CONFIDENTIAL TREATMENT
REDACTED VERSION
PRODUCT DEVELOPMENT AND COMERCIALIZATION AGREEMENT (together with all exhibits
and schedules, the "AGREEMENT"), made as of this 21th day of June, 2005 (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 XX (jointly and severally "ELITE") and IntelliPharmaCeutics
Corp., a Nova Scotia corporation, having its principal place of business at 00
Xxxxxxxxx Xxxx, Xxxxxxx Xxxxxxx, Xxxxxx X0X 0X0 ("IPC", and together with ELITE,
the "PARTIES" and each individually, a "PARTY").
RECITALS:
WHEREAS, IPC and ELITE specialize in the development and
commercialization of time release and other technologies for pharmaceutical
providers;
WHEREAS, IPC is the owner of Know-How (as defined below) and other
proprietary technology relative to the Product (as defined below);
WHEREAS, ELITE and IPC desire to work together to develop,
commercialize and license for manufacture and sale, the Product;
WHEREAS, the Parties desire to set forth herein their respective
agreements with respect to the Product.
NOW, THEREFORE, in consideration of the recitals and the covenants and
conditions herein contained, ELITE and IPC 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, 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. "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. "IPC 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.
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.
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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 [*] generic [*] delayed release
capsules, [*], or either of these.
1.18. "PROTOCOL" shall mean the protocol developed by IPC in
connection with the Studies to be conducted for, and as agreed to by, the
Parties.
1.19. "REGULATORY FILING" shall have the meaning set forth in
Section 3.2(h) hereof.
1.20. "REPRESENTATIVE" shall have the meaning set forth in
Section 2.1 hereof.
1.21. "STUDIES" shall mean the clinical trials needed to
qualify the Product for an ANDA.
1.22. "TERRITORY" shall mean the United States and its
territories, Canada and Mexico.
2. DEVELOPMENT AND COMERCIALIZATION COMMITTEES
2.1. DEVELOPMENT COMMITTEE Within ten (10) days after the
Effective Date, ELITE and IPC shall establish a Development Committee (the
"D-COMMITTEE") comprised of not less than two, and not more than three, persons
("Representatives") selected by each Party. ELITE and IPC shall each designate
an equal number of Representatives to the D-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, IPC and ELITE shall retain an equal number of Representatives on the
Committee and equal voting rights. The D-Committee shall carry out the duties
set forth below in Section 2.4.
2.2. The first meeting of the D-Committee shall be held
within fifteen (15) days from the Effective Date, at which time the procedures
of the D-Committee may be established. Thereafter, the D-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 D-Committee upon at least five (5) days'
notice (which notice shall include a detailed description of all matters to come
before the D-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 D-Committee shall consider all such input.
All decisions by the D-Committee shall be made by unanimous vote of its
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 D-Committee shall
consist of at least one ELITE Representative and one IPC Representative.
Participation at a meeting may be in person,
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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 IPC's offices,
unless otherwise agreed by the Representatives. All Representatives serving on
the D-Committee not in attendance shall be notified in writing immediately of
any action taken or approved by the D-Committee.
2.4. The duties of the D-Committee shall be to:
(1) keep the Parties apprised of any development issues with
respect to the Product and effect a plan of action to resolve same;
(2) monitor the performance and progress of the Development
Plan;
(3) such other matters relating to sub-paragraphs (1)and (2)
above as may be necessary or appropriate to consider.
2.5. If the D-Committee cannot resolve any dispute within its
purview after fifteen (15) days or such other period as may be agreed by the
D-Committee, the dispute will be referred to a designated senior officer of each
of ELITE and IPC, and thereafter, in the event of continued deadlock, will be
resolved pursuant to the deadlock provisions set forth in Section 14.
2.6. COMMERCIALIZATION COMMITTEE At such time as the
D-Committee so recommends, ELITE and IPC shall establish a Commercialization
Committee (the "C-COMMITTEE") comprised of not less than two, and not more than
three, Representatives selected by each Party. ELITE and IPC shall each
designate an equal number of Representatives to the C-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, IPC and ELITE shall retain an equal number of Representatives on the
C-Committee and equal voting rights. The C-Committee shall carry out the duties
set forth below in Section 2.9.
2.7. The first meeting of the C-Committee shall be held
within fifteen (15) days from the date of recommendation for its establishment
by the D-Committee, at which time the procedures of the C-Committee may be
established. Thereafter, the C-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
C-Committee upon at least five (5) days' notice (which notice shall include a
detailed description of all matters to come before the C-Committee at such
meeting for consideration or action). Nothing herein precludes any
Representative for either the D-Committee or the C-Committee from being a
Representative of the other or both committees. Where practical, the D-Committee
and the C-Committee will hold their meetings concurrently.
2.8. At meetings, each Party shall have the right to provide
information for consideration and the C-Committee shall consider all such input.
All decisions by the C-Committee shall be made by unanimous vote of its
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
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taken. A quorum required for any action by the C-Committee shall consist of at
least one ELITE Representative and one IPC 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 IPC's offices, unless otherwise agreed by the
Representatives. All Representatives of the C-Committee not in attendance shall
be notified in writing immediately of any action taken or approved by the
C-Committee.
2.9. The duties of the C- Committee shall be to:
(1) pursue and consider license agreements for the
Commercialization of the Product in the Territory, or in any part thereof, with
any potential Licensee suggested for consideration by either Elite or IPC. The
criteria which the C-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
(2) such other matters relating to paragraph (1) above as
may be necessary or appropriate to consider.
2.10. If the C-Committee cannot resolve any dispute within its
purview after fifteen (15) days or such other period as may be agreed by the
C-Committee, the dispute will be referred to a designated senior officer of each
of ELITE and IPC, 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, with milestones listed, setting
out the specific responsibilities of each of ELITE and IPC 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 reasonable
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, IPC and ELITE
hereby agree to conduct and carry out the activities set forth in Section 3.2,
in the case of IPC and in Section 3.3, in the case of Elite.
3.2. IPC hereby represents and warrants that it has
completed, or agrees that it will complete in accordance with the Development
Plan, certain matters as follows:
(a) IPC has developed and validated 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 written documentation
and reports in relation to these methods;
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(b) IPC has developed formulations and processes for the
manufacture of the Product as required for pilot clinical studies. IPC 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 clinical 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) IPC has managed and overseen the design and the conduct
of successful pilot clinical studies on the Product;
(d) IPC will transfer pharmaceutical analytical methods and
operating procedures relating to the Product to the ELITE facility, and will
provide all reasonable technical and documentary assistance in the transfer and
revalidation process of such methods;
(e) IPC will provide on-site assistance and sufficient
information to designated ELITE personnel to allow ELITE personnel to scale up
the process developed by IPC and to manufacture Product batches for the
additional pilot studies, if any, and the pivotal clinical studies at the ELITE
facility. IPC personnel will be present at the Elite facility and, the Parties
agree, will take an active role in the manufacture of such product batches;
(f) IPC (together with ELITE) will manage and oversee the
design and the conduct of additional pilot clinical 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 IPC and ELITE;
(g) IPC will prepare and file, in the name of IPC, such
patent application(s) on the Product as may be possible, based on IPC's
intellectual property, and take all appropriate steps to receive a grant of such
patent(s) and maintain such patent(s) if granted; and
(h) IPC shall be responsible for the preparation of all
regulatory filings (which shall be filed in IPC'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.
3.3. ELITE hereby agrees that it will complete in accordance
with the Development Plan, certain matters as follows
(a) ELITE will conduct all work reasonably necessary for the
transfer of fully validated pharmaceutical analytical methods (and
implementation thereof) and operating procedures transferred from IPC to the
ELITE facility for the manufacture and release of Product batches for the
Studies;
(b) ELITE will manufacture the Product batches for the
Studies at its premises (whereas, commercial manufacturing shall be as set forth
in Section 6.2);
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(c) 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
IPC, if necessary);
(d) ELITE (together with IPC) will manage and oversee the
design and the conduct of additional pilot clinical studies, if any, and the
pivotal clinical studies for the Product, such studies to be done at the
facilities of such third party CRO as may be acceptable to both Parties;
(e) 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;
(f) ELITE will provide to IPC, for the purposes of
regulatory filing, all necessary documentation and reports in respect of the
manufacture, release and packaging of the Product batches for the pivotal
clinical studies and stability studies; and
(g) ELITE will provide to IPC, for the purposes of
regulatory filing, all other reasonably necessary data, results, documents and
documentary support.
3.4. The Parties shall jointly take the following actions:
(a) The Parties shall agree, as required, as to the identity
of the Party best able to prepare any aspect of any regulatory filing, and each
Party 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. COSTS OF PERFORMING HEREUNDER.
(a) IPC alone will bear the costs for its areas of
responsibilities as set forth in Section 3.2 and ELITE alone will bear the costs
for its areas of responsibilities as set forth in Section 3.3;
(b) IPC and ELITE will share [*] the following costs:
(i) the CRO and other third party costs of all
clinical studies (including pilot studies already completed or to be conducted
after the date hereof), all pivotal studies and all bio-analytics as may
reasonably be required; and
(ii) the cost of all regulatory filing fees for the
regulatory applications to the FDA or to such other regulatory authorities to
whom applications are made.
(c) 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 IPC will
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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.
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 13 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. IPC 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 IPC 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 [*], whether for
itself or any third party.
4.2. ELITE and IPC shall each have the right to discontinue
the Studies at any time prior to completion of such Studies upon 3 days' prior
written notice to the other Party, if ELITE or IPC, as the case may be,
reasonably believes that any serious adverse clinical event may arise.
5. PATENT PROSECUTION, MAINTENANCE AND DEFENSE; OWNERSHIP OF
INTELLECTUAL PROPERTY
5.1. PATENTS. During the Term (including all Renewal Terms),
IPC shall have the sole and exclusive 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.
5.2. INTELLECTUAL PROPERTY. All IPC proprietary information,
Know-How, materials, methods and technology related to the Products including
without limitation, manufacturing information and any related patent
applications and patents owned or controlled by IPC to the extent they cover the
Products or any such information, know-how, materials or technology as applied
to the Product ("IPC INTELLECTUAL PROPERTY RIGHTS") are and shall, in all
events, be the sole and exclusive property of IPC. ELITE and IPC shall take such
actions, and
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execute and deliver such documents, as may be reasonably requested from time to
time by IPC at IPC's expense, to perfect the IPC Intellectual Property Rights.
5.3. IDENTIFICATION OF IPC TECHNOLOGY. At such time as the
Product is commercialized, the Parties agree, as between themselves, that the
Product packaging shall be marked with wording indicating IPC technology (such
as, for example, [*]) subject to the consent of each Licensee.
6. COMMERCIALIZATION OF PRODUCT
6.1. LICENSE. As promptly as is practicable, the C-Committee
shall consider and, where appropriate, approve one or more Licensees suggested
by ELITE or IPC for the Commercialization of the Product in the Territory, such
C-Committee approval not to be unreasonably withheld by the Representatives. IPC
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 C-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. The Parties agree that the
Product will be manufactured by such Person, and at such location, that
maximizes the commercial success of the Product in the marketplace for any
market in the Territory. Nothing herein precludes either IPC or ELITE from
bidding to become such manufacturer for any market, provided only that the issue
of selection of a manufacturing entity should not delay the entry of the Product
into that market.
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: [*] to IPC 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 a
[*] basis as provided above.
(b) To the extent any litigation costs shall have been
equally shared by the Parties 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 first
be divided between the Parties on a [*] basis until such time as such
equally shared litigation costs have been fully recovered by the Parties, and
thereafter shall be divided between the Parties on a [*] basis in accordance
with Section 6.3(a) above. 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
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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
(a) [*]
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(b) INFRINGEMENT CLAIMS. ELITE and IPC shall jointly
investigate and defend any and all claims, actions and proceedings resulting
from an assertion against ELITE or IPC (or a Licensee if ELITE and IPC 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 IPC under
Section 9 hereof, ELITE and IPC shall share [*] in the cost and expenses of the
defense. ELITE and IPC shall be entitled to share [*] all amounts awarded, if
any, in connection with any such enforcement proceeding.
7.3. ENFORCEMENT PROCEEDINGS. ELITE and IPC may jointly bring
enforcement proceeding against any third party if ELITE and IPC determine
jointly that a third-Party is likely materially infringing upon the rights of
ELITE, IPC or a Licensee in the Product. If such enforcement proceedings are
brought jointly, the Parties will share [*] 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 the Parties. Subject
to any circumstance under which a Party declines to participate in any
enforcement proceeding as provided in Section 7.3 above, IPC and ELITE shall
jointly have control of any such litigation, including as regards choice of
counsel and settlement terms.
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8. INSURANCE
8.1. 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. IPC represents and warrants to ELITE, as of the
Effective Date, as follows:
(a) IPC 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 IPC, enforceable against IPC 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) IPC has taken all corporate action required by it to
authorize it to enter into and to perform the Agreement;
(d) IPC has the right to disclose Know-How (and other
IPC Intellectual Property Rights) 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 IPC's knowledge, threatened, against IPC in connection with the Product or
the IPC Intellectual Property Rights;
(f) IPC has good title to all IPC Intellectual Property
Rights, free and clear of all Liens;
(g) IPC 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 and, to the knowledge of
IPC, there is no infringement or unauthorized use by any Person of any of the
IPC Intellectual Property Rights.
(h) there are no agreements between IPC and any third
party that conflict with this Agreement; and
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(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 IPC.
9.2. In respect of the Studies, IPC:
(a) shall, together with ELITE, 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 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 ELITE 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 ELITE, 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 ELITE;
13
(f) will keep ELITE 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); and
(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.
IPC MAKES NO OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, EXCEPT THOSE
EXPRESSLY MADE HEREIN. IPC 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. If a Federal, state or local government or regulatory
authority conducts, or gives notice to IPC of its intent to conduct, an
inspection of the ELITE facility or takes any other regulatory action with
respect to the conduct of the Studies, then IPC shall promptly give ELITE notice
both by telephone and facsimile and supply all information pertinent thereto,
and ELITE shall have an obligation, to be present at any such inspection of its
facilities
9.4 If a Federal, state or local government or regulatory
authority conducts, or gives notice to IPC of its intent to conduct, an
inspection of the facilities where the Studies are being conducted, or takes any
other regulatory action with respect to the conduct of the Studies, then IPC
shall promptly give ELITE notice both by telephone and facsimile and supply all
information pertinent thereto, and ELITE shall have the right, but not the
obligation, to be present at any such inspection of the facilities where the
Studies are being conducted.
9.5. ELITE represents and warrants to IPC, 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;
14
(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; and
(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
9.6. In respect of the manufacture and release of the pivotal
clinical batches and the Studies, ELITE:
(a) will manufacture all 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 IPC 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 IPC 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;
(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 IPC 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.
9.7. 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 IPC and
15
IPC 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 IPC.
10. OBLIGATION OF CONFIDENTIALITY
10.1 The Parties are party to a Confidentiality Agreement,
dated as of July 14, 2003, the term of which is hereby extended to co-incide
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:
(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
16
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 that in the case of Confidential Information of
IPC, such consultants, licensees, agents, prospective licensees and
subcontractors are named by ELITE, and approved by IPC as to the timing and
extent of such disclosure, in advance of such disclosure; 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.
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 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 (other than in the case of
a failure to obtain a satisfactory `freedom to operate' pursuant to Section
7.2(a) in which case there shall be no opportunity to cure such breach).
17
11.3. EFFECT OF TERMINATION. Termination of this Agreement for
any reason shall be without prejudice to:
(a) ELITE's and IPC'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 IPC, 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 IPC of any provision of this Agreement (other than pursuant to
Section 7.2(a) hereof) and the failure of IPC to cure such breach within thirty
(30) days of receipt of written notice by ELITE to IPC of such breach, ELITE
shall continue to receive a [*] 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 IPC:
00 Xxxxxxxxx Xxxx
Xxxxxxx, Xxxxxxx,
00
Xxxxxx X0X 0X0
Attention: Chief Executive Officer
Facsimile: (000)-000-0000
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
IPC 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
IPC.
14.2. If designated senior officers of each of ELITE and IPC
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 either (i) in Ontario in accordance
with the rules of the Arbitration Act (1991) as amended, or (ii) in the State of
New York in accordance with the rules of the American Arbitration Association,
as the Complainant may then choose.
14.3 Where such arbitration is in Ontario, the parties agree
that the Dispute shall be submitted to arbitration (an "Arbitration") by a
single arbitrator (the "Arbitrator") with the Arbitration to take place in the
City of Toronto, pursuant to the provisions of the ARBITRATION ACT, 1991
(Ontario) (the "Arbitration Act"). 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 Court 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 either the State of New Jersey, under the laws of the
19
State of New York, or in the Province of Ontario, under the laws of Ontario, as
the complainant Party may then choose.
15. NON-COMPETITION
15.1 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 of [*].
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 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
20
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 IPC 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.
16.9. All of the obligations, undertakings, agreements,
representations and warranties of ELITE, as set out herein, or in the referenced
CDA of July 14, 2003, are jointly and severally the obligations of each of Elite
Laboratories, Inc., and Elite Pharmaceuticals, Inc.
21
IN WITNESS WHEREOF, ELITE and IPC have executed this Agreement in
duplicate as of the day and year first above written.
ELITE LABORATORIES, INC.
By:
---------------------------------------
Name:
Title:
ELITE PHARMACEUTICALS, INC.
By:
---------------------------------------
Name:
Title:
INTELLI PHARMACEUTICS CORP.
By:
---------------------------------------
Name:
Title:
22
EXHIBIT A
DEVELOPMENT PLAN
Product Development Activity Schedule [*]
[*]
23
