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EXHIBIT 10-B (ii)
SUPPLEMENTAL CO-PROMOTION AGREEMENT
This Agreement is made as of the 13TH day of February, 1991, by and between
Xxxxxx Laboratories, Inc., a Delaware corporation having its principal place of
business at 0000 Xxxxx Xxxxxx Xxxx, X.X. Xxx 00000, Xxxxxxxx, Xxxx 00000
(hereinafter "XXXXXX") and UNIMED, INC., a Delaware corporation having its
principal place of business at 00 Xxxxxxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000
(hereinafter "UNIMED").
WITNESSETH:
WHEREAS, UNIMED is currently the holder of an approved New Drug Application
("NDA") for dronabinol;
WHEREAS, an agreement between the parties dated February 12, 1986, as
supplemented by an agreement between the parties dated November 26, 1990,
appointed XXXXXX the exclusive distributor in the United States and Canada of
dronabinol which it markets under the trade name MARINOL(R); and
WHEREAS, the parties desire to supplement the aforesaid agreements to provide
for the cc-promotion of dronabinol in the United States but maintain XXXXXX as
the exclusive distributor of dronabinol;
NOW, THEREFORE, in consideration of the representations and mutual undertakings
and covenants hereinafter set forth, the parties hereby agree as follows:
ARTICLE I - DEFINITIONS
The following terms shall have the following meanings for all purposes of this
Agreement:
1.1 "Affiliate" shall mean any person, firm, or corporation which controls, is
controlled by or is under common control with XXXXXX or UNIMED. Control shall
mean either the direct or indirect ownership of fifty (50%) percent or more of
the voting stock of the subject entity.
1.2 "Agreement" shall mean this Go-Promotion Agreement, as executed or as it may
hereinafter be supplemented or amended, from time to time, in accordance with
the terms hereof.
1.3 "Product" shall mean Marinol(R) (dronabinol), and any improvements by UNIMED
thereto.
1.4 "FDA" shall mean the United States Food and Drug Administration.
1.5 "DEA" shall mean the United States Drug Enforcement Agency.
1.6 "NDA" shall mean the new drug application.
1.7 "Co-promote" or "Co-Promotion" shall mean the act of making sales calls to
promote the Product to physicians, pharmacists, nurses or other members of the
health care community in the United States during the term of this Agreement.
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ARTICLE II -- AMENDMENT OF PRIOR AGREEMENTS
2.1 The prior agreements between the parties dated February 12, 1986 and
November 26, 1990 are hereby amended far the sole purpose of permitting UNIMED
to be a non-affiliated co-promoter with XXXXXX of the Product in the United
States for the term of this Agreement.
2.2 XXXXXX shall remain the exclusive distributor of the Product, with sole
responsibility for establishing the marketing plan and promotional strategy for
the Product as well as Product pricing, sales terms and conditions of sale. All
provisions of the prior agreements which are not superseded by this Agreement
shall remain in full force and effect.
2.3 XXXXXX hereby grants to UNIMED the right to Co-promote the Product jointly
with XXXXXX in the United States; said right shall extend to all indications,
dosage-forms, formulations, and combinations containing dronabinol which are
approved by the FDA to which UNIMED or its affiliates have rights during the
term of this Agreement.
ARTICLE III - PROMOTION AND TRAINING
3.1 UNIMED agrees that it shall have a field sales force consisting of ten (10)
sales representatives to Co-promote the PRODUCT. UNIMED shall at its own
expense, and not later than ninety (90) days from the date of this Agreement,
hire no less than six (6) sales representatives to Co-promote the PRODUCT.
UNIMED agrees to commence promoting the Product as soon as its first six (6)
sales representatives have been trained by XXXXXX as hereinafter provided.
UNIMED's sales representatives shall be full-time employees, who devote all of
their efforts to the promotion of the Product and/or other UNIMED
pharmaceuticals, including any other pharmaceuticals co-promoted by UNINED. Any
expenses incurred by UNIMED's sales representatives during its Co-promotional
activities shall be paid by UNIMED. In the event that UNIMED's sales force
detailing this Product shall number less than six (6) for a period exceeding
sixty (60) days, XXXXXX shall have the option of terminating this Agreement.
UNIMED agrees to submit its sales representatives to XXXXXX for training and
education with respect to the Product, which training shall not exceed two (2)
consecutive days; the training will not be unlike the training XXXXXX provides
to its own sales representatives. The costs to develop the training materials
and of the actual training shall be paid by XXXXXX. Any incidental expense,
including the costs for the transportation, food and lodging incurred in
training UNIMED's personnel shall be paid by UNIMED. The parties shall mutually
agree as to the time of training and education, including continuing education;
it being recognized that training will be provided in Columbus, Ohio, unless
otherwise agreed, as soon as XXXXXX can reasonably schedule such training after
notification from UNIMED that it has a sufficient number of personnel to fill a
training class. The initial training class to consist of not less than six (6)
persons and all subsequent classes to consist of not less than two(2) persons.
3.2 XXXXXX will not later than twenty-one (21) days after the execution of the
Agreement provide to UNIMED a list of those physicians, pharmacists, nurses,
hospitals, hospices, and other members of the health care community it does not
wish UNIMED's sales representatives to call upon for the purpose of making sales
calls on the Product. Thereafter, from time to time a supplemental list of those
persons and places not to be called upon by UNIMED for the purpose of making
sales calls on the Product shall be prepared by XXXXXX and provided to UNIMED.
While XXXXXX shall have the right to identify any person and/or place not to be
called upon, such supplemental list(s) shall not be so extensive so as to
substantially interfere with UNIMED's sales representatives ability to
Co-promote the PRODUCT. UNIMED agrees to not call upon any of the persons and
places so identified by XXXXXX. UNIMED agrees to keep for a two(2) year period,
a record of each sales call made by its sales representatives; such record shall
identify the date of the sales call and the name and professional status, (i.e.
MD, DO, RPH, RN, etc.) of the person called upon. UNIMED agrees to average no
fewer than seventy (70) sales calls to physicians per sales representative per
month during the term of this Agreement, for the PRODUCT. XXXXXX shall have the
right to periodically audit UNIMED's call records to
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determine that the minimum monthly number of sales calls have been made and
that no persons identified on the aforementioned lists have been called upon.
The audits shall be conducted at ROXANE's expense, upon written request during
normal business hours.
3.3 XXXXXX shall not less than three (3) times per year, and more frequently at
the reasonable request of either party, meet with representatives of UNIMED to
discuss the current marketing plan and promotional strategy and the marketing
plan and promotional strategy for the prior four (4) month period. During these
meetings UNI~ED shall advise XXXXXX of any ideas or strategies it believes will
enhance the sale of the PRODUCT. The parties agree that XXXXXX shall have the
final decision making authority with respect to the marketing plan and
promotional strategy. It is understood that each party shall bear all its own
costs for personnel attending such periodic meetings. It is also agreed that the
aforementioned meetings shall be the only forum for the personnel of both
parties to meet to discuss the PRODUCT's marketing plan and strategy.
3.4 UNIMED agrees to strictly follow ROXANE's marketing plan and promotional
strategy for the Product as XXXXXX may from time to time determine. The
marketing plan shall, among other things, identify which seminars, conventions
and conferences shall be part of the promotional strategy for the Product and
the role of each co-promoter in such seminars, conventions and conferences.
UNIMED shall not be forced to expend any monies to participate in such seminars,
conventions and conferences without its prior approval. The marketing plan will
be provided to UNIMED sufficiently in advance of implementation so that UNIMED
can strictly adhere to any and all of ROXANE's marketing instructions in areas
which shall include, but not be limited to, all sales calls to physicians,
pharmacists, nurses or any other members of the health care community.
XXXXXX shall be solely responsible for direct mail, telephone sales calls,
seminars, meetings and conferences, company-sponsored speakers programs, visual
aids, journal than the FDA and/or DEA, as well as all contacts with hospital and
retail buying groups, and the selection of, calls on, distributors for the
Product, Under no circumstances shall UNIMED's sales force discuss with any
customer or potential customer, any existing or potential contract concerning
the Product.
3.5 UNIMED agrees that it will not use in its promotion any promotional
materials, sales aids, educational materials, scientific reprints or any audio,
visual or written matter which has not been prepared and furnished by XXXXXX nor
shall UNIMED in any manner alter the promotional or advertising materials which
have been provided by XXXXXX. XXXXXX agrees to provide UNIMED with all of the
materials prepared by it to Co-promote the Product. Quantities of the
aforementioned materials shall be provided to UNIMED, sufficiently in advance of
the planned implementation dates, so that UNIMED's sales representatives can
properly incorporate such materials into their sales presentations. From time to
time after a marketing plan and promotional strategy has been implemented XXXXXX
may find it necessary to offer its sales representatives clarification,
reinforcement, or additional information. Such communications will be sent to
UNINED's home office for transmittal to their sales representatives.
3.6 All questions, inquiries and information regarding the Product received by
UNIMED or its sales representatives shall be forwarded by UNIMED to XXXXXX as
soon as possible after receipt. Questions and inquiries concerning scientific or
medical issues, including adverse event reports Shall be forwarded to ROXANE's
Vice President of Medical Affairs. Questions and inquiries concerning sales,
marketing and potential new distributors shall be forwarded to ROXANE's Vice
President of Sales and Marketing. UNIMED's sales representatives shall not take
orders for the Product, but shall instead refer such customers or potential
customers to a XXXXXX distributor nor shall they contact a XXXXXX distributor
for any reason concerning the Product. XXXXXX shall provide UNIMED, from time to
time, with a current list of its distributors, including their addresses.
3.7 XXXXXX agrees to provide to UNIMED a monthly sales report that is mutually
acceptable to both parties.
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3.8 UNIMED will forward to XXXXXX, any request for formal or informal clinical
studies.
3.9 Each party shall in its sole discretion be free to hire sales
representatives and to determine the qualifications, salaries, and duties of
those sales representatives.
3.10 Each party will furnish to the other the names and addresses of the sales
representatives. This information will be updated as sales representatives are
hired or terminated. Each party agrees to instruct its respective sales forces
that they shall not meet to discuss the promotion of the PRODUCT, provided that
inadvertent contacts shall not constitute a breach of this Agreement.
All communications to the XXXXXX or UNIMED sales representatives will be made
only by their respective managements.
ARTICLE IV - INDEMNIFICATION
4.1 Notwithstanding anything in this Agreement or the agreements dated February
12, 1986 and dated November 26, 1990 to the contrary, UNIMED represents and
warrants to XXXXXX that it will limit its promotional activities to the
materials provided by XXXXXX and that it will follow ROXANE'S marketing plan and
promotional strategy.
4.2 UNIMED agrees to indemnify XXXXXX and hold it harmless from and against any
claims, damages, liabilities, harm, loss, costs, penalties, lawsuits, threats of
lawsuit, recalls or other governmental action including reasonable attorneys'
fees, arising out of UNIMED's breach of the warranties set forth in Paragraphs
4.1 and 7.2 or which results from the negligent acts or willful malfeasance of
UNIMED in promoting the Product in a manner inconsistent with the Products
labeling or promotional or other materials supplied by XXXXXX.
4.3 XXXXXX agrees to indemnify UNIMED and hold it harmless from and against any
claims, damages, liability, harm, loss, costs, penalties, lawsuits, threats of
lawsuit, recalls or other governmental action, including reasonable attorney's
fees which arises as the result of UNIMED's use of promotional materials,
provided by XXXXXX, which fails to conform to applicable law.
4.4 Notwithstanding the above provisions of this Article, in the event of a
breach of this Agreement by UNIMED, other than a breach of Paragraph 3.4 or 3.5,
which breach UNIMED shall have failed to remedy within thirty (30) days after
notice thereof, this Agreement shall be considered null and void. In addition,
in such event, the February 12, 1986 agreement shall be fully reinstated in full
force and effect including Paragraph 2.1 thereof which appoints XXXXXX as
exclusive distributor of Product in the Territory.
4.5 The indemnification obligations herein shall apply on a first dollar basis
without limitation or reduction due to any deductible or self-insured retention
which either party may have under their respective insurance coverages.
ARTICLE V TERMINATION
5.1 Because in its performance of this Agreement UNIMED will be making sales
calls on physicians and others bearing sales materials of XXXXXX with ROXANE's
name and logo, in the event UNIMED wishes to detail, market or promote any
narcotic analgesic and/or narcotic topical anesthetic product, identified on
Schedule A, a copy of which is attached hereto and made a part hereof. UNIMED
will inform XXXXXX in writing of its intent to do so no earlier than six (6)
months prior thereto. In such event XXXXXX shall have the option, at its sole
discretion, within 120 days of being so informed, to terminate this Agreement.
5.2 UNIMED may terminate this Agreement upon thirty (30) days prior notice.
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5.3 In the event of termination of this Agreement by either party for any
reason, the February 12, 1986 agreement shall be fully reinstated in full force
and effect however the continuing obligations set forth under Articles IV and VI
shall survive.
5.4 Termination of this Agreement shall be without prejudice to any remedies
which either party may then or thereafter have hereunder at law or in equity.
The act of termination, however, shall not create liability on either party.
ARTTCLE VI - CONFIDENTIALITY
6.1 Except for the proper exercise of any rights granted or reserved under other
provisions of this Agreement, each party agrees that it will take such
precautions as it normally takes with its own confidential or proprietary
information to keep confidential and not to publish or otherwise disclose to a
third party except as permitted or anticipated herein, any information of a
confidential or proprietary nature furnished by the other party to it in
connection with this Agreement, including, without limitation, technology,
marketing strategy, specifications, product information, pre-clinical and
clinical data, inventions, processes, know-how, sales force information, sales
data, plans, trade secrets, call lists, business information, and adverse
reaction reports (together called "Confidential Information") without the prior
written consent of the other party, except to the extent that such Confidential
Information is required to be disclosed for the purpose of complying with law or
government regulations. Nothing in this Paragraph shall prevent disclosure or
use by the receiving party of the Confidential Information of the other party
that:
(i) was known or used by the receiving party, as evidenced by its
written records made prior to the time of receipt hereunder;
(ii) either before or after the time of disclosure becomes known to the
public other than by an unauthorized act or omission of the receiving
party or its Affiliates, employees or agents;
(iii) lawfully is disclosed to a third party having the right
Confidential Information; or
(iv) that may be developed by the receiving party independently from the
Confidential Information provided by the other party hereto as evidenced
by the receiving party's written records.
Notwithstanding the restrictions set forth in this paragraph, each party shall
be entitled at all times to use all Confidential Information provided by the
other party in order to perform its obligations or exercise its rights under
this Agreement.
ARTICLE VII -- REASONABLE EFFORTS AND ADHERENCE TO LAWS
7.1 UNIMED warrants that it shall use reasonable efforts to co-promote the
Product in the United States.
7.2 Each party warrants that it will conform to all applicable law in its
activities pursuant to this Agreement.
ARTICLE VIII - FORCE MAJEURE
8.1 Neither party shall be considered in default or be liable to the other for
any delay in performance or non-performance caused by circumstances beyond the
control of the party, including but not limited to Acts of God, fire, flood,
war, order of any court, or other causes which cannot be controlled by the party
who failed to perform.
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ARTICLE IX - ASSIGNMENT
9.1 This Agreement, may not be assigned by either party without the prior
written consent of the other.
ARTICLE X - MISCELLANEOUS
10.1 The provisions of this Agreement shall be deemed separable. If any part of
this Agreement is rendered invalid or unenforceable, such rendering shall not
affect the validity or enforceability of the remainder of this Agreement unless
the part or parts which are invalid or unenforceable shall substantially impair
the value of the whole Agreement to either party.
10.2 Neither XXXXXX nor UNIMED shall publicly disclose the specific terms of
this Agreement other than what may be required by the Securities Exchange
Commission (SEC). Except as required by SEC filings the transactions
contemplated hereby or performance hereunder, shall not be disclosed without:
first obtaining the written consent of the other party hereto unless there has
been a prior public disclosure of the information being disclosed by the other
party or with the other party's consent.
10.3 It is understood and agreed that neither party shall attempt to employ or
employ any person then currently on the other's staff who is currently or has
been involved within the preceding twenty-four (24) months in the marketing,
sale or promotion of the Product during the term of this Agreement and for a
period of twenty-four (24) months after the termination of this Agreement or any
renewal thereof.
10.4 UNIMED sales representatives are to be instructed not to discuss their
compensation plan with any XXXXXX sales representative in the event there is
coincidental contact in the normal course of business.
10.5 This Agreement sets forth the entire Agreement of the parties respecting
its subject matter and supersedes all previous oral or written agreements
between the parties on such subject matter. No provision of this Agreement may
be modified or waived except in a writing duly executed by both parties.
10.6 Any and all communications required as provided for in this Agreement shall
be in writing and sent to the last known address of the headquarter offices of
the respective parties. Any notice to XXXXXX shall be addressed to
Xxxxxx Laboratories, Inc.
0000 Xxxxx Xxxxxx Xxxx
X.X. Xxx 00000
Xxxxxxxx, Xxxx 00000
Attention: President
with a copy to
General Counsel
Xxxxxx Laboratories, Inc,
c/o 00 Xxxx Xxxxx Xxxx
X.X. Xxx 000
Xxxxxxxxxx, Xxxxxxxxxxx 00000
Any notice to UNIMED shall be addressed to:
Unimed, Inc.
00 Xxxxxxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attention: President
10.7 The parties are each acting hereto as independent contractors and not as an
agent or employee of the other.
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10.8 This Agreement shall be interpreted under and governed by the law of the
State of Ohio.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized officers as of the date and year first above written.
UNIMED, INC.
BY: /s/ Xxxxxxx X. Xxxxxxxx
TITLE: President
XXXXXX LABORATORIES, INC.
BY: /s/ Xxxxxx X. Wjota
TITLE: President
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SCHEDULE "A"
As single entities or in any combination product.
Codeine
Morphine
Methadone
Oxycodone
Meperidine
Hydromorphone
Levorphanol
Hydrocodone
Fentanyl
Oxymorphone
Buprenorphine
Cocaine Hydrochloride
