Exhibit 10.1
CONFIDENTIAL
EXCLUSIVE CO-PROMOTION
AGREEMENT
T HIS A GREEMENT is entered into as of October 30, 2003 (the
“Effective Date”) by and between C
ONCEPTUS
, I NC . a
Delaware corporation, having an address of 1021 Howard Avenue, San
Carlos, California 94070 and its permitted assigns hereunder
(hereinafter referred to as “CONCEPTUS” ), and
G YNECARE
W ORLDWIDE D IVISION OF E THICON , I NC . , a
New Jersey corporation, having an address of U.S. Route #22,
Somerville, New Jersey 08876 and its permitted assigns hereunder
(hereinafter referred to as “GYNECARE”, together
with CONCEPTUS, the “Parties” and each a
“Party” ).
R ECITALS
W HEREAS , CONCEPTUS is presently manufacturing and
marketing the CONCEPTUS Essure ™ permanent birth control device (together with
any Improvements thereto and next generation birth control devices,
“Essure” ); and
W HEREAS , GYNECARE is presently manufacturing and
marketing the GYNECARE Thermachoice® uterine balloon therapy
system (together with any Improvements thereto and next generation
uterine balloon therapy systems, “Thermachoice”
and together with Essure, the “Product Lines”
and each a “Product Line” ); and
W HEREAS , each of the Parties has a professional Sales
Force (as hereinafter defined) that calls on customers in the
Territory (as hereinafter defined) in order to promote their
respective Product Lines; and
W HEREAS , CONCEPTUS desires to enhance its marketing of
Essure in the Territory by enlisting the support and participation
of the GYNECARE Sales Force as provided in this Agreement;
and
W HEREAS , GYNECARE desires to enhance its marketing of
Thermachoice in the Territory by enlisting the support and
participation of the CONCEPTUS Sales Force as provided in this
Agreement.
A GREEMENT
N OW ,
T HEREFORE
, in consideration of the foregoing premises and
the mutual covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
1. D EFINITIONS
An “Affiliate” of
a person or entity means any individual, sole proprietorship, firm,
partnership, corporation, trust, joint venture or other entity,
whether de jure or de facto , which, directly or
indirectly, controls, is controlled by or is under common control
with such person or entity. As used in this definition,
“control” means the possession, directly or indirectly,
of the power to direct or cause the direction of the policies and
management of a person or entity, whether by the ownership of
stock, by contract or otherwise.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
“Agreement” shall mean this Exclusive Co-Promotion
Agreement.
“Calendar
Quarter” shall mean
each of the three (3) month periods commencing with January 1st,
April 1st, July 1st and October 1st and ending, respectively, on
the following March 31st, June 30th, September 30th and December
31st.
“Commercial
Year” shall mean
each twelve (12) month period starting on the Effective Date or an
anniversary thereof, as applicable, during the Term of this
Agreement.
“CONCEPTUS
Patents” shall mean
any patent or patent application in the Territory owned or
controlled by CONCEPTUS during the Term of this Agreement relating
to the Essure, method of manufacture or the use thereof.
“CONCEPTUS
Trademarks” shall
mean the trademarks set forth in Schedule A, such marks being owned
and registered by CONCEPTUS or a CONCEPTUS Affiliate.
“Confidential
Information” shall
have the meaning provided in Section 12.1 hereof.
“Detail”
(or “Details”
and “Detailing” ) means, with respect to either
or both of the Product Lines, the activity undertaken by a sales
representative during a face-to-face sales call on physicians or
other health care professionals to provide information on the use,
safety, effectiveness, warnings and other relevant characteristics
of either or both of the Product Lines, in a fair and balanced
manner consistent with the requirements of the FD&C Act,
including, but not limited to, the regulations of 21 CFR Part 202,
and using, as necessary or desirable, labeling or promotional
materials, in an effort to increase use of the Product
Lines.
“Effective
Date” shall be the
date shown at the top of page 1 of this Agreement.
“Essure
Labeling” shall
mean the labeling described in the FDA PMA submission for Essure,
including but not limited to any required patient information, all
labels and other written, printed or graphic matter upon any
container, wrapper or any package insert or outsert utilized with
or for the Essure created and developed by or for
CONCEPTUS.
“FDA”
shall mean the United States
Department of Health and Human Services, Food and Drug
Administration or any successor entity.
“FD&C
Act” shall mean the
United States Federal Food, Drug and Cosmetics Act, as amended from
time to time.
“GYNECARE
Patents” shall mean
any patent or patent application in the Territory owned or
controlled by GYNECARE during the Term of this Agreement relating
to the Thermachoice device, method of manufacture or the use
thereof.
“GYNECARE
Trademarks” shall
mean the trademarks set forth in Schedule B, such marks being owned
and registered by GYNECARE or a GYNECARE Affiliate.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
“GYNECARE Managed Strategic
Customers” shall
mean the list of customers attached hereto as Schedule C. Such list
may be modified by the mutual written agreement of the
Parties.
“Improvements”
shall mean any adaptation, change,
redesign, improvement, modification or development to a Product
Line, the Raw Materials or the method or process of manufacture or
process of manufacture or production of a Product Line.
“JMC”
shall mean the Joint Management
Committee formed by the parties to monitor all aspects of the
Agreement, discuss issues and advise each Party prior to making
certain decisions, including, developing marketing strategies,
plans and budgets for co-marketing the Product Lines and
coordinating marketing and sales activities and press releases
relating to this Agreement, as further described in Section 2.2
hereof.
“Marketing
Plan” shall have
the meaning provided in Section 2.2 hereof.
“Net
Sales” shall mean
the revenue received by a Party, its Affiliates or sublicensees
from the sale of its Product Line in the Territory to an
independent third party less the following amounts: (i) discounts,
including promotional, trade, volume or cash discounts, or rebates
or coupon redemptions actually allowed or granted; (ii) credits or
allowances actually granted upon claims or returns or pricing
allowances, regardless of the party requesting the return; (iii)
freight charges paid for customer delivery; (iv) sales, use, ad
valorem or other taxes or other governmental charges levied on
or measured by the invoiced amount whether absorbed by the billing
or billed party and (v) allowances or credits to customers for
damaged or defective goods.
“Promotion
Expenses” shall
mean those costs, excluding corporate and administrative overhead,
marketing personnel resources, sales representative costs and
incentives but including costs incurred by a Party or for its
account which are specifically identifiable to the advertising,
promotion and marketing of the Product Lines by the Parties in the
Territory and related professional promotion and education (to the
extent not performed by sales representatives), including, without
limitation, television and electronic advertisements, advertorials
and infomercials, print advertisements, direct mail, exhibitions at
seminars and conferences, promotional samples, sales and
promotional literature or other materials and market research, in
each case consistent with the Marketing Plan and otherwise with the
terms of this Agreement.
“Promotional
Materials” shall
mean all sales representative training materials and all written,
printed, graphic, electronic, audio or video matter, including but
not limited to journal advertisements, sales visual aids, leave
items, reprints, direct mail, direct-to-consumer advertising,
internet postings, broadcast advertisements, and sales reminder
aids (for example, scratch pads, pens and other such items), in
each case created by the Party or the Parties or on its or their
behalf and used or intended for use by either or both of the
Parties in connection with any promotion of either or both of the
Product Lines hereunder.
“Raw
Materials” shall
mean the materials, components, and packaging required to
manufacture and package a Product Line in accordance with the
Specifications.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
“Recommend” or
“Recommendation” shall mean in the case of CONCEPTUS,
CONCEPTUS’s sales representatives providing marketing
materials and recommending to potential customers the Thermachoice
device exclusively over any other endometrial ablation products or
procedures for use with the Essure Product Line and in the case of
GYNECARE, GYNECARE’s sales representatives providing
marketing materials and recommending to potential customers the
Essure device exclusively over any other permanent birth control
products or procedures for use with the Thermachoice.
“Regulatory
Approvals” shall
mean any approvals (including, but not limited to, FDA approval,
labeling, pricing and reimbursement approvals), product, biologic
and/or establishment licenses, registrations or authorizations of
any federal, state or local regulatory agency, department, bureau
or other governmental entity, necessary for the commercial
manufacture, use, storage, importation, export, transport or sale
of a Product Line in the Territory.
“Sales
Force” of a Party
shall mean such Party’s sales personnel calling on customers
or potential customers of a Product Line or the Product Lines in
the Territory.
“Specifications”
shall mean the requirements with
which a Product Line must conform as specified by 21 CFR
§820.181 and device specifications, production process
specifications, quality assurance procedures and specifications,
packaging and labeling specifications, and installation,
maintenance and servicing procedures and methods that are contained
in the Device Master Record for the Product Line.
“Term of this
Agreement” shall
have the meaning provided in Section 8.1 hereof.
“Territory” shall mean the United States and its territories
and possessions, including overseas United States military
establishments.
“Thermachoice
Labeling” shall
mean the labeling described in the FDA PMA submission for
Thermachoice, including but not limited to any required patient
information, and all labels and other written, printed or graphic
matter upon any container, wrapper or any package insert or outsert
utilized with or for Thermachoice created and developed by
GYNECARE.
“Third
Party” shall mean
any entity other than CONCEPTUS or GYNECARE.
2. M ANAGEMENT
2.1 Management.
The Parties shall establish a Joint
Management Committee consisting of two (2) representatives of each
Party which will meet at least twice a year, at mutually agreeable
times and locations, to discuss and coordinate the Recommendation
and/or Detailing of the Product Lines by the Parties’ Sales
Forces in the Territory and the strategies and programs that should
be developed to maximize sales of the respective Product Lines. An
alternate member designated by a Party may serve temporarily in the
absence of a permanent member designated by such Party. No business
shall be transacted at any meeting of the JMC unless a quorum of
members is present at the time when the meeting proceeds to
business. A quorum shall be at least two (2) members present in
person or by their alternate, one (1) of whom
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
must be a representative appointed by CONCEPTUS
and one (1) of whom must be a representative appointed by GYNECARE.
[*] The JMC shall coordinate any announcement, news release,
public statement, publication or presentation relating to this
Agreement subject to Section 14.15. Each Party shall bear its own
costs of participating in the JMC. If the JMC is unable to reach
agreement on an issue, the respective Chief Executive Officers or
Presidents of the Parties shall use commercially reasonable efforts
to jointly resolve the deadlock
2.2 Marketing Plan.
The JMC shall develop and approve a
rolling two-year plan and periodic budgets for each Party for
Recommendation of the Product Lines in the Territory, promotion and
Detailing of the Essure Product Line in the Territory, and
physician training for Essure, all as provided in this Agreement
(the “Marketing Plan” ). The Marketing Plan
shall include a marketing, promotion and sales strategy for the
co-marketing of the Product Lines by the Parties in the Territory,
provided however , each Party shall have the ultimate
decision making authority and have complete discretion over the
deployment, marketing, promotion and sales strategy employed by its
own Sales Force in connection with the Marketing Plan. The
Marketing Plan shall include a budget for each Party for marketing,
promotion, clinical and regulatory expenses relating to the Product
Lines during the Term of this Agreement. Each Party agrees to
provide for in its own internal, periodic budget, funds to meet its
obligations under the mutually agreed upon JMC budget and to expend
such funds as provided in the JMC budget, provided however ,
neither party shall be required to provide for or expend more than
[*] a year pursuant to the JMC budget, unless otherwise
agreed to by the Parties. [*]
2.3 Meetings of the
JMC.
(a) The JMC shall hold meetings at such times and
places as shall be determined by the entire membership of the JMC
(it being expected that meetings will alternate between the San
Carlos, California offices of CONCEPTUS and the Somerville, New
Jersey offices of GYNECARE), but in no event shall such meetings be
held less frequently than twice a calendar year;
(b) The JMC may conduct meetings in person or by
telephone or video conference or other means, provided that any
decision made during a telephone conference meeting is evidenced in
writing signed by one (1) of the members of the JMC from each
Party;
(c) By mutual consent of the representatives of each
Party, such consent not to be unreasonably withheld, either Party
may invite other personnel of its organization to attend
appropriate meetings of the JMC;
(d) The JMC shall keep minutes reflecting actions
taken at meetings;
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
(e) The JMC may act without a meeting if prior to
such action the JMC members agree regarding such action and a
written consent thereto is signed by the Co-Chairs of the JMC;
and
(f) The JMC may amend or expand upon the foregoing
procedures for its internal operations by unanimous written
consent.
2.4 Limitations of JMC
Powers. The JMC shall not
have any power to amend this Agreement or bind or incur liability
on behalf of either Party hereto without such Party’s express
prior written authorization, and shall have only such powers as are
specifically delegated to them hereunder.
2.5 Authority to Call
Meetings. Notwithstanding
the regular meeting schedule of the JMC, a meeting of the JMC may
be called by either Party on ten (10) days written notice to the
other, unless such notice is waived by the other Party. In the
event of any meeting called pursuant to a notice under this Section
2.5, the Party calling the meeting shall provide with the notice an
agenda for the meeting together with the information that such
Party believes is relevant for the items to be discussed. Neither
Party shall call more than two (2) additional meetings per
Commercial Year for the JMC under this Section 2.5 without the
other Party’s consent. The meeting called under this Section
2.5 shall be held in Chicago, Illinois unless otherwise agreed to
by the Parties.
3. SCOPE; FDA S UPPLEMENT A PPROVAL AND C O -P ROMOTION OF P RODUCT L INES
It is the objective of the Parties
to (a) Recommend and/or Detail as provided below each other’s
Product Line to potential customers in the Territory after FDA
approval of Supplement 1 and prior to the expiration or termination
of this Agreement, and (b) provide for the training of preceptors
and physicians in the Essure and Thermachoice Product Lines. To
achieve this and other objectives, the Parties agree as
follows:
3.1 Grant and [*]
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
3.2 FDA Supplement Approval. The Parties
shall cooperate in the activities and be responsible for the
expenses necessary to obtain FDA approval for the use of
Thermachoice with Essure by supplementing the Essure Pre-Market
Approval Application (“PMA”) as set forth on Schedule
3.2. The FDA approval shall be sought in two (2) separate PMA
Supplements, with Supplement 1 seeking approval for the claim that
Thermachoice can be safely and effectively used with Essure, but
noting the absence of clinical data on expulsion and placement
rates (“Supplement 1”) and with Supplement 2 seeking
approval for removing the note regarding expulsion and placement
rates from the claim of safe and effective use based on additional
clinical studies (“Supplement 2”). To the extent
expenses are shared, the Parties shall jointly own , with
full rights of use, the clinical and bench testing data relating to
the activities necessary to obtain FDA approval for the use of
Thermachoice with Essure and Supplement 1 and Supplement 2.
CONCEPTUS shall prepare the submissions to the FDA and GYNECARE
shall
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
have the right to review and comment on the
submission, but CONCEPTUS shall conduct all dialogue and contact
with the FDA in connection with the supplemental PMA submissions.
The JMC shall first attempt to resolve any disputes between the
Parties resulting from any submissions or cost over-runs or
delays
3.3 Preceptors and Physician
Training.
(a) [*] CONCEPTUS shall be
responsible for contracting with and training the CONCEPTUS
Preceptors. CONCEPTUS, at its sole expense, shall be responsible
for paying all the costs of the training of the Preceptors,
including providing the personnel, equipment and samples to teach
and certify the CONCEPTUS Preceptors to teach and certify other
physicians in the proper use of the Essure device. CONCEPTUS, upon
not less than thirty (30) days written notice, will notify GYNECARE
of the times, dates and locations on the training sessions at which
the CONCEPTUS Preceptors will be trained. CONCEPTUS will use all
reasonable commercial efforts to contract for and appropriately
train the CONCEPTUS Preceptors.
(b) [*] CONCEPTUS will
contract for as independent contractors and be responsible for the
payment of the costs of the CONCEPTUS Preceptors, which payment
shall not exceed [*] per full day and [*] per half
day of physician training and certification. [*] CONCEPTUS
will provide Essure demo devices as needed for each physician to be
trained by the CONCEPTUS Preceptors. [*]
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
CONCEPTUS shall have the right to review and
monitor the physician training conducted by the CONCEPTUS
Preceptors and to recommend any modifications to training to
promote consistency and quality or lower cost.
3.4 Promotion Efforts.
After Supplement 1 has been approved
by the FDA and prior to the expiration or termination of this
Agreement and subject to the terms and conditions of this
Agreement, GYNECARE shall deploy its Sales Force to Recommend and
Detail the Essure Product Line and CONCEPTUS shall deploy its Sales
Force to Recommend the Thermachoice Product Line in accordance with
the Marketing Plan. Each of the Parties acknowledges that the other
Party’s commitments regarding JMC funds under Section 2.2 and
training under Section 3.3, and the payments made to it under this
Agreement under Article 4 constitute complete and adequate
consideration for its entering into this Agreement and shall
constitute complete satisfaction of any duty, whether express or
implied, which could be imposed upon the other Party to
commercially exploit its rights under this Agreement or to
Recommend or Detail the other Party’s Product Line and are
accepted by each Party in lieu of any other minimum promotional
efforts obligation on the part of the other Party, including
without limitation, with respect to the promotion of the other
Party’s Product Line. Each Party acknowledges, understands
and agrees, that it shall not challenge in any subsequent claim or
action any decision or action regarding the commercial exploitation
of the Products made or taken by any director, officer, employee or
individual acting as agent of the other Party or its Affiliates in
what such individual subjectively believes to be in its (or its
Affiliate’s) best interests, and that they are not required
to take into account the interests of the other Party, unless such
decision or action constitutes a material breach by it of any of
its obligations under this Agreement. Except as otherwise expressly
agreed to in the Marketing Plan, all business decisions, including,
without limitation, the sale, price and promotion of a
Party’s Product Line under this Agreement, shall be within
the sole discretion of such Party.
3.5 Mutual
Obligations.
(a) Each of the Parties shall supervise, train and
maintain such competent and qualified sales representatives as may
be required to perform the obligations as provided in this
Agreement and in the Marketing Plan. GYNECARE shall make available
for CONCEPTUS to train each of GYNECARE’s sales
representatives who calls on potential customers in the Territory
so that they are qualified to Detail Essure to physicians and
CONCEPTUS shall have the right to administer a reasonable
proficiency examination to each such GYNECARE sales representative.
CONCEPTUS shall provide sufficient CONCEPTUS personnel, equipment,
samples and training for the GYNECARE sales representatives calling
on the potential customers in the Territory to be appropriately
trained. This training is expected to be one (1) to two (2) days in
total for all GYNECARE sales representatives. [*] GYNECARE
will use its commercially reasonable efforts to arrange for its
sales representatives to be trained by CONCEPTUS at mutually
convenient times, locations and numbers (but not less than
[*] sales representatives per session, unless approved by
CONCEPTUS). Each Party shall be responsible for the costs and
expenses of its respective employees, including travel and
accommodations, in performing or attending such training. Each
Party shall be responsible for the compliance of its Sales Force
with all relevant terms of this Agreement and the Marketing
Plan.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
(b) Each of the Parties shall in all material
respects conform its practices and procedures relating to its
obligations under this Agreement for the Recommendation, and/or
Detailing and promotion of the Product Lines in the Territory to
all applicable laws, regulations and guidelines, including the
FD&C Act, the Federal Health Care Programs Anti-Kickback Law,
42 U.S.C. 1320a-7b(b), the Health Industry Manufacturers
Association ( “HIMA” ) and the American Medical
Association ( “AMA” ) Guidelines on Gifts to
Physicians from Industry (the “AMA Guidelines”
), as the same may be amended from time to time, and shall promptly
notify the other Party of and provide the other Party with a copy
of any correspondence or other reports with respect to the
Recommendation Detailing or promotion of the Product Lines
submitted to or received from the U.S. Department of Health and
Human Services or its components (including the FDA and the Office
of the Inspector General), Health Canada, HIMA or the AMA relating
to such laws, regulations and guidelines.
(c) At one Party’s reasonable request, the
other Party shall provide copies of any written communications
disseminated by it generally to its Sales Force promoting the
Product Lines in the Territory relating to the Marketing Plan and
the joint marketing strategy for the Product Lines other than
compensation, salary or benefit plans or information.
(d) In connection with the Recommendation, Detailing
or promotion of the Product Lines hereunder, no Party shall make
any statement, representation or warranty, oral or written,
concerning the Product Lines that is inconsistent with, or contrary
to, the Thermachoice Labeling, the Essure Labeling, the Promotional
Materials or the Marketing Plan.
(e) Each of the Parties shall give prompt written
notice to the other Party of the date on which its Sales Force
commences promoting the other Party’s Product Line in the
Territory.
(f) Each of the Parties shall use commercially
reasonable efforts to promptly refer but shall in no way be
responsible for soliciting orders for the other Party’s
Product Lines to the other Party.
(g) During the term hereof and for a period of six
(6) months after the expiration or termination of this Agreement,
neither Party shall solicit for employment or employ any officer or
employee of the other Party of whom it first became aware as a
direct result of this Agreement; provided that this provision shall
not prevent either Party from employing any such persons who
contact it on their own initiative (without any actions by such
Party to encourage such contact) or respond to general
solicitations of employment not specifically directed towards
employees of the other Party.
3.6 Proprietary Rights in the
Product Lines and Promotional Materials. (a) CONCEPTUS retains and shall retain
all proprietary rights and proprietary interests in Essure until
the point of sale and in all Promotional Materials relating
thereto. GYNECARE will neither have nor represent that it has any
control or proprietary or property interests in Essure Promotional
Materials solely developed or created by or on behalf of CONCEPTUS.
Nothing
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
contained herein shall be deemed to grant
GYNECARE, either expressly or by implication, a license or other
right or interest in any patent, trademark, copyright or other
similar property of CONCEPTUS except as may be necessary for
GYNECARE to Recommend and Detail Essure as expressly provided for
in this Agreement and the Marketing Plan.
(b) GYNECARE retains and shall retain all
proprietary rights and proprietary interests in Thermachoice until
the point of sale and in all Promotional Materials relating
thereto. CONCEPTUS will neither have nor represent that it has any
control or proprietary or property interests in Thermachoice
Promotional Materials solely developed or created by or on behalf
of GYNECARE. Nothing contained herein shall be deemed to grant
CONCEPTUS, either expressly or by implication, a license or other
right or interest in any patent, trademark, copyright or other
similar property of GYNECARE except as may be necessary for
CONCEPTUS to Recommend Thermachoice as expressly provided for in
this Agreement and the Marketing Plan.
3.7 Promotional
Materials.
(a) During the Term of this Agreement, CONCEPTUS
shall create or co-create and develop with GYNECARE such
Promotional Materials solely relating to Essure as are determined
by the JMC to be necessary or appropriate under the Marketing Plan
for distribution in the Territory, it being understood that the
costs thereof shall be included in Promotion Expenses hereunder.
CONCEPTUS shall provide GYNECARE with such Promotional Materials,
in amounts which the Parties jointly determine are reasonable under
the terms of the Marketing Plan. CONCEPTUS shall be responsible for
complying with all regulatory requirements in the creation of such
Promotional Materials and complying with any applicable government
filing requirements.
(b) During the Term of this Agreement, GYNECARE
shall create or co-create and develop with CONCEPTUS such
Promotional Materials solely relating to Thermachoice as are
determined by the JMC to be necessary or appropriate under the
Marketing Plan for distribution of the Product Lines in the
Territory, it being understood that the costs thereof shall be
included in Promotion Expenses hereunder. GYNECARE shall provide
CONCEPTUS with such Promotional Materials, in amounts which the
Parties jointly determine are reasonable under the terms of the
Marketing Plan. GYNECARE shall be responsible for complying with
all regulatory requirements in the creation of such promotional
materials and complying with any applicable government filing
requirements.
(c) Other than with the advice and prior written
consent of CONCEPTUS, GYNECARE shall not create or develop sales,
promotional or other similar materials relating to the Essure for
distribution to Third Parties.
(d) Other than with the advice and prior written
consent of GYNECARE, CONCEPTUS shall not create or develop sales,
promotional or other similar materials relating to Thermachoice for
distribution to Third Parties.
(e) All co-promotional materials, sales materials or
other similar materials and materials using a Party’s
trademarks, trade names and/or trade dress shall be reviewed by
such Party’s Copy Review/Sign-Off Committee prior to release
for use by the other Party.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
(f) Notwithstanding anything to the contrary herein,
neither Party shall be required to distribute any Promotional
Materials prepared after the Effective Date which it believes in
good faith are inaccurate or misleading. The Parties shall
distribute Promotional Materials of the type identified in this
Section 3.7 in accordance with the terms of this Agreement and the
Marketing Plan. Except as specifically permitted by this Section
3.7, neither Party shall distribute or have distributed any
materials bearing the name of the other without the prior written
approval of the other.
(g) CONCEPTUS shall own all right, title and
interest in and to the Promotional Materials relating solely to
Essure, including all copyrights appurtenant thereto but excluding
any rights in or to the GYNECARE trademark. CONCEPTUS hereby grants
to GYNECARE the limited, revocable right, during the Term of this
Agreement, to use Promotional Materials generated pursuant to the
Marketing Plan solely in connection with its promotion of Essure
hereunder in accordance with the terms of this Agreement and the
Marketing Plan.
(h) GYNECARE shall own all right, title and interest
in and to the Promotional Materials relating solely to
Thermachoice, including all copyrights appurtenant thereto but
excluding any rights in or to the CONCEPTUS trademark. GYNECARE
hereby grants to CONCEPTUS the limited, revocable right, during the
Term of this Agreement, to use Promotional Materials generated
pursuant to the Marketing Plan solely in connection with its
promotion of Thermachoice hereunder in accordance with the terms of
this Agreement and the Marketing Plan.
(i) The Parties shall jointly own all right, title
and interest in and to the Promotional Materials relating to both
Product Lines, including all copyrights appurtenant thereto but
excluding any rights in or to the other Party’s trademarks,
trade names and/or trade dress.
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
3.8 Sales and Distribution;
Recalls. Each Party shall
have the sole right and responsibility, and shall bear all costs
related thereto, to take such actions with respect to its Product
Line in its sole discretion in accordance with legal requirements
to maintain the authorization and/or ability to market its Product
in the Territory and to establish the terms and conditions for sale
of its Product Line, including, without limitation, the following:
manufacturing and distributing, sales, providing customer support
in a timely, comprehensive manner, including handling medical
queries, all interactions that are technical or clinical in nature
and which require more than a basic knowledge of its Product Line
and its characteristics and performing other functions consistent
with consumer practice and the Marketing Plan with respect to its
Product Line, responding to product and medical complaints relating
to its Product Line, quality assurance, technical support, returns,
voluntary and regulatory recalls of product, Regulatory Approvals
and compliance, and communications with regulatory agencies.
Notwithstanding the foregoing, each Party may communicate directly
with regulatory agencies regarding its own marketing activities.
Each Party shall use its commercially reasonable efforts to assist
and cooperate with the other Party as may be necessary or required
in any recall or market withdrawal of the other Party’s
Product Line and any and all reasonable and documented costs and
expenses incurred by the assisting Party shall be reimbursed by the
other Party, except to the extent such recall or market withdrawal
was the result of the failure of assisting Party to comply with its
obligations under this Agreement.
3.9 Regulatory
Submissions. Each Party,
either directly or through a designated Third Party, shall prepare
and maintain at its own expense all technical files and submissions
necessary to obtain and maintain all necessary approvals or
concurrences required to sell its Product Line in the
Territory.
3.10 Customer
Complaints. In accordance
with the system of the FDA and all other applicable laws, rules and
regulations, each Party shall maintain responsibility for (i)
managing all customer complaints or product inquires relating to
its Product Line, (ii) reporting to government agencies and (iii)
all corrective action where appropriate. Each Party agrees to
provide all necessary and required support to fulfill all domestic
laws and regulations with regards to customer complaints, and
vigilance reporting relating to its Product Line.
4. P AYMENT T ERMS .
4.1 GYNECARE Payments to
CONCEPTUS. In
consideration for CONCEPTUS granting GYNECARE the exclusive right
to Recommend and Detail Essure in the Territory, GYNECARE shall pay
CONCEPTUS [*] within thirty (30) days of the execution of
this Agreement and [*] within thirty (30) days of receipt of
the FDA approval of Supplement 1.
4.2 CONCEPTUS Payments to
GYNECARE. CONCEPTUS shall
pay to GYNECARE [*] of Net Sales of Essure sold to the
GYNECARE Managed Strategic Customers in the Territory during the
previous Calendar Quarter commencing with Net Sales occurring on or
after the date of the FDA approval of Supplement 1 and continuing
through the Term of the this Agreement (as amended from time to
time by the
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately.
mutual written agreement of the Parties). Within
sixty (60) days after the end of each full or partial Calendar
Quarter during the Term of this Agreement, CONCEPTUS shall deliver
to GYNECARE a true and accurate report of Net Sales sold by it, its
Affiliates and distributors to the GYNECARE Managed Strategic
Customers during such Calendar Quarter in the Territory,
accompanied by all payments due under this Section 4.2 for the
period covered by such report. Such report shall also include the
information reasonably necessary for the GYNECARE to calculate Net
Sales to the GYNECARE Managed Strategic Customers of the Essure
product.
4.3 Method of Payment.
Any payments due to a Party under
this Agreement shall be made in U.S. dollars by wire transfer to a
bank and account designated in writing by such Party.
5. T RADEMARKS
5.1 Essure Labeling; Ownership of
CONCEPTUS Trademarks. No
CONCEPTUS products distributed by CONCEPTUS in the Territory will
bear the GYNECARE Trademarks without the prior written approval of
GYNECARE. The Essure Product Line shall be distributed under the
CONCEPTUS Trademarks and ownership and use of the CONCEPTUS
Trademarks shall be governed by the following
provisions:
(a) CONCEPTUS or an Affiliate of CONCEPTUS shall
retain the ownership of the entire right, title and interest in and
to the CONCEPTUS Trademarks.
(b) CONCEPTUS shall, at its cost and expense,
maintain the CONCEPTUS Trademarks in the Territory. GYNECARE agrees
that in using CONCEPTUS Trademarks in its activities under this
Agreement it will not represent in any way that it has any right or
title to the ownership of the CONCEPTUS Trademarks or the
registration thereof, and the registration will remain in the
ownership of CONCEPTUS. Such CONCEPTUS Trademarks will be used by
GYNECARE on behalf of, and in the interest of CONCEPTUS, and
GYNECARE will first obtain the written approval of CONCEPTUS of the
form and manner in which the CONCEPTUS Trademarks will be used
upon, in connection with, or in relation to materials other than
Promotion Materials as may be permitted by this
Agreement.
(c) GYNECARE recognizes CONCEPTUS’s title in
and to the CONCEPTUS Trademarks and to the registration thereof,
and will not, at any time, do or authorize any act or thing that
will in any way violate or impair the rights of CONCEPTUS in and to
the CONCEPTUS Trademarks and the registration thereof. Wherever
CONCEPTUS’s trademarks or tradenames are used, e.g. ,
on any package, label or advertisement, the first or most prominent
use shall always be accompanied by a legend acceptable to CONCEPTUS
indicating that Essure ™ is a trademark of CONCEPTUS and the CONCEPTUS
trademarks and tradenames are licensed to GYNECARE by
CONCEPTUS.
(d) GYNECARE shall, upon CONCEPTUS’s request,
and at CONCEPTUS’s expense, reasonably assist CONCEPTUS in
any action reasonably necessary or desirable to protect the
CONCEPTUS Trademarks used or proposed t
