Document:

ex10_27f.htm

Exhibit 10.27(f)

Terms of Separation for Linda G. Havard

From: Shapiro, Howard

To: Havard, Linda

Date: Mon. Nov. 30 2009

Subject: Separation

Linda,

This will confirm the commitments Playboy has made concerning your separation:

1. Your employment will terminate effective as of the end of the business day on December 31, 2009.

2. Playboy will reimburse you for the reasonable costs of up to 12 months of outplacement, with a service provider of your choice.

3. Playboy will pay any legal fees you’ve incurred up to November 19, 2009 concerning your separation.

4, If on or before February 28, 2010 there is a “Potential Change in Control” as defined in your Amended and Restated Severance Agreement, then on the closing of a Change in Control of Playboy your severance benefits will cease and you will instead be entitled to the benefits of your Amended and Restated Severance Agreement, according to its terms; provided that such closing occurs within 2010.  However, any payment to you under the Amended and Restated Severance Agreement will be reduced by any severance pay you receive under your 12-month severance agreement between December 31, 2009 and the date of closing of such Change in Control.

5. As to the Company’s D&O policy, while you remain a Playboy employee, you will be entitled to the same D&O coverage afforded to the Company’s other directors and officers.  Once you cease being a Playboy employee, you will be entitled to that D&O coverage afforded to former officers of the Company.

6. You will be paid for 35 vacation days.

7. As long as you are receiving severance pay under your 12 month severance agreement, you will remain covered by Playboy’s group health benefit plans (including, without limitation, medical, dental and vision benefits), at the same employee contribution rate and plan benefits applicable to active employees.

8. You may elect to continue your health insurance coverage under the Consolidated Omnibus Reconciliation Act of 1985, as amended (“COBRA”), paying premiums as they become due, after the severance pay set out in paragraph 7. above has ceased.  Coverage may be continued for you under COBRA for up to eighteen (18) months.

With best wishes,

Howard S. Shapiro

Executive Vice President, Law and Administration

General Counsel and SecretaryUnassociated Document

    

     

    EXHIBIT
10.56

     

    AMENDED
AND RESTATED

     

    MANUFACTURING
AND SUPPLY AGREEMENT

     

    This
Amended and Restated Manufacturing And Supply Agreement (“Agreement”), effective as of
01 December, 2009 (“Effective
Date”), is made by and between Novartis Vaccines and Diagnostics, Inc
with its headquarters located at 350 Massachusetts Avenue, Cambridge, MA 02139
USA (“Novartis”), and
BioMimetic Therapeutics, Inc., a Delaware corporation with its headquarters
located at 389 Nichol Mill Lane, Franklin, Tennessee 37067 (“BMTI”).

     

    BACKGROUND

     

    BMTI and
Chiron Corporation (“Chiron”) previously entered
into an exclusive, Manufacturing and Supply Agreement effective July 28, 2004
(“Original
Agreement”).

     

    On April
20, 2006, Novartis acquired Chiron and thereby assumed Chiron’s rights and
responsibilities under the Original Agreement.  Under the Original
Agreement Novartis has manufactured and supplied BMTI with a Product consisting
of purified bulk recombinant human platelet derived growth factor (“PDGF”), as
described in Novartis' FDA-approved Biological License Application therefor
(“Novartis' BLA”), for
use in the Exclusive Fields (as defined below).

     

    The
parties now wish to amend and restate the Original Agreement to better define
the parties’ rights and obligations regarding the Product (as defined
below).  The parties therefore hereby agree to the terms and
conditions set forth herein, including the Exhibits, which are attached hereto
and incorporated herein, by reference.

     

     In
the event of any conflict between any Exhibit and this Agreement, this Agreement
shall be controlling.

     

    AGREEMENT

     

    
      	
              1.

            	
              Definitions.

            

    

     

    For
purposes of this Agreement, the following definitions shall apply, and the terms
defined herein in plural shall include the singular and vice-versa.

     

    
      	
               
      

            	
              1.1.

            	
              “Affiliate”
      means any corporation or other entity that controls, is controlled by or
      is under common control with Novartis or BMTI, as applicable, as of the
      Effective Date or during the term of this Agreement. “Control” means the
      ownership, directly or indirectly, of 50% or more of the voting stock of a
      corporate entity, or of 50% or more of the beneficial interest of an
      entity other than a corporation.

            

    

     

    
      	
               
      

            	
              1.2.

            	
              “cGMPs” means
      the then-current Good Manufacturing Practices applicable
      to the manufacture, processing, packaging, testing and release of bulk
      pharmaceutical products for human use, established by regulatory
      authorities within any relevant jurisdiction of the European Union, United
      States and Canada.

            

    

     

    
      	
               
      

            	
              1.3.

            	
              “Changed
      Services” has the meaning given in Section
  2.3.

            

    

     

    
      	
               
      

            	
              1.4.

            	
              “Novartis' BLA”
      has the meaning given in the second paragraph of the Background,
      above.

            

    

     

    
      	
               
      

            	
              1.5.

            	
              “Claims” has
      the meaning given in Section 8.3.

            

    

     

    
      	
               
      

            	
              1.6.

            	
              “Confidential
      Information” has the meaning given in Section
  7.1.

            

    

     

    
      	
               
      

            	
              1.7.

            	
              “Conforming” or
      “Conformity,”
      (a) in reference to Product, means Product that is shown to have been
      manufactured in accordance with applicable cGMPs and to meet the
      Specifications.

            

    

     

    
      	
               
      

            	
              1.8.

            	
              “FDA” means the
      U.S. Food and Drug Administration.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              1.9.

            	
              “Facility” or
      “Facilities”
      means Novartis’, its Affiliate’s, or any Subcontractor’s licensed
      biological production facilities located in Vacaville,
      California.

            

    

     

    
      	
            	
              1.10.

            	
              “Exclusive
      Field(s)” means the treatment of: (1) periodontal and dental
      diseases, (2) craniomaxillofacial applications and, (3) other skeletal
      applications including the healing of bone, cartilage, tendon and
      ligaments of the skeletal systems.  Field shall include
      treatments in humans and animals. For the avoidance of doubt, the Parties
      agree that the treatment of Parkinson disease and Huntington disease,
      and/or any other brain-related disease will be specifically excluded from
      the Exclusive Field(s).

            

    

     

    
      	
            	
              1.11.

            	
              “Nonconforming”
      or “Nonconformity,”
      means Product that is shown not to be
  Conforming.

            

    

     

    
      	
            	
              1.12.

            	
              “Notice Period”
      has the meaning given in Section
11.1.

            

    

     

    
      	
            	
              1.13.

            	
              “Product” means
      Saccharomyces
      derived cGMP purified bulk recombinant human platelet derived
      growth factor, rhPDGF-BB, packaged in ** bottles containing approximately
      ** grams of rhPDGF-BB, as specified in Novartis'
  BLA.

            

    

     

    
      	
            	
              1.14.

            	
              “Quality
      Agreement” has the meaning given in Section
  6.8.

            

    

     

    
      	
            	
              1.15.

            	
              “Registrations”
      shall mean any and all government approvals necessary for the import,
      storage or handling of the Product and the manufacturing, import,
      marketing, distribution and sale of the product containing the Product as
      labeled, packaged and presented for sale to the health care trade or any
      part of the manufacturing process.

            

    

     

    
      	
            	
              1.16.

            	
              “Regulatory
      Authorities” shall mean any governmental authority in any country
      or group of countries competent to grant any
  Registrations.

            

    

     

    
      	
            	
              1.17.

            	
              “Specifications”
      shall mean the specifications for the Product as set forth in the Quality
      Agreement which may only be amended upon mutual written agreement of the
      parties.

            

    

     

    
      	
            	
              1.18.

            	
              “Subcontractor(s)”
      shall mean any Affiliates of Novartis and/or other third parties
      subcontracted by Novartis to perform part or all of its obligations
      hereunder.

            

    

     

    
      	
            	
              1.19.

            	
              “Sublicensee(s)”
      shall mean any Affiliates of BMTI and/or other third parties sublicensed
      by BMTI to exercise part or all of its rights
  hereunder.

            

    

     

    
      	
              2.

            	
              Product
      Manufacture, Supply And Use.

            

    

     

    
      	
            	
              2.1.

            	
              Product Supply And
      Purchase. During the term of this Agreement, and specifically
      limited to the use of the Product in the Exclusive Fields, Novartis shall
      manufacture exclusively for and supply exclusively to BMTI, and BMTI shall
      purchase exclusively from Novartis, Product for use in the Exclusive
      Fields.  For the avoidance of doubt, Novartis shall be entitled
      to manufacture and supply the Product to third parties for use in fields
      other than the Exclusive Fields.  Subject to Section 11.1,
      Novartis shall be entitled to subcontract or delegate all or any portion
      of its obligations hereunder to any Subcontractor. Novartis shall use its
      commercially reasonable efforts to ensure that any Subcontractor performs
      its obligations pursuant to the terms of this Agreement, and Novartis
      shall remain ultimately responsible for performance under this
      Agreement.

            

    

     

    
      	
            	
              2.2.

            	
              Use
      Restrictions. BMTI understands and acknowledges that Novartis'
      rights to supply Product are derived in part from third-party licenses
      that restrict the uses of Product; accordingly, BMTI agrees not to use,
      sell, import, or sublicense Product, or to make, use, sell, import, or
      sublicense any product incorporating Product, other than in the Exclusive
      Fields.

            

    

     

    
      	
            	
              2.3.

            	
              Changed
      Services. Changes to the Products and manufacturing may only be
      made in accordance with the Quality Agreement. Actual and direct costs
      incurred by a party as a result of changes will be allocated as
      follows:

            

    

     

    
      	
            	
              2.3.1.

            	
              Novartis shall solely
      bear all actual and related costs resulting
  from:

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              2.3.1.1.

            	
              Changes
      requested by Novartis (on its own behalf or on behalf of any
      Subcontractor); and

            

    

     

    
      	
            	
              2.3.1.2.

            	
              Changes
      requested or required by the Regulatory Authorities relating to the
      Facility, Process, or Product and all investments related to the
      establishment, maintenance and improvement of cGMP compliance shall be
      fully borne by Novartis; and

            

    

     

    
      	
            	
              2.3.1.3.

            	
              Changes
      in the materials and/or Novartis of key components of the
      Product.

            

    

     

    
      	
            	
              2.3.2.

            	
              BMTI
      shall solely bear all actual and related costs resulting
    from:

            

    

     

    
      	
            	
              2.3.2.1.

            	
              Changes
      requested by BMTI;

            

    

     

    
      	
            	
              2.3.2.2.

            	
              Changes
      requested or required by the Regulatory Authorities relating to the
      marketing of any BMTI product containing the Product (other than listed
      under Section 2.3.1.2 above);

            

    

     

    
      	
            	
              2.3.2.3.

            	
              Changes
      in text of prescribing information (package insert) and labeling to the
      extent that this is relevant to this
Agreement.

            

    

     

    
      	
            	
              2.4.

            	
              BMTI
      Sublicensees. In the event that BMTI sublicenses any of its rights
      in the Exclusive Field to an Affiliate or third party BMTI shall ensure
      that such Sublicensee complies with the terms of this Agreement, to the
      extent that they apply and BMTI shall be responsible for any breach of
      this Agreement that is caused (directly or indirectly) by the performance
      (or failure to perform) of such
Sublicensee.

            

    

     

    
      	
            	
              2.5.

            	
              Novartis
      warrants that it holds and will continue to hold throughout the term of
      this Agreement all Registrations required by it in connection with its
      obligations under this Agreement.  Novartis warrants that it
      will not produce Product outside of the United States during the Term of
      this Agreement.  BMTI warrants that it or it’s Sublicensees
      holds and will continue to hold throughout the term of this Agreement all
      Registrations required by it in connection with any product containing the
      Product and/or its obligations under this
  Agreement.

            

    

     

    
      	
              3.

            	
              Forecasts,
      Purchase Orders And Shipment

            

    

     

    
      	
            	
              3.1.

            	
              Forecast

            

    

     

    
      	
            	
              3.1.1.

            	
              Subject
      to Section 3.2 below, upon execution of this Agreement, BMTI shall provide
      Novartis with a written non-binding ** (**) month, rolling forecast (“Forecast”) of the
      number of grams of Product that BMTI will require in each month of the **
      (**) month period (the “Forecasted Requirements”)
      , and
      the requested delivery date(s). The Forecasted Requirements shall be in
      increments of ** grams per container.  With the exception of the
      first ** months of the Forecast which shall be binding, and subject to
      Section 3.1.2 below, such Forecasted Requirements shall be updated
      quarterly. BMTI will use all commercially reasonable efforts to provide
      accurate and consistent Forecasts, acting in good
  faith.

            

    

     

    
      	
            	
              3.1.2.

            	
              The
      first ** months of the Forecast shall be binding upon the parties (“Binding Requirements”)
      and may not be changed without each party’s prior written consent.
      The ** up to and including the ** month of the Forecast shall be binding
      on the parties to the extent that BMTI may not increase or decrease the
      monthly requirements for Product by more than **% (in whole **-gram
      increments), without Novartis' prior written
  consent.

            

    

     

    
      	
            	
              3.1.3.

            	
              At
      least ** (**) months prior to the date on which BMTI would like Product
      delivered, BMTI shall submit to Novartis a binding purchase order covering
      the Binding Requirements and, if desired, any additional Product (in
      **-gm/container increments) that BMTI would like to receive at that time
      (each, a “Purchase
      Order”). The Purchase Order shall specify the requested dates of
      delivery of the ordered Product. Novartis will acknowledge receipt, in
      writing, of all Purchase Orders received hereunder within **
      days.

            

    

     

    
      	
            	
              3.1.4.

            	
              Subject
      to compliance by BMTI with Section 3.1.1 Novartis will fill each
      properly-submitted Purchase Order, to the extent of the Binding
      Requirements, by the delivery date requested therein or another date
      mutually agreed upon by the parties, in writing. If BMTI agrees to delay a
      delivery date at Novartis’ request, with respect to the Binding
      Requirements such an agreement shall not be deemed a waiver of BMTI’s
      rights hereunder with respect to Novartis’ failure to meet the original
      delivery date. Novartis will use commercially reasonable efforts to supply
      any additional Product ordered but does not guarantee that such Product
      will be supplied.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    
      
        	
              	
                3.2.

              	
                Minimum Shelf
      Life.  At the time of delivery to BMTI's designated
      carrier, Product shall have a remaining shelf life of not less than **
      months unless otherwise agreed between the
  parties.

              

      

    

     

    
      	
              4.

            	
              Delivery,
      Inspection, Acceptance And Rejection Of
Product.

            

    

     

    
      	
            	
              4.1.

            	
              Delivery.
      Novartis shall make Product and related Deliverables available to BMTI's
      designated carrier on or before the delivery date set forth in the
      Purchase Order. All shipments shall be FCA (Incoterms 2000) the Facility,
      provided that the Facility is located in the United
  States.

            

    

     

    
      	
            	
              4.2.

            	
              Acceptance And
      Rejection. BMTI shall have ** (**) business days from the date of
      receipt of the Product to determine whether it is
      Conforming.  BMTI shall promptly notify Novartis, in writing, of
      any Nonconforming Product and the specific reasons for such
      Nonconformity.  Failure to reject Product within such **
      business days shall be deemed acceptance of the
  Product.

            

    

     

    
      	
            	
              4.3.

            	
              Disputes Re
      Conformity. If BMTI notifies Novartis of any alleged Nonconformity
      of Product, the invoice for such Product shall not be due or payable until
      the Nonconformity issue is resolved, and BMTI has accepted such Product or
      replacement Product. The parties shall in good faith attempt to resolve
      the issue within ** (**) days of BMTI's notice, and if unable to do so,
      shall follow the Dispute Resolution process set forth in Section
      14.9.

            

    

     

    
      	
            	
              4.4.

            	
              Exclusive
      Remedy. If any  Products received by BMTI are
      Nonconforming, Novartis, shall replace the Nonconforming Product as soon
      as is reasonably commercially practicable, at no additional charge to BMTI
      if BMTI has already paid for the Nonconforming Product or in the event
      that BMTI has not paid the original invoice BMTI will be responsible for
      paying the invoice for the replacement Product. Such replacement shall be
      Novartis' sole liability and BMTI's sole remedy with respect to
      Nonconforming Product.

            

    

     

    
      	
              5.

            	
              Compensation.

            

    

     

    
      	
            	
              5.1.

            	
              Product
      Pricing. BMTI will pay Novartis the amounts set forth in Annex 2,
      at the times specified therein and in accordance with the payment terms
      described in Section 6.6 of Annex
2.

            

    

     

    
      	
            	
              5.2.

            	
              Taxes. Prices
      and fees do not include any national, state or local sales, use,
      value-added or other taxes, customs duties, or similar tariffs or fees
      that Novartis may be required to pay or collect upon the delivery of
      Product hereunder or upon collection of the prices and fees or otherwise.
      Should any tax or levy be made (other than any such tax based on the
      income of Novartis), BMTI agrees to pay such tax or levy and to indemnify
      Novartis for any claim for such tax or levy demanded, including applicable
      penalties and interest, other than to the extent (if any) due to Novartis'
      failure to comply with its obligations to collect or to remit such tax.
      BMTI agrees to provide Novartis with appropriate resale certificate
      numbers and other documentation satisfactory to the applicable taxing
      authorities to substantiate any claim of exemption from any such taxes or
      fees.

            

    

     

    
      	
            	
              5.3.

            	
              Third Party
      Royalties. BMTI shall reimburse Novartis for all royalties that
      Novartis is required to pay to third parties, in order to manufacture and
      supply Product to BMTI, including the royalties described in Annex 2. If
      either party is put on notice by a third party of alleged infringement of
      the intellectual property rights of such third party by Novartis or any of
      its Subcontractors in the manufacture of Product, such party shall
      promptly inform the other party thereof. BMTI shall promptly resolve any
      matter relating to such alleged infringement that relates solely to
      Products supplied hereunder, and shall timely pay all amounts due
      resulting from or relating to the manufacture of Product supplied
      hereunder or the commercial sale of any product incorporating Product
      supplied hereunder.   These payments shall be in addition
      to the compensation payable to Novartis provided in Annex
      2.  Notwithstanding the foregoing, Novartis shall be responsible
      for resolving any infringement issues that relate exclusively to the
      manufacturing methods used by Novartis to produce the Product and do not
      result from BMTI’s reformulation or configuration of the Product into BMTI
      products or the manner in which BMTI products are
  used.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              5.4.

            	
              Payments. All
      payments shall be made in United States Dollars by wire transfer of
      immediately available funds to an account as specified by Novartis in
      writing from time to time. If any payment due hereunder is not paid in
      full on the due date, interest at the prime rate (as announced from time
      to time by Bank of America N.A.) plus two percent, or the maximum
      permitted by law, whichever is lower, shall accrue and become payable upon
      any unpaid balance from the date such payment was due until it is paid in
      full.

            

    

     

    
      	
              6.

            	
              Quality
      And Regulatory Matters.

            

    

     

    
      	
            	
              6.1.

            	
              Novartis
      shall operate its facilities, process equipment, software and programs
      such as environmental monitoring, calibration, validation, compliance,
      cGMP training and maintenance in accordance with cGMPs, Novartis’ Standard
      Operating Procedures, Novartis’ applicable regulatory licenses and
      requirements, and the relevant terms of the Quality
    Agreement.

            

    

     

    
      	
            	
              6.2.

            	
              Right to Review
      Processes. Novartis shall maintain all quality assurance
      manufacturing records, batch production records and other records directly
      related to Product manufactured in accordance with the Quality Agreement.
      The requirements for Inspections and Audits are defined in the Quality
      Agreement.  All information obtained by BMTI pursuant to this
      Section 6.2 shall be subject to the confidentiality provisions of Article
      7.

            

    

     

    
      	
            	
              6.3.

            	
              Product Complaints.
      Subject to Section 8.3 of this Agreement, BMTI shall be responsible
      for handling all complaints regarding products that incorporate the
      Product. Novartis will notify BMTI of any complaints it receives and will
      provide, at BMTI's expense, such assistance in investigating such
      complaints as provided in the Quality Agreement. Should such investigation
      show that the complaint was a result of Nonconforming Product manufactured
      under the control of Novartis  or any of its Subcontractors,
      then any expenses owed or paid by BMTI pursuant to this Section 6.3 for
      Novartis' assistance shall be cancelled or refunded to BMTI. The parties
      shall in good faith freely exchange information that will enable them to
      determine the nature and cause of such complaints. BMTI shall have the
      authority to resolve any outstanding complaints. BMTI shall promptly
      notify Novartis if such a complaint is based upon an alleged defect in the
      manufacture of Product.

            

    

     

    
      	
            	
              6.4.

            	
              Recalls. The
      handling of recalls and withdrawals of products incorporating Product
      shall be governed by the terms of the Quality Agreement.  Where
      Novartis is deemed responsible pursuant to Section 4, Novartis will
      cooperate fully with BMTI in the event of any such recall or withdrawal
      and will provide such assistance in connection therewith as BMTI may
      reasonably request. Costs related to a Product recall or return will be
      borne by the party determined to be responsible for the costs of replacing
      the Product in accordance with Section
  4.  

            

    

     

    
      	
            	
              6.5.

            	
              Cross-Reference
      Rights. BMTI shall have the right to reference Novartis' BLA on the
      Product, (and manufacturing information submitted by Novartis to
      Regulatory Authorities in connection therewith), in their applications to
      Regulatory Authorities for investigational or marketing approval of any
      product containing Product for use within the Exclusive Field. Novartis
      shall be responsible for maintaining such Novartis BLA on the Product in
      good standing with regulatory Authorities, at no expense to BMTI. Any
      other work with respect to regulatory filings shall be subject to Section
      2.3 (Changed Services).

            

    

     

    
      	
            	
              6.6.

            	
              European Cross-Reference
      Rights. Novartis recognizes the critical importance of BMTI having
      access to an acceptable Drug Substance Master File covering the Product in
      the European Union.  Novartis will use its commercially
      reasonable endeavors to work with BMTI to prepare an acceptable Drug
      Substance Master File, at BMTI’s cost and expense and/or provide BMTI with
      reasonable information and documents that enable BMTI or its Sublicensees
      to obtain regulatory approval and continue selling products containing the
      Product in Europe.

            

    

    

    
      	
            	
              6.7.

            	
              Environmental, Health
      and Safety.  Novartis shall comply with the Novartis
      Health, Safety and Environmental Protection Policy set forth in Annex 4
      hereof.

            

    

     

    
      	
            	
              6.8.

            	
              Quality Agreement.
      Concurrently herewith, the parties shall execute a Quality
      Agreement (“Quality
      Agreement”) to fulfill applicable legal and regulatory
      requirements.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              6.9.

            	
              Trading Services
      Procedure. The parties agree to the terms and procedures set forth
      in the Trading Services Procedures, attached hereto as Annex
      3.

            

    

     

    
      	
              7.

            	
              Confidential
      Information.

            

    

     

    
      	
            	
              7.1.

            	
              Definition.
      During the term of this Agreement, the parties may provide to one another
      confidential information, including but not limited to each party's
      proprietary materials and/or technologies, economic information, business
      or research strategies, trade secrets and material embodiments thereof
      which may be disclosed by such party and/or its Affiliates to the other
      party and/or its Affiliates which (a) if in written form, is clearly
      marked “confidential,” (b) if in oral form, is summarized in writing and
      marked “confidential” delivered to the recipient within thirty (30) days
      after the oral disclosure, (c) if further disclosed, could reasonably be
      expected to result in competitive harm to the disclosing party, or (d)
      consists of or relates to any unpublished patent application (herein
      defined as “Confidential
Information”).

            

    

     

    
      	
            	
              7.2.

            	
              Exclusions.
      Confidential Information shall not include information that (a) is shown
      by contemporaneous documentation of the recipient to have been in its
      possession prior to receipt from the disclosing party, (b) is or becomes,
      through no fault of the recipient, publicly known, (c) is furnished to the
      recipient by a third party without breach of an obligation of
      confidentiality, (d) is independently developed by the recipient without
      use of the disclosing party's Confidential Information or (e) is required
      to be disclosed by law, provided that the recipient gives the disclosing
      party as much advance notice of the requirement as is reasonably
      possible.

            

    

     

    
      	
            	
              7.3.

            	
              Obligations.
      During the term of this Agreement and for ** (**) years thereafter, the
      recipient shall maintain the disclosing party's Confidential Information
      in confidence, except that BMTI may disclose this Agreement in its
      entirety to parties evaluating a business relationship with BMTI, provided
      that such parties are under written obligations of confidentiality and
      non-use with respect to this Agreement at least as restrictive as those
      set forth herein with respect to Novartis' Confidential Information. The
      recipient shall use the disclosing party's Confidential Information solely
      to exercise its rights and perform its obligations under this Agreement,
      unless otherwise mutually agreed in writing, and shall at all times
      protect the disclosing party's Confidential Information with at least the
      same degree of care it uses to protect its own Confidential Information,
      such care to be of the type and degree that would be used by a reasonable
      and prudent business person. The recipient acknowledges that breach of
      confidentiality may result in irreparable financial harm to the disclosing
      party and that the disclosing party may seek all remedies in law or equity
      for such a breach.

            

    

     

    
      	
            	
              7.4.

            	
              Return of Confidential
      Information. Upon request by the disclosing party, the recipient
      shall return or destroy (as evidenced by a written certificate of
      destruction) all Confidential Information of the disclosing party in its
      possession; provided, however, that one copy of such Confidential
      Information may be retained in the recipient's legal files for purposes of
      monitoring compliance with the provisions
  hereof.

            

    

     

    
      	
              8.

            	
              Insurance;
      Indemnity; Limitations on
Liability.

            

    

     

    
      	
            	
              8.1.

            	
              Insurance of
      Novartis. Novartis represents and warrants that it presently
      maintains and shall continue to maintain in full force and effect, at its
      own cost and expense, insurance or self-insurance to cover the risks
      associated with its obligations
hereunder.

            

    

     

    
      	
            	
              8.2.

            	
              BMTI Insurance.
      BMTI represents and warrants that it presently maintains and shall
      continue to maintain in full force and effect, at its own cost and
      expense, insurance to cover the risks associated with its obligations
      hereunder. The terms of such insurance coverage shall be evidenced by
      certificates of insurance to be furnished to Novartis within 30 days of
      the Effective Date and as may be reasonably requested thereafter. Such
      certificates shall name Novartis, its Affiliates and their respective
      agents, employees and directors as additional insured and shall provide
      that thirty (30) days' written notice shall be given to Novartis prior to
      cancellation or expiration of any of the terms of coverage or any
      policy.

            

    

     

    
      	
            	
              8.3.

            	
              Indemnification by
      BMTI. BMTI shall indemnify and hold Novartis, its Affiliates and
      their respective directors, officers, employees and agents (collectively,
      “Novartis
      Indemnitees”), harmless from and against all claims, damages,
      demands, proceedings, liabilities, losses, costs and expenses, including
      reasonable attorneys' fees (collectively, “Claims”), to the extent
      arising from (a) the development, manufacture, use or sale of
      any  Product (except where the Product is Nonconforming provided
      always that BMTI has complied with the procedure set out in Section 4.2)
      or of any product incorporating Product, including but not limited to any
      such Claim for product liability (whether based on strict liability,
      inherent design defect, negligence, failure to warn, breach of contract or
      any other theory of liability), or (b) any acts or omissions of BMTI or
      any of its directors, officers, employees or agents, and from any Claim
      alleging that the manufacture, use or sale of any Product, or product
      incorporating Product infringes any intellectual property rights of a
      third party; provided, however, that BMTI shall have no liability or
      responsibility to indemnify Novartis Indemnitees to the extent a Claim is
      attributable to the negligence, gross negligence, or intentional
      misconduct of
Novartis.    

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              8.4.

            	
              Indemnification by
      Novartis.  Novartis agrees to indemnify and hold BMTI,
      its Affiliates and their respective directors, officers, employees and
      agents (collectively, “BMTI Indemnitees”),
      harmless from and against all Claims arising from or are attributable to
      the negligence, gross negligence, or intentional misconduct of Novartis or
      its directors, officers, agents or employees, permitted contractors, or
      consultants provided however, Novartis shall have no liability or
      responsibility to indemnify BMTI Indemnitees to the extent a Claim is
      attributable to the negligence, gross negligence, or intentional
      misconduct of BMTI.

            

    

     

    
      	
            	
              8.5.

            	
              Limitation on
      Damages. EXCEPT WITH RESPECT TO SECTIONS 8.3 and 8.4, IN NO EVENT
      SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY, ITS AFFILIATES OR ANY
      THIRD PARTY FOR LOST PROFITS OR FOR ANY SPECIAL, CONSEQUENTIAL,
      INCIDENTAL, PUNITIVE OR INDIRECT DAMAGES ARISING FROM A BREACH OF THIS
      AGREEMENT, INCLUDING WITHOUT LIMITATION ANY BREACH OF A WARRANTY CONTAINED
      HEREIN OR OF ANY OBLIGATION TO PERFORM SERVICES OR TO PROVIDE PRODUCT BY A
      SPECIFIED TIME.

            

    

     

    
      	
              9.

            	
              Representations
      and Warranties.

            

    

     

    
      	
            	
              9.1.

            	
              Of
      Novartis.

            

    

     

    Novartis
warrants that (a) at the time of delivery to BMTI's designated carrier, Products
will be Conforming and (b) as of the Effective Date, to the best of Novartis'
knowledge, there are no legal actions pending or threatened to be filed against
Novartis that would prevent the manufacture or commercial sale of Product, as
contemplated hereunder.

     

    
      	
            	
              9.2.

            	
              Of
      BMTI.  BMTI represents that its Sublicensees are
      contractually prohibited from selling any product containing Product
      outside the Exclusive Field.  BMTI warrants that it will use
      commercially reasonable efforts to enforce this contractual restriction on
      its Sublicensees.    BMTI further warrants that any
      third party to whom it sells Product for incorporation into a product
      shall be contractually obligated to restrict the use thereof to within the
      Exclusive Field.

            

    

     

    
      	
            	
              9.3.

            	
              Of Each Party.
      Each party represents and warrants to the other party that (a) such party
      has full power and authority to execute and deliver this Agreement and to
      perform its obligations hereunder, (b) the execution, delivery and
      performance by such party of this Agreement has been duly and validly
      authorized, and no additional authorization or consent is required in
      connection with the execution, delivery and performance by such party of
      this Agreement and (c) this Agreement has been duly executed and delivered
      by such party and constitutes a valid and legally binding obligation of
      such party, enforceable in accordance with its
  terms.

            

    

     

    
      	
            	
              9.4.

            	
              No Other
      Warranties. EXCEPT FOR THE WARRANTIES PROVIDED IN THIS ARTICLE 9,
      NOVARTIS MAKES NO WARRANTY, EXPRESS OR IMPLIED, REGARDING THE PRODUCT,
      INCLUDING WITHOUT LIMITATION ANY WARRANTY REGARDING THEIR FITNESS FOR ANY
      PURPOSE, THEIR QUALITY, THEIR MERCHANTABILITY OR THEIR NON-INFRINGEMENT OF
      INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. ANY REPRESENTATIONS OR
      WARRANTIES MADE BY ANY PERSON OR ENTITY, INCLUDING EMPLOYEES OR
      REPRESENTATIVES OF NOVARTIS, THAT ARE INCONSISTENT HEREWITH, SHALL BE
      DISREGARDED AND SHALL NOT BE BINDING ON
  NOVARTIS.

            

    

     

    
      	
              10.

            	
              Term
      And Termination.

            

    

     

    
      	
            	
              10.1.

            	
              Term. This
      Agreement shall come into force as of the Effective Date and shall remain
      in force for an initial period of three (3) years from the Effective Date
      (“Initial Term”),
      unless sooner terminated pursuant to Section 10.2, and shall automatically
      renew thereafter for consecutive three-year periods (each an “Extension Term”, and
      collectively together with the Initial Term it shall be
      referred to as the “Term”), unless either
      party has notified the other in writing, at least two (2) years prior to
      the end of the Initial Term or upon six (6) months notification period,
      at
      any time during any Extension Term of its intention to terminate
      the Agreement.  For the avoidance of doubt, the Parties agree
      that neither Party may provide to the other, termination notice of this
      Agreement, within the first twelve (12) months after the Effective
      Date.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        7

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              10.2.

            	
              Termination.
      This Agreement may be terminated: 

            

    

     

    
      	
            	
              10.2.1.

            	
              By
      either party:

            

    

     

    
      	
               
      

            	
              (a)

            	
              upon
      any material breach of this Agreement by the other party; provided,
      however, that the party alleging such breach must first give the other
      party written notice thereof, which notice must state the nature of the
      breach in reasonable detail and that the party giving such notice views
      such alleged breach as a basis for terminating this Agreement under this
      Section 10.2.1(a), and the party receiving such notice must have failed,
      within sixty (60) days after receipt of such notice, (i) to cure such
      alleged breach or (ii) to develop and implement a plan reasonably
      acceptable to the aggrieved party to remedy the breach within a reasonable
      period of time, or

            

    

     

    
      	
               
      

            	
              (b)

            	
              if
      (i) the other party makes an assignment for the benefit of its creditors
      or files a voluntary petition under federal or state bankruptcy or
      insolvency laws, (ii) a receiver or custodian is appointed for all or
      substantially all of the other party's business, (iii) proceedings are
      instituted against the other party under federal or state bankruptcy or
      insolvency laws that have not been stayed or dismissed within sixty (60)
      days, (iv) all or substantially all of the other party's business or
      assets become subject to attachment, garnishment or other process or (v) a
      court or other governmental authority of competent jurisdiction determines
      that the other party is insolvent, such early termination to be effective
      immediately upon the occurrence of the applicable
  event.

            

    

     

    
      	
            	
              10.2.2.

            	
              By
      Novartis:

            

    

     

    
      	
               
      

            	
              (a)

            	
              effective
      upon written notice to BMTI, that Novartis is in receipt of notice from a
      third party that the manufacture or supply of Product infringes a patent
      or other intellectual property right of such party, unless BMTI obtains
      the consent of such party for Novartis to continue to manufacture and
      supply Product, whether such consent is by license or other written
      agreement,

            

    

     

    
      	
               
      

            	
              (b)

            	
              upon
      sixty (60) days notice to BMTI, if BMTI fails to use commercially
      reasonable efforts to obtain Product marketing approvals from Regulatory
      Authorities of the European Union, unless BMTI demonstrates, within such
      60-day period, that it is using commercially reasonable efforts to obtain
      such marketing approvals, or

            

    

     

    
      	
               
      

            	
              (c)

            	
              pursuant
      to Section 11.1(c).

            

    

     

    
      	
            	
              10.2.3.

            	
              By
      BMTI:

            

    

     

    
      	
               
      

            	
              (a)

            	
              effective
      upon written notice to Novartis, subject to payment of the fees specified
      in Annex 2; or

            

    

     

    
      	
               
      

            	
              (b)

            	
              upon
      60 days written notice to Novartis that BMTI cannot obtain commercially
      reasonable terms for any third-party license required by Novartis to
      manufacture Product, in which case, no compensation shall be payable to
      Novartis other than amounts due and owing under any outstanding Binding
      Requirements and Purchase Orders;
or

            

    

     

    
      	
               
      

            	
              (c)

            	
              upon
      written notice to Novartis if Novartis has failed to deliver the Binding
      Requirements of Purchase Order within one hundred twenty (120) days of the
      delivery date requested therein; or

            

    

     

    
      	
               
      

            	
              (d)

            	
              pursuant
      to Section 11.2.

            

    

     

    
      	
            	
              10.3.

            	
              BMTI Rights Upon
      Termination.  As a nonexclusive remedy to termination by
      BMTI pursuant to Section 10.2.1 and 10.2.3(c) at BMTI’s option following
      such a termination Novartis shall be obligated to supply BMTI with the
      Minimum Supply Quantities as set forth below in Section 11.2 and conduct
      the technology transfer as set forth in Section
  11.3.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              10.4.

            	
              Survival.
      Expiration or termination of this Agreement for any reason shall not
      release either party from any liability, obligation or agreement that has
      already accrued or preclude either Party from pursuing all rights and
      remedies it may have hereunder at law or in equity with respect to any
      breach of this Agreement prior to such expiration or termination. The
      provisions of Articles 6, 7 and 8, and Sections, 4.3, 4.4, 5.2, 5.3, 10.3,
      10.4, 11.2, 11.3, 14.5, 14.8 and 14.9 shall survive expiration or
      termination of this Agreement.

            

    

     

    
      	
              11.

            	
              Novartis' Option to Subcontract,
      Assign or Terminate.

            

    

     

    
      	
            	
              11.1.

            	
              Option.
      Notwithstanding anything to the contrary stated herein, if Novartis
      decides to sell or otherwise transfer ownership of its Vacaville Facility
      to a third party (excluding for the avoidance of doubt, an Affiliate) or
      to discontinue all manufacture of the Product, or Novartis terminates this
      Agreement for any reason other than pursuant to its termination rights
      under Sections 10.2.1 and 10.2.2, upon at least six (6) months prior
      written notice (“Notice
      Period”) to BMTI, Novartis, at its sole discretion, must either (a)
      subcontract, under Section 2.1, the manufacture of Product hereunder to a
      qualified third-party, provided that Novartis maintains ownership of the
      Product’s Drug Substance Master File and remains ultimately responsible
      for performance hereunder, (b) assign Novartis' rights and obligations
      hereunder, to a qualified third-party manufacturer subject to Section
      12.1, and subject to BMTI’s supply of Product hereunder being
      uninterrupted by such assignment, or (c) terminate this Agreement, subject
      to Sections 11.2 and 11.3.

            

    

     

    
      	
            	
              11.2.

            	
              Minimum Supply
      Obligation. Prior to any termination pursuant to Sections 10.3 or
      11.1, at BMTI’s written request, Novartis shall manufacture, for supply to
      BMTI:

            

    

     

    
      	
               
      

            	
              (a)

            	
              the
      greater of either: (i) that quantity of Product ordered during the ** (**)
      month period immediately preceding Novartis' notice multiplied by **, or
      (ii) up to **gm of Product;

            

    

     

    
      	
               
      

            	
              (b)

            	
              any
      lesser quantities of Product requested by BMTI (but no less than BMTI is
      required to purchase pursuant to Article 3);
or

            

    

     

    
      	
               
      

            	
              (c)

            	
              such
      other quantities of Product upon which the parties may agree, in
      writing.

            

    

     

    BMTI
shall be obligated to purchase from Novartis all Conforming Product so ordered,
pursuant to the terms hereof, within ** (**) years of the date of Novartis'
notice or such other termination triggering event.

     

    
      	
            	
              11.3.

            	
              Technology
      Transfer. If Novartis terminates this Agreement pursuant to Section
      11.1(c) upon request by BMTI, Novartis shall (i) use commercially
      reasonable efforts to assist BMTI to identify a new supplier of the
      Product; and (ii) timely transfer all Novartis technology required or
      useful for Product manufactured to such new supplier or a qualified
      third-party manufacturer selected by BMTI, provided that such manufacturer
      agrees in writing to treat all such technology and related information as
      confidential, under terms at least as restrictive as those contained
      herein, and to limit its use of such technology to Product manufactured
      for BMTI.  Such technology shall include, but not be limited to:
      all regulatory files, the Drug Substance Master File, all product and
      method development and validation reports, Becaplermin master cell banks
      and all procedures related to the qualification, development, validation
      and maintenance thereof.  Novartis shall not charge BMTI for
      such services; however, BMTI shall be responsible for all third-party
      charges.

            

    

     

    
      	
              12.

            	
              Third-Party
      Relationships.

            

    

     

    
      	
            	
              12.1.

            	
              Novartis
      Transfer.  If Novartis Assigns, or otherwise transfers
      any aspect of the manufacturing of the Product to a third party pursuant
      to Article 11 or as otherwise permitted under Section 14.3 but, for the
      avoidance of doubt not including Section 2.1, Novartis shall ensure that
      such third party is contractually obligated to honor BMTI’s rights and
      Novartis’ obligations with respect to those aspects of manufacturing so
      assigned.  Any reference to BMTI rights or Novartis obligations
      set forth herein with respect to the manufacturing of the Product
      (including, but not limited to, the rights and obligations set forth in
      Article 6 relating to quality and regulatory matters) shall extend to any
      such Assignee of Novartis.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              12.2.

            	
              Third-Party
      Confidentiality.  BMTI represents that its Sublicensees
      are contractually obligated to maintain the confidentiality of
      Confidential Information on terms at least as restrictive as those set
      forth in Article 7, and warrants that it shall use its commercially
      reasonable efforts to enforce such obligations.  BMTI shall
      provide Novartis with prompt notice of any breach of such obligations by
      any of its Sublicensees.  Novartis represents that any
      Subcontractor of the manufacture of the Product is and/or will be
      contractually obligated to maintain the confidentiality of Confidential
      Information of BMTI on terms at least as restrictive as those set forth in
      Article 7, and warrants that it shall use its commercially reasonable
      efforts to enforce such obligations. Novartis shall provide BMTI with
      prompt notice of any breach of such obligations by its
      Subcontractors.

            

    

     

    
      	
              13.

            	
              Notices.

            

    

     

    Any
notice to be given hereunder shall be in writing and shall be deemed given when
so delivered in person, by overnight courier (with receipt confirmed) or by
facsimile transmission (with receipt confirmed by telephone or by automatic
transmission report) or, if given by mail, upon receipt, as follows (or to such
other persons and/or addresses as may be specified in writing to the other party
hereto):

    

    
      
        	
                If to
      BMTI:

              	
                With a copy
      to:

              
	
                BioMimetic
      Therapeutics, Inc.

              	
                BioMimetic
      Therapeutics, Inc.

              
	
                389
      Nichol Mill Lane

              	
                389
      Nichol Mill Lane

              
	
                Franklin,
      TN 37067

              	
                Franklin,
      TN 37067

              
	
                Attention:
      President and CEO

              	
                Attention:
      General Counsel

              
	
                Facsimile:
      (615) 844-1281

              	
                Facsimile:
      (615) 844-1281

              
	 	 
	
                If to Novartis,
      to:

              	
                With a copy
      to:

              
	
                Novartis
      Vaccines and Diagnostics, Inc

              	
                Novartis
      Vaccines and Diagnostics, Inc

              
	
                4560
      Horton Street

              	
                4560
      Horton Street

              
	
                Emeryville,
      CA 94608-2916

              	
                Emeryville,
      CA 94608-2916

              
	
                Attention:
      Site CFO

              	
                Attention:
      VP, Corporate Counsel Site Head

              
	
                Facsimile:
      +1 510 655 99 10

              	
                Facsimile:
      +1 617 871 89 11

              

      

    

     

    
      	
              14.

            	
              Miscellaneous.

            

    

     

    
      	
            	
              14.1.

            	
              Force Majeure.
      Failure or delay by a party in the performance of its obligations
      hereunder shall be excused to the extent that performance is rendered
      impossible by strike, fire, flood, earthquake, windstorm, power or
      utilities shortage, governmental acts, orders or restrictions, or any
      other cause, to the extent that the failure to perform is beyond the
      reasonable control and not caused by the negligence or willful misconduct
      of the non-performing party, provided that if such Force Majeure event
      extends beyond one hundred and twenty (120) days, the unaffected party may
      forthwith terminate this Agreement.

            

    

     

    
      	
            	
              14.2.

            	
              Independent
      Contractors. The relationship of BMTI and Novartis hereunder is
      that of independent contractors, and nothing contained herein shall be
      construed (a) to give either party the power to direct or control the
      day-to-day activities of the other, (b) to constitute the parties as
      partners, joint venturers, co-owners or otherwise as participates in a
      joint or common undertaking or (c) to allow a party to create or assume
      any obligation on behalf of the other party for any purpose
      whatsoever.

            

    

     

    
      	
            	
              14.3.

            	
              Assignment.
      Other than as provided in Section 11.1(a), neither party may transfer or
      assign, whether directly or indirectly, this Agreement or its rights or
      obligations herein, without the prior written consent of the other party,
      which consent shall not be unreasonably withheld, except that either party
      may transfer or assign any of its rights and obligations hereunder to any
      Affiliate or to any corporation or a person that acquires all or
      substantially all of the business or assets of such party to which this
      Agreement relates or pursuant to a merger or consolidation. Each party
      shall notify the other promptly following any such transfer, assignment,
      merger or consolidation. Any purported assignment in contravention of this
      Section 14.3 shall, at the option of the non-assigning party, be null and
      void. This Agreement shall be binding upon and inure to, the benefit of
      the parties hereto, their successors and permitted
  assigns.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              14.4.

            	
              Waiver. No
      waiver of any term or condition of this Agreement shall be valid or
      binding on either party unless agreed in writing by the party to be
      charged. The failure of either party to enforce at any time any of the
      provisions of the Agreement, or the failure to require at any time
      performance by the other party of any of the provisions of this Agreement,
      shall in no way be construed to be a present or future waiver of such
      provisions, nor in any way affect the validity of either party to enforce
      each and every such provision
thereafter.

            

    

     

    
      	
            	
              14.5.

            	
              Severability.
      If any provisions of this Agreement are held to be void or unenforceable
      in any particular country, then such void or unenforceable provisions
      shall be replaced in such country by valid and enforceable provisions that
      will achieve, as far as possible, the economic business intentions of the
      parties. Those provisions not held to be void or unenforceable shall
      remain in full force and effect, to the extent consistent with such
      economic business intentions

            

    

     

    
      	
            	
              14.6.

            	
              Publicity.
      Except as provided in Section 7.2(e), neither party shall disclose this
      Agreement or any of the terms hereof to any third party, whether in
      writing or orally, without the prior written consent of the other party,
      except that either party may disclose the existence and the general
      subject matter, but not the financial or other terms, of this Agreement in
      any circumstances that such party deems desirable from a business
      standpoint. In addition, except as provided in Article 7, including in
      particular Section 7.2(e), either party may make any disclosure if but
      only to the extent such disclosure is, on advice of counsel, required by
      applicable law. The disclosing party shall use all commercially reasonable
      efforts to preserve the confidentiality of this Agreement and the terms
      hereof notwithstanding any such required disclosure and shall give the
      other party as much advance written notice of such required disclosure as
      is reasonably practicable. If either party is required to file this
      Agreement with the Securities and Exchange Commission or any other
      Regulatory Authority, such party shall apply for confidential treatment of
      this Agreement to the fullest extent permitted by law, shall provide the
      other party a copy of the confidential treatment request far enough in
      advance of its filing to give the other party a meaningful opportunity to
      comment thereon, and shall incorporate in such confidential treatment
      request any reasonable comments of the other
  party.

            

    

     

    
      	
            	
              14.7.

            	
              No Implied Rights in
      Intellectual Property. Except as expressly provided herein, neither
      party shall have any right, title or interest in or to any patents, patent
      applications, know-how (whether or not patentable) or other intellectual
      property rights of the other party, including but not limited to rights to
      the other party's biological materials, manufacturing processes or
      formulations, analytical methods or
assays.

            

    

     

    
      	
            	
              14.8.

            	
              Governing Law.
      This Agreement and the performance of the parties thereunder shall be
      construed in accordance with and governed by the laws of the State of New
      York, without regard to the conflict of law principles
      thereof.

            

    

     

    
      	
            	
              14.9.

            	
              Dispute
      Resolution. Except as otherwise provided in Section 4.3, any
      dispute arising under this Agreement shall be submitted for resolution to
      the responsible executive of each party. Such executives shall endeavor,
      diligently and in good faith, to resolve the dispute within thirty (30)
      days. If the dispute has not been resolved by that time, either party may
      pursue its legal remedies. For the purpose of any dispute which cannot be
      resolved amicably, the parties hereby irrevocably submit to the exclusive
      jurisdiction of the ordinary courts of New York, USA, without restricting
      any right of appeal, and the parties hereby waive any objection which they
      may have now or hereafter to the laying of venue of any proceedings in
      said courts and to any claim that such proceedings have been brought in an
      inconvenient forum and further irrevocably agree that a judgment or order
      in any such proceedings shall be conclusive and binding upon each of them
      and may be enforced in the courts of any other
    jurisdiction.

            

    

     

    
      	
            	
              14.10.

            	
              Counterparts.
      This Agreement may be executed in two or more counterparts, each of which
      shall be deemed an original and all of which together shall constitute one
      instrument.

            

    

     

    
      	
            	
              14.11.

            	
              Entire
      Agreement. This Agreement, including the exhibits hereto,
      constitutes the entire agreement of the parties with respect to the
      subject matter hereof, and supersedes all prior or contemporaneous
      understandings or agreements, whether written or oral, between BMTI and
      Novartis with respect to such subject matter. No amendment or modification
      hereof shall be valid or binding upon the parties unless made in writing
      and signed by the duly authorized representatives of both
      parties.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        11

        
          

        

      

      
        
        

      

    

    
       

      
        	NOVARTIS
      VACCINES AND DIAGNOSTICS,
      INC	BIOMIMETIC THERAPEUTICS,
      INC.
	 	 	 	 	 	 
	
                By:

              	
                /s/
      Karl Kohrhoun

              	 
      	
                By:

              	
                /s/
      Samuel E. Lynch

              	 
      
	 
      	
                Karl
      Kohrhoun

              	 
      	 	
                Samuel
      E. Lynch

              	 
      
	 	
                Chief
      Financial Officer, Emeryville 

              	 	 
      	
                President
      and CEO

              	 
      
	 
      	 
      	 
      	 
      	 
      	 
      
	
                Date:  December
      31, 2009

              	Date:  December
      31, 2009

      

       

    

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

    ANNEX
1

    QUALITY
AGREEMENT AND ADDITIONAL TERMS

     

    To be
attached once finalized

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        13

        
          

        

      

      
        
        

      

    

     

    ANNEX 2
COMPENSATION

     

    
      	
              1.

            	
              Product
      Prices

            

    

     

    
      	
              A.

            	
              2009 Prices.
      Annual Product Prices will vary depending on the quantity ordered during
      the relevant year, as shown below. Prices for 2009 shall be as
      follows:

            

    

     

    
      	
              Quantity
      Ordered in 2008

            	
              Price

            	 
      
	
              First
      ** grams:

            	
              $**

            	
              /
      gram

            
	
              Next
      ** grams:

            	
              $**

            	
              /
      gram

            
	
              Next
      ** or more grams:

            	
              $**

            	
              /
      gram

            

    

     

    These
prices shall be adjusted annually, in accordance with § 7.10,
below.

     

    
      	
              B.

            	
              Adjustment for Dosage
      Changes. If BMTI’s dosage for Product in all of its commercial
      product package configurations is less than or equal to ** mg/package, the
      sales price will be $**/gram.

            

    

     

    
      	
              C.

            	
              Items Included in
      Product Price. Product Price will
  include:

            

    

     

    
      	
            	
              ·

            	
              All
      raw materials

            

    

    
      	
            	
              ·

            	
              The
      cost of operating the Facilities

            

    

    
      	
            	
              ·

            	
              Performance
      of all in-process and release assays on each Product
  lot

            

    

    
      	
            	
              ·

            	
              Disposal
      of waste streams

            

    

    
      
        	
              	
                ·

              	
                Lot
      documentation Deliverables (QA disposition memorandum, COA and COC for
      Product lot)

              

      

    

    
      
        	
              	
                ·

              	
                Ongoing
      stability testing

              

      

    

    
      
        	
              	
                ·

              	
                Resolution
      of manufacturing deviations

              

      

    

    
      
        	
              	
                ·

              	
                Environmental
      monitoring

              

      

    

    
      
        	
              	
                ·

              	
                Staff
      cGMP training, routine compliance audits and routine revalidation of
      process and Facility equipment and systems, per
  SOPs

              

      

    

    
      
        	
              	
                ·

              	
                Project
      coordination and progress
reports

              

      

    

     

    (Any
analytical tests requested by BMTI and performed by Novartis, other than
Novartis’ standard COA release testing shall be charged at the Additional
Services Rate.)

     

    
      	
              2.

            	
              Third
      Party Royalties

            

    

     

    BMTI
shall pay Novartis for third-party royalties in accordance with its License
Agreements, as provided in Section 5.3 of the Agreement, including the
following:

     

    
      	
              License

            	
              Royalty

            
	
              Genentech
      Itakura/Riggs

            	
              1.0%

            
	
              Genentech/WRF

            	
              1.0%

            
	
              UC's
      Kurjan

            	
              0.5%

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        14

        
          

        

      

      
        
        

      

    

     

    
      	
              3.

            	
              Minimum
      Purchase Requirements

            

    

     

    

    
      	
              A.

            	
              BMTI
      shall purchase at least the following quantities of Product (the “Minimum Purchase
      Requirements”) during the Term of this
  Agreement:

            

    

    

    
      	
              Year

            	
              Minimum
      Purchase (grams)

            
	
              2008

            	
              **

            
	
              2009

            	
              **

            
	
              2010

            	
              **

            
	
              2011

            	
              **

            
	
              2012

            	
              **

            
	
              2013
      and thereafter

            	
              **

            

    

     

    
      	
              4.

            	
              Travel

            

    

     

    BMTI
shall pay Novartis for any travel authorized by BMTI, at cost plus
15%.

     

    
      	
              5.

            	
              Additional
      Services

            

    

    

    Subject
to § 8, below, BMTI shall pay Novartis for any additional services approved in
writing by BMTI at the rate of $**/person-hour, for
services performed by Novartis, and at cost plus **%, for services performed by
independent contractors (jointly, the “Additional Services
Rate”).

     

    
      	
              6.

            	
              Payment
      Terms

            

    

     

    Payments
shall be due within ** days of BMTI's receipt of the applicable
invoice.

     

    
      	
              7.

            	
              Early
      Termination Fee

            

    

     

    If BMTI
terminates the Agreement pursuant to Section 10.2.3(a) thereof, BMTI shall pay
Novartis a non-refundable, non-creditable termination fee equal to **, within **
days of such termination.

     

    
      	
              8.

            	
              Price
      Adjustment

            

    

     

    Novartis
may revise the prices of the Product and the Additional Services Rate annually
by any amount of increase in the United States Producer Price Index 2834
(Pharmaceutical Preparations) during the preceding year.

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        15

        
          

        

      

      
        
        

      

    

     

    Annex
3 – Trading Services Procedure

     

    
      	
               
      

            	
              1.

            

    

    
       

      
        
          **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

          
          

        

        
          16

          
            

          

        

        
          
          

        

      

    

     

    ANNEX 4

    

    HEALTH, SAFETY &
ENVIRONMENTAL

    PROTECTION
POLICY

     

    
      	
               
      

            	
              1.

            	
              NOVARTIS
      agrees to use commercially reasonable endeavours to comply in all respects
      with the applicable laws and regulations on health, safety and
      environmental protection and with generally accepted standards of health,
      safety and environmental
protection.

            

    

     

    
      	
               
      

            	
              2.

            	
              The
      persons engaged in performing the manufacture shall have adequate training
      in health, safety and environmental protection issues associated with
      handling hazardous materials.

            

    

     

    
      	
               
      

            	
              3.

            	
              NOVARTIS
      agrees that it will use commercially reasonable endeavours to ensure that
      all waste will be disposed of in compliance with all applicable laws and
      regulations, and that discarded printed material and products are not
      illegally used.

            

    

     

    
      	
               
      

            	
              4.

            	
              NOVARTIS
      shall use commercially reasonable endeavours to handle and store all
      materials used to perform the manufacture under suitable containment
      conditions.

            

    

     

    
      	
               
      

            	
              5.

            	
              NOVARTIS
      shall use commercially reasonable endeavours to handle and store any
      materials used to perform the services with caution and prudence, since
      not all of the characteristics are necessarily
  known.

            

    

     

    
      	
               
      

            	
              6.

            	
              NOVARTIS
      shall under no circumstances administer to any humans or animals any of
      the materials used to perform the
manufacture.

            

    

     

    
      	
               
      

            	
              7.

            	
              NOVARTIS
      shall inform BMTI without delay of any serious safety, health and/or
      environmental issues which are relevant to the performance of the
      manufacture or to the Materials.

            

    

     

    
      	
              8.

            	
              NOVARTIS
      shall be fully liable with respect to any claim (whether from private
      parties or from public bodies), which may arise from NOVARTIS’ failure to
      meet applicable occupational health, safety or environmental protection
      laws and/or regulations.

            

    

     

    
      
        **
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.

        
        

      

      
        17

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