Exhibit 99.1
June 6, 2005 Execution Version
Confidential Materials omitted and filed
separately with the
Securities and Exchange Commission. Asterisks
denote omissions.
Promotion and Cooperation Agreement
Parties
This Promotion and Cooperation Agreement (the
“Agreement”) is effective June 6, 2005, (the
“Effective Date”) by and between Primus
Pharmaceuticals, Inc., with offices at 4725 N Scottsdale Rd, Suite
200 Scottsdale, AZ 85251 (“Primus”) and CollaGenex
Pharmaceuticals, Inc. with offices at 41 University Drive, Newtown,
Pennsylvania 18940 (“CollaGenex”).
Recitals
WHEREAS , Primus is engaged in the manufacture,
promotion and sale of Novacort ™ 2% hydrocortisone acetate and 1% pramoxine HCl)
and Alcortin ™ (1% iodoquinol and 2% hydrocortisone) (the
“Products”), which are used to treat certain
dermatological indications; and
WHEREAS , CollaGenex has a direct sales force which
specializes in the sale of pharmaceuticals used to treat
dermatological indications and who directly call on dermatologists
(the “Dermatologist Direct Sales Force”);
and
WHEREAS, Primus wishes to expand sales by promoting the
Products to dermatologists and CollaGenex is willing and able to
so.
Primus and CollaGenex (each a
“Party”) Agree As Follows:
1. Promotion Services .
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(a)
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Territory. During the term of this Agreement, Primus grants
to CollaGenex the right to promote the Products to dermatologists,
physician’s assistants who can write prescriptions and work
in dermatologists’ offices, nurse practitioners who can write
prescriptions and work in dermatologists’ offices and Doctors
of Osteopathy who are characterized as having a prevailing
dermatology specialization, within the United States. The United
States shall include the 50 states and the District of Columbia
(the “Territory”). The Territory may be expanded at any
time by mutual agreement to include the territories, possessions
and commonwealths of the United States.
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(b)
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Review of Prescriber
Data. The determination
of which prescribers are within the Territory shall initially be
based on how a practitioner is characterized in a
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industry standard commercially
available data base approved by the Steering Committee (as defined
below). When CollaGenex has generated actual call data, it shall
share such data with the Steering Committee, and the Steering
Committee will identify any prescribers on whom CollaGenex has
called, but who are not characterized in the data base approved by
the Steering Committee as having a dermatology specialization. For
each such prescriber the Steering Committee shall determine
either:
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(i)
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that such
prescriber is not properly part of the Territory, in which case
CollaGenex shall not receive credit for any future prescriptions
written by such prescriber, or
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(ii)
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that such
prescriber is properly part of the Territory, in which case
CollaGenex shall receive credit for all future prescriptions
written by such prescriber.
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(c)
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Guiding
Principles. In making
such determinations the Steering Committee shall be guided by the
following principles:
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(i)
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The prevailing
nature of the prescriber’s practice shall be
dermatology;
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(ii)
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Primus is not
liable to compensate any third party in connection with
prescriptions written by the prescriber.
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(d)
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Non-Compete;
Non-solicitation. Each
Party agrees that, in consideration for receiving and acquiring the
limited right to use market and other proprietary information of
the other Party, it will not, for the term of this Agreement and
for a period of [**] thereafter, market or sell any product which,
in the case of Primus, is an oral systemic therapy for
dermatological conditions containing chemically modified
tetracyclines, and in the case of CollaGenex is a topical steroid
or topical anaesthetic that is a direct competitor to Novacort, or
a topical antifungal or topical antifungal steroid combination that
is a direct competitor to Alcortin. Furthermore, unless the
soliciting party can demonstrate contact with such employee prior
to their employment by the other party, during the term of this
Agreement and for a period of one year thereafter, neither Party
shall solicit the employment of any employee of the other Party
that is at such time working for the other Party.
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(e)
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Subcontractors. CollaGenex shall have the right to appoint
agents or co-promoters, at its own cost, to promote the Products or
to satisfy its obligations under this Agreement, with the prior
written consent of Primus, which shall not be unreasonably
withheld.
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(f)
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Trademarks.
Primus grants CollaGenex the right
to use trademarks and trade names belonging to Primus which relate
to the Products for the purpose of promoting the Products according
to the guidelines agreed by the Steering
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Committee (as defined below).
CollaGenex shall not alter, modify or otherwise change the
Trademarks. Primus further agrees that CollaGenex may use its own
name and logo in connection with such trademarks, provided that the
manner of such use has first been approved by the Steering
Committee. Nothing in this limited grant of rights shall imply that
either Party acquires, nor will it acquire any further rights
whatever in or to the trademarks or trade names of the other
Party.
2. Steering Committee .
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(a)
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Committee
Responsibilities. Various
roles and decisions under this Agreement shall be assigned to a
joint committee (the “Steering Committee”) for the
purpose of giving each Party equal voice in decisions relating to
the marketing of the Products, ensuring open communication between
the parties and optimizing sales of the Products.
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(b)
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Make Up of
Steering Committee. The
Steering Committee will be formed by two voting representatives of
each Party. The co-chairs of the Steering Committee may request the
input or attendance of others at Steering Committee meetings, but
such invitees shall not have a vote on any matter before the
Committee. The co-chairs of the Steering Committee shall be each
Party’s head of marketing.
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(c)
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Process of
the Steering Committee .
The Steering Committee will meet as often as necessary and no less
often than once in each quarter, within the ten day period
beginning 50 days of the end of each calendar quarter (or at
whatever time necessary to ensure timely approval of
CollaGenex’s invoices), in order to review each of the
matters referred to it under this Agreement (all of which are
listed on Exhibit A, for ease of reference, and in order to provide
an example of the agenda items that the Steering Committee will
address). At least two meetings each year shall be attended in
person, one at the premises of each Party. Each party shall pay
their own costs for attending each meeting.
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(d)
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Coordination
with Plan of Action Meetings . Notwithstanding the calendaring guidelines set
out in the preceding paragraph, the Steering Committee will use its
best efforts to coordinate its meetings and the execution of its
plans with the CollaGenex Plan of Action (POA) schedule, and to
that end may reschedule meetings outside the calendaring guidelines
or schedule additional meetings, in order to ensure that marketing
plans are timely defined, timely completed and timely
communicated.
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(e)
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Decisions of the Steering
Committee . Decisions of
the Steering Committee shall be taken by unanimous vote, and shall
be reflected in written minutes of each meeting. Such minutes shall
be circulated to the co-chairs after each meeting, for amendment
and approval as appropriate. Any decision on which the Parties are
not able to agree shall not be taken. If not taking such a decision
inhibits either
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Party from performing its
obligations under this Agreement, the Parties shall be free to
consider the matter in issue to be a dispute, and to resolve it
through the escalation procedure described in article 13
below.
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(f)
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Basis for
Steering Committee Decisions. All Steering Committee decisions shall be based
on ROI analysis using all such data and market research as the
Committee determines necessary and advisable to request. Where such
data is already provided to the Parties by IMS, Verispan or an
industry standard commercially available data base approved by the
Steering Committee, the Steering Committee shall base its decisions
on the average of such data points. All decisions will be driven by
the desire to leverage marketing and sample expenditures in an
optimal way, and to allocate resources to programs that optimize
long term sales volume, sales force efficiency and profitability of
the Products and marketing initiatives.
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(g)
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Right to
Audit. Either Party my
request that it have the opportunity to audit any information
presented by the other Party to the Steering Committee, and the
Steering Committee shall arrange a mutually convenient time for
such audit, which shall be within normal business hours, shall be
at the audited Party’s place of business, shall not exceed
three days in duration and shall be entirely at the auditing
Party’s expense.
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3. CollaGenex Obligations .
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(a)
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Sales
Force. CollaGenex will,
at its own expense, maintain, manage and compensate a Dermatologist
Direct Sales Force sufficient at all times to achieve primary
detail equivalents for the Products within the following frequency
ranges, which shall assume that a secondary detail is equivalent to
[**] primary details, and a tertiary detail is equivalent to [**]
primary details:
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1 st Year (Eff Date – June 30,
06)
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[**]
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2 nd Year (July 1, 06 – June 30,
07)
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[**]
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3 rd Year (July 1, 07 – June 30,
08)
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[**]
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Each Quarterly Report (as defined
below) will set out the details actually performed during that
quarter.
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(b)
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Training. CollaGenex will ensure that all the
Dermatologist Direct Sales Force are trained in the promotion and
sale of the Products according to the guidelines agreed by the
Steering Committee. Primus shall, at its own expense, cooperate
with and contribute to such training. All other direct costs
related to the training of the sales force shall be borne by
CollaGenex.
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(c)
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Promotion.
CollaGenex shall use all reasonable
efforts to sell and to increase the sales of the Products in the
Territory by detailing physicians, calling on
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pharmacies, and supporting managed
care coverage. CollaGenex will promote the Products in a manner
consistent with the indications authorized by Primus, all FDA
requirements and the standards of professional conduct and
diligence reasonably expected by physicians and by CollaGenex in
the promotion of its own products. CollaGenex shall not sell the
Products outside the Territory, nor to any other person that is
selling or that intends to sell the Products outside the
Territory.
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(d)
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Sales Force
Automation. The Products
will be included on the CollaGenex Sales Force Automation (SFA)
system to facilitate physician profiling and targeting and sampling
of the Products in a manner consistent with any guidelines agreed
by the Steering Committee. Automated sales aids for the Products
will also be created and placed on the representative’s
laptop computers to facilitate promotional activity.
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(e)
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Forecasting. CollaGenex shall provide to the Steering
Committee a rolling twelve month forecast of anticipated
prescription demand and sample usage in the Territory. Such
forecast shall be updated and submitted quarterly, together with
CollaGenex’s Quarterly Report.
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(f)
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Sample
Ordering. CollaGenex
shall order samples according to the procedure and with the lead
times and payment terms set out on Exhibit B, and shall track its
distribution of such samples according to the requirements of the
PDMA. CollaGenex shall share with the Steering Committee all
suggestions to lower the cost of samples.
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(g)
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Sales
Targets . CollaGenex
shall achieve at least the following combined levels of sales of
the Products in the Territory, calculated with reference to
prescriptions filled data available from industry standard and
commercially available sources approved by the Steering Committee
and assuming sales at Net Sales Price (as defined on Exhibit D),
during the following time periods:
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1 st Year
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$[**]
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2 nd Year
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$[**]
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3 rd Year
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$[**]
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Thereafter, the Steering Committee
shall set sales targets.
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(h)
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Incentive
Program. CollaGenex will
establish an incentive program that reflects the primary detail
position of the Products in the First Year and the secondary detail
position in the Second Year for the Products. The incentive
compensation in the second and third years will be sufficient to
ensure that the Products attain a reasonable level of sustained
focus from the sales force. The incentive compensation in the third
year will reflect any agreement of CollaGenex and Primus with
respect to the detail position for the Products during such year.
CollaGenex will share with the Steering Committee, those aspects of
its incentive plan that relate to the promotion of the
Products.
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(i)
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Reports. Within 50 days of the end of each calendar
quarter, CollaGenex shall submit to Primus and the Steering
Committee a report referencing all the items listed on Exhibit C
(the “Quarterly Report”).
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(j)
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Professional
Affairs. CollaGenex will
be responsible for collecting information pertaining to all product
inquiries as required by the appropriate Code of Federal
Regulations. All such information, together with AE reports and
other product information collected by CollaGenex, will be made
available to Primus within 72 hours of receipt by CollaGenex, or at
such earlier time as may be appropriate under applicable
regulations.
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(k)
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Insurance CollaGenex shall at all times maintain product
liability insurance covering the Products and naming Primus as an
additional insured, in an amount not less than $5 million aggregate
and per occurrence.
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(l)
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Customer
Service. CollaGenex shall
field and refer to Primus any Product questions and Product issues
that arise from the marketplace, and cannot be adequately and
promptly answered. It shall instruct customers that such questions
and issues should be referred to Primus.
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(m)
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Access. CollaGenex shall grant to Primus such reasonable
access to its sales events and sales personnel as Primus shall
request, including the right to participate in sales events related
to the Products and to ride along with representatives promoting
the Products.
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4. Primus Obligations
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(a)
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Purchase of
the Products. Primus will
have the Products contract-manufactured, and purchase them for a
price (“COGS”) which shall be made known to CollaGenex.
Primus shall use its reasonable efforts to reduce the COGS on an
ongoing basis.
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(b)
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Quality
Control. Primus shall
ensure that it, or its contract manufacturer, maintains all
necessary quality controls, and that the Products are manufactured
in accordance with GMP.
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(c)
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Distribution. Primus shall be responsible for ensuring that
the Products are timely distributed to wholesalers and that
sufficient inventories of the Products are maintained at all points
in the supply chain to the wholesale level, to ensure that the
Products are readily available for delivery to customers at all
times.
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(d)
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Recalls . Primus shall be solely responsible for managing
Product returns and for taking all decisions and actions relating
to the recall or proposed recall of any of the Products. All third
party or out of pocket costs of recall will be borne by Primus.
CollaGenex will assist in any recall activities and Primus shall
reimburse such reasonable out of pocket expenses as it incurs in
doing so.
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(e)
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Relations
with Payors. Primus shall
be primarily responsible, with support and cooperation from
CollaGenex, for negotiating agreements with providers, managed care
organizations, payors, wholesalers, group purchasing organizations,
and the like, regarding the Products.
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(f)
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Samples All samples shall be [**] supplied to CollaGenex
[**]% in accordance with the procedure outlined in Exhibit C.
Primus will continually work to decrease the overall cost of
samples. The Steering Committee will define a sample plan to
determine allocations of samples and to minimize cost of samples.
Primus will be responsible for submitting sample forecasts to their
manufacturer and assuring that samples are available to support the
sample plan determined by the Steering Committee. The combined
sample costs shall not exceed:
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1 st Year
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$[**]
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2 nd Year
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$[**]
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3 rd Year
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$[**]
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(g)
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Promotional
Materials. Primus shall
provide reasonable quantities of all necessary and available
promotional materials, including electronic PDF files, that may be
reasonably requested by CollaGenex in connection with the training
of CollaGenex’s Dermatologist Direct Sales Force and its
promotion of the Products in the manner approved by the Steering
Committee. Primus shall own all right, title and interest in and to
such promotional materials, but CollaGenex has the right to use the
promotional materials for promotion and detailing of the Products.
Use of any new promotional materials, or any change or development
to any promotional materials, requires the approval of the Steering
Committee.
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(h)
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Booking of
Sales. Primus shall book
all sales of the Products, and shall be solely responsible for
handling all aspects of order processing, invoicing and collection
of all receivables.
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(i)
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Customer
Service. Primus shall be
responsible for all customer service support, including handling
medical queries, responding to Product complaints, processing all
product returns and performing other functions that CollaGenex is
unable to handle promptly itself, which are consistent with
customary practice for prescription pharmaceuticals. CollaGenex
shall refer all requests for such support to Primus within the time
frames outlined above.
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(j)
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Regulatory
Compliance. Primus shall
be responsible for all communicating with any governmental agencies
and for satisfying their regulatory requirements relating to the
promotion and sale of the Products in the Territory, provided,
however, that CollaGenex shall promptly inform Primus of any
adverse or other event that might be reportable, as soon as it may
become aware of the same.
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(k)
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Defense of
Intellectual Property. Primus will, to the extent it is authorized or
permitted by its licensors, vigorously assert and defend the
patents relating to the Products, and will take all reasonable
measures, taking into account the cost and potential commercial
benefit of such actions at its sole discretion, to seek to enjoin
the entry into the market of any generic product that might
infringe such patents.
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(l)
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Insurance Primus shall at all times maintain product
liability insurance covering the Products and naming CollaGenex as
an additional insured, in an amount not less than $5 million
aggregate and per occurrence.
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(m)
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Reports. Within 50 days of the end of each calendar
quarter, Primus shall submit to CollaGenex and the Steering
Committee a report referencing its marketing expenses, its COGS and
its pro forma calculation of Gross Profit (as defined below) for
such quarter.
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5. Marketing
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(a)
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Steering
Committee. The Steering
Committee shall have responsibility for setting and approving the
marketing strategy, as well as individual marketing programs and
budgets relating to the Products prior to implementation, and for
monitoring the same on an ongoing basis.
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(b)
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Marketing
Budget. The budget for
marketing expenses shall not exceed the following for the following
time periods:
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Effective Date – June 30, 2006
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$[**]
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July 1, 2006 – June 30, 2007
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$[**]
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July 1, 2007 – June 30, 2008
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$[**]
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(c)
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Allocation
of Marketing Expenses. All Product specific incremental Marketing
Expenses (excluding samples, field sales expenses and any other
matters specifically made the financial responsibility of one Party
or the other under this Agreement) shall be paid for [**]% by
Primus and [**]% by CollaGenex. Preexisting expenses of either
Party that are not specific to the generation of prescriptions for
the Products, such as expenses related to the acquisition of
non-Product specific market data from IMS, Verispan or an industry
standard commercially available data base approved by the Steering
Committee, shall no
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