SUPPLY AGREEMENT
This SUPPLY AGREEMENT (the "Agreement") dated as of June 15, 1999, is
between ZLB Central Laboratory Blood Transfusion Service, SRC, a foundation
organized and existing under the laws of Switzerland having a principal place of
business at Xxxxxxxxxxxxxxx 00, xx 0000 Xxxx 00, Xxxxxxxxxxx ("ZLB"), and
Haemacure Corporation, a Canadian corporation having a principal place of
business at 0000 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxx, Xxxxxx
("Haemacure").
RECITALS:
A. ZLB and Haemacure are entering into a license agreement of even date
herewith (the "License Agreement") relating to ZLB's rights to produce for sale
and sell fibrin sealant products utilizing HAE Technology and Patent Rights (as
defined in the License Agreement).
B. ZLB shall manufacture the Products (as defined below) for Haemacure
under Haemacure's label.
C. The parties are entering into this Agreement under which ZLB will act
as a manufacturer for Haemacure and sell the resulting Products to Haemacure, as
provided herein.
AGREEMENT:
Now, therefore, in consideration of the premises and of the mutual
covenants contained herein, the parties hereto agree as follows.
1. Definitions.
(a) "Affiliate" shall mean with respect to any Person, any other Person
that directly, or indirectly through one or more intermediaries,
controls or is controlled by or is under common control with such
Person. For purposes hereof, the term "control" (including, with its
correlative meanings, the terms "controlled by" and "under common
control with"), with respect to any Person, means the possession,
directly or indirectly, of the power to direct or cause the direction
of the management and policies of such Person (whether through the
ownership of voting securities, by contract or otherwise); provided,
that in each event in which any Person owns directly or indirectly
more than 50% of the securities having ordinary voting power for the
election of directors or other governing body of a corporation or more
than 50% of the ownership interest of any other Person, such Person
shall be deemed to control such corporation or other Person.
(b) "Approval Date" shall mean the date upon which the Initial Product is
approved by any regulatory agency for sale in a given country.
(c) "Device" shall mean any accessory, applicator or other device supplied
by Haemacure to ZLB and approved by the relevant authority including
the approval of the market authorities of such markets in which the
Product is to be sold for packaging with the Products.
(d) "Net Sales" shall mean the gross amount invoiced or otherwise charged
by Haemacure and its Affiliates for the sale or other disposition of
Products, less the following deductions (to the extent not recovered
or recoverable from any person): (a) trade and/or quantity discounts
actually allowed and taken in amounts as are customary in the trade,
(b) sales and other excise taxes and customs duties paid, absorbed or
allowed, (c) transportation, postage and insurance costs, (d) amounts
repaid, credited or allowed by reason of rejection, defects or
returns; and (e) amounts allocated for any Device sold with the
Product. In the event of any sale or other disposition of any Products
by Haemacure to any Affiliate thereof for resale to its customers,
"Net Sales" shall be based on the greater of the gross amount invoiced
or otherwise charged by Haemacure to such Affiliate or the gross
amount invoiced or otherwise charged by such Affiliate to its
customers for such Products.
(e) "Products" shall include substances defined as products according to
the definition in Art. 1.11 under the License Agreement (also herein
referred to as "Substances" including devices as defined under Art.
1.3 of the License Agreement, except as provided in Section 2(d)
hereof.
2. Manufacturing and Supply.
(a) Manufacture and Supply. During the term of this Agreement, ZLB shall
manufacture for and supply to Haemacure, and Haemacure shall purchase
from ZLB, all of Haemacure's requirements of the Products according to
Section 4 hereof and the specifications for the Product as of the date
of approval in the various jurisdictions (as to be attached to this
Agreement at the time of such approval as Exhibit A, the
"Specifications"). The parties agree that the Specifications may be
modified or revised by mutual agreement of the parties, upon request
of the FDA or other regulatory body, and in the event of any such
modification or revision, the Specifications as so modified or revised
shall be the Specifications for purposes of this Agreement.
(b) Volume Variations. The parties agree that the Products for purposes of
this Agreement shall include any Volume Variations included in any
regulator filing. "Volume Variations" means such quantities as ZLB
may, in its discretion, manufacture during the term of this Agreement.
ZLB agrees to use commercially reasonable efforts to cause Volume
Variations requested by Haemacure to be approved by the FDA or other
regulatory body and, if approved, to be manufactured for sale by
Haemacure under the terms of this Agreement.
(c) Devices. Products supplied pursuant to Section 2(a) shall include the
Device to the extent that the Product circular or regulatory rule or
regulation requires the use of
2
the specific Device in order to use or promote the Product. Haemacure
may, from time to time, deliver to ZLB sterilized Devices to be
packaged with the Products. ZLB shall be compensated for any
packaging. The parties further agree to cooperate in obtaining
regulatory approval for Haemacure's ability to promote a given Device
with the Products.
(d) Excluded Products. Notwithstanding the incorporation of HAE Technology
or Patent Rights, Haemacure shall have no rights to Products under
this Supply Agreement to the extent Haemacure has not received a
cross-license to the Product pursuant to Section 2.5 of the License
Agreement.
(e) Warranties.
(1) ZLB warrants that all Product shipped to Haemacure pursuant to
this Agreement shall at the time of such shipment (i) be free
from defects in materials, designs and workmanship; (ii) meet the
Specifications; (iii) have product dating not less than as
provided in the Specifications or as agreed upon by the parties;
and (iv) not be adulterated or misbranded within the meaning of
the Federal Food, Drug and Cosmetic Act (the "Act").
(2) Haemacure warrants that all Devices and materials supplied and
shipped to ZLB to be used for packaging and production by ZLB (i)
be free from defects in materials, designs and workmanship and
(ii)meet the applicable regulatory specifications.
(f) ZLB Responsibility. In performing the manufacturing operations, ZLB
shall do the following unless Devices developed and delivered by a
third parties are concerned:
(1) Comply with all relevant materials, manufacturing, in-process
controls, label control and quality control specifications,
Product drawings/blueprints and operating procedures which are
applicable to the manufacture of the Products or subsequently
changed in accordance with this Agreement;
(2) Perform the release function for each lot of Product;
(3) Prepare and maintain a lot history record, including record of
any Product retention which may have been issued against the lot
during the manufacturing process, the action taken and the
disposition of the retention;
(4) Maintain and comply with the quality system as described in the
Quality Manual applicable to the manufacture of the Product:
(5) Maintain and comply with the standard operating procedures which
are applicable to the Product (relating to Product
3
manufacturing, testing and critical engineering system monitoring
and control, cleaning/sanitation, calibration of equipment,
preventive maintenance, employee training, pest control,
environmental control/monitoring, equipment/process validation,
labeling/packaging control, failure investigations, internal
quality audits, complaint handling, computer systems validation
and maintenance, Product release, Product/process change control
and delegation of authority).
(g) Resale. Subject to the terms of this Agreement and the License
Agreement, Haemacure may resell Product in such manner, at such prices
and upon such terms as Haemacure shall determine. The Parties agree
that ZLB may come up with the request to define a minimum price (on a
cost plus basis) to be negotiated between the parties before the first
delivery takes place, but in no event shall the minimum be less than
cost plus 40% as described in the 1996 Agreement. Haemacure is an
independent contractor, not an agent or employee of ZLB. Neither party
shall have any responsibility or liability for the actions of the
other except as specifically provided herein or in the License
Agreement. Neither party shall have any right or authority to bind or
obligate the other party in any manner or make any representation or
warranty on behalf of the other party.
3. Regulatory responsibility.
(a) ZLB shall:
(1) Be responsible, at its own cost, to prepare, submit and prosecute
all applications for certification or registration and/or any
other regulatory approvals required in connection with the sale
and/or use of Products by HAE and ZLB in all jurisdictions during
the term of this Agreement, including conducting all clinical
trials.
(2) Comply with the Good Manufacturing Practices or other relevant
regulations issued by the regulatory agencies including any
Product approvals or notices relating to the Product.
(3) Notify Haemacure within three business days of every visit to a
relevant facility by a regulatory agency, if the visit affects or
concerns the Products.
(4) Respond to any notices, warning letters and/or similar regulatory
inquiries which relate to the Product and supply Haemacure within
three business days of receipt and/or response with copies of
such notices and letters and the responses.
(5) Communicate to Haemacure within three business days of receipt
Product complaints relating to the Product received by ZLB,
maintain complaint and Adverse Drug Reaction ("ADR") files on
4
the Product as required by applicable law and cooperate with
Haemacure in the resolution of Product complaints.
(6) Conduct Product recalls, withdrawals or quarantines as required
by FDA, other competent authorities or the specific
circumstances.
(b) Haemacure shall:
(1) Supply ZLB with labeling for the Product which complies with the
specific regulatory agency requirements and which indicates that
Haemacure is the seller of the Product and indicates that ZLB is
the manufacturer of the Product;
(2) Communicate with and assist ZLB regarding the complaint analyses
and decisions relating to ADR filings as to the Product;
(3) Assist ZLB in resolving with the regulatory agencies any
complaints and ADRs as to the Product, and
(4) Comply with ZLB's Standard Operating Procedures for Recall Policy
as attached to Exhibit B and for Reporting Adverse Experiences as
attached to Exhibit C, and
(4) Assist ZLB in all recalls, withdrawals or quarantines relating to
the Product; if ZLB should notify Haemacure of a recall,
Haemacure shall promptly notify all of its customers who receive
the Product, in a manner commensurate with the hazard and recall
strategy contained in the U.S. FDA guidelines set forth in 21 CFR
Part 7, Subpart c and such other applicable regulatory agency;
and
(5) Not mislabel, misbrand or adulterate any of the Product received
from ZLB under this Agreement.
(c) Recalls. ZLB and Haemacure shall share equally all expenses incurred
pursuant to subsections 3(b)(3), (4) and (5) above for Product
supplied hereunder, except if such actions are taken due to ZLB's
failure to manufacture the Product in accordance with its
responsibilities under Sections 2 and 3 of this Agreement, then ZLB
shall bear all such expenses, including the cost of replacement
Product. Haemacure shall not recall any Product without ZLB's consent
and participation, which shall not be unreasonably withheld. In the
event that Haemacure recalls the Product because Haemacure has
evidence that the Product violates any provision of applicable, which
violation or need to recall is due to ZLB's failure to manufacture the
Product in accordance with its responsibilities under Sections 2 and 3
of this Agreement, ZLB shall pay or reimburse Haemacure for all costs
and expenses of such recall, including expenses or obligations to
third parties, the cost of notifying customers and costs
5
associated with the return of recalled Product by customers, provided
that any losses, costs or expenses arising from property damage,
personal injury or death shall be borne as provided in Section 6
hereof.
(d) Labeling. ZLB agrees to use all commercially reasonable efforts to
obtain a timely approval of all labeling and advertising for
Haemacure's sale of the Product. ZLB shall promptly provide Haemacure
with copies of any correspondence from the regulatory agency regarding
such labeling and advertising. Haemacure shall have the option of
attending meetings with regulatory agencies regarding Haemacure
labeling. To the extent possible, ZLB shall make all filings with
regulatory agencies to allow Haemacure to correspond directly with
regard to its labeling and advertising.
(e) Non-Disclosure. ZLB and Haemacure agree to use all commercially
reasonable efforts to establish mutually acceptable procedures to
permit Haemacure to have its labeling and advertising for the Product
approved by the U.S. FDA without pre-publication disclosure of such
labeling and advertising to ZLB other than as may be necessary for ZLB
compliance personnel to review and process the labeling and
advertising with the FDA. Such procedures shall include requiring
confidentiality agreements from such ZLB compliance personnel.
(f) Confidentiality. ZLB agrees to keep confidential information regarding
regulatory approval of Haemacure's labeling for the Product, and
information regarding Haemacure's orders and shipments for the
Product, and all of the foregoing information shall be disclosed only
to those employees of ZLB that have a need to know it in order to
review and process labeling and advertising, fill shipments and
orders, and answer such inquiries.
4. Forecasts and Orders.
(a) Orders. ZLB will manufacture the Products according to the capacity as
agreed to be installed by ZLB according to the Parties estimate in
1997 and specified in each order submitted by Haemacure, and will
deliver the Products to the location, in the quantities and by the
date specified in such order. The terms and conditions of this
Agreement, as supplemented only by the delivery dates and quantity of
Products contained in a written order, shall govern all sales of
Products hereunder notwithstanding any additional, different or
conflicting terms set forth in an acknowledgement or other forms of
correspondence with Haemacure (all of which additional, different or
conflicting terms, if any, are hereby expressly rejected). A firm
order is to be based on forecasts and planning indications according
to the following time frame:
Firm Order: Final and binding confirmation for an order ("Final
order") must be received by ZLB at least 6 months prior to the
date that the Products must be shipped from the Facility. The
entire amount of all Final Orders for a business year shall not
deviate more than 20% from the Forecast as defined hereinafter.
6
Forecast: Haemacure shall give ZLB a forecast for Products to be
supplied in any quarter of the business year ("Quarter") at least
10 months prior to the first day of this Quarter.
(b) Cancellation. No order accepted by ZLB may be cancelled or altered by
Haemacure except upon terms and conditions acceptable to Haemacure, as
evidenced by its written consent. Haemacure may cancel any order at
any time, with or without cause, and Haemacure's liability for such
cancellation shall be limited to ZLB's out-of-pocket costs and
expenses incurred for such cancelled order.
(c) Product Forecasts. For planning purposes only, and not as a firm order
or promise to purchase, upon the date of ZLB's submission of a license
with any regulatory agency, Haemacure shall provide ZLB with a
forecast of the Product (or developed Product, as the case may be)
that Haemacure anticipates that it will order during the year
following the Approval Date. Haemacure shall give ZLB a forecast of
orders of Product that Haemacure expects to place with ZLB during the
first 15 months by not later than 1st September, 2001. Haemacure will
provide Product forecasts in accordance with this Section 4 for
Products other than the initial Product.
(d) Shipping. Unless otherwise agreed to in writing by the parties, all
Products manufactured by ZLB shall be shipped to Haemacure ExWorks
(IncoTerms 1990) the facility. All risk of loss and damage to the
Products while at the Facility will remain with ZLB.
(e) Long Range. The parties shall cooperate in good faith in providing
other, longer range forecasts which shall be useful in budget planning
for the parties.
(f) Allocation. ZLB will use all commercially reasonable efforts to
allocate Product fairly and equitably to Haemacure, based on the
relative potential sales by Haemacure and any other marketing company
ZLB appoints or itself, provided that Haemacure shall be allocated the
lesser of 50% of the Product or its firm orders, it being expressly
understood that Haemacure is only willing to enter the License
Agreement if it is guaranteed its fair allocation of Products pursuant
to this Agreement.
(g) Title. Title to finished, released Product shall pass to Haemacure
when the Product is placed on Haemacure's designated carrier at ZLB's
manufacturing facility. All freight, insurance (and any customs
duties) for on-time shipments shall be paid by Haemacure. ZLB shall
pay any additional, expedited shipping charges for late shipments
resulting from ZLB's failure to comply with its obligations under
Sections 2 or 3 hereof.
(h) Claims Procedure. Haemacure shall inspect and analyze the Products for
conformity with the applicable order and the Specifications within
thirty (30) days after receipt by Haemacure of such shipment of
Products. Haemacure shall make all claims with respect to the Products
as follows:
7
(1) Claims for Damage During Transit. Any claims by Haemacure for loss or
damage to Products while in transit shall be made by Haemacure to its
carrier or agent and not to ZLB.
(2) Claims for Delivery Error. Any claim that a shipment contains a
shortage of Products or other error in delivery must be made by
Haemacure to ZLB in writing within thirty (30) days from the date of
receipt by Haemacure of such shipment of Products together with a
reasonably detailed description of the amount of the shortage or other
delivery error. Haemacure's failure to make a claim in accordance with
the foregoing sentence shall constitute agreement by Haemacure that
there was no error in delivery. Provided that Haemacure makes a claim
in accordance with this Section 4(h) and proves that such shipment
contains a shortage of Products or other error in delivery, ZLB, at
Haemacure's option, shall deliver to Haemacure to the location(s)
designated by Haemacure, at ZLB's risk and cost and expense, the
amount of Products in shortage in such shipment, or credit Haemacure
the amount of such shortage.
(3) Claims for Non-Conforming Goods. In the event that Haemacure claims
that upon delivery any of the Products are non-conforming because of
ZLB's failure to perform according to its contractual duties
hereunder, Haemacure may reject the same, provided that (i) within
thirty (30) days after receipt by Haemacure of such shipment of
Products, Haemacure notifies ZLB of such rejection, in writing,
together with a reasonably detailed description of why the Products
have been rejected ("Rejection Notice"), (ii) Haemacure returns to ZLB
the rejected Products or shipment, subject to the terms and conditions
hereinafter provided, within thirty (30) days after Haemacure sends
the Rejection Notice, and (iii) none of the Products (except for
reasonable test and inspection quantities) has been changed from its
original condition. Haemacure's failure to make a claim in accordance
with the foregoing sentence shall constitute unqualified acceptance of
all shipments and Products. Provided that the rejected Products have
been rejected by Haemacure in accordance with the terms of the
preceding sentence and are proved to have been non-conforming because
of ZLB's failure to perform according to its contractual duties
hereunder, (i) ZLB shall reimburse Haemacure for all costs and
expenses incurred by Haemacure in shipping the rejected Products back
to ZLB, (ii) the risk of loss with respect to the rejected Products
shall pass to ZLB upon delivery of the rejected Products by Haemacure
to the carrier/shipping agent designated by Haemacure for the delivery
8
of the reject Products to ZLB, (iii) ZLB, at Haemacure's option, will
replace all rejected Products with conforming Products or refund to
Haemacure the price that Haemacure paid for such rejected Products,
and (iv) any such replacement Products will be shipped, at ZLB's risk
and expense, to the location(s) designated by Haemacure.
(i) Warranty Claims. In the event that Haemacure, in good faith, claims
that any of the Products are in breach of the warranties set forth in
Section 2(e) above, Haemacure may make such a claim provided that: (i)
such claim is made by Haemacure no later than later of the expiry of
the shelf life or two (2) years after such Products are delivered to
Haemacure; (ii) such claim is made in writing and contains a
reasonably detailed description of the reason that the Products are in
breach of the warranties contained in Section 2(e); (iii) Haemacure
returns the Products in question to ZLB no later than one hundred
sixty (60) days after Haemacure makes its claim to ZLB; and (iv) none
of the Products in question (except for reasonable use, test and/or
inspection quantities) has been changed from its original condition.
The failure by Haemacure to make a warranty claim in accordance with
the terms of the foregoing sentence shall constitute a waiver by
Haemacure of all claims for breach of warranty by Haemacure with
respect to the applicable Products. Provided that Haemacure makes its
warranty claim in accordance with the terms of this Section 4(i) and
the Products are proved to be in breach the warranties provided in
Section 2(e): (1) ZLB shall reimburse Haemacure for all costs and
expenses incurred by Haemacure in shipping the Products back to ZLB,
(2) the risk of loss with respect to the Products shall pass to ZLB
upon delivery of the Products by Haemacure to the carrier/shipping
agent designated by Haemacure to ship the Products back to ZLB, (3)
ZLB, at Haemacure's option, will replace all Products with conforming
Products or refund to Haemacure the price that Haemacure paid for such
Products, at no cost to Haemacure, and (4) such replacement Products
will be shipped, at ZLB's risk and expense, to the location(s)
designated by Haemacure. Provided that Haemacure makes a warranty
claim in accordance with the terms of this Section 4(i), Haemacure
shall make available to ZLB or to an independent auditing company all
records and documents related to the custody of such Products by
Haemacure or its customers.
5. Pricing and Payment:
(a) Prices. The purchase price to be paid by Haemacure to ZLB for the
initial Products which are currently the subject of Phase III
clinicals (or developed thereafter any improvement or modification
prior to initial licensure) shall be 60% of the Net Sales price, and
for Products shall be 70% of Net Sales price.
(b) Most Favorite Pricing. Anything to the contrary notwithstanding, ZLB
agrees that the price to Haemacure for any Product shall at no time
and in no event exceed the price contemporaneously charged by ZLB to
any other customer or marketing partner for the equivalent order of
volumes, terms and conditions for the Products.
9
(c) Payment. Haemacure shall pay to ZLB a first installment owed pursuant
to Section 5(a) within 45 days based on the Net Sales of Products
during the preceding calendar quarter. Haemacure shall pay to ZLB
final payment for the delivery 45 days after the end of each calendar
quarter based on the Net Sales of Products during that calendar
quarter. Such payments shall be accompanied by a statement setting
forth the Net Sales of the Products by Haemacure and its Affiliates,
which statement shall indicate (i) the gross amount invoiced or
otherwise charged by Haemacure and its Affiliates for the sale or
other disposition of the charged by Haemacure and its Affiliates for
the sale or other disposition of the Products, and (ii) the Net Sales
of the Products.
(d) Records. Haemacure shall keep complete and accurate records of the Net
Sales of the Products in sufficient detail to all the royalties
payable hereunder to be accurately determined. ZLB shall have the
right for a period of two years after receiving any report or
statement with respect to prices due and payable hereunder to appoint
an independent accounting firm reasonably acceptable to Haemacure to
inspect and audit the relevant records of Haemacure and its Affiliates
to very such report or statement. Haemacure and its Affiliates shall
make their records available for inspection and audit by such
independent accounting firm of ZLB during regular business hours at
such place or places where such records are customarily kept, upon
reasonable notice to Haemacure, to the extent reasonably necessary to
verify the accuracy of the reports and payments required hereunder;
provided, that such inspection and audit right shall not be exercised
more than once in any calendar year with respect to Haemacure or any
Affiliate thereof. ZLB shall be responsible for the cost of any such
inspection and audit by an independent accounting firm, unless such
inspection and audit discloses for any calendar quarter examined that
there shall have been a discrepancy of greater than 5% between the
prices payable by Haemacure hereunder and the royalties actually paid
to ZLB with respect to such calendar quarter, in which case Haemacure
shall be responsible for the payment of the entire cost of such
inspection and audit. ZLB agrees to hold confidential all information
concerning royalty payments and reports, and all information obtained
from Haemacure or any Affiliate thereof in the course of an inspection
or audit hereunder, except to the extent that it is necessary for ZLB
to disclose such information in order to enforce its rights under this
Agreement or if required by law or any governmental authority
(including, without limitation, any stock exchange upon which ZLB's
shares or other securities may be traded); provided, however, if any
party shall be required by law to disclose any such Confidential
Information to any other Person, such party shall give prompt written
notice thereof to the other party and impose upon any Person entitled
to obtain such Confidential Information such obligations of
confidentiality as may be lawfully available.
6. Indemnification.
(a) ZLB Indemnification. ZLB agrees to indemnify Haemacure and defend and
hold it harmless from any liability, loss, expense, cost, damages,
claim or judgment (including reasonable attorneys' fees) arising out
of (i) any claim for property damage, personal injury or death which
is alleged to have been caused by ZLB's failure to manufacture the
Product in accordance with Section 2(e) or (ii) ZLB's breach of this
Agreement. ZLB agrees to maintain an adequate insurance policy
covering product liability and covering loss or
10
damages to inventory of the Product in its possession and ownership,
the respective coverage being in excess of USD 1 Mio.
(b) Haemacure Indemnification. Haemacure agrees to indemnify ZLB and
defend and hold it harmless from any liability, loss, expense, cost,
damages, claim or judgment (including reasonable attorneys' fees)
arising out of Haemacure's breach of this Agreement. Haemacure agrees
to maintain an adequate insurance policy covering product liability
and covering loss of or damages to inventory of the Product in its
possession and ownership, the respective coverage being in excess of
USD 1 Mio.
(c) Binding. The foregoing indemnity obligations shall be binding upon and
shall inure to the benefit of ZLB and Haemacure and their respective
Affiliates, successors and assigns.
(d) Notice. Upon obtaining knowledge of the institution of any action,
proceeding, or other event which could give rise to a claim for
indemnity hereunder, the party seeking indemnification shall promptly
notify the other party thereof. Failure of any indemnified party to
promptly give such notice shall not relieve the indemnifying party of
its obligation to indemnify under this Section 6, but as a result of
any such failure, the indemnified party shall not be liable to the
indemnifying parties for the amount of actual damages caused by such
failure. If such claim or demand relates to a claim or demand asserted
by a third party, the indemnifying party shall have the right at its
expense to employ counsel to defend such claim or demand and the
indemnified party shall have the right, but not the obligation, to
participate in the defense of any such claim or demand at its own
expense. So long as the indemnifying party is defending such claim or
demand in good faith, the indemnified party will not settle such claim
or demand without the indemnifying party's consent. The indemnified
party shall make available to the indemnifying party all records and
other materials reasonably required by it in contesting a claim or
demand asserted by a third party against the indemnified party and
shall cooperate in the defense thereof.
7. Term and Termination.
(a) The term of this Agreement shall begin on the date hereof and end on
the tenth (10th) anniversary of the Approval Date.
(b) Either party may terminate this Agreement in the event that the other
party files or has filed against it (and such filing is not dismissed
or stayed within 60 days) a petition in bankruptcy or enters into any
similar arrangement for the benefit of its creditors.
(c) Either party may terminate this Agreement if the other party commits a
material breach of its obligations hereunder and such breach is not
cured within 60 days after receipt of notice specifying such breach.
11
8. Confidentiality.
(a) Confidentiality. During the term of this Agreement and for a period of
3 years thereafter, each party shall keep strictly confidential and
shall not disclose to any third party any proprietary or confidential
information disclosed to it by the other Party hereunder in writing,
or orally disclosed hereunder and confirmed in writing as being
confidential promptly after its oral disclosure, except to the extent
such disclosed information
(1) is or becomes generally available to the public through no fault
on the part of the receiving party, or
(2) was known to the receiving party prior to receipt thereof as
evidenced by prior written documents in the possession of the
receiving party, or
(3) is subsequently disclosed to the receiving party in good faith by
a third party who is not under an obligation of secrecy as to the
information disclosed.
(b) Inter-Party Disclosures. It is agreed that, for the purpose of this
Agreement, specific disclosures of information disclosed to each other
shall not be deemed to be within the foregoing exceptions merely
because they are embraced by general disclosures in the receiving
party's possession or in the public domain.
(c) Third Parties. Each party hereby undertakes to impose the same
obligation of secrecy on its employees, licensees or sub-licensees,
contractors or agents, as the case may be.
9. Governing Law and Arbitration.
(a) Governing Law. The validity, construction, interpretation and
performance of this Agreement shall be governed by the substantive
Laws of Switzerland expressly excluding the conflict of law rules.
(b) Arbitration. Any or all disputes arising between the parties hereto
from or in connection with this Agreement or in respect of the
conclusion interpretation, breach or enforcement thereof shall, where
not capable of being settled amicably, be settled to the exclusion of
recourse to the ordinary courts of law finally and with binding effect
by arbitration under the Rules of the International Chamber of
Commerce by an arbitration tribunal consisting of three arbitrators
appointed in accordance with the said Rules, save that each party is
entitled as a provisional and protective measure to seek injunctive
relief from an ordinary court of law as may be possible under Canadian
or Swiss law. The foregoing shall also apply to the decision
respecting the jurisdiction of the arbitration tribunal and the
validity of this arbitration clause. Any such arbitration shall be
held in Paris and be conducted in the English language.
12
10. Force Majeure.
Neither party shall be liable to the other party for non performance or
delay in performance of any of its obligations under this Agreement due to
causes reasonably beyond its control including fire, flood, strikes, labor
troubles or other industrial disturbances, unavoidable accidents, governmental
regulations, riots, and insurrections. Upon the occurrence of such a force
majeure condition the affected party shall immediately notify the other party
with as much detail as possible and shall promptly inform the other party of any
further developments. Immediately after the cause is removed, the affected party
shall perform such obligations with all due speed unless the Agreement is
previously terminated in accordance with Article 10 hereof.
11. Notices.
(a) Modifications. No modification hereof shall be of any force or effect
unless reduced to writing and signed by the parties claimed to be
bound thereby and no modification shall be effected by the
acknowledgement or acceptance of any order containing different
conditions.
(b) Notice. All communication notices or the like between the parties
shall be valid when made by telegraph or telex communication
subsequently to be confirmed in writing and addressed to the following
addresses:
To ZLB: CEO
ZLB CENTRAL LABORATORY,
BLOOD TRANSFUSION SERVICE SRC,
Xxxxxxxxxxxxxxx 00,
0000 Xxxx 00, Xxxxxxxxxxx
Facsimile: x00 00 000 00 00
with a copy to: Xxxxxxx & Streichenberg
XX Xxx 0000
XX-0000 Xxxx, Xxxxxxxxxxx
Attn: Xxxxx X. Xxxxxx
Facsimile: x00 00 000 00 00
To Licensor: CEO
HAEMACURE CORPORATION
One Sarasota Xxxxx
Xxx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000,
Xxxxxxxx XX 00000, XXX
13
with a copy to: Xxxxx & Xxxxxxx
000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
12. Severability.
(a) In the event any provision of this Agreement is declared illegal or
unenforceable, it is the intent of both parties that the remaining
provisions shall continue in full force and effect and that the
illegal or unenforceable provision shall be substituted by a provision
having a similar commercial effect.
13. No Waiver.
(a) No waiver. No waiver of any breach of any part of the terms or
conditions herein contained to be performed by the other party shall
not be construed as a waiver of any subsequent breach whether for the
same or any other term or condition hereof
14. Miscellaneous.
(a) Assignment by ZLB. This Agreement and all rights, liabilities and
obligations hereunder shall be binding upon and inure to the benefit
of ZLB. Haemacure expressly agrees that all rights and duties
contained in this Agreement may be transferred and assigned to the new
ZLB AG after its incorporation. ZLB agrees that any assignment of its
rights shall be subject to all the obligations owed to Haemacure
hereunder.
(b) Assignment by Haemacure. This Agreement and all rights, liabilities,
and obligations hereunder shall be binding upon and inure to the
benefit of Haemacure or any of its successors, or assignees, provided
that Haemacure may only assign its rights under this obligation in
whole and not in part. Haemacure covenants that for the term of this
Agreement it will not assign nor make any commitments or offers in a
manner that conflicts with the rights of ZLB created by this
Agreement.
14
(c) Entire Agreement. Along with the License Agreement, this Agreement
constitutes the legal, valid, binding and enforceable obligation and
sets forth the entire understanding of the parties and supersedes and
cancels any prior communications, understandings and agreements
between the parties relating to the subject matter hereof and may not
be amended or modified except in writing executed by each of the
parties.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.
For and on behalf of Haemacure For and on behalf of ZLB
By: By:
--------------------------- ------------------------------
Typed name: Typed name:
------------------- ----------------------
Position: Position:
--------------------- ------------------------
15
Exhibit A
According to this Agreement ZLB shall manufacture for and supply to Haemacure,
and Haemacure shall purchase from ZLB products to be produced according the
following Specifications:
The Product consists of two components (a) Fibrinogen (and its associated
proteins Factor XIII and Fibronectin), whether in liquid or lyophilized form,
isolated by repeated salt precipitation in the presence of amino-6-hexanoic
acid, the latter being used to prevent co-precipitation of plasminogen (b)
Thrombin, whether in liquid or lyophilized form, isolated by ion-exchange
chromatography over a sulpho-alkyl group - containing gel, with elution of the
protein by acetate buffer.
And such other Products, as and when approved in the forms appropriate.
16
Exhibit B
Document:
"Haemacure Corporation, Standard Operating Procedure; Recall Policy;
Issued by ZLB/Gan/KS (Doc No: Soprepoh/20.5.99)"
17
Exhibit C
Document:
"Haemacure Corporation, Standard Operating
Procedure; Reporting Adverse Experiences;
Issued by ZLB/Gan/KS (Doc No: Sopadexh/20.5.99)"
18
