DATED DECEMBER 7, 2010 iCo THERAPEUTICS INCORPORATED and IMMUNE PHARMACEUTICALS LTD. PRODUCT SUBLICENSE AGREEMENT
Exhibit 10.30
EXECUTION VERSION
DATED DECEMBER 7, 2010
iCo THERAPEUTICS INCORPORATED
and
IMMUNE PHARMACEUTICALS LTD.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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.
Confidential
CONTENTS
Section |
Heading | Page |
1. | Definitions | 1 |
2. | License and Sublicense Grants | 8 |
3. | Technology Transfer | 9 |
4. | Product Development; Regulatory and Safety | 10 |
5. | Commercialization and Marketing | 13 |
6. | Non-Competition | 14 |
7. | Payments | 14 |
8. | Provisions Relating to Payment of Consideration | 17 |
9. | Intellectual Property and Patent Rights | 18 |
10. | Confidentiality | 21 |
11. | Press Release and Publication | 23 |
12. | Trade Marks | 24 |
13. | Xoma Agreement and Dyax Rights | 24 |
14. | Representations, Warranties, Covenants and Indemnification | 25 |
15. | Term and Xxxxxxxxxxx | 00 |
00. | Effect of Termination of Agreement 33 | 28 |
17. | Miscellaneous | 29 |
18. | Assignment | 29 |
19. | Waiver | 30 |
20. | Severability | 30 |
21. | Force Majeure | 30 |
22. | Counterparts | 31 |
23. | Entire Agreement; Amendment | 31 |
24. | Independent Contractors and Relationship of the Parties | 31 |
25. | Expenses | 31 |
26. | Further Assurances | 31 |
27. | Headings and Construction | 31 |
28. | No Third Party Beneficiaries | 32 |
29. | Use of Affiliates or Sublicensees | 32 |
Redacted Xoma Agreement | 41 | |
XOMA NOTICE | 62 | |
iCo-008 Study Reports and Protocols | 67 | |
Press Release | 68 | |
Notices | 70 |
Portions of this Exhibit, indicated by the xxxx “[***]”, 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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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 Xxxxx 000, 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX, Xxxxxx, X0X 0X0 (“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 Xxxxxxxx, 0xx Xxxxx, Xxx Xxxx, XX (“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.
“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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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“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.
“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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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“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.
“Dyax Agreements” shall mean (i) that certain license agreement dated 31 December 1997 made between Dyax Corp (“Dyax”) and CAT relating to diagnostic products (the “Dyax Diagnostics Agreement”), (ii) that certain license agreement dated 31 December 1997 made between Dyax and CAT relating to therapeutic products (the “Dyax Therapeutics Agreement”), and (iii) that certain amendment agreement dated 31 January 2003 and made between CAT and Dyax (the “Dyax Amendment Agreement”).
“Dyax Patent Rights” shall mean a sublicense under the rights Controlled by iCo under the Dyax Agreements granted in accordance with Sections 1 and 2 of Schedule 5, subject to the obligations on the sublicensee set out in Section 3 of Schedule 5.
“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.
“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 gastro-intestinal 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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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“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.
“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;
(d) has a resolution passed for its winding-up, official management or liquidation (other than pursuant to a consolidation, amalgamation or merger);
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(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, 000 Xxxx Xxxx, Xxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxxx.
“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.
“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).
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
“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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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“Qualified Financing” shall mean the financing of IMPH following its incorporation in which outside investors invest: (i) at least [***] (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.
“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 Dyax Patent Rights and the Xoma 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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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“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.
“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.
“XOMA Agreement” shall mean the License Agreement dated 22nd December 2002 and made by and between XOMA Ireland Limited and CAT, a redacted version of which is set out in Schedule 6.
“XOMA Notice” shall mean the notice set out in Schedule 2.4 of the XOMA Agreement and which is attached hereto in Schedule 7.
“XOMA Patent Rights” shall have the meaning set out in the XOMA Agreement.
“XOMA Rights” shall mean those rights and obligations set out in the XOMA Notice and XOMA 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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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 Dyax 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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
(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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(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.
(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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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) + 10% if as part of a forecasted order or otherwise cost + 20%. 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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(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.
(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:
First dosing in a Phase III (or pivotal) clinical trial: | [***] |
First BLA/MAA (or equivalent) filing: | [***] |
First BLA/MAA approval: | [***] |
Upon achieving US$ 100 Million in aggregate | [***] |
sales of Licensed Product for use in GI | |
Indications: |
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(b) Each of the milestone payments in Section 7.3(a) shall be due and payable [***].
(c) If the BLA/MAA filing milestone in Section 7.3(a) is achieved for a particular Indication prior to the achievement of the Phase III milestone event (e.g., a BLA filing on the basis of Phase II data) for such Indication, the milestone payment with respect to the Phase III milestone as to such Indication will also become due and payable at the same time.
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.
7.4 IMPH shall pay iCo royalties for the period of time described in Section 7.9 in an amount equal to eight and a half percent (8.5%) 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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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 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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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 xxxx “[***]”, 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. Portions marked by * were summarized]
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12. Trade Marks
12.1 Neither Party shall use the name, trade xxxx, 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. Xoma Agreement And Dyax Rights
13.1 Unless otherwise defined in this Agreement or specified in this Section 13, capitalised words and phrases used in this Section 13 and Schedules 8 and 9 shall have the meanings attributed to them in the XOMA Agreement.
13.2 IMPH hereby acknowledges and agrees that:
(a) the redacted version of the XOMA Agreement and the XOMA Notice attached hereto as Schedules 8 and 9 were provided to IMPH prior to the Effective Date; and
(b) IMPH shall, and shall procure that its Affiliates and all Sub-IMPHs shall, abide by each of the limitations, restrictions and other obligations applicable to CAT Collaborators (which for the purposes of this Agreement shall be further limited and restricted to Licensed Products and iCo-008 only) as provided in the XOMA Notice; and
(c) any sums paid or payable to iCo by IMPH under the terms of this Agreement shall not constitute or be deemed to constitute payments to XOMA; and
(d) it shall only Dispose of Licensed Antibody Phage Display Materials (which for the purposes of this Agreement shall be further limited and restricted to Licensed Products and iCo-008 only) or any materials the use of which results in the practice of any method within the scope of any Valid Claim (as defined in the XOMA Agreement) of the XOMA Patent Rights but only to a Third Party (as defined in the XOMA Agreement) who otherwise meets the definition of CAT Collaborator; and
(e) notwithstanding the rights set out under the XOMA Agreement, IMPH agrees that, in accordance with the other provisions of this Agreement (including the scope of the licenses granted under Section 2) that its rights under the XOMA Agreement shall be solely in relation to Licensed Products and iCo-008.
13.3 iCo hereby acknowledges and agrees that:
(a) IMPH is and shall be entitled to the benefits of all of the licenses and other rights provided for in the XOMA Agreement subject always to the provisions of the XOMA Agreement, solely with respect to Licensed Products and iCo-008; and
(b) XOMA is an intended Third Party beneficiary of the provisions of this Section 13.
13.4 IMPH hereby acknowledges that:
(a) The rights in respect of the Dyax Patent Rights which will be comprised in the sublicenses granted by iCo to IMPH under Section 2.1 of this Agreement are and will be subject to IMPH agreeing to be bound by Section 2.1 (as amended by Section 15 of the Dyax Amendment Agreement), Section 6 and Section 8 of each of the Dyax Diagnostics Agreement and Dyax Therapeutic Agreement. Section 2.1 (as amended by Section 15 of the Dyax Amendment Agreement), Section 6 and Section 8 are attached hereto as Schedule 5 and IMPH hereby agrees that it shall be bound by the provisions of each such section and clause as provided herein; and
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(b) The Sublicensed Rights that are sub-licensed to IMPH under this Agreement can never exceed the rights that iCo is able to sublicense under the terms of the CAT Agreement and CAT’s agreements with such Third Parties.
13.5 IMPH hereby agrees to comply with all applicable terms and conditions of the Dyax Agreement and the XOMA Agreement (to the extent such terms are set forth in the Schedules to this Agreement).
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
(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
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(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.
(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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
(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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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(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.
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 xxxx “[***]”, 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. Portions marked by * were summarized]
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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:
(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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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.
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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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) Xxx 0000 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.
30. Use of Affiliates or Sublicensees
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/ Xxxxxx Xxxxx | By: | /s/ Xxxxxx Xxx | |
Name: | Xxxxxx Xxxxx | Name: | Xxxxxx Xxx | |
Title: | CEO | Title: | CEO | |
Date: | December 7, 2010 | Date: | December 7, 2010 |
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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Schedule 1
Amino Acid Sequence of iCo-008 Antibody
[***]
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Confidential
Schedule 2
iCo Background Patents
[***]
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Confidential
Schedule 3
iCo Product Patents
Application Filing Date |
Application Number | Country | Status | Patent Number |
Date of Grant | |||||
02/03/2001 | 0105237.2 | United Kingdom | Granted | 2361704 | 10/04/2002 | |||||
02/03/2001 | 09/798058 | United States of America | Granted |
6946546 |
20/09/2005 | |||||
02/03/2001 | 0135852 | Australia | Granted | 778392 | 24/03/2005 | |||||
02/03/2001 | PI0108923-4 | Brazil | Pending | |||||||
02/03/2001 | 2401342 | Canada | Granted | 2401342 | 03/08/2010 | |||||
02/03/2001 |
01907990.4 |
European Patent Office | Granted | 1259615 | 12/11/2008 | |||||
02/03/2001 | 01907990.4 | Switzerland | Granted | 1259615 | 12/11/2008 | |||||
02/03/2001 | 01907990.4 | Germany | Granted | 1259615 | 12/11/2008 | |||||
02/03/2001 | 01907990.4 | France | Granted | 1259615 | 12/11/2008 | |||||
02/03/2001 | 01907990.4 | Ireland | Granted | 1259615 | 12/11/2008 | |||||
02/03/2001 | 000000 | Xxxxxx | Granted | 151499 | 01/10/2010 | |||||
02/03/2001 | 0000-000000 | Xxxxx | Pending | |||||||
02/03/2001 | 521182 | New Zealand | Granted | 521182 | 10/03/2005 | |||||
02/03/2001 | 200205292-6 | Singapore | Granted | 91497 | 28/04/2006 | |||||
09/01/2003 | 10/220418 | United States of America | Granted | 7323311 | 29/01/2008 | |||||
17/12/2007 | 11/958210 | United States of America | Pending |
and including any and all foreign counterparts of the above applications, and 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 the above, to the extent the above are Controlled by iCo.
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Schedule 4
Development Plan
[***]
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Schedule 5
Dyax Patent Rights
License Agreement for Therapeutic Products and License Agreement for Diagnostic Products [both dated December 31 1997 (“Effective Date”).
1. | License grant to CAT (in same terms for both Therapeutic and Diagnostic licenses) |
Section 2.1 | Subject to the terms and conditions set forth herein, Licensor hereby grants Sublicensee and its Affiliates a world-wide, nonexclusive, royalty-bearing license (without the right to grant sublicenses) under Patent Rights (i) to research, develop, make, have made, use, import, sell and have sold Licensed Products in the Field of Use, and (ii) to research, develop, make and use Licensed Intermediates in the Field of Use (a) for sale or transfer to any Commercial Party, or (b) for transfer to any third party who is not permitted by Sublicensee or its Affiliates to commercialise such Licensed Intermediates or any Licensed Product. |
Defined Terms:
“Commercial Party” means any party, other than an Affiliate of Sublicensee, which has been authorized by Sublicensee to make, have made, use, sell or have sold Licensed Products and (i) to which Sublicensee (or any of its Affiliates), sells, transfers, or otherwise makes available any Licensed Intermediate or (ii) for which Sublicensee (or any of its Affiliates) performs services or provides proprietary information, with respect to any Licensed Intermediate.
“End User” means a person or entity whose use of a product results in its destruction, loss of activity, and/or loss of value.
“Field of Use” [for the Therapeutic License] means research and development and human or non-human therapeutics only, and not any in vitro or in vivo diagnostics, purification or separations, research products, or other industrial purposes.
“Field of Use” [for the Diagnostic License] means research and development and human or non-human in vitro diagnostic or research agent uses only, and not any therapeutic, in vivo diagnostics, purification or separations, or other industrial purposes.
“Licensor” means Dyax Corp.
“Sublicensee” means Cambridge Antibody Technology Limited.
“Licensed Intermediate” means any fusion protein (including without limitation any chimeric binding protein), genetic package (including without limitation any virus, spore or cell) or other intermediate compound, or any compound derived from any of the foregoing, that is (i) discovered, made or developed by Sublicensee using a method covered in whole or in party by Patent Rights or (ii) is otherwise covered by Patent Rights.
“Licensed Product” [for the Therapeutic License] means any product intended for sale to an End User as a human or non-human therapeutic that prior to or after the Effective Date is discovered, made or developed, whether by Sublicensee, its Affiliates or any Commercial Party, using a Licensed Intermediate or a method covered in whole or in part by Patent Rights.
“Licensed Product” [for the Diagnostic License] means any product intended for sale to an End User as a human or non-human in vitro diagnostic or research agent and containing one or more antibodies as a binding moiety that prior to or after the Effective Date is discovered, made or developed, whether by Sublicensee, its Affiliates or any Commercial Party, using a Licensed Intermediate or a method covered in whole or in part by Patent Rights.
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“Valid Claim” means either (a) a claim of an issued patent that has not been held unenforceable or invalid by an agency or a court of competent jurisdiction in any unappealable or unappealed decision or (b) a claim of an issued patent from a published pending patent application in a country where provisional rights of enforcement are perfected, retroactive to the date of publication, and that has not been abandoned or finally rejected without the possibility of appeal or refilling.
“Patent Rights” means all Valid Claims (defined below) of United States Patent Nos 5,223, 409, 5,403,484 and 5,571,698 (collectively, the “U.S. Patents”), reissues re-examinations, renewals and extensions thereof, and all continuations, continuations-in-part and divisionals of the applications for such patents in the United States and all counterparts thereto in countries outside the United States, all of which patents and patent applications as of the Effective Date are listed in Attachment B. Patent Rights shall not include (i) Valid Claims in U.S. Patent No. 5,233,409 to the extent they cover single chain antibodies, nor (ii) Valid Claims of any continuation, continuation-in-part or divisional applications of the U.S. Patents or any counterparts of the U.S. Patents in countries outside of the United States, that cover particular protein or peptide sequences, or nucleic acids thereof, that bind to a specific biological or molecular target.
“Attachment B” – Patent Rights
Country |
Application/Patent Number |
Filing Date | Patent No | Issue Date | ||||
US | 07/664,989* | 3/1/91 | 5,223,409 | 6/29/93 | ||||
US | 9,319 | 1/26/93 | 5,403,484 | 4/4/95 | ||||
US | 08/057,667 | 6/18/93 | 5,571,698 | 11/5/96 | ||||
US | 08/415,922 | 4/3/95 | Allowed | |||||
US | 12/18/97 | |||||||
PCT | US89/03731 W09002809 (pub) |
9/1/89 3/22/90 |
||||||
EPO | 89/910702.3 EP436597 (pub) |
9/1/89 7/17/91 |
436,597 | 4/2/97 | ||||
EPO div | 96/112867.5 | 8/9/96 | ||||||
Japan | 00000000 JP4502700 (pub) |
9/1/89 5/21/92 |
||||||
Canada | 610,176 | 9/1/89 | ||||||
Ireland | IR89/2834 | 9/4/89 | ||||||
Israel (& divs) | 91501 | 9/1/89 | ||||||
PCT | US92/01456 W09215677 (pub) |
2/27/92 9/17/92 |
||||||
EPO | 92/908057.0 | 2/27/92 | ||||||
Canada | 2105300 | 2/27/92 | ||||||
Japan | 00000000 | 2/27/92 |
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Country |
Application/Patent Number |
Filing Date | Patent No | Issue Date | ||||
PCT | US92/01539 X00000000 (pub) |
2/28/92 9/17/92 |
||||||
EPO | 92/908799.7 | 2/28/92 | ||||||
Canada | 2105303 | 2/28/92 | ||||||
Japan | 00000000 | 2/28/92 |
· | CIP of US SN487,063 filed 3/2/90 which is a CIP of US SN 240,160 filed 9/2/88. |
2. | CAT’s Rights to Grant Sub-licenses |
These rights are set out in an Amendment Agreement to the December 31, 1997 agreements and are as follows:
“CAT may grant a sub-license under the Patent Rights to any Third Party to which CAT is licensing, selling or otherwise transferring Antibodies or Antibody Libraries (as defined in the Amendment Agreement between Dyax and CAT dated as of January 3, 2003) solely for use by such Third Party with the Antibodies or Antibody Libraries licensed, sold or otherwise transferred from CAT and solely for the purpose of developing therapeutic Antibody products or diagnostic Antibody products”.
Additional Definitions
“Antibody” means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof
“Antibody Library” means any Antibody library constructed using processes which are covered by a claim of an issued and unexpired patent included within the Antibody Phage Display Patents which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.
As a condition to any such sub-license, CAT requires any sub-licensee to be bound by the terms of Section 2.1 (License Grant), Section 6 (Indemnification) and Section 8 (Confidentiality & Publicity) of the Original Agreements which are as follows:
3. | Obligations on Sublicensees |
(a) | Grant of license limited to Section 2.1 as set out above; |
(b) | Any sub-licensee shall have no right to grant further sub-licenses; |
(c) | Section 6 (Indemnification) |
“Each party shall indemnify, defend, and hold harmless the other party and its Affiliates and their directors, officers, employees, and agents and their respective successors, heirs and assigns (the “Indemnities”) against any liability, damage, loss or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments concerning any product, process or service of the indemnifying party or its Affiliates that is made, used, sold or provided pursuant to any right or license granted by the other party under this Agreement.” |
Section 8 (Confidentiality and Publicity) | |
Section 8.1 | Confidentiality: With respect to any confidential information received from
the other party (“Confidential Information”), each party undertakes and agrees to: |
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(a) | only use the Confidential Information 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 of this Agreement have access to the Confidential Information on a strictly “need to know” basis and are informed of the secret and confidential nature of it; |
(c) | keep the Confidential Information secret, confidential, safe and secure and shall not directly or indirectly disclose or permit to be disclosed the same to any third party, including any consultants or other advisors, without the prior written consent of the disclosing party except to the extent disclosure is necessary in connection with its use as envisaged under this Agreement; |
(d) | ensure that the Confidential Information will not be covered by any lien or other encumbrance in any way; and |
(e) | not copy, reproduce or otherwise replicate for any purpose or in any manner whatsoever any documents containing the Confidential Information except to the extent necessary in connection with its use as envisaged under this Agreement. |
8.2 | Exceptions to Confidentiality: The obligations referred to in Section 8.1 above shall not extend to any Confidential Information which: |
(a) | is or becomes generally available to the public otherwise than be reason of breach by a recipient party of the provision of Section 8.1; |
(b) | is known to the recipient party and is at its free disposal (having been generated independently by the recipient party or a third party in circumstances where it has not been derived directly or indirectly from the disclosing party’s Confidential Information prior to its receipt from the disclosing party), provided that evidence of such knowledge is furnished by the recipient party to the disclosing party within twenty-eight (28) days of recipient of that Confidential Information; |
(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 Confidential Information; and |
(d) | is required by law to be disclosed (including as part of any regulatory submission or approval process) and then only when prompt written notice of this requirement has been given to the disclosing party so that it may, if so advised, seek appropriate relief to prevent such disclosure, 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 on the timing and content of such disclosure. |
8.3 | Publicity: No public announcement or other disclosures to third parties concerning the terms of this Agreement, shall be made, whether directly or indirectly, by any third party to this Agreement (except confidential disclosures to professional advisors) without first obtaining the approval of the other party and agreement upon the nature and text of such announcement or disclosure with the exception that: |
(a) | A party may disclose these terms which it is required by regulation or law to disclose, provided that it takes advantage of all provisions to keep confidential as many terms of this Agreement as possible; and |
(b) | the party desiring to make any such public announcement or other disclosure shall inform the other party of the proposed announcement or disclosure in reasonably sufficient time prior to public release, and shall provide the other party with a written copy thereof, in order to allow such party to comment upon such announcement or disclosure. Each party agrees that it shall cooperate fully with the other with respect to all disclosures regarding this Agreement to the U.S. Securities Exchange Commission, the UK Stock Exchange and any other comparable body including requests for confidential information or proprietary information of either party included in any such disclosure. The parties agree that Licensor shall be entitled from time to time to include the name of Sublicensee within a list of licensee under the Patent Rights in a public announcement.] |
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Schedule 6
Redacted Xoma Agreement
LICENSE AGREEMENT
This License Agreement (this “Agreement”), effective as of December 22, 2002 (the “Effective Date”), is entered into by and between XOMA Ireland Limited, a company with limited liability organized under the laws of the Republic of Ireland having offices at Xxxxxxx Xxxxxxx Xxxxx, Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx (with its Affiliates, “XOMA”), and Cambridge Antibody Technology Limited (with its Affiliates, “CAT”), an English company having a principal place of business at Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxx, Xxxxxxxxx, XX0 0XX, Xxxxxxx.
BACKGROUND
A. | XOMA is the owner or exclusive licensee of certain patent rights; |
B. | CAT wishes to acquire non-exclusive licenses under such patent rights on the terms and conditions set forth below; and |
C. | XOMA is willing to grant CAT non-exclusive licenses on the terms and conditions set forth below. |
NOW, THEREFORE, in consideration of the promises and the mutual covenants hereinafter recited, the parties agree as follows:
ARTICLE 1
DEFINITIONS
In this Agreement, the following terms shall have the meanings set forth in this Article.
1.1 | “Affiliate” means any corporation or other entity which is directly or indirectly controlling, controlled by or under common control with a party hereto. For purposes of this Agreement, “control” (including, with correlative meanings, the terms “controlled” and “controlling”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of the subject corporation or other entity, whether through the ownership of voting securities, by agreement or otherwise. |
1.2 | “Antibody” means, for purposes of Sections 1.5, 1.6, 1.20 and 1.27 only, 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. |
1.3 | “Antibody Phage Display” means the authorized use of Licensed Antibody Phage Display Materials to conduct Research and Development. |
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1.4 | “CAT Collaborator” means any person or entity who is an authorized end-user or intended recipient of Licensed Antibody Phage Display Materials (including a CAT Library), Licensed Immunoglobulins or Licensed Immunoglobulin Information transferred from CAT and/or a person or entity on whose behalf CAT knowingly engages in Antibody Phage Display; provided, however, that except for the entities identified on Schedule 1.4 such person or entity shall not be deemed to be a CAT Collaborator unless and until the requirements of Section 2.4 are complied with. An initial list of CAT Collaborators with whom CAT has an agreement in full force and effect as of the Effective Date is identified on Schedule 1.4; provided, that such entities are in compliance with all of the provisions of this Agreement applicable to CAT Collaborators or will be within a reasonable time after the Effective Date. No person or entity shall be deemed to be a CAT Collaborator if such person or entity is engaged in a Commercial Antibody Phage Display Business unless, pursuant to a written agreement (other than this Agreement), executed after the Effective Date, XOMA has granted to such person or entity a valid license or covenant not to xxx under the XOMA Patent Rights which explicitly extends to the activities identified in this third sentence of Section 1.4; provided, that a CAT Collaborator listed in column (a) of Schedule 1.4 shall retain its status as such, notwithstanding that it may after the Effective Date engage in a Commercial Antibody Phage Display Business, but in all cases only with respect to activities of such CAT Collaborator that are carried out pursuant to and in accordance with its arrangement with CAT and the applicable terms of this Agreement using Licensed Antibody Phage Display Materials and/or Licensed Immunoglobulins provided by CAT. XOMA shall provide CAT prompt written notice of those written agreements or covenants not to xxx which satisfy the requirements of the prior sentence. No person or entity may claim the status of CAT Collaborator with respect to any acts or activities which are unrelated to the use of Licensed Antibody Phage Display Materials, Licensed Immunoglobulins and/or Licensed Immunoglobulin Information provided by CAT. |
1.5 | “CAT Library” means the collection of bacteriophages each of which displays an Antibody or a collection of host cells containing such collection of bacteriophages controlled by CAT as of the Effective Date and all updates, additions and improvements to such collection of bacteriophages or collection of host cells containing such collection of bacteriophages. |
1.7 | “Change in Control” means, with respect to a particular entity, any transaction or series of transactions as a result of which any person or group (as defined under the U.S. Securities Exchange Act of 1934, as amended) becomes, directly or indirectly, the beneficial owner of more than fifty percent (50%) of the total voting power of such entity’s equity securities or otherwise gains control of such entity. |
1.8 | “Commercial Antibody Phage Display Business” means, with respect to antibody phage display services, antibody phage display libraries, products for use in antibody phage display or the bacterial expression of antibodies, and antibody phage display materials, the out-licensing, commercial manufacture, sale, offer for sale, import for sale or export for sale of such services, libraries, products and materials. |
1.9 | “Confidential Information” means any proprietary or confidential information or material disclosed by a party to the other party pursuant to this Agreement, which is (i) disclosed in tangible form hereunder and is designated thereon as “Confidential” at the time it is delivered to the receiving party, or (ii) disclosed orally hereunder and identified as confidential or proprietary when disclosed and such disclosure of confidential or proprietary information is confirmed in writing within thirty (30) days by the disclosing party. |
1.10 | “Diagnostic Product” means a Product used solely to diagnose any disease or condition in any animal, including a human. |
1.11 | “Dispose” means to transfer, assign, lease, or in any other fashion dispose of control, ownership or possession, but shall not mean to license or sell. “Disposition” shall have the correlative meaning. |
1.12 | “Immunoglobulin” means any molecule, including without limitation full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and scFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including, by way of example and without limitation, any naturally occurring, synthetic, or recombinant form of such a molecule; provided, however, that “Immunoglobulin” shall not include a molecule or gene encoding such a molecule which comprises solely a single variable domain (heavy or light). |
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1.13 | “Insolvency Event” means any one of the following: |
· | a notice shall have been issued to convene a meeting for the purpose of passing a resolution to wind up CAT, or such a resolution shall have been passed other than (i) a resolution for the solvent reconstruction or reorganization of CAT, or (ii) for the purpose of inclusion of any part of the share capital of CAT in the Official List of the London Stock Exchange or in the list of the New York Stock Exchange, American Stock Exchange or quotation of the same on the Nasdaq Stock Market in relation to an initial public offering; or |
· | a resolution shall have been passed by CAT’s directors to seek a winding up or administration order, or a petition for a winding up or administration order shall have been presented against CAT, or such an order shall have been made; or |
· | a receiver, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of CAT or over a substantial part of its assets or any Third Party takes steps to appoint such an officer in respect of CAT or an encumbrancer takes steps to enforce or enforces its security; or |
· | a proposal for a voluntary arrangement shall have been made in relation to CAT under Part I Insolvency Act 1986 (UK); or |
· | a step or event shall have been taken or arisen outside the United Kingdom which is similar or analogous to any of the steps or events listed at (a) to (d) above; or |
· | CAT proposes or makes any general assignment, composition or arrangement with or for the benefit of all or some of CAT’s creditors or makes or suspends or threatens to suspend making payments to all or some of CAT’s creditors or CAT submits to any type of voluntary arrangement; or |
· | CAT is deemed to be unable to pay its debts within the meaning of Section 123 Insolvency Act 1986 (UK). |
1.14 | “Library License” means that certain Antibody Library License Agreement dated December 22, 2002 by and between CAT and XOMA Technology Ltd. |
1.15 | “Licensed Antibody Phage Display Materials” means (i) any collection or library of polynucleotide sequences (including without limitation a CAT Library), created by CAT and under the exclusive control of CAT, which encodes at least one Immunoglobulin and which is contained in filamentous bacteriophage and/or bacteriophage or phagemid cloning vectors capable of propagation in bacteria; or (ii) any collection or library of bacteriophage (including without limitation a CAT Library), created by or under the exclusive control of CAT, wherein an Immunoglobulin is expressed as a fusion protein comprising an Immunoglobulin and an outer surface polypeptide of a bacteriophage. For the avoidance of doubt, and without expanding the definition thereof, specifically excluded from the definition of Licensed Antibody Phage Display Materials are (x) any article of manufacture or composition of matter suitable for display, expression or secretion of an Immunoglobulin in or from any organism or system other than bacteria and (y) any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the control of any entity, other than CAT, engaged in a Commercial Antibody Phage Display Business; provided that, notwithstanding the foregoing, any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the exclusive control of a CAT Collaborator shall constitute Licensed Antibody Phage Display Materials, but only to the extent derived by such CAT Collaborator exclusively from Licensed Antibody Phage Display Materials created by or under the exclusive control of CAT and properly transferred by CAT to such CAT Collaborator in accordance with the applicable provisions of this Agreement and, with respect to such transfers after the Effective Date, such CAT Collaborator acknowledges that the transfer restrictions and other provisions hereof apply thereto. “Licensed Antibody Phage Display Materials” shall not include any such article of manufacture or composition of matter infringing or arising out of the infringement of any Valid Claim of any patent or patent application under the control of CAT and which is excluded from the scope of any license grant made to XOMA Technology Ltd. pursuant to the Library License solely by virtue of Section 1.1.10.3, 1.1.13(ii) or 7.9 thereof, which are set forth on Schedule 1.15. |
1.16 | “Licensed Immunoglobulin” means any Immunoglobulin discovered, isolated or characterized by CAT or a CAT Collaborator through the use of Licensed Antibody Phage Display Materials. “Licensed Immunoglobulin” shall not include any such Immunoglobulin infringing or arising out of the infringement of any Valid Claim of any patent or patent application under the control of CAT and which is excluded from the scope of any license grant made to XOMA Technology Ltd. pursuant to the Library License solely by virtue of Section 1.1.10.3, 1.1.13(ii) or 7.9 thereof, which are set forth on Schedule 1.15. |
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1.17 | “Licensed Immunoglobulin Information” means any data, know-how or other information relating, concerning or pertaining to a Licensed Immunoglobulin, including, without limitation, data, know-how or other information characterizing or constituting such Licensed Immunoglobulin’s polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property. “Licensed Immunoglobulin Information” shall not include any such data, know-how or other information infringing or arising out of the infringement of any Valid Claim of any patent or patent application under the control of CAT and which is excluded from the scope of any license grant made to XOMA Technology Ltd. pursuant to the Library License solely by virtue of Section 1.1.10.3, 1.1.13(ii) or 7.9 thereof, which are set forth on Schedule 1.15. |
1.18 | “Major Market” means the United States of America, the United Kingdom, Germany, France, Italy, Spain or Japan. |
1.19 | “Marketing Authorization” means any approval (including all applicable pricing and governmental reimbursement approvals) required from the relevant regulatory or other competent authority to market or sell a Product in any country. |
1.20 | “Microarray” means an Antibody based assay containing two (2) or more CAT Library Antibodies of different analyte specificities for the purpose of detecting and/or measuring two (2) or more different analyte molecules in the same assay. |
1.21 | “MRC” means the Medical Research Council. |
1.22 | [Text intentionally omitted.] |
1.23 | “Phase III Clinical Trial” means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a Marketing Authorization application that would satisfy the requirements of X.X. 00 XXX 312.21(c) or its non-U.S. equivalent. |
1.24 | “Product” means any composition of matter or article of manufacture, including without limitation any diagnostic, prophylactic or therapeutic or product, which (a) contains a Licensed Immunoglobulin; or (b) was discovered or created by or arose directly out of use of Licensed Antibody Phage Display Materials or the conduct of Antibody Phage Display by CAT or a CAT Collaborator; or (c) is sold by or on behalf of CAT or a CAT Collaborator under conditions which, if unlicensed, would constitute infringement of one or more Valid Claims within the XOMA Patent Rights. For the avoidance of doubt, any composition of matter or article of manufacture arising out of CAT’s practice of cell-free ribosome display or yeast display is not included in the definition of Product but only to the extent such practice or the development or manufacture of such composition of matter or article of manufacture does not include the use of any Licensed Antibody Phage Display Materials or the infringement of any Valid Claim of any XOMA Patent Rights. |
1.25 | “Research and Development” means the identification, selection, isolation, purification, characterization, study and/or testing of an Immunoglobulin for any purpose, including, without limitation, the discovery and development of human therapeutics or diagnostics. Included within the definition of “Research and Development” shall be all in vitro or in vivo screening or assays customarily performed in pre-clinical and clinical research and uses associated with obtaining FDA or equivalent agency regulatory approval. “Research and Development” shall not include commercial or industrial manufacture or any activities solely directed to the creation of such capacities. |
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1.26 | “Research Quantities” means only those quantities of an Immunoglobulin reasonably required for Research and Development purposes. |
1.27 | “Target” means (i) DNA and all post-transcriptional material encoded by such DNA, including all naturally occurring or disease-associated truncations, mutations, variants, fragments and post-transcriptional modifications thereof (including but not limited to splice variants) and all material encoded by such post-transcriptional material including but not limited to proteins; (ii) the DNA encoding a polypeptide or protein, as identified by a sequence of amino acids, and all post-translational variants thereof including but not limited to glycosylation and phosphorylation modifications. For the avoidance of doubt for the purposes of this Agreement, an Antibody is not a Target. |
1.28 | “Third Party” means any person or entity other than CAT or XOMA. |
1.29 | “Valid Claim” means a claim of an issued and unexpired patent included within the XOMA Patent Rights or, in the case of Sections 1.15, 1.16 and 1.17, under the control of CAT, in each case that has not been held invalid in a final decision of a court of competent jurisdiction from which no appeal has been or may be taken, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise. |
1.30 | “XOMA Patent Right(s)” means the patent applications and patents listed on Schedule 1.30 hereto and all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; and all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any other patent rights owned by XOMA which XOMA has the right to license or sublicense and which would be infringed by the activities of CAT contemplated hereunder but for this Agreement. XOMA Patent Rights shall also include (i) any improvements of the foregoing that are owned or controlled by XOMA and (ii) any patents or patent applications owned or controlled by XOMA containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications). For the avoidance of doubt and consistent with the interpretation of the foregoing definition that such patents are not included therein, the following patents are excluded from the definition of XOMA Patent Rights: US Patent No. 5,576,195, US Patent No. 5,846,818, and US Patent No. 6,120,787. |
ARTICLE 2
XOMA LICENSE TO CAT
2.1 | Grants. Subject to the other terms and conditions of this Agreement, XOMA hereby grants to CAT a worldwide, non-exclusive, non-transferable license (unless transferred under Section 8.2), solely on its own behalf and on behalf of any CAT Collaborator, without any right to sublicense, under the XOMA Patent Rights to: |
· | Make or have made Licensed Antibody Phage Display Materials; |
· | Solely for Research and Development purposes, conduct Antibody Phage Display; |
· | Make or have made Research Quantities of a Licensed Immunoglobulin; |
· | Transfer Antibody Phage Display Materials, Research Quantities of a Licensed Immunoglobulin or Licensed Immunoglobulin Information to a CAT Collaborator; and |
· | Use, sell, offer to sell, import and export Licensed Immunoglobulins. |
2.2 | Covenant Not To Xxx. XOMA covenants that it shall not initiate any action asserting a claim of infringement under the XOMA Patent Rights against CAT or any CAT Collaborator solely to the extent reasonably necessary to permit the authorized use of Licensed Antibody Phage Display Materials, Licensed Immunoglobulins or Licensed Immunoglobulin Information for activities or in a manner otherwise permitted under the provisions of this Agreement. The covenant not to xxx provided by this Section 2.2: |
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· | shall not extend to infringement of the XOMA Patent Rights arising out of making or the means or methods used to make any amount of a Licensed Immunoglobulin or Product other than Research Quantities; |
· | shall become void and without effect with respect to any entity or person who claims its benefit and fails to materially discharge or comply with any term of its written agreement with CAT provided for in Section 2.4, but only with respect to such entity or person; |
· | is personal to CAT or, as applicable, a CAT Collaborator, and, except as provided for by Section 8.2, cannot be assigned or transferred; and |
· | subject to and without prejudice to the release set forth in Section 2.8, does not constitute a release or waiver of past, present or future infringement of the XOMA Patent Rights by CAT or any Third Party, including, without limitation, any CAT Collaborator acting outside of the scope of the written agreement with CAT provided for in Section 2.4. |
2.3 | No Implied Rights. Only the rights and licenses granted pursuant to the express terms of this Agreement shall be of any legal force or effect. No license or other rights shall be deemed to have been granted to CAT or a CAT Collaborator other than as expressly provided for in this Agreement. For the avoidance of doubt, the grants of rights made pursuant to Sections 2.1 and 2.2 do not include, and expressly exclude, the following: |
· | any right or license to engage in any activities on behalf of or in collaboration with any Third Party, other than a CAT Collaborator; |
· | any right or license to make or have made any amount (other than Research Quantities) of a Licensed Immunoglobulin or Product by practicing the XOMA Patent Rights; provided, however, that CAT or, as applicable, a CAT Collaborator shall be permitted to make or have made any Licensed Immunoglobulin by any means of its selection other than those which otherwise infringe a Valid Claim of the XOMA Patent Rights; and/or |
· | any right to release any Third Party, including a CAT Collaborator, from any claim of infringement under the XOMA Patent Rights. |
2.4 | Transfer Restrictions. |
(a) | Except for any person or entity constituting a CAT Collaborator as of the Effective Date, CAT shall not (i) undertake any Antibody Phage Display activities on behalf of a Third Party or (ii) Dispose of Licensed Antibody Phage Display Materials, a Licensed Immunoglobulin, Licensed Immunoglobulin Information or the product of the practice of any method within the scope of the Valid Claims of the XOMA Patents (“Transferred Materials”) to any Third Party until (in the case of either clause (i) or clause (ii)) such time as CAT has provided to such Third Party the redacted copy of this Agreement referred to in Section 4.2 and the form of notice set out at Schedule 2.4. For the avoidance of doubt, any person or entity constituting a CAT Collaborator on the Effective Date may continue to claim the status of CAT Collaborator with respect to articles of manufacture or compositions of matter Disposed of by CAT after the Effective Date only to the extent CAT and such person or entity comply with the requirements of this Section 2.4 with respect thereto. |
(b) | If CAT enters into a written arrangement after the Effective Date with any Third Party or any entity identified in column (a) of Schedule 1.4 arising out of or relating to activities as to which it or such Third Party does or intends to claim the benefits of any of the licenses or other grants provided for by this Agreement, such written arrangement shall contain provisions (i) pursuant to which the recipient of any Transferred Materials agrees to abide by each of the limitations, restrictions and other obligations applicable to CAT Collaborators provided for by this Agreement as described in Schedule 4.2, including, without limitation, the restrictions on use of Transferred Materials for purposes other than Research and Development; (ii) providing that any amounts paid to CAT shall not constitute payments to XOMA; and (iii) permitting a CAT Collaborator to further Dispose of Licensed Antibody Phage Display Materials or any materials the use of which results in the practice of any method within the scope of any Valid Claim of the XOMA Patent Rights, but only to a Third Party who otherwise meets the definition of a CAT Collaborator as described in Schedule 4.2. Without limiting the foregoing, such CAT Collaborator may transfer to a Third Party a Licensed Immunoglobulin or Licensed Immunoglobulin Information derived from Licensed Antibody Phage Display Materials under this Agreement. XOMA shall be, and the agreements subject to this Section 2.4 shall provide that XOMA shall be, an intended third party beneficiary with respect to the foregoing provisions. If no Disposition of Transferred Materials is contemplated by such arrangement, then the provisions of this Section 2.4(b) shall not apply. If, however, there is a subsequent Disposition of Transferred Materials to such Third Party, then such Disposition must occur under a written agreement which contains the provisions required by this Section 2.4(b) or the Third party shall not have the benefit of any of the licenses or other rights granted in this Agreement. |
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(c) | The provisions of Sections 2.4(a) and (b) shall not apply to any persons or entities engaged solely in academic, non-commercial activity or who are merely evaluating CAT’s technology and who subsequently do not enter into any written arrangement. Such persons or entities shall not have the benefit of any of the licenses or other rights granted in this Agreement unless and until the requirements of Sections 2.4(a) and (b) have been complied with. |
2.5 | Reports, Records and Audits. |
(a) | Thirty (30) days after the end of each calendar quarter, commencing with the first calendar quarter commencing after the Effective Date, CAT shall deliver to XOMA a written report which shall specify the name, address and contact person for each and every CAT Collaborator and any person or entity receiving Licensed Antibody Phage Display Materials or a Licensed Immunoglobulin (other than persons or entities engaged solely in academic, non-commercial activity or who are merely evaluating CAT’s technology and who subsequently do not enter into any written arrangement). |
(b) | Not later than thirty (30) days after the end of each calendar year, commencing with the first calendar year to commence after the Effective Date, as and to the extent publicly disclosed by CAT (whether in press releases, government filings or otherwise), CAT shall deliver to XOMA written materials pertaining to the current status of activities or compositions of matter as to which CAT claims the right of license hereunder. |
(c) | CAT shall maintain records fully and properly reflecting those activities covered by this Agreement (including, without limitation, work done with the Licensed Antibody Phage Display Materials) and/or to be reported to XOMA pursuant to this Section 2.5 (the “Records”), in reasonable detail and in good scientific manner for at least three (3) years. Upon the written request of XOMA and not more than once in each calendar year, CAT shall permit an independent consultant appointed by XOMA and reasonably acceptable to CAT and which executes a confidentiality agreement reasonably acceptable to CAT, at XOMA’s expense, to have access during normal business hours to such of the records of CAT as may be reasonably necessary to verify fulfillment of the terms of this Agreement, as well as the accuracy of the reports hereunder. CAT shall verify in writing any statements by CAT personnel as to their accuracy and correctness. The consultant shall not be permitted to see or receive any specific information concerning targets or antibodies of either CAT or any of its collaborators and shall disclose to XOMA only the results and conclusions of its review and the specific details concerning any discrepancies. No other information shall be shared by the consultant without the prior express written consent of CAT unless disclosure is required by law, regulation or judicial order. |
2.6 | Ownership; Enforcement. At all times XOMA will retain ownership of the XOMA Patent Rights and may use and commercialize such XOMA Patent Rights itself or with any Third Party. XOMA retains the right, at its sole discretion, to enforce, maintain and otherwise protect the XOMA Patent Rights. CAT will reasonably cooperate with XOMA, at XOMA’s expense, with respect to any actions XOMA may choose to take related to the enforcement, maintenance or protection of the XOMA Patent Rights; provided that nothing in the last sentence of this Section 2.6 shall require CAT to breach any contractual obligations to any Third Party. |
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2.7 | Oppositions and/or Appeals to Oppositions. So long as XOMA is in material compliance with its obligations under this Agreement, and subject to any specific contractual obligations of CAT existing on the Effective Date in circumstances constituting, in the reasonable, written opinion of counsel to CAT, a breach thereof, CAT agrees not to enter into any opposition to and/or appeal from any decision by the patent authorities of any country regarding the XOMA Patent Rights and shall not knowingly assist or otherwise cooperate with another party in any such opposition or appeal. |
2.8 | Release. For consideration set forth herein (including payment in full of the amounts set forth in Section 3.1), the sufficiency of which (once so paid) is hereby acknowledged, XOMA permanently and forever and without further payment or condition releases CAT and its current, former and future parents, subsidiaries, related entities, and their fiduciaries, predecessors, successors, officers, directors, shareholders, agents, employees and permitted assigns and those Third Parties identified upon Schedule 1.4 from any and all claims, causes of action, liabilities, demands, rights of action and/or damages (actual, direct, consequential or otherwise) of any nature and of every kind, known or unknown, suspected or unsuspected, disclosed and undisclosed, as of the Effective Date arising out of and/or based upon or relating in any way to any infringement or alleged infringement of the XOMA Patent Rights (the “Release”); provided, however, that the Release provided for in this Section 2.8 shall extend only to claims, causes of action, liabilities, demands, rights of action and/or damages existing as of the Effective Date and which arose solely out of those activities specified in Schedule 1.4. XOMA acknowledges that it may discover facts different from or in addition to those which it now knows or believes to be true and that the Release shall be and remain effective in all respects notwithstanding such different or additional facts or the discovery thereof. XOMA expressly waives the benefits of any statutory provision or common law rule that provides, in sum or substance, that a release does not extend to claims which the party does not know or suspect to exist in its favor at the time of executing the release, which if known by it, would have materially affected its agreement to release the other party. In particular, but without limitation, XOMA expressly waives the provisions of California Civil Code section 1542, which statute reads: |
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.
Nothing in this Section 2.8 shall be deemed to be a release of any claim, demand or right of action XOMA may now or in the future have against [XXX] as of the Effective Date or any of their collaborators. The Release shall become irrevocable only upon receipt by XOMA of payment in full by CAT of the amounts set forth in Section 3.1 and shall be revoked in its entirety and null and void ab initio, immediately and without further action of the parties, in the event any such payment by CAT is not received in full by XOMA on or prior to the date on which such amount is due, regardless of any payment received thereafter.
2.9 | CAT Covenant Not To Xxx. CAT covenants that it shall not initiate or permit any Third Party over whom it has control to initiate or knowingly assist in any way in the initiation or prosecution of any action asserting any claims, including claims of infringement, under any patents or patent applications under CAT’s control or with respect to which it has the right to xxx against XOMA or any Third Party working with XOMA solely to the extent such claims arise out of XOMA’s activities constituting practice or infringement of any Valid Claim of the XOMA Patent Rights; provided, however, that the covenant contained in this Section 2.9 shall not extend to any claim of a patent or patent application that specifically claims a particular Immunoglobulin or a particular Target. |
ARTICLE 3
[Text intentionally omitted.]
ARTICLE 4
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CONFIDENTIALITY
4.1 | Confidential Information. Except as expressly provided herein, the parties agree that, for the term of this Agreement and for five (5) years thereafter, the receiving party shall keep completely confidential and shall not publish or otherwise disclose and shall not use for any purpose except for the purposes contemplated by this Agreement any Confidential Information furnished to it by the disclosing party hereto, except to the extent that it can be established by the receiving party by written proof that such Confidential Information: |
· | was already known to the receiving party, other than under an obligation of confidentiality, at the time of disclosure; |
· | was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving party; |
· | became generally available to the public or otherwise part of the public domain after its disclosure other than through any act or omission of the receiving party in breach of this Agreement; or |
· | was subsequently lawfully disclosed to the receiving party by a person other than a party hereto. |
4.2 | Permitted Use and Disclosures. Each party hereto may use or disclose information disclosed to it by the other party to the extent such use or disclosure is reasonably necessary in complying with applicable law or government regulations or conducting clinical trials; provided, however, that if a party is required to make any such disclosure of another party’s Confidential Information, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to the latter party of such disclosure and will use its reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise). Attached hereto as Schedule 4.2 is a redacted copy of this Agreement which CAT shall be free, without obtaining any consent from XOMA, to provide to Third Parties who indicate an interest in becoming a CAT Collaborator. |
4.3 | Confidential Terms. Except as expressly provided herein, CAT agrees not to disclose any terms of this Agreement to any Third Party without the consent of XOMA, and XOMA agrees not to disclose any terms of this Agreement to any Third Party without the express written consent of CAT; provided that disclosures may be made as required by securities or other applicable laws, or confidentially to a party’s accountants, attorneys and other professional advisors. |
4.4 | Agreement Announcement. The parties hereby agree to the release of a press release in the form attached hereto as Schedule 4.4 upon full execution of this Agreement and that the consummation of this Agreement, as well as such terms as are expressly described in such press release, shall be deemed to be in the public domain. |
ARTICLE 5
REPRESENTATIONS AND WARRANTIES
5.1 | Representations and Warranties. |
(a) | XOMA represents and warrants to CAT that: (i) it is the sole and exclusive owner or exclusive licensee of all right, title and interest in the XOMA Patent Rights; (ii) XOMA has the legal right, authority and power to enter into this Agreement; (iii) this Agreement shall constitute a valid and binding obligation of XOMA enforceable in accordance with its terms; (iv) the performance of obligations under this Agreement by XOMA will not result in a breach of any agreements, contracts or other arrangements to which it is a party; and (v) based on the representation by CAT set forth in Section 5.1(b)(iv), to XOMA’s knowledge the patents set forth in the last sentence of Section 1.30 need not be licensed to CAT. |
(b) | CAT represents and warrants to XOMA that: (i) CAT has the legal right, authority and power to enter into this Agreement; (ii) this Agreement shall constitute a valid and binding obligation of CAT enforceable in accordance with its terms; (iii) the performance of obligations under this Agreement by CAT will not result in a breach of any agreements, contracts or other arrangements to which it is a party; and (iv) CAT does not use and has not used the pelB signal sequence. |
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5.2 | Disclaimer. Nothing in this Agreement is or shall be construed as: |
(a) | A warranty or representation by XOMA as to the validity or scope of any claim or patent within the XOMA Patent Rights; |
(b) | An admission, acceptance, acknowledgment, statement, declaration, or representation by either party as to the infringement, validity or scope of any claim or patent within the patents licensed hereunder or as to which rights are granted hereunder; |
(c) | A warranty or representation that anything made, used, sold, or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of any patent rights or similar intellectual property right of any Third Party; or |
(d) | An obligation to bring or prosecute actions or suits against Third Parties for infringement of any of the XOMA Patent Rights. |
5.3 | No Other Warranties. EXCEPT AS OTHERWISE SET FORTH IN SECTION 5.1 ABOVE, XOMA MAKES NO WARRANTIES WITH RESPECT TO ANY OF THE PATENT RIGHTS LICENSED HEREUNDER, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND XOMA SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF SUCH PATENT RIGHTS OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. |
5.4 | Certain Agreements. CAT represents and warrants that it has in its possession, and agrees that throughout the term of this Agreement and for five (5) years thereafter it will maintain in an accessible location, true, complete and legible copies of each of the agreements set forth on Schedule 1.4 as in effect on the Effective Date, including all schedules, exhibits and other similar documents necessary for the correct interpretation of the provisions thereof. |
ARTICLE 6
INDEMNIFICATION
6.1 | Indemnification. CAT agrees to indemnify, defend and hold XOMA and its directors, officers, employees and agents (the “Indemnified Parties” and each, an “Indemnified Party”) harmless from and against any and all liabilities, losses and expenses (including, without limitation, reasonable attorneys and professional fees and other costs of litigation), resulting from any claims, demands or causes of action by any party other than CAT (each, a “Liability”) arising out of (i) the possession, manufacture, use, sale or other disposition of Product, Licensed Antibody Phage Display Materials, Licensed Immunoglobulin or the provisions of any service or goods relating thereto by CAT or any customer, vendor or other representative of CAT, whether based on breach of warranty, negligence, product liability or otherwise, or (ii) the exercise of any right granted to CAT pursuant to this Agreement, except to the extent, in each case, that such Liability is caused by the negligence or willful misconduct of XOMA. |
6.2 | Procedure. To receive the benefit of indemnification under Section 6.1, an Indemnified Party must (a) promptly notify CAT in writing of a claim or suit; provided that failure to give such notice shall not relieve CAT of its indemnification obligations except where, and solely to the extent that, such failure actually and materially prejudices the rights of CAT; (b) provide reasonable cooperation (at CAT’s expense); and (c) tender to CAT (and its insurer) full authority to defend or settle the claim or suit; provided that no settlement requiring any admission by the Indemnified Party or that imposes any obligation on the Indemnified Party shall be made without the Indemnified Party’s consent, which consent shall not be unreasonably withheld; and provided, further, that nothing herein shall be deemed to give CAT any right to control any proceeding involving the XOMA Patent Rights or any claim XOMA may bring against any Third Party. CAT shall not have any obligation to indemnify the other party in connection with any settlement made without CAT’s written consent. The Indemnified Party has the right to participate at its own expense, such expense not to be deemed a Liability, in the claim or suit and in selecting counsel therefor. The Indemnified Party shall cooperate with CAT (and its insurer), as reasonably requested. |
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ARTICLE 7
TERM AND TERMINATION
7.1 | Term. Subject to Sections 7.4 and 7.5 hereof, the term of this Agreement will commence on the Effective Date and remain in full force and effect until the expiration of the last patent within the XOMA Patent Rights unless earlier terminated pursuant to Sections 7.2, 7.3 or 7.6. |
7.2 | Termination Event. This Agreement may be terminated by either CAT or XOMA upon any material breach or default by XOMA or CAT, as the case may be, in the performance of any obligation or condition of this Agreement or if any representation or warranty made by XOMA or CAT, as the case may be, in this Agreement is untrue or materially misleading, in any case effective fifteen (15) days after giving notice to the breaching party of such termination in the case of a payment breach and sixty (60) days after giving written notice to the breaching party of such termination in the case of any other breach, which notice shall describe such breach in reasonable detail. The foregoing notwithstanding, (a) if such breach is cured or shown to be non-existent within the aforesaid fifteen (15) or sixty (60) day period, the notice shall be deemed automatically withdrawn and of no effect and the notifying party shall provide written notice to the breaching party of the withdrawal; (b) no such termination shall be effective so long as the parties are engaged in arbitration under Section 8.13 in connection with such breach or default; and (c) with respect to any person or entity constituting a CAT Collaborator as of the date of such a termination by XOMA, any such termination shall be effective against such CAT Collaborator unless, within forty-five (45) days after written notice from XOMA of such termination, such CAT Collaborator executes a written agreement with XOMA directly obligating such CAT Collaborator to comply with all of the provisions of this Agreement applicable to CAT Collaborators and to fulfill the obligations of CAT (including without limitation any royalty obligations) with respect to any and all Licensed Antibody Phage Display Materials and Licensed Immunoglobulins Disposed of by CAT to such CAT Collaborator as of the date of such termination. Upon any termination by XOMA under this Section 7.2, CAT shall promptly (and in any event not later than forty-five (45) days thereafter) deliver to XOMA a written report specifying as of the date of such termination the information required by Section 2.5(a). |
7.3 | Termination for Insolvency. If voluntary or involuntary proceedings by or against CAT are instituted in bankruptcy under any insolvency law, or a receiver or custodian is appointed for CAT, or an Insolvency Event occurs in relation to CAT, or substantially all of the assets of CAT are seized or attached and not released within sixty (60) days thereafter, XOMA may immediately terminate this Agreement effective upon notice of such termination. |
7.4 | Effect of Termination. |
(a) | Termination of this Agreement shall not release any party hereto from any liability which, at the time of such termination, has already accrued to the other party or which is attributable to a period prior to such termination nor preclude either party from pursuing any rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. It is understood and agreed that monetary damages may not be a sufficient remedy for any breach of this Agreement and that the non-breaching party may be entitled to injunctive relief as a remedy for any such breach. Such remedy shall not be deemed to be the exclusive remedy for any such breach of this Agreement, but shall be in addition to all other remedies available at law or in equity. |
(b) | Upon any termination of this Agreement, CAT and XOMA shall promptly return to the other party all Confidential Information received from the other party (except that each party may retain one copy for its files solely for the purpose of determining its rights and obligations hereunder). |
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(c) | Except as expressly provided in Section 7.2, all licenses granted under Article 2 hereof shall terminate and be of no further effect upon the termination of this Agreement. No termination of this Agreement shall in and of itself effect the validity of any provision hereof during any period prior thereto or the applicability of any provision hereof to any activities conducted prior thereto. |
7.5 | Survival. Sections 2.5, 2.6, 2.8, 2.9, [Text intentionally omitted.] , 7.2, 7.4, 7.5 and 7.6, and Articles 4, 5, 6 and 8 of this Agreement, shall survive any termination hereof; provided, however, that Section 2.9 shall not survive any termination of this Agreement by CAT pursuant to Section 7.2. Section 2.1 shall survive termination but only as provided in the parenthetical clause of the immediately preceding sentence and as to any Product for which the license hereunder is fully paid up prior to the date of termination in accordance with the third sentence of Section 3.2(a). |
7.6 | Contested Validity. Except to the extent CAT is compelled to do so by legal process and subject to any specific contractual obligations of CAT existing on the Effective Date in circumstances constituting, in the reasonable, written opinion of counsel to CAT, a breach thereof, if CAT, a CAT Collaborator or any person or entity controlled by any of the foregoing contests, directs another to contest or knowingly assists another in contesting the validity or enforceability of any of the XOMA Patent Rights licensed hereunder, XOMA shall have the right to terminate all of the rights and licenses hereby granted to CAT and any CAT Collaborator under the XOMA Patent Rights; provided, however, that in the event a CAT Collaborator or any person or entity controlled by a CAT Collaborator contests the validity or enforceability of any of the XOMA Patent Rights licensed hereunder other than at the direction, and without the knowing assistance, of CAT, then the foregoing termination right of XOMA shall apply only to the rights hereby granted to such CAT Collaborator; and provided, further, that, in the event of any such termination resulting from activities of CAT, with respect to any person or entity constituting a CAT Collaborator as of the date of such termination, any such termination shall be effective against such CAT Collaborator unless, within forty five (45) days after written notice from XOMA of such termination, such CAT Collaborator executes a written agreement with XOMA directly obligating such CAT Collaborator to comply with all of the provisions of this Agreement applicable to CAT Collaborators and to fulfill the obligations of CAT (including without limitation any royalty obligations) with respect to any and all Licensed Antibody Phage Display Materials and Licensed Immunoglobulins Disposed of by CAT to such CAT Collaborator as of the date of such termination. Upon any termination under this Section 7.6 resulting from activities of CAT, CAT shall promptly (and in any event not later than forty five (45) days thereafter) deliver to XOMA a written report specifying as of the date of such termination the information required by Section 2.5(a). |
ARTICLE 8
MISCELLANEOUS PROVISIONS
8.1 | Governing Laws. This Agreement and any dispute, including without limitation any arbitration, arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of the state of California, without reference to conflicts of laws principles. |
8.2 | Assignment. |
(a) | Neither party may transfer or assign this Agreement, directly or indirectly, or any of its rights hereunder, other than to one or more of its Affiliates and other than to a successor of XOMA Ltd. under a Change in Control of XOMA Ltd. or to a successor of Cambridge Antibody Technology Group plc under a Change in Control of Cambridge Antibody Technology Group plc to which Section 8.3 does not apply, without the prior written consent of the other party. Any such attempted transfer or assignment in violation of this Section 8.2 shall be void; provided, that in the event of a permitted Change in Control, the original party’s (or its successor’s) obligations hereunder shall continue. This Agreement shall be binding upon and inure to the benefit of the parties and their permitted successors and assigns. |
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(b) | Notwithstanding the first sentence of Section 8.2(a), in the event CAT disposes of at least a majority interest of a subsidiary, Affiliate or other business unit the primary business of which is the making and/or selling of Microarrays (a “Microarray Spin-out”), the entity resulting from such Microarray Spin-out shall not have the benefit of this Agreement unless, within thirty (30) days after consummation of that Microarray Spin-out, such entity executes and delivers to XOMA for execution a written agreement incorporating all of the terms of this Agreement (including without limitation the license grant in Section 2.1, the covenant not to xxx in Section 2.2 and the royalty obligations of Sections 3.2 through 3.5, in the latter case modified to apply to such entity’s revenues from (i) its use of Licensed Antibody Phage Display Materials, (ii) services provided by it arising out of the license grants in such agreement and/or (iii) the sale by it of Products), other than Section 3.1 and this Section 8.2(b). |
8.3 | Certain Changes in Control. |
(a) | Notwithstanding any other provision of this Agreement to the contrary, except as set forth in Section 8.3(b), this Agreement shall automatically terminate, without further action by the parties, in the event of (i) a transaction or series of related transactions in which [XXX] is a party and which results in a Change of Control of CAT, or (ii) a transaction or series of related transactions in which CAT is a party and which results in a Change in Control of a person or entity described in clause (i) above; provided, that this Section 8.3(a) shall not apply if CAT shall make to XOMA a cash payment of [XXX] Dollars (US$[XXX]) within five (5) business days following consummation of such transaction or series of related transactions. |
(b) | In the event that (i) a transaction or series of related transactions described in Section 8.3(a) is consummated in accordance with the proviso thereto and (ii) the party to such transaction or series of transactions other than CAT (the “Acquisition Party”) has in place at the time of such transaction or series of transactions a license agreement with XOMA under the XOMA Patent Rights covering substantially the same activities as are covered by this Agreement (a “Separate License”), then (A) for so long as the phage display businesses of CAT, on the one hand, and the Acquisition Party, on the other hand, are operated as separate business units (as reflected in contemporaneous Records and similarly reliable documents of the Acquisition Party), then the Separate License shall apply to the business of the Acquisition Party and this Agreement shall apply to the business of CAT; and (B) if the phage display businesses of CAT, on the one hand, and the Acquisition Party, on the other hand, are no longer operated as separate business units, then this Agreement shall apply to the combined phage display business of CAT and the Acquisition Party, except that the Separate License shall continue to apply to any composition of matter or article of manufacture identified as a potential product by the separate business unit operating the phage display business of the Acquisition Party while such business was separately operated (as reflected in contemporaneous Records and similarly reliable documents of the Acquisition Party). Nothing herein shall affect any license or grant of rights by any Acquisition Party to XOMA or, except as expressly provided above with respect to obligations directly related to the activities covered by this Agreement, any obligations of any Acquisition Party to XOMA. |
8.4 | Waiver. No waiver of any rights shall be effective unless consented to in writing by the party to be charged and the waiver of any breach or default shall not constitute a waiver of any other right hereunder or any subsequent breach or default. |
8.5 | Severability. In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without said provision. |
8.6 | Notices. All notices, requests and other communications hereunder shall be in writing and shall be delivered or sent in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto, and shall be effective on receipt: |
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CAT: | Cambridge Antibody Technology Limited Xxxxxxxx Building Xxxxxx Xxxx Xxxxxxxxx, XX0 0XX Xxxxxxx Attn: Company Secretary |
XOMA: | XOMA Ireland Limited Xxxxxxx Xxxxxxx Xxxxx Xxxxxxx, Xxxxxx Xxxxx Xxxxxxx Attn: Company Secretary |
with a copy (which shall not constitute
notice) to:
XOMA (US) LLC
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
X.X.X.
Attn: Company Secretary
8.7 | Independent Contractors. Both parties are independent contractors under this Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to constitute XOMA or CAT as partners or joint venturers with respect to this Agreement. Except as expressly provided herein, neither party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any other contract, agreement, or undertaking with any third party. |
8.8 | Compliance with Laws. In exercising their rights under this license, the parties shall comply in all material respects with the requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the exercise of rights under this Agreement. CAT shall be responsible, at its expense, for making any required registrations or filings with respect to this Agreement and obtaining any necessary governmental approvals with respect hereto. |
8.9 | Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by one party to the other are, for all purposes of Section 365(n) of Title XI of the United States Code (“Title XI”), licenses of rights to “intellectual property” as defined in Title XI. During the term of this Agreement each party shall create and maintain current copies to the extent practicable of all such intellectual property. If a bankruptcy proceeding is commenced by or against one party under Title XI, the other party shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of such other party, shall be promptly delivered to it (a) upon such party’s written request following the commencement of such bankruptcy proceeding, unless the party subject to such bankruptcy proceeding, or its trustee or receiver, elects within thirty (30) days to continue to perform all of its obligations under this Agreement, or (b) if not delivered as provided under clause (a) above, upon such other party’s request following the rejection of this Agreement by or on behalf of the party subject to such bankruptcy proceeding. If a party has taken possession of all applicable embodiments of the intellectual property of the other party pursuant to this Section 8.9 and the trustee in bankruptcy of the other party does not reject this Agreement, the party in possession of such intellectual property shall return such embodiments upon request. If a party seeks or involuntarily is placed under Title XI and the trustee rejects this Agreement as contemplated under 11 U.S.C. 365(n)(1), the other party hereby elects, pursuant to Section 365(n) of Title XI, to retain all rights granted to it under this Agreement to the extent permitted by law. |
8.10 | Use of Name. Neither party shall use the name or trademarks of the other party, except to the extent that a party is permitted to use the Confidential Information of the other party pursuant to Article 4, without the prior written consent of such other party. |
8.11 | Further Actions. Each party agrees to execute, acknowledge and deliver such further instruments, and do such other acts, as may be necessary and appropriate in order to carry out the purposes and intent of this Agreement. |
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8.12 | Entire Agreement; Amendment. This Agreement constitutes the entire and exclusive Agreement between the parties with respect to the subject matter hereof and supersedes and cancels all previous discussions, agreements, commitments and writings in respect thereof. No amendment or addition to this Agreement shall be effective unless reduced to writing and executed by the authorized representatives of the parties. |
8.13 | Arbitration. |
(a) | Solely with respect to any dispute between the parties to this Agreement (other than any dispute which arises out of or relates to alleged infringement, validity and/or enforceability of the XOMA Patent Rights) upon ten (10) days written notice, any party involved in the dispute may initiate arbitration by giving notice to that effect to the other party or parties involved in the dispute and by filing the notice with the American Arbitration Association or its successor organization (“AAA”) in accordance with its Commercial Arbitration Rules. Such dispute shall then be settled by arbitration in New York, New York, in accordance with the Commercial Arbitration Rules of the AAA or other rules agreed to by the parties involved in the dispute, by a panel of three neutral arbitrators, who shall be selected by the parties involved in the dispute using the procedures for arbitrator selection of the AAA. |
(b) | The parties acknowledge that this Agreement evidences a transaction involving interstate commerce. Insofar as it applies, the United States Arbitration Act shall govern the interpretation of, enforcement of, and proceedings pursuant to the arbitration clause in this Agreement. Except insofar as the United States Arbitration Act applies to such matters, the agreement to arbitrate set forth in this Section 8.13 shall be construed, and the legal relations among the parties shall be determined in accordance with, the substantive laws of the State of New York. |
(c) | The panel shall render its decision and award, including a statement of reasons upon which such award is based, within thirty (30) days after the arbitration hearing. The decision of the panel shall be determined by majority vote among the arbitrators, shall be in writing and shall be binding upon the parties involved in the dispute, final and non-appealable. Judgment upon the award rendered by the panel may be entered in any court having jurisdiction thereof in accordance with Section 8.14(a). |
(d) | Except as provided under the United States Arbitration Act, no action at law or in equity based upon any dispute that is subject to arbitration under this Section 8.13 shall be instituted. |
(e) | All expenses of any arbitration pursuant to this Section 8.13, including fees and expenses of the parties’ attorneys, fees and expenses of the arbitrators, and fees and expenses of any witness or the cost of any proof produced at the request of the arbitrators, shall be paid by the non-prevailing party. |
8.14 | Venue; Jurisdiction. |
(a) | Any action or proceeding brought by either party seeking to enforce any provision of, or based on any right arising out of, this Agreement must be brought against any of the parties in the courts of the State of California. Each party (i) hereby irrevocably submits to the jurisdiction of the state courts of the State of California and to the jurisdiction of any United States District Court in the State of California, for the purpose of any suit, action, or other proceeding arising out of or based upon this Agreement or the subject matter hereof brought by any party or its successors or assigns, (ii) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action, or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action, or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court, and (iii) hereby waives and agrees not to seek any review by any court of any other jurisdiction that may be called upon to grant an enforcement of the judgment of any such California state or federal court. |
55 |
(b) | Process in any action or proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement may be served on any party anywhere in the world. Each party consents to service of process by registered mail at the address to which notices are to be given and further consent that any service of process, writ, judgment or other notice of legal process shall be deemed and held in every respect to be effectively served upon it in connection with proceedings in the State of California, if delivered to CT Corporation System, whose current address is 0000 Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxx Xxxxx, XX 00000, which each party irrevocably designates and appoints as its authorized agent for the service of process in the courts in the State of California. Nothing herein shall affect the right of a party to serve process in any other manner permitted by applicable law. Without affecting the validity of process served otherwise pursuant to this Section 8.14(b), XOMA shall simultaneously provide CAT with written notice thereof. Each party further agrees that final judgment against it in any such action or proceeding arising out of or relating to this Agreement shall be conclusive and may be enforced in any other jurisdiction within or outside the United States of America by suit on the judgment, a certified or exemplified copy of which shall be conclusive evidence of the fact and of the amount of its liability. |
(c) | Each party agrees that it shall not, and that it shall instruct those in its control not to, take any action to frustrate or prevent the enforcement of any writ, decree, final judgment, award (arbitral or otherwise) or order entered against it with respect to this Agreement or the XOMA Patent Rights and shall agree to be bound thereby as if issued or executed by a competent judicial tribunal having personal jurisdiction situated in its country of residence or domicile. |
8.15 | Counterparts. 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. |
IN WITNESS WHEREOF, XOMA and CAT have executed this Agreement in duplicate originals by duly authorized officers.
CAMBRIDGE ANTIBODY TECHNOLOGY LIMITED |
XOMA IRELAND LIMITED | |||
By: | By: | |||
Name: Title: |
Xxxx Xxxx, Director duly authorized for and on behalf of XOMA Ireland Limited in the presence of: | |||
56 |
Schedule 1.4
[XXX]
57 |
SCHEDULE 1.15
CERTAIN LIBRARY LICENSE PROVISIONS
1.1.10 “CAT Background IP Third Party Improvements” – shall mean any Materials and Know How which constitute improvements of, enhancements to or modifications of the CAT Background IP and:
1.1.10.1 | which are conceived, originated or reduced to practice by Third Party licensees of CAT (other than a XOMA Collaborator or XOMA licensee) of the CAT Background IP; and |
1.1.10.2 | which come into the Control of CAT during the term of [the Library License] pursuant to agreements between CAT and such Third Parties; and |
1.1.10.3 | for which no consideration was payable by CAT to such Third Parties pursuant to such agreements; and |
which CAT has the right to license to XOMA hereunder.
“CAT Background Patent Rights” – shall mean the Patent Rights more particularly set out in Schedule 1 relating to the CAT Library and its use together with any Patent Rights which become Controlled by CAT after the Effective Date which relate to the CAT Library or its use. For the avoidance of doubt, CAT Background Patent Rights do not and shall not include (i) the CAT Diabodies Patent Rights, (ii) any Patent Rights acquired by or licensed to CAT after the Effective Date for which the consideration paid by CAT exceeds one hundred thousand US dollars (US$100,000), or equivalent in the case of non-cash consideration and (iii) the practice of the CAT Background Patent Rights within the fields licensed to Third Parties pursuant to the agreements set out in Schedule 5 (the “Additional Excluded Fields”) for as long as such Additional Excluded Fields are exclusively licensed to such Third Parties pursuant to those agreements.
Nothing in this Agreement shall confer any right upon XOMA and XOMA shall not exercise or use the CAT IP in the commercial sale or sublicense of single variable domains (heavy or light) of Antibodies.
To aid in understanding the foregoing, the following additional definitions from the Library License are provided:
“CAT Background IP” – shall mean the CAT Background Materials, CAT Background Know How, CAT Background Patent Rights and the CAT Library.
1.1.11 “CAT Background Know How” – shall mean (a) all of the Know How Controlled by CAT at the Effective Date which relates to the CAT Library and its use and (b) any Know How which relates to any improved version of the CAT Library made available to XOMA by CAT during the term of the Library License [as defined in the Library License] as set forth in Section 4.2 [of the Library License].
1.1.12 “CAT Background Materials” – shall mean (a) the Materials (including without limitation cloning and expression vectors, polynucleotides and phagemid vectors) comprising or relating to the CAT Library at the Effective Date and (b) the Materials (including without limitation cloning and expression vectors, polynucleotides and phagemid vectors) comprising or relating to any improved version of the CAT Library made available to XOMA by CAT during the term of the Library License [as defined in the Library License] as set forth in Section 4.2 [of the Library License].
1.1.18 “CAT IP” – shall mean CAT Background IP, CAT Foreground IP and CAT Foreground Patent Rights.
1.1.28 “Control”, “Controls” or “Controlled by” – shall mean either (a) being an Affiliate of either XOMA or CAT, (b) with respect to any item of CAT IP or XOMA IP, the possession of (whether by ownership or license, other than pursuant to [the Library License]) or the ability of such [p]arty to grant access to or a license or sublicense thereof without violating the terms of any agreement or other arrangement with any Third Party existing at the time such [p]arty would be required hereunder to grant the other [p]arty such access or license or sublicense or (c) with respect to any Materials, the CAT Library or an Antibody, physical possession.
1.1.35 “Effective Date” – shall mean the date of execution of [the Library License] by [CAT and XOMA].
58 |
1.1.55 “Patent Rights” – shall mean 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.
59 |
SCHEDULE 1.30
PATENT RIGHTS
Title: | Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use |
Inventors: | Robinson, Liu, Horwitz, Wall, Better |
1) | Based on PCT/US86/02269, which is a continuation-in-part of U.S. Serial No. 06/793,980 filed November 1, 1985 (abandoned). |
COUNTRY | SERIAL NO. | PATENT NO. |
*United States | 06/793,980 | |
Australia | 65981/86 | Issued 606,320 |
Canada | 521,909 | Abandoned |
Denmark | 3385/87 | Pending |
Taiwan | 75105650 | Issued 51922 |
*United States | U.S. National Phase of PCT/US86/02269 |
2) | Based on PCT/US88/02514, which corresponds to U.S. Serial No. 07/077,528, which is a continuation-in-part of PCT/US86/02269 (abandoned), which is a continuation-in-part of U.S. Serial No. 06/793,980 (abandoned). |
COUNTRY | SERIAL NO. | PATENT NO. |
Australia | 23244/88 | Issued 632,462 |
Austria | EP 88907510.7 | Granted EP/0371998 |
Belgium | EP 88907510.7 | Granted EP/0371998 |
Canada | 572,398 | Granted 1,341,235 |
Xxxxxxx | 000/00 | Pending |
Europe | EP 88907510.7 | Granted EP/0371998 |
Europe | EP 95119798.7 | Granted EP/0731167 |
France | EP 88907510.7 | Granted EP/0371998 |
Germany | EP 88907510.7 | Granted EP/0371998 |
Italy | EP 88907510.7 | Granted EP/0000000 |
Japan | 506481/88 | Granted 0000000 |
Luxembourg | EP 88907510.7 | Granted EP/0371998 |
Netherlands | EP 88907510.7 | Granted EP/0371998 |
Sweden | EP 88907510.7 | Granted EP/0371998 |
Switzerland/ | ||
Liechtenstein | EP 88907510.7 | Granted EP/0371998 |
United Kingdom | EP 88907510.7 | Granted EP/0371998 |
Europe | EP 93100041.8 | Granted EP/0550400 |
Austria | EP 93100041.8 | Granted EP/0550400 |
Belgium | EP 93100041.8 | Granted EP/0550400 |
France | EP 93100041.8 | Granted EP/0550400 |
Germany | EP 93100041.8 | Granted EP/0550400 |
Italy | EP 93100041.8 | Granted EP/0550400 |
Luxembourg | EP 93100041.8 | Granted EP/0550400 |
Netherlands | EP 93100041.8 | Granted EP/0550400 |
Sweden | EP 93100041.8 | Granted EP/0550400 |
Switzerland/ | ||
Liechtenstein | EP 93100041.8 | Granted EP/0550400 |
United Kingdom | EP 93100041.8 | Granted EP/0550400 |
*United States | 07/077,528 |
3) | Based on U.S. Serial No. 07/501,092 filed March 29, 1990, which is a continuation-in-part of U.S. Serial No. 07/077,528 (Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use; Robinson, Liu, Horwitz, Wall, Better) and of U.S. Serial No. 07/142,039 (Novel Plasmid Vector with Pectate Lyase Signal Sequence; Lei, Xxxxxx). |
60 |
COUNTRY | SERIAL NO. | PATENT NO. |
*United States | 07/501,092 | |
*United States | 07/987,555 | |
*United States | 07/870,404 | |
*United States | 08/020,671 | |
United States | 08/235,225 | 5,618,920 |
United States | 08/299,085 | 5,595,898 |
United States | 08/472,691 | 6,204,023 |
United States | 08/467,140 | 5,698,435 |
United States | 08/450,731 | 5,693,493 |
United States | 08/466,203 | 5,698,417 |
*Cases abandoned in favor of a continuing application.
61 |
Schedule 7
XOMA NOTICE
XOMA owns a number of patents said to cover various aspects of bacterial antibody expression and phage display.
XOMA has licensed these patents on a non-exclusive basis to CAT.
Under the license agreement with XOMA:
CAT cannot provide phage display services or transfer phage display materials, products or information to you without first showing you a redacted copy of its license from XOMA and this notice.
If you and CAT enter into a written agreement by which you become a “CAT Collaborator”, then you will be permitted to use phage display services, phage display materials, products and information from CAT to research, develop and commercialise antibody products.
Collaborators do not, however, have the right to produce commercial quantities of antibodies under the XOMA license. Rather, collaborators only have the right to make research and development quantities of antibodies under that license. Thus, the collaborator may wish to obtain a commercial production license from XOMA (which may be available), or produce commercial quantities of antibodies using another method.
If you and CAT enter into a written agreement, that agreement must contain the following provisions:
Terms pursuant to which you, as the recipient of any transferred materials, would agree to abide by each of the limitations, restrictions and other applicable obligations provided for by the license agreement with XOMA, including, without limitation, the restrictions on use of such transferred materials for purposes other than research and development.
A provision stating that any amounts paid to CAT shall not constitute payments to XOMA.
An agreement by you to further dispose of phage display materials or materials covered by the XOMA patents only to a third party who otherwise meeting the definition of a “CAT Collaborator” set forth in the license agreement with XOMA.
Schedule 1.30
Patent Rights
Title: Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use Inventors: Robinson, Liu, Horwitz, Wall, Better 1) Based on PCT/US86/02269, which is a continuation-in-part of U.S. Serial No. 06/793,980 filed November 1, 1985 (abandoned).
COUNTRY SERIAL NO. PATENT NO.
-------- -------- --------
*United States 06/793,980
Australia 65981/86 Issued 606,320
Canada 521,909 Abandoned
Denmark 3385/87 Pending
Taiwan 75105650 Issued 51922
*United States U.S. National Phase of
PCT/US86/02269
2) Based on PCT/US88/02514, which corresponds to U.S. Serial No. 07/077,528, which is a continuation-in-part of PCT/US86/02269 (abandoned), which is a continuation-in-part of U.S. Serial No. 06/793,980 (abandoned).
COUNTRY SERIAL NO. PATENT NO.
-------- -------- --------
Australia 23244/88 Issued 632,462
Austria EP 88907510.7 Granted EP/0371998
Belgium EP 88907510.7 Granted EP/0371998
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
62 |
Canada 572,398 Granted 1,341,235
Xxxxxxx 000/00 Pending
Europe EP 88907510.7 Granted EP/0371998
Europe EP 95119798.7 Granted EP/0731167
France EP 88907510.7 Granted EP/0371998
Germany EP 88907510.7 Granted EP/0371998
Italy EP 88907510.7 Granted EP/0000000
Japan 506481/88 Granted 0000000
Luxembourg EP 88907510.7 Granted EP/0371998
Netherlands EP 88907510.7 Granted EP/0371998
Sweden EP 88907510.7 Granted EP/0371998
Switzerland/
Liechtenstein EP 88907510.7 Granted EP/0371998
-2-
COUNTRY SERIAL NO. PATENT NO.
-------- -------- --------
United Kingdom EP 88907510.7 Granted EP/0371998
Europe EP 93100041.8 Granted EP/0550400
Austria EP 93100041.8 Granted EP/0550400
Belgium EP 93100041.8 Granted EP/0550400
France EP 93100041.8 Granted EP/0550400
Germany EP 93100041.8 Granted EP/0550400
Italy EP 93100041.8 Granted EP/0550400
Luxembourg EP 93100041.8 Granted EP/0550400
Netherlands EP 93100041.8 Granted EP/0550400
Sweden EP 93100041.8 Granted EP/0550400
Switzerland/
Liechtenstein EP 93100041.8 Granted EP/0550400
United Kingdom EP 93100041.8 Granted EP/0550400
*United States 07/077,528
3) Based on U.S. Serial No. 07/501,092 filed March 29, 1990, which is a
continuation-in-part of U.S. Serial No. 07/077,528 (Modular Assembly of
Antibody Genes, Antibodies Prepared Thereby and Use; Robinson, Liu,
Horwitz, Wall, Better) and of U.S. Serial No. 07/142,039 (Novel Plasmid
Vector with Pectate Lyase Signal Sequence; Lei, Xxxxxx).
COUNTRY SERIAL NO. PATENT NO.
-------- -------- --------
*United States 07/501,092
*United States 07/987,555
*United States 07/870,404
*United States 08/020,671
United States 08/235,225 5,618,920
United States 08/299,085 5,595,898
United States 08/472,691 6,204,023
United States 08/467,140 5,698,435
United States 08/450,731 5,693,493
United States 08/466,203 5,698,417
___________________
* Cases abandoned in favor of a continuing application.
Schedule 2.4
Form of Notice
XOMA owns a number of patents said to cover various aspects of bacterial antibody expression and phage display.
XOMA has licensed these patents on a non-exclusive basis to CAT.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
63 |
Under the license agreement with XOMA:
CAT cannot provide phage display services or transfer phage display materials, products or information to you without first showing you a redacted copy of its license from XOMA and this notice.
If you and CAT enter into a written agreement by which you become a "CAT Collaborator," then you will be permitted to use phage display services, phage display materials, products and information from CAT to research,
develop and commercialize antibody products.
Collaborators do not, however, have the right to produce commercial quantities of antibodies under the XOMA license. Rather, collaborators only have the right to make research and development quantities of antibodies under that license. Thus, the collaborator may wish to obtain a commercial production license from XOMA (which may be available), or produce commercial quantities of antibodies using another method.
If you and CAT enter into a written agreement, that agreement must contain the following provisions:
Terms pursuant to which you, as the recipient of any transferred materials, would agree to abide by each of the limitations, restrictions and other applicable obligations provided for by the license agreement with XOMA, including, without limitation, the restrictions on use of such transferred materials for purposes other than research and development.
A provision stating that any amounts paid to CAT shall not constitute payments to XOMA.
An agreement by you to further dispose of phage display materials or materials covered by the XOMA patents only to a third party who otherwise meets the definition of a "CAT Collaborator" set forth in the license agreement with XOMA.
Schedule 4.4
Form of Press Release
Investor and Media Contacts:
- ----------------------
Xxxxx Xxxxxx Xxxxx Xxxxx
Corporate Communications & Investor Relations Chief Financial Officer
(000) 000-0000 (000) 000-0000
Cambridge Antibody Technology Contacts:
- -------------------------------
Tel: x00 (0) 0000 000 000
Xxxxx Chambre, Chief Executive Officer
Xxxx Xxxxx, Chief Financial Officer
Xxxxxx Xxxxxxx, Director of Corporate Communications
Xxxxx Shandwick Square Mile (Europe) BMC Communications/The Trout Group
Tel: x00 (0) 00 0000 0000 (USA)
Xxxxx Xxxxx Tel: 000 000 000 0000
Xxxxxx Xxxxxxx Xxxx Xxxxx, ext 17 (media)
Xxxxxxx Xxxxx, ext.15 (investors)
Cambridge Antibody Technology (CAT) and XOMA
Cross-License Antibody Technologies
********************************************************************************
CAMBRIDGE, UK and BERKELEY, CALIFORNIA, USA —December XX, 2002 —Cambridge
Antibody Technology (LSE: CAT; Nasdaq: CATG) and XOMA Ltd. (Nasdaq: XOMA)
announce today that they have entered into a cross-licensing arrangement for antibody-related technologies.
Under the agreement CAT, and its collaborators, receive rights to use the XOMA antibody expression technology for developing products using CAT's phage-based antibody technology, in return for license payments to XOMA. XOMA will receive the right to use CAT's phage antibody libraries for its target discovery and research programs, with an option to develop antibodies into therapeutics. Should any therapeutic antibodies derived from CAT's libraries be identified and developed by XOMA, license payments will be made by XOMA to CAT.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
64 |
Xxxxx Chambre, CAT's Chief Executive Officer, commented, "Clarifying the intellectual property issues in the antibody field remains an important priority for both CAT and XOMA. As CAT progresses with its transition to a product-based biopharmaceutical company, we are pleased to have reached this cross-licensing arrangement with XOMA".
"We are very pleased to enter into this phage-based antibody related licensing arrangement with CAT, a company with excellent capabilities in the important field of antibody drug discovery," said Xxxx Xxxxxxxx, Chairman, President and Chief Executive Officer of XOMA. "Our license to CAT, which is the fourth such license we've entered into with a significant antibody library company this year, further validates the fundamental position our antibody expression technology holds in the phage display arena."
Cambridge Antibody Technology (CAT):
CAT is a UK-based biotechnology company and a leader in the discovery and development of human therapeutic antibodies: HumiraTM, the leading CAT-derived antibody, has been submitted for regulatory review by Xxxxxx (responsible for development and marketing) following the completion of Phase III trials. Six other CAT-derived human therapeutic antibodies are at various stages of clinical trials.
CAT has an advanced proprietary platform technology for rapidly isolating human monoclonal antibodies using phage display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies. These libraries form the basis for the Company's strategy to discover and develop a portfolio of antibody-based drugs.
CAT has alliances with a large number of pharmaceutical and biotechnology companies to discover, develop and commercialize human monoclonal antibody-based products. CAT has also licensed its proprietary human phage antibody libraries to several companies for target validation and drug discovery. CAT's collaborators include: Xxxxxx, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research.
Based near Cambridge, England, CAT currently employs around 290 people.
CAT is listed on the London Stock Exchange and on NASDAQ since June 2001.
CAT raised (pound)41m in its IPO in March 1997 and (pound)93m in a secondary offering in March 2000.
About XOMA and its Antibody Expression Technology:
XOMA scientists were the first to demonstrate the secretion of antibody domains directly from bacterial cells as fully functional, properly folded molecules. XOMA has received nine U.S. patents to date relating to aspects of its bacterial cell expression system, including six patents that broadly cover the secretion of functional immunoglobulins from bacteria, including antibody fragments such mas Fab and single-chain antibodies. Corresponding foreign patents have also been granted. Bacterial antibody expression is an enabling technology used to discover and screen, as well as develop and manufacture, recombinant antibodies for commercial purposes. Bacterial antibody expression is also a key technology used in multiple systems for high-throughput screening of antibody domains. Further information on XOMA's bacterial cell expression technology can be found at l_expression.jsp.
XOMA develops and manufacturers innovative biopharmaceuticals for disease targets that include cancer, immunological and inflammatory disorders, and infectious diseases. XOMA's programs include collaborations: with Genentech, Inc. on the Raptiva(TM) antibody for psoriasis (Phase III), rheumatoid arthritis (Phase II) and other indications; with Onyx Pharmaceuticals, Inc. to develop and manufacture its ONYX-015 product for various cancers (Phase II and III); with Xxxxxx Healthcare Corporation to develop NEUPREX(R) (rBPI-21) for Crohn's disease (Phase II) and other indications; and with Millennium Pharmaceuticals, Inc. on two biotherapeutic agents, CAB-2 and MLN-01, for certain vascular inflammation indications (preclinical). Earlier-stage development programs include compounds to treat cancer, retinopathies, autoimmune diseases and infections. For more information about XOMA's pipeline and activities, please visit XOMA's web site at ..
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
65 |
As to CAT: Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward looking statements are based on numerous assumptions regarding CAT's present and future business strategies and the environment in which CAT will operate in the future. Certain factors that could cause CAT's actual results, performance or achievements to differ materially from those in the forward looking statements include: market conditions, CAT's ability to enter into and maintain collaborative arrangements, success of product candidates in clinical trials, regulatory developments and competition.
As to XOMA:
Statements made in this news release to collaborative arrangements and development capabilities, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to changes in the status of existing collaborative relationships, the availability of future collaborative relationships, the ability of collaborators and other partners to meet their obligations, the timing of results of pending or future clinical trials, market demand for products, actions by the Food and Drug Administration or the US Patent and Trademark Office, and uncertainties regarding the status of biotechnology patents, are discussed in XOMA's most recent annual report on Form 10-K and in other SEC filings. Consider such riskscarefully in evaluating XOMA's prospects.
Schedule 7
XOMA NOTICE
XOMA owns a number of patents said to cover various aspects of bacterial antibody expression and phage display.
XOMA has licensed these patents on a non-exclusive basis to CAT.
Under the license agreement with XOMA:
· | CAT cannot provide phage display services or transfer phage display materials, products or information to you without first showing you a redacted copy of its license from XOMA and this notice. |
· | If you and CAT enter into a written agreement by which you become a “CAT Collaborator”, then you will be permitted to use phage display services, phage display materials, products and information from CAT to research, develop and commercialise antibody products. |
· | Collaborators do not, however, have the right to produce commercial quantities of antibodies under the XOMA license. Rather, collaborators only have the right to make research and development quantities of antibodies under that license. Thus, the collaborator may wish to obtain a commercial production license from XOMA (which may be available), or produce commercial quantities of antibodies using another method. |
· | If you and CAT enter into a written agreement, that agreement must contain the following provisions: |
· | Terms pursuant to which you, as the recipient of any transferred materials, would agree to abide by each of the limitations, restrictions and other applicable obligations provided for by the license agreement with XOMA, including, without limitation, the restrictions on use of such transferred materials for purposes other than research and development. |
· | A provision stating that any amounts paid to CAT shall not constitute payments to XOMA. |
An agreement by you to further dispose of phage display materials or materials covered by the XOMA patents only to a third party who otherwise meeting the definition of a “CAT Collaborator” set forth in the license agreement with XOMA.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
66 |
Schedule 8
iCo-008 Study Reports and Protocols
[***]
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
67 |
Schedule 9
Press Release
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, 0000 |
XXXXXXXXX, Xxxxxx — 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 Xxxxxx Xxx, 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”.
Xx. Xxxxxx Xxxxx, 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.
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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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: xxx.xxxxxxxxxxxxxxx.xxx
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.
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:
Xx. Xxxx Xxxxxxx, CTDO
000-000-0000 x 000
Finance:
Xx. Xxxx Xxxxxxxx, CFO
000-000-0000 x 000
Investor/Media Contact:
Xxxxxxxxx Xxxxxx
000-000-0000 x 000
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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Schedule 10
[TO BE FINALISED]
Notices
Portions of this Exhibit, indicated by the xxxx “[***]”, 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. Portions marked by * were summarized]
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