These excerpts taken from the DEPO 10-K filed Mar 6, 2009.
The terms in
this Agreement with initial letters capitalized, whether used in the singular
or the plural, shall have the meaning set forth below or, if not listed below,
the meaning designated in places throughout this Agreement.
The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.
These excerpts taken from the DEPO 10-Q filed Aug 8, 2008.
As used in this Agreement,
all capitalized terms shall have the definitions as provided herein. Any accounting term used but not defined
herein shall be construed in accordance with generally accepted accounting principles
in the United States of America, as in effect from time to time (GAAP) and all calculations shall be
made in accordance with GAAP. The term financial
statements shall include the accompanying notes and schedules. All other terms used but not defined herein
shall have the meaning given to such terms in the Uniform Commercial Code as
adopted in the State of New York, as amended and supplemented from time to time
In this AGREEMENT, the capitalized words and phrases recited below
shall have the following meanings:
shall mean any corporation or other entity that was, currently is, or in the
future is, directly or indirectly, controlled by, controlling or under common
control with the recited entity. For
this purpose, control shall mean (a) direct or indirect beneficial
ownership of fifty percent (50%) or more of the voting stock, voting rights or
share capital of the recited entity, or at least fifty percent (50%) interest
in the income of such entity, or (b) the ability to otherwise control or
direct the decisions of the board of directors or equivalent governing body
These excerpts taken from the DEPO 10-Q filed Nov 8, 2007.
The terms defined in this
Article 1 shall, for all purposes of this Agreement, have the following
means the chemical compound known as ciprofloxacin hydrochloride.
Affiliate means any
corporation or other entity that directly, or indirectly through one or more
intermediaries, controls, is controlled by, or is under common control with the
designated Party but only for so long as such relationship exists. For the purposes of this section, Control
means ownership of at least fifty percent (or such lesser percent as may be the
maximum that may be owned by foreign interests pursuant to the laws of the
country of incorporation) of the shares of stock entitled to vote for directors
in the case of a corporation and at least fifty percent (or such lesser percent
as may be the maximum that may be owned by foreign interests pursuant to the
laws of the country of domicile) of the interests in profits in the case of a
business entity other than a corporation.
Call means a
face-to-face contact between a member of Esprits sales force and a prescriber
or potential prescriber of Licensed Product during which relevant
characteristics of Licensed Product are described by the member of Esprits
Distribute or Distribution
means the distribution of, and fulfillment of customer orders for, Licensed
Product, as well as the distribution of samples of Licensed Product.
means the date first referred to above.
Esprit Change of Control
means (i) the acquisition by any person or group (as defined in Section
13(d)(3) or 14(d)(2) of the Securities and Exchange Act of 1934, as amended) of
direct or beneficial ownership (as defined in Rule 13d-3 under the Securities
and Exchange Act of 1934, as amended) of more than fifty percent of the voting
stock of Esprit; (ii) any merger, amalgamation or consolidation of Esprit or an
Affiliate of Esprit with another corporation or other entity in which the
stockholders of Esprit, immediately prior to such amalgamation, consolidation,
or merger, own less than fifty percent of the voting stock of the surviving
corporation immediately after such transaction; or (iii) the sale or exclusive
license of substantially all of the assets of Esprit. Notwithstanding the foregoing, for purposes
of Esprit Licensed Product detailing obligations referred to in Section 6.2
below, an Esprit Change of Control does not include any transaction or series
of related transactions between Esprit and any existing stockholder of Esprit
that would otherwise constitute an Esprit Change of Control.
Esprit NDC Number
means any of the following NDC numbers related to Licensed Product Distributed
by Esprit on or before the Effective Date:
(i) NDC No. 1545600103, which corresponds to the three tablet blister
pack commercial presentation of Licensed Product Distributed by Esprit; (ii)
NDC No. 1391300150, which corresponds to the fifty count bottle of Licensed
Product Distributed by Esprit; (iii) NDC No. 1545600150, which corresponds to a
fifty count bottle of Licensed Product; (iv) NDC No. 1545600199, which
corresponds to the three tablet blister pack sample presentation of Licensed
Product Distributed by Esprit to prescribers of Licensed Product.
FDA means the
United States Food and Drug Administration or any successor United States
governmental agency performing similar functions with respect to pharmaceutical
IND means an
Investigational New Drug Application filed with the FDA.
means the once-daily oral tablet formulation that contains Active Ingredient,
is known as ProQuin® XR, and is approved in the Territory under NDA No. 21-744
filed with the FDA on July 18, 2004 (as such NDA may be amended or supplemented
subsequent to the Effective Date).
Market means to
promote, Distribute, market, advertise, sell or offer to sell.
NDA means a New
Drug Application or application for approval to market submitted to the FDA.
Party means Depomed
or Esprit, and Parties means both Depomed and Esprit and their
means any and all scientific, clinical, regulatory, marketing, financial and
commercial information or data, whether communicated in writing, orally or by
any other means, which is owned and under the protection of one Party and is
provided by that Party to the other Party in connection with this Agreement.
means the permission or consent granted by the FDA for the Marketing of the
Licensed Product in the Territory.
means data including, but not limited to, medical, toxicological,
pharmacological and clinical data to the extent necessary to, required for, or
included in any governmental regulatory filing to obtain or maintain Regulatory
Approval to Market the Licensed Product, including post-approval reports,
filings and submissions.
means a person or entity who or which is neither a Party nor an Affiliate of a
the Proquin® trademark, U.S. Registration No. 2,968,719, and all related domain
names identified on Exhibit A, and other common law trademark rights
means any payment by Esprit under this Agreement that is subsequently
invalidated, declared to be fraudulent or preferential or set aside or is
required to be repaid to a trustee, receiver or any other party, under any
bankruptcy, insolvency, reorganization or similar act or law, state, federal or
foreign law, common law or equitable cause.
As used in
this Agreement, the following terms shall have the following meanings:
This excerpt taken from the DEPO 10-K filed Mar 16, 2007.
ARTICLE 1 DEFINITIONS
terms not defined elsewhere in this Agreement have the following respective
Act means the Federal Food, Drug, and Cosmetic Act,
together with any regulation promulgated thereunder, including without
limitation cGMPs, in each case as amended from time to time.
Active Pharmaceutical Ingredient or API shall mean the substance having
the name of Metformin Hydrochloride.
Affiliate shall mean, with respect to
either Party, all corporations or other business entities that, directly or
indirectly, are controlled by, control or are under the common control with
that Party. For this purpose, the meaning of the word control shall mean
having the ability substantially to direct the affairs or management of an
entity, including, but not be limited to, ownership of more than fifty percent
(50%) of the voting shares or interest of such corporation or other business
Annual Volume means that volume of
Product to be manufactured in any year of this Agreement.
Value means the value to be attributed to the API for
certain purposes of this Agreement as set forth on Schedule E.
Applicable Lawmeans all Laws to the extent
applicable to the subject matter of, or the performance by the Parties of their
respective obligations under, this Agreement, including, but not limited to,
(i) with respect to MOVA, the Act and any other Laws of all jurisdictions where
the Products are manufactured, and (ii) with respect to DEPOMED, the Laws of
all jurisdictions where the Products are manufactured, distributed and
Authority means any governmental or
regulatory authority, department, body or agency or any court, tribunal,
bureau, commission or other similar body, whether federal, state, provincial,
county or municipal, including, but not limited to, the FDA.
Batch Records shall mean the executed
manufacturing instructions, the executed packaging order, the analytical
testing results and any other manufacturing related document, such as deviation
or investigation reports.
Certificate of Analysis shall mean
documented test results in written form executed by an authorized responsible
person that demonstrate compliance to the Specifications.
cGMPs shall mean the then current and
applicable good manufacturing practice regulations established in 21 C.F.R.
Parts 210 and 211, as amended and in effect from time to time and other
applicable FDA policies, as applicable and in effect from time to time during
the term of this Agreement.
FDA shall mean the United States Food
and Drug Administration.
Intellectual Property includes,
without limitation, rights in patents, patent applications, formulae, trade-marks,
trade-mark applications, trade-names, Inventions, copyright and industrial
Latent Defect shall mean a defect in
the Product or the API that results in the Product not conforming to the
Specifications and that was not discoverable with commercially reasonable
Laws means all laws, statutes,
ordinances, regulations, rules, by-laws, judgments, decrees or orders of any
Authority, including, but not limited to, the Act and cGMPs.
Materials shall mean all materials
necessary for the manufacture and packaging of the Product, including but not
limited to labels, excipients, packaging components and raw materials,
excluding the Active Pharmaceutical Ingredient.
MOVA Facilities shall mean the MOVA
manufacturing facilities located in Caguas, Puerto Rico.
NDA or ANDA shall mean the New Drug
Application(s) or Abbreviated New Drug Application, as the case may be, for the
Product submitted to the FDA by DEPOMED, including any amendments and
Product shall mean those finished
pharmaceutical products that contain solely Active Pharmaceutical Ingredient as
its active ingredient.
Quality Agreement shall mean the
quality agreement attached hereto as Schedule C.
Specifications shall mean the file for
the Product, which is provided by DEPOMED to MOVA in accordance with the
procedures in Schedule A hereto which contains documents related to such
Product, including but not limited to, the bulk drug specifications, the
formulations, processing specifications, packaging specifications, packaging
bills of material (BOMs), storage requirements, all environmental health and
safety information related to the Product, including material safety data
sheets and finished product specifications that are set forth in Schedule A
hereto for Product manufacturing, packaging and testing, and any revisions
thereto. Specifications shall also include any specifications added to this
Agreement by mutual written agreement of the Parties during the term of this
USA shall mean the United States of
Year means a calendar year.
This excerpt taken from the DEPO 10-Q filed Nov 9, 2006.
means a corporation or business entity that, directly or indirectly, is
controlled by, controls, or is under common control with any entity. For this purpose, control means the direct
or indirect ownership of more than fifty percent of the voting or income
interest in such corporation or business entity, or such other relationship as,
in fact, constitutes actual control.
1.2. Call means
an in-person, face-to-face sales presentation of the Product made by a sales
representative, which presentation is for the purpose of promoting the sale of
1.3. Depomed Net
Sales means, for a particular period, the amount calculated by multiplying
(a) Net Sales for such period by (b) the Depomed Percentage.
Percentage means, for a particular period, the percentage determined by
dividing (a) the total number of Units of prescriptions for Product written
during such period by Prescribers on the Depomed Physician List (not including
any Prescriber who is an Excluded Depomed Physician as of the end of any
calendar month included within such period), by (b) the total number of Units
of prescriptions for Product written during such period, in each case based on
Prescriber Data for the applicable period.
Physician List means the list of Prescribers to whom, pursuant to the
terms of this Agreement, the Depomed Sales Force conducts Calls, as such list
may be amended from time to time either (i) by mutual agreement
of Esprit and Depomed, or (ii) otherwise in accordance with this Agreement. Notwithstanding the foregoing, the Depomed
Physician List will not include urologists, ob/gyns or Prescribers on the
Esprit Target Physician List, and will not include more than 40,000
Termination Detail Amount is an amount equal to ***.
Termination Fee is an amount equal to ***.
1.8. Effective Date
means the date first set forth above.
1.9. Esprit Target
Physician List means those Prescribers identified by Esprit with whom the
Esprit Sales Force conducts Calls, which includes all ob/gyns, urologists and
certain high prescribing primary care physicians, as such list may modified
from time to time upon timely notice to Depomed. Notwithstanding the foregoing, the Esprit
Target Physician List will not include any Prescribers on the Depomed Physician
1.10. Excluded Depomed
Physicians means any Prescriber on the Depomed Physician List who,
following the Promotion Commencement Date ***.
1.11. FDA means
the United States Food and Drug Administration.
1.12. First Position
Detail Call means a Call in which a full Product presentation is
made, during which key Product
attributes are verbally presented, the Product is the first Product
presented and (c) on which the most time is spent during the Call. No more than one presentation in any Call
shall be considered a First Position Detail Call.
1.13. Fiscal Quarter
means the three-month periods ending on March 31, June 30, September 30 and
December 31 of each year, except for the first Fiscal Quarter hereof, which
shall begin on the Promotion Commencement Date and end on the earliest to occur
of the dates set forth in this sentence.
These periods (other than the first Fiscal Quarter referred
to above) correspond to the quarters in the Esprit fiscal year, which ends on
December 31 of each year.
1.14. License Agreement
means that certain Exclusive Marketing and Supply Agreement, dated as of July
21, 2005, by and between Depomed and Esprit as amended by Amendment No.1
thereto of even date herewith.
1.15. Marketing Plan
means a plan for the marketing and detailing of the Product in the Territory to
Prescribers, and may include provisions related to promotional strategies,
detailing plans, pricing, advertising plans and budgets for promotional and
1.16. NDA means a
New Drug Application filed with the FDA.
1.17. Net Sales
means the actual gross amount invoiced on sales of the Product in the Territory
by Esprit, its Affiliates, sublicensees and assigns to independent,
unrelated third parties during a calendar year in bona fide arms length
transactions, less the following deductions allowed and taken by third parties
and not otherwise recovered by or reimbursed to Esprit, its Affiliates,
sublicensees or assigns: (a) freight, insurance 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 and/or duties or allowances on the selling price of the Product which fall
due and are paid as a consequence of such sale; (c) chargebacks, trade,
quantity and cash discounts and rebates actually allowed and taken to the
extent customary in the trade, including, without limitation, governmental
rebates; (d) allowances or credits, including but not limited to, allowances or
credits to customers on account of rejection, defects or returns of the
Product or because of a retroactive price reduction,
and such other deductions (including without limitation shortage deductions)
actually taken by customers that are customary in the trade; and
(e) bad debt. Net Sales shall not
include a sale or transfer to an Affiliate, sublicensee and assign or if done
for clinical, regulatory or governmental purposes where no consideration is
received but the resale by such Affiliate, sublicensee, or assign shall be
considered a sale of the Product.
means physicians and other health care practitioners who are
permitted by law to prescribe Product in the Territory.
1.19. Prescriber Data
means data provided by a third party which measures prescriptions written for
Product (by individual Prescriber) in the Territory during a specified time
period, from a source mutually agreed in writing by the parties.
Commencement Date means the first date upon which the Product is promoted
within the Territory by the Depomed Sales Force in the
Territory to Prescribers.
Information means any and all scientific, clinical, regulatory, marketing,
financial and commercial information or data, whether communicated in writing,
orally or by any other means, which is owned and under the
protection of one party and is provided by that party to the other party in
connection with this Agreement.
1.22. Sales Force
means the sales representatives employed by or on behalf of Depomed or Esprit,
as the case may be, for the detailing of the Product in the Territory to
Prescribers. A partys Sales Force
includes, without limitation, any sales representatives engaged by the party
during through an arrangement with a contract sales organization or other third
party (in the case of Depomed, engaged in accordance with Section 2.5).
Position Detail Call means any Call other than a First
Position Detail Call.
1.24. Supply Agreement
means that certain Supply Agreement, dated
as of July 21, 2005, by and between Depomed and Esprit.
1.25. Term of this
Agreement means the period of time defined in Section 13.1 of this Agreement.
This excerpt taken from the DEPO 10-Q filed Aug 7, 2006.
As used in this
Agreement, the following terms shall have the following meanings: