicensees for ultimate third party use shall be disregarded for purposes of
computing payments under clause 3.1. Payments shall be made only upon sales or transfers between
unrelated third parties and shall be based on arms-length consideration.

     2. Effective Date.

          2.1 This Agreement shall become effective (the “Effective Date”) upon the execution of this
Agreement and both of the following agreements:

               (a) A license from Rutgers to REVA Medical, Inc., a corporation organized under the laws of
the State of California, having a business office at 5751 Copley Drive, San Diego, California
(hereinafter “REVA”) in respect of First Generation Polycarbonates and Second Generation
Polycarbonates for the manufacture, use and sale of vascular devices; and

               (b) An agreement between Integra and REVA providing for payments by REVA to Integra of a fee
per coronary stent sold.

          2.2 Rutgers shall promptly notify Integra in writing when the license described in clause
2.1(a) is executed and Integra shall promptly notify Rutgers in writing when the agreement
described in clause 2.1(b) is executed.

               (a) Promptly following the Effective Date, Integra shall notify in writing, with a copy to
Rutgers, the current manufacturer of tyrosine polymers and advise the manufacturer (1) that
Rutgers, its licensees and its sublicensees have any and all rights necessary to have manufactured
any tyrosine polymers, and (2) to deal directly and exclusively with Rutgers, its licensees and its
sublicensees on a going forward basis, except for winding down Integra’s relationships with the
manufacturer relating to the subject matter of this agreement.

          2.3 The License Agreement shall be terminated and of no further force or effect as of the
Effective Date. As of the Effective Date, Integra irrevocably grants to Rutgers a worldwide
license, with the right to grant sublicenses, to make, have made, use, sell, lease and otherwise
dispose of products employing the Integra Process Patents. The termination of the License
Agreement shall not relieve either party of any obligation or liability accrued thereunder for
royalties,/fees/sublicensing payments or patent costs.

          2.4 Within thirty (30) days following the Effective Date, Integra shall deliver to Rutgers all
tangible documents, information, data and materials described in clause 12.1 of the

2

 

License Agreement, including the Master File and any research data relating to the
biocompatibility of tyrosine polymers, as well as all other materials it has relating to First
Generation Polycarbonates or Second Generation Polycarbonates. Notwithstanding the foregoing,
Integra may retain a copy of such documents and materials for use in rendering such advice as
Rutgers may request pursuant to Section 2.5 hereof. Integra hereby irrevocably assigns to Rutgers
all of its right, title and interest in and to all such tangible documents, information, data and
materials as of the Effective Date.

          2.5 Throughout the term of this Agreement, Integra will provide reasonable assistance,
including, without limitation, the prompt execution of all documents to effect the aforementioned
assignments, to Rutgers in Rutgers’ efforts to effect the transfer of intellectual property,
information, documents, and materials to Rutgers. In addition, Integra will, upon the reasonable
request of Rutgers, provide technical advice to Rutgers on the commercialization of the First
Generation Polycarbonates and the Integra Process Patents and on the Master File during the
three-year period following the date hereof; provided that Integra personnel may render such advice
at times reasonably convenient to Integra and to Rutgers and that Integra shall not be obligated to
devote more than 5 man days to the provision of such advice in the first year following the
execution of this Agreement and no more than two man days in any subsequent year.

     3. Payments.

          3.1 Rutgers shall pay to Integra a portion of any milestone payments and royalties received by
Rutgers from third parties for licensing arrangements made in respect of First Generation
Polycarbonates . The payments shall comprise (i) ***% of milestone payments and of royalties
received by Rutgers until the total amount paid to Integra hereunder exceeds
$*** and (ii) ***% of milestone payments and royalties received by Rutgers
thereafter; but in no case shall the royalties paid to Integra be less than (a) ***% of Net Sales
if End Products contain material whose manufacture would, but for a sublicense granted by Rutgers
or one of its licensees, violate one or more claims of the Integra Process Patents, or (b) ***% of
Net Sales of all other End Products. The agreement between REVA and Rutgers entered into on the
date hereof, and payments received by Rutgers thereunder for use of tyrosines or other materials in
stent, coating and embolotherapy products, shall not be subject to any payments by Rutgers to
Integra under this paragraph 3.1.

          3.2 Rutgers shall deliver to Integra a semi-annual report within thirty (30) days following
the close of any calendar 6 month period in which Rutgers receives a milestone payment or a royalty
under clause 3.1. The report shall set forth the amounts of milestone payments and royalties
received by Rutgers and it shall be accompanied by a check payable to Integra for the amount due.

          3.3 Rutgers shall keep good and accurate books of account sufficient to permit determination
of the payments due hereunder and shall make such books of account available for inspection by an
independent accountant designated by Integra and reasonably acceptable to Rutgers provided that
such accountant executes and delivers to Rutgers a Confidentiality

 

			
	*** 	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment filed separately with the
Commission.

3

 

Agreement in the form appended as Attachment A hereto. Such inspections shall be no more
frequent than twice each calendar year during the term hereof and once within six months after
termination of this Agreement. The designated accountant shall retain in confidence the
information in the books of account and shall report to Integra only the accuracy or inaccuracy of
the reports rendered pursuant to clause 3.2 hereof. Such inspections will be at Integra’s expense
unless the designated accountant identifies underpayment of royalties due by five percent (5%) or
more in which event Rutgers shall pay for such inspection. Integra’s failure to inspect shall not
constitute a waiver of Integra’s right to object to the accuracy of the reports rendered or
payments made under this Agreement.

          3.4 All underpayments discovered pursuant to clause 3.3, plus interest at the then prevailing
prime interest rate published by Citicorp, New York, New York, U.S.A., on the amount underpaid
shall be promptly paid to Integra; provided, however, that no more than one year’s interest shall
be due on such underpayment.

     4. Term and Termination.

          4.1 This Agreement shall be effective on the Effective Date and shall expire on expiration of
the last to expire of the patents listed on Schedule B hereto unless extended or earlier terminated
pursuant to the terms hereof.

          4.2 This Agreement shall automatically terminate in the event (1) substantially all of the
assets of Integra are seized or attached in conjunction with any action against it by a third
party, or (2) Integra is dissolved or the sale of all or substantially all of its assets is made
other than as part of a merger, or (3) an attempt to assign this Agreement is made without the
prior written consent of Rutgers. Notwithstanding the foregoing this agreement shall be assigned
to any entity into which Integra shall combine or merge.

          4.3 This Agreement may be terminated by either party for a material breach by the other party
of the provisions hereof. Such termination shall be effective thirty (30) days after written
notice to the other party of the breach if the breach has not been remedied.

          4.4 The right of either party to terminate under the provisions of this Article shall not be
an exclusive remedy, and either party shall be entitled, if the circumstances warrant,
alternatively or cumulatively, to damages for breach of this Agreement, to an order requiring
performance of the obligations of this Agreement, or to any other legally available remedy.

          4.5 The following Articles shall survive termination or expiration of this Agreement by their
terms: Articles 1, 2, 3.3, 4.4, 4.5 and 5 through 7.

     5. Representation, Warranties and Covenants.

          5.1 Each party represents, warrants and covenants to the other that:

               (a) It has the full power and authority to execute and deliver this Agreement and perform its
covenants, duties and obligations described in this Agreement; and

4

 

               (b) This Agreement is a valid, legal and binding obligation upon such party, enforceable in
accordance with its terms, except as enforceability may be limited by applicable insolvency and
other laws affecting creditors’ rights generally or by the availability of equitable remedies.

          5.2 Integra represents, warrants and covenants to Rutgers that:

               (a) It is validly existing and in good standing;

               (b) The execution of this Agreement and the full and timely performance of the covenants,
duties and obligations described herein have been duly authorized by all necessary corporate action
in accordance with all applicable laws.

               (c) If Integra becomes aware that on the date hereof it possessed intellectual property or
information in tangible form that (i) is necessary or useful to the commercialization of First
Generation Polycarbonates or Second Generation Polycarbonates or the Integra Process Patents and
(ii) was not assigned or licensed to Rutgers hereby, it will promptly disclose to Rutgers the
existence of such intellectual property or information and either assign without cost or grant a
paid up license with right to sublicense of such intellectual property or information to Rutgers.

               (d) It has good title to the documents, information, data and materials (“Materials”) it is
assigning to Rutgers under Article 2.4, and the Integra Process Patents it is licensing under
Article 2.3, free of all liens and encumbrances. Integra believes that, taken as a whole, the
Materials accurately reflect the findings of the scientists engaged in the development of the
materials. Integra represents that to the best of its knowledge and belief, the Integra Process
Patents do not infringe the intellectual property rights of third parties.

     6. No Assignment.

          6.1 Neither this Agreement, nor any rights or obligations hereunder, may be assigned, pledged
or encumbered by either party without the express prior written approval of the other party.

     7. Miscellaneous.

          7.1 A waiver of any breach of any provision of this Agreement shall not be construed as a
continuing waiver of other breaches of the same or other provisions of this Agreement.

          7.2 Nothing herein shall be deemed to create an agency, joint venture or partnership relation
between the parties hereto.

          7.3 This Agreement and Attachments A and B constitute the sole, entire and final agreement and
understanding of the parties with regard to the subject matter hereof and merges and supersedes all
prior discussions, negotiations, understandings and agreements between the parties concerning the
subject matter hereof. Neither party shall be bound by any definition, condition, warranty, right,
duty or covenant other than as expressly stated in this

5

 

Agreement or as subsequently set forth in a written document signed by both parties. Each
party expressly waives any implied right or obligation regarding the subject matter hereof. A
breach or termination of the Reva/Integra agreement referred to in Article 2.1(b) shall not affect
this Agreement.

          7.4 This Agreement shall be interpreted and construed, and the legal relations created herein
shall be determined, in accordance with the laws of the State of New Jersey (excluding conflict of
laws) and the United States.

          7.5 This Agreement may be amended only by a written document signed by authorized
representatives of both parties.

          7.6 Each party hereto agrees to execute, acknowledge and deliver all such further instruments,
and to do all such further acts, as may be necessary or appropriate to carry out the intent and
purposes of this Agreement.

          7.7 The headings contained in this Agreement are for reference purposes only and shall not
affect in any way the meaning or interpretation of this Agreement.

          7.8 Should any part or provision of this Agreement be held unenforceable or in conflict with
the law of any jurisdiction, the validity of the remaining parts or provisions shall not be
affected by such holding.

          7.9 Any and all notices or other communications required or permitted by this Agreement or by
law to be served on or given to either party hereto by the other party shall be in writing and
delivered or sent to:

Vice President, Technology

Integra LifeSciences Corporation

P.O. Box 688

105 Morgan Lane

Plainsboro, NJ 08536

Rutgers, The State University of New Jersey

Office of Corporate Liaison and Technology Transfer

ASB III, 3 Rutgers Plaza

New Brunswick, New Jersey 08901

Att: Director

     Each party may change its address for purposes of this Agreement by written notice to the
other party.

               (a) Each notice or other communication shall be deemed duly served and given on the date when
personally delivered to the party to whom it is directed, when submitted to a nationally recognized
overnight delivery service, prepaid and addressed to the party at the address in paragraph 7.9, or
when deposited in the United States mail, postage

6

 

prepaid, certified-return receipt requested and addressed tot he party at the address in
paragraph 7.9. When transmitted electronically by telex, facsimile, or e-mail, such notice shall
be deemed duly served and given on the date when the party to whom it is directed confirms receipt
in writing.

          7.10 Upon execution of this agreement, the parties will issue a joint press release announcing
the termination of Integra LifeSciences’ license to Rutgers’ polycarbonates, in form and substance
reasonably acceptable to both parties. Integra will refer current and future inquiries regarding
1st Generation Polycarbonates to Rutgers University.

          7.11 The parties acknowledge and agree that REVA shall be a third party beneficiary to this
Agreement with full rights to enforce its terms.

7

 

          7.12 This Agreement may be executed by each party in duplicate originals, each of which shall be
deemed an original, but both originals together shall constitute only one and the same instrument.

     IN WITNESS WHEREOF, the parties have executed this Agreement in duplicate on the signature
page hereof

	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	“Rutgers”
	 
	 	 	 	 	 	 
	 	 	Rutgers, The State University
	 
	 

	 	By: 	 	 	 	 
	 	 	 	 	 
	 

	 	 	Name:	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	Title:	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	Date:	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	“Integra”
	 
	 	 	 	 	 	 
	 	 	Integra LifeSciences Corporation
	 
	 

	 	By: 	 	 	 	 
	 	 	 	 	 
	 

	 	 	Name:	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	Title:	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	Date:	 	 	 
	 	 	 	 	 	 	 

8

 

ATTACHMENT A

CONFIDENTIALITY AGREEMENT

     RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY, having its statewide administrative offices at
                                        
(hereafter referred to as “Rutgers”),               
                          , having a
place of business at             
                
             (hereinafter “Accountant”), and Integra
LifeSciences Corporation, a corporation organized under the laws of the State of Delaware, having a
business office at 105 Morgan Lane, Plainsboro, New Jersey 08536 (hereinafter referred to as
“Integra”).

Background

     According to the terms of an Agreement dated                     ,             between Rutgers and Integra
(the “Agreement”), Rutgers is making available to Accountant its books of account as required by
paragraph 3.3 of the Agreement (“CONFIDENTIAL MATERIAL”) for Accountant’s use in preparing a report
to Integra according to the terms of said paragraph 3.3 (the “Report”).

Agreement

     1. Accountant will not use CONFIDENTIAL MATERIAL except to prepare the Report.

     2. Accountant will not disclose CONFIDENTIAL MATERIAL to Integra or any third party and
Accountant shall provide only the Report to Integra and no other party.

     3. Integra shall treat the Report as confidential under the same terms as required for the
treatment of CONFIDENTIAL MATERIAL hereunder and Integra shall not provide the Report or disclose
its contents to any third party.

     4. Integra will limit access to the Report to those employees of Integra who need to know
about or participate in the review of the Report.

     5. CONFIDENTIAL MATERIAL shall remain the property of Rutgers. Sixty (60) days following
completion of the Report, Accountant will return to Rutgers all CONFIDENTIAL MATERIAL in its
possession and destroy all computer entries relating thereto.

     6. The obligations in paragraphs 1 and 2 shall not apply to CONFIDENTIAL MATERIAL:

          (a) which was known to Accountant and was contained in a writing in Accountant’s possession
before its receipt from Rutgers;

          (b) which at the time of its disclosure to Accountant is, or thereafter becomes through no act
or failure to act on the part of Accountant, part of the public domain; or

Attachment A - 1

 

          (c) which has been rightfully furnished to Accountant by a third party without restriction on
disclosure or use and not in violation of any rights of, or obligations to, Rutgers.

     An individual feature of the information shall not be considered within the above exceptions
merely because the feature is embraced by more general information within the exceptions. A
combination of features of the information shall not be considered within the above exceptions
unless the combination itself and its principle of operation are within the exceptions. The
obligation to maintain the secrecy of CONFIDENTIAL MATERIAL and limit its use shall terminate five
(5) years from the date of each disclosure of CONFIDENTIAL MATERIAL hereunder.

     7. This Confidentiality Agreement shall be governed by the laws of the State of New Jersey
without giving effect to the principles of conflict of laws thereof.

     8. This Confidentiality Agreement constitutes the entire agreement among the parties with
respect to the subject matter hereof, and all prior understandings or agreements between the
parties relating to such subject matter, except for the Confidentiality Agreement, whether oral or
written, are automatically cancelled by the execution of this Agreement. The terms and conditions
set forth herein may only be modified I subsequent writing signed by the parties.

     All notices and other communications shall be considered given and effective when personally
delivered or when mailed, postage prepaid, to the addresses set forth on the first page of this
Agreement or to such other addresses as the parties may designate in writing.

	 	 	 	 	 	 	 	 	 	 	 	 	 
	AGREED:	 	 	 	AGREED:
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Rutgers, The State University of New Jersey	 	 	 	Integra LifeSciences Corporation
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	By:

	 	 	 	 	 	 	 	By:	 	 	 	 
	 	 	 	 	 	 	 	 	   
	 

	 	Name:
	 	 	 	 	 	 	 	Name:	 	 
	 

	 	 	 	 
	 	 	 	 	 	 	 	 
	 

	 	Title:
	 	 	 	 	 	 	 	Title:	 	 
	 

	 	 	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 
	AGREED:	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Accountant	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	By:
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Name:	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Title:	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 

Attachment A - 2

 

ATTACHMENT B: SCHEDULE OF PATENTS

COVERING FIRST GENERATION POLYCARBONATES:

US Patent 5,198,507

US Patent 6,120,491 and its international filings listed below:

	 	 	 	 	 	 	 

	 

	 	 	98957728 3	 	 	European PCT
	 

	 	 	2.309,278	 	 	Canadian PCT
	 

	 	 	730549	 	 	Australian PCT
	 

	 	 	2000-520191	 	 	Japan PCT
	 
	 	 	US98/23857	 	 	Mexico

Attachment B - 1

 

Appendix B

INTEGRA TECHNOLOGY

For purposes of clarity, “INTEGRA TECHNOLOGY” does not include inventions, technology, and
intellectual property thereunder, that have reverted or been assigned to RUTGERS pursuant to the
LICENSE TERMINATION AGREEMENT.

     INTEGRA TECHNOLOGY related to “FIRST GENERATION MATERIAL” is defined as the family of
desaminotyrosyl-L-tyrosine derived polycarbonates which include poly(DTE-carbonate),
poly(DTB-carbonate), poly(DTH-carbonate), poly(DTO-carbonate) and po!y(X%DTR-co-Y%DT-carbonate)s
and tyrosine derived polycarbonates containing the chain-terminating groups derived from acetic
anhydride or the ethyl, butyl, hexyl, or octyl esters of L-tyrosine or desamino tyrosine.

Manufacturing

	1.	 	Specific current research, manufacturing and production information for GMP
productions of (poly(DTE carbonate)s not limited to manufacturing standard operating
procedures related to, but not limited to, equipment, purchased raw materials and material
controls, manufacture processes, quality control procedures and characterization of materials.

	2.	 	Specific current research, manufacturing and production information for non-GMP
productions of poly(X%DTE-co-Y%DT carbonate)s) not limited to manufacturing standard operating
procedures related to, but not limited to, equipment, purchased raw materials and material
controls, manufacture processes, quality control procedures and characterization of materials.

	3.	 	Current laboratory methods for:

	 	(a)	 	Conversion of poly(DTE carbonate) to poly(DTE-co-DT carbonate);
	 
	 	(b)	 	Conversion of high to lower molecular weight;
	 
	 	(c)	 	Confirmation of percent DT achieved;
	 
	 	(d)	 	GPC analysis developed by Integra for first generation materials.
	 
	 	(d)	 	And, access to other non-published studies, reports, or methods related to
material characterization of tyrosine polycarbonates.

MAF and Polycarbonate Biocompatibility

	4.	 	Non-published studies and reports represented in summary form in the Master File, FDA
designated file MAF-1140 Tyrosine-Derived Polycarbonates.

Appendix B - 1

 

	5.	 	Non-published studies and reports related to biocompatibility studies for polycarbonates
other than poly(DTE carbonate)s, e.g., poly(DTB carbonate)s, poly(DTH carbonate)s and poly(DTO
carbonate)s.

Patents — Related To Development And Practice Of The Licensed Intention

	6.	 	Integra LifeSciences patent status and access to current, pending and new disclosures related
to developments of the polymers and products related thereto, and new intellectual property
related to FIRST GENERATION MATERIALS, including but not limited to the following patents:

	 	 	 	 	 
	Patent #	 	Title	 	Issuance Date
	US Pat #6,359,102

	 	Biphasic polymerization process
	 	03/19/02
	EP0991693A1

	 	Biphasic polymerization process
	 	04/12/00
	EP0991693B1

	 	Biphasic polymerization process
	 	09/03/03
	US Pat # 6620356

	 	Porous constructs fabricated by gas induced phase inversion
	 	09/16/03

Appendix B - 2

 

APPENDIX C

RUTGERS PATENT RIGHTS

The following rights are included in the definition of RUTGERS PATENT RIGHTS:

THESE PATENTS ARE INCLUDED IN THE DEFINITION OF RUTGERS PATENT RIGHTS ONLY TO THE EXTENT THEY APPLY
TO “POLYCARBONATES”, AS DEFINED AT THE END OF THIS APPENDIX:

     A. U.S. Patent 6,475,477B1 “Radio-opaque Polymer Biomaterials.”

     B. US Patent 5,099,060 “Synthesis of amino acid-derived bioerodible polymers.” This patent is
included only to the extent that the patented monomers are used in the fabrication of
POLYCARBONATES.

     C. US Patent 5,587,507 “Synthesis of tyrosine derived diphenol monomers.” This patent is
included only to the extent that the monomers produced thereby are used in the fabrication of
POLYCARBONATES.

     D. US Patent 5,658,995 “Copolymers of tyrosine-based polycarbonate and poly(alkylene oxide).”

     E. US Patent 6,048,521 “Copolymers of tyrosine-based polyarylates and poly(alkylene oxide).”

     F. US Patent 6,319,492 B1 “Copolymers of tyrosine-based polyarylates and poly(alkylene
oxide)”.

     G. US Patent 5,198,507 “Synthesis of amino acid-derived bioerodible polymers”.

     H. US Patent 6,120,491 “Biodegradable, anionic polymers derived from the amino acid
L-tyrosine.”

     I. US Patent 6,359,102 issued on March 19, 2002, “Biphasic polymerization process, EP0991693A1
issued on April 12, 2000, “Biphasic polymerization process,” and EP0991693B issued on September
3,2003, “Biphasic polymerization process.”

     J. US Patent 6,620,356 issued on September 16, 2003, “Porous constructs fabricated by gas
induced phase inversion.”

     K. Rutgers Docket 03-175.

“POLYCARBONATES” means tyrosine-derived polymers containing desaminotyrosyl-tyrosine or
desaminotyrosyl-tyrosine alkyl ester repeat units linked together by carbonate backbone linkages as
described in subsections (a) through (e) below and which comprise a subgroup of the polymers
defined by the comprehensive chemical Formula VIII listed under CLAIM 1 in US Patent 6,475,477B1.
POLYCARBONATES exclude all polymers commonly referred to as

Appendix C - 1

 

polyarylates. With reference to said Formula VIII, for the purposes of this License Agreement, a
POLYCARBONATE is a polymer that meets all the following conditions:

a. “A” described in said Formula VIII is limited to being a simple carbonyl group, e.g., carbon
double bonded to oxygen as indicated by Structure 1; AND

(Structure 1)

b. XI and X2 in said Formula VIII are independently Iodine or Bromine atoms; Y1 and Y2 in said
Formula VIII are independently 0, 1, or 2. Non-radio-opaque polymers are obtained if both Y1 and
Y2 are equal to zero (0); AND

c. R7 in said Formula VIII is independently an alkylene group containing up to 4 carbon atoms
(e.g., methylene, ethylene, propylene, or butylene); AND

d. R9 and R12 in said Formula VIII are limited by the requirements that

(i) R4 equals (-CH2-) with subscript “a” equals 2 as defined in Claim 3 of said US patent

(ii) R0 equals (-CH2-) with subscript “m” equals 1 as defined in Claim 3 of said US patent

(iii) Z in Claim 3 is limited to a free carboxylic acid group or carboxylic acid esters or amides
having straight or branched alkyl and alkyl aryl groups containing up to 18 carbon atoms, or esters
and amides of biologically and pharmaceutically active compounds; AND

e. The parameter “f” in said Formula VIII can vary from 0 to 0.99 (including the values of “0” and
“0.99”). The parameter “g” in said Formula VIII can vary from 0 to 1 (including the values of “0”
and “1”). The parameter “k” in said Formula VIII is between 5 and 3,000.

Said definition of POLYCARBONATE contains as a subgroup, but is not limited to the polymers
exemplified by Formula 1 which is shown here for illustrative purposes only. In Formula 1, the I
stands for iodine, DTR stands for desaminotyrosyl-tyrosine alkyl ester, DT Stands for
desaminotyrosyl-tyrosine, and PEG stands for poly(ethylene glycol);

Formula 1. poly(IxDTR-co-f%PEGmw-co-g%DT carbonate)

One potential embodiment of Formula 1. further exemplified is:

poly(I2DTE-co-5%PEG1000-co-30%DT carbonate).

Appendix C - 2

 

APPENDIX D

Reva/Integra License Agreement Royalty Report for the Period                      Through                     

Instructions: Please fill in all boxes (write “none” if not applicable), and sign and date at
bottom. All section numbers refer to the License Agreement.

Answer questions 1 and 2 (AND SIGN AND DATE AT BOTTOM) EVEN IF THERE HAS BEEN NO ACTIVITY in
reporting period.

	1.	 	Number of transactions: by REV A o
 by  Sublicensees o
	 
	2.	 	Any new sublicenses entered into during the period? Yes 
o no o

If yes, attach separate sheet listing names and addresses of sublicensees, and attach sublicense
agreements.

Total
amount enclosed $                                         

REVA Medical, Inc.

	 	 	 	 	 	 	 

	 	 	Date:  	 	 	 	 

	 	 	 	 	 

	Name and Title:  	 	 	 	 

Appendix D - 1 

 

APPENDIX D (Continued)

Continuation sheet number              to REVA/INTEGRA License Agreement Royalty Report for the Period
              through 
            

Use this sheet if there are additional transactions to report.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	By ____ or	 	 	Product or Process	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Date of	 	 	 	 	 	 	Sublicense? (if	 	 	Type (name and id	 	 	 	 	 	 	Deductions per § __	 	 	 	 	 	 	 
	Transaction	 	 	Type of Transaction	 	 	latter, identify)	 	 	number)	 	 	Total Billings	 	 	(specify type)	 	 	Royalties Due	 	 	Customer Name and Address	 

Appendix D - 2

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