Document:

Exhibit 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 [***], filed on [***], 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. [***] (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.
[***]),[***] (serial no. [***]) and [***] (serial no. [***]); 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. [***], 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.

 

24Exhibit 10.14

 

Quality
Tech Services, Inc.

7359
Washington Avenue S., Edina, MN 55439

SERVICE
CONTRACT

Customer
Name:  BioHorizons

 

Customer
Address:  One Perimeter Park South, Suite 230
S. Birmingham, AL 35243

 

The
undersigned       BioHorizons.     “CUSTOMER”
and Quality Tech Services, Inc. “QTS” agree to the following conditions
for the assembly/packaging of CUSTOMER products:

 

1.                                      QTS agrees to manufacture CUSTOMER
products per requirements specified by the following:

 

·                  Purchase Order

·                  Engineering
Drawings and Specifications

·                  Inspection and
Process Control Criteria

 

2.                                      CUSTOMER will provide QTS with
current revision documents.  Purchase
Order revision levels take precedence over all other documents.

 

3.                                      QTS agrees to notify CUSTOMER and
obtain written approval prior to any deviation from or modification to the
product, process or equipment affecting form, fit or function of CUSTOMER
products.

 

4.                                      PRODUCT IDENTIFICATION AND TRACEABILITY

 

QTS
agrees: to provide systems to ensure component and material traceability for
each CUSTOMER process by establishing and maintaining documented procedures
for;

 

·                  identifying the
product from receipt through all stages of production and delivery;

·                  unique
identification of individual product or batches.

·                  to use only
approved material or service vendors;

·                  to notify
CUSTOMER of pending material lot number changes if multi-lot use will be
required.

 

5.                                      PROCESS CONTROL

 

QTS
shall identify and plan the production and servicing processes which directly
affect quality and shall ensure that these processes are carried out under
controlled conditions.  Controlled
conditions shall include:

 

·                  documented
procedures defining the manner of production;

·                  use of suitable
production equipment and a suitable working environment;

·                  compliance with
Quality Requirements Specification (provided with purchase order or detailed in
jointly approved manufacturing procedures);

·                  monitoring and
control of suitable process parameters;

·                  the approval of
processes and equipment, as appropriate;

·                  assign only
trained, qualified personnel to perform manufacturing operations for CUSTOMER
products;

·                  criteria for
workmanship, which shall be stipulated in the clearest practical manner (e.g.,
written standards, representative samples, or illustrations);

·                  suitable
maintenance of equipment to ensure continuing process capability.

 

6.                                      INSPECTION AND TEST STATUS

 

The
inspection and test status of product or materials shall be identified by
suitable means, which indicate the conformance or non-conformance of product
with regard to

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

inspection
and test performed.  The identification
of inspection and test status shall be maintained, as defined in documented
procedures.

 

7.                                      INSPECTION AND TESTING

 

QTS
shall establish and maintain documented procedures for inspection and testing
activities in order to verify that the specified requirements for the product
are met.  The required inspection and
testing, and the records to be established, shall be mutually agreed upon.

 

Receiving inspection and testing

 

QTS
shall ensure that incoming materials are not used or processed until it has
been inspected or otherwise verified as conforming to specified
requirements.  Verification of the
specified requirements shall be in accordance with documented procedures.

 

In-process inspection and testing

 

QTS
shall:

 

·                  inspect and
test the product/package as required by the Quality Requirements Specification
and/or documented procedures;

·                  hold product
until the required inspection and tests have been completed or necessary
reports have been received and verified.

 

Final inspection and testing

 

QTS
shall carry out all final inspection and testing in accordance with the Quality
Requirements Specification and/or documented procedures to complete the
evidence of conformance of the finished product/package to the specified requirements.

 

The
documented procedures for final inspection and testing shall require that all
specified inspection and tests, including those specified either upon receipt
of material or in-process, have been carried out and that the results meet
specified requirements.

 

No
product shall be shipped until all the activities specified in the Quality
Requirements Specification and/or documented procedures have been satisfactory
completed and the associated data and documentation are available and
authorized.

 

Inspection and test records

 

QTS
shall establish and maintain records, which provide evidence that the
product/package has been inspected and/or tested.  These records shall show clearly whether the
product has passed or failed the inspection and/or tests according to defined
acceptance criteria.  Where the product
fails to pass any inspection and/or test, the procedures for control of
non-conforming product shall apply. 
Records shall identify the inspection authority responsible for the
release of product.

 

8.                                      CONTROL OF INSPECTION, MEASURING AND TEST
EQUIPMENT

 

QTS
shall establish and maintain documented procedures to control, calibrate, and
maintain inspection, measuring and test equipment used by QTS to demonstrate
the conformance of product/package to the specified requirements.  Inspection, measuring and test equipment
shall be used in a manner which ensures that the measurement uncertainty is
known and is consistent with the required measurement capability.

 

QTS &
the CUSTOMER shall:

 

·                  determine the
measurements to be made and the accuracy required, and select the appropriate
inspection, measuring, and test equipment that is capable of the necessary
accuracy and precision;

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

·                  Identify all
inspection, measuring and test equipment that can affect product quality.

 

9.                                      CONTROL OF NONCONFORMING PRODUCT

 

QTS
shall establish and maintain documented procedures to ensure that the
product/package that does not conform to specified requirements is prevented
from unintended use.  This control shall
provide for identification, documentation, evaluation, segregation (when
practical), disposition of nonconforming product, and for notification to the
function concerned.

 

Review and disposition of nonconforming product

 

The
responsibility for review and authority for the disposition of nonconforming
product shall be defined.  Nonconforming
product shall be reviewed in accordance with documented procedures.  It may be:

 

·                  reworked to
meet specified requirements, the rework performed must be documented and
accepted/approved by CUSTOMER;

·                  accepted with
or with out repair by concession;

·                  re-graded for
alternative applications;

·                  scrapped.

 

Repaired
and/or reworked product shall be re-inspected in accordance with the Quality
Requirements Specification and/or documented procedures.

 

10.                               QTS agrees to provide CUSTOMER
access to the following:

 

	
  ·     Manufacturing
  Processes

  	
  ·     Test/Inspection
  Records

  
	
  ·     Inspection
  Procedures

  	
  ·     Calibration
  Records

  
	
  ·     Traceability
  Records

  	
  ·     Non-Conformance
  Reports

  

 

11.                               QTS agrees to allow CUSTOMER to
perform facility audits on mutually agreeable frequency and agrees to establish
corrective action programs if required. 
Where CUSTOMER is contractually obligated to do so allow a third party
auditor to perform facility audits in conjunction with CUSTOMER.

 

12.                               QTS agrees to provide the required
certifications (as outlined on purchase orders) with all products and services
stating conformance to all purchase order specifications.

 

13.                               (Excluding records supplied to
CUSTOMER) QTS agrees to maintain ([***]) all records needed to demonstrate
compliance to CUSTOMER purchase orders, specifications and contracts.  Prior to disposing of records QTS shall
notify CUSTOMER and request concurrence that the records may be destroyed or
turn the records over to CUSTOMER for maintenance and disposition.

 

14.                               TERMS AND CONDITIONS

 

14.1                        Invoices and Charges. 
QTS will invoice the Customer for processing services rendered by
QTS.  Payment of each invoice shall be
made by the Customer [***] of the date of receipt of such invoice.  Any amount not so paid shall accrue simple
interest at a rate of [***]% per month from the date of the original invoice
for such amount.  In the event Customer
fails to timely pay any invoice for services rendered, QTS reserves the right,
at its option and upon notification of the Customer, to: (i) refuse to
perform further services for the Customer, (ii) perform further services
for the Customer only on a COD basis, (iii) withhold the shipment of
Product in QTS’ possession until all past due invoices are paid, and/or (iv) make
use of any other remedies legally available to it.  In addition to any amounts 

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

owed for services rendered, Customer shall also
reimburse QTS for any costs incurred in asserting its rights hereunder,
including reasonable attorneys’ fees.

 

14.2                        Performance of Processing Services

 

(a)                               Processing
Requirements.  QTS
shall process products in accordance with the parameters for such products set
forth in Manufacturing Procedures and/or Purchase Orders.

 

(b)                               Validation of
Processing Requirements.  The Food and Drug Administration requires,
and Customer agrees, that Customer shall have exclusive responsibility for the
validation of processing requirements for products prior to the commencement of
commercial distribution of such products. 
The Customer acknowledges and agrees that it is solely and exclusively
responsible for the validation of processing, product sterility, integrity of
product packaging and the adequacy of product labeling.

 

(c)                                Shipment of the
products by QTS.  QTS
shall cause the products to be shipped in accordance with Customer’s written
instructions or per individual Manufacturing Procedures.  When shipping the products ([***]), QTS shall
include documents specifying the name of the products, the number of units of
the products, and the lot number.  QTS
will also conspicuously mark the shipment to show its “non-sterile” or “sterile”
nature with all shipping and handling costs to be borne by the Customer.

 

(d)                               Storage of the
Products or Materials by QTS.  QTS
shall store the products/materials on its premises provided Customer has
adequate insurance protecting all the products/materials while in QTS’ control
and while in transit to and from QTS, from any loss, casualty, or damage.  Customer acknowledges and agrees that in the
event QTS has purchased materials (pouches, labels, boxes, etc.) for
Customer and Customer cancels such order, Customer will be responsible for all
costs associated with such materials including a 15% stocking fee.

 

(e)                                Compliance with
Laws Each of the parties agrees at all times to conduct
its operations in compliance with the applicable requirements of 21 CFR Part 801.150
(“Medical Devices: Processing, Labeling or Repacking”), 21 CFR Part 820 (“Quality
System Regulation: General”), or any successor regulations as well as any other
applicable laws and regulations.

 

14.3                        Limited Warranty; Liability for Product
Damage; Warranty Disclaimer; Limitation of Liability

 

14.3.1              Limited Warranty.

 

(a)                                  QTS warrants to the Customer that it will process the
products in accordance with the parameters referred to in Manufacturing
Procedures or Customer Specification Documents and in accordance with QTS’
quality policy manual in effect when the products are processed.  Notwithstanding the foregoing warranty, the
Customer acknowledges that many factors beyond QTS’ control can affect the
ultimate microbiological condition of the products.  Among these are the quality, type and
original

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

bioburden
of the products and their packaging, the configuration of the products, the
material or construction of the products, the adequacy of the testing
laboratory atmosphere and equipment, the competence of testing laboratory
atmosphere and equipment, the competence of testing laboratory personnel, the
competence and adequacy of sampling techniques, and the care and handling of
the products during distribution.  The
Customer acknowledges that the foregoing limited warranty is personal to the
Customer and that such limited warranty may be enforced against QTS only by the
Customer, and not by any third party (including, without limitation, product
resellers and end-users).

 

(b)                                 If QTS becomes aware of any non-conformity with the limited
warranty given in Section 14.3.1(a) (either through its own investigation
or through written notice of the Customer) within [***] ([***]) days of shipment from QTS of the products subject to the
warranty claim, then Customer’s exclusive remedy, and QTS’ sole liability to
the Customer, shall be limited to (i) reprocessing such products at QTS’
expense if the products are not damaged, or (ii) if the products are
damaged, indemnifying the Customer for its direct manufacturing cost of any of
the products which are damaged by the processing nonconformance and which need
to be replaced, up to a maximum payment per damaged product equal to [***] ([***]) times the
processing cost for such Product.  QTS
will reprocess such products only after receiving the Customer’s written
authorization to do so.

 

14.3.2              Product Damage Caused By QTS.  If a
product is damaged by QTS as a result of physical mishandling by QTS, then
Customer’s exclusive remedy, and QTS sole liability to the Customer, shall be
limited to the amount set forth in Section 14.3.1(b)(ii).  Customer will make every effort to keep cost
to a minimum by refurbishing and/or repackaging wherever feasible.  Customer must present a written request to
QTS for reimbursement for damages under this clause of the Agreement within
[***] ([***]) days of the damage occurrence or lose its indemnification rights
with respect to the damaged products. 
QTS will provide compensation to Customer within [***] ([***]) days of
written notification, provided the damages are not in dispute.

 

14.3.3              Warranty Disclaimer.  QTS makes
no representation, guaranty or warranty, express or implied, other than the
limited warranty contained in section 14.3.1(a).  In particular, QTS makes no representation,
guarantee or warranty, express or implied, concerning the sterility of the
products or degree or sterilization, nor as to the merchantability or fitness
for a particular purpose of products after processing by QTS.

 

14.3.4              Limitation of Liability.  In no event
shall QTS be liable for any special, indirect, incidental, consequential,
punitive or other similar damages,

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

including but not limited to damages arising from
death, bodily injury, property damage (other than damage to the products as
provided in section 14.3. 1 (b)), loss of profits or revenue or loss of use of
the products. Subject to the requirements of section 14.3.1(b), QTS’ aggregate
liability under or as a result of this agreement shall not exceed the gross
proceeds received from the customer during the calendar year when the incident
giving rise to QTS’ liability occurs.

 

14.4                        Term I Termination

 

(a)                               Year-to-Year
Term.  This
Agreement will commence on the date executed by Customer (provided the
Agreement is also executed by QTS) and will continue for an initial term of one
(I) year from such date.  After the
initial term, this Agreement shall be renewed automatically for successive one
year periods unless Customer or QTS provides written notice to the other party,
at least ninety (30) days prior to the end of the initial or any renewal term,
that the Agreement shall not be renewed.

 

(b)                               Termination For
Default.  If either
party is in material default of its obligations under this Agreement, except
for QTS’ refusal to perform pursuant to Section 14.1, the other party may give
written notice that the Agreement will be terminated if the default is not
cured within thirty (30) days.  If such
notice is given and the default, except for QTS’ refusal to perform pursuant to
Section 14.1, is not cured during the thirty (30) day period, then the
party not in default shall have the right to immediately terminate this
Agreement.

 

(c)                                Termination Upon
Insolvency.  This
Agreement shall be terminated effective immediately upon delivery of written
notice by either party of such termination if any of the following occurs: (i) the
institution by or against a party of insolvency, receivership or bankruptcy
proceedings, (ii) such party’s making an assignment for the benefit of
creditors, or (iii) the dissolution of such party.  There shall be no opportunity to “cure” nor
any requirement for advance notice of termination under this section 14.4 (c).

 

14.5                        General Provision

 

(a)                               Governing Law.  The validity, construction, interpretation
and enforcement of this Agreement, or any breach thereof shall be governed by
the laws of the State of the plaintiff of record, applicable to contracts made
and to be performed in that State.

 

(b)                               Indemnification.  The Customer agrees to indemnify, hold
harmless and defend QTS from and against all settlements, judgments, fines,
expenses, losses, costs, deficiencies, liabilities and damages, including
reasonable attorneys’ fees and expenses (collectively, “damages”) incurred or
suffered by QTS arising out of or in connection with (i) any breach by the
Customer of any of its covenants or agreements made in this Agreement, (ii) the
processing of the products, except to the extent such damages arise exclusively
and directly out of negligent acts or omissions of QTS or QTS’ failure to
process the products in accordance with the parameters set forth

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

in Individual
Manufacturing Procedures, or (iii) any claim that the products are not
sterile., or (iv) any claim of personal injury, including death, or other
damage arising out of the use of any and all Products.

 

QTS
agrees to cross-indemnify, hold harmless and defend the Customer from and
against all settlements, judgments, fines, expenses, losses, costs,
deficiencies, liabilities and damages, including reasonable attorneys’ fees and
expenses (collectively, “damages”) incurred or suffered by the Customer arising
out of or in connection with (i) any breach by QTS of any of its covenants
or agreements made in this Agreement, or (ii) the processing of the
products, except to the extent such damages arise exclusively and directly out
of negligent acts or omissions of the Customer or the Customer’s failure to
provide appropriate directions for processing products in accordance with the
parameters set forth in Individual Manufacturing Procedures.

 

(c)                                Entire Agreement.  This Agreement constitutes the final written
expression of the terms of agreement between the parties relating to the
subject matter contained herein and is the complete and exclusive statements of
those terms.  This Agreement supersedes
all prior agreements with respect to such subject matter and merges all prior
discussion between the parties.  All
references to this Agreement shall be deemed to include the schedules
hereto.  No provision in any purchase
order or purchase order confirmation, whether entered into prior to,
concurrently with or after the execution and delivery of this Agreement, shall
be effective to the extent that provision is inconsistent with any provision of
this Agreement.

 

(d)                               Amendments.  This Agreement may be amended only with the
consent of both parties hereto in writing signed by an authorized
representative of each party.

 

(e)                                Severability.  The provisions of this Agreement shall be
deemed severable, and the invalidity, unenforceability or illegality of any
provision of this Agreement shall not in any way affect or impair the validity,
enforceability or legality of the other provisions hereof.

 

(f)                                   No Waiver.  The failure of either party hereto at any
time to require performance by the other party of any provision of this
Agreement shall in no way affect the right of such party to require performance
of that provision, and any waiver by either party of any breach of any
provision of this Agreement shall not be construed as a waiver of any
continuing or succeeding breach of such provision, a waiver of the provision
itself or a waiver of any right under this Agreement.

 

(g)                               Relationship.  Each party to this Agreement is an
independent contractor, and nothing contained herein shall be construed to
create an agency relationship between the parties.

 

(h)                               Force Majeure.  QTS shall not be responsible for any loss,
damages or penalty resulting from delay in processing or delivery when such
delay is due to causes beyond the reasonable control of QTS, including but not

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

 

limited to, labor unrest,
utility interruptions, shortages, riots, insurrection, fires, flood, storm,
earthquake, explosion, act of God, war, terrorism, or governmental action.

 

(i)                                  Insurance.  Customer shall maintain at all times during
the term of the Agreement, adequate insurance protecting all the products/materials
while in QTS’ control, and in Customer’s case while in transit to and from QTS
or QTS’ subcontractors, from any loss, casualty, or damage.  Customer shall maintain product liability
insurance resulting from use of the products. 
QTS will maintain commercial general liability insurance up to $[***]
per occurrence and $[***] general aggregate.

 

IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed by their
respective duly authorized officers as of the date first written below.

 

	
  CUSTOMER:

  	
   

  	
  /s/ William Ross

  	
   

  	
  4/6/04

  	
   

  	
  CFO

  
	
   

  	
   

  	
  Signature

  	
   

  	
  Date

  	
   

  	
  Title

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  QTS
  Officer:

  	
   

  	
  /s/ [illegible]

  	
   

  	
  4/7/04

  	
   

  	
  President/CEO

  
	
   

  	
   

  	
  Signature

  	
   

  	
  Date

  	
   

  	
  Title

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  QTS
  Officer:

  	
   

  	
  /s/ [illegible]

  	
   

  	
  4/7/04

  	
   

  	
  VP of Manufacturing

  
	
   

  	
   

  	
  Signature

  	
   

  	
  Date

  	
   

  	
  Title

  

 

	
  F065
  — Rev. 02

  	
  Effective
  Date: Oct 2003

  	
   

  

 

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

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