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Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Manufacturing Inc. dated October 18, 2004 (the "Agreement")

Supply Agreement

Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Manufacturing Inc. dated October 18, 2004 (the You are currently viewing:
This Supply Agreement involves

ALPHATEC HOLDINGS, INC. | Invibio Inc

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Title: Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Manufacturing Inc. dated October 18, 2004 (the "Agreement")
Governing Law: Colorado     Date: 4/20/2006
Industry: Medical Equipment and Supplies    

Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Manufacturing Inc. dated October 18, 2004 (the
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Exhibit 10.29

 

 

Invibio
biomaterial solutions

13 December 2004

 

 

 

 

Building III

 

 

Calendon Wood Professional Park

[***]

 

3 Calendon Court

Alphatec Manufacturing Inc

 

Greenville

6110 Corte Del Cedro

 

SC29615

Carlsbad

 

 

CA 92009

 

 

USA

 

 

Dear [***]

         Letter of Amendment in respect of Supply Agreement between Invibio Inc. and Alphatec Manufacturing Inc. dated October 18, 2004 (the "Agreement")

        Following discussions, we are writing to confirm that pursuant to section 4.1 of the Agreement, we have agreed to make the following amendments to the Agreement.

1.

Supplier agrees to supply and Buyer agrees to purchase the following additional grades of rod stock LT1R25 at a price of $[***] per meter, LT1R30 at a price of $[***] per meter and LT1R40 at a price of $[***] per meter. For the first order only Buyer may order a minimum of 1 meter for all grades, any subsequent orders shall be for not less than a minimum of 4 meters for LT1R25, 3 meters for LT1R30 and 1 meter for LT1R40, in accordance with the terms and conditions as set out in the Agreement.

2.

Exhibit 2 of the Agreement shall be amended to incorporate the Supply Manufacturing Definitions for the 25mm diameter rod stock (LT1R25) the 30mm diameter rod stock (LT1R30) and the 40mm diameter rod stock (LT1R40), as per the attached Supply Manufacturing Definitions.

        Except as expressly provided in this letter of amendment, all other terms, conditions, and provisions of the Agreement shall continue in full force and effect as provided therein.

        This letter shall be governed by and construed in accordance with the laws of the state of Colorado without regard to the conflict of law provisions thereof.

        IN WITNESS WHEREOF, the parties have confirmed their acceptance of the contents of this letter.

 


 

 

[***]


 

For and on behalf of Invibio, Inc.

 

For and on behalf of Alphatec Manufacturing Inc.


 


 


 


12-14-04


 

Date

 

Date

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.


PEEK-OPTIMA®

 

GRADE: PEEK-OPTIMA LT1R25

SPECIFICATION

 

Page 1 of 1

MANUAL

 

Revision 3

ISSUE 1

 

Date: 17th Spetember 2001

Supply Manufacturing Definition

PEEK-OPTIMA LT1 Extruded Rod.
Grade LT1R25
Diameter 25mm +0.2mm/+1.2mm

Sampling and testing:

        The tests shown below shall be performed by supplier on material taken from the start and end of each production batch. The batch shall meet the requirements of this Supply Manufacturing Definition when the results of these tests agree with the values shown below.

Property


 

 

Test Method


 

 

Units


 

 

Value


 

Tensile strength (at Yield)

 

[***]

 

[***]

 

[***]

Tensile Elongation

 

[***]

 

[***]

 

[***]

Flexural strength

 

[***]

 

[***]

 

[***]

Flexural modulus

 

[***]

 

[***]

 

[***]

Notched impact strength

 

[***]

 

[***]

 

[***]

Density

 

[***]

 

[***]

 

[***]

DSC
T g (Onset)
T c (Recrystallistion)
T m (Melt)

 


[***]

 


[***]

 


[***]

Notes:

[***]

[***]

 

Date: 17 th September 2001

Quality Assurance and Laboratory Manager.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

1


PEEK-OPTIMA LT1 Extruded Rod.
Grade LT1R30
Diameter 30mm +0.2mm/+1.2mm

Sampling and testing:

        The tests shown below shall be performed by supplier on material taken from the start and end of each production batch. The batch shall meet the requirements of this Supply Manufacturing Definition when the results of these tests agree with the values shown below.

Property


 

 

Test Method


 

 

Units


 

 

Value


 

Tensile strength (at Yield)

 

[***]

 

[***]

 

[***]

Tensile Elongation

 

[***]

 

[***]

 

[***]

Flexural strength

 

[***]

 

[***]

 

[***]

Flexural modulus

 

[***]

 

[***]

 

[***]

Notched impact strength

 

[***]

 

[***]

 

[***]

Density

 

[***]

 

[***]

 

[***]

DSC
T g (Onset)
T c (Recrystallistion)
T m (Melt)

 


[***]

 


[***]

 


[***]

Notes:

[***]

[***]

 

Date: 17 th September 2001

Quality Assurance and Laboratory Manager.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

2


PEEK-OPTIMA LT1 Extruded Rod.
Grade LT1R40
Diameter 40mm +0.2mm/+1.2mm

Sampling and testing:

        The tests shown below shall be performed by supplier on material taken from the start and end of each production batch. The batch shall meet the requirements of this Supply Manufacturing Definition when the results of these tests agree with the values shown below.

Property


 

 

Test Method


 

 

Units


 

 

Value


 

Tensile strength (at Yield)

 

[***]

 

[***]

 

[***]

Tensile Elongation

 

[***]

 

[***]

 

[***]

Flexural strength

 

[***]

 

[***]

 

[***]

Flexural modulus

 

[***]

 

[***]

 

[***]

Notched impact strength

 

[***]

 

[***]

 

[***]

Density

 

[***]

 

[***]

 

[***]

DSC
T g (Onset)
T c (Recrystallistion)
T m (Melt)

 


[***]

 


[***]

 


[***]

Notes:

[***]

[***]

 

Date: 17 th September 2001

Quality Assurance and Laboratory Manager.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

3


        THIS AGREEMENT is entered into as of 10-18-04 (the " Effective Date "), by and between Invibio, Inc., a Delaware corporation with offices at 3A Caledon Court, Greenville, South Carolina 29615 (" Supplier "), and Alphatec [please complete corporate details                        , a California corporation with offices at 6110 CORETE DEL CEDRO, CARLSBAD, CA 92009 (" Buyer ").

        WHEREAS, Supplier is engaged in the manufacture and sale of Materials (as defined below).

        WHEREAS, Buyer wishes to purchase Materials from Supplier and Supplier is willing to supply Buyer with Materials, both on the terms and conditions set out in this Agreement.

        NOW THEREFORE, in consideration of the foregoing and the mutual promises set forth below and other good and valid consideration, the sufficiency of which is acknowledged by the parties, Supplier and Buyer agree as follows:

1.1    Definitions

" Acting in Concert " shall mean acting or co-operating pursuant to an agreement or understanding (whether formal or informal);

" Affiliate " of a party shall mean (a) its subsidiaries (as defined below), any Parent (as defined below) of a party and any other Subsidiaries of any such Parent, or (b) any partnership, joint venture or other entity directly or indirectly controlled by, controlling, or under common control with such party, but in each case only for so long as such ownership or control shall continue. Reference in this Agreement to "Buyer" shall encompass all Affiliates of Buyer;

" Agreement " shall mean this Agreement, as it may be amended from time to time as permitted herein;

" Biomaterials " shall mean Supplier's polyaryletherketone resin-based raw material;

" Buyer Products " shall mean all Buyers human implantable devices which comprise polyaryletherketone; all Buyer Products shall be further described in Exhibit A, as amended from time to time;

" Confidential Information " shall mean all confidential information disclosed (whether in writing, orally or by another means and whether directly or indirectly) by a party (the " Disclosing Party ") to the other party (the " Receiving Party ") whether before or after the date of this Agreement including, without limitation, information relating to the financial arrangements set out in this Agreement, the Disclosing Party's products, operations, processes, plans or intentions, product information, know-how, design rights, trade secrets, market opportunities and business affairs;

" Group " shall mean Supplier, its Subsidiaries (as defined below), any Parent (as defined below) of Supplier and any other Subsidiaries of any such Parent;

" Materials " shall mean those polyaryletherketone materials supplied by Supplier to Buyer under the terms of this Agreement, either as Biomaterials or as Stock Shape;

" Parent " of a party shall mean a company which owns or controls in excess of 50% of such party's issued and outstanding voting capital stock, or otherwise has the power to control such party's general activities;

" Specifications " shall mean the specifications for the Biomaterials set forth in Exhibit B. Such specifications may be changed, modified, amended or supplemented from time to time by agreement;

Confidential

         Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

1


        " Standard Conditions " shall mean Supplier's standard conditions of sale set out in Exhibit D;

        " Stock Shape " shall mean extruded rod stock composed of Biomaterials that have been melt processed so as to conform with the Supply Manufacturing Definition;

        " Subsidiary " of a party shall mean a company in respect of which such party owns or controls in excess of 50% of the issued and outstanding voting capital stock, or otherwise has the power to control such company's general activities;

        " Supply Manufacturing Definition " shall mean the dimensional, mechanical and physical properties of the Stock Shape, as set forth in Exhibit C. Such Supply Manufacturing Definition may be changed or modified, amended or supplemented from time to time by Supplier upon giving not less than three months notice to Buyer;

        " Year " shall mean each successive period of 12 months commencing on the Effective Date.

1.1    Interpretation.

        In this Agreement, unless the context requires otherwise, a reference to:

        (a)   an agreement (including this Agreement) is to such agreement as amended, supplemented or novated from time to time and includes a reference to any document which amends, supplements or novates the relevant agreement;

        (b)   any statute or statutory provisions shall be construed as a reference to the same as it may have been, or may from time to time be, amended, modified or re-enacted; and

        (c)   Sections and Exhibits is a reference to a section of, or exhibit to, this Agreement.

1.3    Exhibits.

        The Exhibits form part of this Agreement and shall have the same force and effect as if expressly set out in the body of this Agreement, and any reference to this Agreement shall include the Exhibits.

1.4    Captions.

        The captions in this Agreement are for convenience only and do not affect its interpretation.

2.      SUPPLY OF MATERIALS

         2.1    Supply . Buyer shall purchase from Supplier and Supplier shall sell to Buyer Materials pursuant to an order placed by Buyer with Supplier in accordance with the terms of this Agreement. The Standard Conditions shall apply to all sales made under this Agreement.

         2.2    Use . Buyer shall purchase Materials from Supplier and Supplier shall sell Materials to Buyer for use solely in connection with the manufacture, distribution and sale by Buyer of Buyer Products to third parties.

         2.3    Price . The initial price to be paid by Buyer to Supplier for all consignments of Materials delivered in the first [***] after the Effective Date is US$[***] per kilogram for Suppliers grade of Biomaterials PEEK-OPTIMA LT1 and US$[***] per meter for Suppliers grade of Stock Shape LT1R20. Buyer shall pay each invoice in full within 30 days of the date of the invoice in cleared funds in U.S. dollars to the bank account notified from time to time by Supplier. Time shall be of the essence for payment of invoices. Interest is payable on overdue amounts at the rate of [***]% over the US Prime Rate as published in the Wall Street Journal, Eastern Edition from time to time, to run from the due date for payment until receipt by Supplier of the full amount (including any accrued interest) whether before or after judgment. Supplier may suspend the supply of Materials to Buyer where any amounts are overdue in respect of an order until all such amounts have been paid. All sums payable in respect of an order shall be payable in full by Buyer without deduction of any kind, whether by way of set-off, counterclaim or otherwise howsoever. Buyer shall not be entitled to set-off an amount owing or alleged to be owing to it by

Confidential

         Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

2


Supplier against amounts owing by it to Supplier. Supplier shall be entitled to increase the price per kilogram and/or meter for Materials, by no more than [***]%, once each Year, after the initial [***] period, upon providing thirty (30) days written notice.

         2.4    Milestone Payments . Subject to Standard Condition 3, in consideration for Supplier's provision of [***], other information relating to the general performance and/or other general physical characteristics of the Biomaterials and the Stock Shape, and [***], and in addition to any other payments required to be made to Supplier by Buyer under this Agreement, Buyer shall pay to Supplier the amount of U.S. $[***] said amount to be paid in three (3) installments as follows: (a) U.S. $[***] shall be due and payable upon signing of the agreement; (b) U.S. $[***] shall be due and payable by [***]; (c) U.S. $[***] shall be due and payable by [***] (the " Milestone Payments ").

        In the event that this Agreement is terminated for any reason other than for material breach by Supplier, Buyer shall immediately pay to Supplier all Milestone Payments that would have been due to Supplier under the full term of this Agreement as set forth in Section 3.1

3.      TERM AND TERMINATION

         3.1    Term . This Agreement has a term of ten (10) Years (the " Term ") from the Effective Date, unless terminated earlier in accordance with its terms.

         3.2    Termination by Mutual Agreement . This Agreement may be terminated upon mutual written agreement between the parties. In addition to any other rights of termination which Supplier may have under this Agreement, a party (the " Initiating Party ") may terminate this Agreement with immediate effect by written notice to the other party (the " Breaching Party ") on or at any other time after the Breaching Party being in breach of a material obligation under this Agreement and, if the breach is capable of remedy, failing to remedy the breach within 30 days starting on the day after receipt of written notice from the Initiating Party. That written notice shall contain details of the breach and shall further require the Breaching Party to remedy the breach and state that a failure to remedy the breach may give rise to termination under this Section 3.2. For the purposes of this Section 3.2 a breach is capable of remedy if time is not of the essence in performance of the obligation and if the Breaching Party can comply with obligation within the 30 day period;

3.3    Consequences of Termination .

        (a)   Termination of this Agreement does not affect a party's accrued rights and obligations at the date of termination.

        (b)   In the event of Supplier terminating this Agreement pursuant to any breach (whether pursuant to Section 3.2, 3.4 or otherwise) by Buyer of the terms of this Agreement, or in the event of this Agreement terminating pursuant to Section 4.4 or under any of the Standard Conditions; Supplier shall be entitled to discontinue immediately the supply of Materials and cancel any orders then already accepted from Buyer.

        (c)   Each party's further rights and obligations shall cease immediately on termination except that Buyer shall immediately pay all Milestone Payments that would otherwise have been payable during the Term; and Sections 2 and 4, together with those of the Standard Conditions as are specified as surviving the termination of this Agreement, together with those further Sections and Standard Conditions the survival of which is necessary for the interpretation or enforcement of this Agreement, shall survive termination of this Agreement, and shall continue in full force and effect.

        (d)   Buyer shall return to Supplier all Materials in its possession which have not been integrated into Buyer Products as of the date of termination, and Supplier shall pay Buyer an amount equal to [***]% of the price paid by Buyer per kilogram/meter of Materials returned. Concurrent with the return of Materials under this Section, Buyer shall provide to Supplier a written verification that all Materials in its possession have been returned to Supplier, duly executed by a Buyer employee authorized and empowered to make such a representation on behalf of Buyer.

Confidential

         Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. Asterisks denote omissions.

3


         3.4    Bankruptcy . Buyer shall inform Supplier of the commencement of any bankruptcy insolvency, or administration proceedings by or against Buyer, or the occurrence of any analogous event in the country of incorporation of Buyer if Buyer is not incorporated in the United States of America at least thirty (30) calendar days prior to the date of the commencement of such proceedings. Buyer's failure to timely provide such notice shall be deemed a material, pre-petition incurable breach and shall result in immediate termination of this Agreement, notwithstanding any provision to the contrary contained within this


 
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