EXHIBIT 10.1
*** Certain confidential portions of this exhibit were omitted by means of
redacting a portion of the text. Application has been made to the Securities and
Exchange Commission seeking confidential treatment of such confidential portions
under Rule 24b-2 under the Securities Exchange Act of 1934, as amended. This
exhibit has been filed separately with the Securities and Exchange Commission
without redactions in connection with NuVasive’s confidential treatment request.
Amendment No. 1
to
Exclusive Manufacturing Agreement and Services Agreement
     This Amendment No. 1, effective as of September 26, 2006 (this
“Amendment”), is to that certain Exclusive Manufacturing Agreement (the
“Manufacturing Agreement”) and that certain Services Agreement (the “Services
Agreement”), both dated as of August 4, 2005, by and between NuVasive, Inc., a
Delaware corporation (“NuVasive”), and Pearsalls Limited, a private limited
company incorporated in England and Wales under registration number 03851227
(“Pearsalls”).
     WHEREAS, NuVasive and Pearsalls entered into the Manufacturing Agreement
and the Services Agreement in connection with the purchase and sale of certain
assets of Pearsalls pursuant to that certain Asset Purchase Agreement, dated as
of August 4, 2005 (the “Purchase Agreement”), by and among NuVasive, Pearsalls
and American Medical Instruments Holdings, Inc., a Delaware corporation
(“Pearsalls Parent”);
     WHEREAS, NuVasive, Pearsalls and Pearsalls Parent have agreed to amend the
Purchase Agreement pursuant to that certain Amendment No. 1 to Asset Purchase
Agreement of even date herewith (the “Purchase Agreement Amendment”);
     WHEREAS, in connection with the Purchase Agreement Amendment, NuVasive and
Pearsalls have agreed to amend the Manufacturing Agreement and the Services
Agreement as set forth below effective as of the date hereof in order to amongst
other items terminate the Manufacturing Agreement and the Services Agreement
within 18 months of the effective date of the Purchase Agreement Amendment;
     WHEREAS, Section 16.5 of the Manufacturing Agreement provides that the
Manufacturing Agreement may be amended, or any term thereof modified, by a
written instrument duly executed by NuVasive and Pearsalls; and
     WHEREAS, Section 4.1 of the Services Agreement provides that the Services
Agreement may be amended, or any term thereof modified or supplemented, by a
written instrument signed by an authorized representative of each of NuVasive
and Pearsalls;
     NOW THEREFORE, in consideration of the representations, warranties,
covenants and agreements contained herein, and for other valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the parties mutually
agree as follows:
     1. Section 4.1 of the Manufacturing Agreement is hereby amended and
restated in its entirety to read as follows:
     “4.1 Requirements; Manufacture of Products. During the Term and subject to
the terms and conditions set forth herein, Pearsalls shall manufacture and
supply Cervical Spine Products, the Nottingham Rotator Cuff Product and Other
Products for NuVasive on a non-exclusive basis for the prices specified in
Exhibit C hereto, in accordance with appropriate other Terms of Sale agreed by

 

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the parties and subject to the terms hereof. For the avoidance of doubt,
NuVasive shall have the right in its sole discretion and at all times to
manufacture, and to use third parties to manufacture and supply all or part of
NuVasive’s requirements for Cervical Spine Products, the Nottingham Rotator Cuff
Product and Other Products.”
     2. Section 5.2 of the Manufacturing Agreement is hereby amended and
restated in its entirety to read as follows:
     “5.2 Alternative Manufacturing License. Pearsalls hereby grants to
NuVasive, effective immediately, a non-exclusive, perpetual license under the
Pearsalls Technology to make, have made, offer for sale, sell, distribute, have
distributed, export, have exported, import and have imported, and otherwise
exploit the Products for all purposes in the Territory, including the right to
sublicense (the “Alternative Manufacturing License”). The Alternative
Manufacturing License shall be fully paid-up and royalty-free; no additional
consideration shall be due to Pearsalls thereunder.”
     3. The phrase “provided that, such license shall terminate automatically in
the event that Pearsalls exercises any Right of Reversion that arises under the
Asset Purchase Agreement,” shall be deleted from Section 6.1 (Intellectual
Property) of the Manufacturing Agreement and shall be of no further force or
effect.
     4. Section 12.1 of the Manufacturing Agreement is hereby amended and
restated in its entirety to read as follows:
     “12.1 Term. This Agreement shall take effect on the Effective Date and,
unless terminated earlier pursuant to this Section 12, shall remain in effect
until March 31, 2008 (the “Term”); provided, however, that the Term may be
renewed for successive one-year periods by written agreement of the parties.”
     5. The following new Section 12.4 shall be added to the Manufacturing
Agreement:
     “12.4 Termination for Convenience. NuVasive may terminate this Agreement at
any time without cause by giving Pearsalls one hundred eighty (180) days prior
written notice of termination.”
     6. Section 15 of the Manufacturing Agreement is hereby amended and restated
in its entirety to read as follows:
     “15. ASSIGNMENT
     This Agreement may not be assigned or otherwise transferred, nor, except as
expressly provided hereunder, may any right or obligations hereunder be assigned
or transferred by either party without the prior written consent of the other
party (which consent shall not be unreasonably withheld or delayed); provided,
however, that either party may, without such consent, assign this Agreement and
its rights and obligations hereunder in connection with the transfer or sale of
all or substantially all of its business relating to this Agreement, or in

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the event of its merger or consolidation or Change of Control or similar
transaction if (a) the assignee has the financial wherewithal to perform its
obligations hereunder, as reasonably demonstrated by such assignee, or (b) the
assignment does not relieve the assignor of any of its obligations under this
Agreement. In any case, the assignee shall execute a counterpart of this
Agreement agreeing to be bound by the provisions hereof; in the case of (b), the
counterpart shall acknowledge that it shall be jointly and severally liable with
the assignor and any other assignee of such assignor for all the obligations of
the assignor hereunder.”
     7. Section 16.1 (Notices) of the Manufacturing Agreement is hereby amended
to add the following contact to which copies of any notices sent to Pearsalls
must be delivered:
“Angiotech Pharmaceuticals, Inc.
1618 Station Street
Vancouver, BC V6A 1B6
Attention: General Counsel
Facsimile: (604) 221-6915”
     8. Section 4.6 (Exclusivity), Section 5.1 (Alternative Supply) and
subsection (a) of Section 12.3.3 (Effect of Expiration or Termination) of the
Manufacturing Agreement shall be deleted in their entirety and of no further
force or effect. Such sections shall be deemed “[RESERVED]” in the Manufacturing
Agreement so as not to effect the order of any other sections of the Agreement.
     9. Exhibit C (Product Pricing) to the Manufacturing Agreement shall be
modified as set forth on Attachment A hereto.
     10. Exhibit D (Elective Alternative Manufacturing Fee) to the Manufacturing
Agreement shall be deleted in its entirety and of no further force or effect.
     11. Section 2.1 of the Services Agreement is hereby amended and restated in
its entirety to read as follows:
     “2.1 Term. This Agreement shall become effective as of the Closing Date and
shall continue with respect to each Service until the earlier of (i) the
completion of the Service required pursuant to Exhibit I or (ii) the completion
of the period of time set forth on Exhibit I, in each case unless terminated
sooner pursuant to Section 2.2. Notwithstanding the foregoing, except as set
forth on Exhibit I, this Agreement shall expire as to all Services as of
March 31, 2008.”
     12. Section 4.3 (Notices) of the Services Agreement is hereby amended to
add the following contact to which copies of any notices sent to Pearsalls must
be delivered:
“Angiotech Pharmaceuticals, Inc.
1618 Station Street
Vancouver, BC V6A 1B6
Attention: General Counsel
Facsimile: (604) 221-6915”

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     13. Neither party shall disclose any terms or conditions of this Amendment
to any third party without the prior consent of the other party, except as
required by Applicable Law (as defined in the Manufacturing Agreement) or court
order, provided that the party required to make such disclosure shall provide
written notice to the other party as soon as practicable in order to afford such
party an opportunity to avoid the disclosure or seek a protective order.
     14. Each party hereby represents and warrants to the other parties that:
(i) such party has the authority and right to enter into and perform this
Amendment, (ii) this Amendment is a legal and valid obligation binding upon such
party and is enforceable in accordance with its terms, subject to applicable
limitations on such enforcement based on bankruptcy laws and other debtors’
rights, and (iii) such party’s execution, delivery and performance of this
Amendment will not conflict in any material fashion with the terms of any other
agreement or instrument to which it is or becomes a party or by which it is or
becomes bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having authority over it. Each party
acknowledges and hereby verifies that the other party has not made any
representations or warranties in connection with this Amendment, whether express
or implied, of any kind or character, except as expressly set forth herein.
     15. Except as amended hereby, the Manufacturing Agreement and the Services
Agreement shall remain unchanged and in full force and effect.
     16. The Manufacturing Agreement and the Services Agreement, as amended by
this Amendment, constitute the entire agreement between the parties hereto with
respect to the subject matter hereof, and supersede any and all prior agreements
and undertakings, oral or written, concerning the subject matter hereof. This
Amendment may not be changed or terminated orally, and may only be changed or
terminated by a writing signed by the party against whom such change or
termination is sought.
     17. This Amendment shall be governed by and construed in accordance with
the internal laws (as opposed to the conflicts of law provisions) of the State
of Delaware.
     18. This Amendment may be executed in counterparts, each of which shall be
deemed to be an original and both of which together shall be deemed to be one
and the same instrument. Delivery of signed counterparts by facsimile shall be
fully as effective as if original counterparts were executed and delivered.
[Signature page follows]

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     IN WITNESS WHEREOF, this Amendment has been duly executed by the parties as
of the date first set forth above.

                  NUVASIVE, INC.    
 
           
 
  By:   /s/ Alexis V. Lukianov    
 
           
 
  Name:   Alexis V. Lukianov    
 
           
 
  Title:   Chairman & CEO    
 
           
 
                PEARSALLS LIMITED    
 
           
 
  By:   /s/ K. Thomas Bailey    
 
           
 
  Name:   K. Thomas Bailey    
 
           
 
  Title:   President    
 
           

[SIGNATURE PAGE TO AMENDMENT NO. 1 TO EXCLUSIVE
MANUFACTURING AGREEMENT AND SERVICES AGREEMENT]

 

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ATTACHMENT A
     As of the effective date of this Amendment, the prices for the Cervical
Spine Product set forth on Exhibit C (Product Pricing) to the Manufacturing
Agreement shall be amended and restated as follows:

  •   US $***/unit for commercial clinical use     •   US $***/unit for clinical
trial use (sterile samples)     •   US $***/unit, plus irradiation costs, for
testing samples     •   US $***/unit for non-sterile samples

     Other than the modifications to the Cervical Spine Product pricing set
forth above, all Product pricing and Base Cost set forth on Exhibit C to the
Manufacturing Agreement shall remain unchanged and in full force and effect.
 
***   Certain confidential portions of this exhibit were omitted by means of
redacting a portion of the text. Application has been made to the Securities and
Exchange Commission seeking confidential treatment of such confidential portions
under Rule 24b-2 under the Securities Exchange Act of 1934, as amended. This
exhibit has been filed separately with the Securities and Exchange Commission
without redactions in connection with NuVasive’s confidential treatment request.