EXECUTION VERSION

 

Exhibit 10.30

 

 

DATED DECEMBER 7, 2010 

 

 

 

     

 

iCo THERAPEUTICS INCORPORATED

 

and 

 

IMMUNE PHARMACEUTICALS LTD. 

 

 

 

     

PRODUCT SUBLICENSE AGREEMENT 

 

 

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
 

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CONTENTS

Section

Heading

Page

1.

Definitions

1

2.

License and Sublicense Grants

10

3.

Technology Transfer

11

4.

Product Development; Regulatory and Safety

13

5.

Commercialization and Marketing

17

6.

Non-Competition

18

7.

Payments

19

8.

Provisions Relating to Payment of Consideration

22

9.

Intellectual Property and Patent Rights

24

10.

Confidentiality

28

11.

Press Release and Publication

30

12.

Trade Marks

31

13.

[***] Agreement and [***]

31

14.

Representations, Warranties, Covenants and Indemnification

31

15.

Term and Termination

34

16.

Effect of Termination of Agreement

35

17.

Miscellaneous

37

18.

Assignment

37

19.

Waiver

38

20.

Severability

38

21.

Force Majeure

38

22.

Counterparts

39

23.

Entire Agreement; Amendment

39

24.

Independent Contractors and Relationship of the Parties

39

25.

Expenses

40

26.

Further Assurances

40

27.

Headings and Construction

40

28.

No Third Party Beneficiaries

40

29.

Use of Affiliates or Sublicensees

40

Redacted [***] Agreement

47

[***] NOTICE

48

iCo-008 Study Reports and Protocols

49

Press Release

50

Notices

51

  

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
i 

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PRODUCT SUBLICENSE AGREEMENT

 

THIS PRODUCT SUBLICENSE AGREEMENT is made and entered into on December 7, 2010
(the “Execution Date”) by and between iCo Therapeutics Incorporated, a
corporation organized and existing under the laws of Canada with a place of
business at Suite 760, 777 Hornby Street, Vancouver, BC, Canada, V6Z 1S4
(“iCo”), and Immune Pharmaceuticals Ltd.,, a corporation organized and existing
under the laws of the State of Israel with a place of business for the purpose
of this agreement at 1120 Avenue of the Americas, 7th Floor, New York, NY
(“IMPH”). iCo and IMPH each may be referred to herein individually as a “Party”
or, collectively, as the “Parties”.

 

BACKGROUND

 

A.     iCo owns or controls know-how and other intellectual property rights and
expertise relating to its antibody product referred to as iCo-008 (as defined
below) and is a party to that certain License Agreement with Cambridge Antibody
Technologies dated as of December 20, 2006 (the “CAT Agreement”), under which
iCo has certain exclusive license rights to intellectual property relating to
the iCo-008 product.

 

B.     iCo-008 has demonstrated potential as an anti-eotaxin-1 (as defined
below) human antibody, which may be for the treatment of allergic and
inflammatory and other diseases and conditions.

 

C.     IMPH is an emerging biopharmaceutical company interested in entering into
this sublicense agreement with iCo under which iCo will grant to IMPH the
exclusive rights to develop and commercialize pharmaceutical preparations
containing or comprising iCo-008 for all human uses other than ocular uses
(which uses are expressly reserved exclusively to iCo).

 

Now, Therefore, in consideration of the premises and mutual covenants herein
contained, and for other good and valuable consideration, the receipt and
sufficiency of which are acknowledged, the Parties agree as follows:

 

1.

DEFINITIONS

 

The following capitalized terms shall have the following meanings as used in
this Agreement:

 

“Accounting Standards” shall mean, with respect to IMPH, that IMPH shall
maintain records and books of accounts in accordance with the U.S. generally
accepted accounting policy and practice consistently applied.

 

“Adverse Event” means any untoward medical occurrence in a human patient or
subject who is administered a product, whether or not considered related to the
Product, including, without limitation, any undesirable sign (including abnormal
laboratory findings of clinical concern), symptom or disease associated with the
use of such product, or as otherwise agreed between the Parties in writing in
the Safety Agreement.

  

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
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“Affiliate” shall mean any Person that directly or indirectly controls, or is
controlled by, or is under common control with, a Party to this Agreement. For
the purposes of this definition, “control” (with correlative meanings for the
terms “controlled by” and “under common control with”) means (a) ownership,
directly or through one or more intermediaries, of fifty percent (50%) or more
of the shares of stock entitled to vote for the election of directors of the
applicable entity, in the case of a corporation, or fifty percent (50%) or more
of the equity and governing interest in the case of any other type of legal
entity, or (b) any other arrangement (contractual or otherwise) whereby a Party
has the actual ability to direct and control the management and policies of the
applicable entity. The Parties acknowledge that in the case of certain entities
organized under the laws of certain countries, the maximum percentage ownership
permitted by law for a foreign investor may be less than fifty percent (50%),
and that in such case such lower percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
the management and policies of such entity.

 

“Agreement” shall mean this Product Sublicense Agreement and any and all
Schedules, appendices and other addenda to this agreement, and as this agreement
may be amended by the Parties from time to time in accordance with its
provisions.

 

“Antibody” shall mean a molecule, or a gene encoding such a molecule, comprising
or containing more than one immunoglobulin variable domain or parts of such
domains or any existing or future fragments, variants, modifications or
derivatives thereof and shall expressly exclude any single domain antibody.

 

“Applicable Law” shall mean any applicable laws, rules and regulations,
including any rules, regulations, guidelines or other requirements of relevant
government agencies, that may be in effect from time to time in the applicable
country in the Territory.

 

“Calendar Year” shall mean each successive period of twelve (12) calendar months
commencing on 1st January.

 

“Catalytic Antibody” means an Antibody that binds to and catalyses the chemical
transformation of a substrate and in which an Antibody binding region is
involved in said catalysis.

 

“CAT” means Cambridge Antibody Technologies, or its successor entity MedImmune
(as applicable).

 

“Change of Control” shall mean, with respect to IMPH, an event after the
Effective Date in which (i) any other legal entity or group of legal entities
acquires beneficial ownership of securities of IMPH representing more than fifty
percent (50%) of the voting power of the then outstanding voting securities of
IMPH with respect to the election of directors of IMPH; or (ii) IMPH enters into
a merger, consolidation (including the sale of all or substantially all of its
assets) or similar transaction with another legal entity.

 

“Commercialize” or “Commercialization” shall mean all activities directed to
marketing, promoting, distributing, importing, exporting, offering for sale
and/or selling a Licensed Product for use in the Licensed Field.

  

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
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“Commercialization Plan” has the meaning set out in Section 5.1.

 

“Competent Authority” shall mean any national or local agency, authority,
department, inspectorate, minister, ministry official, parliament or public or
statutory person (whether autonomous or not) of any government of any country
having jurisdiction over either any of the activities contemplated by this
Agreement or the Parties (including responsibility for granting health or
pricing approvals, registrations, import permits or other approvals required
before iCo-008 or a Licensed Product may be tested or marketed) including the
European Commission, the Court of First Instance and the European Court of
Justice, the FDA and the EMEA.

 

“Control,” “Controls,” “Controlled” or “Controlling” shall mean, with respect to
an item of know-how, material, or intellectual property right, that the
applicable Party owns or has a license to such know-how, material, or
intellectual property right and has the ability to grant the licenses or
sublicenses thereunder as provided in this Agreement without violating the terms
of any agreement with any Third Party.

 

“Develop” or “Development” shall mean activities relating to clinical drug
development, including test method development and stability testing, assay
development and audit development, toxicology, formulation, quality
assurance/quality control development, statistical analysis, clinical studies,
process development and scale-up, packaging development, regulatory affairs,
product approval and registration.

 

“Development Plan” shall mean the actual written plan prepared by IMPH that
covers the Development of Licensed Product for use in the Licensed Field, as
such plan may be amended, supplemented or updated from time to time by IMPH.
Such plan shall include, at the appropriate times, an assessment of (i) the
proposed clinical trials, regulatory plans, clinical trial and commercial supply
requirements (ii) process development and manufacturing plans with respect to
the Licensed Product, (iii) an estimated development timetable through to
Marketing Approval, (iv) the identity of the initial development team to be
responsible for implementing such plan, and (v) a preliminary commercialisation
plan for marketing iCo-008 in the Territory. An initial summary Development Plan
has been provided to iCo by IMPH as of the Effective Date, a copy of which is
attached as Schedule 4.

 

“Disclosing Party” shall mean a Party that discloses specific Information to the
other Party.

 

“[***] Agreements” shall mean (i) that certain license agreement [***] made
between [***] and CAT relating to [***].

 

[***]

 

“Effective Date” shall mean the date on which IMPH pays to iCo the License Fee
under Section 7.1 of this Agreement, as provided in Section 7.1.

 

“EMEA” shall mean the European Medicines Agency.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
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“Execution Date” shall mean the date on which IMPH and iCo execute this
Agreement, as set forth in the preamble on the first page hereof.

 

“Equity Position”has the meaning set out in Section 7.1.

 

“FDA” shall mean the U.S. Food and Drug Administration and any successor entity
thereto.

 

“First Commercial Sale” shall mean, with respect to any country in the
Territory, the first sale for monetary value for use or consumption by the
general public of a Licensed Product in such country after Marketing Approval
for such Licensed Product has been obtained in such country.

 

“Force Majeure” shall mean any event outside the reasonable control of the
applicable Party affecting its ability to perform any of its obligations (other
than payment) under this Agreement, including an Act of God, fire, flood,
lightning, war, revolution, act of terrorism, riot or civil commotion, but
excluding strikes, lock-outs or other industrial action, whether of the affected
Party’s own employees or others.

 

“GI Indication” means any Indication comprising or involving a gastrointestinal
disease or condition.

 

“iCo-008” shall mean the human monoclonal antibody having the sequence set forth
in Schedule 1 of this Agreement, which is known as “bertilimumab” or “CAT-213”
and targets eotaxin-1.

 

“iCo Background Know How” shall mean any Information that is Controlled by iCo
at the Effective Date and is required for the development, manufacture, use or
sale of iCo-008 and/or Licensed Product for use in the Licensed Field, excluding
the iCo Product Know How. Notwithstanding anything herein to the contrary, iCo
Background Know-How excludes iCo Patents.

 

“iCo Background IP” shall mean the iCo Background Patents together with any
applicable Sublicensed Rights and any iCo Background Know How.

 

“iCo Background Patents” shall mean all the Patents within the Patent families
listed in Schedule 2 to the extent Controlled by iCo, but excluding (for
clarity) any claims, in any such Patents, that claim Catalytic Antibodies.

 

“iCo IP” shall mean iCo Background IP and iCo Product IP.

 

“iCo Patents” shall mean the iCo Background Patents and the iCo Product Patents.

 

“iCo Product IP” shall mean the iCo Product Patents and any iCo Product Know
How.

 

“iCo Product Know How” shall mean any Information that (a) is Controlled by iCo
at the date of the Agreement or at any time during the Term, and (b) relates
specifically to iCo-008, including the Phase 1 and Phase II data and
notwithstanding anything herein to the contrary, excludes all iCo Patents.

 

  

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
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“iCo Product Patents” shall mean the Patents and Patent applications listed in
Schedule 3 and any Patents issuing from such Patent applications.

 

“IMPH IP” shall mean IMPH Product Improvements, IMPH Patents and IMPH Know How.

 

“IMPH Know How” shall mean all Information that: (i) is Controlled by IMPH or
its Affiliates as of the Effective Date or at any time during the Term of this
Agreement, and (ii) relates to iCo-008 or any Licensed Product (including the
research, development, manufacture, use or commercialization thereof).

 

“IMPH Patents” shall mean all Patents (other than the iCo Patents) that: (i) 
are Controlled by IMPH or its Affiliates as of the Effective Date or at any time
during the Term of this Agreement, and (ii) claim or cover iCo-008 or any
Licensed Product or the manufacture or use thereof.

 

“IMPH Product Improvements” has the meaning set out in Section 9.5.

 

“IND” shall mean an investigational new drug application filed with the FDA as
more fully defined in 21 C.F.R. § 312.3, or its equivalent in any country.

 

“Indication” shall mean, with respect to a Licensed Product, the treatment or
prevention of a particular pathology or group of related pathologies.

 

“Information” shall mean information and materials relating to the subject
matter of this Agreement, including (i) techniques and data, including screens,
models, inventions, methods, test data (including biological, chemical,
pharmacological, biochemical, pharmaceutical, toxicological, safety, preclinical
and clinical test data), physical and analytical and quality control data,
marketing, pricing, distribution, costs, sales data, manufacturing information,
and patent and legal data or descriptions (to the extent that disclosure thereof
would not result in loss or waiver of privilege or similar protection),
(ii) discoveries, trade secrets, specifications, instructions, improvements,
processes, formulae, expertise and other technology, (iii) compositions of
matter, including but not limited to compounds, biological materials and assays
(iv) regulatory filings, including any IND or MAA and (v) other financial and
business information.  As used herein, “clinical test data” shall be deemed to
include all information related to the clinical or preclinical testing of
iCo-008 or Licensed Product, including patient report forms, investigators’
reports, biostatistical, pharmaco-economic and other related analyses, and the
like.

 

“Insolvency Event” means in relation to either Party that the Party:

 

(a)     is dissolved (other than pursuant to a consolidation, amalgamation or
merger);

 

(b)     becomes insolvent (that is, fails generally to pay its debts as they
become due and debts then due substantially exceed liquid assets) and as a
result is unable to continue to perform its material obligations under the
Agreement;

 

(c)     makes a general assignment, arrangement or composition with or for the
benefit of its creditors;

 

  

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
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(d)     has a resolution passed for its winding-up, official management or
liquidation (other than pursuant to a consolidation, amalgamation or merger);

 

(e)     seeks or becomes subject to the appointment of an administrator,
provisional liquidator, conservator, receiver, trustee, custodian or other
similar official for it or for all or substantially all its assets and such
appointment is not dismissed within 30 days;

 

(f)     has a secured party take possession of all or substantially all its
assets or has a distress, execution, attachment, sequestration or other legal
process levied, enforced or sued on or against all or substantially all its
assets and that secured party maintains possession, or that process is not
withdrawn, dismissed, discharged, stayed or restrained, in each case within 30
days of that event; and

 

(h)     causes or is subject to any event with respect to it which, under the
applicable laws of any jurisdiction, has an analogous effect to any of the
events specified in (a) to (f) above (inclusive).

 

“Joint Development Committee” or “JDC” means a committee comprised of
representatives of iCo and IMPH as contemplated by Sections 4.2 and 4.3.

 

“License Fee” has the meaning set out in Section 7.1.

 

“Licensed Field” shall mean use for the treatment or prevention of disease,
infection or other conditions in humans, but expressly excluding any and all
uses in the Ocular Field and all Research Products.

 

“Licensed Product” shall mean any preparation for the use in the Licensed Field
that incorporates iCo-008 (including any preparation formulated and intended for
use in a clinical trial), but excluding, for clarity, any preparation intended
for use in, or primarily useful in, the Ocular Field.

 

“License Shares” has the meaning set out in Section 7.1.

 

“Lonza” shall mean Lonza Biologics plc, 228 Bath Road, Slough, Berkshire, SL1
4DY, England.

 

“Marketing Approval” shall mean all approvals, licenses, registrations or
authorisations of any Competent Authority, including pricing and reimbursement
approvals, necessary for the manufacturing, use, storage, import, transport,
marketing, promotion and/or sale of a Licensed Product in the Field in a
regulatory jurisdiction.

 

“Marketing Approval Application” or “MAA” shall mean an NDA or BLA in the U.S.,
or a comparable filing for Marketing Approval in any other country or group of
countries in the Territory, in each case with respect to a Licensed Product.

 

“Master Cell Bank” shall mean [***].

 

“MRC” shall mean the Medical Research Council.

 

“NDA” shall mean a New Drug Application filed with the FDA, as more fully
defined in 21 C.F.R. § 314.50 et. seq.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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“Net Sales” means, with respect to a Licensed Product sold by IMPH or its
Affiliate or any Sub-sublicensee to a Third Party purchaser, the price invoiced
by the selling party to the purchaser (or in the case of a sale or other
disposal otherwise than at arm’s length, the price that would have been invoiced
to the purchaser in a bona fide arm’s length contract or sale), less the
following applicable deductions to the extent actually allowed or incurred with
respect to such sale: the costs of packing, transport and insurance (to the
extent separately set forth and charged on the invoice), customs duties, any
credits actually given for returned or defective Licensed Products, normal trade
discounts (off of the invoiced price) actually given, and sales taxes, VAT or
other similar tax charged on and included in the invoice price to the purchaser
(but solely to the extent not otherwise reimbursed to selling party).

 

Sales from IMPH to its Affiliates shall be disregarded for purposes of
calculating Net Sales. Any of the items set forth above that would otherwise be
deducted from the invoice price in the calculation of Net Sales but which are
separately charged to Third Parties (i.e., are not invoiced as part of the
License Product purchase invoice) shall not be deducted from the Licensed
Product invoice price in the calculation of Net Sales.

 

(a)     In the case of any sale or other disposal of a Licensed Product between
or among IMPH and its Affiliates, for resale, Net Sales shall be calculated as
above only on the value charged or invoiced on the first arm’s-length sale
thereafter to a Third Party;

 

(b)     In the case of any sale which is not invoiced or is delivered before
invoice, Net Sales shall be calculated at the time of shipment or when the
Licensed Product is paid for, if paid for before shipment or invoice; and

 

(c)     In the case of any sale or other disposal for value, such as barter or
counter-trade, of any Licensed Product, or part thereof, other than in an arm’s
length transaction exclusively for money, Net Sales shall be calculated as above
on the value of the non-cash consideration received or the fair market price (if
higher) of the Licensed Product in the country of sale or disposal.

 

“Ocular Field” shall mean any use for the prevention, treatment or palliation of
any or all ocular indications, disease or conditions, including wet age-related
macular degeneration, vernal keratoconjunctivitis, and atopic
keratoconjunctivitis, by local administration to the eye including intravitreal,
retrobulbar, periocular, topical, subconjunctival routes of administration.

 

“Ocular Product” shall mean any preparation that incorporates iCo-008 (including
any preparation formulated and used in a clinical trial) intended for use in the
Ocular Field.

 

“Option Fee” has the meaning set out in Section 7.1.

 

“Order” shall have the meaning set out in Section 5.6.

 

“Patents” shall mean any and all patent applications and patents, author
certificates, inventor certificates, utility certificates, improvement patents
and models and certificates of addition and all foreign counterparts of them,
including any divisional applications and patents, refilings, renewals,
continuations, continuations-in-part, patents of addition, extensions, reissues,
substitutions, confirmations, registrations, revalidation and additions of or to
any of them, as well as any supplementary protection certificates and equivalent
protection rights in respect of any of them.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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“Person” shall mean any individual, partnership, limited liability company,
firm, corporation, association, trust, unincorporated organization or other
entity.

 

“Phase I,” “Phase II” and “Phase III” (each a “Phase”) shall have the following
meanings:

 

(a)     “Phase I” shall mean a study in humans which provides for the first
introduction into humans of a product, conducted in normal volunteers or
patients to get information on product safety, tolerability, pharmacological
activity or pharmacokinetics, as more fully defined in Federal Regulation 21
C.F.R. § 312.21(a);

 

(b)     “Phase II” shall mean a study in humans of the safety, dose ranging and
efficacy of a product, which is prospectively designed to generate sufficient
data (if successful) to commence Phase III clinical trials, as further defined
in Federal Regulation 21 C.F.R. § 312.21(b);

 

(c)     “Phase III” shall mean a controlled and lawful study in humans of the
efficacy and safety of a product, which is prospectively designed to demonstrate
statistically whether such product is effective and safe for use in a particular
indication in a manner sufficient to file an NDA to obtain regulatory approval
to market the product, as further defined in Federal Regulation 21 C.F.R. §
312.21(c).

 

“Product” shall mean Licensed Product and/or Ocular Product, as applicable.

 

“Qualified Financing” shall mean the financing of IMPH following its
incorporation in which outside investors invest: (i) at [***] (or greater) in
the aggregate in purchasing equity securities of IMPH, provided that such
financing is completed prior to January 30, 2011; or (ii) at least [***] (or
greater) in the aggregate in purchasing equity securities of IMPH, provided that
such financing is completed prior to March 31, 2011 . The Qualified Financing
could be in one or more transactions, provided that if the applicable financing
includes a series of transactions, the reference to Qualified Financing shall
mean the last investment transaction that causes such series of transactions to
meet the above definition of Qualified Financing.

 

“Quarter” shall mean each successive period of three (3) calendar months
commencing on 1st January, 1st April, 1st July and 1st October and the term
“Quarterly” shall be construed accordingly.

 

“Reasonable Endeavors” shall mean, with respect to the efforts to be expended by
Sublicensee to achieve any stated objective, the good faith, reasonable,
diligent efforts to accomplish such objective which shall be at least equivalent
to the efforts that a biotechnology company with similar resources would
normally use to accomplish such objective under similar circumstances for other
products at a similar stage in development or product life and of similar market
potential as Licensed Product.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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“Recipient Party” shall mean a Party that receives Information from the other
Party.

 

“Research” shall mean the scientific, technical and pre-clinical activities
undertaken to evaluate an Antibody for development.

 

“Research Product” shall mean solutions, materials or other products intended
for commercial sale to Third Parties for research use in which the work being
performed with such solutions, materials or other products does not involve the
development of any product offered or intended for offer for commercial sale and
where such commercial product contains iCo-008 or iCo-008-derived molecules or
involves the use of iCo-008 at any stage in its production.

 

“Safety Agreement” has the meaning set out in Section 4.10(e).

 

“Serious Adverse Event” means any Adverse Event occurring at any dose that: (a)
results in death or threatens life; (b) results in persistent or significant
disability/incapacity; (c) results in or prolongs hospitalization; (d) results
in a congenital anomaly or birth defect; or (e) is otherwise medically
significant; or as otherwise agreed between the Parties in writing in the Safety
Agreement.

 

“Sub-sublicensee” shall mean any Affiliate of IMPH or Third Party to which IMPH
grants a sublicense under the license (or sublicense, as applicable) rights
granted to IMPH under Section 2.1 of this Agreement.

 

“Sublicensed Rights” shall mean the [***] Patent Rights and the [***] Rights to
the extent and on the terms that iCo is able to sublicense such rights to IMPH.

 

“Sublicense Revenue” the total gross proceeds, whether consisting of cash or any
other forms of consideration, that are received by or payable from any
Sub-sublicensee to IMPH or its Affiliate in consideration of the grant of a
sublicense under the license rights granted by iCo under the Agreement (such as
upfront license fee, milestone payments and other similar licensing fees), but
excluding: (a) royalties calculated on the sales or other commercial disposition
of Licensed Products by any Sublicensee; and (b) any amounts invested by IMPH
after the Effective Date directly relating to Licensed Product as demonstrated
by Licensee’s written records and in accordance with GAAP. For the avoidance of
doubt, any gross proceeds meeting the definition set forth above in this
Paragraph 1.33, shall be “Sublicense Revenue” irrespective of whether such gross
proceeds are received under one or more separate agreements and irrespective of
how such gross proceeds are referred to or characterized in the sublicense.

 

“Term” shall have the meaning set out in Section 15.1

 

“Territory” shall mean the entire world.

 

“Third Party” shall mean any entity other than iCo or IMPH, excepting Affiliates
of either IMPH or iCo.

 

“United States” or “U.S.” shall mean the United States of America, its
territories and possessions, including the Commonwealth of Puerto Rico.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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“Valid Claim” shall mean, with respect to a Licensed Product in a particular
country, any claim of an iCo Patent: (a) that specifically and/or generically
claims or covers a Licensed Product, and (b) that (i) has not expired, (ii) has
not been held permanently revoked, unenforceable or invalid by a decision of a
court or other governmental Competent Authority of competent jurisdiction, which
decision is not further unappealable, and (iii) has not been abandoned,
disclaimed, denied or admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise.

 

“[***] Agreement” shall mean the License Agreement dated [***] and made by and
between [***] and CAT, a redacted version of which is set out in Schedule 6.

 

“[***] Notice” shall mean the notice set out in Schedule 2.4 of the [***]
Agreement and which is attached hereto in Schedule 7.

 

“[***] Patent Rights” shall have the meaning set out in the [***] Agreement.

 

“[***] Rights” shall mean those rights and obligations set out in the [***]
Notice and [***] Agreement.

 

2.

LICENSE AND SUBLICENSE GRANTS  

 

2.1     Subject to the terms and conditions of this Agreement, and effective
solely upon the Effective Date, iCo grants to IMPH:

 

(a)     The exclusive (even as to iCo) royalty-bearing license or sublicense (as
applicable) under the iCo Product IP in the Territory to use and practice such
iCo Product IP solely to make, have made, use, sell, offer for sale, import,
export, develop, register, and distribute Licensed Products solely for use in
the Licensed Field; and

 

(b)     a non-exclusive royalty-bearing license or sublicense (as applicable)
under the iCo Background IP solely to make, have made, use, sell, offer for
sale, import, export, develop, register, and distribute Licensed Products solely
for use in the Licensed Field.

 

2.2     iCo retains exclusively all rights in the iCo Product IP for all uses
and applications in the Ocular Field. Further, iCo retains a fully sublicensable
right to use the iCo Product IP in the Territory for research purposes, and IMPH
acknowledges that CAT retains certain rights for research purposes under
applicable iCo Product IP owned or controlled by CAT. The licenses granted to
IMPH are limited to the rights expressly granted in Section 2.1, and IMPH
covenants that it and its Affiliates and Sub-sublicensees shall not use or
practice any iCo Product IP or iCo Background IP for any use or purpose or in
any manner except as expressly permitted in the license grants under Section
2.1.

 

2.3     IMPH acknowledges that certain of the iCo Product IP and iCo Background
IP is licensed to iCo pursuant to the CAT Agreement and that the sublicense
rights granted by iCo to IMPH under such rights pursuant to the terms of this
Agreement are subject to all applicable terms and obligations of the CAT
Agreement. IMPH covenants and agrees that it and its Affiliates and Sub-IMPH
shall fully comply with all the terms and conditions of the CAT Agreement in
exercising such sublicense rights. In the event that the CAT Agreement is
amended at any time in the future, iCo shall inform IMPH in advance of any
amendment that likely will materially adversely affect IMPH’s rights hereunder
and shall use good faith efforts to minimize or avoid any such adverse affect
due to such amendment. In addition, iCo shall use its reasonable best efforts to
provide IMPH the right to enter into a license agreement with CAT under the
terms of the CAT Agreement, to the extent the CAT Agreement is terminated by CAT
under circumstances that do not attribute fault to IMPH. All licenses granted
pursuant to Section 2.1 shall be non-transferable, except in connection with an
assignment of the Agreement as permitted in Section 17.4.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
10

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2.4     The licenses (and sublicenses, as applicable) granted in Section 2.1 are
sub-licensable solely in conjunction with iCo-008 or a Licensed Product in the
Licensed Field, and any sublicenses of the Sublicensed Rights must be in
accordance with the rights and obligations under the relevant Sublicensed Rights
and the terms of this Agreement. Further, IMPH may grant only one such
sub-sublicense in respect of any particular country, and such granted rights
shall not be further sublicensable in such country. Each such sub-sublicense
must be granted in accordance with and subject to all the terms of this
Agreement.

 

2.5     IMPH will inform iCo in writing of the identity of all Sub-sublicensees
to which it grants a sublicense within thirty (30) days of granting a sublicense
and will ensure that any Sub-sublicensee (including an Affiliate of IMPH) to
which it grants a sublicense executes a written sublicense agreement that is
subordinate to and consistent and in accordance with this Agreement and the CAT
Agreement. IMPH will remain responsible for all of its obligations under this
Agreement, regardless of whether IMPH has engaged its Sub-sublicense to perform
any such obligation. If the acts or omissions of any such Sub-sublicensee cause
IMPH to be in breach of this Agreement, then IMPH shall remain responsible for
such breach, and IMPH will be liable for any damages or other remedies available
to iCo under contract law as a result of any such breach of this Agreement, to
the extent such breach is not cured and has caused iCo harm and regardless of
any remedy which iCo or IMPH may have against the Sub-IMPH for breach by the
Sub-IMPH. IMPH acknowledges that this Agreement is subordinate and subject to
the CAT Agreement and [***] Agreements.

 

2.6     Subject to the terms and conditions of this Agreement, IMPH hereby
grants to iCo a perpetual, fully-paid, royalty free, exclusive license in the
Territory, with the full rights to grant sublicenses through multiple tiers,
under any IMPH Product Improvements solely to the extent reasonably needed for
iCo (and its Affiliates and other licensees) to use or practice IMPH Product
Improvements for Research and/or to make, have made, use, sell, offer for sale,
import, export, develop, register, and distribute Licensed Products solely for
use in the Ocular Field.

 

3.

TECHNOLOGY TRANSFER   

 

3.1     Within 60 days following the Effective Date (but subject to prior
receipt of the License Fee), at a time requested by IMPH and reasonably
acceptable to iCo, iCo will transfer to IMPH the documents (in electronic form)
set out in Schedule 8 that constitute that part of the iCo Background Know How
and iCo Product Know How as identified at the Effective Date as being needed or
reasonably useful for IMPH to develop and commercialize Licensed Products in the
Licensed Field.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
11

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3.2     iCo shall use reasonable efforts to provide IMPH access to the Master
Cell Bank, for use solely in connection with IMPH manufacture of iCo-008 as
contemplated in this Agreement. As an express precondition to any such access to
the Master Cell Bank from iCo to IMPH, IMPH agrees and understands that the
Master Cell Bank does not have necessary regulatory or Competent Authority
approval for use in connection with human beings or in connection with any Phase
of clinical trials and accordingly would be provided to IMPH “as is” and without
any warranty express or implied as to satisfactory quality or fitness for a
particular purpose and iCo shall not be liable for any such use by IMPH or any
other party of the Master Cell Bank or any loss claim damage or liability of
whatsoever kind or nature which may arise from or in connection with any use of
the Master Cell Bank.

 

3.3     Once the initial transfer of iCo Background Know How and iCo Product
Know How under Section 3.1 is completed, iCo shall thereafter, from time to time
as requested by IMPH and until the fifth (5th) anniversary of the Effective
Date, provide reasonable support in the transfer of any additional iCo
Background Know How and iCo Product Know How by email, fax or telephone, up to a
maximum of twenty five (25) man hours without charge. Any such support in excess
of such [***] hours, if requested by IMPH, will be provided at a cost of [***]
per hour to IMPH and will be invoiced every three (3) months following the
Effective Date, but provided that the total such additional support provided by
iCo under this Section 3.4 shall not exceed a total of one hundred (100) man
hours, unless iCo otherwise agrees in writing.

 

3.4     iCo has informed IMPH that IMPH has no rights whatsoever (whether
express, implied or otherwise) in relation to any agreement between iCo and
Lonza regarding manufacture of Licensed Product, or to the extent that it may
become relevant, use of the Master Cell Bank. Accordingly iCo has brought to the
attention of IMPH that in order for IMPH to manufacture Licensed Product, IMPH
may need an agreement with Lonza in relation to manufacture of Licensed Product.
Likewise, iCo has brought to the attention of IMPH that in order for IMPH to
make use of the Master Cell Bank, IMPH may need an agreement with Lonza.
Notwithstanding the foregoing, iCo agrees to use reasonable efforts to assist
IMPH in seeking to reach an agreement with Lonza regarding manufacture and
supply to IMPH of needed quantities of iCo-008.

 

3.5     After the completion of the initial transfer pursuant to Section 3.1,
from time to time as requested by iCo through the JDC, IMPH shall disclose and
transfer to iCo all IMPH IP that is needed or reasonably useful for iCo to
develop and/or commercialize Ocular Products in the Ocular Field, including all
clinical data and results (including all case report forms and final reports)
generated from the Development of Licensed Product. Such disclosures shall be in
the form reasonably requested by iCo. iCo shall have the right to use all such
IMPH IP in accordance with Section 2.7 above and to the extent such IMPH IP
relates to regulatory matters as set forth below. In addition, IMPH shall
disclose and transfer to iCo, within thirty days after filing, a full and
complete copy of each Marketing Approval Application and any other regulatory
filing (including INDs and equivalent filings) relating to iCo-008 and/or
Licensed Product, and all amendments and supplements thereto, filed by or on
behalf of IMPH, its Affiliate or a Sub-sublicensee. IMPH hereby grants to iCo
the right (with full rights to grant sublicenses) to use all such Marketing
Approval Applications and any other regulatory filings (including all amendments
and supplements thereto and all Information contained therein) in connection
with the Development and/or Commercialization of Licensed Products in the Ocular
Field throughout the Territory (including use in regulatory filings) and grants
to iCo rights of reference (which may be transferred to iCo’s Affiliates and
other licensees) to all such regulatory filings. IMPH agrees to provide to iCo
(and any of its Affiliates and other licensees) a letter confirming the above
rights of reference, and to require all its Affiliates and Sub-sublicensees to
provide to iCo (and any of its Affiliates and other licensees) such a
confirmation letter, on request of iCo.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
12

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4.

PRODUCT DEVELOPMENT; REGULATORY AND SAFETY;    

 

4.1     IMPH shall have the exclusive rights and responsibility to conduct all
Development activities with respect to iCo-008 and Licensed Products solely with
respect to uses in the Licensed Field. All such development work shall be in
accordance with the Development Plan, and IMPH shall use Reasonable Endeavors to
conduct such development, whether through itself and/ or its Affiliates and
Sub-sublicensees work, with the goal of achieving Marketing Approvals of
Licensed Products in the Licensed Field in each country in the Territory where
it is commercially reasonable to do so, as soon as practicable. Such Development
activities shall include using Reasonable Endeavors to Develop at least one
Licensed Product for two Indications that may include a GI Indication or any
other Indication. Such Development shall be at IMPH’s (and/or its Affiliate’s or
Sub-sublicensee’s) expense. Regardless of any rights of the JDC, IMPH (or its
Affiliate or Sub-sublicense, as appropriate) will update the Development Plan
from time to time as appropriate, and will provide iCo copies of each such
updated Development Plan. IMPH has prepared and provided to iCo (as of the
Effective Date) an initial summary Development Plan, which plan provides a
summary of IMPH’s initial plans for Development and Commercializing iCo-008 in
the Licensed Field. Notwithstanding the foregoing rights, Sublicensee covenants
that it and its Affiliates and sublicnsees shall not develop iCo-008 or any
Licensed Product in a formulation that is specifically intended for direct
administration to the eye or otherwise specifically made for use in the Ocular
Field. For clarity, iCo retains exclusive worldwide rights to develop, seek
registrations and approval of, and commercialize (either itself and/or through
its Affiliates or other licensees) iCo-008 and all Ocular Products for all uses
in the Ocular Field.

 

4.2     Within 30 days following the Effective Date, iCo and IMPH shall
establish a joint development committee (the “Joint Development Committee” or
“JDC”) to oversee and coordinate Development of Licensed Products. The JDC shall
be composed of four members, two of whom shall be appointed by iCo and two of
whom shall be appointed by IMPH, all of which shall be employees of the
respective Parties with appropriate experience and authority in Developing the
Licensed Products. The chairperson of the JDC shall be a representative of IMPH
whom shall be responsible for calling and leading the meetings using agenda
prepared jointly by both Parties, but such chairperson shall have no other
special function within the JDC. Each Party may replace its members on the JDC
on written notice to the other Party. The JDC shall hold meetings twice each
year, unless an extraordinary meeting is called by any Party. Each Party shall
bear its own costs to attend and participate in the JDC meetings, including
expenses incurred by the members nominated by it in connection with their
activities as members of the JDC.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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4.3     The JDC is established in order for the representatives of the Parties
to, and shall be authorized to: (a) review, coordinate, and discuss the overall
Development and regulatory strategies for obtaining Marketing Approval for each
Licensed Product in the Territory; (b) oversee and review each Party’s
Development activities with respect to Licensed Products ; (c) act as a forum
for exchange of information and ideas and discussion of any issues that arise in
Development; and (d) decide on and seek to resolve any major strategic issue
raised by any of the Parties or during discussions. Each Party shall provide the
JDC with the requisite Information for its operation in accordance with the
guidelines to be agreed at the first JDC meeting, including specifically any
Information that would adversely affect the other Party’s Development efforts.
All decisions of the JDC shall be made by unanimous vote or written consent,
with iCo and IMPH each having, respectively, one vote in all decisions. The JDC
shall use reasonable efforts to resolve any disputes or disagreements concerning
the matters within its duties. Any dispute or disagreement not resolved will be
decided by the mutual consent of the chief executive officers of the Parties. If
such matter is not then resolved within 30 days of the CEOs initiating
discussions, then IMPH shall have the final decision making authority with
respect to the matter in connection with the Development of the Licensed
Product, provided that such IMPH shall make such decision in a manner that is
consistent with the terms and conditions of this Agreement, and further provided
that IMPH shall not make any decision that may have the result of adversely
impacting the Development, manufacture or commercialization of Ocular Product.
Accordingly, notwithstanding the creation of the JDC, each Party shall retain
the rights, powers and discretion granted to it under this Agreement, and the
JDC is not delegated or vested with any rights, powers or discretion unless such
delegation or vesting is expressly provided in this Agreement, or the Parties
expressly so agree in writing. The JDC shall not have any power to amend or
modify this Agreement, and no decision of the JDC shall be enforceable to the
extent it is in contravention of any terms and conditions of this Agreement.

 

4.4     IMPH (and its Sub-sublicensees) will be responsible from the Effective
Date for all costs associated with the Development of iCo-008 and Licensed
Products and all regulatory filings in the Territory in relation to iCo-008 and
Licensed Products, in each case for use in the Licensed Field.

 

4.5     IMPH will use its Reasonable Endeavors to Develop iCo-008 and Licensed
Products. Without limiting the foregoing, IMPH (and/or its Affiliates and
Sub-sublicensees) shall use Reasonable Endeavors to Development of Licensed
Products by reaching the following milestones: (a) commencement of Phase II
Trial of the first Licensed Product prior to the second anniversary of the
Effective Date; (b) spend on the aggregate of [***] years after the Effective
Date in connection with the Development and manufacturing of the Licensed
Product; and (c) commencement of [***] which time period may be reasonably
extended to adjust for any delays the extent caused by any additional requests
made by FDA or similar Competent Authority during such meetings as a
prerequisite to the commencement of Phase III Trial. The foregoing time schedule
reflects the current Development Plan and may be extended in the event that such
changes are agreed by the Parties as applicable to the then-current Development
Plan or otherwise result from a delay cause by a Competent Authority.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
14

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4.6     IMPH may subcontract to Third Parties specific Development tasks in the
Licensed Field as it determines are appropriate. Any such subcontract shall be
subject to the requirements that:

 

(a)     the subcontractor comply with all relevant terms of this Agreement and
the CAT Agreement; and

 

(b)     IMPH shall remain ultimately responsible for the performance of its
obligations under this Agreement, and if the acts and omissions of any
subcontractor cause IMPH to be in breach of this Agreement or iCo to be in
breach of the CAT Agreement, then IMPH shall remain responsible for such breach,
and IMPH will be liable for any damages or other remedies available to iCo under
contract law as a result of any such breach of this Agreement, to the extent
such breach is not cured and has caused iCo harm, regardless of any remedy which
iCo or IMPH may have against the subcontractor for breach of the subcontract.

 

4.7     IMPH shall maintain, or cause to be maintained, accurate records of all
its (and its Affiliates’ and Sub-sublicensees’) Development activities under
this Agreement in sufficient detail and in good scientific manner appropriate
for Patent and regulatory purposes, which shall be complete and accurate and
shall fully and properly reflect all work done and results achieved in the
performance of its Development activities under the Development Plan, and which
shall be retained by IMPH for at least five (5) years after the termination or
expiry of this Agreement, or for such longer period as may be required by
Applicable Law.

 

4.8     Every six (6) months after the Effective Date in preparation to the JDC
meeting, IMPH shall provide iCo with a written report providing reasonable
detail on the progress and results of all Development activities in the Licensed
Field with respect to iCo-008 and Licensed Products, and once a year shall
update its then-current Development Plan.

 

4.9     Subject to any Third Party obligations, iCo shall keep IMPH reasonably
informed of its activities in Developing, manufacturing and commercializing
Ocular Product in the Ocular Field in the Territory.

 

4.10     No Warranty. Nothing contained herein shall be deemed a warranty by
IMPH that it shall be successful in its Development efforts and failure to meet
the goal of the Development Plan after IMPH met its diligence obligations
hereunder, including investing Reasonable Endeavors as provided in Section 4.1,
shall not constitute a breach of this Agreement.

 

4.11     Regulatory Filings and Safety Matters

 

(a)     All regulatory filings submitted in connection with obtaining Competent
Authority approval to test or market a Licensed Product in the Licensed Field,
including all IND and MAA submissions, Drug Master Files and other regulatory
filings, shall be owned by, and submitted by and in the name of IMPH or its
Affiliates or Sub-sublicensee.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
15

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(b)     iCo shall grant or cause to be granted to IMPH and its Sub-sublicensees
(if any) all necessary cross-reference rights to any relevant Drug Master Files
and other regulatory filings owned by iCo for iCo-008, submitted by iCo or its
Affiliates with any Competent Authority.

 

(c)     Regulatory Coordination. IMPH will have exclusive control over, and
authority and responsibility for, the regulatory strategies relating to the
development and commercialization of all Licensed Products for use in the
Licensed Field, including, without limitation (i) the preparation of all
documents submitted to Competent Authorities and the filing of all INDs, Drug
Approval Applications and other submissions relating to Licensed Products and
(ii) all regulatory actions, communications and meetings with any Regulatory
Authority with respect to any Licensed Products in the Licensed Field. IMPH
shall use Reasonable Endeavors to prepare, file and prosecute all regulatory
filings as needed to obtain Marketing Approvals of Licensed Product as soon as
practicable in each country in the Territory where it is commercially reasonable
to market Licensed Product. Subject to any confidentiality obligations to Third
Parties, each Party shall provide to the other Party on a timely basis all
information controlled by such Party or otherwise in such Party’s possession as
a result of its activities under this Agreement that is necessary for the other
Party to comply with all regulatory obligations on a global basis applicable to
Licensed Products (in the case of IMPH) or Ocular Products (in the case of iCo),
including filing updates, information amendments, annual reports,
pharmacovigilance filings, preclinical research data, preclinical study reports,
investigator notifications and chemistry, manufacturing and controls information
in relation to iCo-008, the Licensed Product or Ocular Product, each of the
foregoing to the extent necessary for the other Party. For clarity, IMPH is
responsible for all adverse event and other safety reporting worldwide with
respect to Licensed Products. All updates and reports provided hereunder shall
be provided in a form as reasonably required by each Party for inclusion in any
regulatory submission. IMPH shall be responsible for interfacing, corresponding
and meeting with all Regulatory Authorities with respect to any Licensed
Product. The Parties shall cooperate with each other to provide all reasonable
assistance and take all actions reasonably requested by the other Party that are
necessary to comply with any law applicable to any Licensed Product and Ocular
Product, as the case may be, including, but not limited to, providing the other
Party with reasonable access during ordinary business hours and upon reasonable
written notice to its personnel, as reasonably necessary for audit purposes
and/or to answer questions or explain any information such Party provides
pursuant to this Section 4.10(c), and the reporting of adverse drug experience
reports (and Serious Adverse Event drug experience reports) to Competent
Authorities.

 

(d)     Review of Correspondence. IMPH shall use reasonable efforts to provide
with at least ten (10) Business Days advance notice of any material meeting with
Competent Authorities which is for the purpose of obtaining Regulatory Approval
for any Licensed Product. To the extent reasonably practicable and subject to
any Third Party confidentiality obligations, IMPH shall provide drafts of any
material documents or correspondence pertaining to any Licensed Product prepared
for submission to the Competent Authority sufficiently in advance of submission
so that iCo may review and comment on the substance of such material documents
or correspondence. IMPH shall promptly provide copies of any material documents
or other correspondence received from the Competent Authority pertaining to
Licensed Product.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
16

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(e)     Pharmacovigilance and Safety Agreement. Subject to the following, IMPH
shall maintain the global safety database for all Licensed Products and shall be
responsible for global pharmacovigilance for Licensed Products. iCo will be
responsible for receipt, evaluation and reporting of all adverse events and
adverse drug reactions arising from its Ocular Product activities under this
Agreement. Subject to the following, IMPH shall be responsible for global
reporting of all Adverse Events occurring with respect to the Licensed Products,
including any Adverse Events reported to IMPH by iCo, in accordance with the
deadlines and requirements of applicable Laws and Governmental Authorities.
Within three (3) months after signing the Agreement, the Parties will enter into
a detailed safety agreement (the “Safety Agreement”), which agreement will be
commercially reasonable and typical for similar agreements and will include
provisions to ensure full coordination between IMPH and iCo with regard to the
Licensed Product or Ocular Product and safety reporting, in accordance with
global regulations and timelines, including iCo collection and transmission of
safety reports to IMPH. The Parties shall periodically review the Safety
Agreement and suggest revisions or and/or updates as necessary or appropriate
based on changes in applicable Laws or other factors. IMPH acknowledges that iCo
has the ultimate responsibility for adverse event reporting and
pharmacovigilance and in satisfaction of such role may conduct all adverse event
reporting and pharmacovigilance activities with respect to Licensed Products, at
its election.

 

5.

COMMERCIALIZATION AND MARKETING   

 

5.1     At least one (1) year prior to the expected date of the receipt by IMPH
(or its Sub-sublicensee) of the first Marketing Approval for use in the Licensed
Field, as indicated in then-current Development Plan, IMPH shall create and
provide to iCo a written summary plan showing a reasonably-detailed summary of
the commercialization and marketing efforts with respect to the relevant
Licensed Product in the Licensed Field in the Territory (the “Commercialization
Plan”). IMPH (or its Sub-sublicensee, as applicable) shall have the right to
amend, supplement and/or update the Commercialization Plan from time to time as
needed or commercially appropriate, and IMPH shall provide to iCo promptly a
copy of each such amended, supplemented or updated Commercialization Plan.

 

5.2     IMPH shall have the exclusive rights and responsibility to conduct all
Commercialization and marketing activities with respect to Licensed Products for
use in the Licensed Field, generally in accordance with the then-current
Commercialization Plan, whether through itself and/or its Sub-sublicensees. IMPH
shall use Reasonable Endeavors to market, promote, sell and otherwise
Commercialize Licensed Products for use in the Licensed Field in each country in
the Territory where Licensed Product has achieved Marketing Approval, with the
goal of maximizing sales of such Licensed Products.

 

5.3     IMPH (and/or its Sub-sublicensees, as applicable) will be responsible
from the Effective Date for all costs associated with the Commercialization and
marketing of the Licensed Products in the Licensed Field and for all regulatory
filings and other regulatory activities by IMPH (and its Sub-sublicensees, as
applicable) in the Territory.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
17

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5.4     To the extent not prohibited by Applicable Law and subject to Competent
Authority and regulatory approval, and if requested by iCo to IMPH in writing,
the iCo company chosen name and company logo (or one specified by CAT, as
applicable) shall be carried on Licensed Product packaging, packaging inserts,
labels, containers and printed material related thereto, with a prominence as
mutually agreed to by iCo and IMPH (such agreement not to be unreasonably
withheld by either Party).

 

5.5     Every 6 months after the date on which the Commercialization Plan is
first received by iCo, IMPH shall provide iCo with a written report setting
forth in reasonable detail the progress and results of all Commercialization
activities of IMPH and all Sub-sublicensees, including a comparison to the
then-current Commercialization Plan.

 

5.6     IMPH agrees that it is responsible for the manufacturing of iCo-008 for
all clinical and Commercialization activities of each of the Parties, with the
goal of utilize economies of scale with the contract manufacturing organization
Lonza. IMPH agrees to use its reasonable efforts to supply iCo all its
requirements of iCo-008 as needed for iCo’s ocular program in the Ocular Field,
such supply to be under a separate supply and transfer pricing agreement, which
shall have commercially reasonable terms and shall be negotiated and agreed to
reasonable and in good faith by the Parties within three (3) months after iCo’s
written request, including without limitations the following provisions: (i)
provisions governing forecasting and ordering mechanisms that are consistent
with the manufacturing and supply agreement between IMPH and Lonza; and (ii)
transfer price shall be based on actual cost incurred by IMPH in connection with
the manufacturing (if IMPH manufactures the product by itself) or procurement
(if IMPH procures such product from a third party) + [***] if as part of a
forecasted order or otherwise cost + [***]. Notwithstanding the foregoing, iCo
retains the rights, at its discretion, to manufacture any or all of its (and its
Affiliates’ and other licensees’) requirements of iCo-008.

 

6.

NON-COMPETITION 

 

6.1     IMPH and its Affiliates shall not (alone or in collaboration with a
Third Party) conduct in the Territory any activities to (including any program
intended to) develop, commercialize, distribute, market or sell (or license or
otherwise grant rights to a Third Party to do any of the foregoing) any product
in the Licensed Field or the Ocular Field containing an Antibody that
specifically binds to eotaxin-1, other than iCo-008 or a Licensed Product (for
clarity, solely for use in the Licensed Field) as contemplated by this
Agreement.

 

6.2     iCo shall not (alone or in collaboration with a Third Party) conduct in
the Territory any activities to (including any program intended to): (a)
develop, commercialize, distribute, market or sell (or license or otherwise
grant rights to its Affiliate or a Third Party to do any of the foregoing) for
use in the Licensed Field any product containing iCo-008.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
18

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7.

PAYMENTS 

 

In consideration of the licenses and other rights granted by iCo to IMPH in this
Agreement, IMPH shall make the following payments to iCo:

 

7.1     Option Fee, License Fee and License Shares

 

(a)     In partial consideration of iCo entering into this Agreement and the
granting of rights to IMPH hereunder to obtain the license and other rights as
of the Effective Date upon payment of the License Fee, IMPH shall pay to iCo,
within five (5) days of the Execution Date, an option fee of one hundred
thousand US dollars (US$100,000) (the “Option Fee”). The Option Fee is
non-refundable but is creditable against the License Fee payment owed as
provided below. In addition, if the Effective Date has not occurred by January
30, 2011, then IMPH shall pay to iCo an option extension fee of one hundred
thousand US dollars (US$100,000), such fee to be paid to iCo by February 1,
2011, which fee shall be non-refundable and non-creditable against the any other
amounts or payment owed by IMPH.

 

(b)     In partial consideration of iCo entering into this Agreement and the
granting of rights to IMPH hereunder as of the Effective Date, including the
license grants pursuant to Section 2.1, IMPH shall pay to iCo a signature fee
(the “Licensee Fee”). The Licensee Fee shall comprise of shares of Financing
Stock (as defined below) with the number of such shares calculated by dividing
US$1,000,000 by the actual per-share price of such shares used in the purchase
of such shares by investors in the Qualified Financing, provided that such
percentage shall be in no event less than two and one half percent (2.5%). In
the event that the number of shares so issued constitutes more than 5% of IMPH
fully diluted capitalization on a fully diluted basis upon the closing of the
Qualified Financing then any excess could be exchanged for cash, at the
discretion of IMPH, at the per-share price at the Qualified Financing. For
illustration purposes, if the Qualified Financing is at a post money valuation
of US$10,000,000, then iCo shall be granted with Financing Stock constituting
10% of the fully diluted capitalization of IMPH or any mixture of shares and
stock as long as it holds as a minimum 5%.

 

(c)     The “Financing Stock” as such term is used above shall mean shares of
IMPH capital stock in the same series of shares as issued to the investors in
the Qualified Financing, the rights, preferences and privileges of which are
reasonably acceptable to iCo. All shares of Financing Stock issued by IMPH in
connection with this Section 7.1 shall be deemed collectively as the “License
Shares”. Such License Shares shall be issued pursuant to a Share Purchase
Agreement between iCo and IMPH similar to the agreement to be agreed with the
investors of the Qualified Financing (the “SPA”), subject to the rest of this
Section 7.1(c). The License Fee shall be paid and the License Shares issued
under Section 7.1(a) shall be issued to iCo within five (5) days of the initial
closing of the Qualified Financing (regardless of the amount actually invested
in such closing but subject to termination of this Agreement as provided in
Section 15.2(a)). The date on which IMPH pays and issues to iCo the total amount
of the License Fee (as determined above) shall be deemed the Effective Date of
this Agreement, and upon such payment all the provisions of this Agreement shall
automatically become in full force and effect (as provided in Section 15.1). All
such amounts of the License Fee paid by IMPH shall be non-refundable and
non-creditable against any other amounts due to iCo under this Agreement. The
amount of License Shares issued to iCo by IMPH as part of the License Fee under
Section 7.1(a) above, as a percentage of IMPH’s fully diluted capitalization,
shall be deemed to be iCo’s “Equity Position” in IMPH.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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(d)     iCo’s Equity Position will be subject to full anti-dilution protection
such that iCo shall maintain its actual percentage ownership of IMPH (on a
fully-diluted and as converted basis) determined at the time of the issuance of
the License Shares, until such time as the License Shares are converted into
ordinary shares as part of a public offering or listing on a recognized stock
exchange (including by way of merger into a public shell), or IMPH is acquired
in a merger or acquisition transaction where all of IMPH’s convertible preferred
shares are exchanged (on an equal per-share basis) for cash (and/or stock of the
acquiring company), and in each case iCo’s maintenance of such Equity Position
shall not be subject to any “pay-to-play” or similar provisions that require iCo
to make further investment in IMPH. Such anti-dilution protection shall be
effected by IMPH adjusting the conversion price or issuing to iCo an amount of
additional Financing Stock that maintains iCo’s Equity Position (so that it
remains at its percentage ownership of IMPH (on a fully-diluted and as converted
basis) determined at the time of the original issuance of the License Shares).
Notwithstanding, the Equity Position will be [***].

 

7.2     Licensed Products Milestone Payments for Two Indications

 

(a)     IMPH shall pay to iCo the following milestone payments upon the first
achievement of the specified milestones by IMPH or any Sub-sublicensee in
respect of a Licensed Product being developed for a particular Indication (e.g,
for GI Indication use or Respiratory Indication use or any other Indication),
regardless of whether the development, promotion, or marketing of the Licensed
Product is discontinued at any time after the achievement of such milestone, but
subject to subsection (b) below:

 

[***]

 

(b)     Each of the milestone payments in Section 7.3(a) shall be due and
payable only [***] times.

 

(c)     [***]      

 

7.3     IMPH shall notify iCo promptly of its or its Sub-sublicensee’s
achievement of any milestone event under Section 7.3, but in any event within
thirty (30) days of the occurrence of the milestone, and accompany such
notification with the relevant milestone payment.  For the avoidance of doubt
the milestone payments will be payable by IMPH whether it is IMPH or its
Sub-sublicensee that achieves the relevant milestone. With respect to any
particular milestone event under Section 7.3, for the applicable milestone
payment associated with the achievement of such event, iCo may elect, in its
sole discretion, to receive the payment either: (i) all in cash; or (ii) all in
IMPH shares (in the amount of shares equivalent to the amount of the milestone
payment at the then-current fair market value of such IMPH shares); or (iii) as
a combination of cash and IMPH shares. To the extent iCo elects to have any
milestone payment (or portion thereof) paid in IMPH shares, such shares shall be
issued pursuant to the applicable terms of the SPA and shall be of the same
class and have the same rights as the License Shares.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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7.4     IMPH shall pay iCo royalties for the period of time described in Section
7.9 in an amount equal to [***] of the Net Sales of Licensed Products sold by or
on behalf of IMPH or its Affiliate or a Sub-sublicensee.

 

7.5     If Sublicensee (or its Affiliate or a Sub-sublicensee) sells a Licensed
Product to a Third Party that purchases other products or services from such
selling party, Sublicensee covenants and agrees that the selling party shall not
discount the purchase price of the Licensed Product to a greater degree than the
selling party generally discounts the prices of the other products and/or
services sold to such Third Party during the same royalty period.

 

7.6     Royalties under Section 7.4 shall be calculated on all of IMPH’s, its
Affiliate’s and Sub-sublicensee’s sales of Licensed Products to a Third Party
and shall accrue at the time of sale. Royalties shall be payable only once for
any given unit of Licensed Product sold.  For purposes of determining Net Sales,
the Licensed Product shall be deemed to be sold when a sale is deemed to occur
under the Accounting Standards and a “sale” shall not include, and no royalties
shall be payable on, transfers (i) between or among IMPH and its Affiliates or
Sub-sublicensees for resale, (ii) by IMPH or its Affiliates or sublicensees of
samples of Licensed Products or clinical trial materials containing Licensed
Product, or (iii) other transfers or dispositions for bona fide charitable,
promotional, preclinical, clinical, regulatory or governmental purposes, in each
case for nil consideration.

 

7.7     In addition to amounts owed under Section 7.4, IMPH shall pay iCo a
royalty (the “Sublicensing Royalty”) equal to [***]% of Sublicensing Revenues
received by or payable to IMPH or its Affiliate from a Sub-sublicense at the
time the sublicense agreement is entered into by IMPH (or its Affiliate) and
such Sub-sublicensee. The foregoing obligation shall expire and no payment shall
be due in the event that [***].

 

7.8     Royalties payable under Section 7.4, as to a particular Licensed
Product, shall be paid on a country-by-country basis from the date of the First
Commercial Sale of the Licensed Product in the particular country.  Such royalty
obligation for such Licensed Product shall expire, on a country-by-country
basis, with respect to each separate Licensed Product, on the later to occur of
(a) the tenth (10th) anniversary of the First Commercial Sale of such Licensed
Product in the applicable country or (b) the expiration date in such country of
the last to expire of any issued iCo Patent that includes at least one Valid
Claim that claims the particular Licensed Product or its manufacture or use.

 

7.9     If Licensed Product sold by or on behalf of IMPH or its Affiliate or a
Sub-sublicensee is used by the end-user in the Ocular Field (as demonstrated,
for example, by IMS data or other similar prescription data), then IMPH shall
pay to iCo an amount, for each such sale of Licensed Product, equal to iCo’s (or
its Affiliates or other licensee’s, as applicable) average gross profit at the
time on the sale of a unit of product containing iCo-008 for use in the Ocular
Field.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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8.

PROVISIONS RELATING TO PAYMENT OF CONSIDERATION

 

8.1     No sums payable under this Agreement (including the License Fee, the
License Shares, and all milestone payments) shall be refundable or creditable
against any other sum payable by IMPH under this Agreement for any reason,
except that the Option Fee is creditable against the License Fee payment or
milestone payments, to the extent any such payment is made in cash (until such
Option Fee has been fully credited).

 

8.2     iCo shall be solely responsible for the payment of royalty and other
payments in respect of the grant of to iCo by CAT of the license rights under
the CAT Agreement, provided however, that in the event iCo is determined to have
committed an uncured material breach of its payment obligations under the CAT
Agreement, IMPH shall be entitled to transfer the amounts due from iCo to CAT
directly to CAT on behalf of iCo to the extent necessary to cure such payment
breach, provided that, in the event IMPH makes any direct payment to CAT that is
not due under the CAT Agreement, IMPH shall reimburse iCo for such amount
promptly. IMPH shall be responsible for paying all other Third Party obligations
of IMPH (or its Affiliate or Sub-IMPH) in relation to Licensed Products in the
Licensed Field sold by IMPH, its Affiliates and Sub-sublicensees.

 

8.3     IMPH shall make the payments due to iCo under Article 7 inclusive in
United States dollars at Quarterly intervals as provided in this Section 8.
Where IMPH receives payment in a currency other than United States dollars, IMPH
will convert the relevant sum due to iCo into United States dollars, using the
conversion rate reported by the Wall Street Journal three (3) Business Days
before the day on which IMPH pays iCo. Such payment will be made without
deduction of exchange, collection, wire transfer or other charges.

 

8.4     Within sixty (60) days following the end of each Quarter after the First
Commercial Sale of each Licensed Product in any country, IMPH shall prepare a
statement which shall show on a country-by-country basis for the previous
Quarter all royalty amounts and other monies due to iCo with respect to Net
Sales amounts invoiced by IMPH and IMPH Affiliates during such Quarter. That
statement shall include the amount of Net Sales broken down to show the country
of the sales and the total Net Sales in such country. The statement shall be
submitted to iCo within such sixty (60) day period together with remittance of
the monies due. With respect to Sublicense Royalties, IMPH shall pay to iCo the
total amount of Sublicense Royalties owed based on a particular payment or
obligation of Sublicense Revenue within 30 days of the date such obligation
accrues to IMPH or its Affiliate or is paid (whichever is earlier).

 

8.5     All payments shall be made free and clear of and without deduction or
deferment in respect of any disputes or claims whatsoever and/or as far as is
legally possible in respect of any taxes imposed by or under the authority of
any government or public authority. Any tax that IMPH is required to pay or
withhold in respect of the payments to be made to iCo hereunder shall be
deducted from the amount otherwise due provided that, in regard to any such
deduction, IMPH shall give iCo reasonable assistance, which shall include the
provision of such documentation as may be required by any revenue authority and
other revenue services, as may be necessary to enable iCo to claim exemption
therefrom or obtain a repayment thereof or a reduction thereof and shall upon
request provide such additional documentation from time to time as is needed to
confirm the payment of tax. Notwithstanding the foregoing, the Parties shall
cooperate with each other and each shall use reasonable, good faith efforts to
ensure, to the maximum extent legally permissible, that the payments to be made
by IMPH to iCo hereunder are not subject to VAT. In the event that, despite such
efforts, a payment made by IMPH is subject to VAT, then the Parties shall share
equally the amount of such VAT payment obligation (with iCo reimbursing IMPH
such amount if IMPH makes the VAT payment).

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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8.6     IMPH shall keep, and shall ensure that IMPH’s Affiliates and
Sub-sublicensees keep, true and accurate records and books of account containing
all data necessary for the calculation of the amounts payable by IMPH to iCo
pursuant to this Agreement. Those records and books of account shall be kept for
seven (7) years following the end of the Quarter to which they relate. Upon
iCo’s written request and, except as set forth in Section 8.6(e), at iCo’s
expense, a firm of nationally recognized accountants appointed by iCo:

 

(a)     shall be given access to and shall be permitted to examine and copy such
books and records of IMPH and IMPH Affiliates and sublicensees as relate
directly to the sale of Licensed Products, at all reasonable times on Business
Days in a manner calculated so as not to disturb the business affairs of the
auditee for the purpose of certifying that the Net Sales or other relevant sums
(including but not limited to milestone payments) calculated by IMPH and IMPH
Affiliates and sublicensees during any Calendar Year were reasonably calculated,
true and accurate or, if this is not their opinion, certify the Net Sales figure
or other relevant sums for such period which in their judgment is true and
correct;

 

(b)     prior to any such examination taking place, such firm of accountants
shall enter into a confidentiality agreement that contains commercially
reasonable terms customary for such audits to protect the confidentiality of
proprietary information of IMPH that is subject to such audits;

 

(c)     any such access examination and certification shall occur no more than
once per Calendar Year and only may occur once with respect to any given time
period covered by such audit unless a discrepancy is discovered in relation to
any Quarter;

 

(d)     IMPH and Sublicensee’s Affiliates and sublicensees shall make available
appropriate personnel to answer reasonable queries by such accountants on the
applicable books and records required for the purpose of that certification; and

 

(e)     the actual cost of the accountant to conduct the audit shall be the
responsibility of iCo, except that if the certification correctly shows IMPH to
have underpaid monies to iCo by more than five percent (5%) of the total amount
otherwise payable in the applicable during the audit period it shall be the
responsibility of IMPH.

 

8.7     If the accountant correctly concludes that additional royalties or other
amounts were owed by IMPH during any period, IMPH shall pay the additional
amounts plus accrued interest (from the date originally owed until paid) within
30 days of the date iCo delivers to IMPH such accountant’s written report so
concluding.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
23

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8.8     All payments made to iCo under this Agreement shall be made to the bank
account of iCo as notified by iCo to IMPH from time to time.

 

8.9     If IMPH fails to make any payment to iCo hereunder on the due date for
payment, without prejudice to any other right or remedy available to iCo, it
shall be entitled to charge IMPH interest (both before and after judgment) on
the amount unpaid at the annual rate of LIBOR (London Interbank Offering Rate)
plus four percent (4%) calculated on a daily basis until payment in full is
made, without prejudice to iCo’s right to receive payment on the due date.

 

8.10     All financial terms and standards defined or used in this Agreement
with respect to both Parties shall be governed by and determined in accordance
with the Accounting Standards.

 

9.

INTELLECTUAL PROPERTY AND PATENT RIGHTS  

 

9.1     As between the Parties, iCo shall have the sole right and responsibility
at its sole discretion and cost, to file, prosecute and maintain the iCo
Background Patents (including to determine whether or not file or continue to
prosecute or maintain any such Patents) and for the conduct of any lawsuits,
claims or proceedings, including any interference or opposition proceeding,
relating to such iCo Background Patents in all countries. All applicable costs
and expenses incurred by iCo after the Effective Date for the iCo Background
Patent prosecution efforts, shall be borne [***] by iCo and IMPH, with IMPH
reimbursing iCo for such costs and expenses based on invoices from iCo (such
invoices to be paid within 30 days of receipt), except as otherwise provided in
Section 9.4 below.

 

9.2     As between the Parties, iCo shall have the sole right and responsibility
(but subject to the terms of the CAT Agreement), in collaboration with IMPH as
discussed in Section 9.3 below, to file, prosecute and maintain the iCo Product
Patents (including to determine whether or not file or continue to prosecute or
maintain any such Patents) and for the conduct of any lawsuits, claims or
proceedings, including any interference or opposition proceeding, relating to
such iCo Product Patents in all countries (collectively, the “Product Patent
Prosecution”). All applicable costs and expenses incurred by iCo after the
Effective Date for the Product Patent Prosecution efforts, shall be borne
equally by iCo and IMPH, with IMPH reimbursing iCo for such costs and expenses
based on invoices from iCo (such invoices to be paid within 30 days of receipt),
except as otherwise provided in Section 9.4 below.

 

9.3     iCo shall keep IMPH reasonably informed of its plans for and progress in
conducting the Product Patent Prosecution. Subject in all cases to the terms of
the CAT Agreement, IMPH shall have the right to review all material documents
relating to the Product Patent Prosecution to the extent directly related to
Licensed Products in the Licensed Field, including draft filings of material
documents, material documents provided by patent offices (such as office
actions), and responses to patent office actions, and to give comments and
recommendations as to the overall strategy regarding the Product Patent
Prosecution and as to specific material actions to be taken in the Product
Patent Prosecution. Before iCo takes any material step in the Product Patent
Prosecution, iCo shall allow IMPH reasonable time to review any material
documents relating to such step or action and to comment on the step or action
proposed to be taken. IMPH shall consider reasonably and in good faith any and
all timely-provided comments and suggestions of iCo and shall seek to
accommodate any reasonable comments and suggestions, provided that it is
understood and agreed that iCo shall not be prevented, by the foregoing, from
taking any action reasonably required to be taken to preserve the patent rights
and continue the Product Patent Prosecution. In the event of any disagreement
between iCo and IMPH as to any issue related to filing, prosecution or
maintenance of the iCo Product Patents or in any lawsuits, claims or proceedings
involved in the Product Patent Prosecution, iCo will have the final decision as
to the matter or issue. IMPH acknowledges that CAT retains certain rights under
the CAT Agreement with respect to prosecution and maintenance of certain iCo
Patents owned or controlled by CAT, and IMPH understands and agrees that all the
above provisions of this Section 9.3 are subject to all the terms, requirements
or obligations of the CAT Agreement.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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9.4     As to any particular Patent in the iCo Background Patents or iCo Product
Patents, IMPH may by written notice to iCo elect to cease continuing paying its
share of the costs and expenses for any Product Patent Prosecution or iCo
Background Patents prosecution and maintenance as to a particular iCo Product
Patent or iCo Background Patent in the applicable country. Upon such notice, and
if elected by iCo in writing, iCo may continue having full control of the
Product Patent Prosecution of such particular iCo Product Patent, or prosecution
and maintenance of the applicable iCo Background Patents, in the applicable
country, and in such case (i) iCo will assume responsibility for paying any and
all costs and expenses incurred in conducting such Product Patent Prosecution of
the particular iCo Product Patent or prosecution and maintenance of the
applicable iCo Background Patents (as applicable), and (ii) such particular iCo
Product Patent or iCo Background Patent shall no longer be licensed to IMPH
under Section 2.1(a).

 

9.5     All improvements (including but not limited to formulation or process
improvements) to the inventions claimed in the iCo Product Patents made by IMPH
or IMPH Affiliates or Sub-sublicensee, and any Patents (including but not
limited to formulation or process Patents) claiming such improvements,
(collectively, “IMPH Product Improvements”) will be owned by IMPH (or its
Affiliate as the case may be), subject to the license rights granted in Section
2.7. IMPH will inform iCo of the existence of any IMPH Product Improvements
promptly after IMPH is aware of such IMPH Product Improvement. IMPH shall have
the sole right, at its sole discretion and cost, to file, prosecute and maintain
Patents relating to IMPH Product Improvements and for the conduct of any
lawsuits, claims or proceedings challenging the validity or enforceability
thereof, including any interference or opposition proceeding relating thereto in
all countries.

 

9.6     If IMPH has not filed a Patent application claiming any particular IMPH
Product Improvement notified to iCo pursuant to Section 9.5 within 120 days of
the date of such notification, or at any point IMPH determines that it shall
abandon an application or granted Patent claiming such IMPH Product Improvement,
then it shall use reasonable efforts to so notify iCo. If iCo desires to
undertake such filing and/or continued prosecution or maintenance of a Patent
claiming such IMPH Product Improvement, iCo shall be entitled to notify IMPH of
such desire. Upon such notice, the Parties shall meet and discuss in good faith
the terms under which IMPH would permit iCo to undertake such prosecution and
maintenance efforts as to such a Patent, which may include IMPH transferring the
IMPH Product Improvement in question to iCo for appropriate consideration, or
other reasonable steps. In any event, iCo grants to IMPH a royalty-free,
non-exclusive, sub-licensable (in conjunction with IMPH’s proprietary technology
and materials), world-wide, irrevocable, perpetual license to use all IMPH
Product Improvements transferred to iCo in accordance with this Section 9.6 for
all purposes.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
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9.7     If at any time any part of Section 9 is held to be or becomes void or
otherwise unenforceable for any reason under any applicable law, the same shall
be deemed omitted from this Agreement and the validity and/or enforceability of
the remaining part of Section 9 shall not in any way be affected or impaired as
a result of that omission. For the avoidance of doubt, the benefit of any
individual or block exemption otherwise applicable to the Agreement by virtue of
either Article 81(3) of the EU Treaty or Sections 4 or 6 to the Competition Act
of 1998 shall not be affected as a result of that omission.

 

9.8     IMPH shall notify iCo promptly if IMPH or its Affiliate or a Sub-IMPH
becomes aware that a Third Party takes or threatens to take any proceedings for
infringement of any Patents of that Third Party by reason of IMPH’s or its
Affiliate’s or a Sub-sublicensee’s use of the iCo Patents or the manufacture,
use or sale of Licensed Products and shall provide iCo with all information in
relation thereto reasonably requested by iCo.

 

9.9     If IMPH becomes aware, or objectively believes, that a Third Party
infringes any iCo Patents, then the IMPH shall promptly notify iCo in writing.

 

9.10     Each Party shall within five (5) working days or as soon as reasonably
possible thereafter advise the other Party of receipt of any notice of:

 

(a)     any certification filed under the U.S. “Drug Price Competition and
Patent Term Restoration Act of 1984” or a successor or equivalent thereof (“ANDA
Act”), claiming that any iCo Product Patents or IMPH Patents are invalid or
claiming that the iCo Product Patents or IMPH Patents will not be infringed by
the manufacture, use or sale of a product for which an application under the
ANDA Act is filed; or

 

(b)     any equivalent or similar certification or notice in any other
jurisdiction.

 

9.11     iCo shall have the right to initiate, prosecute and control legal
action (whether by suit, proceeding or otherwise) in respect of any infringement
by a Third Party of any iCo Background Patents, and in respect of any
infringement of any iCo Product Patents except as provided in Section 9.13 below
with respect to Field Infringements.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
26

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9.12     In respect of any action by a Third Party by the manufacture, use or
sale of a product containing iCo-008 and used in the Licensed Field that
infringes, or that a Party believes infringes, a iCo Product Patent (a “Field
Infringement”), the Parties shall notify each other of such action, and shall
meet promptly to discuss in good faith what steps and actions to take to cause
the cessation of such infringement. Unless the Parties otherwise agree (and
except as otherwise provided in the CAT Agreement), IMPH shall have the right
(but subject to the requirements of the CAT Agreement, as applicable), but not
the obligation, to take such steps and actions, including filing a lawsuit
enforcing the applicable iCo Product Patent, against such infringer with respect
to the Field Infringement. In any action against a Field Infringement brought by
IMPH in accordance with this Section 9.13, IMPH shall have the right to join iCo
as a party to such action if necessary to conduct such action, and each Party
shall reasonably cooperate with the other in regard to the same. In addition,
iCo shall have the right to join in any action brought by IMPH relating to iCo
Product Patents in accordance with this Section 9.13 if necessary in order to
assert the damages incurred by iCo as a result of the alleged infringement,
provided, that (i) the foregoing shall not limit or restrict in any way the
rights of IMPH from exercising control of such action in its discretion, and
(ii) notwithstanding the foregoing, any monetary recovery in connection with
such infringement action shall be allocated in accordance with Section 9.14. If
IMPH does not bring an action against the infringer in a Field Infringement, or
otherwise cause the cessation of such Field Infringement, within 120 days of
IMPH’s awareness of such Field Infringement, or after bringing such action does
not continue to pursue the action diligently to cause the cessation of the Field
Infringement, then iCo may bring such an action to enforce the applicable iCo
Product Patent against such Field Infringement. In such case, iCo shall have the
right to join IMPH as a party to such action, and each Party shall reasonably
cooperate with the other in regard to the same. In addition, IMPH shall have the
right to join in any such action brought by iCo relating to iCo Product Patents
in accordance with this Section 9.13 if necessary in order to assert the damages
incurred by IMPH as a result of the alleged infringement, provided, that (i) the
foregoing shall not limit or restrict in any way the rights of iCo from
exercising control of such action in its discretion, and (ii) notwithstanding
the foregoing, any monetary recovery in connection with such infringement action
shall be allocated in accordance with Section 9.14. IMPH acknowledges that CAT
retains certain rights under the CAT Agreement with respect to the enforcement
of certain iCo Patents owned or controlled by CAT, and IMPH understands and
agrees that all the above provisions of this Section 9.3 are subject to all the
terms, requirements or obligations of the CAT Agreement.

 

9.13     The costs and expenses (including attorneys’ fees) of any action
against a Field Infringement brought in accordance with Section 9.13 shall be
borne by the Party that brings the action (including reasonable costs of the
other Party (such as attorney’s fees) if such Party joins the other Party in
such action), except that if the other Party elects to join such action (as
permitted in Section 9.13), then such other Party shall bear its own costs and
expenses relating to having joined the action. Any monetary recovery in
connection with such infringement action as to a Field Infringement shall be
applied: (a) first to reimburse the Party that brought the action for its
out-of-pocket expenses (including reasonable attorneys’ fees) incurred in
connection with such infringement action, and (b) second to reimburse the other
Party for its out-of-pocket expenses if such other Party elects to join in such
proceedings, and (c) any amounts remaining (after the Parties have been
reimbursed for expenses as provided above), shall be retained by or paid to the
Party that brought the infringement action for such Field Infringement, provided
that any such remaining amounts retained by IMPH shall be deemed Net Sales for
which IMPH shall pay royalties to iCo under Section 7.6.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
27

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10.

CONFIDENTIALITY 

 

10.1     Each Party undertakes and agrees (except as otherwise provided in
Section 10.2) to:

 

(a)     use the Information received from the other Party only for the purposes
envisaged under this Agreement and not to use the same for any other purpose
whatsoever;

 

(b)     ensure that only those of its officers and employees who are directly
concerned with the carrying out of this Agreement have access to such
Information on a strictly applied “need to know” basis and are informed of the
secret and confidential nature of it and are bound by terms similar to the terms
of this Section (with a shorter duration of confidentiality and non-use
obligations no less than five (5) years from the date of disclosure when
appropriate and will not adversely affect the proprietary nature of the
Information);

 

(c)     keep such Information secret and confidential and not disclose or permit
to be disclosed, make available or permit to be made available the same to any
Third Party for any reason without the prior written consent of the Disclosing
Party, except as otherwise permitted in Section 10.3; and

 

(d)     no lien is established over such Information and that such Information
is not encumbered in any other way;

 

(e)     not copy, reproduce or otherwise replicate for any purpose or in any
manner whatsoever any documents containing the Information, except as reasonably
needed to exercise the rights granting or perform the obligations under this
Agreement.

 

10.2     The obligations set forth in Section 10.1 shall not extend to any
Information that the Recipient Party can show:

 

(a)     is or becomes generally available to the public otherwise than by reason
of breach by the Recipient Party of the provisions of Section 10.1;

 

(b)     is known to the Recipient Party and is at its free disposal prior to its
receipt from the Disclosing Party provided that evidence of such knowledge is
proven by competent written records;

 

(c)     is subsequently disclosed to the Recipient Party without obligations of
confidence by a Third Party owing no such obligations to the Disclosing Party in
respect of that Information; or

 

(d)     is developed by or on behalf of Recipient Party independently in
circumstances where no use was made of the Disclosing Party’s confidential
Information in making such development;

 

10.3     Notwithstanding the other provisions of this Section 10, a Party may
disclose specific Information of the other Party to the extent such disclosure
is required by Applicable Law to be disclosed (including as part of any
regulatory submission or approval process, or in response to a court order or
other judicial process); provided, however, that the Party that is required to
make such disclosure shall provide prompt written notice of this requirement to
the Disclosing Party so that it may, if so advised, seek appropriate relief to
prevent or restrict such disclosure, and provided always that in such
circumstances such disclosure shall be only to the extent so required and shall
be subject to prior consultation with the Disclosing Party with a view to
agreeing timing and content of such disclosure. The requirement under this
Section 10.3 to notify the Disclosing Party when Information is required to be
disclosed by a Competent Authority shall not apply when such disclosure is
required as part of any Licensed Product regulatory submission or approval
process.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
28

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10.4     Notwithstanding the other provisions of this Section 10, IMPH may
disclose the iCo Information to its Affiliates and Sub-sublicensees, under
obligations of confidentiality, for use solely as permitted in this Agreement.
Notwithstanding the other provisions of this Section 10, iCo may disclose the
IMPH Information to its Affiliates and to its other sublicensees in the Ocular
Field, under obligations of confidentiality, for use solely as permitted by the
rights granted to iCo in, or retained by iCo under, this Agreement.

 

10.5     All Information owned by and disclosed by the Disclosing Party to the
Recipient Party shall remain the property of the Disclosing Party. In the event
that a court or Competent Authority assumes partial or complete control over the
assets of a Recipient Party based on the insolvency or bankruptcy of that Party,
the Recipient Party shall:

 

(a)     promptly notify such court or Competent Authority:

 

(1)     that Confidential Information received from the Disclosing Party under
this Agreement remains the property of the Disclosing Party; and

 

(2)     of the confidential obligations under this Agreement; and

 

(b)     to the extent permitted by law, take all steps necessary or desirable to
maintain the confidentiality and security of the Disclosing Party’s Information
and to ensure that the court or Competent Authority maintains that Information
in confidence in accordance with this Agreement.

 

10.6     The obligations of the Recipient Party under Section 10.1, as to
particular Information disclosed by the other Party, shall last until the
particular Information is no longer secret and confidential or as otherwise
provided in Section 10.2. Upon termination of this Agreement, the Recipient
Party shall return to the Disclosing Party, or shall destroy, copies,
reproductions or other replicates of the Disclosing Party’s Information (except
for Information that meets one of the exclusions in Section 10.2), except that
the Recipient Party may retain one copy of such Information in its legal
archives for purposes of ensuring its compliance with this Agreement.

 

10.7     The Parties understand and agree that remedies in damages may be
inadequate to protect against any breach of any of the provisions of this
Section 10 by either Party or their employees, officers or any other person
acting in concert with it or on its behalf. Accordingly, each Party shall be
entitled to seek the granting of interim and final injunctive relief by a court
of competent jurisdiction in the discretion of that court against any action
that constitutes or threatens any breach of this Section 10.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
29

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11.

PRESS RELEASE AND PUBLICATION 

 

11.1     The Parties hereby agree to the form of press release set out in
Schedule 9, which shall be released upon execution of this Agreement. No other
public announcement or other disclosures to a Third Party concerning the terms
of this Agreement shall be made, whether directly or indirectly, by any Party,
except as may be legally required, without first obtaining, in the case of an
announcement or disclosure to be made by iCo, the approval of IMPH and, in the
case of an announcement or disclosure made by IMPH, the approval of iCo, such
approvals not to be unreasonably withheld, with the exceptions that:

 

(a)     a Party may disclose the full terms of this Agreement to its investment
bankers, lawyers, accountants and other professional advisors, and to a Third
Party seeking to invest in or to acquire or merge with or be acquired by such
Party (and to such Third Party’s professional advisors) without prior approval
provided that such disclosure is made under terms of confidentiality whether
express or implied; and

 

(b)     a Party may disclose the terms of this Agreement to any securities
exchange or Regulatory Authority or governmental body to which either party is
subject or submits, wherever situated, including the Toronto Stock Exchange or
NASDAQ, whether or not the requirement has the force of law provided that it
uses reasonable efforts to take advantage of all provisions to keep confidential
as many terms of this Agreement as are permitted under Applicable Law; and

 

(c)     a Party may disclose those terms which it is required by Applicable Law
to disclose provided that it uses reasonable efforts to take advantage of all
provisions to keep confidential as many terms of the Agreement as are permitted
under Applicable Law.

 

11.2     iCo may make publications (whether oral, in writing, as abstracts,
slides, posters or other presentation material) regarding this Agreement or any
data or information resulting from the development of Licensed Product, provided
that iCo shall provide to IMPH drafts of, or information concerning, any
proposed publication not less than thirty (30) days prior to the proposed date
of any publication. IMPH shall have twenty (20) days to review such draft or
information and shall be entitled to require that (i) iCo either delay any
publication by no more than twenty (20) days and/or (ii) iCo make such
reasonable changes to the content of such draft publication as IMPH reasonably
requires in order to protect Confidential Information of IMPH the disclosure of
which would materially adversely affect the Commercialization of Licensed
Product by IMPH in the Licensed Field. At the end of the initial twenty (20) day
or any period of delay requested by IMPH, iCo shall be entitled to make such
publication (with any such reasonable changes requested by IMPH).

 

11.3     IMPH may make publications (whether oral, in writing, as abstracts,
slides, posters or other presentation material) regarding this Agreement or any
data or information resulting from the development of Licensed Product with
iCo’s prior written consent, which shall not be unreasonably withheld or
delayed, provided that IMPH shall provide to iCo the draft of any proposed
publication not less than forty-five (45) days prior to the proposed date of any
publication. iCo shall have thirty (30) days to review such draft or information
and shall be entitled to require that IMPH (i) delay such publication by no more
than thirty (30) days and/or (ii) make such reasonable changes to the content of
such draft publication as iCo may reasonably require to protect iCo Confidential
Information. At the end of the initial thirty (30) day or any period of delay
requested by iCo, IMPH shall be entitled to make such publication provided that
IMPH incorporates any such reasonable changes requested by iCo.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
30

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12.

TRADE MARKS 

 

12.1     Neither Party shall use the name, trade mark, trade name or logo of the
other Party or its employees in any publicity, promotion, news release or
disclosure relating to this Agreement or its subject matter, without the prior
express written permission of that other Party, except as may be required by law
or regulation, such permission not to be unreasonably withheld.

 

12.2     Subject to Section 5.4, IMPH shall be entitled, in its sole discretion,
to select the trade marks and trade names for all Licensed Products which trade
marks and trade names for any Licensed Product may vary by country or within a
country, in IMPH’s sole discretion. IMPH shall own all right, title and interest
in and to any such trade marks and trade names described above, and iCo shall
have no rights with respect to any such trade marks and trade names.

 

13.

[***] AGREEMENT AND [***] RIGHTS

 

[***] 

 

14.

REPRESENTATIONS, WARRANTIES, COVENANTS AND INDEMNIFICATION   

 

14.1     Each Party hereby represents and warrants to the other Party as of the
Execution Date that:

 

(a)     it is a corporation duly organised, validly existing and in good
standing under the laws of the jurisdiction in which it is incorporated;

 

(b)     it has the corporate power and authority and the legal right to enter
into this Agreement free from any conflicting right owed to a Third Party and to
perform its obligations hereunder;

 

(c)     it has taken all necessary corporate action on its part to authorise the
execution and delivery of this Agreement and the performance of its obligations
hereunder and that this Agreement has been duly executed and delivered on behalf
of each Party, and constitutes a legal, valid, binding obligation, enforceable
against such Party in accordance with its terms;

 

(d)     all necessary consents, approvals and authorisations of all applicable
Competent Authorities and other persons required to be obtained by such Party in
order to execute this Agreement on behalf of such Party have been obtained; and

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
31

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(e)     the execution and delivery of this Agreement and the performance of such
Party’s obligations do not and will not conflict with or constitute a default or
breach or require any consent under: (i) any other contractual obligation of
such Party; (ii) the provisions of its charter documents; or (iii) any order,
writ, injunction or decree of any court or governmental authority entered
against it or by which any of its property is bound.

 

14.2     iCo hereby represents and warrants to IMPH as of the Execution Date:

 

(a)     iCo has not previously assigned, transferred, licensed, conveyed or
otherwise encumbered its right, title and interest in the iCo Product IP in a
manner that conflicts with the license rights granted to IMPH in Section 2.1.
iCo undertakes not to take any of the foregoing actions during the term hereof,
commencing as of the Execution Date;

 

(b)     to iCo’s knowledge, and except as otherwise disclosed by iCo to IMPH in
writing, it is the exclusive owner or exclusive licensee of the iCo Product IP,
free and clear of any liens, charges and encumbrances, and no other person,
corporate or other private entity, or governmental entity or subdivision
thereof, has or shall have any claim of ownership or rights to practice under
the iCo Product IP in the Licensed Field in a manner that would conflict with
the license rights granted to IMPH in Section 2.1, and no Affiliate of iCo owns
or has license rights to any Patents that claim iCo-008;

 

(c)     to iCo’s knowledge, and except as otherwise disclosed by iCo to IMPH in
writing, there are no written claims, judgments or settlements against or owed
by iCo and no written, pending or threatened claims or litigation relating to
the iCo Product IP or iCo-008; and

 

(d)     there are no license or similar agreements between iCo and a Third
Party, under which iCo would owe royalties or other payments based on the grant
of the license rights to IMPH or the exercise by IMPH (or its Sub-sublicensees)
of the rights licensed to IMPH under the Agreement, other than the CAT
Agreement.

 

(e)     To iCo’s knowledge, iCo is not in material violation or default of any
provisions of the CAT Agreement. To iCo’s knowledge, the execution and delivery
by iCo of this Agreement and the performance of its terms will not result in any
material violation of, or be in conflict with or constitute, with or without the
passage of time and/or giving of notice, a material default under, the CAT
Agreement. iCo undertakes to use its reasonable best efforts to maintain the CAT
Agreement in full force and effect during the term hereof and to inform IMPH of
any basis or threat for a default, conflict or violation immediately following
such time that iCo is aware of the relevant circumstances. In the event that the
CAT Agreement is terminated by CAT in consequence of a default by iCo not
related to or due to IMPH, then IMPH shall be entitled to approach CAT and
request to enter into a license agreement with CAT and iCo shall use its
reasonable best efforts, to the extent feasible, to provide that the CAT
Agreement is terminated solely in connection with the Ocular Field.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
32

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(f)     The table in Schedule 3 lists all iCo Product Patents controlled by or
licensed to iCo existing as of the Execution Date. To its knowledge, iCo has
taken all necessary steps in connection with the due filing, prosecution and
maintenance of the iCo Patents. 

 

Further, iCo will not knowingly take any action that would cause the
representations in subsections (a) through (e) to be materially incorrect as of
the Effective Date.

 

14.3     Except as expressly stated in this Section 14, no representations or
warranties whatsoever are made or given by or on behalf of either of the
Parties, and all such other representations and warranties, whether express or
implied or arising by operation of law or otherwise, are hereby expressly
excluded, including any representations, conditions or warranties to the effect
that:

 

(a)     any of the iCo IP is valid or enforceable; or

 

(b)     any of the acts that may be undertaken by IMPH pursuant to this
Agreement will not infringe the rights of Third Parties.

 

14.4     IMPH acknowledges that most of the iCo IP is licensed (or sublicensed,
as applicable) to iCo by CAT pursuant to the terms of the CAT Agreement.

 

14.5     In addition to any other remedy available to iCo, IMPH hereby agrees to
indemnify, defend and hold iCo and its agents, directors, employees and
Affiliates harmless from and against any and all liabilities, damages, expenses,
judgments and/or losses, including reasonable legal expense and attorney’s fees,
to the extent resulting from any Third Party suits, claims, actions, or demands
resulting from a breach by IMPH of this Agreement or the actions or omissions of
IMPH, its Affiliates or agents or Sub-sublicensees in connection with the
development, commercialization, manufacture, use, handling, storage, sale or
other disposition of Licensed Products by IMPH or its Affiliate or
Sub-sublicensee. IMPH further agrees to indemnify, defend and hold iCo and its
agents, directors, employees and Affiliates harmless from and against any and
all liabilities, damages, expenses, judgments and/or losses, including
reasonable legal expense and attorney’s fees, resulting from any claims,
actions, proceedings, or demands by CAT (or its successor or any of its
affiliates) against iCo (including claims for breach of the CAT Agreement) based
on or resulting from the breach of any obligations under this Agreement or any
of the obligations under the CAT Agreement by IMPH or its Affiliate or
Sub-sublicensee.

 

14.6     In addition to any other remedy available to IMPH, iCo hereby agrees to
indemnify, defend and hold IMPH and its agents, directors, employees and
Affiliates harmless from and against any and all liabilities, damages, expenses
and/or loss, including reasonable legal expense and attorney’s fees, to the
extent resulting from any Third Party suits, claims, actions, or demands based
upon a breach by iCo of this Agreement.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
33

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15.

TERM AND TERMINATION 

 

15.1     Term

 

The Parties agree that as of the Execution Date, the only provisions of this
Agreement that are in force and effective shall be Articles 1 and 15 through 28
and Sections 7.1 and 14.5. No other provisions of these Agreement shall be
effective until the Effective Date. As provided in Section 7.1, upon payment by
IMPH to iCo of the entire License Fee (and provided that iCo has not earlier
terminated the Agreement under Section 15.2(a)), this Agreement and all its
provisions shall then automatically be in full effect, and thereafter, unless
earlier terminated as provided below, the Agreement will continue in full force
and effect on a Licensed Product-by-Licensed Product and country-by-country
basis, until the date no further payments in respect of such Licensed Product in
such country are or may become payable under Section 7 above. Upon the expiry of
such payment obligations, the license rights granted to IMPH hereunder for such
Licensed Product, solely in such country, shall be deemed fully paid up,
perpetual and irrevocable, and IMPH shall have no further obligations under
Section 7 with respect to such Licensed Product and the Net Sales of any such
Licensed Product in such country shall be excluded from the royalty calculations
in Section 7.6.

 

15.2     iCo shall have the right to terminate this Agreement immediately on
written notice to IMPH if:

 

(a)     The Qualified Financing has not occurred and/or IMPH does not pay to iCo
the License Fee (including issuing to iCo the appropriate amount of License
Shares) (i) by January 30, 2011, or (ii) so long as IMPH has paid iCo the option
extension fee as provided in Section 7.1(a), by March 31, 2011 (as applicable);
or

 

(b)     IMPH or a IMPH Affiliate knowingly opposes or assists any Third Party to
oppose, in any patent office or court proceeding, the grant of any patent or
patent application within the iCo Patents, or, in any patent office or court
proceeding, knowingly disputes or assists any Third Party to dispute the
validity of any patent within the iCo Patents or any of the claims thereof,
including opposing any application for amendment thereto; or

 

(c)     IMPH or a IMPH Affiliate commits an action or omission that constitutes
a material breach of the obligations under the CAT Agreement; or

 

(d)     IMPH or a IMPH Affiliate commits a material breach of its obligations
under this Agreement, and fails to remedy such material breach within a period
of sixty (60) days of receipt of a notice from iCo detailing such breach and of
its intention to exercise its rights under this Section, and provided that such
period shall be thirty (30) days for a material breach of a payment obligation;
for the purposes of this Section a “material breach” by IMPH includes the
non-payment of any sum payable by IMPH under this Agreement within thirty (30)
Business Days of its due date for payment; or

 

(e)     IMPH or a IMPH Affiliate is subject to an Insolvency Event.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
34

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15.3     If at the time of a Change of Control the acquiror or merger partner of
IMPH is in a court or patent office proceeding, knowingly opposing or assisting
any Third Party to oppose the grant of any patent or patent application within
the iCo Patents, or is in a court or opposition proceeding, knowingly disputing
or assisting any Third Party to dispute the validity of any Patent within the
iCo Patents or any of the claims thereof, including knowingly opposing any
application for amendment thereto, then such acquiror or merger partner shall
have forty-five (45) days from the date of the Change of Control to withdraw any
such proceedings and/or stop any such assistance, failing which iCo may
forthwith terminate this Agreement.

 

15.4     IMPH shall have the right to terminate the Agreement upon 30 days prior
written notice to iCo.

 

15.5     In the event that iCo commits a material breach of its obligations
under this Agreement, and fails to remedy such material breach within a period
of sixty (60) days of receipt of a notice from IMPH detailing such breach and of
its intention to exercise its rights under this Section 15.5, then IMPH shall
have the right to terminate the Agreement upon written notice to iCo which
termination shall be effective on the thirtieth (30th) days after such new
written notice is delivered to iCo.

 

16.

EFFECT OF TERMINATION OF AGREEMENT 

 

16.1     Termination, relinquishment or expiration of the Agreement for any
reason shall be without prejudice to any obligations that shall have accrued
prior to such termination, relinquishment or expiration, including the payment
obligations under Section 7 hereof and any and all damages arising from any
breach hereunder. 

 

16.2     Sections 2.6, 4.7, 7.1, 8.1, 8.6, 8.7, 8.9, 9.5, 9.6, 9.7, 10, 11.2,
14.4, 14.5, 16 and 17 shall survive the expiration and any termination of this
Agreement in its entirety.

 

16.3     Upon termination of this Agreement in its entirety by either Party,
then:

 

(a)     Without limiting or derogating from sub-section (b) below, IMPH hereby
grants iCo an exclusive, perpetual, irrevocable, sublicenseable, fully-paid,
royalty-free license, effective upon the effective date of such termination,
under any IMPH IP that is owned by IMPH or its Affiliate at the date of
termination to the extent that such IMPH IP is related to, or useful for the
development, manufacture, use or commercialization of, Licensed Product
(collectively, the “Terminated Agreement IP”) solely to research, develop, have
developed, register, make, have made, manufacture, have manufactured, formulate,
use, have used, import, have imported, export, market, have marketed, promote,
advertise, distribute, offer for sale and sell, have sold, transport and
distributed iCo-008, Licensed Products, and any other product that comprises a
VH CDR1, a VH CDR2 and a VH CDR3 domain (as such terms are defined in the text
and claims of US Patent No. 6,946,546) and binds to eotaxin-1. Any license for
IMPH IP that is not Terminated Agreement IP shall be negotiated between the
Parties in good faith upon such termination. In the event this Agreement is
terminated by IMPH pursuant to Section 15.5 due to iCo’s uncured material breach
of its obligations hereunder, then the foregoing rights under this Section
16.3(a) shall be of no force and effect.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
35

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(b)     IMPH shall, as soon as practicable after the effective date of the
termination, transfer and assign to iCo or its nominee, any and all Marketing
Approvals, INDs and other regulatory filings and approvals (including all
clinical data relating to Licensed Product and the global safety database) and
trade marks relating to Licensed Product, for iCo-008 and/or Licensed Product
being researched, developed or commercialized by or on behalf of IMPH or its
Affliate or sublicensee under this Agreement provided that to the extent IMPH
cannot assign any specific items of the foregoing to iCo without violating
applicable laws of any Competent Authority, then with respect to such items IMPH
shall transfer copies thereof and is automatically deemed to grant to iCo the
irrevocable, fully transferable rights of reference to such items, and provided
further that in the event this Agreement is terminated by IMPH pursuant to
Section 15.5 due to iCo’s uncured material breach of its obligations hereunder,
then Parties shall meet and negotiate in good faith the terms for the transfer
of, and/or right of reference to (as applicable), the specific regulatory
filings, approvals and/or trademarks as requested by iCo, which terms shall be
limited to a commercially reasonable royalty on sales of products for which
regulatory approval was based on substantial and material use of the
transferred, to reflect the commercial value (to the achievement of such
approvals of Licensed Products) of information transferred. As soon as
practicable after any such termination, IMPH shall disclose and transfer to iCo
copies of all such approvals, filings and marks.

 

(c)     IMPH shall not after the date of termination itself research, develop,
or commercialise Licensed Products in any country where there is, at the
applicable time, a Valid Claim in the iCo Product Patents claiming such Licensed
Product, except that IMPH shall have the right for a period of three (3) months
after the effective date of termination to dispose in such countries of that
part of its inventory of such Licensed Products on hand as of the effective date
of termination which is the subject of orders for Licensed Products accepted
prior to the effective date of termination and, within thirty (30) days after
disposition of such inventory pursuant to the fulfillment of such orders, IMPH
will forward to iCo a final report and pay all royalties due for Net Sales of
each Licensed Product during such period.

 

(d)     If requested by iCo, IMPH shall negotiate reasonably with iCo regarding
the transfer to iCo of raw materials, work-in-progress and active pharmaceutical
ingredients in IMPH’s control needed to enable the manufacture of the Licensed
Products under the rights set forth above in sub-sections (a) and (b), which
transfer would be on commercially reasonable terms. The Parties shall also
discuss in good faith other assistance, including assistance in relation to
manufacture and supply of the relevant Licensed Products which IMPH may be
willing and able to provide, which assistance would be at iCo’s cost and
expense. For the avoidance of doubt, this Section 16.3(d) shall not be construed
as an obligation for IMPH to enter into a manufacture and/or supply agreement,
such decision to be made at the sole judgement and discretion of IMPH.

 

(e)     iCo shall have the sole right, at its sole discretion, to file,
prosecute and maintain the Patents that cover inventions comprised in the
Terminated Agreement IP that relate specifically to iCo-008 and/or Licensed
Product and are not generally applicable to other products (the “Terminated
Agreement Patents”) and for the conduct of any lawsuits, claims or proceedings
relating to them in all countries, including any interference or opposition
proceedings, provided however that if any such Patent has application or claims
that cover IMPH IP that is not Terminated Agreement IP, that iCo shall exercise
the foregoing rights in cooperation and coordination with IMPH or as the Parties
may otherwise agree in writing in the context of any license agreement as
negotiated under Section 16.3(a) above.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
36

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16.4     Termination Not Sole Remedy

 

Termination is not the sole remedy under this Agreement and, whether or not
termination is effected, all other remedies will remain available except as
agreed to otherwise herein. 

 

17.

MISCELLANEOUS 

 

17.1     This Agreement shall be governed by and construed in accordance with
the laws of the province of British Columbia (and applicable federal laws of
Canada) without reference to conflicts of laws principles thereof. All disputes
arising out of or relating to the existence, negotiation, validity, formation,
interpretation, breach, performance or application of this Agreement shall be
settled by arbitration in accordance with the International Chamber of Commerce
(“ICC”) Arbitration Rules as at present in force and shall be held at New York,
New York in the English language by one arbitrator. The appointing authority
shall be the ICC acting in accordance with the Rules adopted by the ICC for this
purpose.

 

17.2     The Parties will use all reasonable endeavors to resolve any disputes
or issues arising out of this Agreement. The Parties shall refer any such
dispute or issue to the CEO of iCo and the CEO of IMPH, who shall co-operate and
discuss the matter in good faith and seek to resolve the dispute or issue as
amicably as possible within twenty (20) days of the dispute being referred to
them.

 

18.

ASSIGNMENT

 

18.1     This Agreement shall not be assignable by either Party to any Third
Party without the written consent of the other Party, such consent not to be
unreasonably withheld; except that, either Party may assign this Agreement,
without such consent, to an Affiliate or, subject to Section 15.3, to a
successor-in-interest entity that acquires all or substantially all of the
business or assets of such Party to which this Agreement pertains (whether by
merger, reorganization, acquisition, sale or otherwise), provided that such
entity agrees in a writing provided to the other Party to perform and be bound
by the terms and conditions of this Agreement as the successor party to this
Agreement.  Notwithstanding the foregoing, if any permitted assignment to an
Affiliate would result in additional taxes becoming due on payments to iCo under
this Agreement, then the Parties shall negotiate in good faith terms and
conditions under which such assignment would occur in order to minimize, to the
extent possible, any additional taxes. No assignment and transfer shall be valid
and effective unless and until the assignee/transferee shall agree in writing to
be bound by the provisions of this Agreement.  No permitted assignment will
relieve the assignor/transferor of liability hereunder. The terms and conditions
of this Agreement shall be binding on and inure to the benefit of the permitted
successors and assigns of the Parties.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
37

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18.2     In the event of a IMPH Change of Control, IMPH shall so notify iCo
within ninety (90) days of the occurrence of such Change of Control.

 

19.

Notices. Any notice or other communication to be given pursuant to or made under
or in connection with the matters contemplated by this Agreement shall be in
writing in the English language and shall be delivered by courier, sent by post
or sent by facsimile to the address or facsimile number of the recipient set out
in Schedule 10 or as specified by the recipient from time to time in accordance
with this Section 19. Notices sent by e-mail shall not be valid of themselves
and must be confirmed in hard copy form by courier, by post or facsimile.

 

19.1     Any notice given pursuant to Section 19 shall be deemed to have been
received:

 

(a)     in the case of courier or delivery by hand, when delivered; or

 

(b)     in the case of sending by post: when received by the addressee; and

 

(c)     in the case of facsimile, on acknowledgement by the recipient’s
facsimile receiving equipment on a Business Day if the acknowledgement occurs
before 1700 hours local time of the recipient and in any other case on the
following Business Day.

 

20.

WAIVER

 

20.1     Neither Party may waive or release any of its rights or interests in
this Agreement except in writing signed by a duly authorized representative of
that Party and may be given subject to any conditions thought fit by the
grantor.  Unless otherwise expressly stated any waiver shall be effective only
in the instance and for the purpose for which it is given.

 

20.2     The delay or failure of either Party to assert a right hereunder or to
insist upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition.  No waiver by either Party of any condition
or term in any one or more instances shall be construed as a continuing waiver
of such condition or term or of another condition or term.

 

21.

SEVERABILITY

 

21.1     If the whole or any part of this Agreement (including any one or more
of the clauses of this Agreement or any sub-clause or paragraph or any part of
one or more of these clauses) is or becomes or is declared illegal, invalid or
unenforceable in any jurisdiction for any reason (including both by reason of
the provisions of any legislation and also by reason of any decision of any
court or Competent Authority which either has jurisdiction over this Agreement
or has jurisdiction over any of the Parties) then:

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
38

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(a)     in the case of the illegality, invalidity or un-enforceability of the
whole of this Agreement it shall terminate in relation to the jurisdiction in
question; or

 

(b)     in the case of the illegality, invalidity or un-enforceability of part
of this Agreement and the failure of the Parties to negotiate in good faith an
enforceable amendment of this Agreement that attempts to reflect the Parties’
original intent as much as possible, that part shall be severed from this
Agreement in the jurisdiction in question and that illegality, invalidity or
un-enforceability shall not in any way whatsoever prejudice or affect the
remaining parts of this Agreement which shall continue in full force and effect.

 

22.

FORCE MAJEURE 

 

22.1     If a Party (the “Non-Performing Party”) is unable to carry out any of
its obligations under this Agreement due to Force Majeure, this Agreement shall
remain in effect but the Non-Performing Party’s relevant obligations under this
Agreement and the corresponding obligations of the other Party under this
Agreement, shall be suspended for a period equal to the circumstance of Force
Majeure or six (6) months whichever is the shorter.

 

22.2     If Force Majeure is continuing at the expiry of the said period of six
(6) months, the other Party may give written notice to terminate this Agreement
to the Non Performing Party.

 

23.

COUNTERPARTS  

 

23.1     This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.

 

24.

ENTIRE AGREEMENT; AMENDMENT 

 

24.1     This Agreement and the Schedules hereto constitute the entire agreement
and understanding between the Parties and supersedes all prior oral or written
understandings, arrangements, representations or agreements between them
relating to the subject matter of this Agreement. The Parties acknowledge that
no claims shall arise in respect of any understandings, arrangements,
representations or agreements so superseded. No director, employee or agent of
any Party is authorised to make any representation or warranty to another Party
not contained in this Agreement, and each Party acknowledges that it has not
relied on any such oral or written representations or warranties. Nothing in
this Agreement removes or overrides any right of action by any Party in respect
of any fraudulent misrepresentation, fraudulent concealment or other fraudulent
action.

 

24.2     No variation, amendments, modification or supplement to this Agreement
shall be valid unless made in writing in the English language and signed by a
duly authorised representative or representatives of each Party.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
39

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25.

INDEPENDENT CONTRACTORS AND RELATIONSHIP OF THE PARTIES  

 

25.1     Nothing herein shall be construed to create any relationship of
employer and employee, agent and principal, partnership or joint venture or any
other legal entity, between the Parties or to constitute one Party as the agent
of the other.  Each Party is an independent contractor.  Neither Party shall
assume, either directly or indirectly, any liability of or for the other Party. 
Neither Party shall have the authority to bind or obligate the other Party and
neither Party shall represent that it has such authority. Neither this Agreement
nor any of the transactions contemplated by this Agreement shall be construed as
a partnership for any tax purposes. Moreover, each of the Parties agrees not to
construe this Agreement, or any of the transactions contemplated by this
Agreement, as a partnership for any tax purposes.

 

26.

EXPENSES  

 

26.1     Except as provided otherwise herein, each of the Parties hereto shall
bear its own expenses (including all compensation and expenses of counsel,
financial advisors and consultants) incurred in connection with the preparation
and execution of this Agreement and the consummation of the transactions
contemplated hereby.

 

27.

FURTHER ASSURANCES  

 

27.1     IMPH and iCo hereby agree without the necessity of any further
consideration, to execute, acknowledge and deliver any and all such other
documents and take any such other reasonable action as may be reasonably
necessary to carry out the intent and purposes of this Agreement.

 

28.

HEADINGS AND CONSTRUCTION 

 

28.1     Headings used herein are for convenience only and shall not in any way
affect the construction of or be taken into consideration in interpreting this
Agreement. Except where the context requires otherwise, whenever used the
singular includes the plural, the plural includes the singular, the use of any
gender is applicable to all genders. Whenever this Agreement refers to a number
of days, unless otherwise specified, such number refers to calendar days. The
term “including” or “includes” as used in this Agreement means “including
without limitation” as to the generality of any description preceding such term.
The wording of this Agreement shall be deemed to be the wording mutually chosen
by the Parties and no rule of strict construction shall be applied against
either Party. To the extent there is any conflict or inconsistency between the
terms of this Agreement and the Schedules attached hereto, the terms of this
Agreement shall prevail.

 

29.

NO THIRD PARTY BENEFICIARIES 

 

29.1     None of the provisions of this Agreement shall be for the benefit of or
enforceable by any Third Party including any creditor of any Party hereto,
whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise. No
such Third Party shall obtain any right under any provision of this Agreement or
shall by reason of any such provision make any claim in respect of any debt,
liability or obligation (or otherwise) against any Party hereto.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
40

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30.

USE OF AFFILIATES OR SUBLICENSES 

 

30.1     IMPH may satisfy any or all of its obligations under this Agreement by
the actions of one or more of its Affiliates or Sub-sublicensees, provided that
IMPH shall remain responsible for satisfying (or providing that an Affiliate or
Sub-sublicensee satisfies) all of its obligations under this Agreement in
accordance with and subject to Sections 2.6 and 4.5.

 

In Witness Whereof, the Parties have executed this Agreement in duplicate
originals by their duly authorized representatives as of the date and year first
above written.

 

IMMUNE PHARMACEUTICALS, LTD.

 

iCo THERAPEUTICS INCORPORATED

 

 

 

By:

 /s/ Daniel Teper

 

By:

 Andrew Rae

 

 

 

Name:

Daniel Teper

 

Name:

 Andrew Rae

 

 

 

Title:

CEO

 

Title:

 CEO

 

 

 

Date:

 December 7, 2010

 

Date:

 December 7, 2010

         

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
41

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Schedule 1

Amino Acid Sequence of iCo-008 Antibody

 

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 
42

--------------------------------------------------------------------------------

 

 

Confidential

 

Schedule 2
iCo Background Patents

 

 

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
43

--------------------------------------------------------------------------------

 

 

Confidential

 

Schedule 3

 

iCo Product Patents

 

 

 

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
44

--------------------------------------------------------------------------------

 

 

Schedule 4

 

Development Plan

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
45

--------------------------------------------------------------------------------

 

 

Schedule 5

 

[***] Rights

 

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 

 
46

--------------------------------------------------------------------------------

 

 

Schedule 6

 

[***] Agreement

[***]

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
47

--------------------------------------------------------------------------------

 

 

Schedule 7

[***]

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
48

--------------------------------------------------------------------------------

 

 

Schedule 8

 

iCo-008 Study Reports and Protocols

 

[***]

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
49

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Schedule 9

 

Press Release

 

 

[ex10-30img001.gif]          PRESS RELEASE

 

 

iCo Therapeutics Grants License Option for Bertilimumab (iCo-008) Systemic Uses
to Immune Pharmaceuticals for US$33 Million Plus Royalties

 

For Immediate Release 

November XX, 2010 

 

VANCOUVER, Canada — iCo Therapeutics Inc. (TSX-V: ICO) (the “Company”) today
announced that iCo has granted Immune Pharmaceuticals (IMPH), based in Israel
and the United States, an option to an exclusive license for the development and
commercialization rights to the systemic uses of iCo-008, iCo’s human monoclonal
antibody targeting eotaxin-1.

 

Highlights

 

 

●

Licence Option is for systemic uses including: Inflammatory Bowel Disease and
Severe Asthma.

 

 

●

iCo has retained worldwide exclusive rights to all ocular applications.

 

 

●

IMPH will pay iCo a non-refundable option fee creditable upon conversion against
an upfront license fee payment of US $1 million.

 

 

●

iCo may receive up to an additional US$32 million in milestone payments as well
as royalties on net sales of licensed products.

 

Non ocular uses of the drug may include asthma and prevalent inflammatory bowel
conditions. iCo will retain worldwide exclusive rights to all uses and
applications in the ocular field. iCo estimates the market for ocular
applications, including age-related macular degeneration and sight-threatening
ocular allergies exceeds $2 billion.

 

“iCo has retained the rights to all ocular indications for iCo-008. Research has
shown that iCo-008 interdicts a well-established target involving several
potentially devastating and large market ocular diseases, and we look forward to
enabling multiple late stage trials in these indications,” stated Andrew Rae,
President & CEO of iCo Therapeutics. “In addition, iCo remains focused on
advancing the company’s lead program, iCo-007, into a Phase II trial in Diabetic
Macular Edema in early 2011”.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
50

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Dr. Daniel Teper, CEO of Immune Pharmaceuticals stated, “A close relationship
has been established between eotaxin levels and disease activity in patients
with severe gastro-intestinal or respiratory conditions. Bertilimumab promises
to be a first in class human monoclonal antibody, opening new treatment options
in Inflammatory Bowel Disease and Severe Asthma.”

 

Immune Pharmaceuticals plans to prepare Bertilimumab for several Phase II
clinical programs in a number of inflammatory conditions, starting with Crohn’s
Disease.

 

About iCo-008

iCo-008 (also known as Bertilimumab or CAT-213) is a human immunoglobulin
monoclonal antibody targeting eotaxin-1, a member of the chemokine family of
proteins that act as messenger molecules between the cells of the immune system.
iCo-008 has been in 126 patients in Phase I and II studies, has a good safety
profile and has shown evidence of efficacy in a severe allergy indication.
iCo-008 may be indicated for inflammatory disorders including severe asthma,
Inflammatory Bowel Disease, Crohn’s Disease and Ulcerative Colitis.

 

Recent published scientific literature (Takeda et al, Nature 2009. “CCR3 is a
Target for Age-related Macular Degeneration Diagnosis and Therapy”) has
indicated that iCo-008, a ligand for CCR3, may be effective in treating wet age
related macular degeneration (wAMD). iCo is currently planning exploratory
studies for iCo-008 in wAMD and a Phase II study in severe ocular allergies
(vernal & atopic keratoconjunctivitis).

 

iCo licensed the exclusive world-wide rights to iCo-008 from
AstraZeneca/Cambridge Antibody Technology in 2007.

 

About iCo Therapeutics

iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on
redosing or reformulating drugs with clinical history for new or expanded
indications. iCo has exclusive worldwide rights to three products: iCo-007,
moving into Phase II for the treatment of DME, iCo-008; a product with Phase II
clinical history to be developed for severe ocular allergies and age-related
macular degeneration; and iCo-009, an oral formulation of Amphotericin B for
sight and life-threatening diseases. iCo-009 also represents a new drug delivery
technology with the potential to reprofile other parenteral administered drugs
to the oral route of administration. iCo was recently awarded a Gold Leaf Award
as the Early Stage Company of the Year from BIOTECanada and is a Canada's Top
10™ Competition winner. iCo trades on the TSX Venture Exchange under the symbol
“ICO”. For more information, visit the Company website at:
www.icotherapeutics.com

 

About Immune Pharmaceuticals

Immune Pharmaceuticals is an Israel and U.S. based biopharmaceutical company
focused on the development of monoclonal antibodies addressing significant unmet
medical needs in the treatment of cancer, inflammation, and infectious diseases.
Immune Pharmaceuticals has built a robust pipeline of clinical and pre-clinical
candidates based on novel targets and fully human antibody technology.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

  

 
51

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No regulatory authority has approved or disapproved the content of this release.
The TSX Venture Exchange does not accept responsibility for the adequacy or
accuracy of this release.

 

Forward Looking Statements

 

Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements to
be materially different from those implied by such statements, and therefore
these statements should not be read as guarantees of future performance or
results. All forward-looking statements are based on iCo Therapeutics’ current
beliefs as well as assumptions made by and information currently available to
iCo Therapeutics and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date of
this press release.  Due to risks and uncertainties, including the risks and
uncertainties identified by iCo Therapeutics in its public securities filings;
actual events may differ materially from current expectations. iCo Therapeutics
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.

 

Business Development:

Dr. John Clement, CTDO

604-602-9414 x 222

 

Finance:

Mr. John Meekison, CFO

604-602-9414 x 224

 

Investor/Media Contact:

Frederica Jensen

604-602-9414 x 226

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

 

 
52

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Schedule 10

 

[TO BE FINALISED]

Notices

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Exchange Act of 1934, as amended.

53