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EXHIBIT
10.5
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
INTELLECTUAL PROPERTY
ASSIGNMENT
AGREEMENT
BETWEEN
QLT USA,
INC.
AND
ARIUS TWO,
INC.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
TABLE OF CONTENTS
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Page |
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ARTICLE I DEFINITIONS
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1 |
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Section 1.01
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Definitions
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1 |
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Section 1.02
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Defined Terms
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6 |
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Section 1.03
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No Amendment to License
Definitions
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6 |
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ARTICLE II PURCHASE, SALE, ASSIGNMENT,
AND LICENSE
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6 |
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Section 2.01
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Purchase and Sales
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6 |
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Section 2.02
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Know-How License
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7 |
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Section 2.03
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Consideration
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7 |
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Section 2.04
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Termination of License
Agreement
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7 |
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Section 2.05
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Expenses
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7 |
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ARTICLE III PATENT
INFRINGEMENT
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8 |
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Section 3.01
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Infringement Claimed by Third
Parties
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8 |
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Section 3.02
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Indemnification of Seller
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8 |
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Section 3.03
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Indemnification of Buyer
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8 |
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Section 3.04
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Payment of Costs and Expenses
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8 |
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Section 3.05
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Termination of Obligations
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9 |
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ARTICLE IV CONFIDENTIALITY
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9 |
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Section 4.01
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Confidentiality
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9 |
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Section 4.02
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Disclosure of Agreement
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9 |
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ARTICLE V REPRESENTATIONS AND
WARRANTIES
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10 |
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Section 5.01
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Corporate Power
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10 |
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Section 5.02
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Due Authorization
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10 |
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Section 5.03
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Binding Obligation
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10 |
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Section 5.04
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Ownership of Purchased Assets
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11 |
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Section 5.05
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Patent Proceedings
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11 |
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Section 5.06
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Legal Proceedings
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11 |
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Section 5.07
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Limitation on Warranties
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11 |
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Section 5.08
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Limitation of Liability
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11 |
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ARTICLE VI COVENANTS
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12 |
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Section 6.01
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Access to Books and Records
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12 |
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
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Section 6.02
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Commercially Reasonable
Efforts
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12 |
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Section 6.03
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Compliance
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12 |
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Section 6.04
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Further Actions
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12 |
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ARTICLE VII DELIVERIES
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13 |
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Section 7.01
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Deliveries By Seller
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13 |
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Section 7.02
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Deliveries By Buyer
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13 |
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ARTICLE VIII MISCELLANEOUS
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14 |
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Section 8.01
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Governing Law
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14 |
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Section 8.02
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Waiver
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14 |
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Section 8.03
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Severability
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14 |
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Section 8.04
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Notices
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14 |
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Section 8.05
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Independent Contractors
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15 |
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Section 8.06
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Rules of Construction
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15 |
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Section 8.07
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Publicity
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15 |
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Section 8.08
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Entire Agreement; Amendment
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15 |
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Section 8.09
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Headings
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16 |
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Section 8.10
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Waiver of Jury Trial
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16 |
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Section 8.11
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Counterparts
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16 |
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Section 8.12
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Assignment
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16 |
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Exhibit A
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- |
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BEMA
Patent Rights |
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Exhibit B
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Guaranty |
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Exhibit C
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Patent
and Trademark Assignment Agreement |
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Exhibit D
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Patent
and Trademark Security Agreement |
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Exhibit E
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Secured
Promissory Note |
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Exhibit F
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Security
Agreement |
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Exhibit G
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Termination Agreement |
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
INTELLECTUAL PROPERTY
ASSIGNMENT AGREEMENT
This Intellectual Property
Assignment Agreement (the “Agreement”) is made as of
September 5, 2007 (the “Effective Date”) by and
between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a
Delaware corporation with its principal office at 2579 Midpoint
Drive, Fort Collins, CO 80525-4417 (“Seller”), and
Arius Two, Inc., a Delaware corporation with its principal office
at 2501 Aerial Center Parkway, Suite 205, Morrisville, NC 27560
(“Buyer”). Seller and Buyer are sometimes referred to
collectively herein as the “Parties” or singly as a
“Party.”
RECITALS
WHEREAS, Seller and
Arius Pharmaceuticals, Inc. (“Arius”) entered into that
certain License Agreement dated May 27, 2004, as amended
July 14, 2005 and August 2, 2006 (as amended, the
“License Agreement”); and
WHEREAS , Seller has
agreed to sell to Buyer, and Buyer has agreed to purchase from
Seller the BEMA assets related specifically to the United
States.
NOW, THEREFORE , in
consideration of the foregoing recitals and the mutual covenants
and agreements contained herein, the Parties hereto, intending to
be legally bound, do hereby agree as follows:
AGREEMENT
ARTICLE I
DEFINITIONS
Section 1.01
Definitions . The following terms as used in this
Agreement shall have the meaning set forth below:
“ Affiliate
” means an individual, trust, business trust, joint venture,
partnership, corporation, association or any other entity which
owns, is owned by or is under common ownership with, a Party. For
the purposes of this definition, the term “owns”
(including, with correlative meanings, the terms “owned
by” and “under common ownership with”) as used
with respect to any Party, shall mean the possession (directly or
indirectly) of more than 50% of the outstanding voting securities
of a corporation or comparable equity interest in any other type of
entity.
“ Applicable
Laws ” means all applicable laws, rules, regulations and
guidelines that may apply to the performance of either
Party’s obligations under this Agreement.
“ Assumed
Liabilities ” means all obligations and liabilities
arising out of Buyer’s ownership of the Purchased Assets,
whether arising prior to or after the Effective Date; except for
such obligations and liabilities for which Seller is obligated to
indemnify Buyer under Section 3.03 of this
Agreement.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ BEMA ”
means Seller’s proprietary bioerodible, mucoadhesive
multi-layer polymer film.
“ Claims ”
shall mean and include all past, present and future disputes,
claims, controversies, demands, rights, obligations, liabilities,
actions and causes of action of every kind and nature.
“ Combination
Product ” means a Worldwide Product (as defined below)
that is sold together with any other products and/or services at a
unit price, whether packaged together or separately with another
pharmaceutical product or other device, equipment, instrumentation,
or other components (other than solely containers or packaging
exclusively for the Worldwide Product).
“ Commercially
Reasonable Efforts ” shall mean, except as otherwise
explicitly set forth in this Agreement, those efforts consistent
with the exercise of prudent scientific and business judgment, as
applied to products having comparable market potential within the
relevant product lines of that Party and generally accepted
practices in the pharmaceutical industry. “Comparable market
potential” shall be fairly determined by a Party in good
faith and without limitation may be based upon market size, price,
competition, patent rights, product liability issues and general
marketing parameters.
“ Competent
Authorities ” means, collectively, all governmental
entities, foreign or domestic, responsible for the regulation of
medicinal products intended for human use.
“ Confidential
Information ” means any confidential or proprietary
information of a Party, whether in oral, written, graphic or
electronic form. Confidential Information shall not include any
information which the receiving Party can prove by competent
evidence:
(a) is now, or hereafter
becomes, through no act or failure to act on the part of the
receiving Party, generally known by or available to the
public;
(b) is known by the receiving
Party at the time of receiving such information, as evidenced by
its written records maintained in the ordinary course of
business;
(c) is hereafter furnished to
the receiving Party by a Third Party, as a matter of right and
without restriction on disclosure;
(d) is independently
developed by the receiving Party, as evidenced by its written
records maintained in the ordinary course of business, without
knowledge of, and without the aid, application or use of, the
disclosing Party’s Confidential Information; or
(e) is the subject of a
written permission to disclose provided by the disclosing
Party.
2
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Control
” means the possession of the ability to assign to Buyer as
provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
“ Encumbrance
” means any lien, pledge, hypothecation, mortgage, security
interest, encumbrance, equitable interest, preference, right of
possession, lease, tenancy, license, proxy, covenant, order,
option, right of first refusal or preemptive right, whether arising
out of an obligation to pay any taxes or otherwise.
“ BEMA Know-How
” means all Know-How related to BEMA or any Product which is
under the Control of Seller as of the Effective Date, including,
but not limited to, data and documentation of clinical trials,
pharmacological, toxicological, clinical, assay, control, and
manufacturing data, techniques, processes, methods, or systems, and
any other information relating to BEMA, excluding the BEMA Patent
Rights.
“ Marks ”
means all right, title, and interest in “BEMA” or any
additional trademarks or service marks owned by Seller with respect
to the BEMA Technology, alone or accompanied by any logo or design
and any non-English language equivalents in figure, sound or
meaning, whether registered or not, including but not limited to
any and all such rights in the Territory existing solely under
common law, statute, or similar bases not requiring explicit
government notice or registration.
“ BEMA Patent
Rights ” means all Patent Rights claiming BEMA or any
Improvement, or which are necessary, useful, or appropriate to
develop, manufacture, or commercialize Products, and under the
Control of Seller as of the Effective Date, which shall include but
not be limited to the patents and patent applications listed on
Exhibit A .
“ BEMA
Technology ” means the BEMA Patent Rights and the BEMA
Know-How.
“ Books and
Records ” means, in whatever media, any and all books and
records, reports and accounts and data in connection with or
related to any Product, BEMA Technology, or Marks, or any research,
development, or other activities primarily related to the foregoing
(including but not limited to those related to filing, prosecution,
and/or maintenance of the BEMA Patent Rights).
“ US Patent Term
” means, on a Product-by-Product basis, the period of time
ending on the expiration of the last to expire of the BEMA Patent
Rights covering such Product in the Territory.
“ Ex-US Purchase
Agreement ” means that certain Intellectual Property
Assignment Agreement, dated August 2, 2006, between the
Parties.
“ Ex-US BEMA Patent
Rights ” means all Patent Rights assigned to Buyer
pursuant to the Ex-US Purchase Agreement.
“ Ex-US Product
” means individually and collectively any product which would
infringe one or more valid claims of the Ex-US BEMA Patent
Rights.
3
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Territory
” means the United States.
“ FDA ”
means the Food and Drug Administration, the governmental entity
responsible in the United States for the regulation of medicinal
products intended for human use.
“ GAAP ”
means generally accepted accounting principles of the United States
consistently applied on a basis consistent throughout the periods
indicated and consistent with each other.
“ Governmental
Approval ” means all permits, licenses and
authorizations, including but not limited to, import permits and
Marketing Authorizations required by any Competent Authority as a
prerequisite to the manufacturing, marketing or selling of the
Product for human therapeutic use.
“ Guaranty
” means that certain Guaranty to be executed by BioDelivery
Sciences International, Inc. (“BDSI”), owner of all of
the outstanding capital stock of Buyer, in the form attached hereto
as Exhibit B .
“ Improvement
” means any and all developments, inventions or discoveries
directly relating to the BEMA Technology developed or acquired by,
or under the Control of, a Party at any time prior to or following
the Effective Date and shall include, but not be limited to, such
developments intended to enhance the safety and/or efficacy of any
Product.
“ Know-How
” means all know-how, trade secrets, inventions, data,
processes, techniques, procedures, compositions, devices, methods,
formulas, protocols and information, whether or not patentable,
which are not generally publicly known, including, without
limitation, all chemical, biochemical, toxicological, and
scientific research information, whether in written, graphic or
video form or any other form or format.
“ Marketing
Authorization ” means all necessary and appropriate
regulatory approvals, including but not limited to, variations
thereto, and Pricing and Reimbursement Approvals to put a Product
on the market in a particular jurisdiction.
“ Net Sales
” means the gross amounts invoiced by Buyer, its Affiliates
or sublicensees for sales of the Worldwide Product by Buyer, its
Affiliates, or its sublicensees, as applicable, to a Third Party in
a bona fide arm’s length transaction, less the following
items: *** . Net Sales shall not include any sales or
transfers of Worldwide Products by Buyer or its Affiliates to
Affiliates or sublicensees pursuant to manufacturing or
distribution agreements where such Affiliate or sublicensee will
ultimately sell such Worldwide Product and such amounts received in
connection with sale will be included in Net Sales.
A Worldwide Product shall be
considered sold when billed out or invoiced. Components of Net
Sales shall be determined in the ordinary course of business in
accordance with historical practice and using the accrual method of
accounting in accordance with GAAP.
In the event Buyer transfers
Worldwide Product to a Third Party in a bona fide arm’s
length transaction, for consideration, in whole or in part, other
than cash or to a Third Party in
4
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
other than a bona fide arm’s
length transaction, the Net Sales price for such Worldwide Product
shall be deemed to be the standard invoice price then being
invoiced by Buyer in an arms length transaction with similar
customers. The Net Sales of a Combination Product shall be
calculated as if the invoiced sales price for a Product included
within the Combination Product is *** . In the event that
Buyer includes a Worldwide Product as part of a single bundled sale
of separate products with separately stated prices, the Net Sales
attributable to such Worldwide Product shall be the higher of
*** .
“ Patent and
Trademark Assignment Agreement ” means the Patent and
Trademark Assignment Agreement executed by Seller in the form
attached hereto as Exhibit C .
“ Patent and
Trademark Security Agreement ” means that certain Patent
and Trademark Security Agreement between Buyer and Seller in the
form attached hereto as Exhibit D .
“ Patent Rights
” means all rights under patents and patent applications, and
any and all patents issuing therefrom (including utility, model and
design patents and certificates of invention), together with any
and all substitutions, extensions (including supplemental
protection certificates), registrations, confirmations, reissues,
divisionals, continuations, continuations-in-part, re-examinations,
renewals and foreign counterparts of the foregoing, and all
improvements, supplements, modifications or additions.
“ Pricing and
Reimbursement Approvals ” means any pricing and
reimbursement approvals which may or must be obtained before
placing a Product on the market in a particular
jurisdiction.
“ Product
” means a Product, as defined in the License Agreement,
excluding an Ex-US Product.
“ Purchased
Assets ” means (i) the Marks, (ii) BEMA
Technology, (iii) Books and Records, (iv) all Government
Approvals (as defined in the License Agreement) and appropriate
correspondence, clearance or transfer letters, or any other form of
authorization, license, permit, or the like from regulatory
authorities with respect to Government Approvals, to the extent not
previously assigned to Buyer under the License Agreement, and
(v) any and all benefits, privileges, causes of action, and
remedies relating to any of the foregoing, whether before or
hereafter accrued, including, without limitation, all rights in, to
and under applications for, filings, registrations or renewals, and
rights to apply for, file, register, maintain, extend or renew any
of the foregoing and the right to bring actions for past, present
or future infringement of or otherwise enforce any of the foregoing
and to settle and retain the proceeds of such actions (including,
without limitation, all causes of actions relating to any of the
foregoing, claims and demands or other rights accruing with respect
to any of the foregoing, or arising from any infringement of the
BEMA Technology and the Marks, before or after the Effective Date),
and any and all other rights corresponding thereto throughout the
world.
“ Secured Promissory
Note ” means that certain secured promissory note made by
Buyer in favor of Seller in the form attached hereto as
Exhibit E , the terms and conditions of which are
incorporated herein by reference.
5
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Security
Agreement ” means that certain Security Agreement between
Buyer and Seller in the form attached hereto as
Exhibit F .
“ Third Party
” means any entity other than: (a) Seller,
(b) Buyer or (c) an Affiliate of Seller or
Buyer.
“ United States
” or “US” means the United States of America, its
territories and possessions, including the Commonwealth of Puerto
Rico.
“ Worldwide
Product ” means, collectively, all Ex-US Products and
Products.
Section 1.02
Defined Terms . Each of the following terms is
defined in the Section set forth opposite such term
below:
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Agreement
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Preamble |
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Arius
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Recitals |
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Assumed Liabilities
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Section 2.01 |
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Buyer
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Preamble |
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CDC
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Recitals |
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Closing Cash Payment
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Section 2.03(a) |
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Effective Date
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Preamble |
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Indemnified Party
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Section 3.04 |
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Indemnifying Party
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Section 3.04 |
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License Agreement
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Recitals |
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Loss
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Section 3.02 |
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Party(ies)
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Preamble |
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Purchase Price
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Section 2.03 |
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Seller
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Preamble |
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Third Party Claim
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Section 3.01 |
Section 1.03 No
Amendment to License Definitions . The definition of
certain terms above which are also separately defined above shall
not in any way alter, amend, or be used to interpret the
definitions established under the License Agreement.
ARTICLE II
PURCHASE, SALE,
ASSIGNMENT, AND LICENSE
Section 2.01
Purchase and Sales . Subject to the terms and
conditions set forth in this Agreement, effective on the Effective
Date, Seller hereby conveys, assigns, and transfers to Buyer, and
Buyer hereby acquires from Seller, for the Purchase Price, free and
clear of all Encumbrances, the Purchased Assets and shall assume,
pay, discharge, and perform all Assumed Liabilities. For a period
of three months following the Effective Date, Seller will cooperate
with Buyer, as reasonably requested by Buyer and at Buyer’s
expense, which expense shall be commercially reasonable and
documented, in effecting the transfer of the Marks to Buyer and
enabling Buyer to file registrations, applications therefor, or
equivalent formal legal recognition of, or rights with respect to,
the Marks in Buyer’s name in the Territory, and Buyer shall
own all right, title, and interest thereto in the
Territory.
6
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
Section 2.02
Know-How License . To the extent any BEMA Know-How or
Improvement cannot be severed from Know-How related to technology
or intellectual property other than BEMA Technology and assigned to
Buyer as contemplated by this Agreement, Seller hereby grants to
Buyer an exclusive, perpetual, royalty-free, fully-paid license in
the Territory, with rights of sublicense, under and to such
Know-How and Improvements (to the extent not claimed in any BEMA
Patent Rights and concerning or related to BEMA (and not any
technology other than BEMA)) made, obtained, or Controlled by
Seller and related Books and Records to use, develop, market,
advertise, promote, distribute, offer for sale, sell, export and
import, manufacture, and have manufactured Products, provided that,
following the expiration of the US Patent Term, such license shall
be non-exclusive, fully-paid, perpetual and
royalty-free.
Section 2.03
Consideration . As consideration for the Purchased
Assets, Buyer shall pay to Seller total consideration of $7,000,000
(the “Purchase Price”). The Purchase Price shall be
payable as follows:
(a) $3,000,000 (the
“Closing Cash Payment”), by wire transfer of
immediately available funds on the Effective Date to an account
designated by Seller; and
(b) $4,000,000, as evidenced
by a secured promissory note, to Seller as follows:
(i) $2,000,000, within ten
(10) business days after the initial Governmental Approval of
a Product in the United States; and
(ii) $2,000,000, the first
time that cumulative Net Sales exceed $30,000,000. Such payment
shall be made within 30 days following the end of the calendar
quarter during which cumulative Net Sales exceed such
amount.
For the avoidance of doubt,
each payment referred to in this Section 2.03(b) shall be paid
only once by Buyer and only be become due and payable at such time
as the event described in the relevant subsection has
occurred.
Section 2.04
Termination of License Agreement . Pursuant to the
form of termination agreement attached hereto as Exhibit G
(the “Termination Agreement”), to be executed by Arius,
Seller, and CDC prior to or as of the Effective Date, the License
Agreement shall termina
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