PARTNERSHIP AGREEMENT
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
This
Partnership Agreement ("Agreement") is entered into as of the 7th day of
November,
2006 ("Effective Date") by and between RxElite, Inc. ("RxElite"), a Delaware
corporation,
whose principal place of business is 0000 Xxxxx Xxxx, Xxxxx 000, Xxxxxxxx,
XX
00000
and
Core Tech Solutions, Inc. ("Core Tech"), a New Jersey corporation, whose
principal place of business is 00 Xxxx Xx., Xxxx Xxxxxxx, XX 00000.
WHEREAS,
RxElite is a rapidly growing U.S. generic pharmaceutical company utilizing
"best
in
class" manufacturing and research and development; and,
WHEREAS,
Core Tech Solutions, Inc. is a corporation that owns and is developing and
manufacturing
products and technology in the areas of transdermal (TDS) and topical delivery
systems;
and,
WHEREAS,
RxElite and Core Tech, hereinafter referred to as the Parties, wish to
establish
a business partnership agreement in accordance with the terms set forth
herein.
Article
I - Definitions
1.1. "Licensed
Products" shall mean the Fentanyl transdermal systems produced by Core
Tech, equivalent, according to the U.S. FDA, to the brand product Duragesic®,
manufactured
by a division of Xxxxxxx and Xxxxxxx.
1.2. "Technology"
shall mean the copyright, trade secret, know-how, data, drug applications,
and other information (whether or not patentable or qualifying as a trade
secret) relating
to the "Field of Use" and the "License Products" that Core Tech owns, or
hereafter develops,
individually or in conjunction with RxElite, and that may hereafter be provided
to or revealed
to RxElite by Core Tech, pursuant to the terms of this Agreement.
Page
1 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
1.3. "Field
of
Use" shall mean the "Licensed Product" for sale, distribution and use of the
Fentanyl
Transdermal System, equivalent, according to the U.S. FDA, to the brand product
Duragesic®,
manufactured by a division of Xxxxxxx and Xxxxxxx.
1.4. "License
Period" shall mean collectively the respective periods commencing on the
date
hereof and ending (unless terminated) with no end date.
1.5. "Gross
Sales" shall mean the gross sales of Licensed Products billed to customers
by
RxElite,
its Subsidiaries, and its sub-Licensees, less the following:
(a) allowances
and adjustments actually credited to customers for damaged and returned
Licensed Products;
(b) trade,
quantity, cash, and prompt payment discounts actually allowed and taken;
and
(c) third-party
charges of the following kinds, collected by the seller from the buyer
and
separately identified on the invoice: transportation charges, sales taxes,
and
excise taxes
and
duties.
Gross
Sales shall also include and be deemed to have been made with respect to any
Licensed Products used by RxElite, any Subsidiary, or any sub-Licensee, for
its
own purposes, or
transferred to any third-party for less than the transferee is then charging
in
normal arms-length
sales transactions; and Gross Sales in all such cases shall be deemed to have
been made at the prices therefore at which such Licensed Products are then
being
sold to the customers of such users
or
transferors (or of RxElite, if a subsidiary is a user but not a seller) in
arms-length transactions.
1.6. "Net
Profits" shall mean the Gross Sales of Licensed Products as defined in Section
1.5,
less
the following:
(a) Core
Tech
product transfer price;
(b) direct
customer rebates, including Medicaid and Medicare rebates; and,
Page 2
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
(c)
liability insurance for the licensed product, direct warehousing and
transportation
costs not attributed to the "Gross Sales" calculation.
1.7 "Subsidiary"
shall mean any corporation, partnership, or other business organization
that
directly or indirectly controls, is controlled by, or is under common control
with RxElite.
1.8 "Territory"
shall mean the United States and World Wide rights if payment in full
for
World-Wide rights is paid according to the terms below.
Article
II — Core Tech Responsibilities
2.1. Research
and Development Activities:
Core
Tech shall provide the following services
in relation to the approval of a Fentanyl Transdermal System, equivalent,
according to the
U.S.
FDA, to the brand product Duragesic®, manufactured by a division of Xxxxxxx and
Xxxxxxx.:
| · |
Analytical
Method Transfer & Validation; and,
|
| · | Product Scale up. |
2.2. Clinical
and U.S. Regulatory Activities:
Core
Tech shall provide the following services
in relation to the approval of a Fentanyl Transdermal System, equivalent,
according to the
U.S.
FDA, to the brand product Duragesic®, manufactured by a division of Xxxxxxx and
Xxxxxxx.:
· cGMP
Manufacturing of Clinical and
Registration Batches (1 x 25k batch each)
placebo, 12.5, 25, 50, 75, 100 μg/hr,
QC Release of Clinical and Registration
batches;
· Pivotal
Bioequivalence Study (XX
subjects to complete) - Duragesic® (25μg/hr,
10 cm2,
0.6
mg/24hr) vs. Core Tech Generic Fentanyl Transdermal System
(25μg/hr,
10 cm2,
0.6
mg/24hr);
Page 3
of 27
THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
| · |
Cumulative
Irritation Combination Study (XX Subject to complete) - Core Tech
Placebo Transdermal System, (00μg/hr,
10
cm2,
0.0 mg/24hr);
|
| · |
Completion
of Clinical Studies;
|
| · |
XX Year
Stability Study of Clinical and Registration Batches;
and,
|
| · |
ANDA
Compilation and Filing with U.S.
FDA.
|
2.3.
Manufacturing
Activities.
Core
Tech shall provide the following services in relation
to the approval of a Fentanyl Transdermal System, equivalent, according to
the
U.S.
FDA, to the brand product Duragesic®, manufactured by a division of Xxxxxxx
and Xxxxxxx.;
·
Manufacturing
of Process Validation
Batches, 5 strengths, 3 batches per strength, XX
patches/batch for 5 cm2,
10
cm2,
20
cm2
and XX
patches/batch
for 30 cm2,
40
cm2
(total
all the strengths combined XX patches)
·
Launch
batches - Following regulatory
approval, manufacture Fentanyl Transdermal System in conformity with mutually
agreed quantities;
· Delivery
of approved products to
RxElite in mutually agreed minimum lot sizes
and
FDA-approved packaging, delivered to mutually determined locations according
to mutually agreed schedules;
| · |
Establish
and support warranties against defects in manufacture or packaging
of
products;
|
| · |
Execute
any supplementary filings to regulatory authorities in connection
with
manufacture of products; and,
|
Page 4
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
· Sell
to
RxElite product at the cost which will be reset according to actual audited
costs quarterly. The estimated costs for each carton (1 patch/pouch, 5
pouches
/
carton - 5-pack configuration carton), not including product packaging,
Instructions for Use, product inserts and shipping cases, is presented below.
Raw material cost fluctuations may impact transfer pricing. These estimates
are
based upon
the
mutually agreed upon minimum quantity of XX million patches XX Year.
XX
|
Estimated
Transfer
Price
from Core Tech to RxElite*
|
Patch
Size
|
Price/Single
Patch
|
Price/5
Patches per Carton
|
|||
|
12.5
μg/hr
|
5
cm2
|
XX/patch
|
$XX/carton
|
|||
|
25
μg/hr
|
10
cm2
|
XX
/patch
|
$XX/carton
|
|||
|
50
μg/hr
|
20
cm2
|
XX
/patch
|
$XX/carton
|
|||
|
75
μg/hr
|
30
cm2
|
XX
/patch
|
$XX/carton
|
|||
|
100
μg/hr
|
40
cm2
|
XX
/patch
|
$XX/carton
|
*Note:
XX
2.4
Core
Tech
shall grant RxElite a first right of refusal to develop, manufacture
and distribute
any other generic transdermal system (patch products, including the generic
form
of XX
[XX
patch]) for itself or a client. RxElite will respond to any first right
of refusal
within 30 days and if terms are agreed upon by both parties, commence
development within
90
days of the first right of refusal.
Page
5 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
2.5
If
Core Tech is unable to file an ANDA within 30 months for a Fentanyl Transdermal
System, equivalent, according to the U.S. FDA, to the brand product Duragesic®,
manufactured
by a division of Xxxxxxx and Xxxxxxx or Core Tech chooses to no longer pursue
an
approval,
then RxElite shall have foil access to and a right to utilize all work created
during the filing
process on a royalty free non-exclusive basis for its own uses separate of
Core
Tech. This condition
shall be considered null and void if RxElite defaults on the responsibilities
of
this agreement
causing delays in the Core Tech ANDA submission.
Article
III - RxElite Responsibilities
·
3.1.
Development
Funding and Clinical Studies.
RxElite
shall provide the following
services in relation to the development support of a Fentanyl Transdermal
System, equivalent, according to the U.S. FDA, to the brand product Duragesic®:
XX
by
wire transfer within
3
business days of the signing of this agreement by both parties; and
·
XX
·
XX
Of
the
above funding, XX is allocated for reimbursement
of clinical study expenses to be incurred during the FDA regulatory approval
process.
3.2.
US Process
Validation.
RxElite
shall provide the following services in relation to the product validation
lots
and US regulatory support of a Fentanyl Transdermal System:
Page
6 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
· An
estimated additional XX
transfer
to produce required process
validation batches in relation to the ANDA approval (this product is
intended
to be sold under the profit share terms of this agreement, once FDA approval
has
been finalized). Funding to be received within 30 days of filing of ANDA.
Estimated pricing reflects XX
patches at a projected cost of XX
per
patch. Actual pricing including above mentioned packaging requirements
to
be
provided by Core Tech at the time of manufacture. Core Tech and RxElite
will
jointly determine the final Product Process Validation schedule
requirements.
The
above
payments shall be considered payment in full to Core Tech for the development
and approval of an ANDA for the Fentanyl Transdermal System, equivalent,
according
to the U.S. FDA, to the brand product Duragesic®. All development, clinical,
process validation,
and regulatory approval payments are non-refundable. Any payment amount
or
payment
timeline not met by RxElite shall null and void this agreement, unless
agreed
upon by both parties in writing. Additional funding to procure expanded
manufacturing capacity or to purchase
initial product inventories may be addressed at any time and must be
agreed upon
in writing
by both Parties. Both parties shall have access to review ANDA filing
documents
paid for
and
completed during the term of this agreement for viewing and verification
purposes only.
If
this
agreement becomes null and void due to default on payments from RxElite
to Core
Tech,
then Core Tech shall reimburse RxElite the full amount paid to date by
RxElite,
minus external
fees and expenses specific to this agreement (including expenses associated
with
procuring
a new distribution partner), within three years of FDA approval and the
commencement
of sales of the Fentanyl transdermal system produced by Core Tech, equivalent,
according
to the U.S. FDA, to the brand product Duragesic®, manufactured by a division of
Xxxxxxx
and Xxxxxxx. In the event of default, Core Tech will own and maintain
the rights
of the licensed
product to continue all research, regulatory, development, clinical,
marketing
and distribution
activities at its own discretion. If Core Tech is unable to sign and
execute an
equivalent
partnership agreement with an alternate manufacturing and distribution
entity
for the sales
of
the Fentanyl transdermal system within one year of RxElite's default,
all monies
invested
will be retained by Core Tech.
Page
7 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
3.3 Worldwide
Regulatory Filing.
RxElite
shall provide the following services in relation
to the worldwide regulatory support of a Fentanyl Transdermal
System:
3.3.1 EU
Funding for Clinical Studies and Regulatory Filings: RxElite shall
pay
Core
Tech
an additional XX
within
one year of the signing of this agreement, and an
additional XX
within
XX
of
signing this agreement XX to
secure
the Worldwide marketing, sales and distribution rights for the Fentanyl
Transdermal
System.
3.3.2 If
RxElite chooses not pay to for non-U.S. rights, all other terms of
this
agreement remain binding and at that time, Core Tech will own and maintain
the
non-U.S.
rights of the licensed product to continue all research, regulatory,
development, clinical,
marketing and distribution activities at its own discretion.
3.3.3 Clinical
Studies:
This
payment shall be applied to regulatory, clinical and filing
costs in Europe (EU) for approval of the Fentanyl Transdermal System
equivalent to
regulatory authority to the brand product Duragesic.
3.3.4 Product
Validation:
RxElite
shall pay in addition to the above, by wire transfer,
all necessary costs for process validation batches necessary for the
approval
in each
respective country , and this product will be sold under the profit
share terms
of this agreement,
once approval has been finalized in each country. Additional development
fees
for
further country filings shall be agreed upon by both parties and paid
to Core
Tech from
RxElite as due for each country filing.
3.4.
Marketing
and Distribution.
RxElite
shall provide the following services in relation to
the
marketing and distribution of a Fentanyl Transdermal System, equivalent,
according to the U.S.
FDA,
to the brand product Duragesic®, manufactured by a division of Xxxxxxx and
Xxxxxxx:
Page
8 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
a) Develop
and execute a sales and marketing plan consistent with manufacturing
targets established by both companies;
b) Provide
market research and analysis to support product manufacturing and
marketing;
c) Coordinate
customer service with information and processing of warranty claims;
d) Provide
warehousing and logistics to support distribution of products and maintain
accurate distribution records;
e) Staff
a
Post-Approval Compliance Program that will log customer complaints
and oversee adverse events reporting; and,
f) RxElite
will assist Core Tech in managing and qualification of expansion, build
out
and secure vault activities that are required or advantageous to the
production
of the licensed product.
3.5.
Manufacturing
Requirements.
RxElite
shall provide a Fentanyl Transdermal System manufacturing
product requirement schedule to Core Tech including: a two-year rolling
forecast, six
month
committed delivery projections and monthly purchase orders. Orders will be
finalized and firm and binding 90 days in advance of each monthly
order.
3.5.1.
Manufacturing
Minimum Orders.
RxElite
will guarantee the purchase of a minimum
of XX
Fentanyl
Transdermal System patches XX of
the
licensed product per year throughout the duration of this contract
commencing with the year ANDA approvals is obtained. For this requirement,
a
year
will
be defined as commencing from the date of ANDA approval or release for sale
of
the first commercially available batch whichever comes last and its subsequent
yearly anniversary
dates. Any portion of the year in which this agreement is in effect will be
deemed
a
full year for the purposes of maintaining the minimum manufacturing requirement
obligations on a prorated basis.
Page
9 of
27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
3.5.2. If
RxElite purchases less than the minimum quantities outlined in this
Agreement then RxElite shall have up to 90 days to "Catch Up", by ordering
increased
quantities equal to the shortfall for the previous year during the Catch Up
period.
Manufacturing Minimums can be adjusted higher or lower by written agreement
of
both
parties. If Core Tech is unable to supply enough product during the Catch Up
period
to
satisfy minimums, then the catch up period shall be extended until all Catch
Up
product is supplied by Core Tech.
3.5.3. If
RxElite does not meet its manufacturing minimums, and is not able
to
Catch Up according to Section 3.4.1, then RxElite shall lose its exclusive
rights to the
U.S.
market. If exclusivity is lost by RxElite, then all other terms of this
agreement EXCEPT
SECTION 2.4 AND SECTION 16 shall remain in full force on a non-exclusive
basis,
with minimum orders of 2 million patches per order required. RxElite will not
have
any
profit sharing participation or royalty for Core Tech produced product for
customers
other than RxElite or its licensees if exclusivity is lost.
3.5.4. Manufacturing
Minimum Production. Core
Tech
will guarantee the production of a minimum of XX Fentanyl Transdermal System
patches XX the licensed product per year throughout the duration of this
contract commencing with the year ANDA approvals is obtained. For this
requirement, a year will be defined as commencing from the date of ANDA approval
or
release for sale of the first commercially available batch whichever comes
last
and its subsequent yearly anniversary dates. Any portion of the year in which
this agreement is in
effect
will be deemed a full year for the purposes of maintaining the minimum
manufacturing
requirement obligations on a prorated basis.
Page
10
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
3.5.5. If
Core
Tech produces less than the minimum quantities outlined in
this
Agreement then Core Tech shall have up to 90 days to "Catch Up", by producing
increased
quantities equal to the shortfall for the previous year during the Catch Up
period.
Manufacturing Minimums can be adjusted higher or lower by written agreement
of
both
parties. Core Tech retains the right to qualify another manufacturing supply
source
separate of the Core Tech facility, utilizing the ANDA developed by Core Tech
as
part
of
this agreement, and RxElite will cooperate in facilitating a second source
to
meet licensed
product requirements.
3.5.6. If
Core
Tech does not meet its manufacturing minimums, and is not
able
to Catch Up according to Section 3.5.1, then RxElite shall be allowed to qualify
second
manufacturing supply source separate of Core Tech, utilizing the ANDA expertise
developed
by Core Tech as part of this agreement, and Core Tech will cooperate with
RxElite in facilitating the qualification of a second facility, at the expense
of RxElite. The
production outside of Core Tech to meet minimum shortfalls according to the
terms of
this
Section 3.5.2 shall be on a royalty free basis with no profit
share.
3.6 Deliveries.
All
deliveries under this Agreement shall be made FOB to one of RxElite's
warehouse, as set forth in the order for the applicable Products.
3.7 Risk
of Loss.
Risk of
loss of any kind to the Products manufactured and shipped pursuant
to this Agreement shall rest with Core Tech during the manufacturing process
and
shipment
to RxElite. Upon delivery to and written acceptance of the Product by RxElite,
the risk of loss shall pass to RxElite. Nothing in this Section is intended
to
restrict or eliminate RxElite's right
to
revoke acceptance or reject nonconforming goods as permitted under the Uniform
Commercial
Code, or otherwise enforce the terms of any express or implied warranty
associated with
the
goods. The intent of this Section is solely to allocate the risk of loss due
to
casualty or otherwise,
including, without limitation, deterioration, breakage, accidental loss, and
acts of god.
Article
IV - Grant: Sublicenses
4.1. Grant.
Subject
to the terms and conditions set forth herein, Core Tech hereby grants
to
RxElite, to the extent that it lawfully may, use of the Technology only for
the
purpose of marketing,
selling, and distributing Fentanyl Transdermal System in the Territory (the
"License").
Page
11
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
4.2. Reserved
Rights.
Core
Tech reserves to itself (a) all rights not granted to RxElite hereunder,
including the rights to use and permit the use of the product and technology
for
any purpose not in conflict with the provisions of the License, and (b)
notwithstanding the terms of the
License, the right at all times to make, have made, and use Licensed Products
for Core Tech's own research purposes.
4.3. Sublicenses.
RxElite
shall also have the right to grant to its subsidiaries or other sub-Licensees,
exclusive or non-exclusive sublicenses under the License during the License
Period,
provided, however, and RxElite agrees that:
a) the
terms
and conditions of each sublicense shall be consistent with the terms
and
conditions of this Agreement;
b) each
sublicense shall provide that the obligations to Core Tech of this Agreement
shall be binding on the sub-Licensee and be enforceable by Core Tech upon
RxElite;
c) Core
Tech
shall have the right to approve any sublicense to a company not owned
partially or fully by RxElite, that grants exclusive rights of any kind to
anyone,
such approval not to be unreasonably withheld;
d) RxElite
shall furnish to Core Tech a true and complete copy of each sublicense
agreement and each amendment thereto, promptly after the sublicense or
amendment has been agreed upon;
Page
12
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
e)
No
Subsidiary or other sub-Licensee shall have the right to further license,
sublicense,
or assign its rights without the written
approval
of Core Tech;
f)
No
sublicense shall relieve RxElite of any of its obligations hereunder, and
RxElite
shall be responsible for the acts or omissions of its Subsidiaries and
sub-Licensees
and for compliance by them with their obligations, and RxElite shall
take
all
steps necessary to enforce that compliance to the extent required to allow
RxElite
to fully comply with all of its obligations under this Agreement;
and,
g)
RxElite
shall not receive from sub-Licensees anything of value in lieu of cash
payments in consideration for any sublicense under this Agreement without
the
prior
written consent of Core Tech, which consent will not to be unreasonably
withheld.
ARTICLE
V - PROFIT PAYMENTS. RECORDS.
5.1. Profits.
RxElite
and Core Tech shall split profits obtained from the sale of the licensed
product XX. Profits shall be calculated as defined
in Section 1.6. Core Tech's transfer price shall be all direct costs plus an
agreed upon overhead
allocation.
5.2. Statements;
Payments.
RxElite
shall, within thirty (30) days after the last days of March,
June, September, and December in each year or portion thereof during the License
Period,
and within thirty (30) days after the end of the License Period, provide Core
Tech with a statement
accounting for the Gross Sales of Licensed Products by RxElite, its
Subsidiaries, and its
sub-Licensees (and with copies of the corresponding statements to RxElite from
its subsidiaries
and sub-Licensees), for the immediately preceding three (3) month period or
portion thereof,
accompanied by statement of Net Profit calculation and payment for all amounts
collected
from RxElite customers under this Article V for that period or portion thereof.
Each such
statement shall be certified by the Chief Executive Officer of RxElite as being
true, correct, and
complete, and shall include at least the following: Gross Sales calculations
and
number of units
of
different Licensed Products manufactured, sold and otherwise disposed of; total
xxxxxxxx for
each
Licensed Product sold; accounting for all applicable Gross Sales calculations
and deductions
allowed; accounting for all applicable Net Profit calculations and deductions
allowed; and
payment due.
Page
13 of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
5.3. Records.
Audits.
Both
Parties shall keep (and cause to be kept) and maintain complete
and accurate records of all manufacturing related costs, raw material costs,
Gross Sales of
the
Licensed Products and accounting for all applicable Net Profit calculations
and
deductions by
RxElite, its Subsidiaries, and, its sub-Licensees, in accordance with generally
accepted accounting
procedures. Such records shall be accessible to independent certified public
accountants
selected by either Party and reasonably acceptable to the other Party, by audits
conducted
not more than once a year during the License Period and for one year after
the
termination
thereof, at any reasonable times during business hours, for the purpose of
verifying Core
Tech
product transfer price, Net Profits and any fees due thereon. Such accountants
shall disclose
to both Parties only information relating to the accuracy of the records kept
and the payments
made, and shall be under a duty to keep confidential any other information
obtained from
such
records. Both Parties, their Subsidiaries, and their sub-Licensees shall not
be
required to
retain
such records for more than five (5) years after the close of any calendar
quarter-year.
5.4. Substantial
Underpayment of Profit Share or Overcharge of Transfer Price.
If any
such audit reveals that the aggregate paid during any four consecutive calendar
quarters
was more than five percent (5%) more or less than the amount that should have
been paid,
then the reasonable expenses of the audit shall be borne by the other Party,
which shall pay those
expenses within thirty (30) days after demand therefore by the other Party
accompanied by the
accountants' statement therefore and its sub-Licensees, in accordance with
generally accepted accounting
procedures. Such records shall be accessible to independent certified public
accountants
selected by either Party and reasonably acceptable to the other Party, by audits
conducted
not more than once a year during the License Period and for one year after
the
termination
thereof, at any reasonable times during business hours, for the purpose of
verifying Core
Tech
product transfer price, Net Profits and any payments due thereon. Such
accountants shall
disclose to either Party only information relating to the accuracy of the
records kept and the payments
made, and shall be under a duty to keep confidential any other information
obtained from
such
records. Both Parties, their Subsidiaries, and their sub-Licensees shall not
be
required to retain such records for more than five (5) years after the close
of
any calendar quarter-year.
Page
14 of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
Core
Tech
product transfer price, Net Profits and any payments due thereon. Such
accountants shall
disclose to either Party only information relating to the accuracy of the
records kept and the payments
made, and shall be under a duty to keep confidential any other information
obtained from
such
records. Both Parties, their Subsidiaries, and their sub-Licensees shall not
be
required to retain such records for more than five (5) years after the close
of
any calendar quarter-year.
5.4.1.
Any Underpayment
of
Profit Share or Overcharge of Transfer Price shall be
paid
back to the other Party within 30 days after discovered and presented in writing
to the other Party according to the provisions of section 5.4 of this
Agreement.
ARTICLE
VI - REGULATORY APPROVAL AND MAINTENANCE
6.1 Regulatory
Approval Ownership and Maintenance.
Core
Tech shall own, hold and maintain
the U.S. FDA Abbreviated New Drug Application (ANDA) and any other regulatory
approvals
from other countries of the Fentanyl transdermal systems and shall pay all
reasonable costs
associated with ANDA maintenance throughout the license agreement.
6.2 Recall
of Products.
In the
event Core Tech shall be required (or shall voluntarily decide)
to initiate a recall, withdrawal, or field correction of any Product
manufactured as part of this
Agreement, whether or not such recall has been requested or ordered by any
state
or Federal agency,
Core Tech shall notify RxElite within one (1) business day, and RxElite shall
follow any other
instructions reasonably provided by Core Tech. Core Tech shall bear all costs
and expenses
associated with any recall, withdrawal, or field correction as a result of
any
negligence or
intentional misconduct of Core Tech , and shall reimburse RxElite for all costs
and expenses reasonably
incurred by RxElite as a result thereof. If, however, a recall, withdrawal
or
field correction
is initiated by RxElite as a result of any negligence or intentional misconduct
of RxElite
(and not resulting from the quality of Core Tech's services, or any
non-compliance with the
terms
and conditions of this Agreement or any defect in any of the Products including,
without
limitation, any adulteration, damage or other non-conformity), RxElite shall
bear its costs
and
expenses with respect thereto and shall reimburse Core Tech for all costs and
expenses reasonably
incurred by Core Tech as a result thereof.
Page
15
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
6.3 Returns.
Core Tech shall reimburse RxElite for the cost and expense of any Licensed
Products returned to RxElite as a result of any:
a) Recall,
withdrawal or field correction,
b) Defect
(whether inherent or otherwise) in any Products supplied by Core Tech
hereunder (including, without limitation, any adulteration, damage or
other
non-conformity), determined to have occurred prior to product acceptance
by RxElite, and/or
c) Any
negligence or intentional misconduct of Core Tech.
6.4 Adverse
Events.
During
the Term, Core Tech shall be responsible for reporting to the
appropriate regulatory authorities all adverse experiences reported to it with
respect to the Products
manufactured and supplied by Core Tech in accordance with all applicable laws
and regulations.
Each party shall provide to the other party the name of an appointed safety
representative
of such party to whom all adverse experiences reports and queries shall be
reported,
and the parties shall mutually agree upon procedures for adverse event reporting
to each
other and to the appropriate regulatory authorities in accordance with
applicable laws and regulations.
ARTICLE
VII - CONFIDENTIALITY
7.1.
Limitations
on Use, Disclosure.
Parties
agree to treat as confidential, and to use and
disclose only for the purposes of making Licensed Products, all Confidential
Technology. Parties
agree that they will exercise every reasonable precaution to prevent the
disclosure of Confidential
Technology by any of their directors, officers, employees, or agents to other
parties, other
than to Subsidiaries and to RxElite sub-Licensees. Any Confidential Technology
disclosed to
Subsidiaries or sub-Licensees shall be disclosed on the basis of and subject
to
the confidentiality
provisions of this Agreement. RxElite agrees to limit the disclosure of the
Confidential Technology to those in RxElite, its Subsidiaries, and its
sub-Licensees who have been identified in writing to Core Tech, who have a
need
to know for the purpose of making Licensed
Products, and who have been instructed by RxElite on the terms of this Agreement
and have agreed to comply with those terms both on behalf of their employers
and
as individuals.
Page
16
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
7.2. Cessation.
Any
information which is Confidential Technology at the date of disclosure
thereof to RxElite shall cease to be Confidential Technology, and RxElite,
its
Subsidiaries,
and its sub-Licensees shall be released from the provisions of Section 7.1
at to
such information
on the date when, through no act or omission on the part of RxElite, its
Subsidiaries, or
its
sub-Licensees, such information becomes (a) publicly known by way of a single
publication
in which such Confidential Technology is disclosed in reasonable detail, or
(b)
so widely
known and used in combination that it can be said to be generally available
to
the public. The
minimum payments and fees due to Core Tech hereunder with respect to Net
Profits, shall not
in
any way be reduced or otherwise adversely affected by reason of any Confidential
Technology
ceasing to be or failing to have the characteristics of Confidential Technology
as defined
herein.
7.3. Time
Limit.
The
provisions of this Article V shall continue to apply to any information
which is Confidential Technology for so long as it shall remain such,
notwithstanding
any termination of this Agreement or the License or expiration of the License
Period,
provided, however, that the obligations of confidentiality under this Article
shall in any event
expire and cease to exist three (3) years from the date of Termination of this
agreement.
ARTICLE
VIII - DILIGENCE
RxElite
agrees to use its best efforts to effect introduction of Licensed Products
in
the Field
of
Use into the commercial market as soon as practical, consistent with sound
and
reasonable
business practices and judgments. Except as listed below, Core Tech shall have
the right
to
terminate the License and Core Tech's obligations under this Agreement if
Licensee fails to
perform activities toward commercialization of the Licensed Products as measured
by specific minimum
purchased quantities outlined in this agreement as outlined in Section 3.5.
If
RxElite purchases less than the minimum quantities outlined in this Agreement
then RxElite shall have up
to 90
days to Catch Up, by ordering increased quantities equal to the shortfall for
the previous year during the Catch Up period.
Page
17 of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
Core
Tech
shall dedicate sufficient manufacturing capacity on a continuous basis
throughout
the term of this agreement to manufacture the Products to be supplied to RxElite
and will
use
its best effort to deliver all RxElite orders in a timely manner. If Core Tech
is not able to
deliver an order within 90 days of order then the minimum order requirement
for
that period of time will be waved on a pro rata basis vs. the annual minimum.
As
soon as Core Tech is able to deliver orders in a timely manner after a delay,
then required minimums shall resume. If a second site is qualified as outlined
in Section 3.5.6 then annual minimums for both parties will be
reduced by the amount produced at the secondary site.
ARTICLE
IX - COMMITMENT AND RELEASE
9.1. During
the term of this agreement, Core Tech and RxElite will not cooperate with
any
other
third party that is involved in development, marketing, sales or distribution
of
the Licensed
Products in the Field of Use without mutual disclosure and prior
agreement.
9.2. Both
Parties are free to pursue their other collaborations or partnerships outside
of
the Licensed Products in the Field of Use.
ARTICLE
X - REPRESENTATIONS, WARRANTIES, AND LIMITATIONS
10.1. Compliance
with Laws.
Core
Tech shall comply with all applicable laws and
regulations (including, without limitation, all FDA requirements and licenses)
in performing its
obligations under this Agreement. Without limiting the foregoing, Core Tech
shall conduct its
manufacturing and delivery operations consistent with current good manufacturing
practices ("cGMP")
in the U.S. pharmaceutical industry and all applicable laws and regulations
(including, without
limitation, all FDA regulatory requirements and current cGMP as set forth in
21
C.F.R. §§
210
and 211 for methods to be used in, and the facilities or controls to be used
for, the manufacture,
processing, packing and handling of any Products to assure that it is safe,
and
has the
identity and strength and meets the quality and purity characteristics that
it
purports, or is represented
to possess).
Page
18
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
10.2. Manufacturing
Standards.
Core
Tech shall manufacture and supply all Products in
accordance with the Specifications for the Products and shall ensure that all
Products, upon delivery
to RxElite's warehouse, (a) meet the applicable Specifications for such
Products, and (b)
have
at least 20 months of shelf life.
10.3. Core
Tech Representations.
Core
Tech represents and warrants to RxElite that:
a) Core
Tech
is a corporation organized and existing under the laws of the State
of
New Jersey and has the power and authority to enter into this
Agreement.
b) Core
Tech
has taken all necessary action to authorize its execution and delivery
of this Agreement by the representatives of Core Tech who carried out
such
execution and delivery, and to authorize the performance by Core Tech of-its
obligations hereunder.
c) Execution
and delivery of this Agreement and its performance by Core Tech will not result
in any breach or violation of, or constitute a default under, any
agreement, instrument, judgment, or order to which Core Tech is a party or
by
which
it is bound.
10.4
RxElite
Representations.
RxElite
represents and warrants to Core Tech that:
a)
RxElite is a corporation organized and existing under the laws of State of
Delaware
and has the power and authority to enter into this Agreement.
Page
19
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
b) RxElite
has taken all necessary action to authorize its execution and delivery
of this Agreement by the representatives of RxElite who carried out such
execution
and delivery, and to authorize the performance by RxElite of its obligations
hereunder.
c) Execution
and delivery of this Agreement and its performance by RxElite will
not
result in any breach or violation of, or constitute a default under, any
agreement,
instrument, judgment, or order to which RxElite is a party or by which it is
bound.
ARTICLE
XI - INDEMNITY, INSURANCE, INFRINGERS
11.1.
Indemnification.
Core
Tech agrees to defend, indemnify, and hold RxElite harmless
from any claims of any kind, whether in tort, contract, equity, or law, arising
from or relating
to the goods manufactured and supplied by Core Tech pursuant to this Agreement
or any failure of Core Tech to comply with the terms and conditions of this
Agreement, except if and to the
extent any such claims arise from or relate to (a) defects in the Products
sold
by RxElite if those
defects were determine to have occurred due to damage or adulteration caused
by
RxElite (including,
without limitation, any adulteration, damage or other non-conformity), (b)
any
negligence
or intentional misconduct of RxElite, or (c) any failure by RxElite to comply
with the terms
and
conditions of this Agreement. RxElite agrees to defend, indemnify, and hold
Core
Tech
harmless from and against any and all third party claims asserted against Core
Tech resulting
from any negligence or intentional misconduct of RxElite, except if and to
the
extent any
such
claims arise from or relate to (d) defects determined to have occurred at time
of manufacture
according to cGMP guidelines and according to the specifications of the approved
ANDA
or
regulatory approval in each respective country or jurisdiction, and/or
standards, storage
or handling by Core Tech in the Products (whether inherent or otherwise) sold
by
RxElite
if those Products were manufactured or supplied by or on behalf of Core Tech
(including,
without limitation, any adulteration, damage or other non-conformity), (e)
any
negligence
or intentional misconduct of Core Tech, or (f) any failure by Core Tech to
comply with
the
terms and conditions of this Agreement.
Page
20
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
11.2.
Defense,
Settlement.
Each
Party will pay its own legal expense in defense of any claim
against such Party not indemnified in Section 11.1
11.3.
Insurance.
Core
Tech agrees to obtain and maintain a policy of general liability insurance
upon commencement of clinical evaluation and throughout the rest of the Term
of
this Agreement
insuring against loss for all commercial liability, including products
liability, with minimum
policy limits of at least Ten Million Dollars per occurrence. RxElite shall
be
designated
as an additional insured on the licensed products and policy coverage shall
not
be canceled
or reduced except upon at least 30 days' written notice to RxElite. Upon
RxElite's request,
Core Tech shall provide a certificate of insurance to RxElite at any time during
the Term of
this
Agreement. RxElite agrees to obtain and maintain a policy of general liability
insurance upon
commencement of clinical evaluation and throughout the rest of the Term of
this
Agreement
insuring against loss for all commercial liability, including products
liability, with minimum
policy limits of at least Ten Million Dollars per occurrence. Upon Core Tech's
request, RxElite
shall provide a certificate of insurance to Core Tech at any time during the
Term of this Agreement.
ARTICLE
XII -
TERM,
TERMINATION AND RENEWAL
12.1. The
original term of this agreement shall be 8 years. The agreement shall be
auto-renewed
for successive 1 year periods as long as RxElite continues to purchase the
minimum required
quantities.
Page
21
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
12.2. Events.
The
Agreement may be terminated by either Party pursuant one of the following
subsections:
a)
Material
Default.
If
either party shall fail after thirty (30) days written notice
from the other party to pay the other party any fees or other payments due
and
payable hereunder, or shall fail in any material way to perform any other
agreement required to be performed under this Agreement, or if any Subsidiary
or sub-Licensee shall be in material breach of any conditions or obligations
affecting the other party and compliance with which both parties are responsible
for hereunder, or if any representation or warranty of either party contained
in
this Agreement shall prove to have been inaccurate or misleading in any material
way when made (referred to collectively and individually
as a "material default"), then, without limitation of and in addition
to any and all other rights and remedies available to either party with
respect
to such material default, either party may terminate the Agreement and
their
obligations hereunder by written notice to the other party at any time
after
the
expiration of such thirty (30) day notice period if the other party has
not
cured
the material default and the effects thereof within the 30 day notice
period.
ARTICLE
XIII - NOTICE
Any
notice or communication required to be given hereunder in writing shall be
given
by registered
or certified mail, return receipt requested, or delivered by courier, return
receipt requested,
charges and postage prepaid, addressed to the parties, respectively, at the
addresses of their
principal offices stated above or at such other respective substitute addresses
as the addressee
may designate in writing to the other party.
IF
TO
RXELITE: Xxxxxxxx Xxxxxxxx, President, RxElite, Inc., 0000 Xxxxx Xxxx, Xxxxx
000,
Xxxxxxxx, XX 00000; Tel. (000) 000-0000, Fax. (000) 000-0000.
IF
TO
CORE TECH: Xx. Xxxxx Xxxxx, President & CEO, Core Tech Solutions, Inc., 00
Xxxx Xxxxx, Xxxx Xxxxxxx, XX 00000-0000; Tel. (000) 000-0000 Fax. (000)
000-0000.
Page
22
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
ARTICLE
XIV - MISCELLANEOUS PROVISIONS.
14.1. Assignment.
Both
Parties shall not assign the License or this Agreement without the
prior
written consent of the other Party, which consent shall not be unreasonably
withheld in the
case
of the other Party's sale of all or substantially all of its business, if the
assignee shall assume
all obligations under this Agreement. In any event, no assignment or other
transfer by the
Parties shall relieve them of any obligations hereunder and they shall always
continue to be primarily
and jointly and severally liable (along with such assignee or other transferee)
for the performance
of all obligations of the original Party and such assignee or other transferee
hereunder.
14.2. Compliance
with laws.
Both
parties agree that they, their Subsidiaries, and its sub-Licensees
will comply with all applicable mandatory or permissive patent marking laws,
rules,
and regulations and comply with all other laws, rules, and regulations of all
governmental authorities
applicable to any of their activities contemplated by this Agreement, and will
comply with
all
necessary and desirable practices in connection therewith, such as any
appropriate-products
liability labeling and compliance with safety recommendations of trade
associations or governmental
authorities.
14.3. Independent
Contractors.
The
parties hereto shall be independent contractors with
respect to each other, and nothing contained herein shall be construed as
constituting either of
them
as the agent, principal, employee, servant, joint venturer, or partner of the
other for any purpose
whatsoever.
14.4.
Non-solicitation.
During
the term of this Agreement and for two (2) year after its termination,
RxElite and Core Tech agree that neither shall directly or indirectly solicit
for employment
any staff of the other party who have been directly and substantively involved
in performance
under this Agreement. The parties further agree not to take any action that
would attempt
to get around this restriction such as assisting or enabling a third party
to
solicit.
Page
23
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
14.5. Governing
Law.
This
Agreement shall be governed by and construed in accordance
with Delaware law.
14.6. Sole
Agreement.
This
Agreement and any Exhibits annexed hereto (each of which
is
hereby made part hereof by this reference), and any other documents which
may be
expressly
incorporated by reference herein, constitute the entire and only agreement
between the parties
concerning the subject matter hereof; and all prior negotiations,
representations, warranties,
agreements, and understandings related thereto are superseded
hereby.
14.7. Severability. If
any
provision of this Agreement shall to any extent be found to be
invalid or unenforceable, the remainder of this Agreement shall not be affected
thereby, and any
such
invalid or unenforceable provision shall be reformed so as to be valid and
enforceable to
the
fullest extent permitted by law.
14.8. Headings.
Headings of Articles, Sections, and subsections included herein are for
convenience
of reference only and shall not be used to construe this Agreement.
14.9. This
Agreement may not be released, discharged, abandoned, amended, or modified
in any manner, except by an instrument in writing signed on behalf of each
of
the Parties
by their duly authorized representatives.
14.10. The
Parties shall pay their own expenses incident to the preparation of this
Agreement
and the related agreements contemplated therein.
14.11.
The
Agreement may be executed in any number of counterparts, each of which
shall
be
treated as an original but all of which, collectively, shall constitute a
single
instrument.
14.12. Core
Tech
and RxElite have participated jointly in the negotiation and drafting of
this
Agreement. In the event an ambiguity or question of intent or interpretation
arises, this Agreement
shall be construed as if drafted jointly by the Parties and no presumption
or
burden of proof
shall arise favoring or disfavoring any party by virtue of the authorship
of any
of the provisions
of this Agreement.
Page
24
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
ARTICLE
XV - ARBITRATION
15.1. Arbitration.
All
disputes, controversies, or differences which may arise between
the parties out of or in relation to or in connection with this Agreement,
or
for the breach
thereof, which cannot be resolved by mutual agreement, shall be finally settled
by arbitration
to be held in accordance with the Commercial Arbitration Rules (the "Rules")
of
the American Arbitration Association (the, "Association") as the Rules then
exist. Both legal and equitable
remedies shall be available to the arbitrator(s). The arbitration award shall
be
final and binding
on the parties hereto and shall be enforceable in any court having
jurisdiction.
ARTICLE
XVI - XX
XX
Page
25
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
XX
ARTICLE
XVII - EFFECT OF PARTIAL INVALIDITY
17.1
The
invalidity of any part of this Agreement shall not be deemed to affect the
validity of any other part of this Agreement. In the event that any provision
of
this Agreement is held to be invalid or unenforceable, the parties agree that
the remaining provisions
shall be deemed to be in full force and effect as if they had been executed
by
both
parties subsequent to the expungement of the invalid or unenforceable provision.
If
a
provision is deemed invalid or unenforceable due to its scope or breadth, such
provision
shall be deemed valid to the extent of the scope or breadth permitted by
law.
ARTICLE
XVIII - MISCELLANEOUS ITEMS
18.1 Entire
Agreement.
This
Agreement shall constitute the entire Agreement between
the parties related to the subject matter hereof. Any prior understanding,
agreement
or representation between the parties of any kind (whether written or oral)
preceding
the date of this Agreement including all previously signed agreements shall
not
be
binding on either party except to the extent expressly set forth in this
Agreement.
18.2 Counterparts.
This
Agreement may be executed in any number of counterparts,
each of which shall be deemed to be an original, but all of which together
shall
constitute the same instrument.
18.3 No
Waiver.
The
failure of either party to this Agreement to insist upon the
performance of any of its terms and conditions, or the waiver of any breach
of
any of
the
terms and conditions of this Agreement, shall not be construed as later waiving
any terms and conditions, but they shall continue and remain in full force
and
effect as if
no
forbearance or waiver had occurred.
Page
26
of 27
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT,
WHICH
HAVE BEEN REMOVED AND REPLACED WITH
AN
“XX”,
HAVE BEEN OMITTED AND FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT UNDER RULE 406
PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND
RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
Accepted:
 |
11/07/2006 | ||
|
Xxxxx X. Xxxxx, Ph.D.
President
and CEO
Core
Tech Solutions, Inc.
|
Date | ||
| EIN: 00-0000000 | |||
| DNB: 00-000-0000 | |||
| Accepted: | |||
 |
11-9-2006 | ||
|
Xxxxxxxx Xxxxxxxx
President
RxElite,
Inc.
|
Date
|
||
|
EIN:
|
|||
|
DNB:
|
Page
27
of 27
