License (this
“Agreement”) made as of April 13, 2006, by and
between Acuity Pharmaceuticals, Inc., a Delaware
corporation, with its principal offices at 3701 Market Street,
Philadelphia, PA, 19104 (“ Acuity ”) and
Pathogenics, Inc ., a Delaware Corporation with its
principal offices at 99 Derby Street, Suite 200, Hingham, MA
02043 (“ Pathogenics ”) . (Acuity and
Pathogenics are sometimes referred to herein individually as a
“ Party ” and collectively as the “
Parties ”).
WHEREAS, Acuity is
engaged in the research, development and commercialization of
ophthalmic pharmaceutical products;
WHEREAS,
Pathogenics is a biopharmaceutical company engaged in the
acquisition, development and commercialization of novel
therapeutics that have potential significant commercial viability
and that target certain unmet market needs;
WHEREAS,
Pathogenics has exclusively licensed rights to N-Chlorotaurine, a
chemical substance produced within the body by white blood cells
during an inflammatory reaction (“ N-Chlorotaurine
”), initially developed by researchers at the University
Hospital of Innsbruck and the Institute of Hygiene and Social
Medicine, Leopold-Franzens-University of Innsbruck, Austria (the
“ Institute ”);
WHEREAS, Acuity
and Pathogenics believe that N-Chlorotaurine could be developed
into an efficacious treatment for conjunctivitis and other related
ocular conditions;
WHEREAS,
researchers at the Institute are preparing to conduct clinical
trials in Austria (the “Austrian Clinical Trials”) to
determine if N-Chlorotaurine can be used as an efficacious
treatment for conjunctivitis and other related ocular
conditions;
WHEREAS, Acuity
desires to obtain from Pathogenics, and Pathogenics desires to
grant to Acuity, an exclusive worldwide license to all of
Pathogenics’ rights in and to N-Chlorotaurine for the
development and commercialization of ophthalmic pharmaceutical
products for use in humans in accordance with the terms of this
Agreement.
NOW, THEREFORE, in
consideration of the mutual promises, covenants, agreements,
representations and warranties hereinafter set forth, and intending
to be legally bound, the Parties hereby agree as
follows:
“Affiliate” means any entity that directly or
indirectly Owns, is Owned by, or is under common Ownership with a
Party to this Agreement. “Owns” or
“Ownership” means direct or indirect possession of more
than fifty percent (50%) of the votes of holders of a
corporation’s voting securities or a comparable equity
interest in any other type of entity.
“Agency” means the FDA or any governmental
regulatory authority responsible for granting approvals for the
sale of Licensed Products in the United States or any foreign
country.
“Agreement” means this Agreement, together with
all exhibits and attachments.
“Clinical Trials” means all trials and studies
of the application of Licensed Products in humans or clinical
studies performed by Acuity for any purpose including without
limitation for purposes of obtaining regulatory approval in the
United States or any foreign country and marketing Licensed
Products in the United States or any foreign country.
“Commercially Reasonable Efforts” means, with
respect to the efforts to be expended by a Party with respect to
any objective, diligent, good faith efforts to accomplish such
objective as such Party would normally use to accomplish a similar
objective under similar circumstances, it being understood and
agreed that with respect to the development and commercialization
of Licensed Products, such efforts shall be substantially
equivalent to those efforts and resources commonly used by a
bio-pharmaceutical company for a similar pharmaceutical product
owned by it or to which it has rights, which product is at a
similar stage in its development or product life and is of similar
market potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative products in the
marketplace, the patent and other proprietary position of the
product, the likelihood of regulatory approval given the regulatory
structure involved, the profitability of the product, alternative
products and other relevant factors.
“Confidential Information” has the meaning set
forth in Section 6.1.
“
Effective Date ” means the day and year first
indicated above.
“EMEA” means the European Medicines Evaluation
Agency, or any successor thereto.
“FDA” means the United States Food and Drug
Administration, or any successor thereto.
“Field
of Use” means the treatment of ophthalmic diseases or
infection, such as but not limited to, viral conjunctivitis,
bacterial conjuctivitis and herpetic keratitis.
“Fiscal
Quarter” means each period of three (3) months
ending on March 31, June 30, September 30, or
December 31.
“GAAP” means generally accepted accounting
principles as in effect from time to time in the United
States.
“IND” means an “investigational new drug
application” as defined by the United States Food, Drug, and
Cosmetic Act, as amended (the “Act”), and applicable
FDA rules and regulations or a foreign equivalent.
“Licensed Products” means products whose
manufacture, use or sale would, but for the existence of this
Agreement, infringe a valid claim of the Pathogenics Patent
Rights.
“MHW” means the Ministry of Health and Welfare
of Japan, or any successor thereto.
Page 2 of 20
“NDA” means a “new drug
application,” as defined in the Act and applicable FDA rules
and regulations, including an application of the type described in
section 505(b)(2) of the Act.
“Net
Sales” means the total gross proceeds to Acuity on sales
to Third Parties representing sales actually collected by Acuity
and its Affiliates, less deductions for the following to the extent
actually paid or allowed with respect to the such sales:
(a) sales
and excise taxes and duties (including import duties) paid or
allowed by a selling party and any other governmental charges
imposed upon the manufacture or sale, after giving effect to any
rebates or refunds relating to such taxes or duties received by
Acuity;
(b) rebates
and chargebacks (including rebates to social and welfare systems)
actually paid;
(c) allowances,
chargebacks, and credits to Third Parties on account of rejected,
damaged, outdated, returned, withdrawn, or recalled product or on
account of retroactive price reductions affecting such product;
and
(d) amounts
paid to Third Parties on account of rebate payments, including
Medicaid rebates.
Taxes, the legal
incidence of which is on the purchaser and separately shown on
Acuity’s or its Affiliates’ invoices, and
transportation, insurance and postage charges, if prepaid by Acuity
or its Affiliates and billed on Acuity’s or its
Affiliates’ invoices as a separate item, shall not be
considered a component of Net Sales. Components of Net Sales shall
be determined in the ordinary course of business in accordance with
Acuity’s historical practice and using the accrual method of
accounting in accordance with GAAP.
The supply of a
product as commercial samples or for use in clinical trials or
studies shall not be included within the computation of Net
Sales.
Where (i) a
product is sold by Acuity or an Affiliate as one of a number of
items without a separate price; or (ii) the consideration for
a product shall include any non-cash element; or (iii) the
product is transferred by Acuity or an Affiliate in any manner
other than an invoiced sale, the Net Sales price applicable to any
such transaction shall be deemed to be Acuity’s average Net
Sales price for the applicable quantity of a product to the
relevant class of customers at that time.
“Net
Sublicense Payments” means (a) cash payments made to
Acuity in consideration of the sublicense; and (b) the fair
market value of any non-cash consideration received by Acuity from
a sublicense in consideration of the sublicense other than;
provided, however that the following shall not be included in the
calculation of Net Sublicense Payments (i) reasonable amounts
received in exchange for equity investments in Acuity by a
sublicensee, (ii) sponsored research funding paid to Acuity by
a sublicensee in a bona fide transaction for future research to be
performed by Acuity; (iii) payments for consulting services
actually performed by Acuity in a bona fide transaction at arms
length rates; and (iv) intellectual property rights received
by Acuity from a sublicensee, including, but not limited to,
licenses or sublicenses to intellectual property rights, covenants
not to compete against Acuity, or agreements not to assert claims
against Acuity.
Page 3 of 20
“Patents” means all valid claims in all patent
applications, and all foreign patents and patent applications based
thereon, including any continuations, divisionals,
continuations-in-part, extensions, reissues and re-examinations of
any of the foregoing and all patents issuing from any of the
foregoing applications.
“Pathogenics Improvements” means any
improvements to the Pathogenics Patent Rights and Pathogenics
Know-how, in each case owned by Pathogenics as of the date hereof,
that are conceived, created, developed, and/or otherwise invented
by Pathogenics, by Acuity.
“Pathogenics Intellectual Property” means the
Pathogenics Patent Rights, Pathogenics Improvements, and the
Pathogenics Know-how.
“Pathogenics Know-how” means Technical
Information owned, developed, or controlled by Pathogenics as of
the date of this Agreement or during the Term of this
Agreement.
“Pathogenics Patent Rights” means any valid
claim of any Patent issued based on a patent application previously
or hereafter filed by or on behalf of Pathogenics or previously or
subsequently assigned, licensed, or granted to, or acquired by,
Pathogenics, including without limitation Patents and patent
applications based on Pathogenics Improvements.
Exhibit A lists all the patents and patent applications
giving rise to Pathogenics Patent Rights as of the date of this
Agreement.
“Technical Information” means all techniques and
data and other know-how and technical information, including
inventions (including patentable inventions), practices, methods,
concepts, know-how, trade secrets, documents, computer data, source
code, apparatus, clinical and regulatory strategies and data, test
data, analytical and quality control data, manufacturing data or
descriptions, development information, drawings, specifications,
designs, plans, proposals and technical data and manuals and all
other proprietary information concerning the development,
manufacture, production, quality control, storage, distribution and
sale of N-Chlorotaruine or and any of its derivatives or
analogs.
“Third
Party” means any entity other than Pathogenics or Acuity
or their Affiliates.
ARTICLE II
LICENSE GRANT; DILIGENCE OBLIGATION
2.1. License
Grants to Acuity . Pathogenics hereby grants to Acuity, and
Acuity hereby accepts from Pathogenics, a sole and exclusive (even
as to Pathogenics) irrevocable right and license, including the
right to sublicense, under and to Pathogenics Intellectual Property
to make, have made, use, sell, offer for sale, import or otherwise
commercialize N-Chlorotaurine and Licensed Products in the Field of
Use with any territory.
2.2.
Technology Transfer and Assistance . Pathogenics shall provide
reasonable assistance to Acuity to effect the orderly transfer to
Acuity of Pathogenics Know-How, including the transfer to Acuity of
all Pathogenics Materials. Pathogenics will use reasonable efforts
to provide this assistance to Acuity as soon as practicable.
Pathogenics shall cooperate with Acuity in connection with efforts
to develop and commercialize N-Chlorotaurine in the Field of
Use.
Page 4 of 20
2.3. No
Restrictions on Business . Pathogenics agrees that Acuity is in
the business of developing, and selling ophthalmic pharmaceutical
products and that, subject to Section 3.2, nothing in this
Agreement shall be construed as restricting such business or
imposing on Acuity the duty to develop, register, market, and/or to
sell Licensed Products hereunder to the exclusion of or in
preference to any other product or otherwise preclude Acuity from
developing other pharmaceutical products. Correspondingly, except
as set forth herein, nothing herein shall be construed as
restricting the business of Pathogenics.
2.4.
Diligence: Development and Commercialization . Acuity shall use
Commercially Reasonable Efforts to develop and commercialize the
Licensed Product. The obligations set forth in this
Section 2.4 are expressly conditioned upon the absence of any
serious adverse conditions or event relating to the safety or
efficacy of the Technology or Product including the absence of any
action by any regulatory authority limiting the development or
commercialization of the Technology or Product.
2.5.
Sublicenses . Acuity shall have the right to grant sublicenses
to any Third Party to develop, make, have made, use, import, offer
for sale, market, commercialize, distribute and sell and otherwise
dispose of the Technology or Product for use in the Field-of-Use
and the Territory; provided, however that any such sublicense shall
be consistent with the terms of this Agreement. In the event that
Acuity proposes to grant a sublicense to any Third Party, Acuity
shall give Pathogenics a written notice prior to entering into the
sublicense describing the proposed sublicense, including the
specific rights proposed to be sublicensed and the material
commercial and professional terms of the proposed sublicense.
Acuity shall also provide Pathogenics with a copy of any sublicense
agreements. Upon any termination of this Agreement pursuant to
Section 9.2, Pathogenics may elect to have any existing
sublicense agreement(s) survive and be assigned by Acuity to
Pathogenics provided that (i) the sublicensee is not in breach
of its sublicense agreement at the time of such termination of this
Agreement, and (ii) any sublicensee who desires its sublicense
to survive shall promptly agree in writing to be bound by the
applicable terms of and assume all obligations of Acuity under this
Agreement.
ARTICLE III
AUSTRIA DEVELOPMENT PROGRAM
3.1. Austrian
Clinical Trials . Acuity will have non-exclusive rights to all
data resulting from the Austrian Clinical Trials. Pathogenics will
use its best efforts to cause the researchers at the Institute and
any person participating in the Austrian Clinical Trials to provide
Acuity with all data resulting from such trials. Acuity shall treat
all information disclosed to it under this Section 3.1 as
Confidential Information (as herein defined).
3.2. Austrian
Trial Acceleration Funding.
(a) Upon
the completion of a Phase I clinical trial in Austria to study
N-Chlorotaurine in the Field of Use, Pathogenics will use its best
efforts to cause the researchers at the Institute and any person
participating in the Austrian Clinical Trials to prepare, or cause
to be prepared, and deliver to Acuity a final report for the Phase
I clinical trial (the “ Final Report ”). Acuity
shall treat all information disclosed to it under this
Section 3.2 as Confidential Information (as herein
defined).
Page 5 of 20
(b) The
scope and form of the Final Report shall be mutually agreed upon by
Pathogenics and Acuity prior to its delivery.
(c) Acuity
shall have thirty (30) days from the delivery of the Final
Report to determine, in Acuity’s sole reasonable discretion,
if the Final Report justifies the initiation of a Phase II clinical
trial in Austria.
(d) If
Acuity determines that the Final Report justifies the initiation of
a Phase II clinical trial in Austria:
(i) Acuity
shall make available to the Institute and or the Phase II clinical
investigators, up to $75,000 to be used to accelerate the Phase II
clinical trial. Acuity, Pathogenics, and the researchers Institute
and or the Phase II clinical investigators will jointly determine
how this money will be utilized.
(ii) Acuity
shall use its Commercially Reasonable Efforts to initiate
chemistry, manufacturing and pre-clinical activities as are
necessary to file an IND with the FDA to initiate a phase I
clinical trial in the United States using N-Chlorotaurine as a
treatment for an ophthalmic indication. Acuity shall own all right,
title, and interest in any data generated in the course of such
activities and all applications and data submitted to the any
Agency. Acuity will provide Pathogenics with any data generated in
the course of such activities and all applications and data
submitted to any Agency, and Pathogenics will have non-exclusive
rights to this information for research and development activities
outside the Field of Use. Pathogenics shall treat all information
disclosed to it under this Section 3.2 as Confidential
Information (as herein defined).
(e) If
Acuity determines that the Final Report fails to justify the
initiation of a Phase II clinical trial in Austria and Pathogenics
reasonably disagrees with this conclusion, Pathogenics shall have
the right to terminate this Agreement upon thirty (30) days
notice to Acuity of this determination if Acuity fails to reverse
its determination during this thirty-day period.
ARTICLE IV
MILESTONES, FEES, AND ROYALTY PAYMENTS; ACCOUNTING
4.1. Austrian
Phase I Clinical Trial Completion Fee . In consideration of the
license grant provided by Pathogenics to Acuity, Acuity agrees to
pay to Pathogenics a one time $100,000 payment upon the successful
completion of the Austrian Phase I clinical trial.
4.2. Milestone
Payments . In consideration of the license grant provided by
Pathogenics to Acuity, and conditioned upon Acuity having
determined that the Final Report justifies the initiation of a
Phase II clinical trial in Austria, Acuity agrees to pay to
Pathogenics, the following milestone payments upon the successful
completion of the milestones set forth below for the first Licensed
Product hereunder:
Page 6 of 20
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment
|
|
Sublicense
|
US Phase I Clinical Trial initiated
|
|
$
|
200,000
|
|
|
|
60
|
%
|
US Phase II Clinical Trial initiated
|
|
$
|
400,000
|
|
|
|
50
|
%
|
US Phase III Clinical Trial initiated
|
|
$
|
1,000,000
|
|
|
|
40
|
%
|
|
|
|
$
|
575,000
|
|
|
|
30
|
%
|
|
|
|
$
|
825,000
|
|
|
|
30
|
%
|
|
|
|
$
|
325,000
|
|
|
|
30
|
%
|
|
|
|
$
|
1,000,000
|
|
|
|
20
|
%
|
|
|
|
$
|
1,500,000
|
|
|
|
20
|
%
|
|
|
|
$
|
500,000
|
|
|
|
20
|
%
|
(a) Each
of the foregoing payments shall be made only once. Thereafter, no
additional Milestone Payments shall be due or payable by Acuity to
Pathogenics for License Products.
4.3. License
Fee . In consideration for the license granted to Acuity under
Section 2.1 of this Agreement, Acuity agrees to pay to
Pathogenics a one time $50,000 license fee (“ License
Fee ”) within 2 business days of the execution of this
Agreement.
4.4. Royalty
Payments . During the Term, Acuity will pay to Pathogenics a
royalty on all Net Sales of Licensed Products sold by Acuity and
its Affiliates equal to six percent (6%) of Net Sales of Licensed
Products.
4.5.
Sublicense Fees. During the Term, Acuity will pay to
Pathogenics a sublicense fee in a decreasing range as set forth
above in Section 4.2 from a maximum of sixty percent (60%) to
a minimum of twenty percent (20%) of the Net Sublicense Payments
received by Acuity from sublicensees who sell Licensed Products
pursuant to a sublicense agreement with Acuity, the sublicense fee
depending upon what milestone stage has been successfully
completed. Prior to the successful completion of the first
milestone as set forth above in Section 4.2, any Third Party
sublicensee shall be treated for the purpose of this section as an
Affiliate of Acuity, and Acuity shall pay Pathogenics a pass
through royalty on all Net Sales of Licensed Products sold by its
Third Party sublicensees equal to six percent (6%) of Net Sales of
Licensed Products as set forth above in
Section 4.4.
4.6.
Withholding Taxes . Acuity shall be entitled to deduct from its
payments to Pathogenics the amount of any withholding taxes,
value-added taxes or other taxes, levies or charges with respect to
such amounts payable by Acuity, or any taxes in each case required
to be withheld by Acuity to the extent Acuity pays the appropriate
governmental authority on behalf of Pathogenics such taxes, levies
or charges. Acuity shall deliver to Pathogenics, upon reasonable
request, proof of payment of all such taxes, levies and other
charges and appropriate documentation which is necessary to obtain
a tax credit, to the extent such tax credit can be
obtained.
Page 7 of 20
(a) Acuity
shall provide written notice to Pathogenics the satisfaction of
such milestone trigger.
(b) Acuity
will pay the applicable milestone payments within thirty
(30) days of written notice of the achievement of the
applicable milestone.
(c) Royalties
and Sublicense Fees payable under Section 4.4 or
Section 4.5 will be paid not later than sixty (60) days
following the end of each Fiscal Quarter, or not later than sixty
(60) days from the date that is as soon thereafter as may be
practicable in order for Acuity to determine the royalty payable.
All payments shall be accompanied by a report in writing showing
for the quarter for which such royalty payment applies:
(i) the Net Sales of Licensed Products for which royalties are
required pursuant to Section 4.4 (along with a reasonably
detailed description of the calculation thereof) in United States
dollars; (ii) the Sublicense Fees payable pursuant to
Section 4.5 in United States dollars; and (iii) the
withholding taxes, if any, required by law to be deducted with
respect to such royalties and Sublicense Fees and the amounts paid
to the appropriate governmental authority with respect to such
royalties and Sublicense Fees.
4.8. Minimum
Annual License Fee . If total payments (including any payments
required pursuant to Section 3.2 or Sections 4.1 through
4.5) required to paid to Pathogenics for the annual periods set
forth below are less than the minimum amount set forth below,
Acuity shall pay Pathogenics an amount (the “Annual Minimum
Payment”) for that annual period equal to the difference
between the total payments required for such annual period and the
Annu
|