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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
"):
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(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.
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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:
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(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:
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(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.
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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
continue the prosecution and maintenance of such patents or patent
applications in IPSEN’s name and at ACADIA’s
expense.
6.2 Patent Term Extension; Supplemental Patent Protection
. IPSEN shall have the exclusive right to seek patent term
extensions or supplementary protection certificates in any country
in the Territory with respe
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