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 COLLABORATION AGREEMENT
THIS PRODUCT COLLABORATION AGREEMENT, made as of November 10, 2006 by
and between ELITE Pharmaceuticals, Inc., a corporation organized and existing
under the laws of Delaware having its principal place of business at 000 Xxxxxx
Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx 00000 ("ELITE") and THEPHARMANETWORK, LLC, a
limited liability company organized and existing under the laws of New Jersey
with a principal place of business at 000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
Xxx Xxxxxx 00000 ("TPN").
RECITALS
WHEREAS, TPN is engaged in the research and development of generic
pharmaceutical products and has accumulated considerable knowledge in the field
of pharmaceutical product development management services.
WHEREAS, ELITE is engaged in the business of research and development,
manufacturing, sales and marketing of oral controlled release products.
WHEREAS, TPN wishes to collaborate with ELITE and provide product
development services including analytical methods development and validation and
formulation of a generic pharmaceutical product in the Territory.
NOW, THEREFORE, in consideration of the mutual covenants contained in
this Agreement, the Parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 DEFINITIONS. Capitalized terms used in this Agreement, whether in the
singular or plural, have the meanings set forth in SCHEDULE 1 which is attached
hereto and made part of this Agreement, or as otherwise specifically defined in
this Agreement.
ARTICLE II
PRODUCT DEVELOPMENT SERVICES
2.1 PROVISION OF DEVELOPMENT SERVICES. During the term of this Agreement, TPN
shall provide the product development services described on SCHEDULE 2 attached
to this Agreement (the "DEVELOPMENT SERVICES") to ELITE and its Collaboration
Parties in connection with the development of the Product. ELITE shall be
responsible for the payment of
ELITE: _____ 1 TPN: _____
* 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.
[*] costs and expenses incurred by the Collaboration Parties in connection with
the active pharmaceutical ingredients. Any and all out-of-pocket costs and
expenses will be split between TPN ([*]%) and ELITE ([*]%); provided, however,
that TPN's share of the out of pocket expenses will accrue and will be recouped
by Elite out of TPN's [*] ([*]%) percent royalty share upon commercialization of
the product. Each party should be responsible for paying its own labor costs.
2.2 PROVISION OF DEVELOPMENT SUPPORT AND COMMERCIALIZATION SERVICE. During
the term of this Agreement, ELITE shall provide the development support and
commercialization services described on SCHEDULE 2 attached to this Agreement
and made a part hereof to TPN in connection with the development support and
commercialization of the Product (the "Support Services"). ELITE shall be
responsible for the payment of [*] costs and expenses incurred by the
Collaboration Parties in connection with the active pharmaceutical ingredients.
Any and all out-of-pocket costs and expenses will be split between TPN ([*]%)
and ELITE ([*]%) provided, however, that TPN's share of the out of pocket
expenses will accrue and be recouped by Elite out of TPN's [*] ([*]%) percent
royalty share upon commercialization of the product.
2.3 ANDA HOLDER. TPN shall be the owner and party of record of all regulatory
filings with respect to the Product, including the ANDA for the Product. ELITE
shall cooperate with TPN and the Collaboration Parties, as TPN reasonably
requires, in preparing such regulatory filings, including, without limitation,
any and all data contained therein.
2.4 IDENTIFICATION OF PRODUCT. Commencing promptly after the execution and
delivery of this Agreement, TPN and ELITE shall work together to determine the
specific synthetic narcotic analgesic drug product from which a generic
equivalent shall be developed as the Product. TPN and ELITE shall discuss, in
good faith, each synthetic narcotic analgesic drug product suggested by a party
and use commercially reasonable efforts to agree upon the specific synthetic
narcotic analgesic drug product from which a generic equivalent shall be
developed within sixty (60) days of the date hereof, unless such period is
otherwise extended by the mutual consent of the parties.
ARTICLE III
COMPENSATION
3.1 DEVELOPMENT PAYMENTS. ELITE shall, within thirty (30) days after receipt
of written notice from TPN of the completion of each milestone specified in
SCHEDULE 3 hereto, make the payment to TPN which is payable upon completion of
such milestone.
3.2 ROYALTY PAYMENTS TO TPN. ELITE shall, within thirty (30) days after
receipt of royalty payments from the Marketing Partner (selected pursuant to
Section 4.2 hereof) with respect to sale of the Product remit to TPN an amount
equal to [*] percent ([*]%) of the royalty payment received. Royalty payments
due to TPN shall continue with respect to the Product
ELITE: _____ 2 TPN: _____
* 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.
during the term of this Agreement. If ELITE later determines that any royalty
payment was miscalculated for any reason whatsoever, ELITE shall pay to TPN the
amount that should have been paid to TPN pursuant to this Agreement but was not
paid, and TPN shall pay to ELITE any amount that was paid to TPN pursuant to
this Agreement but should not have been paid. Any payment required to be made
pursuant to a subsequent recalculation (if any) shall be made within thirty (30)
days of the paying party's receipt of written notice of the recalculated amount.
3.3 RECORDS AND AUDIT. ELITE shall keep full, true and accurate books of
account containing all particulars with respect to royalty payments received
from the Marketing Partner for the purpose of showing the amounts payable to TPN
hereunder. Such books of accounts shall be kept at ELITE's principal place of
business. During the term of this Agreement and for one (1) year after its
termination or expiration, such books and the supporting data shall be available
at ELITE's principal place of business, at mutually acceptable times and upon
reasonable prior written notice during normal business hours for inspection by a
firm of certified public accountants selected by TPN and acceptable to ELITE,
which consent shall not be unreasonably withheld for the purpose of verifying
ELITE's royalty statements; PROVIDED, HOWEVER, that such examination shall not
take place more often than once each calendar year and shall not cover more than
the preceding three (3) years, with no right to audit any previous period. The
cost of inspection is to be paid by TPN. All information provided to TPN or its
accountants pursuant to this Section 3.3 shall be subject to the MCA referenced
in Article V. If requested by ELITE, the accounting firm designated by TPN shall
be required to execute a confidentially agreement containing terms and
conditions substantially equivalent to those provided in the MCA.
ARTICLE IV
MANUFACTURING, PACKAGING, DELIVERY AND DISTRIBUTION
4.1. MANUFACTURING; PACKAGING & DELIVERY Following ANDA approval, ELITE shall
manufacture the Product on [*] in accordance with the terms and conditions of
the Marketing Partner Agreement.
4.2 LICENSE FOR DISTRIBUTION The Parties shall mutually select a third party
for distribution of the Product in the territory (the "Marketing Partner").
ARTICLE V
CONFIDENTIALITY
ELITE and TPN acknowledge that the Mutual Confidentiality Agreement
between the Parties dated as of the Effective Date of this Agreement (the "MCA")
is in full force and effect as provided therein. A copy of the MCA is appended
to, and is hereby incorporated into and made a part of, this Agreement as
SCHEDULE 4. No Party shall make any press release regarding this Agreement or
the Product that names the other Party without the written consent of such other
Party.
ELITE: _____ 3 TPN: _____
* 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.
ARTICLE VI
DISCLAIMERS, REPRESENTATIONS, WARRANTIES AND INDEMNIFICATIONS
6.1 TPN REPRESENTATIONS, WARRANTIES AND COVENANTS. TPN represents and
warrants to and covenants with ELITE as follows:
6.1.1 COMPANY EXISTENCE AND AUTHORITY. As of the Effective Date, TPN:
(a) is a limited liability company duly organized, validly existing and
in good standing under the laws of the State of New Jersey in which it is
formed, (b) has full company power and authority and the legal right to
own and operate its property and assets and to carry on its business as
it is now being conducted and as contemplated in this Agreement,
including the right to grant the license granted hereunder, (c) has the
company power and authority and the legal right to enter into this
Agreement and perform its obligations hereunder, (d) has taken all
necessary company action on its part required to authorize the execution
and delivery of the Agreement and the performance of its obligations
hereunder, and (e) has delivered this Agreement, which has been duly
executed and constitutes a legal, valid, binding obligation of TPN and is
enforceable against it in accordance with its terms.
6.1.2 COMPLIANCE WITH LAWS. In carrying out its work under this
Agreement, all TPN work shall be carried out in compliance with any
applicable laws including, without limitation, federal, state, or local
laws, regulations, or guidelines governing the work at the site where
such work is being conducted.
6.1.3 NO DEBARMENT. TPN will comply at all times with the provisions
of the Generic Drug Enforcement Act of 1992 and will upon request certify
in writing to ELITE that none of its employees nor any person providing
services to TPN in connection with the Collaboration have been debarred
under the provisions of such Act.
6.1.4 NO ACTIONS. TPN has not taken nor will it take any action, which
would, in TPN' s good faith judgment, interfere with the performance of
any obligations of TPN set forth in this Agreement.
6.2 ELITE REPRESENTATIONS, WARRANTIES AND COVENANTS. ELITE represents and
warrants to and covenants with TPN as follows:
6.2.1 CORPORATE EXISTENCE AND AUTHORITY. As of the Effective Date,
ELITE: (a) is a corporation duly organized, validly existing and in good
standing under the laws of Delaware, (b) has full corporate power and
authority and the legal right to own and operate its property and assets
and to carry on its business as it is now being conducted and as
contemplated in this Agreement, including the right to grant license
granted hereunder, (c) has the corporate power and authority and the
legal right to enter into this Agreement and perform its obligations
hereunder, (d) has taken all necessary corporate action on its part
required to authorize the execution and delivery of the
ELITE: _____ 4 TPN: _____
* 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.
Agreement and the performance of its obligations hereunder, and (e) has
delivered this Agreement, which has been duly executed and constitutes a
legal, valid, binding obligation of ELITE and is enforceable against it
in accordance with its terms.
6.2.2 COMPLIANCE WITH LAWS. In carrying out its work under this
Agreement, all ELITE work shall be carried out in compliance with any
applicable laws including, without limitation, federal, state, or local
laws, regulations, or guidelines governing the work at the site where
such work is being conducted.
6.2.3 NO DEBARMENT. ELITE will comply at all times with the provisions
of the Generic Drug Enforcement Act of 1992 and will upon request certify
in writing to TPN that none of its employees nor any person providing
services to ELITE in connection with this Collaboration or this Agreement
have been debarred under the provisions of such Act.
6.2.4 NO ACTIONS. ELITE has not taken nor will it take any action,
which would, in ELITE's good faith judgment, interfere with the
performance of any obligations of ELITE set forth in this Agreement.
6.3 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Without
limiting the generality of the foregoing, each Party expressly does not warrant
(a) the success of any research and development undertaken pursuant to this
Agreement, (b) the safety for any purpose of the technology it provides
hereunder or (c) that the Product will be successfully marketed following its
approval for commercial sale.
6.4 TPN'S RIGHT TO INDEMNIFICATION. ELITE shall indemnify each of TPN, its
Affiliates, permitted successors and assigns, and the directors, officers,
employees, agents and counsel thereof (the "TPN INDEMNITEES"), and defend and
hold each TPN Indemnitee harmless from and against any and all liabilities,
damages, losses, settlements, claims, actions, suits, penalties, fines, costs or
expenses (including, without limitation, reasonable attorneys' fees) (any of the
foregoing, "DAMAGES") incurred by or asserted against any TPN Indemnitee of
whatever kind or nature, including, without limitation, any claim or liability
based upon negligence, warranty, strict liability or violation of government
regulation arising out of or relating to: (a) any breach of or failure to
perform any representation, warranty or covenant made by ELITE pursuant to this
Article V; (b) any material breach of this Agreement by ELITE; or (c) the use,
handling, storage, sale or other disposition of the Product that is sold by
ELITE, its Affiliates or agents following receive of approval for the commercial
sale of the Product; except, in each such case in subparagraphs (a) through (c)
above, to the extent that such Damages result from the negligence or misconduct
of a TPN Indemnitee or TPN's breach of or failure to perform any representation,
warranty or covenant under Section 6.1.
ELITE: _____ 5 TPN: _____
* 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.
6.5 ELITE'S RIGHT TO INDEMNIFICATION. TPN shall indemnify each of ELITE, its
Affiliates, successors and assigns, and the directors, officers, employees,
agents and counsel thereof (the "ELITE INDEMNITEES"), and defend and hold each
ELITE Indemnitee harmless from and against any and all Damages incurred by or
asserted against any ELITE Indemnitee of whatever kind or nature, including,
without limitation, any claim or liability based upon negligence, warranty,
strict liability or violation of government regulation arising out of or
relating to: (a) any breach of or failure to perform any representation,
warranty or covenant made by TPN pursuant to this Article V or (b) any material
breach of this Agreement by TPN; except, in each such case, in subparagraphs (a)
and (b) above, to the extent that such Damages result from the negligence or
misconduct of a ELITE Indemnitee or ELITE's breach of or failure to perform any
representation or warranty under Section 6.2.
6.6 INDEMNIFICATION PROCEDURES WITH RESPECT TO THIRD PARTY CLAIMS. Promptly
after a Party entitled to indemnification under Section 6.4 or 6.5 (an
"INDEMNITEE") receives notice of any pending or threatened claim against it (an
"ACTION"), such Indemnitee shall give written notice to the Party to whom the
Indemnitee is entitled to look for indemnification pursuant to Section 6.4 or
6.5, as applicable (the "INDEMNIFYING PARTY"), of the commencement thereof,
provided that the failure so to notify the Indemnifying Party shall not relieve
it of any liability that it may have to any Indemnitee hereunder, except to the
extent the Indemnifying Party demonstrates that it is prejudiced thereby. In
case any Action that is subject to indemnification under this Article V shall be
brought against an Indemnitee and it shall give written notice to the
Indemnifying Party of the commencement thereof, the Indemnifying Party shall be
entitled to participate therein and, if it so desires, to assume the defense
thereof with counsel reasonably satisfactory to such Indemnitee and, after
notice from the Indemnifying Party to the Indemnitee of its election to assume
the defense thereof, the Indemnifying Party shall not be liable to such
Indemnitee under this Article V for any fees of other counsel or any other
expenses, in each case subsequently incurred by such Indemnitee in connection
with the defense thereof, other than reasonable costs of investigation.
Notwithstanding an Indemnifying Party's election to assume the defense of any
such Action that is subject to indemnification under this Article V, the
Indemnitee shall have the right to employ separate counsel and to participate in
the defense of such Action, and the Indemnifying Party shall bear the reasonable
fees, costs and expenses of such separate counsel if: (i) the use of counsel
chosen by the Indemnifying Party to represent the Indemnitee would present such
counsel with a conflict of interest; (ii) the actual or potential defendants in,
or targets of, any such Action include both the Indemnifying Party and the
Indemnitee, and the Indemnitee shall have reasonably concluded that there may be
legal defenses available to it which are different from or additional to those
available to the Indemnifying Party (in which case the Indemnifying Party shall
not have the right to assume the defense of such Action on the Indemnitee's
behalf); (iii) the Indemnifying Party shall not have employed counsel reasonably
satisfactory to the Indemnitee to represent the Indemnitee within a reasonable
time after notice of the institution of such Action; or (iv) the Indemnifying
Party shall authorize the Indemnitee to employ separate counsel at the
Indemnifying Party's expense. If an Indemnifying Party assumes the defense of
such Action, no compromise or settlement thereof may be effected by the
Indemnifying Party without the Indemnitee's written consent, which consent shall
not be unreasonably withheld or delayed,
ELITE: _____ 6 TPN: _____
* 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.
unless (1) there is no finding or admission of any violation of law or any
violation of the rights of any other Party and no effect on any other claims
that may be made against the Indemnitee and (2) the sole relief provided is
monetary damages that are paid in full by the Indemnifying Party. Unless the
Parties shall otherwise agree, or unless there shall be a finding of liability
of either Party to the other, the Parties shall be jointly liable with respect
to the claims of any third Party claims.
6.7 LIMITATION ON DAMAGES. Notwithstanding any provision of this Agreement to
the contrary, neither Party shall be entitled in connection with any breach or
violation of this Agreement to recover any punitive, exemplary or other special
damages or any indirect, incidental or consequential damages, including without
limitation damages relating to loss of profit, business opportunity or business
reputation. Each Party, as a material inducement to the other Party to enter
into and perform its obligations under this Agreement, hereby expressly waives
its right to assert any claim relating to such damages and agrees not to seek to
recover such damages in connection with any action, suit or proceeding relating
to this Agreement. The foregoing shall not limit the right of any person
entitled to indemnification in accordance with the provisions of this Article V
with respect to all components of any claim, award or judgment against such
person by any unaffiliated third party.
6.8 EXCLUSIVE REMEDY. In the absence of fraud or the intentional breach of
this Agreement, the indemnification provisions contained in this Article VI
shall constitute the sole and exclusive recourse and remedy of the Parties for
monetary damages arising out of any breach or violation of any of the
representations, warranties, covenants or agreements contained in this
Agreement. Nothing herein shall be deemed to limit the right of either Party to
seek injunctive or other equitable relief in connection with the failure of the
other Party to perform any covenant or agreement contained in this Agreement.
ARTICLE VII
INTELLECTUAL PROPERTY
7.1 TPN OWNERSHIP OF INTELLECTUAL PROPERTY. TPN shall own sole and exclusive
ownership of, and all right, title, and interest in and to all developments,
improvements and enhancements thereof conceived of or made by TPN or any of its
employees or agents to the Product during the term of this Agreement. The ANDA
shall be filed in the name of TPN and shall be owned by TPN.
7.2 LICENSE OF ANDA. TPN shall license the right to manufacture, use and sell
the Product to ELITE, subject to Elite maintaining required compliance with all
regulatory agencies having jurisdiction over the Product.
ELITE: _____ 7 TPN: _____
* 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.
ARTICLE VIII
TERM AND TERMINATION
8.1 TERM OF COLLABORATION. This Agreement shall become effective on the
Effective Date and shall continue in effect for a period of fifteen (15) years
from the date of first commercial sale of the Product unless terminated in
accordance with this Article VIII. The Parties hereto may agree, by written
consent signed by both Parties, to renew this Agreement for an additional five
(5) year term (or such longer or shorter period of time as the Parties may agree
in writing).
8.2 TERMINATION FOR BREACH. Either Party may terminate this Agreement by
notice to the other Party at any time during the term of this Agreement if the
other Party is in breach of any material obligations hereunder and has not cured
such breach within ninety (90) days after notice requesting cure of the breach
or such longer period of time as is required to cure such breach as long as the
breaching Party is proceeding in good faith to cure; provided, however, that in
any case when a breach is alleged regarding the payment of money hereunder, the
time period will be thirty (30) days and undisputed amounts must be paid prior
to such time to avoid breach. Upon material breach by a Party of its obligations
hereunder, if such Party decides not to terminate this Agreement, such Party
shall have the right to offset any costs it may incur as a result of curing such
breach against the amounts payable to the breaching Party for the performance of
such obligations.
8.3 TERMINATION UPON INSOLVENCY.
8.3.1 VOLUNTARY PROCEEDING. In the event that a Party shall (1)
voluntarily commence any proceeding or file any petition seeking relief
under any federal, state or local bankruptcy, insolvency, liquidation,
receivership or similar law (a "BANKRUPTCY LAW"); (2) consent to the
institution of, or fail to intervene in a timely and appropriate manner,
any such proceeding or the filing of any such petition; (3) apply for or
consent to the appointment of a receiver, trustee, custodian,
sequestrator or similar official for such Party or for a substantial part
of its property or assets; (4) file an answer admitting the material
allegations of a petition filed against it in any such proceeding; or (5)
make a general assignment for the benefit of creditors, the other Party,
at its sole option, may terminate this Agreement at any time by delivery
of written notice of termination to the party subject to such event.
8.3.2 INVOLUNTARY PROCEEDING. In the event that a Party shall be
subject to the commencement of any involuntary proceeding or the filing
of any involuntary petition in a court of competent jurisdiction seeking
(1) relief in respect of such Party or of a substantial part of any of
its property or assets under any Bankruptcy Law; (2) the appointment of a
receiver, trustee, custodian, sequestrator, or similar official for such
Party or for a substantial part of its property or assets; or (3) the
winding-up or liquidation of such Party, and such proceeding or petition
shall continue undismissed for one hundred twenty (120) days or an order
or decree approving or ordering any of the foregoing shall continue
unstayed and in effect for sixty (60) days, the other Party, at its sole
option, may terminate this Agreement at any time by delivery of written
notice of termination to the party subject to such event.
ELITE: _____ 8 TPN: _____
* 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.
8.4 ADDITIONAL TERMINATION RIGHTS. The Agreement shall be terminated if ELITE
and TPN mutually determine that due to changes in the market for the Product,
including the costs of obtaining the active drug substance and the Product, the
introduction of competitive products and changes in the reimbursement policies
of third party payors, it is not economically viable to market, distribute and
sell the Product.
8.5 ACCRUED RIGHTS/SURVIVING OBLIGATIONS. Except as expressly provided in
this Agreement, expiration or termination of this Agreement will not relieve the
Parties of any obligation that accrued prior to such expiration or termination.
Upon expiration or early termination of this Agreement, all rights and
obligations of the Parties shall cease, except as follows:
(a) The obligations to pay sums accruing hereunder up to the date of
termination or expiration shall survive;
(b) The obligations of ELITE, pursuant to Section 3.2 hereof, to
remit to TPN [*] ([*]%) percent of royalties received shall
survive;
(c) The obligations of confidentiality set forth in Article V shall
survive;
(d) TPN's obligations under Article VII shall survive;
(e) The obligations for record keeping and accounting reports set
forth in Article III shall survive for so long as the Product is
sold. At such time after termination or expiration of this
Agreement when sales or other dispositions of Product has
ceased, ELITE shall render a final report along with any royalty
payments due;
(f) TPN's rights to inspect books and records as described in
Article III shall survive;
(g) Any cause of action or claim of TPN or ELITE accrued or to
accrue because of any breach or default by the other Party
hereunder shall survive; and
(h) All other terms, provisions, representations, rights and
obligations contained in this Agreement that are intended to
survive as specifically set forth elsewhere in this Agreement
shall survive.
ARTICLE IX
MISCELLANEOUS
9.1 FORCE MAJEURE. No Party will be held liable or responsible to the other
Party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of the Agreement (except
payment obligations) when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party including,
ELITE: _____ 9 TPN: _____
* 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.
but not limited to, fire, flood, embargo, war, acts of war (whether war be
declared or not), acts or terrorism, insurrection, riot, civil commotion,
strike, lockout or other labor disturbance, act of God or act, omission or delay
in acting by any governmental authority or the other Party. The affected Party
will notify the other Party of such force majeure circumstances as soon as
reasonably practical and will use its commercially reasonable efforts to remedy
such circumstances as soon as practicable.
9.2 ASSIGNMENT. This Agreement may not be assigned or otherwise transferred,
nor, except as expressly provided hereunder, may any right or obligations
hereunder be assigned or transferred, by a Party without the written consent of
the other Party; provided, however, that either Party may, without such consent,
assign the Agreement and its rights and obligations hereunder to (i) any
Affiliate or (ii) to any successor by merger or sale of substantially all of its
business unit to which this Agreement relates, or in the event of its merger or
consolidation or change in control or similar transaction. This Agreement shall
be binding upon the permitted successors and permitted assigns of the Parties.
Any assignment not in accordance with this Section 9.2 shall be void.
9.3 SEVERABILITY. In the event that any of the provisions contained in this
Agreement are held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions contained
herein will not in any way be affected or impaired thereby, unless the absence
of the invalidated provision(s) adversely affect the substantive rights of the
Parties. The Parties will replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s), which, insofar as
practical, implement the purposes of this Agreement.
9.4 NOTICES. All notices or other communications which are required or
permitted hereunder will be in writing and deemed to be effective (a) on the
date of delivery if delivered in person and written confirmation of delivery is
provided, (b) on the date sent by facsimile or other electronic transmission,
provided such receipt is verified, (c) on the day following date of deposit with
an overnight courier if a receipt confirming delivery by overnight courier is
provided, or (d) five days after mailing if mailed by first-class certified
mail, postage paid, to the respective addresses given below, or to another
address as it will designate by written notice given to the other Party.
IF TO TPN, TO:
ThePharmaNetwork, LLC
000 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxxxxx X. Rome/ President & CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
ELITE: _____ 10 TPN: _____
* 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.
WITH A COPY (WHICH SHALL NOT CONSTITUTE NOTICE) TO:
Attention: Xxxxx Xxxxxxxxx, Esq./Director
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
IF TO ELITE, TO:
ELITE Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxxxx Xxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
WITH A COPY (WHICH SHALL NOT CONSTITUTE NOTICE) TO:
Reitler Xxxxx & Xxxxxxxxxx, LLC
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention:Xxxxx Xxxxxxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
9.5 DISPUTE RESOLUTION. In the event of any controversy or claim arising from
or relating to any provision of this Agreement, or any term or condition hereof,
or the performance by a Party of its obligations hereunder, or its construction
or its actual or alleged breach, the Parties will try to settle their
differences amicably between themselves. If the Parties are not able to resolve
such dispute within such thirty (30) day period, then the Parties shall initiate
arbitration on an expedited basis before one arbitrator in New York City, New
York in accordance with the then effective Commercial Arbitration Rules of the
American Arbitration Association (the "AAA"). The arbitration shall be
administered by AAA, or its successor, pursuant to its Commercial Arbitration
Rules, and judgment on the award rendered by the arbitrator may be entered in
any court of competent jurisdiction. The arbitrator will have no authority to
award punitive or other damages not measured by the prevailing party's actual
damages, except as may be required by statute. The arbitrator shall award to the
prevailing party, if any, as determined by the arbitrator, all of such
prevailing party's costs and fees. In absence of a determination of a prevailing
party, the Parties shall split equally all expenses of the arbitration and shall
bear their own attorneys', expert, and witness fees and costs. The decision and
award of the arbitrator shall be accompanied by a reasoned opinion and shall be
enforceable in any court of competent jurisdiction. The foregoing shall not
limit the right of either Party to commence litigation before any court of
competent jurisdiction for the purpose of obtaining specific performance or
other equitable remedies in connection with the enforcement of this Agreement,
to maintain the status quo between the Parties pending the commencement of
arbitration proceedings as provided herein, or in connection with any claim for
indemnification,
ELITE: _____ 11 TPN: _____
* 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.
contribution or other relief in connection with this Agreement with respect to
any claim, action, suit or proceeding involving an unaffiliated third party.
9.6 CHOICE OF LAW. This Agreement will be governed by and construed in
accordance with the laws of the State of New York and the United States without
reference to any rules of conflict of laws.
9.7 ENTIRE AGREEMENT. This Agreement (including all Schedules hereto),
constitutes the entire agreement between the Parties with respect to the subject
matter hereof, and supersedes all previous arrangement with respect to the
subject matter hereof, whether written or oral. Any amendment or modification to
this Agreement shall be made in writing signed by both Parties.
9.8 HEADINGS. The captions to the several Articles and Sections hereof are
not a part of the Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
9.9 INDEPENDENT CONTRACTORS. It is expressly agreed that the Parties will be
independent contractors and that the relationship between the Parties will not
constitute a partnership, joint venture or agency. No Party will have the
authority to make any statements, representations or commitments of any kind, or
to take any action, which will be binding on the other Party, without the prior
consent in writing of such other Party.
9.10 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of the Agreement.
9.11 WAIVER. The waiver by a Party hereto of any right hereunder or the
failure to perform or of a breach by another Party will not be deemed a waiver
of any other right hereunder or of any other breach or failure by said other
Party whether of a similar nature or otherwise.
9.12 JOINTLY PREPARED. This Agreement has been prepared jointly and shall not
be strictly construed against either Party.
9.13 COUNTERPARTS. This Agreement may be executed in two or more counterparts,
each of which will be deemed an original, but all of which together will
constitute one and the same instrument.
9.14 EXHIBITS. The exhibits, schedules and appendices listed below, as the
same may be amended from time to time pursuant to this Agreement, are hereby
incorporated within and made a part of this Agreement:
ELITE: _____ 12 TPN: _____
* 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.
Schedule 1 Definition of Terms
Schedule 2 Roles and Responsibilities of TPN and ELITE
Schedule 3 Payments upon Milestone Achievement
Schedule 4 Mutual Confidentiality Agreement
ELITE: _____ 13 TPN: _____
* 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.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
Effective Date
ELITE PHARMACEUTICALS, INC.,
a Delaware corporation
By: /s/ Xxxxxxx Xxxx
--------------------------------
Name: Xxxxxxx Xxxx
Title: President
Date: November 10, 2006
--------------------------------
THEPHARMANETWORK, LLC,
a New Jersey limited liability company
By: /s/ Xxxxxxxxx Rome
--------------------------------
Xxxxxxxx X. Rome
President/CEO
Date: November 10, 2006
--------------------------------
ELITE: _____ 14 TPN: _____
* 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.
SCHEDULE 1
DEFINITION OF TERMS
"AFFILIATE" means any person, organization, corporation or other business entity
that controls, directly or indirectly, the power to direct, or cause the
direction of, the management and policies of another person, organization,
corporation or entity, whether through the ownership of voting securities or by
contract or court order or otherwise. For purposes of this definition, an entity
will be deemed to control another entity if it owns or controls, directly or
indirectly, at least fifty percent (50%) of the outstanding voting stock or
other voting rights entitled to elect directors or their equivalent of such
other entity.
"ANDA" means an Abbreviated New Drug Application as defined in 21 C.F.R. 314 and
any versions thereof governing the FDA as may be amended from time to time.
"COLLABORATION" means, collectively, the development, manufacturing, supply and
commercialization of the generic equivalent of Product.
"COLLABORATION PARTIES" means supplier of the active pharmaceutical ingredient
for use in the manufacture of the Product and marketing partner for the Product.
"COST OF GOODS SOLD" means costs of supplying Product calculated in accordance
with a Party's accounting methods consistently applied which methodology shall
be calculated in compliance with GAAP.
"EFFECTIVE DATE" means the last date on which the last Party executes this
Agreement.
"FDA" means the United States Food and Drug Administration or any successor
agency having the administrative authority to regulate the approval for
marketing of new human pharmaceutical or biological therapeutic products in the
United States.
"FIRST COMMERCIAL SALE" means with respect to the Product the first sale to an
unaffiliated third party by the designated marketing company. First Commercial
Sale shall not include transfer of reasonable quantities of any free samples of
Product or reasonable quantities of Product solely for development purposes,
such as for use in experimental studies or clinical trials.
"GROSS PROFIT" means Net Sales less Cost of Goods Sold.
"NET SALES" means, with respect to sales of the Product, the gross amount
invoiced by the Marketing Partner or its Affiliates to unaffiliated third
parties purchasing the Product, less the following items to the extent and
provided that such items are actually incurred:
(a) trade, cash, quantity and promotional discounts which
effectively reduce the net selling price;
ELITE: _____ i TPN: _____
* 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.
(b) excise, sales, value added or other taxes imposed upon and paid
with respect to such sales (excluding taxes based on income);
(c) freight, insurance and other transportation charges reasonably
incurred by the Marketing Partner in shipping the Product to
third parties and included in the amount invoiced to such third
parties and amounts repaid or credited by reason of rejections,
defects, recalls or returns or retroactive price reductions, all
as consistent with customary industry practice; and
(d) all charge back payments, discounts and rebates (whether
mandated or otherwise) granted to managed health care
organizations or to federal, state and local governments, their
agencies, and purchasers and reimbursers or to trade customers,
including but not limited to, wholesalers and chain and pharmacy
buying groups and charge back payments, discounts and rebates
(whether mandated or otherwise) charged by national or local
government.
Net Sales shall be determined from the books and records of the Marketing
Partner, maintained in accordance with GAAP, consistently applied. Net Sales
excludes:
(i) The transfer of reasonable and customary quantities of free
sample of Product and the transfer of Product as clinical trial
materials, other than for subsequent resale;
(ii) Sales or transfers of Product among a Party and its Affiliates
unless the receiving Party is the consumer or user of the Product;
and
(iii) Use by a Party of Product in connection with the securing of
regulatory approval or validating of a manufacturing process or the
obtaining of other necessary marketing approvals for Product (unless
such Product is subsequently sold).
"PARTY" means ELITE or TPN.
"PARTIES" means ELITE and TPN.
"PRODUCT" means the drug product to be mutually agreed upon by the parties that
is a generic equivalent of a synthetic narcotic analgesic drug product.
"TERRITORY" means United States of America.
ELITE: _____ ii TPN: _____
* 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.
SCHEDULE 2
ROLES AND RESPONSIBILITIES OF TPN AND ELITE
I. The strategic direction and day-to-day management of the Collaboration
until the successful scale up of the submission batch shall be the
responsibility of TPN. TPN responsibilities include the following (the
"Development Services"):
(a) to perform the completion of methods development, validation,
formulation and transfer of technology to designated Elite
personnel;
(b) to prepare and file the ANDA in the name of TPN for the Product
with the FDA and any and all pre-and post approval regulatory
inquiries, audit or investigations pertinent to the ANDA.
(c) to identify, evaluate, and provide a source for active and
inactive pharmaceutical ingredients for the Product;
II. The strategic direction and day-to-day management of the Collaboration
during the commercialization period and provision of development support shall
be the responsibility of ELITE. ELITE's responsibilities include the following
(the "Support Services"):
(a) to directly purchase active pharmaceutical ingredients,
excipient and any and all materials and supplies required to manufacture
the batch;
(b) to provide reasonably adequate facilities to TPN for use in its
development efforts particularly method validation, process scale-up,
validation batches, preparation and filing of ANDA and responses to FDA
letters and inspections;
(c) to perform commercial production and product launch at [*]
thereof;
III. ELITE and TPN shall be mutually responsible to:
(a) review and approve the use of any Collaboration Parties during
the development period;
(b) periodically review the progress and results of the
Collaboration to ensure that TPN and ELITE are meeting their commitments
for both milestones and financial support and are each fulfilling all of
their respective contractual obligations;
(c) jointly identify, evaluate and select the Marketing Partner for
the Product with ELITE.
ELITE: _____ i TPN: _____
* 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.
SCHEDULE 3
PAYMENTS UPON MILESTONE ACHIEVEMENT
ELITE shall make payments for the Development Services provided by TPN
pursuant to the Agreement at the completion of the Milestones for each of the
Products, as set forth below:
------------------------------- ------------------------------- -------------------------------
PRODUCT MILESTONE PAYMENT TO TPN
------------------------------- ------------------------------- -------------------------------
1. Upon receipt of API $[*] within 30 days
The drug product to be
mutually agreed upon by ------------------------------- -------------------------------
the parties that is a generic 2. Filing of ANDA $[*] within 30 days
equivalent of a synthetic
narcotic analgesic drug ------------------------------- -------------------------------
product 3. Approval of ANDA $[*]
------------------------------- -------------------------------
TOTAL $[*]
------------------------------- ------------------------------- -------------------------------
ELITE: _____ i TPN: _____
* 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.
SCHEDULE 4
MUTUAL CONFIDENTIALITY AGREEMENT
ELITE: _____ i TPN: _____
MUTUAL CONFIDENTIAL AGREEMENT
This MUTUAL CONFIDENTIAL AGREEMENT ("CDA") is made as of ___________, 2006
(EFFECTIVE DATE") by and among THEPHARMANETWORK, LLC, a limited liability
company formed under the laws of New Jersey having a principal office located at
000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxx Xxxxxx 00000 ("TPN)" and ELITE
PHARMACEUTICALS, INC., a company formed under the laws of the State of Delaware
having a principal office located at Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx 00000
("ELITE") (each individually a "PARTY", collectively the "PARTIES).
1. BUSINESS PURPOSE: Pursuant to entering into a contemplated product
opportunity discussions between the parties (the "Business Purpose"), each party
or its affiliates, parent companies, subsidiaries, divisions or related
companies (the "DISCLOSING PARTY") may disclose to the other party or its
affiliates, parent companies, subsidiaries, divisions or related companies (the
"RECEIVING PARTY") certain confidential information of such party to be used
only for the Business Purpose, and the Receiving Party agrees to protect such
information from unauthorized use and disclosure.
2. CONSIDERATION: In consideration of the mutual disclosure of such
information by the parties pursuant to the Business Purpose, both parties agree
to be bound by the terms of this CDA.
3. INFORMATION COVERED: This CDA will apply to all information disclosed by
the Disclosing Party (or on the Disclosing Party's behalf) to the Receiving
Party, whether directly or indirectly, in writing, orally, electronically or by
drawings or inspection of equipment, products, facilities, software or other
property of the Disclosing Party, including, but not limited to, (a) any
information, regardless of form, proprietary to or maintained in confidence by
the Disclosing Party, including, without limitation, any information, patents,
patent applications, technical data or know-how relating to products,
formulations, manufacturing, discoveries, ideas, inventions, concepts, software,
equipment, designs, drawings, specifications, techniques, processes, systems,
models, data, source code, object code, documentation, diagrams, flow charts,
research, development, business plans or opportunities, business strategies,
marketing plans or opportunities, marketing strategies, future projects or
products, projects or products under consideration, procedures, sales data, and
information related to finances, costs, prices, suppliers, vendors, licensors,
licensees, business partners, customers, consumers and employees; and (b) any
other information marked as confidential or, if not disclosed in writing,
identified as confidential at the time of disclosure and summarized in a written
document that is marked confidential and delivered within thirty (30) days after
the disclosure date ("CONFIDENTIAL INFORMATION"). In the event that Confidential
Information is disclosed orally by the Disclosing Party, and not reduced to
writing and communicated to the Receiving Party within thirty (30) days
following such oral disclosure, the burden or proof shall be on the Disclosing
Party to demonstrate the confidential nature and extent of such oral disclosures
if it wishes to enforce any obligation of confidentiality.
4. OBLIGATIONS: The parties agree that (a) the Receiving Party will treat all
Confidential Information with the same degree of care as the Receiving Party
accords to its own confidential information, but in no case less than reasonable
care; (b) the Receiving Party will not use, disseminate, or in any way disclose
any Confidential Information, except to its personnel or authorized
representatives to the extent such persons have a specific need to know such
information necessary for the Business Purpose, and for any other purpose the
Disclosing Party may hereafter authorize, provided that all such persons shall
have agreed in writing to be bound by terms and conditions substantially similar
to, and no less restrictive with respect to limitations on use and disclosure
than, those of this CDA; and (c) the Receiving Party will deliver to the
Disclosing Party, within five (5) days following the receipt of a written
request by the Disclosing Party, all tangible embodiments of the Confidential
Information including copies, notes, packages, pictures, diagrams, computer
memory media, and all other materials reflecting or containing Confidential
Information with a certification of its return, except that the Receiving Party
may retain one (1) complete record copy for archival purposes to confirm
compliance with this CDA. In particular, each party understands that the other
party's Confidential Information may be considered material, non-public
information under U.S. federal and state securities laws and other securities
laws and either party could be found to be in violation thereof if it takes
advantage of such information by (a) trading in the other party's or any other
party's stock based on Confidential Information, or (b) furnishing information
to others in connection with the trading of such stock.
5. TERM: This CDA is effective as of the Effective Date indicated above and
shall terminate on the later of (a) the date on which the parties are not longer
interested in pursuing the Business Purpose; or (b) fifth (5th) anniversary of
the Effective Date, except that the obligations set forth in Section 4 above
with respect to Confidential Information disclosed prior to such termination
shall survive the termination of this agreement.
--------------------------------------------------------------------------------
6. INFORMATION NOT COVERED: The Receiving Party will have no obligation with
respect to any portion of the Disclosing Party's Confidential Information that
(a) is now, or hereafter becomes, through no act or failure to act on the part
of the Receiving Party, generally known or available to the public; (b) was
acquired by the Receiving Party before receiving such information from the
Disclosing Party and without restriction as to use or disclosure as evidenced by
written record; (c) is hereafter rightfully furnished to the Receiving Party by
a third party, without restriction as to use or disclosure; (d) is information
which the Receiving Party can document was independently developed by it or on
its behalf without reference to the Disclosing Party's Confidential Information
received hereunder; or (e) is disclosed with the prior written consent of the
Disclosing Party. The Receiving Party may disclose the Confidential Information
pursuant to the requirements of a governmental agency or operation of law,
provided that it gives the Disclosing Party reasonable advance notice sufficient
to contest such requirement of disclosure, takes all reasonable and lawful
actions to avoid and/or minimize the extent of such disclosure, and cooperates
with the Disclosing Party, at the Disclosing Party's cost, if the Disclosing
Party wishes to seek a protective order.
7. NO OBLIGATION: Nothing contained in this CDA shall be construed to obligate
in any way either party to enter into any transaction whatsoever.
8. NO LICENSE GRANTED: Nothing in this CDA shall be construed to imply the
grant of any license to the Receiving Party to make, use or sell, or otherwise
commercialize any portion of the Confidential Information.
9. INJUNCTIVE RELIEF: The Receiving Party acknowledges that the unauthorized
disclosure or use of the Disclosing Party's Confidential Information by the
Receiving Party may cause irreparable harm and significant injury to the
Disclosing Party, the degree of which may be difficult to ascertain.
Accordingly, the Receiving Party agrees that the Disclosing Party will have the
right to seek an immediate injunction enjoining any breach of this CDA, as well
as the right to pursue any and all other rights and remedies available at law or
in equity for such a breach.
10. ASSIGNMENT: Neither party may assign, delegate or transfer any of its
rights or obligations hereunder without the prior written consent of the other
party, provided that either party shall have the right to assign this CDA to its
affiliates, subsidiaries, related companies, divisions or successors. Any such
unauthorized assignment or transfer shall be void. All covenants and agreements
hereunder shall inure to the benefit of, and be binding upon, the parties, their
successors and permitted assigns.
11. CHOICE OF LAW: This CDA will be construed, interpreted, and applied in
accordance with the laws of the State of New Jersey, USA, without regard to the
conflicts of law principles thereof.
12. NOTICE: Any notice or communication required or permitted to be given
hereunder may be delivered by hand, deposited with an overnight courier,
confirmed facsimile, or mailed by registered or certified mail, return receipt
requested, postage prepaid, in each case to the address of the recipient as
listed above or at such other address as may hereafter be furnished in writing
by either party to the other party. Such notice will be deemed to have been
given as of the date it is delivered, mailed, faxed or sent, whichever is
earlier.
13. ENTIRE AGREEMENT: This CDA is the complete and exclusive statement
regarding the subject matter hereof and supersedes all prior agreements,
understandings and communications, oral or written, between the parties
regarding the subject matter hereof; provided, however, that any and all other
written agreements or provisions of agreements between the parties (or their
respective predecessors, affiliates, subsidiaries) that relate to confidential
information or trade secrets shall remain in full force and effect. Any
amendment to or modification of this CDA, or any waiver of any provision hereof,
shall be in writing and signed by both parties. Any waiver by the Disclosing
Party of any provision of this CDA shall not operate or be construed as a waiver
of any subsequent breach of such provision or any other provision hereof.
14. COUNTERPARTS AND FAX SIGNATURES: This CDA may be executed by the parties
hereto in separate counterparts, each of which when so executed and delivered
shall be an original, and all of which shall together constitute one and the
same instrument. This CDA may be executed and delivered by facsimile signatures.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, each of the parties hereto has executed this CDA by
its duly authorized officer or representative.
THEPHARMANETWORK, LLC,
a New Jersey limited liability company
By:
------------------------------------
Xxxxxxxx X. Rome
President/CEO
Date:
------------------------------------
ELITE PHARMACEUTICALS, INC.
a Delaware corporation
By:
------------------------------------
(name of officer)
(position)
Date:
------------------------------------
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