CONFIDENTIAL TREATMENT REQUEST
[ * ] INDICATES INFORMATION THAT HAS
BEEN OMITTED PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST AND
THIS INFORMATION HAS BEEN FILED UNDER
SEPARATE COVER WITH THE COMMISSION
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
THIS PRODUCT DEVELOPMENT AND LICENSE AGREEMENT (together with all exhibits and
schedules, the "Agreement"), dated as of June 22, 2005 ( the "Effective Date")
by and between ELITE LABORATORIES, INC., a corporation organized and existing
under the laws of Delaware, and having its principal place of business at 000
Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 ("ELITE") and PLIVA, INC., a corporation
organized and existing under the laws of New Jersey, and having its principal
place of business at 00 Xxxxx Xxxx Xxxxxx, Xxxx Xxxxxxx, XX 00000 ("PLIVA").
RECITALS:
PLIVA is engaged in the development, manufacturing, marketing and distribution
of generic pharmaceutical products in the Territory (as defined below) and
possesses qualified marketing and distribution systems and organizations to
enable it to effectively promote, market and distribute such products throughout
the Territory;
ELITE is the owner of Know-How (as defined below) and other proprietary
technology relative to the Product (as defined below);
ELITE and PLIVA desire to further develop and market the Product in the
Territory; and
Elite desires to grant to PLIVA the exclusive right to purchase, market, promote
and distribute the Product in the Territory under PLIVA's label, and PLIVA
desires to accept and exercise the right, all upon such terms and conditions as
are set forth in this agreement.
ELITE and PLIVA agree as follows:
1. DEFINITIONS
The following terms as used in this Agreement shall have the meanings set
forth in this Article:
1.1. "AFFILIATE" shall mean any corporation, firm, partnership or other
entity, which owns or controls, is owned or controlled by, or is
under common control with, PLIVA or ELITE, as the case may be. The
term "control"
means the] ownership, directly or indirectly, of at least fifty
percent (50%) of the equity or voting power of the owned or
controlled entity.
1.2. "APPLICABLE LAW" shall mean the United States Food, Drug and
Cosmetic Act of 1938, as may be amended from time to time, and the
regulations and guidelines promulgated pursuant thereto, as amended
from time to time, and all other laws, regulations, rules and
guidelines of any governmental authority in the Territory pertaining
to the development, manufacture, packaging, labeling, storage,
distribution, marketing, sale or intended use of the Product.
1.3. "CGMP" shall mean all applicable good manufacturing practices,
including but not limited to current "good manufacturing practices"
and any other methods used for the manufacturing, testing,
validation, labeling, packaging, storage, shipment and installation
of any and all pharmaceutical products, equipment and related
materials to ensure that such products and materials meet the legal
requirements for safety and effectiveness as established by the
United States Food and Drug Administration ("FDA") or comparable
governmental authority in any country outside the United States
where the Product is distributed under this Agreement, including,
specifically, without limitation, Title 21, Part 211 of the United
States Code of Federal Regulations.
1.4. "CONFIDENTIAL INFORMATION" shall mean any information pertaining to
the Product from time to time communicated by or on behalf of the
disclosing party, including, without limitation, trade secrets,
Know-How, pricing, costs, suppliers, licensees, customer
information, patent rights, scientific, technical, commercial and
medical product development information, manufacturing, methods,
processes and production, contractual arrangements, results,
discoveries and inventions, procedures and forms, financial and
other business information, forecasts, strategies and other data,
whether of a written, oral or visual nature.
1.5. "COST OF GOODS" shall mean (i) ELITE's fully absorbed direct and
indirect cost of manufacturing, labeling and packaging the Product,
including without limitation the cost of all active pharmaceutical
ingredients, materials, and components included in the Product, plus
(ii) [*]
1.6. "COMMERCIALIZATION", "COMMERCIALIZING", or "COMMERCIALIZE" shall
mean all activities relating to manufacture, promotion,
distribution, marketing and sale of the Product in the Territory.
1.7. "ED-COSTS" shall mean the fees, costs and expenses incurred by Elite
in meeting its obligations pursuant to Section 2.1 and Section
2.2(a) plus any amount paid to outside counsel by ELITE in procuring
the freedom to operate opinion provided for in Section 4.2.
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1.8. "FIELD" shall mean treatment of [*].
1.9. "KNOW-HOW" shall mean all technology, data, information, processes
and methods necessary or useful in the production, testing,
registration or marketing of the Product.
1.10. "LICENSEE" shall mean the recipient of a license granted by ELITE to
Commercialize the Product in the Territory. PLIVA shall be the
designated and exclusive Licensee hereunder for the Territory.
1.11. "MARKETING AUTHORIZATION" shall mean the final approval of all
regulatory authorities necessary to market the Product in a
particular country in the Territory, including as applicable pricing
and reimbursement approval and all other approvals required in a
particular country in the Territory for the marketing, distribution
and sale of the Product in the Field in the normal course of
business.
1.12. "NET PROFIT" shall mean the Price LESS the Cost of Goods.
1.13. "PD-COSTS" shall mean the fees, costs and expenses incurred by PLIVA
in connection with the Studies plus the milestones actually paid to
ELITE pursuant to Section 5.2 plus any amount paid to outside
counsel by PLIVA in procuring the freedom to operate opinion
provided for in Section 4.2.
1.14. "PRICE" shall mean the sales price paid by third parties to PLIVA
for Product, less only the following deductions to the extent
actually incurred, all determined in accordance with generally
accepted accounting principles:
(1) customs and excise duties or other sales taxes (but, for the
avoidance of doubt not income or corporation tax), directly
related to the sale of the Product;
(2) costs incurred by PLIVA in respect of transport, shipping and
insurance costs; and industry standard or mandatory discounts
or rebates related to the sale of the Product, including,
without limitation, any credit in respect of any Federal or
state Medicaid, Medicare or similar program; and
(3) amounts repaid or credited by PLIVA, consistent with its
ordinary or customary business practices for similar products,
by reason of the rejection or return of goods and allowances,
including trade, quantity and cash discounts and any other
adjustments, including those granted on account of price or
shelf stock adjustments, billing errors, rejected goods,
damaged goods, recalls, returns, rebates,
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chargebacks, reimbursements, similar payments granted or given to
wholesalers or other distributors, buying groups, health care
insurance carriers or other institutions.
1.15. "PRODUCT" shall mean [*] that is approved by FDA as AB rated as
bioequivalent to [*], a product sold commercially by [*] (the
"REFERENCED DRUG"), for use in the Field and which meets the
specifications set forth in the ANDA to be filed pursuant to this
Agreement (the "SPECIFICATIONS").
1.16. "TERM" shall have the meaning set forth in Section 12 hereof.
1.17. "TERRITORY" shall mean the United States of America and its
territories and possessions, including the Commonwealth of Puerto
Rico.
2. PRODUCT DEVELOPMENT
2.1. ELITE shall be responsible for Product formulation, methods
development and validation.
2.2. ELITE shall obtain and submit to PLIVA, for PLIVA's review and
approval (such approval not to be unreasonably withheld, conditioned
or delayed), a proposal or proposals, including costs, from a third
party to conduct pilot and pivotal bioequivalence studies for the
Product to evidence bioequivalence to the Referenced Drug in
accordance with study plan protocols to be agreed to by ELITE and
PLIVA (the "STUDIES"). Following its approval, PLIVA shall engage
such third party to conduct the Studies, and the cost of all Studies
shall be borne by PLIVA.
(a) ELITE shall complete any additional formulation work, if
necessary, complete process development and scale-up,
including in-process controls and all necessary stability
studies with respect to the Product, and manufacture Product
biobatches reasonably required to conduct such Studies.
2.3. Each of ELITE and PLIVA agrees that, during the Term, except for the
Studies contemplated hereunder, neither it nor any of its Affiliates
will conduct clinical studies for any other generic version of [*],
whether for itself or any third party, for distribution or sale in
the Territory.
2.4. ELITE and PLIVA shall each have the right to discontinue the Studies
at any time prior to completion of such Studies upon three (3) days'
prior written notice to the other party, if ELITE or PLIVA, as the
case may be, reasonably believes that health and safety issues may
arise.
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2.5. ELITE shall inform PLIVA of any changes in the Product development
plan. ELITE shall use commercially reasonable efforts to assure
PLIVA that the Product shall be available to PLIVA to market at the
time agreed to by ELITE and PLIVA in writing pursuant to this
Agreement.
2.6. ELITE shall perform its obligations in this Section 2 in accordance
with Applicable Laws.
3. REGULATORY FILINGS
Following successful completion of the pivotal biostudy for the
Product, ELITE shall be responsible for the preparation, filing and
prosecution with the FDA of an abbreviated New Drug Application
("ANDA") for the Product. The ANDA shall be in the name of ELITE.
ELITE shall bear the cost of the ANDA preparation, filing and
prosecution. Each party shall reasonably cooperate with the other
party in connection with the preparation of the ANDA. Each party
shall have the right to review and comment upon any and all prepared
applications and filings prior to submission to the relevant
governmental authorities.
4. INTELLECTUAL PROPERTY OWNERSHIP, MAINTENANCE AND DEFENSE
4.1. INTELLECTUAL PROPERTY. All rights, title and interest in and to all
intellectual property rights relating to the Product, including
without limitation, inventions, discoveries, creations, information,
data, reports, results, and/or improvements to any Confidential
Information, Know-How, study inventions, regulatory filings, patent
rights, processes, techniques, and any improvements, modifications,
alterations thereto and patents issuing thereon made during the Term
hereof whether in connection with the Study or otherwise
("Intellectual Property Rights") are and shall, in all events, be
the sole and exclusive property of ELITE. PLIVA shall take such
actions, and execute and deliver such documents, as may be
reasonably requested from time to time by ELITE, at ELITE's expense,
to perfect ELITE's Intellectual Property Rights. ELITE grants to
PLIVA and PLIVA accepts, during the Term, an exclusive,
non-transferable license to ELITE's Intellectual Property Rights to
allow PLIVA to offer for sale the Product in the Territory. PLIVA
may not grant any sublicense to ELITE's Intellectual Property Rights
without ELITE's prior written consent, which consent may be granted
or withheld in ELITE's sole discretion.
4.2. FREEDOM TO OPERATE. PLIVA and ELITE shall, under a joint defense
agreement, obtain, within 120 days of the effective date, a "freedom
to operate" opinion from outside counsel with respect to the
manufacture, use and sale of the Product in each country in the
Territory. Either party shall have the right to terminate this
Agreement with respect to a country if
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not satisfied with the opinion(s) for such country by notifying the
other party in writing within 30 days of receipt of the opinion. The
obligations of each party accrued to through the Effective Date of
any such notice, including the obligation to reimburse for costs
incurred, shall survive termination of this Agreement.
4.3. DEFENSE OF PRODUCT. PLIVA and ELITE shall be responsible for, and
shall share equally the cost of, defending the Product and the
parties hereto against any lawsuits in accordance with the terms and
conditions of Article 7.
5. FINANCIAL TERMS
5.1. PAYMENTS. For all Product supplied to PLIVA under this Agreement
ELITE shall invoice PLIVA, referencing in each invoice the purchase
order(s), if any, to which the invoice relates, the Cost of Goods
and the quantity of units of Product shipped. PLIVA shall pay each
invoice within forty five (45) days of the invoice date. Any late
payments or underpayments under this Agreement shall bear interest
at the prime rate from the initial due date until payment in full.
5.2. MILESTONES. PLIVA shall pay to Elite the following milestones
payments:
a) [*] simultaneously with the execution and delivery of this
Agreement, or, if later, on the thirtieth day following
delivery by ELITE of the legal opinion described in Section
4.2 of this Agreement (unless the Agreement has theretofore
been terminated under Section 4.2).
b) [*] upon (i) completion of a successful pivotal bioequivalence
study where the Product meets the FDA guidelines for
bioequivalence, and (ii) submission to and acceptance by the
FDA of the ANDA for the Product .
c) [*] upon FDA approval of the Product.
5.3 PROFIT SHARE.
(a) Within forty five (45) days following the end of each calendar
quarter during the Term following the first commercial sale of the
Product hereunder, PLIVA shall provide ELITE with a detailed
statement for such period showing for all Product sold by PLIVA
during such period the number of units sold, the Price for those
units, and the Net Profit for such period. PLIVA shall pay to ELITE
a percentage of the Net Profit for such period within fifteen (15)
days of delivery to ELITE of the statement showing such calculation.
(b) The percentage payable to ELITE shall be determined as follows.
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(1) Within thirty (30) days of FDA approval of the Product, ELITE shall
provide to PLIVA a detailed statement of the ED-Costs and PLIVA
shall provide to ELITE a detailed statement of the PD-Costs.
(2) If the ED-Costs exceed the PD-Costs, then ELITE shall be entitled to
recover the amount by which the ED-Costs exceed the PD-Costs.
(3) If the PD-Costs exceed the ED-Costs, then PLIVA shall be entitled to
recover the amount by which the PD-Costs exceed the PD-Costs.
(4) The Party entitled to recover the amount of the difference shall
receive or retain, as the case may be, [*] of the Net Profit until
such amount is recovered. Thereafter, the Parties shall [*].
5.4 AUDIT; INSPECTION. Within one hundred eighty (180) days following the
close of each calendar year during the Term and for a period of twenty four
months following expiration or earlier termination of this Agreement, upon the
request of a party ("Requesting Party") the other party shall provide the
Requesting Party's accountants, at Requesting Party's sole cost and expense,
with access, during regular business hours and upon reasonable prior written
notice, and subject to the confidentiality undertakings contained in Section 10
of this Agreement, to the other party's books and records relating to the
Product in the Field in the Territory solely for purposes of verifying costs and
expenses and Net Profit in connection with this Agreement, and for verifying the
accuracy of the calculations hereunder for the calendar year then ended and for
the two calendar years prior thereto. If any such verification shows any
underpayment or overpayment, a correcting payment or a refund shall be made
within thirty (30) days of completion of such verification and submission of the
results thereof, with details of the calculations included therein. In the event
such verification shows an underpayment of more than [*] was made by the
Requesting Party to the other party, the other party will be required to pay for
the costs reasonably incurred by Requesting Party in connection with its
inspection.
6. MANUFACTURE, SUPPLY AND COMMERCIALIZATION OF PRODUCT
6.1 During the Term, and on and subject to the terms and conditions of
this Agreement, ELITE shall manufacture and supply or, with PLIVA's prior
written consent (such consent not to be unreasonably withheld, conditioned
or delayed), subcontract the manufacture and supply of, the Product in the
Territory exclusively to PLIVA for resale by PLIVA in the Territory, in
such quantities and at such times as are specified in the purchase orders
placed by PLIVA pursuant to this Agreement. PLIVA shall purchase its
requirements of Product for resale in the Territory exclusively from
ELITE.
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6.2 ELITE will supply the Product to PLIVA in finished form, labeled in
accordance with the ANDA, and packaged ready for resale in accordance with
Section 6.5 (d) hereof. ELITE shall manufacture, store and ship the
PRODUCT to PLIVA, and PLIVA shall store, ship, market and distribute the
PRODUCT in the Territory, in accordance with cGMPs, Applicable Laws, the
Specifications, and the terms and conditions of this Agreement.
6.3 The Product to be supplied by ELITE to PLIVA hereunder shall bear
PLIVA's label. ELITE shall provide to PLIVA a sample of the printed
labeling and packaging for the Product for PLIVA's approval. ELITE shall
label and package all Product in accordance with the ANDA, cGMPs, and the
applicable requirements of the FDA. PLIVA grants to ELITE a limited
license to use PLIVA's trademarks for purposes of packaging and labeling
Product as described in this section.
6.4 PLIVA shall diligently market and promote the Product in the
Territory, using such commercially reasonable efforts to maximize Product
sales and Net Manufacturing Profits. PLIVA shall devote such marketing
efforts to the Product as it would exert for products of its own with
comparable market size and profit potential under comparable competitive
conditions. At least once per calendar quarter PLIVA shall provide to
ELITE, in writing, an outline of PLIVA's sales expectations for the
Product for the upcoming three calendar quarters.
6.5 (a) At least one hundred twenty (120) days prior to the anticipated
launch date of the Product in the Territory, and thereafter at least
thirty days prior to each calendar quarter during the Term, PLIVA shall
provide ELITE with a written forecast of PLIVA's estimated Product
requirements for each of the following four calendar quarters. The
forecasts will be non-binding, except as provided below.
(b) PLIVA shall make all Product purchases hereunder by submitting
firm purchase orders to ELITE. Each such purchase order shall be in
writing and shall specify the quantity of Product ordered (which shall be
in batch size, or multiples thereof) and the requested delivery date(s).
Purchase orders shall be placed at least ninety days before the desired
delivery date. Each purchase order shall be subject to ELITE's acceptance,
in whole or in part. In the event of a conflict between the terms and
conditions of any purchase order and this Agreement, the terms and
conditions of this Agreement shall prevail.
(c) In each calendar quarter, PLIVA shall be obligated to place
purchase orders for a quantity of Product constituting at least seventy
five percent of the estimated quantity for that quarter as contained in
the forecast provided in the previous quarter.
(d) All Product supplied under this Agreement shall be delivered FOB
ELITE's manufacturing site. PLIVA shall pay all freight, insurance and
other charges applicable to the sale and transport of the Product to
PLIVA's facilities.
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Title and risk of loss and damages to Product shall pass to PLIVA upon
delivery to PLIVA's designated carrier.
(e) If a shipment of Product of any portion thereof fails to conform
to the applicable Specifications, then PLIVA shall have the right to
reject such nonconforming shipment of Product or the nonconforming portion
thereof, as the case may be. PLIVA shall give written notice to ELITE of
its rejection within fifteen days of PLIVA's receipt of the Product,
specifying the grounds for such rejection. The nonconforming Product shall
be held for ELITE's disposition, or shall be returned to ELITE, as
directed by ELITE in writing. Nonconforming Product shall be returned to
ELITE within ten (10) business days of ELITE's so directing. ELITE shall
replace each nonconforming shipment of Product, or the nonconforming
portion thereof, with conforming Product as soon as reasonably practicable
after receipt of notice or rejection thereof. If ELITE disputes any claim
of nonconforming Product and the parties cannot resolve the dispute within
thirty days, then the dispute shall be subject to the dispute resolution
provisions of Section 17 hereof.
(f) ELITE and PLIVA each agree to notify the other within
twenty-four (24) hours of any serious and unexpected adverse reactions
reported to either of them resulting from the use of the Product (whether
inside or outside of the Territory). ELITE and PLIVA shall each notify the
other promptly of any other complaints or adverse reactions from third
parties reported to either of them resulting from use of the Product sold
under PLIVA's label.
(g) (i) In the event either party believes it may be necessary to
conduct a recall, field correction, market withdrawal, stock recovery, or
other similar action with respect to any Product sold by ELITE to PLIVA
under this Agreement (a "RECALL"), ELITE and PLIVA shall consult with each
other as to how best to proceed, it being understood and agreed that the
final decision as to any Recall of any Product shall be made by ELITE;
provided, however, that PLIVA shall not be prohibited hereunder from
taking any action that it is required to take by applicable law. (ii) In
the event the Recall of the Product is solely as a result of (1) the
manufacture, supply, storage, or distribution by ELITE of Product; (2) a
breach by ELITE of its representations, warranties or obligations under
this Agreement; or (3) the grossly negligent or intentionally wrongful act
of ELITE or its representatives, then ELITE shall bear all costs and
expenses of such Recall, including, without limitation expenses related to
communications and meetings with all required regulatory agencies,
expenses of replacement stock (not including backorder reimbursement), the
cost of notifying customers and costs associated with shipment of Product
being recalled from customers and shipment of an equal amount of
replacement Product to those customers (collectively, "RECALL COSTS"). In
all other events, PLIVA shall bear all of the Recall Costs.
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7. INDEMNIFICATION
7.1 INFRINGEMENT CLAIMS. ELITE and PLIVA shall be jointly responsible
for searching, reviewing and evaluating any patents or published patent
applications pertaining to the manufacture, use and sale of Product in
each country in the Territory, including without limitation, relating
to active pharmaceutical ingredients and Product formulation. PLIVA and
ELITE jointly shall investigate and defend any and all claims, actions
and proceedings resulting from an assertion against ELITE or PLIVA (or
a Licensee if ELITE and PLIVA have agreed to indemnify such Licensee)
that the Product infringes upon a third party's intellectual property
rights ("INFRINGEMENT CLAIM"). PLIVA and ELITE shall be jointly
responsible for the cost and expenses of the defense, including without
limitation damages, awards, and settlement costs. The parties shall
provide such assistance as the other party may from time to time
reasonably request in connection with the evaluation and defense of any
potential or actual Infringement Claim.
7.2 ENFORCEMENT PROCEEDINGS. ELITE and PLIVA shall jointly bring
enforcement proceeding against any third party if ELITE and PLIVA
determine jointly that a third-party is likely infringing upon the
rights of ELITE, PLIVA or a Licensee of the Product. PLIVA and ELITE
shall be jointly responsible for the cost and expenses arising from
such enforcement proceeding, including without limitation damages,
awards, and settlement costs. All such costs and expenses shall be
allocated equally between ELITE and PLIVA. ELITE and PLIVA shall share
equally all amounts awarded in connection with any such enforcement
proceeding.
7.3 INDEMNIFICATION OBLIGATIONS OF THE PARTIES.
(a) Each party shall indemnify, defend and hold harmless the
other party and its Affiliates from and against any and all
losses, costs, expenses, liabilities, claims, actions,
damages, personal injury, or loss of life, including without
limitation, reasonable attorney's fees (collectively,
"Losses"), arising directly from such party's (i) grossly
negligent acts or omissions or willful misconduct; and/or (ii)
breach of this Agreement.
(b) ELITE and PLIVA shall jointly defend any and all claims,
actions and proceedings brought by any third party relating to
the Product. PLIVA and ELITE shall be jointly responsible for
the cost and expenses of defense, including without limitation
damages, awards and settlement costs, except for Losses for
which one party is entitled to indemnification from the other
party under Section 7.3 (a) above. ELITE and PLIVA shall
jointly select counsel for any such claim, action or
proceeding. Neither party may settle or consent to judgment in
any such action without the other party's consent if such
settlement or judgment would impose any obligation, financial
or otherwise, on the non-settling party that would not be
fully covered by the settling party's indemnification under
this Agreement.
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7.4 NOTWITHSTANDING ANY PROVISION TO THE CONTRARY CONTAINED IN THIS AGREEMENT,
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR A LICENSEE FOR
ANY CONSEQUENTIAL, INCIDENTAL, OR PUNITATIVE DAMAGES (INCLUDING LOSS OF PROFITS,
LOSS OF ENTERPRISE, AND LOSS OF OPPORTUNITY) , REGARDLESS OF WHETHER FOR BREACH
OF WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR
OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
8. INSURANCE
Each party agrees to maintain in force, during the Term and for a period
of 24 months thereafter, product liability insurance coverage in minimum
limits of $5,000,000 each. Each party shall instruct its insurance carrier
to notify the other party of any change, modification or cancellation of
insurance thirty days prior to such change, modification or cancellation
taking effect.
9. REPRESENTATIONS AND WARRANTIES
9.1 ELITE represents and warrants to PLIVA, as of the Effective Date, as
follows:
(1) ELITE has the legal right and full corporate power and
authority to enter into this Agreement and to perform the
same;
(2) the Agreement constitutes valid and binding obligations on
ELITE in accordance with its terms except as limited by
applicable bankruptcy, insolvency, reorganization and other
laws of general application affecting the enforcement of
creditors' rights generally, and except as enforcement of
rights to indemnity and contribution hereunder may be limited
by principles of public policy;
(3) ELITE has taken all corporate action required by it to
authorize it to enter into and to perform the Agreement;
(4) ELITE has the right to disclose Know-How to PLIVA as is
necessary for PLIVA to perform its obligations hereunder;
(5) to ELITE's knowledge, there are no infringement proceedings
pending against ELITE in connection with the Product;
(6) there are no agreements between ELITE and any third party that
conflict with this Agreement;
(7) no consent or approval of any third party, court or
governmental agency is required in connection with the
execution and performance of this Agreement by ELITE;
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(8) ELITE will manufacture all Product in accordance with cGMPs
and all Applicable Laws;
(9) ELITE is not enjoined from manufacturing nor is ELITE
currently sanctioned by the FDA pursuant to any issued 483
inspection reports;
(10) ELITE's employees and agents are not and have not been
debarred by FDA pursuant to 21 USC Section 335(a) or involved
in any investigation or proceeding which could lead to
debarment;
(11) ELITE does not and will not knowingly employ or use the
services of any individual or entity that has been debarred or
convicted of a felony or who is currently under investigation
for such conviction;
(12) all laboratory, scientific, technical or commercial
information that is submitted by ELITE to PLIVA or to any
regulatory health authority relating to the Product should be
complete, true, accurate and correct and shall not contain any
knowingly false information, misrepresentation and/or
omission; and
(13) ELITE will perform all necessary record keeping as required
under applicable federal and state laws regarding the
manufacture of the Product, environmental impact of the
manufacturing and all potential or adverse product defects.
ELITE MAKES NO OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, EXCEPT
THOSE EXPRESSLY MADE HEREIN. ELITE SPECIFICALLY DISCLAIMS ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A
PARTICULAR PURPOSE.
9.2 PLIVA represents and warrants to ELITE, as of the Effective Date, as
follows:
(1) PLIVA has the legal right and full corporate power and
authority to enter into this Agreement and to perform the
same;
(2) the Agreement constitutes valid and binding obligations on
PLIVA in accordance with its terms except as limited by
applicable bankruptcy, insolvency, reorganization and other
laws of general application affecting the enforcement of
creditors' rights generally, and except as enforcement of
rights to indemnity and contribution hereunder may be limited
by principles of public policy;
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(3) PLIVA has taken or will have taken all corporate action
required by it to authorize it to enter into and to perform
the Agreement;
(4) there are no agreements between PLIVA and any third party that
conflict with this Agreement;
(5) no consent or approval of any third party, court or
governmental agency is required in connection with the
execution and performance of this Agreement by PLIVA;
(6) PLIVA will transport, store, handle, distribute, market and
sell all Product in accordance with cGMPs and all Applicable
Laws;
(7) PLIVA's employees and agents are not and have not been
debarred by the FDA pursuant to 21 U.S.C. Section 335(a) or
involved in any investigation or proceedings which could lead
to debarment;
(8) in the performance of its obligations under this Agreement,
PLIVA does not and will not knowingly employ or use the
services of any individual or entity that has been debarred,
convicted of a felony or who is currently under investigation
for such conviction; and
(9) PLIVA will perform all necessary record keeping as required
under applicable federal and state laws regarding the
transport, handling, storage and distribution of the Product,
environmental impact of the manufacturing and all potential or
adverse product defects.
PLIVA MAKES NO OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, EXCEPT
THOSE EXPRESSLY MADE HEREIN. PLIVA SPECIFICALLY DISCLAIMS ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A
PARTICULAR PURPOSE.
10. OBLIGATION OF CONFIDENTIALITY
10.1 All Confidential Information disclosed by a party ("Disclosing
Party") shall be treated by the other party ("Receiving Party") as
confidential and shall not be disclosed or revealed to any third party and
shall be used solely in connection with the performance of this Agreement;
provided, however, that Confidential Information shall not include
information that the Receiving Party can document as having been:
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(1) public knowledge prior to the disclosure, or which hereafter
becomes public knowledge through no fault of the Receiving Party;
(2) lawfully in the Receiving Party's possession prior to the time
of disclosure by Receiving Party;
(3) received, after the time of disclosure, from a third party not
under a similar obligation of confidentiality to Disclosing Party;
or
(4) independently developed by Receiving Party's employees without
access to Disclosing Party's Confidential Information.
10.2 The Receiving Party shall take all such precautions as it normally
takes with its own Confidential Information, but in no event less than
reasonable precautions, to prevent improper disclosure; provided, however,
that Confidential Information may be disclosed within the limits required
(A) to obtain any authorization from the FDA or any other United States or
foreign governmental or regulatory agency or, with the prior written
consent of the Disclosing Party; (B) to be disclosed pursuant to (i) any
order of any court having jurisdiction and power to order such information
to be released or made public; or (ii) any lawful action of a governmental
or regulatory agency.
10.3 In addition to and without limiting any other remedies available to a
Receiving Party at law or in equity, the Receiving Party shall also be
entitled to seek immediate injunctive relief in any court to restrain any
breach or threatened breach of a Receiving Party and to enforce the
provisions of this Section 10. Each party acknowledges and agrees that
there is may be no adequate remedy at law or in equity for any such breach
or threatened breach and, in the event that any proceeding is brought
seeking injunctive relief, the Receiving Party shall not use as a defense
thereto that there is an adequate remedy at law.
10.4 The Receiving Party may disclose Confidential Information of the
Disclosing Party to the Receiving Party's employees, consultants,
licensees, prospective licensees and subcontractors on a need-to-know
basis; provided, however, that (i) any such disclosure shall be pursuant
to confidentiality undertakings with terms at least as restrictive as
those specified herein; and (ii) any violation of this Agreement by such
persons shall be deemed a breach of the Receiving Party. Any of the
persons mentioned above who are provided with access to Confidential
Information shall be informed by the Receiving Party of the Receiving
Party's obligations hereunder.
10.5 The confidentiality obligations of each party under this Section 10
shall survive the expiration or earlier termination of this Agreement,
howsoever terminated.
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10.6 The parties shall cooperate and agree upon any public statement
concerning the existence, subject matter or any term of this Agreement by
or on behalf of any Party prior to any issuance, dissemination or release.
Subject to Section 10.2, neither party may issue, disseminate or release
any such public statement without the prior written approval of the other
parties, which consent shall not be unreasonably withheld or delayed.
10.7 The confidentiality obligations contained in this Article 10 are in
addition to and not in substitution for any confidentiality obligations of
the parties undertaken pursuant to the Non-Disclosure Agreement between
ELITE and PLIVA dated June 22, 2004 (which agreement shall continue in
full force and effect as therein provided).
11. TERM OF AGREEMENT
This Agreement shall become Effective Date and shall continue in force, in
with respect to any particular country in the Territory, for a ten (10)
year period from the date the Product is first commercially sold in that
country by PLIVA ("Initial Term"), unless terminated earlier under Article
12. Upon expiration of the Initial Term, and any extension term as
hereafter provided ("Renewal Term" and together with the Initial Term, the
"Term"), the Term shall automatically be renewed for additional periods of
three (3) years each, unless written notice is given by either party to
the other at least one (1) year prior to the end of the Initial Term or
any of the Renewal Term of such party's decision not to extend the term of
the Agreement upon expiration of the then existing term.
12. TERMINATION
12.1 This Agreement may be terminated by a party:
(1) upon breach of this Agreement by the other party (including,
without limitation, the failure to timely perform any
obligation under this Agreement), and after sixty (60) days
prior written notice to the breaching party, the notice to
become effective at the end of the sixty (60) day period
unless the breach is sooner cured by the breaching party;
(2) if a successful pivotal biostudy demonstrating the Product
meets FDA guidelines for bioequivalence is not completed
within one (1) year from the Effective Date, or if the parties
are unable to obtain Marketing Authorization from FDA within
the later of (i) two (2) years from the completion of the
Studies or (ii) five (5) years of the Effective Date;
(3) if there are no patents which present a risk of infringement
in the Territory and the first commercial launch of the
Product in the
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Territory under this Agreement does not occur within sixty
(60) days of the date a Marketing Authorization for the
Territory is obtained;
(4) upon the other party's insolvency or voluntary filing of a
petition for bankruptcy, or the placing of the business of the
other party in the hand of a receiver; or
(5) if the Net Profit received by that party in respect of the
Product is less than [*] for any calendar year after the first
full calendar year of commercial sales hereunder.
12.2 EFFECT OF TERMINATION. Termination of this Agreement for any reason
shall be without prejudice to:
(1) ELITE's and PLIVA's right to receive all amounts accrued and
unpaid under Sections 2, 3 or 5 up to the date of such
termination;
(2) any provisions clearly meant to survive termination or
expiration of this Agreement, including without limitation
representations, warranties, indemnification and
confidentiality obligations as well as Sections 1, 4, 7, 8, 9,
10, 12, and 14, shall remain in full force and effect.
(3) the rights of inspection and audit set out in Section 5.4
shall continue in force as required under the terms of this
Agreement; and
(4) any other remedies which either party may then or thereafter
have hereunder or otherwise.
12.3 RIGHTS TO ANDAs. Without limiting any other right or remedy available
to PLIVA, on ELITE's breach of this Agreement (if such breach is not cured
within the time period provided in Section 12.1 (1) above), then at
PLIVA's request ELITE shall, within the Territory, transfer to PLIVA, at
no charge, the ANDA (or comparable Marketing Authorization outside of the
United States) for the Product, and ELITE promptly shall take such other
actions as reasonably requested by PLIVA from time to time to evidence
PLIVA's exclusive rights to the ANDA or comparable Marketing Authorization
and all information contained therein, subject to PLIVA having theretofore
reimbursed ELITE in full for the Elite Product Development Costs.
13. NOTICES
13.1 Any notice provided for herein shall be in writing and is effective
upon receipt: (i) when delivered by hand with proof of delivery; (ii) when
sent by facsimile with fax confirmation, provided same is sent all by
regular mail within
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forty-eight (48) hours; (iii) three (3) days following deposit for mailing
by first class registered or certified mail, return receipt requested; one
day following deposit for mail with an overnight carrier; or (iv) when
received by the addressee, by delivery service (return receipt requested).
Notices shall be delivered to the addresses set forth below:
If to ELITE: 000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Chief Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to PLIVA: 00 Xxxxx Xxxx Xxxxxx
Xxxx Xxxxxxx, XX 00000
Attention: General Counsel
Telephone: 000-000-0000
Facsimile: 000-000-0000
14. MISCELLANEOUS
14.1 Neither party shall be liable for any failure to deliver or receive
or any delay to perform its obligations hereunder when such failure or
delay shall be caused (directly or indirectly) by fire; flood; accident;
explosion; equipment or machinery breakdown; sabotage; strike, or any
labor disturbance (regardless of the reasonableness of the demands of
labor); civil commotions; riots; invasions; wars (present or future);
acts, restraints, requisitions, regulations, or directions of any
governmental entity; voluntary or mandatory compliance with any request of
any governmental entity; facility shut down; voluntary or mandatory
compliance with any request for material represented to be for purposes of
(directly or indirectly) producing articles for national defense or
national defense facilities; shortage of labor, fuel, power or raw
materials; inability to obtain raw materials or supplies; failures of
normal sources of supplies; inability to obtain or delays of
transportation facilities; any act of God; any act of the other party; or
any cause (whether similar or dissimilar to the foregoing) beyond the
reasonable control of such party (each cause a "Force Majeure Event").
14.2 Either party hereto may assign this Agreement in whole or in part to
any Affiliate or Affiliates who shall be substituted directly in whole or
in part for it hereunder, provided, however, that the assignor shall
guarantee the performance of its Affiliate assignee hereunder. This
Agreement shall not otherwise be assignable by either party without the
prior written consent of the other party, which consent shall not be
unreasonably withheld, conditioned or delayed.
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14.3 This Agreement shall be governed by and interpreted in accordance
with the laws of the State of New Jersey, United States of America without
regard to its conflict of laws principles, and should legal action become
necessary to enforce its terms, the prevailing party shall be entitled to
reasonable costs and attorneys' fees.
14.4 In connection with any litigation out of or relating to the subject
matter of this Agreement, each of the parties hereto (a) irrevocably
consents and submits to the exclusive jurisdiction of the state and
federal courts located in New Jersey, and (b) agrees that service of
process may be effected, in addition to any other means permitted by the
applicable rules of court, by mailing such process certified mail, return
receipt requested or by reputable overnight courier provided a receipt
against delivery at their respective addresses set forth above is
obtained.
14.5 The terms and provisions contained in this Agreement constitute the
entire Agreement between the parties and, except as provided in Section
11.7 hereof, shall supersede all previous communications, representations,
agreements or understandings, either oral or written, between the parties
hereto with respect to the subject matter hereof and no agreement or
understanding varying or extending these Agreements shall be binding upon
either party hereto, unless in writing which specifically refers to the
Agreement, signed by fully authorized officers or representatives of the
respective parties and the provisions of these Agreements not specifically
amended thereby shall remain in full force and effect.
14.6 Any waiver must be explicit and in writing. The waiver by either of
the parties to this Agreement of any breach of any provision hereof by the
other party shall not be construed to be a waiver of any succeeding breach
of such provision or a waiver of the provision itself.
14.7 If and to the extent that any court or tribunal of competent
jurisdiction holds any of the terms, provisions or conditions or part
thereof of this Agreement, or the application hereof of any circumstances,
to be invalid or to be unenforceable in a final non-appealable order, the
remainder of this Agreement and the application of such term, provision or
condition or part thereof to circumstances other than those as to which it
is held invalid or unenforceable shall not be affected thereof, and each
of the other terms, provisions and conditions of this Agreement shall be
valid and enforceable to the fullest extent of the laws.
14.8 The relationship of ELITE and PLIVA under this Agreement is that of
independent contractors. Neither party shall be deemed to be the agent of
the other nor authorized to take any action binding upon the other.
14.9 This Agreement may be executed in counterparts, each of which shall
be deemed to be an original and all together shall be deemed to be one and
the same Agreement. All headings in this Agreement are inserted for
convenience of reference only and shall not affect its meaning or
interpretation.
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15. AGREEMENT TO PERFORM NECESSARY ACTS
Each party to this Agreement agrees to perform any further acts and
execute and deliver any documents that may be reasonably necessary to
carry out the provisions of this Agreement.
16. DISPUTE RESOLUTION
16.1 Should any dispute or difference arise between ELITE and PLIVA or the
Committee during the Term of this Agreement, then either party may
forthwith give notice to the other party that it wishes such dispute or
difference to be referred to a designated senior officer of each of ELITE
and PLIVA.
16.2 If designated senior officers of each of ELITE and PLIVA agree upon a
resolution or disposition of the matter, they shall each sign a statement
which sets out the terms of their agreement. If, however, the parties'
designated senior officers are still unable to resolve their differences
within 60 days of its being referred to them, either party may pursue any
legal remedy available to it. Nothing contained herein shall be deemed to
limit or restrict a party from seeking equitable remedies, such as a
preliminary or permanent injunction, if necessary, from a court of
competent jurisdiction located in the State of New Jersey.
17. QUALITY AGREEMENT
17.1 PLIVA and ELITE shall enter into an agreement with respect to quality
and regulatory issues (the "Quality Agreement") substantially in the form
attached hereto as Exhibit A.
17.2 If any term in this agreement is inconsistent with any term in the
Quality Agreement, the term in the Quality agreement shall control.
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IN WITNESS WHEREOF, ELITE and PLIVA have executed this Agreement in duplicate as
of the day and year first above written.
ELITE LABORATORIES, INC.
By:
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Its
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PLIVA, INC.
By:
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Its
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