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EXHIBIT 10.2
LICENSE AND DEVELOPMENT AGREEMENT
This License and Development Agreement (the "Agreement") is made and entered
into by and between:
YAMANOUCHI EUROPE B.V., a company organized and existing under the laws of the
Kingdom of the Netherlands, having its registered office at Xxxxxxxxxxxx 00,
0000 XX Xxxxxxxxxx, Xxx Xxxxxxxxxxx ("YAMANOUCHI");
and
CONNETICS CORPORATION, a company organized and existing under the laws of the
State of Delaware, having its principal place of business at 0000 Xxxx Xxxxxxxx
Xxxx, Xxxx Xxxx, Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America ("CONNETICS").
YAMANOUCHI and CONNETICS are sometimes referred to individually as a "PARTY" and
collectively as the "PARTIES."
RECITALS
A. YAMANOUCHI has developed the PRODUCT (as defined below) and wishes to have
the PRODUCT developed, manufactured, promoted, sold and distributed in the
TERRITORY (as defined below);
X. XXXXXXXXXX has the right to grant rights under the PATENTS (as defined
below), and YAMANOUCHI KNOW-HOW (as defined below) and TRADEMARKS (as
defined below) to other parties and is willing to grant such rights to
CONNETICS on the conditions contained in this Agreement;
C. CONNETICS has at its disposal facilities to develop, manufacture, promote,
market, sell and distribute the PRODUCT in the TERRITORY and has
experience and knowledge in the market for the PRODUCT;
D. CONNETICS and YAMANOUCHI are parties to a Letter of Intent dated April 5,
2002, pursuant to which CONNETICS paid YAMANOUCHI an "Exclusive
Negotiation Fee" in the amount of USD 100,000 (One Hundred Thousand U.S.
Dollars);
E. CONNETICS desires to obtain a license from YAMANOUCHI to develop,
manufacture, promote, market, distribute, and sell the PRODUCT in the
TERRITORY on the terms and conditions contained in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set
forth in this Agreement, the PARTIES do hereby agree as follows:
[LOGO] Yamanouchi Yamanouchi Europe B.V.
2002-0267
AGREEMENT
1 - DEFINITIONS
In this Agreement the following expressions will have the meanings stated,
whether used in the singular or the plural:
AFFILIATE - a legal entity directly or indirectly
controlling, controlled by or under
common control with either PARTY, or
owning at least fifty percent (50%) of
the voting rights of such legal entity.
CONNETICS KNOW-HOW - all information and materials,
including, without limitation,
pharmaceutical, pharmacological and
medical data and information, as well as
developing, manufacturing, technical,
commercial, promotional and marketing
information and experience, knowledge,
ideas, and other intellectual property,
patentable or otherwise, tangible or
intangible, owned or developed by
CONNETICS or its AFFILIATES as of the
date of this Agreement or thereafter,
relating to the PRODUCT.
LICENSE - the license granted by YAMANOUCHI to
CONNETICS in Section 2 of this
Agreement.
NET SALES - determined using the accrual basis of
accounting in accordance with generally
accepted accounting principles (GAAP) in
the United States and as reported by
CONNETICS to the U.S. Securities and
Exchange Commission, applied in a manner
consistent with practices consistent
with those in the pharmaceutical
industry in the TERRITORY, but in any
event NET SALES shall not be less than
[*] below the actual gross invoice sales
of PRODUCT by CONNETICS or its
AFFILIATES, sublicenses, distributors,
or other agents to third parties. If at
any point in the future CONNETICS
determines that the limitation on
deductions is adversely impacting its
ability to compete effectively in the
marketplace, it shall have the right to
request YAMANOUCHI to enter into good
faith discussions to renegotiate the [*]
limitation in line with then-prevailing
commercial practice.
PATENTS - the patents and/or patent applications
as specified in Annex III to this
Agreement and all patents issued on any
such patent applications, and all
counterparts, additions, divisions,
continuations, continuations-in-part,
substitutions, extensions,
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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reissues, patent term extensions and
renewals thereof in any country of the
TERRITORY.
PRODUCT - the pharmaceutical specialty for human
administration as listed in Annex I to
this Agreement and any improvements
developed from time to time.
TERRITORY - as to the PATENTS and the YAMANOUCHI
KNOW-HOW, exclusively the United States
of America (including its territories
and possessions) and Canada, and
non-exclusively Mexico; as to the
TRADEMARKS, exclusively in the United
States of America (including its
territories and possessions), Canada,
and Mexico.
TRADEMARKS - the trademarks set forth in Annex II,
or, if the U.S. Food and Drug
Administration rejects the use of those
trademarks for the PRODUCT, any other
trademark mutually acceptable to
CONNETICS and YAMANOUCHI and owned by
YAMANOUCHI.
TRADEMARK TERM - With respect to the right to use the
TRADEMARKS, this Agreement shall remain
in effect and shall not expire for as
long as YAMANOUCHI continues to maintain
the registration of the TRADEMARKS in
the TERRITORY, provided that CONNETICS
continues to sell PRODUCT pursuant to
this Agreement and the Agreement is not
otherwise expressly terminated by
YAMANOUCHI or CONNETICS.
YAMANOUCHI KNOW-HOW - all information and materials,
including, without limitation,
pharmaceutical, pharmacological and
medical data and information, as well as
developing, manufacturing, technical,
commercial, promotional and marketing
information and experience, knowledge,
ideas, improvements, and other
intellectual property, patentable or
otherwise, tangible or intangible, owned
or developed by YAMANOUCHI or its
AFFILIATES as of the date of this
Agreement or thereafter, relating to the
PRODUCT or the PATENTS, whether or not
covered by the PATENTS, or relating to
topical products containing a retinoid
and an antibiotic, and, in each case,
which is necessary or useful to the use,
development, manufacture, marketing,
promotion, distribution, sale and/or
commercialization of the PRODUCT in the
TERRITORY.
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2 - GRANT
2.1 Subject to the terms and conditions of this Agreement, YAMANOUCHI grants
to CONNETICS during the term of this Agreement and CONNETICS accepts (a)
the LICENSE under the PATENTS and the YAMANOUCHI KNOW-HOW to develop,
manufacture, promote, market, sell and distribute the PRODUCT exclusively
in the United States of America (including its territories and
possessions), and Canada, and non-exclusively in Mexico; and (b) the
rights under the TRADEMARKS to develop, manufacture, promote, market, sell
and distribute the PRODUCT exclusively in the United States of America
(including its territories and possessions), Canada, and Mexico.
YAMANOUCHI further grants to CONNETICS the right to sublicense the rights
granted in this Section as permitted under Section 19.1.
2.2 CONNETICS shall during the term of this Agreement refrain from seeking
customers for the PRODUCT outside the TERRITORY.
2.3 YAMANOUCHI and CONNETICS are independent contractors. CONNETICS has no
power or authority to legally represent YAMANOUCHI, or to make and/or
enter into agreements with buyers of the PRODUCT on behalf of or in the
name of YAMANOUCHI without YAMANOUCHI's prior express written approval.
YAMANOUCHI has no power or authority to legally represent CONNETICS, or to
make and/or enter into agreements with buyers of the PRODUCT on behalf of
or in the name of CONNETICS without CONNETICS' prior express written
approval.
2.4 CONNETICS is allowed to perform or have performed any studies of whatever
nature in order to develop sales of the PRODUCT without the prior written
approval of YAMANOUCHI. CONNETICS shall have the right to present in any
form, including but not limited to lectures, slides, abstracts, posters,
and the like or submit for publication the results of any such studies.
CONNETICS agrees to submit all such materials or a synopsis thereof to
YAMANOUCHI at least thirty (30) days prior to the date on which such
presentation or submission is proposed to be made. If YAMANOUCHI
reasonably determines and notifies CONNETICS within the initial thirty
(30) day period that the presentation or submission contains patentable
material, YAMANOUCHI may request an additional thirty (30) days to allow
it to prepare and file any patent application(s) as YAMANOUCHI believes
are reasonably necessary to protect its interests prior to publication. If
YAMANOUCHI reasonably believes that such publication will harm the sales
potential of the PRODUCT or the validity or prosecution of the patents
relating to the PRODUCT , YAMANOUCHI may withhold its approval for
publication, provided, however, that YAMANOUCHI acknowledges that certain
university-based physicians who participate in U.S. clinical trials for
the PRODUCT may require the absolute right to publish results of their
experience with the PRODUCT. Any clinical study agreement that CONNETICS
enters into in connection with the PRODUCT must contain language that
provides sufficient time (at least 60 days) for YAMANOUCHI to evaluate the
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proposed publication and to take the necessary steps, including a patent
application to protect its interest prior to publication.
3 - INFORMATION & CONFIDENTIALITY
3.1 During the term of this Agreement YAMANOUCHI shall within reason and at
YAMANOUCHI'S expense provide CONNETICS with YAMANOUCHI KNOW-HOW in the
possession of YAMANOUCHI that may be useful for developing, manufacturing,
promoting, marketing, distributing or selling the PRODUCT in the
TERRITORY. CONNETICS shall not be considered in default of its obligations
under this AGREEMENT for any delay in development that is attributable
directly and solely to the failure by YAMANOUCHI to furnish requested
information within a reasonable period as agreed to by the PARTIES.
3.2 The PARTIES expressly agree that all YAMANOUCHI KNOW-HOW received and
acquired by CONNETICS as a consequence of this Agreement shall be held
strictly confidential by CONNETICS and shall remain YAMANOUCHI's property.
During the term of this Agreement, CONNETICS may disclose YAMANOUCHI
KNOW-HOW to its AFFILIATES, employees, agents, consultants, other
representatives, regulatory authorities and others to accomplish the
purposes of this Agreement, provided that they have agreed in writing (or
in the case of regulatory authorities, are bound by law) to observe the
confidentiality of the information. Notwithstanding the above, nothing in
this Section 3.2 shall apply to YAMANOUCHI KNOW-HOW which CONNETICS can
establish by competent evidence:
a) was known to CONNETICS at the time it received the information;
b) is at the time of receipt, or subsequently becomes, known to the
public or generally available to the public through no act or
omission by CONNETICS;
c) is furnished to CONNETICS at any time by a third party who has no
obligation to keep the information confidential;
d) is required to be disclosed by CONNETICS by law or to the relevant
authorities for the performance of its obligations under this
Agreement;
e) is the subject of a written permission to disclose provided by
YAMANOUCHI.
3.3 The PARTIES expressly agree that all CONNETICS KNOW-HOW received and
acquired by YAMANOUCHI as a consequence of this Agreement shall be held
strictly confidential by YAMANOUCHI and shall remain CONNETICS' property.
During the term of this Agreement, YAMANOUCHI may disclose CONNETICS
KNOW-HOW to its AFFILIATES, employees, agents, consultants, other
representatives, regulatory authorities and others to accomplish the
purposes of this Agreement, provided that they have agreed in writing (or
in the case of regulatory authorities, are bound by law) to observe the
confidentiality of the information. Notwithstanding the above, nothing in
this Section shall apply to CONNETICS KNOW-HOW which YAMANOUCHI can
establish by competent evidence:
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a) was known to YAMANOUCHI at the time it received the information;
b) is at the time of receipt, or subsequently becomes, known to the
public or generally available to the public through no act or
omission by YAMANOUCHI;
c) is furnished to YAMANOUCHI at any time by a third party who has no
obligation to keep the information confidential;
d) is required to be disclosed by YAMANOUCHI by law or to the relevant
authorities for the performance of its obligations under this
Agreement;
e) is the subject of a written permission to disclose provided by
CONNETICS.
4 - PAYMENTS
4.1 CONNETICS shall develop and manufacture the PRODUCT at its own expense and
risk.
4.2.1 In consideration of the licenses and rights granted by YAMANOUCHI to
CONNETICS in this Agreement, CONNETICS shall pay to YAMANOUCHI the sum of
USD 2,000,000 (Two Million U.S. Dollars) upfront, and [*] when it
successfully reaches specific milestones, as follows:
Upfront payments:
AMOUNT EVENT
USD 100,000 Upfront fee (previously paid at the time of the Letter of Intent
and which is creditable towards the Upfront payment)
USD 900,000 Upfront fee payable upon execution by both PARTIES of this
Agreement
USD 1,000,000 Upfront fee payable on 1 July 2002
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Milestone payments:
[*]
4.2.2 Payments pursuant to Section 4.2.1 shall be made in USD and are due within
fourteen (14) days of the event or date indicated. For any delay in
payment beyond the 14th day, CONNETICS shall pay a pro rata interest
amount of one and a half percent (1.5%) per month over the amount due.
Payments shall be made by bank transfer to an account as designated by
YAMANOUCHI.
4.3.1 In further consideration of the licenses and rights granted by YAMANOUCHI
to CONNETICS, during the term of this Agreement (except as it relates to
the TRADEMARKS) CONNETICS shall pay to YAMANOUCHI for the use of the
PATENTS and/or the YAMANOUCHI KNOW-HOW a royalty on CONNETICS' NET SALES
of the PRODUCT for each calendar year as follows:
[*]
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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4.3.2 Payments pursuant to Section 4.3.1 shall be made in USD and are due within
forty-five (45) days after the end of each calendar quarter. For any delay
in payment beyond the 45th day, CONNETICS shall pay a pro rata interest
amount of one and a half percent (1.5%) per month over the amount due.
Payments shall be made by bank transfer to an account as designated by
YAMANOUCHI.
4.4.1 In further consideration of the licenses and rights granted by YAMANOUCHI
to CONNETICS, and subject to Section 16.5, CONNETICS shall pay to
YAMANOUCHI a royalty equal to [*] on CONNETICS' NET SALES of the PRODUCT
for the use of the TRADEMARKS during the TRADEMARK TERM. This royalty is
in addition to the royalties for the use of the YAMANOUCHI KNOW-HOW.
4.4.2 Payments pursuant to Section 4.4.1 shall be made in USD and are due within
forty-five (45) days after the end of each calendar month. For any delay
in payment beyond the 45th day, CONNETICS shall pay a pro rata interest
amount of one and a half percent (1.5%) per month over the amount due.
Payments shall be made by bank transfer to an account as designated by
YAMANOUCHI.
4.5 Without YAMANOUCHI's prior written approval, CONNETICS shall not be
entitled to set off any counterclaims against any kind of payments due.
4.6 To the extent there is a statutory tax withholding obligation on a payment
(or other remittance) due YAMANOUCHI, CONNETICS shall be entitled to
withhold from such payment the amount, if any, of any withholding tax
assessable to YAMANOUCHI. CONNETICS shall advise YAMANOUCHI and provide it
with copies of the tax receipts for all taxes deducted from the payment
due YAMANOUCHI.
5 - MINIMUM ROYALTY
5.1 Beginning at the time of the launch of the PRODUCT in the TERRITORY,
CONNETICS shall pay YAMANOUCHI a minimum annual royalty equal to the
applicable royalty percentage in Section 4.3.1 above multiplied by [*] of
the projected NET SALES based on the annual sales forecast provided by
CONNETICS pursuant to Section 5.2. The minimum annual royalty for a given
calendar year will be considered overdue if it has not been paid by
January 31 of the following year. The amount of any minimum annual royalty
paid in respect of a given calendar year shall be applied against
royalties due and owing under Article 4 in that calendar year.
5.2 Each year following the launch of the PRODUCT, in the last quarter of each
calendar year CONNETICS shall provide YAMANOUCHI with a sales forecast
with respect to the
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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following year, which forecast shall be realistic and consistent with the
prevailing market and regulatory environment at the time the forecast is
given. If YAMANOUCHI believes that the sales forecast provided by
CONNETICS is not realistic or consistent with the prevailing market and
regulatory environment at the time, the PARTIES shall discuss the matter
in good faith and agree upon a forecast that is acceptable to both
PARTIES.
5.3 If CONNETICS fails to pay the minimum royalty as per Section 5.1 (and
furthermore fails to pay that amount in the subsequent three (3) month
period), the exclusive rights granted under Article 2 of this Agreement
will become non-exclusive at the end of the subsequent three (3) month
period.
5.4 If the exclusive license to CONNETICS becomes non-exclusive by operation
of Section 5.3, the PARTIES agree to negotiate in good faith how CONNETICS
may cooperate with YAMANOUCHI to obtain market authorization in the
non-exclusive part of the TERRITORY.
6 - BOOKS AND RECORDS
6.1 CONNETICS shall furnish YAMANOUCHI with reports within thirty-five (35)
days after the end of each calendar quarter stating the quantity of the
PRODUCT sold and the NET SALES during the preceding quarter.
6.2 CONNETICS shall keep complete and accurate records pertaining to the
manufacture and commercialization of the PRODUCT in sufficient detail to
permit YAMANOUCHI to confirm development and commercialization efforts,
sale of PRODUCT, accuracy of calculations of NET SALES and royalties and
all other payments required to be made under this Agreement. All records
and information required under this Agreement shall be maintained for the
longer of (a) five (5) years following the year in which any such efforts
or payments were made under this Agreement; or (b) such longer period as
may be required by law.
6.3 YAMANOUCHI shall have the right to audit CONNETICS' records using a
mutually acceptable, nationally recognized firm of independent certified
accountants. Such accountants will have access, on reasonable notice, to
CONNETICS, its AFFILIATES' or its sublicensees' records, as the case may
be, during reasonable business hours for the purpose of verifying any
royalty payable under this Agreement for the two (2) preceding years.
Notwithstanding the foregoing, the right to audit CONNETICS' records
pursuant to this Section may not be exercised more than once in any
calendar year. The accountant shall provide both YAMANOUCHI and CONNETICS
with a copy of any report prepared as a result of the audit. YAMANOUCHI
shall bear the full cost of such audit unless such audit discloses an
underpayment by more than [*] of the amount due during such period. In
such case, CONNETICS shall bear the full cost of such audit.
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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7 - MARKETING AUTHORISATIONS
7.1 CONNETICS shall, with YAMANOUCHI's reasonable assistance if requested,
conscientiously pursue the obtaining and maintaining of the necessary
approvals and authorizations for the PRODUCT in the U.S.A. and Canada,
provided that CONNETICS shall have sole discretion in determining whether
and what type of product registration is required in each country. The
PARTIES agree to negotiate in good faith the best process and respective
responsibilities for obtaining approval to sell PRODUCT in Mexico.
7.2 CONNETICS shall bear all costs in connection with obtaining and
maintaining registrations (except registrations relating to the PATENTS
and the TRADEMARKS), marketing approvals, clearances, or authorizations
necessary for CONNETICS to be able to develop, manufacture, promote, sell
and distribute the PRODUCT in the TERRITORY.
7.3 If YAMANOUCHI terminates this AGREEMENT pursuant to Section 16.3,
CONNETICS shall, if applicable, fully cooperate in arranging for the
transfer of all approvals and authorizations granted in the TERRITORY in
respect of the PRODUCT to YAMANOUCHI, or another party designated by
YAMANOUCHI, at YAMANOUCHI's cost and expense.
8 - TRADEMARKS
8.1 The PRODUCT shall be sold by CONNETICS only and exclusively under the
TRADEMARKS. The TRADEMARKS are and shall remain under all circumstances
the property of YAMANOUCHI. CONNETICS is only entitled to use the
TRADEMARKS for the developing, manufacturing, distribution, marketing,
promotion and sale of the PRODUCT during the TRADEMARK TERM.
8.2 Neither CONNETICS, YAMANOUCHI nor any YAMANOUCHI AFFILIATE or sublicensee
of YAMANOUCHI shall use in the TERRITORY any trademark which might be
conflicting or cause confusion with the TRADEMARKS.
8.3 YAMANOUCHI shall maintain and reasonably defend the TRADEMARKS at its cost
and expense. Failure to maintain the TRADEMARKS shall relieve CONNETICS of
the obligation to pay royalties pursuant to Section 4.4.1 for the period
that the TRADEMARKS used by CONNETICS are not valid.
8.4 CONNETICS shall report as soon as this information becomes available of
any infringement or potential infringement of the TRADEMARKS in the
TERRITORY and CONNETICS shall offer any reasonable assistance required by
YAMANOUCHI to address the infringement or potential infringement.
YAMANOUCHI and CONNETICS
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shall confer about the appropriate action to be taken in connection with
the reported infringement.
8.5 After the TRADEMARK TERM or any earlier termination of this Agreement by
YAMANOUCHI under Section 16.3, CONNETICS shall immediately cease any and
all use of the TRADEMARKS. The registration of CONNETICS as licensee of
the TRADEMARKS with the recordal office in the TERRITORY, if appropriate,
shall be stricken upon the termination of the TRADEMARK TERM or the
termination of this Agreement by YAMANOUCHI pursuant to Section 16.3.
9 - QUALITY OF THE PRODUCT
9.1 The PRODUCT manufactured by CONNETICS shall be manufactured in conformity
with the specifications of the relevant regulatory authorities in the
TERRITORY and all other applicable laws and regulations in the TERRITORY.
10 - SALES PROMOTION
10.1 During the term of this Agreement CONNETICS shall use commercially
reasonable best efforts in the promotion and sale of the PRODUCT in the
TERRITORY in a manner which is equal to that in which it would promote and
sell its own products. CONNETICS makes no warranty, express or implied,
concerning the success of the development plan, the success of the
marketing and commercialization of the PRODUCT, or the commercial utility
of the PRODUCT. In order to safeguard a consistent image for the PRODUCT,
YAMANOUCHI and CONNETICS shall meet at least once per calendar year in
order to discuss the promotion of the PRODUCT in the TERRITORY and in
particular the presentation of the PRODUCT profile and its
characteristics.
10.2 CONNETICS shall yearly furnish YAMANOUCHI with reports on its sales
promotion activities as well as with specimens of sales promotion material
used for the PRODUCT. Similarly, YAMANOUCHI shall provide CONNETICS with
specimens of sales promotional materials used for the PRODUCT outside of
the TERRITORY. The PARTIES agree to negotiate in good faith how such
materials might be used by the other PARTY.
10.3 CONNETICS shall be responsible for labeling and packaging the PRODUCT
consistent with the labelling and packaging approved by any applicable
regulatory authorities in the TERRITORY. The inner and outer packaging of
the PRODUCT shall include language similar to: Under License From
Yamanouchi Europe B.V., The Netherlands. In addition, prior to launch of
the PRODUCT in the TERRITORY, the PARTIES shall determine by mutual
agreement whether it is prudent to include the numbers of the PATENTS on
the label for the PRODUCT.
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10.4 CONNETICS shall bear all expenses for the sales promotion of the PRODUCT
in the TERRITORY.
11 - COMPLIANCE WITH LAWS
CONNETICS shall in the performance of its activities under this Agreement
comply with all laws, regulations and other requirements which are
applicable in the TERRITORY with respect to such activities and more
specifically to develop, manufacture, purchase, market, promote and sell
the PRODUCT.
12 - LIABILITY
12.1 CONNETICS shall indemnify and hold YAMANOUCHI harmless from and against
any and all third party claims for damage or injury to persons and
property or for loss of life resulting from the use, development,
manufacture, marketing, sale or distribution of the PRODUCT in the
TERRITORY by CONNETICS pursuant to this Agreement, unless such damage or
injury is caused by the negligent or intentional acts or omissions of
YAMANOUCHI or its agents.
12.2 YAMANOUCHI shall indemnify and hold CONNETICS harmless from and against
any and all third party claims for damage or injury to persons and
property or for loss of life resulting from the pharmacological effects of
the PRODUCT, currently available and currently listed in Annex I, inside
of the TERRITORY, and for the use, development, manufacture, marketing,
sale or distribution of the PRODUCT in Mexico by YAMANOUCHI, its
AFFILIATES, or other sublicenses or representatives, in each case unless
such damage or injury is caused by the negligent or intentional acts or
omissions of CONNETICS or its agents.
12.3 CONNETICS shall promptly inform YAMANOUCHI of any significant liability
claims or threat of liability claims in connection with the PRODUCT and in
case of adverse events CONNETICS shall act in accordance with the Data
Exchange Agreement attached as Annex IV. YAMANOUCHI shall inform CONNETICS
of any significant liability claim or threat of liability in connection
with the PRODUCT, whether or not the threat or claim stems from activity
within the TERRITORY.
13 - PATENTS
13.1 YAMANOUCHI hereby declares that it has the right to grant CONNETICS the
rights and licenses granted under this Agreement. YAMANOUCHI declares
furthermore that it does not, however, warrant the validity of the
PATENTS. However, YAMANOUCHI
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declares that at the date of this Agreement YAMANOUCHI is not aware that
any third party is infringing the PATENTS in the TERRITORY and YAMANOUCHI
has received no notices that the PRODUCT infringes any third party's
rights. The PARTIES agree that if, at any time during the term of this
Agreement, any of the PATENTS is declared or found to be invalid, or if
the PRODUCT is found to infringe a patent owned by a third party, the
PARTIES will negotiate in good faith a reduction in the royalties to be
paid pursuant to Section 4.3.1. CONNETICS may not file any nullity or
revocation suit or take any action which is intended to destroy, partially
or totally, the validity of the patents relating to the PRODUCT , inside
or outside of the TERRITORY, whether such action is filed directly or
through another party.
13.2 YAMANOUCHI shall maintain and reasonably defend the PATENTS at its cost
and expense. Each PARTY shall promptly give notice in writing to the other
PARTY in the event that it becomes aware of: (a) any infringement or
suspected infringement of any PATENTS relating to the PRODUCT; or (b) any
claim that the PRODUCT's use, manufacture, sale or other disposal
infringes the rights of any third party. The PARTIES shall consult within
two (2) weeks to decide what steps shall be taken to prevent or terminate
such infringement. If YAMANOUCHI fails to take action to protect or defend
the PATENTS within thirty (30) days from the consultation between the
PARTIES, CONNETICS shall be entitled to take all such action as it
considers to be necessary or appropriate at its own expense to defend such
claim and shall be entitled and subject to all damages and other sums
which may be recovered or awarded against it as a result of the action.
13.3 Each PARTY shall render any reasonable assistance required by the other
PARTY with respect to this Article 13.
13.4 CONNETICS shall have the right, with YAMANOUCHI's prior written approval,
which will not be unreasonably withheld, to file on behalf of and as agent
for YAMANOUCHI, all applications and to take all actions necessary (a) to
obtain the benefits of the U.S. Drug Price Competition and Patent Term
Restoration Act of 1984 and any amendments thereto to the extent such
benefits relate to PRODUCT, and (b) to extend the lives of the PATENTS
relating to the PRODUCT, to the extent permitted by any other law or
regulation by, among other things, applying for supplemental protection
certificates.
14 - COMPETING PRODUCTS
During the term of this AGREEMENT, neither YAMANOUCHI nor any YAMANOUCHI
AFFILIATE or sublicensee of YAMANOUCHI that has rights to the PRODUCT
outside the U.S.A. and Canada, will, directly or indirectly, license,
sell, market, promote or distribute other products incorporating the
combination of a retinoid
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2002-0267
and an antibiotic in the U.S.A. or Canada. Also during the term of this
AGREEMENT neither YAMANOUCHI nor any YAMANOUCHI AFFILIATE or sublicensee
of YAMANOUCHI will license, sell, market, promote or distribute a product
based upon tretinoin and/or clindamycin in the VELAC gel formulation in
the U.S.A. or Canada. During the term of this AGREEMENT, CONNETICS will
not license, sell, market, promote or distribute any other products
incorporating the combination of a retinoid and an antibiotic in the
TERRITORY without first obtaining YAMANOUCHI's written approval, which
approval shall not be unreasonably withheld.
15 - ADVERSE EVENTS AND REACTIONS
15.1 CONNETICS and YAMANOUCHI shall notify each other in writing of any
information or announcements coming to their attention, as well as the
origin of such information or announcements, with regard to:
a) adverse events which are observed in relation to the PRODUCT;
b) characteristics which could impair the safety or efficacy of the
PRODUCT;
c) complaints concerning the pharmaceutical quality or packaging of the
PRODUCT.
15.2 CONNETICS and YAMANOUCHI shall cause the adverse drug reaction data
exchange agreement, which is attached to this Agreement as Annex IV, to be
entered into by their respective medical safety departments
contemporaneously with the signing of this Agreement. The data exchange
agreement, as it may be amended from time to time, shall have the same
effect as an agreement between the PARTIES.
16 - DURATION
16.1 This Agreement shall be effective as of the date of the last signature
below, after it has been signed by both PARTIES, and will remain in force
on a country-by-country basis in the TERRITORY for a period of [*] from
the date of first commercial sale in each respective country of the
TERRITORY or until the expiration or abandonment of the last of the
PATENTS (including any extensions in any country of the TERRITORY), which
ever date is the later. After expiration of this Agreement, CONNETICS
shall have a non-exclusive fully paid license to the YAMANOUCHI KNOW-HOW.
16.2 Notwithstanding the provisions in Section 16.1 the LICENSE with respect to
the TRADEMARKS shall continue during the TRADEMARK TERM. CONNETICS shall
continue to pay the TRADEMARK royalties in accordance with Articles 4.4.1,
4.4.2 and 4.5 unless this Agreement is terminated by either PARTY pursuant
to Section 16.3 or 16.4, or until the TRADEMARK TERM expires.
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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16.3 Either PARTY may terminate this Agreement early and without judicial
intervention as follows:
a) by either PARTY in case of a breach of one or more of the provisions
of this Agreement by the other PARTY, in which case the
non-breaching PARTY shall be entitled to terminate this Agreement by
letter with thirty (30) days' notice (or with immediate effect, if
the breach is not capable of being cured). If the breach can be
cured, the breaching PARTY shall have the right during the 30-day
notice period to cure the breach, or to produce a plan for curing
the breach that is acceptable to the non-breaching PARTY. This
Agreement shall then automatically terminate at the end of the term
of notice, unless meanwhile the breach of contract in question has
been remedied or a mutually agreeable plan to cure is put into
effect;
b) immediately upon written notice by either PARTY in case of a
petition for bankruptcy, suspension of payment, voluntary
liquidation or otherwise of the other PARTY;
c) in case of termination of this Agreement by a PARTY on (one of) the
grounds as mentioned in this Section 16.3 the breaching PARTY is not
entitled to any compensation.
16.4 CONNETICS may terminate this Agreement early and without judicial
intervention as follows:
a) if clinical efficacy is not sufficiently proven at the end of Phase
II clinical trials;
b) if clinical efficacy is not sufficiently proven at the end of Phase
III clinical trials;
c) failure to obtain authorization to market the PRODUCT in the U.S.,
sufficiently proven to YAMANOUCHI;
d) if CONNETICS can prove to YAMANOUCHI that the commercial conditions
of the topical acne market have changed dramatically since the
launch of the PRODUCT; by giving YAMANOUCHI no less than six (6)
months advance written notice; or
e) in the event of a substantial number of adverse experiences with the
PRODUCT, sufficiently proven to YAMANOUCHI such that they could
reasonably be expected to substantially diminish the commercial
value of the PRODUCT.
For termination under this Section 16.4, CONNETICS will not be entitled to
any refund of any amounts paid prior to the date of termination. Moreover,
CONNETICS shall give YAMANOUCHI or its designee full cooperation in
arranging for the transfer of all
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approvals and authorizations granted in the TERRITORY in respect of the
PRODUCT to YAMANOUCHI or its designee. Such transfer shall be at
YAMANOUCHI's cost and expense.
16.5 The rights and obligations of the PARTIES set forth in Article 8 shall
survive until the end of the TRADEMARK TERM. In addition, the rights and
obligations of the PARTIES set forth in Art. 3, Sections 6.2, 6.3, 7.3,
and 8.5, and Articles 12, 13, 15 and 18 shall survive any termination of
this Agreement.
16.6 After termination of this Agreement by YAMANOUCHI pursuant to Section
16.3, CONNETICS shall cease the use of the PATENTS, the YAMANOUCHI
KNOW-HOW and the TRADEMARKS and the use, development, manufacture,
marketing, sale and distribution of the PRODUCT.
16.7 Upon early termination of this Agreement pursuant to Section 16.3,
CONNETICS shall have the right to sell all remaining PRODUCT in its
inventory within twelve (12) months after the date of termination, subject
to the payment to YAMANOUCHI of the royalties set forth in Articles 4 and
5. Thereafter, CONNETICS agrees to destroy any remaining supply of PRODUCT
at YAMANOUCHI'S request and direction.
17 - FORCE MAJEURE
The PARTIES shall not be liable for failure or delay in performance of the
obligations under this Agreement if such failure is caused by war, riot,
rebellion, invasion, earthquake, storm, fire, flood, acts of God,
interruption of transportation, embargo, explosion, inability to procure
or shortage of supply of materials, governmental orders and restrictions,
strike, lockout, labour disputes, or any other cause beyond the control of
the PARTIES. Either PARTY invoking Force Majeure shall notify the other
PARTY as soon as possible and provide appropriate information on the
presumed cause and duration of the Force Majeure situation. The PARTIES
shall co operate to minimize the adverse events of Force Majeure on the
performance of this Agreement.
18 - APPLICABLE LAW AND COURT OF LAW; DISPUTE RESOLUTION
18.1 This Agreement shall be construed in accordance with the laws of England
and Wales.
18.2 The PARTIES agree to submit all disputes arising out of in connection with
this Agreement to the International Chamber of Commerce in The Hague, The
Netherlands.
18.3 It is the objective of the PARTIES to facilitate the resolution of
disputes under this AGREEMENT in an expedient manner by mutual cooperation
and without resort to litigation. Accordingly, the PARTIES agree to take
all commercially reasonable efforts to
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resolve in an amicable manner any dispute between them concerning
diligence obligations and/or questions of breach and default in connection
with this AGREEMENT.
19 - ASSIGNMENT
19.1 CONNETICS shall have the right to grant sublicenses of its rights under
this Agreement (i) to any of its AFFILIATES, without the consent of, but
with written notice to, YAMANOUCHI, and (ii) to any non-affiliated third
party upon YAMANOUCHI'S prior written consent, which consent shall not be
unreasonably withheld, conditioned, or delayed. CONNETICS shall remain
liable for the obligations to YAMANOUCHI under this Agreement unless
YAMANOUCHI expressly releases CONNETICS in writing.
19.2 Either PARTY may transfer or assign this Agreement (a) to an AFFILIATE of
such PARTY which agrees in writing to undertake the obligations under this
Agreement provided the assigning PARTY remains primarily liable, (b) in
connection with the sale of all or substantially all of the assigning
PARTY'S related business, and (c) to a non-affiliated third party with the
prior written consent of the other PARTY, which consent shall not be
unreasonably withheld.
19.3 If CONNETICS merges with a third party and is not the surviving entity, or
if CONNETICS assigns its rights and obligations under this AGREEMENT to a
third party as outlined in Section 19.2, CONNETICS must prove to
YAMANOUCHI that it has informed the third party of the obligations it has
to YAMANOUCHI and that the third party has acknowledged and agreed to
those obligations. If YAMANOUCHI merges with a third party and is not the
surviving entity, or is taken over by a third party, CONNETICS will remain
obligated to the third party in accordance with the conditions set forth
in this AGREEMENT.
20 - NOTIFICATION OF PARTIES
20.1 Except as otherwise specifically provided in this Agreement, any notice or
other documents to be given under this Agreement shall be in writing and
shall be deemed to have been duly given if sent by registered or certified
mail, or by internationally recognized air courier, or by facsimile
transmission to a PARTY, 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 YAMANOUCHI, to:
Yamanouchi Europe B.V.
Elizabethof 19
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2353 EW Leiderdorp
The Netherlands
Attn: Director Legal Affairs Europe
Facsimile: x00 00 0000000
If to CONNETICS, to:
Connetics Corporation
0000 Xxxx Xxxxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: 000-000-0000
Any such notice or other document shall be deemed to have been received by
the addressee three (3) business days following the date of confirmed
receipt of the notice or other document by post, or simultaneously with
the transmission or delivery, where the notice or other document is sent
by overnight courier, by hand or if given by facsimile.
21 - INTERPRETATION OF AGREEMENT
21.1 This Agreement, including Annexes, constitutes the entire agreement of the
PARTIES with respect to the subject matter, and supersedes all prior or
contemporaneous understandings or agreements, whether written or oral,
between CONNETICS and YAMANOUCHI with respect to the subject matter in
this Agreement. There are no promises, terms, conditions or obligations,
oral or written, expressed or implied, other than those contained in this
Agreement with respect to the subject matter in this Agreement. The terms
of this Agreement shall supersede all previous oral or written agreements
that may exist or have existed between the PARTIES. Specifically, this
Agreement supersedes in their entirety the Letter of Intent dated April 5,
2002, the Confidentiality Agreement dated December 14, 2001 and the
Confidentiality Agreement dated March 1, 2002 relating to the subject
matter of this Agreement.
21.2 English shall be the controlling language of this Agreement, and in case
of any translation of this Agreement in whatever language, the English
text shall prevail.
21.3 If any provision of this Agreement is or becomes or is deemed to be
invalid, illegal, or unenforceable in any jurisdiction: (a) such provision
will be deemed amended to conform to applicable laws of such jurisdiction
so as to be valid and enforceable, or, if it cannot be so amended without
materially altering the intention of the PARTIES, it will be stricken; (b)
the validity, legality and enforceability of such provision will not in
any way be affected or impaired thereby in any other jurisdiction; (c) a
suitable and equitable provision shall be substituted in order to carry
out, so far as may be valid and enforceable, the intent and purpose of
such invalid and unenforceable provision; and (d) the remaining
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provisions of this Agreement will remain in full force and effect. The
PARTIES agree to renegotiate in good faith any term held invalid and to be
bound by the mutually agreed substitute provision in order to give the
most approximate effect intended by the PARTIES.
21.4 In case either PARTY in the course of its business makes use of general
terms and conditions concerning sales, purchases and/or licenses, such
general terms and conditions will have no effect on the interpretation or
validity of this Agreement.
21.5 This Agreement can only be revised, amended or extended by means of a
written document duly signed on behalf of all PARTIES.
21.6 No failure or delay on the part of a PARTY to require the strict
performance of any term, covenant or condition of this Agreement or to
exercise any right or remedy available on a breach thereof will operate as
a waiver of any such breach or of any such right or remedy, unless a
waiver is made in writing signed by the waiving PARTY. No waiver of any
such right will be deemed a waiver of any other right under this
Agreement.
21.7 This Agreement shall not be deemed to create any partnership, joint
venture, or agency relationship between the PARTIES. Each PARTY shall act
under this Agreement as an independent contractor.
IN WITNESS WHEREOF, the PARTIES have caused this Agreement to be executed by
their respective authorised officers.
Leiderdorp, The Netherlands California, United States of America
13th May 2002 13th May 2002
YAMANOUCHI EUROPE B.V. CONNETICS CORPORATION
Signature: /s/ Prof. P. van Brummelen Signature: /s/ Xxx Xxxxxxx
--------------------------- ---------------------------
Name: Prof. P. van Brummelen Name: Xxx Xxxxxxx
-------------------------------- --------------------------------
Position: EXECUTIVE VICE PRESIDENT R&D Position: CEO
---------------------------- ----------------------------
Signature: /s/ Mr. I. S. C. Xxxxxxx Signature: /s/ Xxxx Xxxxxxx
--------------------------- ---------------------------
Name: Mr. I. S. C. Xxxxxxx Name: Xxxx Xxxxxxx
-------------------------------- --------------------------------
Position: VICE PRESIDENT BUSINESS Position: CFO
DEVELOPMENT ----------------------------
----------------------------
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ANNEX I
PRODUCT
Any pharmaceutical formulation or composition of tretinoin optionally combined
with clindamycin that uses or incorporates the YAMANOUCHI KNOW-HOW, including
specifically VELAC gel.
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ANNEX II
TRADEMARKS
[*]
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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2002-0267
ANNEX III
PATENTS
[*]
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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2002-0267
ANNEX IV
ADVERSE DRUG REACTION DATA EXCHANGE AGREEMENT and ADVERSE EVENT REPORT
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2002-0267
ADVERSE DRUG REACTION
DATA EXCHANGE
AGREEMENT
THE PRODUCT AS MENTIONED IN ARTICLE 1 OF THE LICENSE
AND DEVELOPMENT AGREEMENT BETWEEN CONNETICS
CORPORATION AND YAMANOUCHI EUROPE B.V.
BETWEEN
Pharmacoepidemiology Department
YAMANOUCHI EUROPE BV
AND
SAFETY DEPARTMENT OF
CONNETICS
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PROCEDURES FOR THE EXCHANGE OF ADVERSE DRUG REACTION DATA WITH RESPECT TO
THE PRODUCT AS MENTIONED IN ARTICLE 1 OF THE LICENSE AND DEVELOPMENT
AGREEMENT BETWEEN CONNETICS CORPORATION AND YAMANOUCHI EUROPE B.V.
1. SCOPE
This agreement describes the procedures and defines the responsibilities of the
pharmacovigilance unit of Yamanouchi Europe Pharmacoepidemiology Department
("Yamanouchi"), and CONNETICS CORPORATION ("CONNETICS"), to ensure adequate
Adverse Drug Reaction (ADR) data exchange and compliance with the regulatory
requirements of ADR data reporting. This agreement replaces any previous Adverse
Drug Reaction Data Exchange Agreements. Updates of this agreement are expected.
2. DEFINITIONS
Definitions used will conform to the current ICH guidelines E2 A-C, and
regulations of the U.S. Food and Drug Administration. Terms set forth in all
capital letters shall have the meaning set forth in the License and Development
Agreement between Connetics Corporation and Yamanouchi Europe B.V.
3. PRODUCT CONCERNED
The PRODUCT as defined in Article 1 of the License and Development Agreement
between Connetics Corporation and Yamanouchi Europe B.V.
4. REGULATORY DOCUMENTS
CONNETICS will be responsible for making and maintaining a Summary of Product
Characteristics (SPC) for the PRODUCT for the TERRITORY.
5. DATABASE
CONNETICS will be responsible for maintaining a complete ADR database.
6. ADR DATA EXCHANGE
Exchange will be between the pharmacoepidemiology department of YAMANOUCHI and
the safety department of CONNETICS. Both parties will collect and distribute the
data in their own safety networks. The language of all exchange will be English.
Abbreviations must be spelled out.
DATA EXCHANGE AGREEMENT PAGE 1
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The format of data exchange will be hard copy (fax) or electronic (*.pdf files,
preferably password protected). Although YAMANOUCHI will not market the PRODUCT,
it will be necessary under applicable laws and regulations for CONNETICS to
collect all available information regarding the safety of the PRODUCT. The
following language shall apply to the extent that such information comes to the
attention of YAMANOUCHI as the licensor of the PRODUCT or otherwise. CONNETICS
acknowledges that YAMANOUCHI has no affirmative obligation to seek out such
information.
6.1 SPONTANEOUS REPORTS
SERIOUS ADRS
YAMANOUCHI will forward by fax all reports of serious ADRs in CIOMS I format to
CONNETICS within the same day for all fatal and life-threatening ADRs. All other
serious ADRs should be forwarded no later than five (5) calendar days after
receipt by YAMANOUCHI. The type of report (spontaneous), clock date, seriousness
and case assessment (causality / expectedness) and company medical evaluation
are printed on the CIOMS form. Where possible copies of the original reporter's
report should be forwarded too, together with a translation into English if the
original report is written in another language. The type of report
(spontaneous), clock date, seriousness, case assessment (causality/expectedness)
and company medical evaluation will be printed on the CIOMS form or on the
covering letter.
NON-SERIOUS ADRS
YAMANOUCHI will provide CONNETICS with all reports of non-serious spontaneous
ADRs in CIOMS I format on at least a monthly basis. CONNETICS will incorporate
all such data in the Periodic Safety Update Reports.
6.2 REPORTS FROM CLINICAL STUDIES
Data of serious ADRs from clinical studies will be exchanged as described in 6.1
for spontaneous reports.
Non-serious ADR data from clinical trials will be exchanged with the final study
report if it has an impact on the current SPC. CONNETICS will incorporate such
data in the PSURs.
6.3 FOLLOW-UP INFORMATION
CONNETICS is responsible for obtaining follow-up information required for proper
assessment of the case, except that there is no obligation to follow up on
non-serious ADRs that occur in clinical trials.
6.4 REPORTS FROM LITERATURE
CONNETICS will have the primary responsibility for reviewing the literature,
including unpublished scientific papers to the extent it is made aware of them.
DATA EXCHANGE AGREEMENT PAGE 2
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7. PERIODIC SAFETY UPDATE REPORTS (PSURS)
CONNETICS will be responsible for preparing PSURs according to the current ICH
and U.S. FDA guidelines and regulatory requirements.
8. SUBMISSION TO REGULATORY AUTHORITIES
CONNETICS will submit the appropriate reports of individual case reports to the
regulatory authorities of the countries in their territories within the time
frames required by the current regulations in each country.
9. REGULATORY AUTHORITY REQUESTS FOR ADDITIONAL INFORMATION
A) ADDITIONAL INFORMATION ON A SPECIFIC CASE:
If the regulatory authority requests follow-up information, CONNETICS will
submit the response to the requesting regulatory authority. If necessary,
CONNETICS will obtain the requested information from the reporter.
B) ADDITIONAL INFORMATION OF A MORE GENERAL NATURE (E.G., SUMMARY OF CERTAIN
TYPES OF CASES)
Regulatory authority requests for safety information of a more general nature
will be answered by CONNETICS. If YAMANOUCHI receives the request for additional
information on a specific case, it will send a copy to CONNETICS at the earliest
moment possible.
10. SIGNALLING
CONNETICS will be responsible for identifying new risks of the products
concerned and informing YAMANOUCHI immediately.
11. SERIOUS SAFETY ISSUE
In the event of a serious safety issue first brought to the attention of
CONNETICS, even if YAMANOUCHI Europe has not marketed the PRODUCT, the
YAMANOUCHI nominated safety contact should be informed of this as soon as it is
practically possible, and vice versa.
DATA EXCHANGE AGREEMENT PAGE 3
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12. NOMINATED SAFETY CONTACT PERSONS
Yamanouchi: P.H. Gerritsen-van Schieveen, MD, MFPM
Manager PharmacoEpidemiology
Yamanouchi Europe BV
X/x Xxx 000
0000 XX Xxxxxxxxxx
Xxx Xxxxxxxxxxx
Tel: x00 (0) 00 000 0000
Fax: x00 (0) 00 000 0000
CONNETICS:
Xxxxx Xxxxxxxx, M.D.
Manager, Safety
Connetics Corporation
0000 Xxxx Xxxxxxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
X.X.X.
Tel.: + 000-000-0000
Fax.: + 000-000-0000
Leiderdorp, The Netherlands California, United States of America
13th May 2002 13th May 2002
YAMANOUCHI EUROPE B.V. CONNETICS CORPORATION
Signature: /s/ Prof. P. van Brummelen Signature: /s/
--------------------------- ---------------------------
Name: Prof. P. van Brummelen Name:
-------------------------------- --------------------------------
Position: EXECUTIVE VICE PRESIDENT R&D Position:
---------------------------- ----------------------------
/s/ Mr. I.S.C. Xxxxxxx
Mr. I.S.C. Xxxxxxx
VICE PRESIDENT BUSINESS DEVELOPMENT
DATA EXCHANGE AGREEMENT PAGE 4
