Exhibit 99.1
Confidential Treatment
Requested
Under 17 C.F.R. Sections 200.80(b)(4) and
240.24b-2.
Omitted Portions Filed Separately
with
the Securities Exchange
Commission
LICENSE
AGREEMENT
License Agreement (this “
Agreement ”) dated as of November 30, 2006,
between ACADIA Pharmaceuticals Inc., a Delaware corporation, with
offices located at 3911 Sorrento Valley Boulevard, San Diego, CA
92121, USA (“ ACADIA ”), and Société
de Conseils, de Recherches et d’Applications Scientifiques
SAS, a French corporation member of the IPSEN GROUP with offices
located at 42 rue du Docteur Blanche, 75016 Paris, FRANCE (“
IPSEN ”).
WHEREAS, ACADIA is developing and
commercializing certain compounds or pharmaceutical
products;
WHEREAS, IPSEN owns or controls
certain patents and patent applications, relating to the Licensed
Product (as defined below); and
WHEREAS, IPSEN desires to grant, and
ACADIA desires to be granted, a non-exclusive license in the
Territory (as defined below) to such patents and patent
applications, to pursue regulatory approval and commercialization
of Licensed Product all on the terms and conditions as set forth
herein below.
NOW, THEREFORE, in consideration
of the mutual covenants and agreements provided herein, ACADIA and
IPSEN hereby agree as follows:
For purposes of this Agreement, the
following definitions shall be applicable:
1.1 “Acadia Patent
Rights” means the
Patents and Patent Applications listed in Exhibit A here
attached (including any Patents issuing from such Patent
Applications).
1.2
“Affiliate” means, with respect to a party to this
Agreement, any entity directly or indirectly controlled by,
controlling, or under common control with, such party to this
Agreement, but only for so long as such control shall continue. For
purposes of this definition, “control” (including, with
correlative meanings, “controlled by”,
“controlling” and “under common control
with”) of an entity means possession, direct or indirect, of
(i) the power to direct or cause direction of the management
and policies of such entity (whether through ownership of
securities or partnership or other ownership interests, by contract
or otherwise), or (ii) at least fifty percent (50)% of the
outstanding voting securities (whether directly owned or issuable
pursuant to any option, warrant or other similar arrangement) or
other comparable equity interests of such entity.
1.3 “Commercial
Sale” means the
sale of Licensed Product whether by ACADIA, ACADIA’s
Affiliates or Sublicensees to a third party and shall exclude
(i) any transfer of Licensed Product by ACADIA to its
Affiliates or Sublicensees and (ii) any distribution of
Licensed Product for use in Development Activities or as
samples.
1.4
“Compound” means any of the […***…] compounds,
[…***…], listed in Exhibit C here attached. Such list
may be amended by ACADIA from time to time subject to prior notice
to IPSEN and provided that (i) such new compounds are
[…***…] and (ii) such list as amended contains
[…***…] compounds.
1.5 “Development
Activities” shall
mean any research, development, manufacturing or registration
activities relating to the Compounds and/or the Licensed
Products.
1.6 “Effective
Date” shall mean
the date set forth in the opening paragraph of this
Agreement.
1.7 “FDA”
shall mean the Food and Drug
Administration of the United States of America.
1.8
“Field” means
all human uses […***…]. For the sake of clarity,
conditions that can cause or otherwise be associated with
[…***…] shall remain included in the Field. For
example, […***…]. For the avoidance of doubt, the Field
shall not include the following […***…].
1.9 “Ipsen Patent
Rights” means the
Patents and Patent Applications listed in Exhibit B here
attached (including any Patents issuing from such Patent
Applications).
1.10 “Issued Valid
Claim” means any
claim from an issued and unexpired Patent under the Ipsen Patent
Rights, which covers a Licensed Product and but for this License
Agreement ACADIA could not make, have made, develop, use, sell,
offer for sale, commercially exploit, or import the Licensed
Product without said license, and which has not been abandoned,
revoked or held unenforceable or invalid by a decision of a court
or other governmental authority of competent jurisdiction, and
which has not been disclaimed, denied or admitted to be invalid or
unenforceable through reissue or disclaimer or
otherwise.
1.11 “Licensed
Product” means any
product containing one or more Compounds as an active
ingredient.
1.12 “Major
Countries” means
the […***…].
1.13 “Net
Sales” means with
respect to any Licensed Product, gross sales of ACADIA, its
Affiliates and Sublicensees (each, a “ Selling Party
”) of such Licensed Product to unaffiliated third
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parties, less (i) actual bad debts related
to such Licensed Product, (ii) credits for sales returns and
allowances actually paid, granted or accrued, (iii) trade,
quantity and cash discounts and any other adjustments actually
allowed and taken with respect to such invoiced amounts, including,
but not limited to, granted on account of price adjustments,
billing errors, rejected goods, damaged or defective goods,
recalls, returns, rebates, chargeback rebates, reimbursements or
similar payments granted or given to wholesalers or other
distributors, buying groups, health care insurance carriers or
other institutions, adjustments arising from consumer discount
programs, (iv) customs or excise duties, sales tax,
consumption tax, value added tax, and other taxes (except income
taxes) or duties relating to sales, (v) any payment in respect
of sales to any government, or to any Regulatory Authority, or with
respect to any government-subsidized program or managed care
organization, and (vi) freight and insurance, in each case as
determined from books and records of the Selling Party maintained
in accordance with generally acceptable accounting principles in
the United States of America, consistently applied. For the
avoidance of doubt, Net Sales shall not include any distribution of
Licensed Product for use in Development Activities or as samples
and shall not include sales by ACADIA to its Affiliates and
Sublicensees for resale, provided that if ACADIA sells a Licensed
Product to an Affiliate or to a Sublicensee for resale, Net Sales
shall include the amounts invoiced by such Affiliate or Sublicensee
to non-Affiliate third parties on the resale of such Licensed
Product.
1.14 “Other
Countries” means
any country of the Territory other than the Major
Countries.
1.15
“Patents” means any issued and unexpired patents,
certificates of invention, and any supplemental protection
certificates together with any issued and unexpired extensions,
registrations, confirmations, reissues, substitutions, requests for
continued examination, term restorations, divisions, continuations
or continuations-in-part, reexamination or renewals thereof.
“Patents” shall include any patent or Patent issuing
upon any Patent Application
1.16 “Patent
Applications” means
any patent applications, provisional applications, or applications
for certificates of invention, which have not become
Patents.
1.17 “Pending Valid
Claim” any claim
from a Patent Application under the Ipsen Patent Rights, which
covers a Licensed Product and but for this License Agreement ACADIA
could not make, have made, develop, use, sell, offer for sale,
commercially exploit, or import the Licensed Product without said
license, and which has not been abandoned, revoked or held
unenforceable or invalid by a decision of a court or other
governmental authority of competent jurisdiction, and which has not
been disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.
1.18 “Phase III Clinical
Trial” means a
clinical trial that […***…].
1.19 “Regulatory
Application” means
all regulatory applications submitted to a Regulatory Authority for
Regulatory Approval (together with supporting
documentation).
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1.20 “Regulatory
Approval” means all
approvals, licenses, registrations or authorizations necessary for
the marketing, sale and/or use of a Licensed Product in a
particular jurisdiction including any pricing or reimbursement
approval.
1.21 “Regulatory
Authority” means
any national, supra-national (e.g., the FDA, the European
Commission, the Council of the European Union, or the European
Medicines Agency (“EMEA”)), regional, state or local
regulatory agency, department, bureau, commission, council or other
governmental entity in any jurisdiction of the Territory involved
in the granting of Regulatory Approval for pharmaceutical
products.
1.22 “Royalty
Payments” shall
have the meaning ascribed to it in Section 4.5 of this
Agreement.
1.23
“Sublicensee” means any third party (other than an ACADIA
Affiliate) to whom ACADIA or an ACADIA Affiliate has granted the
right, directly or indirectly, to research, develop, make and/or
sell any Licensed Product, provided that Sublicensee shall exclude
wholesalers and resellers of Licensed Product, which do not engage
in any marketing or promotion of the Licensed Product.
1.24
“Term” have
the meaning ascribed to it in Section 9 of this
Agreement.
1.25
“Territory” means all countries of the world.
2.1 Non-Exclusive
License . Subject to the
terms and conditions of this Agreement, IPSEN hereby grants to
ACADIA and its Affiliates, and ACADIA hereby accepts, a
non-exclusive license, with the right to grant and authorize
sublicenses, under the Ipsen Patent Rights to research, develop,
have developed, make, have made, use, sell, offer for sale,
commercially exploit, and import the Licensed Products in the Field
in the Territory.
2.2 Sublicenses
. ACADIA shall have the right to
appoint Sublicensees. Immediately upon execution of any sublicense
agreement, ACADIA shall provide to IPSEN the terms and conditions
of the executed agreement with such Sublicensee including all
financial terms for the purpose of the implementation of
Section 4.4 of this Agreement. ACADIA shall ensure that all of
the applicable terms and conditions of this Agreement shall apply
to the Sublicensee to the same extent as they apply to ACADIA
hereunder for all purposes. ACADIA assumes full responsibility for
the performance of all obligations so imposed on such Sublicensee
and will itself account to IPSEN for all payments due under this
Agreement by reason of such sublicense.
2.3 Retained Rights
. Except as otherwise provided in
this Agreement, IPSEN and its Affiliates retain the right to use
the Ipsen Patent Rights for any purpose whatsoever.
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3.1 Reporting
. ACADIA shall, in a timely manner,
notify IPSEN of major events in the development of the Compounds or
Licensed Products (including without limitation the occurrence of
the events triggering the Milestone Payments as provided for in
Section 4.2 of this Agreement) and shall provide to IPSEN
within sixty (60) days after the end of each calendar year,
annual status reports summarizing the Development Activities
conducted during the past calendar year for each Compound or
Licensed Product.
3.2 Diligence
. In the event ACADIA is not
conducting any Development Activities with respect to the Compounds
or the Licensed Products for a period of more than three
(3) years, Ipsen shall have the option to terminate this
Agreement by notifying ACADIA its intention to do so pursuant to
this Section 3.2. In the event (i) ACADIA fails to resume
Development Activities within sixty (60) days as from receipt
of Ipsen’s notification and (ii) ACADIA fails to notify
Ipsen of its commitment to resume Development Activities in the
sixty (60) days following receipt of such Ipsen notice, this
Agreement shall automatically terminate without further
notification upon expiry of the sixty-day period following delivery
of the Ipsen notice.
4.1 Upfront Payment
. ACADIA shall pay to IPSEN Two
Hundred and Fifty Thousand (250,000) US Dollars within thirty
(30) days following the Effective Date. Such payment shall be
non-refundable and non-creditable.
4.2 Milestone Payments
. ACADIA shall make the following
creditable (pursuant to Section 4.4), non-refundable milestone
payments to IPSEN within thirty (30) days following the
occurrence of the following events (the “ Milestone
Payments ”):
(a) […***…] US Dollars
upon […***…];
(b) […***…] US Dollars
upon […***…];
(c) […***…] US Dollars
upon […***…].
For clarity, ACADIA shall make the
foregoing Milestone Payments only once for the first Licensed
Product to reach that stage.
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4.3 Acquisition Fee
. In the event of a
Change-of-Control (as defined below), ACADIA, or the new entity
resulting from the Change-of-Control, shall have an option to
assume ACADIA’s rights and obligations under this Agreement
by paying to IPSEN, within thirty (30) days as from the
effective date of the Change-of-Control, a one-time only payment of
[…***…] US Dollars (the “ Acquisition Fee
”). Such Acquisition Fee shall be non-refundable and
non-creditable. ACADIA, or the new entity resulting from the
Change-of-Control, shall inform Ipsen by written notice of the
occurrence of a Change-of-Control and shall notify Ipsen of the
decision to exercise this option within thirty (30) days as
from the effective date of Change-of-Control. In the event Ipsen
does not receive a notice of intention to exercise the option
within thirty (30) days as from the effective date of the
Change-of-Control or evidence of payment of the Acquisition Fee
within thirty (30) days as from the effective date of the
Change-of-Control, ACADIA shall be deemed to have breached a
material provision of this Agreement and Section 10.1(a) of
this Agreement shall apply. The Acquisition Fee shall not be
payable more than once.
For the purpose of this clause,
“Change-of-Control” means:
(i) […***…];
(ii) a transaction (being either a
direct or indirect transaction) which would result in:
(a) […***…],
or
(b) a merger, reorganization or
other business consolidation occurring in which ACADIA is not the
surviving entity, or any reverse merger occurs in which ACADIA is
the surviving entity, but which would result in either case
in:
(1) […***…],
or
(2) […***…],
(iii) […***…];
or
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(iv) […***…].
In the event that (a) ACADIA
assigns, delegates or sublicenses any rights under Section 2.1
of this Agreement to one or more of its Affiliates or
(b) ACADIA sells, conveys, transfers, leases or disposes
otherwise of all or substantially all of the assets of ACADIA
including the Compounds and Licensed Products to one or more of its
Affiliates, or (c) ACADIA sells, conveys, transfers, leases or
disposes of the Compounds or Licensed Product business to one or
more of its Affiliates, then Change-of-Control shall also mean any
of the events described in (i) to (iv) above if they
relate to such ACADIA Affiliate(s).
Notwithstanding the foregoing, a
Change-of- Control shall be deemed to occur on account of the
events described in (i) to (iv) only if the person(s)
benefiting from such a Change-of-Control is a Competing Entity. For
the purpose of this section, a Competing Entity shall mean a
company that, at the time of the Change-of-Control, is researching
or developing or markets a pharmaceutical product anywhere in the
world.
4.4 Sublicensing
Revenues . In the event
ACADIA enters into an agreement with a Sublicensee in accordance
with the provisions of Section 2.2 of this Agreement, ACADIA
shall pay to IPSEN […***…] percent
([…***…]%) of any upfront payments (excluding the fair
market value of equity sold, funding for the sole purpose of
supporting identified and planned research and development works
relating to the Compounds and/or the Licensed Products, transfer of
goods and materials at cost plus an industry standard premium, and
bona fide loans) or milestone payments (including without
limitation milestone payments relating to research, development,
regulatory or commercial events) received from any such Sublicensee
(“ Ipsen Sublicense Share ”) within thirty
(30) days following the receipt of such payments by ACADIA,
provided that in no event will Ipsen Sublicense Share include any
portion of sales for Licensed Products used to calculate royalties
under Section 4.5 of this Agreement.
(a) any Milestone Payment already
paid by ACADIA to IPSEN (if any) shall be deducted from any
payments to be made by ACADIA to IPSEN with respect to an Ipsen
Sublicense Share, provided, however, that (i) a Milestone
Payment shall be deducted from an Ipsen Sublicense Share only once
and (ii) if a Milestone Payment is credited only partially
against a Ipsen Sublicense Share, the remaining non-credited amount
of such Milestone Payment shall be creditable against future Ipsen
Sublicense Share(s);
(b) any payment relating to an Ipsen
Sublicense Share, after deduction of Milestone Payment as provided
for in Section 4.4(a) above, shall be creditable against any
Milestone Payments remaining to be paid under Section 4.2
above, provided, however, that (i) an Ipsen Sublicense Share
shall be creditable against future Milestone Payments only once;
(ii) if an Ipsen Sublicense Share is credited only partially
against a Milestone Payment, the remaining non-credited amount of
such Ipsen Sublicense Share shall be creditable against future
Milestone Payment(s); and
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(c) once all Milestone Payments have
been triggered and credited against Ipsen Sublicense Share(s),
ACADIA shall pay to IPSEN all forthcoming Ipsen Sublicense Share(s)
without any deduction.
For the avoidance of doubt, the
parties acknowledge that, it is their intention that, under this
Section 4.4, ACADIA pays to IPSEN the higher of (i) the
total amount of Milestone Payments triggered as provided for in
Section 4.2 of this Agreement and (ii) the total amount
of the Ipsen Sublicense Shares. An example of the mechanism of
credit of Milestone Payments and Ipsen Sublicense Shares is
attached as Exhibit D of this Agreement.
4.5 Royalty Payments
. ACADIA shall pay to IPSEN on a
product-by-product and country-by-country basis a royalty
calculated as detailed in Exhibit E (collectively, the “
Royalty Payments ”).
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5.
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ACCOUNTING AND PROCEDURES FOR
PAYMENT.
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5.1 Reports and
Payments . Beginning with
the first Commercial Sale in the Territory, ACADIA shall provide to
IPSEN a quarterly payment report as follows: Within sixty
(60) days after the end of each calendar quarter, ACADIA shall
deliver to IPSEN a true and accurate report, giving such
particulars of the business conducted by ACADIA, its Affiliates and
Sublicensees, if any, during such calendar quarter as are pertinent
to account for Royalty Payments due under Section 4.5 of this
Agreement. Such report shall include at least (i) the total of
Net Sales during such quarter on a country-by-country basis;
(ii) the calculation of Royalty Payments under this Agreement;
and (iii) the total Royalty Payments so calculated and due to
IPSEN. Simultaneously with the delivery of each such report, ACADIA
shall pay to IPSEN the total Royalty Payments, if any, due to IPSEN
for the period of such report. If no Royalty Payments are due,
ACADIA shall so report.
5.2 Calculation of Net
Sales . All Royalty
Payments to IPSEN under this Agreement shall be made in U.S.
dollars. When calculating Net Sales, ACADIA shall convert the
amount of invoiced sales in currencies other than U.S. dollars into
U.S. dollars using an exchange rate equal to the weighted average
of the rates of exchange for the currency of the country from which
the Royalty Payments are payable as published by The Wall Street
Journal, New York edition, (or by the Financial Times, should such
currency not be published in The Wall Street Journal) during the
calendar quarter for which a payment is due.
5.3 Method of Payments
. All payments hereunder shall be
made by electronic transfer in immediately available funds via
either bank wire transfer, an ACH (automated clearing house)
mechanism, or any other means of electronic funds transfer, at
ACADIA’s election, to such bank accounts as IPSEN shall
designate. All payments under this Agreement which are not paid
when due shall bear interest from the date due until paid at a rate
equal to the one-month European Interbank Offered Rate (EURIBOR) as
reported by the European Banking Federation (or a successor or
similar organization) plus four percent (4%) effective from
the date that payment was due.
5.4 Inspection of
Records . ACADIA shall
keep, and shall cause its Affiliates and Sublicensees to keep, full
and accurate books and records setting forth gross sales of each
Licensed Product, Net Sales of each Licensed Product, itemized
deductions from gross sales taken to calculate Net Sales and
Royalty Payments payable hereunder to IPSEN for each such Licensed
Product.
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ACADIA shall permit IPSEN, by independent
qualified public accountants (the “ Auditors ”)
selected by IPSEN and accepted by ACADIA, to examine such books and
records at any reasonable time. Such audit shall be binding upon
the Parties should ACADIA have accepted the Auditors selected by
IPSEN within thirty (30) days as from notification by IPSEN of
its intent to conduct an inspection and of the identity of the
Auditors selected by IPSEN for this purpose (absence of answer from
ACADIA within this thirty-day period being deemed to be an approval
of the Auditors by ACADIA). In the event ACADIA notifies its
refusal to approve the appointment of the Auditors, the parties
shall use reasonable commercial efforts to agree upon other
Auditors within sixty (60) days as from the date of
ACADIA’s notification. Should the parties fail to agree upon
such Auditors, IPSEN shall have the right to appoint any Auditors
for the purpose of conducting the inspection of ACADIA’s
records. The Auditors may be required by ACADIA to enter into a
reasonably acceptable confidentiality agreement, and in no event
shall the Auditors disclose to IPSEN any information other than
such as relates to the accuracy of reports and payments made or due
hereunder. IPSEN shall bear the cost of any such examination and
review; provided that if the inspection and audit shows an
underpayment of Royalty Payments of more than five percent
(5%) of the amount due for the applicable period, then ACADIA
shall promptly reimburse IPSEN for all external costs incurred in
connection with such examination and review. ACADIA shall promptly
pay to IPSEN the amount of any such underpayment revealed by an
examination and review together with late payment interest pursuant
to Section 5.3 of this Agreement. Any overpayment of Royalty
Payments by ACADIA revealed by an examination and review shall be
fully-creditable against future Royalty Payments, as applicable,
under Section 4.5 of this Agreement. Absent manifest error,
the Auditors’ report shall be binding upon the parties in the
case these Auditors have been accepted by ACADIA or chosen by
mutual agreement of the parties.
5.5 Withholding Taxes
. If provision is made in law or
regulation of any country in the Territory for withholding of taxes
of any type, levies or other charges with respect to any amounts
payable by ACADIA to IPSEN pursuant to this Agreement, ACADIA shall
deduct the amount of such taxes from the payment to IPSEN and shall
promptly pay such tax, levy or charge for and on behalf of IPSEN to
the proper governmental authority and ACADIA shall promptly furnish
IPSEN with certificate of taxes deducted under such withholding tax
laws. IPSEN and ACADIA shall cooperate with each other in obtaining
any exemption from or reduced rate of tax available under any
applicable law or tax treaty.
Except as set forth above, ACADIA
and IPSEN shall pay for their own account all sales, turnover,
income, revenue, value added and other taxes levied on account of
payments accruing or made under this Agreement. All amounts
expressed in this Agreement exclude such taxes which where required
by law shall be charged at the applicable rate.
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6.
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PATENTS AND
INFRINGEMENT.
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6.1 Prosecution and
Maintenance . IPSEN shall
be solely responsible, at its own expense, for the prosecution and
maintenance of the Ipsen Patent Rights. IPSEN agrees to keep ACADIA
reasonably informed regarding such prosecution and maintenance and
to solicit and reasonably consider ACADIA’s suggestions and
comments regarding all material aspects of such patent
prosecutions. If IPSEN decides to abandon any patents or patent
applications within the Ipsen
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Patent Rights, ACADIA shall have the option to
con