Document:

Exhibit
10.12

 

LICENSE AGREEMENT

 

This
Agreement, effective as of August 4, 1999 (the “Effective Date”), is by
and between:

 

Hospital
for Joint Diseases Orthopaedic Institute (hereinafter “HJD”), a corporation
organized and existing under the laws of the State of New York and having a
place of business at 301 East 17th Street, New York, New York  10003

 

AND

 

Orthogen
Corporation (hereinafter “Orthogen”), a corporation organized and existing
under the laws of the State of New Jersey having its principal office at 530
Morris Avenue, Suite 204, Springfield, New Jersey 07081.

 

RECITALS

 

WHEREAS,
Drs. John Ricci and Harold Alexander, formerly of HJD and Dr. Sally
Frenkel, currently of HJD (hereinafter “the HID Scientists”), and Dr. Charles
Naiman of Orthogen, have made certain inventions relating to the control of
cell and tissue growth on surfaces, all as more particularly described in
pending U.S. patent applications and counterpart foreign patent applications
co-owned by HJD and Orthogen, identified in annexed Appendix I and forming an
integral part hereof (hereinafter “the Inventions”);

 

WHEREAS,
subject to the terms and conditions hereinafter set forth, HJD is willing to
grant to Orthogen and Orthogen is willing to accept from HJD the License (as
hereinafter defined);

 

NOW,
THEREFORE, in consideration of the mutual promises and agreements contained
herein, the parties hereto hereby agree as follows:

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

1

 

1.             Definitions.

 

a.                                       “Calendar Year” shall mean any
consecutive period of twelve months commencing on the first day of January of
any year.

 

b.                                      “Corporation Entity” shall mean
any company or other legal entity controlling, controlled by or under common
control of Orthogen.  For purposes of
this definition the term “control” shall mean: (i) in the case of a
corporate entity, the direct or indirect ownership of at least a majority of
the stock or participating shares entitled to vote for the election of
directors, (ii) in the case of a partnership, the power customarily held
by a general partner to direct the management and policies of such partnership,
or (iii) in the case of a joint venture, whether in corporate, partnership
or other legal form, a more than nominal economic interest.

 

c.                                       “Date of First Commercial Sale”
shall have the meaning set forth in Section 4.b. hereof.

 

d.                                      “Field” shall mean the control of
tissue or cell growth on synthetic substrates.

 

e.                                       “License” shall mean the exclusive
worldwide license to practice the Research Technology for the development,
manufacture, use and sale of the Licensed Products (as hereinafter defined) in
the Field.

 

f.                                         “Licensed Products” shall mean
implants or cell growth systems, or any product or process to control cell
growth on synthetic substrates, as covered by a claim of any unexpired
HJD/Orthogen Joint Patent (as hereinafter defined) which has not been
disclaimed or held invalid by a court of competent jurisdiction from which no
appeal can be taken.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

2

 

g.                                      “Licensed Service” shall mean any
service delivered, performed or provided by Orthogen or Corporation Entity
which utilizes Licensed Products.

 

h.                                      “Net Sales” shall mean the total
amount invoiced in connection with sales of the Licensed Products or Services
to any person or entity that is not a Corporation Entity or a sublicensee of
Orthogen or a Corporation Entity under the License, after deduction of all the
following to the extent applicable to such sales;

 

i)                                         [***];

 

ii)                                      [***];

 

iii)                                   [***];

 

iv)                                  [***]; and

 

v)                                     [***].

 

i.                                          “HJD Know-How” shall mean the
Inventions.

 

j.                                          “HJD/Orthogen Joint Patents” shall
mean all United States and foreign patents and patent applications, and any
divisions, continuations, in whole or in part, reissues, renewals and
extensions thereof, and pending applications therefore which claim Inventions
and which are identified on annexed Appendix I.

 

k.                                       “Research Technology” shall mean
HJD rights in the Invention and all HJD/Orthogen Joint Patents and Know-How.

 

2.             Effective Date.

 

This
Agreement shall be effective as of the Effective Date and shall remain in full
force and effect until it expires or is terminated in accordance with Section 11
hereof.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

3

 

3.             Patents and Patent Applications.

 

a.                                       All costs and fees incurred in
connection with all patent prosecution proceedings with respect to the
HJD/Orthogen Joint Patents shall be borne solely by Orthogen.

 

b.                                      If at any time during the term of
this Agreement Orthogen decides that it is undesirable, as to one or more
countries, to prosecute or maintain any patents or patent applications within
the HJD/Orthogen Joint Patents, it shall give prompt written notice thereof to
HJD, and upon receipt of such notice Orthogen shall be released from its
obligations to bear all of the expenses to be incurred thereafter as to such
countries in conjunction with such patent(s) or patent application(s) and
such patent(s) or application(s) shall be deleted from the Research
Technology and HJD shall be free to grant non-exclusive rights in and to the
Research Technology in such countries to third parties, without further notice
or obligation to Orthogen, and Orthogen shall have non-exclusive rights to
exploit the Research Technology in such countries.

 

4.             Grant of License.

 

a.                                       Subject to the terms and conditions
hereinafter set forth, HJD hereby grants to Orthogen and Orthogen hereby
accepts from HJD the License.

 

b.                                      The License granted to Orthogen in
Section 4.a. hereto shall commence upon the Effective Date and shall
remain in force on a country-by-country basis, if not previously terminated
under the terms of this Agreement, for fifteen (15) years from the Date of
First Commercial Sale in such country or until the expiration date of the last
to expire of the HJD/Orthogen Joint Patents whichever shall be later.  Orthogen shall inform HJD in writing of the
Date of First Commercial Sale 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

4

 

with respect to each Licensed Product and/or Service in each country as
soon as practicable after the making of each such first commercial sale.

 

c.                                       Orthogen shall be entitled to
grant sublicenses under the License on terms and conditions in compliance and
not inconsistent with the terms and conditions of this Agreement (i) to a
Corporation Entity or (ii) to other third parties for consideration and in
an arms-length transaction.  All
sublicenses shall only be granted by Orthogen under a written agreement, a copy
of which shall be provided by Orthogen to HJD as soon as practicable after the
signing thereof. Each sublicense granted by Orthogen hereunder shall be subject
and subordinate to the terms and conditions of this License Agreement and shall
contain (inter-alia) the following provisions:

 

(1)           the sublicense shall expire
automatically on the termination of the License;

 

 

(2)           the sublicense shall not be
assignable, in whole or in part;

 

(3)           the sublicensee shall not grant
further sublicenses; and

 

(4)                                  the sublicense agreement
shall include the text of Section 9 of this Agreement and shall state that
HJD is an intended third party beneficiary of such sublicense agreement for the
purpose of enforcing such indemnification and insurance provisions.

 

5.             Payments for License.

 

a.                                       In consideration for the grant and
during the term of the License with respect to each Licensed Product or
Service, Orthogen shall pay to HJD:

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

5

 

i)                                         For a dental Licensed Product, a
royalty of [***]% of the Net Sales of Orthogen, or any sublicensee of Orthogen
(not being a Corporation Entity).

 

ii)                                      For a medical Licensed Product, a royalty
of [***]% of the Net Sales of Orthogen, or any sublicensee of Orthogen (not
being a Corporation Entity).

 

iii)                                   For a Licensed Service, a royalty
of [***]% of the Net Sales of Orthogen.

 

iv)                                  [***]% of any monetary
consideration, not based on Net Sales, received by Orthogen from a sublicensee
of Orthogen (not being a Corporation Entity) under the terms of, or as a
consideration for the grant of, a sublicense of any rights or for grant of an
option to acquire such a sublicense.

 

b.                                      In the event that a patent license
from a third party is necessary for the manufacture or sale of a Licensed
Product, Orthogen shall be entitled to deduct from royalties which would
otherwise be due HJD under Section 5.a. hereof, the amount of royalties
which Orthogen must pay to such third party for such license. In no event,
however, shall this deduction exceed [***] of the royalties otherwise due under
this Agreement.

 

c.                                       For the purpose of computing the
royalties due to HJD hereunder, the year shall be divided into two parts ending
on June 30 and December 31. 
Not later than [***] ([***]) days after each December and June in
each Calendar Year during the term of the License, Orthogen shall submit to HJD
a full and detailed report of royalties or payments due HJD under the terms of
this Agreement for the

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

6

 

preceding half year (hereinafter “the Half-Year Report”), setting forth
the Net Sales and/or lump sum payments and all other payments or consideration
from sublicensees upon which such royalties are computed and including at least

 

i)                                         the quantity of Licensed Products
or Services used, sold, transferred or otherwise disposed of;

 

ii)                                      the selling price of each Licensed
Product or Service;

 

iii)                                   the deductions permitted under
subsection 1.h. hereof to arrive at Net Sales; and

 

iv)                                  the royalty computations and
subject of payment.

 

If
no royalties or other payments are due, a statement shall be sent to HJD
stating such fact.  Payment of the full
amount of any royalties or other payments due to HJD for the preceding half
year shall accompany each Half-Year Report on royalties and payments. Orthogen
shall keep for a period of at least six (6) years after the date of entry,
full, accurate and compete books and records consistent with sound business and
accounting practices and in such form and in such detail as to enable the
determination of the amounts due to HJD from Orthogen pursuant to the terms of
this Agreement.

 

d.                                      Within [***] ([***]) days after
the end of each Fiscal Year, commencing on the Date of First Commercial Sale
Orthogen shall furnish HID with a report (hereinafter “the Annual Report”),
certified by an independent certified public accountant, relating to the
royalties and other payments due to HID pursuant to this Agreement in respect
of the Calendar Year covered by such Annual Report 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

7

 

and containing the same details as those specified in Section 5.c.
above in respect of the Half-Year Report.

 

e.                                       On reasonable notice and during
regular business hours, HJD or the authorized representative of HJD shall each
have the right to inspect the books of accounts, records and other relevant
documentation of Orthogen or of Corporation Entity and the sublicensees of
Orthogen or of Corporation Entity insofar as they relate to the production,
marketing and sale of the Licensed Products and Services, in order to ascertain
or verify the amount of royalties and other payments due to HJD hereunder, and
the accuracy of the information provided to HJD in the aforementioned reports.

 

f.                                         Beginning on January 1, 2002
and continuing thereafter until this Agreement shall terminate or expire,
Orthogen agrees that if the total royalties paid to HJD under subsection 5.a.
hereof for dental products do not amount to [***] dollars ($[***]) in 2002,
[***] dollars ($[***]) in 2003 and [***] dollars ($[***]) each year thereafter,
Orthogen will pay to HJD within [***] ([***]) days after the end of each such
Calendar Year, as additional royalty, the difference between the amount of the
total royalties paid to HJD by Orthogen for dental products in such Calendar
Year and the appropriate annual minimum amount, failing which HJD shall have
the right solely at its election, upon written notice to Orthogen, to terminate
this Agreement with regard to dental products for cause.

 

g.                                      Beginning on January 1, 2005
and continuing thereafter until this Agreement shall terminate or expire,
Orthogen agrees that if the total royalties paid to HJD under subsection 5.a.
hereof for medical products do not amount to [***] dollars 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

8

 

($[***]) in 2005, [***] dollars ($[***]) in 2006 and [***] dollars
($[***]) each year thereafter, Orthogen will pay to HJD within [***] ([***])
days after the end of each such Calendar Year, as additional royalty, the
difference between the amount of the total royalties paid to HJD by Orthogen
for medical products in such Calendar Year and the appropriate annual minimum
amount, failing which HJD shall have the right solely at its election, upon
written notice to Orthogen, to terminate this Agreement with regard to medical
products for cause.

 

6.             Method of Payment.

 

a.                                       Royalties due to HJD hereunder
shall be paid to HJD in United States dollars. Any such royalties on or other
payments relating to transactions in a foreign currency shall be converted into
United States dollars based on the closing buying rate of the Morgan Guaranty
Trust Company of New York applicable to transactions under exchange regulations
for the particular currency on the last business day of the accounting period
for which such royalty or other payment is due.

 

b.                                      Orthogen shall be responsible for
payment to HJD of all royalties due on sale, transfer or disposition of
Licensed Products or Services by Corporation Entity or by the sublicensees of
Orthogen or of Corporation Entity.

 

7.             Development and
Commercialization.

 

a.                                       Orthogen undertakes to use
reasonable diligence to carry out a development plan, including but not limited
to, the performance of all efficacy, pharmaceutical, safety, toxicological and
clinical tests, trials and studies and all other activities necessary in order
to obtain the approval of the FDA for the production, use and 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

9

 

sale of the Licensed Products and Services.  Orthogen further undertakes to exercise due
diligence and to employ its reasonable diligence to obtain or to cause its
sublicensees to obtain, the appropriate approvals of the health authorities for
the production, use and sale of the Licensed Products, in each of the other
countries of the world in which Orthogen or its sublicensees intend to produce,
use, and/or sell Licensed Products.

 

b.                                      Provided that applicable laws, rules and
regulations require that the performance of the tests, trials, studies and
other activities specified in subsection a. above shall be carried out in
accordance with FDA Good Laboratory Practices and in a manner acceptable to the
relevant health authorities, Orthogen shall carry out such tests, trials,
studies and other activities in accordance with FDA Good Laboratory Practices
and in a manner acceptable to the relevant health authorities. Furthermore, the
Licensed Products and Services shall be produced in accordance with FDA Good
Manufacturing Practice (“GMP”) procedures in a facility which has been
certified by the FDA as complying with GMP, provided that applicable laws, rules and
regulations so require.

 

c.                                       Orthogen undertakes to begin the
regular commercial production, use, and sale of the Licensed Products and Services
in good faith and as soon as is practicable in accordance with the development
plan and to continue diligently thereafter to commercialize the Licensed
Products and Services.

 

d.                                      If Orthogen shall not
commercialize the Licensed Products or Services within a reasonable time frame,
unless such delay is necessitated by FDA or other regulatory agencies, HJD
shall notify Orthogen in writing of Orthogen’s failure to

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

10

 

commercialize and shall allow Orthogen sixty (60) days to cure its
failure to commercialize.  Orthogen’s
failure to cure such delay to HJD’s reasonable satisfaction within such 60-day
period shall be a material breach of this Agreement.

 

8.             Infringement of HJD/Orthogen
Joint Patents.

 

a.                                       In the event a party to this
Agreement acquires information that a third party is infringing one or more of
the HJD/Orthogen Joint Patents, the party acquiring such information shall
promptly notify the other party to the Agreement in writing of such
infringement.

 

b.                                      In the event of an infringement of
an HJD/Orthogen Joint Patent, Orthogen shall be privileged but not required to
bring suit against the infringer.  Should
Orthogen elect to bring suit against an infringer and HJD is joined as a party
plaintiff in any such suit, HJD shall have the right to approve the counsel
selected by Orthogen to represent Orthogen and HJD.  The expenses of such suit or suits that
Orthogen elects to bring, including any expenses of HJD incurred in conjunction
with the prosecution of such suit or the settlement thereof, shall be paid for
entirely by Orthogen and Orthogen shall hold HJD free, clear and harmless from
and against any and all costs of such litigation, including attorneys’
fees.  Orthogen shall not compromise or
settle such litigation without the prior written consent of HID which shall not
be unreasonably withheld.

 

c.                                       In the event Orthogen exercises
the right to sue herein conferred, it shall have the right to first reimburse
itself out of any sums recovered in such suit or in settlement thereof for all
costs and expenses of every kind and character, 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

11

 

including reasonable attorneys’ fees, necessarily involved in the
prosecution of any such suit, and if after such reimbursement, any funds shall
remain from said recovery, Orthogen shall promptly pay to HJD an amount equal
to [***] percent ([***]%) of such remainder and Orthogen shall be entitled to
receive and retain the balance of the remainder of such recovery.

 

d.                                      If Orthogen does not bring suit
against said infringer pursuant to Section 8.b. herein, or has not
commenced negotiations with said infringer for discontinuance of said
infringement, within [***] ([***]) days after receipt of such notice, HJD shall
have the right, but shall not be obligated, to bring suit for such
infringement. Should HJD elect to bring suit against an infringer and Orthogen
is joined as a party plaintiff in any such suit, Orthogen shall have the right
to approve the counsel selected by HJD to represent HJD and Orthogen, and HJD
shall hold Orthogen free, clear and harmless from and against any and all costs
and expenses of such litigation, including attorneys’ fees.  If Orthogen has commenced negotiations with an
alleged infringer of the HJD/Orthogen Joint Patent for discontinuance of such
infringement within such [***]-day period, Orthogen shall have an additional
[***] ([***]) days from the termination of such initial [***]-day period to
conclude its negotiations before HJD may bring suit for such infringement.  In the event HJD brings suit for infringement
of any HJD/Orthogen Joint Patent, HJD shall have the right to first reimburse
itself out of any sums recovered in such suit or settlement thereof for all costs
and expenses of every kind and character, including reasonable attorneys’ fees
necessarily involved in the prosecution of such suit, and if after such
reimbursement, any funds shall 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

12

 

remain from said recovery, HJD shall promptly pay to Orthogen an amount
equal to [***] percent ([***]%) of such remainder and HJD shall be entitled to
receive and retain the balance of the remainder of such recovery.

 

e.                                       Each party shall always have the
right to be represented by counsel of its own selection in any suit for
infringement of the HJD/Orthogen Joint Patents instituted by the other party to
this Agreement under the terms hereof. 
The expense of such counsel shall be borne by the party initiating such
infringement suit.

 

f.                                         Orthogen agrees to cooperate fully
with HJD at the request of HJD, including, by giving testimony and producing
documents lawfully requested in the prosecution of any suit by HJD for
infringement of the HJD/Orthogen Joint Patents; provided, HJD shall pay all
reasonable expenses (including attorneys’ fees) incurred by Orthogen in
connection with such cooperation.  HJD
shall cooperate with Orthogen at the request of Orthogen, including by giving
testimony and producing documents lawfully requested, in the prosecution of any
suit by Orthogen for infringement of the HJD/Orthogen Joint Patents; provided,
that Orthogen shall pay all reasonable expenses (including attorneys’ fees)
incurred by HJD in connection with such cooperation.

 

9.             Liability and Indemnification.

 

a.                                       Orthogen shall indemnify, defend
and hold harmless HJD and its trustees, officers, medical and professional
staff, employees, students and agents and their respective successors, heirs
and assigns (the “Indemnitees”), against any liability, damage, loss or expense
(including reasonable attorneys’ fees and expenses of litigation) incurred by
or imposed upon the Indemnitees or any one of them in 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

13

 

connection with any claims, suits, actions, demands or judgments (i) arising
out of the design, production, manufacture, sale, use in commerce or in human
clinical trials, lease, or promotion by Orthogen or by a licenses, Corporation
Entity or agent of Orthogen of any Licensed Product, process or service
relating to, or developed pursuant to, this Agreement or (ii) arising out
of any other activities to be carried out pursuant to this Agreement.

 

b.                                      With respect to an Indemnitee,
Orthogen’s indemnification under subsection a.(i) of this Section 9
shall apply to any liability, damage, loss or expense whether or not it is
attributable to the negligent activities of such Indemnitee.  Orthogen’s indemnification obligation under
subsection a.(ii) of this Section 9 shall not apply to any liability,
damage, loss or expense to the extent that it is attributable to the negligent
activities of any such Indemnitee.

 

c.                                       Orthogen agrees, at its own
expense, to provide attorneys reasonably acceptable to HJD to defend against
any actions brought or filed against any Indemnitee with respect to the subject
of indemnity to which such Indemnitee is entitled hereunder, whether or not
such actions are rightfully brought.

 

10.           Security for Indemnification.

 

a.                                       At such time as any Licensed
Product, process or service relating to, or developed pursuant to, this
Agreement is being commercially distributed or sold (other than for the purpose
of obtaining regulatory approvals) by Orthogen or by a licensee, Corporation
Entity or agent of Orthogen, Orthogen shall at its sole costs and expense, procure
and maintain policies of comprehensive general liability insurance in amounts
not less than $[***] per incident and $[***] annual 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

14

 

aggregate for dental products and not less than $[***] per incident and
$[***] annual aggregate for medical products. 
Such policies shall name the Indemnitees as additional insureds.  Such comprehensive general liability
insurance shall provide (i) product liability coverage and (ii) broad
form contractual liability coverage for Orthogen’s indemnification under Section 9
of this Agreement.  If Orthogen elects to
self-insure all or part of the limits described above (including deductibles or
retentions which are in excess of $[***] annual aggregate) such self-insurance
program must be acceptable to HJD.

 

The
minimum amounts of insurance coverage required under this Section 10 shall
not be construed to create a limit of Orthogen’s liability with respect to its
indemnification under Section 9 of this Agreement.

 

b.                                      Orthogen shall provide HJD with
written evidence of such insurance upon request of HJD.  Orthogen shall provide HJD with written
noticed at least sixty (60) days prior to the cancellation, non-renewal or
material change in such insurance; if Orthogen does not obtain replacement insurance
providing comparable coverage within such sixty (60) day period, HJD shall have
the right to terminate this Agreement effective at the end of such sixty (60)
day period without notice or any additional waiting periods.

 

c.                                       Orthogen shall maintain such
comprehensive general liability insurance beyond the expiration or termination
of this Agreement during (i) the period that any product, process or
service, relating to, or developed pursuant to, this Agreement is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Orthogen or by a sublicensee, Corporation Entity or 

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

15

 

agent of Orthogen and (ii) a reasonable period after the period
referred to in (c)(i) above which in no event shall be less than fifteen
(15) years.

 

11.           Expiry and Termination.

 

a.                                       Unless earlier terminated pursuant
to this Section 10 or Section 5.e., hereof, this Agreement shall
expire upon the expiration of the period of the License in all countries as set
forth in Section 4.b. above.

 

b.                                      At any time prior to expiration of
this Agreement, either party may terminate this Agreement forthwith for cause,
as “cause” is described below, by giving written notice to the other
party.  Cause for termination by one
party of this Agreement shall be deemed to exist if the other party materially
breaches or defaults in the performance or observance of any of the provisions
of this Agreement and such breach or default is not cured within sixty (60)
days or, in the case of failure to pay any amounts due hereunder, thirty (30)
days (unless otherwise specified herein) after the giving of notice by the
other party specifying such breach or default, or if either HJD or Orthogen
discontinues its business or becomes insolvent or bankrupt.

 

d.                                      Upon termination of this Agreement
for any reason and prior to expiration as set forth in Section 10.a.
hereof, all rights in and to the Research Technology previously held by HJD
shall revert to HJD.

 

e.                                       Termination of this Agreement
shall not relieve either party of any obligation to the other party incurred
prior to such termination.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

16

 

f.                                         Sections 9, 10, 11 and 15 hereof
shall survive and remain in full force and effect after any termination,
cancellation or expiration of this Agreement.

 

12.           Representations and Warranties by
Orthogen.

 

Orthogen
hereby represents and warrants to HJD as follow:

 

a.                                       Orthogen is a corporation duly
organized, validly existing and in good standing under the laws of the State of
New Jersey.  Orthogen has been granted
all requisite power and authority to carry on its business and to own and
operate its properties and assets.  The
execution, delivery and performance of this Agreement have been duly authorized
by the Board of Directors of Orthogen.

 

b.                                      There is no pending or, to
Orthogen’s knowledge, threatened litigation involving Orthogen which would have
any effect on this Agreement or on Orthogen’s ability to perform its
obligations hereunder; and

 

c.                                       There is no indenture, contract,
or agreement to which Orthogen is a party or by which Orthogen is bound which
prohibits or would prohibit the execution and delivery by Orthogen of this
Agreement or the performance or observance by Orthogen of any term or condition
of this Agreement.

 

13.           Representations and Warranties by
HJD.

 

HJD
hereby represents and warrants to Orthogen as follows:

 

a.                                       HJD is a corporation duly
organized, validly existing and in good standing under the laws of the State of
New York.  HJD has been granted all
requisite power and authority to carry on its business and to own and operate
its properties and assets. The execution, delivery and performance of this
Agreement have been duly authorized by the Board of Trustees of HJD.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

17

 

b.                                      There is no pending or, to HJD’s
knowledge, threatened litigation involving HJD which would have any effect on
this Agreement or on HJD’s ability to perform its obligations hereunder; and

 

c.                                       There is no indenture, contract,
or agreement to which HJD is a party or by which HJD is bound which prohibits
or would prohibit the execution and delivery by HJD of this Agreement or the
performance or observance by HJD of any term or condition of this Agreement.

 

14.                                 No Assignment.

 

Neither
Orthogen nor HJD shall have the right to assign, delegate or transfer at any
time to any party, in whole or in part, any or all of the rights, duties and
interest herein granted without first obtaining the written consent of the
other to such assignment.

 

15.                                 Use of Name.

 

Without
the prior written consent of the other party, neither Orthogen nor HJD shall
use the name of the other party or any adaptation thereof or of any staff
member, employee or student of the other party:

 

a.                                       in any product labeling,
advertising, promotional or sales literature;

 

b.                                      in connection with any public or
private offering or in conjunction with any application for regulatory
approval, unless disclosure is otherwise required by law, in which case either
party may make factual statements concerning the Agreement or file copies of
the Agreement after providing the other party with an opportunity to comment
and reasonable time within which to do so on such statement in draft.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

18

 

Except
as provided herein, neither HJD nor Orthogen will issue public announcements
about this Agreement without prior written approval of the other party.

 

16.                                 Miscellaneous.

 

a.                                       In carrying out this Agreement the
parties shall comply with all local, state and federal laws and regulations
including but not limited to, the provisions of Title 35 United States Code
§200 et  seq. and 15 CFR §368 et  seq.

 

b.                                      If any provision of this Agreement
is determined to be invalid or void, the remaining provisions shall remain in
effect.

 

c.                                       This Agreement shall be deemed to
have been made in the State of New York and shall be governed and interpreted
in all respects under the laws of the State of New York.

 

d.                                      Any dispute arising under this
Agreement shall be resolved in an action in the courts of New York State or the
federal courts located in New York State, and the parties hereby consent to
personal jurisdiction of such courts in any action.

 

e.                                       All payments or notices required
or permitted to be given under this Agreement shall be given in writing and
shall be effective when either personally delivered or deposited, postage
prepaid, in the United States registered or certified mail, addressed as
follows:

 

To HJD:                                                                                                                                                    John N.
Kastanis

President and CEO

Hospital for Joint Diseases

301 East 17th Street

New York, NY 10003

 

and to:                                                                                                                                                           Isaac T.
Kohlberg

Vice Provost, New York
University

c/o NYU School of Medicine

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

19

 

550 First Avenue

New York, NY 10016

 

To Orthogen:                                                                                                                        Orthogen
Corporation

530 Morris Avenue

Suite 204

Springfield, NJ 07081

 

Attention:                                         Harold
Alexander

President

 

or
such other address or addresses as either party may hereafter specify by
written notice to the other.  Such
notices and communications shall be deemed effective on the date of delivery or
fourteen (14) days after having been sent by registered or certified mail,
whichever is earlier.

 

f.                                         This Agreement (and the annexed
Appendices) constitute the entire Agreement between the parties and no
variation, modification or waiver of any of the terms or conditions hereof
shall be deemed valid unless made in writing and signed by both parties
hereto.  This Agreement supersedes any
and all prior agreements or understandings, whether oral or written, between
Orthogen and HJD.

 

g.                                      No waiver by either party of any
non-performance or violation by the other party of any of the covenants,
obligations or agreements of such other party hereunder shall be deemed to be a
waiver of any subsequent violation or non-performance of the same or any other
covenant, agreement or obligation, nor shall forbearance by any party be deemed
to be a waiver by such party of its rights or remedies with respect to such
violation or non-performance.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

20

 

h.                                      The descriptive headings contained
in this Agreement are included for convenience and reference only and shall not
be held to expand, modify or aid in the interpretation, construction or meaning
of this Agreement.

 

i.                                          It is not the intent of the
parties to create a partnership or joint venture or to assume partnership
responsibility or liability.  The
obligations of the parties shall be limited to those set out herein and such
obligations shall be several and not joint.

 

IN
WITNESS WHEREOF, the parties hereto have executed this Agreement effective as
of the date and year first above written.

 

	
   

  	
   

  	
  HOSPITAL
  FOR JOINT DISEASES

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /S/ John N. Kastanis

  
	
   

  	
   

  	
  John
  N. Kastanis

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:
  

  	
  President
  and CEO

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  8/12/99

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  ORTHOGEN
  CORPORATION

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /S/ Harold Alexander

  
	
   

  	
   

  	
  Harold
  Alexander, Ph.D.

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:
  

  	
  President

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  August 4, 1999

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

21

 

APPENDIX I

 

HJD/Orthogen
Joint Patents

 

United
States

 

	
  Serial
  No.

  	
   

  	
  Filed

  	
   

  	
  Title

  	
   

  	
  Status

  
	
  09/187,584
  

  	
   

  	
  11/06/98

  	
   

  	
  Implantation
  of Surgical Implants with Calcium Sulfate

  	
   

  	
  Pending

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  08/996,244
  

  	
   

  	
  12/22/97
  

  	
   

  	
  Control
  of Cell Growth and Textured Substrates 

  	
   

  	
  Pending
  

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  cip
  of 08/639,712 (now abandoned)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  con
  of 08/390,805 (now abandoned)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  con
  of 08/146,790 (now abandoned)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

Foreign

 

	
  Country

  	
   

  	
  App. No.

  	
   

  	
  Title

  	
   

  	
  Status

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Canada

  	
   

  	
  2,175,660

  	
   

  	
  Control
  of Cell Growth

  	
   

  	
  Request
  examination before 11/02/01

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Europe

  	
   

  	
  95
  90 17 92.2

  	
   

  	
  Control
  of Cell Growth

  	
   

  	
  Pending

  

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

22Exhibit 10.13

 

LICENSE AGREEMENT

 

between

 

THE UAB RESEARCH FOUNDATION

 

and

 

BIOHORIZONS DENTAL IMPLANTS, L.L.C.

 

Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Registrant’s
application requesting confidential treatment pursuant to Rule 406 of the
Securities Act of 1933, as amended.

 

 

TABLE OF CONTENTS

 

	
  1.

  	
  DEFINITIONS

  	
  4

  
	
   

  	
   

  	
   

  
	
  2.

  	
  PATENT
  PROSECUTION AND MAINTENANCE

  	
  5

  
	
   

  	
   

  	
   

  
	
  3.

  	
  GRANT

  	
  6

  
	
   

  	
   

  	
   

  
	
  4.

  	
  ROYALTIES
  AND LICENSE FEES

  	
  6

  
	
   

  	
   

  	
   

  
	
  5.

  	
  DUE
  DILIGENCE

  	
  8

  
	
   

  	
   

  	
   

  
	
  6.

  	
  SUBLICENSING
  RIGHTS

  	
  9

  
	
   

  	
   

  	
   

  
	
  7.

  	
  PROGRESS
  AND ROYALTY REPORTS

  	
  9

  
	
   

  	
   

  	
   

  
	
  8.

  	
  BOOKS
  AND RECORDS

  	
  10

  
	
   

  	
   

  	
   

  
	
  9.

  	
  LIFE
  OF THE AGREEMENT

  	
  10

  
	
   

  	
   

  	
   

  
	
  10.

  	
  TERMINATION
  BY UABRF

  	
  11

  
	
   

  	
   

  	
   

  
	
  11.

  	
  TERMINATION
  BY LICENSEE

  	
  11

  
	
   

  	
   

  	
   

  
	
  12.

  	
  DISPOSITION
  OF LICENSED PRODUCTS ON HAND UPON TERMINATION

  	
  11

  
	
   

  	
   

  	
   

  
	
  13.

  	
  PATENT
  MARKING

  	
  11

  
	
   

  	
   

  	
   

  
	
  14.

  	
  USE
  OF NAMES AND TRADEMARKS

  	
  11

  
	
   

  	
   

  	
   

  
	
  15.

  	
  LIMITED
  WARRANTY

  	
  12

  
	
   

  	
   

  	
   

  
	
  16.

  	
  PATENT
  INFRINGEMENT

  	
  12

  
	
   

  	
   

  	
   

  
	
  17.

  	
  INDEMNIFICATION
  AND INSURANCE

  	
  14

  
	
   

  	
   

  	
   

  
	
  18.

  	
  NOTICES

  	
  15

  
	
   

  	
   

  	
   

  
	
  19.

  	
  ASSIGNABILITY

  	
  15

  
	
   

  	
   

  	
   

  
	
  20.

  	
  LATE
  PAYMENTS

  	
  15

  
	
   

  	
   

  	
   

  
	
  21.

  	
  WAIVER

  	
  15

  
	
   

  	
   

  	
   

  
	
  22.

  	
  GOVERNING
  LAWS

  	
  15

  
	
   

  	
   

  	
   

  
	
  23.

  	
  UAB
  POLICIES; FEDERAL LAWS

  	
  16

  
	
   

  	
   

  	
   

  
	
  24.

  	
  FOREIGN
  GOVERNMENT APPROVAL OR REGISTRATION

  	
  17

  

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

2

 

	
  25.

  	
  EXPORT
  CONTROL LAWS

  	
  17

  
	
   

  	
   

  	
   

  
	
  26.

  	
  FORCE
  MAJEURE

  	
  17

  
	
   

  	
   

  	
   

  
	
  27.

  	
  DISPUTE
  RESOLUTION

  	
  17

  
	
   

  	
   

  	
   

  
	
  28.

  	
  MISCELLANEOUS

  	
  18

  

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

3

 

LICENSE AGREEMENT

 

THIS
AGREEMENT is made and effective this 29th day of June,
1995 (the “Effective Date”) by and between The UAB Research Foundation, a
non-profit organization, organized exclusively for charitable, scientific, and
educational purposes within the meaning of 501(c)(3) of the Internal
Revenue Code and any revisions thereof and existing under the laws of the State
of Alabama and having an administrative office at 701 S. 20th Street, Suite 1120G/AB,
hereinafter referred to as “UABRF,” and BioHorizons Dental Implants, L.L.C., a
limited liability company, having a principal place of business: at 2129
Montgomery Highway, Birmingham, Alabama 
35209, hereinafter referred to as “LICENSEE”.

 

RECITALS

 

WHEREAS,
UABRF is organized exclusively for charitable, scientific, and educational
purposes within the meaning of Section 501(c)(3) of the Internal
Revenue Code of the United States of America or any corresponding provisions
thereof;

 

WHEREAS,
LICENSEE desires to exclusively license the patents and patent applications
defined as UABRF Patent Rights in accordance with the terms and conditions of
this Agreement, and both parties wish to enter into this Agreement as of the
Effective Date.

 

NOW
THEREFORE, in consideration of the premises and of the faithful performance of
the covenants herein, the parties agree as follows:

 

1.                                      DEFINITIONS

 

1.1                                 “Affiliate” shall mean LICENSEE
and any company or other legal entity other than LICENSEE in whatever country
organized, controlling, controlled by or under common control with
LICENSEE.  The term “control” means
possession, direct or indirect, of the powers to direct or cause the direction
of the management and policies of LICENSEE, whether through the ownership of
voting securities, by contract or otherwise.

 

1.2                                 “Confidential Information” shall
mean any information, document, material, design, or communication relating to
the business or research of LICENSEE, or relating to the UABRF Patent Rights or
Licensed Products, which is marked as confidential or proprietary, or which, in
the exercise of reasonable judgment would be deemed to be confidential or
proprietary and not publicly available; provided, however, Confidential Information
shall not include information which, at the time of its receipt, is generally
available in the public domain, or thereafter becomes available to the public
through no act of the receiving party; or which was independently known prior
to its receipt, or made available to the receiving party as a matter of lawful
right by a third party.

 

1.3                                 “First Commercial Sale” shall mean
in each country, the first sale of any Licensed Product by LICENSEE or its
Affiliates or its Sublicensees other than for testing or experimental purposes,
following approval of its marketing by the appropriate governmental agency for
the country in which the sale is to be made and, when governmental approval is
not required, the first sale other than for testing or experimental purposes in
that country.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

4

 

1.4                                 “Licensed Method” shall mean any
process or method which is covered by UABRF Patent Rights or whose use or
practice would constitute an infringement of any claim within UABRF Patent
Rights.

 

1.5                                 “Licensed Product” shall mean any
article, composition, apparatus, substance, chemical, or any other material
that either is covered by UABRF’ Patent Rights or whose manufacture, use or
sale would constitute an infringement of any claim within UABRF’ Patent Rights
or any article, composition, apparatus, chemical, substance or any other
material made, used, or sold for use with a Licensed Method.

 

1.6                                 “Net Sales” shall mean the total
amount received by LICENSEE or its Affiliates from the sale or distribution of
Licensed Products other than for testing or experimental purposes, less the sum
of the following deductions where applicable: 
[***].

 

1.7                                 “UABRF Patent Rights” shall mean
UABRF rights to any subject, matter claimed in or covered by the claims in
patent application serial number 08/356,597, filed on December 15, 1994,
assigned to UABRF; any continuing applications thereof including division but
excluding continuation in part applications except to the extent that any such
continuation-in-part has claims directed to subject matter specifically
described and enabled in the patents and/or applications listed above; any
patents issuing on said application or continuing applications including
reissues and reexaminations thereof; any foreign applications or patents
corresponding directly thereto; or any other UABRF Case No. designating a
case disclosed prior to the effective date of this Agreement and relating to
that body of technology described in Section 1.7 of this Agreement.

 

2.                                      PATENT PROSECUTION AND MAINTENANCE

 

2.1                                 Commencing on the Effective Date,
LICENSEE shall assume the responsibility to file, prosecute and maintain the
United States and foreign patents and applications comprising UABRF Patent
Rights (such actions referred to collectively herein as “Patent Protection”)
and shall pay all costs and fees associated with such Patent Protection.  LICENSEE shall use qualified patent counsel
it selects, subject to the written approval of UABRF, which approval shall not
be unreasonably withheld, and all such patents shall be in the name of
UABRF.  LICENSEE shall provide UABRF or
its designated representative with copies of each patent application, office
action, response to office action, request for terminal disclaimer, and request
for reissue or reexamination of any patent or patent application under UABRF
Patent Rights sufficiently prior to the filing of such application, response or
request to allow for review and comment by UABRF, provided that LICENSEE may
take action reasonably necessary to protect UABRF Patent Rights in Licensed
Products or Licensed Methods, if deadlines necessitate that such action be
taken prior to comments by UABRF. 
LICENSEE shall use all reasonable efforts to amend any patent application
to include claims requested by UABRF in order to extend protection of UABRF
Patent Rights that relate to any Licensed Product or Licensed Method, including
applying for an extension of the term of any patent included within UABRF
Patent Rights, if appropriate, under the Drug Price Competition and Patent Term
Restoration Act of 1984.  LICENSEE shall
prepare all such documents, and UABRF agrees to execute such documents and to
take such additional action as LICENSEE may reasonably request in connection
therewith.  Neither party shall allow any
UABRF Patent Rights for which 

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

5

 

LICENSEE
is licensed and is underwriting the costs to lapse or become abandoned without
written authorization on reasonable written notice from the other party.

 

2.2                                 UABRF and LICENSEE shall consult
with each other and patent counsel in good faith and mutually determine the
extent to which Patent Protection should be pursued, and in which countries it
should be pursued, and shall mutually agree on strategies for Patent Protection
based on what Patent Protection is commercially reasonable and appropriate to
the diligent commercialization of the Licensed Products.  LICENSEE shall underwrite the legal fees and
costs of Patent Protection in those countries and to the extent that the
Parties so agree.  These obligations
shall continue for so long as this Agreement remains in effect; provided,
however, that LICENSEE may terminate its obligations to underwrite any given
application or patent that the Parties have agreed to pursue, upon thirty (30)
days prior written notice to UABRF. 
UABRF will use its best efforts to curtail patent costs immediately upon
receipt of such a notice from LICENSEE. 
UABRF may continue prosecution and/or maintenance of such application(s) or
patent(s) at its sole discretion and expense; provided, however, that
LICENSEE shall have no further right or licenses thereunder.

 

3.                                      GRANT

 

3.1                                 Subject to the limitations set
forth in this Agreement, UABRF hereby grants to LICENSEE and its Affiliates a
worldwide, irrevocable royalty-bearing license in, under and to UABRF Patent
Rights to make, have made, use, and sell Licensed Products and to practice
Licensed Method.

 

3.2                                 Except as otherwise provided
herein, the license granted in paragraph 3.1 shall be exclusive for the Term of
the Agreement as set forth in Section 9. 
During the Term of the Agreement, UABRF shall not offer to any third
party a license under Patent Rights to make, have made, use or sell Licensed
Product or to practice the Licensed Method, shall not solicit any offers
therefor and shall not engage in any negotiations with a view to consummating
any such license.

 

3.3                                 The License granted hereunder
shall be subject to any overriding obligations to the U.S Government.

 

3.4                                 UABRF expressly reserves the right
to allow UAB faculty, students, fellows and trainees to use UABRF Patent Rights
solely for educational and research purposes at UAB, and not for commercial
purposes or for any other purpose that is inconsistent with the rights granted
to LICENSEE hereunder.

 

4.                                      ROYALTIES AND LICENSE FEES

 

4.1                                 Within thirty (30) days after the
Effective Date, LICENSEE shall pay to UABRF a license fee of [***] Dollars
($[***]).  With six (6) months after
the Effective Date, LICENSEE shall pay one-half (1/2) of the total amount of
patent expenses incurred to-date by UABRF in connection with protection of
UABRF Patent Rights as set forth on Exhibit A, attached hereto and
incorporated by reference herein, and within one (1) year of the Effective
Date, Licensee shall pay UABRF the remaining one-half (1/2) of said patent
expenses, as set, forth on Exhibit A.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

6

 

4.2                                 Throughout the Life of this
Agreement, LICENSEE shall pay to UABRF for sale of Licensed Products sold by
LICENSEE or its Affiliates or its sublicensees an earned royalty of
[***]percent ([***]%) of the Net Sales of Licensed Products.  It is acknowledged and agreed that, in the
event Licensee reasonably determines that licenses from third parties are necessary
or appropriate to advance the development or commercialization of Licensed
Products, LICENSEE shall provide notice to UABRF and shall document the costs
of such licenses, and the parties shall in good faith agree upon commercially
reasonable reductions in the royalty rate.

 

4.3                                 Upon the receipt by LICENSEE of
notice that a Licensed Product has been approved by the applicable U.S. federal
regulatory authorities for commercial sale, LICENSEE shall pay UABRF [***]
Dollars ($[***]), which shall be a credit against the royalties on Net Sales and
the annual Minimum loyalties that thereafter are due and owing.

 

4.4                                 Beginning on the earlier of (i) the
next January 1 after the first year anniversary of the date of First
Commercial Sale of Licensed Products anywhere in the world, or (ii) January 1,
2003, and continuing thereafter for the Term of the Agreement, LICENSEE shall
pay to UABRF cumulative minimum annual royalties, as follows:  The minimum annual royalty shall be paid to
UABRF by the end of the first calendar quarter of the year in which it is due,
and shall be credited against the total earned royalties and sublicense fees
due and owing for the calendar year in which the minimum payment was made.  The amount of the first such minimum royalty
shall be [***] Dollars ($[***]).  The
annual minimum royalty shall increase by [***] Dollars ($[***]) each January 1
thereafter for three (3) years until the amount reaches [***] Dollars
($[***]).  Thereafter, the annual minimum
royalty-shall be [***] Dollars ($[***]) per year for the Term of the Agreement.

 

4.5                                 Paragraphs 1.7, 1.5, and 1.4
define UABRF Patent Rights, Licensed Products and Licensed Methods so that
royalties shall be payable on products and methods covered by both pending
patent applications and issued patents. 
Earned royalties shall accrue in each country for the duration of UABRF
Patent Rights in that country.

 

4.6                                 Royalties accruing to UABRF shall
be paid to UABRF on a quarterly basis. 
Each such payment will be for royalties which accrued within the most
recently completed calendar quarter and payment shall be made by LICENSEE
within [***] ([***])[***] of the end of such calendar quarter.

 

4.7                                 All monies due UABRF shall be
payable in United States funds collectible at par in Birmingham, Alabama.  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 converted into equivalent United States funds.  The exchange rate will be that established by
the Bank of America in San Francisco, California on the last day of the
reporting period.

 

4.8                                 Any tax for the account of UABRF
required to be withheld by LICENSEE under the laws of any foreign country,
shall be promptly paid by LICENSEE for and on behalf of UABRF to the
appropriate governmental authority, and LICENSEE shall use efforts to furnish
UABRF with proof of payment of such tax. 
LICENSEE shall be responsible for all bank transfer charges.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

7

 

4.9                                 If at any time legal restrictions
prevent the prompt remittance of part or all royalties by LICENSEE with respect
to any country where a Licensed Product is sold, LICENSEE shall have the right
and option to make such payments by depositing the amount thereof in local
currency to UABRF’s account in a bank or other depository in such country.

 

5.                                      DUE DILIGENCE

 

5.1                                 Commencing upon the Effective
Date, LICENSEE shall diligently, earnestly and with reasonable effort, to the
extent it is commercially practicable, proceed with further research and
development, manufacture and sale of Licensed Products and endeavor to market
the same within a commercially reasonable time after execution of this
Agreement and in quantities sufficient to meet the market demands therefor.

 

5.2                                 LICENSEE shall endeavor to obtain
all necessary governmental approvals for the manufacture, use and sale of
Licensed Products.  LICENSEE shall have
the sole discretion for making all decisions as to how to commercialize, market
and sell Licensed Products.

 

5.3                                 UABRF shall have the right and
option to terminate this Agreement subject to Section 5.4 below, if
LICENSEE is unable to perform any of the following:

 

(a)                                  Within one hundred eighty (180)
days from the Effective Date, develop research laboratory facilities, either
through construction, purchase or third-party contractual arrangements,
sufficient to continue development of Licensed Product and/or Licensed Method;

 

(b)                                 Within two (2) years from the
Effective Date, file at least one application for applicable federal regulatory
approval of a Licensed Product with the U.S. FDA.

 

(c)                                  Within three (3) years of the
Effective Date, secure additional financial commitments reasonably necessary to
permit the continued development by LICENSEE of Licensed Product and Licensed
Method consistent with the requirements of this Agreement in a minimum amount
of no less than Two Hundred Fifty Thousand Dollars ($250,000).

 

(d)                                 Within five (5) years from
the Effective Date, file a second application for applicable regulatory
approval with the FDA covering a second Licensed Product or have at
least one Licensed Product in U.S. FDA clinical trials.

 

5.4                                 To exercise the right to terminate
this Agreement for lack of diligence, UABRF must give LICENSEE written notice
of the deficiency.  LICENSEE thereafter
has ninety (90) days to cure the deficiency or to request dispute resolution
under Article 27.  If UABRF has not
received by the end of the ninety (90) day period, such a written request or
commercially reasonable evidence that the deficiency has been cured or that
LICENSEE has taken action that is designed to correct the deficiency within a
commercially reasonable period of time thereafter, then UABRF may, at its
option, terminate this Agreement by giving written notice to LICENSEE.  These notices shall be subject to Article 19
(Notices).

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

8

 

6.                                      SUBLICENSING RIGHTS

 

6.1                                 UABRF also grants to LICENSEE the
right to issue sublicenses to third parties to make, have made, use, and sell
Licensed Products and to practice Licensed Methods provided LICENSEE has
current exclusive rights thereto under this Agreement.  Such sublicenses shall include all of the
rights of and obligations (including royalty obligations) due to UABRF (and, if
applicable, the United States Government) that are contained in this
Agreement.  In the event that LICENSEE
receives sublicense fees in any form (including cash, equity, or other
remuneration) over and above earned royalties as consideration for such
sublicense (excluding payments made by sublicensee to LICENSEE in consideration
for services rendered or for research or for rights to patents or other
technology other than UABRF Patent Rights) (“Sublicense Fees”), LICENSEE shall
pay to UABRF within [***] ([***]) days of LICENSEE’S receipt of Sublicense
Fees, the following amounts (In the event the sublicensee Fees are in a form
other than cash, the fair market value of the remuneration shall be used in
calculating payment due to UABRF.):

 

(a)                                  For sublicenses issued prior to the
earlier of:  January 1, 2000 or the
date that LICENSEE receives notice that a Licensed Product has been approved by
the applicable U.S. regulatory authorities for community sale, [***] percent
([***]%) of the Sublicense Fee;

 

(b)                                 For sublicenses issued after the
next January 1 following the earlier date specified in (a) hereinabove,
the percentage of the Sublicense Fee that LICENSEE shall pay to UABRF shall
decline [***] percent ([***]%) each calendar year until the percentage of the
Sublicense Fee owed by LICENSEE to UABRF shall be [***] percent ([***]%).

 

(c)                                  Thereafter, LICENSEE shall pay
UABRF a percentage of Sublicense Fees received by LICENSEE during the term of
this Agreement that is the lower of [***]percent ([***]%) or the earned
percentage used to calculate the royalty rate.

 

6.2                                 LICENSEE shall provide UABRF with
the name, address, and pertinent financial and other information reasonably
requested by UABRF concerning each sublicensee hereunder and shall summarize
and deliver all reports due UABRF from sublicensees.

 

6.3                                 Upon termination of this Agreement
for any reason, at the option of UABRF, all sublicensee shall be assigned to
UABRF, and shall remain in full force and effect under the terms and conditions
thereof with UABRF as the licensor, but the duties of UABRF shall only extend
to UABRF duties under this Agreement.

 

7.                                      PROGRESS AND ROYALTY REPORTS

 

7.1                                 Beginning January 1, 1996 and
semi-annually thereafter, LICENSEE shall submit to UABRF a progress report
covering LICENSEE’s activities related to the development and, testing of all
Licensed Products and the obtaining of the governmental approvals necessary for
marketing.  These progress reports shall
be made for each Licensed Product until the First Commercial Sale of that
Licensed Product occurs anywhere in the world.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

9

 

7.2                                 LICENSEE also agrees to report to
UABRF in its immediately subsequent progress and royalty report the date of
First Commercial sale of a Licensed Product in each country.

 

7.3                                 After the First Commercial Sale of
a Licensed Product anywhere in the world, LICENSEE will make quarterly royalty
reports to UABRF on or before each February 28, May 31, August 31
and November 30 of each year (i.e. within two (2) months from the end
of each calendar quarter).  Each such
royalty report will cover LICENSEE’S most recently completed calendar quarter
and will show (a) the gross sales and Net Sales of Licensed Products sold
by LICENSEE or its Affiliates or Sublicensee during the most recently completed
calendar quarter; (b) the number of each type of Licensed Product sold; (c) the
royalties, in U.S. dollars, payable hereunder with respect to such sales; and (d) the
exchange rates used.

 

7.4                                 If no sales of Licensed Products
have been, made during any reporting period, a statement to this effect shall
be provided.

 

8.                                      BOOKS AND RECORDS

 

8.1                                 LICENSEE shall keep books and
records accurately showing all Licensed Products manufactured, used and/or sold
under the terms of this Agreement.  Such
books and records shall be preserved for at least five (5) years from the
date of the royalty payment to which they pertain and shall be open to
inspection by representatives or agents of UABRF at reasonable times upon
reasonable advance notice to LICENSEE.

 

8.2                                 The fees and expenses of UABRF
representatives performing such an examination shall be borne by UABRF.  However, if such examination establishes a
deficiency in royalties paid by Licensee of more than [***]percent ([***]%) of
the total royalties duo for any year, then the fees and expenses of the
examination shall be borne by LICENSEE.

 

9.                                      LIFE OF THE AGREEMENT

 

9.1                                 Unless otherwise terminated by
operation of law or by acts of the parties in accordance with the terms of this
Agreement, this Agreement shall be in force from the Effective Date and shall
remain in effect for the life of the last-to-expire patent in UABRF Patent
Rights, or until the last patent application licensed under this Agreement is
abandoned and no patent in UABRF Patent Rights ever issues, whichever occurs
last.  At the end of said period,
LICENSEE shall have a fully paid, perpetual royalty-free license to continue to
make, have made, use and sell Licensed Products and to practice Licensed
Methods.

 

9.2                                 Any termination of this Agreement
shall not affect the rights and obligations set forth in the following
Articles:

 

Article 8
- Books and Records

Article 12
- Disposition of Licensed Products on hand upon Termination

Article 14
- Use of Names and Trademarks

Article 15
- Limited Warranty

Article 17
- Indemnification

Article 26
- Dispute Resolution

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

10

 

10.          TERMINATION BY UABRF

 

10.1         Subject to Article 6, if
LICENSEE should violate or fail to perform any material term or covenant of
this Agreement, then UABRF may give written notice of such default (Notice of
Default) to LICENSEE.  If LICENSEE should
fail to repair or demonstrate diligent efforts to commence the repair of such
default within ninety (90) days of the effective date of such notice, UABRF
shall have the right to terminate this Agreement and the licenses herein by a
second written notice (Notice of Termination) to LICENSEE.  If a Notice of Termination is sent to
LICENSEE, this Agreement shall automatically terminate thirty (30) days after
the receipt of such notice.  These
notices shall be subject to Article 18 (Notices).  Such termination shall not relieve LICENSEE
of its obligation to pay any royalty or fees owing at the time of such
termination and shall not impair any accrued right of either party under this
Agreement.

 

11.          TERMINATION BY LICENSEE

 

11.1         LICENSEE shall have the right at
any time to terminate this Agreement in whole or as to any portion of UABRF
Patent Rights by giving notice in writing to UABRF.  Such notice of termination shall be subject
to Article 18 (Notices) and termination of this Agreement shall be
effective ninety (90) days from the effective date of such notices.

 

11.2         Any termination pursuant to the
above paragraph shall not relieve LICENSEE of any obligation or liability
accrued hereunder prior to such termination or rescind anything done by
LICENSEE or any payments made to UABRF hereunder prior to the time such
termination becomes effective, and such termination shall not affect in any
manner any rights of either party arising under this Agreement prior to such
termination.

 

12.          DISPOSITION OF LICENSED PRODUCTS ON HAND
UPON TERMINATION

 

12.1         Upon termination of this Agreement
LICENSEE shall have the privilege of disposing of all previously made or
partially made Licensed Products, but no more, within a period of [***] ([***])
[***]; provided, however, that the sale of such Licensed Products shall be
subject to the terms of this Agreement including, but not limited to, the
payment of royalties other than minimum royalties at the rate and at the time
provided herein and the rendering of reports thereon.

 

13.          PATENT MARKING

 

13.1         LICENSEE agrees to mark all
Licensed Products made, used or sold under the terms of this Agreement, or
their containers, in accordance with the applicable patent marking laws.

 

14.          USE OF NAMES AND TRADEMARKS

 

14.1         Nothing contained in this Agreement
shall be construed as one party conferring on the other any right to use in
advertising, publicity, or other promotional activities any name, trade name,
trademark, or other designation (including contraction, abbreviation or
simulation of any of the foregoing), unless required by law.  The use of any designation of UABRF, UAB, “The
University of Alabama - Birmingham,” or the name of any campus of the
University of Alabama requires the prior written approval of UABRF, except when
such name is used in a factual 

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

11

 

manner to
identify UABRF as the source of the Patent Rights or to identify UAB as the
location of the initial research on the technology included in the Patent
Rights.

 

15.          LIMITED WARRANTY

 

15.1         UABRF warrants to LICENSEE that it
has the lawful right to grant this license.

 

15.2         This license and the inventions
covered herein are provided without warranty of merchantability or fitness for
a particular purpose or any other warranty, express or implied.  UABRF makes no representations or warranty
that the Licensed Products or Licensed Methods will not infringe any patent or
other proprietary right.

 

15.3         In no event will UABRF be liable
for any incidental, special or consequential damages resulting from the
exercise of this license or the use of Licensed Products.

 

15.4         Nothing in this Agreement shall be
construed as:

 

(a)           a warranty or representation by UABRF as to the
validity or scope of any UABRF Patent Rights; or,

 

(b)           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 of third parties; or,

 

(c)           an obligations to bring or prosecute actions or
suits against third parties for patent infringement except as provided in Article 16;
or,

 

(d)           conferring by implication, estoppel or otherwise any
license or rights under any patents of UABRF other than UABRF Patent Rights as
defined herein, regardless of whether such patents are dominant or subordinate
to UABRF’ Patent Rights; or,

 

(e)           an obligation to furnish any know-how not provided
in UABRF Patent Rights.

 

16.          PATENT INFRINGEMENT

 

16.1         In the event that either Party
shall learn of the substantial infringement of any patent in UABRF Patent
Rights, such Party shall call attention thereto in writing and shall provide
the other Party 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 UABRF Patent Rights without first obtaining consent of the other party,
which consent shall not be unreasonably denied. 
Both parties shall diligently and in good faith cooperate with each
other in seeking to terminate such infringement without litigation.

 

16.2         LICENSEE may request that UABRF
take legal action against the infringement of UABRF Patent Rights.  Such request shall be made in writing and
shall include reasonable evidence of such infringement and actual or potential
damages to LICENSEE.  If the infringing 

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

12

 

activity
has not been abated within [***] ([***]) days following the effective date of
such request, UABRF shall have the right to commence suit on its own account;
or refuse to participate in such suit.

 

UABRF shall give notice of its election in writing to LICENSEE by the end
of the [***] ([***]) day after receiving notice of such request from
LICENSEE.  LICENSEE may thereafter bring
suit for patent infringement in its own name, if and only if UABRF elects not
to commence suit or fails to respond to LICENSEE’S request by the end of the
[***] ([***]) day and if the infringement occurred during the period and in a
jurisdiction where LICENSEE has exclusive rights under this Agreement.  However, in the event LICENSEE elects to
bring suit in accordance with this paragraph, UABRF may thereafter join such
suit at its own expense.  LICENSEE shall
have the right to join any such litigation brought by UABRF at LICENSEE’s cost
and expense and with counsel of LICENSEE’s choice.

 

16.3         In the event of a potential
infringement of UABRF Patent Rights under the Drug Price Competition and Patent
Term Restoration Act of 1984 (Public Law 98-417), or in the event that action
must be taken in order to preserve the rights of the parties to take action
against infringers, the required notice periods set forth in Section 16.2
hereinabove shall be replaced by the time periods necessary to preserve the
right to take legal action against such infringement.

 

16.4         Such legal action as is decided
upon shall be at the expense of the party on account of whom suit is brought
and with the exception of Paragraph 16.6 herein all recoveries recovered thereby
shall belong to such party; provided, however, that legal action brought
jointly by UABRF and LICENSEE and fully participated in by both shall be at the
joint expense of the Parties and all recoveries shall be applied first toward
full (or proportional, if the recovery is insufficient to reimburse fully)
reimbursement of the legal fees and expenses incurred by each party relating to
the suit, and the balance remaining from any such recoveries shall be shared
jointly by them in proportion to the share of expense reasonably paid by each
party.

 

16.5         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.  Such litigation shall be controlled by the party
bringing the suit, except that UABRF may be represented by counsel of its
choice in any suit brought by LICENSEE.

 

16.6         In the event that LICENSEE shall
undertake the enforcement and/or defense of any UABRF Patent Rights by
litigation, LICENSEE may withhold the royalties (including the annual minimum
royalty payments) otherwise due UABRF during the pendency of such
litigation.  Any recovery of damages by
LICENSEE for any such suit shall be applied first in satisfaction of any
unreimbursed expenses and legal fees of LICENSEE relating to the suit, and,
second, toward reimbursement of UABRF for any royalties withheld and applied
pursuant to this paragraph 16.6.  The
balance remaining from any such recovery shall be retained by LICENSEE and
LICENSEE shall pay UABRF a royalty on such balance at the royalty rate which is
applicable under Article 4.

 

16.7         In the event that any patent or
any claim thereof included within the UABRF Patent Rights shall be held invalid
or unenforceable in a final decision by a court of competent jurisdiction, all
obligations to pay royalties based on such patent or claim or any claim
patentably 

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

13

 

indistinct
therefrom shall cease, pending a final decision by a court of competent
jurisdiction from which no appeal has or can be taken.  LICENSEE shall not, however, be relieved from
paying any royalties that are based on another patent or claim not involved in
such decision.  In the event that the
UABRF Patents Rights are then held to be valid or enforceable by the Court in a
decision that cannot be appealed, LICENSEE will pay to UABRF the royalties that
accrued before such decision or otherwise due during the pendency of the
appeal, in accordance with Section 16.6 hereinabove.

 

17.          INDEMNIFICATION AND INSURANCE

 

17.1         LICENSEE agrees to indemnify, hold
harmless and defend UABRF, its officers, employees, and agents and the
inventors of the patent and patent applications in UABRF Patent Rights
(collectively, “Indemnitees”) from and against any and all liability, claims,
suits, losses, damages , costs, fees, and expenses from third parties resulting
from or arising out of exercise of this license (collectively, “Damages”),
except to the extent such Damages are caused in whole or in part by the actions
or inactions of the Indemnitees; provided, however, such indemnification is
conditioned upon: (a) UABRF promptly notifying LICENSEE in writing of any
claim or suit brought against any of the Indemnitees in respect of which UABRF
intends to invoke the provisions of this Article 18, and (b) Indemnitees
cooperating fully with LICNSEE in defense of any such claim or suit, and (c) LICENSEE
having full authority and control, using counsel of its choice, over the
defense or settlement of such claim or suit. 
LICENSEE will keep UABRF informed on a current basis of its defense of
any claims pursuant to this Article 17.

 

17.22       Commencing after First Commercial
Sale of a Licensed Product anywhere in the world, LICENSEE, at its sole cost
and expense, shall insure its activities in connection with this Agreement and
obtain, keep in force and maintain insurance, to the extent that it is
commercially reasonable and practicable to maintain such insurance, and shall
furnish UABRF with certificates of insurance evidencing compliance with all
requirements, as follows:

 

(a)           Each Occurrence - $[***]

(b)           Products/Completed Operations
Aggregate - $[***]

(c)           Personal and Advertising Injury -
$[***]

(d)           General Aggregate (commercial form
only) - $[***]

 

Such
insurance shall:

 

(a)           Provide for thirty (30) day
advance written notice to UABRF of any modification.

(b)           Indicate that UABRF has been
endorsed as an Insured under the coverages referred to under the above, if such
co-insurance is available and commercially reasonable to obtain.

(c)           Include a provision that the
coverages will be primary and will not participate with nor will be excess over
any valid and collective insurance or program of self-insurance carried or
maintained by UABRF.

 

LICENSEE
shall not be required to insure its activities relative to the products’
liability risks until commencing use of Licensed Products on humans.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

14

 

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 or (b) five
(5) days after mailing if mailed by first-class certified mail, postage
paid, to the respective addresses given below, or to such other address as it
shall designate by written notice given to the other party.

 

In the case of LICENSEE:                  BIOHORIZONS DENTAL IMPLANTS, L.L.C.

2129
Montgomery Highway

Birmingham,
Alabama 35209

 

Attention:  Martha Warren Bidez, Ph.D.

 

In the case of UABRF:                        THE UAB
RESEARCH FOUNDATION

701
S. 20th Street

1120G/AB

Birmingham,
AL 35294-0111

Attention:
 Peter G. Ulrich

 

19.          ASSIGNABILITY

 

19.1         This Agreement is binding upon and
shall inure to the benefit of the parties, their successors and assigns, but
shall be assignable by LICENSEE only with the written consent of UABRF, which
consent shall not be unreasonably withheld. 
The consent of UABRF shall not be required where the assignment is in
conjunction with the transfer of all or substantially all of the business of
LICENSEE to which this Agreement relates.

 

20.          LATE PAYMENTS

 

20.1         In the event royalty payments or
fees are not received by UABRF within [***] ([***]) days of the date they are
due, LICENSEE shall pay to UABRF interest charges at a rate per annum of [***]
([***]) percent simple interest calculated from the date payment was due until
actually received by UABRF.

 

21.          WAIVER

 

21.1         It is agreed that no 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.          GOVERNING LAWS

 

22.1         This Agreement shall be
interpreted and construed in accordance with the laws of the State of Alabama,
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.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

15

 

23.          UAB POLICIES; FEDERAL LAWS

 

23.1         UAB Policies. 
LICENSEE acknowledges and agrees that all provisions of this Agreement
and any licenses hereunder shall be subject to UAB policy and federal law,
including without limitation all provisions of the Bayh-Dole Act and its
progeny, and that LICENSEE will assist and facilitate UABRF in obtaining
compliance with all aspects of UAB policy and federal law as they relate to
this Agreement.

 

23.2         Confidential Information. 
The free dissemination of information is an essential and long-standing
policy of UAB; however, UAB acknowledges that it may properly hold in
confidence data supplied by another entity, which UAB or such other entity
considers essential for the conduct of a research program or for compliance
with the terms of a license agreement relating to the results of University
research.  Accordingly, UABRF agrees that
UAB and UABRF shall maintain policies under which Confidential Information
relating to the Licensed Patents, Licensed Products, and business information
of LICENSEE may not be published or otherwise disclosed except to UABRF or UAB
personnel who has a need to know such information in order to comply with this
Agreement or UAB policy or federal law, without the prior written authorization
of LICENSEE and UABRF further agrees that it shall promptly notify LICENSEE of
any disclosure of such Confidential Information.

 

23.3         Publication. 
The parties acknowledge that publication, presentation, and discussion
of research are important objectives of UAB, but that procedures relating to
publication are desirable and necessary in order to protect the patent rights
of the parties and to protect against unauthorized disclosure of Confidential
Information.  UABRF and UAB personnel
shall therefore be free to produce publications (but not containing
Confidential Information as described in Section 23.2 hereinabove, which
shall not be disclosed), subject to the following provisions:

 

(a)           UABRF shall provide LICENSEE with preliminary drafts
of any proposed publication relating to the License Patents at least sixty (60)
days, in the case of written manuscripts, and at least thirty (30) days, in the
case of abstracts or outlines of oral presentations, prior to the intended
submission for publication, in order to allow LICENSEE to review the draft for
disclosure of information which may be patentable or copyrightable or
confidential.  At the end of such period,
UABRF shall be free to submit the publication or make the oral presentation,
unless LICENSEE has identified a disclosure of patentable information or
Confidential Information.

 

(b)           If LICENSEE informs UABRF that the proposed
publication includes a disclosure of Confidential Information, the Confidential
Information shall be redacted prior to publication or, if redaction is not
possible, the publication shall not be made until LICENSEE approves such
publication.

 

(c)           In the event that LICENSEE identifies disclosure of
inventions or patent rights not yet filed in the proposed publication, both
parties and their patent counsel shall use good faith efforts to have patent
applications claiming inventions disclosed by such publication filed within thirty
(30) days of the notification of such patentable information and, upon filing
of such applications, the publication may be released; provided, however, that 

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

16

 

extensions
of such thirty-day period that are reasonably necessary due to inability to
complete the application filings shall be granted upon mutual agreement by the
parties, and neither party shall unreasonably withhold its consent to such
request.

 

(d)           Notwithstanding any provisions to the contrary, this
Agreement shall not be construed or permitted to prohibit any publication
undertaken by a UAB student in furtherance of his or her degree requirement,
unless such limitation or prohibition is expressly approved by UAB and the
student.  This clause shall not, however,
limit the obligation to provide preliminary drafts of publications prior to
submission pursuant to the provisions of this Section 23.3.

 

24.          FOREIGN GOVERNMENT APPROVAL OR REGISTRATION

 

24.1         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 sha11 assume all
legal obligations to do so.

 

25.          EXPORT CONTROL LAWS

 

25.1         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.

 

26.          FORCE MAJEURE

 

26.1         The parties to this Agreement
shall be excused from any performance required hereunder if such performance is
rendered impossible or unfeasible due to any catastrophes or other major event
beyond their reasonable control, including, without limitation, war, riot, and
insurrection; laws, proclamations, edicts, ordinances or regulations; strikes,
lockouts or other serious labor disputes; and floods, fires, explosions, or
other natural disasters.  When such
events have abated, the parties’ respective obligations hereunder shall resume.

 

27.          DISPUTE RESOLUTION

 

27.1         The parties to this Agreement
hereby express that any controversy or claim arising out of or relating to the
interpretation, performance or breach of any provision of this Agreement shall
be resolved exclusively by the following mechanisms:

 

(a)           The parties hereto shall first engage in a good
faith effort to negotiate any such controversy or claim by communications
between them.  Said negotiations may be
oral or written.  To the extent that they
are oral, they should be confirmed in writing.

 

(b)           Should the above stated negotiations be
unsuccessful, the parties shall engage in mediation pursuant to the American
Arbitration Association Commercial Mediation Rules, or such other mediation rule as
the parties may otherwise agree.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

17

 

(c)           Should the above stated mediation be unsuccessful,
the parties agree to arbitrate any such controversy or claim with the express
understanding that this Agreement is affected by interstate commerce.  Said arbitration shall be conducted pursuant
to the American Arbitration Association Licensing Agreement Arbitration Rules,
or such other arbitration rules as the parties may otherwise agree.

 

(d)           The cost of the above stated mediation shall be borne
equally between the parties.  The cost of
the above stated arbitration shall be borne by the party against whom an award
is issued and in favor of the prevailing party. 
In either event, each party shall bear the cost of their own attorney
fees and costs.

 

(e)           Judgment upon the award rendered by the arbitrator(s) shall
be binding on the parties and may be entered by either party in the court or
forum, state or federal, having jurisdiction.

 

28.          MISCELLANEOUS

 

28.1         The headings of the several
sections 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, in
which event, it shall be effective as of the date recited on page one.

 

28.3         No amendment or modification
hereof shall be valid or binding upon the parties unless made in writing and
signed on behalf of each party.

 

28.4         This Agreement embodies the entire
understanding of the parties and shall supersede all previous communications,
representations or understandings, either oral or written, between the parties
relating to the subject matter hereof.

 

28.5         If any provision(s) contained
in this Agreement are or become invalid, are ruled illegal by any court of
competent jurisdiction or are deemed unenforceable under then current
applicable law from time to time in effect during the term hereof, it is the
intention of the parties that the remainder of this Agreement shall not be
affected thereby provided that a party’s rights under this Agreement are not
materially affected.  It is further the
intention of the parties that in lieu of each such provision which is invalid,
illegal, or unenforceable, there be substituted or added as part of this
Agreement a provision which shall be as similar as possible in economic and
business objectives as intended by the parties to such invalid, illegal or
unenforceable provision, but shall be valid, legal and enforceable.

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

18

 

IN
WITNESS WHEREOF, both UABRF and LICENSEE have executed this Agreement, in
duplicate originals, by their respective officer hereunto duly authorized, on
the day and year hereinafter written.

 

LICENSEE

 

	
  By:

  	
  /S/
  Martha Warren Bidez, Ph.D.

  	
   

  	
  By:

  	
  /S/
  Carl E. Misch, D.D.S.

  
	
   

  	
  Martha
  Warren Bidez, Ph.D.

  	
   

  	
   

  	
  Carl
  E. Misch, D.D.S.

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Member

  	
   

  	
  Title:

  	
  Member

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  June 29,
  1995

  	
   

  	
  Date:

  	
  June 29,
  1995

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  UABRF

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /S/Kenneth
  J. Roozen, Ph.D.

  	
   

  	
   

  
	
   

  	
  Kenneth
  J. Roozen, Ph.D.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Executive
  Director

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
  July 7,
  1995

  	
   

  	
   

  
								

 

Portions
of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933,
as amended.

 

19

 

AMENDMENT TO LICENSE AGREEMENT

 

This
AMENDMENT TO LICENSE AGREEMENT (the “Amendment”), made and executed as of the
12th day of March, 2007 (the “Effective Date”), by and between THE UAB RESEARCH FOUNDATION, a non-profit organization
organized and existing under the laws of the State of Alabama (“UABRF”), and BIOHORIZONS IMPLANT SYSTEMS, INC., a Delaware
corporation (referred to as “BioHorizons” or “LICENSEE”).

 

RECITALS:

 

UABRF
and BioHorizons (as successor-in-interest to BioHorizons Dental Implants, L.L.C.)
are parties to a License Agreement executed on June 29 and July 7,
1995 (the “License Agreement”).  There
have arisen certain disagreements between the parties as to the royalties and
other amounts payable under the License Agreement and the ownership of certain
intellectual property.  The parties are
entering into this Amendment to resolve and settle such disagreements and to
further amend the License Agreement, all on the terms and subject to the
conditions set forth herein.

 

NOW,
THEREFORE, in consideration of the premises and the mutual promises and
covenants hereinafter set forth, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties
hereto do hereby agree as follows:

 

1.             Royalties on International Sales.  On or before March 31, 2007, BioHorizons
will pay to UABRF $[***] in full
and complete satisfaction of any and all claims by UABRF for earned royalties
owed by BioHorizons through December 31, 2006, with respect to foreign
sales of Licensed Products manufactured in the U.S.

 

2.             Amendments to the License Agreement.  The following sections of the License
Agreement shall be replaced by the designated amended sections.

 

Section 1.5
of the License Agreement is replaced by the following amended Section 1.5

 

“Licensed
Product” shall mean any article, composition, apparatus, substance, chemical,
or any other material that either is covered by UABRF Patent Rights or whose
manufacture, use, or sale would constitute an infringement of any claim within
UABRF Patent Rights or any article, composition, apparatus, chemical, substance
or any other material made, used, or sold for use with a Licensed Method.  Without limiting the foregoing definition and
for the sake of clarity, Licensed Products shall include, but not be limited
to, any product sold by or on behalf of LICENSEE that is marked with a patent
number included within the UABRF Patent Rights and the following products
currently marketed by or on behalf of LICENSEE (including similar products as
they may be renamed): BioHorizons® internal, BioHorizons® one-piece,
BioHorizons® maestro, and BioHorizons® overdenture.

 

Section 1.7
of the License Agreement is replaced by the following amended Section 1.7.

 

“UABRF
Patent Rights” shall mean UABRF rights to any subject matter claimed in or
covered by the claims in US Patent No. 5,628,630 (serial

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

20

 

no.
08/356,597), 5,823,777 (serial no. 08/796,347) and 5,954,504 (serial no. 08/828,673);
any continuing applications thereof including divisions but excluding
continuation-in-part applications except to the extent that any such
continuation-in-part has claims directed to the subject matter specifically
described and enabled in the patents and/or applications listed above; any
patents issuing on said applications or continuing applications including
reissues and reexaminations thereof; any foreign patent applications or patents
corresponding directly to any of the foregoing; or any other UABRF Case No. designating
a case disclosed prior to the Effective Date of this Agreement and relating to
that body of technology described in Section 1.7 of this Agreement.  For the avoidance of doubt, “UABRF Patent
Rights” expressly shall not include U.S. Patent Nos. 5,927,979; 6,045,361;
6,068,480; 6,083,004, their foreign counterparts, or any other patent or patent
application claiming priority to any of the foregoing, and UABRF hereby
disclaims any ownership or other interest in or to all of the foregoing.

 

The
first sentence of Section 2.1 of the License Agreement shall be replaced
by the following sentence:

 

Commencing
on the Effective Date, UABRF shall assume the responsibility to maintain the
United States patents and applications comprising UABRF Patent Rights (such
actions referred to collectively herein as “Patent Protection”) and shall pay
all reasonable costs and fees associated with such Patent Protection.

 

Section 4.2
of the License Agreement is replaced by the following amended Section 4.2.

 

4.2
Throughout the Term of this Agreement, LICENSEE shall pay to UABRF for the sale
of Licensed Products sold by LICENSEE or its Affiliates or its sublicensees an
earned royalty of [***] percent ([***]%) of the Net Sales of Licensed Products;
provided that LICENSEE shall pay to UABRF a minimum annual royalty of [***]
U.S. dollars (US$[***]).  The minimum
annual royalty shall be paid to UABRF by the end of the last calendar quarter
of the year in which it is due, and shall be credited against the total earned
royalties and sublicense fees due and owing for the calendar year in which the
minimum annual royalty payment was made. 
The parties agree that the total aggregate royalties and other
consideration payable under this Agreement shall not exceed [***] U.S. dollars
(US$[***]) for any given calendar year, regardless of the Net Sales of Licensed
Products sold by LICENSEE or its Affiliates or its sublicensees. Such royalties
shall be in lieu of, and in full satisfaction of any obligation of LICENSEE
with respect to, any royalties otherwise provided for in this License
Agreement.  If a Licensed Product is sold
in combination with other products (the combination referred to as a “Bundle”),
the royalty base used for determining the royalty due on such Licensed Product
shall be the Net Sales of the Bundle multiplied by the fraction A/B, where A is
the average cost of the Licensed Product for the then current reporting period
on a standalone basis and B is the total average cost for the then current
reporting period of each of the components (including the Licensed Product) in
the entire Bundle. LICENSEE shall not be required to pay royalties with respect
to Net Sales of any abutments, crowns, tools or other components sold with the
Licensed Products.

 

Section 4.5
of the License Agreement is replaced by the following amended Section 4.5.

 

Paragraphs
1.7, 1.5, and 1.4 define UABRF Patent Rights, Licensed Products and Licensed
Methods, respectively, so that royalties shall be payable on products and
methods covered by

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

21

 

both
pending patent applications and issued patents. LICENSEE and UABRF hereby agree
that earned royalties on the sale of Licensed Products shall accrue in each
country for the duration of UABRF Patent Rights in that country; provided that
in the case of any UABRF Patent Rights that were allowed to go abandoned prior
to the Effective Date of this Amendment, royalties shall be payable as if such
UABRF Patent Rights were still in effect (in relation to the claims as they
existed at the time of such abandonment) up until the date that would have been
the expiration date for such UABRF Patent Rights had they not been abandoned.

 

Section 28.6
is added to the License Agreement

 

LICENSEE
hereby assigns its [***]percent ([***]%) of its entire right, title and
interest in [***] to UAB-RF in partial consideration for rights granted to it
as set forth in this Agreement. LICENSEE hereby agrees to execute any and all
documents, at the expense of UABRF, that may be required to effect such
assignment.

 

Sections
4.1, 4.3, 4.4, 5.3, 5.4 of the License Agreement are hereby deleted in their
entirety.

 

3.             Amendment of License Agreement.  The License Agreement is hereby amended to
give effect to the foregoing sections of this Agreement, and is otherwise
ratified and confirmed (as heretofore amended) in all respects.

 

4.             Miscellaneous.  This Agreement shall be binding on, and shall
inure to the benefit of, the successors and assigns of the parties.  This Agreement may be executed in any number
of counterparts, each of which shall be deemed an original, but all of which
taken together shall constitute one and the same instrument.  The parties agree that both parties have
participated in the drafting and negotiation of this Agreement, and no rule of
construction shall apply that construes this Agreement in favor of or against
any party by reason of such party’s role in drafting this Agreement.

 

5.             Mutual Release.

 

(a)           The parties
acknowledge and agree that this Amendment is entered into for the purpose of
settling a bona fide dispute between them. Accordingly, each party does hereby forever waive and release, and discharge
the other party (and such party’s officers, directors, parents, subsidiaries,
employees, agents and affiliates) from, any and all claims, charges, actions,
suits, damages and liabilities of any kind whatsoever, known or unknown,
liquidated or contingent, at law or in equity, arising from or by reason of any
act or omission of the other party from the beginning of time through and
including the Effective Date, which arises from or relates in any way to: (i) the
royalty or other payment obligations of LICENSEE with respect to Net Sales of
Licensed Products in all the territories of the world; and (ii) the
abandonment of certain UABRF Patent Rights in jurisdictions outside of the U.S.
(“Claims”), and each party agrees not to bring suit with respect to any such
Claims.

 

(b)           Notwithstanding the
foregoing, nothing in this Agreement shall be deemed  to waive, release or discharge any Claims
that relate to (a) the warranty of UABRF in Section 15.1 of the
License Agreement, (b) any Claims that are the subject of indemnification
by

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

22

 

BioHorizons
under Section 17.1 of the License Agreement, or (c) any actions or
suits to enforce the obligations of a party under this Amendment.

 

[SIGNATURE PAGE FOLLOWS]

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

23

 

IN
WITNESS WHEREOF, the parties, by their undersigned duly authorized signatories,
have executed and delivered this Amendment as of the day and year first above
written.

 

	
   

  	
  BIOHORIZONS
  IMPLANT SYSTEMS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By

  	
  /S/
  R. Steven Boggan

  
	
   

  	
   

  	
  Its

  	
  CEO

  
	
   

  	
   

  
	
   

  	
  THE
  UAB RESEARCH FOUNDATION

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By

  	
  /s/
  [Illegible]

  
	
   

  	
   

  	
  Its

  	
  CEO

  
					

 

Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to
Rule 406 of the Securities Act of 1933, as amended.

 

24

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