Exhibit 10.43
Portions of this document have been redacted pursuant to a Request
for Confidential Treatment filed with the Securities and Exchange Commission.
Redacted portions are indicated with the notation "*****"
AMENDMENT NO. 1 TO SUPPLY AND SERVICES AGREEMENT
THIS AMENDMENT NO. 1 TO SUPPLY AND SERVICES AGREEMENT (this "Amendment")
is made and entered into as of the 12th day of February 2002 (the "Effective
Date") by and between PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation
("PPTI") and SPINE WAVE, INC., a Delaware corporation ("Company") and amends the
terms and conditions of that certain Supply and Services Agreement dated as of
April 12, 2001 by and between the Company and PPTI (the "Original Agreement").
W I T N E S S E T H:
WHEREAS, PPTI and Company are parties to the Original Agreement;
WHEREAS, PPTI and the Company desire to amend certain of the terms of
the Original Agreement;
NOW, THEREFORE, in consideration of the mutual covenants contained
herein and for other good and valuable consideration, the receipt, sufficiency
and adequacy of which is hereby acknowledged, the parties hereto agree as
follows:
A. Definitions and Sections. All capitalized terms used but not defined
in this Amendment shall have the meanings ascribed thereto in the Original
Agreement. Section and Schedule references in this Amendment shall be to
Sections of and Schedules to the Original Agreement, as amended hereby.
B. Amendment of Section 2(a) and 2(b). Sections 2(a) and 2(b) are hereby
deleted and amended and restated to read as follows:
(a) During the Initial Term, PPTI shall provide Materials to
Company and Company shall purchase Materials from PPTI for Non-Clinical
Use as set forth in Amended and Restated Schedule 1 attached hereto.
(b) During the Start-Up Term subsequent to the Initial Term, PPTI
shall provide Materials to the Company and Company shall purchase
Materials from PPTI as set forth in the Amended and Restated Schedule 2
attached hereto.
C. Amendment of Section 5.1. The last sentence of Section 5.1 is hereby
deleted and amended and restated to read as follows: PPTI shall provide the
accommodations listed above to the Company at no additional charge to the
Company.
D. Amendment of Sections 6(c) and 6(d). Sections 6(c) and (d) are hereby
deleted and amended and restated to read as follows:
(c) The parties agree that the Additional Term began on February
12, 2002 and will end on February 11, 2003, absent a default or breach
of the Original Agreement as amended hereby. On the first day of March,
2002 (subject to a fifteen (15) business day grace period) and on the
first day of each of the next five (5) consecutive months thereafter
(e.g. April 1, 2002 through August 1, 2002, both inclusive), the Company
shall pay PPTI the sum of*****. On the first day of September, 2002 and
on the first day of each consecutive month thereafter throughout the
remainder of the Additional Term, the Company shall pay PPTI the sum
of*****. PPTI shall throughout the Additional Term continue to apply
project accounting to the work under the Original Agreement and
within***** after the close of each month during the Additional Term and
within***** following the termination of the Original Agreement, PPTI
shall provide the Company with a statement (i) setting forth the
Materials, Additional Services, Design Services and other services
provided to Company by PPTI and the related costs, and (ii) itemizing
any applicable credits due to the Company as set forth below and
additional payments due PPTI pursuant to paragraph (d) below. The
Company shall make any payment due to PPTI within***** after receipt of
the statement. Any credit due to the Company shall be***** during or for
the Additional Term, exclusive of the monthly payments specified above.
(d) Notwithstanding anything else to the contrary contained
herein, the parties agree that:
(i) Upon expiration of the Initial Term, if the Company
has paid the Minimum Payment each month of the Initial Term and
has not received an aggregate of Initial Services and/or
Materials equal to*****, the Company shall receive a credit from
PPTI equal to***** which may be applied toward payments by the
Company to PPTI for Materials, Additional Services, Design
Services and/or other services provided hereunder after the
Additional Term.
(ii) Any credit due the Company upon expiration of the
Additional Term, may be applied to Materials, Additional
Services, Design Services and/or other services provided
hereunder during the***** period following the expiration of the
Additional Term or as the Company may reasonably request
following consultation with PPTI. With respect to the Injectable
Disk Nucleus product, for each***** period subsequent to the
Additional Term, the amount charged by PPTI to the Company for
aggregate actual***** costs per R&D personnel***** costs for each
of the***** set forth in the Amended and Restated Schedule 5,
or***** Cost per each Qualified Lot, shall not exceed***** during
the prior***** period.
(iii) Intentionally omitted.
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
(iv) During the Additional Term, specific external PPTI
expenses authorized in writing by the Company for special
supplies, services, or equipment in an amount greater than*****
in the aggregate per activity or task shall be paid by the
Company to PPTI within ten (10) days of delivery of an invoice
therefor from or on account of PPTI.
(v) During the Additional Term, the***** cost component of
PPTI's***** Cost for R&D personnel shall be determined***** as
follows: (a) the***** PPTI***** cost*****costs***** costs,*****
by (b) the***** during the*****. However, during the Additional
Term, PPTI shall assess costs incurred by Company using a*****
cost per R&D personnel***** and at the end of the Additional Term
or upon termination of the Original Agreement, PPTI shall
calculate the actual***** cost per R&D personnel***** during the
Additional Term (or applicable portion thereof). To the extent
that the amounts paid by the Company hereunder exceed the
actual***** cost per R&D personnel*****, the Company shall be
entitled to a credit which may be applied as provided above. The
Company shall pay to PPTI within***** of invoice after the close
of the Additional Term (or applicable portion thereof) such
amount, if any by which the aggregate actual***** cost per R&D
personnel***** exceeds the amounts paid by the Company hereunder,
provided, however, that Company shall not be liable for aggregate
actual***** cost per R&D personnel***** that exceeds the amounts
paid by the Company hereunder by more than***** unless the*****
number of R & D personnel during the***** the***** number of R &
D personnel as of*****in which case Company shall not be liable
for aggregate actual***** cost per R&D personnel***** that
exceeds the amounts paid by the Company hereunder by more
than*****.
(vi) During the Additional Term, for each of the***** set
forth in the Amended and Restated Schedule 5, PPTI shall not
charge Company for***** costs that exceed by more than***** costs
for each of such***** as of the*****, unless during the
Additional Term PPTI***** as defined in the***** dated March 21,
2002, in which case PPTI shall not charge Company for***** costs
that exceed by more than***** the***** costs for each of
such***** as of*****
(vii) On or before the first day of August, 2002, PPTI and
the Company shall review the estimated Materials, Additional
Services, Design Services and/or other services to be provided by
PPTI to the Company for the remainder of the
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Additional Term. The Company agrees to adjust the monthly payment
as required to cover any material underpayment, taking into
account***** specified in paragraph (c) above***** by the
Company.
E. Schedules. The Amended and Restated Schedules 1, 2, 3, and 5 attached
hereto supercede and replace in their entirety the existing Schedules 1, 2, 3
and 5 to the Original Agreement.
F. Continuing Agreement. Each party hereby acknowledges that there have
occurred no defaults under or breaches of the Original Agreement by the other
party. Except as otherwise provided herein, the Original Agreement continues
unchanged and in full force and effect.
G. Conflicts. This Amendment supersedes all prior or contemporaneous
understandings or agreements, whether written or oral, between the Company and
the PPTI with respect to such amendment. In the event of any conflict between
the terms of this Amendment and the terms of the Original Agreement, the terms
of this Amendment shall govern and control.
H. Further Assurances. The Company and PPTI agree to execute such
further instruments, agreements and document, and to take such further action as
may be reasonably necessary to carry out the intent of this Amendment.
I. Counterparts. This Amendment may be executed by the parties hereto in
one or more counterparts and all of said counterparts taken together shall be
deemed to constitute one and the same instrument.
J. Governing Law. This Amendment shall be governed by, and construed in
accordance with, the laws of the State of California.
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
IN WITNESS WHEREOF, the parties have caused this Amendment to be duly
executed as of the day and year first above written.
SPINE WAVE, INC.
By:/s/ Xxxx XxXxxxxxx
-----------------------------------------
Xxxx XxXxxxxxx
President and Chief Executive Officer
PROTEIN POLYMER TECHNOLOGIES, INC.
By:/s/ J. Xxxxxx Xxxxxxxx
-----------------------------------------
J. Xxxxxx Xxxxxxxx
President and Chief Executive Officer
AMENDED AND RESTATED SCHEDULE 1
MATERIALS DURING THE INITIAL TERM AND FOR NON-CLINICAL USE
----------------------------------------------------------
During the Initial Term, PPTI shall supply Materials to the Company for
Non-Clinical Use at the Company's request as follows:
------------------------------------------------- ------------------------------
Material supplied by PPTI: Cost to Company:
------------------------------------------------- ------------------------------
For each Qualified Lot of Material (except as ***** per each Qualified Lot
set forth below)
------------------------------------------------- ------------------------------
For each Off-the-Shelf Lot of Material *****
------------------------------------------------- ------------------------------
For each Additional Qualified Lot of Material ***** per each Qualified Lot
------------------------------------------------- ------------------------------
"Additional Qualified Lot" shall mean any Qualified Lot of Material ordered by
Company (i) after the Company orders***** Qualified Lots of Material and (ii) in
excess of***** for any***** period; provided that, for purposes of clarity,
orders in any***** shall be counted toward any***** period with either the
immediately preceding or immediately subsequent*****, but not both.
"Off-the-Shelf Lot" shall mean any lot of Material existing in PPTI's inventory
as of the date of the Agreement.
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 1 - 1
AMENDED AND RESTATED SCHEDULE 2
MATERIALS DURING THE START-UP TERM SUBSEQUENT TO THE INITIAL
TERM AND FOR CLINICAL USE
------------------------------------------------------------
During the Start-Up Term subsequent to the Initial Term or for purchases
of Materials made for Clinical Use during the Start-Up Term, PPTI shall provide
Materials to the Company at the Company's request as follows:
------------------------------------------------- -----------------------------------------------
Material: Cost:
------------------------------------------------- -----------------------------------------------
For each Qualified Lot* supplied by PPTI for ***** per each Qualified Lot,*****
non-clinical use (except as set forth below)
------------------------------------------------- -----------------------------------------------
For each Excess Qualified Lot* supplied by PPTI ***** per each Excess Qualified
for non-clinical use Lot,*****
------------------------------------------------- -----------------------------------------------
For each Qualified Lot* supplied by PPTI for ***** per each Qualified Lot,*****
clinical use
------------------------------------------------- -----------------------------------------------
Qualified Lot* supplied by third-party contract ***** per each Qualified Lot
manufacturer
------------------------------------------------- -----------------------------------------------
"Excess Qualified Lot" shall mean any Qualified Lot of Material ordered by
Company when PPTI accepts orders for more than***** of Material in any*****
period during the Additional Term, any such***** determined consecutively from
the start of the Additional Term.
*****
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 2 - 1
AMENDED AND RESTATED SCHEDULE 3
QUALITY CONTROL PROCEDURES
--------------------------
------------------------------------------------------ -------------------------
Procedure/Test ***** Cost* ($)
------------------------------------------------------ -------------------------
*****
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* Current as of the Effective Date of the Original Agreement; to be adjusted
from time to time to reflect changes in PPTI's actual***** Cost or***** Cost, as
applicable.
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 3 - 1
AMENDED AND RESTATED SCHEDULE 5
ADDITIONAL SERVICES
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During the Additional Term, PPTI shall provide to Company, at Company's
request, the***** set forth below or***** subject to Company's reasonable prior
approval, for the stated***** an IDE to FDA approval for the Injectable Disc
Nucleus product.
----------------------------------------- --------------------------------------
*****
----------------------------------------- --------------------------------------
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***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
