CERTAIN MATERIAL
(INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
Dated as of July 21,
2008
This PROMOTION
AGREEMENT (this “ Agreement ”) is made as of
July 21, 2008 (the “ Effective Date ”), by
and between Depomed, Inc., a California corporation (“
Depomed ”), and Santarus, Inc., a Delaware corporation
(“ Santarus ”). Each of Depomed and Santarus is
referred to herein individually as a “ party ”
and collectively as the “ parties .”
WHEREAS, Depomed
desires to engage Santarus to promote and market the Products in
the Territory (each as defined below), and Santarus desires to
promote and market the Products, all in accordance with the terms
and conditions contained 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:
As used in this
Agreement, the following terms shall have the following
meanings:
Section 1.1
“ 500mg Product ” means the once-daily
formulation of 500 mg of metformin HCl that is the subject of NDA
No. 21-748 filed with FDA on April 27, 2004 (as such NDA
may be amended or supplemented subsequent to the filing
date).
Section 1.2
“ 1000mg Product ” means the once-daily
formulation of 1000 mg of metformin HCl that is the subject of NDA
No. 21-748 filed with FDA on April 27, 2004 (as such NDA
may be amended or supplemented subsequent to the filing
date).
Section 1.3
“ 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 1.4
“ AcuForm Patent License ” has the meaning
set forth in Section 10.1.
Section 1.5
“ Adverse Drug Experience ” means any “
adverse drug experience ” as defined or contemplated
by 21 C.F.R. 314.80 or 312.32, associated with a
Product.
Section 1.6
“ Adverse Drug Experience Report ” means any
oral, written or electronic report of any Adverse Drug Experience
transmitted to any Person.
Section 1.7
“ Advertising/Marketing/Educational Expenses ”
means the following Santarus expenses for directly Promoting the
Products and conducting Educational Programs with respect to the
Products in the Territory: (a) all out-of-pocket costs for
Samples incurred as contemplated by Section 6.5 as well as all
out-of-pocket costs for Sample warehousing and distribution,
(b) all out-of-pocket costs for Promotional Materials and
training materials, (c) all
out-of-pocket
costs for sales training meetings to the extent attributable to the
Products, (d) all out-of-pocket costs for the purchase of
Prescriber Data (including any prescriber data for competitive
products), (e) all out-of-pocket costs associated with market
research, advisory boards, speaker programs, trade shows and
“lunch and learns” and other outreach programs with
respect to the Products, (f) all costs related to scientific
liaisons, and national and regional account managers to the extent
attributable to the Products, (g) all costs related to up to
one (1) full-time equivalent dedicated product manager;
(h) all Medical Affairs Expenses reimbursed by Santarus
pursuant to Section 4.7; and (i) all other out-of-pocket
costs and expenses of Santarus for directly Promoting the Products
and conducting Educational Programs with respect to the Products in
the Territory. In the case of Product voucher, coupon, loyalty card
or other co-pay assistance programs approved by the JCC, all
out-of-pocket costs of Santarus associated with such programs
(other than redemption costs) shall be treated as
Advertising/Marketing/ Educational Expenses. Notwithstanding the
foregoing, (A) the costs set forth in items (f) and
(g) above shall be subject to a $[***] cap per Agreement
Quarter and (B) the costs set forth in item (c) above
shall be subject to a $[***] cap during the Launch Period and to a
$[***] cap during each twelve (12) month period thereafter;
and such costs in excess of the caps set forth in clauses
(A) and (B) shall not be treated as
Advertising/Marketing/Educational Expenses.
Section 1.8
“ 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.
Section 1.9
“ Agreement ” has the meaning set forth in the
preamble to this Agreement.
Section 1.10
“ 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 1.11
“ 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 1.12
“ Annual Plan ” has the meaning set forth in
Section 4.5(a).
Section 1.13
“ Baseline Percentage ” means the percentage
determined by dividing (a) the total number of Units of
Product prescribed by Professionals on the Depomed Physician List
during the two (2) complete Agreement Quarters prior to
delivery by Depomed of its intention to commence Promotion and
Detailing of the Product in the Territory pursuant to
Section 4.9, by (b) the total number of Units of Product
prescribed by all Professionals during such two (2) complete
Agreement Quarters, based on Prescriber Data for such two
(2) complete Agreement Quarters, as such percentage may be
amended pursuant to Section 4.9.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
2
Section 1.14
“ BLS ” means Biovail Laboratories International
SRL, or any Person which succeeds to the obligations of Biovail
Laboratories International SRL under the BLS Agreements.
Section 1.15
“ BLS Agreements ” means, collectively, the BLS
License Agreement, the BLS Manufacturing Transfer Agreement and the
BLS Supply Agreement.
Section 1.16
“ BLS Fees ” means, for any period, the sum of
the following amounts actually paid by Depomed to BLS in such
period: (a) earned royalty payments made pursuant to
Section 4.6 of the BLS Manufacturing Transfer Agreement
attributable to Promotion Net Sales of the 500mg Product, and (b)
(i) the Supply Price (as defined under the BLS Supply
Agreement) for the 1000mg Product or (ii) in the event that
BLS is no longer supplying the 1000mg Product under the BLS Supply
Agreement, earned royalty payments made pursuant to
Section 4.2 of the BLS Manufacturing Transfer Agreement
attributable to Promotion Net Sales of the 1000mg Product; but only
to the extent and for so long as such amounts are actually paid by
Depomed in respect of supply or the Promotion Net Sales for such
period under the applicable BLS Agreement. In the event the amounts
actually paid under any such BLS Agreement are reduced or
terminate, or Depomed receives a credit for any prior payment of
BLS Fees or receives any other payment from BLS under any BLS
Agreement, the BLS Fees will correspondingly be reduced or
terminate or the credit or other payment shall be applied to the
then-current calculation of BLS Fees.
Section 1.17
“ BLS License Agreement ” means that certain
Amended and Restated License Agreement (Extended Release Metformin
Formulations — Canada), dated as of December 13, 2005,
by and between Depomed and BLS, as the same may be amended from
time to time.
Section 1.18
“ BLS Manufacturing Transfer Agreement ” means
that certain Manufacturing Transfer Agreement (Controlled Release
Metformin Formulations — USA), dated as of December 13,
2005, by and between Depomed and BLS, as the same may be amended
from time to time.
Section 1.19
“ BLS Supply Agreement ” means that certain
Supply Agreement (Extended Release Metformin Formulations —
U.S.A.), dated as of December 13, 2005, between Depomed and
BLS, as amended on June 30, 2007, as the same may be amended
from time to time.
Section 1.20
“ Branded Extended Release Metformin Products ”
shall mean (i) Glucophage XR (metformin hydrochloride)
Extended Release Tablets (NDA No. 21202) and Fortamet
(metformin hydrochloride) Extended Release Tablets (NDA
No. 21574), each in the dosage strengths and formulations
marketed as of the Effective Date (and excluding any generic forms
of such products); and (ii) the Products.
Section 1.21
“ Branded Metformin Products ” shall mean
(i) Glucophage (metformin hydrochloride) Tablets (NDA
No. 20357) in the dosage strengths and formulations marketed
as of the Effective Date (and excluding any generic forms of such
product); and (ii) the Branded Extended Release Metformin
Products.
3
Section 1.22
“ 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 a Product pursuant to
its regulations, guidelines or otherwise.
Section 1.23
“ Co-Chairs ” has the meaning set forth in
Section 3.2.
Section 1.24
“ COGS ” means, for a particular period,
Depomed’s cost of goods sold (calculated in accordance with
Section 7.3(c)) for the Products in the Territory for such
period, but not including (i) BLS Fees, (ii) expenses
which are to be deducted from gross sales in reaching the
calculation of Net Sales hereunder, and (iii) costs of Samples
purchased from Depomed by Santarus hereunder.
Section 1.25
“ Combination Product ” has the meaning set
forth in Section 13.1.
Section 1.26
“ Confidentiality Agreement ” means that certain
Confidentiality Agreement, dated as of May 20, 2004, between
Depomed and Santarus.
Section 1.27
“ 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 1.28
“ DDMAC ” means the FDA’s Division of Drug
Marketing, Advertising and Communications, or any successor
Governmental Authority performing comparable functions in the
Territory.
Section 1.29
“ Depomed ” has the meaning set forth in the
preamble to this Agreement.
Section 1.30
“ Depomed Gross Margin ” means, for a particular
period, (A) Depomed Net Sales for such period minus (B)
(i) all BLS Fees for such period (multiplied by the Depomed
Percentage for such period) and (ii) COGS for such period
(multiplied by the Depomed Percentage for such period).
Section 1.31
“ Depomed Net Sales ” means, for a particular
period, Net Sales for such Period, multiplied by the Depomed
Percentage for such period.
Section 1.32
“ Depomed Percentage ” means, for a particular
period during which Depomed is Promoting and Detailing a Product
pursuant to Section 4.9, the difference of (a) the
percentage determined by dividing (i) the total number of
Units of Product prescribed during such period by Professionals on
the Depomed Physician List, by (ii) the total number of Units
of Product prescribed during such period by all Professionals, in
each case based on Prescriber Data for the applicable period; minus
(b) the Baseline Percentage; provided that the Depomed
Percentage shall not be less than zero.
Section 1.33
“ Depomed Physician List ” means the list of
obstetrics and gynecology Professionals to whom the Depomed Sales
Force may present Details, as such list may be
4
amended from
time to time as contemplated by this Agreement; provided
that the list must conform to the requirements of
Section 4.9.
Section 1.34
“ Depomed Promotional Materials ” has the
meaning set forth in Section 4.9(d).
Section 1.35
“ Depomed Sales Force ” means the field force of
Sales Representatives employed or contracted by Depomed.
Section 1.36
“ Depomed Supply Failure ” means any
circumstances under which any back-up manufacturing rights in favor
of Depomed pursuant to any supply arrangement relating to the
applicable formulation of the Product are applicable as a result of
a failure to fill wholesaler and distributor orders of the
applicable Product.
Section 1.37
“ Depomed Trademarks ” means
(a) Glumetza ® , (b) the AcuForm™ 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
and other trademark related rights. The Depomed Trademarks are
attached hereto as Schedule 1.37 .
Section 1.38
“ Detail ” means an in-person, face-to-face
sales presentation of a Product made by a Sales Representative to a
Professional, including a P1 Detail or P2 Detail.
Section 1.39
“ Educational Programs ” means any activities
undertaken with respect to the education of Professionals,
pharmacists, managed care representatives or customers regarding a
Product or any indication for a Product or funded by unrestricted
educational grants, including educational programs and seminars and
education materials.
Section 1.40
“ Effective Date ” has the meaning set forth in
the preamble to this Agreement.
Section 1.41
“ Evaluation Period ” has the meaning set forth
in Section 13.1.
Section 1.42
“ Executive Officers ” means the Chief Executive
Officers of Santarus and Depomed (or, if there is no such officer,
its President or other executive officer designated by the Chief
Executive Officer).
Section 1.43
“ FDA ” means the United States Food and Drug
Administration or any successor agency performing comparable
functions in the Territory.
Section 1.44
“ 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 1.45
“ Force Majeure Event ” has the meaning set
forth in Section 16.7.
Section 1.46
“ GAAP ” has the meaning set forth in
Section 7.3(c).
5
Section 1.47
“ Generic Drug Act ” has the meaning set forth
in Section 9.1(j).
Section 1.48
“[***]” means [***].
Section 1.49
“ 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 1.50
“ Gross Margin ” means, for a particular period,
(A) Promotion Net Sales for such period minus (B) (i) all
BLS Fees for such period (multiplied by the Promotion Percentage
for such period), and (ii) COGS for such period (multiplied by
the Promotion Percentage for such period).
Section 1.51
“ Initial Agreement Quarter ” means the period
commencing on the Effective Date and ending on December 31,
2008.
Section 1.52
“ JAMS ” has the meaning set forth in
Section 3.5(b).
Section 1.53
“ JCC ” has the meaning set forth in
Section 3.1.
Section 1.54
“ Launch Period ” means the period beginning on
the Effective Date and ending on March 31, 2009.
Section 1.55
“ Launch Plan ” means the plan and schedule for
the commercial re-launch of the Products in the Territory during
the Launch Period, including the parties’ responsibilities
for the activities associated with such commercial re-launch of the
Products, a budget for the activities to be undertaken in
connection with such commercial re-launch. The initial Launch Plan
describing a summary of the plan and schedule for commercial
re-launch is attached hereto as Schedule 1.55
.
Section 1.56
“ Legal Requirements ” means laws, rules and
regulations of any Governmental Authority in the Territory,
including, for clarity, all guidelines, policies and procedures
referenced in Section 5.3 of this Agreement.
Section 1.57
“ Mediation Notice ” has the meaning set forth
in Section 3.5(b).
Section 1.58
“ Medical Affairs Expenses ” means all of
Depomed’s out-of-pocket costs related to the handling of
medical inquiries under Section 4.7 to the extent attributable
to the Product.
Section 1.59
“ Metformin Product Rights ” has the meaning set
forth in Section 13.1.
Section 1.60
“ Minimum Detailing Obligations ” has the
meaning set forth in Section 4.1(b).
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
|
6
Section 1.61
“ Minimum Detailing Period ” has the meaning set
forth in Section 4.1(b).
Section 1.62
“ 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 a Product and all subsequent submissions, supplements and
amendments thereto, including NDA No. 21-748 filed with the
FDA on April 27, 2004 (as such NDA may be amended or
supplemented subsequent to the filing date).
Section 1.63
“ Negotiation Period ” has the meaning set forth
in Section 13.1.
Section 1.64
“ 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 to
arrive at net sales 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 to the
extent added to the sales price and set forth separately as such on
the total amount invoiced; (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, or because of a
retroactive price reduction; and (e) redemption costs
associated with any Product voucher, coupon, loyalty card or other
co-pay assistance programs approved by the JCC, or listed in
Schedule 4.5(h) . Net Sales shall not include a sale or
transfer to an Affiliate, licensee, sublicensee or assign of
Santarus 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
Santarus or Depomed shall be considered a sale of such Product. For
purposes of clarity, it is the intent of the parties that
“Net Sales” for the purposes of this Agreement shall be
consistent with the GAAP net sales reported by Depomed in its
periodic reports with the U.S. Securities and Exchange
Commission.
Section 1.65
“ 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 1.66
“ P1 Detail ” means a Detail in which the
promotional message involving a Product is presented in the first
position and is the principal topic of discussion during the
contact.
Section 1.67
“ P2 Detail ” means a Detail in which the
promotional message involving a Product is presented in the second
position and is emphasized more than any other product in the
Detail, except for the product in the P1 Detail.
Section 1.68
“ PDMA ” means the Prescription Drug Marketing
Act, as amended, and the rules and regulations promulgated
thereunder.
7
Section 1.69
“ Patheon ” means Patheon Puerto Rico, Inc.
(f/k/a MOVA Pharmaceutical Corporation), or any Person which
succeeds to the obligations of Patheon Puerto Rico, Inc. under the
Patheon Agreement.
Section 1.70
“ Patheon Agreement ” means that certain
Commercial Manufacturing Agreement, dated as of December 19,
2006, by and between Depomed and Patheon, as the same may be
amended from time to time.
Section 1.71
“ 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 1.72
“ Prescriber Data ” means data provided by a
Third Party which measures prescriptions filled for Products (by
individual prescriber) in the Territory during a specified time
period, from a source mutually agreed in writing by the parties (it
being understood that each of IMS Health Incorporated and Wolters
Kluwer is a source agreeable to the parties).
Section 1.73
“ Product(s) ” means any pharmaceutical product
formulation for human use containing metformin or any other salt,
chiral forms or metabolites thereof as the sole active
pharmaceutical ingredient, including the 500mg Product and the
1000mg Product.
Section 1.74
“ Product Complaints ” means any report
concerning the quality, purity, quantity, weight, pharmacologic
activity, labeling, identity or appearance of a Product.
Section 1.75
“ Professional ” means a physician or other
health care practitioner who is permitted by law to prescribe
Products.
Section 1.76
“ Promote, ” “ Promotional ”
and “ Promotion ” mean, with respect to a
Product, any activities undertaken to encourage sales or use of
such 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 1.77
“ Promotion Commencement Date ” has the meaning
set forth in Section 4.1(e).
Section 1.78
“ Promotion Fees ” has the meaning set forth in
Section 7.2(a).
Section 1.79
“ Promotion Net Sales ” means Net Sales
multiplied by the Promotion Percentage.
Section 1.80
“ Promotion Percentage ” means, for a particular
period, 100% minus the Depomed Percentage for such period, if any
Depomed Net Sales occur in such period.
Section 1.81
“ Promotional Effort ” has the meaning set forth
in Section 4.1(a).
Section 1.82
“ Promotional Materials ” has the meaning set
forth in Section 4.4(a).
8
Section 1.83
“ 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 Santarus’ compensation of its Sales Representatives,
information contained within the Annual Plan and Launch 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 1.84
“ Regulatory Approval ” means any and all
consents or other authorizations or approvals required from a
Governmental Authority to market and sell a Product in the
Territory, but excluding any form of reimbursement
approval.
Section 1.85
“ Safety Stock ” has the meaning set forth in
Section 6.1.
Section 1.86
“ Sales Force Expenditures ” means the costs
allocated to the Santarus Sales Force in accordance with
Section 4.1(c).
Section 1.87
“ Sales Representatives ” means sales
representatives employed by Santarus or Depomed, or a Third Party
engaged by Santarus or Depomed, to Detail the Products, who have
been trained and equipped to Detail the Products in accordance with
this Agreement.
Section 1.88
“ Samples ” has the meaning set forth in
Section 6.5.
Section 1.89
“ Santarus ” has the meaning set forth in the
Preamble to this Agreement.
Section 1.90
“ Santarus CAC ” means Santarus’ Copy
Approval Committee.
Section 1.91
“ Santarus Manufacturing Notice ” has the
meaning set forth in Section 6.6.
9
Section 1.92
“ Santarus Sales Force ” means the field force
of Sales Representatives employed or engaged by Santarus, including
field-based sales force management such as regional and district
sales managers.
Section 1.93
“ Santarus Trademarks ” means the trademarks set
forth on Schedule 1.93 , including the “
Santarus ” trademark and associated design and
logo.
Section 1.94
“ 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 1.95
“ Serious Adverse Drug Experience Report ” means
any Adverse Drug Experience Report that involves a Serious Adverse
Drug Experience.
Section 1.96
“ Subcontracting ” means subcontracting or
sublicensing a party’s rights or obligations hereunder
(a) pursuant to which a Third Party will manufacture the
Products; or (b) pursuant to which a Third Party Sales
Representative is engaged to Promote the Products. “
Subcontractor ” means the Third Party with whom the
Subcontracting agreement is entered into.
Section 1.97
“ 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 or sale of a
Product and all proprietary 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.
Section 1.98
“ Term ” has the meaning set forth in
Section 8.1.
Section 1.99
“ Territory ” means the United States, including
its territories and possessions and Puerto Rico.
Section 1.100
“ Third Party ” means any Person other than
Santarus or Depomed or their respective Affiliates.
Section 1.101
“ Unit ” means one (1) tablet of the 1000mg
Product and two (2) tablets of the 500mg Product; provided
that “Unit” shall have such other meaning as the
parties may negotiate in good faith in the event that either party
reasonably determines that the then current definition of Unit does
not equitably reflect differences in value between the 500mg
Product and the 1000mg Product for purposes of calculating the
Baseline Percentage and the Depomed Percentage.
Section 1.102
“ United States Bankruptcy Code ” means the U.S.
Bankruptcy Code, 11 U.S.C. §§ 101, et seq.
10
Section 1.103
“ Valid Claim ” means a claim in any issued
patent or pending patent application which (a) has not been
held invalid or unenforceable by a non-appealed or un-appealable
decision of a court or government agency or other appropriate body
of competent jurisdiction and has not been admitted invalid through
disclaimer or dedication to the public, and (b) has not
expired, been determined to be unenforceable, been cancelled,
withdrawn, abandoned or been on file with the applicable patent
office for more than seven (7) years from the earlier of its
date of filing or earliest claim of priority under 35 U.S.C.
§119 or §120 and its successors in the United
States.
Section 1.104
“ Volume Forecast ” has the meaning set forth in
Section 6.3.
Section 2.1
Grant of Promotion Rights
During the Term,
subject to the terms and conditions of this Agreement (including
Depomed’s right to elect to Promote the Products as set forth
in Section 4.9), Depomed hereby grants to Santarus and its
Affiliates and Santarus and its Affiliates hereby accept an
exclusive right to Promote the Products under the Depomed
Trademarks in the Territory, on the terms and subject to the
conditions set forth herein. Depomed agrees that its and its
Affiliates’ right to Promote the Products is limited to the
rights set forth in Section 4.9.
Except pursuant to
Section 16.9 or in connection with the use of Third Party
Sales Representatives, Santarus shall not assign, 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 be withheld by Depomed in its sole
discretion.
Section 2.3
Limitation on Metformin Promotion
Except as
expressly contemplated by this Agreement (including
Article XIII hereof) and subject to Section 13.1 hereof,
Santarus shall not promote, market or distribute any product
containing metformin hydrochloride as the sole active ingredient in
the Territory during the Term of this Agreement, other than the
Products.
Section 2.4
Retention of Rights
Depomed retains
and shall retain all proprietary and property interests in the
Products until the point of sale or, in the case of Samples, until
delivered to Santarus as contemplated by Section 6.5. Santarus
will not have nor represent that it has any control or proprietary
or property interests in the Products, except for the licenses and
rights specifically granted hereunder. Except as expressly set
forth herein, nothing contained herein shall be deemed to grant
Santarus, 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 Santarus to Promote the
Products pursuant to this Agreement or to manufacture the Products
in accordance with Section 6.6. Except
11
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 Santarus or its
Affiliates, except as may be necessary for Depomed to Promote the
Products pursuant to this Agreement.
ARTICLE III
JOINT COMMERCIALIZATION COMMITTEE
Section 3.1
Establishment
The parties agree
to establish, for the purposes specified herein, a Joint
Commercialization Committee (the “ JCC ”). The
parties acknowledge and agree that the JCC does not have the power
to amend, modify or waive any of the terms or conditions of this
Agreement.
Section 3.2
Joint Commercialization Committee
The JCC shall be
established by the parties and shall be comprised of four
(4) members, two (2) of whom shall be appointed by
Depomed and two (2) of whom shall be appointed by Santarus.
Each party has indicated to the other its initial appointments to
the JCC. 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 JCC
members may be changed by unanimous vote of the JCC from time to
time as appropriate; provided, that the JCC shall in all cases be
comprised of an equal number of members from each of Depomed and
Santarus. Santarus and Depomed each will designate one
representative of such party to serve as co-chairs of the JCC (the
“ Co-Chairs ”). The members appointed to the JCC
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 Santarus and Depomed shall not be
members of the JCC.
Section 3.3
JCC Responsibilities
Except as
otherwise set forth herein, the JCC shall provide strategic
oversight of all Promotional activities for the Products hereunder,
it being understood that Santarus shall be responsible for
directing such Promotional and marketing activities. The
responsibilities of the JCC shall be exercised consistent with this
Agreement and shall include, but shall not be limited
to:
(a) reviewing
the Annual Plan as contemplated by Section 4.5(a);
(b) reviewing
material modifications by Santarus to the Annual Plan or the Launch
Plan;
(c) reviewing
Santarus’ Product Promotion strategies and objectives,
including Product positioning, messaging and branding;
(d)
if applicable, monitoring the Depomed Sales Force call plan for
coordination with the Santarus Sales Force;
12
(e) monitoring
advertising placement and market responses, including any
post-implementation reviews;
(f) reviewing
and approving any Volume Forecasts and reviewing any Sample
forecasts, consistent with Section 6.3;
(g) establishing
pricing for commercial sale of Products by or on behalf of Depomed,
including the timing of any pricing changes;
(h) reviewing
sales incentive compensation plans for the Santarus Sales Force
related to the Products;
(i) establishing
contracting guidelines for the distribution of the Products (or if
no such guidelines have been established, approving any new or
amended contracts);
(j) establishing
contracting guidelines for the managed care and government markets
(or if no such guidelines have been established, approving any new
or amended contracts);
(k) proposing
any new packaging design for the Products (subject to
Depomed’s approval, and followed by and subject to applicable
FDA and other Legal Requirements);
(l) establishing
the Net Sales forecast for 2009 for purposes of calculating the
minimum Advertising/Marketing/Educational Expenses for that year in
accordance with Section 4.1(d);
(m) reviewing
and approving any Product voucher, coupon, loyalty card or other
co-pay assistance programs;
(n) reviewing
and approving any proposed material capital expenditures relating
to the manufacture of the Products; and
(o) such
other functions as may be mutually agreed upon by the parties from
time to time.
For the
avoidance of doubt, (i) the JCC shall not have any review or
approval rights with respect to any matters relating to the
development of the Products, (ii) any decisions of the JCC
with respect to matters which relate to Regulatory Approval for a
Product shall require Depomed’s prior written consent,
(iii) the JCC cannot require Santarus to pay more than the
minimum amounts described in Section 4.1 with respect to
Advertising/Marketing/Educational Expenses or Sales Force
Expenditures, and (iv) “reviewing” as set forth above
shall not imply any approval right or other decision-making power
on the part of the JCC.
Section 3.4
Meetings of the JCC.
13
Meetings of the
JCC may be called by the Co-Chairs of the JCC from time to time
and, upon no less than ten (10) days’ notice, shall
otherwise be called when requested by a party; provided, however,
that meetings of the JCC shall be held monthly during the first six
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 JCC 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
(2) 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 JCC meetings additional, non-voting participants (not to
exceed ten such participants at any JCC 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 JCC. The parties shall cause their respective
representatives on the JCC to use their reasonable efforts to
resolve all matters presented to them as expeditiously as possible.
The party hosting any meeting shall propose the agenda for the
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 JCC.
(a) In
the event that the JCC 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 JCC, 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 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 (15) 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 attorneys’ fees. Either party may
seek equitable relief prior to the mediation to preserve the status
quo pending the completion of that process. Except
14
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 (30) days after delivery of the Mediation Notice,
whichever occurs first.

|