*Confidential
treatment has been requested as to certain portions of this exhibit
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934,
as amended.
CO-PROMOTION
AGREEMENT
THIS
CO-PROMOTION AGREEMENT (“Agreement”),
entered into as of this 7th day of January 2010, is by and between
GALDERMA LABORATORIES, L.P. , a Texas limited partnership,
having as its principal place of business at 14501 North Freeway,
Fort Worth, Texas 76177 (“PhotoMedex”), and
PHOTOMEDEX, INC ., a Delaware corporation, having as its
principal place of business 147 Keystone Drive, Montgomeryville, PA
18936 (“PhotoMedex”) (each a “party”,
collectively “parties”).
WHEREAS,
Galderma
has exclusive rights to market, sell and distribute the Product (as
defined below) in the Territory (as defined below);
WHEREAS,
PhotoMedex
is engaged in the business of and has specialized expertise and
capabilities in, among other things, the promotion of procedural
products and services to physicians; and
WHEREAS,
Galderma
and PhotoMedex desire to work together to promote the Product upon
the terms and conditions set forth 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:
1.0
DEFINITIONS.
Capitalized
terms used herein without definition shall have the meanings
specified in this Section 1.0 (such definitions to be equally
applicable to both the singular and plural forms of the terms
defined). Unless otherwise specified, all references in
this Agreement to “Sections” are to Sections of this
Agreement.
1.1
“Act”
shall mean the United States Federal Food, Drug and Cosmetic Act,
as it may be amended from time to time.
1.2
“Affiliate(s)”
shall mean any person or entity directly or indirectly,
controlling, controlled by or under common control and/or ownership
with Galderma or PhotoMedex. Ownership or control for purposes of
this Section 1.2 shall mean (a) in the case of corporate entities,
direct or indirect ownership of at least fifty percent (50%) of the
stock having the right to vote for the election of directors and
(b) in the case of non-corporate entities, direct or indirect
ownership of the equity interest necessary to direct the management
and policies of such non-corporate entities. As to
Galderma, as of the Effective Date, “Affiliate” shall
specifically include, but is not limited to, Galderma S.A.,
Galderma Pharma S.A., Nestlé S.A. and L’Oréal
S.A.
1.3
“Applicable
Laws and Regulations” shall mean all applicable federal,
state and local laws, regulations, rules or guidelines that govern
the services and transactions contemplated by this Agreement,
including without limitation the Act, as the same may be amended
from time to time.
1.4
“Commercially
Reasonable Efforts” shall mean efforts and resources normally
used by a party for a product owned by it or to which it has
rights, which is of similar market potential at a similar stage 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.
1.5
“Quarterly
Report” shall mean a report, similar in substance and format
to the attached Schedule 1, which sets forth PhotoMedex’s
efforts in promoting and marketing the Product during the preceding
calendar quarter (or any portion thereof) and includes at a
minimum: (i) the number of Product Calls, the name, address, and
specialty of each healthcare professional upon whom the Product
Call was made, and a breakdown of First Position Details and Second
Position Details made and recorded
based
on data recorded by the PDT Sales Force, as defined in 3.3; (ii)
such other information as may be reasonably required in the
then-current Marketing Plan; (iii) sales strategies; (iv) market
and sales target analysis; (v) sales force deployment; (vi)
forecast vs. plan comparison; and (vii) such other information as
mutually agreed upon by the parties.
1.6
“Effective
Date” shall mean January 1, 2010.
1.7
“FDA”
shall mean the United States Food and Drug Administration or any
successor entity thereto.
1.8
“First
Position Detail” shall mean a Product Call in which the
promotional message involving the Product is presented first and is
a principal topic of discussion during the Product Call, with an
emphasis on the Product comparable to PhotoMedex’s current
practices for internal and other external product(s) in the first
position.
1.9
“Generic
Version” shall mean a drug product that the FDA has approved
under an Abbreviated New Drug Application or “505(b)(2)
application” according to the provisions of the Act, or
subsequently enacted amendments to such provisions, where the
approved drug product was found by the FDA to be therapeutically
equivalent to the Product.
1.10
“Good
Manufacturing Practices” shall mean the current standards for
manufacture, as set forth in the Act and applicable regulations and
guidelines promulgated thereunder or successors thereto, as shall
be in effect from time to time during the Term.
1.11
“Improvement”
shall mean any other strengths or regimens of Metvixia
®
(methyl
aminolevulinate) Cream, 16.8% that has at least one indication for
the treatment of non-hyperkeratotic actinic keratoses and developed
by Galderma or a third party, which is not covered by the
regulatory filings in the Territory.
1.12
“Ineligible
Person” means a person who is currently excluded, debarred,
suspended or otherwise ineligible to participate in the U.S.
federal health care programs or in a U.S. federal procurement or
non-procurement programs, or has been convicted of a criminal
offense that falls within the ambit of 42 U.S.C. 1320a-7(a), but
has not yet been excluded, debarred, suspended or otherwise
declared ineligible.
1.13
“Marketing
Materials” shall have the meaning ascribed to it in Section
4.3.
1.14
“Marketing
Plan” shall mean PhotoMedex’s annual calendar plan,
similar in substance and format to the attached Schedule 2, for the
promotion, marketing and sale of the Product. The
Marketing Plan shall set forth the manner in which the Product is
to be promoted and marketed during the period to which the
Marketing Plan relates and shall include, at a minimum: (a) the
number of estimated annual Product Calls and First and Second
Position Details to be provided by PhotoMedex, which shall meet or
exceed the requirements set forth in Section 3.5; (b) any training
programs to be conducted; and (c) such other information relating
to the marketing of the Product as deemed advisable by the Steering
Committee or otherwise agreed upon by the parties.
1.15
“Net
Sales” shall mean the gross sales invoiced by Galderma for
Sales of the Product in the Territory, less the following: (a)
customary quantity, trade, and/or early payment discount,
allowances, chargebacks, rebates, and price adjustments or
reductions allowed or given; (b) actual credits, rebates, or
Product returned or destroyed by customers; and (c) sales and other
excise taxes and duties directly related to the sale, to the extent
included in the gross invoiced amount and separately itemized on
the invoice, all applied in accordance with IFRS. For
purposes of clarity, any Product delivered to a third party without
charge or any Product used in any new clinical or
marketing-initiated trial supported by Galderma without charge to
the user shall not be included in Net Sales. See
Schedule 3 for Net Sales formula.
1.16
“Non-Serious
Adverse Event” shall mean any adverse drug experience
associated with the use of the Product in humans, whether or not
considered drug-related, which is not a Serious Adverse
Event.
1.17
“Product”
shall mean any and all presentations of Galderma’s
Metvixia ®
(methyl
aminolevulinate) Cream, 16.8% (“Metvixia”), and
Aktilite ®
CL128
lamp including all Improvements as defined in Section 1.11, as
packaged and labeled in accordance with Applicable Laws and
Regulations and New Drug Application #021415
(“NDA”).
1.18
“Product
Calls” shall mean face-to-face contacts by the PhotoMedex
Sales Force with the Target Group during which time the promotional
message involving the Product is presented in the first or second
position and is a principal topic of discussion and, in each case,
the promotional message is substantially completed.
1.19
“Renewal
Term” shall have the meaning ascribed to it in Section
6.0.
1.20
“Sales”
shall mean the total of all sales of the Product to third parties
by Galderma and/or its Affiliate(s) in the Territory at list price,
not reduced by discounts, allowances, rebates, returns or other
adjustments.
1.21
“Second
Position Detail” shall mean Product Calls in which the
promotional message involving the Product is presented second, with
an emphasis on the Product comparable to PhotoMedex’s current
practices for internal or other external product(s) in the second
position.
1.22
“Serious
Adverse Event” shall mean any serious and unexpected adverse
drug experience, as defined by FDA in 21 C.F.R. Section 314.80,
Section 312.32, or any successor regulation(s) associated with the
use of the Product in humans, whether or not considered
drug-related.
1.23
“Target
Group” shall mean certain healthcare professionals (including
but not limited to dermatologists, plastic surgeons, cosmetic
surgeons, and general practitioners) practicing Photodynamic
Therapy in the Territory as identified by Galderma and PhotoMedex
on an ongoing basis.
1.24
“Technical
Complaint” shall mean any complaint that questions the
purity, identity, potency or quality of the Product, its packaging
or labeling or the compliance of any batch of the Product with
Applicable Laws and Regulations and current Good Manufacturing
Practices; any complaint that concerns any incident that causes the
Product or its labeling to be mistaken for, or applied to, another
article; any bacteriological contamination or significant chemical,
physical or other change or deterioration in the Product; any
failure of one or more batches of the Product to meet the
specifications therefore in the NDA; or any complaint or evidence
of tampering with the Product.
1.25
“Term”
shall have the meaning ascribed to it in Section 6.0.
1.26
“Territory”
shall mean the United States of America, including the District of
Columbia, its possessions and territories.
1.27
“PhotoMedex
Promotional Activities” shall have the meaning ascribed to it
in Section 3.1.
1.28
“PhotoMedex
Sales Force” or “PDT Sales Force” shall mean the
sales representatives employed or contracted by PhotoMedex to
promote the Product to the Target Group in the Territory throughout
the Term and any Renewal Term.
2.0
GRANTS
OF RIGHTS. Galderma
hereby grants to PhotoMedex, on a co-exclusive basis (together with
Galderma and its Affiliates), the right to promote the Product in
the Territory during the Term and any Renewal Term (or any part
thereof) upon and subject to the terms and conditions set forth in
this Agreement.
3.0
RESPONSIBILITIES OF PHOTOMEDEX.
3.1
Product
Promotion. PhotoMedex
shall use Commercially Reasonable Efforts to market and promote the
Product in the Territory to the Target Group and other healthcare
professionals (the “PhotoMedex Promotional Activities”)
in accordance with the then-current Marketing Plan and the other
terms and conditions set forth in this Agreement.
3.2 Employees.
PhotoMedex shall, and shall cause its employees to,
comply with all regulatory, professional and legal requirements,
including, without limitation, the FDA’s regulations and
guidelines concerning the advertising of prescription drug
products, the Prescription Drug Marketing Act and any and all
promotional or compliance policies, rules and regulations
applicable to PhotoMedex employees, including PhotoMedex’s
internal promotional guidelines, which may be applicable to the
PhotoMedex Promotional Activities. PhotoMedex will
timely provide a true and correct copy of such internal promotional
guidelines to Galderma, and shall promptly provide to Galderma
copies of any amendments, revisions or restatements to the
same. No employee of PhotoMedex shall knowingly make any
representation, statement, warranty or guaranty with respect to the
Product that is not consistent with current labeling of the Product
or approved Marketing Materials, deceptive or misleading, or that
disparages the Product or the good name, goodwill and reputation of
Galderma. PhotoMedex shall use Commercially Reasonable Efforts to
ensure that the PhotoMedex Promotional Activities will be provided
in a professional, ethical and competent manner. During
the Term and any Renewal Term, PhotoMedex will use Commercially
Reasonable Efforts to not hire or employ an Ineligible Person as
either an employee or contractor to PhotoMedex to promote the
Product as contemplated under this Agreement.
3.3
Minimum
Sales Force. PhotoMedex
agrees that from and after the Effective Date it will maintain in
the Territory a well-trained sales force, consisting of full-time
sales representatives focused on promoting the Product in
accordance with the then current Marketing Plan to the Target Group
(“PDT Sales Force”). Throughout the remainder of the
Term or Renewal Term(s), PhotoMedex shall use Commercially
Reasonable Efforts to ensure that the number of sales
representatives comprising the PDT Sales Force meets the
requirements necessary to meet the minimum Product
Calls. Before initiating any Product Calls, PhotoMedex
will have a well-trained sales force consisting of not less than 30
full-time sales representatives, 5 full-time managers, 2 full-time
field trainers, and 5 tele-marketing
representatives. PhotoMedex will expand the sales force as
necessary to meet market demand based upon the initial market
acceptance of the Product and the Steering Committee’s
mutually agreeable recommendation.
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Training
Costs. Except
as otherwise agreed by the parties herein, Galderma shall be
responsible for the costs and expenses related to training the PDT
Sales Force, except that PhotoMedex shall be responsible for
lodging, transportation, and other associated costs (including but
not limited to costs of airfare, ground transportation, and food
and beverage) related to training the PDT Sales
Force. Notwithstanding the foregoing, Galderma agrees to
pay PhotoMedex up to $10,000.00 for the incremental costs incurred
by Photomedex for the additional lodging of the PDT Sales Force
during training.
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Prior
Review and Approval. To
the extent practicable, all formal written, electronic and visual
communications provided to the PDT Sales Force regarding training,
strategy, positioning or selling messages for the Product will be
subject to prior review and timely approval through
Galderma’s promotional review approval process.
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3.5
Minimum
Requirements.
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Product
Calls. PhotoMedex
guarantees that a minimum of [**](pro-rated for any partial
calendar years) Product Calls shall be made by the PDT Sales Force
on the Targets Group during each calendar year. The PDT Sales Force
shall promote the Product on every Product Call to an applicable
healthcare professional.
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Product
Position. Subject
to any changes made by the Steering Committee, the PDT Sales Force
shall promote the Product in First Position Detail with respect to
the Target Group. For all other Product Calls on
applicable healthcare professionals the PDT Sales Force shall
promote the Product in Second Position Detail.
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3.6
Data
Collection and Reporting Systems. As
soon as practicable, PhotoMedex will, at no expense to Galderma,
establish and maintain during the Term and any Renewal Term, true
and
accurate
data collection and reporting systems for Product Calls, the name,
address, and specialty of each healthcare professional upon whom
the Product Call was made with First Position Details, Second
Position Details, and Product samples distributed to the Target
Group.
3.7
Quarterly
Report. PhotoMedex
shall provide Galderma with a Quarterly Report within thirty (30)
calendar days after the end of each calendar quarter (or any
portion thereof) during the Term and any Renewal
Term. Each such Quarterly Report shall
measure compliance with the minimum requirements set forth in
Section 3.5 above and be provided to Galderma in a format similar
to the attached Schedule 1.
3.8
Marketing
Plan. On
January 1 of each calendar year, PhotoMedex shall provide to
Galderma during the Term and any Renewal Term a Marketing Plan as
defined in Section 1.15.
3.9
Sales
Projection Report. PhotoMedex
shall provide to Galderma a twelve (12) month rolling sales
forecast for the Product updated on a quarterly basis. This Sales
Projection Report shall be due with the Quarterly
Report.
3.10
Compliance
with Laws. In
connection with the PhotoMedex Promotional Activities and Product
Calls and all other activities under this Agreement, PhotoMedex
will