Document:

QuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.8    
    

CONCEPTUS, INC.  

 
  AMENDED AND RESTATED
  2002 NON-QUALIFIED STOCK OPTION PLAN    
    

(Effective as of August 8, 2002)

(Amended and Restated December 16, 2005)  

  

 
 

TABLE OF CONTENTS    
    

	 
	 	 
	 	Page

	1.	 	PURPOSES OF THE PLAN	 	1
	

2.	
 	

DEFINITIONS	
 	

1
	

3.	
 	

STOCK SUBJECT TO THE PLAN	
 	

3
	

4.	
 	

ADMINISTRATION OF THE PLAN	
 	

3
	

5.	
 	

ELIGIBILITY	
 	

4
	

6.	
 	

LIMITATIONS	
 	

5
	

7.	
 	

TERM OF PLAN	
 	

5
	

8.	
 	

TERM OF OPTION	
 	

5
	

9.	
 	

OPTION EXERCISE PRICE AND CONSIDERATION	
 	

5
	

10.	
 	

EXERCISE OF OPTION	
 	

6
	

11.	
 	

NON-TRANSFERABILITY OF OPTIONS AND STOCK PURCHASE RIGHTS	
 	

8
	

12.	
 	

STOCK PURCHASE RIGHTS	
 	

8
	

13.	
 	

ADJUSTMENTS UPON CHANGES IN CAPITALIZATION, MERGER OR ASSET SALE	
 	

8
	

14.	
 	

TIME OF GRANTING OPTIONS AND STOCK PURCHASE RIGHTS	
 	

10
	

15.	
 	

AMENDMENT AND TERMINATION OF THE PLAN	
 	

10
	

16.	
 	

INABILITY TO OBTAIN AUTHORITY	
 	

11
	

17.	
 	

RESERVATION OF SHARES	
 	

11
	

18.	
 	

INVESTMENT INTENT	
 	

11
	

19.	
 	

GOVERNING LAW	
 	

11

i

  

CONCEPTUS, INC.  

 
  AMENDED AND RESTATED
  2002 NON-QUALIFIED STOCK OPTION PLAN    
    

        1.     Purposes
of the Plan.    The purposes of the Conceptus, Inc. Amended and Restated 2002 Non-Qualified Stock
Option Plan are to attract and retain the best available personnel for positions of substantial responsibility, to provide additional incentive to the Employees and Consultants of the Company and to
promote the success of the Company's business. 

        2.     Definitions.    As
used herein, the following definitions shall apply: 

        (a)   "Acquisition"
means (i) any consolidation or merger of the Company with or into any other corporation or other entity or person in
which the stockholders of the Company prior to such consolidation or merger own less than fifty percent (50%) of the Company's voting power immediately after such consolidation or merger, excluding
any consolidation or merger effected exclusively to change the domicile of the Company; or (ii) a sale of all or substantially all of the assets of the Company. 

        (b)   "Administrator"
means the Board or the Committee responsible for conducting the general administration of the Plan, as applicable, in
accordance with Section 4 hereof. 

        (c)   "Applicable
Laws" means the requirements relating to the administration of stock option plans under U.S. state corporate laws, U.S. federal
and state securities laws, the Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws of any foreign country or jurisdiction where Options
or Stock Purchase Rights are granted under the Plan. 

        (d)   "Board"
means the Board of Directors of the Company. 

        (e)   "Code"
means the Internal Revenue Code of 1986, as amended, or any successor statute or statutes thereto. Reference to any particular Code
section shall include any successor section. 

        (f)    "Committee"
means a committee appointed by the Board in accordance with Section 4 hereof. 

        (g)   "Common
Stock" means the Common Stock of the Company, par value $0.003 per share. 

        (h)   "Company"
means Conceptus, Inc., a Delaware corporation. 

        (i)    "Consultant"
means any consultant or adviser if: (i) the consultant or adviser renders bona fide services to the Company or any
Parent or Subsidiary of the Company; (ii) the services rendered by the consultant or adviser are not in connection with the offer or sale of securities in a capital-raising transaction and do
not directly or indirectly promote or maintain a market for the Company's securities; and (iii) the consultant or adviser is a natural person who has contracted directly with the Company or any
Parent or Subsidiary of the Company to render such services. 

        (j)    "Director"
means a member of the Board. 

        (k)   "Employee"
means any person, including an Officer or Director, who is an employee (as defined in accordance with Section 3401(c) of
the Code) of the Company or any Parent or Subsidiary of the Company. An Employee shall not cease to be an Employee in the case of (i) any leave of absence approved by the Company or
(ii) transfers between locations of the Company or between the Company, its Parent, any Subsidiary, or any successor. Neither service as a Director nor payment of a director's fee by the
Company shall be sufficient, by itself, to constitute "employment" by the Company. 

1

 

        (l)    "Exchange
Act" means the Securities Exchange Act of 1934, as amended, or any successor statute or statutes thereto. Reference to any
particular Exchange Act section shall include any successor section. 

        (m)  "Fair
Market Value" means, as of any date, the value of a share of Common Stock determined as follows: 

        (i)    If
the Common Stock is listed on any established stock exchange or a national market system, including, without limitation, the Nasdaq National Market or The Nasdaq
SmallCap Market of The Nasdaq Stock Market, its Fair Market Value shall be the closing sales price for a share of such stock (or the closing bid, if no sales were reported) as quoted on such exchange
or system on the day of determination (or the most recent day on which sales were reported if none were reported on such date), as reported in The Wall Street Journal or such other source as the
Administrator deems reliable; 

        (ii)   If
the Common Stock is regularly quoted by a recognized securities dealer but selling prices are not reported, its Fair Market Value shall be the mean between the high
bid and low asked prices for a share of the Common Stock on the day of determination (or the most recent day on which bid and asked prices were reported if none were reported on such date); or 

        (iii)  In
the absence of an established market for the Common Stock, the Fair Market Value thereof shall be determined in good faith by the Administrator. 

        (n)   "Holder"
means a person who has been granted or awarded an Option or Stock Purchase Right or who holds Shares acquired pursuant to the
exercise of an Option or Stock Purchase Right. 

        (o)   "Non-Qualified
Stock Option" means an option that is not intended to qualify as an incentive stock option within the meaning of
Section 422 of the Code. 

        (p)   "Officer"
means the Chief Executive Officer, President, Secretary, Chief Financial Officer, Chairman of the Board or any Vice Presidents of
the Company, any other person designated an "officer" of the Company by the Board in accordance with the Company's Bylaws or any person who is an "officer" within the meaning of
Rule 16a-1(f) under the Exchange Act or Nasdaq Rule 4350(i). 

        (q)   "Option"
means a Non-Qualified Stock Option granted pursuant to the Plan. All Options granted under this Plan shall be
Non-Qualified Stock Options 

        (r)   "Option
Agreement" means a written agreement between the Company and a Holder evidencing the terms and conditions of an individual Option
grant. The Option Agreement is subject to the terms and conditions of the Plan. 

        (s)   "Parent"
means any corporation, whether now or hereafter existing (other than the Company), in an unbroken chain of corporations ending with
the Company if each of the corporations other than the last corporation in the unbroken chain owns stock possessing more than fifty percent of the total combined voting power of all classes of stock
in one of the other corporations in such chain. 

        (t)    "Plan"
means this Conceptus, Inc. Amended and Restated 2002 Non-Qualified Stock Option Plan. 

        (u)   "Restricted
Stock" means Shares acquired pursuant to the exercise of an unvested Option in accordance with Section 10(h) below or
pursuant to a Stock Purchase Right granted under Section 12 below. 

2

 

        (v)   "Rule 16b-3"
means that certain Rule 16b-3 under the Exchange Act, as such Rule may be amended from
time to time. 

        (w)  "Securities
Act" means the Securities Act of 1933, as amended, or any successor statute or statutes thereto. Reference to any particular
Securities Act section shall include any successor section. 

        (x)   "Service
Provider" means an Employee, Director or Consultant. 

        (y)   "Share"
means a share of Common Stock, as adjusted in accordance with Section 13 below. 

        (z)   "Stock
Purchase Right" means a right to purchase Common Stock pursuant to Section 12 below. 

        (aa) "Subsidiary"
means any corporation, whether now or hereafter existing (other than the Company), in an unbroken chain of corporations
beginning with the Company if each of the corporations other than the last corporation in the unbroken chain owns stock possessing more than fifty percent of the total combined voting power of all
classes of stock in one of the other corporations in such chain. 

        3.     Stock
Subject to the Plan.    Subject to the provisions of Section 13 of the Plan, the shares of stock subject to Options or
Stock Purchase Rights shall be Common Stock, initially shares of the Company's Common Stock, par value $0.003 per share. Subject to the provisions of Section 13 of the Plan, the maximum
aggregate number of Shares which may be issued upon exercise of such Options or Stock Purchase Rights is 1,000,000 Shares. Shares issued upon exercise of Options or Stock Purchase Rights may be
authorized but unissued, or reacquired Common Stock. If an Option or Stock Purchase Right expires or becomes unexercisable without having been exercised in full, the unpurchased Shares which were
subject thereto shall become available for future grant or sale under the Plan (unless the Plan has terminated). Shares which are delivered by the Holder or withheld by the Company upon the exercise
of an Option or Stock Purchase Rights under the Plan, in payment of the exercise price thereof or tax withholding thereon, may again be optioned, granted or awarded hereunder, subject to the
limitations of this Section 3. If Shares of Restricted Stock are repurchased by the Company at their original purchase price, such Shares shall become available for future grant under the Plan. 

        4.     Administration
of the Plan. 

        (a)   Administrator.    Either
the Board or a Committee of the Board delegated administrative authority hereunder shall administer the
Plan and, in the case of a Committee, the Committee shall consist solely of two or more Directors, each of whom is both an "outside director," within the meaning of Section 162(m) of the Code,
and a "non-employee director" within the meaning of Rule 16b-3. Within the scope of such authority, the Board or the Committee may (i) delegate to a committee of
one or more members of the Board who are not then "outside directors," within the meaning of Section 162(m) of the Code, the authority to grant awards under the Plan to eligible persons who are
either (1) not then "covered employees," within the meaning of Section 162(m) of the Code and are not expected to be "covered employees" at the time of recognition of income resulting
from such award or (2) not persons with respect to whom the Company wishes to comply with Section 162(m) of the Code and/or (ii) delegate to a committee of one or more members of
the Board who are not "non-employee directors," within the meaning of Rule 16b-3, the authority to grant awards under the Plan to eligible persons who are not then
subject to Section 16 of the Exchange Act. The Board may abolish the Committee at any time and revest in the Board the administration of the Plan. Appointment of Committee members shall be
effective upon acceptance of appointment. Committee members may resign at any time by delivering written notice to the Board. Vacancies in the Committee may be filled only by the Board. 

3

 

        (b)   Powers
of the Administrator.    Subject to the provisions of the Plan and the specific duties delegated by the Board to such
Committee, and subject to the approval of any relevant authorities, the Administrator shall have the authority in its sole discretion: 

        (i)    to
determine the Fair Market Value; 

        (ii)   to
select the Service Providers to whom Options and Stock Purchase Rights may from time to time be granted hereunder; 

        (iii)  to
determine the number of Shares to be covered by each such award granted hereunder; 

        (iv)  to
approve forms of agreement for use under the Plan; 

        (v)   to
determine the terms and conditions of any Option or Stock Purchase Right granted hereunder (such terms and conditions include, but are not limited to, the exercise
price, the time or times when Options or Stock Purchase Rights may vest or be exercised (which may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and
any restriction or limitation regarding any Option or Stock Purchase Right or the Common Stock relating thereto, based in each case on such factors as the Administrator, in its sole discretion, shall
determine); 

        (vi)  to
determine whether to offer to buyout a previously granted Option as provided in subsection 10(i) and to determine the terms and conditions of such offer and
buyout (including whether payment is to be made in cash or Shares); 

        (vii) to
prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the
purpose of qualifying for preferred tax treatment under foreign tax laws; 

        (viii)   to
allow Holders to satisfy withholding tax obligations by electing to have the Company withhold from the Shares to be issued upon exercise of an Option
or Stock Purchase Right that number of Shares having a Fair Market Value equal to the minimum amount required to be withheld based on the statutory withholding rates for federal and state tax purposes
that apply to supplemental taxable income. The Fair Market Value of the Shares to be withheld shall be determined on the date that the amount of tax to be withheld is to be determined. All elections
by Holders to have Shares withheld for this purpose shall be made in such form and under such conditions as the Administrator may deem necessary or advisable; 

        (ix)  to
amend the Plan or any Option or Stock Purchase Right granted under the Plan as provided in Section 15; and 

        (x)   to
construe and interpret the terms of the Plan and awards granted pursuant to the Plan and to exercise such powers and perform such acts as the Administrator deems
necessary or desirable to promote the best interests of the Company which are not in conflict with the provisions of the Plan. 

        (c)   Effect
of Administrator's Decision.    All decisions, determinations and interpretations of the Administrator shall be final and
binding on all Holders. 

        5.     Eligibility.    Non-Qualified
Stock Options and Stock Purchase Rights may be granted under this Plan only to the
following classes of persons: (i) except as provided in (ii) below, Consultants and Employees who are not Officers or Directors of the Company, and (ii) newly hired Employees
(including Employees who will become Officers or Directors of the Company) and who have not previously been employed by the Company and with respect to whom Options are to be granted as an inducement
essential to such Employees' entering into employment contracts with the Company. 

4

 

Notwithstanding
the foregoing, a Consultant shall not be eligible for the grant of an Option if, at the time of grant, a Form S-8 Registration Statement under the Securities Act
("Form S-8") is not available to register either the offer or the sale of the Company's securities to such Consultant because of the nature of the
services that the Consultant is providing to the Company, or because the Consultant is not a natural person, or as otherwise provided by the rules governing the use of Form S-8,
unless the Company determines both (i) that such grant (A) shall be registered in another manner under the Securities Act (e.g., on a
Form S-3 Registration Statement) or (B) does not require registration under the Securities Act in order to comply with the requirements of the Securities Act, if applicable,
and (ii) that such grant complies with the securities laws of all other relevant jurisdictions. 

        6.     Limitations.

        (a)   Each
Option shall be designated by the Administrator in the Option Agreement as a Non-Qualified Stock Option. 

        (b)   Neither
the Plan, any Option nor any Stock Purchase Right shall confer upon a Holder any right with respect to continuing the Holder's employment or consulting
relationship with the Company, nor shall they interfere in any way with the Holder's right or the Company's right to terminate such employment or consulting relationship at any time, with or without
cause. 

        (c)   No
Service Provider shall be granted, in any calendar year, Options or Stock Purchase Rights to purchase more than 800,000 Shares. The foregoing limitation shall be
adjusted proportionately in connection with any change in the Company's capitalization as described in Section 13. For purposes of this Section 6(c), if an Option is canceled in the same
calendar year it was granted (other than in connection with a transaction described in Section 13), the canceled Option will be counted against the limit set forth in this Section 6(c).
For this purpose, if the exercise price of an Option is reduced, the transaction shall be treated as a cancellation of the Option and the grant of a new Option. 

        7.     Term
of Plan.    The Plan shall become effective upon its initial adoption by the Board and shall continue in effect until it is
terminated under Section 15 of the Plan. No Options or Stock Purchase Rights may be issued under the Plan after the tenth (10th) anniversary of the date upon which the Plan is initially adopted
by the Board. 

        8.     Term
of Option.    The term of each Option shall be stated in the Option Agreement; provided,
however, that the term shall be no more than ten (10) years from the date of grant thereof. 

        9.     Option
Exercise Price and Consideration. 

        (a)   The
per share exercise price for the Shares to be issued upon exercise of an Option shall be such price as is determined by the Administrator. 

        (b)   The
consideration to be paid for the Shares to be issued upon exercise of an Option, including the method of payment, shall be determined by the Administrator. Such
consideration may consist of (1) cash, (2) check, (3) with the consent of the Administrator, other Shares which (x) in the case of Shares acquired from the Company, have
been owned by the Holder for more than six (6) months on the date of surrender, and (y) have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the
Shares as to which such Option shall be exercised, (4) with the consent of the Administrator, surrendered Shares then issuable upon exercise of the Option having a Fair Market Value on the date
of exercise equal to the aggregate exercise price of the Option or exercised portion thereof, (5) property of any kind which constitutes good and valuable consideration, (6) with the
consent of the Administrator, delivery of a notice that the Holder has placed a market sell order with a broker with respect to Shares then issuable upon exercise of the Options and that the broker
has been directed to pay a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price, provided,
that payment of such proceeds is then made to the Company upon settlement of such sale, or (7) with the consent of the Administrator, any combination of the foregoing methods of payment. 

5

   
        10.   Exercise of Option. 

        (a)   Vesting;
Fractional Exercises.    Options granted hereunder shall be vested and exercisable according to the terms hereof at such
times and under such conditions as determined by the Administrator and set forth in the Option Agreement. An Option may not be exercised for a fraction of a Share. 

        (b)   Deliveries
upon Exercise.    All or a portion of an exercisable Option shall be deemed exercised upon delivery of all of the
following to the Secretary of the Company or his or her office: 

        (i)    A
written or electronic notice complying with the applicable rules established by the Administrator stating that the Option, or a portion thereof, is exercised. The
notice shall be signed by the Holder or other person then entitled to exercise the Option or such portion of the Option; 

        (ii)   Such
representations and documents as the Administrator, in its sole discretion, deems necessary or advisable to effect compliance with Applicable Laws. The
Administrator may, in its sole discretion, also take whatever additional actions it deems appropriate to effect such compliance, including, without limitation, placing legends on share certificates
and issuing stop transfer notices to agents and registrars; 

        (iii)  Upon
the exercise of all or a portion of an unvested Option pursuant to Section 10(h), a Restricted Stock purchase agreement in a form determined by the
Administrator and signed by the Holder or other person then entitled to exercise the Option or such portion of the Option; and 

        (iv)  In
the event that the Option shall be exercised pursuant to Section 10(f) by any person or persons other than the Holder, appropriate proof of the right of such
person or persons to exercise the Option. 

        (c)   Conditions
to Delivery of Share Certificates.    The Company shall not be required to issue or deliver any certificate or
certificates for Shares purchased upon the exercise of any Option or portion thereof prior to fulfillment of all of the following conditions: 

        (i)    The
admission of such Shares to listing on all stock exchanges on which such class of stock is then listed; 

        (ii)   The
completion of any registration or other qualification of such Shares under any state or federal law, or under the rulings or regulations of the Securities and
Exchange Commission or any other governmental regulatory body which the Administrator shall, in its sole discretion, deem necessary or advisable; 

        (iii)  The
obtaining of any approval or other clearance from any state or federal governmental agency which the Administrator shall, in its sole discretion, determine to be
necessary or advisable; 

        (iv)  The
lapse of such reasonable period of time following the exercise of the Option as the Administrator may establish from time to time for reasons of administrative
convenience; and 

        (v)   The
receipt by the Company of full payment for such Shares, including payment of any applicable withholding tax, which in the sole discretion of the Administrator may be
in the form of consideration used by the Holder to pay for such Shares under Section 9(b). 

        (d)   Termination
of Relationship as a Service Provider.    If a Holder ceases to be a Service Provider other than by reason of the
Holder's disability or death, such Holder may exercise his or 

6

 

her
Option within such period of time as is specified in the Option Agreement to the extent that the Option is vested on the date of termination. In the absence of a specified time in the Option
Agreement, the Option shall remain exercisable for three (3) months following the Holder's termination. If, on the date of termination, the Holder is not vested as to his or her entire Option,
the Shares covered by the unvested portion of the Option immediately cease to be issuable under the Option and shall again become available for issuance under the Plan. If, after termination, the
Holder does not exercise his or her Option within the time period specified herein, the Option shall terminate, and the Shares covered by such Option shall again become available for issuance under
the Plan. 

        (e)   Disability
of Holder.    If a Holder ceases to be a Service Provider as a result of the Holder's disability, the Holder may
exercise his or her Option within such period of time as is specified in the Option Agreement to the extent the Option is vested on the date of termination. In the absence of a specified time in the
Option Agreement, the Option shall remain exercisable for twelve (12) months following the Holder's termination. If, on the date of termination, the Holder is not vested as to his or her entire
Option, the Shares covered by the unvested portion of the Option shall immediately cease to be issuable under the Option and shall again become available for issuance under the Plan. If, after
termination, the Holder does not exercise his or her Option within the time specified herein, the
Option shall terminate, and the Shares covered by such Option shall again become available for issuance under the Plan. 

        (f)    Death
of Holder.    If a Holder dies while a Service Provider, the Option may be exercised within such period of time as is
specified in the Option Agreement, by the Holder's estate or by a person who acquires the right to exercise the Option by bequest or inheritance, but only to the extent that the Option is vested on
the date of death. In the absence of a specified time in the Option Agreement, the Option shall remain exercisable for twelve (12) months following the Holder's termination. If, at the time of
death, the Holder is not vested as to his or her entire Option, the Shares covered by the unvested portion of the Option shall immediately cease to be issuable under the Option and shall again become
available for issuance under the Plan. The Option may be exercised by the executor or administrator of the Holder's estate or, if none, by the person(s) entitled to exercise the Option under the
Holder's will or the laws of descent or distribution. If the Option is not so exercised within the time specified herein, the Option shall terminate, and the Shares covered by such Option shall again
become available for issuance under the Plan. 

        (g)   Regulatory
Extension.    A Holder's Option Agreement may provide that if the exercise of the Option following the termination of
the Holder's status as a Service Provider (other than upon the Holder's death or Disability) would be prohibited at any time solely because the issuance of shares would violate the registration
requirements under the Securities Act, then the Option shall terminate on the earlier of (i) the expiration of the term of the Option set forth in Section 8 or (ii) the expiration
of a period of three (3) months after the termination of the Holder's status as a Service Provider during which the exercise of the Option would not be in violation of such registration
requirements. 

        (h)   Early
Exercisability.    The Administrator may provide in the terms of a Holder's Option Agreement that the Holder may, at any
time before the Holder's status as a Service Provider terminates, exercise the Option in whole or in part prior to the full vesting of the Option; provided,
however, that Shares acquired upon exercise of an Option which has not fully vested may be subject to any forfeiture, transfer or other restrictions as the Administrator may
determine in its sole discretion. 

7

 

        (i)    Buyout
Provisions.    The Administrator may at any time offer to buyout for a payment in cash or Shares, an Option previously
granted, based on such terms and conditions as the Administrator shall establish and communicate to the Holder at the time that such offer is made. 

        11.   Non-Transferability
of Options and Stock Purchase Rights.    Options and Stock Purchase Rights may not be sold,
pledged, assigned, hypothecated, transferred, or disposed of in any manner other than by will or by the laws of descent or distribution and may be exercised, during the lifetime of the Holder, only by
the Holder. 

        12.   Stock
Purchase Rights. 

        (a)   Rights
to Purchase.    Stock Purchase Rights may be issued either alone, in addition to, or in tandem with Options granted under
the Plan and/or cash awards made outside of the Plan. After the Administrator determines that it will offer Stock Purchase Rights under the Plan, it shall advise the offeree in writing of the terms,
conditions and restrictions related to the offer, including the number of Shares that such person shall be entitled to purchase, the price to be paid, and the time within which such person must accept
such offer. The offer shall be accepted by execution of a Restricted Stock purchase agreement in the form determined by the Administrator. 

        (b)   Repurchase
Right.    Unless the Administrator determines otherwise, the Restricted Stock purchase agreement shall grant the
Company the right to repurchase Shares acquired upon exercise of a Stock Purchase Right upon the termination of the purchaser's status as a Service Provider for any reason. The purchase price for
Shares repurchased by the Company pursuant to such repurchase right and the rate at which such repurchase right shall lapse shall be determined by the Administrator in its sole discretion, and shall
be set forth in the Restricted Stock purchase agreement. 

        (c)   Other
Provisions.    The Restricted Stock purchase agreement shall contain such other terms, provisions and conditions not
inconsistent with the Plan as may be determined by the Administrator in its sole discretion. 

        (d)   Rights
as a Shareholder.    Once the Stock Purchase Right is exercised, the purchaser shall have rights equivalent to those of a
shareholder and shall be a shareholder when his or her purchase is entered upon the records of the duly authorized transfer agent of the Company. No adjustment shall be made for a dividend or other
right for which the record date is prior to the date the Stock Purchase Right is exercised, except as provided in Section 13 of the Plan. 

        13.   Adjustments
upon Changes in Capitalization, Merger or Asset Sale. 

        (a)   In
the event that the Administrator determines that any dividend or other distribution (whether in the form of cash, Common Stock, other securities, or other property),
recapitalization, reclassification, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase, liquidation,
dissolution, or sale, transfer, exchange or other disposition of all or substantially all of the assets of the Company, or exchange of Common Stock or other securities of the Company, issuance of
warrants or other rights to purchase Common Stock or other securities of the Company, or other similar corporate transaction or event, in the Administrator's sole discretion, affects the Common Stock
such that an adjustment is determined by the Administrator to be appropriate in order to prevent dilution or enlargement of the benefits or potential benefits intended by the Company to be made
available under the Plan or with respect to any Option, Stock
Purchase Right or Restricted Stock, then the Administrator shall, in such manner as it may deem equitable, adjust any or all of: 

        (i)    the
number and kind of shares of Common Stock (or other securities or property) with respect to which Options or Stock Purchase Rights may be granted or awarded
(including, but not limited to, adjustments of the limitations in Section 3 on the maximum 

8

 

number
and kind of shares which may be issued and adjustments of the maximum number of Shares that may be purchased by any Holder in any calendar year pursuant to Section 6(c)); 

        (ii)   the
number and kind of shares of Common Stock (or other securities or property) subject to outstanding Options, Stock Purchase Rights or Restricted Stock; and 

        (iii)  the
grant or exercise price with respect to any Option or Stock Purchase Right. 

        (b)   In
the event of any transaction or event described in Section 13(a), the Administrator, in its sole discretion, and on such terms and conditions as it deems
appropriate, either by the terms of the Option, Stock Purchase Right or Restricted Stock or by action taken prior to the occurrence of such transaction or event and either automatically or upon the
Holder's request, is hereby authorized to take any one or more of the following actions whenever the Administrator determines that such action is appropriate in order to prevent dilution or
enlargement of the benefits or potential benefits intended by the Company to be made available under the Plan or with respect to any Option, Stock Purchase Right or Restricted Stock granted or issued
under the Plan or to facilitate such transaction or event: 

        (i)    To
provide for either the purchase of any such Option, Stock Purchase Right or Restricted Stock for an amount of cash equal to the amount that could have been obtained
upon the exercise of such Option or Stock Purchase Right or realization of the Holder's rights had such Option, Stock Purchase Right or Restricted Stock been currently exercisable or payable or fully
vested or the replacement of such Option, Stock Purchase Right or Restricted Stock with other rights or property selected by the Administrator in its sole discretion; 

        (ii)   To
provide that such Option or Stock Purchase Right shall be exercisable as to all shares covered thereby, notwithstanding anything to the contrary in the Plan or the
provisions of such Option or Stock Purchase Right; 

        (iii)  To
provide that such Option, Stock Purchase Right or Restricted Stock be assumed by the successor or survivor corporation, or a parent or subsidiary thereof, or shall
be substituted for by similar options, rights or awards covering the stock of the successor or survivor corporation, or a parent or subsidiary thereof, with appropriate adjustments as to the number
and kind of shares and prices; 

        (iv)  To
make adjustments in the number and type of shares of Common Stock (or other securities or property) subject to outstanding Options and Stock Purchase Rights, and/or
in the terms and conditions of (including the grant or exercise price), and the criteria included in, outstanding Options, Stock Purchase Rights or Restricted Stock or Options, Stock Purchase Rights
or Restricted Stock which may be granted in the future; and 

        (v)   To
provide that immediately upon the consummation of such event, such Option or Stock Purchase Right shall not be exercisable and shall terminate;  provided, that for a specified period of time prior to
such event, such Option or Stock Purchase Right shall be exercisable as to all Shares covered
thereby, and the restrictions imposed under an Option Agreement or Restricted Stock purchase agreement upon some or all Shares may be terminated and, in the case of Restricted Stock, some or all
shares of such Restricted Stock may cease to be subject to repurchase, notwithstanding anything to the contrary in the Plan or the provisions of such Option, Stock Purchase Right or Restricted Stock
purchase agreement. 

        (c)   Subject
to Section 3, the Administrator may, in its sole discretion, include such further provisions and limitations in any Option, Stock Purchase Right,
Restricted Stock agreement or certificate, as it may deem equitable and in the best interests of the Company. 

        (d)   If
the Company undergoes an Acquisition, then any surviving corporation or entity or acquiring corporation or entity, or affiliate of such corporation or entity, may
assume any Options, 

9

 

Stock
Purchase Rights or Restricted Stock outstanding under the Plan or may substitute similar stock awards (including an award to acquire the same consideration paid to the stockholders in the
transaction described in this subsection 13(d)) for those outstanding under the Plan. In the event any surviving corporation or entity or acquiring corporation or entity in an Acquisition, or
affiliate of such corporation or entity, does not assume such Options, Stock Purchase Rights or Restricted Stock or does not substitute similar stock awards for those outstanding under the Plan, then
with respect to (i) Options, Stock Purchase Rights or Restricted Stock held by participants in the Plan whose status as a Service Provider has not terminated prior to such event, the vesting of
such Options, Stock Purchase Rights or Restricted Stock (and, if applicable, the time during which such awards may be exercised) shall be accelerated and made fully exercisable and all restrictions
thereon shall lapse at least ten (10) days prior to the closing of the Acquisition (and the Options or Stock Purchase Rights terminated if not exercised prior to the closing of such
Acquisition), and (ii) any other Options or Stock Purchase Rights outstanding under the Plan, such Options or Stock Purchase rights shall be terminated if not exercised prior to the closing of
the Acquisition. 

        (e)   Notwithstanding
the foregoing, in the event that the Company becomes a party to a transaction that is intended to qualify for "pooling of interests" accounting treatment
and, but for one or more of the provisions of this Plan or any Option Agreement or any Restricted Stock purchase agreement would so qualify, then this Plan and any such agreement shall be interpreted
so as to preserve such accounting treatment, and to the extent that any provision of the Plan or any such agreement would disqualify the transaction from pooling of interests accounting treatment
(including, if applicable, an entire Option Agreement or Restricted Stock purchase agreement), then such provision shall be null and void. All determinations to be made in connection with the
preceding sentence shall be made by the independent accounting firm whose opinion with respect to "pooling of interests" treatment is required as a condition to the Company's consummation of such
transaction. 

        (f)    The
existence of the Plan, any Option Agreement or Restricted Stock purchase agreement and the Options or Stock Purchase Rights granted hereunder shall not affect or
restrict in any way the right or power of the Company or the stockholders of the Company to make or authorize any adjustment, recapitalization, reorganization or other change in the Company's capital
structure or its business, any merger or consolidation of the Company, any issue of stock or of options, warrants or rights to purchase stock or of bonds, debentures, preferred or prior preference
stocks whose rights are superior to or affect the Common Stock or the rights thereof or which are convertible into or exchangeable for Common Stock, or the dissolution or liquidation of the Company,
or any sale or transfer of all or any part of its assets or business, or any other corporate act or proceeding, whether of a similar character or otherwise. 

        14.   Time
of Granting Options and Stock Purchase Rights.    The date of grant of an Option or Stock Purchase Right shall, for all
purposes, be the date on which the Administrator makes the determination granting such Option or Stock Purchase Right, or such other date as is determined by the Administrator. Notice of the
determination shall be given to each Service Provider to whom an Option or Stock Purchase Right is so granted within a reasonable time after the date of such grant. 

        15.   Amendment
and Termination of the Plan. 

        (a)   Amendment
and Termination.    The Board may at any time wholly or partially amend, alter, suspend or terminate the Plan. 

        (b)   Effect
of Amendment or Termination.    No amendment, alteration, suspension or termination of the Plan shall impair the rights of
any Holder, unless mutually agreed otherwise between the Holder and the Administrator, which agreement must be in writing and signed by the Holder and the Company. Termination of the Plan shall not
affect the Administrator's ability to 

10

 

exercise
the powers granted to it hereunder with respect to Options, Stock Purchase Rights or Restricted Stock granted or awarded under the Plan prior to the date of such termination. 

        (c)   Repricing
Prohibited.    Notwithstanding any provision in this Plan to the contrary, absent approval of the stockholders of the
Company no Option may be amended to reduce the per Share exercise price of the Shares subject to such Option below the per Share exercise price as of the date the Option is granted. In addition,
absent approval of the stockholders of the Company no Option may be granted in exchange for, or in connection with, the cancellation or surrender of an Option having a higher per Share exercise price. 

        16.   Inability
to Obtain Authority.    The inability of the Company to obtain authority from any regulatory body having jurisdiction,
which authority is deemed by the Company's counsel to be necessary to the lawful issuance and sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to
issue or sell such Shares as to which such requisite authority shall not have been obtained. 

        17.   Reservation
of Shares.    The Company, during the term of this Plan, shall at all times reserve and keep available such number of
Shares as shall be sufficient to satisfy the requirements of the Plan. 

        18.   Investment
Intent.    The Company may require a Plan participant, as a condition of exercising or acquiring stock under any Option
or Stock Purchase Right, (i) to give written assurances satisfactory to the Company as to the participant's knowledge and experience in financial and business matters and/or to employ a
purchaser representative reasonably satisfactory to the Company who is knowledgeable and experienced in financial and business matters and that he or she is capable of evaluating, alone or together
with the purchaser representative, the merits and risks of exercising the Option or Stock Purchase Right; and (ii) to give written assurances satisfactory to the Company stating that the
participant is acquiring the stock subject to the Option or Stock Purchase Right for the participant's own account and not with any present intention of selling or otherwise distributing the stock.
The foregoing requirements, and any assurances given pursuant to such requirements, shall be inoperative if (A) the issuance of the shares upon the exercise or acquisition of stock under the
applicable Option or Stock Purchase Right has been registered under a then currently effective registration statement under the Securities Act or (B) as to any particular requirement, a
determination is made by counsel for the Company that such requirement need not be met in the circumstances under the then applicable securities laws. The Company may, upon advice of counsel to the
Company, place legends on stock certificates issued under the Plan as such counsel deems necessary or appropriate in order to comply with applicable securities laws, including, but not limited to,
legends restricting the transfer of the stock. 

        19.   Governing
Law.    The validity and enforceability of this Plan shall be governed by and construed in accordance with the laws of
the State of Delaware without regard to otherwise governing principles of conflicts of law. 

11

QuickLinks

Exhibit 10.8

AMENDED AND RESTATED 2002 NON-QUALIFIED STOCK OPTION PLAN

TABLE OF CONTENTS

AMENDED AND RESTATED 2002 NON-QUALIFIED STOCK OPTION PLANQuickLinks
 -- Click here to rapidly navigate through this document

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Exhibit 10.34    
    

ACCELLENT-CONCEPTUS  

 
  SUPPLY AGREEMENT    
    

        This Supply Agreement (the "Agreement") dated as of November 7, 2005 (the "Effective Date") is
between Accellent Corp., a Colorado company with its principal office at 100 Fordham Road, Building C, Wilmington, MA 01887 ("Supplier"), and Conceptus
Incorporated, with its principal office at 1021 Howard Avenue, San Carlos, CA 94070 (the "Purchaser"). 

        WHEREAS,
the Purchaser has developed and designed a medical device and seeks to have such device manufactured for it by the Supplier; and 

        WHEREAS,
the Supplier has expertise in the manufacture of medical devices and components and desires to provide manufacturing services for the Purchaser. 

        NOW,
THEREFORE, in consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties agree as follows: 

1.    Definitions.    Unless otherwise defined in this Agreement, as used herein, the following defined
terms shall have the meanings given them below. 

        1.1   Affiliate.    "Affiliate"
means any entity which directly or indirectly controls, is controlled by, or is under common control
with the referenced party. 

        1.2   Approved
Supplier List.    "Approved Supplier List" has the meaning given in Section 3.7. 

        1.3   Bankruptcy
Event.    "Bankruptcy Event" means the institution of voluntary or involuntary proceedings by or against a person or
entity in bankruptcy or under any insolvency law, or the appointment of a receiver or custodian for such person or entity, or the institution of proceedings by or against such person or entity for
corporate reorganization or the dissolution of such person or entity, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or an
assignment by such person or entity for the benefit of its creditors. 

        1.4   Competitor.    "Competitor"
means any company that sells a non-surgical female tubal sterilization device or process. 

        1.5   Controlled
Environment Room.    "Controlled Environment Room" shall mean a room that is used to manufacture Products having a
controlled environment to limit particulate and microorganisms. 

        1.6   Change
in Control.    "Change in Control" means the direct or indirect (i) sale or other disposition of all or
substantially all of Supplier's assets, or (ii) transfer of more than fifty percent (50%) of the outstanding voting interests or economic interests of Supplier; provided that an initial public
offering of stock by Supplier shall not constitute a "Change in Control." 

        1.7   Delivery
Date.    "Delivery Date" has the meaning given in Section 3.4. 

        1.8   Delivery
Schedule.    "Delivery Schedule" has the meaning given in Section 3.4. 

        1.9   Event
of Default.    "Event of Default" has the meaning given in Section 13. 

        1.10 Forecast.    "Forecast"
has the meaning given in Section 3.3. 

 

        1.11 Incoming
Inspection.    "Incoming Inspection" means measuring, examining, and testing that gauges one or more characteristics of
a Product component and the comparison of such component with the specified requirements to determine such component's conformity to the Specifications. 

        1.12 Intellectual
Property.    "Intellectual Property" has the meaning given in Section 10.1. 

        1.13 Intellectual
Property Rights.    "Intellectual Property Rights" has the meaning given in
Section 10.1. 

        1.14 Procedures.    "Procedures"
has the meaning given in Section 2.1. 

        1.15 Process.    "Process"
means the methods and all referenced procedures used in the manufacture of the Product. 

        1.16 Product.    "Product"
means a kit containing two (2) Essure devices, as further described in
Exhibit A hereto. 

        1.17 Product
Device Master Record.    "Product Device Master Record" means the Product Device Master Record for the Product required
by the Regulatory Authorities, as it may be revised and in effect from time to time. 

        1.18 Purchase
Order.    "Purchase Order" means a purchase order for Products in a form provided by Purchaser. 

        1.19 Purchase
Price.    "Purchase Price" has the meaning given in Section 3.1. 

        1.20 Qualified
Trainer.    "Qualified Trainer" shall mean Manufacturer's designated individual(s) who can perform training on
manufacturing processes, test methods and/or standard operating procedures as developed and approved by Purchaser. 

        1.21 Regulatory
Authority.    "Regulatory Authority" means the Food and Drug Administration of the United States (the
"FDA") or, any successor agency or, if applicable in the context, the government agency performing the same regulatory function as the FDA in another country. 

        1.22 Specifications.    "Specifications"
means the specifications for the Product as provided in the Product Device Master Record. 

        1.23 Term.    "Term"
has the meaning given in Section 12.1. 

2.    Supply Rights.    

        2.1   Manufacture
and Supply.    Supplier agrees, pursuant to the Delivery Schedule, to
procure inventory, which includes raw materials, components and other supplies, and to manufacture, test, assemble, inspect and deliver the Products pursuant to the Specifications for each such
Product. Supplier recognizes and agrees that the specific manufacturing site employed for the production of the Products must be approved and accepted by the Purchaser. Supplier agrees to provide
adequate capacity to meet the volumes agreed by the parties in accordance with Section 3.4. All materials for use in Products, including but not limited to raw
materials, supplies, and completed Product will be stored by Supplier in a secure, segregated, and controlled area to prevent theft, loss, degradation or damage of such materials. Supplier shall
maintain lot traceability of raw materials, work in process and finished Product. All components used in the Products shall be processed through Incoming Inspection. All materials and components that
do not meet the applicable Specifications shall be quarantined and investigated through the Supplier's non-conformance procedure. Supplier's personnel responsible for manufacturing,
testing, and inspecting Product shall be trained in the Procedures (as defined below) by a Qualified Trainer. Supplier's quality assurance personnel shall ensure Products meet Specifications. Supplier
agrees to manufacture Products in a Controlled Environment Room (CER), which shall be monitored for particulate and microbial control on a quarterly basis. The Incoming Inspection,
non-conformance procedure, quality assurance procedures and other manufacturing, testing, and 

2

 

inspection
procedures used by Supplier in connection with the manufacture of the Products are collectively the "Procedures." All Procedures, and any changes thereto, must
be approved by Purchaser prior to their use by Supplier. Purchaser acknowledges that Supplier is in the business of providing contract manufacturing services to the medical device industry and,
subject to the terms of this Agreement, reserves the right to supply, develop, manufacture, sell, resell, or carry-on similar activities to any third party, including competitors of the
Purchaser. 

        2.2   Purchase
Requirements.    Purchaser is not required to purchase any specific quantity of Products under this Agreement. 

        2.3   Essure
Catheter Assembly Manufacturing Transfer.    Exhibit C contains the terms and
conditions under which Supplier shall transfer the manufacturing capabilities for the next generation of the Essure catheter assembly (i.e., the ESS305 Essure Catheter Assembly, or
"ESS305") from Purchaser's location in San Carlos, California to Supplier's facility in Juarez, Mexico. Once the transfer has been completed and the manufacturing line has
been validated and approved in writing by Purchaser, all ESS305 products manufactured by Supplier after that point will deemed "Products" and be governed by the terms of this Agreement. 

3.    Purchase Orders, Prices, Terms, Delivery, Forecasts.    

        3.1.  Purchase
Price.    The purchase price ("Purchase Price") for each Product purchased from Supplier
shall be as set out on Exhibit B and shall be due and payable no later than thirty (30) days from the date of the invoice for such Product. Invoices shall be
dated the date the applicable Products are shipped. The price for Products during the Term and assumptions upon which they are predicated shall be as defined in
Exhibit B and the following: (i) at any time, in the event of increases in the amount of five percent (5%) or more in the market price of raw materials,
components or packaging materials purchased by Supplier from vendors on the Approved Supplier List in order to manufacture the Products (collectively, "Materials") the
Supplier shall notify Purchaser of such increase and the parties shall discuss methods to mitigate such increase, including the use of alternate vendors, provided that to the extent the parties are
unable to mitigate such increase Supplier may pass the incremental increase through to Purchaser (with no markup); (ii) Supplier shall notify Purchaser of, and pass through to Purchaser, any
decreases in the price of Materials that equal or exceed five percent (5%); (iii) if the parties share the cost of any Product engineering changes, process improvements, and procurement or
alternate sourcing activities (collectively, "Changes") that result in a cost reduction, the amount of such cost reduction will be shared by the Supplier and Purchaser,
with each receiving fifty percent (50%) of such cost reduction after implementation of the Changes, provided that mutually agreed, nonrecurring expenses associated with such cost reductions will be
retired by the party bearing such expenses prior to sharing, and (iv) if Purchaser pays the entire cost of any Changes, Purchaser shall realize the entire amount of any cost reduction resulting
from such Change in the form of a lower Product price. In addition to the Supplier's other rights and remedies, Supply may elect to charge interest at the rate of 10% per annum or the highest rate
permitted under applicable law, whichever is lower, on any undisputed amount (i) of the Purchase Price owed under this Agreement, or (ii) due pursuant to the services provided under
Exhibit C, which amounts are not paid when due. 

        3.2.  Orders,
Shipping Terms, and Inconsistencies.    Supplier shall pack all Products for shipment in accordance with Purchaser's
Specifications and otherwise in a commercially reasonable manner to protect against damage. All shipments of Products shall be F.O.B. Supplier's facility, and shall be accompanied by a packing slip
which describes the Products and states the Order number. Title to and all risk of loss or damage concerning the Products shall pass to Purchaser immediately upon the sooner of delivery of the
Products to either (i) the Purchaser, (ii) a common carrier or (iii) any private carrier designated by Purchaser (or designated by Supplier and approved by Purchaser) for shipment
to Purchaser's designated point of delivery. Purchaser's rejection of any Products purchased hereunder shall not shift any risk for those Products until they are returned to and received by Supplier
pursuant to Supplier's written instructions. If there is any conflict or inconsistency between this Agreement and 

3

 

any
Purchase Order confirmation, acceptance or any similar document, the terms of this Agreement shall govern and control. 

        3.3   Forecasts.    On
the first day of each calendar quarter, Purchaser shall provide Supplier with an updated Product forecast
("Forecast") that reflects Purchaser's estimated aggregate purchase requirements of Product for the subsequent three (3) month period. 

        3.4   Purchase
Orders.    Purchaser may from time to time provide Supplier with specific quantities of Product to be delivered to
Purchaser on specific Delivery Dates (as defined below), which dates and quantities will be mutually agreed to by the parties. The schedule of agreed upon Delivery Dates and quantities of Products to
be delivered on such dates shall become the delivery schedule ("Delivery Schedule"). Supplier shall supply the quantities of Product meeting the Specifications on the date
detailed in the Delivery Schedule for such Products (the "Delivery Date"). 

        3.5   Notice
of Anticipated Failure to Make Timely Delivery.    The Supplier will notify the Purchaser in the event that Supplier
becomes aware that the Supplier will not be able to make delivery of Products by the dates required by Section 3.4. 

        3.6   Purchaser-Supplied
Components.    In the event Supplier has a shortage of components for Products, Purchaser may, at its
discretion, supply components to Supplier at Supplier's expense upon the written consent of Supplier and only in such amounts as are necessary for firm orders then placed by Purchaser. Such
components, including provision for failed parts, shall be delivered to Supplier not later than four (4) weeks prior to the scheduled Delivery Date for the related Products to Purchaser. Should
Purchaser be unable to meet Purchaser's requirements for delivery of Products, Purchaser may at its option require Supplier to either: (i) ship Products to Purchaser absent the missing
components on or after seven (7) days from the scheduled Delivery Date; or (ii) hold the Products pending receipt of such components from Purchaser. Under these circumstances, Purchaser
will give written notification to Supplier prior to the scheduled Delivery Date. Nothing in this Section relieves Supplier of its other obligations under this Agreement. 

        3.7   Approved
Supplier List.    Purchaser shall provide a bill of materials and approved supplier list ("Approved
Supplier List" or "ASL") for each Product to be manufactured hereunder. Supplier shall manufacture the Products using components obtained solely from
vendors included on the ASL, as it may change from time to time, as approved by Purchaser. The ASL shall not be amended without prior written approval of Purchaser. If Supplier desires to use a
supplier from Supplier's own list of approved suppliers, Supplier shall provide Purchaser with a written proposal describing the reasons to use such supplier. Purchaser may accept or reject the
proposal in its sole discretion. If Purchaser accepts the proposal, the proposed supplier will be subject to evaluation and approval processes approved by Purchaser. Supplier will not order any
materials or components for the Products from such supplier until Purchaser has provided written approval to make such orders. 

        3.8   Quarterly
Review.    The parties agree to establish a quarterly business review process pursuant to which the parties will review
(either in person, by telephone, video conference or other mutually agreeable means) Product quality, cycle time, manufacturing capacity, delivery, market conditions, and any other matters or concerns
relevant to this Agreement. Each party shall bear its own costs and expenses related to the quarterly business review. 

        3.9   Excess
and Obsolete Inventory. 

        3.9.1. If
Purchaser cancels a Product order specified in the Delivery Schedule less than thirty (30) days prior to the applicable Delivery Date, Purchaser shall be
responsible for the Purchase Price of the Products specified in such order unless otherwise agreed by the parties. 

        3.9.2 Purchaser
shall be responsible for any non-returnable inventory (including finished Products, work-in-process, components, or raw
material) or non-cancelable orders for components 

4

 

or
raw material that are rendered excess or obsolete (as determined in Supplier's reasonable discretion)(collectively, "Excess Inventory") to the extent such Excess
Inventory is caused by (a) Purchaser's cancellation of orders specified in a Forecast with shipment dates specified in the Delivery Schedule between thirty (30) and
one-hundred and twenty (120) days from the date of cancellation, (b) a sustained reduction in Product purchases specified in the Forecast of more than twenty-five
(25%) over a three- (3) month period, (c) engineering change orders agreed by the parties, (d) the end of a Product's life, or (e) the termination or expiration of this
Agreement (excluding termination of the Agreement by Purchaser in accordance with Section 5.2 or Section 13.1, in which case Purchaser shall not be responsible for any Excess Inventory),
provided that in each case (a) through (e) above the Excess Inventory cannot reasonably and without material cost to the Supplier be utilized on other Supplier products or returned to
its suppliers. The cost to Purchaser of the Excess Inventory described above shall be the Purchase Price for finished Products and the Supplier's burdened cost (including labor (if expended), storage,
and documented restocking charges paid by Supplier to its suppliers, but excluding a mark-up) for all other items Supplier shall provide Purchaser an invoice that itemizes and describes in
reasonable detail the foregoing charges with respect to Excess Inventory and the reasons Supplier cannot avoid such charges within thirty (30) days after the event described in subsections
(a) through (e) above that gave rise to such charges. In no event shall Purchaser's responsibility for charges with respect to Excess Inventory exceed an amount equal to the total
Purchase Price paid by Purchaser for all Products in the one-hundred and twenty day (120) day period immediately preceding Supplier's initial claim for charges related to Excess
Inventory. 

4.    Changes to Specifications.    

        4.1.  Changes
by Purchaser.    If the Purchaser desires to change the Specifications, it will notify the Supplier of such proposed
change in writing. Within thirty (30) days following receipt of such a notice from the Purchaser, the Supplier shall notify the Purchaser of the cost of implementing such change and the impact
such a change would have on the Purchase Price and the manufacturing lead-time. The Purchaser will then notify the Supplier in writing whether it wants to implement such change taking into
account the implementation costs and the manufacturing lead time and Purchase Price impact. Specifications for any change to the Product shall be finalized by the Purchaser in a mutually agreed to
time-frame prior to the placement of the first order for each Product to be manufactured with such changed Specifications. After approval by the Purchaser, such change shall then become
part of the Specifications. 

        4.2   Changes
by Supplier to Specifications or Process.    No changes to the Specifications shall be made by the Supplier without the
prior written approval of the Purchaser. Supplier shall not make any changes to the manufacturing process which may require the submission of any amendment, filing or other documentation with any
Regulatory Authority unless such change has been identified, reviewed and approved in writing by the Purchaser. The Purchaser shall provide a response to any such proposed changes as soon as is
practicably possible after receipt. 

5.    Quality and Regulatory Matters.    

        5.1   Facility
Reviews.    The Purchaser or its designee shall have the right, upon reasonable advance written notice and during regular
business hours, to inspect the facilities being used by the Supplier for production of the Products solely to confirm that such facilities are adequate to meet the requirements of this Agreement, the
Regulatory Authority, ISO13485, and any applicable successors to those ISO requirements. Supplier shall reasonably cooperate with Purchaser and its designee with respect to such inspections. If any
such inspection reveals that the manufacturing facilities do not satisfy such requirements, then the Purchaser shall provide written notice of such fact, which notice shall contain in reasonable
detail the deficiencies found in the manufacturing facilities and, if practicable, those steps the Supplier should undertake in order to remedy such deficiencies. Any inspection made by the Purchaser
under this section shall occur no more frequently than once each calendar quarter (unless 

5

 

otherwise
required by law, including by direction of the Regulatory Authority) and shall be designed to cause the least amount of disruption to the operations of the Supplier as is reasonably
possible. Such inspections shall be limited to the manufacture of Products, and shall not include any trade secrets or other confidential information unless the Purchaser and its designee (if
applicable) has signed a confidentiality agreement reasonably satisfactory to the Supplier. 

        5.2   Remedying
Deficiencies.    The Supplier shall be responsible for remedying any deficiencies identified by the Purchaser under
Section 5.1 at Supplier's cost and expense within sixty (60) days following written notice from the Purchaser. With respect to any such inspections for which
any deficiencies are not capable of being remedied by the Supplier within sixty (60) days of the notification thereof, then the Supplier and the Purchaser shall discuss in good faith a
corrective action plan which will enable the Products to be supplied in accordance with this Agreement until such deficiencies are remedied. If the parties are unable to reach agreement after an
additional sixty (60) days as to such alternative manufacturing arrangements, then the Purchaser shall have the right to terminate this Agreement upon written notice to the Supplier. 

        5.3   Records.    The
Supplier will maintain its records with respect to the manufacture of the Products for ten (10) years after
the date of manufacture of the last Product under this Agreement, after which Supplier shall transfer such records to Purchaser. 

        5.4   Medical
Device Reporting.    Purchaser shall be responsible to report events in compliance with FDA Medical Device Reporting
Regulation set forth in 21 CFR Part 803 and any applicable international regulations. Purchaser agrees to make Medical Device Reports available to Supplier within three (3) days
of the initial receipt of any report that reasonably suggests that one of the Products (i) may have caused or contributed to a death or serious injury or (ii) has malfunctioned. 

        5.5   Notices
from Regulatory Authorities.    A party receiving (the "Regulatory Receiving Party")
communications from any Regulatory Authority, including any FDA Form 483 Report on Inspectional Observations or equivalent notice, shall provide to the other party within
twenty-four (24) hours copies of any such communications it receives related to the Products. 

        5.6   Permits,
etc.    The Purchaser shall obtain, at the Purchaser's sole expense, all permits, licenses, approvals, consents, and
authorizations from all governmental authorities as may be necessary or appropriate to market, solicit orders for, and sell the Products. 

        5.7   Product
Complaints.    In reviewing customer complaints concerning the Products, the Purchaser shall be considered the
"manufacturer" for regulatory purposes, and shall receive and log all complaints from customers using the Products. If after evaluation by the Purchaser of the complaints, the Purchaser reasonably
believes that a complaint relates to a breach by the Supplier of the warranty contained in Section 6.1, the Purchaser will forward the complaint and the related
Product to the Supplier. The Supplier will then evaluate the complaint. If the Product does not comply with the warranty contained in Section 6.1, then the Supplier
shall be responsible to remedy the noncompliance as provided in Section 6.2. If the Product complies with the warranty contained in
Section 6.1, then (i) the Supplier will return the Product to the Purchaser with the Supplier's evaluation, and the costs of shipping the Product between the
Purchaser, the Supplier, and the customer shall be the Purchaser's responsibility; and (ii) to the extent the Supplier's investigations of the complaints repeatedly result in Products that do
not breach the warranty and impose an unreasonable financial burden on the Supplier, then the parties will review the circumstances and attempt to make the Supplier whole with respect to such burden. 

        5.8   Sterilization
services.    Sterilization services with respect to any Product will be provided only if requested by Purchaser and
will only be performed by a third-party supplier approved by Purchaser and solely at Purchaser's expense. With respect to any such sterilization services, Supplier and Purchaser will jointly review
the sterilization protocol and report, which will include the results of the 

6

 

sterilization
validation/revalidation. Purchaser will have final approval responsibility for all sterilization documentation (and the services provided thereunder) and is
ultimately responsible for verification and certification of product sterility. Supplier and Purchaser will define the terms of the product transfer and mutually agree to the
terms of sterile lot release. 

        5.9   Certain
Quality Requirements.    Without limiting its other obligations under this Agreement, Supplier shall comply with the
quality requirements set forth in Exhibit D. 

6.    Product Warranty and Limited Remedies; Customer Complaints.    

        6.1   Warranty.    The
Supplier warrants that each Product shall materially comply with the Specifications for a period of two
(2) years following the date of its shipment, provided that this warranty shall not apply to non-conformities and shall be void to the extent such non-conformities are
not caused by Supplier's or Supplier's agents' or contractors' acts or omissions. 

        6.2   Remedies.    If
any Product does not conform to the warranty stated in Section 6.1 above, the
Supplier shall, at Purchaser's option, within ninety (90) days repair or replace such Product at the Supplier's own expense, and ship such repaired or replacement Product back to either the
Purchaser or the applicable customer at the Supplier's own expense, or credit to the Purchaser the Purchase Price for the Product. The foregoing warranty, and the remedies provided for in this
Section 6.2, are expressly conditioned upon (i) Purchaser providing Supplier with prompt written notice of any nonconforming Product prior to the expiration
of the warranty period, which notice must identify with particularity the non-conformity, and (ii) Purchaser's full cooperation with Supplier in all reasonable respects relating
thereto. All defective Products which are covered by the foregoing warranty shall be shipped to the Supplier at its expense for such repair or replacement. 

        6.3   Exclusions
From Warranty.    The warranty set forth in Section 6.1 above does not include
Products that have defects or failures resulting from Purchaser's design of the Products (as such design is described in the design history record of the Product). Purchaser bears all design
responsibility for the Product. 

        6.4   Product
Recalls.    In the event of a Product recall caused by Supplier's breach of the warranty provided in
Section 6.1, Supplier shall at its cost and expense replace all Product lots recalled (regardless of the number of nonconforming Products, if any, in such lots),
and pay any associated shipping and handling costs with respect to such lots. Without limiting Supplier's liability under Sections 7.1(i) and
7.1(ii), the foregoing represents Supplier's sole obligation with respect to Product recalls. 

        6.5   LIMITATIONS.    THE
WARRANTY PROVIDED IN SECTION 6.1 ABOVE IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS. ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. EXCEPT WITH RESPECT TO EACH PARTY'S
CONFIDENTIALITY OBLIGATIONS UNDER SECTION 11, NEITHER PARTY WILL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR REVENUES;
AND EXCEPT WITH RESPECT TO EACH PARTY'S INDEMNIFICATION OBLIGATIONS UNDER SECTION 7, NEITHER PARTY'S AGGREGATE LIABILITY UNDER THIS AGREEMENT, WHETHER BASED UPON CONTRACT, TORT, OR OTHERWISE,
SHALL EXCEED THE ACTUAL AMOUNTS PAID BY PURCHASER FOR PRODUCTS DURING THE IMMEDIATELY PRECEDING TWELVE (12) MONTH PERIOD FROM WHEN THE CLAIM FOR LIABILITY AROSE, REGARDLESS OF WHETHER THE
PRODUCTS WERE PURCHASED DURING SUCH PERIOD UNDER THIS AGREEMENT OR UNDER THE "CONTRACT MANUFACTURING AGREEMENT" BETWEEN CONCEPTUS AND VENUSA LTD. DATED JUNE 20, 2003 (the
"June 20, 2003 Agreement"). 

7

 

        6.5   Disputes.    If
the Supplier disagrees with a claim that a Product does not conform to the warranty provided in
Section 6.1, then the parties agree to submit the disputed Product to an independent party which has the capability of testing the Product to determine whether or
not it does so conform. In the event the parties cannot agree upon such independent party, or in the event it is not possible to acquire the services of such an independent party, then such dispute
shall be resolved pursuant to Section 14.11. The cost of the independent testing party shall be borne by the party against whom the testing party finds, as directed
by the testing party. 

7.    Indemnification.    In order to distribute between themselves the responsibility for third party
claims arising out of this Agreement, and except as otherwise specifically limited or provided for herein, the parties agree as set forth in Sections 7.1 through
7.3 below: 

        7.1   By
Supplier.    The Supplier agrees to indemnify, defend and hold the Purchaser harmless against any and all claims, suits,
proceedings, expenses, recoveries and damages of or by third parties, including court costs and reasonable attorneys fees and expenses, to the extent they arise out of, are based on, or are caused by
(i) any material breach by the Supplier of its warranty provided in Section 6.1, which breach causes bodily harm, death, or property damage, (ii) the
willful misconduct or gross negligence of the Supplier, or (iii) any claim of infringement of any Intellectual Property Right of any third party based upon or arising out of the Supplier's
manufacturing processes with respect to the Products. The Purchaser will promptly notify the Supplier of any such claim or demand which comes to its attention. 

        7.2   The
Purchaser.    The Purchaser agrees to indemnify, defend and hold the Supplier harmless against any and all claims, suits,
proceedings, expenses, recoveries, and damages of or by third parties, including court costs and reasonable attorneys fees and expenses, to the extent they arise out of, are based on, or are caused by
(i) defects or alleged defects in the design of the Products, (ii) any allegation or claim that the design for the Products infringes upon the Intellectual Property Rights of third
parties, (iii) statements, whether written or oral, made or alleged to be made by the Purchaser or its Affiliates or any other party on the packaging or labeling of any of the Products, or in
the advertising, publicity, promotion, or sale of any of the Products, (iv) the storage, sale, shipment, promotion, or distribution of the Products (except to the extent that such claims are
covered by Supplier's indemnity in Section 7.1), (v) the use or operation of the Products (except to the extent that such claims are covered by Supplier's
indemnity in Section 7.1), or (vi) any allegation or claim that the Products are not sterile. The Supplier will promptly notify the Purchaser of any such
claim or demand which comes to its attention. 

        7.3   General.    The
party claiming indemnity (the "Indemnified Party") shall provide the party from whom
indemnity is being sought (the "Indemnifying Party") with reasonable assistance, at the Indemnifying Party's expense, in connection with the defense of the claim for which
indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing, at the Indemnified Party's cost; however, the Indemnifying Party shall
have the right to assume and conduct the defense of the claim with counsel of its choice and shall retain final decision-making authority with respect to the conduct of the defense. The Indemnifying
Party shall not settle any claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money by the
Indemnifying Party. So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle any such
claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (i) the Indemnified Party
may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the claim in any manner the Indemnified Party may deem reasonably appropriate (and the
Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith) and (ii) the Indemnifying Party will remain responsible to indemnify the
Indemnified Party as provided in this Section 7. 

8

   
8.    Insurance.    

        8.1   Each
party agrees to procure and maintain in full force and effect during the term of this Agreement and for three years thereafter valid and collectible insurance
policies in connection with the supply and sale of Products pursuant to this Agreement and provide; (i) for commercial general liability coverage in the amount of $1,000,000 each occurrence and
$2,000,000 general aggregate excluding Products and Completed Operations coverage and written on an occurrence basis and, (ii) Products and Completed Operations coverage in the amount of
$5,000,000 per occurrence, $10,000,000 in the aggregate and written on a claims made basis. Such policies shall endeavor to provide for thirty (30) days written notice of cancellation to the
other party. Upon either party's request, the other party shall provide to the requesting party a certificate of insurance coverage. 

9.    Trademarks; Use of Supplier Name.    

        9.1   Trademarks.    For
purposes of this Section 9.1, "Trademark"
shall mean the Purchaser's trademarks that are associated with the Products and which are approved by Purchaser for use by Supplier in the manufacture of the Products. In consideration of the fees set
forth herein, Purchaser further grants to Supplier a non-exclusive license during the Term to use the Trademarks on and solely in connection with the manufacture of the Products, and for
this purpose to affix, subject to Purchaser's prior written approval, the Trademarks to or on the Products and to or on any packaging materials used in connection with the Products. Any and all uses
of the Trademarks shall be subject to the prior written approval of Purchaser. Supplier shall not remove trademark notices from any Product or component thereof without the prior written consent of
Purchaser. Supplier shall not use the name, Trademarks or logos associated with the Products in its business name or in any manner other than as specified in this Section. Purchase shall have and
retain ownership of all Trademarks. The Purchaser acknowledges that such trademark ownership rights do not extend to the Supplier's proprietary formulae, processes, or other written proprietary
information that Supplier has trademark ownership or rights to as of the Effective Date. 

        9.2   Use
of Name.    Unless legally required by applicable law, neither party shall use the other party's name in its advertising or
elsewhere, without the prior written approval of the other party. 

10.    Intellectual Property; Tooling.    

        10.1 Intellectual
Property Rights.    Each party shall retain sole ownership of, and all Intellectual Property Rights to, any
Intellectual Property of any kind owned by that party as of the Effective Date. Purchaser shall own any and all Intellectual Property Rights in and to the Products, and to any and all improvements to
Products developed during the term of this Agreement, whether such improvements are developed by Supplier or by Purchaser, or jointly by the parties. Supplier shall own any and all Intellectual
Property Rights in and to any and all improvements to its manufacturing processes that it develops during the term of this Agreement. Subject to Section 11 of this
Agreement and all of Purchaser's Intellectual Property Rights, Purchaser acknowledges and agrees that: (i) Supplier is in the business of designing, developing, manufacturing, prototyping and
assembling metal and plastic components for specialized medical devices, and that Supplier may develop products, devices, instruments or other items for other persons which are identical or similar in
functionality to the Products; (ii) Supplier, its employees and agents shall be free to use and employ their general skills, know-how, and expertise, and to use, disclose, and
employ any generalized ideas, concepts, know-how, methods, techniques, processes or skills gained or learned during the course of this Agreement; and (iii) Supplier may perform
similar services for third parties using the same personnel that Supplier may utilize for rendering services for Purchaser hereunder. For the purposes of this Agreement, the term
"Intellectual Property" means inventions, works of authorship, improvements, developments, or innovations and other creative works (whether or not patentable or
copyrightable, conceived or made or reduced to practice), know-how, technical information, pending patent applications, registrations, divisions and continuations thereof, registered and
unregistered copyrights, and all associated goodwill, designs, drawings, specifications, manufacturing methods and processes. "Intellectual Property Rights" 

9

 

means
any proprietary rights applicable to any Intellectual Property, including any patent, copyright, trademark, trade secret and similar rights in any jurisdiction throughout the world. 

        10.2 Tooling
and Equipment.    Supplier shall provide tooling that is not specific to the Product at its own expense. Purchaser shall
pay for or obtain and consign to Supplier for its use any Product-specific tooling and other reasonably necessary non-recurring expenses specific to the Product, as such tooling and
expenses are described on Exhibit B (as updated by the parties) or otherwise approved in writing by Purchaser ("Set-Up
Property"). Purchaser shall own title to all Set-Up Property. Supplier shall hold and maintain all Set-Up Property for Purchaser and shall exercise reasonable
care in the use and custody of such property and shall use such property only in performing its obligations under this Agreement. Purchaser will bear responsibility for repair to Set-Up
Property resulting from normal wear and tear. Supplier will bear responsibility for loss of or damage to Set-Up Property resulting from Supplier's negligence. Supplier will mark all
Set-Up Property to clearly identify it as being the property of Purchaser. Supplier shall not grant any security interest, incur any liens or any other encumbrances on said
Set-Up Property. Upon any termination or expiration of this Agreement or upon Purchaser's written request, Supplier will promptly return all Set-Up Property in good and
workable condition, with the exception of normal wear and tear, to a location identified by Purchaser at Purchaser's cost. Supplier agrees that equipment used to manufacture Product shall be
calibrated and traceable to NIST standards, and be validated as appropriate. 

11.    Confidentiality; Press Releases.    

        11.1 Confidentiality.    The
Purchaser and the Supplier will be exchanging Confidential Information (as defined herein) relating to
the Products and their manufacture, and relating to the services provided by Supplier pursuant to Exhibit C, at the inception of and from time to time during the
term of this Agreement and the Purchaser may have access to or observe the Confidential Information of Supplier. For the purposes of this Agreement, "Confidential
Information" means any and all information or proprietary materials (in every form and media) not generally known in the relevant trade or industry made available by either party (in
such case, the "Disclosing Party") to the other (in such case, the "Receiving Party") in connection with the efforts contemplated hereunder
and which may reasonably be understood as confidential, including (i) all Intellectual Property, (ii) existing or contemplated products, services, designs, inventions, technology,
processes, technical data, engineering, techniques, methodologies and concepts and any information related thereto, and (iii) information relating to business plans, sales or marketing methods
and customer lists or requirements. Notwithstanding the foregoing, each party acknowledges that any and all information concerning the other party's
Intellectual Property is confidential and that no further writing designating it as such is necessary. The Receiving Party will maintain the information in confidence using the same standard of care
it uses to maintain its own information in confidence, but in any case, no less than reasonable commercial diligence, and will not use such information for itself or disclose it to others except as
necessary to fulfill its obligations or exercise its rights under this Agreement; provided that the Receiving Party shall not disclose the Disclosing Party's Confidential Information to any employee
or third party unless such employee or third party is under a duty of confidentiality with respect to such information at least as protective as the duty set forth in this section. Such obligation of
confidentiality and non-use shall not apply to information which (i) is known to the Receiving Party prior to the disclosure as demonstrated by documentary evidence, (ii) is
publicly known as of the date of the disclosure, (iii) becomes publicly known after the date of disclosure through no fault of the Receiving Party, (iv) is received from a third party
who has, to the Receiving Party's knowledge, no obligation of confidentiality to the Disclosing Party or (v) is developed independently by the Receiving Party as demonstrated by documentary
evidence. Such obligation of confidentiality and non-use shall survive any expiration or termination of this Agreement. The restrictions on disclosure contained in this
Section 11.1 shall not apply to any information which is required to be disclosed by court rule or governmental law or regulation, provided that the Receiving Party
gives the Disclosing Party prompt 

10

 

notice
of any such requirement and cooperates with the Disclosing Party, at the Disclosing Party's expense, in attempting to limit such disclosure. 

        11.2 Intentionally
Deleted 

        11.3 Publicity.    Unless
required by law, neither party will originate any publicity, news release, or other public announcement,
written or oral, whether to the public, press or otherwise, relating to this Agreement or any amendment hereto or to performance hereunder or the existence of an arrangement between the parties,
without the prior written approval of the other party, such approval not to be unreasonably withheld. 

        11.4 Use
of Names in Promotions.    Neither party shall use the name of the other for advertising or promotional claims without the
prior written consent of the other party. 

        11.5 Damages
Inadequate.    The parties acknowledge that monetary damages may be an inadequate remedy for any breach by a party of its
obligations under Section 10.1 and Sections 11.1 through 11.3 and that the
non-breaching party shall be entitled to seek injunctive relief and specific performance to enforce the breaching party's obligations, in addition to whatever remedies the
non-breaching party may be entitled to. 

        11.6 Return.    Each
party shall return all Confidential Information of the other party in its possession within ten (10) days
after any expiration or termination of this Agreement or otherwise upon the other party's request. 

12.    Term and Termination.    

        12.1 Term;
Renewal.    Unless sooner terminated as provided in Section 12.2 below, this Agreement
shall have a term commencing on the Effective Date and expiring on December 31, 2008, and the term of this Agreement shall be automatically renewed for successive one (1) year terms
thereafter unless one party gives written notice to the other party of non-renewal at least one (1) year prior to the expiration of the then current term. The initial term together
with any renewal terms are the "Term." 

        12.2 Termination.    This
Agreement may be terminated: 

        (a)   upon
written notice by a party to the other party, if the other party becomes subject to a Bankruptcy Event or commits an Event of Default (as defined in
Section 13 below); or 

        (b)   by
written notice from the Purchaser to the Supplier in accordance with Section 5.2. 

        12.3 Effect
of Termination.    Upon any expiration or termination of this Agreement the provisions of
Sections 1, 5.3, 5.4, 5.5, 6,
7, 8, 10, 11, 12.2, and 14
shall survive such termination and expiration. 

13.    Default.    

        13.1 Rights
Upon an Event of Default.    Upon the occurrence of an Event of Default (as defined below) under this Agreement, in
addition to whatever other remedies the non-defaulting party may be entitled to, the non-defaulting party may terminate this Agreement upon written notice to the defaulting
party stating the grounds for such default. The occurrence of any one or more of the following acts, events or occurrences shall constitute an "Event of Default" under
this Agreement: 

        (a)   either
party becomes the subject of a Bankruptcy Event; or 

        (b)   the
Purchaser fails to make undisputed payments of the Purchase Price when due and such failure continues for ninety (90) days; provided that Supplier may suspend
performance under this Agreement in the event Purchaser fails to make undisputed payment of the Purchase Price when due and such failure continue for thirty (30) days; or 

        (c)   either
party breaches any other material provision of this Agreement and fails to remedy such default within sixty (60) days after receipt of written notice
thereof, which notice shall state, with particularity, the grounds for such claimed default. 

11

 

14.    Miscellaneous.    

        14.1 Independent
Contractor Status.    The relationship between the Supplier and the Purchaser established hereby is that of
independent contractors, and nothing contained herein shall be deemed to create a relationship of employer and employee, principal and agent, partners, or otherwise. Neither party shall have any
authority to obligate the other in any respect nor hold itself out as having any such authority. All personnel of the Supplier shall be solely employees of the Supplier and shall not represent
themselves as employees of the Purchaser, and all personnel of the Purchaser shall be solely employees of the Purchaser and shall not represent themselves as employees of the Supplier. 

        14.2 Binding
Effect; Benefits; Assignment.    This Agreement shall inure to the benefit of and be binding upon the parties hereto and
their respective permitted successors and assigns. Nothing contained herein shall give to any other person any benefit or any legal or equitable right, remedy or claim. Any assignment of this
Agreement by either party shall require the prior written consent of the other party which shall not be unreasonably withheld; provided that (i) a change in ownership of a party's stock or
other ownership interest, or of any stock or ownership interest in any entity which, directly or through one or more intermediaries, controls the party, shall not constitute an assignment of this
Agreement or require the other party's consent, and (ii) either party may assign this Agreement to a purchaser of such party's business (whether through a sale of all or substantially all of
such party's assets, merger, consolidation, reorganization, or similar transaction) upon written notice to the other party; provided further that, in each case, if any such change in ownership
interests would result in Supplier being owned or controlled by a Competitor, Purchaser may elect to terminate this Agreement in connection with such change in Supplier's ownership as of the date
specified in Purchaser's notice of termination. Any assignment of this Agreement shall be subject to the assignee agreeing in writing to assume the benefits and obligations of this Agreement. Any
attempt to assign this Agreement in violation of this section shall be null and void. 

        14.3 Entire
Agreement; Amendments.    The parties hereto acknowledge that this Agreement sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and shall not be subject to any change or modification except by the execution of a written instrument signed by the parties
hereto. To the extent of any conflict or inconsistency between this Agreement and any Purchase Order, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. The
parties agree that this Agreement supersedes the June 20, 2003 Agreement and that any claims arising with respect to the Products, regardless of when such Products were purchased by Purchaser,
including warranty claims and claims for indemnification, shall be subject to the terms and conditions of this Agreement and shall not be subject to the terms and conditions of the June 20,
2003 Agreement. 

        14.4 Severability.    In
the event that any provision of this Agreement would be held in any jurisdiction to be invalid, prohibited or
unenforceable for any reason, such provision, as to such jurisdiction, shall be ineffective, without invalidating the remaining provisions of this Agreement or affecting the validity or enforceability
of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it
shall, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this Agreement or affecting the validity or enforceability of such provision in any other
jurisdiction. 

        14.5 Remedies.    Unless
otherwise expressly provided, all remedies hereunder are cumulative, are in addition to any other remedies
provided for by law and may, to the extent permitted by law, be exercised concurrently or separately, and the exercise of any one remedy shall not be deemed to be an election of such remedy or to
preclude the exercise of any other remedy. 

        14.6 Force
Majeure.    The obligations of the Supplier and the Purchaser hereunder (except for the Purchaser's obligations to make
payment in full for Products when due) shall be subject to any delays 

12

 

or
non-performance caused in whole or part by any act of God; extraordinary acts of any government or any agency or subdivision thereof; fire; strikes (excluding strikes by Supplier's
workforce); war; transportation delays affecting the general public; riots or acts of a public enemy; terrorist acts; and similar events; in each case that are not caused by any act or omission of the
affected party and that are beyond the reasonable control of such party. The party which is not performing its obligations under this Agreement as a result of an event of force majeure shall use
diligent efforts to resume compliance with this Agreement as soon as possible. Should the event of force majeure continue unabated for a period of sixty (60) days or more, the parties shall
enter into good faith discussions with a view to alleviating its affects or to agreeing upon such alternative arrangements as may be fair and reasonable having regard to the circumstances prevailing
at that time, provided that Purchaser may at any time after such sixty (60) day period terminate this Agreement, without liability to Supplier,
provided that upon such termination Conceptus shall purchase all completed Product inventory and Product components that exist at the time of termination and that meet the Specifications. For clarity,
Conceptus shall not be obligated to purchase an amount of Products (or components thereof) that exceeds the amount of the Product Purchase Requirement. 

        14.7 Notices.    Any
notice, request, consent or communication (collectively, a "Notice") under this Agreement shall be effective if
it is in writing and (i) personally delivered, (ii) sent by certified or registered mail, postage prepaid, return receipt requested, (iii) sent by an internationally recognized
overnight delivery service, with delivery confirmed, or (iv) telexed or telecopied, with receipt confirmed, addressed as set forth in this Section or to such address as shall be furnished by
either party hereto to the other party hereto. A Notice shall be deemed to have been given as of (i) the date when personally delivered, (ii) when received if delivered by the United
States Postal Service, certified or registered mail, properly addressed, return receipt requested, postage prepaid, or by overnight delivery service, or (iii) immediately, upon confirmation of
receipt of the telex or telecopy, as the case may be. All Notices shall specifically state: the provision (or provisions) of this Agreement with respect to which such Notice is given and shall be
addressed as follows: 

	If to the Supplier to:	 	If to the Purchaser to:
	

Accellent Corp.

100 Fordham Road

Building C

Wilmington, MA 01887

ATTN: Executive VP Sales & Marketing	
 	

Conceptus, Inc.

1021 Howard Avenue

San Carlos, CA 94070
	

with a copy to:	
 	

with a copy to:
	

Christine Mikail, Esq.

Reed Smith LLP

136 Main Street, Suite 250

Princeton Forrestal Village

Princeton, NJ 08540	
 	

J.D. Marple, Esq.

Latham & Watkins LLP

135 Commonwealth Drive

Menlo Park, CA 94025

        14.8 Waivers.    The
failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of
this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party. 

        14.9 Counterparts.    This
Agreement may be executed in any number of counterparts, and execution by each of the parties of any one of
such counterparts will constitute due execution of this Agreement. Each such counterpart hereof shall be deemed to be an original instrument, and all such counterparts together shall constitute but
one agreement. 

13

 

        14.10 Headings.    The
article and section headings contained in this Agreement are for reference purposes only and shall not affect
in any way the meaning or interpretation of this Agreement. 

        14.11 Governing
Law; Dispute Resolution.    This Agreement shall be construed, governed, interpreted and applied in accordance with
the laws of the State of Delaware, without regard to the conflict of law principles of such State. Any controversy or claim arising out of or relating to this Agreement or the validity, inducement, or
breach thereof (each such controversy or claim is hereinafter referred to as a "Dispute"), shall be settled as follows: 

        (a)   Officers
at or above the Vice President level of each party shall attempt to resolve any Dispute prior to commencing the procedures set forth in below. 

        (b)   If
after 14 calendar days the officers are unable to resolve the Dispute, the Chief Executive Officer and/or the highest ranking officer of each party shall
submit to non-binding mediation which shall take place for a period of one day in San Carlos, CA before a mediator that is knowledgeable about the subject matter of the Dispute and that is
mutually acceptable to the parties. If the parties are unable to agree on the selection of a mediator, a mediator will be chosen by an arbitrator selected pursuant to the rules of the American
Arbitration Association (AAA) who will then select such mediator from a list of distinguished neutral mediators maintained by the AAA. The mediator shall confer with the parties to design procedures
to conclude the mediation within no more than 30 days after initiation. Under no circumstances shall the commencement of arbitration under paragraph (c) below be delayed more than
30 days from the initial notice of a Dispute by the mediation process specified in this paragraph (b). Each party has the right to pursue any provisional relief from the appropriate
court, such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the mediation or arbitration, even though
mediation or arbitration has not been commenced or completed. Disputes with respect to a party's obligations or rights under Section 10 or
Section 11 shall not be subject to this Section 14. 

        (c)   If
during such one-day mediation the parties are unable to resolve the Dispute, the Dispute shall be settled by arbitration before a single arbitrator in
accordance with the Commercial Arbitration Rules of the AAA then pertaining, except where those rules conflict with this Section 14.11, in which case this
Section 14.11 controls. The parties hereby consent to the jurisdiction of the Federal District Court in San Francisco, CA and the state courts of California for the
enforcement of these provisions and the entry of judgment on any award rendered hereunder. Should such court for any reason lack jurisdiction, any court with jurisdiction shall enforce this clause and
enter judgment on any award. The arbitrator shall be an attorney specializing in business litigation who has at least 15 years of experience with a law firm or corporation of over 25 lawyers or
was a judge of a court of general jurisdiction. The arbitration shall be held in San Carlos, CA and the arbitrator shall apply the substantive law of Delaware, except that the interpretation and
enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. Within 30 days of initiation of arbitration, the parties shall reach agreement upon and thereafter
follow procedures assuring that the arbitration will be concluded and the award rendered within no more than three (3) months from selection of the arbitrator. Failing such agreement, the AAA
will design and the parties will follow such procedures. Consistent with the limitations on liability provided in Section 6.3, the parties agree neither to request
or seek to enforce any punitive, exemplary or consequential damages from the arbitrator and the arbitrator shall not be empowered to grant any such damages. The arbitrator shall issue written findings
of fact and conclusions of law. 

        (d)   The
arbitrator shall be bound by the express terms of this Agreement and may not amend or modify such terms in any matter. Any award rendered by the arbitrator shall be
binding on the parties and shall be consistent with the terms of this Agreement, and such terms shall control the 

14

 

rights
and obligations of the parties. The proceedings shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard both parties' confidential information. The fees
of the arbitrator shall be split equally between the parties, unless the arbitrator determines that either party's positions in the dispute were frivolous or based in bad faith, in which case such
party shall pay the entire arbitrator's fee. 

        IN
WITNESS WHEREOF, duly authorized representatives of the parties hereto have duly executed this Supply Agreement as of the date first above written. 

	SUPPLIER	 	PURCHASER
	

Accellent Corp.	
 	

Conceptus, Inc.
	

By:	

/s/  GARY D. CURTIS      
	
 	

By:	

/s/  GREGORY E. LICHTWARDT      

	

Name:	

Gary D. Curtis
	
 	

Name:	

Gregory E. Lichtwardt

	

Title:	

Ex VP Sales & Marketing
	
 	

Title:	

Executive Vice President

	

Date:	

November 7, 2005
	
 	

Date:	

November 4, 2005

	

 	

 	
 	

 	

 

15

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

EXHIBIT A
  
  PRODUCTS    
    

ESS-205—Essure
System Catheter, Snap Fit Kit with E2091 included. 

SSI001-M5—Split
Introducer 5-Pack Kit. 

ESS-305—Essure
System Catheter, Snap Fit Kit with E2091 included. 

16

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
  EXHIBIT B
  
  PRODUCT PRICES    
    

	

	Part Name
	Part Number
	Product

Quantity
	Unit Price
	 	Note

	

	 	 	 	$[***] Per Product	 	Pricing is valid for shipments from November 1, 2005 - December 31, 2005
	 	 	

	ESSURE Device	ESS205	0 - 49,999
50,000 - 74,999
 75,000+	$[***] Per Product
$[***] Per Product
 $[***] Per Product	 	This pricing schedule is valid for shipments beginning January 1, 2006. Prices will change throughout the year based on the number of Products shipped.
	

	Split Introducer

5-Pack	SSI-001-M5	240 5-Packs

(minimum order)	$[***] Per 5-Pack	 	 
	

	 	 	 	 	 	 
	 	 	 	 	 	 
	

	Part Name
	Part Number
	Product

Quantity
	Unit Price
	 	Note

	

	

ESSURE Device	
ESS305	0 - 49,999
50,000 - 74,999
 75,000+	$[***] Per Product
$[***] Per Product
 $[***] Per Product	 	This pricing schedule is valid for all ESS305 Products shipped. Prices will change throughout the year based on the number of Products shipped.
	

General Notes:  

        1.     This
quotation is effective with all shipments made after November 1, 2005. On January 1, 2006 and every January 1 thereafter, the Product quantity
for purposes of determining the volume discounts will be set at zero. Pricing will then be adjusted per the above schedule during that calendar year. 

        2.     Each
Essure kit contains two split introducers (P/N E2091) and these are included in the unit price. One of the new pallet configurations resulting from the new packaging
calls for an additional 240 5-packs of the split introducers. The costs for these additional split introducers are not included in the unit price, and they will be billed separately. 

        3.     The
Products will be produced in Supplier's Juarez Mexico facility. 

        4.     The
parties expect that Supplier will begin shipping ESS305 Products promptly after FDA approval. 

        5.     The
Unit Price for the Products may be adjusted in accordance with Section 3.1 of the Agreement. In addition, the Unit Price for the
ESS305 Essure device may be adjusted to the extent that any of the assumptions listed under "Key Assumptions" prove to be inaccurate during the period Supplier is providing services under
Exhibit C and such inaccuracy causes Supplier's cost to manufacture the ESS305 Essure device to increase. 

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

17

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

EXHIBIT C
  
  ENGINEERING SERVICES    
    

 
 

Table of Contents    
    

	Executive Summary	 	19
	

Key Assumptions	
 	

20
	

Cost Estimate for the Project	
 	

21
	

Unit Price Estimates	
 	

21
	

Transfer Team	
 	

22
	

Payment Terms and Execution	
 	

23
	

Supplier Capabitities	
 	

24
	

Appendix I: Engineering Services Terms and Conditions	
 	

25
	

Appendix II: Conceptus Supplied Costed BOM	
 	

27
	

Appendix III: Preliminary Project Gantt	
 	

 

18

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Executive Summary    
    

	

	Project Scope	 	[***]
	

	Key Purchaser Requirements	 	•

•	A clean room environment (controlled or Class 100,000) is required

[***]
	

	Timeline & NRE Price Estimate	 	[***]
	

	Customer Deliverables	 	In order to ensure program success, Supplier requires the following Purchaser Deliverables prior to the project start:
	

 	
 	

•	

Complete Electronic Copies of all Drawings, Specifications and Work Instructions.
	 	 	•	Supply Chain information, including contact information and quotations reflecting the prices included in the BOM provided by Purchaser.
	

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

19

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Key Assumptions    
    

        In preparing this proposal for Purchaser, Supplier has made the following assumptions: 

	•
	All
material costs and assembly times have been provided by Purchaser. The costed BOM date is 8/3/05.

	•
	Supplier
has not included any costs for biocompatibility, transit or age testing in this proposal. These costs will be the responsibility of Purchaser, if required, and will
be agreed to as a Change of Scope to this project.

	•
	Purchaser
is responsible for defining product inputs and is ultimately responsible for assessing clinical efficacy; Supplier will work closely with Purchaser to transfer the
product design into a production process.

	•
	Supplier
has implemented a phased approach to transferring product lines into our manufacturing facilities. This phased approach will ensure that the product line being
transferred is complete, efficient, meets the proposed schedule, and meets all of Purchaser's quality expectations. The planning and attention to detail are critical to ensuring that product line
tribal knowledge is not lost when transferred.

	•
	Supplier
understands that the product line is not mature and that Purchaser has an updated product specification for the product line, updated product line validation
protocol (OQ & PQ), and an up-to-date product line verification protocol.

	•
	Supplier
assumes that Purchaser has available to Supplier, updated detail parts drawings, a complete Bill of Materials for the product line, including complete supply chain
information, and complete product line routings/assembly procedures. The timeline and project cost estimated in this proposal are contingent upon the timely receipt of documentation, drawings, supply
chain information and their completeness.

	•
	Supplier
assumes that Purchaser has complete IQ type protocols for all equipment, and updated FMEAs & PFMEAs for the product line, which are available for review by
Supplier personnel upon request.

	•
	Supplier
assumes that Purchaser will provide a reasonable amount of training support for Supplier personnel on the current assembly line, located at the existing assembly
facility, for an agreed upon period of time, as well as providing a reasonable amount of skilled labor necessary to assist Supplier complete the transfer to Supplier's facility. Purchaser will be
responsible for the travel and compensation for these Purchaser resources.

	•
	Supplier
assumes that Purchaser will transfer all existing equipment and fixturing used for production to Supplier; no equipment design or procurement provisions are
included in the scope of this proposal. Capital equipment specific to the product line are to be supplied by Purchaser; custom fixturing will be supplied by and/or paid for directly by Purchaser, and
will include all design documentation and preventive maintenance procedures.

	•
	Force
majeure events (as described in Section 14.6 of the Agreement) may affect the timeline and schedule provided.

	•
	Supplier
will work with Purchaser prior to the project start to align the Supplier transfer plan with the Purchaser transfer plan.

	•
	Purchaser
is responsible for ensuring Purchaser-supplied materials meet incoming inspection requirements and comply with quality requirements per the drawings.

	•
	Additional
Terms & Conditions that apply to this proposal are located in Appendix I. 

20

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Cost Estimate for the Project    
    

	

	 
	 	Engineering

Labor
	 	Travel

Estimate
	 	Materials
	 	Totals

	

	Total Timeline:

16-20 Weeks	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

        The
Engineering Labor estimate is broken down into the following components and timing: 

	

	 
	 	Project

Management
	 	Engineering
	 	Quality
	 	Total

	

	Month 1	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

	Month 2	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

	Month 3	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

	Month 4	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

	Total	 	$[***]	 	$[***]	 	$[***]	 	$[***]
	

        In
addition, it is our expectation and estimate that we will require the following quantities of components for IQ/OQ/PQ and training activities: 

	 
	 	Training
	 	Validation

	Inner/Outer Coil Subassembly	 	500	 	200
	Inner Catheter Assembly	 	1,000	 	500
	Delivery Catheter Assembly	 	200	 	100
	Final Device	 	200	 	200

        The
estimated costs of all materials involved will be $[***] and will cover the training of all operators involved in volume production of this product. The
actual number of units required for validation will be agreed to by both Purchaser and Supplier and will affect the material costs. Supplier proposes to invoice Purchaser the actual costs of the
training components required to successfully transfer the production line and provide validated assemblies. 

        All
finished assemblies that are considered saleable product will be invoiced at the agreed upon contract price between our organizations. 

        This
is a good faith estimate based on managing projects of similar scope and complexity. If unanticipated contingencies or changes in project scope potentially cause the estimate to be
exceeded, Purchaser's written authorization will be required prior to incurring expenses beyond this estimate. Travel Expenses are estimated and will be billed at cost, as incurred. 

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

21

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Transfer Team    
    

        Supplier has assembled the following Juarez team members to participate in the transition of the assembly process from Purchaser to Supplier's Juarez MX facility: 

	Core Team
	[***] - Team Leader/Senior Engineer
	[***] - Engineer
	[***] - Engineer
	[***] - Quality Engineer
	[***] - Engineer, Documentation
	[***] - CAD Operator
	

Management Support
	[***] - Business Unit Manager
	[***] - Engineering Manager

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

22

 
CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

Payment Terms  

To
initiate this proposed project, Supplier requires an authorization of $[***] for Engineering Services and related expenses, which may include tooling, travel, materials,
outside services and other items allocated to this project. A deposit of $[***], which will be credited against final invoices, is also required prior to the project start. 

Prior
to the end of each phase of the project, Supplier will provide Purchaser with an updated cost estimate for the following phase. A purchase order will then be required to continue into the next
phase of this project. 

Invoices
will be sent monthly on a Time & Materials basis; a final invoice for final expenses will be sent upon completion of this work. Each Supplier invoice shall contain a detailed
description of the time spent by personnel working on the project, the billable rate for such personnel, and the tasks performed by such personnel during such time. 

Payment
Terms are Net 30; past due invoices will incur interest charges at the rate of 10% per annum. 

Terms &
Conditions related to Supplier's Engineering Services is provided in Appendix I of this proposal and shall have full force and effect over the
content of this proposal. 

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

23

 
CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Supplier Capabilities    
    

Supplier
has established a clear leader in the field of medical device outsourcing. We have 3,500 employees and focus the breadth of our expertise on: 

	•
	Increased
speed to market

	•
	Lower
total delivered cost

	•
	Continuous
improvement 

Supplier
provides complete design to assembly services of custom precision components and completed devices on a global basis. We have manufacturing facilities in the United States, Mexico and Europe.
Our Integrated OutsourcingSM model provides supply chain management to companies looking to bring new products to market quickly and cost-effectively. 

The
comprehensive scope of our services includes product development, functional design and analysis, complete project management, thin wall plastic and metal tubing, precision machining, metal
stamping and wire forming, metal and plastic injection molding, grinding and coiling, laser processing, radiopaque markers, assembly, packaging, labeling, contract sterilization and order fulfillment.
Supplier has the capability to accommodate a product anywhere in its lifecycle—from rapid prototyping of early designs to pilot production, to large scale, off-shore
manufacturing in a QSR-compliant operation. Our product experience is very broad within the three core market segments we serve; endoscopy, cardiology and orthopaedics. 

The
Engineering Services group in our Boston Technical Center numbers more than 35 professionals with backgrounds in mechanical engineering, material science, manufacturing and quality engineering and
project management. Dedicated teams handle your project from initiation through validation ensuring a seamless transition from design to manufacturing. Our Project Manager is accountable to you until
the successful transition of the project to production manufacturing. 

Supplier
is ISO 9001 and ISO 13485 certified and registered with the FDA and is committed to continuous improvement of its business processes. Additional information can be found on our web site,
www.accellent.com. 

Integrated
Outsourcing is a service mark of Accellent, Inc. 

24

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Appendix I: Engineering Services Terms and Conditions    
    

The
terms and conditions set forth in the main body of the Agreement apply to the information exchanged by the parties and the services provided in connection with this
Exhibit C except in the event of a conflict between such terms and conditions and the terms and conditions set forth below, in which case the terms and conditions
set forth below shall govern to the extent of such conflict. 

Services.    "Services" means all work performed by Supplier as detailed in this Exhibit C. 

Responsibilities for Accepted Services.  

Supplier.    With
respect to any Services accepted by Purchaser, Supplier shall be responsible for its warranty and indemnity obligations as provided below. 

Purchaser.    Subject
to Supplier's warranty and indemnity obligations below, upon acceptance by Purchaser of any Services, (i) Purchaser shall be fully
and solely responsible for the design and validation of the Products and (ii) Supplier shall work closely with Purchaser to translate design inputs
into measurable specifications; however, Purchaser is responsible for defining product inputs and is solely responsible for assessing clinical efficacy. 

Warranty  

Supplier
Warranty.    Supplier warrants that the Services hereunder shall be performed in accordance with the transfer plan agreed by the parties in writing and
in a manner consistent with prevailing industry standards. If any Services do not conform to this warranty, Supplier shall be obligated, as Purchaser's sole remedy (provided that this section does not
limit in any manner Purchaser's ability to recover under Supplier's indemnity set forth below), to make commercially reasonable efforts to bring the non-conforming Services into
conformance at Supplier's expense. 

THE
WARRANTY EXPRESSLY STATED ABOVE IS THE ONLY WARRANTY APPLICABLE TO THE SERVICES. SUPPLIER MAKES NO REPRESENTATION OR WARRANTY IN THIS EXHIBIT C TO PURCHASER CONCERNING ANY PRODUCTS CONTEMPLATED BY
ANY SERVICES, INCLUDING TITLE TO ANY INTELLECTUAL PROPERTY INVOLVED IN THE DESIGN OR MANUFACTURE OF SUCH PRODUCTS, THE PERFORMANCE OF ANY SUCH PRODUCTS, OR THEIR SAFETY OR THEIR FUNCTIONALITY. ALL
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE SERVICES ARE DISCLAIMED. NEITHER PARTY SHALL BE LIABLE UNDER
THIS EXHIBIT C FOR ANY PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, PERSONAL INJURY AND PROPERTY DAMAGE, EQUIPMENT DAMAGE, LOSS OF PROFITS OR REVENUES OR
BUSINESS, COST OF CAPITAL, COST OF PURCHASE, COST OF RECALL (WITHOUT LIMITING SUPPLIER'S OBLIGATIONS UNDER SECTION 6.4 OF THE AGREEMENT), OR COST OF REPLACEMENT GOODS. EXCEPT WITH RESPECT TO
SUPPLIER'S INDEMNIFICATION OBLIGATIONS BELOW, EACH PARTY'S AGGREGATE LIABILITY UNDER THIS EXHIBIT C, WHETHER BASED UPON CONTRACT, TORT, OR OTHERWISE,
SHALL NOT EXCEED THE ACTUAL AMOUNTS PAID BY PURCHASER FOR THE SERVICES PROVIDED UNDER THIS PROPOSAL DURING THE IMMEDIATELY PRECEDING TWELVE (12) MONTH PERIOD FROM WHEN THE CLAIM FOR LIABILITY
AROSE. 

25

 

Indemnities  

Supplier
agrees to defend and indemnify and hold Purchaser and its officers, directors, employees, and agents harmless against any and all claims, suits, proceedings, expenses, recoveries, and
damages, including court costs and reasonable attorneys fees and expenses, by third parties against Purchaser to the extent they arise out of, are based on, or are caused by Supplier's negligence in
the performance of Services. Purchaser will promptly notify the Supplier of any such claim or demand which comes to its attention. The indemnification procedures contained in
Section 7.3 of the Agreement shall apply to this indemnity. 

26

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

Appendix II: Purchaser Supplied Costed BOM    
    

[***]

	[***]
	Confidential
information in this Exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to
the omitted portions. 

27

  

CONFIDENTIAL

CERTAIN INFORMATION HAS BEEN REDACTED

CONFIDENTIAL TREATMENT REQUESTED  

 
 

EXHIBIT D
  
  QUALITY ASSURANCE PROCEDURES    
    

Supplier
shall manufacture Products per the requirements specified in the Purchase Orders, the Specifications, the Agreement, and any inspection and process control criteria provided by Purchaser to
Supplier. 

Supplier
shall obtain Purchaser's written approval of all materials, processes, methods, and equipment used to manufacture Products, and shall not deviate from such use without Purchaser's prior
written approval. 

Supplier's
manufacturing processes shall at all times conform to the current good manufacturing practices of the Regulatory Authority, as well as all other regulatory requirements and guidelines of
the Regulatory Authority. Supplier shall maintain an FDA site registration number during the term of the Agreement. 

Without
limiting Supplier's other obligations under the Agreement, Supplier shall perform the following functions in connection with its manufacture of the Products:

         1.     Supplier shall ensure component and material traceability for Products by establishing and maintaining documented procedures
for identifying
materials from receipt through all stages of production and delivery. 

         2.     Supplier shall ensure that production processes are carried out under controlled conditions that include: 

	•
	Documented
procedures defining the manner of production,

	•
	Use
of production equipment and a controlled working environment that meet or exceed industry standards,

	•
	Compliance
with the Food and Drug Administration ("FDA") Quality System Regulations and all applicable international Quality Management System Standards,

	•
	Monitoring
and control of process parameters and Product characteristics,

	•
	Approval
of all processes and equipment prior to use,

	•
	Assignment
of only trained, qualified personnel to perform manufacturing operations,

	•
	Specification
of workmanship criteria that meet or exceed industry standards, which criteria shall be specified and communicated to workers clearly (e.g. written standards,
representative samples, or illustrations),

	•
	Maintenance
of equipment in a manner that meets or exceeds industry standards and ensures continuing process capability.

	•
	The
inspection and test status of materials shall be clearly identified, which status shall indicate the conformance or non-conformance of materials with regard
to inspections and tests performed. Records of the identification of inspection and test status shall be maintained as defined in documented procedures and the Agreement. 

28

 

         3.     Supplier shall establish and maintain documented procedures for inspection and testing activities in order to verify that the
specified
requirements for the materials are met. The required inspection and testing, and the records to be established, shall be detailed in a quality plan or documented procedures. 

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

         5.     Supplier shall inspect and test the Products as required by the Quality Requirements Specification and documented procedures.

        6.     Supplier shall not ship completed Products until the required inspection and tests have been completed or necessary reports
have been received and
verified. 

         7.     Supplier shall carry out all final inspection and testing in accordance with the Quality Requirements Specification and
documented procedures to
complete the evidence of conformance of the finished materials to the Specifications and other requirements. 

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

         9.     No Products shall be shipped to Purchaser until all the activities specified in this Exhibit C and the documented
procedures have been
satisfactorily completed and the associated data and documentation are available and have been reviewed for compliance with the Specifications and other requirements and authorized. 

        10.   Supplier shall establish and maintain records that provide evidence that the Product has been inspected and tested. These records shall
clearly
identify whether a Product has passed or failed the inspections and tests according to defined acceptance criteria. Where the Product fails to pass any inspection or test, the procedure for control of
non-conforming Product shall apply. The responsibility for release of Products for shipment shall be identified and recorded. 

         11.   Supplier shall establish and maintain documented procedures to control, calibrate, and maintain inspection, measuring and test equipment
used by
Supplier's subcontractors (which subcontractors must be approved in writing by Purchaser prior to their use by Supplier) to demonstrate the conformance of Products or Product components to the
specified requirements. Inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement
capability. 

         12.   Supplier shall specify, subject to Purchaser's approval, the measurements to be made and the accuracy required with respect to
inspections and
testing and shall select, subject to Purchaser's approval, the appropriate inspections and tests. Supplier shall ensure that all measuring and test equipment is capable of the necessary accuracy and
precision. Supplier shall also calibrate all inspection, measuring and test equipment at prescribed intervals as necessary to ensure such equipment can accurately and correctly inspect, measure and
test Products and Product components. 

         13.   Supplier shall establish and maintain documented procedures to ensure that Products that do not conform to specified requirements,
including the
Specifications, are not shipped to Purchaser. This procedure shall provide for identification, documentation, evaluation, segregation, disposition of non-conforming Product, and for
notification of Purchaser with respect to such Products. The responsibility for review and authority for the disposition of non-conforming Product shall be defined in 

29

 

the
Procedures. Non-conforming Products may be disposed of in accordance with the following procedures: 

	•
	They
may be, upon Purchaser's prior written approval, (a) reworked to meet specified requirements, including the Specifications, (b) accepted with or without
report by concession, (c) regarded for alternative applications (e.g., DEMO), or (d) scrapped.

	•
	Reworked
Products shall be re-inspected to original Specifications and in accordance with the documented procedures. 

        14.   Supplier shall adhere to requirements of Purchaser's Corrective and Preventive Action Program (CAPA) of identified non-conformances
affecting Product and/or processes under control of Supplier. 

         15.   All procedures, processes, and functions described above in this Exhibit C (collectively, "Processes") shall be subject to
Purchaser's
review and approval. Upon Purchaser's request, Supplier shall make available or demonstrate at Supplier's facilities any or all Processes to Purchaser. In the event Purchaser discovers a deficiency in
a Process, Supplier shall provide Purchaser with a plan within five (5) days after Purchaser's notice of the deficiency to Supplier, and Supplier shall remedy such deficiency within fifteen
(15) days after Purchaser's approval of such plan, unless another time period is agreed by the parties. 

         16.   Supplier shall provide Purchaser access to the following in connection with Purchaser's review of the Processes: 

	•
	Manufacturing
Process

	•
	Inspection
Procedures

	•
	Traceability
Records

	•
	Test/Inspection
Records

	•
	Calibration
Records

	•
	Non-Conformance
Records 

         17.   Supplier shall provide the required certifications with all Products and services stating conformance to all applicable specifications
and
standards, including the Specifications. 

30

QuickLinks

Exhibit 10.34

SUPPLY AGREEMENT

EXHIBIT A PRODUCTS

EXHIBIT B PRODUCT PRICES

EXHIBIT C ENGINEERING SERVICES

Table of Contents

Executive Summary

Key Assumptions

Cost Estimate for the Project

Transfer Team

Supplier Capabilities

Appendix I: Engineering Services Terms and Conditions

Appendix II: Purchaser Supplied Costed BOM

EXHIBIT D QUALITY ASSURANCE PROCEDURES

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00099-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00099-of-00352.parquet"}]]