|
Exhibit 10.2
|
| |
|
EXCLUSIVITY,
MANUFACTURING AND SUPPLY AGREEMENT
|
| |
|
THIS EXCLUSIVITY,
MANUFACTURING AND SUPPLY AGREEMENT (hereinafter referred to as "
Agreement ") is made and entered into as of August
23, 2007 (the " Effective Date ") is made by and
between Dermworx Incorporated, a Delaware corporation, with its
offices at 934 S. Southlake Drive, Hollywood, Florida 33019
(hereinafter referred to as " Dermworx ", which reference
may include its Affiliates), and IGI, Inc., a Delaware corporation,
with its offices at 105 Lincoln Avenue, Buena, New Jersey 08310
(hereinafter referred to as " IGI ", which reference
may include its Affiliates). Dermworx and IGI are sometimes
referred to herein individually as a " Party " or
collectively as " Parties ".
|
| |
|
THIS Agreement, upon
execution, will supersede and replace the earlier agreement, dated
October 11, 2006, in between Dermworx and IGI.
|
| |
|
RECITALS
|
| |
|
WHEREAS, Dermworx has been
formed to develop, market and sell dermatological pharmaceuticals
and cosmeceuticals ("Dermatological Drugs");
|
| |
|
WHEREAS, IGI owns or has
rights to certain intellectual property trade marked as
Novasome® and has know-how to develop and manufacture
formulations using such technology (hereinafter referred to as
"Technology ");
|
| |
|
WHEREAS, IGI has developed
one 2% Salicylic Acid lotion Product (Product code # RL1109B)
utilizing the Technology (hereinafter referred as the "
Product "), determined by Dermworx to be suitable for the
treatment of acne;
|
| |
|
WHEREAS, Dermworx desires an
exclusive license to market and sell the Product in North, South
and Central America, and in the United Kingdom;
|
| |
|
WHEREAS, IGI possesses the
facilities, equipment, technologies, intellectual property rights
(either through direct ownership or license), and has the technical
know-how and capacity to produce such Product for
Dermworx;
|
| |
|
WHEREAS, as a condition to
maintain the exclusive rights Dermworx desires, IGI is to be
exclusive manufacturer of the finished packaged Product for its
purchase according to the provisions of this Agreement;
|
| |
|
1
|
<PAGE>
|
WHERAS, Dermworx and IGI
desire to set forth and define their relationship on the subject
matter contained herein, including but not limited to
consideration, Funding, and their respective rights, benefits,
duties and liabilities.
|
| |
|
NOW, THEREFORE, in
consideration of the mutual covenants and agreements herein
contained, and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties agree
as follows:
|
| |
|
1.
DEFINITIONS .
|
| |
|
1.10 "
Affiliates " means any Person or entity controlling,
controlled by or under common control with that Person or entity.
"Control" for this purpose means the possession, directly or
indirectly, of the power to direct or cause the direction of the
management and policies of a Person or entity, whether through the
ownership of voting securities or interests, by contract, or
otherwise.
|
| |
|
1.11 "
Business Day " shall mean any day which is neither a
Saturday, a Sunday nor a legal holiday on which banks are
authorized or required to be closed in the state of New
Jersey.
|
| |
|
1.12 "
Certificate of Analysis " means a summary of the quality
control testing, as described in the Product Specifications,
performed by IGI for the Finished Product supplied under this
agreement.
|
| |
|
1.13 "
cGMP " means the then-current good manufacturing practices
established by the U.S. Food and Drug Administration, as may be
amended from time to time.
|
| |
|
1.14 " Contract
Year " means, (i) with respect to the first Contract Year, the
period commencing on the Effective Date and ending on the last day
of the month in which the first anniversary of the Effective Date
falls, and (ii) with respect to any subsequent Contract Year, the
one year period commencing upon the first day of the month
following the month in which an anniversary of the Effective Date
falls.
|
| |
|
1.15 "
Facility " shall mean any IGI manufacturing facility used
for the Production of the Products.
|
| |
|
1.16 "
FDA Act " shall mean the federal Food, Drug and Cosmetic
Act, as amended.
|
| |
|
2
|
<PAGE>
|
1.17 "
Field " means any Product recognized in the trade as a
pharmaceutical, cosmetic or personal care Product.
|
| |
|
1.18
"First Commercial Sale " shall mean the first sale by
Dermworx of a Product for Trade.
|
| |
|
1.19 "
Finished Product " shall mean the Product together with all
Labeling, branding, trade dress and packaging set forth in the
Product Specifications.
|
| |
|
1.20 "
Formulations " shall mean the Products as further described
and set forth on Exhibit A .
|
| |
|
1.21 "
Improvements " shall mean enhancements to the formulation
and manufacturing process.
|
| |
|
1.22
"Launch" shall mean the date of the first commercial
shipment of the Product by Dermworx or its affiliates to a third
party customer in the Territory.
|
| |
|
1.23 "
Novasome® Technology " shall mean certain proprietary
technology involving the use of amphiphiles to prepare bi-layer
membrane structures.
|
| |
|
1.24 "
Person " means an individual, a partnership, a corporation,
an association, a joint stock company. a trust, a joint venture, an
unincorporated organization, or a governmental entity (or
department, agency or political subdivision thereof).
|
| |
|
1.25 "
Product Sale Period " means the one year period starting
from the earlier of November 30, 2007 or the shipment of the
Product to Dermworx designated warehouse from IGI manufacturing
facility in Buena, NJ.
|
| |
|
1.26 "
Specification " shall mean the specification for the Product
set forth on Exhibit B .
|
| |
|
1.27 "
Territory " means the North America, South America, Central
America and the United Kingdom.
|
| |
|
1.28 "
Third Party " means any person or legal entity other than
IGI, Dermworx or their Affiliates.
|
| |
|
1.29 "
Trade Secrets " shall mean all categories of trade secrets
as defined in the Uniform Trade Secrets Act including inventions,
clinical information, manufacturing and Production
|
| |
|
3
|
<PAGE>
|
processes, experience,
procedures and techniques, methods, practices, know-how, formulae,
research and development information, business information,
supplier and customer lists and related information, and all other
confidential and proprietary information and rights.
|
| |
|
2. PRODUCT
REQUIREMENTS .
|
| |
|
2.1 Exclusive Supply of
the Product . For the period commencing on the Effective Date
IGI shall supply, or cause to be supplied, and Dermworx shall
purchase all of Dermworx's requirements of the Finished Product,
for use in the Field in the Territory on the terms, and subject to
the conditions, of this agreement. IGI agrees that, during the Term
of this Agreement, Dermworx shall have the exclusive right to
purchase the Product from IGI and its Affiliates for resale in the
Field and the Territory until such time as Dermworx fails to
satisfy the guaranteed minimum royalties requirements specified in
Section 5.1.1 below and forfeits its exclusive right to purchase
the Product in accordance with Section 5.1.2 below.
|
| |
|
2.2 General
Responsibilities . IGI will be responsible at its expense for
all scale-up, validation, stability, Finished Product testing and
stability, and fill and finish work related to the manufacture of
the Product.
|
| |
|
2.3 Product
Specifications . The specifications for the Product are set
forth in Exhibit B attached hereto, which may be changed
from time to time upon written agreement of the parties (the "
Specifications ").
|
| |
|
3. ESTIMATES,
ORDERS AND TERMS OF SALE .
|
| |
|
3.1 Product Estimates
. At least sixty (60) days prior to the start of each calendar
quarter, Dermworx shall provide IGI with a written estimate of the
amounts of the Product that it will require during such quarter and
for each of the three (3) calendar quarters subsequent thereto. The
parties agree that the Product estimates produced pursuant to this
Section 3.1 are for convenience purposes only, and that such
Product estimates shall not obligate Dermworx to purchase any
specific amount of Products.
|
| |
|
3.2 Purchase Orders .
Dermworx shall provide IGI with binding purchase orders for the
purchase of the Product, which will specify, at a minimum, item
ordered, volume ordered, price, and requested delivery date ("
Purchase Orders "). Purchase Orders must be delivered to IGI
at least forty-five (45) Business Days prior to the shipment date
requested in such Purchase Order. IGI may reject any Purchase Order
that does not conform to the requirements of this paragraph of the
Agreement. In addition, in the event Customer submits Purchase
Orders for Product in excess of one-hundred fifty percent (150%) of
the forecasts provided pursuant to Section 3.1, IGI may delay the
shipment date for the excess by such reasonable period as is
necessary for Dermworx to manufacture such excess.
|
| |
|
4
|
|
3.3 Terms of Sale .
Notwithstanding any different terms which may be contained in any
Purchase Order or other form(s) submitted by Dermworx to IGI, all
sales of Products by IGI to Dermworx shall be controlled by and
subject to the terms and conditions of sale set forth on Exhibit
C hereto, which are hereby incorporated into and made a part of
this Agreement. Any acceptance by IGI of any Purchase Order shall
be deemed to restate all of the terms and conditions set forth in
this Agreement and Exhibit C applicable to such sale and no
modification or amendment to such terms of sale shall be effective
unless in writing executed by an officer of IGI and an officer of
Dermworx explicitly stating that it is the intention of the parties
to modify such terms and conditions of sale.
|
| |
|
3.4 Launch of the
Product . The launch by Dermworx of the Product shall occur no
later than January 31, 2008.
|
| |
|
3.5
Inability to Supply .
|
| |
|
(a) Subject to Article 9, if
IGI is unable or shall otherwise fail to supply all of Dermworx's
Purchase Orders for the Product as contemplated hereby, including
but not limited to by reason of Section 8.3, IGI shall use
reasonably diligent efforts to provide for supply of the Product
from Third Parties capable of supplying such items who reasonably
demonstrate that they can supply Dermworx's orders of the Product
according to the terms of this Agreement for a continuous period of
ninety (90) days. In the event IGI causes Third Parties to supply
Products in accordance with this Section 3.5 (a), IGI shall cause
such items to be supplied to Dermworx at a price not to exceed the
price for the Product as set forth in Exhibit A .
|
| |
|
(b) In the event IGI is
unable to cause a Third Party to manufacture Product to meet its
obligations to Dermworx under the terms of Section 3.5 (a) of this
Agreement, IGI shall facilitate and reasonably cooperate with
procedures for disclosure of IGI's technical information and
know-how concerning the manufacture of the Product, and taking into
account the highly confidential nature of the IGI Confidential
Information, to enable a Third Party mutually agreeable to the
Parties who will act as a Third Party Contract Manufacturer for
IGI, and Dermworx will have the right to purchase through IGI such
Product manufactured by the Third Party Contract
Manufacturer.
|
| |
|
(c) In the event that either
sub-paragraph (a) or (b) of this sub-paragraph 3.5 becomes
effective, then the Third Party contractor and Dermworx shall be
granted a limited, non-assignable, royalty free license from IGI
for its intellectual property covering the Product and
manufacturing thereof. This limited license shall be self executing
when a Third Party contractor is engaged, and shall have a term of
months for the period of time that it is necessary for the Third
Party contractor to manufacture and package the Product. This
limited license shall terminate upon IGI resuming manufacturing of
the Product.
|
| |
|
5
|
<PAGE>
|
4. PRICE AND
PAYMENT .
|
| |
|
4.1 Development Fee .
Dermworx shall pay IGI Two Hundred and Fifty Thousand Dollars
($250,000) for the development of the Product. For the purpose of
clarity, the $250,000 payment by Dermworx to IGI on November 30,
2006 against the Agreement of October 11, 2006 shall be applied and
credited in full to this new Agreement and Dermworx will not owe
IGI for the Product development as stated above.
|
| |
|
4.2 Price for the
Product . The price for the Product shall be the sales price
(from IGI to Dermworx) for such Product as set forth in Exhibit
A hereto as adjusted as set forth in this Section 4 (the "
Price "). The Prices for Products shall be fixed during the
first twelve (12) months of the Term (the " Fixed Period ")
defined in 8.1 hereunder, and such Prices shall be subject to
adjustment pursuant to Section 4.2 after the Fixed
Period.
|
| |
|
4.3 Price Adjustments
. Notwithstanding anything to the contrary in Section 4.2 above,
after the Fixed Period, Prices shall be adjusted automatically
annually to reflect an average increase in the Producer Price Index
for Finished Goods Excluding Foods (PPIFLF) or a successor index as
published by the United States Department of Labor (or such other
governmental authority as may be charged with compiling such index
from time to time) for the preceding twelve (12) month
period.
|
| |
|
4.4 Payment . Terms of
payment by Dermworx to IGI shall be fifty percent (50%) cash down
payment with Dermworx purchase order, balance due within thirty
(30) days of receipt of the Product covered by the invoice for that
Product when delivered. The amount due under all such Purchase
Orders which have not been timely paid and no good faith dispute
exists as to such Purchase Order, shall incur interest of 18% per
annum. Other than Product for which Dermworx and IGI have a good
faith dispute over the payment thereof, if Dermworx does not comply
fully with the foregoing payment terms on Product for which there
is no dispute after having been given a opportunity to cure the
same pursuant to Section 7.2, then IGI, at its option, may defer
additional shipments until overdue accounts have been paid, suspend
Production of the Product, and/or pursue collection actions and
other available remedies. In the event that Dermworx in good faith
disputes any amount due under an invoice, Dermworx shall pay the
undisputed amount due and may withhold payment only of the disputed
portion of the invoice. The parties shall discuss the disputed
amount in good faith and seek to resolve such dispute.
|
| |
|
6
|
<PAGE>
|
5. ROYALTY
PAYMENTS .
|
| |
|
5.1 Upon Dermworx effecting
sales of the Product, IGI shall be paid a [***] royalty on Net
Sales ("Royalty") as in 5.2 hereunder.
|
| |
|
5.1.1 In
consideration of the exclusivity granted to Dermworx hereunder,
Dermworx and permitted Affiliates of Dermworx shall guarantee IGI a
minimum royalty payment of [***]
|
| |
|
5.1.2 The
exclusivity of the Product granted to Dermworx will become non
exclusive if the conditions specified in 5.1.1 above are not met.
However, in the event that Dermworx does not generate enough sales
to pay above specified royalty amount to IGI, Dermworx can maintain
exclusivity of the Product in the Territory by paying
|
|