EX-10.12 LICENSE AND COLLABORATION AGREEMENT
Published on April 2, 2007
EXHIBIT 10.12
LICENSE AND COLLABORATION AGREEMENT
License and Collaboration Agreement (this Agreement) made as of June 2, 2005, by and between
Acuity Pharmaceuticals, Inc., a Delaware corporation, with its principal offices at 3701 Market
Street, Philadelphia, PA, 19104 (Acuity) and Intradigm Corporation with its principal offices at
12115 Parklawn Drive, Suite K, Rockville, MD 20852 (Intradigm), (Acuity and Intradigm are
sometimes referred to herein individually as a Party and collectively as the Parties).
BACKGROUND
WHEREAS, Intradigm is an RNAi delivery technology company, with proprietary technology and
expertise in drug delivery;
WHEREAS, Intradigm has developed formulation and drug delivery technology with commercial
promise for formulation of oligonucleotides to enhance and aid in delivery to desired target
tissues that may be applicable to the development of ophthalmic therapeutics that can be delivered
less invasively than intra-ocular injection, such as topical application.
WHEREAS, Acuity has proprietary technology and expertise in the area of ophthalmic
pharmaceutical clinical development;
WHEREAS, Acuity and Intradigm share a mutual interest in a collaboration aimed at the further
development and commercialization of a therapeutic encompassing or employing a short interfering
RNA (an siRNA) that is deliverable to the posterior pole of the eye which may be administered by
topical application for pharmaceutical use in humans (the Topical siRNA); and
WHEREAS, Acuity and Intradigm intend to utilize their capabilities, capitalize on each others
expertise, and put forth commercially reasonable efforts to achieve the objectives of this
collaboration.
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:
ARTICLE I
DEFINITIONS
DEFINITIONS
Acuity Improvements means any improvements to the Acuity Patent Rights and Acuity Know-how,
in each case owned by Acuity as of the date hereof, that are conceived, created, developed, and/or
otherwise invented by Acuity, by Intradigm, or jointly by Acuity and Intradigm, under the Research
and Development Plan or pursuant to this Agreement.
Acuity Intellectual Property means the Acuity Patent Rights, Acuity Improvements, and the
Acuity Know-how.
Acuity Know-how means Technical Information owned, developed, or controlled by Acuity (other
than as a result of this Agreement) as of the date of this Agreement or during the Term of this
Agreement.
Acuity Patent Rights means any valid claim of any Patent issued based on a patent
application previously or hereafter filed by or on behalf of Acuity or subsequently assigned,
licensed, or granted to, or acquired by, Acuity (other than pursuant to this Agreement), including
without limitation Patents and patent applications based on Acuity Improvements.
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 corporations 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 the Topical siRNA 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 the Topical siRNA on
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
of the Topical siRNA 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 Topical siRNA,
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 including the royalties payable to Third Parties, alternative products and other
relevant factors. In evaluating profit potential or strategic value Acuity shall not consider the
payments required to be made to Intradigm under this Agreement.
Confidential Information has the meaning set forth in Section 9.1.
Control means, with respect to an item of information or intellectual property right, the
possession of the ability to grant a license or sublicense as provided for herein under such item
or right without violating the terms of any agreement or other arrangement, express or implied,
with any Third Party.
Critical Field of Use means the treatment of ophthalmic diseases characterized by excessive
or unwanted neovasculature, angiogenesis or leakage such as but not limited to Wet AMD, diabetic
retinopathy, diabetic macular edema, retinal vein occlusion, neovascular
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glaucoma, retinopathy of prematurity, Von Hippel Angioma, von-hippel landau, Corneal
Neovascularization, Rubeosis, Pterygium or Iris Neovascularization as well as, dry AMD, drusen and
uveitis.
Effective Date means the day and year first indicated above.
Excluded Field of Use means the treatment of ophthalmic diseases in the Critical Field of
Use or Non-Critical Field of Use (other than through the use of the Topical siRNA) in which a drug
is delivered through systemic administration only (and not through, in whole or in part, topical
application, ocular injection or any other method).
Excluded Territory means China, Hong Kong, Taiwan, Japan, Korea, Singapore, Thailand,
Indonesia, Malaysia, Australia and New Zealand.
FDA means the United States Food and Drug Administration, or any successor thereto.
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.
Intradigm Improvements means any improvements to the Intradigm Patent Rights and Intradigm
Know-how, in each case owned by Intradigm as of the date hereof, that are conceived, created,
developed, and/or otherwise invented by Intradigm, by Acuity, or jointly by Intradigm and Acuity,
under the Research and Development Plan or pursuant to this Agreement.
Intradigm Intellectual Property means the Intradigm Patent Rights, Intradigm Improvements,
and the Intradigm Know-how.
Intradigm Know-how means Technical Information owned, developed, or controlled by Intradigm
as of the date of this Agreement or during the Term of this Agreement.
Intradigm Novel siRNA Target means a gene or mRNA that could be targeted with siRNA
identified in the Intradigm Patent Rights, where the gene or mRNA has not previously been described
in the literature or otherwise known to Acuity.
Intradigm Patent Rights means any valid claim of any Patent issued based on a patent
application previously or hereafter filed by or on behalf of Intradigm or subsequently assigned,
licensed, or granted to, or acquired by, Intradigm, including without limitation Patents and patent
applications based on Intradigm Improvements. Exhibit A lists all the patents and patent
applications giving rise to Intradigm Patent Rights as of the date of this Agreement.
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Intradigm Sublicensed Products means Licensed Products (other than the Topical siRNA) that
are sold by a Third Party under a sublicense from Acuity for which Acuity would be required to pay
a royalty to Intradigm pursuant to Section 7.4 of this Agreement, if such product were sold by
Acuity or its Affiliates.
Jointly-Owned Intellectual Property means developments, discoveries, inventions, ideas,
processes, methods, compositions, formulae, techniques, information and data, whether or not
patentable, conceived, developed or reduced to practice jointly by one or more employees of Acuity
on the one hand and one or more employees of Intradigm on the other hand in connection with the
research and development activities performed pursuant to this Agreement which are not Intradigm
Improvements or Acuity Improvements.
Launch means the date of first commercial shipment of the Topical siRNA by Acuity, its
Affiliates, distributors, or sublicensees to Third Party customers in the United States or any
foreign country after receipt of Regulatory Approval for the Topical siRNA from the FDA or other
relevant Agency, as may be necessary in such country.
Licensed Products means products whose manufacture, use or sale would, but for the existence
of this Agreement, infringe a valid claim of the Intradigm Patent Rights.
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 Acuitys or
its Affiliates invoices, and transportation, insurance and postage charges, if prepaid by Acuity
or its Affiliates and billed on Acuitys 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 Acuitys historical practice and using the accrual
method of accounting in accordance with GAAP.
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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 Acuitys 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.
Non-Critical Field of Use means the treatment of any and all ophthalmic disease, other than
those included in the Critical Field of Use.
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.
Product Success Criteria means, with respect to the Topical siRNA, those criteria agreed
between the Parties and to be set forth in the Research and Development Plan.
Regulatory Approval means the Topical siRNA license or marketing approval necessary as a
prerequisite for marketing the Topical siRNA in the United States or any foreign country.
Research and Development Plan means the development program for the Topical siRNA as
described in Section 4.1 hereof which shall be agreed upon by the Parties within 30 days 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 Licensed Products or
the Topical siRNA.
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Third Party means any entity other than Intradigm or Acuity or their Affiliates.
ARTICLE II
OWNERSHIP OF INTELLECTUAL PROPERTY; LICENSE GRANTS
OWNERSHIP OF INTELLECTUAL PROPERTY; LICENSE GRANTS
2.1. Ownership of Inventions.
(a) Except as provided in this Article II, Intradigm shall own all right, title, and interest
in and to the Intradigm Intellectual Property and Acuity shall assign any rights it may have in
such Intradigm Improvements to Intradigm. Acuity shall own all right, title, and interest in and
to the Acuity Intellectual Property and Intradigm shall assign any rights it may have in such
Acuity Improvements to Acuity.
(b) Any Intradigm Improvements conceived or reduced to practice during the Term shall become
the property of Intradigm, whether conceived or reduced to practice by or on behalf of Acuity and
Acuity shall assign any rights it may have in such Intradigm Improvements to Intradigm.
(c) Any Acuity Improvements conceived or reduced to practice during the Term shall become the
property of Acuity, whether conceived or reduced to practice by or on behalf of Intradigm and
Intradigm shall assign any rights it may have in such Acuity Improvements to Acuity.
(d) Jointly-Owned Intellectual Property shall be owned jointly by Acuity and Intradigm.
2.2. License Grants to Acuity.
(a) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and
exclusive (even as to Intradigm) irrevocable right and license, including the right to sublicense,
under and to Intradigm Intellectual Property to make, have made, use, sell, offer for sale, import
or otherwise commercialize Licensed Products in the Critical Field of Use.
(b) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and
exclusive (even as to Intradigm) irrevocable right and license, including the right to sublicense,
under and to Jointly-Owned Intellectual Property to make, have made, use, sell, offer for sale,
import or otherwise commercialize Topical siRNA and Licensed Products in the Critical Field of Use
and the Non-Critical Field of Use.
2.3. Revocable License Grant to Acuity.
(a) Intradigm hereby grants to Acuity, and Acuity hereby accepts from Intradigm, a sole and
exclusive (even as to Intradigm), revocable in part (pursuant only to Section 2.3(b) and (c)) right
and license, including the right to sublicense, under and to Intradigm Intellectual Property to
make, have made, use, sell, offer for sale, import or otherwise commercialize Licensed Products in
the Non-Critical Field of Use.
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(b) After February 1, 2007, Intradigm may notify Acuity that Intradigm intends (by itself or
with a partner) to commercialize a therapeutic in the Non-Critical Field of Use which is not then
being pursued by Acuity (the Optioned Therapeutic). Intradigm shall be required to include with
such notification sufficient documentation to demonstrate to Acuity (through means reasonably
acceptable to Acuity) that Intradigm is financially and technologically capable of commercializing
the Optioned Therapeutic.
(i) Upon receipt of such notification and upon Acuitys acknowledgment (which shall not be
unreasonably withheld) that Intradigm is capable of such commercialization, Acuity shall have 120
days from such notification to provide Intradigm with a development plan demonstrating Acuitys
financial and technical ability (including Acuitys ownership of, or ability to obtain a license
to, intellectual property which is required to commercialize the Optioned Therapeutic) and intent
to commercialize the Optioned Therapeutic.
(ii) At this time, if Acuity desires to commercialize the Optioned Therapeutic, Acuity will
enter into a binding agreement with Intradigm that requires Acuity to expend a mutually agreed upon
amount of capital to commercialize the Optioned Therapeutic over an agreed upon time period.
(iii) If Acuity (A) fails to notify Intradigm during this 120-day period of Acuitys intent
to, and reasonably demonstrates its financial and technological ability to, commercialize the
Optioned Therapeutic or (B) Acuity materially breaches the agreement described in Section
2.3(b)(ii), Intradigm shall be free to pursue commercialization of the Optioned Therapeutic and the
license granted by Intradigm to Acuity in Section 2.2(a) shall be revoked to the extent and only to
the extent necessary for Intradigm to commercialize the Optioned Therapeutic.
2.4. Revocable License Grant to Intradigm.
(a) Acuity hereby grants to Intradigm, and Intradigm hereby accepts from Acuity, a sole and
exclusive (even as to Acuity), revocable (pursuant only to Section 2.4(b)), royalty free, right and
license, including the right to sublicense, under and to Intradigm Intellectual Property to make,
have made, use, sell, offer for sale, import or otherwise commercialize Licensed Products in the
Excluded Field of Use in the Excluded Territory.
(b) If Intradigm fails to enter into a binding agreement to develop therapeutic products for
the Excluded Field of Use in the Excluded Territory by December 31, 2005, the license granted by
Acuity to Intradigm in Section 2.4(a) shall be terminated without any further action by Acuity or
Intradigm.
2.5. Maintenance of Records. Each Party shall maintain full and accurate records concerning
their activities under this Agreement for the purpose of documenting any intellectual property
developed hereunder. Such records shall be maintained for the later of either three (3) years
after the end of the Term or for the pendency of any patent application covering any Jointly-Owned
Intellectual Property.
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ARTICLE III
OVERVIEW OF COLLABORATION
OVERVIEW OF COLLABORATION
3.1. Scope of Collaboration. The Parties shall work together to research and develop the
Topical siRNA. All research and development work shall be conducted in accordance with a Research
and Development Plan to be agreed upon by Acuity and Intradigm within thirty (30) days of the date
of this Agreement (the Research and Development Plan).
3.2. Additional Collaboration. The Parties shall exercise good-faith negotiations to enter
into a separate collaboration aimed at the further development and commercialization of one or more
therapeutics encompassing or employing an siRNA that is deliverable to the posterior pole of the
eye which may be administered by systemic application for pharmaceutical use in humans (the
Systemic siRNA). The financial terms of the Systemic siRNA collaboration shall be consistent
with and substantially similar to the provisions of Sections 7.1, 7.3, 7.4, 7.5 and 7.6(a) of this
Agreement, after taking into account and considering the relevant market for the Systemic siRNA and
its expected commercial success.
3.3. Recordkeeping. Each Party shall record, to the extent practical, all Technical
Information relating to its research and development activities under the Research and Development
Plan in written form, which writing shall be consistent with standard practices of each Party and
what is normal and customary in the pharmaceutical industry in the United States or as may be
required by applicable law or regulation. All such written records of the Parties shall be
maintained in a form sufficient to satisfy all Agencies.
ARTICLE IV
RESEARCH AND DEVELOPMENT PROGRAM
RESEARCH AND DEVELOPMENT PROGRAM
4.1. Research and Development Plan. The Research and Development Plan for the Topical siRNA,
including tasks, allocation of responsibilities, estimated development timelines, and estimated
development budgets, will be mutually agreed upon by Acuity and Intradigm within thirty (30) days
of the date of this Agreement. The Research and Development Plan will also include the Product
Success Criteria which will govern Acuitys obligation to commercialize the Topical siRNA. The
Parties may periodically modify the Research and Development Plan, within the scope of and in a
manner consistent with this Agreement, further detail the responsibilities of each Party within the
general scope of responsibilities set forth herein, each in accordance with Section 4.4. In the
event that an estimated development timeline will not be met, the Party with responsibility for
meeting that timeline shall notify the other Party and the Parties shall work together in good
faith to bring the project back on schedule.
4.2. Joint Development Committee.
(b) The Development Program and all pre-clinical testing of the Topical siRNA shall be
conducted under the direction of a joint development committee (the JDC). The JDC shall be
composed of two (2) named representatives of Acuity and two (2) named representatives of Intradigm.
The named representatives shall designate one member to serve as chairperson of the JDC. Each
Party will identify its representatives to the JDC within
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five (5) days after the date of this Agreement and each Party shall have the right to replace
its representatives at any time in its sole discretion after giving notice to the other Party.
(c) The purposes of the JDC shall be to review, direct, supervise and coordinate all
operational and scientific aspects of the development of the Topical siRNA and all pre-clinical
testing of the Topical siRNA (the Development Program). As part of its responsibilities, the JDC
shall (i) within thirty (30) days of the Effective Date, finalize the terms of the Research and
Development Plan, (ii) review the development of Intradigm under the Development Program, (iii)
monitor the progress of the Development Program and evaluate the work performed and the results
obtained in relation to the goals of the Development Program, (iv) approve any necessary or
desirable modifications to, the Development Program and the Research and Development Plan, and (v)
such other functions to which the Parties agree. The Party hosting each meeting of the JDC
promptly shall prepare and deliver to the other Party within fifteen (15) business days after the
date of such meeting, minutes of such meeting setting forth all decisions of the JDC relating to
the Development Program in form and content reasonably acceptable to the other Party.
(d) The JDC shall meet at least twice each quarter until the Development Program is completed
(the Collaboration Term), at such times and places as agreed to by Intradigm and Acuity. The JDC
and any of its members may meet or attend meetings by telephone or video conference. The JDC will
communicate regularly by telephone, facsimile and video conference. Meetings and telephone and
video conferences of the JDC may be attended by such other directors, officers, employees,
consultants and other agents of Intradigm and Acuity as the Parties from time to time reasonably
agree. Intradigm and Acuity will bear their own costs in attending such meetings.
(e) The JDC will review the characteristics of the compounds identified under the Development
Program, and the JDC will select the final compound or compounds which will be used for clinical
testing.
(f) All final decisions of the JDC shall be made by majority vote of all of the members.
4.3. Joint Obligations.
(a) Each Party agrees to commit the qualified and experienced personnel, facilities,
equipment, expertise and other resources necessary to perform its obligations under this Agreement
and the Research and Development Plan.
(b) Except as set forth in Section 4.4, each Party will fund its own costs and expenses in the
performance of its research and development obligations provided pursuant to this Agreement and the
Research and Development Plan.
(b) The Parties shall keep each other fully informed of the status of the development of the
Topical siRNA including, without limitation, providing written reports as requested throughout the
performance of the Research and Development Plan, stating in reasonable detail all efforts made and
in process, and all significant progress achieved.
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(c) The Parties will each designate a primary project contact with respect to the Topical
siRNA throughout the performance of the Research and Development Plan.
4.4. Intradigm Obligations.
(a) Intradigm shall use commercially reasonable efforts to diligently perform its obligations
under this Agreement, including, without limitation, those to be set forth in the Research and
Development Plan, all in accordance with all applicable laws, ordinances, rules, regulations,
orders, licenses and other requirements now or hereafter in effect.
(b) Intradigm shall be required to allocate one and one-half (1.5) FTEs (and no more) during
the term of the Collaboration for the areas of activity set forth in the Research and Development
Plan.
(c) Intradigm shall make available to Acuity all Intradigm Intellectual Property and Technical
Information and assistance as may reasonably be necessary for Acuitys development, submission for
applicable Regulatory Approval, and commercialization of the Topical siRNA, including formulation
and process development, development of stability indicating methods (including methods for
dissolution, assay and stability), and achievement of stability under accelerated stability
conditions for two months or under ambient conditions for six months, stability data, methods
validation, formulation trials, in-process and finished Products specifications, Product
development reports for the Topical siRNA, and identification and sourcing of any excipients used
in the formulation of the Topical siRNA, all as more particularly described herein and in the
Research and Development Plan.
(d) Intradigm shall maintain records in sufficient detail and otherwise in accordance with
good laboratory practices or current good manufacturing practices, as the case may be, and as are
required to properly reflect, and will document in a manner appropriate for purposes of supporting
any Agency filings, and pre-approval inspections, all work done and results achieved by Intradigm
in the performance of the Research and Development Plan (including all data in a form required
under any applicable governmental regulations). Subject to the confidentiality provisions of
Article X hereof, Intradigm shall provide Acuity with copies of all such records relating to the
Topical siRNA.
4.5. Acuity Obligations.
(a) Acuity
shall use Commercially Reasonable Efforts to diligently perform its
obligations under this Agreement, including, without limitation,
those set forth in the Research and Development Plan, all in
accordance with all applicable laws, ordinances, rules, regulations,
orders, licenses and other requirements now or hereafter in
effect.
(b) In consideration for Intradigms performance of its obligations under this Agreement and the Research and Development Plan, Acuity shall pay Intradigm $180,000 per year per FTE employed by Intradigm pursuant
to Section 4.6(b).
(c) Acuity
shall maintain records in sufficient detail and otherwise in
accordance with good laboratory practices, good clinical practices,
or current good
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manufacturing practices, as the case may be, and as are required to properly reflect, and will
document all work done and results achieved in the performance of the Research and Development Plan
including all records of any Clinical Trials. Subject to the confidentiality provisions of Article
IX hereof, Acuity shall provide Intradigm with the right to inspect such records relating to the
Topical siRNA.
(d) Acuity shall keep Intradigm fully informed as to the continuing status of its Clinical
Trials and development efforts for the Topical siRNA, including the status of the preparation and
filing of any Regulatory Approvals with applicable Agencies as well as the anticipated Launch of
the Topical siRNA and the status of the conduct and completion of Clinical Trials. In connection
therewith, Acuity shall provide to Intradigm quarterly reports during the Term, stating in
reasonable detail all efforts made and in process, and significant progress achieved. In addition,
Acuity shall communicate to Intradigm any material issues or problems. Acuity shall include in
such reports information concerning the status of the regulatory filings for the Topical siRNA and
shall notify Intradigm of the substance of all material written communications with any Agencies
relating to the Topical siRNA.
ARTICLE V
HEALTH REGISTRATION OBLIGATION
HEALTH REGISTRATION OBLIGATION
5.1. Clinical Development; Regulatory Approvals. After the Topical siRNA compound is selected
and approved by the JDC, Acuity shall use its Commercially Reasonable Efforts to prepare, file,
and prosecute all Agency filings and applications to obtain all Regulatory Approvals for the
Topical siRNA in the United States and any foreign country that Acuity chooses in its sole
discretion, at Acuitys sole expense. Acuity shall own all right, title, and interest in any FDA
or other Regulatory Approvals which are obtained for the Topical siRNA, including all data
generated in the course of Clinical Trials and all applications and data submitted to the FDA or
other Agency.
5.2. NDA. Acuity shall use Commercially Reasonable Efforts to file an NDA to seek Regulatory
Approval to use and sell the Topical siRNA in the United States and any foreign country that Acuity
chooses in its sole discretion, at Acuitys sole expense upon satisfaction of the Product Success
Criteria.
5.3. Maintenance of Regulatory Approvals. Acuity shall use Commercially Reasonable Efforts to
maintain the Regulatory Approvals for use, sale and marketing of Topical siRNA in the United States
and any foreign country that Acuity chooses in its sole discretion, at Acuitys sole expense.
5.4. Intradigm Assistance. Intradigm shall provide such assistance to Acuity in obtaining and
maintaining Regulatory Approvals in the United States and any foreign country as reasonably
requested by Acuity.
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ARTICLE VI
MARKETING AND SALE OF THE PRODUCT
MARKETING AND SALE OF THE PRODUCT
6.1. Marketing and Sale of the Topical siRNA.
(a) Upon the Launch of the Topical siRNA, Acuity, either itself or through its Affiliates, or
distributors, shall use its Commercially Reasonable Efforts to market, distribute, and sell the
Topical siRNA in the United States and any foreign country that Acuity chooses in its sole
discretion and shall exercise such diligence in this regard as shall be reasonable in light of the
size of the market and potential market for the Topical siRNA and in a manner consistent with which
it markets other Acuity products of comparable market size in the particular country.
(b) Acuity shall control and make all decisions regarding the strategy and tactics of
marketing, selling, and otherwise commercializing the Topical siRNA, including, without limitation,
the method of sales and distribution, organization and management of sales and marketing, packaging
and labeling, appointment of distributors pursuant to Section 6.2, and other terms and conditions
for such sales and marketing, and shall exercise Commercially Reasonable Efforts in such regard to
maximize the economic opportunity for the Topical siRNA.
6.2. Distributors; Sublicensees. Acuity may designate and appoint one or more Third Parties
to act as its agent(s) or sublicensees in connection with the marketing, sale and distribution of
the Topical siRNA.
6.3. Regulatory Compliance. Acuity shall use Commercially Reasonable Efforts to comply with
applicable regulations regarding procedures for reporting to appropriate Agencies, and to report,
investigate, issue responses and execute any corrective action plan to post-marketing Topical siRNA
complaints/field reports in a timely manner in accordance with applicable regulations.
6.4. No Restrictions on Business. Intradigm agrees that Acuity is in the business of
developing, and selling pharmaceutical products and that, subject to Acuitys obligations in
Articles IV, V and VI, 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 the Topical siRNA
hereunder to the exclusion of or in preference to any other product or otherwise preclude Acuity
from developing or practicing any Acuity Intellectual Property or developing other pharmaceutical
products. Correspondingly, except as expressly set forth herein, nothing herein shall be construed
as restricting the business of Intradigm.
ARTICLE VII
MILESTONES, FEES, AND ROYALTY PAYMENTS; ACCOUNTING
MILESTONES, FEES, AND ROYALTY PAYMENTS; ACCOUNTING
7.1. Milestones.
(a) In consideration of Intradigms commitment to provide its research and development
obligations as provided herein, including, without limitation, under the Research and Development
Plan, Acuity agrees to pay to Intradigm, for the Topical siRNA developed hereunder, the following
milestone payments related to the development and
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commercialization of one or more Topical siRNA therapeutics. It is also expected that
substantially similar milestone payments will be paid in connection with development of each of one
ore more Systemic siRNA therapeutics pursuant to a separate collaboration agreement to be
negotiated in good faith by the Parties.
Notice of Opening of IND from FDA |
$ | 100,000 | ||
Enrollment of first patient in a Phase II Clinical Trial |
$ | 500,000 | ||
Enrollment of first patient Phase III Clinical Trial |
$ | 500,000 | ||
Phase III Clinical Trial completed successfully |
$ | 1,000,000 | ||
NDA Approval in the U.S. |
$ | 3,000,000 |
(b) Notwithstanding anything to the contrary contained herein, in the event Acuity exercises
its right to terminate the continued development and commercialization of the Topical siRNA
pursuant to Sections 12.2 or 12.3 hereof prior to the achievement of any or all of the applicable
milestones provided in Section 7.1 relating to the Topical siRNA, Acuity shall be required to make
payment to Intradigm only with respect to the milestones which were achieved prior to the
Termination Date and no further milestone payments relating to the Topical siRNA shall accrue after
the Termination Date.
7.2. License Fee. In consideration for the license granted to Acuity under Section 2.1 of
this Agreement, Acuity agrees to pay to Intradigm, the following:
(a) $300,000 within 10 days of the execution of this Agreement; and
(b) $150,000 on December 31, 2005.
7.3. Royalty Payments on Topical siRNA. During the Term, Acuity will pay to Intradigm a
royalty on all Net Sales of the Topical siRNA sold by Acuity and its Affiliates equal to four
percent (4%) of Net Sales of Topical siRNA. The royalty payments described in Section 7.4 shall
not be applicable for sales of the Topical siRNA.
7.4. Royalty Payments on Licensed Products other than Topical siRNA. During the Term, Acuity
will pay to Intradigm a royalty equal to the percentage set forth below on all Net Sales of the
Licensed Products sold by Acuity and its Affiliates (other than the Topical siRNA), as follows:
(a) Acuity will pay to Intradigm a royalty on all Net Sales of Licensed Products which
incorporate a targeted nanoparticle covered by the Intradigm Patent Rights sold by Acuity and its
Affiliates equal to two percent (2%) of Net Sales of such Licensed Products.
(b) Acuity will pay to Intradigm a royalty on all Net Sales of Licensed Products which
incorporate a nucleic acid carrier covered by the Intradigm Patent Rights sold by Acuity and its
Affiliates equal to two percent (2%) of Net Sales of such Licensed Products.
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(c) Acuity will pay to Intradigm a royalty on all Net Sales of Licensed Products which
incorporate a ligand covered by the Intradigm Patent Rights sold by Acuity and its Affiliates equal
to two percent (2%) of Net Sales of such Licensed Products.
(d) Acuity will pay to Intradigm a royalty on all Net Sales of Licensed Products which
incorporate an Intradigm Novel siRNA Target covered by the Intradigm Patent Rights sold by Acuity
and its Affiliates equal to eight percent (8%) of Net Sales of such Licensed Products.
(e) More than one royalty payment described in this Section 7.4 may be required to be paid
(e.g., for Licensed Products which incorporate a ligand covered by the Intradigm Patent Rights and
a targeted nanoparticle covered by the Intradigm Patent Rights); provided however, that the maximum
royalty on any Licensed Product sold by Acuity during the term shall be ten percent (10%) of Net
Sales of such Licensed Product.
7.5. Reduction of Royalties. If Acuity is required to pay royalties to Intradigm and one or
more Third Parties that, in the aggregate, exceed ten percent (10%) of Net Sales (the Total
Royalty) to commercialize a Licensed Product or the Topical siRNA, the royalties due to Intradigm
with respect to such Licensed Product or Topical siRNA shall be reduced by one percent (1.0%) for
every one percent (1%) that the Total Royalty exceeds ten percent (10%). In no event shall the
royalties due to Intradigm be reduced below two percent (2%) pursuant to this Section 7.5.
7.6. Sublicense Fees.
(a) During the Term, Acuity will pay to Intradigm a sublicense fee equal to eight percent (8%)
of the Net Sublicense Payments received by Acuity from sublicensees who sell Topical siRNA pursuant
to a sublicense agreement with Acuity.
(b) During the Term, Acuity will pay to Intradigm a sublicense fee equal to thirty percent
(30%) of the Net Sublicense Payments received by Acuity from sublicensees who sell Intradigm
Sublicensed Products (other than Topical siRNA) pursuant to a sublicense agreement with Acuity.
7.7. Withholding Taxes. Acuity shall be entitled to deduct from its payments to Intradigm 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 Intradigm such taxes,
levies or charges. Acuity shall deliver to Intradigm, 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.
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7.8. Timing of Payments
(a) The milestone payments payable under Section 7.1 will be paid within thirty (30) days of
achievement of the applicable milestone.
(b) The Party having primary responsibility for the completion of the applicable milestone
shall provide written notice to the other Party not later than fifteen (15) days following the
satisfaction of such milestone trigger.
(c) Royalties payable under Section 7.3 or Section 7.4 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 Topical siRNA and Licensed Products for which
royalties are required pursuant to Section 7.4 (along with a reasonably detailed description of the
calculation thereof); (ii) the royalties payable pursuant to Section 7.3 in United States dollars;
and (iii) the withholding taxes, if any, required by law to be deducted with respect to such
royalties and the amounts paid to the appropriate governmental authority with respect to such
royalties.
7.9. Stock Issuance.
(a) Within thirty (30) days following the Effective Date, Acuity will issue and register in
the name of Intradigm a certificate for 250,000 shares of Common Stock of Acuity (the Restricted
Shares).
(b) The Restricted Shares shall be grated to Intradigm pursuant to a stock grant agreement
between Acuity and Intradigm, the form of which is attached as Exhibit B (the Stock Grant
Agreement).
(c) The Restricted Shares will be subject to vesting pursuant to the milestones and time
periods described in the Stock Grant Agreement.
(d) Intradigm shall make such written disclosures and representations and warranties, and
shall fully cooperate with, Acuity and its counsel as may reasonably be requested by them
concerning compliance with any applicable securities laws, rules or regulations applicable to the
issuance of such Restricted Shares to Intradigm. The certificates for the Restricted Shares to be
issued to Intradigm will contain a legend on the face thereof which will preclude Intradigm from
selling or otherwise transferring such shares until the date upon which there is an effective
registration statement applicable to such shares which will allow them to be publicly traded.
7.10. No Other Payments. Intradigm acknowledges and agrees that other than the payments
provided in this Article VII, and all other payment, indemnity and reimbursement obligations set
forth in this Agreement, Intradigm shall not be entitled to any amounts received by Acuity or its
Affiliates and sublicensees from the use, commercialization, license or sale of its rights under
this Agreement, regardless of the form or manner of payment (including milestones, royalties or
other amounts).
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7.11. Audit. Acuity shall maintain and shall require its Affiliates and sublicensees to
maintain, at their respective offices accurate and complete books and records of the Net Sales of
the Topical siRNA, consistent with sound business and accounting practices. Upon the written
request Intradigm, but not more than once in any calendar year, Acuity shall permit an independent
certified public accounting firm of nationally recognized standing, selected by Intradigm and
acceptable to Acuity, to have access during normal business hours to such records of Acuity as
shall be necessary to verify the accuracy of the royalty reports provided hereunder for any year
ending not more than thirty-six (36) months prior to the date of such request. The accounting firm
shall disclose to Intradigm only whether the records are accurate or not and the specific details
concerning any discrepancies, and shall provide a copy of its report to Acuity. No other
information shall be shared. If the audit of royalties shows an underpayment of royalty payments
by Acuity of more than the greater of (i) $25,000 or (ii) five percent (5%), then the expenses of
the audit of royalties shall be borne by Acuity; otherwise the expenses of the audit of royalties
shall be borne by Intradigm. If such accounting firm concludes that additional royalties were owed
or that royalties were overpaid during such period, then Acuity shall pay the additional royalties
or Intradigm shall credit or pay Acuity such overpayment within thirty (30) days of the date that
such accounting firms written report is delivered to the parties.
7.12. Confidential Financial Information. Each Party shall treat all financial information of
the other Party as Confidential Information of the other Party, and shall retain and shall cause
its employees and agents to retain, all such financial information in confidence.
ARTICLE VIII
CERTAIN PROVISIONS REGARDING PATENTS
CERTAIN PROVISIONS REGARDING PATENTS
8.1. Patent Filings, Prosecution and Maintenance of Intradigm Patent Rights.
(a) Intradigm shall have the first right, using in-house or outside legal counsel selected at
Intradigms sole discretion, to prepare, file, prosecute, maintain and extend patent applications
and patents concerning all such Intradigm Patent Rights in the United States and any foreign
country that Intradigm chooses in its sole discretion, for which Intradigm shall bear the costs
relating to such activities. Intradigm shall solicit Acuitys advice and review of the nature and
text of any such patent applications in reasonably sufficient time prior to filing thereof, and
Intradigm shall take into account Acuitys reasonable comments related thereto. Intradigm and
Acuity shall treat all information disclosed to it under this Section 8.1 as Confidential
Information (as herein defined).
(b) If Intradigm elects not to file, prosecute or maintain any Intradigm Patent Rights or any
ensuing Patents or claims encompassed by any Intradigm Patent Rights in the United States or any
foreign country, Intradigm shall give Acuity notice thereof within a reasonable period prior to
allowing such patent applications or Patents or such claims encompassed by such patent applications
or Patents to lapse or become abandoned or unenforceable, and Acuity shall thereafter have the
right, at its sole expense and in the name of Intradigm, to prepare, file, prosecute and maintain
patent applications and patents or divisional applications related to such claims encompassed by
such patent applications or patents
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concerning all such inventions and discoveries in countries of its choice throughout the
world. In such case, Intradigm shall assign (or grant Acuity a perpetual irrevocable royalty free
license, if an assignment can not be made) to Acuity all of its rights under such patent or patent
application in any country in which Acuity prosecutes and/or maintains such patent rights.
8.2. Enforcement of Intradigm Patent Rights.
(a) In the event that a Party learns that any Intradigm Patent Rights necessary for the
development, manufacture, use and/or sale of the Topical siRNA are infringed or misappropriated by
activities of a Third Party in any country, or are subject to a declaratory judgment action arising
from such infringement in such country, such Party shall promptly notify the other Party hereto.
(b) Intradigm shall have the initial right (but not the obligation) to enforce such Intradigm
Patent Rights, or defend any declaratory judgment action with respect thereto, at its expense.
(c) In the event that Intradigm fails to initiate a suit to enforce such Intradigm Patent
Rights against such a Third Party in any jurisdiction within sixty (60) days after notification of
such infringement or decides that does not desire to defend such declaratory judgment action,
Acuity may initiate such suit in the name of Intradigm with regard to the applicable Intradigm
Patent Rights against such infringement or assume the defense of the declaratory judgment action,
at the expense of Acuity. The Party involved in any such claim, suit or proceeding (the Enforcing
Party), shall keep the other Party hereto reasonably informed of the progress of any such claim,
suit or proceeding and shall allow the other Party to participate in the action at the other
Partys sole cost and expense. Intradigm and Acuity shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or
settlement thereof from any recovery made by any Party. Any remaining amounts shall be distributed
between the Enforcing Party, with the Enforcing Party receiving 75% of any such net recovery and
the other Party 25%.
8.3. Patent Filings, Prosecution and Maintenance of Joint Technology Patent Rights.
(a) Acuity shall have the first right, using in-house or outside legal counsel selected at
Acuity at its sole discretion, to prepare, file, prosecute, maintain and extend patent applications
and patents concerning all such Jointly Owned Intellectual Property in Rights in the United States
and any foreign country that Acuity chooses in its sole discretion, for which Acuity and Intradigm
shall equally share the costs relating to such activities. Acuity shall solicit Intradigms advice
and review of the nature and text of any such patent applications in reasonably sufficient time
prior to filing thereof, and Acuity shall take into account Intradigms reasonable comments related
thereto. Intradigm and Acuity shall treat all information disclosed to it under this Section 8.3
as Confidential Information (as herein defined).
(b) If Acuity elects not to file, prosecute or maintain any Jointly Owned Intellectual
Property or any ensuing Patents or claims encompassed by any Jointly Owned Intellectual Property in
the United States or any foreign country, Acuity shall give
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Intradigm notice thereof within a reasonable period prior to allowing such patent applications
or Patents or such claims encompassed by such patent applications or Patents to lapse or become
abandoned or unenforceable, and Intradigm shall thereafter have the right, in the name of Acuity
and Intradigm, to prepare, file, prosecute and maintain patent applications and patents or
divisional applications related to such claims encompassed by such patent applications or patents
concerning all such inventions and discoveries in countries of its choice throughout the world. In
such case, Acuity shall either: (i) continue to share equally in the costs of prosecuting or
maintaining such patent rights or (ii) assign (or grant to Intradigm a perpetual irrevocable
royalty free license, if an assignment can not be made) to Intradigm all of its rights under such
patent or patent application in any country in which Intradigm prosecutes and/or maintains such
patent rights.
8.4. Injunction and/or Failure to Obtain Third Party License. Without limiting any other
remedy that may be available to Acuity under this Agreement, Acuity shall have the right to
terminate this Agreement in its entirety or only as to the affected country, immediately upon
written notice to Intradigm if at any time during the term of this Agreement: (i) a permanent
injunction is issued by a court of competent jurisdiction enjoining Acuitys sale of the Topical
siRNA in a country, or (ii) Acuity ceases the sale of the Topical siRNA in a country as a result of
a failure of either Party to obtain, upon commercially reasonable terms, a license (or immunity
from suit) from a Third Party alleging infringement in such country.
ARTICLE IX
CONFIDENTIALITY
CONFIDENTIALITY
9.1. Confidentiality and Non-Use Obligations. (a) During the Term of this Agreement and for
five (5) years thereafter without regard to the means of termination, neither Acuity nor Intradigm
shall use, for any purpose other than the purposes of this Agreement, reveal or disclose to any
Third Party information and materials disclosed by the other Party (whether prior to or during the
Term of this Agreement), and marked as confidential or for which the receiving Party knows or has
reason to know are or contain trade secrets or other proprietary information of the other Party
(the Confidential Information) without first obtaining the written consent of the other Party.
(b) The Parties shall take all reasonable precautions to prevent the use or disclosure of such
Confidential Information without first obtaining the written consent of the other Party, except (i)
as may be required for securing Regulatory Approval, including pricing approval in the United
States and any foreign country, or as may otherwise be required to be disclosed to an Agency in the
United States and any foreign country; or (ii) as required in connection with any filings made by
the Securities and Exchange Commission or similar non-U.S. regulatory authorities or by the
disclosure policies of a major stock exchange. Each Party agrees that prior to the release or
dissemination of the other Partys Confidential Information to any Affiliate or sublicensee, such
Party shall cause the person to whom such Confidential Information is to be released to be bound by
a confidentiality agreement providing for a level of protection of such Confidential Information at
least equivalent to the terms of this Article X.
(c) These restrictions upon disclosure and use of Confidential Information shall not apply to
any specific portion of Confidential Information which:
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(i) is Confidential Information that can be demonstrated by the written records of the
recipient to have already been in the possession of the recipient free of any restrictions as to
its use or disclosure at the time of disclosure by the other Party;
(ii) is or later becomes available to the public, as evidenced by documents which were
generally published, other than by the fault of the recipient; or
(iii) is received from a Third Party having legitimate possession thereof and the independent
legal right to make such disclosure and such Third Party does not place any restriction as to the
use or disclosure on the recipient.
(d) Any patent applications and information therein filed or to be filed by either Party shall
be deemed (i) to be Confidential Information of that Party subject to the provisions of this
Article IX and (ii) to have been disclosed in confidence to the other Party.
(e) Notwithstanding the foregoing, the recipient may disclose any Confidential Information to
the extent required by an order of any court or other governmental authority having competent
jurisdiction, but only after the other Party is (i) notified in writing and provided with a copy of
such order; and (ii) given an opportunity to prevent such disclosure or obtain reasonable
protection for such Confidential Information. In any such event, the recipient shall cooperate
fully with other Party in connection with obtaining any protective order or other appropriate
remedy to prevent disclosure of Confidential Information.
9.2. Press Releases and Public Announcements. Neither Party to this Agreement shall issue any
press release or other publicity materials, or make any public presentation with respect to the
terms or conditions of this Agreement without the prior written consent of the other Party (such
consent not to be unreasonably withheld or delayed). The restrictions provided in this Section 9.2
shall not apply to disclosures deemed by Acuity in its discretion to be required by law or
regulation, including as may be required in connection with any filings made with the Securities
and Exchange Commission or any similar non-U.S. regulatory authority, or by the disclosure
policies of the Nasdaq Stock Market, Inc.
ARTICLE X
REPRESENTATIONS AND WARRANTIES
REPRESENTATIONS AND WARRANTIES
10.1. Legal and Governmental Compliance. Each Party shall comply with all laws, rules and
regulations applicable to the activities undertaken by such Party hereunder.
10.2. Intradigm Representations and Warranties. Intradigm represents and warrants to Acuity
that the following are true and correct as of the date hereof:
(a) Intradigm is a Delaware corporation duly organized, validly existing, and in good standing
under the laws of Delaware and has full corporate power to own its properties and conduct the
business presently being conducted by it, and is duly qualified to do business in, and is in good
standing under, the laws of all jurisdictions in which its activities or assets require such
status, except in any case where the failure to be so qualified and in good standing would not be
material.
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(b) Intradigm has full corporate right, power and authority to perform its obligations
pursuant to this Agreement, and this Agreement and the transactions contemplated hereby have been
duly and validly authorized by all necessary corporate action on the part of Intradigm. This
Agreement has been duly and validly executed by Intradigm. Upon execution and delivery of this
Agreement, it will be the valid and binding obligation of Intradigm, enforceable in accordance with
its terms, subject to equitable principles and applicable bankruptcy, insolvency, reorganization,
moratorium and similar laws affecting creditors right and remedies generally.
(c) The execution, delivery and performance of this Agreement does not, and the consummation
of the transactions herein contemplated will not violate any law, rule, regulation, order, judgment
or decree binding on Intradigm, or result in a breach of any term of the certificate of
incorporation or by-laws of Intradigm or any contract, agreement or other instrument to which
Intradigm is a party, except in each case to an extent not material.
(d) Intradigm is the sole owner of the entire right, title and interest in and to the
Intradigm Patent Rights and no other Person (including any government) has any license, claim or
other right or interest in or to the Intradigm Patent Rights as of the Effective Date.
(e) To Intradigms actual knowledge, the use of the Intradigm Intellectual Property in the
development, manufacture and sale of the License Products or the Topical siRNA will not infringe,
misappropriate or otherwise conflict with any intellectual property or other rights of any Third
Party as of the Effective Date.
(f) Intradigm is not aware of any infringement of the Intradigm Patent Rights as of the
Effective Date.
(g) There are no judicial, arbitral, regulatory or administrative proceedings or
investigations, claims, actions or suits relating to the Intradigm Patent Rights pending against
or, to Intradigms knowledge, threatened against Intradigm or its Affiliates in any court or by or
before any governmental body or agency in the United States or any foreign country.
10.3. Representations and Warranties of Acuity. Acuity represents and warrants to Intradigm
that the following are true and correct as of the date hereof:
(a) Acuity is a corporation duly organized, validly existing and in good standing under the
laws of the State of Delaware and has full corporate power to own its properties and conduct the
business presently being conducted by it, and is duly qualified to do business in, and is in good
standing under, the laws of all states in which its activities or assets require such status,
except in any case where the failure to be so qualified and in good standing would not be material.
(b) Acuity has full corporate right, power and authority to perform its obligations pursuant
to this Agreement, and this Agreement and the transactions contemplated hereby have been duly and
validly authorized by all necessary corporate action on the part of Acuity. This Agreement has
been duly and validly executed by Acuity. Upon execution and
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delivery of this Agreement, it will be the valid and binding obligation of Acuity enforceable
in accordance with its terms, subject to equitable principles and applicable bankruptcy,
insolvency, reorganization, moratorium and similar laws affecting creditors rights and remedies
generally.
(c) The execution, delivery and performance of this Agreement does not, and the consummation
of the transactions therein contemplated will not violate any law, rule, regulation, order,
judgment or decree binding on Acuity or result in a breach of any term of the certificate of
incorporation or by-laws of Acuity or any contract, agreement or other instrument to which Acuity
is a party, except in each case to an extent not material. No authorization is required by Acuity
for the execution, delivery, or performance of this Agreement by Acuity, except in each case to an
extent not material.
10.4. Limitation on Warranties. Except as expressly provided in this Agreement, neither Party
makes any representation or warranty to the other, whether express or implied, either in fact or by
operation of law, by statute or otherwise, and both Parties specifically disclaim any and all
implied or statutory warranties, including, without limitation, any warranty of merchantability or
warranty of fitness for a particular purpose. In addition, each Party understands and agrees that
neither Party warrants or commits that the Topical siRNA will be successfully developed, be
submitted for applicable Regulatory Approval (except as expressly required under this Agreement),
receive applicable Regulatory Approval or be successfully marketed or commercialized. Without
limiting the indemnity obligations set forth in Article XII for the items described therein,
neither Party shall have liability or responsibility to the other Party for any such failure in the
research and development, Agency approval, manufacturing, marketing or sales efforts, except to the
extent such failure results from the Partys willful misconduct or gross negligence.
ARTICLE XI
INDEMNIFICATION; INSURANCE
INDEMNIFICATION; INSURANCE
11.1. Indemnification.
(a) Acuity Indemnification. Acuity agrees to indemnify and hold forever harmless Intradigm
and its Affiliates and each of their agents, directors, officers and employees from and against any
loss, damage, action, proceeding, expense, liability, physical or emotional injury or death, or
loss of service or consortium, including reasonable attorneys fees (Loss) arising from or in
connection with (i) the research, development, manufacture, use, offer for sale, sale or
importation by Acuity or its Affiliates of Licensed Products or Topical siRNA, except for
any Loss for which Intradigm has agreed to indemnify Acuity pursuant to Section 11.1(b) below; (ii)
the breach or inaccuracy of any representations, warranties or covenants made by Acuity in this
Agreement; and (iii) the gross negligence or willful misconduct of Acuity or its Affiliates or any
of their agents, directors officers or employees.
(b) Intradigm Indemnification. Intradigm agrees to indemnify and hold forever harmless Acuity
and its Affiliates and each of their agents, directors, officers, and employees from and against
any Loss arising from or in connection with: (i) Intradigms or its Affiliates research and
development activities in connection with the Topical siRNA or the activities of any Intradigm
personnel in connection with the research, development, manufacture,
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use, sale, storage or handling of the Topical siRNA, except for any Loss for which
Acuity has agreed to indemnify Intradigm pursuant to Section 11.1(a) above; (ii) the breach or
inaccuracy of any representations, warranties or covenants made by Intradigm in this Agreement,
(iii) the gross negligence or willful misconduct of Intradigm or its Affiliates or any of their
agents, directors, officers or employees; and (iv) the research, development, manufacture, use,
offer for sale, sale or importation of Licensed Products by Intradigm or any of its Affiliates or
any of their distributors, sublicensees or agents.
11.2. Procedure. A Party seeking indemnity hereunder (an Indemnified Party) shall promptly
notify the other Party (the Indemnifying Party) upon being notified or otherwise made aware of a
suit, action or claim; provided that failure to provide such notice shall not affect the obligation
of the Indemnifying Party to indemnify except to the extent that the Indemnifying Party is
materially prejudiced thereby. The Indemnifying Party shall defend and control any proceedings,
and the Indemnified Party shall be permitted to participate at its own expense, unless there shall
be a conflict of interest which would prevent representation by joint counsel, in which event the
Indemnifying Party shall pay for the Indemnified Partys separate counsel pursuant to Section 11.1
above. The Indemnifying Party may not settle the suit or otherwise consent to any judgment in such
suit without the written consent of the Indemnified Party (such consent not to be unreasonably
withheld or delayed). The Parties shall cooperate in the defense of any Third Party claim.
11.3. Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OR EXPENSES, INCLUDING DAMAGES FOR LOST PROFITS, LOSS
OF OPPORTUNITY OR USE OF ANY KIND, SUFFERED BY THE OTHER PARTY, WHETHER IN CONTRACT, TORT OR
OTHERWISE.
11.4. Insurance.
(a) During the term of this Agreement and for a period of five (5) years after its expiration
or earlier termination, each Party shall obtain, at its sole cost and expense, liability insurance
applicable to its performance under this Agreement that meets the following requirements:
(b) the insurance shall insure such Party against all liability related to its activities
relating to the development, manufacture, use or sale of Products (whether such Partys liability
arises from its own conduct or by virtue of its participation in this Agreement), including
liability for bodily injury, property damage, wrongful death, and any contractual indemnity
obligations imposed by this Agreement; and
(c) the insurance shall be in amounts that are reasonable and customary in the United States
in the pharmaceutical industry, but in no event shall liability insurance relating to manufacture,
use, sale or distribution of a marketed Product maintained by such Party cover less than (a) two
million dollars ($2,000,000) per occurrence (or claim) and an annual aggregate of two million
dollars ($2,000,000) during clinical testing of Licensed Products and Topical siRNA and (b) a
commercially reasonable amount after completion of clinical testing. All such policies shall
include a contractual endorsement naming the other Party to this
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Agreement as an additional insured and require the insurance carriers to provide such other
Party with no less than thirty (30) days written notice of any change in the terms or coverage of
the policies or their cancellation.
ARTICLE XII
TERM; TERMINATION
TERM; TERMINATION
12.1. Term. This Agreement shall take effect as of the date hereof and shall continue in
effect for twenty years unless earlier terminated in accordance with the provisions of this Article
XII (such date being referred to as the Termination Date).
12.2. Acuity Product Specific Termination.
(a) Acuity may terminate its obligations under Article IV, Article V, Section 7.1 and Section
7.3, in whole or in part on a country by country basis, if Acuity shall have reasonably determined
to terminate or discontinue the clinical testing, regulatory approval or commercialization of the
Topical siRNA.
(b) Upon such termination, the Parties rights and obligations under this Agreement (exclusive
of the confidentiality obligations of Article IX and indemnity obligations of Article XI hereof,
each of which shall survive the termination) shall terminate as to the countries so terminated and
be of no further force or effect as to the countries so terminated.
12.3. Notification of Termination by Acuity. Acuity shall exercise its right of termination
by the provision of written notice to Intradigm within sixty (60) days of the occurrence of any of
the events set forth in Section 12.2, such notice to contain the details supporting such
termination.
12.4. Termination of Agreement by the Parties. This Agreement may be terminated:
(a) By mutual written consent of each of Intradigm and Acuity; or
(b) Upon written notice by a Party if (i) the other Party shall have been dissolved, ceased
active business operations or liquidated, unless such dissolution, cessation or liquidation results
from reorganization, acquisition, merger or similar event, or (ii) bankruptcy or insolvency
proceedings, including any proceeding under Title 11 of the U.S. Code, have been brought by or
against the other Party and, in the event such a proceeding has been brought against the other
Party, remains undismissed for a period of sixty (60) days, or an assignment has been made for the
benefit of such Partys creditors or a receiver of such Partys assets has been appointed (a
Bankruptcy Event); or
(c) By either Acuity or Intradigm, upon ninety (90) days prior written notice, if the other
Party is in material default, and fails to cure such breach within ninety (90) days following
receipt of written notice from the non-breaching Party specifying the breach to be cured.
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12.5. Consequences of Termination.
(a) Upon termination of this Agreement in whole each Party shall return to the other all
relevant records and materials in its possession or control containing confidential information of
the other Party.
(b) At the time of any termination of this Agreement under Section 12.4 other than termination
by Intradigm under 12.4(c), if the Topical siRNA has been Launched in the affected country prior to
such termination, then Acuity shall have the option to maintain in effect the license granted
hereunder respecting the Topical siRNA, subject to Acuitys obligation to pay royalties under
Section 7.3 above.
12.6. Surviving Rights. Termination of this Agreement for any reason shall be without
prejudice to:
(a) The rights and obligations of the parties provided in Section 2.1, Articles IX and XI
hereof, and the representations and warranties provided in Article X, all of which shall survive
such termination;
(b) Any other rights, obligations or liabilities which shall have accrued to the benefit of
either Party prior to such termination (including without limitation Acuitys obligation to pay all
milestone and royalty payments which shall have accrued hereunder up to and including the effective
date of such termination), all of which shall survive such termination; and
(c) Any other rights of remedies provided at law or in equity which either party may otherwise
have against the other.
ARTICLE XIII
MISCELLANEOUS
MISCELLANEOUS
13.1. Force Majeure. Neither Party shall lose any rights hereunder or be liable to the other
Party for damages or loss on account of failure of performance by the defaulting Party if the
failure is occasioned by government action, war, fire, explosion, flood, strike, lockout, embargo,
act of God, or any other similar cause beyond the reasonable control of the defaulting Party,
provided that the Party claiming force majeure has exerted all reasonable efforts to avoid or
remedy such force majeure and given prompt notice to the other Party.
13.2. Notices. All notices, requests, consents, and other communications under this Agreement
shall be in writing and shall be delivered by hand, sent via overnight courier, sent by facsimile,
or mailed by first class certified or registered mail, return receipt requested, postage prepaid:
If to Acuity: to | With a copy to: | |||||||||
Acuity Pharmaceuticals, Inc. | Pepper Hamilton LLP | |||||||||
3701 Market Street | 3000 Two Logan Square | |||||||||
Philadelphia, PA, 19104 | Philadelphia, PA 19103 | |||||||||
Attn: Dale R. Pfost, Ph.D. | Attn: Ilan Katz |
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If to Intradigm: to | ||||||||||
Intradigm Corporation | ||||||||||
12115 Parklawn Drive, Suite K | ||||||||||
Rockville, MD 20852 | ||||||||||
Attn: John A. Spears, Ph.D. |
or to such other person or entity or at such other address as any party shall designate by notice
to the other in accordance herewith.
Notices provided in accordance with this Section 13.2 shall be deemed delivered (i) upon
personal delivery with signature required, (ii) one Business Day after they have been sent to the
recipient by reputable overnight courier service (charges prepaid and signature required) (iii)
upon confirmation, answer back received, of successful transmission of a facsimile message
containing such notice if sent between 9:00 a.m. and 5:00 p.m., local time of the recipient, on any
Business Day, and as of 9:00 a.m. local time of the recipient on the next Business Day if sent at
any other time, or (iv) three Business Days after deposit in the mail. The term Business Day as
used in this Section 13.2 shall mean any day other than Saturday, Sunday or a day on which banking
institutions are not required to be open in the State of New Jersey.
13.3. Governing Law; Dispute Resolution.
(a) This Agreement shall be governed by the laws of the State of Delaware, as such laws are
applied to contracts entered into and to be performed within such state, as though made and to be
fully performed therein without regard to conflicts of law principles thereof. The Parties agree
to submit to the personal jurisdiction in any Federal or State court of competent jurisdiction
seated in the State of Delaware, and waive any objection as to venue or inconvenience of forum.
(b) The Parties shall initially attempt in good faith to resolve any significant controversy,
claim, allegation of a Default or dispute arising out of or relating to this Agreement (hereinafter
collectively referred to as a Dispute) through negotiations between senior executives of Acuity
and Intradigm. If the Dispute is not resolved within thirty (30) days (or such other period of
time mutually agreed upon by the Parties) of notice of the Dispute, then the Parties agree to
submit the Dispute to non-binding mediation on terms and procedures to be mutually agreed to for a
period of ninety (90) days. Any mediation proceedings shall be treated as settlement discussions
and therefore shall be confidential, and no mediator may testify for either Party in any later
proceeding relating to the dispute. No recording or transcript shall be made of the mediation
proceedings. Each Party shall bear its own costs and expenses of mediation, and the Parties shall
share equally the fees and expenses of the mediator.
(c) If the Dispute is not resolved through negotiations or mediation as set forth above, then
either Party may commence litigation; provided, that this Section 13.3 shall not be construed to
prevent a Party from seeking injunctive relief without observing the requirements of Section
13.3(b).
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13.4. Non-waiver of Rights. Except as specifically provided for herein, the waiver from time
to time by any of the Parties of any of their rights or their failure to exercise any remedy shall
not operate or be construed as a continuing waiver of same or of any other of such Partys rights
or remedies provided in this Agreement.
13.5. No Agency. Neither Party shall by virtue of this Agreement have any power to bind the
other to any obligation nor shall this Agreement create any relationship of agency, partnership or
joint venture.
13.6. Severability. If any term, covenant, or condition of this Agreement or the application
thereof to any Party or circumstance shall, to any extent, be held to be invalid or unenforceable,
then (i) subject to clause (ii) of this Section 13.6 the remainder of this Agreement, or the
application of such term, covenant or condition other than those as to which it is held invalid or
unenforceable, shall not be affected thereby and each term, covenant, or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law and (ii) the
Parties hereto covenant and agree to renegotiate any such term, covenant, or application thereof in
good faith in order to provide a reasonably acceptable alternative to the term, covenant, or
condition of this Agreement or the application thereof that is invalid or unenforceable.
13.7. Entire Agreement. This Agreement, including the exhibits and schedules hereto as in
effect from time to time pursuant to the terms hereof, sets forth all the covenants, promises,
agreements, warranties, representations, conditions, and understandings between the Parties hereto
in the scope of the collaboration, and supersedes and terminates all prior agreements and
understanding between the parties under this Agreement. No subsequent alteration, amendment,
change, or addition to this Agreement shall be binding upon the Parties hereto unless reduced to
writing and signed by the respective authorized officers of the Parties.
13.8. Assignment. No Party shall, without the prior written consent (not to be unreasonably
withheld or delayed) of the other Party having been obtained, assign or transfer this Agreement to
any Third Party, provided, however, that any Party may assign or transfer this Agreement to any
Affiliate, provided that the assigning Party shall guarantee the performance of that Affiliate, or
to any successor by merger of such Party, or to the Purchaser of all or substantially all of such
assets of its business, without the prior written consent of the other Party hereto. This
Agreement shall be binding upon and shall inure to the benefit of the Parties and their successors
and permitted assigns.
13.9. Facsimile Execution. This Agreement may be executed in facsimile counterparts each of
which is hereby agreed to have the legal binding effect of an original signature. The Parties
hereto agree to forward the original signatures by overnight mail to the other Party upon
execution.
13.10. License Survival During Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement to the Intradigm Intellectual Property are, and shall otherwise be deemed to be,
for purposes of Paragraph 365(n) of the U.S. Bankruptcy Code, licenses of rights to Intellectual
Property as defined under Paragraph 101(35A) of the U.S. Bankruptcy Code. The parties agree that
Acuity, as a licensee of such rights under this Agreement, shall retain and may fully exercise all
of its rights and elections under the U.S.
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Bankruptcy Code, subject to performance by Acuity of its obligations under this Agreement.
The parties further agree that, in the event Intradigm elects to terminate this Agreement because
of a Bankruptcy Event and Acuity elects to continue the licenses under this Agreement as
contemplated by the preceding sentence, then Acuity shall be entitled, upon reasonable request, to
have access, in confidence, to such of Intradigm Intellectual Property not already in Acuitys
possession, as shall be reasonably necessary to make use of the license rights under this Agreement
without participation by Intradigm.
****
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the day and year first indicated above.
ACUITY PHARMACEUTICALS, INC. | ||||||
By: | /s/ Dale R. Pfost
|
|||||
Name: Dale R. Pfost | ||||||
Title: President and Chief Executive Officer | ||||||
INTRADIGM CORPORATION | ||||||
By: | /s/ John A. Spears
|
|||||
Name: John A. Spears | ||||||
Title: Chairman and Chief Executive Officer |
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