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MARKED WITH ASTERISKS (***).]
EXHIBIT 10.10
MANUFACTURING AGREEMENT
Between
OPOCRIN S.P.A. - having its registered office at via Pacinotti, 3 - 41040 Corlo
di Formigine (Modena) Italy - Via Pacinotti 3 thereinafter referred to as
OPOCRIN)
and
PARTEC having its registered office at 216 Jaffa Road, Jerusalem 94383 Israel
(thereinafter referred to as PARTEC)
(together called PARTIES)
have agreed, on 16 April 1999, as follows:
WHEREAS
OPOCRIN is an Italian firm which has been producing for many years biological
products in bulk from animal glands and tissues. One of these products is
porcine Sulodexide (Glucuronylglucosaminglycansulphate) . ("DS") which OPOCRIN
has been supplying ALFA WASSERMANN (thereinafter referred to as ALFA) for its
specialty VESSEL, since the date of its commercialization.
PARTEC is an Israeli company specialized in the development and marketing of
biopharmaceutical products and is interested in buying DS from OPOCRIN pursuant
to the terms set forth in this Agreement for a product to be registered,
approved and marketed throughout the world (hereinafter referred to as the
TERRITORY).
NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:
PRODUCTION
1. OPOCRIN agrees to manufacture and PARTEC agrees to purchase amounts
of DS as PARTEC shall order from time to time for sale by PARTEC,
or its licensees, affiliates or partners, in the TERRITORY. OPOCRIN
may, subject to PARTEC's prior written agreement, procure the
supply of DS to PARTEC from a third party, provided that such
supply of DS shall conform in all respects to the requirements set
forth in this Agreement. Partec shall purchase, at a minimum,
amounts of DS from Opocrin sufficient to meet its needs for all
clinical trials of Sulodexide during the term of this Agreement.
Such amounts shall not be less than ten (10) kilograms for the
Phase II trials and one hundred (100) kilograms for the Phase III
trials, provided that the conduct of such trials is approved by the
United States Food and Drug Administration (the "FDA"). Provided
that OPOCRIN continues to comply with its obligations under this
Agreement, PARTEC agrees that it shall continue to purchase from
OPOCRIN all the DS it shall require for the sale and distribution
of Sulodexide subsequent to the approval of such sale by the FDA,
and shall recommend to its sublicensees, if any, that they should
purchase their DS needs from OPOCRIN as well.
2. OPOCRIN states that its production of DS is made according to its
own Drug Master File ("D.M.F.") (which was supplied by ALFA to
PARTEC under a separate agreement) which shall comply with
acceptable manufacturing procedures. OPOCRIN agrees to comply in
the future with the regulations and guidelines promulgated from
time to time by the FDA and other regulatory authorities and
current Good Manufacturing Practices ("cGMP"). The above mentioned
D.M.F. contains an International Validation to exclude the presence
of conventional viruses in the final product.
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3. PARTEC's purchase of DS from OPOCRIN shall not confer on PARTEC or
its licensees, affiliates and/or partners, any licensee, express or
implied, of OPOCRIN's proprietary, confidential information and
know-how.
4. OPOCRIN requires a minimum lead time from the placement of an order
up to the date of delivery of forty five (45) Italian business
days. Provided that PARTEC has not been declared in breach of this
Agreement by OPOCRIN, OPOCRIN may not refuse a production order
from PARTEC made pursuant to this Agreement.
5. OPOCRIN shall give written notice of at least sixty (60) days to
PARTEC in the event that it takes any operational or strategic
decision that could affect, in any way, the timely and appropriate
fulfillment of OPOCRIN's obligations set forth in this Agreement
and shall take all necessary steps to prevent such decision having
such effect.
6. OPOCRIN agrees that in the event that (a) it becomes unable to meet
the needs of PARTEC for the production of DS; or (b) PARTEC has
sublicensed some or all of its rights to produce and sell
Sulodexide to a third party that, in spite of PARTEC's
recommendation to purchase its DS needs from OPOCRIN, chooses to
move the manufacture of DS from OPOCRIN to another manufacturer,
OPOCRIN shall transfer, without cost to PARTEC beyond the amounts
set forth in paragraph 10, below, all information produced by it in
connection with the fulfillment of its obligations under this
Agreement, but not proprietary to OPOCRIN, to PARTEC for
transmission to such other manufacturer. In the event that
information proprietary to OPOCRIN is required by the other
manufacturer to produce DS according to the specifications
required, OPOCRIN shall be entitled to a reasonable license fee for
such information upon reasonable terms and conditions to be
negotiated between OPOCRIN and the relevant parties. Absent the
successful conclusion of such a license agreement to OPOCRIN's
proprietary information, OPOCRIN shall have no obligation to
release such proprietary information to PARTEC or any third party.
7. OPOCRIN shall supply all the data in its possession required by
PARTEC in connection with its Initial New Drug application with the
FDA within twenty one (21) days of PARTEC's request for such data.
In addition, OPOCRIN, at the appropriate time, shall generate, in
return for the *** payment set forth in paragraph 10, below, all
reasonable data necessary to support an approvable D.M.F. and shall
provide PARTEC with a letter of authorization referencing the
"closed section" of the D.M.F. for the purposes of complying with
FDA requirements ("Letter of Authorization").
8. As soon as practicable after receiving FDA approval for an
appropriate IND, and in each September thereafter, the PARTIES
shall meet to discuss forecasts of PARTEC's anticipated future
needs. Should the parties agree that PARTEC's anticipated future
needs exceed OPOCRIN's manufacturing capacity, OPOCRIN shall submit
a plan within three (3) months of the data such under-capacity
becomes known to the parties whereby it shall increase such
capacity.
PRICE, SHIPPING AND TERMS OF DELIVERY
9. The per kilogram price for the DS being purchased in connection
with the Phase II and III clinical trials shall be calculated by
multiplying the per kilogram United States bulk price of sodium
heparin at the time each order is placed by PARTEC by a factor of
***. The price quoted by OPOCRIN on each order shall be the total
price invoiced to and paid by PARTEC and shall subsume any and all
costs incurred by OPOCRIN in the performance and production of such
order. The parties shall negotiate in good faith the yearly price
for DS once, and if, the FDA grants its approval for the commercial
marketing of DS.
10. Within ten (10) days of the date of the execution of this
Agreement, PARTEC shall pay to OPOCRIN the amount of ***. This
payment represents (a) a *** non-refundable payment in
consideration of the set-up work that OPOCRIN is required to do at
the proper time to comply with its obligations under this
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Agreement, including, but not limited to, the preparation of the
D.M.F., the Letter of Authorization and all supporting materials;
and (b) a *** non-refundable advance against payment for the DS to
be purchased in connection with the Phase II clinical trials.
Within ten (10) days of the successful completion of the Phase II
trials, PARTEC shall pay to OPOCRIN the amount of *** as an advance
against payment for the DS to be purchased in connection with the
Phase III clinical trials. In the event that such Phase III trials
are not held, OPOCRIN shall refund PARTEC this *** prepayment.
11. OPOCRIN sells DS, C.L.F. arrival at a location of PARTEC's
choosing. All orders of DS shall be shipped by OPOCRIN in a manner
that accords with cGMP quality and accreditation requirements.
OPOCRIN shall provide all reasonable documentation necessary to
allow the release of the order from any reasonable customs
restrictions to either PARTEC or a third party designated by
PARTEC, but shall not be responsible for the final clearing of the
order from customs. PARTEC shall be responsible for paying all
appropriate customs duties and charges.
12. PARTEC shall pay for each order of DS as follows: Fifty percent
(50%) of the purchase price by Swift telex transfer to OPOCRIN not
later than 30 (thirty) days from the date of invoice; and fifty
percent (50%) of the purchase price by Swift telex transfer to
OPOCRIN not later than fifty (50) days from the date of the AWB
accompanying the order.
WARRANTY AND QUALITY CONTROL
13. OPOCRIN warrants:
a) That DS shall be of the kind and quality described in the
product specifications of the relative D.M.F.,
b) That the certificate of analysis which will accompany DS is
correct and has been produced using accepted procedures and
standards and by reputable workers, and
c) That it shall update the D.M.F. as required by relevant
governmental requirements of the FDA, with a copy to PARTEC.
14. OPOCRIN agrees that it shall perform a thorough quality control
check on each batch of DS manufactured pursuant to an order
submitted by PARTEC and that such check shall include, but not
necessarily be limited to, characterization and statistical
analysis of potency.
15. At least six (6) weeks Prior to the scheduled dispatch of each
batch of DS, OPOCRIN shall send a sample of the batch to PARTEC, or
to a third party designated in writing by PARTEC. PARTEC shall have
the sample analyzed according to the technique set out in the
D.M.F. and shall communicate the results of the analysis to OPOCRIN
within four (4) weeks of receipt of the sample. If, after
conducting the quality testing set forth in this paragraph, a
sample is determined to have failed such quality testing, OPOCRIN
shall replace, within twenty (20) Italian business days of receipt
of written notification by PARTEC, the defective sample at its own
expense and pay all freight with respect to such replacement.
PARTEC assumes sole responsibility for determining whether the DS
is suitable for the use contemplated by PARTEC.
16. PARTEC, or a third party chosen by it, shall analyze each batch of
DS upon receipt and shall inform OPOCRIN within fourteen (14) days
of PARTEC's receipt of the batch of any discrepancy between the
analysis of the sample provided and approved under paragraph 14,
above, and the analysis of the batch of DS. If, after conducting
the analysis set forth in this paragraph, a batch is determined to
be different than the sample approved under paragraph 14, above,
OPOCRIN shall replace, within 3 (three) weeks of receipt of written
notification by PARTEC, the defective batch at its own expense with
a sample of a new batch in the manner set forth in paragraph 15,
above, and pay all freight and duty with respect to such
replacement,
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CONFIDENTIAL
provided, however, PARTEC has stored the batch under proper
conditions from the date it received such batch. In the event of
any disagreement over the analysis conducted pursuant to this
paragraph, the PARTIES shall use all reasonable means to reach
agreement.
17. In the event that the sample or the batch of DS manufactured by
OPOCRIN to replace the defective batch should itself fail to pass
the agreed upon quality control standards set forth in the D.M.F.
and this Agreement, OPOCRIN shall pay any definitively
ascertainable consequential damages incurred by PARTEC as a result
of the delay in production of Sulodexide tablets engendered by a
delay caused by such failure, including, but not limited to, any
costs associated with the cancellation of tablet manufacturing
previously scheduled in reliance upon OPOCRIN's timely production
and delivery of conforming DS, provided that in no event shall such
damages, even if proven, exceed one-third (1/3) of the purchase
price of such batch.
18. Any dispute regarding the quality of a batch delivered pursuant to
this Agreement that cannot be settled amicably within thirty (30)
days after it arose shall be referred to an independent testing
organization that meets appropriate Good Laboratory Practices or to
a consultant of recognized repute within the European
Pharmaceutical Industry mutually agreed upon by the parties. If the
parties cannot agree on the appointment of such organization or
consultant within forty five (45) days after the dispute arose,
either party may request the chairman of the International Chamber
of Commerce to appoint an organization or consultant. The
determination of the organization or consultant so chosen or
appointed shall be final and binding on the parties. Any fees and
expenses of the organization or consultant shall be borne by the
party against which the determination is made.
RECORDS AND CONFIDENTIALITY
19. OPOCRIN shall maintain the appropriate records in connection with
the production of DS for PARTEC pursuant to this Agreement. At
least once in each six (6) month period (beginning with the
execution of this Agreement), OPOCRIN shall provide PARTEC with a
complete set of such records in electronic and typed form. All
records required to be maintained by this Agreement shall be
maintained in the English language.
20. The parties recognize that in the course of fulfilling their
respective obligations pursuant to this Agreement, they will have
occasion to disclose to each other confidential and proprietary
information. Accordingly, they agree to execute a non-disclosure
agreement substantially in the form as annexed to this Agreement as
Attachment A.
LIABILITY AND INDEMNIFICATION
21. Other than as set forth in paragraph 17 above, OPOCRIN shall only
be liable for any injury, monetary or otherwise, suffered by PARTEC
or any third party in connection with the Product or its use, if
and only to the extent such injury was caused by the Product at
issue not being manufactured in conformance with the requirements
of the D.M.F. and the other provisions of this Agreement.
22. PARTEC agrees to indemnify, hold harmless and defend OPOCRIN, its
trustees, officers, employees, and agents from and against any and
all claims, suits, losses, damages, costs; fees, expenses
(including reasonable attorney's fees), and other liabilities
asserted by third parties, both government and non-government,
resulting from or arising out of the manufacture and supply of the
Product carried out pursuant to this Agreement; provided, however,
that PARTEC shall not be liable for (a) negligence, international
wrongdoing, or failure to follow the provisions of this Agreement,
by OPOCRIN, its trustees, officers, employees and agents and (b)
any and all claims for damages to OPOCRIN property or for bodily
injury, death or property damage to employees of OPOCRIN arising
out of the performance of this Agreement, except for the negligent
or international acts solely of the PARTEC with respect to both (a)
and (b) above, Without limiting the foregoing, except for the
negligence or willful misconduct of OPOCRIN, PARTEC agrees to
indemnify and defend OPOCRIN from all
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CONFIDENTIAL
liabilities, demands, damages, expenses and losses (including
reasonable attorney fees and expenses of litigation) arising out of
the use by PARTEC, or any party acting on behalf of or under
authorization from PARTEC, of the Product; provided, however, that
the Product has been manufactured in accordance with the provisions
of this Agreement. This paragraph shall survive termination of this
Agreement.
23. OPOCRIN agrees to indemnify, hold harmless and defend the PARTEC,
its directors, officers, employees, and agents from and against any
and all claims, suits, losses, damage, costs, fees, expenses
(including reasonable attorney's fees), and other liabilities
asserted by third parties, both government and non-government,
resulting from or arising out of the manufacture and supply of the
Product carried out pursuant to this Agreement as a result of the
negligence, intentional wrongdoing or failure to follow the
provisions of this Agreement, of OPOCRIN, its trustees, officers,
employees and agents and any and all claims for bodily injury,
death or property damage to employees of OPOCRIN or to any third
party acting on behalf of or under the authorization of OPOCRIN
arising out of the performance of this Agreement; provided,
however, that OPOCRIN shall not be liable for the negligent or
intentional acts solely of PARTEC. Except as provided in paragraph
(a) above, OPOCRIN, its trustees, officers, employees and agents
shall incur no liability under this section with respect to any
claims, suits, losses, damages, costs, fees, expenses (including
reasonable attorney's fees), and other liabilities asserted by
third parties, both government and non-government, as a result of
product liability and/or patent infringements.
TERM AND TERMINATION
24. Unless otherwise terminated pursuant to this section, this
Agreement shall remain in force for a period for ten (10) years
from the date of its execution.
25. Notwithstanding the provisions of paragraph 24, above, this
Agreement may be terminated; (a) by either party upon one hundred
and eighty (180) days advance written notice, provided that should
such termination notice be given while OPOCRIN is filling a
previously placed order, such termination shall not take effect
until such order has been completed and supplied to and paid for by
PARTEC; or (b) immediately by either party; (i) if one of the
parties shall be declared insolvent or bankrupt; (ii) if a petition
is filed in any court and not resolved within sixty (60) days to
declare one of the parties bankrupt or for a reorganization
pursuant to the applicable bankruptcy or insolvency laws; or (iii)
if either party becomes involved in any voluntary bankruptcy or
other voluntary insolvency proceedings.
26. Upon the effective date of termination of this Agreement for any
reason, OPOCRIN shall cease accepting orders from PARTEC for the
production of DS and the parties shall return any and all
confidential information belonging to the other party in their
possession.
MISCELLANEOUS PROVISIONS
27. Independent Contractors: The relationship between OPOCRIN and
PARTEC is that of independent contractors and neither's agents,
representatives, or employees shall be considered employees of the
other. The parties shall each conduct their respective businesses
on their own initiative and responsibility and shall have no
authority to incur any obligations on behalf of the other. Except
as otherwise set forth in this Agreement, each party shall pay all
costs and expenses of whatever nature incurred by it in connection
with its activities under this Agreement, including but not
limited, to any commissions paid to agents, representatives, or
employees engaged or employed by it and expenses for travel,
entertainment, offices or any other items.
28. Notices: All notices under this Agreement shall be in writing and
shall be addressed as follows:
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CONFIDENTIAL
TO OPOCRIN
Via Pacinotti, 3
41040 Corlo di Formigne
Modena, Italy
Attention: Dr. G. Veronesi
TO PARTEC
216 Jaffa Road
Jerusalem 94383 Israel
Attention: Bob Trachtenberg
General Counsel
or at such other address as such party may specify in writing from
time to time. All notices shall be sent by certified or registered
mail, first-class postage prepaid, by courier delivery or by
personal delivery, and shall be deemed effective upon actual
receipt, if by personal or courier delivery, and seven (7) days
after its dispatch, if by certified or registered mail.
29. Force Majeure: Neither party shall be liable to the other for its
failure to perform any of its obligations hereunder during any
period in which such performance is delayed by circumstances beyond
its reasonable control, including, but not limited to fire, flood,
war, embargo, strike, riot, inability to secure materials and
transportation facilities or the intervention of any governmental
authority. If such delaying cause shall continue for more than
ninety (90) days, the party injured by the inability of the other
to perform shall have the right upon written notice to either (a)
terminate this Agreement or (b) treat this Agreement as suspended
during the delay and reduce any commitment in proportion to this
duration of this delay.
30. Successors: The terms and conditions of this Agreement shall be
binding on any successors of either party, where such successor has
acquired majority control of such party, provided that either party
or its successor shall be entitled to terminate this Agreement
pursuant to the provisions of paragraph 25(a), above.
31. Assignment: Either party shall be entitled to assign its rights
under this Agreement to a third party upon written notice to the
other party provided that such third party, (a) in the reasonable
opinion of the non-assigning party, is capable of fulfilling the
responsibilities of the assigning party; and (b) adopts the terms
and conditions of this Agreement in writing delivered to the
non-assigning party.
32. Resolution of Disputes: Any disputes arising out of this Agreement
shall be adjudicated before a single arbitrator pursuant to the
rules of the International Chamber of Commerce in Geneva,
Switzerland. Nothing in this paragraph shall prevent either party
from applying to the appropriate judicial authority in whatever
jurisdiction the other party may be sued for provisional relief as
necessary to protect its rights under this Agreement, including,
but not limited to, applications for injunctions and temporary
restraining orders, provided that any proceedings beyond the
proceeding for provisional relief shall be transferred, by consent
of the parties, to the International Chamber of Commerce for
adjudication as set forth above. All pleadings, correspondence,
documents, testimony or other material introduced in any proceeding
before the International Chamber of Commerce in respect to this
Agreement shall be in the English language as shall all
deliberations and proceedings had therein.
33. Entire Agreement: This Agreement, including the Attachments,
constitutes the entire agreement between the parties with respect
to this subject matter and supersedes all previous proposals, both
oral and written, negotiations, representations, commitments,
writings and all other communications between the parties. Each
party acknowledges that in entering into this Agreement, it has not
relied on any promises, inducements or representations of the other
<PAGE>
party that are not explicitly set forth in this written Agreement.
This Agreement may not be released, discharged or modified except
by an instrument in writing signed by the parties.
34. Severability: If any provision of this Agreement is determined by a
court of competent jurisdiction to be invalid or unenforceable,
such determination shall not affect the validity or enforceability
of any other part or provision of this Agreement.
35. Authoritative Language: This Agreement has been drafted and agreed
to in the English language, and is the authoritative version for
interpretation and construction by any adjudicative body.
36. Waiver: No waiver of any breach of any provisions of this Agreement
shall constitute a waiver unless made in writing and signed by an
authorized representative of the non-breaching party.
37. Headings: The headings provided in this Agreement are for
convenience and organization only and shall not be construed as
having any substantive effect.
IN WITNESS WHEREOF, each party to this Agreement has executed this Agreement by
a duly authorized representative as of the date set forth above.
OPOCRIN S.P.A. PARTEC LTD.
By: /s/ DR. GIORGIO GIUSTI By: /s/ MORRIS LASTER
------------------------------ -------------------------------
Dr. Giorgio Giusti
Title: President Title: CEO
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CONFIDENTIAL
ATTACHMENT A
PARTEC LTD
Bio-Medical Venture & Management
CONFIDENTIALITY AGREEMENT
This Agreement dated 16 April 1999 shall serve to set forth the terms and
conditions under which Partec Ltd. ("Partec") shall disclose to Opocrin, S.P.A.
("Opocrin") (or the "Receiving Party" or the "Disclosing Party", as appropriate)
proprietary and confidential information to each other, including, but not
limited to any and all information, know-how and data, technical or
non-technical, and product samples and specifications relating to the
manufacture of Sulodexide (the "Information").
1. The Receiving Party agrees not to divulge the Information which the
Disclosing Party discloses to it and which is marked as "Confidential" (the
"Confidential Information") to any third party or parties, or use said
Confidential Information for any purposes other than those purposes set forth in
the Manufacturing Agreement executed between the parties on 16 April 1999. The
Receiving Party further agrees to limit disclosure only to those of its
officers, employees, agents, affiliates and consultants as the Receiving Party
considers necessary. The Receiving Party shall take all reasonable steps to
prevent the disclosure of the Confidential Information as provided herein. This
obligation shall be binding upon the Receiving Party and shall continue for a
period of five (5) years from each date such Confidential Information is
disclosed to the Receiving Party.
2. Nothing in the foregoing shall be construed to prevent the Receiving Party
from disclosing or using any Information or from using Confidential Information
which:
(a) was in the Receiving Party's possession or control prior to the date of
disclosure;
(b) was in the public domain or enters into the public domain through no
improper act on the Receiving Party's part or on the part of any of the
Receiving Party's employees;
(c) is approved for public release by written authorization by the Disclosing
Party;
(d) is developed independent of the information derived from the Confidential
Information;
(e) is required to be disclosed by legal, administrative or judicial order; or
(f) is rightfully given to the Receiving Party from sources independent of the
Disclosing Party, its employees or agents.
3. Oral information which the Disclosing Party wishes to be kept confidential
must be reduced to writing and provided to the Receiving Party within thirty
(30) days of the initial disclosure to the Receiving Party by the Disclosing
Party and conspicuously marked "Confidential."
4. It is understood and agreed that any and all propriety rights, including,
but not limited to, patent rights, trademarks and proprietary rights in and to
the Confidential Information disclosed to the Receiving Party shall be and
remain in the possession of the Disclosing party and the Receiving party shall
have no right, title or interest in or to any of the Confidential Information.
In addition, nothing in this Agreement shall be construed as establishing any
joint venture or other business relationship, as granting to the Receiving Party
any license or right under any patent rights or as representing any commitment
by either party to enter into any license or other agreement by implication or
otherwise.
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5. This Agreement constitutes the entire agreement of the parties pertaining to
the subject matter hereof, and all prior or contemporaneous understandings or
agreements, whether written or oral, between the parties with respect to such
subject matter are hereby superseded in their entirety. The parties have made no
agreements, representations or warranties relating to the subject matter of this
Agreement which are not set forth herein and no agreement, understanding or
promise subsequent to the date hereof relating to the subject matter of this
Agreement, the Confidential Information or otherwise between or by one of the
parties hereto shall be binding upon either party unless in writing and executed
by both The Disclosing Party and the Receiving Party and neither party shall be
reasonable in relying on oral statements made by the other which are not
contained in a written agreement.
6. This Agreement may not be modified, amended or waived in any manner except
by an instrument in writing signed by each of the parties hereto. The waiver by
either party of compliance with any provision of this Agreement by the other
party shall not operate or be construed as a waiver of such party of a provision
of this Agreement. Neither party may assign its rights or obligations hereunder.
7. This Agreement shall be governed by and construed in accordance with the
laws of the United Kingdom without regard to the conflicts of the law principles
thereof.
8. In addition, each party warrants to the other party that the person signing
this Agreement on behalf of the such party is fully authorized to bind the such
party to the obligations set forth in this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their respective duly authorized representatives as of the day and year
written above.
OPOCRIN S.P.A. PARTEC, LTD.
By: /s/ DR. GIORGIO GIUSTI By: /s/ MORRIS LASTER, MD
--------------------------------- ------------------------------
Name: Dr. Giorgio Giusti Name: Morris Laster, MD
Title: President Title: CEO
