Exhibit 10.48.1
AGREEMENT
dated: 1 st July 2005
between
VERNALIS DEVELOPMENT LIMITED
and
ENDO PHARMACEUTICALS INC
re.
CO-PROMOTION OF FROVATRIPTAN IN
U.S.A.
The confidential portions of this exhibit have
been filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN
***.
CONTENTS
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Clause
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Description
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Page
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Definitions
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1
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Grants of
Rights
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4
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Responsibilities of Vernalis
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5
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Responsibilities of Endo
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10
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Training,
Marketing Materials and Non-Hiring of Employees
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11
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Certain
Regulatory Matters
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12
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Joint
Co-Promotion Team
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14
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Recordkeeping
and Audits
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17
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Term and
Termination
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18
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Confidentiality
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20
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Indemnification
and Insurance; Limitation of Liability
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20
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Representations
and Warranties
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21
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Notices
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21
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Entire
Agreement
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21
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Miscellaneous
Provisions
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22
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Exhibits
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Example of
Vernalis Detail Report
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Sample Schedule
of Phase One Training
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Allocation of
call plan
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Specialty Sales
Representative Hiring Profile
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CO-PROMOTION AGREEMENT
This CO-PROMOTION
AGREEMENT (this “Agreement”) is entered into and
effective as of this 1 st day of July, 2005 (the “Effective
Date”), by and between ENDO PHARMACEUTICALS INC., a Delaware
corporation whose principal place of business is at 100 Endo
Boulevard, Chadds Ford, PA 19317, USA (together with its
Affiliates, “Endo”), and VERNALIS DEVELOPMENT LTD., a
company organized under the laws of England and Wales whose
principal place of business is at Oakdene Court, 613 Reading Road,
Winnersh, Wokingham, RG41 5UA, England
(“Vernalis”).
RECITALS
WHEREAS, Vernalis
granted to Endo a sole and exclusive license to Commercialise its
product known as frovatriptan in the Territory by way of a License
Agreement dated July 14, 2004 (the “License”) as
and to the extent more particularly set forth in the
License;
WHEREAS, Endo is
engaged in the business of and has expertise in, among other
things, the promotion to physicians of pharmaceutical
products;
WHEREAS, the
License provides Vernalis certain rights to Commercialise (and in
particular to co-promote) the Product in the USA in accordance with
the terms set forth in the License and such additional terms as may
be agreed between the parties;
WHEREAS, Vernalis
has exercised its option to co-promote Product in the USA, and Endo
and Vernalis desire to work together to promote the Product in the
USA upon the terms and conditions set forth herein;
WHEREAS, the
parties wish to set forth in this Agreement the detailed terms and
conditions to govern such co-promotion and to amend, restate and
supercede Article 9 and Schedule 10 of the License and
make the other specific amendments to the License explicitly stated
in Section 11, but otherwise leave the License (and that
certain Safety Agreement, Loan Agreement and Security Agreement
between the Parties in connection with the License)
unaffected.
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 is hereby acknowledged, the
parties hereto agree as follows:
1. Definitions .
Capitalized terms used herein shall have the meanings specified in
this Section 1 (such definitions to be equally applicable to
both the singular and plural forms of the terms defined). Other
capitalized terms used in this Agreement, unless otherwise set
forth in this Section 1, shall have the meanings set forth in
the License.
“Act”
shall mean the United States Federal Food, Drug and Cosmetic Act,
as it may be amended from time to time.
“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.
“Annual
Co-Promotion Plan” shall mean a written sales plan relating
to the sales and promotion of the Product in the USA by Endo sales
representatives and Vernalis Specialty Sales Personnel as annually
prepared by the Joint Co-Promotion Team.
“Audited
Party” shall have the meaning set forth in
Section 8.2(a).
“Auditing
Party” shall have the meaning set forth in
Section 8.2(a).
“Endo
Copyright” means copyright or any other intellectual property
analogous to copyright including any rights in designs subsisting
or relating to any Documents, designs or other embodiments of the
trade dress for the Product, any form of advertisement in whatever
media, Marketing Materials, sales training materials, samples or
other promotional gifts or any other materials in which such rights
are capable of subsisting as a matter of law in all cases which are
generated by or upon behalf of Endo or its Affiliates during the
period of this Agreement in connection with the advertising,
promotion, marketing or sale or other Commercialization of
Product.
“Endo
Trademarks” means (i) the name and mark ENDO and the
associated Endo logo, and (ii) any other trademarks other than
the Vernalis Trademarks used, owned by or licensed to Endo in
relation to the Product (including without limitation the MAM
Product (if and when it receives Marketing Authorization)). This
definition shall not be read to modify in any way Section 13.1
of the License.
“FDA”
means the United States Food and Drug Administration or any
successor entity thereto.
“Governmental
or Regulatory Authority” shall mean any U.S. court, tribunal,
arbitrator, agency, commission, official or other instrumentality
of any federal, state, county, city or other political subdivision
thereof.
“Initial
Term” shall have the meaning set forth in
Section 9.1.
“Joint
Co-Promotion Team” shall have the meaning set forth in
Section 7.
“License”
means the License Agreement dated as of July 14, 2004 between
Endo and Vernalis.
“Marketing
Materials” shall have the meaning set forth in
Section 5.3.
“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.
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“PDMA”
shall mean the Prescription Drug Marketing Act, as amended, and the
implementing rules and regulations thereunder.
“Person”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority, or any other
form of entity not specifically listed herein.
“Phase One
Training” shall mean a Product training program (including
compliance training) designed by Endo and provided to sales
representatives, a sample of which is set forth in Exhibit B
hereto. Phase One Training may include sales force automation
training if so requested by Vernalis and if Vernalis uses the same
sales force automation system as Endo.
“Product”
shall have the meaning set forth in the License.
“Product
Details” shall mean face-to-face contacts by a sales
representative with a Target Healthcare Professional for the
purpose of discussing information about the Product.
“Product
Technical Complaint” or “PTC” 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, including the Act, and
current Good Manufacturing Practice; 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 therefor in the NDA; or any
complaint or evidence of tampering with the Product.
“Product
Trademarks” shall mean the Vernalis Trade Marks, including
without limitation the trademark Frova® associated with the
Product, any other related trademark or service mark containing the
word “Frova” and any other trademark or service mark
(whether registered or unregistered) currently used on or with the
Product or in any Marketing Material in the U.S. and its
territories.
“Safety
Agreement” shall mean the Safety Data Exchange Agreement
version 12 August 2004 entered into between Endo
Pharmaceuticals Inc. and Vernalis Development Ltd.
“Specialty
Sales Personnel” shall have the meaning set forth in the
License for Vernalis Specialty Sales Force
“Target
Healthcare Professionals” shall mean medical professionals
with prescribing or dispensing authority and who practice in the
medical specialties set forth on Exhibit C, as may be amended
by agreement of the Parties from time to time.
“Term”
shall have the meaning set forth in Section 9.1.
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“USA”
shall mean the United States of America and its
territories.
“Vernalis
Detail Report” shall have the meaning set forth in
Section 3.2.
“Vernalis
Detailing Services” shall have the meaning set forth in
Section 3.1(a).
2. Grants of Rights
.
2.1
Co-Promotion Rights .
a.
Endo hereby grants to Vernalis, together with Endo, and to the
extent, if any, that Vernalis does not already have the right to do
so under the License given the rights it has retained thereunder,
the right to promote the Product in the USA during the Term subject
to the terms and conditions set forth in this Agreement.
b.
The promotion rights granted to Vernalis herein shall not prevent
Vernalis from promoting other products in the USA. The Parties
agree that during the time in which Vernalis is co-promoting the
Product in the USA, the Specialty Sales Personnel shall have the
right to detail other products in addition to the Product provided
that such other products are not (x) for the treatment of
migraine or post herpetic neuralgia or (y) in direct
competition in the USA with products in other therapeutic areas
that are being Commercialised by Endo or are in Phase III Clinical
Trial or have completed clinical proof of principle by
Endo.
2.2
Rights to Trademarks and Copyrights .
a.
Licenses .
(i) Endo
hereby grants to Vernalis a non-exclusive, royalty-free license to
use the Endo Trademarks and Endo Copyright solely in connection
with performing its obligations and exercising its rights to
co-promote the Product pursuant to the terms and conditions of this
Agreement.
b.
Required Use and Compliance .
(i) Except
for the use of the Endo Trademarks and Endo Copyright in labeling,
package inserts, Product monographs, packaging for Products, and
Marketing Materials, each party shall promote the Product only
under the Product Trademarks. To avoid any doubt, the Vernalis
Specialty Sales Personnel are permitted to use business cards
indicating their association with Vernalis and bearing any
trademark or tradename of Vernalis and are permitted in their
Product promotion to refer to their association with
Vernalis.
(ii) To
the extent Vernalis makes any use of the Endo Trademarks in writing
other than in a writing provided by Endo, Vernalis shall ensure
that each use of the Endo Trademarks in writing is accompanied by
an acknowledgement that the Endo Trademarks are owned by Endo.
Vernalis shall not (A) use the Endo Trademarks in a way that
might materially prejudice their distinctiveness or validity
or
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the goodwill of Endo therein, or
(B) use in its Product-related activities any trademarks or
tradenames so resembling any of the Endo Trademarks as to be likely
to cause confusion or deception.
c.
Notice of Infringement— Endo Trademarks.
(i) Vernalis
shall give Endo prompt notice of any infringement or threatened
infringement of which it becomes aware of any of the Endo
Trademarks used in connection with the Product in the
USA.
(ii) Endo
shall determine in its sole discretion what action, if any, to take
in response to the infringement or threatened infringement of any
Endo Trademark. The costs of any such action in response to the
infringement or threatened infringement in the USA shall be borne
solely by Endo. Endo shall keep Vernalis informed of such action
and shall use reasonable efforts to advise Vernalis to the extent
such action impacts or affects the Vernalis Specialty Sales
Personnel’s Product promotion in the USA.
d.
Notice of Infringement — Product Trademarks. The parties
rights and obligations as regards infringement of the Product
Trademarks are as set forth in Clauses 13.7 — 13.11 of the
License.
3. Responsibilities of
Vernalis .
3.1
Promotion by Vernalis .
a.
Commencing after January 1, 2006 and by January 31, 2006,
and continuing throughout the Term, Vernalis shall promote the
Product to Target Healthcare Professionals in the USA in accordance
with the then-current Annual Co-Promotion Plan (collectively, the
“Vernalis Detailing Services”). The targeting and
frequency of Product Details to be provided by Vernalis will be
determined by the Joint Co-Promotion Team.
b.
By January 31, 2006, Vernalis shall have hired and shall
thereafter maintain a sales force of Specialty Sales Personnel
detailing the Product in the USA to Target Healthcare
Professionals, and such sales force shall complete the number of
Product Details specified in the then current Annual Co-Promotion
Plan, not to exceed the maximum number of details set forth in
Clause 9.1.2 of the License, in each calendar year during the Term.
All Product Details made by Vernalis and reimbursed by Endo shall
contribute to Endo’s Estimated Detailing Effort as set forth
in the License.
c.
Vernalis shall after 31 Jan 2006 and at all times during the
remainder of the Term of this Agreement, use Commercially
Reasonable Efforts to provide at least the number of Product
Details set forth in the Annual Co-Promotion Plan. If for any
*** consecutive calendar quarters, Vernalis fails to provide
a minimum of *** of the required Product Details set forth
for Vernalis to provide in the Annual Co-Promotion Plan, then Endo
shall have the right to terminate this Agreement upon ***
days prior written notice to Vernalis; provided, however, that if
the reason Vernalis has failed to provide such *** is for a
reason which meets the definition of Force Majeure,
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then Endo shall not be entitled
to terminate this Agreement on that basis and the Joint
Co-Promotion Team shall agree in good faith to an appropriate
adjustment to the Annual Co-Promotion Plan going
forward.
d.
Vernalis shall notify Endo prior to September 30, 2005 and
prior to June 30 of each year thereafter during the Term of
the proposed number of Product Details to be included in the
promotion of the Product for the following calendar year. Vernalis
may revise the proposed number of Product Details provided to Endo
by up to *** as long as such revisions are made in writing
on or before August 31 st of
subsequent years. For planning purposes only, at the same time as
Vernalis notifies Endo of the proposed number of Product Details,
Vernalis shall also notify Endo of the estimated number of
Specialty Sales Personnel Vernalis intends to employ for Product
Details.
e.
In performing its duties hereunder, Vernalis shall, and shall cause
its employees and designees 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, state laws and
regulations relating to promotion of pharmaceutical products, the
American Medical Association’s Guidelines on Gifts to
Physicians, the OIG Compliance Program Guidelines for
Pharmaceutical Manufacturers, the PhRMA Guidelines for Marketing
Practices, and the ACCME Standards for Commercial Support of
Continuing Medical Education, which may be applicable to the
co-promotion of the Product by Vernalis. No employee or designee of
Vernalis shall (i) make any representation, statement,
warranty or guaranty with respect to the Product that is not
consistent with then-current labeling of the Product or Marketing
Materials approved by Endo, that is deceptive or misleading or that
disparages the Products or the good name, goodwill and reputation
of Endo or (ii) make any arrangements with, make payments to
or provide gifts or other incentives to any healthcare
professionals in violation of applicable laws, regulations or
guidelines relating thereto. Vernalis covenants that its services
hereunder will be provided in a professional, ethical and competent
manner in accordance with the foregoing standards. Notwithstanding
Section 9.2 hereof, upon written notice to Vernalis by Endo,
Vernalis shall take prompt action to address any breach of this
Section 3.1(e) and, within *** days shall submit to
Endo a written plan to correct such breach. If the breach is not
cured within *** days after Endo’s receipt of such
corrective plan, or if Vernalis fails to timely submit to Endo such
corrective plan, Endo may, where the breach has been caused by one
or more identifiable Vernalis Specialty Sales Personnel, require
that such Specialty Sales Personnel cease to promote the Product
and, in all other cases, may terminate this Agreement immediately
upon written notice to Vernalis.
f.
Vernalis shall ensure that its Specialty Sales Personnel are
familiar with the procedures, obligations, rights, and
responsibilities imposed by the terms of this Agreement as
applicable to the performance of promotional activities hereunder.
Vernalis shall at all times ensure that its Specialty Sales
Personnel are providing Vernalis Detailing Services that are
consistent with the marketing messages developed and communicated
to Vernalis by Endo and shall use only Marketing Materials provided
by Endo.
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g.
To avoid any doubt, nothing express or implied in this
Section 3.1 (including without limitation Sections 3.1(a)
and 3.1(b)) shall be read to limit in any way Vernalis’
rights under Section 6.2 of the License.
h.
To avoid any doubt, because Endo determines and provides the
Marketing Materials for Product promotion in the USA, nothing
express or implied in this Section 3.1 or elsewhere in this
Agreement shall be read to make Vernalis liable for its Product
promotion based on the content of the Marketing Materials provided
by Endo; provided that Vernalis Specialty Sales Personnel are
properly using and promoting such content in accordance with
applicable laws and instructions from Endo.
3.2
Vernalis Detail Reports . Vernalis shall provide Endo with a
report (each a “Vernalis Detail Report”), within
*** calendar days after the end of each calendar quarter
during the Term (and within such period after the end of the Term
as may be necessary to finalize this Agreement), setting forth the
following information regarding the efforts of Vernalis Specialty
Sales Personnel in promoting the Product during the preceding
quarter (or part thereof): (i) the number of Product Details
made and recorded by Vernalis standard record keeping procedures
based on data recorded by the Specialty Sales Personnel and
(ii) such other information as may be required in the
then-current Annual Co-Promotion Plan or deemed appropriate by the
Joint Co-Promotion Team (provided that Vernalis has in its
discretion agreed to include such information required in such
plan, but in any case data provided must be sufficient to allow
Endo to meet its obligations to report detailing activity to
Vernalis consistent with the format set forth in Schedule 5 of
the License). Each such Vernalis Detail Report shall be in an
electronic format and in hard copy form. An example of a Vernalis
Detail Report is attached to this Agreement as Exhibit B. Each
Vernalis Detail Report shall be treated as Confidential Information
of Vernalis pursuant to Section 10 of this Agreement and shall
not be disclosed to third parties without Vernalis’ prior
written approval or direction. Vernalis shall use Commercially
Reasonable Efforts to use sales force tracking and reporting
systems that are complimentary with Endo’s sales force
tracking and reporting systems.
3.3
Vernalis Specialty Sales Personnel .
a.
Hiring . Vernalis shall be solely responsible for the
recruitment and hiring of the Specialty Sales Personnel; provided
that:
(i) In
recruiting its Specialty Sales Personnel Vernalis shall hire
representatives who, at a minimum, have the qualifications of
*** . Vernalis shall take into consideration Endo’s
hiring profile for specialty sales representatives, which is
attached hereto as Exhibit D, as may be subsequently
amended,
(ii) Incentive
compensation for Product promotion for Vernalis Specialty Sales
Personnel shall be based partly upon similar performance metrics as
those which apply to Endo sales representatives for promotion of
the Product, and
(iii) Upon
*** days written request from Vernalis, Endo shall implement
a referral program to provide an incentive to its sales
representatives to refer
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qualified candidates to Vernalis
for the Specialty Sales Personnel positions and Vernalis shall
reimburse Endo for all amounts paid to Endo sales representatives
under such referral program.
b.
Costs .
(i) Endo
shall reimburse Vernalis quarterly the Cost Per Detail up to
*** over the proposed number of Product Details provided by
Vernalis under the terms of Section 3.1(d) above, but not to
exceed the maximum number of Product Details set forth in the
following table. Such reimbursement shall include reimbursement for
all Product Details made in any year by Vernalis Specialty Sales
Personnel to Target Healthcare Professionals not included in the
allocated lists agreed pursuant to Section 3.3(c)
(‘non-allocated Target Healthcare Professionals’);
provided that at least *** of all Product Details made in
any year by Vernalis Specialty Sales Personnel are made to Target
Healthcare Professionals included in the allocated lists agreed
pursuant to Section 3.3 (c) (‘allocated Target
Healthcare Professionals’). If the proportion of Product
Details made in any year by Vernalis Specialty Sales Personnel to
allocated Target Health Care Professionals is less than ***
of total Product Details, the number of reimbursed Product Details
to non-allocated Target Health Care Professionals shall be adjusted
such that the proportion of such Product Details is not in excess
of *** of all Product Details to be reimbursed.
(ii) For
example, if Vernalis, according to Section 3.1 (d), has
provided a proposed number of Product Details of *** and,
subsequently, Vernalis Specialty Sales Personnel complete
*** Product Details, *** of which are to allocated
Target Healthcare Professionals, the following reimbursement
calculation applies. First, the criterion that the proportion of
Product Details to allocated Target Healthcare Professionals is at
least *** is applied. In this example, this is calculated as
follows: the number of Product Details to allocated Target
Healthcare Professionals *** is divided by *** . As
this number of Product Details is less than the maximum number of
Product Details for which Endo is required to pay *** , Endo
is therefore required to pay for *** Product Details. To the
extent necessary, reimbursement payments will be reconciled on an
annual basis.
(iii) Endo
shall make such reimbursement payment within *** days after
receipt by Endo of the complete Vernalis Detail Report (which shall
serve as an invoice, so long as it is so labeled). Endo shall pay
such costs to Vernalis in US Dollars by wire transfer of
immediately available funds to an account designated by Vernalis to
Endo in writing. Endo shall have no obligation to reimburse the
Cost Per Detail after *** . Vernalis may in its discretion
elect to continue to Detail the Product in the USA at no cost to
Endo after *** . All payments by Endo shall be made in
accordance with Section 11.15 of the License.
8
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YEARS
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2006
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2007
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2008
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2009
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2010
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Maximum no. of Details to be
reimbursed
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***
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***
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***
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***
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***
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% of Cost per Detail where all Vernalis
Specialty Sales Personnel Detail only the Product
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***
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***
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***
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***
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***
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% of Cost per Detail where any Vernalis
Specialty Sales Personnel Detail one or more other
products
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***
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***
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***
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***
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***
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(iv) Unless
otherwise set forth in this Agreement, Vernalis shall be
responsible for all other costs and expenses associated with its
Specialty Sales Personnel including without limitation, salary,
bonus, benefits, pension, insurance, social security, travel,
entertainment, budgets and any other related obligations such as
income tax withholding and all applicable reporting requirements.
Sales representatives of either party shall not be eligible for
awards, prizes, contests or other incentives offered by the other
party to its sales representatives, unless otherwise agreed between
the parties, in writing.
(v) Vernalis
shall be solely responsible for providing and financing fleet
services to its Specialty Sales Personnel.
(vi) In
the instances where Endo allocates a designated promotional budget
to individual sales representatives for the purposes of completing
specific marketing-directed promotional activities, Endo shall
provide such promotional budget to Vernalis Specialty Sales
Personnel at the same time as provided to Endo sales
representatives and as agreed by the Joint Co-Promotion
Team.
c.
Allocation . Vernalis and Endo shall agree on the call
planning and targeting of Specialty Sales Personnel; which shall be
allocated per physician specialty as set forth in Exhibit C. Unless
the parties otherwise agree, such allocation shall
(i) allocate
calls equitably between the parties’ respective sales
representatives, including without limitation in relation to
decile, geographic location and key opinion leaders; and
(ii) specify
a list of *** Target Healthcare Professionals (identifying
from within that list *** Target Healthcare Professionals to
be treated as priority for Product Details) available for each of
the Vernalis Specialty Sales Personnel to undertake Product Details
within their respective geographic locations.
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The parties recognize that some
Target Healthcare Professionals may receive Product Details from
both Endo sales representatives and Vernalis Specialty Sales
Personnel; however the parties agree that the Vernalis Speciality
Sales Personnel and Endo sales representatives shall not make
Product Details to the same Target Healthcare Professionals in the
Primary Care and *** fields.
d.
CSO . Vernalis may enlist the services of a contract sales
organization (“CSO”) for the purpose of providing
Product Details to Target Healthcare Professionals in the
*** field only, in accordance with t