EXHIBIT 10.28
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT is made and entered into this day of by and between
PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation (" Supplier")and
FEMCARE UROLOGY LIMITED, a corporation under the laws of the United Kingdom and
Wales having offices at Xx. Xxxxx'x Xxxxxx, Xxxxxxxxxx, XX0 0XX, Xxxxxxx
("Purchaser").
WITNESSETH:
WHEREAS, Purchaser and Supplier are party to that certain License and
Development Agreement dated January 26, 2000 (the "License Agreement")pursuant
to which Purchaser has been granted an exclusive license to Commercialize the
Product in the Territories in the Field.
WHEREAS, pursuant to the License Agreement, all of the Product that is
marketed by Purchaser is to be manufactured by Supplier or by another company
selected by Supplier and approved by Purchaser for the term of the License
Agreement.
WHEREAS, Supplier possesses and is further developing the Know-How and
Patents to commercially manufacture the Product.
WHEREAS, Supplier desires to manufacture and sell to Purchaser, and
Purchaser desires to engage Supplier to manufacture and supply to it, the
Product, in each case subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained herein
and for other good and valuable consideration, the receipt, sufficiency and
adequacy are hereby acknowledged, the parties hereto agree as follows:
1. PREAMBLES AND DEFINITIONS. The preambles set forth above are an
integral part of this Agreement and are incorporated herein by this reference.
All capitalized terms used but not defined in this Agreement shall have the
meanings ascribed thereto in the License Agreement.
2. SUPPLY AND PURCHASE OF PRODUCT.
(a) During the five year period beginning with the date of this
Agreement (the "Exclusive Term"), Purchaser hereby agrees to purchase and to
cause its Affiliates to purchase from Supplier or such person as Supplier shall
designate, the entire requirements of Product by Purchaser, its Affiliates,
distributors and sublicensees. After the expiration of the Exclusive Term,
Purchaser may, but shall not be required to purchase and to cause its Affiliates
to purchase Product from Supplier or Supplier's designee. All Product supplied
by Supplier pursuant to this Agreement shall be resold and distributed solely in
the Territories for use in the Field. The Purchaser and its Affiliates,
distributors and sublicensees shall not resell the Product to any person in the
Territories knowing or
having reasonable basis to believe that such person intends to re-sell the
Product outside of the Territories or use or resell the Product outside of the
Field.
(b) Supplier agrees to manufacture, package, sell and ship or cause to be
manufactured, packaged, sold and shipped, the Product to Purchaser, in finished
*** units, subject to Purchaser satisfying its obligations hereunder. All
purchases by Purchaser or its Affiliates will be made by purchase orders issued
by Purchaser or such Affiliate to Supplier setting forth the quantities of
Product ordered and the anticipated delivery date. Quantities of Product shall
be identified by units.
(c) Purchaser shall provide to Supplier upon the commencement of the Term
and in all events not less than 120 days before the expected beginning of the
first Marketing Year and thereafter not less than 90 days prior to the
commencement of each subsequent Marketing Year a bona fide (based on a realistic
estimate of sales in the relevant Marketing Year) 12 month projection of
anticipated (not guaranteed) Product purchases by Calendar Quarter by Purchaser
and its Affiliates during the upcoming Marketing Year ("Annual Estimate").
Supplier shall have 15 days in which to review the Annual Estimate and advise
Purchaser as to whether or not it has the available capacity to manufacturer and
supply the Annual Estimate. Supplier shall use all reasonable efforts to put
itself in a position whereby it is able to agree with the Purchaser's Annual
Estimate for the applicable Marketing Year. If Supplier, having applied such
reasonable efforts, advises Purchaser that it cannot manufacture and supply
Product equal to the Annual Estimate, Supplier may arrange for a third party
manufacturer selected by it and approved by Purchaser, which approval shall not
be unreasonably withheld or delayed, to assist Supplier in the manufacturer and
supply of Product. If Supplier shall be unable to timely manufacture or have
manufactured Product equal to the Annual Estimate, Supplier and Purchaser shall
negotiate and adopt a revised Annual Estimate and in such negotiations the
Supplier shall use its reasonable efforts to reduce the Purchaser's original
Annual Estimate by the smallest number of units reasonably practicable. In such
a case, if the revised Annual Estimate is less than the Minimum Purchase
requirement for the subject Marketing Year (as expressed in units), the Minimum
Purchase requirement for that Marketing Year shall be reduced to the dollar
amount (using the table in Section 5(a))corresponding to the number of units in
the revised Annual Estimate and a corresponding adjustment shall be made for the
Minimum Royalty payable under the License Agreement.
(d) Purchase orders for the Product shall be placed with Supplier at
least 90 days prior to Purchaser's anticipated delivery date. All Product will
be purchased in quantities of not less than one-twelfth (1-12th) of the Annual
Estimate unless otherwise requested in advance by Purchaser and agreed to by
Supplier, which agreement shall not be unreasonably withheld or delayed.
Purchaser
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*** Material is confidential and has been omitted and filed separately with the
Securities and Exchange Commission.
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submitted in accordance with this Agreement shall be firm and binding upon
Purchaser after acceptance by Supplier. Purchase orders for Product shall be
deemed acceptable to Supplier provided that the quantities and delivery dates do
not deviate materially from the Marketing Year Annual Estimate developed by
Purchaser. Purchase orders shall be deemed to have been accepted by Supplier
seven (7) calendar days after delivery of the purchase order to Supplier unless
within said seven (7) day period Supplier shall give notice to Purchaser of the
unacceptability of said purchase order for a reason for non-acceptance permitted
under this Agreement (which reason shall be set out in the notice).
(e) Supplier shall supply ordered Product as requested by Purchaser to
the extent that the purchase order does not exceed by an amount greater than
fifty percent (50%) from the corresponding month within the Annual Estimate.
Supplier shall use all reasonable efforts to fill each purchase order delivered
by Purchaser or its Affiliates within 90 days of delivery of such purchase order
or such lesser period of time and Purchaser and Supplier shall, in advance,
agree.
3. DELIVERY
(a) Delivery of Product to Purchaser and its Affiliates shall be F. O. B.
Supplier's manufacturing facility, and shall be accompanied by a packing slip
which describes the Product, identifies the purchase order number and shows the
shipment's destination. Purchaser shall arrange insured common carrier
transportation of Product to Purchaser's distribution center or where Purchaser
shall otherwise direct. Title to and risk of loss of Product shall pass to
Purchaser at the time of delivery to the carrier. Supplier shall promptly xxxx
Purchaser for all Product delivered. All invoices shall be accompanied by the
applicable commercial bills of lading. Unless otherwise specified by Purchaser,
all Product shall be shipped on a first manufactured-first shipped basis,
provided that no Product shall have an expiration date less than six (6) months
from the date of shipment unless otherwise agreed to in writing by Purchaser.
All Product shall be packaged for shipping using protocols designated by
Supplier taking into consideration the method and timing of transport identified
by Purchaser, which protocols shall be promptly furnished in writing to
Purchaser. Purchaser shall notify Supplier of any change in the method and
timing of transporting Product a reasonable time before Product delivery so that
Supplier may develop appropriate shipping protocols. Subject to the forgoing,
the shipment of Product delivered to Purchaser or its Affiliates shall be at the
sole risk of Purchaser.
(b) Any required governmental, regulatory or customs approvals for
domestic or international shipment of the Product shall be the responsibility of
Purchaser or its designated agent. Supplier will cooperate and assist Purchaser
in complying with any applicable international shipping requirements.
(c) All shipping cartons and units of Product within each shipping carton
shall bear a readily visible code or other notation identifying the
manufacturing lot number, expiration date and Product name. All shipping cartons
and units of Product within each shipping carton shall comply with all
applicable laws and regulations regarding the packaging and labeling of medical
devices.
(d) The parties shall use all reasonable efforts to schedule the timely
shipment of Product pursuant to the requirements as established in the accepted
purchase orders. For purposes of this Agreement, a timely shipment shall be a
shipment delivered to the common carrier not later than two weeks after the
agreed upon date.
(e) Purchaser shall notify Supplier of any short shipment claims within
ten (10) days of receipt of a shipment of Product.
4. PRODUCTION AND QUALITY CONTROL.
(a) Supplier warrants, represents and covenants that all Product produced
for or sold to Purchaser and its Affiliates shall be manufactured free from
defects in materials and workmanship in accordance with specifications set forth
in approved production protocols and shall be in compliance with Quality System
Regulations and IS0 9001 Standards in effect at the time of production and/or
such other lawful and appropriate standards as the parties may agree upon. All
Product will have passed suitable Supplier required quality control tests.
Purchaser acknowledges that production specifications may be changed from time
to time to comply with applicable laws and regulations. Supplier shall delivery
to Purchaser a copy of test results for each lot of Product supplied to
Purchaser or its Affiliates.
(b) Each of Supplier and Purchaser shall conduct such quality control
procedures and inplant quality control checks as it shall deem reasonably
necessary. Supplier shall use the same quality control procedures and checks as
it applies in the manufacturing of Product for its own use and sale. Purchaser
shall audit Supplier's quality control activities and results or conduct its own
quality control testing, or provide that its Affiliates, distributors or sub-
licensees conduct quality control testing, within 30 days of delivery of Product
to Purchaser or direct to Purchaser's Affiliates distributors or sub-licensees.
Purchaser shall immediately, and in all events within seven days of discovery or
of the end of the 30 day period, whichever shall first occur, bring to the
attention of Supplier any Product that does not meet Purchaser's audit or
quality control procedures and checks. Product lots that meet Supplier's quality
control requirements and which are not objected to by Purchaser within 30 days
of delivery as provided above shall be presumed to be free from defects in
material and workmanship, in the absence of manifest error.
(c) Each party agrees to notify the other within 48 hours of learning
of (i) the failure of any Product to meet standards found in said Product's
Regulatory Approval or (ii) third-party complaints pertaining to Product.
Purchaser shall use its reasonable efforts to promptly resolve any third party
complaints relating to the Product in a manner consistent with Purchaser's
approach to the resolution of complaints lodged against other products marketed
by Purchaser and its Affiliates (subject to Supplier, as required by Purchaser's
quality control manual, providing Purchaser with any information in its
possession that may facilitate prompt and favorable resolution of any such
complaints and without limitation, within 72 hours of the delivery of the
complaint to Supplier). In the event that Purchaser cannot resolve such
complaint as aforesaid, Purchaser shall notify Supplier and the parties shall
jointly attempt to resolve the problem.
(d) In the event that any governmental agency or authority issues a
recall or takes similar action in connection with any Product sold or
distributed by Purchaser and its Affiliates, its distributors or sub-licensees
in a Territory, or Purchaser reasonably considers it necessary to recall
Product, Purchaser shall, within 24 hours, advise Supplier by telephone, e-mail
or facsimile transmission and Supplier and Purchaser shall agree on an
appropriate course of action. Purchaser shall assume complete responsibility for
conducting such recall; however, Supplier shall provide Purchaser with any
information that may be in Supplier's possession or control concerning the
manufacture of the Product which Purchaser reasonably may require to conduct
such recall. Supplier and Purchaser shall cooperate to identify and correct
deficiencies, if any, in the manufacture, shipment, storage or distribution of
the Product. In the event of such a recall or if Supplier requests Purchaser to
recall Product, Purchaser and its Affiliates, distributors and sublicensees
shall immediately cease all sales of such Product and take all appropriate
actions to recall such Product. Supplier shall bear the expenses of any recall
requested by it or resulting from (i) defective manufacture, packaging or
shipment by Supplier or (ii) any willful misconduct, negligence or gross
negligence of Supplier, or any failure of Supplier to comply with the terms of
this Agreement, that causes such Product recall. Purchaser shall bear the
expenses of any other recall. For the purpose of this Agreement expenses of
recall include, without limitation, the expenses of notification and destruction
or return of the recalled Products, but not the expense or service fees
associated with salesmen's time which shall be borne by Purchaser.
(e) Supplier shall retain samples of all ingredients, packaging
materials, records and data as may be in accordance with the sample and record
retention policies which Supplier uses in connection with manufacture of Product
for its own account; provided such retention shall at all times be in accordance
with all applicable Regulatory Approvals, Quality System Regulations and IS0
9001 Standards. Purchaser shall have the right, from time to time, to review
Supplier's manufacturing procedures and operations and its records relating to
the manufacture and shipment of Product. No inspection or testing of Product by
Purchaser, or failure to test or inspect, shall relieve Supplier of its
obligations hereunder. Copies of any certificates, reports, test results or
other information produced by Supplier, or by a third party consultant or
contractor at Supplier's request, that directly relate to lots of Product sold
to Purchaser shall, upon the written request of Purchaser, be furnished to
Purchaser and may be relied upon by it.
(f) The parties recognize that the holder of or applicant for Regulatory
Approvals for a country may be required to submit information and file reports
to various governmental agencies on Product under clinical investigation,
Product proposed for Commercialization, or Commercialized Product. Consequently,
each party agrees to provide to the other within three (3) business days of the
initial receipt of a report of any adverse experience with Product that is
serious or unexpected. Serious adverse experience means any experience that
suggests a significant hazard, contraindication, side effect or precaution, or
any experience that is fatal or life threatening, is permanently disabling,
requires or prolongs inpatient hospitalization, or is a congenital anomaly,
cancer, or overdose. An unexpected adverse experience is one not identified in
nature, specificity, severity or frequency in the current investigatory brochure
or labeling for the Product. In the case
experience or unexpected adverse experience relating to such Product so that
Purchaser can report such experience to Supplier pursuant to the provisions
hereunder.
5. PRICE AND PAYMENT TERMS.
(a) Purchaser will pay the unit price for each accepted Product. The unit
price within each Marketing Year shall be the greater of that amount which is
equal to *** of Purchaser's Net Sales price per Unit or as follows:
Marketing ***
Year
First ***
Second ***
Third ***
Fourth ***
Fifth ***
All prices of Product shall be stated in U. S. Dollars and all payments made
under this Agreement (or any invoice issued in accordance with this
Agreement) shall be paid in U. S. Dollars and shall be without deduction of any
taxes or other charges except as required by law. Per unit invoice pricing shall
be based on the number of units previously delivered (in accordance with the
first sentence of Section 3(a) above) during the Marketing Year and being
delivered under the purchase order then being filled net of any units returned
and scheduled to be returned by Purchaser to Supplier. All invoices for Products
sold to Purchaser and its Affiliates shall be the obligation of Purchaser.
However, any Affiliate of Purchaser may pay any invoice or account payable
obligation of Purchaser directly to Supplier with the same effect as if the
payment had been made by Purchaser.
(b) The unit price shall include manufacturing, packaging, and Supplier's
quality control measures as Supplier applies to Product used or sold by
Supplier. Purchaser shall provide to Supplier in writing the packaging and
labeling requirements for the Product, which requirements, when determined,
shall meet all applicable Quality System Regulations and IS0 9001 Standards
and/or such other lawful and appropriate standards as the parties may agree
upon, and shall become part of the Product specifications for the Product. Such
requirements shall be specified within a reasonable period of time prior to the
first shipment of Product in order to allow Supplier to be able to satisfy
Purchaser's requirements. In addition, from time to time upon reasonable prior
notice to Supplier, Purchaser may make changes to such packaging and labeling
specifications should
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*** Material is confidential and has been omitted and filed separately with the
Securities and Exchange Commission.
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Purchaser determine such changes are necessary or desirable and subject to then
satisfying all applicable Regulatory Approvals. To the extent permitted under
applicable law, Purchaser shall credit Supplier as the licenser or manufacturer
of the technology used in the Product.
(c) The unit price as specified in Section 5(a) shall apply during the
first five (5) Marketing Years. Thereafter, not less than 60 days prior to the
end of the fifth Marketing Year, and not less than 60 days prior to the end of
every second Marketing Year thereafter, Supplier and Purchaser may agree to
revise any of the prices for the forthcoming marketing years. In no event shall
the price to be paid to Supplier by Purchaser and its Affiliates be less than
***of Purchaser's Net Sales price per unit in the Territory. If the average
number of units required per treatment procedure in the Clinical Efficacy Trials
exceeds ***, the parties shall (subject to Supplier increasing its or its
approved contract manufacturing capacity of Products to allow for the
consequential increase in demand) adjust the unit price and unit volume
increments per Marketing Year, and volume of product per unit, in a manner which
takes into account the assumptions used by the parties to determine the
Minimum Purchase requirement specified in Section 5(e).
(d) The terms of payment are net upon shipment of Product. Any invoice
not paid when due shall be subject to late and service charges equal to l-
1/2% per month of the amount past due. Notwithstanding anything in the foregoing
to the contrary, any purchase order submitted or to be filled within the last
four months of the term of this Agreement or the termination of Supplier's
obligations under this Agreement shall be accompanied by an unconditional,
irrevocable letter of credit issued by a banking institution having facilities
in New York City, New York that is reasonably acceptable to Supplier in the full
face amount of the extended price of the Product ordered, and payable to
Supplier or its assignee which letter of credit shall be drawable upon
presentment of the letter of credit and bills of lading evidencing delivery of
the Product pursuant to such purchase order.
(e) If for any Marketing Year Purchaser shall not have purchased from
Supplier the Minimum Purchase requirement for such Marketing Year, Purchaser
shall pay to Supplier within 45 days following the close of the applicable
Marketing Year the amount by which the applicable Minimum Purchase requirement
for the Product exceeds the actual revenue derived by Supplier from the sale of
Product to Purchaser. The Minimum Purchase requirement is as follows:
Marketing Year Minimum Purchases
First ***
Second ***
Third ***
Fourth ***
Fifth ***
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*** Material is confidential and has been omitted and filed separately with the
Securities and Exchange Commission.
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The parties agree that the Minimum Purchase requirements shall not apply in
any Marketing Year in which (i) the Minimum Royalty under the License Agreement
is not payable to Supplier due to Purchaser's affirmative election under Section
4.02(b) of the License Agreement, or (ii) the quantity of Product corresponding
to the Minimum Purchase requirement has been ordered by Purchaser but Supplier
has failed to timely till the accepted purchase orders required to be filled
within said Marketing Year or committed a breach of this Agreement that prevents
the Minimum Purchase requirements being achieved. In the event of (ii), if there
continues to be a delivery of Product to Purchaser, the Minimum Purchase
requirements shall be reduced by dollar amount corresponding to the number of
units of Product ordered by Purchaser for timely delivery on the Marketing Year
which are not delivered to Purchaser in such Marketing Year but if Supplier has
failed to deliver to Purchaser for six (6) months or more during the Marketing
Year, any Product ordered by Purchaser and scheduled for timely delivery within
the Marketing Year, the Minimum Purchase requirements for such Marketing Year
shall be waived and for the next Marketing Year the Minimum Purchase requirement
shall revert to that in effect for the immediately preceding Marketing Year (or
if in the two Marketing Years the Minimum Purchase requirements are the same,
the Minimum Purchase requirement shall be reduced by 20%) and a corresponding
adjustment shall be made to subsequent Marketing Years and to the Minimum
Royalty requirements under the License Agreement. Notwithstanding the forgoing,
the Minimum Purchase requirement shall be suspended during any period during
which Product cannot be Commercialized as a result of any inherent defect in the
Product, any Recall required by any applicable regulatory body that is not
specific to identified Product lots that are replaced within a reasonable period
of time, or the Product being found to not be safe for use in humans.
6. MARKETING AND TECHNICAL SUPPORT
(a) Supplier agrees to provide Purchaser (but not to its Affiliates or
distributors), with such reasonable technical support as Purchaser may from time
to time request with respect to the Commercialization of the Product, including
access to research data, interpretation of such research data, assistance in
initial backgrounding of Purchaser sales, marketing and technical service
personnel, competitive analysis and general advice and counsel pertinent to
supporting the Products in the marketplace. Such support shall be provided at no
additional cost to Purchaser. To the extent appropriate, such data shall be
subject to the confidentiality obligations set forth in the License Agreement.
(b) Purchaser agrees to provide to Supplier copies of all training,
advertising and promotional materials for the Product, as those materials become
available, including translations thereof into the English language. Purchaser
agrees that all such materials shall be prepared in accordance with all
applicable laws and regulations.
(c) Supplier shall promptly refer to Purchaser all customer inquiries and
correspondence which Supplier receives from persons within a Territory in the
Field relating to the Product.
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7. REPRESENTATIONS, WARRANTIES AND COVENANTS.
(a) Supplier represents and warrants to Purchaser that it is duly
authorized and empowered to enter into and perform this Agreement; and the
execution and performance of this Agreement by Supplier 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 Supplier is a party or by which Supplier is
bound.
(b) Supplier represents and warrants to Purchaser that prior to first
shipment of the Product it will have received all necessary licenses, permits
and Regulatory Approvals for manufacture and export of the Product to the
applicable Territories and that there have been no recalls of Product.
(c) Supplier agrees to adhere to all known laws, rules and regulations
applicable to the manufacture of Product under this Agreement and warrants that
the Product will be manufactured in accordance with all Product specifications
and will be delivered to Purchaser free and clear of all third party claims,
liens and encumbrances.
(d) Purchaser represents and warrants to Supplier that it is duly
authorized and empowered to enter into and perform this Agreement; and the
execution and performance of this Agreement by Purchaser 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 Purchaser is a party or by which Purchaser is
bound.
(e) Purchaser represents and warrants to Supplier that the Product will,
when Commercialization takes place in a Territory, have received the necessary
Regulatory Approvals in such Territory, and covenants to offer or sell, directly
or indirectly, Product only in the Territories and Field in which all necessary
Regulatory Approvals have been obtained.
(f) Provided that Supplier is not in breach of this Agreement, Purchaser
shall not during the Exclusive Term purchase Product from any supplier other
than Supplier or a manufacturer authorized to manufacture Product by Supplier
without in each instance the prior written consent of Supplier. Purchaser shall
purchase Product solely for resale purposes as provided herein and shall not
combine the Product with any other components by further manufacturing or
otherwise. Purchaser shall not during the Exclusive Term manufacture or
distribute in any Territories any other Competitive Product. Purchaser agrees to
commercialize the Product in accordance with the terms and conditions of the
License Agreement.
8. MARKETING YEAR: 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 thirty (30) days following written notice thereof from the non-
defaulting party specifying the event of default; (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 120 days after filing; or (iii) the License Agreement is
terminated or expires.
(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 (and
reasonable adjustment made to the Minimum Purchase requirement, if such
suspension shall continue for more than 30 consecutive days) 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, failure
or inability to obtain suitable and sufficient labor, materials or
transportation facilities, or law, regulation or governmental order, whether or
not valid, restricting performance; provided, however, that such party shall
take reasonable measures to remove the disability or restriction and resume
operations at the earliest possible date, and further provided that nothing
contained herein shall excuse the obligation to pay money (except to the extent
that a Minimum Purchase requirement is adjusted as aforesaid).
(b) Subject to compliance with Section (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 Section (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.
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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
Indernnitor's failure to comply with any law or regulation applicable to the
performance of its obligations under this Agreement, (iii) Product seizures made
as a direct result of the Indemnitor's negligence, gross negligence or willful
misconduct in the performance of or failure to perform, its obligations under
this Agreement and any liabilities of Indernnitor in respect of recalls under
Article 4(d), and (iv) any labels or advertising used by the Indemnitor, in any
such case that is not based on any act or omission or alleged act or omission of
the Indemnitee. 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, Supplier will not be responsible for or
bound by any compromise made by Purchaser in any matter in which Purchaser is
indemnified by Supplier. Without its prior consent, Purchaser will not be
responsible for or bound by any compromise made by Supplier in any matter in
which Purchaser is indemnified by Supplier.
(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. Each of Supplier and Purchaser (and
each Affiliate of Purchaser purchasing and selling Product) shall at all times
during the term of this Agreement and for a period of 12 months after the
expiration or termination of this Agreement carry such products liability
(comprehensive general liability insurance) in such amounts and subject to such
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requirements and restrictions as may be customary in the Territory (in the case
of Purchaser or its Affiliates)or in the United States (in the case of
Supplier).
12. ARBITRATION.
(a) Excepting only actions and claims relating to actions commenced by a
third party against Supplier or Purchaser (including, without limitation, for
injuries caused by a Product or in respect to a trademark or patent infringement
claims), any controversy or claim arising out of or relating to the terms and
conditions of this Agreement, or the decision to agree upon these terms, or the
breach thereof, including questions of validity, infringement, or termination
hereof, shall be settled exclusively by arbitration in accordance with the rules
of the American Arbitration Association. If such controversy or claim relates to
patent validity or infringement, then the Patent Arbitration Rules of the AAA
shall apply, otherwise the International Arbitration Rules of the AAA shall
apply. Notwithstanding the forgoing to the contrary or in the arbitration rules
invoked or in this Section 12, the parties retain the right to request a
judicial authority to invoke interim measures of protection, and such request
shall not be deemed incompatible with this agreement to arbitrate or a waiver of
the right to arbitrate.
(b) There shall be one (1) arbitrator to be mutually agreed upon by the
parties and to be selected from the Regional Panel of Distinguished Neutrals. If
the parties are unable to agree upon such an arbitrator who is willing to serve
within ten (10)days of receipt of the demand by the other party, the parties
shall within three (3) days select one of the five (5) largest international
accounting firms (excluding those providing services for the parties) and engage
the managing partner or senior officer of its New York City office to designate
a partner of such firm to serve as the arbitrator. Failing that, then the AAA
shall appoint an arbitrator willing to serve from the Regional Panel of
Distinguished Neutrals, or if no such panel exists, then from an appropriate AAA
panel. It shall be the duty of the arbitrator to set dates for preparation and
hearing of any dispute and to expedite the resolution of such dispute.
(c) The arbitration shall be held in the City of New York, State of New
York, U. S. A. 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. The arbitrator shall permit
and facilitate discovery, which will be conducted in accordance with the Federal
Rules of Civil Procedure, taking into account the needs of the parties and the
desirability of making discovery expeditious and cost-effective. The arbitrator
will set a discovery schedule with which the parties will comply and attend
depositions if requested by either party. The arbitrator will entertain such
presentation of sworn testimony or evidence, written briefs and/or oral argument
as the parties may wish to present; however, no testimony or exhibits will be
admissible unless the adverse party was afforded an opportunity to examine such
witness and to inspect and copy such exhibits during the pre-hearing discovery
phase. The arbitrator shall among his other powers and authorities, have the
power and authority to award interim or preliminary relief. The arbitrator shall
not be empowered to award either party exemplary, consequential or punitive
damages or any enhanced damages for willful infringement and the parties shall
be deemed to have waived any right to such damages. A qualified court reporter
will record and transcribe the proceeding. The decision of the arbitrator will
be in writing and judgment upon the award by the arbitrator may be entered in
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any court having jurisdiction thereof. Prompt handling and disposal of the issue
is important. Accordingly, the arbitrator is instructed to assume adequate
managerial initiative and control over discovery and other aspects of the
proceeding to schedule discovery and other activities for substantially
continuous work, thereby expediting the arbitration as much as is deemed
reasonable to him, but in all events to effect a final award within 365 days of
the arbitrator's selection or appointment and within 20 days of the close of
evidence. The proceedings shall be confidential and the arbitrator shall issue
appropriate protective orders to safeguard both parties'confidential
information. The fees of the arbitrator and the AAA shall be paid as designated
by the arbitrator or, if he shall not so designate, they shall be split equally
between the parties.
13. ESCROW AGREEMENT. Notwithstanding the Effective Date of this Supply
Agreement, Supplier agrees to place into escrow when and as required under the
Escrow Agreement of even date herewith sealed containers containing a copy of
the Escrow Materials (as defined in the Escrow Agreement) for the Product to be
held subject to the terms and conditions of the Escrow Agreement. Supplier
shall, upon placing the Escrow Materials into escrow, so notify Purchaser of
such fact in writing.
14. NOTICES. Any notice provided for under this Agreement shall be
given by sending such notice to the noticed party by personal delivery, telecopy
or mail at the following address:
To Purchaser: FEMCARE UROLOGY LIMITED
Xx. Xxxxx Xxxxxx
Xxxxxxxxxx XX0 0XX Xxxxxx Xxxxxxx
Telecopy No: 011-44-l 00-000-0000
Attn: X. Xxxxxxx
To Supplier: Protein Polymer Technologies, Inc.
00000 Xxxxxxxx Xxxxxx Xxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Telecopy No: (000)000-0000
Attn: President
Any such notice delivered personally shall be effective upon confirmation of
receipt. Any such notice delivered by telecopy shall be effective upon
confirmation of receipt if received prior to 5:00 p.m., recipient's time, or
on the next business day following confirmation of receipt if received after
5:00 p.m., recipient's time, on the date of transmittal. Any such notice
delivered by mail shall be effective on the fifth (5th) business day following
deposit in first class mail, postage prepaid. Either party may change its notice
address by written notice to the other party.
15. MISCELLANEOUS.
(a) This instrument, together with 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
13
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 this 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 have the right to assign this Agreement or any
interest herein without the prior written consent of the other except in
connection with the sale or other disposition of all or substantially all of the
assets of the assigning party or its parent corporation.
(d) Supplier and Purchaser 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 Supplier nor Purchaser 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 in accordance with the laws of the
State of Delaware (U. S. A.). The invalidity of any provision of this Agreement
shall not impair the validity of any other provision; and any provision hereof
which might otherwise be invalid or contravene any applicable law shall hereby
be deemed to be amended to the extent necessary to remove the cause of such
invalidity and to the extent practicable to continue the intent of such
provision and of this Agreement, and such provision, as so amended, shall remain
in full force and effect as a part hereof.
(g) This Agreement shall be binding upon and enure to the benefit of the
parties hereto, their successors and permitted assigns.
(h) Those provisions of this Supply Agreement dealing with rights and
obligations upon and/or after termination of this Supply Agreement shall survive
termination of this Supply Agreement to the extent necessary to give effect to
such provisions.
(i) If either party terminates this Supply Agreement in accordance with
the terms herein, the terminating party shall owe no penalty or indemnity to the
terminated party on account of such termination.
(j) 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.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed
as of the day and year first above written.
FEMCARE UROLOGY LIMITED
By:
-----------------------------------
Printed Name:
----------------------
Title:
-----------------------------
PROTEIN POLYMERTECHNOLOGIES, INC.,
a Delaware corporation
By:
-----------------------------------
-----------------------------------
President
THE UNDERSIGNED PARENT COMPANY OF FEMCARE UROLOGY LIMITED, TO INDUCE PROTEIN
POLYMER TECHNOLOGIES, INC. TO ENTER INTO THIS AGREEMENT AND FOR OTHER GOOD AND
VALUABLE CONSIDERATION, THE RECEIPT, ADEQUACY AND SUFFICIENCY OF WHICH IS HEREBY
ACKNOWLEDGED, HEREBY IRREVOCABLY AND UNCONDITIONALLY GUARANTEES THE TIMELY AND
FULL PERFORMANCE AND PAYMENTS UNDER THIS AGREEMENT BY FEMCARE UROLOGY LIMITED
AND AGREES THAT IT SHALL BE BOUND BY THE ARBITRATION PROVISIONS HEREIN AS IF A
FULL PARTY HERETO.
Date: , 2000
-----------------
FEMCARE, LTD.
By:
--------------------------------
Name:
---------------------------
Title:
--------------------------
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