Exhibit 10.2
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT
WERE OMITTED AND REPLACED WITH “***”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF
THE EXCHANGE ACT OF 1934.
AMENDED AND RESTATED PROMOTION
AGREEMENT
This AMENDED AND RESTATED PROMOTION AGREEMENT
(this “ Agreement ”) is made as of September 21,
2007 (the “ Effective Date ”), by and between
Depomed, Inc., a California corporation (“ Depomed
”), and Watson Pharma, Inc., a Delaware corporation (“
Watson ”). Each of Depomed and Watson is referred to
herein individually as a “ Party ” and
collectively as the “ Parties ”.
WHEREAS, Depomed and Watson are parties to that
certain Promotion Agreement, dated as of July 18, 2007 related to
the Product (the “ Original Agreement
”);
WHEREAS, Depomed and Watson desire to amend and
restate the Original Agreement as set forth herein;
NOW, THEREFORE, in consideration of the
foregoing and of the mutual covenants herein contained, the Parties
hereto intending to be legally bound hereby agree as
follows:
ARTICLE
I
DEFINITIONS
As
used in this Agreement, the following terms shall have the
following meanings:
Section 1.1
“ 2007 Plan ” has the meaning set forth in
Section 4.5.
Section 1.2
“ Act ” means the United States Federal Food,
Drug and Cosmetic Act, 21 U.S.C. 301, et. seq. , as it may
be amended from time to time, and the regulations promulgated
thereunder, including the Generic Drug Act.
Section 1.3
“ Adverse Drug Experience ” means any
“adverse drug experience” as defined or contemplated by
21 C.F.R. 314.80 or 312.32, associated with the Product.
Section 1.4
“ Adverse Drug Experience Report ” means any
oral, written or electronic report of any Adverse Drug Experience
transmitted to any Person.
Section 1.5
“ Affiliate ” means, with respect to any Person,
any other Person that directly or indirectly controls, is
controlled by or is under common control with, such first Person.
For the purposes of this definition, “ control ”
(including, with correlative meanings, the terms “
controlling ,” “ controlled by ”
and “ under common control with ”), as applied
to any Person, means the possession, directly or indirectly, of the
power to direct or cause the direction of the management and
policies of that Person, whether through the ownership of voting
securities, by contract or otherwise. Notwithstanding the
foregoing, for purposes of this Agreement, a Wholesaler Affiliate
shall not constitute an Affiliate of Watson.
Section 1.6
“ Agreement ” has the meaning set forth in the
preamble to this Agreement
Section 1.7
“ Agreement Month ” means each calendar month
during the Term (including any partial calendar month in the case
of the first and last calendar months of the Term).
Section 1.8
“ Agreement Quarter ” means the Initial
Agreement Quarter, each successive period of three months during
the Term after the Initial Agreement Quarter and the Final
Agreement Quarter.
Section 1.9
“ Alert Report ” is the report per FDA 21 CFR
314.80 Reporting Requirements for postmarketing 15-day
“Alert” reports; these are adverse drug experience
reports that are both serious and unexpected, and must be reported
in writing to the FDA within 15 calendar days.
Section 1.10
“ Annual Plan ” has the meaning set forth in
Section 4.5.
Section 1.11
“ cGMP ” shall mean current “Good
Manufacturing Practices” as such term is defined from time to
time by the FDA or other relevant Governmental Authority having
jurisdiction over the manufacture or sale of the Product pursuant
to its regulations, guidelines or otherwise.
Section 1.12
“ Channel ” shall mean the long-term sales
channel as reported in the Prescriber Data, which includes but is
not limited to nursing homes and assisted living facilities.
Section 1.13
Co-Chairs ” has the meaning set forth in Section
3.2.
Section 1.14
“ COGS ” means, for a particular period,
Depomed’s expenses for cost of goods sold (calculated in
accordance with Section 7.2(d)) for Product in the Territory for
such period including any expenses incurred directly in connection
with the distribution of the Product in the Territory. The COGS as
of the Initial Effective Date is set forth on
Schedule 1.14.
Section 1.15
“ Confidentiality Agreement ” means that certain
Confidentiality Agreement, dated as of February 26, 2007, between
Depomed and Watson.
Section 1.16
“ Control ” or “ Controlled ”
means, with respect to patents, know-how or other intellectual
property rights of any kind, the possession by a Party of the
ability to grant a license or sublicense of such rights without the
payment of additional consideration and without violating the terms
of any agreement or arrangement between such Party and any Third
Party.
Section 1.17
“ DDMAC ” means the FDA’s Division of Drug
Marketing, Advertising and Communications.
Section 1.18
“ Depomed ” has the meaning set forth in the
preamble to this Agreement.
Section 1.19
“ Depomed APL ” means Depomed’s
Advertising and Promotional Labeling Committee responsible for
reviewing and approving Promotional Materials related to the
Product.
Section 1.20
“ Depomed Trademarks ” means (a) the
ProQuin® trademark, (b) the AcuForm TM trademark,
for which Depomed has sought registration for in the United States
Patent and Trademark Office, and (c) Depomed®, and, in each
case, all related domain names, successor trademarks and other
trademark related rights. The Depomed Trademarks are attached
hereto as Schedule 1.20 .
Section 1.21
“ Detail ” means an in-person, face-to-face
sales presentation of the Product made by a Sales Representative to
a Professional, including a P1 Detail or a P2 Detail, and after
December 31, 2008, a P3 Detail.
Section 1.22
“ Detail Minimum ” means, for a particular
period, the sum of (A) the Urology Detail Minimum for such period,
plus (B) the Ob/Gyn Detail Minimum for such period.
Section 1.23
“ Detail Shortfall ” means, for a particular
period, the remainder of (A) the Detail Minimum for such period,
minus (B) the actual number of PDEs performed during such period.
In determining the actual number of PDEs performed during any
period (including without limitation for purposes of Section
8.2(a)): (a) only PDEs performed on Professionals on the
Watson Physician List shall be taken into account; and (b) not more
than 100% of the P1 Details, 100% of the P2 Details and 100% of the
P3 Details (if applicable) required to be performed for such period
within each of the Urology Field and the Ob/Gyn Field, as reflected
in the applicable Annual Plan(s) or 2007 Plan, shall be taken into
account.
Section 1.24
“ Detail Shortfall Ratio ” means, for any
period, the quotient of (A) the remainder of (x) the Detail Minimum
for such period, minus (y) the Detail Shortfall for such Period (if
any), divided by (B) the Detail Minimum for such period.
Notwithstanding the foregoing, if the Detail Shortfall is a
negative number, the Detail Shortfall Ratio shall be equal to
1.0.
Section 1.25
“ Educational Programs ” means any activities
undertaken with respect to the medical education of Professionals
and customers regarding the Product and the market or funded by
unrestricted educational grants, including educational programs and
seminars and continuing medical education materials.
Section 1.26
“ Effective Date ” has the meaning set forth in
the preamble to this Agreement.
Section 1.27
“ Esprit ” means Esprit Pharma, Inc., a Delaware
corporation.
Section 1.28
“ Esprit License Agreement ” means the Exclusive
License and Marketing Agreement, dated as of July 21, 2005, between
Depomed and Esprit, as amended.
Section 1.29
“ Esprit Promotional Materials ” has the meaning
set forth in Section 4.3(b).
Section 1.30
“ Esprit Termination Agreement ” means the
Termination Agreement between Depomed and Esprit, dated as of July
5, 2007, providing for, among other matters, the termination of the
Esprit License Agreement.
2
Section 1.31
“ Executive Officers ” means the Chief Operating
Officer of Depomed (or, if there is no such officer, its President
or Chief Executive Officer) and the President, Brand Division of
Watson (or, if there is no such officer, its President or Chief
Executive Officer).
Section 1.32
“ FDA ” means the United States Food and Drug
Administration or any successor agency performing comparable
functions in the Territory.
Section 1.33
“ Field ” means the Urology Field and the Ob/Gyn
Field, subject to provisions of Sections 7.4 and 8.2(a).
Section 1.34
“ Field Baseline Prescriptions Per Month ”
means, subject to Section 8.2(a), the monthly average number of
Units of Product included within total prescriptions dispensed
during the three-month period beginning on June 1, 2007 and ending
on August 31, 2007 in the Territory within the Field (as reflected
in the Prescriber Data).
Section 1.35
“ Field Baseline Prescriptions ” means, for any
particular period, the result of (A) Field Baseline Prescriptions
Per Month, multiplied by (B) the number of months within such
period (rounded to the nearest one-tenth of one month).
Section 1.36
“ Field COGS ” means, for a particular period,
the result of (A) COGS for such period, multiplied by (B) the Field
Ratio for such period.
Section 1.37
“ Field Gross Margin ” means, for a particular
period, the result of (A) the remainder of (x) Field Net Sales for
such period minus (y) Field COGS for such period, multiplied by (B)
the Detail Shortfall Ratio for such period.
Section 1.38
“ Field Net Sales ” means, for a particular
period, the result of (A) Net Sales for such period, multiplied by
(B) the Field Ratio for such period.
Section 1.39
“ Field Prescription Units ” means, for a
particular period, the remainder of (A) the sum of (i) the number
of Units of Product included within prescriptions filled during
such period in the Territory within the Field, as reflected in the
Prescriber Data, plus (ii) the number of Units of Product included
within the Channel for such period, as reflected in the Prescriber
Data, minus (B) Field Baseline Prescriptions for such period.
Section 1.40
“ Field Ratio ” means, for a particular period,
the sum of (A) the quotient of (i) Field Prescription Units for
such period, divided by (ii) the number of Units of Product
included within Product prescriptions filled during such period in
the Territory, as reflected in the Prescriber Data (such quotient
being the “ Field Physician Ratio ”), plus (B)
the product of (i) the quotient of (x) PA/NP Prescription Units for
such period, divided by (y) the number of Units of Product included
within Product prescriptions filled during such period in the
Territory, as reflected in the Prescriber Data, multiplied by (ii)
the Field Physician Ratio.
Section 1.41
“ Final Agreement Quarter ” means the period
commencing on the first day following the last full Agreement
Quarter during the Term and ending on the last day of the
Term.
Section 1.42
“ Force Majeure Event ” has the meaning set
forth in Section 15.7.
3
Section 1.43
“ GAAP ” has the meaning set forth in Section
7.2(c).
Section 1.44
“ Governmental Authority ” shall mean any court,
agency, authority, department, regulatory body or other
instrumentality of any government or country or of any national,
federal, state, provincial, regional, county, city or other
political subdivision of any such government or any supranational
organization of which any such country is a member, which has
competent and binding authority to decide, mandate, regulate,
enforce, or otherwise control the activities of the Parties
contemplated by this Agreement.
Section 1.45
“ Initial Agreement Quarter ” means the period
commencing on the Effective Date and ending on September 30,
2007.
Section 1.46
“ Initial Effective Date ” means July 18,
2007.
Section 1.47
“ JAMS ” has the meaning set forth in Section
3.5(b).
Section 1.48
“ JSC ” has the meaning set forth in Section
3.1.
Section 1.49
“ Legal Requirements ” means laws, rules and
regulations of any Governmental Authority in the Territory.
Section 1.50
“ Minimum Sales Force Level ” has the meaning
set forth in Section 4.3(a).
Section 1.51
“ NDA ” means any “new drug
application” (as such term is used under the Act) filed or
acquired by Depomed or any Affiliate with the FDA with respect to
the Product and all subsequent submissions, supplements and
amendments thereto, including NDA No. 21-744 filed with the FDA on
July 18, 2004 (as such NDA may be amended or supplemented
subsequent to the Initial Effective Date).
Section 1.52
“ Net Sales ” means, for a particular period,
the gross amount invoiced on sales of Product in the Territory
recognized as gross revenue in accordance with GAAP by Depomed, its
Affiliates, licensees, sublicensees and assigns to independent,
unrelated Third Parties during such period in bona fide arms’
length transactions, less the following deductions, calculated in
accordance with GAAP: (a) freight, insurance (but only insurance
with respect to shipping the Product), and other transportation
charges to the extent added to the sales price and set forth
separately as such on the total amount invoiced; (b) any sales,
use, value-added, excise taxes or duties or allowances on the
selling price of Product; (c) chargebacks, trade, quantity and cash
discounts and rebates to the extent customary in the trade,
including governmental rebates; (d) allowances or credits,
including allowances or credits to customers on account of
rejection, defects or returns of the Product entering trade after
the Promotion Commencement Date, or because of a retroactive price
reduction; and (f) costs associated with any Product voucher
or co-pay assistance programs, to the extent funded by Depomed and
approved by Watson. Net Sales shall not include a sale or transfer
to an Affiliate, licensee, sublicensee or assign of Watson or
Depomed or if done for clinical, regulatory or governmental
purposes where no consideration is received; but the resale by such
Affiliate, licensee, sublicensee or assign of Watson or Depomed
shall be considered a sale of such Product.
4
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
Section 1.53
“ Ob/Gyn Detail Minimum ” means, for a
particular period, [***] of the PDEs required to be performed on
Professionals on the Watson Physician List within the Ob/Gyn Field
for such Period, as reflected in the Annual Plan(s) or the 2007
Plan (as applicable) for such period and in Sections 4.1(c) –
(j) of this Agreement (as applicable).
Section 1.54
“ Ob/Gyn Field ” means Professionals practicing
obstetrics and/or gynecology, as so identified by primary AMA
specialty, and set forth in the Prescriber Data.
Section 1.55
“ Order ” means any award, decision, injunction,
judgment, decree, order, ruling, or verdict entered, issued, made,
or rendered by any Governmental Authority or by any
arbitrator.
Section 1.56
“ P1 Detail ” means a Detail where the Product
is the first item presented.
Section 1.57
“ P2 Detail ” means a Detail where the Product
is the second item presented.
Section 1.58
“ P3 Detail ” means a Detail where the Product
is the third item presented.
Section 1.59
“P A/NP Prescription Units ” means, for a
particular period, the number of Units of Product included within
Product prescriptions filled during such period in the Territory
that result from prescriptions written by Physician Assistants and
Nurse Practitioners, as reflected in the Prescriber Data.
Section 1.60
“ PDE ” means a Primary Detail Equivalent, and
is equivalent to either of the following: [***]. Details
other than P1 Details, P2 Details and P3 Details will have no
effect on any calculation of PDEs. P3 Details will have no effect
on the calculation of PDEs prior to December 31, 2008.
Section 1.61
“ PDMA ” means the Prescription Drug Marketing
Act, as amended, and the rules and regulations promulgated
thereunder.
Section 1.62
“ Person ” means any individual, corporation
(including any non-profit corporation), general or limited
partnership, limited liability company, joint venture, estate,
trust, association, organization, labor union, or other entity or
Governmental Authority.
Section 1.63
“ Prescriber Data ” means IMS Health National
Prescription Audit data, which measures both total prescriptions
dispensed and extended units dispensed (i.e., Units) for
Product in the Territory, separately setting forth the
Urology Field, the Ob/Gyn Field, the sales Channel (long term
care), and prescriptions attributable to Physician Assistants and
Nurse Practitioners during a specified time period, or such data
from an alternative source mutually agreed in writing by the
Parties.
Section 1.64
“ Product ” means the once-daily oral tablet
formulation containing ciprofloxacin as the sole active
pharmaceutical ingredient known as ProQuin XR and approved in the
Territory under NDA No. 21-744 approved by the FDA on May 19, 2005
(as such NDA may be amended or supplemented subsequent to the
Initial Effective Date).
Section 1.65
“ Product Complaints ” means any report
concerning the quality, purity, quantity, weight, pharmacologic
activity, labeling, identity or appearance of the Product.
Section 1.66
“ Professional ” means a physician or other
health care practitioner who is permitted by law to prescribe
Product.
Section 1.67
“ Promote ,” “ Promotional ”
and “ Promotion ” mean, with respect to the
Product, any activities undertaken to encourage sales or use of the
Product, including Details, product sampling, detail aids,
drop-offs, coupons, discount cards, journal advertising, direct
mail programs, direct-to-consumer advertising, convention exhibits
and all other forms of marketing, advertising, public relations or
promotion.
Section 1.68
“ Promotion Commencement Date ” has the meaning
set forth in Section 4.1(b).
Section 1.69
“ Promotion Fees ” has the meaning set forth in
Section 7.1(a).
Section 1.70
“ Promotional Effort ” has the meaning set forth
in Section 4.1(a).
Section 1.71
“ Promotional Materials ” has the meaning set
forth in Section 4.4(a).
Section 1.72
“ Proprietary Information ” means any
proprietary or confidential information communicated from one Party
to the other in connection or relating to this Agreement, which is
identified as confidential or proprietary, or which the other Party
knows or has reason to know is confidential or proprietary,
including the Technology and financial, marketing, business,
technical and scientific information or data, information related
to Watson’s compensation of its Sales Representatives,
information contained within the Annual Plan and 2007 Plan, and the
information described in Section 4.6, whether communicated in
writing, orally or electronically. Proprietary Information shall
not include information that the receiving Party can show through
written documentation:
(a)
at the time of disclosure, is publicly known;
(b)
after the time of disclosure, becomes part of the public domain,
except by breach of an agreement between the disclosing Party or
any Affiliate thereof and the receiving Party or any Affiliate
thereof;
(c)
is or was in the possession of the receiving Party or any Affiliate
thereof at the time of disclosure by the disclosing Party and was
not acquired directly or indirectly from the disclosing Party or
any Affiliate thereof or from any other party under an agreement of
confidentiality to the disclosing Party or any Affiliate thereof;
and
(d)
is or was developed by the receiving Party or its Affiliates
without use of or reference to the other Party’s Proprietary
Information.
Section 1.73
“ Regulatory Approval ” means any and all
consents or other authorizations or approvals required from a
Governmental Authority to market and sell the Product in the
Territory, but excluding any form of reimbursement approval.
2
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
Section 1.74
“ Sales Representatives ” means sales
representatives employed by Watson to Promote the Product, who have
been trained and equipped to Promote the Product in accordance with
this Agreement. Third Parties may only be engaged as Sales
Representatives if they are full-time contractors of Watson,
exclusive to Watson, and carry Watson’s business card.
Section 1.75
“ Samples ” has the meaning set forth in Section
6.5.
Section 1.76
“ Serious Adverse Drug Experience ” means any
Adverse Drug Experience, including those subject to expedited
reporting as defined in the regulations cited below, that is fatal
or life-threatening, requires hospitalization or prolongation of
existing hospitalization, results in persistent or significant
disability or incapacity, is a congenital anomaly/birth defect, or
is of comparable medical significance or any other event which
would constitute a “serious” Adverse Drug Experience
pursuant to the terms of 21 C.F.R. 314.80 or 312.32.
Section 1.77
“ Serious Adverse Drug Experience Report ” means
any Adverse Drug Experience Report that involves a Serious Adverse
Drug Experience.
Section 1.78
“ Tail Gross Margin Percentage ” means the
following:
(a)
if this Agreement terminates on or after September 30, 2010 and
before September 30, 2011, [***] (if the Tail Period is eight
calendar quarters) or [***] (if the Tail Period is four calendar
quarters);
(b)
if this Agreement terminates on or after September 30, 2011 and
before September 30, 2012, [***] (if the Tail Period is eight
calendar quarters) or [***] (if the Tail Period is four calendar
quarters); or
(c)
if this Agreement terminates on or after September 30, 2012, [***]
(if the Tail Period is eight calendar quarters) or [***] (if the
Tail Period is four calendar quarters).
If
this Agreement terminates only in part with respect to the Ob/Gyn
Field or the Urology Field pursuant to Section 8.2(a), the Tail
Gross Margin Percentage shall be determined as set forth in clauses
(a) – (c) above with respect to each sub-Field upon the
termination of this Agreement with respect to that
sub-Field).
Section 1.79
“ Tail Period ” means, [***]. Notwithstanding
the foregoing, but subject to Section 8.7(c), there shall be no
Tail Period unless the Term shall be in effect until at least
September 30, 2010. If this Agreement terminates only in part with
respect to the Ob/Gyn Field or the Urology Field pursuant to
Section 8.2(a), there shall be a separate Tail Period for each
sub-Field, and the length of each such Tail Period shall be
determined as set forth in the immediately preceding sentence.
Section 1.80
“ Technology ” means all pharmacological,
toxicological, preclinical, clinical, technical or other
information, data and analysis and know-how relating to the
registration, manufacture, packaging, use, marketing and sale of
the Product and all proprietary
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
rights relating thereto owned by Depomed or its
Affiliates or to which Depomed or its Affiliates has rights so as
to be able to license, and relating or pertaining to the
Product.
Section 1.81
“ Term ” has the meaning set forth in Section
8.1.
Section 1.82
“ Territory ” means the United States, including
its territories and possessions and Puerto Rico.
Section 1.83
“ Third Party ” means any Person other than
Watson or Depomed or their respective Affiliates.
Section 1.84
“ Unit ” means a single tablet of the
Product.
Section 1.85
“ United States Bankruptcy Code ” shall mean the
U.S. Bankruptcy Code, 11 U.S.C. §§ 101, et seq
.
Section 1.86
“ Urology Detail Minimum ” means, for a
particular period, [***] of the PDEs required to be performed on
Professionals on the Watson Physician List within the Urology Field
for such Period, as reflected in the Annual Plan(s) or the 2007
Plan (as applicable) for such period and in Sections 4.1(c) –
(j) of this Agreement (as applicable).
Section 1.87
“ Urology Field ” means Professionals practicing
urology, as so identified by primary AMA specialty and set forth in
the Prescriber Data.
Section 1.88
“ Volume Forecast ” has the meaning set forth in
Section 6.3.
Section 1.89
“ Watson ” has the meaning set forth in the
preamble to this Agreement.
Section 1.90
“ Watson Physician List ” means the list of
Professionals to whom the Watson Sales Force presents Details,
which list has been agreed to in writing by the Parties prior to
the Effective Date (it being understood that such list includes
[***]. The Watson Physician List is subject to change from time to
time throughout the Term of this Agreement to reflect the then
current [***], or as otherwise agreed in writing by the
Parties.
Section 1.91
“ Watson Sales Force ” means the field force of
Sales Representatives employed or contracted by Watson to Promote
the Product in the Territory within the Field.
Section 1.92
“ Watson Trademarks ” means the trademarks set
forth on Schedule 1.92 .
Section 1.93
“ Wholesaler Affiliate ” shall mean an affiliate
of Watson, substantially all of the business of which consists of
the wholesale distribution of pharmaceutical products.
ARTICLE
II
GRANT
Section 2.1
Grant of Promotion Rights .
During the Term, subject to the terms and conditions of this
Agreement, Depomed hereby grants to Watson and its Affiliates and
Watson and its Affiliates hereby accept a co-exclusive right
(together with Depomed and its Affiliates only) to Promote the
Product under the Depomed Trademarks in the Territory within the
Field and Channel on the terms and subject to the conditions set
forth herein.
Section 2.2
Sublicense . Watson shall
not sublicense, subcontract or otherwise transfer or delegate any
of its rights or obligations under this Agreement without the
express written consent of Depomed, which consent may not be
unreasonably withheld or delayed by Depomed.
Section 2.3
Limitation on Promotion
.
(a)
During the Term of this Agreement, the Watson Sales Force shall not
(i) Promote in the Territory any product containing ciprofloxacin
hydrochloride, or (ii) Promote in the Territory within the Field
any product for the treatment of urinary tract infections, in each
case other than the Product.
(b)
During the period beginning on the Initial Effective Date and
ending on December 31, 2008, Watson shall not, and shall cause if
Affiliates not to, Promote in the Territory any product containing
ciprofloxacin hydrochloride, other than the Product.
Section 2.4
Retention of Rights .
Depomed retains and shall retain all proprietary and property
interests in the Product until the point of sale or, in the case of
Samples, until delivered to Watson as contemplated by Section 6.5.
Watson will not have nor represent that it has any control or
proprietary or property interests in the Product, except for the
licenses and rights specifically granted hereunder. Except as
expressly set forth herein, nothing contained herein shall be
deemed to grant Watson, by implication, a license or other right or
interest in any patent, trademark or other similar property of
Depomed or its Affiliates, except as may be necessary for Watson to
Promote the Product pursuant to this Agreement. Except as expressly
set forth herein, nothing contained herein shall be deemed to grant
Depomed, by implication, a license or other right or interest in
any patent, trademark or other similar property of Watson or its
Affiliates, except as may be necessary for Depomed to Promote the
Product pursuant to this Agreement.
Section 2.5
Esprit Termination Agreement
. Depomed has entered into the Esprit Termination Agreement,
which provides for, among other matters, the termination of the
Esprit License Agreement and a transition plan providing for the
transition of the Product back to Depomed from Esprit that includes
specific activities and timelines (the “ Transition
Plan ”). Watson has reviewed the Transition Plan. Depomed
will use its reasonable best efforts to cause Esprit to comply with
its obligations under the Esprit Termination Agreement and the
Transition Plan. So long as Depomed uses its reasonable best
efforts to cause Esprit to comply with its obligations under the
Esprit Termination Agreement and the Transition Plan, Depomed shall
not
2
be
in breach of this Agreement as a result of any failure by Esprit to
comply with its obligations under the Esprit Termination Agreement
or the Transition Plan.
ARTICLE
III
JOINT
STEERING COMMITTEE
Section 3.1
Establishment . The Parties
agree to establish, for the purposes specified herein, a Joint
Steering Committee (the “ JSC ”). The Parties
acknowledge and agree that the JSC does not have the power to
amend, modify or waive any of the terms or conditions of this
Agreement.
Section 3.2
Joint Steering Committee .
The JSC shall be established by the Parties and shall be comprised
of four members, two of whom shall be appointed by Depomed and two
of whom shall be appointed by Watson. Each Party’s respective
initial appointments to the JSC are set forth on Schedule
3.2 hereto. A Party may change any of its representatives at
any time if a new person is appointed to any of the foregoing
positions by giving written notice to the other Party. The total
number of JSC members may be changed by unanimous vote of the JSC
from time to time as appropriate; provided , that the JSC
shall in all cases be comprised of an equal number of members from
each of Depomed and Watson. Watson and Depomed each will designate
one representative of such Party to serve as co-chairs of the JSC
(the “ Co-Chairs ”). The members appointed to
the JSC by each Party shall be employees of such Party and shall be
vested with appropriate decision-making authority and power by such
Party. The Chief Executive Officers of Watson and Depomed shall not
be members of the JSC.
Section 3.3
JSC Responsibilities . The
responsibilities of the JSC shall be exercised consistent with this
Agreement and shall include, but shall not be limited to:
(a)
reviewing and approving the Annual Plan as contemplated by Section
4.5 (which approval shall include, without limitation, approval of
the number of P1 Details, P2 Details and P3 Details to be performed
by the Watson Sales Force for periods after December 31,
2008);
(b)
monitoring and reviewing compliance with the 2007 Plan or the
Annual Plan;
(c)
reviewing Product Promotion strategies and objectives, including
Product positioning, messaging and branding;
(d)
reviewing Product-related activities associated with managed
markets, trade pipeline, manufacturing, and distribution;
(e)
reviewing pricing for the Product;
(f)
reviewing Product-related regulatory matters;
(g)
reviewing sales incentive compensation for the Watson Sales Force
related to the Product for periods through December 31, 2008;
3
(h)
reviewing and approving sales incentive compensation for the Watson
Sales Force related to the Product for periods after December 31,
2008;
(i)
such other functions as may be mutually agreed upon by the Parties
from time to time.
For the
avoidance of doubt, (i) the JSC shall not have any review or
approval rights with respect to any matters relating to the
development of the Product and (ii) any decisions of the JSC with
respect to matters which relate to Regulatory Approval for the
Product shall require Depomed’s prior written
consent.
Section 3.4
Meetings of the JSC .
Meetings of the JSC may be called by the Co-Chairs of the JSC from
time to time and, upon no less than five days’ notice, shall
otherwise be called when requested by a Party; provided ,
however , that meetings of the JSC shall be held on at least
a monthly basis during the first three months of the Term, and on
at least a quarterly basis thereafter. If possible, the meetings
shall be held in person or where appropriate, by video or telephone
conference. Unless otherwise agreed, the location of any in-person
meetings of the JSC shall alternate between the corporate offices
of the Parties. The Parties shall determine the form of the
meetings. Subject to Section 3.5, decisions shall be made
unanimously, each Party having one (1) vote regardless of the
number of representatives present or voting; provided , that
no such vote shall be valid unless each Party is represented by at
least two members either by written proxy or actual presence at the
meeting at which the vote is taken. Subject to appropriate
confidentiality undertakings where applicable, each Party shall
have the right, upon written notice to the other Party, to have
present at JSC meetings additional, non-voting participants (not to
exceed six such participants at any JSC meeting without the consent
of the other Party). Such additional participants shall not be
deemed to be, or have any rights or responsibilities of, a member
of the JSC. The Parties shall cause their respective
representatives on the JSC to use their reasonable efforts to
resolve all matters presented to them as expeditiously as possible.
Watson shall propose the agenda for each regular meeting and
appoint a secretary to the meeting who shall record the minutes of
the meeting. Such minutes shall be circulated to the Parties
promptly following the meeting for review and comment and for
unanimous ratification by both Parties. Each Party shall bear its
own travel and related costs incurred in connection with
participation in the JSC.
Section 3.5
JSC Disputes .
(a)
In the event that the JSC is, after a period of ten (10) days,
unable to make a decision due to a lack of required unanimity,
either Party may submit the matter being considered to the
Executive Officers for a joint decision. In such event, either
Co-Chair of the JSC, by written notice to the other Party, shall
formally request the dispute be resolved by the Executive Officers,
specifying the nature of the dispute with sufficient detail to
permit adequate consideration by the Executive Officers. The
Executive Officers shall diligently and in good faith attempt to
resolve the referred dispute expeditiously and, in any event,
within fifteen (15) days of receiving such written
notification.
(b)
In the event that the Executive Officers are unable to reach a
resolution of any referred dispute after good faith negotiations
during the fifteen (15) day period referred to in
4
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
Section 3.5(a) above and in the event such
dispute is not related to compliance with this Agreement,
regulatory matters, or the validity, breach or interpretation of
this Agreement, either Party may commence mediation within fifteen
days after the conclusion of such fifteen (15) day period by
providing to the other Party a written request for non-binding
mediation, setting forth the subject of the dispute and the relief
requested (a “ Mediation Notice ”). The Parties
will cooperate with Judicial Arbitration and Mediation Services
(“ JAMS ”) and with one another in selecting a
mediator from JAMS’ panel of neutrals, and in scheduling the
mediation proceedings. The Parties shall endeavor to conclude any
mediation under this Section 3.5 within thirty (30) days after
delivery by either Party of Mediation Notice. The Parties covenant
that they will participate in the mediation in good faith and that
they will share equally in its costs; provided that each Party will
be responsible for its own attorney’s fees. Either Party may
seek equitable relief prior to the mediation to preserve the status
quo pending the completion of that process. Except for such an
action to obtain equitable relief, neither Party may commence a
civil action with respect to the matters submitted to mediation
until after the completion of the initial mediation session, or
thirty days after delivery of the Mediation Notice, whichever
occurs first.
(c)
In furtherance of the foregoing provisions of Section 3.5(b), in
connection with any mediation conducted as set forth pursuant to
Section 3.5(b) with respect to a Detailing or Incentive
Compensation Dispute (as defined below), each Party shall submit to
the mediator selected pursuant to Section 3.5(b) and to the other
Party, at least two weeks in advance of the mediation proceedings,
a brief summarizing and supporting its contentions with respect to
the dispute for the purpose of facilitating the mediation
proceedings. If the Parties fail to resolve any Detailing or
Incentive Compensation Dispute following the completion of
mediation proceedings with respect to such Detailing or Incentive
Compensation Dispute (a “ Detailing or Incentive
Compensation Impasse ”), Depomed may terminate this
Agreement pursuant to Section 8.2(c). A “ Detailing or
Incentive Compensation Dispute ” is any dispute regarding
either (i) the incentive compensation payable to the Watson Sales
Force in respect of the Product for any period after December 31,
2008 where Watson proposes that less than [***] of the incentive
compensation payable to Watson Sales Representatives detailing the
Product will be dependent on sales of the Product, or (ii) the
number of P1 Details, P2 Details or P3 Details to be performed by
Watson for any period after December 31, 2009 where Watson proposes
to perform fewer than [***] annual PDEs (on a pro-rated basis for
partial years).
(d)
The Parties agree that items that are solely reviewed by the JSC,
and not both reviewed and approved by the JSC, are not subject to
the dispute resolution mechanism set forth in this Section 3.5. Any
disputes referred to the Executive Officers for resolution pursuant
to this Section 3.5 shall not be subject to any dispute resolution
mechanism or procedure unless and until the dispute resolutions
procedures set forth in this Section 3.5 are exhausted.
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
ARTICLE
IV
PRODUCT
PROMOTION
Section 4.1
Product Promotion .
(a)
Subject to applicable Legal Requirements, as well as the provisions
of this Agreement, Watson shall, from and after the Promotion
Commencement Date, at its sole expense, use commercially reasonable
efforts to Promote the Product in the Territory within the Field in
accordance with the 2007 Plan or Annual Plan for subsequent years
(the “ Promotional Effort ”). For purposes of
the preceding sentence, Watson’s commercially reasonable
efforts shall mean at least the same degree of effort (including
with respect to the reach and frequency of Details) that Watson
would use for the Promotion of any of Watson’s products that
represent a similar commercial opportunity. The Parties acknowledge
that efforts that constitute commercially reasonable efforts may
change during the Term. All statements, core selling messages and
materials to be utilized by Watson to Promote the Product shall be
consistent in all material respects with the Promotional Materials
provided or utilized by Depomed. Watson will cause the Watson Sales
Force and Watson employees and agents acting on Watson’s
behalf to comply with this Agreement and all applicable Legal
Requirements in connection with the Promotion of the Product. It is
understood, and Watson agrees, that it will be accountable for the
acts or omissions of the Watson Sales Force and its employees and
agents to the extent such acts or omissions fail to comply with
Watson’s obligations under this Agreement.
(b)
Watson shall commence (the date of such commencement, the “
Promotion Commencement Date ”) Promotion (including
Details by the Watson Sales Force) of the Product in accordance
with this Agreement and the performance of the other obligations
contained herein that are required to be performed from and after
the Promotion Commencement Date as soon as practicable following
the date hereof, but no later than October 15, 2007.
(c)
During the period beginning on the Promotion Commencement Date and
ending four months thereafter, Watson shall perform a P1 Detail on
at least [***] of the Professionals on the Watson Physician List
within the Urology Field at least once every [***];
(d)
During the period beginning on the Promotion Commencement Date and
ending on December 31, 2007, Watson shall:
(i)
perform an aggregate of at least [***] P1 Details and [***] P2
Details on Professionals on the Watson Physician List within the
Urology Field; and
(ii)
perform an aggregate of at least [***] P2 Details on Professionals
on the Watson Physician List within the Ob/Gyn Field.
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
(e)
During each Agreement Quarter in 2008, Watson shall perform at
least [***] P1 Details and [***] P2 Details on Professionals on the
Watson Physician List within the Urology Field.
(f)
During the Agreement Quarters ending on March 31, 2008 and December
31, 2008, Watson shall perform at least [***] P1 Details on
Professionals on the Watson Physician List within the Ob/Gyn
Field.
(g)
During the Agreement Quarters ending on June 30, 2008 and September
30, 2008, Watson shall perform at least [***] P2 Details on
Professionals on the Watson Physician List within the Ob/Gyn
Field.
(h)
During each Agreement Quarter in 2009, Watson shall perform at
least [***] Details on Professionals on the Watson Physician List
within the Urology Field, which Details shall be allocated between
P1 Details, P2 Details and P3 Details as reflected in the Annual
Plan for 2009 approved by the JSC.
(i)
During each Agreement Quarter during the Term commencing with the
Agreement Quarter beginning on January 1, 2009, Watson shall
perform such number of Details on Professionals on the Watson
Physician List within the Ob/Gyn Field, and allocated between P1
Details, P2 Details and P3 Details, as is reflected in the Annual
Plan approved by the JSC for the applicable year.
(j)
During each Agreement Quarter during the Term commencing with the
Agreement Quarter beginning on January 1, 2010, Watson shall
perform such number of Details on Professionals on the Watson
Physician List within the Urology Field, and allocated between P1
Details, P2 Details and P3 Details, as is reflected in the Annual
Plan approved by the JSC for the applicable year.
(k)
Representations to Customers
. Watson will not make any false or misleading representations
to Professionals, customers or others regarding Depomed or the
Product and will not make any representations, warranties or
guarantees with respect to the specifications, features or
capabilities of the Product that are not consistent with the
applicable then-current FDA approved labeling, package insert or
other documentation accompanying or describing the Product,
including Depomed’s standard limited warranty and
disclaimers. Watson agrees to undertake timely and complete
corrective action for any deviations from this Section 4.2, subject
to discussion and review by Depomed’s regulatory affairs and
quality assurance department.
Section 4.2
Watson Sales Force Staffing,
Training and Compensation .
(a)
Watson agrees that from and after the Promotion Commencement Date,
the Watson Sales Force will be staffed with at least [***]
full-time Sales Representatives (subject to vacancies consistent
with average vacancy rate experienced by Watson across its total
sales force) who are actively promoting the Product in accordance
with the 2007 Plan or Annual Plan (the “ Minimum Sales
Force Level ”). Throughout the remainder of the Term,
Watson shall use
Confidential
Information, indicated by [***], has been omitted from this filing
and filed separately with the Securities Exchange
Commission
its
commercially reasonable efforts to ensure that the number of Sales
Representatives comprising the Watson Sales Force meets or exceeds
the Minimum Sales Force Level.
(b)
Watson shall be solely responsible for all costs and expenses of
compensating its Sales Representatives. Consistent with applicable
Legal Requirements, Watson shall pay incentive compensation to
Watson Sales Representatives with respect to the Product in
accordance with Watson’s incentive compensation;
provided , however , that through December 31, 2007,
at least [***] and through December 31, 2008, at least [***] of the
incentive compensation payable to Watson Sales Representatives
detailing the Product will be dependent on sales of the Product. In
addition, Depomed may sponsor sales contests or other special
incentive compensation, at its own expense, for Watson’s
sales force with Watson’s approval. Watson will be
responsible for implementing any such contest or incentive
compensation.
(c)
Watson shall notify its Sales Representatives prior to the
Promotion Commencement Date, consistent with its procedures for
Watson’s other products, of the total potential incentive
compensation for the Product. Promptly after the adoption by Watson
of an incentive compensation payment plan with respect to the
Product pursuant to, and in compliance with, this Agreement, and
promptly after any material amendments to such plan, Watson shall
provide to Depomed a summary of the methodology used by Watson to
make incentive compensation payments for the Product pursuant to
such plan.
(d)
The Parties hereby agree that Depomed shall provide to Watson, at
no charge to Watson and in quantities agreed by the Parties in
writing prior to the Initial Effective Date, previously generated
training materials and/or associated electronic copies thereof
where applicable. Watson shall furthermore have the option to
purchase from Depomed, in sufficient quantities for the Watson
Sales Force, additional training materials for the Product created
or owned by Depomed, at Depomed’s out-of-pocket cost for such
materials. It is anticipated that Watson will utilize
Depomed’s training materials in connection with the
Product-related training of its Sales Representatives. Any training
materials for Watson’s Sales Representatives developed or
created by Watson shall be subject to Depomed’s review as
Promotional Materials as provided in Section 4.4. Watson shall, at
its own expense prior to the Promotion Commencement Date, train its
Sales Representatives using such training materials, the other
Promotional Materials and such programs as Watson shall deem
appropriate that are in compliance with Watson’s obligations
hereunder and all other Legal Requirements. Such programs shall
include training with respect to reporting Adverse Drug Experiences
and technical complaints. After the initial training, Watson shall
periodically provide additional training to each of its Sales
Representatives, and shall update its training materials as
appropriate in connection with such additional training, in
accordance with this Section 4.3. Representatives of Depomed may
attend, at Depomed’s expense, any Watson training session
related to the Product. Watson will notify Depomed at least two
weeks in advance of any such training session.
Section 4.3
Promotional Materials; Educational
Materials .
(a)
Subject to Section 4.4(b), The Parties may, each at its sole
expense, create prototypes of promotional, advertising, marketing
and educational materials (“ Promotional
Materials ”) to support the
Promotional Effort for the Product in the Territory within the
Field. Such Promotional Materials may include, by way of example,
detailing aids; leave items; journal advertising; appropriate
reprints and reprint carriers; and product monographs. All
Promotional Materials used by the Watson Sales Force will be
subject to the review and approval of the Depomed APL. All
Promotional Materials developed by Watson hereunder shall
prominently display such Depomed Trademark(s) as shall be specified
by Depomed to Watson
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