Document:

Exhibit 10.11

 

AGREEMENT

 

This
agreement (“Agreement”) is made as of the 1st day of January 2010,
by and between Osteotech, Inc., a Delaware corporation with offices at 51
James Way, Eatontown, NJ 07724 (“OTI”) and BioHorizons Implant Systems, inc., a
corporation with offices at 2300 Riverchase Center, Birmingham, Alabama 35244 (“BioHorizons”).

 

WHEREAS,
OTI and BioHorizons are parties (collectively the “Parties”) to a certain
agreement dated January 1, 2006, which expired on December 31, 2009;
and

 

WHEREAS,
the Parties wish to enter into a new Agreement; and

 

NOW,
THEREFORE, in consideration of the mutual agreements, covenants,
representations and warranties contained herein and for all other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, intending to be legally bound hereby, the Parties hereby agree as
follows:

 

ARTICLE I

 

CERTAIN DEFINITIONS

 

1.1           Description of Products.  Exhibit A hereto, as the same may be
amended from time to time by mutual agreement of the Parties, set forth a list
of the allograft bone products which OTI is currently processing (the “Products”).

 

1.2           Description of the Market.  The “Dental Market” referred to in this
Agreement is the market consisting or oral surgeons, periodontists, implantologists
and the general dental community other than hospitals.

 

1.3           Description of the Territory.  The exclusivity granted to BioHorizons under
this Agreement shall be limited to the Dental Market in the fifty states of the
United States of America, the District of Columbia, and the possessions and
territories of the United States.  Sales
or Distribution of products defined in Exhibit A, outside of the defined
areas described above, is not permitted without the express written consent of
OTI.

 

ARTICLE II

 

EXCLUSIVITY ARRANGEMENT

 

2.1           Exclusivity.  OTI hereby agrees to sell the Products
exclusively to BioHorizons in the Territory for resale to the Dental Market in
the Territory for the term of this Agreement provided BioHorizons purchases the
minimum quota of such Products set forth in Exhibit B hereto and is
otherwise in compliance with the terms and conditions hereof.  In partial consideration thereof, BioHorizons
will take all such actions as may be commercially necessary to promote, market,
and sell the Products, including by way of example and not limitation,

 

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

 

maintaining the necessary sales force and offices necessary to do so,
promptly handling all inquiries from customers and potential customers, and
attending at its own expense such seminars as OTI may reasonably suggest.

 

2.2           Price.  The prices at which OTI agrees to sell each
of the Products to BioHorizons during the term of this exclusive arrangement
are set forth in Exhibit A hereto. Such prices shall be [***], the risk of
loss will pass to BioHorizons upon [***], and (subject to the proviso in the
next paragraph) such sales shall be considered complete [***].  OTI shall announce to DISTRIBUTOR in writing
annual changes in prices each year by [***] to become effective on [***] of the
succeeding year.  Notice of other changes
to prices shall be in writing, given to DISTRIBUTOR at least [***] ([***])
calendar days in advance of their effective date.  OTI agrees to accept and honor at the
prevailing price all orders that are placed by BioHorizons in writing and
accepted in writing by OTI at least [***] ([***]) Business Days prior to the
effective date of any price changes. At the time of the announcement of any
price changes. OTI will issue an amended Exhibit A.

 

2.3           Quality Assurance; Return of Non-Qualifying
Products. 
BioHorizons agrees to inspect all Products promptly upon their arrival
at its facilities and to notify Osteotech ion writing of any discrepancies or
quality control issues of which it becomes aware. Such written notification
must be given to Osteotech no later than [***] ([***]) days after BioHorizons
receipt of any Products.  If Osteotech
concludes in its reasonable determination that a discrepancy or quality control
issue has indeed occurred, it will issue a return authorization (“Return
Authorization”) to BioHorizons, replace any nonconforming Products, and use its
commercially reasonable efforts to resolve any quality control issues.  Promptly upon its receipt of the Return
Authorization with respect to a given shipment of Products (but not more than
[***] ([***]) days thereafter) BioHorizons shall return the nonconforming
Products to Osteotech at Osteotech’s cost) and Osteotech will, at Osteotech’s
option, either (i) replace or (ii) provide a credit to BioHorizons
for the same.  No Products will be
replaced by Osteotech, and no credit will be issued, for any Products in the
absence of a Return Authorization therefor or in cases of a Product recall initiated
by Osteotech or the US Food and Drug Administration, other than as a
consequence of an act or omission of BioHorizons, in which case Osteotech will
issue a refund or credit to BioHorizons, as appropriate.

 

ARTICLE III

 

3.1           Good Faith Efforts.  BioHorizons agrees to promote the Products to
the dental Market in the Territory such that the demand therefor shall be
sufficient to enable BioHorizons to meet the minimum purchase quota
requirements set forth on Exhibit D hereto.  BioHorizons acknowledges that its failure to
do so, and/or its failure to meet such minimum quotas, shall give rise to the
remedies set forth elsewhere in this Agreement.

 

3.2           Purchase Orders.

 

(a)           BioHorizons shall from time to time prepare and
submit to OTI purchase orders stating the number and category of Products that it
wishes to purchase.  Such purchase

 

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

 

orders
shall be in writing and shall constitute binding commitments to accept the
number and category of Products stated therein, in accordance with the terms
and conditions of this Agreement. 
BioHorizons may cancel a purchase order only with the prior written
approval of OTI.

 

(b)           BioHorizons shall distribute only Products purchased
directly from OTI or any entity designated in advance by OTI in writing;

 

3.3           Response to Purchase Orders.  As soon as practicable after its receipt of a
purchase order from BioHorizons submitted in accordance with the terms hereof,
OTI shall accept such purchase order unless it determines it cannot reasonably
ship the quantities called for in the purchase order.  If OTI does not accept purchase order in
whole or part, it will provide BioHorizons with written notice as to the
portion (if any) of such purchase order it will accept. BioHorizons will in
such event obtain from OTI the amount of available Products.  BioHorizons agrees that, absent OTI’s express
written acceptance thereof, terms and conditions contained in any purchase
order issued by BioHorizons for Products, other than the number and category of
Products ordered, shall not be binding on OTI to the extent such terms and
conditions are material and either additional or inconsistent with those
contained in this Agreement.  BioHorizons
must place at least [***] corresponding to the amount of Product covered by the
next calendar quarter minimum purchase requirement or forecast.

 

3.4           Payments.  Payment by BioHorizons with respect to
purchase orders will be made pursuant to OTI’s announced terms and conditions
thereof, pursuant to invoices issued by OTI, [***] ([***]) days, with late
payments bearing interest at the lesser of [***] percent ([***]%) [***] or the
highest rate permitted under applicable law.

 

ARTICLE IV

 

EXPRESS WARRANTY; EXCLUSION OF OTHER WARRANTIES

 

4.1           Express Warranty.  Subject to the terms and conditions of this
Agreement, Osteotech warrants that the Products, when and as delivered to
[***], will conform in all material respects to the published specifications
therefor.  All claims and remedies for a
breach of this warranty are limited in the manner set forth in this
Agreement.  The sole and exclusive remedy
of BioHorizons, as well as of any customer of BioHorizons to whom BioHorizons
sells any of the Products, to the extent such limitation is permitted by
applicable law, are those set forth in Section 3.3 and 5.2 (b) hereof.  Should remedies fail of their essential
purpose, then Osteotech may refund to the person in question the amounts paid
by it for the Products failing to satisfy this warranty, and such refund shall
be the sole and exclusive remedy for such person with respect hereto.

 

4.2           Exclusion of Other Warranties.  The warranty stated in section 5.1 is
Osteotech’s sole and exclusive warranty pertaining to the products, and
Osteotech hereby disclaims all other warranties, express or implied warranties
of merchantability and fitness for a particular purpose.   In no event shall Osteotech be liable to
BioHorizons or any of its customers, successors or assigns, or any other
person, for any indirect, special, or consequential damages, including

 

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

 

(without limitation) lost profits, costs of delay, any failure of
delivery, costs of lost or damaged products, or liabilities to third parties
arising from any source.

 

ARTICLE V

 

TRADEMARKS: MARKING OF PRODUCTS

 

5.1           Limited License.  BioHorizons may use and display the
trademarks of OTI to identify and market the Products only on marketing
materials supplied by OTI or approved by OTI prior to their use.  In each case, BioHorizons will comply with
OTI trademark advertising guidelines and/or other instructions with respect to
such use.  No other use of OTI’s
trademarks is authorized.

 

ARTICLE VI

 

COMPETITIVE PRODUCTS

 

6.1           Commitment.  So long as this Agreement remains in effect
and for [***] ([***]) [***] thereafter, BioHorizons shall not distribute, sell
or act as an agent or representative of any person or entity whose products or
services compete directly with the Allograft Products Osteotech offers in the
territory as defined in Section 1.3.

 

ARTICLE VII

 

CONFIDENTIALITY

 

7.1           Confidential Information.  Each f the Parties hereby acknowledges that
in the course of performing its obligations hereunder, the other party may
disclose to it certain information and know-how of a technical, financial,
operational, or other sort, which the disclosing party has identified as such
that is non-public and otherwise proprietary or confidential to the disclosing
party.  Each party acknowledges that any
such proprietary or confidential information disclosed to it is of considerate
commercial value and that the disclosing party would likely be economically or
otherwise disadvantaged or harmed by the direct or indirect disclosure thereof,
except as specifically authorized by the disclosing party.  Each party therefore agrees to keep in strict
confidence and trust all such information that may from time to time be
disclosed to it, and agrees not to disclose such information to any third party
for any purpose without the prior consent of the other.  Each of the Parties agrees that because of
the extraordinary nature of such information the disclosing party’s breach or
threatened breach of its nondisclosure obligation, and that the disclosing
party would suffer irreparable injury and damage as a result of any such
breach.  Accordingly, in the event either
party breaches or threatens to breach the obligations of confidentiality set
forth in this section, in addition to and not in lieu of any legal or other
remedies such party may pursue hereunder or under applicable law, each party
hereby consents to the granting of equitable relief against it by a court of
competent jurisdiction, without the necessity of proving actual damages or
posting any bond or other security thereof, prohibiting any such breach or
threatened breach in any proceeding upon a motion for such equitable relief, a
party’s ability to answer in damages shall not be a bar, and 

 

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

 

4

 

shall not be interposed as a defense, to the granting of such equitable
relief.  The provisions of this section
shall survive the termination of this Agreement for any reason.  The provisions of this section shall not
apply to any information identified as confidential if and to the extent it was
(i) independently developed by the receiving party after Closing as
evidenced by documentation in such party’s possession, (ii) lawfully
received by it free of restrictions from another source having the right to
furnish the same or (iii) generally known or available to the public
without breach of this Agreement by the receiving party.

 

ARTICLE VIII

 

TERM AND TERMINATION; EVENTS OF DEFAULT

 

8.1           Term.  This Agreement shall be effective as of the
date first set forth above and shall continue in force and effect for a period
of three (3) years, unless extended or terminated pursuant to the
provisions of this Agreement.

 

8.2           Extensions.  This Agreement shall automatically renew in
successive one (1) year increments without further action by either party
unless one of the Parties gives notice to the other to the contrary no later
than ninety (90) days prior to the expiration of any period in which this
Agreement is in effect, and provided further that BioHorizons is in compliance
with all its undertakings hereunder at the time of any such extension.

 

8.3           Events of Default; Remedies Upon Default.  (a)  It shall be considered an event of
default under this Agreement (an “event of Default”) if:

 

(i)              BioHorizons fails to
purchase in any applicable year the required minimum purchase of Products for
Osteotech as defined in the Agreement.

 

(ii)             BioHorizons does not meet or
exceed its annual purchase requirements, as shown in Exhibit; Osteotech will
have the right to terminate this Agreement with 60 days written notice.

 

(iii)            either party commits an act
of bankruptcy or becomes the subject of any proceeding under the Bankruptcy
Code or any state bankruptcy laws, or becomes insolvent, or if any substantial
part of its property becomes subject to any levy, seizure, assignment or
application for sale which shall not have been dismissed within thirty (30)
day.

 

(iv)            either party breaches any
material term or condition of this Agreement and fails to cure such breach
within thirty (30) days after being given written notice of such breach or
failure by the other, except that the notice and cure period will be sixty (60)
days for breaches covered in section 8.3 (a)

 

8.4           Effect of Termination.

 

(a)           On the occurrence of an Event of Default by
BioHorizons under section 8.3 (a)(i) hereof, OTI may, at its option and
upon sixty (60) days written notice to BioHorizons either (i) terminate
this Agreement in its entirety, (ii) convert BioHorizons exclusive rights 

 

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

 

hereunder
to non-exclusive rights, thereby permitting OTI to provide the Products to the
Dental Market in the Territory to other parties, or (iii) convert
BioHorizons’ rights to purchase Products at discounted prices set forth on Exhibit A
into a right to purchase such Products at prices and on terms and conditions
OTI may announce from time to time; in the event OTI chooses alternatives (ii) or
(iii) all other terms of this Agreement, and this Agreement as a whole,
shall remain in full force and effect as thereby amended.

 

(b)           On the occurrence of an Event of Default under
section 8.3(a)(ii), the non-defaulting party shall have the right to terminate
this Agreement on notice to the defaulting party.

 

(c)           On the occurrence of an Event of Default under
8.3(a)(iii), the non-breaching party may, but shall not be obligated to,
terminate this Agreement on written notice to the other.

 

ARTICLE IX

 

SURVIVAL

 

9.1           Survival.  Notwithstanding the termination of this
Agreement for any reason, Sections 4.1, 4.2, 7.1, 9, 10, 11.3, 11.4, and 11.13
shall survive such termination and remain in full force and effect for five (5) years
from the date of termination.

 

ARTICLE X

 

IDEMNIFICATION

 

10.1         Indemnification.  BioHorizons and OTI will each indemnify,
defend and hold harmless the other party and its directors, officers,
employees, agents and representatives from any and all loss, cost, damages and
expense (including court costs and attorneys’ fees) arising in connection with
third party claims or government investigations or prosecutions directly
arising from or based on (i) any actual or alleged wrongful or negligent
act or omission by such indemnifying party, and (iii) any breach by such
indemnifying party of this Agreement.

 

10.2         Limitation on Liability.  Notwithstanding any provision to the contrary
contained herein, the indemnifying party shall not be liable to the indemnified
party or any other party for any indirect, special, exemplary, consequential or
punitive damages or lost profits.

 

ARTICLE XI

 

MISCELLANOUS

 

11.1         Remedies Cumulative.  The remedies provided by this Agreement are
not intended to be exclusive.  Each shall
be cumulative and shall be in addition to all other remedies available to
either party under law or equity.

 

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

 

11.2         Further Assurances.  Each party agrees to execute, acknowledge,
file and record such further documents, and do such further acts and things as
may be required hereunder or as shall be reasonably necessary to carry out the
intent and purposes of this Agreement.

 

11.3         Governing Law.  This Agreement shall be construed in
accordance with the laws of the State of New Jersey without regard to the laws
of any other jurisdiction that might be applied because of its conflicts of law
principles.

 

11.4         Entire Agreement; No Third-Party Beneficiaries.  This Agreement and its Exhibits together
constitute the complete understanding and agreement of the Parties with respect
to the subject matter hereof, and supersede all prior communications with
respect thereto.  They may not be
modified, amended or in any way altered, except in writing signed by both
Parties.  No agent of any party hereto is
authorized to make any representation, promise or warranty inconsistent with
the terms hereof.  This Agreement shall
be binding upon and shall inure solely to the benefit of the Parties and their
respective successors and permitted assigns, and nothing in this Agreement,
express or implied, is intended to or shall confer upon any other person any
legal or equitable right or benefit of any nature under or by reason of this
Agreement.

 

11.5         Captions.  Captions used herein are for convenience or
reference only, and shall not be used in the construction or interpretation
hereof.

 

11.6         Counterparts.  This Agreement may be executed in
counterparts, all of which together shall be deemed one and the same Agreement.

 

11.7         Parties Independent Contractors.  The Parties to this Agreement are and shall
remain independent contractors, and nothing herein shall be construed to create
a partnership or joint venture between them, and neither shall have the power
or authority to bind or obligate the other in any manner not expressly set forth
herein.  No employee or agent or
BioHorizons is authorized to make any claims or representations or provide any
warranties, express or implied, with respect to the Products not contained in
the written materials supplied by OTI to BioHorizons hereunder.

 

11.8         Severability.  If any provision or provisions of this
Agreement shall be held to be invalid, illegal or unenforceable, the validity,
legality and enforceability of the remaining provisions shall not in any way be
affected or impaired thereby unless either OTI or BioHorizons shall, in its
reasonable determination, conclude that it shall be materially prejudiced
thereby, in which case it may terminate this Agreement on thirty (30) days
written notice to the other Parties hereto.

 

11.9         No Waiver.  No term or provision hereof shall be deemed
waived and no breach excused unless such waiver or consent shall be in writing
and signed by the party claimed to have waived or consented.  Any consent by any party to, or waiver of, a
breach by the other, whether express or implied, shall not constitute a consent
to, waiver of, or excuse for any other different or subsequent breach.

 

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

 

11.10       Assignment.  Except as otherwise provided herein, this
Agreement may not be transferred or assigned by BioHorizons to any person
without OTI’s prior written consent at OTI’s sole discretion.  Any attempt to do so shall be null and void.

 

11.11       Force Majure.  In the event either party’s performance is
delayed, prevented, obstructed or inhibited because of any Act of God, fire,
casualty, delay or disruption in transportation, flood, war, strike or any
other act beyond its reasonable control, such party’s performance shall be
excused and the time for performance extended for the period of delay or
inability to perform resulting from such occurrence.  The occurrence of such an event shall not
constitute an Event of Default hereunder.

 

11.12       Notices.  All notices, requests or communications
required hereunder shall be in writing and shall be deemed to have been duly
given (i) upon delivery, if delivered personally against written receipt (ii) three
(3) days after posting, by certified mail, postage prepaid, return receipt
requested, (iii) upon confirmed receipt, if delivered by telecopier or (iv) the
next day, if delivered by a recognized overnight commercial courier, such as
Federal Express or UPS, addressed in each instance to the Parties at the
following addresses (or at such other addresses as shall be given by either of
Parties to the other in accordance with this section):

 

If
to OTI:

 

Osteotech, Inc.

51
James Way

Eatontown,
NJ  07724

Attn:  Legal Dept.

 

If
to BioHorizons:

 

BioHorizons
Implant Systems, Inc.

2300
Riverchase Center

Birmingham,
AL 35243

 

11.13       No Presumption Against Drafting Party.  Each party acknowledges that it has been
represented by counsel in connection with this Agreement and the transactions
contemplated hereby. Accordingly, any rule of law or legal decision that
would require interpretation of any claimed ambiguities against the drafting
party has no application and is expressly waived.

 

(Signature page to follow )

 

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

 

8

 

IN
WITNESS WHEREOF, each party has caused this Agreement to be duly executed on
its behalf by its duly authorized representative as of the date first written
above.

 

	
  OSTEOTECH, INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /S/ Sam Owusu-Akyaw

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Sam Owusu-Akyaw

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  President & CEO

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  BIOGHORIZONS IMPLANT
  SYSTEMS, INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /S/ R. Steven Boggan

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  R. Steven Boggan

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  President & 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.

 

9

 

EXHIBIT A

 

2010 PRODUCT AND PRICING

 

	
  Product
  Code

  	
   

  	
  Grafton® DBM Description

  	
   

  	
  Suggested

  End User

  Fees

  	
   

  	
  2010

  BioHorizons

  Pricing

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
   [***]

  	
   

  	
  $

  	
   [***]

  	
   

  

 

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

 

EXHIBIT B

 

MINIMUM INVENTORY PURCHASE TARGETS AND REQUIREMENTS

 

	
   

  	
   

  	
   

  	
   

  	
  Q1

  	
   

  	
  Q2

  	
   

  	
  Q3

  	
   

  	
  Q4

  	
   

  	
  Total

  	
   

  
	
  US Market Year 2010*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Total

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

[***].

 

US
Market - Years 2011-2012

 

2011

 

[***]

 

2012

 

[***]

 

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.

 

11Exhibit
10.12

 

LICENSE AGREEMENT

 

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

 

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

 

AND

 

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

 

RECITALS

 

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

 

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

 

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

 

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

 

1

 

1.             Definitions.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

2

 

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

 

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

 

i)                                         [***];

 

ii)                                      [***];

 

iii)                                   [***];

 

iv)                                  [***]; and

 

v)                                     [***].

 

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

 

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

 

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

 

2.             Effective Date.

 

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

 

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

 

3

 

3.             Patents and Patent Applications.

 

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

 

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

 

4.             Grant of License.

 

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

 

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

 

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

 

4

 

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

 

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

 

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

 

 

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

 

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

 

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

 

5.             Payments for License.

 

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

 

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

 

5

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

6

 

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

 

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

 

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

 

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

 

iv)                                  the royalty computations and
subject of payment.

 

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

 

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

 

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

 

7

 

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

 

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

 

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

 

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

 

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

 

8

 

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

 

6.             Method of Payment.

 

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

 

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

 

7.             Development and
Commercialization.

 

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

 

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

 

9

 

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

 

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

 

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

 

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

 

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

 

10

 

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

 

8.             Infringement of HJD/Orthogen
Joint Patents.

 

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

 

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

 

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

 

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

 

11

 

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

 

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

 

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

 

12

 

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

 

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

 

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

 

9.             Liability and Indemnification.

 

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

 

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

 

13

 

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

 

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

 

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

 

10.           Security for Indemnification.

 

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

 

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

 

14

 

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

 

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

 

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

 

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

 

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

 

15

 

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

 

11.           Expiry and Termination.

 

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

 

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

 

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

 

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

 

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

 

16

 

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

 

12.           Representations and Warranties by
Orthogen.

 

Orthogen
hereby represents and warrants to HJD as follow:

 

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

 

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

 

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

 

13.           Representations and Warranties by
HJD.

 

HJD
hereby represents and warrants to Orthogen as follows:

 

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

 

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

 

17

 

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

 

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

 

14.                                 No Assignment.

 

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

 

15.                                 Use of Name.

 

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

 

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

 

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

 

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

 

18

 

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

 

16.                                 Miscellaneous.

 

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

 

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

 

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

 

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

 

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

 

To HJD:                                                                                                                                                    John N.
Kastanis

President and CEO

Hospital for Joint Diseases

301 East 17th Street

New York, NY 10003

 

and to:                                                                                                                                                           Isaac T.
Kohlberg

Vice Provost, New York
University

c/o NYU School of Medicine

 

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

 

19

 

550 First Avenue

New York, NY 10016

 

To Orthogen:                                                                                                                        Orthogen
Corporation

530 Morris Avenue

Suite 204

Springfield, NJ 07081

 

Attention:                                         Harold
Alexander

President

 

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

 

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

 

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

 

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

 

20

 

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

 

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

 

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

 

	
   

  	
   

  	
  HOSPITAL
  FOR JOINT DISEASES

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /S/ John N. Kastanis

  
	
   

  	
   

  	
  John
  N. Kastanis

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:
  

  	
  President
  and CEO

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  8/12/99

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  ORTHOGEN
  CORPORATION

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /S/ Harold Alexander

  
	
   

  	
   

  	
  Harold
  Alexander, Ph.D.

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:
  

  	
  President

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  August 4, 1999

  

 

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

 

21

 

APPENDIX I

 

HJD/Orthogen
Joint Patents

 

United
States

 

	
  Serial
  No.

  	
   

  	
  Filed

  	
   

  	
  Title

  	
   

  	
  Status

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

Foreign

 

	
  Country

  	
   

  	
  App. No.

  	
   

  	
  Title

  	
   

  	
  Status

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Request
  examination before 11/02/01

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending

  

 

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

 

22

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00175-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00175-of-00352.parquet"}]]