LICENSE AGREEMENT
Between
Elite
Pharmaceuticals, Inc.
And
Precision
Dose, Inc.
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
This
License Agreement (“Agreement”) is entered into as of the 10th day of September,
2010 by and between PRECISION DOSE, INC., an Illinois corporation (“PRECISION
DOSE”), and ELITE PHARMACEUTICALS, INC. and ELITE LABORATORIES, INC. (a
subsidiary of Elite Pharmaceuticals, Inc.), both Delaware corporations
(collectively, “ELITE”).
WHEREAS, ELITE has ownership rights to
products specified on Schedule A (the “Products”) as of September 10, 2010, and
PRECISION DOSE wishes to license from ELITE the right to purchase, market and
sell the Products on the terms and conditions set forth in this
Agreement;
NOW, THEREFORE, in consideration of the
mutual covenants and agreements set forth in this Agreement, and for other good
and valuable consideration, the receipt of which is hereby acknowledged, the
parties hereto agree as follows:
Article
1
GRANT
OF LICENSE
6.1. License. ELITE
hereby grants to PRECISION DOSE a license (“License” or “Licensing Rights”)
without the right to further sublicense, to market and sell the Products in
North America (including the United States, Canada and Puerto Rico), including
the right to reference the ANDA Number, where appropriate, for approval to
market the Product in North America.
6.2.
Exclusive Marketing Rights. ELITE
hereby grants to PRECISION DOSE exclusive marketing rights (“Exclusive Marketing
Rights”) to market and sell the Products in the United States, and Puerto
Rico). ELITE agrees that it shall not (and it shall not authorize,
permit or suffer any of its affiliates to), directly or indirectly, sell or
distribute a Product in North America at any time during the term of this
agreement unless specifically authorized under the terms of this Agreement.
ELITE hereby grants to PRECISION DOSE non-exclusive marketing rights to market
and sell the Products in Canada.
6.3. Trademarks.
PRECISION DOSE agrees and acknowledges that it shall not acquire by virtue of
this Agreement any interest in or to any trademarks or trade names of ELITE,
except that ELITE authorizes PRECISION DOSE to place the ELITE and PRECISION
DOSE trade names and trademarks on marketing and packaging materials of the
Products during the term of this Agreement. The labeling will incorporate the
following statement: “Manufactured by Elite Laboratories, Inc., 000 Xxxxxx
Xxxxxx, Xxxxxxxxx, XX 00000”.
6.4. Manufacturing. ELITE
will only manufacture the Products at the manufacturing site designated by
Product on Schedule A. The parties agree that, except for regulatory
prohibitions or mutual agreement of the parties that a Product is not
commercially viable, ELITE will be able to manufacture and ship all the Products
to PRECISION DOSE within two years of the date of this Agreement.
6.5. Licensed Trade
Secrets. The information exchanged between ELITE and PRECISION DOSE
pursuant to this Agreement is expressly subject to the Mutual Confidentiality
and Non-Disclosure Agreement entered into by the parties and dated June 25, 2010
(the “Confidentiality Agreement”) and whose term is hereby made coterminous with
this Agreement.
PRECISION
DOSE-ELITE License Agreement
09-10
-10
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
6.6. Improvements. Any
new information, developments, or improvements relating to the Products subject
to this Agreement, and any patent or copyright rights arising from or related
thereto (collectively, “Improvements”) will be owned solely by ELITE but shall
be automatically included in the License, and if PRECISION DOSE develops an
Improvement that may be used beyond the Products which are the subject of this
Agreement, then ELITE does now automatically grant a worldwide, non-exclusive,
irrevocable, royalty-free right for PRECISION DOSE to use the
Improvement.
Article
2
COMPENSATION
2.1. License Fee and Milestone
Payments. In return for the Licensing Rights described in this
Agreement, PRECISION DOSE shall pay to ELITE the milestone payments (“Milestone
Payments”) and a license fee (“License Fee”) compensation specified in Schedule
C.
2.2. Records. PRECISION
DOSE shall keep complete and accurate records of all sales of the Products and
the calculation of net sales and gross profit of the Products. ELITE shall have
the right, at ELITE’s expense and after thirty (30) days’ prior written notice
to PRECISION DOSE, through an independent certified public accountant, on a
mutually agreeable date, to examine such records at any time within one (1) year
after the due date of the License Fee payments to which such records relate,
during regular business hours, during the life of this Agreement and for twelve
(12) months after expiration of ELITE’s last production lot of Product sold to
PRECISION DOSE, in order to verify the accuracy of the reports to be made under
this Agreement. If the accountant determines that PRECISION DOSE has
under-compensated ELITE, the findings shall be shared with PRECISION DOSE. If
PRECISION DOSE agrees that PRECISION DOSE has not paid ELITE all of the
compensation ELITE was entitled to receive, or it is later determined that
PRECISION DOSE did not pay all of the compensation due to ELITE, then PRECISION
DOSE shall pay the proper amount of compensation and all costs and expenses
incurred by ELITE to hire the accountant and all of the accountant’s expenses,
and all legal expenses, to obtain the appropriate compensation. If PRECISION
DOSE disputes in good faith the accuracy of the results of such examination, the
parties will retain a second independent certified public accountant whose
examination will be binding upon both parties. The losing party will pay all of
the expenses of both independent certified public accountant
examinations.
2.3. Reports. PRECISION
DOSE will provide Reports as stipulated in Schedule C.
2.4. Payments
by PRECISION DOSE.
|
(a)
|
All
Milestone Payments will be made by check and mailed to ELITE within ten
(10) days after the payment becomes
due.
|
|
(b)
|
The
License Fee shall be paid to ELITE in monthly payments based upon the
previous month’s Products that PRECISION DOSE shipped to its customers.
All License Fee payments shall be made by check and mailed to ELITE within
thirty (30) days after the end of each calendar month. A copy of the
Report for the prior month will accompany the
check.
|
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
3
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
|
(c)
|
A
late fee of 1% per month will be accrued for all payments which PRECISION
DOSE fails to pay when due.
|
Article
3
ENFORCEABILITY
3.1. Manufacturing and Supply
Agreement. This Agreement shall not become enforceable until the parties
have executed a separate Manufacturing and Supply Agreement (the “Manufacturing
Agreement”). Inclusive in such Manufacturing and Supply Agreement shall be a
Quality Agreement.
3.2. Cost of Goods
Summary. ELITE shall provide a detailed summary of the Cost of Goods for
each product on Schedule B, and the parties shall further address the summary
and price adjustments in their Manufacturing and Supply Agreement.
Article
4
TERM
AND TERMINATION
4.1. Term. This
Agreement shall become effective as of the date hereof and shall continue until
fifteen (15) years from such date (the “Initial Term”), unless terminated
earlier by mutual agreement of the parties or by one of the parties in
accordance with this Article 4; provided further that the parties shall have the
option, by mutual agreement, to extend the Initial Term of this Agreement for
three (3) successive terms of five (5) years each (each a “Renewal Term” and
collectively with the Initial Term, the “Term”) by the parties exchanging
written notice of such election not less than six (6) months prior to the
expiration of the Initial Term or then current Renewal Term.
4.2. Modification
for Lack of Licensing Fees and Minimum Unit Volumes.
|
(a)
|
PRECISION
DOSE hereby agrees to exert commercially reasonable efforts and shall
devote the same efforts to marketing the Products that PRECISION DOSE
exerts for its other major pharmaceutical products being marketed in the
United States.
|
|
(b)
|
If
after twelve (12) months of a Product’s launch, the Gross Profit declines
for any Product to the point that the License Fee paid to ELITE is less
than {***} for a six (6) month period for that Product, other than through
the fault of ELITE, then ELITE may terminate the Exclusive Marketing
Rights granted hereunder to PRECISION DOSE as it relates to that
individual Product. If ELITE desires to terminate the Exclusive
Marketing Rights granted hereunder, then ELITE shall give PRECISION DOSE
ninety (90) days written notice that it will no longer have the Exclusive
Marketing Rights to sell the particular
Product.
|
|
(c)
|
If
PRECISION DOSE’s unit volume sales of an API specific group of Products (“
Product Group”), (initially defined as Hydromorphone, Naltrexone, or
{***}Product Groups), does not meet its minimum annual unit volume
forecast for that Product Group in the initial launch year, or does not
meet its subsequent minimum annual unit volume forecast (as defined in
Schedule D) for a Product Group, then PRECISION DOSE shall have the
following six (6) months to achieve one-half of the prior year’s minimum
annual unit volume forecast and if PRECISION DOSE still fails to meet such
volume minimum during the six months described, then PRECISION DOSE shall
lose its Exclusive Marketing Rights of such Product
Group.
|
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
4
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
|
(d)
|
If
PRECISION DOSE loses its Exclusive Marketing Rights on any Product or
Product Group, Precision Dose may at its option continue to market the
Product or Product Group under the License according to the terms of this
Agreement and other agreements between the parties, but without Exclusive
Marketing Rights to such Product or Product
Group.
|
4.3. Termination by Mutual
Agreement. The parties may terminate this Agreement any time
by mutual written agreement.
4.4. Termination by
Breach. Upon the breach or default in the performance or
observance of any of the material provisions of this Agreement by either Party,
when such breach or default is not cured by the responsible Party within sixty
(60) days after written notice by the other Party, the other Party may terminate
this Agreement upon an additional thirty (30) days written notice to the other
Party. Termination will be without prejudice to either Party to recover any and
all damages to which it may be entitled, or to exercise any other
remedies.
4.5. Termination by ELITE Upon
Bankruptcy or Reorganization of PRECISION DOSE. If PRECISION DOSE enters
into any proceeding (whether voluntary or otherwise) in bankruptcy,
reorganization or arrangement for the appointment of a receiver or trustee to
take possession of its assets, or any other proceeding under any law for the
relief of creditors or makes an arrangement for the benefit of its creditors,
and remains in such proceeding for 30 days, then ELITE shall retain its rights
to the Products and may terminate this Agreement without further payment to
PRECISION DOSE.
4.6. Licensing Rights upon
Termination. Except as otherwise provided in this Agreement,
upon termination of this Agreement: all rights, privileges, and licenses will
terminate and revert to ELITE, and PRECISION DOSE must not thereafter make any
use whatsoever of any trade secrets, except that it is agreed that upon
termination notwithstanding any other terms of this Agreement, PRECISION DOSE
may retain one archival copy to have sufficient information solely to respond to
state and federal regulatory inquiries regarding the Products.
4.7. Accrued
Rights. Expiration or termination of this Agreement shall be
without prejudice to the right of either Party to receive all payments accrued
and unpaid at the effective date of such expiration or termination, without
prejudice to the remedy of either Party in respect to any previous breach of the
representations, warranties or covenants herein contained, without prejudice to
any rights to indemnification set forth herein and without prejudice to any
other provision hereof which expressly or necessarily calls for performance
after such expiration or termination. PRECISION DOSE expressly retains the right
to sell Product on-hand after termination of this Agreement and shall remain
bound to pay ELITE the Licensing Fee as provided in this Agreement.
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
5
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
Article
5
REPRESENTATIONS,
WARRANTIES AND COMPETITION, COOPERATION UPON
BANKRUPTCY
OF ELITE
5.1. PRECISION DOSE
Representations. PRECISION DOSE hereby represents and warrants
to ELITE that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and performance
of this Agreement by PRECISION DOSE does not conflict with or constitute a
breach of any order, judgment, agreement, or instrument to which it is a party;
(c) the execution, delivery and performance of this Agreement by PRECISION DOSE
does not require the consent of any person; and (d) none of its officers or
directors has ever been convicted of a felony under the laws of the United
States for conduct relating to the development or approval of a drug product or
relating to the marketing or sale of a drug product
5.2. ELITE
Representations. ELITE hereby represents and warrants to PRECISION DOSE
that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and performance
of this Agreement by ELITE does not conflict with or constitute a breach of any
order, judgment, agreement, or instrument to which it is a party; (c) the
execution, delivery and performance of this Agreement by ELITE does not require
the consent of any person; and (d) none of its officers or directors has ever
been convicted of a felony under the laws of the United States for conduct
relating to the development or approval of a drug product or relating to the
marketing or sale of a drug product.
5.3. Non-competition by PRECISION
DOSE. PRECISION DOSE hereby covenants and agrees that without the prior
written consent of ELITE during the Term of this Agreement, and for 1 year after
the last shipment of Product by PRECISION DOSE if the agreement is terminated
due to breach of the Agreement by PRECISION DOSE, PRECISION DOSE will not
directly or indirectly market any of the Products Licensed to PRECISION DOSE by
ELITE pursuant to this Agreement. This section is not intended to prohibit
PRECISION DOSE from marketing and selling a product which addresses the same
therapeutic indication as a Product, as long as that other product does not
contain the same API as the Product(s) in this Agreement.
5.4. Cooperation Upon Bankruptcy
Event of ELITE. ELITE shall use, and cause its representatives and
affiliates to use, best efforts to make all necessary arrangements and take all
required actions to permit PRECISION DOSE to retain all rights licensed
hereunder with respect to the Products in the event that ELITE (i) is dissolved or liquidated, (ii) commences a voluntary
case or other proceeding seeking liquidation, reorganization or other relief with
respect to itself or its debts under any bankruptcy, insolvency or other similar law,
(iii) is subject to an involuntary case or
other proceeding seeking liquidation, reorganization or other relief with
respect to ELITE and an order for
relief entered or such proceeding has not be dismissed or discharged within
sixty (60) days of commencement, (v) has made an assignment for the
benefit of creditors, or (vi) otherwise
ceases to conduct business during the Term (each, an “Extraordinary
Event”). If ELITE breaches its obligations under the Manufacturing
Agreement as a result of an Extraordinary Event (a “Manufacturing Breach”), then
PRECISION DOSE will have the right to enter into a manufacturing arrangement
with a manufacturer other than ELITE in order to continue the manufacturing of
the Products. Without limitation of the foregoing, ELITE covenants and agrees
that:
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
6
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
|
(a)
|
this
Agreement involves intellectual property rights and PRECISION DOSE shall
be entitled to all benefits and protections afforded by Section 365(n) of
the United States Bankruptcy Code and any successor or similar statutes,
including the right to elect to retain the rights under this Agreement
and, upon a Manufacturing Breach, to receive, without additional cost, a
licensed copy of all embodiments of the Products (but subject to any
restrictions on ELITE’S right to disclose any such embodiments which are
not proprietary to ELITE), including, without limitation, technical
information necessary for the continued manufacture of the Products by a
third party (collectively, the “Product
Materials”);
|
|
(b)
|
Product
Materials received by PRECISION DOSE pursuant to subsection (a) above
shall be used by PRECISION DOSE and its affiliates and contractors solely
to enable the manufacture of the Products upon a Manufacturing Breach and
to continue to market, enhance and improve the Products in accordance with
this Agreement; and
|
|
(c)
|
PRECISION
DOSE shall hold any Product Materials in the strictest confidence and
treat such Product Materials as proprietary and confidential information
of ELITE in accordance with the Confidentiality
Agreement.
|
Article
6
MISCELLANEOUS
6.1. Waiver; Remedies and
Amendment. Any waiver by any party hereto of a breach of any provisions
of this Agreement will not be implied and will not be valid unless such waiver
is recited in writing and signed by such party. Failure of any party to require,
in one or more instances, performance by the other party or parties in strict
accordance with the terms and conditions of this Agreement will not be deemed a
waiver or relinquishment of the future performance of any such terms or
conditions or of any other terms and conditions of this Agreement. A waiver by
any party of any term or condition of this Agreement, including this Section
6.1, shall be valid only if in writing and will not be deemed or construed to be
a waiver of such term or condition for any other term. All rights, remedies,
undertakings, obligations and agreements contained in this Agreement will be
cumulative and none of them will be a limitation of any other remedy, right,
undertaking, obligation or agreement of any party. This Agreement may not be
amended except in a writing signed by all parties.
6.2. Affiliates, Assignment, No
Inconsistent Agreements. The parties agree that PRECISION DOSE may
exercise its rights under this Agreement through its wholly owned subsidiary
TAGI PHARMA, INC. (“TAGI”), and references herein to PRECISION DOSE shall
include TAGI. PRECISION DOSE may not otherwise assign its rights and obligations
hereunder without the prior written consent of ELITE. Neither PRECISION DOSE nor
ELITE will enter into any agreement that is inconsistent with its obligations
hereunder.
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
7
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
6.3. Counterparts. This
Agreement may be executed in any number of counterparts, each of which when so
executed will be deemed to be an original and all of which when taken together
will constitute this Agreement.
6.4. Governing Law; Dispute
Resolution; Venue. This Agreement will be governed by and
construed in accordance with the laws of the state of New York without regard to
conflict of law or choice of law rules. Any controversy or claim pursuant to
this Agreement or the breach thereof shall be referred for decision forthwith to
a senior executive of each Party not directly involved in the dispute. If no
agreement is reached within thirty (30) days of the request by one Party to the
other to refer the same to such senior executive, then such controversy or claim
shall be settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association; such arbitration to be held in
Rockford, Illinois on an expedited basis. Judgment upon the award rendered by
the Arbitrator(s) may be entered in any court having jurisdiction
thereof.
6.5. Headings. The
headings set forth at the beginning of the various sections of this Agreement
are for convenience and form no part of the Agreement between the
parties.
6.6. Notices. All
notices, requests, instructions, consents and other communications to be given
pursuant to this Agreement shall be in writing and shall be deemed received (a)
on the same day if delivered in person, by same-day courier or by facsimile,
electronic mail or other electronic transmission, (b) on the next day if
delivered by overnight mail or courier, or (c) on the date indicated on the
return receipt, or if there is no such receipt, on the third calendar day
(excluding Sundays) if delivered by certified or registered mail, postage
prepaid, to the party for whom intended to the following addresses:
If to
PRECISION DOSE:
PRECISION
DOSE
000
Xxxxxxxxxxx Xxxx
Xxxxx
Xxxxxx, XX 00000
Attn: President
With a
copy to:
Xxxxxx
Law Offices
0000
Xxxxxx Xxxxx Xx., Xxx 0X
Xxxxxxxx,
XX 00000
Attn:
Xxxxxxx X. Xxxxxx XX
If to
ELITE:
ELITE
PHARMACEUTICALS, Inc.
000
Xxxxxx Xxxxxx
Xxxxxxxxx,
Xxx Xxxxxx 00000
Attention: President
and CEO
With a
copy to:
Xxxxxxxxxx
& Xxxxx
Xxxxxxx
Plaza
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
8
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
00000
Xxxxxxxx Xxxxxxxxx
Xxxxx
000
Xxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention:
Xxxxx Xxxxxxxxx
6.7. Each
party may by written notice given to the other in accordance with this Agreement
change the address to which notices to such party are to be
delivered.
6.8. Severability. If
any provision of this Agreement is held by a court of competent jurisdiction to
be invalid or unenforceable, it will be modified, if possible, to the minimum
extent necessary to make it valid and enforceable or, if such modification is
not possible, it will be stricken and the remaining provisions will remain in
full force and effect.
6.9. Survival. The
rights and obligations which accrue to a party during the term of this agreement
shall survive the termination of this Agreement.
6.10. Force
Majeure. No party to this Agreement will be liable for failure
or delay in the performance of any of its obligations hereunder, if such failure
or delay is due to causes beyond its reasonable control including, without
limitation, acts of God, earthquakes, fires, strikes, acts of war, or
intervention of any governmental authority, but any such delay or failure will
be remedied by such party as soon as possible after the removal of the cause of
such failure or delay.
6.11. Entire
Understanding. This Agreement, including the schedules
attached hereto, contains the entire understanding relative to the matters
addressed herein, and supersedes all prior and collateral communications,
reports, and understandings, if any, between the parties regarding the matters
addressed herein.
6.12. Drafting. The
parties 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.
..
6.13. Not a Joint
Venture. This Agreement does not constitute or create (and the
Parties do not intend to create hereby) a joint venture, pooling arrangement,
Partnership, or formal business organization of any kind between and among any
of the Parties, and the rights and obligations of the Parties shall be only
those expressly set forth herein. The relationship hereby established between
PRECISION DOSE and ELITE is solely that of licensee and licensor, each is an
independent contractor engaged in the operation of its own respective business.
Neither Party shall be considered to be an agent of the other for any purpose
whatsoever. Each Party shall be responsible for providing its own personnel and
workers compensation, medical coverage or similar benefits and shall be solely
responsible for the payment of social security benefits, unemployment insurance,
pension benefits, withholding any required amounts for income and other
employment-related taxes and benefits of its own employees, and shall make its
own arrangements for injury, illness or other insurance coverage to protect
itself, its Affiliates, its subcontractors and personnel from any damages, loss
and/or liability arising out of the performance of this Agreement. Neither Party
has the power or authority to act for, represent or bind the other (or its
Affiliates) in any manner.
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
9
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
IN
WITNESS WHEREOF, the parties have executed this Agreement on the date first set
forth above.
ELITE
PHARMACEUTICALS, INC.
|
PRECISION
DOSE, INC.
|
|||
By:
|
By:
|
|||
Name:
|
Xxxxx
Xxxx
|
Name:
|
Xxxxxx
Xxxxxxx
|
|
Title:
|
President
|
Title:
|
President
|
|
Date:
|
Date:
|
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
10
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE
A
Product
List
Products
Manufactured by ELITE:
Name
|
ANDA
#
|
Approved Manufacturing
Site
|
||
Xxxxxxxxxxxxx
0xx, 0xx and 2mg Tablets, 100’s and 500’s
|
76-723
(8 mg)
|
ELITE
– 135 and 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
|
||
Naltrexone
50mg Tablets, 30’s and 100’s
|
75-274
|
ELITE
– 135 and 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
|
||
{***}Tablets, 100’s and
1,000’s
|
{***}
|
ELITE
– 135 and 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
|
||
{***}Capsules, 100,s and
1000’s
|
Product
not yet approved
|
ELITE
– 135 and 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX
00000
|
Note:
Temporary packaging (defined as less than twelve (12) months) of these products
may be done at the Epic Pharma, LLC facility located at 000-00 X. Xxxxxxx
Xxxxxx, Xxxxxxxxx, X.X. 00000, unless Precision Dose consents to extend the
timeframe beyond twelve (12) months, with such consent not to be unreasonably
withheld.
PRECISION
DOSE-ELITE License Agreement
09-10-10
11
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE
B
Standard
Manufacturing Costs (FOB, Northvale facility)
Bottles
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||||||||||
Batch
|
Bottle
|
Per
|
Batch
|
Cost/
|
||||||
ITEM
|
Size
|
Size
|
Batch
|
Cost
|
Bottle
|
|||||
Hydromorphone
|
||||||||||
8mg
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
500’s
|
{***}
|
{***}
|
{***}
|
|||||||
4mg
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
500’s
|
{***}
|
{***}
|
{***}
|
|||||||
2mg
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
500’s
|
{***}
|
{***}
|
{***}
|
|||||||
Naltrexone
|
||||||||||
50mg
|
{***}
|
30’s
|
{***}
|
{***}
|
{***}
|
|||||
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
||||||
{***}
|
||||||||||
{***}Tablets
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
{***}
|
1,000’s
|
{***}
|
{***}
|
{***}
|
||||||
{***} Capsules
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
{***}
|
1,000’s
|
{***}
|
{***}
|
{***}
|
||||||
{***}
Capsules
|
{***}
|
100’s
|
{***}
|
{***}
|
{***}
|
|||||
|
{***}
|
|
1,000’s
|
|
{***}
|
|
{***}
|
|
{***}
|
NOTE:
Includes all Product manufacturing and packaging costs, quality assurance and
batch quality control testing. Stability testing will be at an additional
cost.
*
{***}
PRECISION
DOSE-ELITE License Agreement
09-10-10
12
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE
C
Compensation
for Licensing Rights
Milestone
Payments
PRECISION
DOSE will pay to ELITE Milestone Payments totaling {***}, according to the
following schedule:
|
·
|
$200,000
shall be paid to ELITE upon signing of this enforceable License
Agreement
|
|
·
|
${***}
shall be paid to ELITE upon FDA approval and initial shipment of the
“Products” to PRECISION DOSE according to the following
schedule:
|
|
§
|
Hydromorphone
8mg — ${***}
|
|
§
|
Hydromorphone
4mg and 2mg — ${***}
|
|
§
|
Naltrexone
50mg — ${***}
|
|
§
|
{***}tablet
— ${***}
|
|
§
|
{***}
Capsules (All) — ${***}
|
License
Fee
PRECISION
DOSE will pay to ELITE a License Fee that is a percentage of the product gross
profit (“Product Gross Profit”) of PRECISION DOSE, as defined below, generated
on Products sold and shipped to its customers by PRECISION DOSE according to the
following schedule:
|
·
|
Xxxxxxxxxxxxx
0xx, 0xx, and 2mg Tablets — @ {***}% of Product Gross
Profit
|
|
·
|
Naltrexone
50mg Tablets — @ {***}% of Product Gross
Profit
|
|
·
|
{***}mg
Tablets , {***}mg Capsules and {***}mg Capsules — @ {***}% of Product
Gross Profit
|
Product
Gross Profit is defined as: Net Sales - Cost of Goods = Product Gross
Profit.
|
§
|
Net Sales is defined
as: Net Invoice Price less the following: Charge backs, Buying
Groups/Wholesaler Administrative Fees/Rebates, Allowances, Medicaid and
Returns.
|
|
§
|
Cost of Goods is defined
as: The total number of units sold and included in Net Sales
multiplied by the Standard Manufacturing Cost ( “$/Bottle Cost”) set forth
on Schedule B plus Quality Assurance and Quality Control (including
Testing and Stability Costs) and Warehouse/Distribution (including inbound
and outbound) of ELITE and PRECISION DOSE, also known as Unit Cost
.
|
The
calculation of Product Gross Profit and the Licensing Fee shall be performed by
Precision Dose and presented to Elite as a report (“Report”) which shall include
the following information:
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
13
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
REPORT
ITEMS
Gross
Invoice Sales
|
Total
Sales for Month
|
|
Cash
Discount
|
Cash
Discount
|
|
Net
Invoice Sales
|
Total
Sales - Cash Discount
|
|
Deductions
|
Allowances
(including wholesale service fees; customer admin. fees; Medicaid rebate;
state program rebates; administration fees) price adjustments;
returns; charge backs.
|
|
Net
Sales
|
Net
Invoice Sales – Deductions
|
|
Cost
of Goods
|
Total
Units x Unit Cost
|
|
Gross
Profit
|
Net
Sales less Cost of Goods
|
|
Margin
%
|
Margin
Percentage (Gross Profit divided by Gross Invoice
Sales)
|
|
Amount
Due
|
Gross Profit $ |
x
{***}%:
Hydromorphone
|
x
{***}%:
Naltrexone
|
||
x {***}%: {***}
|
Whenever
possible, the Report will be made using actual sales, charge backs,
administrative fees/rebates, price adjustments, and returns; however, in some
cases estimated numbers may be required because of timing of CBs, fees, returns,
etc. A true up Report will be completed and presented to ELITE within 60 days
after the end of each calendar year.
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
14
{***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE
D
Minimum
Annual Unit Forecast for Each Product Group
(As
of August 27, 2010)
Year 1
|
Year 2
|
Year 3
|
Year 4
|
Year 5
|
||||||
(Units
in 000 — Tablets)
|
||||||||||
Hydromorphone
8mg
|
{***}
|
{***}
|
{***}
|
{***}
|
{***}
|
|||||
Naltrexone
50mg
|
{***}
|
{***}
|
{***}
|
{***}
|
{***}
|
|||||
{***}
{***}mg Tabs
|
|
{***}
|
|
{***}
|
|
{***}
|
|
{***}
|
|
{***}
|
NOTE: The
above committed unit volumes are {***}% of the unit volumes in the Target
Financial Forecasts previously provided for Profit Split
calculations.
For
purposes of this Provision, the minimum annual forecast will be reviewed
annually for any changes in the competitive environment, and revised by the
Parties as mutually agreed. As the additional products become available, the
combined Product Group minimum annual quantities will be reassessed according to
the then current market conditions.
PRECISION
DOSE-ELITE License Agreement
09-10 -10
Execution Version
15