Exhibit 10.41
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 "*****"
SUPPLY AND SERVICES AGREEMENT
THIS SUPPLY AND SERVICES AGREEMENT (this "Agreement") is made and
entered into this 12th day of April, 2001 (the "Effective Date") by and between
PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation ("PPTI") and SPINE
WAVE, INC., a Delaware corporation ("Company").
W I T N E S S E T H:
WHEREAS, PPTI and Company are parties to the License Agreement between
Company and PPTI of even date herewith (the "License Agreement") wherein Company
has acquired from PPTI a license to Intellectual Property for use in the Field.
WHEREAS, PPTI has experience in the development of Products and has the
facilities, equipment, employees, materials and other resources to accomplish
development and manufacturing activities, on behalf of Company, with respect to
the Intellectual Property.
WHEREAS, Company desires to engage PPTI to perform such services and
provide such materials in connection with the development and manufacturing
activities, and PPTI is willing to provide such services and materials.
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:
1. Definitions. All capitalized terms used but not defined in this Agreement
shall have the meanings ascribed thereto in the License Agreement. The
following terms shall have the meanings set forth below:
"Additional Services" shall mean the individuals, services and rates set
forth on Schedule 5 attached hereto.
"Additional Term" shall mean the term commencing on the first day of the
eleventh (11th) consecutive month following the Effective Date and expiring on
the last day of the twenty-fourth (24th) consecutive month following the
Effective Date.
"Clinical Use" shall mean use in human clinical trials.
"Direct Cost" shall mean solely the costs and expenses of (i) raw
materials and supplies, (ii) payroll costs (burdened to include benefits and
payroll taxes, but not facilities or overhead costs), (iii) that portion of
utilities used in the manufacture of Qualified Lots and (iv) the applicable
quality control tests as set forth on Schedule 3.
"Escrow Agreement" shall mean that certain escrow agreement between PPTI
and Company of even date herewith.
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"Escrow Materials" shall have the meaning set forth in the Escrow
Agreement.
"Fully-Burdened Cost" shall mean all of the direct and proportional
indirect costs and expenses for providing the specified Materials or services,
including but not limited to raw materials and supplies, labor, equipment,
utilities, facilities and overhead as determined according to generally accepted
accounting principles (GAAP) consistently applied.
"Initial Services" shall mean the individuals, services and rates set
forth on Schedule 4 attached hereto.
"Initial Term" shall mean the term commencing on the Effective Date and
continuing for ten (10) consecutive months thereafter.
"Materials" shall mean materials provided by PPTI to the Company
including a minimum of two (2) protein polymers plus crosslinker used in prior
spine studies by PPTI and the manufacture of protein polymers on an ongoing as
requested basis of up to one Qualified Lot per month.
"Non-Clinical Use" shall mean use in pre-clinical studies, including
animal studies.
"PPTI Facilities" shall mean PPTI's offices and laboratory space located
at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ or, in the event PPTI
no longer maintains offices and laboratory space at such address, such new
address as PPTI shall maintain offices and/or laboratory space.
"Protein Polymer Design and Supply Services Escrow Materials" shall have
the meaning set forth in the Escrow Agreement.
"Purchase Agreement" shall mean that certain founders stock purchase
agreement entered into between PPTI and the Company of even date herewith.
"Qualified Lot" shall mean any lot of Material which has successfully
passed the quality control procedures set forth on Schedule 3 and designated for
such lot by Company.
"Regulatory Approval" shall mean with respect to any country, filing for
and receipt of all regulatory agency or other registrations and approvals
required in such country in respect of Materials for any purpose specified in
this Agreement or, if no purpose is specified, to enable the Materials to be
manufactured and for Non-Clinical Use or Clinical Use to take place in such
country.
"Start-Up Term" shall mean the term commencing on the Effective Date and
continuing until the earlier of i) the date on which the Company completes the
sale or sales of shares of its preferred stock resulting in aggregate gross
proceeds to the Company in excess of $10 million, or ii) upon the expiration of
twenty-four (24) consecutive months following the Effective Date; provided
however, that in no event shall this term expire prior to the last day of the
twelfth consecutive month following the Effective Date.
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"Voting Agreement" shall mean that certain voting agreement entered into
between PPTI, the Company and the Company's stockholders dated of even date
herewith.
2. Supply of Materials.
(a) During the Start-Up Term, PPTI shall provide Materials to
Company and Company shall purchase Materials from PPTI for Non-Clinical Use as
set forth in Schedule 1 attached hereto.
(b) After the Start-Up Term or for purchases of Materials made
for Clinical Use during the Start-Up Term, PPTI shall provide Materials to the
Company and Company shall purchase Materials from PPTI as set forth in Schedule
2 attached hereto.
(c) At Company's request and expense at any time after the
Initial Term, PPTI shall promptly establish, qualify, procure any necessary
permits and certifications for and otherwise prepare for operation a back-up
manufacturing site for the manufacture of any protein polymers manufactured by
PPTI or that PPTI is obligated to manufacture under this Agreement. PPTI agrees
that any contract between PPTI and a third party for such back-up manufacturing
site shall provide for *****
3. Production and Quality Control.
(a) PPTI warrants, represents and covenants that all Materials
produced for or sold to Company shall be manufactured free from defects in
materials and workmanship and in accordance with specifications set forth in
paragraph (b) below. Further, PPTI warrants, represents and covenants that the
Materials will meet the specifications in any applicable Regulatory Approvals,
including compliance with applicable Quality System Regulations and ISO 9001
Standards in effect at the time of production and/or such other lawful and
appropriate standards as the parties may agree upon in writing. Company
acknowledges that production specifications may be changed from time to time to
comply with applicable laws and regulations.
(b) At Company's request, PPTI shall perform one or more of the
quality control procedures set forth on Schedule 3 for each lot of Material
provided to Company. PPTI shall deliver to Company a copy of test results for
each lot of Material supplied to Company. All Material supplied to Company shall
have passed such quality control tests and PPTI shall immediately bring to the
attention of Company any Material that did not meet such quality control
requirements. Materials that meet such quality control requirements and which
are not objected to by Company within thirty (30) days after receipt shall be
presumed to be free from defects in material and workmanship, in the absence of
manifest error.
(c) PPTI shall retain samples of all ingredients, packaging
materials, records and data as may be in accordance with the sample and record
retention policies which PPTI uses in connection with manufacture of Materials
for its own account; provided such retention shall at
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all times be in accordance with all applicable Regulatory Approvals, Quality
System Regulations and ISO 9001 Standards. Company shall have the right, no more
frequently than once every twelve (12) months, to review PPTI's manufacturing
procedures and operations and its records relating to the manufacture and
shipment of Materials. No inspection or testing of Materials by Company, or
failure to test or inspect, shall relieve PPTI of its obligations hereunder.
Copies of any certificates, reports, test results or other information produced
by PPTI, or by a third party consultant or contractor at PPTI's request, that
directly relate to lots of Material sold to Company shall, upon the written
request of Company, be furnished to Company and may be relied upon by it.
4. Services.
(a) During the Initial Term, PPTI shall provide Initial Services
as specified in Schedule 4 attached hereto at the Company's request on an as
needed basis;
(b) During the Additional Term, PPTI shall provide Additional
Services as specified in Schedule 5 attached hereto at the Company's request on
an as needed basis;
(c) In the event Company determines to have a third-party
construct DNA encoding protein polymers and conduct related research and
development services including, but not limited to, process development and
assay development ("Design Services"), the Company and PPTI shall proceed as
follows:
(i) Company shall first deliver to PPTI a proposal setting
forth the specific Design Services requested (the "Noticed Design Services").
(ii) Upon expiration of the***** following receipt of such
notice, PPTI shall give written notice to Company of its intention to provide
the Noticed Design Services. If PPTI does not timely give such written notice to
Company, the applicable Protein Polymer Design and Supply Services Escrow
Materials shall be released from escrow in accordance with Section 5(a)(viii) of
the Escrow Agreement.
(iii) In the event PPTI elects to provide the Noticed
Design Services, PPTI shall provide such services to Company ***** and the
parties shall negotiate in good faith all other terms and conditions relating to
the provision of the Noticed Design Services, including, all benchmarks,
deliverables, and remedies for breach. In the event the parties are unable to
execute an agreement for the Noticed Design Services within***** after PPTI
delivers its notice (the "Negotiation Period"), Company may enter into
negotiations with any third party to provide the Noticed Design Services upon
terms not less favorable in the aggregate to Company than those specified in the
last written offer made by PPTI to Company. In determining whether any third
party's terms are less favorable in the aggregate to Company, the parties shall
consider PPTI's proposed*****. Upon execution of an agreement
with a third party according to the provisions set forth herein, the applicable
Protein Polymer Design and Supply Services Escrow Materials shall be released
from escrow in accordance with Section 5(a)(viii) of the Escrow Agreement.
(iv) Company may not enter into an agreement for the
Noticed Design Services on terms less favorable in the aggregate to Company
without first re-offering the
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Noticed Design Services on such terms to PPTI, and PPTI shall have ***** to
accept such proposal (the "Re-Offer Period"). In the event that PPTI does not
accept within the Re-Offer Period, Company shall have the right to execute an
agreement with such third party to provide the Noticed Design Service and the
applicable Protein Polymer Design and Supply Services Escrow Materials shall be
released from escrow in accordance with Section 5(a)(viii) of the Escrow
Agreement.
(v) If Company has not entered into a definitive agreement
with a third party for the Noticed Design Services within ninety (90) days after
the later of the expiration of the Negotiation Period or the Re-Offer Period,
then the Company shall repeat the procedure set forth in this paragraph (c)
prior to entering in to any such definitive agreement.
(vi) PPTI hereby consents to and acknowledges that, upon
release to Company of the applicable Protein Polymer Design and Supply Services
Escrow Materials, according to the terms of this paragraph (c) and Section
5(a)(viii) of the Escrow Agreement, Company, or any third party employed by
Company, shall have the right to use such materials to perform the Noticed
Design Services; provided however, that Company's transfer of such materials to
any third-party shall be conditioned on PPTI's prior approval, which shall not
be unreasonably withheld, delayed or conditioned.
(vii) PPTI hereby acknowledges that the Company shall at
all times be free to perform the Design Services itself without adhering to the
requirements of this paragraph (c) and that, notwithstanding anything to the
contrary contained herein, the applicable Protein Polymer Design and Supply
Services Escrow Materials shall be released to Company in accordance with
Section 5(a)(viii) of the Escrow Agreement.
(d) Upon formation of a scientific review board by Company and
until expiration of the License Agreement, PPTI shall, subject to Company's
reasonable approval, appoint one (1) individual to serve as a member of such
board; provided however, that*****. Company shall pay PPTI $1,000 per quarter
and reimburse reasonable out-of-town travel and lodging expenses related to such
individual's participation on the board; provided however, that PPTI shall not
invoice and Company shall not be obligated to pay any amounts for such service
during the Initial Term other than reimbursement of reasonable out-of-town
travel and lodging expenses.
(e) Upon mutual agreement by PPTI and the Company, PPTI will
reasonably attempt to provide other additional support and services as may be
requested by Company upon the terms and conditions mutually agreed to by the
parties in writing.
5. Work Space and Equipment.
5.1 General. During the Initial Term and, at Company's request
during the Additional Term, PPTI shall provide the following accommodations to
the Company at PPTI Facilities to support feasibility studies within the scope
of the License Agreement:
*****
*****
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*****
During the Initial Term, PPTI shall provide the accommodations listed above to
Company at no cost. During the Additional Term, PPTI shall charge Company*****
for such accommodations as used by Company.
6. Price and Payment Terms.
(a) On the Effective Date and thereafter on a monthly basis
during the Initial Term the Company shall pay PPTI ***** (such monthly amount
referred to as the "Minimum Payments"). During the Initial Term, PPTI will not
invoice Company for any payment amounts for Materials and Initial Services
accrued during the Initial Term, and any such payment amounts shall be paid, if
necessary, in accordance with Section 6(b) and 6(d) below.
(b) Within***** after expiration of the Initial Term,
PPTI shall provide the Company with a statement (i) setting forth the Materials
and Initial Services provided during the Initial Term and the related costs for
such Materials and Initial Services, and (ii) itemizing any applicable credits
due to Company or excess payments due to PPTI pursuant to paragraph (d) below.
(c) Upon expiration of the Initial Term and within***** after the
expiration of each consecutive***** period thereafter, 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) deducting any applicable credits to offset
such expenses due to the Company pursuant to paragraph (d) below. Company shall
make such payment within fifteen (15) days after receipt of the statement.
(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 such difference which may be applied
toward payments by the Company to PPTI according to paragraph (d)(ii) below, or
for Materials, Additional Services, Design Services and/or other services
provided hereunder.
(ii) Upon expiration of the Initial Term, if the Company
has paid the Minimum Payment each month of the Initial Term and has received an
aggregate of Initial Services and/or Materials in excess of*****, the
Company shall be required to pay such additional amounts within fifteen (15)
days after receipt of the statement described in paragraph (c) above; provided
however, in the event that this Agreement is terminated prior to the expiration
of the Initial Term, Company*****
(iii) Until the Company receives at least one (1)
Qualified Lot of Material from PPTI, the Company shall not be required to pay
PPTI any amounts in excess of an aggregate of $100,000.
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(e) PPTI shall keep and maintain adequate records and books of
account documenting all of its expenses related to the services and materials
provided to Company hereunder. At Company's request and expense, PPTI shall
permit a certified independent public accountant selected by Company to have
access, no more than once in each year during the term of this Agreement and
once during the twelve (12)-month period following receipt by PPTI of the last
payment from Company of amounts due hereunder, during regular business hours and
upon reasonable notice to PPTI, to such records and books for the sole purpose
of verifying costs invoiced hereunder; provided, however, that if such certified
independent public accountant reasonably determines that such costs have been,
after adjustments herein provided for, overstated or understated by PPTI,
Company shall promptly pay any such understatement to PPTI and PPTI shall
promptly refund any such overpayment to Company, and if such costs were
overstated by PPTI by an amount equal to or greater than*****, PPTI shall also
pay all reasonable fees and disbursements of such certified independent public
accountant incurred in the course of making such determination.
7. Representations, Warranties and Covenants.
(a) PPTI represents and warrants to Company that it is duly
authorized and empowered to enter into and perform this Agreement; and the
execution and performance of this Agreement by PPTI does not and will not
conflict with or violate any contract, agreement, indenture, mortgage,
instrument, writ, judgment, or order of any court, arbiter or governmental or
quasi-governmental body to which PPTI is a party or by which PPTI is bound.
(b) PPTI represents and warrants to Company that prior to first
shipment of the Materials it will have received all necessary licenses, permits
and Regulatory Approvals for manufacture of Materials.
(c) PPTI agrees to adhere to all known laws, rules and
regulations applicable to the manufacture of Materials under this Agreement and
warrants that the Materials will be manufactured in accordance with all
applicable specifications and will be delivered to Company free and clear of all
third party claims, liens and encumbrances.
(d) PPTI represents and warrants to Company that PPTI shall use
commercially reasonable efforts to perform the Initial Services, Additional
Services, Design Services and all other services performed hereunder in a good
and workmanlike manner.
(e) PPTI represents and warrants to Company that it has
sufficient right and title to and ownership of, sufficiently free and clear of
all liens, claims and encumbrances of any nature, the Intellectual Property and
has sufficient right or title to or ownership of, sufficiently free and clear of
all liens, claims and encumbrances of any nature all equipment related to the
manufacture and design of protein polymers, to perform its obligations under
this Agreement.
(f) Company represents and warrants to PPTI that it is duly
authorized and empowered to enter into and perform this Agreement; and the
execution and performance of this Agreement by Company does not and will not
conflict with or violate any contract, agreement, indenture, mortgage,
instrument, writ, judgment, or order of any court, arbiter or governmental or
quasi-governmental body to which Company is a party or by which Company is
bound.
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(g) *****
8. Term and Termination.
(a) The term of this Agreement shall commence as of the date
hereof and, unless terminated earlier pursuant to the provisions of this
Agreement, shall expire upon the expiration or termination of the License
Agreement.
(b) The obligations of a party under this Agreement (but not its
rights hereunder) may be terminated by such party if: (i) subject to Section 9
below, the other party fails to perform any material term, provision, covenant
or obligation imposed upon it under this Agreement, which failure or refusal
shall continue for***** following written notice thereof from the non-defaulting
party specifying the event of default; or (ii) the other party is dissolved or
liquidated, makes a general assignment for the benefit of its creditors, files a
voluntary petition under any applicable bankruptcy or insolvency law, has a
receiver appointed for its property, or has a petition for bankruptcy or
insolvency filed against it which petition is not dismissed or vacated
within***** after filing; in both instances, PPTI shall be under no obligation
to provide Company with Materials, Initial Services, Additional Services or
Design Services during the cure period if Company has failed to pay PPTI any
sums due under this Agreement and Company shall not be entitled to Escrow
Materials during the cure period.
(c) The failure of a party to terminate its obligations under
this Agreement by reason of the breach of any of the provisions by the other
party shall not be construed as a waiver of the rights or remedies available for
any subsequent breach of the terms and provisions of this Agreement.
(d) A party electing to terminate its obligations under this
Agreement shall also be entitled to pursue such additional remedies at law or in
equity that it may have as a result of a breach of or default under this
Agreement by the other party.
(e) Any party bringing action to enforce the obligations of the
other party or its rights under this Agreement shall be entitled to recover all
costs and expenses (including reasonable attorneys fees and court costs)
incurred by it in such enforcement action.
9. Force Majeure.
(a) The obligations of a party hereunder shall be suspended by
the occurrence of any event beyond the control of such party, such as acts of
God, war, warlike conditions, strikes, lockouts, power failures, the elements,
embargoes, or law, regulation or governmental order, whether or not valid,
restricting performance; provided, however, that such party shall
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take reasonable measures to remove the disability or restriction and resume
operations at the earliest possible date.
(b) Subject to compliance with paragraph (c) below, any delay in
or failure of performance by either party under this Agreement as a result of a
Force Majeure shall not be considered a breach of this Agreement during the
period of delay.
(c) Any party affected by such Force Majeure who wishes to rely
on the provisions of paragraph (a) above shall as soon as reasonably practicable
give notice to the other party specifying the matters constituting Force Majeure
together with such evidence thereof as it can reasonably give and specifying the
period for which it is estimated that such delay will continue.
10. Indemnification.
(a) Each party ("Indemnitor") agree to indemnify, defend and hold
harmless the other party ("Indemnitee") from and against all liabilities,
losses, costs, damages and expenses (excluding fees and disbursements of the
Indemnitee's counsel and court costs, except as provided below) caused by,
arising out of resulting from (i) the Indemnitor's gross negligence or willful
misconduct in carrying out its obligations under this Agreement, (ii) the
Indemnitor's failure to comply with any law or regulation applicable to the
performance of its obligations under this Agreement, (iii) any liabilities of
Indemnitor in respect of recalls, in any such case that is not based on any act
or omission or alleged act or omission of the Indemnitee, (iv) a claim of
intellectual property infringement caused by the specific manner of use of a
Product by Company, or its Affiliates, sub-licensees or distributors, (v) with
respect to the Materials manufactured by PPTI, any claim of infringement of
composition of matter or method of manufacture by PPTI, or (vi) with respect to
Materials not manufactured by PPTI, any claim of infringement of intellectual
prorperty rights relating to*****. The indemnity provided above shall not extend
to any liabilities, losses, costs, damages or expenses caused by or resulting
from or arising out of any act or omission or breach of representation, warranty
or covenant of the Indemnitee.
(b) Each party agrees to give the other party prompt notice of
any claim or demand made or the institution of any suit or proceeding brought
upon the grounds referred to under this Section 10, and to permit the Indemnitor
to conduct the defense of any such claim, demand, suit, or proceeding, and to
give the Indemnitor all information in its possession which is pertinent to the
defense of any such claim, demand, suit or proceeding, and to give the
Indemnitor the authority and assistance appropriate or necessary to enable the
Indemnitor to carry on such defense and any appeal from a judgment or decree
rendered in any such suit or proceeding. However, nothing in this Section 10(b)
will prevent the Indemnitee from engaging its own counsel in any such matter
and, if there shall exist a bona fide conflict between the rights and interest
of the indemnifying party and the indemnified party, from being indemnified with
respect to such engagement to the extent provided in this Section 10.
(c) Without its prior consent, PPTI will not be responsible for
or bound by any compromise made by Company in any matter in which Company is
indemnified by PPTI.
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Without its prior consent, Company will not be responsible for or bound by any
compromise made by PPTI in any matter in which Company is indemnified by PPTI.
(d) The Indemnitee agrees to give the Indemnitor prompt notice of
any claim, demand, suit or proceeding asserted, made or brought against the
Indemnitee (including any claim, demand, suit or proceeding asserted, made or
brought by any governmental authority) for which the Indemnitor might be liable
under the foregoing provisions. However, the failure to give prompt notice shall
not relieve the Indemnitor from its obligations hereunder unless the failure to
give prompt notice has materially and adversely affected the Indemnitor's
defense of the claim or action.
11. Product Liability Insurance. Company and PPTI shall, prior to
commencement of activities involving Clinical Use of the Materials, and at all
times thereafter until 12 months after the expiration or termination of this
Agreement, each carry such products liability and comprehensive general
liability insurance, naming the other party as an insured under such policy, and
in such amounts and subject to such other requirements and restrictions as may
be customary in the United States. PPTI and Company shall have the right to
audit the other party to ensure compliance with this obligation. The parties
agree that any failure to comply with the obligations of this Section 11 shall
be deemed a material breach of this Agreement.
12. Confidentiality.
(a) Subject to paragraph (c) and the terms of the Escrow
Agreement, during the term of this Agreement and for a period of*****
thereafter, each party shall maintain in confidence and shall not disclose to
any third party any know-how, trade secrets, business or technical information
or other information ("Confidential Information") received from the other party
relating to Product, and shall not use the other party's Confidential
Information except for the purposes of this Agreement without the prior written
consent of such other party. These confidentiality and non-use obligations shall
not apply to any Confidential Information that the receiving party can
demonstrate:
(i) at the time of disclosure to the receiving party was,
or thereafter becomes, a part of the public domain through no fault of the
receiving party, its Affiliates, distributors or sub-licensees;
(ii) was subsequently lawfully disclosed to the receiving
party by a third party not under an obligation of confidentiality with or
through the disclosing party;
(iii) was in the lawful possession of the receiving party
prior to disclosure by the disclosing party; or
(iv) is required to be disclosed by judicial or
administrative order provided that notice is given to the disclosing party and
the disclosing party has an opportunity to seek a protective order, and further
provided, that disclosure is limited to compliance with the judicial or
administrative order.
(b) During the term of this Agreement, each party shall take all
reasonable steps to:
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(i) prevent any disclosure in breach of paragraph (a) of
Confidential Information of the other which would be materially prejudicial to
the interests of the other party;
(ii) limit the disclosure of information to such of its
Affiliates, distributors and sub-licensees and their respective employees as
require the information for the purposes of this Agreement; and
(iii) procure that the persons referred to in subparagraph
(ii) of this paragraph (b) enter into appropriate confidentiality agreements.
(c) Immediately upon the expiration or other termination of this
Agreement and the License Agreement, and except as provided for in the Escrow
Agreement, Company shall return to PPTI all of the Confidential Information in
its possession or control, except that one copy of such information may be
retained by Company's counsel under seal to evidence compliance with this
Agreement.
(d) Except as required by law or as expressly set forth herein,
neither party shall make any public statement, press release or other
announcement relating to the terms or existence of this Agreement, or the
business relationship of the parties, without the prior written consent of the
other party.
13. Limited Liability. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT
OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE OR OBLIGATED UNDER ANY SECTION OF
THIS AGREEMENT OR UNDER CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY FOR ANY SPECIAL, EXEMPLARY, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES.
14. Notices. Notices hereunder shall be in writing and shall be deemed
to have been duly given if personally delivered or when sent by facsimile or
other telegraphic means. Such notices shall be effective upon receipt, if by
personal delivery, or if by facsimile, on the date of the confirmation of "ok"
transmission. Addresses and persons to be notified may be changed by either
party by giving written notice thereof to the other party.
To Company: Spine Wave, Inc.
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Telecopy No: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: ▇▇▇▇▇ ▇▇▇▇▇
With a copy to: ▇▇▇▇▇▇▇, Phleger & ▇▇▇▇▇▇▇▇ LLP
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Attention ▇▇▇ ▇. ▇▇▇▇▇▇▇, Esq.
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
To PPTI: Protein Polymer Technologies, Inc.
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Telecopy No: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: President
With a copy to: Piper, Marbury, ▇▇▇▇▇▇▇ & ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Esq.
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
15. Miscellaneous.
(a) This instrument, together with the Purchase Agreement, Voting
Agreement, the License Agreement and the Escrow Agreement constitute the entire
agreement between the parties with respect to the subject matter hereof. This
Agreement shall not be amended, varied, modified or supplemented except by an
agreement in writing signed by the party to be charged. To the extent the terms
of this Agreement shall conflict with the terms of the License Agreement, the
terms of the License Agreement shall control.
(b) The headings used herein are for ease of reference only and
are not to be used in the interpretation or construction of this Agreement.
(c) Neither party shall assign or otherwise transfer this
Agreement or any part hereof (and any attempt to do so will be void) to any
third party without the prior written permission of the other party, except to
an entity that acquires all or substantially all of such party's assets or
operations.
(d) PPTI and Company shall at all times be and remain independent
contractors and not agents, partners or joint venturers of the other for any
purpose whatsoever and neither PPTI nor Company shall have authority to create
or assume any obligation, express or implied, in the name of or on behalf of the
other party or to bind the other party in any manner whatsoever.
(e) The failure of either party to enforce at any time or for any
period of time any one or more of the provisions hereof shall not be construed
to be a waiver of such provisions or of the right of such party thereafter to
enforce each such provision.
(f) This Agreement shall be construed and the rights of the
parties shall be determined in accordance with the substantive laws of the State
of California, without regard to its conflict of laws principles, except that
the arbitration provisions contained in the License Agreement shall apply to
this Agreement.
(g) This Agreement shall be binding upon and enure to the benefit
of the parties hereto, their successors and permitted assigns.
(h) Sections 6(e), 7(g), 8(d), 8(e), 10, 11, 12 and 13 dealing
with rights and obligations upon and/or after termination of this Agreement
shall survive termination of this Agreement to the extent necessary to give
effect to such provisions.
12
(i) This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original and together shall constitute one and
the same instrument.
13
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed as of the day and year first above written.
SPINE WAVE, INC.
By:/s/ ▇▇▇▇▇ ▇▇▇▇▇
------------------------------------------
▇▇▇▇▇ ▇▇▇▇▇
President and Chief Executive Officer
PROTEIN POLYMER TECHNOLOGIES, INC.
By:/s/ J. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
------------------------------------------
J. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
President and Chief Executive Officer
[SIGNATURE PAGE TO SUPPLY AND SERVICES AGREEMENT]
SCHEDULE 1
MATERIALS DURING THE START-UP TERM AND FOR NON-CLINICAL USE
-----------------------------------------------------------
During the Start-Up 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***** Qualified Lot 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 this Agreement.
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 1 - 1
SCHEDULE 2
MATERIALS AFTER THE START-UP TERM AND FOR CLINICAL USE
------------------------------------------------------
After the Start-Up 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:
------------------------------------------------- ------------------------------
Qualified Lot supplied by PPTI ***** per each Qualified Lot
------------------------------------------------- ------------------------------
Qualified Lot supplied by third-party contract ***** per each Qualified Lot
manufacturer
------------------------------------------------- ------------------------------
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 2 - 1
SCHEDULE 3
QUALITY CONTROL PROCEDURES
*****
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 3 - 1
SCHEDULE 4
INITIAL SERVICES
*****
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 4 - 1
*****
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 4 - 2
SCHEDULE 5
ADDITIONAL SERVICES
*****
-----------
***** Material is confidential and has been omitted and filed
separately with the Securities and Exchange Commission.
Schedule 5 - 1