EXHIBIT 10.1
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 COMMERCIALIZATION AGREEMENT
ELITE PHARMACEUTICALS, INC. AND ORIT LABS LLC
PRODUCT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (together with all exhibits
and schedules, the "AGREEMENT"), made as of this tenth day of January, 2006 (the
"EFFECTIVE DATE"), by and between ELITE LABORATORIES, INC., a Delaware
corporation having its principal place of business at 000 Xxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 XXX, and ELITE PHARMACEUTICALS, INC., a Delaware
corporation, having its principal place of business at 000 Xxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 XXX (jointly and severally "ELITE") and Orit Laboratories
LLC, having its principal place of business at 000 Xxxxxxxxx Xxxxxx, Xxxx
Xxxxxxxx, XX 00000 XXX and its Affiliates, ("ORIT"), and together with ELITE,
the "PARTIES" and each individually, a "PARTY").
RECITALS:
WHEREAS, ORIT and ELITE specialize in the development and
commercialization of time release and other technologies for pharmaceutical
providers;
WHEREAS, Elite is in the business of research and development, and
manufacturing pharmaceutical drug products in a manner conforming with
applicable regulations found at 21 CFR Parts 210 and 211 ("cGMPs");
WHEREAS, ORIT is in the business of pharmaceutical product formulation
development and pharmaceutical product analytical test method development and
ANDA filing in a manner conforming with applicable regulations found at 21 CFR
Parts 210 and 211 ("cGMPs') and marketing, sales and distribution of
pharmaceutical products;
WHEREAS, ELITE and ORIT desire to work together to co-develop,
commercialize and/or license for manufacture and sale of, the Product;
WHEREAS, the Parties desire to set forth herein their respective
agreements and convenants with respect to the Product.
NOW, THEREFORE, in consideration of the recitals and the covenants and
conditions herein contained, ELITE and ORIT agree as follows:
* Portions of this exhibit have been omitted and filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.
1. DEFINITIONS
The following terms as used in this Agreement shall have the meanings set
forth in this Article:
1.1. "AFFILIATE" shall mean, as to either Party, any Person
which owns or controls or which is owned or controlled by or the common control
with such Party to the extent of at least fifty percent (50%) of the equity or
voting power of the owned or controlled entity.
1.2. "ANDA" shall have the meaning set forth in Section
3.2(b).
1.3 "BIOEQUIVALENCE" shall have the meaning bioequivalence
according the regulations set forth by the regulatory agency in the relevant
territory for generic drug products.
1.3. "CFR" shall mean the Code of Federal Regulations, as may
be amended from time to time.
1.4. "CONFIDENTIAL INFORMATION" shall mean any information
pertaining to the Product or the Study from time to time communicated by or on
behalf of either Party or the other or developed pursuant to the Study,
including, without limitation, trade secrets, Know-How, pricing, costs,
suppliers, Licensees, customer information, patent rights, scientific,
technical, commercial and medical product development, product formulations and
technical specifications including, but not limited to the Product, methods of
analysis and testing, manufacturing methods, processes and production, batch
records, contractual arrangements, results, discoveries and inventions,
procedures and forms, and all information related to the Studies including
without limitation, the Protocol, whether of a written, oral or visual nature.
1.5. "COMMERCIALIZATION", "COMMERCIALIZING", or
"COMMERCIALIZE" shall mean all activities relating to manufacture, promotion,
distribution, marketing and sale of the Product in the Territory.
1.6. "COMMITTEE" shall have the meaning set forth in Section
2.1 hereof.
1.7. "CRO" shall have the meaning set forth in Section 3.2(f)
hereof.
1.8. "DEVELOPMENT PLAN" shall mean the Product Development
Activity Schedule annexed hereto as Exhibit A.
1.9. "FDA" shall mean the U.S. Food and Drug Administration.
1.10. "INTELLECTUAL PROPERTY RIGHTS" shall have the meaning
set forth in Section 5.2 hereof.
1.11. "KNOW-HOW" shall mean all technology, data, information,
formulations, technical specifications, processes and methods necessary or
useful in the manufacturing, production, testing or registration of drug
products, including but not limited to, the Product.
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1.12. "LICENSEE" shall mean any Person that holds a license
approved by the Parties and granted by the Parties to Commercialize the Product
in the Territory pursuant to a License Agreement.
1.13. "LIEN" shall mean any lien, pledge, mortgage, security
interest, claim, lease, charge, option, right of first refusal or first offer,
easement, transfer restriction, voting requirement or any other encumbrance,
restriction or limitation.
1.14. "LICENSE AGREEMENT" shall have the meaning set forth in
Section 6.1 hereof.
1.15. "MARKETING AUTHORIZATION" shall mean the final approval
of all regulatory authorities necessary to market the Product in the Territory,
including as applicable pricing and reimbursement approval and all other
approvals required in the Territory for the marketing, distribution and sale of
the Product in the normal course of business.
1.16. "PERSON" shall mean any individual, partnership,
limited-liability company, corporation, joint venture, trust, association or any
other entity, domestic or foreign.
1.17. "PRODUCT" shall mean a generic, extended release drug
product for treatment of anxiety based upon one or more reference drug products
to be mutually agreed upon by the Parties during the Term and any renewal Term
if applicable as covered in Section 11.1.
1.18. "PROPRIETARY RIGHTS" The term "Proprietary Rights"
means, with respect to the Product, all know-how, technical and clinical data
generated during the Term related to the development of the Product (including,
without limitation, inventions, whether or not patentable and whether or not
tested or reduced to practice, any and all data, techniques, discoveries,
developments, designs, trade secrets, confidential business information,
know-how and tangible expressions, tests, reports, processes, formulae,
specifications, improvements, results, experiments, samples, statistics and test
analyses relating to the Product), except to the extent any of the foregoing is
based on or incorporates Confidential Information of any Party to this Agreement
or of any third party.
1.19. "PROTOCOL" shall mean the protocol developed by ORIT and
ELITE in connection with the Studies to be conducted for, and as agreed to by,
the Parties.
1.20. "REGULATORY FILING" shall have the meaning set forth in
Section 3.2(h) hereof.
1.21. "REPRESENTATIVE" shall have the meaning set forth in
Section 2.1 hereof.
1.22. "STUDIES" shall mean the clinical trials needed to
qualify the Product including Bioequivalence studies for a generic drug product
submission to the appropriate regulatory agency for the relevant Territory.
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1.23. "TERRITORY" shall mean the United States and its
territories, Canada and Mexico.
2. DEVELOPMENT AND COMERCIALIZATION COMMITTEE
2.1. DEVELOPMENT AND COMMERCIALIZATION COMMITTEE Within ten
(10) days after the Effective Date, ELITE and ORIT shall establish a Development
and Commercialization Committee (the "COMMITTEE") comprised of not less than
two, and not more than three, persons ("Representatives") selected by each
Party. ELITE and ORIT shall each designate an equal number of Representatives to
the Committee, with each Party having the right to increase the number of
Representatives at any time to the maximum of three upon written notice to the
other Party; PROVIDED, HOWEVER, in any event, ORIT and ELITE shall retain an
equal number of Representatives on the Committee and equal voting rights. The
Committee shall carry out the duties set forth below in Section 2.4.
2.2. The first meeting of the Committee shall be held within
fifteen (15) days from the Effective Date, at which time the procedures of the
Committee may be established. Thereafter, the Committee shall meet on such
schedule as deemed appropriate by the Representatives, but not less frequently
than each calendar quarter, with any one Representative being empowered to call
a meeting of the Committee upon at least five (5) days' notice (which notice
shall include a detailed description of all matters to come before the Committee
at such meeting for consideration or action).
2.3. At meetings, each Party shall have the right to provide
information for consideration and the Committee shall consider all such input.
All decisions by the Committee shall be made by unanimous vote of the
Representatives. For greater certainty, a vote is unanimous if, and only if, all
of the Parties' Representatives in actual attendance at any such meeting,
irrespective of the Party they represent, vote for the same outcome of any
decision to be taken. A quorum required for any action by the Committee shall
consist of at least one ELITE Representative and one ORIT Representative.
Participation at a meeting may be in person, by telephone conference call or by
video conference, so long as all participants can hear and be heard by one
another at all times throughout the meeting. If the meeting is in person, it
shall be held alternately at ELITE's and ORIT's offices, unless otherwise agreed
by the Representatives. All Representatives serving on the Committee not in
attendance shall be notified in writing immediately of any action taken or
approved by the Committee.
2.4. The duties of the Committee shall be to:
A. Keep the Parties apprised of any development
issues with respect to the Product and effect a plan of action to
resolve same;
B. Monitor the performance and progress of the
Development Plan;
C. Pursue and consider license agreements for the
Commercialization
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of the Product in the Territory, or in any part thereof, with any
potential Licensee suggested for consideration by either ELITE or ORIT.
The criteria which the Committee shall take into account in the
consideration of any such license agreements shall include, but are not
limited to, the maximization of market penetration and revenues for the
Product in the Territory, or in any part thereof; and
D. Such other matters relating to sub paragraphs 2.4
A, 2.4 B, and 2.4 C above as may be necessary or appropriate to
consider.
2.5. If the Committee cannot resolve any dispute within its
purview after fifteen (15) days or such other period as may be agreed by the
Committee, the dispute will be referred to a designated senior officer of each
of ELITE and ORIT, and thereafter, in the event of continued deadlock, will be
resolved pursuant to the deadlock provisions set forth in Section 14.
3. RESPONSIBILITIES OF THE PARTIES
3.1. THE DEVELOPMENT PLAN
The Development Plan, with milestones listed, setting out the specific
responsibilities of each of ELITE and ORIT that will be required in order to
complete development of the Product, and to secure regulatory approval necessary
to the manufacture and sale of the Product in the Territory, is annexed hereto
as EXHIBIT A. Each of the Parties agrees to use commercially reasonable best
efforts to perform each of the milestone activities required to be performed by
such Party on or before the dates required for performance of such activity
under the Development Plan. Subject to all the terms and conditions of this
Agreement, including but not limited to the provisions of Section 5, and in
order to achieve the milestones set forth in the Development Plan, ORIT and
ELITE hereby agree to conduct and carry out the activities set forth in Section
3.2, in the case of ORIT and in Section 3.3, in the case of ELITE. Exhibit A can
be modified by mutual agreement of the Parties at any time.
Pursuant to the Development Plan ORIT will provide
formulation, analytical and formulation services, and personnel, to assist ELITE
in developing the Product. Elite will be responsible for all other aspects of
product development including financing the product development except for
ORIT's responsibilities covered in Section 3.2
3.2. ORIT'S DUTIES
ORIT hereby agrees that it will complete in accordance with the
Development Plan, at Elite facilities and using Elite equipment (Elite's
facilities remain under Elite control and Orit will work within their structure)
, certain matters as follows:
(A) ORIT will develop and validate all pharmaceutical
analytical methods necessary and sufficient for the analysis of the drug
substance, impurities, and degradation products, including stability indicating
methods, and has prepared or will prepare all necessary
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written documentation and reports in relation to these methods ready to be
inserted into the ANDA;
(B) ORIT will develop formulations and processes for the
manufacture of the Product as required for pilot Bioequivalence studies. ORIT
will transfer the technology in relation to the formulations and the processes
to the ELITE facility during the scale-up process at the ELITE facility, and
will make such adjustments and optimizations of such formulations and processes
during such scale-up and during the pivotal Bioequivalence studies phase of the
development program, with a view to filing an Abbreviated New Drug Application
("ANDA") with the FDA with respect to the Product;
(C) ORIT will transfer pharmaceutical analytical methods and
operating procedures relating to the Product to the ELITE facility, will further
develop and validate these methods at ELITE facilities, and will provide all
reasonable technical and documentary assistance in the transfer and revalidation
process of such methods;
(D) ORIT will provide on-site assistance and sufficient
information to designated ELITE personnel to allow ELITE personnel to scale up
the process developed by ORIT and to manufacture Product batches for the
additional pilot studies, if any, and the pivotal clinical studies at the ELITE
facility.
(E) ORIT will provide to ELITE such assistance as ELITE may
require to manage and oversee the design and the conduct of pilot Bioequivalence
studies, if any, and pivotal clinical studies for the Products, such studies to
be done at the facilities of such third party contract research organization
("CRO") as may be acceptable to both ORIT and ELITE;
(F) ORIT will provide to ELITE, for the purposes of regulatory
filing, all necessary documentation, including but not limited to the
formulation and process, and reports in respect of the manufacture, release and
packaging of the Product batches for the pivotal clinical studies and stability
studies; and
(G) ORIT will provide to ELITE, for the purposes of regulatory
filing, all other reasonably necessary data, results, documents and documentary
support.
3.3 ELITE'S DUTIES
ELITE hereby agrees that it will complete certain matters in accordance
with the Development Plan as follows:
(A) ELITE will be responsible for conducting the CMC
(chemistry, manufacturing and controls) activities including production, quality
controls, and stability studies with respect to the Product (with input from
ORIT, if necessary);
(B) ELITE will allow ORIT to complete the necessary lab and
development work necessary under Section 3.2 at Elite's facilities. The
facilities remain under Elite's control and Orit will complete their work within
Elite's facility rules and supervision. Elite will also
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allow the use of necessary laboratory and production equipment and will provide
laboratory and production materials for this work.
(C) ELITE (together with ORIT) will manage and oversee the
design and the conduct of pilot Bioequivalence studies, if any, and the pivotal
Bioequivalence studies for the Product, such studies to be done at the
facilities of such third party CRO as may be acceptable to both Parties;
(D) ELITE will oversee the packaging and labeling of the
Product at a mutually agreed upon packaging facility for the purpose of the
pivotal clinical studies and the stability studies;
(E) ELITE will prepare and file, in the joint names of ORIT
and ELITE, such patent application(s) on the Product as may be possible, based
on the Intellectual Property of the parties , and take all appropriate steps to
receive a grant of such patent(s) and maintain such patent(s) if granted; and
(F) ELITE shall be responsible for the preparation of all
regulatory filings (which shall be filed in ELITE's sole name), including all
clinical investigational new drug applications in connection with the
applications for regulatory approval for the Product in each jurisdiction of the
Territory (each a "REGULATORY FILING"), all as required under applicable laws of
the Territory.
3.4 REGULATORY FILINGS
The ELITE shall prepare any aspect of any regulatory filing,
and ORIT will co-operate with the other to provide such assistance as may be
requested or necessary to complete such regulatory filing at the earliest
opportunity.
3.5 PERFORMANCE AND COSTS OF PERFORMING HEREUNDER; PAYMENT BY
ELITE
(A) ORIT shall bear [ * ] manpower costs relating to its
services for development of the Product described under Section 3.2 hereof.
(note: Elite will provide facility, equipment and materials for this work)
(B) ELITE alone will bear [ * ] the costs for Product
development which are not borne by ORIT pursuant to subsection (a) above;
(C) ORIT and ELITE will share [ * ] the costs of patent
application preparation and filing costs.
(D) ELITE shall pay to ORIT $[ * ] upon execution of this
agreement. This money is fully refundable to ELITE if an in vitro dissolution
profile matching the branded product is not satisfactorily achieved within the
time allowed for Item 1 in Exhibit A.
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(E) Upon satisfactory completion of the pilot Bioequivalence
study for the U.S. (demonstration of bioequivalence according to the FDA
requirements) Elite will pay to ORIT the sum of $[ * ].
(F) It is the intention of the Parties that a commercial
Licensee or Licensees should bear all litigation costs in relation to regulatory
filing or defense of the Product arising after filing with regulatory
authorities. To the extent that such costs, as may arise after the date of this
Agreement and before or after filing, are not borne by such Licensee(s), ELITE
and ORIT will share in the costs of such legal defense of the Product and/or
defense against any litigation against the Parties in respect of the Product as
follows: [ * ] by ELITE and [ * ] by ORIT.
3.6 STANDARD OF PERFORMANCE. The Parties must use reasonable,
timely efforts to fulfill their respective obligations set forth in this Section
3 hereof and elsewhere in this Agreement to pursue the development and
Commercialization of the Products in accordance with the estimated timetables as
set forth in the Development Plan. A Party's failure to fulfill its obligations
shall provide the other Party with the right to terminate this Agreement in
accordance with the provisions of Section 14 hereof.
3.7 COOPERATION. Each Party shall use reasonable efforts to
cooperate with the other Party in connection with the preparation of each
regulatory filing relating to the Product. ELITE shall have the right to review
and comment upon any and all prepared applications and filings prior to
submission to the relevant governmental authorities. ELITE shall manufacture
bio-batches as required for submission purposes.
4. CLINICAL STUDIES
4.1 SELECTION OF THIRD PARTY
ORIT and ELITE shall jointly determine the identity of, and
thereafter engage, a reputable third party to conduct the clinical studies for
the Product in accordance with the Development Plan (the "STUDIES") and such
third party shall be contractually bound to fulfill its obligations to conduct
such Studies in accordance with 21 CFR ss.312.52 and all applicable laws. Each
of ORIT and ELITE agrees that, during the Term (and any Renewal Term), except
for the Studies contemplated hereunder, neither it nor any of its Affiliates
will conduct clinical studies for any other generic version of the targeted
branded product for the Product whether for itself or any third party.
4.2. DISCONTINUANCE
ELITE and ORIT shall each have the right to discontinue the
Studies at any time prior to completion of such Studies upon 5 days prior
written notice to the other Party, if ELITE or ORIT, as the case may be,
reasonably believes that any serious adverse clinical event may arise.
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5. PATENT PROSECUTION, MAINTENANCE AND DEFENSE; OWNERSHIP OF
INTELLECTUAL PROPERTY
5.1. PATENTS. During the Term (including all Renewal Terms),
ORIT and ELITE shall each have the right to file and obligation to maintain all
patent rights relating to the Product throughout the Territory and shall,
subject to the provisions set forth herein, use reasonable efforts to file
patent applications to protect the Product. All patent application expenses for
the Product will be shared by the Parties on a [ * ] basis.
5.2. INTELLECTUAL PROPERTY. Subject to the provisions of
Section 5.1, 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 of this
Agreement (collectively, "Intellectual Property") are and shall, in all events,
be the sole and exclusive property of the Party who develops such Intellectual
Property. Parties hereby agree to grant to Licensee the exclusive right and
license to use such Intellectual Property in a commercial manner for the
production of the Product and to the other Party for the use in the development
of the Product. Notwithstanding the above, in no event shall any of the Parties
hereto use the Intellectual Property in connection with the development of any
product containing the active pharmaceutical ingredient molecule used in the
Product.
6. COMMERCIALIZATION OF PRODUCT
6.1. License. As promptly as is practicable, the Committee
shall consider and, where appropriate, approve one or more Licensees suggested
by ELITE or ORIT for the Commercialization of the Product in the Territory. Such
Committee approval shall not be unreasonably withheld by the Representatives.
ORIT and ELITE shall jointly negotiate in good faith with such Licensee(s) upon
standard industry terms for an exclusive license for Licensee's
Commercialization of the Product in all or a portion of the Territory ("LICENSE
AGREEMENT"), the terms of which License Agreement shall be approved by a
unanimous decision of the Committee, such approval not to be unreasonably
withheld by the Representatives. The main criterion for the grant of such
Licenses shall be the maximization of the commercial success of the Product in
the marketplace for any market in the Territory.
6.2. COMMERCIAL MANUFACTURE. Following ANDA approval, Elite
shall be responsible for manufacturing, storing and overseeing the labeling,
packaging and shipping of the Product in a manner that complies with all
applicable legal requirements, including , but not limited to the laws and
regulations enforced by the FDA. Elite shall be paid a transfer price as agreed
upon with the licensee and with ORIT.
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6.3. ROYALTIES AND OTHER PROCEEDS.
(A) Subject to Section 6.3(b) below, during the Term of this
Agreement (including all Renewal Terms), all license fees from each Licensee
(including, without limitation, milestones, royalties, fees and other
consideration paid by any Licensee) and all other profits from the sale of the
Product (including sale proceeds and other consideration) shall be divided by
the Parties as follows [but not including the transfer price as covered in
section 6.2]: [ * ] to ORIT and [ * ] to ELITE. Each License Agreement shall
provide that all fees payable by each Licensee shall be paid to the Parties
directly. If the Product is sold to a third party in accordance with the mutual
agreement of the Parties, the proceeds of the sale shall be divided on [ * ] to
ELITE and [ * ] to ORIT basis .
(B) To the extent any litigation costs shall have been shared
[ * ] to ELITE and [ * ] to ORIT in accordance with the provisions of Sections
3.5(c) , 7.2 or 7.3, all amounts payable under Section 6.3(a) above shall be
divided between the Parties [ * ] to ELITE and [ * ] to ORIT. The provisions of
this Section 6.3(b) do not apply where any costs or expenses are the sole
obligation of one of the Parties. For purposes of this Section 6.3(b),
"litigation costs" shall include all litigation costs relating to the Product,
including products liability litigation, patent or other intellectual property
litigation, and litigation in relation to the regulatory approval of the
Product.
7. INDEMNIFICATION
7.1. 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) negligent acts or omissions or
willful misconduct, (ii) any breach of any representation or warranty provided
by such Party to the other Party hereunder, and/or (iii) any violation of the
terms of this Agreement.
(B) NOTWITHSTANDING ANY PROVISION TO THE CONTRARY CONTAINED IN
THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR
ASSUME LIABILITY TO A LICENSEE FOR ANY CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE
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.
7.2. INFRINGEMENT.
ELITE and ORIT shall jointly investigate and defend any and
all claims, actions
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and proceedings resulting from an assertion against ELITE or ORIT (or a Licensee
if ELITE and ORIT have agreed to indemnify such Licensee) that the Product
infringes upon a third party's intellectual property rights ("Infringement
Claim"). Subject to claims ELITE may assert due to a breach of representation or
warrant by ORIT under Section 9 hereof, ELITE and ORIT shall share [ * ] to
ELITE and [ * ] to ORIT in the cost and expenses of the defense. ELITE and ORIT
shall be entitled to share [ * ] to ELITE and [ * ] to ORIT all amounts awarded,
if any, in connection with any such enforcement proceeding.
7.3. ENFORCEMENT PROCEEDINGS. ELITE and ORIT may bring
enforcement proceeding against any third party [ * ] to ELITE and [ * ] to ORIT
if ELITE and ORIT determine jointly that a third-Party is likely materially
infringing upon the rights of ELITE, ORIT or a Licensee in the Product. If such
enforcement proceedings are brought jointly, the Parties will share [ * ] ELITE/
[ * ] ORIT in all costs or proceeds of such litigation, including without
limitation all awards of damages and settlement proceeds. Subject to any
agreement with any Licensee as may be licensed for the commercialization of the
Product, either Party may in its sole discretion, decline to participate in such
enforcement proceeding as complainant, in which case the other Party may proceed
with the litigation, bearing all costs and receiving all proceeds of such
litigation.
7.4 RESPONSIBILITY FOR LITIGATION. For the avoidance of
doubt, it is the intention of the Parties that a commercialization partner or
Licensee shall bear the primary responsibility for all products liability
litigation, patent or other intellectual property litigation, or litigation in
relation to the regulatory approval of the Product. To the extent that such
litigation expenses are not borne by such commercialization partner or Licensee,
or to the extent that either Party is required by operation of law to take part
in such litigation in any way, it is the intention of the Parties that all costs
and proceeds of such litigation are to be borne [ * ] by ELITE and [ * ] ORIT by
the Parties. Subject to any circumstance under which a Party declines to
participate in any enforcement proceeding as provided in Section 7.3 above, ORIT
and ELITE shall jointly have control of any such litigation, including as
regards choice of counsel and settlement terms.
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 $1,000,000 per claim and $5,000,000 per occurrence. Prior to
commercialization, those limits shall be reduced to $1,000,000 per claim and
$2,000,000 per occurrence. Each Party shall instruct its insurance carrier to
notify the other Party of any change, modification or cancellation of insurance
thirty (30) days prior to such change, modification or cancellation taking
effect.
9. REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE PARTIES
9.1. ORIT represents and warrants to ELITE, as of the
Effective Date, as follows:
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A. ORIT has the legal right and full corporate power
and authority to enter into this Agreement and to
perform the same
B. the Agreement constitutes valid and binding
obligations of ORIT, enforceable against ORIT 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
C. ORIT has taken all corporate action required by it
to authorize it to enter into and to perform the
Agreement
D. ORIT has the right to disclose Know-How (and other
Intellectual Property Rights) for the Product to
ELITE as well as all other information as is
necessary for ELITE to perform its obligations
hereunder
E. There are no infringement proceedings pending, or,
to ORIT's knowledge, threatened, against ORIT in
connection with the Product or ORITS Intellectual
Property Rights
F. ORIT has good title to all ORIT Intellectual
Property Rights, free and clear of all Liens
G. ORIT has not received any notice of infringement
of, or conflict with, any license, patent,
copyright, trademark, service xxxx or other
intellectual property right of any other Person for
the Product and, to the knowledge of ORIT, there is
no infringement or unauthorized use by any Person
of any of the ORIT Intellectual Property Rights for
the Product
H. There are no agreements between ORIT and any third
party that conflict with this Agreement
I. 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
ORIT
9.2. In respect of the Clinical Studies, ELITE
A. Shall, supervise the conduct of the Studies in
accordance with the terms hereof, to ensure that
such CRO as is selected to carry out the Studies is
contractually bound to do so, and does so,
including by way of a transfer in writing under 21
CFR 312.52, in accordance with the Protocol,
generally accepted standards of good clinical
practice and all
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applicable local, state and Federal laws and
regulations governing the performance of clinical
investigations, including without limitation,
regulations governing the protection of human
subjects (e.g., 21 C.F.R. Part 50) and
Institutional Review Boards (e.g., 21 C.F.R. Part
58), and regulations governing the conduct of
clinical trials (21 C.F.R. Part 312), and financial
disclosure by clinical investigators (21 C.F.R.
Part 54), and privacy of protected health
information (45 C.F.R. Parts 160 and 164)
B. Represents to ORIT that its employees and agents
are not currently debarred by the FDA pursuant to
21 U.S.C. ss.335(a) or involved in any
investigation or proceedings which could lead to
debarment
C. Does not and will not knowingly use, in the
performance of its obligations hereunder, the
services of any debarred entity or individual, or
of any individual that has been convicted of a
felony or who is currently under investigation for
such conviction
D. All laboratory, scientific, technical and/or other
data submitted to ELITE or any regulatory health
authority relating to the Study shall be, to the
best of its knowledge at the time of such
submission, complete, true, accurate and correct
and shall not contain any knowingly false
information, misrepresentation and/or omission
E. Shall, with notification to ORIT, ensure that a
transfer in writing under 21 CFR 312.52 is provided
to any CRO for the Studies, which CRO shall then be
responsible for the identification, documentation,
and monitoring of adverse events in Patients in
accordance with 21 C.F.R. ss.312.32 and 21 C.F.R.
ss.314.80, the Protocol and as otherwise required
under all applicable laws, rules and regulations,
and shall promptly report all such adverse events
in subjects to XXXX
X. Will keep ORIT advised of any results of the Study
via a written report
G. Shall, ensure that a transfer in writing under 21
CFR 312.52 is provided to any CRO for the Studies,
which CRO shall then be responsible to perform
record keeping and reporting obligations in
accordance with 21 C.F.R. 312.62(b), 21 C.F.R.
312.57(c) and 21 C.F.R. 312.62(c)
H. Each Party will notify the other of any
deficiencies and other issues or inquiries
presented by the FDA or other regulatory agency
with respect to the Study and provide any
assistance requested by the other to satisfactorily
respond to the FDA or such other regulatory agency
13
ORIT MAKES NO OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, EXCEPT THOSE
EXPRESSLY MADE HEREIN. ORIT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY,
NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.
9.3. ELITE represents and warrants to ORIT, as of the
Effective Date, as follows:
A. ELITE has the legal right and full corporate power
and authority to enter into this Agreement and to
perform the same
B. The Agreement constitutes valid and binding
obligations of ELITE, enforceable against 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
C. ELITE has taken or will have taken all corporate
action required by it to authorize it to enter into
and to perform the Agreement
D. There are no agreements between ELITE and any third
party that conflict with this Agreement
E. 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
9.4. In respect of the manufacture and release of the pivotal
clinical batches and the Studies, ELITE:
A. Will manufacture all clinical materials according
to generally accepted good manufacturing practices
and good laboratory practices in accordance with
all pertinent state and federal laws and
regulations, including, without limitation, in
accordance with 21 CFR ss.210 and ss.211
B. Represents to ORIT that it is not enjoined from
manufacturing nor is ELITE currently sanctioned by
the FDA pursuant to any issued 483 inspection
reports
C. Represents to ORIT that its employees and agents
are not and have not been debarred by the FDA
pursuant to 21 USC ss. 335(a) or involved in any
investigation or proceeding which could lead to
debarment
14
D. Does not and will not knowingly use, in the
performance of its obligations hereunder, the
services of any debarred entity or individual, or
of any individual that has been convicted of a
felony or who is currently under investigation for
such conviction
E. Represents that all laboratory, scientific,
technical or commercial information that is
submitted by ELITE to ORIT or to any regulatory
health authority relating to the product should be
complete, true, accurate and correct , to the best
of its knowledge at the time of such submission,
and shall not contain any knowingly false
information, misrepresentation and/or omission
F. 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.
9.5. INSPECTION OF ELITE FACILITIES
If a Federal, State or local government or regulatory
authority conducts or gives notice of an inspection of the facilities of ELITE,
ELITE will promptly inform ORIT and ORIT shall have the right, but not the
obligation to be present to any such inspection or regulatory action. ELITE will
provide all records and correspondence regarding such action within five (5)
business days of a request from ORIT.
10. OBLIGATION OF CONFIDENTIALITY
10.1. The Parties are party to a Confidentiality Agreement,
dated as of December 1, 2005, (the "CDA") the term of which is hereby extended
to coincide with the term of the obligations of confidentiality herein set out,
pursuant to which each Party agreed to maintain confidentiality with respect to
certain information to be disclosed by the other Party (the "Existing CDA"). In
addition to the obligations set forth in the CDA, 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, and such Confidential Information shall not be used in whole or
in part by either Party, whether alone or in co-operation with any other person,
to formulate, develop, manufacture or commercialize any other drug product;
PROVIDED, HOWEVER, that Confidential Information shall not include information
that the Receiving Party can document as having been:
15
(A) Public knowledge prior to the disclosure, or which
hereafter becomes public knowledge through no fault of the Receiving Party;
(B) Lawfully in the Receiving Party's possession prior to the
time of disclosure by Disclosing Party;
(C) Received, after the time of disclosure, from a third party
not under a similar obligation of confidentiality to Disclosing Party; or
(D) Independently developed by Receiving Party's employees
without access to Disclosing Party's Confidential Information or knowledge of
the Development Agreement
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 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, agents, prospective licensees and subcontractors on a
need-to-know basis; PROVIDED, HOWEVER, that (i) any such disclosure shall be
pursuant to a written confidentiality agreement 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 by 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.
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, 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.
16
11. TERM AND TERMINATION
11.1. Subject to Section 11.2 hereof, the term of the
Agreement shall be the greater of (i) a fifteen (15) year period from the date
the Product is first commercially sold in the Territory to a third party, or
(ii) the life of all applicable patent(s), if any, whichever is longer (the
"TERM"). This Agreement shall automatically renew for 3-year renewal periods
(each a "RENEWAL TERM") unless terminated by either Party by providing the other
Party with twelve (12) months written notice prior to any renewal period.
11.2. This Agreement may be terminated by a Party prior to the
end of the Term (or any applicable Renewal Term):
A. By mutual agreement of the Parties; or
B. Upon breach of this Agreement by the other Party
(including, without limitation, the failure to
timely perform in a reasonable manner any
obligation identified on the Development Plan), and
the failure of such breaching Party to cure such
breach with thirty (30) days of receipt of written
notice to the breaching Party of such breach.
11.3. EFFECT OF TERMINATION. Termination of this Agreement for
any reason shall be without prejudice to:
A. ELITE's and ORIT's right to receive all amounts
accrued and unpaid under Section 6 up to the date
of such termination;
B. 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, 7, 8, 9, 10, 11, 12, 14 and 16
and solely in the case of Section 11.5, Section
6.3, shall remain in full force and effect; and
C. Any other remedies which either Party may then or
thereafter have hereunder or otherwise.
11.4. Subject to Section 11.5, the Parties agree that upon
termination of this Agreement, all rights in the Product, the formulation or
formulations of the Product, the methods and processes applicable to the
Product, clinical data and documentation associated with Product testing, and
regulatory documentation in relation to applications for approval to market the
Product, remain with or revert to ORIT, which may then use each or all of them
for its own purposes in its sole discretion.
11.5. Upon the termination of this Agreement as a result of
the breach by ORIT of any provision of this Agreement(other than pursuant to
Section 7.2(a) hereof) and the failure of ORIT to cure such breach within thirty
(30) days of receipt of written notice by ELITE to
17
ORIT of such breach, ELITE shall continue to receive an [ * ] share of all
license fees and other consideration resulting from the licensing of rights to,
or sale of, the Product in accordance with Section 6.3 hereof.
12. NOTICES
12.1. 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 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
Facsimile: (000) 000-0000
If to ORIT: 000 Xxxxxxxxx Xxxxxx
Xxxx Xxxxxxxx, X.X. 00000
Attention:
Facsimile:
13. 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.
14. DISPUTE RESOLUTION
14.1. Should any dispute or difference arise between ELITE and
ORIT 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
ORIT.
14.2. If designated senior officers of each of ELITE and ORIT
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
10 business days of its being referred to them ("DEADLOCK"), either Party may
request in a written notice to the other Party that such controversy (the
Dispute) be resolved by binding arbitration in the State of New Jersey in
accordance with the rules of the American Arbitration Association (the :AAA")..
18
14.3 If the parties are unable to agree on the identity of an
Arbitrator within 10 days of the written proposal of an Arbitrator by one of
them, either party may, with 10 days' prior notice to the other party, apply to
the AAA to appoint an Arbitrator pursuant to the Arbitration Act. The
Arbitration shall take place and be completed expeditiously with written and
verbal submissions by the Parties to the Arbitrator to be completed within 45
days of the Arbitrator's appointment. Pending a final determination by the
Arbitrator, the costs of the Arbitration shall be paid by the parties equally
and the parties shall separately pay their own respective costs. The
determination of the Arbitrator with regard to any Dispute shall be final and
binding upon the parties and there shall be no appeal therefrom. The Arbitrator
shall have jurisdiction to award the costs of the Arbitration, including the
fees of the Arbitrator as between the parties, and to direct the payment of
interest in respect of any amount, at such rates and from and to such dates as
are determined by the Arbitrator to be appropriate.
14.4 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, under the laws of the State of New Jersey.
15. NON-COMPETITION
For so long as the Product to be developed herein
remains under active development or on sale in the marketplace in any country of
the Territory under the terms of the Agreement herein, the respective Parties
covenant and agree that they will not, whether alone or in co-operation with any
other person, develop, formulate, manufacture or commercialize any other drug
product which is a generic equivalent of the targeted branded product for the
Product.
16. MISCELLANEOUS
16.1. 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").
16.2. 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
19
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.
16.3. This Agreement shall be governed by and interpreted in
accordance with the laws of the State of New York, United States of America
without regard to their 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.
16.4. The terms and provisions contained in this Agreement,
together with the Existing CDA as amended hereby, constitute the entire
Agreement between the Parties 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.
16.5. 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.
16.6. 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.
16.7. The relationship of ELITE and ORIT 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.
16.8. 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.
20
IN WITNESS WHEREOF, ELITE and ORIT have executed this Agreement in
duplicate as of the day and year first above written.
ELITE LABORATORIES, INC.
By: /s/ Xxxxxxx Xxxx
----------------------------------
Name: Xxxxxxx Xxxx
Title: CEO 1/10/06
ELITE PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx Xxxx
----------------------------------
Name: Xxxxxxx Xxxx
Title: CEO 1/10/06
ORIT LABORATORIES LLC
By: /s/ Xxxxxx X. Xxxxx
----------------------------------
Name: Xxxxxx X. Xxxxx
Title: President and CEO 1/10/06
21
EXHIBIT A
DEVELOPMENT PLAN
Product Development Activity Schedule
=======================================================================================================================
RESPONSIBILITY
# ACTIVITIES ------------------- COMMENTS
ELITE ORIT
=======================================================================================================================
[ * ]
-----------------------------------------------------------------------------------------------------------------------
1 [ * ] [ * ] [ * ] [ * ] from signing of agreement
-----------------------------------------------------------------------------------------------------------------------
2 [ * ] [ * ] [ * ]
-----------------------------------------------------------------------------------------------------------------------
[ * ] [ * ] [ * ]
-----------------------------------------------------------------------------------------------------------------------
3 [ * ] [ * ] after completion of Step 1
-----------------------------------------------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ] after completion of Step 3
-----------------------------------------------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ] after completion of Step 3A
-----------------------------------------------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ] after signing of agreement
-----------------------------------------------------------------------------------------------------------------------
4 [ * ] [ * ] [ * ]
-----------------------------------------------------------------------------------------------------------------------
5 [ * ] [ * ] [ * ]
-----------------------------------------------------------------------------------------------------------------------
6 [ * ] [ * ] after completion of
[ * ] [ * ] successful pivotal study report
-----------------------------------------------------------------------------------------------------------------------
7 [ * ] Marketing Partner
-----------------------------------------------------------------------------------------------------------------------
22
