EXHIBIT 10.2
DISTRIBUTION AGREEMENT
By and Between
SENETEKPLC
and
LAVIPHARM S.A.
Dated as of March 21, 2003
(***) CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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DISTRIBUTION AGREEMENT
This agreement ("Agreement") is made and entered into as of March 21,
2003, by and between Senetek Plc, a United Kingdom corporation ("SENETEK"), and
Lavipharm S.A., a Greek corporation ("LAVIPHARM").
SENETEK holds certain patents for Kinetin, including the right to
manufacture, have manufactured and sell products containing Kinetin. LAVIPHARM
desires to market and sell in the ethical market channel specific formulations
containing Kinetin for use as a skin care product. SENETEK is willing to grant
LAVIPHARM the exclusive right to market and sell such formulations subject to
the terms and conditions of this Agreement.
Accordingly, in consideration of the mutual promises, covenants, and
conditions set forth below, the parties agree as follows:
1. DEFINITIONS
1.1 When used in this Agreement, each of the following capitalized
terms shall have the respective meaning set forth in this Article.
1.2 "Affiliate" means, with respect to any Person, another Person
controlled by, controlling or under common control with such
Person.
1.3 "Authorized Channel" means the sale of the products in the
ethical market channel (pharmacy outlet) for use by patients
under the care and supervision of physicians and/or
dermatologists.
1.4 "Base Price" means the price per 55 gallon drum of the products
during the first Contract Year as set forth on Exhibit F and as
thereafter adjusted pursuant to Section 3.3.3 for subsequent
Contract Years and, during any period that LAVIPHARM elects to
manufacture Products as provided in Section 2.2 or 4.5, means
the price per kilogram of Kinetin active ingredient during the
first Contract Year as set forth on Exhibit F and as thereafter
adjusted pursuant to Section 3.3.3.
1.5 "Best Efforts" means that commercially reasonable degree of
effort, expertise, knowledge and resources which one skilled,
able, familiar with and experienced in the matters set forth
herein would utilize and otherwise apply with respect to
fulfilling an obligation.
1.6 "SENETEK Confidential Information" means the Know-How,
non-public information concerning the Patents, Improvements,
marketing, sales, financial, scientific, and other non-public
and/or proprietary information concerning the products,
projects, business and operations of SENETEK disclosed by
SENETEK to LAVIPHARM.
1.7 "Calendar Quarter" means a period beginning on the first day of
January, April, July or October and ending on the last day of
March, June, September, or December, respectively.
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1.8 "Contract Year" means a period beginning on first day of a
calendar year and ending on the last day of such calendar year,
provided, that the first Contract Year shall be the period
beginning on the date of this Agreement and ending on December
31, 2004 and the last Contract Year shall be the period ending
on the date of termination of this Agreement.
1.9 " Disruption Period" means any period during which SENETEK is
unable to deliver the Products to LAVIPHARM and has notified
LAVIPHARM at least thirty (30) days in advance.
1.10 "Improvement" means any information, discovery, creation,
derivative work, invention, or trade secret, whether or not
patented or patentable or copyrighted or copyrightable, that
relates to or is based upon the Patents or Know-How and is
developed or otherwise acquired by either party or its
respective affiliates.
1.11 "Know-How" means such know-how, special knowledge, technical or
other information, whether or not patented or patentable, owned
or controlled by SENETEK or its Affiliates at any time prior to
or during the term of this Agreement specifically related to the
development, manufacture or use of any Product.
1.12 "LAVIPHARM Confidential Information" means marketing, sales,
financial, scientific, and other non-public and/or proprietary
information concerning the products, projects, business and
operations of LAVIPHARM including the manufacture, use, or sale
of the Products disclosed by LAVIPHARM to SENETEK.
1.13 "Net Sales" as used herein means the gross amount billed for
commercial sales of the Products sold, or otherwise distributed
to any party by LAVIPHARM, its Affiliates or its sub-licensees
or distributors (not including sales by LAVIPHARM to its
Affiliates or sub- licensees or distributors), less the
following deductions:
(a) trade, quantity, or cash discounts, applicable to
gross amounts billed and allowed, paid or otherwise
included in determining net sales in accordance with
generally accepted accounting principles applied by
LAVIPHARM in preparing its audited financial statements
consistently from period to period ("GAAP");
(b) credit or allowance, if any, given or made on
account of a reasonable number of returns (supported by
appropriate documentation) of Products previously
delivered.
1.14 "Patents" means the patents for Kinetin set forth on Exhibit A.
1.15 "Person" means an individual, legal entity, government or agency
thereof.
1.16 "Product(s)" means the lotion formulation containing Kinetin as
set forth in Exhibit B (the "Lotion"), the cream formulation
containing Kinetin as set forth in exhibit C (the "Cream"), the
SPF lotion formulation containing Kinetin as set forth in
Exhibit D (the "SPF Lotion"), the eye product formulation
containing Kinetin as set forth in Exhibit E (the "Eye
Product"), and all line extensions and enhanced
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formulations of the foregoing, provided that during any period
that LAVIPHAM is manufacturing Product pursuant to Section 2.2
or 4.5, "Product" shall mean, for purposes of Sections 4.2
through 4.4 hereof, the Kinetin active ingredient to be
incorporated into Product.
1.17 "Specifications" means the specifications for the Lotion set
forth in Exhibit B, for the Cream set forth in Exhibit C, for
the SPF Lotion set forth in Exhibit D, for the eye product set
forth in Exhibit E, and for all line extensions and enhanced
formulations of the foregoing.
1.18 "Territory" means Greece and Cyprus.
1.19 "Term" means the period starting on the date of this Agreement
and ending upon the expiration of the last to expire of the
Patents, unless this Agreement is sooner terminated in
accordance with its terms.
1.20 "Trademark" means LAVIPHARM's registered trademarks held by
LAVIPHARM in the Territory used to designate the Product for its
sale under the terms of the present Agreement.
1.21 "Unit" means an individual unit of Products packaged by
LAVIPHARM as specified by LAVIPHARM from time to time and
acceptable to SENETEK.
2. GRANT OF RIGHTS TO SELL
2.1 Supply. During the Term, SENETEK agrees to supply and deliver to
LAVIPHARM, and LAVIPHARM agrees to purchase from SENETEK,
Products in bulk in such quantities as LAVIPHARM requests. All
orders for Product shall be made pursuant to written purchase
orders and in accordance with the binding forecasts delivered to
SENETEK in accordance with Section 4.3.
2.2 Right to Manufacture. After 180 days from the date of the first
delivery of bulk supply by SENETEK to LAVIPHARM, LAVIPHARM shall
have an option to transfer the manufacturing process for the
Products to a manufacturing site designated by LAVIPHARM;
provided that the designated manufacturing site is qualified and
acceptable to SENETEK and provided further that LAVIPHARM
commits to purchase Kinetin from SENETEK as the sole supplier at
a price equal to (***) per Kilogram (kg), subject to adjustment
not more frequently than once per Contract Year to reflect
increases in SENETEK's cost of goods, which adjustment shall be
limited to the amounts by which third party invoices to SENETEK
for manufacturing, packing and shipping kinetin have increased
since the last annual adjustment, if any, and shall not include
increases in Senetek's overheads.
2.3 Grant. SENETEK hereby grants to LAVIPHARM during the Term hereof
the exclusive right to package, market, distribute and sell the
Products under the Trademark in the Authorized Channel within
the Territory, and from an after such date as LAVIPHARM may
exercise the option to transfer manufacturing of Products as
provided in Section
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
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2.2 or 4.5, the exclusive right to manufacture the Products
under the Trademark in the Territory, in each case subject to
terms of this Agreement (the "Rights").
2.4 Other Countries. Beginning ninety (90) days after the date of
this Agreement, LAVIPHARM and SENETEK shall negotiate in good
faith to reach agreement upon terms under which LAVIPHARM may
sell the Products in the Authorized Channel in areas outside the
Territory either directly or indirectly (e.g. through sub
distributors with which SENETEK would not have direct
cooperation,), provided that each party shall have full
discretion in deciding whether, and upon what terms, it will
agree to sales outside the Territory. SENETEK however
acknowledges that LAVIPHARM is exporting its product lines under
the Trademark to the countries/companies set forth in Exhibit H.
Senetek agrees that the identities of such existing and any new
proposed sub-distributors in other countries shall be deemed to
be Confidential Information, not to be used by Senetek otherwise
than for purposes of performing this Agreement.
2.5 Exclusivity. With the exception of ICN Pharmaceuticals Inc.,
SENETEK shall not grant any other party the right to sell the
Products in the Authorized Channel in the Territory during the
Term (the "Exclusivity Right'). The Exclusivity Right may be
terminated by SENETEK upon notice given to LAVIPHARM if
LAVIPHARM fails to meet any Minimum Purchase Requirement set
forth in Section 3.2 or any Minimum Unit Sales Requirement set
forth in Section 5.1.6, or fails to market the Products in
Greece by the first Calendar Quarter of 2004 or fails to launch
marketing and distribution efforts in Greece as set forth in
Section 5.1.5.
2.6 No Other Rights. It is expressly understood that this Agreement
grants no rights to LAVIPHARM for the sale of the Products, or
to the formulas therefore, or under the Patents except those
express rights set forth in Sections 2.1 through 2.5. Without
limiting the foregoing, it is understood and agreed that
LAVIPHARM has no right pursuant to this Agreement to, and shall
not, (i) sell or permit its customers to sell the Products
outside the Authorized Channel within the Territory, or (ii)
manufacture or have made other than by SENETEK any Products
(other than pursuant to Sections 2.2 and 4.5 of this Agreement).
Upon any termination of this Agreement, LAVIPHARM shall have no
right of any kind with respect to the Products, Patents or any
Improvements for which LAVIPHARM may receive a license other
than the right to complete the sale of Products then lawfully in
its possession subject to the payment of royalties pursuant to
Section 3.3.2. Nothing in the foregoing sentence shall diminish
LAVIPHARM's rights in the Trademark or any trademark or other
intellectual property owned by LAVIPHARM and used in connection
with the Products. SENETEK agrees not to contest LAVIPHARM's
rights in the Trademark or to perform any act or omission
adverse to those rights or that could, in any manner, tarnish,
degrade, or disparage the Trademark or that reflect adversely on
LAVIPHARM's business or reputation both during the Term and
after the expiration or termination of this Agreement. SENETEK
will cooperate fully and in good faith with LAVIPHARM, at
LAVIPHARM'S request and expense, for the purpose of securing,
preserving and protecting Lavipharm's rights in the Trademark.
In particular, any goodwill and improved reputation generated by
the promotion, distribution, and sale of the Products with the
Trademark shall inure to the benefit of LAVIPHARM, provided that
the foregoing shall not be deemed to give LAVIPHARM any rights
to sell the Products, or
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to the formulas therefore, or under the Patents, except as set
forth in the first sentence hereof.
3 PURCHASE COMMITMENTS
3.1 Initial Order. By executing this Agreement, LAVIPHARM places a
non- cancelable order for 55 gallons of the Lotion, 55 gallons
of the Cream, 55 gallon of the SPF Lotion, and 55 gallon of the
Eye Product (the "Initial Order").
3.2 Minimum Purchase Requirements. During each Contract
Year, LAVIPHARM shall purchase not less than the number
of gallons set forth below (the "Minimum Purchase
Requirement"):
Contract Year SKUs Total Gallons
------------- ---- -------------
1
Lotion (***)
Cream (***)
SPF Lotion (***)
Eye Product (***)
Total
2
Lotion (***)
Cream (***)
SPF Lotion (***)
Eye Product (***)
Total
3 - 7 (each year)
Lotion (***)
Cream (***)
SPF Lotion (***)
Eye Product (***)
Total
remaining years to be agreed at
least nine (9)
months in advance
of the relevant
year.
The Minimum Purchase Requirement may be met with any combination of
Products (including line extensions and/or additional formulations) purchased by
LAVIPHARM in bulk pursuant to this Agreement. In the event LAVIPHARM fails to
meet the Minimum Purchase Requirement, SENETEK shall have the right to terminate
the Exclusivity Right provided to LAVIPHARM pursuant to Section 2.5 above.
Notwithstanding the foregoing, effective during any period that LAVIPHARM is
manufacturing Products pursuant to Section 2.2 or 4.5, in lieu of the fore gong
quantities of Bulk the Minimum Purchase Requirement shall be that number of
kilograms of Kinetin active ingredient that, pursuant to the Specifications, are
required to manufacture the quantities of Bulk set forth above.
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
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3.3 Payment.
3.3.1 Base Price. With respect to the Initial Order,
LAVIPHARM shall provide to SENETEK written delivery instructions
from time to time, specifying the quantities of Bulk it wishes
to be delivered, not less than ninety (90) days prior to the
requested delivery date, and payment with respect to such Bulk
shall be due on the date of delivery, F.O.B. SENETEK'S point of
shipment, provided that LAVIPHARM shall in any event take
delivery of the full Initial Order and make payment in full
therefore not later than December 31, 2003. With respect to each
subsequent order, SENETEK may send an invoice for the Base Price
for Product ordered by LAVIPHARM at any time after shipment.
LAVIPHARM shall pay SENETEK such amount within sixty (60) days
of the date of such invoice. Late payments shall be subject to a
monthly processing fee of nine tenth of one percent (0.9%) of
the amount due or, if such amount is not permitted by law, the
minimum amount permitted by law. Shipping charges shall be
invoiced upon shipment and paid by LAVIPHARM as otherwise set
forth in this Section 3.3.1.
3.3.2 Royalties. In further consideration of the grant
of the rights under this Agreement, LAVIPHARM shall pay to
SENETEK a royalty of (***) per Unit, but no less than (***)
percent (***) of Net Sales from the Products. The royalty shall
be paid by LAVIPHARM to SENETEK quarterly with respect to sales
of the Products during each Calendar Quarter within thirty (30)
days after the end of such Calendar Quarter. Each royalty
payment shall be accompanied by a statement setting forth in
reasonable detail the basis for the calculation of the royalty
amount paid. LAVIPHARM shall permit SENETEK reasonable access to
the data necessary to audit such calculation upon request from
SENETEK provided that any such audit shall be conducted by
independent auditors located in Greece or by the Greek office or
affiliate of an international firm of independent auditors, as
selected by SENETEK. Any such audit shall be commenced by
SENETEK no later than two (2) year following the end of the
relevant Contract Year, and no more than one such audit shall be
conducted during any twelve (12) month period. SENETEK shall pay
the costs of such independent audit unless the audit finds that
LAVIPHARM's calculation of total Net Sales in any calendar year
was understated by more than 5% from the calculations arrived at
by the audit.
3.3.3 Adjustments to Base Price. At the end of the first
Contract Year and at the end of each following Contract Year,
the Base Price, as previously adjusted, shall be adjusted based
on changes in actual costs during the just completed Contract
Year subject to adjustment not more frequently than once per
Contract Year to reflect increases in SENETEK's cost of goods,
which adjustment shall be limited to the amounts by which third
party invoices to SENETEK for manufacturing, packing and
shipping kinetin have increased since the last annual
adjustment, if any, and shall not include increases in SENETEK's
overheads.
4 MANUFACTURE AND DELIVERY OF PRODUCTS
4.1 Source. The Products shall be manufactured at a third party
manufacturing facility to be designated by SENETEK promptly
following agreement by the parties upon the
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
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Specifications, or at such other third party manufacturing
facility as SENETEK may designate from time to time.
4.2 Orders. Orders for Products in bulk shall be delivered to
SENETEK at the following address:
SENETEK PLC
000 Xxxxxxx Xxxx Xxxx, XX 00000
Attention: Purchasing Department
or at such other address as SENETEK may give LAVIPHARM at least thirty
(30) days prior written notice.
4.3 Requirements Forecasts. LAVIPHARM shall provide SENETEK with a
rolling twelve (12) month forecast of its requirements for
Products under this Agreement to be updated quarterly, and
delivered to SENETEK at least thirty (30) days in advance of the
period forecasted. The first ninety (90) days of each forecast
shall constitute a firm order that is not subject to
cancellation by LAVIPHARM.
4.4 Delivery. SENETEK shall use its best efforts to fulfill orders
within ninety (90) days of he date they are confirmed by
SENETEK. LAVIPHARM may not cancel any order after it is
confirmed. SENETEK shall ship the Products F.O.B. its
manufacturer's point of shipment from the place of manufacture
to such location within the Territory as LAVIPHARM specifies in
the Order. LAVIPHARM shall reimburse SENETEK for all reasonable
costs of shipping, including without limitation reasonable costs
of insurance. Such costs shall be reflected in invoices
delivered pursuant to Section 3.3.1.
4.5 Interim Manufacturing License. During any Disruption Period,
LAVIPHARM or its designee shall have a non-exclusive license to
use the Patents, Know-How and SENETEK Confidential Information
to produce the Products (the "License"). All manufacturing of
the Products pursuant to the License shall be completed in
compliance with the specifications set forth in this Agreement
for the Products. The License shall terminate upon the first to
occur of (a) notice from SENETEK to LAVIPHARM that it is able to
resume production or (b) termination of this Agreement.
5 REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS OF THE
PARTIES
5.1 Representations, Warranties and Covenants of LAVIPHARM.
LAVIPHARM represents, warrants and covenants as follows:
5.1.1 Qualifications and Authorization. LAVIPHARM is a
corporation duly formed, validly existing and in good standing
in the state of Greece with full corporate power and authority
to conduct its business as it is now conducted and to enter into
and perform this Agreement. LAVIPHARM is duly licensed or
qualified to do business and is in good standing in each
jurisdiction in which its operations or ownership of assets in
connection with this Agreement requires such licensing or
qualification.
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5.1.2 No Conflict or Violation. Neither the execution,
delivery or performance of this Agreement, nor compliance by
LAVIPHARM with any of the provisions hereof, will (i) violate or
conflict with any provision of the Certificate of Incorporation
or Bylaws of LAVIPHARM, (ii) violate, conflict with, or result
in a breach of any provision of, or constitute a default (or an
event which, with notice or lapse of time or both, would
constitute a default) under, or result in the creation of any
encumbrance upon any of LAVIPHARM's assets under, any of the
terms, conditions or provisions of any material contract,
indebtedness, note, bond, indenture, security or pledge
agreement, commitment, license, lease, franchise, permit,
agreement, or other instrument or obligation to which LAVIPHARM
is a party, or (iii) violate any statute, rule, regulation,
ordinance, code, order, judgment, ruling, writ, injunction,
decree or award applicable to LAVIPHARM, except, in the case of
each of clauses (i), (ii) and (iii) above, for such violations,
conflicts, breaches, defaults or creations of encumbrances
which, in the aggregate, would not have a material adverse
affect on the business of LAVIPHARM or its ability to perform
this Agreement.
5.1.3 Compliance with Laws. LAVIPHARM shall comply in
all material respects with any law, regulation, ordinance,
order, injunction, decree or requirement applicable in each
country of manufacture or sale by LAVIPHARM to the marketing or
sale of the Products or applicable to any manufacture,
packaging, storage, shipment or handling of Products by its
designated manufacturer pursuant to Section 2.2 or 4.5.
5.1.4 Products Standards. LAVIPHARM warrants that any
Products manufactured by its designated manufacturer will be
manufactured in accordance with the Specifications, and that
such Products will conform in all respects to the Specifications
when delivered to the shipper for shipment to LAVIPHARM. Unless
otherwise expressly agreed by SENETEK, all Kinetin used in the
manufacture of any such Products shall be sourced exclusively
from SENETEK or its designated supplier.
5.1.5 Marketing Efforts. LAVIPHARM will promote and
market the Products in a manner consistent with its efforts for
other products and general industry practice and the promotion
and marketing plan as attached as Exhibit G (the "Promotion
Commitment").
5.1.6 Product Launch. LAVIPHARM will use its best
efforts to begin marketing the product no later than the end of
the third Calendar Quarter of 2003.
5.1.7 Minimum Unit Sales. LAVIPHARM shall achieve
Product sales in the Territory during the first Contract Year of
not less than (***) Units and during the second Contract Year of
not less than (***) units For each subsequent Contract Year, the
Minimum Unit Sales shall be a number of units equal to the sum
of (i) the prior Contract Year's Minimum Unit Sales in the
Territory plus (ii) fifty percent (50%) of the amount by which
LAVIPHARM's actual Unit sales for such prior Contract Year
exceeded such Minimum Unit Sales. LAVIPHARM shall be permitted
(but shall not be obligated) to cure a failure to achieve
Minimum Unit Sales for a particular Contract Year by making
payment to SENETEK, within thirty (30) days after the end of
such Contract Year, of the royalty that would have been due if
LAVIPHARM had achieved
*** Confidential portions of this material have been omitted and
filed separately with the securities and Exchange Commission.
9
such Minimum Unit Sales, provided that LAVIPHARM shall not be
permitted to so cure its failure to achieve Minimum Unit Sales
in two successive Contract Years.
5.1.8 Acknowledgement of SENETEK's Patents' Validity,
Enforceability and Ownership. In consideration of the benefits
of Sections 2.1 through 2.5, LAVIPHARM, for itself and its
Affiliates, successors and permitted assigns and sub- licensees,
irrevocably acknowledges, admits and concedes that (i) all
rights, title and interest in the SENETEK Patents are owned by
SENETEK and its Affiliates, (ii) all claims of the SENETEK
Patents as well as all claims that are narrower in scope than
the claims of the SENETEK Patents are valid and enforceable, and
(iii) all claims of any patent that may issue from any
application whose subject matter in whole or in part is entitled
to the benefit of the filing date(s) of the SENETEK Patents
(including, without limitation, continuations,
continuations-in-part, divisional patents, reexaminations,
renewals, extensions, reissues, and foreign counterparts) that
are equal to or narrower in scope than the claims of the SENETEK
Patents are valid and enforceable. LAVIPHARM, for itself and its
Affiliates, successors and permitted assigns and sub- licensees,
does also forever relinquish and waive all rights to dispute
said ownership, validity and enforceability in any proceeding of
any nature, covenants that it and they will not assert, either
affirmatively or defensively, in any proceeding of any nature,
any matter inconsistent with said ownership, validity and
enforceability, agrees and acknowledges that the foregoing shall
act as a complete defense and bar to any proceeding of any
nature challenging such ownership, validity and enforceability
or any of them, and consents to the entry of temporary and
permanent injunctions to bar any breach or threatened breach of
any of the foregoing, without the filing on behalf of SENETEK of
any bond or other security.
5.2 Representations and Warranties and Covenants of SENETEK. SENETEK
represents, warrants and covenants as follows:
5.2.1 Qualifications and Authorization. SENETEK is a
corporation duly formed, validly existing and in good standing
in the laws of England with full corporate power and authority
to conduct its business as it is now conducted and to enter into
and perform this Agreement. SENETEK is duly licensed or
qualified to do business and is in good standing in each
jurisdiction in which its operations or ownership of assets in
connection with this Agreement requires such licensing or
qualification.
5.2.2 No Conflict or Violation. Neither the execution,
delivery or performance of this Agreement, nor compliance by
SENETEK with any of the provisions hereof, will (i) violate or
conflict with any provision of the Certificate of Incorporation
and Bylaws of SENETEK, (ii) violate, conflict with, or result in
a breach of any provision of, or constitute a default (or an
event which, with notice or lapse of time or both, would
constitute a default) under, or result in a creation of any
encumbrance upon any of SENETEK's assets under, any of the
terms, conditions or provisions of any material contract,
indebtedness, note, bond, indenture, security or pledge
agreement, commitment, license, lease, franchise, permit,
agreement, or other instrument or obligation to which SENETEK is
a party, or (iii) violate any statute, rule, regulation,
ordinance, code, order, judgment ruling, writ, injunction,
decree or award applicable to SENETEK, except, in the case of
each of clauses (i), (ii) and (iii) above, for such
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violations, conflicts, breaches, defaults or creations of
encumbrances which, in the aggregate, would not have material
adverse effect on the business of SENETEK or its ability to
perform this agreement.
5.2.3 Products Standards. SENETEK warrants that the
Products manufactured by its designated manufacturer will be
manufactured in accordance with the Specifications, and that
such Products will conform in all respects to the Specifications
when delivered to the shipper for shipment to LAVIPHARM.
5.2.4 Compliance with Law. SENETEK shall comply in all
material respects with any law, regulation, ordinance, order,
injunction, decree or requirement applicable to the manufacture,
packaging, storage, shipment and sale of the Products.
5.2.5 Patents. SENETEK owns the Patents. To the
knowledge of SENETEK: (i) the Patents do not infringe upon the
rights of any third party; and (ii) the Patents are valid. In
the event SENETEK intends to file any additional patent
applications with respect to the Products, SENETEK shall, to the
extent possible do so without impairing its intellectual
property rights or violating agreements with or intellectual
property rights of others, furnish a draft of the proposed
filing to LAVIPHARM for review and comments at least thirty (30)
days in advance of filing. Any such draft shall be treated as
SENETEK Confidential Information and shall not constitute an
offer to sell any product to LAVIPHARM.
5.2.6 Survival. The representations and warranties made
in this Agreement shall survive the termination of this
Agreement for the longer of (a) the statute of limitations
applicable to claims for the breach of such representation or
warranty and (b) such other period as may be specified in this
Agreement.
6 CONFIDENTIAL INFORMATION AND ANNOUNCEMENTS
6.1 SENETEK Confidential Information. LAVIPHARM shall not (a) use
SENETEK Confidential Information except to perform its
obligations under this Agreement, or (b) disclose SENETEK
Confidential Information to any Person (except to its employees
and agents who reasonably require same for the purpose hereof
and who are bound to LAVIPHARM by the same obligations as to
confidentiality) without the express written permission of
SENETEK, unless such disclosure is required by order of a court
of competent jurisdiction.
6.2 LAVIPHARM Confidential Information. SENETEK shall not (a) use
LAVIPHARM Confidential Information except to perform its
obligations under this Agreement, or (b) disclose LAVIPHARM
Confidential Information to any Person (except to its employees
and agents who reasonably require same for the purpose hereof
and who are bound to SENETEK by the same obligations as to
confidentiality) without the express written permission of
LAVIPHARM, unless such disclosure is required by order of a
court of competent jurisdiction.
6.3 No License. The furnishing of Confidential Information by one
party to the other shall not constitute any grant, option or
license to the other under any patent or other rights now or
hereafter held by the furnishing party.
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6.4 Announcements. The parties will issue an agreed upon press
release upon the execution of this Agreement. Except for such
release and except as may otherwise be required by law, neither
party will disclose the terms of this Agreement to any other
Person; provided, however, that each party may make such
disclosure of the terms of this Agreement to its employees and
agents as is necessary to permit such party to perform its
obligations under this Agreement; provided further that any such
employee or agent agrees to maintain the confidentiality of this
Agreement. Except as may be required by law, neither party will
disclose the results of any clinical studies or other technical
data concerning the Products; provided, however, that each party
may make such disclosures (or permit disclosures) to show that
products including Kinetin are more effective than those that do
not include Kinetin.
6.5 Survival. The provisions of this Article 6 shall survive
termination of this Agreement and continue for a period of five
(5) years.
7 INDEMNIFICATION, INSURANCE AND LIMITS ON LIABILITY
7.1 Indemnification of SENETEK. LAVIPHARM shall defend, indemnify,
and hold harmless SENETEK, its officers, agents, employees and
affiliates from any loss, claim, action, damage, expense or
liability (including defense costs and attorneys' fees)
(collectively, "Claims") arising out of or related to a breach
or alleged breach of any representation, warranty or covenant
made by LAVIPHARM herein, or the manufacturing pursuant to
Section 2.2 or 4.5, or handling, possession, marketing, sale or
other use of the Products, except insofar as such claims are
related to or arise from SENETEK's negligence or breach of this
Agreement.
7.2 Indemnification of LAVIPHARM. SENETEK shall defend, indemnify,
and hold harmless LAVIPHARM, its officers, agents, employees and
affiliates from any Claims arising out of or related to a breach
or alleged breach of any representation, warranty, or covenant
made by SENETEK herein, or SENETEK's manufacture or handling of
the Products, except insofar as such claims are related to or
arise from LAVIPHARM's negligence or breach of this Agreement.
7.3 Insurance. LAVIPHARM shall maintain at its expense commercial
general liability insurance in a principal amount of not less
than the coverage generally maintained by companies of similar
size in the industry, but in no event shall LAVIPHARM be
required to maintain coverage in excess of one (1) million
dollars per occurrence and ten (10) million dollars in the
aggregate. Within thirty (30) calendar days after the date of
this Agreement, LAVIPHARM shall furnish to SENETEK a certificate
evidencing such insurance. SENETEK may elect not to ship any
product until such insurance is in place and the certificate of
coverage is provided, and may thereafter suspend shipment if it
reasonably believes such insurance is not in place until
LAVIPHARM provides SENETEK reasonable assurance that such
coverage is in place without any gap in coverage during the Term
and will be maintained as required by this Agreement.
7.4 No Consequential Damages. EXCEPT FOR CLAIMS THAT INCLUDE
CONSEQUENTIAL DAMAGES PAID TO PERSONS THAT ARE NOT
12
AFFILIATES OF AN INDEMNIFIED PARTY, NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR CONSEQUENTIAL DAMAGES, LOST PROFITS,
INJURY TO REPUTATION OR SIMILAR CLAIMS. EXCEPT FOR CLAIMS BY
THIRD PARTIES ARISING FROM THE FAILURE OF THE PRODUCTS SUPPLIED
BY SENETEK PURSUANT TO THIS AGREEMENT TO CONFORM TO THE
SPECIFICATIONS AT THE TIME OF SHIPMENT, UNDER NO CIRCUMSTANCES
SHALL SENETEK OR ITS AFFILIATES HAVE ANY LIABILITY ARISING FROM
THIS AGREEMENT IN EXCESS OF THE HIGHEST AGGREGATE AMOUNT PAID AS
BASE PRICE AND ROYALTIES OVER THE COURSE OF ANY TWO CONTRACT
YEAR PERIOD.
8 RECALLS
8.1 Responsibility. In the event any Product(s) must be recalled
from the channel of distribution by reason of failure to meet
any requirements of law or otherwise, LAVIPHARM shall have the
sole responsibility to effect the recall. SENETEK shall
cooperate with LAVIPHARM in implementing any such recalls to the
extent such cooperation is necessary to effect the recall,
provided that LAVIPHARM advances SENETEK'S expenses therefore,
except as provided in Section 8.2.
8.2 Reimbursement of LAVIPHARM. In the event the recall results from
or is caused by an act or omission of SENETEK for which it is
required to indemnify LAVIPHARM pursuant to Section 7.2, SENETEK
shall reimburse LAVIPHARM for any costs and/or expenses
reasonably expended by LAVIPHARM as a consequence of the recall.
Without limiting the general nature of the foregoing, SENETEK
will provide replacement Products or raw material or Kinetin for
recalled Products and for any Products that cannot be shipped
due to the condition requiring the recall.
9 TERM AND TERMINATION
9.1 Term. The term of this Agreement shall commence on the date of
this Agreement and shall terminate on the date of termination in
accordance herewith.
9.2 Termination. Each party shall have the right to terminate this
Agreement at any time upon written notice to the other in the
event (i) the other party fails to perform any material
obligation and such failure continues for a period of sixty (60)
days after notice thereof with respect to a payment failure or,
with respect to any other failure, such failure continues for a
period of sixty (60) days after notice thereof, or (ii) the
other party is declared insolvent or bankrupt by a court of
competent jurisdiction, or a voluntary petition of bankruptcy is
filed in any court of competent jurisdiction by the other party,
or the other party makes or executes any assignment for the
benefit of creditors, or (iii) LAVIPHARM fails to meet Minimum
Purchase Requirement as set forth in Section 3.2 for two (2)
successive Contract Years or fails to meet the Minimum Unit
Sales as set forth in Section 5.1.7 for two (2) successive
Contract Years (if LAVIPHARM did not exercise its right to cure
the first Contract Year's failure) or for three (3) successive
Contract Years (if LAVIPHARM did exercise its right to cure the
first Contract Year's failure). In addition, LAVIPHARM may
terminate this Agreement without cause (i) at any time after the
end of the fifth Contract Year upon six (6) months' written
notice to SENETEK or (ii) at any time upon nine (9) months'
written
13
notice to SENETEK in the event LAVIPHARM's total number of units
sold of the Products do not achieve the following threshold:
Contract Year Amount
------------- ------
1 (***)
2 (***)
3 (***)
4 (***)
5 (***)
10 MISCELLANEOUS
10.1 Method of Payments. All payments due under this Agreement shall
be paid in U.S. Dollars by a check drawn on a United States bank
or by wire transfer of immediately available funds.
10.2 No Joint Venture. It is not the intent of the parties hereto to
form any partnership or joint venture. Each Party shall, in
relation to its obligations hereunder, act as an independent
contractor, and nothing in this Agreement shall be construed to
give either party the power or authority to act for, bind or
commit the other.
10.3 Governing Law. This Agreement shall be governed by and
interpreted in accordance with the laws of the United Kingdom
(regardless of that or any other jurisdiction's choice of law
principles). LAVIPHARM and SENETEK irrevocably submit to the
jurisdiction of the United Kingdom courts for the adjudication
of any disputes related to or arising out of this Agreement.
10.4 No Assignment. Neither party to this Agreement may assign its
rights or obligations under this Agreement without the prior
written consent of the other party to this Agreement; provided,
however, that either party may assign its rights to any
affiliate company or a person that acquires substantially all of
the assets of such party; provided further, that no such
assignment shall relieve the assigning party of its obligations
under this Agreement.
10.5 Force Majeure. No party hereto shall be liable to any other in
damages for, nor shall this Agreement be terminable by reason
of, any delay or default in such party's performance hereunder
if such delay or default is caused by conditions beyond such
party's control including, but not limited to, acts of God,
regulation or law or other action of any government or any
agency thereof, war, insurrection, civil commotion, destruction
of production facilities or materials by earthquake, fire, flood
or storm, labor disturbances, epidemic, or failure of suppliers,
public utilities or common carriers. Each party hereto agrees to
promptly notify the other party of any event of force majeure
under this Section 11.5 and to employ all reasonable efforts
towards prompt resumption of its performance hereunder when
possible if such performance is delayed or interrupted by reason
of such event.
***Confidential portions of this material have been omitted and
filed separately with the securities and Exchange Commission.
14
10.6 Notices. Unless otherwise provided herein, any notice required
or permitted to be given hereunder (a "Notice") shall be mailed
by certified mail or generally recognized express courier
service with signature required for delivery, postage prepaid,
or delivered by hand to the party to whom such Notice is
required or permitted to be given hereunder. If mailed, any such
Notice shall be deemed to have been given as of the date of
receipt, as evidenced by the date appearing on the delivery
notice. If delivered by hand, any such Notice shall be deemed to
have been given when received by the party or agent of such
party to whom such Notice is given, as evidenced by written and
dated receipt of the receiving party.
All Notices to LAVIPHARM shall be addressed as follows:
LAVIPHARM S.A.
Xxxxx Xxxxxxx
000 00 Xxxxxx
Xxxxxx
Attn.: Mr Paris Yassis
All Notices to SENETEK shall be addressed as follows:
SENETEK PLC
000 Xxxxxxx Xxxx
Xxxx, XX 00000
Either party may change the address to which any Notice to it is
to be addressed by notification to the other party as provided
herein.
10.7 Captions. The captions in this Agreement are solely for
convenience of reference and shall not be used for purposes of
interpreting or construing the provisions hereof.
10.8 Severability. Should any part or provision of this Agreement be
held unenforceable or in conflict with the applicable laws or
regulations of any applicable jurisdiction, the invalid or
unenforceable part or provision shall be replaced with a
provision which accomplishes, to the extent possible, the
original business purpose of such part or provision in a valid
and enforceable manner, and the remainder of this Agreement
shall remain binding upon the parties hereto.
10.9 Waiver. No failure on the part of any party hereto to exercise,
and no delay in exercising, any right, privilege or power
hereunder shall operate as a waiver or relinquishment thereof;
nor shall any single or partial exercise by any party hereto of
any right, privilege or power hereunder preclude any other or
further exercise thereof, or the exercise of any other right,
privilege or power.
10.10 Entire Agreement. This Agreement together with its Schedules and
Exhibits constitute the entire agreement and understanding
between the parties hereto with respect to the subject matter of
this Agreement and shall supersede any prior agreements,
negotiations, understandings, representations, statements and
writings relating thereto.
15
This Agreement may not be amended or modified except in a
writing signed by a duly authorized officer of the party against
whom enforcement of such amendment is sought.
10.11 Counterparts. This Agreement may be executed in one or more
counterparts by exchange of facsimile copies of signature pages,
each of which will be deemed an original and all of which
together will constitute one and the same instrument.
10.12 Document Preparation. The parties acknowledge that this
Agreement is a product of extensive negotiations and that no
inference should be drawn regarding the preparation of this
document.
To evidence this Agreement, the parties have caused their duly
authorized representatives to execute this Agreement as of the date first
written above.
LAVIPHARM SA
By: /s/
-----------------------
Name: Xxxxx Vranopoulos
---------------------
Title: Chief Operating Officer
-----------------------
SENETEKPLC
By: /s/
-----------------------
Name: Xxxxxxx Xxxxxx
--------------
Title: COO & MD Europe
---------------
16
EXHIBIT A
PATENT
Country: Greece
Patent No: 0584068
Issue Date: 10/06/1999
Title: Method/Composition for Ameliorating Adverse Effects of Aging Expiry
Date: 05/16/2011
Status: Granted
Country: Greece
Patent No: 0584062 Issue Date: 1/7/1998
Title: Method and Composition for Treating Hyperproliferative Skin Diseases
Expiry Date: 05/16/2011
Status: Granted
17
EXHIBIT B
LOTION SPECIFICATIONS
[to set forth Lotion formulation]
18
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name: Lotion with 0.1% KINETIN (#MCLT2-119-2005)
I. General Description
-------------------
White viscous lotion
II. Analytical Requirements
Property Limits Test Method
----------------------- ------ -----------
A. Appearance White viscous lotion
To Match Master
B. Odor Characteristic
To Match Master
C. Color White to off white
To Match Master
D. pH 5.0 - 6.0
E. Viscosity @25(DEG)C, 5,000 - 25,000 cps
LVT #3@12RPM
F. Total Solids (%) 9.50 - 11.50%
G. Specific Gravity 0.97 - 1.03
III. Chemical Requirements
Parameter Target Limits Test Method
---------------------- ------ ------ -----------
A. KINETIN 0.10% 0.095 - 0.105%
IV. Microbiological Requirements
Property Limits Test Method
---------------------------- ------ -----------
A. Mesophilic Aerobic * 100
Bacteria
B. Yeast * 100
C. Mold * 100
D. Gram Negative None Detected
Bacteria
* MEANS LESS THAN
19
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name:
Spec Ref. Minimum Test Frequency
Paragraph Property Release Retest Audit
APPEARANCE 3 PER LOT*
ODOR 3 PER LOT*
COLOR 3 PER LOT*
pH 3 PER LOT*
VISCOSITY 3 PER LOT*
MESOPHILIC 3 PER LOT**
AEROBIC BACTERIA
YEAST 3 PER LOT**
MOLD 3 PER LOT**
GRAM NEGATIVE 3 PER LOT**
BACTERIA
Special Instructions:
MASTER SAMPLE TO BE RENEWED EVERY 12 MONTHS.
Sampling Plan:
* SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
BATCH OR LOT AND TESTED SEPARATELY.
** SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
EACH PACKAGING/FILLING SHIFT AND MAY BE COMPOSITED.
20
Product: Lotion with 0.1% KINETIN (MCLT2-119-2005)
ITEM CODE RAW MATERIAL PERCENTAGE WEIGHT
--------- ------------ -----------------
Water (***)
Stearyl Alcohol (Xxxxxxx 18; COGNIS) (***)
Glyceryl Stearate and PEG-100 Stearate (***)
(Mazo1 165; BASF)
Glycerin (Xxxxx 917; HENKEL) (***)
Hybrid Safflower Oil (Lipovol SO; LIPO) (***)
Phenoxyethanol (and) Methylparaben (and) (***)
Ethylparaben (and) Propylparaben (and)
Butylparaben (Sepicide HB; SEPPIC)
Octyl Hydroxystearate(Norfox 171; Xxxxxx, Fox&Co) (***)
Cetyl Alcohol (***)
(Crodacol C-95; CRODA or Xxxxxxx 16NF; COGNIS)
Dimethicone (FLUID 200, 350 cst. DOWCORNING) (***)
Sodium Benzoate (VELSICOL) (***)
Phytosterol (Generol 122; HENKEL) (***)
Panthenol Liquid (50% soln; ROCHE) (***)
Carbomer (Carbopol 940; XXXXXXXX) (***)
Triethanolamine (OXYCHEM) (***)
Kinetin (SENETEK) (***)
Sodium Hydroxide (***)
Disodium EDTA (Dissolvine NA-2; AKZO NOBEL) (***)
Tocopheryl Acetate (ROCHE) (***)
Aloe Barbadensis Gel (***)
(Aloe Xxxx Gel REG. 40X; XXXXX LABS)
Royal Jelly Extract (ACTIVE ORGANICS) (***)
Chamomile Extract BG (XXXX) (***)
Ascorbic Acid (ROCHE) (***)
TOTAL 100.0000
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
21
EXHIBIT C
CREAM SPECIFICATIONS
[To set forth cream formulation]
22
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name: Cream with 0.1% KINETIN (#MCCR1-123-200S)
I. General Description
White to off white cream
II. Analytical Requirements
Property Limits Test Method
----------------------- ------ -----------
A. Appearance Cream
To Match Master
B. Odor Characteristic
To Match Master
C. Color White to off white
To Match Master
D. pH 5.0 - 6.0
E. Viscosity @25(DEG)C, LVT #T-E 200,000 - 320,000 cps
@12RPM
F. Total Solids(%) 20.0 - 26.0%
G. Specific Gravity 0.97 - 1.03
III. Chemical Requirements
Parameter (target) Limits Test Method
--------------------- ------ -----------
A. KINETIN (target; 0.100%) 0.095 - 0.105%
IV. Microbiological Requirements
Property Limits Test Method
---------------------------- ------ -----------
A. Mesophilic Aerobic Bacteria * 100
B. Yeast * 100
C. Mold * 100
D. Gram Negative Bacteria None Detected
* MEANS LESS
23
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name:
Spec Ref. Minimum Test Frequency
Paragraph Property Release Retest Audit
APPEARANCE 3 PER LOT*
ODOR 3 PER LOT*
COLOR 3 PER LOT*
pH 3 PER LOT*
VISCOSITY 3 PER LOT*
MESOPHILIC 3 PER LOT**
AEROBIC BACTERIA
YEAST 3 PER LOT**
MOLD 3 PER LOT**
GRAM NEGATIVE 3 PER LOT**
BACTERIA
Special Instructions:
MASTER SAMPLE TO BE RENEWED EVERY 12 MONTHS.
Sampling Plan:
* SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE AND END OF
BATCH OR LOT AND TESTED SEPARATELY.
** SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE AND END OF
EACH PACKAGING/FILLING SHIFT AND MAY BE COMPOSITED.
24
Product: Cream with 0.1% KINETIN (#MCCRl-123-2005)
ITEM CODE RAW MATERIAL PERCENTAGE WEIGHT
Water (***)
Avocado Oil (LIPO; LIPOVOL A) (***)
Almond Oil (LIPO; LIPOVOL ALM) (***)
Glyceryl Stearate and PEG-I00 Stearate (***)
(Xxxxx 165; BASF)
Stearic Acid (Emersol132; COGNIS) (***)
Glycerin (Xxxxx 917; HENKEL) (***)
Cetearyl Alcohol and Ceteareth 20 (***)
(Cosmowax J; CRODA)
Phenoxyethanol (and) Methylparaben (and) (***)
Ethylparaben (and) Propylparaben (and)
Butylparaben (Sepicide HB; SEPPIC)
Sorbitan Monostearate (Span 60 NF; UNIQEMA) (***)
Dimethicone (FLUID 200, 350 cst. DOW CORNING) (***)
Titanium dioxide XX0000, XXX,XXXX, Bacteria (***)
controlled (Xxxxxxxxx, Xxxxx & Xxxxxxx)
Sodium Benzoate (VELSICOL) (***)
Kinetin (***)
PEG-14M (polyox WSR 205; AMERCHOL) (***)
Sodium Hydroxide (***)
Disodium EDTA (Dissolvine NA-2; AKZO NOBEL) (***)
Tocopheryl Acetate (ROCHE) (***)
Aloe Barbadensis Gel (***)
(ALOE XXXX GEL REG. 4 OX; XXXXX LABS)
Royal Jelly Extract (Active Organics) (***)
Chamomile extract BG (XXXX) (***)
Ascorbic Acid (ROCHE) (***)
TOTAL 100.0000
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
25
EXHIBIT D
SPF LOTION SPECIFICATIONS, AS OF MARCH 21ST, 2003, PENDING TO BE AMENDED
AND/OR FINALIZED UNTIL MAY 2003
[To set forth SPF Lotion forn1ulation]
26
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product: SPF LOTION with 0.1% KINETIN (#MCSPF2-121-2005)
I. General Description
-------------------
White lotion
II. Analytical Requirements
Property Limits Test Method
----------------------- ------ -----------
A. Appearance Viscous lotion
To Match Master
B. Odor Characteristic
To Match Master
C. Color White to off white
To Match Master
D. pH 6.5 - 7.5
E. Viscosity @25(DEG)C, LVT #T-E 10,000 - 35,000 cps
@12RPM
F. Total Solids (%) 21.0 - 27.0%
G. Specific Gravity 0.97 - 1.03
II. Chemical Requirements
Parameter (target) Limits Test Method
----------------------- ------ -----------
A. KINETIN (target: 0.10%) 0.095 - 0.105%
IV. Microbiological Requirements
Property Limits Test Method
---------------------------- ------ -----------
A. Mesophilic Aerobic Bacteria * 100
B. Yeast * 100
C. Mold * 100
D. Gram Negative Bacteria None Detected
* MEANS LESS THAN
27
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name:
Spec Ref. Minimum Test Frequency
Paragraph Property Release Retest Audit
APPEARANCE 3 PER LOT*
ODOR 3 PER LOT*
COLOR 3 PER LOT*
pH 3 PER LOT*
VISCOSITY 3 PER LOT*
MESOPHILIC 3 PER LOT**
AEROBIC BACTERIA
YEAST 3 PER LOT**
MOLD 3 PER LOT**
GRAM NEGATIVE 3 PER LOT**
BACTERIA
Special Instructions:
MASTER SAMPLE TO BE RENEWED EVERY 12 MONTHS.
Sampling Plan:
* SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
BATCH OR LOT AND TESTED SEPARATELY.
** SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
EACH PACKAGING/FILLING SHIFT AND MAY BE COMPOSITED.
28
Product: SPF LOTION with O.1% KINETIN (#MCSPF2-121-2005)
Item Code Raw Material Percentage Weight
--------- ------------ -----------------
Water (***)
Octylmethoxycinnamate (***)
Octyl Palmitate (and) Titanium Dioxide (and) (***)
Alumina (and) Polyhydroxystearic Acid (and) Silica
TIOVEIL OF; UNIQEMA)
Propylene Glycol (***)
Phenylbenzimimidazole Sulfonic Acid (***)
(EUSOLEX 232; RONA)
Octylhydroxy Stearate (Norfox 171;XXXXXX,FOX&CO) (***)
Triethanolamine (OXYCHEM) (***)
Aluminum Starch Octenylsuccinate (***)
(Dry Flo-PC, National Starch)
Phenoxyethanol (and) Methylparaben (and) (***)
Ethylparaben (and) Propylparaben (and)
Butylparaben (Sepicide HB; SEPPIC)
Cyclomethicone (DC345; DC) (***)
Cetyl Dimethicone (ABIL WAX 9801; GOLSSCHMIDT) (***)
Glyceryl Stearate and PEG-100 Stearate (***)
(Xxxxx 165; BASF)
Cetyl Alcohol (COGNIS/CRODA) (***)
Behenyl Dimethicone (***)
(ABIL WAX 2440; XXXXXXXXXXX)
Carbomer (Carbopol ETD2001; XXXXXXXX) (***)
Stearic Acid (Emersol 132; COGNIS) (***)
PEG-20 Almond Glycerides (CROVOL A-40, CRODA) (***)
Sodium Benzoate (VELSICOL) (***)
Acrylate/C10-30 Alkyl Acrylate Crosspolymer (***)
(PEMULEN TR-2, XX XXXXXXXX)
Xanthan Gum (Keltrol T; KELCO) (***)
Kinetin (SENETEK) (***)
Sodium Hydroxide (***)
Disodium EDTA (Dissolvine NA-2; AKZO NOBEL) (***)
Panthenol Liquid (50%, ROCHE) (***)
Tocopheryl Acetate (ROCHE) (***)
Aloe Barbadensis Gel (ALOE XXXX GEL REG. 40X;
0.0100 XXXXX LABS)
Chamomile Extract BG (XXXX) (***)
Ascorbic Acid (ROCHE) (***)
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
29
EXHIBIT E
EYE PRODUCT SPECIFICATIONS
[To set forth Eye Product formulation]
30
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name: EYE GEL with O.025% KINETIN (#MCEY4-127-2005)
I. General Description
-------------------
Opaque viscous gel
II. Analytical Requirements
Property Limits Test Method
----------------------- ------ -----------
A. Appearance Opaque viscous gel
To Match Master
B. Odor Characteristic
To Match Master
C. Color White opaque
To Match Master
D. pH 6.5 - 7.5
E. Viscosity @25(DEG)C, 10,000 -50,000 cps
LVT #T-F @12RPM
F. Total Solids (%) 0.7 - 1.3%
G. Specific Gravity .97 - 1.03
III. Chemical Requirements
Parameter Target Limits Test Method
--------------------- ------------- -----------
A. KINETIN 0.025% 0.020 - 0.030%
IV. Microbiological Requirements
Property Limits Test Method
---------------------------- ------ -----------
A. Mesophilic Aerobic * 100
Bacteria
B. Yeast * 100
C. Mold * 100
D. Gram Negative Bacteria None Detected
* MEANS LESS THAN
31
PRODUCT SPECIFICATION
Item Code:
Loc:
Ref:
Spec Date:
QCP Revision:
Product Name:
Spec Ref. Minimum Test Frequency
Paragraph Property Release Retest Audit
APPEARANCE 3 PER LOT*
ODOR 3 PER LOT*
COLOR 3 PER LOT*
pH 3 PER LOT*
VISCOSITY 3 PER LOT*
MESOPHILIC 3 PER LOT**
AEROBIC BACTERIA
YEAST 3 PER LOT**
MOLD 3 PER LOT**
GRAM NEGATIVE 3 PER LOT**
BACTERIA
Special Instructions:
MASTER SAMPLE TO BE RENEWED EVERY 12 MONTHS.
Sampling Plan:
* SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
BATCH OR LOT AND TESTED SEPARATELY.
** SAMPLES TO BE SELECTED FROM THE BEGINNING, MIDDLE, AND END OF
EACH PACKAGING/FILLING SHIFT AND MAY BE COMPOSITED.
32
Product: EYE GEL with 0.025% OR 0.01% KINETIN (#MCEY4-127-2005)
ITEM CODE RAW MATERIAL PERCENTAGE WEIGHT
DEIONIZED WATER (***)
BIOPOLYSACCHARIDE GUM-1 (***)
FUCOGEL 1000PP; Solabia/Barnet)
PROPYLENE GLYCOL (***)
HYALURONIC ACID & GLUCOSAMINOGLYCAN (***)
(ACTIGLIDE; ACTIVE ORGANICS)
ACTIFIRM TS (ACTIVE ORGANICS) (***)
WITCH XXXXX DISTILLATE (***)
GINKOBILOBA EXTRCT BG (ACTIVE ORGANICS) (***)
Phenoxyethanol (and) Methylparaben (and) (***)
Ethylparaben (and) Propylparaben(and)
Butylparaben (Sepicide HB; SEPPIC)
CARBOMER (CARBOPOL ETD 2001; XX XXXXXXXX) (***)
SODIUM HYDROXIDE 30% aqueous solution (***)
CUCUMBER EXTRACT BG (XXXX) (***)
OLETH-20 (AMEROXOL OE-20; AMERCOL) (***)
DISODIUM EDTA (Dissolvine NA-2; AKZO NOBEL) (***)
KINETIN (SENETEK) (***) or (***)
50%PANTHANOL (ROCHE) (***)
ALLANTOIN (BARNET) (***)
SODIUM PCA (AJIDEW N-50; AJINOMOTO) (***)
TOCOPHEROL (COVIOX T-50;) (***)
ASCORBIC ACID (ROCHE) (***)
TOTAL 100.000
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
33
EXHIBIT F
BASE PRICE
(bulk Product per gallon ordered and shipped in 55 gallon drums)
Lotion US$ (***)
Cream US$ (***)
Eye Gel US$ (***)
SPF Lotion US$ (***)
(Kinetin active per Kilogram)
1 kg Kinetin US$ 1(***)
*** Confidential portions of this material have been omitted and filed
separately with the Securities and Exchange Commission.
34
EXHIBIT G
LAVIPHARM MARKETING AND PROMOTION COMMITTMENT
35
MARKETING PLAN CASTALIA KINETIN
YEAR 1 OCT '03 -DEC '04
OBJECTIVE ACTION PLAN TIMING
----------------------------------- --------------------------------------------------------- -------------------------------
Establishement to the market obtain Launch a new line under the brand name CAST ALIA with 4 Presentation to the pharmacies
market share innovative references against the symptoms of photodamage oct'03
with a strong andioxidant ingredient Numb. 6
furfuryladenine 0,1%
Dermatologist Detailing * Full coverage of Derms * Oct '03
4 Medical reps / 4 times per year * Special visits to
Brand image building, gain hight op.Leaders * Oct '03
* Mailing to Derms
prescription market share in Derms * Professional press advertising / articles / PR * * Oct '03
Participation in 4 Dermatological congress(local,
national) * Jan '03
Presentation Material
* Monography with full clinical data of kinetin * Oct '03
* Scientific sales folder * Oct '03
* Reminder technical leaflet * Oct '03
* Samples of the 4 references * Oct '03
* Trial doses of 2 references * Oct '03
Pharmacists * Year sell-out contracts * Jan '04
* Sellout animations * Jan '04
* Sampling 100000 mini tubes * Oct '03
* Training seminars * Jan '04
Multiplication effect of the * Pharmacists sales folder
Medical pull
Create credibility and gain market
share in pharmacies
Consumers * New CASTALIA line, new packaging * Oct '03
* Attractive visual * Oct '03
* Consumer leaflet * Oct '03
Communication effect + increase * P.O.P. material: counter display stands, show cards * Jan '04
visibility / awareness * Institutional image for windows (300 pharmacies) * Jan '04
* Press releases dossier * Oct '03
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EXHIBIT H
CASTALIA DISTRIBUTION
TERRITORY COMPANY
1. CHINA PROFEX
2. KOREA BANDO NEWPHARM
3. TAIWAN ORIENT EUROPHARMA Co, Ltd
4. XXXXXX XXXXXXXX
0. XXXXXXX XXXXXX
0. XXXXX XXXXXX MEDICOPHARM
7. U.A.E. METROMED
8. CYPRUS LAVIPHARM CYPRUS Ltd.
37
