CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.*** MARKETING AND PROMOTION AGREEMENT
EXHIBIT
10.38.4
CONFIDENTIAL
TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED
WITH THE COMMISSION.***
THIS
MARKETING AND PROMOTION AGREEMENT
(this
“Agreement”)
is
entered into and effective as of this 8th day of September, 2005 (the
“Effective
Date”),
by
and between KING PHARMACEUTICALS, INC., a Tennessee corporation (“King”),
and
INYX, INC., a Nevada corporation (“Inyx”).
WHEREAS,
King
owns certain technology and proprietary materials related to the drugs Intal
and
Tilade;
WHEREAS,
Inyx is
a developer and manufacturer of pharmaceutical aerosol products;
and
WHEREAS,
the
parties have entered that certain Collaboration Agreement, dated as of the
date
hereof (the “Collaboration
Agreement”),
for
the purpose of pursuing a collaboration relating to the development, marketing,
and promotion of Products (as defined herein);
NOW,
THEREFORE,
in
consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto agree as
follows:
1.
|
DEFINITIONS
|
(a)
|
Definitions.
(b)
Unless otherwise specifically defined in this Agreement, each capitalized
term used herein will have the meaning assigned to such term in the
Collaboration Agreement.
|
(c)
|
In
addition to the terms defined elsewhere herein, as used in this Agreement,
the following terms have the meanings specified below when used in
this
Agreement:
|
“Agreement”
means
this Agreement, together with all appendices, exhibits, and schedules referenced
herein or attached hereto, and as the same may be amended or supplemented from
time to time hereafter pursuant to the provisions hereof.
“Baseline
Amounts”
has the
meaning set forth in Section 8.1(a)(i).
“Collaboration
Agreement”
has the
meaning set forth in the recitals.
“Commercially
Reasonable Efforts”
means
efforts and resources normally used by a party for a product owned by it or
to
which it has rights, which product is of similar market potential at a similar
state in its development or product life, taking into account issues of safety,
efficacy, product profile, the competitiveness of the marketplace, the
proprietary position of the product, the regulatory structure involved, the
profitability of the applicable products, and other relevant commercial
factors.
CONFIDENTIAL
TREATMENT
“Copromotion
Date”
has the
meaning set forth in Section 3.2.
“Detail(s)”
or
“Detailing”
means a
face-to-face contact by a sales representative with a Physician, for the primary
purpose of delivering a sales message related to the Products, during which
time
the Product is discussed for either the longest period of time during the
contact or, at a minimum, discussed no less than the second longest period
of
time during the contact. Further, the discussion of the Product must be specific
to include at a minimum the Product name, FDA or Regulatory Authority by country
approved indication, key attribute tied to a patient benefit, and a request
by
the sales representative that the Physician prescribe the Product for an
appropriate patient type.
“Detail
Cost”
means
the fully allocated cost per Detail to be established by the AMC each year
and
included in the Marketing Plan and Budget for such year. For purposes hereof,
“fully allocated” shall include all costs associated with Details, including
salaries, bonuses, and benefits (including automobile expenses) of sales
representatives, allocations of sales managers with respect to oversight of
Detailing, the fully allocated cost of services overhead directly related to
Details, and allocation of all administrative and general expenses directly
related to Details. Detail Costs shall be determined by GAAP, applied on a
consistent basis.
“Details
Shortfall”
has the
meaning set forth in Section 8.3.
“Effective
Date”
has the
meaning set forth in the recitals.
“Electing
Party”
has the
meaning set forth in Section 8.3.
“Excess
Details”
has the
meaning set forth in Section 8.3.
“Exaeris”
has the
meaning set forth in Section 2.3.
“Initiation
Date”
means
the later to occur of (i) the Regulatory Approval of the NDA, or foreign
counterpart, for a particular Product or (ii) the Copromotion Date.
“Inyx”
has the
meaning set forth in the recitals.
“Inyx
Detail Report”
has the
meaning set forth in Section 3.4.
“King”
has the
meaning set forth in the recitals.
“King
Detail Report”
has the
meaning set forth in Section 4.3(a).
“King
Summary Sales Report”
has the
meaning set forth in Section 4.3(b).
CONFIDENTIAL
TREATMENT
2
“Marketing
Data”
has the
meaning set forth in Section 4.1(b).
“Marketing
Materials”
has the
meaning set forth in Section 5.2(a).
“Minimum
Targeted Details”
has the
meaning set forth in Section 8.3.
“Nonelecting
Party”
has the
meaning set forth in Section 8.3.
“Nonperforming
Party”
has the
meaning set forth in Section 9.5(a).
“Offset
Amount”
has the
meaning set forth in Section 8.2(c).
“PDMA”
means
the Prescription Drug Marketing Act, as amended, and the implementing rules
and
regulations thereunder.
“Performing
Party”
has the
meaning set forth in Section 9.5(a).
“Physicians”
means
primary care physicians (i.e.,
general
practitioners, family practitioners, internal medicine physicians, and doctors
of osteopathy), allergists, pediatricians, pulmonologists, and other prescribers
of asthma therapy, including allied health professionals such as physician
assistants and nurses, and consistent with the Marketing Plan and Budget, in
each case who are authorized by applicable law to prescribe the
Products.
“Primary
Detail(s)”
means a
Detail with respect to a Product during which such Product is in the first
position of the sales call and discussion of such Product takes up no less
than
two thirds of the time of the entire sales call.
“Subject
Quarter”
has the
meaning set forth in Section 8.3.
“Term”
has the
meaning set forth in Section 9.1.
“Trademark”
means
any trademarks and trade names, whether or not registered, and any trademark
applications, registrations, renewals, extensions, or modifications thereto
in
the Territory together with all goodwill associated therewith, trade dress,
and
packaging that are applied to or used with Products, and any promotional
materials relating thereto.
1.2
|
Interpretation.
When a reference is made in this Agreement to Articles, Sections,
Exhibits, or Schedules, such reference will be to an Article or Section
of
or Exhibit or Schedule to this Agreement unless otherwise indicated.
The
headings contained in this Agreement are for reference purposes only
and
will not affect in any way the meaning or interpretation of this
Agreement. Whenever the words “include,”“includes,” or “including” are
used in this Agreement, they will be deemed to be followed by the
words
“without limitation.” Unless the context otherwise requires, (i) “or” is
disjunctive but not necessarily exclusive, (ii) words in the singular
include the plural and vice versa, and (iii) the use in this Agreement
of
a pronoun in reference to a party hereto includes the masculine,
feminine,
or neuter, as the context may require. The Schedules and Exhibits
hereto
will be deemed part of this Agreement and included in any reference
to
this Agreement. This Agreement will not be interpreted or construed
to
require any Person to take any action, or fail to take any action,
if to
do so would violate any applicable
law.
|
CONFIDENTIAL
TREATMENT
3
2.
|
GRANT
OF RIGHTS TO INYX
|
2.1
|
Copromotion
Rights.
King hereby grants to Inyx and its Affiliates, on a non-exclusive
basis,
together with King and its Affiliates, the right to promote the Products
in the Territory during the Term of this Agreement, upon and subject
to
the terms and conditions set forth in this Agreement; provided that
the
license to promote a particular Product will only be effective on
the
Initiation Date of such Product in the applicable country of the
Territory
in which such Product has received Regulatory Approval and only for
so
long as such Product has Regulatory Approval in such country. The
parties
acknowledge and agree that, during the Term, the license granted
to Inyx
under Section 4.1 of the Collaboration Agreement will include a
non-exclusive right under the Technology and Patent Rights to sell,
offer
for sale, and import the Products in the Territory, subject to the
terms
of this Agreement and the Collaboration
Agreement.
|
2.2
|
Trademark.
|
(a)
|
Required
Use and Compliance.
Inyx will promote the Products only under the Trademarks, which as
of the
Effective Date are listed on Schedule 2.2 attached hereto, which
schedule
will be updated from time to time during the
Term.
|
(b)
|
Validity
of Trademarks.
Inyx acknowledges that King will have sole and exclusive ownership
of all
right, title, and interest on a worldwide basis, with full rights
to
license or sublicense, subject to the licenses granted Inyx hereunder,
in
and to any and all Trademarks. Inyx understands and agrees that it
will
not have, assert, or acquire any right, title, or interest in or
to any of
the Trademarks.
|
(c)
|
Use
of Trademarks.
In connection with the subject matter hereof, Inyx will maintain
quality
standards for all of its uses of the Trademarks in connection with
the
Products that are substantially equivalent to or, at King’s option,
stricter than those standards used by King in connection with its
promotion of the Products. Subject to the foregoing, Inyx acknowledges
and
agrees that King has the right, at any time, to modify or supplement
such
quality standards and that Inyx must implement such new standards
or
changes following receipt of notice of such additions or changes.
In order
to determine whether Inyx is in compliance with this Section 2.2(c),
at
the reasonable written request of King, and at Inyx’s expense, Inyx: (i)
will provide King with copies, photographs, or representative samples
of
its advertising copy, promotional materials, or other materials bearing
any of the Trademarks; and (ii) upon reasonable notice and during
normal
business hours, will provide to King or its representatives access
to
Inyx’s premises. Inyx covenants and agrees that it will not use any
Trademarks in connection with any goods or products other than the
Products, notwithstanding that such goods or products are dissimilar
to
the Products or have a different use.
|
CONFIDENTIAL
TREATMENT
4
2.3
|
Sublicensee.
The parties acknowledge that Inyx may sublicense its rights granted
hereunder to Exaeris Inc. (“Exaeris”);
provided that Exaeris agrees, in writing, to be bound by the terms
of this
Agreement and the applicable terms of the other Collaboration Documents,
including the confidentiality and assignment provisions thereof;
and
provided further that the right to sublicense to Exaeris will immediately
terminate at such point as Exaeris is no longer a wholly owned subsidiary
of Inyx. As of the Effective Date, Inyx represents and warrants that
Exaeris is a wholly owned subsidiary of Inyx. Inyx acknowledges and
agrees
that, as provided in Section 4.2 of the Collaboration Agreement,
Inyx will
remain liable for all obligations, including obligations to perform,
under
this Agreement and for all actions of Exaeris under such sublicense.
Notwithstanding such sublicense, Exaeris will not be deemed a third
party
beneficiary under this Agreement.
|
3.
|
RESPONSIBILITIES
OF INYX
|
3.1
|
Promotion
by Inyx.
(a)
With respect to each Product, commencing as of the Initiation Date
relating to such Product and continuing throughout the Term, Inyx
will use
its Commercially Reasonable Efforts to promote such Product in the
Territory in accordance with the then current Marketing Plan and
Budget.
The nature of the promotion of the Products required as part of Inyx’s
promotion obligations hereunder will be determined by the AMC and
set
forth in then-current Marketing Plan and Budget, but such obligations
may
include the following:
|
(i)
|
Detailing
the Products to Physicians in the
Territory;
|
(ii)
|
meeting
targeted and minimum quarterly Detail requirements;
and
|
(iii)
|
attendance
at specified medical conventions to promote the
Products.
|
(b)
|
Until
the AMC determines otherwise, all Details that Inyx is required to
perform
pursuant to this Article 3 shall be Primary Details with respect
to
Intal.
|
(c)
|
In
performing its duties hereunder, Inyx will, and will cause its employees
and the employees of its relevant Affiliates to, comply with all
regulatory, professional, and legal requirements, including the FDA’s
regulations and guidelines concerning the advertising of prescription
drug
products, the American Medical Associations’ Guidelines on Gifts to
Physicians, the PhRMA Guidelines for Marketing Practices, and the
ACCME
Standards for Commercial Support of Continuing Medical Education,
which
may be applicable to the services (including the warehousing, handling,
and distribution of the Products and Products samples) to be provided
by
Inyx hereunder. No employee of Inyx or of any of its relevant Affiliates
will make any representation, statement, warranty, or guaranty with
respect to the Products that is not consistent with current labeling
of
the Products or promotional materials approved by the AMC, that is
deceptive or misleading, or that disparages the Products or the good
name,
good will, or reputation of King. Inyx represents and warrants that
its
services hereunder will be provided in a professional, ethical, and
competent manner.
|
CONFIDENTIAL
TREATMENT
5
3.2
|
Inyx
Sales Force.
Inyx agrees that, immediately after the Effective Date, Inyx or its
Affiliates will begin developing a specialty sales force for purposes
of
fulfilling its obligations hereunder consisting of at least *** field
sales representatives and ancillary sales support staff. Without
limiting
the obligations to use Commercially Reasonable Efforts, Inyx must
demonstrate to the reasonable satisfaction of the AMC, as evidenced
by
written approval from the AMC, that such sales force has been developed
and fully organized and has completed a core training program on
the
Products conducted by King, as well as sales effectiveness training
conducted by King under guidelines agreed by the AMC. After Inyx
has
demonstrated the foregoing, Inyx may begin Detailing the Products.
Beginning on the date of the first such Detail (such date, the
“Copromotion
Date”),
and continuing thereafter throughout the Term, Inyx agrees that it
will
have at least *** field sales representatives and ancillary sales
support
Detailing the Products and conducting other active promotion in the
Territory, except as otherwise agreed to by the parties.
|
3.3
|
Costs
of Inyx Sales Force. (a)
Until the Copromotion Date, except as agreed to by the parties, and
subject to the terms and conditions of this Agreement, Inyx will
be solely
responsible for the costs and expenses of establishing and maintaining
Inyx’s (and its Affiliates’) sales force of the size required by Section
3.2, and conducting Inyx’s other activities under this Agreement;
following the Copromotion Date, such costs and expenses of Inyx will
be
deemed Collaboration Costs. Notwithstanding the foregoing, Inyx will
pay
incentive compensation to its sales representatives having primary
responsibility for Detailing the Products with respect to sales of
the
Products in the Territory in accordance with Inyx’s incentive compensation
plans for its own products, it being understood that Inyx will determine
the target payout for the Products in a manner consistent with the
way in
which it determines the target payouts for prescription drug products
of
comparable commercial potential. In connection with the development
of
Inyx’s sales force, (i) all training will be conducted in accordance
with Section 5.1, (ii) the content and strategic direction
of any
training provided by Inyx that relates specifically to the Products
will
be coordinated with the AMC, and (iii) all costs with respect to
training
Inyx’s sales force with respect to the Products will be deemed
Collaboration Costs.
|
CONFIDENTIAL
TREATMENT
6
(b)
|
To
the extent practicable, all written, electronic, and visual communications
provided to any of Inyx’s (and its Affiliates’) sales representatives
regarding strategy, positioning, or selling messages for the Products
will, at the request of the AMC, be subject to review by the AMC
in
accordance with
Section 5.2(a).
|
3.4
|
Inyx
Detail Reports.
Commencing on the Initiation Date and throughout the Term, Inyx will
provide the AMC and King with a report (each an “Inyx
Detail Report”)
within thirty (30) calendar days after the end of each Calendar Quarter,
with the first such report due for the Calendar Quarter during which
the
Initiation Date occurs, setting forth the following information regarding
the efforts of Inyx’s sales representatives in promoting and Detailing the
Products during the preceding quarter (or part thereof): (i) the
number of Details made and recorded by Inyx’s standard record keeping
procedures, and approved by the AMC, based on data recorded by the
sales
representatives; (ii) the names and addresses of the Physicians
called upon and the date of the Detail; (iii) the percentage
of
Physicians Detailed who were provided with samples of the Products;
(iv) the actual number of such samples delivered on each Detail
and
the dates of such delivery; (v) a breakdown of all information required
to
be contained in each report on an individual sales representative
and
aggregate basis; and (vi) such other information as may be
required
in the then current Marketing Plan and Budget. Each such Inyx Detail
Report will be in an electronic format and in hard copy form. Inyx
will
also provide King on-request access to all call reporting data at
the
lowest level of information content, through file extraction or electronic
query, Detailing and sampling data at the Physician-sales representative
level, including such measures as prescriptions, decile, target status,
products Detailed, order of the Detail, products, and quantity sampled.
This data shall be in the electronic format readily used by analytic
functions such as market research or business
analysis.
|
4.
|
RESPONSIBILITIES
OF KING
|
4.1
|
Marketing
by King. (a)
With respect to each Product, commencing as of the Initiation Date
relating to such Product and continuing throughout the Term, King
will use
its Commercially Reasonable Efforts to market and promote the Products
in
the Territory in accordance with the then current Marketing Plan
and
Budget. The nature of the promotion of the Products required as part
of
King’s marketing obligations hereunder will be determined by the AMC and
set forth in then-current Marketing Plan and Budget, but such obligations
may include the following:
|
(i)
|
marketing
and promoting the Products to Physicians in the
Territory;
|
CONFIDENTIAL
TREATMENT
7
(ii)
|
meeting
targeted and minimum quarterly Detail requirements;
and
|
(iii)
|
attendance
at specified medical conventions to promote the
Products.
|
All
costs
and expenses associated with the foregoing and with the support described in
Section 4.1(b) will be deemed Marketing Costs and, as such, Collaboration
Costs.
(b)
|
In
addition, King will provide the following marketing support for the
Products: (i) direct marketing to Physicians that are high-potential
primary care prescribers; and (ii) development and maintenance of
a
marketing database, which includes contract information, response
data,
behavioral data, demographic data, and attitudinal data (collectively,
“Marketing
Data”).
King will provide Inyx with access to the Marketing Data, including
all
primary and secondary market data and research, and historical data
as may
be reasonably requested by Inyx; provided, however, that the sharing
of
any purchased data by King with Inyx will be subject to the approval
of
the data sources; and provided further that all such Marketing Data
will
be deemed the Confidential Information of
King.
|
(c)
|
In
performing its duties hereunder, King will, and will cause its employees
and the employees of its relevant Affiliates to, comply with all
regulatory, professional, and legal requirements, including the FDA’s
regulations and guidelines concerning the advertising of prescription
drug
products, the American Medical Associations’ Guidelines on Gifts to
Physicians, the PhRMA Guidelines for Marketing Practices, and the
ACCME
Standards for Commercial Support of Continuing Medical Education,
which
may be applicable to the services (including the warehousing, handling,
and distribution of the Products and Products samples) to be provided
by
King hereunder. No employee of King or of any of its relevant Affiliates
will make any representation, statement, warranty, or guaranty with
respect to the Products that is not consistent with current labeling
of
the Products or promotional materials approved by the AMC, that is
deceptive or misleading, or that disparages the Products. King represents
and warrants that its services hereunder will be provided in a
professional, ethical, and competent
manner.
|
4.2
|
Costs
of King Sales Force. (a)
From the Effective Date, except as agreed to by the parties and subject
to
the terms and conditions of this Agreement, to the extent King elects
to
have a sales force, King will be solely responsible for the costs
and
expenses of establishing, maintaining, and training such sales force
of
King (and its Affiliates); provided that all such costs and expenses
incurred will be deemed Collaboration Costs. In connection with the
foregoing, (i) such training will be conducted in accordance with
Section
5.1 and (ii) the content and strategic direction of any training
provided
by King that relates specifically to the Products will be coordinated
with
the AMC.
|
CONFIDENTIAL
TREATMENT
8
(b)
|
To
the extent practicable, all written, electronic, and visual communications
provided to any of King’s (and its Affiliates’) sales representatives
regarding strategy, positioning, or selling messages for the Products
will, at the request of the AMC, be subject to review by the AMC
in
accordance with Section 5.2(a).
|
4.3
|
King
Detail and Sales Reports. (a)
Commencing on the Initiation Date and throughout the Term, if King
elects
to establish, and at such time as King has established, a sales force,
King will provide the AMC and Inyx with a report (each a “King
Detail Report”)
within thirty (30) calendar days after the end of each Calendar Quarter,
with the first such report due for the Calendar Quarter during which
such
sales force has been established, setting forth the following information
regarding the efforts of King’s sales force in promoting and Detailing the
Products during the preceding quarter (or part thereof): (i) the
number of Details made and recorded by King’s standard record keeping
procedures, and approved by the AMC, based on data recorded by the
sales
representatives; (ii) the names and addresses of the Physicians
called upon; (iii) the percentage of Physicians Detailed who
were
provided with samples of the Products; (iv) the average number
of
such samples delivered on each Detail; (v) a breakdown of all information
required to be contained in each report on an individual sales
representative and aggregate basis; and (vi) such other information
as may
be required in the then current Marketing Plan and Budget. Each such
King
Detail Report will be in an electronic format and in hard copy
form.
|
(b)
|
Commencing
on the Initiation Date and throughout the Term, within fifteen (15)
days
after the end of each month, King will provide to the AMC and Inyx
a
summary report (each a “King
Summary Sales Report”)
setting forth the gross sales of the Products in the Territory for
such
month, the gross sales of the Products in the Territory since
January 1 of such year, and the itemized deductions taken
in
calculating all Net Sales with respect to such gross sales, the Net
Sales
of the Products in the Territory for such month, and the Net Sales
of the
Products in the Territory since January 1 of such year. All
reports
required by this Section 4.3(b) will be provided to the AMC and Inyx
either by facsimile or transmitted electronically, in each ease with
a
confirmation copy sent by mail.
|
(c)
|
Commencing
on the Initiation Date and throughout the Term, King will furnish
to the
AMC and Inyx, within thirty (30) calendar days after the end of each
Calendar Quarter (including the final Calendar Quarter), a report
setting
forth in reasonable detail the calculation of the total Net Sales
of
Products in the Territory for such Calendar Quarter in a form approved
by
the AMC.
|
CONFIDENTIAL
TREATMENT
9
4.4
|
Shipment,
Billing of the Product.
King (and its Affiliates) will have the sole responsibility for the
shipment, distribution, warehousing, billing, and order confirmation
of
all Products and for the collection of receivables resulting from
sales of
the Products in the Territory. AMC may make recommendations to King
from
time to time regarding the price of and pricing strategies for the
Products during the Term, including, without limitation, price increases
and decreases and the timing thereof; provided, however, that King
will
have the sole authority to determine the price of the Products during
the
Term, including price increases and decreases and the timing thereof.
During the term of the Manufacturing and Supply Agreement, the manufacture
of the Products and Product samples will be in accordance with the
terms
of such agreement, and Inyx will ensure that adequate quantities
of the
Products and Product samples are available to meet the anticipated
demand
for the Products and Product samples during the Term of this Agreement.
Thereafter, King will manufacture or cause to be manufactured the
Products
and Product samples in accordance with all applicable laws and will
use
its Commercially Reasonable Efforts to ensure that adequate quantities
of
the Products and Product samples are available to meet the anticipated
demand for the Products and Product samples during the Term of this
Agreement.
|
4.5
|
Product
Pricing.
King (and its Affiliates) will have sole responsibility for setting
the
Product price or offering discounts to customers. The AMC will make
recommendations to King, or its internal pricing committee, on either
the
wholesale average costs price or any discount deemed necessary to
maintain
an effective market position. King, or its pricing committee, will
take
such recommendations under advisement, but King will retain ultimate
authority with regard to price and
discounts.
|
5.
|
TRAINING
AND PROMOTIONAL MATERIAL
|
5.1
|
Training. (a)
Each of the parties agrees to make its sales representatives available
for
training with respect to the marketing and sale of the Products.
The
parties agree that King will, subject to the AMC’s approval, be
responsible for developing and conducting training programs for each
of
Inyx’s and King’s sales forces, with all costs associated with so
developing and conducting to be deemed Collaboration Costs. Inyx
will
participate in conducting such training to the extent requested by
King.
Training will be carried out at a time that is mutually acceptable
to the
parties and will be conducted on an ongoing basis to assure a consistent,
focused promotional strategy. As additional members are added to
the
parties’ respective sales forces responsible for marketing or promoting
the Products, training will be given to groups of the newly selected
members.
|
(b)
|
The
AMC will decide where the training of each party’s sales representatives
will occur, and the costs of transporting, housing, and maintaining
the
parties’ respective personnel for such training, to the extent included in
the Marketing Plan and Budget, will be deemed Collaboration Costs.
Subject
to the oversight of the AMC, all sales and marketing training materials
will be prepared and supplied by King, and the cost of such training
materials will be included as part of the Collaboration
Costs.
|
CONFIDENTIAL
TREATMENT
10
5.2
|
Promotional
Materials. (a)
All written sales, sales training, Detailing aids, promotional, and
advertising materials (“Marketing
Materials”)
relating to the Products will be prepared by King, with such materials
being consistent with standards and guidelines approved by the AMC.
All
Marketing Materials developed by King will be reviewed and approved
in
accordance with King’s established copy clearance process. Upon final
approval of all Marketing Materials, King will be responsible for
printing
such approved Marketing Materials and providing Inyx with sufficient
copies thereof.
|
(b)
|
In
all written or visual materials related to the Products that identify
either of the parties, the parties will be presented and described
to the
medical communities (including, for example, the physician, pharmacy,
governmental, reimbursement, and hospital sectors) as joining in
the
promotion of the Products in the Territory. All such written and
visual
materials and all documentary information, promotional material,
and oral
presentations (where practical) regarding the promoting of the Products
will state this arrangement and will display the names and logos
of the
parties with equal prominence, as permitted by applicable
law.
|
(c)
|
All
costs and expenses associated with the preparation and distribution
of
such Marketing Materials will be included in the Marketing Plan and
Budget
and will be deemed Collaboration
Costs.
|
(d)
|
All
Marketing Materials will be deemed Improvements and will be subject
to the
provisions of Article 5 of the Collaboration Documents.
|
6.
|
PRODUCT
SAMPLES
|
6.1
|
Supply,
Storage, and Distribution of Samples. (a)
Inyx will provide King, from time to time on a schedule and in such
quantities to be reasonably determined by the AMC, with samples of
the
Products to be used by the parties for marketing and promoting the
Products in the Territory. Inyx will ship the samples to one central
warehouse of King, as designated by King, and the risk of loss and
responsibility for handling and warehousing of the samples will pass
to
King upon delivery to such
warehouse.
|
(b)
|
Inyx
and King will be responsible for distributing the samples of the
Products
to their respective sales forces in a timely manner. Each party will
also
be responsible for securing the return of and reconciling existing
sample
inventories from discontinued field sales representatives.
|
CONFIDENTIAL
TREATMENT
11
(c)
|
All
Products samples provided to King and Inyx sales representatives
hereunder
will be accompanied by an appropriate Certificate of Analysis of
the
Products specifications and an indication of expiration
dating.
|
6.2
|
Use
of Samples. (a)
Each party will be responsible for accountability and compliance
with the
PDMA, and other applicable federal, state, and local laws and regulations
relating to such samples or the distribution of same. Inyx and King
each
will be responsible for adherence by its respective sales representatives
to such laws and regulations. Each party or its appointed agents
will have
the right to audit the records and/or reports for the Products samples,
as
required to be kept by the other party under the PDMA, pursuant to
the
provisions of Article 10 of the Collaboration
Agreement.
|
6.3
|
Cost
of Samples. (a)
All costs and expenses associated with the manufacture, shipment,
warehousing, storage, and distribution of Products samples will be
included in the Marketing Plan and Budget and will be deemed Collaboration
Costs.
|
7.
|
CERTAIN
REGULATORY MATTERS
|
7.1
|
Licenses.
Each party hereto will, at its sole cost and expense, maintain in
full
force and effect all necessary licenses, permits, and other authorizations
required by law, regulation, ordinance, or statute to carry out its
duties
and obligations under this
Agreement.
|
7.2
|
Regulatory
Responsibility.
As provided in Article 9 of the Collaboration Agreement, King will
be
responsible for all regulatory matters regarding the Products, subject
to
AMC oversight; provided, however, that King will provide Inyx with
copies
of all communications received from any Regulatory Authority concerning
the Products or any Marketing
Materials.
|
7.3
|
Efficacy
and Safety Information.
King will furnish Inyx with efficacy and safety information reasonably
requested by Inyx to assist Inyx in promoting the Products to Physicians
in the Territory, including relevant clinical and safety data included
in
the NDA for the Products and additional information, if any, related
to
the efficacy and safety profile of the Products since the Products’
approval by the applicable Regulatory Authority. King will also provide
Inyx with updates to annual reports required to be delivered by King
pursuant to this Agreement. Except for that information that is to
be
disclosed to Physicians in connection with conducting Details, such
information will be treated as the Confidential Information of
King.
|
7.4
|
Returns.
Any Products returned to Inyx will be shipped directly to King’s or its
designee’s nearest facility, with shipping and other direct costs to be
deemed Collaboration Costs. Inyx will incur no liability or any nature
in
the handling of such returns unless such Products were stored improperly
by Inyx.
|
CONFIDENTIAL
TREATMENT
12
8.
|
NET
SALES SHARING AND EXPENSES
|
8.1
|
Net
Sales Sharing. (a)
From the Effective Date until the Copromotion Date, King will retain
all
Net Sales of Products. Following the Copromotion Date, the parties
agree
to share the Net Sales in the following manner:
|
(i)
|
with
respect to annual Net Sales of Products up to and including the amount
for
such Calendar Year set forth in Schedule 8.1 attached hereto (the
“Baseline
Amounts”),
King will retain *** of the Net Sales, and Inyx will be entitled
to the
remaining ***; and
|
(ii)
|
with
respect to annual Net Sales of Products above the Baseline Amounts
for
such Calendar Year, King will retain *** of the Net Sales, and Inyx
will
be entitled to the remaining ***.
|
(b)
|
As
provided in Section 4.3(c), following the Initiation Date, King will
provide to the AMC an accounting of all Net Sales received by it
with
respect to all Products. Within fifteen (15) days thereafter, the
AMC will
produce a report setting forth the calculation of Net Sales and its
allocation between the parties in accordance with this Section 8.1.
The
report will also set forth the amount of any payments that King must
make
to Inyx in order to achieve such apportionment between the parties.
All
such payments, subject to Section 8.2(c), will be made within sixty
(60)
days following the end of the applicable Calendar Quarter. As provided
in
Section 4.4, King will book all Net Sales, and distribute same to
Inyx in
accordance with this Section 8.1, and King will be responsible for
all
billing and collection activities with respect to Net Sales.
|
(c)
|
All
Net Sales incurred in currencies other than U.S. Dollars will be
converted
to U.S. Dollars based on the exchange rate quoted in The Wall Street
Journal, NY Edition on the last business day of the applicable Calendar
Quarter.
|
8.2
|
Marketing
Costs. (a)
In
accordance with Article 3 of the Collaboration Agreement, King and
Inyx
will develop, and the AMC will approve, a Marketing Plan and Budget,
which
will include the Collaboration Costs to be incurred by the parties,
including Marketing Costs.
|
(b)
|
Each
party understands and acknowledges that all Collaboration Costs incurred
by a party on and after the Effective Date will *** and that each
party
will submit the reports with respect to Collaboration Costs required
under
Article 3 of the Collaboration
Agreement.
|
(c)
|
To
the extent the amounts owed to King for Collaboration Costs, including
Marketing Costs, with respect to a particular Calendar Quarter exceed
the
amounts owed to Inyx for Collaboration Costs with respect to such
Calendar
Quarter (such difference, the “Offset
Amount”),
King may deduct as credits from payment of Inyx’s portion of Net Sales due
under Section 8.1 such Offset Amount.
|
CONFIDENTIAL
TREATMENT
13
8.3
|
Excess
Detail Costs.
With respect to any Calendar Quarter during the Term at such time
as King
has developed a sales force, if a party (the “Electing
Party”)
determines, based on the Inyx Detail Reports or the King Detail Reports,
as the case may be, that the other party is failing to conduct the
minimum
number or percentage of Details (such minimum, the “Minimum
Targeted Details,”
and the difference between such minimum and the number of Details
actually
conducted, the “Details
Shortfall”)
required to be conducted by such other party in such Calendar Quarter
(the
“Subject
Quarter”)
by the Marketing Plan and Budget for such quarter, then the Electing
Party, so long as it has conducted its Minimum Targeted Details for
the
Subject Quarter, may elect to conduct a greater number of Details
than the
Minimum Targeted Details for such Electing Party (such greater number
of
Details, the “Excess
Details”)
pursuant to the terms of this Section 8.3. In such event, the Electing
Party will notify the other party (the “Nonelecting
Party”)
within ten (10) days of the Electing Party’s receipt of the Inyx Detail
Reports or King Detail Reports, as applicable, reflecting the Details
Shortfall. Following such notice, the Nonelecting Party will have
until
the end of the Calendar Quarter immediately following the Subject
Quarter
to cure its failure by providing a sufficient number of Details to
meet
the Nonelecting Party’s Minimum Targeted Details for such immediately
following Calendar Quarter and make up for such Details Shortfall
from the
Subject Quarter. If the Nonelecting Party fails to so cure such Details
Shortfall within such time period, the Electing Party may conduct
a number
of Excess Details in the next succeeding Calendar Quarter equal to
the
Details Shortfall of the Nonelecting Party; and, within thirty (30)
days
after delivery of notice by the Electing Party of the Excess Details
so
conducted, the Nonelecting Party will pay to the Electing Party an
amount
equal to the then-current Detail Cost multiplied by the number of
Excess
Details. Notwithstanding the foregoing, the prior approval of the
AMC will
be required for any payments to an Electing Party under this Section
8.3
on Excess Details in excess of *** of the Minimum Targeted Details
for
such Electing Party for the Subject Quarter. In addition, at the
end of
each Calendar Year, the AMC, after review of the Details conducted
by, and
the Minimum Targeted Details allocated to, each party during such
Calendar
Year, may require the Nonelecting Party to pay the Electing Party
for any
Excess Details conducted by the Electing Party during such Calendar
Year
and not previously reimbursed by the Nonelecting
Party.
|
9.
|
TERM
AND TERMINATION
|
9.1
|
Term
of Agreement.
The term of this Agreement (the “Term”)
will commence as of the Effective Date hereof and will continue until
the
later of December 31, 2015 and the last date on which any Approved
New
Product is sold, unless terminated sooner or extended as provided
below.
|
CONFIDENTIAL
TREATMENT
14
9.2
|
Termination
by Either Party. (a)
Each
party will have the right to terminate this Agreement at any time
upon
written notice to the other party, if such other party breaches in
a
material way any of the representations, warranties, covenants, or
agreements set forth in this Agreement or otherwise materially defaults
in
the performance of any of its duties or obligations under this Agreement,
which breach or default is not cured within sixty (60) days after
written
notice is given to the breaching party specifying the breach or default.
|
(b)
|
Each
party may, by written notice delivered to the breaching party, terminate
this Agreement if there are two or more similar or substantially
similar
material breaches of this Agreement by the breaching party within
any
12-month period, which termination will be effective thirty (30)
days
following such written notice; provided, however, that any failure
of a
non-breaching party to exercise this termination right with respect
to
certain breaches will not be deemed a waiver of the ability of such
non-breaching party to exercise this right upon any subsequent breach.
|
(c)
|
To
the extent permitted by law, each party will have the right to terminate
this Agreement immediately upon notice to the other party, if such
other
party is declared bankrupt or insolvent, if there is an assignment
for the
benefit of creditors, or if a receiver is appointed or proceedings
commenced (and not dismissed within sixty (60) days), voluntarily
or
involuntarily, under any bankruptcy or similar
law.
|
(d)
|
Each
party will have the right to terminate this Agreement at any time,
at
will, upon one (1) year’s prior written notice to the other party.
|
9.3
|
Automatic
Termination.
This Agreement will automatically terminate upon the termination
or
expiration of the Collaboration Agreement.
|
9.4
|
*
*
*
|
9.5
|
Failure
to Meet Detailed Requirements. (a)
Notwithstanding any provision in this Agreement to the contrary,
in the
event that either party (the “Nonperforming
Party”)
fails to perform at least *** of the minimum number of Details such
party
is required to perform during any Calendar Year and the other party
(the
“Performing
Party”)
has performed at least *** of the minimum number of Details it is
required
to perform during such Calendar Year, such Performing Party will
have
sixty (60) days from its receipt of the Nonperforming Party’s final Detail
Report for such Calendar Year to notify the Nonperforming Party that
it is
in breach of such obligations, in which event the Nonperforming Party
will
have the opportunity to cure such default (in addition to any right
to
cure under Section 8.3 hereof) by providing a sufficient number of
extra
Details to make up for such short fall prior to the end of the first
full
Calendar Quarter following the Calendar Quarter in which the Performing
Party provides such breach notice to the Nonperforming Party. In
the event
the Nonperforming Party fails to so cure such default, the Performing
Party may, by providing written notice within thirty (30) days after
the
end of such Calendar Quarter, terminate this Agreement on sixty (60)
days’
prior notice to the Nonperforming Party.
|
CONFIDENTIAL
TREATMENT
15
(b)
|
If
the Performing Party fails to give timely notice of the Nonperforming
Party’s breach or of termination due to the Nonperforming Party’s failure
to cure such breach in accordance with this Section 9.5, the Performing
Party will be deemed to have waived its rights under this Section
9.5 with
respect to such breach; provided, however, that any such waiver will
not
be construed as a waiver of such Performing Party’s rights under this
Section 9.5 as to any further breaches by the Nonperforming Party.
Notwithstanding the foregoing, the parties agree that the Nonperforming
Party will not be in breach of its Detailing obligations for any
Calendar
Year hereunder if the Nonperforming Party provides at least *** of
the
minimum number of Details it is required to perform during such Calendar
Year, and, for purposes of determining whether such *** has been
reached,
a Nonperforming Party may include any Excess Details (i) that were
performed by the Performing Party during such Calendar Year pursuant
to
Section 8.3 and (ii) for which the Nonperforming Party has paid the
Performing Party.
|
9.6
|
Effects
of Termination. (a)
Neither the termination nor expiration of this Agreement will release
or
operate to discharge either party from any liability or obligation
that
may have accrued prior to such termination or expiration. Any termination
of this Agreement as provided herein will not be an exclusive remedy
but
will be in addition to any remedies whatsoever that may be available
to
the terminating party.
|
(b)
|
Notwithstanding
the giving of any notice of termination pursuant to this Article
9, each
party will continue to fulfill its obligations under this Agreement
at all
times until the effective date of any such
termination.
|
9.7
|
Actions
Upon Termination.
Upon the termination or expiration of this Agreement for any reason,
Inyx
will immediately cease all of its promotional and Detailing activities
for
the Products, discontinue any use of the Trademarks, and return to
King or
destroy all sales training, Marketing Materials for the Products
containing Trademarks, and any remaining Products samples (not already
distributed or destroyed with destruction certified by Inyx). After
any
termination, King will retain the right to use any sales training
and
Marketing Materials developed under the auspices of the AMC during
the
term of this Agreement, provided, however, that King will have no
further
right to use Inyx’s name or logos in connection
therewith.
|
9.8
|
Survival.
The provisions of Articles 8 (to the extent applicable pursuant to
Section
9.9), 9, 10, and 11 and Sections 2.2(b) and 4.3(c) (with respect
to
furnishing a final report) will survive any expiration or termination
of
this Agreement.
|
CONFIDENTIAL
TREATMENT
16
9.9
|
Payments
Upon Termination. (a)
The expiration or termination of this Agreement pursuant to this
Article 9
will not release either party from any obligation to pay to the other
party any amounts accrued under Article 8 of this Agreement in connection
with activities completed, Marketing Costs accrued, and Net Sales
realized
with respect to the period prior to the effective date of such expiration
or termination.
|
(b)
|
Within
thirty (30) days after the expiration or termination of this Agreement,
Inyx will provide to the AMC and King (i) an Inyx Detail Report
for
the month during which such expiration or termination occurs (and
all Inyx
Detail Reports for prior months that were required to be submitted
to the
AMC and King pursuant to Section 3.4 but were not submitted); (ii) a
reasonably detailed statement of Marketing Costs incurred by Inyx
during
the period of January 1 of the Calendar Year in which such
expiration
or termination occurs through the effective date of such expiration
or
termination; and (iii) a reasonably detailed statement of
costs and
expenses incurred by Inyx in performing Excess Details, if any, during
such period.
|
(c)
|
Within
thirty (30) days after the expiration or termination of this Agreement,
King will provide to the AMC and Inyx (i) a King Detail Report
for
the month during which such expiration or termination occurs (and
all King
Detail Reports for prior months that were required to be submitted
to the
AMC and Inyx pursuant to Section 4.3 but were not submitted); (ii) a
reasonably detailed statement of Marketing Costs incurred by King
during
the period of January 1 of the Calendar Year in which such expiration
or
termination occurs through the effective date of such expiration
or
termination; (iii) a reasonably detailed statement of costs and expenses
incurred by King in performing Excess Details, if any, during such
period;
and (iv) a statement of Net Sales during such
period.
|
(d)
|
Within
thirty (30) days after receipt of such information from King and
Inyx, the
AMC will determine the net amounts due and or payable by Inyx and
King,
and such amounts will be paid by the parties within thirty (30) days
after
such AMC determination.
|
10.
|
COLLABORATION
AGREEMENT
|
10.1
|
AMC
and Dispute Resolution. (a)
The parties acknowledge and agree that the provisions with respect
to the
AMC in Article 2 of the Collaboration Agreement, including the dispute
resolution provisions in Section 2.7 of the Collaboration Agreement,
will
apply with respect to the parties activities under this
Agreement.
|
CONFIDENTIAL
TREATMENT
17
(b)
|
In
addition to the specific matters addressed in the Collaboration Agreement
and elsewhere in this Agreement, and subject to the other provisions
of
the Collaboration Documents, including King’s final decision-making
authority, as set forth in Section 2.7(c) of the Collaboration Agreement,
during the Term, the AMC will approve the
following:
|
(i)
|
marketing
and promotion activities for the
Products;
|
(ii)
|
the
market definition against which the Products will be
measured;
|
(iii)
|
Products
production forecasts;
|
(iv)
|
Marketing
Costs;
|
(v)
|
targets
for sales force staffing, number, and frequency of quarterly and
annual
Details;
|
(vi)
|
Products
positioning, strategy, and
objectives;
|
(vii)
|
determination
of the format and quantities of promotional sales, marketing, and
educational materials for the Products that will be provided to the
Physicians called upon in the Details by either party’s sales
representatives; and
|
(viii)
|
quantities
and schedule of delivery of Products samples to be provided to each
party’s sales representatives and to the Physicians called upon in the
Details by each party’s sales
force.
|
10.2
|
Recordkeeping
and Audits.
The parties acknowledge and agree that the provisions governing
recordkeeping and audit rights contained in Article 10 of the
Collaboration Agreement will apply with respect to the parties activities
under this Agreement and are incorporated
herein.
|
10.3
|
Confidentiality.
The parties acknowledge and agree that the confidentiality obligations
set
forth in Section 12 of the Collaboration Agreement are incorporated
herein
in their entirety.
|
10.4
|
Indemnification
and Insurance.
The parties acknowledge and agree that the provisions governing
indemnification and insurance contained in Article 13 of the Collaboration
Agreement will apply with respect to the parties activities under
this
Agreement and are incorporated
herein.
|
10.5
|
Competitor
Products.
Inyx acknowledges and agrees that it is subject to the non-competition
provisions of Section 7.1 of the Collaboration Agreement, which provisions
will continue throughout the term of the Collaboration Agreement
notwithstanding the termination or expiration of this
Agreement.
|
CONFIDENTIAL
TREATMENT
18
11.
|
MISCELLANEOUS
PROVISIONS
|
11.1
|
Notices. Except
as otherwise specifically provided herein, any notice or other documents
to be given under this Agreement will be in writing and will be deemed
to
have been duly given if sent by registered post, nationally recognized
overnight courier, or confirmed facsimile transmission to a party
(followed by hard copy by mail), or delivered in person to a party
at the
address or facsimile number set out below for such party or such
other
address as the party may from time to time designate by written notice
to
the other:
|
If
to
King:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
President
Facsimile:
(000) 000-0000
with
a
copy to:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
Executive Vice President and General Counsel
Facsimile:
(000) 000-0000
and
Xxxxx
Day
000
Xxxx
00xx Xxxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Xxxx X. Xxxxxx, Esq.
Facsimile:
(000) 000-0000
If
to
Inyx:
Inyx,
Inc.
000
Xxxxx
Xxxxxx
00xx
Xxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Chairman and CEO
Facsimile:
(000) 000-0000
CONFIDENTIAL
TREATMENT
19
with
a
copy to:
Xxxxxxx
Xxxxx LLP
10th
Floor, 00000-000 Xxxxxx
Xxxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
Attn:
Xxxx X. Xxxxxxxxxx, Q.C.
Facsimile:
(000) 000-0000
Any
such
notice or other document will be deemed to have been received by the addressee
three (3) business days following the date of dispatch of the notice or other
document by post or, where the notice or other document is sent by overnight
courier, by hand, or is given by facsimile, simultaneously with the transmission
or delivery thereof.
11.2
|
Assignment.
Inyx may not assign or otherwise transfer this Agreement or any interest
herein or right hereunder without the prior written consent of King,
and
any such purported assignment, transfer, or attempt to assign or
transfer
any interest herein or right hereunder will be void and of no effect.
King
may freely assign and otherwise transfer this Agreement or any interest
herein or right hereunder without Inyx’s consent. Subject to the
foregoing, this Agreement will be binding upon and inure to the benefit
of
the parties hereto and their respective permitted successors and
assigns.
|
11.3
|
Governing
Law.
This Agreement will be construed under and in accordance with, and
governed in all respects by, the laws of the State of New York, without
regard to its conflicts of law
principles.
|
11.4
|
Non-Waiver.
The failure of either party to enforce or to exercise, at any time
or for
any period of time, any term of or any right arising pursuant to
this
Agreement does not constitute, and will not be construed as, a waiver
of
such term or right, and will in no way affect that party’s right later to
enforce or exercise such term or
right.
|
11.5
|
Entire
Agreement.
This Agreement, together with the other Collaboration Documents,
contains
all of the terms agreed to by the parties regarding the subject matter
hereof and thereof and supersede any prior agreements, understandings,
or
arrangements between them, whether oral or in writing. This Agreement
may
not be amended, modified, altered, or supplemented except by means
of a
written agreement or other instrument executed by both of the parties
hereto. No course of conduct or dealing between the parties will
act as a
modification or waiver of any provisions of this
Agreement.
|
11.6
|
Consent
to Jurisdiction.
Each of the parties hereby submits to the exclusive general jurisdiction
of the courts of the State of New York and the courts of the United
States
of America for the Eastern District of New York in any action or
proceeding arising out of or relating to this Agreement and to the
jurisdiction of the appellate courts to which appeals are required
to be
taken from any of the foregoing. Each of the parties waives any defense
of
inconvenient forum to the maintenance of any such action or proceeding.
Any party may make service on any other party by sending or delivering
a
copy of the process to the party to be served at the address and
in the
manner provided for the giving of notices in Section 11.1 above.
Nothing
in this Section 11.6, however, will affect the right of any party
to serve
legal process in any other manner permitted by law or
equity.
|
CONFIDENTIAL
TREATMENT
20
11.7
|
Equitable
Relief.
Each party acknowledges that a breach by it of the provisions of
this
Agreement cannot reasonably or adequately be compensated in damages
in an
action at law and that such a breach may cause the other party irreparable
injury and damage. By reason thereof, each party agrees that the
other
party is entitled to seek, in addition to any other remedies it may
have
under this Agreement or otherwise, preliminary and permanent injunctive
and other equitable relief to prevent or curtail any breach of this
Agreement by the other party; provided, however, that no specification
in
this Agreement of a specific legal or equitable remedy will be construed
as a waiver or prohibition against the pursuing of other legal or
equitable remedies in the event of such a breach. Each party agrees
that
the existence of any claim, demand, or cause of action of it against
the
other party, whether predicated upon this Agreement, or otherwise,
will
not constitute a defense to the enforcement by the other party, or
its
successors or assigns, of the covenants contained in this
Agreement.
|
11.8
|
Severability.
In the event that any of the provisions or a portion of any provision
of
this Agreement is held to be invalid, illegal, or unenforceable by
a court
of competent jurisdiction or a governmental authority, such provision
or
portion of provision will be construed and enforced as if it had
been
narrowly drawn so as not to be invalid, illegal, or unenforceable,
and the
validity, legality, and enforceability of the enforceable portion
of any
such provision and the remaining provisions will not be adversely
affected
thereby.
|
11.9
|
Relationship
of the Parties.
The parties hereto are acting and performing as independent contractors,
and nothing in this Agreement creates the relationship of partnership,
joint venture, sales agency, or principal and agent. Neither party
is the
agent of the other, and neither party may hold itself out as such
to any
other party. All financial obligations associated with each party’s
business will be the sole responsibility of such
party.
|
11.10
|
Counterparts.
This Agreement will become binding when any one or more counterparts
hereof, individually or taken together, will bear the signatures
of each
of the parties hereto. This Agreement may be executed in any number
of
counterparts, each of which will be deemed an original as against
the
party whose signature appears thereon, but all of which taken together
will constitute but one and the same
instrument.
|
CONFIDENTIAL
TREATMENT
21
11.11
|
Force
Majeure.
Neither party will be liable to the other party for any failure to
perform
as required by this Agreement if the failure to perform is due to
circumstances reasonably beyond such party’s control including acts of
God, civil disorders or commotions, acts of aggression, fire, explosions,
floods, drought, war, sabotage, embargo, utility failures, material
shortages, a national health emergency, or appropriations of property.
A
party whose performance is affected by a force
majeure
event will take prompt action using its reasonable best efforts to
remedy
the effects of the force
majeure
event. If, as a result of a force
majeure
event, a party is unable to fully perform its obligations hereunder
for
any consecutive period of one hundred eighty (180) days, the other
party
will have the right to terminate this Agreement, upon providing written
notice to the nonperforming party, such termination to be effective
thirty
(30) days from the date of such notice.
|
11.12
|
Interpretation.
The parties hereto acknowledge and agree that: (a) each party and
its
representatives have reviewed and negotiated the terms and provisions
of
this Agreement and have contributed to its revision; and (b) the
terms and
provisions of this Agreement will be construed fairly as to each
party
hereto and not in favor of or against either party regardless of
which
party was generally responsible for the preparation or drafting of
this
Agreement.
|
11.13
|
Third
Party Beneficiaries.
This Agreement is not intended to confer upon any non-party rights
or
remedies hereunder, except as may be received or created as part
of a
valid assignment.
|
11.14
|
Use
of Party’s Name.
Except as expressly provided or contemplated hereunder and except
as
otherwise required by applicable law, no right is granted pursuant
to this
Agreement to either party to use in any manner the trademarks or
name of
the other party, or any other trade name, service xxxx, or trademark
owned
by or licensed to the other party in connection with the performance
of
the Agreement. Notwithstanding the above, either party will be permitted
to use the other party’s name and marks, as may be required under
applicable law, in connection with securities or other public
filings.
|
[Signatures
on following page]
CONFIDENTIAL
TREATMENT
22
IN
WITNESS WHEREOF, the parties have duly executed this Marketing and Promotion
Agreement as of the first date written above.
KING PHARMACEUTICALS, INC. | ||
|
|
|
By: | /s/ Xxxxx Xxxxxxxx | |
Xxxxx Xxxxxxxx |
||
President and CEO |
INYX, INC. | ||
|
|
|
By: | /s/ Xxxx Xxxxxxx | |
Xxxx Xxxxxxx |
||
Chairman and CEO |
CONFIDENTIAL
TREATMENT
SCHEDULE
2.2
TRADEMARKS
Country
|
Xxxx
|
Registration
Number
|
U.S.
|
INTAL
|
876359
|
U.S.
|
TILADE
|
1259079
|
Canada
|
INTAL
|
164043
|
Canada
|
TILADE
|
394582
|
CONFIDENTIAL
TREATMENT
SCHEDULE
8.1
BASELINE
AMOUNTS
Calendar
Year
|
2005
|
2006
|
2007
|
2008
|
2009
|
2010
|
2011
|
2012
|
Net
Sales
|
***
|
***
|
***
|
***
|
***
|
***
|
***
|
***
|
Dollars
in Millions
CONFIDENTIAL
TREATMENT