Document:

Exhibit 10.24

 

Execution Version

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

LICENSE AND OPTION AGREEMENT

 

BY AND BETWEEN

 

MEDIMMUNE, LLC

 

AND

 

BULLDOG PHARMACEUTICALS, INC.

 

 

Table of Contents

 

		
 
    	
Page
    
	
 
    	
 
    	
 
    
	
ARTICLE 1
    	
DEFINITIONS
    	
1
    
	
 
    	
 
    	
	
ARTICLE 2
    	
GRANT OF RIGHTS
    	
18
    
	
 
    	
 
    	
	
ARTICLE 3
    	
DEVELOPMENT AND   REGULATORY
    	
20
    
	
 
    	
 
    	
	
ARTICLE 4
    	
COMMERCIALIZATION
    	
26
    
	
 
    	
 
    	
	
ARTICLE 5
    	
OPTION RIGHTS
    	
26
    
	
 
    	
 
    	
	
ARTICLE 6
    	
PAYMENTS
    	
33
    
	
 
    	
 
    	
	
ARTICLE 7
    	
OWNERSHIP OF   INTELLECTUAL PROPERTY RIGHTS
    	
40
    
	
 
    	
 
    	
	
ARTICLE 8
    	
CONFIDENTIALITY
    	
47
    
	
 
    	
 
    	
	
ARTICLE 9
    	
REPRESENTATIONS AND   WARRANTIES
    	
53
    
	
 
    	
 
    	
	
ARTICLE 10
    	
INDEMNIFICATION AND   INSURANCE
    	
58
    
	
 
    	
 
    	
	
ARTICLE 11
    	
TERM AND TERMINATION
    	
61
    
	
 
    	
 
    	
	
ARTICLE 12
    	
MISCELLANEOUS
    	
66
    
	
 
    	
 
    	
	
Exhibits:
    	
 
    	
	
 
    	
 
    	
	
Schedules:
    	
 
    	

 

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LICENSE AND OPTION AGREEMENT

 

This License and Option Agreement (this “Agreement”) is entered into and made effective as of the 24th day of July, 2013 (the “Effective Date”), by and between MedImmune, LLC, a limited liability company organized and existing under the laws of Delaware, having a principal office located at One MedImmune Way, Gaithersburg, MD 20878 (“MedImmune”), and Bulldog Pharmaceuticals, Inc., a company organized and existing under the laws of the British Virgin Islands, having a registered office located at Midocean Chambers, Road Town, Tortola, British Virgin Islands (“Kolltan”).  MedImmune and Kolltan are each referred to herein by name or as a “Party” or, collectively, as “Parties.”

 

RECITALS

 

WHEREAS, Kolltan is a wholly-owned subsidiary of Kolltan Pharmaceuticals, Inc.;

 

WHEREAS, Kolltan possesses expertise in the Research, Development, Manufacture and Commercialization (each as defined below) of pharmaceutical products;

 

WHEREAS, MedImmune controls certain intellectual property and regulatory materials and biological materials related to the Licensed Antibody (as defined below);

 

WHEREAS, Kolltan is interested in receiving certain licenses and other rights under which it may Research, Develop, Manufacture and Commercialize the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products (each as defined below), in each case in the Field in the Territory (each as defined below), and MedImmune is willing to grant Kolltan such licenses and other rights on the terms and conditions set forth in this Agreement; and

 

WHEREAS, the Parties desire to set forth herein the terms and conditions of the licenses and other rights to enable Kolltan to Research, Develop, Manufacture and Commercialize the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products.

 

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 hereby acknowledged, the Parties agree as follows:

 

ARTICLE 1
 DEFINITIONS

 

As used in this Agreement, the following terms shall have the meanings set forth in this ARTICLE 1:

 

1.1                               “Accounting Standards” means generally accepted accounting principles (GAAP) as practiced in the United States; provided, however, that from and after such time (if any) as Kolltan elects to maintain its books in accordance with International Financial Reporting Standards (“IFRS”), Accounting Standards shall mean IFRS.

 

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1.2                               “Affiliate” means, as to a Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with said first Person, regardless of whether such Affiliate is an Affiliate on the Effective Date or becomes an Affiliate after the Effective Date.  For purposes of this definition, a Person shall be deemed to “control” another Person if it (a) owns, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage which is the maximum allowed to be owned by a Person in a particular jurisdiction) of such other Person, or has other comparable ownership interest with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the general management and policies of the Person.

 

1.3                               “Annual Net Sales” means, for any Licensed Product or Follow-On Product, as the case may be, in any Calendar Year, aggregate Net Sales of such Licensed Product or Follow-On Product, as applicable, in such Calendar Year, but excluding any Net Sales of such Licensed Product or Follow-On Product, as applicable, in any country if the applicable sale is made after the expiration of the Royalty Term for such Licensed Product or Follow-On Product, as applicable, in such country.

 

1.4                               “Antibody” means any antibody, or any antigen-binding fragment thereof, with a unique amino acid sequence.  Two antibodies that have different amino acid sequences (even if differing by only a single amino acid) shall be deemed to be different Antibodies.

 

1.5                               “Applicable Law” or “Applicable Laws” means all laws, statutes, rules, regulations, orders, judgments, or ordinances having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision that may be in effect from time to time and applicable to the activities contemplated by this Agreement.

 

1.6                               “BLA” means a Biologics License Application and any amendments or supplements thereto filed with the FDA pursuant to 21 C.F.R. Part 601 or any other application that is required for the purpose of marketing and selling a biological product and is filed with a Regulatory Authority outside the United States, including, with respect to the EU, a Product License Application, Marketing Authorization Application and/or manufacturing and importation license.

 

1.7                               “Business Day” means a day on which banking institutions in New York, NY are open for business, excluding any Saturday or Sunday.

 

1.8                               “Calendar Quarter” means a period of three (3) consecutive months ending on the last day of March, June, September, or December.

 

1.9                               “Calendar Year” means a period of time commencing on January 1 and ending on the following December 31.

 

1.10                        “Clinical Trial(s)” means individually and collectively a Phase 1 Clinical Trial, a Phase 1b/2a Clinical Trial, a Phase 2 Clinical Trial, a Phase 3 Clinical Trial, a Phase 4 Study and a Post Approval Study.

 

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1.11                        “Combination Product” means a Licensed Product or Follow-On Product, as the case may be, that (a) includes the Licensed Antibody or a Follow-On Antibody, as applicable, as an active pharmaceutical ingredient, together with one or more other active ingredients, and (b) is sold either as a fixed dose or with separate doses in a single package.

 

1.12                        “Commercialization” or “Commercialize” means any activities directed to obtaining pricing and/or reimbursement approvals, marketing, promoting, distributing, importing, offering to sell, and/or selling a product, including post-Regulatory Approval promotional activities conducted at scientific conferences or similar events.

 

1.13                        “Commercially Reasonable Efforts” means, with respect to a Party, such level of efforts required to carry out an obligation in a sustained manner consistent with the efforts normally used by pharmaceutical or biopharmaceutical companies, as applicable, of comparable size and resources to such Party, for a similar activity with respect to the Research, Development, Manufacture or Commercialization of products that (a) are at a similar stage in their product life as the relevant Licensed Product or Follow-On Product, as applicable, and (b) that have commercial and market potential similar to the relevant Licensed Product or Follow-On Product, as applicable,, taking into account issues of intellectual property scope, subject matter and coverage, safety and efficacy, product profile, competitiveness with respect to Third Party products in the marketplace, and profitability (including pricing and reimbursement status achieved or likely to be achieved).

 

1.14                        “Competing Product” means any pharmaceutical product that (a) comprises or incorporates an Antibody as an active pharmaceutical ingredient alone or in combination with one or more other active agents and (b) operates by targeting HER-3.

 

1.15                        “Control,” “Controls,” “Controlled” or “Controlling” means, with respect to any Know-How, Patent, Regulatory Documentation or other intellectual property right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party of the right to assign or grant access to, or grant a license or sublicense under, such Know-How, Patent, Regulatory Documentation or other intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to make such assignment or grant such access, license or sublicense; provided, however, that any Know-How, Patent, Regulatory Documentation or other intellectual property right that is licensed or acquired by a Party from a Third Party after the Effective Date (other than rights arising from the In-License Agreements) that would otherwise be considered to be under the Control of such Party shall not be deemed to be under the Control of such Party if the application of such definition in the context of any licenses or sublicenses granted to the other Party under this Agreement would require the granting Party to make additional payments or royalties to such Third Party in connection with such license or sublicense grants pursuant to an arm’s length agreement between the granting Party and such Third Party, unless the other Party agrees to pay such additional payments or royalties to the Third Party.

 

1.16                        “Cover” or “Covered” means, for any product, technology, process or method and any Valid Claim, that the composition, manufacture, use, offer for sale, sale or importation of such product or the practice of such technology, process or method would, absent ownership of a

 

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Patent that includes such Valid Claim or a license or sublicense under such Valid Claim, infringe such Valid Claim (assuming, in the case of a Valid Claim that has not yet issued, that such Valid Claim had issued).  A product, technology, process or method shall be deemed Covered by a Patent if it is Covered by at least one Valid Claim included in such Patent.

 

1.17                        “Data Package Delivery Date” means the date on which Kolltan completes delivery to MedImmune of (a) the full data set of clinical trial data (including validated data for primary and secondary endpoints) in the clinical trial database for a Phase 1b/2a Clinical Trial of the Licensed Antibody or a Licensed Product for each of two (2) indications as provided in Section 5.1.1, and (b) the clinical data and non-clinical and/or Development data and information required to be delivered under Sections 5.1.2 and 5.1.3 together with the full data set described in clause (a) above.

 

1.18                        “Develop” or “Development” means development activities relating to the development of compounds, biologics, or processes, and submission of information to a Regulatory Authority for the purpose of obtaining Regulatory Approval of a product.  Development includes non-clinical activities, pharmacology studies, toxicology studies, manufacturing process development activities, analytical method development activities, formulation development activities, chemical analysis, bioanalytical analysis, material performance studies (including measurements of stability, physical form, dissolution, and visual and spectroscopic analysis), pharmacokinetic studies, clinical studies, biomarker and companion diagnostic discovery and development, regulatory affairs activities, and all other activities relating to seeking, obtaining or maintaining any Regulatory Approvals from the FDA or any other applicable Regulatory Authority.

 

1.19                        “Dollars” or “$” means the legal tender of the United States.

 

1.20                        “Dyax Agreement” means that certain Amended and Restated License Agreement, dated July 26, 2012 between MedImmune Limited and Dyax Corp.

 

1.21                        “EMA” means the European Medicines Agency, or any successor entity thereto.

 

1.22                        “EU” means all of the member countries of the European Union as of the applicable time during the Term.  For clarity, the member countries of the European Union as of the Effective Date are Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom.

 

1.23                        “Executive Officers” means (a) with respect to Kolltan, the Chief Executive Officer of Kolltan, and (b) with respect to MedImmune, the Executive Vice President, Research and Development of MedImmune.

 

1.24                        “Existing IND” means application number 116023 for the treatment of advanced solid tumors, filed with the FDA and effective as of January 11, 2013.

 

1.25                        “Existing Proceeding” means any post-grant proceeding that is being prosecuted by MedImmune or its Affiliates as of the Effective Date and that relates to a Patent that (a) could

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

be relevant to the exercise by Kolltan of the rights, licenses and sublicenses granted to Kolltan by MedImmune under this Agreement (including the making, using, selling, offering for sale or import of the Licensed Antibody or any Licensed Product, Follow-On Antibody or Follow-On Product) or (b) could otherwise affect the Research, Development, Manufacture, or Commercialization of the Licensed Antibody or any Licensed Product, Follow-On Antibody or Follow-On Product.  For the avoidance of doubt, Existing Proceeding includes the opposition proceeding set forth in Exhibit 9.2.6.

 

1.26                        “FDA” means the U.S. Food and Drug Administration, or any successor entity thereto.

 

1.27                        “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

 

1.28                        “Field” means any use in humans, including diagnosis, prophylaxis and treatment of human disease.

 

1.29                        “First Commercial Sale” means, for any Licensed Product or Follow-On Product, as the case may be, in any country, the first sale or other transfer for consideration of such Licensed Product or Follow-On Product, as applicable, in such country by or on behalf of Kolltan, its Affiliates or its Sublicensees for use or consumption pursuant to a Regulatory Approval (or as otherwise permitted by the applicable Governmental Authority) in such country, including any sales or other transfers for consideration to distributors (subject to the next sentence), that results in the recognition of revenue.  Sale or other transfer for consideration of a Licensed Product or Follow-On Product, as the case may be, in a country by Kolltan to an Affiliate or Sublicensee of Kolltan shall not constitute a First Commercial Sale in such country where such Affiliate or such Sublicensee (a) is not the end user of such Licensed Product or Follow-On Product, as applicable, and has purchased or received such Licensed Product or Follow-On Product, as applicable, for purposes of re-selling, transferring, distributing or otherwise commercially disposing of such Licensed Product or Follow-On Product, as applicable, or (b) is solely acquiring such Licensed Product or Follow-On Product, as applicable, for the purposes set forth in subsections (a)-(c) of Section 1.98.  In no event shall any sales in any country for sampling be deemed a First Commercial Sale in such country.

 

1.30                        “Follow-On Antibody” means any Antibody, other than the Licensed Antibody, that is Covered by a claim of a national stage application of or claiming priority to Intl. Appl. No. [**].  For avoidance of doubt, Follow-On Antibody includes any antibody or antigen-binding fragment thereof fused or conjugated to a molecule, which antibody is Covered by a claim of a national stage application of or claiming priority to Intl. Appl. No. [**].

 

1.31                        “Follow-On Product” means any pharmaceutical product (including all forms, presentations, doses and formulations) that comprises or incorporates any Follow-On Antibody as an active pharmaceutical ingredient alone or in combination with one or more other active agents.

 

1.32                        “Follow-On Product Transaction” means any sale by Kolltan of, or any grant of any license or sublicense by Kolltan under, Kolltan’s rights to Commercialize any Follow-On

 

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Product; provided, however, that any Kolltan Sale or Financing, or any assignment or deemed assignment of this Agreement by Kolltan in connection with a Kolltan Sale or Financing, shall not be deemed a Follow-On Product Transaction.

 

1.33                        “Follow-On Program” means the Parties’ rights and obligations under this Agreement with respect to Follow-On Antibodies and Follow-On Products.

 

1.34                        “GCP” means the then-current standards, practices and procedures (a) promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA; (b) set forth in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 and Commission Directive 2005//28/EC of 8 April 2005; (c) set forth in ICH Guideline for Good Clinical Practice E6; (d) set forth in analogous Applicable Laws of an applicable Regulatory Authority; and (e) set forth in any Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing.

 

1.35                        “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, as such regulations may be amended from time to time, and analogous Applicable Laws of an applicable Regulatory Authority.

 

1.36                        “GMP” means then-current standards for the manufacture of pharmaceutical products, pursuant to (a) the FD&C Act (21 U.S.C. 321 et seq.); (b) relevant United States regulations in Title 21 of the United States Code of Federal Regulations (including Parts 11, 210, and 211); (c) European Community Directives 2003/94 and 91/356/EC; (d) the European Community Guide to Good Manufacturing Practice for Medicinal Intermediate Products; (e) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; (f) analogous Applicable Laws of an applicable Regulatory Authority at the time of Manufacture; and (g) all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing.

 

1.37                        “Governmental Authority” means any United States federal, state or local or any non-United States government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or governmental arbitral body.

 

1.38                        “HER-3” means the protein that (a) is also known as ErbB3 or EGFR3; (b) is an alias of V-erb-b2 erythroblastic leukemia viral oncogene homolog 3; (c) is a member of the ErbB family of receptor tyrosine kinases; and (d) has its DNA sequence located on human chromosome 12q13.

 

1.39                        “ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

 

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1.40                        “IND” means an Investigational New Drug Application filed with FDA or a similar application filed with an applicable Regulatory Authority outside of the United States such as a clinical trial application (CTA).

 

1.41                        “In-License Agreement” means each agreement pursuant to which MedImmune is granted a license or sublicense under the In-Licensed IP.  As of the Effective Date, the In-License Agreements are the agreements set forth on Exhibit 1.41.

 

1.42                        “In-Licensed IP” means the Patents and Know-How set forth on Exhibit 1.42.

 

1.43                        “Insolvency Event” means, as to a Party, (a) the entry of an order for relief with respect to such Party under the Bankruptcy Code or any other bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect; (b) the commencement of an involuntary proceeding against such Party under the Bankruptcy Code or any other bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, if not dismissed, bonded or stayed within ninety (90) days after such commencement; (c) the making by such Party of a general assignment for the benefit of creditors; or (d) the appointment of or taking possession by a receiver, liquidator, assignee, custodian, or trustee of all or substantially all of the business or property of such Party.

 

1.44                        “Joint Information and Inventions” means Know-How that is first made or discovered jointly by (a) one or more employees, consultants or agents of MedImmune or its Affiliates and (b) one or more employees, consultants or agents of Kolltan or its Affiliates, in the course of Research, Development, Manufacture or Commercialization of the Licensed Antibody and Licensed Products.

 

1.45                        “Joint IP” means the Joint Know-How and the Joint Patents.

 

1.46                        “Joint Know-How” means all Joint Information and Inventions except to the extent disclosed by published Joint Patents.

 

1.47                        “Joint Patents” means Patents that Cover Joint Information and Inventions.

 

1.48                        “Know-How” means all tangible and intangible (a) information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, strategies, skill, experience, data, results (including pharmacological, toxicological and non-clinical and clinical test data and results, and Research or Development data, reports and batch records), analytical and quality control data, analytical methods (including applicable reference standards), full batch documentation for all product forms, packaging records, release, stability, storage and shelf-life data, Manufacturing process information, results and descriptions, and software and algorithms (but excluding any Regulatory Documentation) and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material (including reagents and antibodies).

 

1.49                        “Kolltan Development Costs” means the sum of (a) all Out-of-Pocket Costs incurred by Kolltan or its Affiliates under this Agreement as of a specified time that are specifically identifiable to (i) the Research or Development of the Licensed Antibody or Licensed Products or (ii) the Manufacture of the Licensed Antibody or Licensed Products in

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

support of such Research or Development, including the validation, qualification and subsequent audit of Manufacturing facilities, and (b) an amount equal to the lesser of (x) the number of Kolltan employee hours attributable to Kolltan’s activities set forth in the foregoing subsections (i) and (ii) of clause (a) above multiplied by [**] Dollars ($[**]) and (y) [**] percent ([**]%) of the amount described in clause (a) above.  For avoidance of doubt, the Upfront Fee shall not be included in the Kolltan Development Costs.

 

1.50                        “Kolltan Indemnitees” means Kolltan and its Affiliates and Sublicensees and the directors, officers, employees and consultants of Kolltan and its Affiliates and Sublicenses.

 

1.51                        “Kolltan Information and Inventions” means Know-How that (a) is Controlled by Kolltan or its Affiliates during the Term and (b) relates to the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product, or the Manufacture of the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product; provided, however, that Kolltan Information and Inventions excludes any Joint Information and Inventions.

 

1.52                        “Kolltan IP” means the Kolltan Know-How and the Kolltan Patents.

 

1.53                        “Kolltan Know-How” means all Kolltan Information and Inventions except to the extent disclosed by published Kolltan Patents.

 

1.54                        “Kolltan Patents” means Patents Controlled by Kolltan or its Affiliates during the Term that Cover Kolltan Information and Inventions; provided, however, that Kolltan Patents excludes any Joint Patents.

 

1.55                        “Kolltan Sale or Financing” means (a) any transaction or series of related transactions that results in the sale or other disposition of all or substantially all of Kolltan’s assets; (b) any merger, consolidation or similar business combination involving Kolltan; or (c) any issuance, sale or exchange of any securities of Kolltan, whether in a public or private offering.

 

1.56                        “Licensed Antibody” means MedImmune’s proprietary Antibody known as MEDI3379 (anti-HER3), with respect to which the Existing IND has been filed, and/or its parent Antibody 2C2 (anti-HER3), or any isotype thereof.

 

1.57                        “Licensed Product” means any pharmaceutical product (including all forms, presentations, doses and formulations) that comprises or incorporates the Licensed Antibody as an active pharmaceutical ingredient alone or in combination with one or more other active agents.

 

1.58                        “Licensed Program” means the Parties’ rights and obligations under this Agreement with respect to the Licensed Antibody and Licensed Products.

 

1.59                        “Lonza Agreement” means that certain Licenses and Services Agreement made effective as of January 21, 2005 by and between AstraZeneca AB and Lonza Biologics PLC, as (a) novated by that certain Novation Agreement effective January 1, 2007 by and among Lonza

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Biologics PLC, Lonza Sales AG and AstraZeneca AB and (b) amended by Amendment No. 1 made effective as of March 20, 2009.

 

1.60                        “Major Indication” means any indication with a market potential of at least [**] Dollars ($[**]) in peak year sales in the Territory, as determined by Kolltan, in consultation with MedImmune, by reference to standard industry sources.

 

1.61                        “Manufacture” or “Manufacturing” means all activities related to the manufacturing of a product in all of its forms, including test method development, formulation development, process development, process and product characterization (including upstream and downstream processing), manufacturing scale-up, manufacturing for use in non-clinical and clinical studies, manufacturing for commercial sale, packaging, storage, quality assurance/quality control development, quality control testing (including in-process, release and stability testing) and release of product or any component or ingredient thereof, and regulatory activities related to all of the foregoing.

 

1.62                        “MedImmune Additional Information and Inventions” means Know-How (a) that is Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term; (b) that relates to the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product; and (c) the practice of which is reasonably useful in order to Research, Develop or Commercialize the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product in the Field in the Territory; provided, however, that MedImmune Additional Information and Inventions excludes any MedImmune Information and Inventions, any MedImmune Manufacturing Information and Inventions and any Joint Information and Inventions.

 

1.63                        “MedImmune Additional IP” means the MedImmune Additional Know-How and the MedImmune Additional Patents.

 

1.64                        “MedImmune Additional Know-How” means all MedImmune Additional Information and Inventions except to the extent disclosed by published MedImmune Additional Patents.

 

1.65                        “MedImmune Additional Patents” means Patents Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term that Cover MedImmune Additional Information and Inventions; provided, however, that MedImmune Additional Patents excludes any MedImmune Patents and any Joint Patents.

 

1.66                        “MedImmune Indemnitees” means MedImmune, its Affiliates and the directors, officers, employees and consultants of MedImmune and its Affiliates.

 

1.67                        “MedImmune Information and Inventions” means Know-How (a) that is Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term; (b) that relates to the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product; and (c) the practice of which is necessary to Research, Develop or Commercialize the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product in the Field in the Territory; provided, however, that MedImmune

 

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Information and Inventions excludes any MedImmune Manufacturing Information and Inventions and any Joint Information and Inventions.

 

1.68                        “MedImmune IP” means the MedImmune Know-How and the MedImmune Patents.

 

1.69                        “MedImmune Know-How” means all MedImmune Information and Inventions except to the extent disclosed by published MedImmune Patents.

 

1.70                        “MedImmune Manufacturing Information and Inventions” means Know-How (a) that is Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term and (b) either (i) the practice of which is necessary in order to Manufacture the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product in the Field in the Territory or (ii) is expressly disclosed in the Existing IND; provided, however, that MedImmune Manufacturing Information and Inventions excludes any Joint Information and Inventions.  For avoidance of doubt, MedImmune Manufacturing Information and Inventions shall not include any Know-How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process.

 

1.71                        “MedImmune Manufacturing Know-How” means all MedImmune Manufacturing Information and Inventions except to the extent disclosed by published MedImmune Manufacturing Patents.

 

1.72                        “MedImmune Manufacturing Patents” means Patents Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term that Cover MedImmune Manufacturing Information and Inventions; provided, however, that MedImmune Manufacturing Patents excludes any Joint Patents; and provided, further, that any Patents that qualify as both (a) MedImmune Manufacturing Patents and (b) either MedImmune Patents or MedImmune Additional Patents shall, for purposes of ARTICLE 7, be treated as MedImmune Patents or MedImmune Additional Patents, as applicable.

 

1.73                        “MedImmune Patents” means Patents Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term that Cover MedImmune Information and Inventions; provided, however, that MedImmune Patents excludes any Joint Patents.

 

1.74                        “MRC Agreement” means that certain Agreement, dated January 7, 1997, between Medical Research Council, Cambridge Antibody Technology Limited and Cambridge Antibody Technology Group plc, as may be amended from time to time.

 

1.75                        “Net Sales” means, with respect to Licensed Products or Follow-On Products, as the case may be, the gross amounts billed or invoiced by or on behalf of Kolltan, its Affiliates or its Sublicensees to Third Parties that are not Sublicensees for the sale or other transfer for consideration of Licensed Products or Follow-On Product, as applicable, less the following deductions, determined in each case in accordance with the Accounting Standards:

 

(a)                                 normal and customary trade, quantity or prompt settlement discounts allowed and taken;

 

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(b)                                 refunds, chargebacks and any other allowances given and taken which effectively reduce the gross amounts billed or invoiced;

 

(c)                                  product returns, credits, allowances and bad debt write-offs;

 

(d)                                 rebates, reimbursements, fees, taxes or similar payments to (i) wholesalers and other distributors, pharmacies and other retailers, buying groups (including group purchasing organizations), health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, governmental entities, or other institutions or health care organizations to the extent actually paid or credited; or (ii) patients and other Third Parties arising in connection with any program that provides low income, uninsured or other patients the opportunity to obtain discounted Licensed Products or Follow-On Product, as applicable;

 

(e)                                  discounts mandated by, or granted to meet the requirements of, Applicable Law, including required chargebacks and retroactive price reductions;

 

(f)                                   transportation, freight, postage charges and other charges such as insurance, relating thereto, in each case included as a specific line item on a bill or an invoice to such Third Parties; and

 

(g)                                  taxes, excises or other governmental charges upon or measured by the production, sale, transportation, delivery or use of goods, in each case included as a specific line item on a bill or an invoice to such Third Parties.

 

Sales or other transfers for consideration of Licensed Products or Follow-On Products, as the case may be, (1) between Kolltan and its Affiliates and/or its Sublicensees (except to the extent that such Affiliates or Sublicensees are end users of such Licensed Products or Follow-On Products, as applicable) or (2) provided to Third Parties without charge, in connection with research and development, Clinical Trials, compassionate use, humanitarian and charitable donations, or indigent programs or for use, in reasonable and customary quantities, as samples, shall in each case ((1) and (2)) be excluded from the computation of Net Sales, and no payments will be payable on such sales or such other transfers for consideration.

 

If a Licensed Product or Follow-On Product is sold or otherwise commercially disposed of for consideration other than cash or in a transaction that is not at arm’s length between the buyer and the seller, then the gross amount to be included in the calculation of Net Sales shall be the amount that would have been invoiced had the transaction been conducted at arm’s length and for cash.  Such amount that would have been invoiced shall be determined, wherever possible, by reference to the average selling price of the relevant Licensed Product or Follow-On Product in arm’s length transactions in the relevant country.

 

Notwithstanding the foregoing, to the extent a Licensed Product or Follow-On Product, as the case may be, is sold as a Combination Product:

 

(i)                                     if, on a country-by-country basis, each of such Licensed Product or Follow-On Product, as applicable, and the other active ingredient(s) in such Combination Product are sold separately in a country, Net Sales with respect to such

 

11

 

Combination Product in such country for the purpose of determining milestones and royalties due hereunder shall be calculated by multiplying the actual Net Sales of the Combination Product in such country by the fraction A/(A+B), where “A” is the total weighted (by sales volume) average Net Sales price of such Licensed Product or Follow-On Product, as applicable, as sold separately in such country and “B” is the total weighted (by sales volume) average net sales (calculated in a manner analogous to the manner in which Net Sales are calculated as set forth above) price of such other active ingredient(s)as sold separately in such country;

 

(ii)                                  if, on a country-by-country basis, such Licensed Product or Follow-On Product, as applicable, is sold separately in a country but the other active ingredient(s) in such Combination Product are not sold separately in such country, Net Sales with respect to such Combination Product in such country for the purpose of determining milestones and royalties due hereunder shall be calculated by multiplying the actual Net Sales of the Combination Product in such country by the fraction A/C, where “A” is the total weighted (by sales volume) average Net Sales price of the Licensed Product or Follow-On Product, as applicable, as sold separately in such country and “C” is the total weighted (by sales volume) average Net Sales price of the Combination Product in such country;

 

(iii)                               if, on a country-by-country basis, such Licensed Product or Follow-On Product, as applicable, is not sold separately in a country, but each of such Licensed Product or Follow-On Product, as applicable, and the other active ingredient(s) in such Combination Product are sold separately in at least one country, Net Sales with respect to such Combination Product in such first country for the purpose of determining milestones and royalties due hereunder shall be calculated by multiplying the actual Net Sales of such Combination Product in such first country by the fraction D/(D+E), where “D” is the worldwide average Net Sales price of the Licensed Product or Follow-On Product, as applicable, as sold separately, and “E” is the worldwide average net sales (calculated in a manner analogous to the manner in which Net Sales are calculated as set forth above) price of the other active ingredients included in the Combination Product as sold separately; and

 

(iv)                              if, on a country-by-country basis, none of clauses (i) through (iii) above is applicable with respect to a country, Net Sales with respect to such Combination Product in such country for the purpose of determining milestones and royalties due hereunder shall be determined by the Parties in good faith based on the fair market value of the contribution of the Licensed Product or Follow-On Product, as applicable, to the total fair market value of the Combination Product, using, to the extent practicable, the principles outlined in clauses (i) through (iii) above.

 

1.76                        “Out-of-Pocket Costs” means amounts actually paid by a Party or its Affiliates to a Third Party that are identifiable to the applicable activities under this Agreement, which amounts or commitments are not cancelable by such Party without penalty or otherwise reasonably capable of recovery from such Third Party.

 

1.77                        “Patent” means (a) all patents and patent applications in any country or supranational jurisdiction, and (b) any substitutions, divisionals, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations,

 

12

 

extensions, supplementary protection certificates and the like of any such patents or patent applications.

 

1.78                        “Patent Matter” means any Dispute that relates to the inventorship, infringement, enforceability or validity of any Patent.

 

1.79                        “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

 

1.80                        “Phase 1 Clinical Trial” means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the United States.

 

1.81                        “Phase 1b/2a Clinical Trial” means a human clinical trial of a product as a single agent or in combination for any indication that (a) is intended for dose exploration, examination of pharmacological or clinical activity (including dose response, dose escalation, duration of effect or kinetic/dynamic relationship assessments) and preliminary determination of efficacy and safety in the target patient population, and (b) contains a sufficient number of well characterized and clinically uniform subjects for the applicable indication using a pre-specified and uniform dose, or, if in combination, a fixed combination regimen, to assess the response rate and safety of the investigational agent.  As used herein, “response rate” in the case of a Phase 1b/2a Clinical Trial of the Licensed Antibody or Licensed Product must be sufficiently robust, and demonstrate clinical benefit compared to standard of care (historical controls can be used), up to a maximum obligation of 40 subjects in the uniform dose cohort.

 

1.82                        “Phase 2 Clinical Trial” means a human clinical trial for which the primary endpoints include a determination of dose ranges or an indication of efficacy of a product in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country other than the United States.

 

1.83                        “Phase 3 Clinical Trial” means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in the indication being investigated in a manner sufficient to obtain Regulatory Approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. §312.21(c), or an equivalent clinical trial in a country other than the United States.

 

1.84                        “Phase 4 Study” means (a) a human clinical trial for a product for an indication that is required by a Regulatory Authority as a condition of (but is not completed before) obtaining the initial Regulatory Approval for such product for such indication and (b) any trial, test or study that is required or requested by a Regulatory Authority as a condition of maintaining the initial Regulatory Approval for a product for an indication, excluding any Post Approval Study.

 

1.85                        “Post Approval Study” means any human clinical study or other test or study with respect to a product for an indication that is not required in order to obtain or maintain Regulatory Approval for such product for such indication.  For clarity, any human clinical study

 

13

 

that is intended to expand the product labeling for such product shall be deemed not to be a Post Approval Study.  Subject to the foregoing, Post Approval Study may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator or company sponsored or initiated studies and health economics studies.

 

1.86                        “Product Acquisition Price” means the greater of (a) the applicable Product FMV and (b) the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which the applicable payment is made in accordance with this Agreement.

 

1.87                        “Product FMV” means the fair market value of the Product Rights based on a calculation of risk adjusted net present value and, if deemed necessary by the Panel, using one or more additional standard methodologies generally accepted in the valuation industry (including review of comparable programs).

 

1.88                        “Product Rights” means, as of the applicable time under this Agreement, (a) all right, title and interest of Kolltan or its Affiliates in and to the Licensed Antibody and any Licensed Products, including the rights, licenses and sublicenses granted by MedImmune hereunder, (b) to the extent not included in clause (a) above, the assignments to be made by Kolltan pursuant to Section 11.7.2(f), and (c) to the extent not included in clause (a) above, the licenses to be granted by Kolltan pursuant to Section 11.7.2(g), in each of the foregoing cases by reference to then-existing and future plans for Development of the Licensed Antibody and Licensed Products as reflected in any ongoing schedule of activities or otherwise in any Development plans to which Kolltan has committed, including for the specific indications included in any completed or in-progress Phase 1b/2a Clinical Trials with respect to the Licensed Antibody and Licensed Products, including the estimated costs for Development.

 

1.89                        “Program” means each of the Follow-On Program and the Licensed Program.

 

1.90                        “Qualified Bidder” means any Third Party bidder participating in the auction conducted by Kolltan pursuant to Section 5.4.3(e)(i) that is generally regarded within the biopharmaceutical industry as an entity that does not (a) inappropriately disclose or misuse the confidential information of its customers and licensors or (b) infringe the patent rights or misappropriate the trade secrets of its customers and licensors.

 

1.91                        “Qualified Contract Manufacturer” means any Third Party contract manufacturer that is generally regarded within the biopharmaceutical industry as an entity that does not (a) inappropriately disclose or misuse the confidential information of its customers and licensors or (b) infringe the patent rights or misappropriate the trade secrets of its customers and licensors.

 

1.92                        “Regulatory Approval” means all approvals, licenses, registrations or authorizations of any applicable Regulatory Authority necessary for the Commercialization (excluding pricing and/or reimbursement approvals) of a biological product for a particular indication in a country.

 

1.93                        “Regulatory Authority” means the FDA in the United States or any health authority in another country that is a counterpart to the FDA and holds responsibility for

 

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regulating development of and/or granting Regulatory Approval for a biological product in such country, including the EMA, and any successor(s) thereto.

 

1.94                        “Regulatory Documentation” means all INDs (and/or clinical trial applications), BLAs (and/or marketing applications), and other regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approvals, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. §314.420 and any non-United States equivalents), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval, including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority, and any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, methods, processes and reports, executed batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities, in each case related to, or required to Develop, Manufacture or Commercialize, a biological product.

 

1.95                        “Research” means the use, discovery, identification, research, characterization, modification, derivatization and optimization of Antibodies and other biological products.

 

1.96                        “Research Program” means each of the internal MedImmune Research programs listed on Exhibit 1.96.

 

1.97                        “Royalty Term” means (a) with respect to the relevant Licensed Product, for any country, the period (i) commencing on the First Commercial Sale of the first Licensed Product in such country and (ii) expiring on the later of (x) the tenth (10th) anniversary of such First Commercial Sale and (y) the expiration of the last to expire Valid Claim of an issued MedImmune Patent in such country that Covers the sale of the relevant Licensed Product in such country, and (b) with respect to the relevant Follow-On Product, for any country, the period (i) commencing on the First Commercial Sale of the first Follow-On Product in such country and (ii) expiring on the later of (x) the tenth (10th) anniversary of such First Commercial Sale and (y) the expiration of the last to expire Valid Claim of an issued MedImmune Patent in such country that Covers the sale of the relevant Follow-On Product in such country.

 

1.98                        “Sublicensee” means a Third Party to whom Kolltan, as permitted under this Agreement, grants a license or sublicense, as the case may be, under the MedImmune IP, MedImmune Additional IP or Joint IP to Research, Develop, Manufacture, Commercialize or otherwise use the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product, or otherwise grants rights to distribute, promote or sell Licensed Products or Follow-On Products; provided, however, Sublicensee does not include any Third Party who purchases a Licensed Product or Follow-On Product under a limited license or sublicense, as the case may be, as required to enable such Third Party (a) to perform final packaging for such Licensed Product or Follow-On Product for local distribution, (b) to conduct a confirmatory Clinical Trial of such Licensed Product or Follow-On Product to support a filing for Regulatory Approval of such Licensed Product or Follow-On Product in such Third Party’s distribution territory or (c) to prepare and make a filing for a Regulatory Approval of such Licensed Product or Follow-On Product in such Third Party’s distribution territory.

 

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1.99                        “Term” means the period commencing on the Effective Date and ending on the expiration or earlier termination of this Agreement.

 

1.100                 “Territory” means the entire world.

 

1.101                 “Third Party” means any Person other than MedImmune or Kolltan that is not an Affiliate of MedImmune or of Kolltan.

 

1.102                 “United States” or “U.S.” means the United States of America and all of its territories and possessions.

 

1.103                 “Unredacted Provision” means any provision of any In-License Agreement that was attached to an email sent by Christian Dinneen-Long to W. Bradford Middlekauff on July 25, 2013 at 4:30pm, 4:31pm, 4:32pm or 4:33pm Eastern Standard Time, which provision was included in such attachment in unredacted form; provided, however, that Unredacted Provisions excludes any provision that is partially redacted or incorporates any term the definition of which is redacted or partially redacted (including by incorporating any other term the definition of which is redacted or partially redacted).

 

1.104                 “UT Agreement” means that certain Exclusive Patent License Agreement, effective November 1, 2005, between the Board of Regents of the University of Texas System on behalf of the University of Texas Southwestern Medical Center at Dallas and MedImmune, Inc., as amended by Amendment #1 to Exclusive License Agreement, effective December 13, 2011.

 

1.105                 “Valid Claim” means (a) a claim of an issued patent that has not expired or been abandoned, or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) or (b) a claim within a patent application which application has not been pending for more than five (5) years from the date of its first filing and which claim has not been revoked, cancelled, withdrawn, held invalid or abandoned.

 

1.106                 Additional Definitions.  Each of the following definitions is set forth in the section of this Agreement indicated below:

 

	
Definition:
    	
 
    	
Section:
    
	
 
    	
 
    	
 
    
	
Actual Kolltan Development Costs
    	
 
    	
5.4.4
    
	
Auction License Agreement
    	
 
    	
5.4.3(e)(ii)
    
	
Audited Party
    	
 
    	
6.9.1
    
	
Auditing Party
    	
 
    	
6.9.1
    
	
Bankruptcy Code
    	
 
    	
2.4
    
	
Buyout Amount
    	
 
    	
5.4.1(b)
    
	
Clinical and Research Supply Agreement
    	
 
    	
3.6.3(a)
    
	
Co-Development and Co-Commercialization Agreement
    	
 
    	
5.4.1(c)
    
	
Co-Development and Co-Commercialization Agreement   Terms
    	
 
    	
5.4.1(c)
    

 

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Definition:
    	
 
    	
Section:
    
	
 
    	
 
    	
 
    
	
Commercial Supply Agreement
    	
 
    	
3.6.4(a)
    
	
Confidential Information
    	
 
    	
8.1
    
	
Court
    	
 
    	
12.2
    
	
Disclosing Party
    	
 
    	
8.1
    
	
Dispute
    	
 
    	
12.1
    
	
Effective Date
    	
 
    	
Preamble
    
	
Election Notice
    	
 
    	
5.4.1
    
	
Estimated Kolltan Development Costs
    	
 
    	
5.4.4
    
	
Exercise Notice
    	
 
    	
5.3.1(a)
    
	
Existing Confidentiality Agreement
    	
 
    	
8.4
    
	
Expert
    	
 
    	
5.2.2(a)
    
	
Final Kolltan Development Costs
    	
 
    	
5.4.4
    
	
Follow-On Product Transaction
    	
 
    	
2.5
    
	
Kolltan
    	
 
    	
Preamble
    
	
Kolltan ROFN Notice
    	
 
    	
2.5
    
	
Indemnified Party
    	
 
    	
10.3
    
	
Indemnifying Party
    	
 
    	
10.3
    
	
Indirect Taxes
    	
 
    	
6.9.3
    
	
Information Delivery Period
    	
 
    	
5.2.2(a)
    
	
Inventory
    	
 
    	
3.6.1
    
	
Losses
    	
 
    	
10.1
    
	
Materials
    	
 
    	
3.6.1
    
	
MedImmune
    	
 
    	
Preamble
    
	
MedImmune ROFN Notice
    	
 
    	
2.5
    
	
Non-Paying Party
    	
 
    	
6.9.2
    
	
Option Period
    	
 
    	
5.3.1(a)
    
	
Option Termination Date
    	
 
    	
3.5.2(a)
    
	
Panel
    	
 
    	
5.2.2(a)
    
	
Party or Parties
    	
 
    	
Preamble
    
	
Paying Party
    	
 
    	
6.9.1
    
	
Paying Party Withholding Tax Action
    	
 
    	
6.9.1
    
	
Product Acquisition Price Notice
    	
 
    	
5.2.2(b)
    
	
Receiving Party
    	
 
    	
8.1
    
	
Resolution Period
    	
 
    	
12.1
    
	
Same or Later Stage Clinical Trial
    	
 
    	
12.4.2(a)(i)
    
	
Selection Period
    	
 
    	
5.2.2(a)
    
	
Sublicensed Rights
    	
 
    	
11.7.6
    
	
Third Party Transaction
    	
 
    	
5.5
    
	
Triggering Sale
    	
 
    	
12.4.2(a)(i)
    
	
Trigger Period
    	
 
    	
5.2.1(a)
    
	
Trigger Notice
    	
 
    	
5.2.1(a)
    
	
Upfront Fee
    	
 
    	
6.1
    

 

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ARTICLE 2
 GRANT OF RIGHTS

 

2.1                               License Grants to Kolltan.

 

2.1.1                     Licensed Antibody and Licensed Products.  Subject to the terms of this Agreement, MedImmune hereby grants Kolltan (a) an exclusive, royalty-bearing (to the extent provided in Section 6.4), non-transferable (except in accordance with Section 12.4) license or sublicense, as applicable, with the right to sublicense (subject to Sections 2.2 and 5.5), under MedImmune’s and its Affiliates’ interests in MedImmune IP, MedImmune Additional IP and Joint IP, to Research, Develop, Manufacture and Commercialize the Licensed Antibody and Licensed Products in the Field in the Territory; and (b) an exclusive, royalty-bearing (to the extent provided in Section 6.4), non-transferable (except in accordance with Section 12.4) license or sublicense, as applicable, with the right to sublicense (subject to Sections 2.2 and 5.5), under MedImmune’s and its Affiliates’ interests in MedImmune Manufacturing Know-How and MedImmune Manufacturing Patents, to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Research, Development and Commercialization activities hereunder.

 

2.1.2                     Follow-On Antibodies and Follow-On Products.  Subject to the terms of this Agreement, MedImmune hereby grants Kolltan (a) an exclusive, royalty-bearing (to the extent provided in Section 6.4), non-transferable (except in accordance with Section 12.4) license or sublicense, as applicable, with the right to sublicense (subject to Section 2.2), under MedImmune’s and its Affiliates’ interests in MedImmune IP, MedImmune Additional IP and Joint IP, to Research, Develop, Manufacture and Commercialize Follow-On Antibodies and Follow-On Products in the Field in the Territory; and (b) an exclusive, royalty-bearing (to the extent provided in Section 6.4), non-transferable (except in accordance with Section 12.4) license or sublicense, as applicable, with the right to sublicense (subject to Section 2.2), under MedImmune’s and its Affiliates’ interests in MedImmune Manufacturing Know-How and MedImmune Manufacturing Patents, to Manufacture Follow-On Antibodies and Follow-On Products for use in Kolltan’s Research, Development and Commercialization activities hereunder.

 

2.2                               Sublicenses.  Subject to Section 5.5 and in accordance with the requirements as set forth on Exhibit 9.2.9(b), Kolltan shall have the right to grant sublicenses within the scope of the licenses and sublicenses under Section 2.1 to its Affiliates and to Third Parties; provided, however, that any such sublicense granted to a Third Party shall be pursuant to a written agreement that subjects the sublicensee to all relevant restrictions and limitations set forth in this Agreement, including the confidentiality provisions of ARTICLE 8.

 

2.3                               Rights Retained by MedImmune.  Any rights of MedImmune not expressly granted to Kolltan pursuant to this Agreement shall be retained by MedImmune.  Notwithstanding the exclusive licenses and sublicenses granted to Kolltan under Section 2.1, but subject to Section 7.9 and ARTICLE 8, MedImmune and its Affiliates retain the right (a) to practice under the MedImmune IP, MedImmune Additional IP and Joint IP solely (except as set forth under clause (b) below with respect to Joint IP) as necessary to (i) exercise their rights and perform their obligations hereunder, (ii) complete any activities under any Research Program

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

that are ongoing as of the Effective Date and (iii) conduct (or permit Third Parties to conduct) Research, Development or Commercialization activities other than Research, Development or Commercialization of the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products; and (b) to practice under the Joint IP, MedImmune Manufacturing Know-How and MedImmune Manufacturing Patents solely (except as set forth under clause (a) above with respect to Joint IP) as necessary to (i) exercise their rights and perform their obligations under this Agreement, the Clinical and Research Supply Agreement (if any) and the Commercial Supply Agreement (if any) and (ii) conduct (or permit Third Parties to conduct) Manufacturing activities other than Manufacture of the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products.

 

2.4                               Section 365(n) of the Bankruptcy Code.  All rights and licenses granted under or pursuant to any section of this Agreement are, and shall be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the “Bankruptcy Code”) or any analogous provision of Applicable Law outside the United States, licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code or any analogous provision of Applicable Law outside the United States.  Each Party shall retain and may fully exercise all of its respective rights and elections under the Bankruptcy Code or any analogous provision of Applicable Law outside the United States.  In the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code or any analogous provision of Applicable Law outside the United States, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property subject to any rights or licenses granted to such other Party under or pursuant to this Agreement and to all embodiments thereof, which, if not already in such other Party’s possession, shall be promptly delivered to (or otherwise made available to, as appropriate) such other Party upon such other Party’s written request.  Any agreements supplemental hereto shall be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code or any analogous provision of Applicable Law outside the United States.

 

2.5                               Right of First Negotiation for a Follow-On Product Transaction.  If Kolltan desires to enter into a Follow-On Product Transaction (as defined below) with respect to any Follow-On Product, Kolltan shall provide written notice thereof to MedImmune, including a reasonably detailed description of such Follow-On Product and any completed or ongoing Development activities (including a summary of any relevant clinical and non-clinical data) with respect thereto (“Kolltan ROFN Notice”).  MedImmune shall have the right, exercisable by written notice delivered to Kolltan within [**] days after delivery of the Kolltan ROFN Notice (the “MedImmune ROFN Notice”), to trigger its right of first negotiation under this Section 2.5 with respect to such Follow-On Product.  If MedImmune delivers a MedImmune ROFN Notice within such [**] day period, then (a) the Parties shall negotiate in good faith regarding a definitive agreement for a Follow-On Product Transaction with respect to such Follow-On Product until such time (if any) as MedImmune shall discontinue such negotiations, but in no event for longer than [**] days unless the Parties otherwise mutually agree.  During such period, Kolltan shall not negotiate or enter into any agreement with any Third Party for a Follow-On Product Transaction with respect to such Follow-On Product.  If MedImmune does not deliver a MedImmune ROFN Notice within such [**] day period, or if MedImmune delivers a MedImmune ROFN Notice within such [**] day period but the Parties fail to enter into a definitive agreement for a Follow-On Product Transaction with respect to such Follow-On

 

19

 

Product within the applicable negotiation period, then (subject to any restrictions set forth in any provision of this Agreement other than this Section 2.5) Kolltan shall be free to negotiate and enter into an agreement with any Third Party for a Follow-On Product Transaction with respect to such Follow-On Product and (notwithstanding anything the contrary in this Section 2.5) Kolltan shall have no further obligations and MedImmune shall have no further rights under this Section 2.5 with respect to such Follow-On Product.  For clarity, subject to the preceding sentence, in no event shall any Follow-On Product Transaction between Kolltan and a Third Party reduce or otherwise adversely affect any rights of MedImmune or obligations of Kolltan under this Agreement, including Kolltan’s payment obligations pursuant to ARTICLE 6.

 

ARTICLE 3
 DEVELOPMENT AND REGULATORY

 

3.1                               Development.  Subject to the terms and conditions of this Agreement, as between the Parties, Kolltan shall be solely responsible for all costs, activities and decision-making related to the Development of the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products in the Field in the Territory.

 

3.2                               Regulatory.  Subject to the terms and conditions of this Agreement, as between the Parties, Kolltan shall be solely responsible for all submissions to and all communications and interactions with Regulatory Authorities with respect to the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products.  MedImmune shall not make any submissions to or otherwise communicate or interact with any Regulatory Authority with respect to the Licensed Antibody or any Licensed Product, Follow-On Antibody or Follow-On Product unless Applicable Law requires such action, in which case MedImmune shall, unless prohibited by Applicable Law, (a) as promptly as practicable provide Kolltan with a draft of any proposed submission or communication and (b) consider in good faith any reasonable comments provided in a timely manner by Kolltan with respect to such proposed submission or communication.  MedImmune shall promptly forward to Kolltan (i) any communication received by MedImmune from any Regulatory Authority with respect to the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products and (ii) any information received by MedImmune from any Third Party specifically relating to the safety or efficacy of the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products.

 

3.3                               Diligence.  Kolltan shall, at its own expense, (a) conduct (i) a Phase 1 Clinical Trial of the Licensed Antibody or a Licensed Product and (ii) a Phase 1b/2a Clinical Trial of the Licensed Antibody or a Licensed Product for at least two indications, and (b) use Commercially Reasonable Efforts to complete any additional clinical trials required for Kolltan to submit a BLA (or ex-US equivalent) to a Regulatory Authority(ies) to obtain Regulatory Approval for at least one Licensed Product in the United States, France, Germany, Italy, Spain and the United Kingdom.  Kolltan shall use Commercially Reasonable Efforts with respect to the Research, Development, Manufacture or Commercialization of any Follow-On Antibody or Follow-On Product; provided, however, that such Commercially Reasonable Efforts shall not operate to impair or adversely affect Kolltan’s obligation to use Commercially Reasonable Efforts in the foregoing subsection (b).

 

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3.4                               Transfer of Know-How and Regulatory Documentation.

 

3.4.1                     Know-How.  Promptly after the Effective Date, MedImmune shall (a) transfer to Kolltan all MedImmune Know-How and MedImmune Additional Know-How described in clause (b) of Section 1.48, including the MedImmune Know-How and MedImmune Additional Know-How described in Exhibit 3.4.1, including any data or study reports generated since the filing of the Existing IND (provided, however, that MedImmune shall not have any obligation under this Section 3.4.1 to prepare or finalize any study reports), and (b) disclose to Kolltan all MedImmune Know-How and MedImmune Additional Know-How other than MedImmune Know-How and MedImmune Additional Know-How transferred pursuant to clause (a) above.  Such transfers and disclosures shall be made (x) in any manner or form reasonably requested by Kolltan (provided, however, that any data generated since the filing of the Existing IND shall be transferred in the form in which such data exists as of the Effective Date) and (y) at MedImmune’s expense.

 

3.4.2                     Research Programs.  Without limiting Section 3.4.1, upon the completion or other termination of any Research Program, MedImmune shall, at its own expense, transfer and/or disclose to Kolltan all Know-How developed under such Research Program that is Controlled by MedImmune.  Such transfers and disclosures shall be made (a) in any manner or form reasonably requested by Kolltan (provided, however, that any data included in such Know-How shall be transferred in the form in which MedImmune has collected or maintained such data prior to such transfer) and (b) at MedImmune’s expense.

 

3.4.3                     Regulatory Documentation.  MedImmune hereby assigns to Kolltan all of MedImmune’s right, title and interest in and to any Regulatory Documentation relating to the Licensed Antibody or Licensed Products Controlled by MedImmune as of the Effective Date, including the Existing IND.  Promptly after the Effective Date, MedImmune shall (a) transfer and/or disclose to Kolltan all such Regulatory Documentation and (b) provide Kolltan with an executed copy of a letter notifying the FDA of the assignment of the Existing IND to Kolltan.  MedImmune shall submit such assignment letter to the FDA as soon as reasonably possible following the Effective Date and shall promptly notify Kolltan of MedImmune’s correspondence with the FDA with respect to such assignment.  Promptly (but in no event more than five (5) Business Days) thereafter, Kolltan shall submit to the FDA its acceptance of such transfer and provide MedImmune with written notice of such acceptance.  The transfers and disclosures described in clause (a) above shall be made (x) in any manner or form reasonably requested by Kolltan and (y) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.

 

3.5                               Cooperation.

 

3.5.1                     Assistance.  Without limiting any other obligations of MedImmune under this Agreement, MedImmune shall, at its own expense, for a period of three (3) months following the completion of the transfers, disclosures and assignments described in Section 3.4, use reasonable efforts to provide Kolltan with information or assistance reasonably requested by Kolltan in relation to the Know-How and Regulatory Documentation transferred, disclosed or assigned pursuant to Section 3.4 to ensure an expeditious transition of the applicable Research and Development activities.  Such information and assistance shall not exceed (a) during the first (1st) such month, an aggregate of seventy (70) hours, (b) during the second (2nd) such month, an aggregate of fifty (50) hours, and (c) during the third (3rd) such month, an aggregate of thirty (30) hours. Following such three (3) month period, if requested by Kolltan, the Parties shall discuss in good faith the possibility of entering into a consulting agreement pursuant to which MedImmune would provide additional information and assistance to Kolltan at Kolltan’s expense.

 

3.5.2                     Information.

 

(a)                                 Every six (6) months or otherwise upon reasonable request of MedImmune from time to time, Kolltan shall provide a reasonably detailed written update to MedImmune regarding Kolltan’s Development activities hereunder with respect to the Licensed Antibody and Licensed Products; provided, however, that (i) Kolltan shall not be required to provide more than two (2) such written updates in any Calendar Year, and (ii) from and after the date on which the provisions of Sections 5.3 and 5.4 are of no further force or effect in

 

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accordance with Section 5.2.1(b), or MedImmune has no further rights under ARTICLE 5 in accordance with Section 5.4.3(b) (the “Option Termination Date”), Kolltan shall not be required to provide more than one (1) such written update in any Calendar Year.

 

(b)                                 Every six (6) months or otherwise upon reasonable request of MedImmune from time to time, Kolltan shall provide a reasonably detailed written update to MedImmune regarding Kolltan’s Development activities hereunder with respect to Follow-On Antibodies and Follow-On Products; provided, however, that (i) Kolltan shall not be required to provide more than two (2) such written updates in any Calendar Year, and (ii) for any Follow-On Product, from and after the date on which MedImmune has no further rights under Section 2.5 with respect to such Follow-On Product, Kolltan shall not be required to provide more than one (1) such written update with respect to such Follow-On Product in any Calendar Year.

 

3.6                               Inventory; Supply.

 

3.6.1                     Assignment of Inventory.  MedImmune hereby assigns to Kolltan all of MedImmune’s right, title, interest and risk of loss in and to all quantities in the possession or under the control of MedImmune as of the Effective Date of the Licensed Antibody and Licensed Product (“Inventory”) and the materials used in the production of the Licensed Antibody and Licensed Product (“Materials”) , which quantities of Inventory and Materials are (except in the case of certain types of Materials) set forth in Exhibit 3.6.1.  The foregoing sentence notwithstanding, MedImmune may retain reference samples of Inventory and Materials.

 

3.6.2                     Storage, Filling and Delivery of Inventory.

 

(a)                                 MedImmune shall store, formulate, fill and deliver Inventory and Materials as described in Exhibit 3.6.2(a) and shall:

 

(i)                                     store the Inventory and Materials in accordance with Applicable Law and the applicable specifications set forth in Exhibit 3.6.2(a)(i) and use at least the same level of care in storing the Inventory and Materials as MedImmune uses in storing its own inventory of similar products, but no less than industry standard level of care;

 

(ii)                                  conduct stability testing of the Inventory in accordance with Applicable Law;

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

(iii)                               upon the written request of Kolltan from time to time, (x) fill, finish and prepare for shipment, in accordance with Applicable Law and the specifications set forth in Exhibit 3.6.2(a), specified quantities of the Inventory, (y) prepare for shipment, in accordance with Applicable Law and the specifications set forth in Exhibit 3.6.2(a), specified quantities of the Materials, and (z) deliver such quantities of Inventory and Materials to Kolltan or any Third Party designated by Kolltan FCA MedImmune’s facility (Incoterms 2010), in each case ((x), (y) and (z)) in accordance with reasonable written instructions provided by Kolltan, including as to timing and manner of delivery; provided, however, that (1) with respect to any quantity of Inventory that is, as of the date of Kolltan’s request, in vialed form, MedImmune shall not be required to deliver such quantity to Kolltan or its designee in less than [**] months from the date of such request, and (2) with respect to any quantity of Inventory that is, as of the date of Kolltan’s request, not in vialed form, MedImmune shall not be required to deliver such quantity to Kolltan or its designee in less than [**] months from the date of such request; and

 

(iv)                              maintain appropriate property insurance coverage for losses arising from MedImmune’s failure to exercise due care over the Inventory and Materials, for as long as, and to the extent that, the Inventory and Materials remain at MedImmune’s facility; provided, however, that MedImmune’s obligation under this clause (iv) shall terminate with respect to any quantity of the Inventory or Materials upon delivery of such quantity to the shipping carrier designated by Kolltan in accordance with clause (iii) above.

 

(b)                                 MedImmune shall notify Kolltan promptly after (i) discovering that any quantity of Inventory or Materials has not been Manufactured, stored or maintained in accordance with Applicable Law or any applicable specifications or is otherwise not in a condition reasonably suitable for use by Kolltan in conducting its Research and Development activities hereunder or (ii) determining that it is unable, or reasonably expects to be unable, to comply with any of its obligations under Section 3.6.2(a).  MedImmune shall not transfer or otherwise dispose of any quantity of Licensed Antibody or Licensed Product from the Inventory except in accordance with Applicable Law, MedImmune’s standard practices and policies (to the extent previously disclosed to Kolltan) and Kolltan’s reasonable written instructions.

 

(c)                                  MedImmune hereby represents and warrants that:

 

(i)                                     the Inventory was Manufactured in accordance with Applicable Law and the applicable product specifications set forth in Exhibit 3.6.2(c)(i), which Exhibit includes specifications for drug product and unformulated drug substance, as well as the justification of specifications for drug product (which in turn references a Guideline for Release Specifications for Monoclonal Antibodies (DEV000 GB 0049 ED 002), a copy of which was provided to Kolltan);

 

(ii)                                  as of the date on which any quantity of the Inventory or Materials is delivered to Kolltan or its designee hereunder, such quantity will have been stored and maintained in accordance with Applicable Law and the applicable storage specifications set forth in Exhibit 3.6.2(a)(i); and

 

(iii)                               as of the Effective Date, stability testing of the Inventory has been conducted in accordance with Applicable Law;

 

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(iv)                              as of the date of the last stability testing of the Inventory conducted prior to the Effective Date, the Inventory conformed to the applicable product specifications set forth in Exhibit 3.6.2(c)(i).

 

Except as expressly set forth in this Agreement, MedImmune makes no, and hereby disclaims all, other representations and warranties whatsoever concerning the Inventory and Materials, including any and all implied warranties of merchantability, fitness for a particular purpose and against infringement.

 

3.6.3                     Clinical and Research Supply of Licensed Antibody and Licensed Products.

 

(a)                                 Within thirty (30) days after the Effective Date, the Parties shall commence good faith negotiations regarding a supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune at rates not materially different from those charged by Third Party contract manufacturers, additional quantities of the Licensed Antibody and Licensed Products for use by Kolltan in conducting Research and Development activities with respect to the Licensed Program and the Follow-On Program, all in accordance with the principles set forth in Exhibit 3.6.3(a) (the “Clinical and Research Supply Agreement”).

 

(b)                                 If (i) the Parties fail to enter into the Clinical and Research Supply Agreement within sixty (60) days after the commencement of negotiations pursuant to Section 3.6.3(a) (or such longer period as may be agreed by the Parties), or (ii) the Clinical and Research Supply Agreement is entered into by the Parties but is terminated for any reason other than breach by Kolltan, then upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Research and Development activities hereunder.  The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process.  Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith.  The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.  The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

 

3.6.4                     Commercial Supply.  After the Option Termination Date:

 

(a)                                 if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and

 

(b)                                 if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder.  The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process.  Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith.  The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.  The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

 

3.6.5                     Supply of Media.  In each instance where MedImmune transfers MedImmune Manufacturing Know-How to Kolltan or a Qualified Contract Manufacturer pursuant to this Section 3.6, for a period of [**] months after the completion of such transfer, MedImmune shall sell to Kolltan, at MedImmune’s standard cost, such quantities of MedImmune’s proprietary cell culture media and nutrient feeds used in the Manufacture of the Licensed Antibody as may be reasonably requested by Kolltan in connection with the Manufacture by Kolltan or such Qualified Contract Manufacturer of the Licensed Antibody or

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Licensed Products. Kolltan shall not reverse engineer, or have a third party reverse engineer, MedImmune’s proprietary cell culture media and nutrient feeds.

 

ARTICLE 4
 COMMERCIALIZATION

 

4.1                               In General.  Subject to the terms and conditions of this Agreement, as between the Parties, Kolltan shall be solely responsible for all costs, activities and decision-making related to the Commercialization of Licensed Products and Follow-On Products in the Field in the Territory.

 

4.2                               Trademarks.  Kolltan, its Affiliates and Sublicensees shall select the trademarks under which to market Licensed Products and Follow-On Products, which trademarks shall not contain the word “MedImmune” or be identical to or likely to cause confusion with the MEDIMMUNE trademark or any trademark for any pharmaceutical product of MedImmune or any of its Affiliates.

 

4.3                               Standards of Conduct.  Kolltan shall in all respects comply with all Applicable Law and applicable guidelines concerning the advertising, sales and marketing of prescription drug products in Commercializing Licensed Products and Follow-On Products under this Agreement.

 

ARTICLE 5
 OPTION RIGHTS

 

5.1                               Delivery of Data.

 

5.1.1                     Upon receipt and review by Kolltan of a validated data set (including the full data set) from the clinical trial database for any Phase 1b/2a Clinical Trial of the Licensed Antibody or a Licensed Product, which data set comprises the clinical trial data for a cohort of not less than [**] patients (or, if less, the number of remaining enrolled patients in such Phase 1b/2a Clinical Trial), and which data Kolltan has not previously delivered to MedImmune, Kolltan shall promptly deliver such data to MedImmune.

 

5.1.2                     Together with its delivery of any data set pursuant to Section 5.1.1, Kolltan shall (to the extent it has not already done so) deliver to MedImmune all data in Kolltan’s possession as of the date of such delivery that is contained in the clinical trial database for any Phase 1 Clinical Trial of the Licensed Antibody or a Licensed Product.

 

5.1.3                     Together with its delivery of any data set pursuant to Section 5.1.1 and the data pursuant to Section 5.1.2, Kolltan shall (to the extent it has not already done so) deliver to MedImmune all non-clinical and/or Development data and information in Kolltan’s possession as of the date of such delivery that (a) was generated by Kolltan’s Research, Development or Manufacturing activities with respect to the Licensed Antibody or Licensed Products hereunder and (b) is likely to be useful to MedImmune’s determination to deliver a Trigger Notice pursuant to Section 5.2.1 or Exercise Notice pursuant to Section 5.3.1, including any such pharmacokinetic data, pharmacodynamics data, biomarker data and genetic or epigenetic characterization of patients.

 

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5.1.4                     After the Data Package Delivery Date, if Kolltan comes into possession of any data or information that Kolltan would have been required to deliver to MedImmune under Section 5.1.2 or 5.1.3 if such data or information had been in Kolltan’s possession as of the Data Package Delivery Date, or if MedImmune reasonably requests any other information related to the data and information described in Section 5.1.1, 5.1.2 or 5.1.3 or the foregoing clause of this Section 5.1.4, Kolltan shall promptly deliver such data or information to MedImmune.

 

5.2                               Trigger Period; Determination of Product Acquisition Price.

 

5.2.1                     Trigger Period.

 

(a)                                 From time to time between (i) the date on which Kolltan delivers the first data summary to MedImmune pursuant to Section 5.1.1 and (ii) the earlier of (x) ten (10) Business Days after the Data Package Delivery Date and (y) December 31, 2017 (the “Trigger Period”), MedImmune shall have the right, exercisable by written notice to Kolltan (a “Trigger Notice”), to trigger a determination of the Product Acquisition Price in accordance with Section 5.2.2.  For clarity, MedImmune shall have the right to deliver multiple Trigger Notices during the Trigger Period; provided, however, that subject to Section 5.3.2, after MedImmune has delivered any Trigger Notice, it shall not deliver a subsequent Trigger Notice unless and until MedImmune revokes such earlier Trigger Notice in writing (provided, however, that MedImmune shall not be entitled to revoke any Trigger Notice after the Parties have received notice of the applicable Product FMV pursuant to Section 5.2.2(a)) or the Option Period with respect to such earlier Trigger Notice expires without MedImmune’s having delivered an Exercise Notice.

 

(b)                                 If (i) MedImmune does not deliver a Trigger Notice to Kolltan prior to the expiration of the Trigger Period, (ii) as of the expiration of the Trigger Period, the Option Period with respect to any Trigger Notices previously delivered by MedImmune has expired without MedImmune’s having delivered an Exercise Notice, or (iii) any Option Period that has not expired as of the expiration of the Trigger Period expires without MedImmune’s having delivered an Exercise Notice, then the provisions of Sections 5.3 and 5.4 shall be of no further force or effect.  If MedImmune provides written notice to Kolltan during the Trigger Period that MedImmune declines to deliver any further Trigger Notices, then the provisions of Sections 5.3, 5.4 and 5.5 shall be of no further force or effect.

 

5.2.2                     Determination of Product Acquisition Price.

 

(a)                                 In the event MedImmune delivers a Trigger Notice to Kolltan prior to the expiration of the Trigger Period, the Parties shall obtain a determination of the Product FMV as of the date on which such Trigger Notice was delivered, in accordance with this Section 5.2.2(a). Within eight (8) Business Days after MedImmune’s delivery of any Trigger Notice (the “Selection Period”), each Party shall select an independent expert suitably qualified to determine the applicable Product FMV, who, at a minimum, shall have expertise in the valuation of development-stage biological oncology products (each, an “Expert”), and the two Experts thereby selected shall, as promptly as practicable, select a third Expert (such three Experts, collectively, the “Panel”). As soon as practicable after the selection of the Panel, the Parties shall meet with the Panel in order to agree upon a process for delivering to the Panel such information in the Parties’ possession as the Panel may request in connection with the determination of the applicable Product FMV, which delivery shall be completed no later than five (5) Business Days after such initial meeting with the Panel (the “Information Delivery Period”). The Parties shall use reasonable efforts to cause the Panel to determine the applicable Product FMV and provide written notice to the Parties thereof within seven (7) Business Days after expiration of the Information Delivery Period (or, if the Panel is unable to comply with such timing, as promptly thereafter as practicable). The Panel’s determination of applicable Product FMV shall be based on the agreement of a majority of the Panel members. Subject to Section 5.3.2, the determination of the Panel shall be binding on the Parties. Each Party shall bear its own costs and expenses with respect to the determination of the applicable Product FMV. Subject to Section 5.3.2, the reasonable costs and expenses of the Panel shall be borne by MedImmune.

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

(b)           Within five (5) Business Days after the Parties receive notice of the applicable Product FMV pursuant to Section 5.2.2(a), Kolltan shall provide written notice to MedImmune of (i) Kolltan’s good faith estimate of the Kolltan Development Costs as of the end of the calendar month immediately preceding the date of the applicable Trigger Notice, (ii) Kolltan’s good faith estimate of the Kolltan Development Costs for the [**] month period immediately following the period covered by estimate described in clause (i) above, and (iii) the Product Acquisition Price, on the assumption that the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which the applicable payment is made in accordance with this Agreement will be equal to the sum of the estimates described in clauses (i) and (ii) above (the “Product Acquisition Price Notice”), and shall include reasonable supporting documentation.

 

5.3          Option Period; New Determination of Product Acquisition Price.

 

5.3.1       Option Period.

 

(a)           If, within three (3) Business Days after delivery of any Product Acquisition Price Notice, MedImmune reasonably requests any additional supporting documentation relating to Kolltan’s estimates of the Kolltan Development Costs included therein, Kolltan shall provide such additional supporting documentation to MedImmune within five (5) Business Days after the date of such request. For a period of five (5) Business Days after the expiration of the three (3) Business Day period described in the preceding sentence (or, if applicable, the date on which Kolltan satisfies its obligation under the preceding sentence to provide additional supporting documentation), (i) the Parties shall engage in informal, nonbinding discussions regarding their respective interests with respect to their rights and obligations under this Section 5.3 and Section 5.4 with respect to such Product Acquisition Price Notice and (ii) within twelve (12) Business Days after the conclusion of such five (5) Business Day period (each, an “Option Period”), MedImmune shall have the option, exercisable by written notice to Kolltan (each, an “Exercise Notice”), to trigger the rights and obligations of the Parties under Section 5.4 with respect to such Product Acquisition Price Notice.

 

(b)           If MedImmune does not deliver an Exercise Notice to Kolltan prior to the expiration of an Option Period, then the Parties shall have no further rights or obligations under Section 5.4 with respect to the applicable Product Acquisition Price Notice.  If MedImmune provides written notice to Kolltan during an Option Period that MedImmune

 

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declines to provide an Exercise Notice during such Option Period, then such Option Period shall be deemed expired and the Parties shall have no further rights or obligations under Section 5.4 with respect to the applicable Product Acquisition Price Notice.

 

5.3.2       New Determination of Product Acquisition Price.  Notwithstanding anything to the contrary in Section 5.2, if at any time after the delivery by the Parties of information to the Panel pursuant to Section 5.2.2(a) and prior to the expiration of the applicable Option Period or, if MedImmune delivers an Exercise Notice to Kolltan prior to the expiration of the applicable Option Period, during any period for any election or rejection by a Party under Section 5.4.1 or 5.4.2, Kolltan receives additional data from (i) any Phase 1 Clinical Trial of the Licensed Antibody or any Licensed Product, (ii) any Phase 1b/2a Clinical Trial of the Licensed Antibody or a Licensed Product or (iii) any non-clinical studies or Development activities with respect to the Licensed Antibody or Licensed Products that would, in the case of any of (i), (ii) or (iii), likely have materially affected the determination of the Product FMV, (a) Kolltan shall promptly deliver such data to MedImmune (regardless of whether Kolltan would otherwise be required to deliver such data to MedImmune pursuant to Section 5.1) and (b) for a period of eight (8) Business Days after the date of such delivery, either Party shall have the right, exercisable by written notice to the other Party, to trigger a new determination of the Product Acquisition Price, factoring in such new information. If either Party exercises its right under clause (b) above, unless otherwise agreed by the Parties, (w) ongoing activities (if any) to determine the Product Acquisition Price shall terminate, (x) the current Option Period (if any) shall be deemed expired without MedImmune’s having delivered an Exercise Notice, (y) the Parties shall have no further rights or obligations under Section 5.4 with respect to any Product Acquisition Price Notice delivered prior such Party’s exercise of its right under clause (b) above, and (z) a new determination of the Product FMV and the Product Acquisition Price shall be made in accordance with the provisions of Section 5.2.2 (which shall again trigger the applicable provisions of this Section 5.3 and Section 5.4); provided, however, that the costs and expenses of the Panel for such new determination shall be borne by the Party that exercised its right under clause (b) above.

 

5.4          Kolltan Election; MedImmune Rights.

 

5.4.1       Kolltan Election.  In the event MedImmune delivers an Exercise Notice in accordance with Section 5.3.1(a) with respect to any Product Acquisition Price Notice, Kolltan shall elect, in its sole discretion, by written notice to MedImmune delivered within three (3) Business Days after MedImmune’s delivery of such Exercise Notice (the “Election Notice”), one of the following:

 

(a)           to terminate this Agreement with respect to the Licensed Program, subject to MedImmune’s payment to Kolltan of an amount equal to the Product Acquisition Price, in which case the provisions of Section 5.4.3(a) shall apply;

 

(b)           subject to MedImmune’s rights under Section 5.4.2(a), to terminate all further rights of MedImmune under this ARTICLE 5, subject to Kolltan’s payment to MedImmune of an amount equal to the greater of (i) fifty percent (50%) of the difference between (A) the Product Acquisition Price and (B) the sum of (x) the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which

 

29

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

the applicable payment is made and (y) Eight Million Dollars ($8,000,000) (the amount described in this clause (i), the “Co-Agreement Amount”) and (ii) Twenty Million Dollars ($20,000,000) (the greater of the amounts described in clauses (i) and (ii), the “Buyout Amount”); or

 

(c)           subject to MedImmune’s rights under Section 5.4.2(b), to require the Parties to enter into a co-development and co-commercialization agreement (the “Co-Development and Co-Commercialization Agreement”) in accordance with the terms set forth on Exhibit 5.4.1(c) (the “Co-Development and Co-Commercialization Agreement Terms”).

 

Together with any Election Notice, Kolltan shall provide to MedImmune its then-current good faith estimate, for each potentially applicable scenario described in Section 5.4.3, of the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which the applicable payment will be made by Kolltan or MedImmune as well as a good faith estimate of the Kolltan Development Costs for the [**] month period following delivery of the Election Notice, together with reasonable supporting documentation.  Kolltan shall provide MedImmune with monthly written updates to such estimates during any period in which the MedImmune is exercising its rights under Section 5.4.2 or the Parties are negotiating the Co-Development and Co-Commercialization Agreement under Section 5.4.3(c) or 5.4.3(d).

 

5.4.2       MedImmune Rights.  In the event MedImmune delivers an Exercise Notice in accordance with Section 5.3.1(a):

 

(a)           in the event Kolltan, pursuant to the Election Notice, makes an election under Section 5.4.1(b), MedImmune shall have the right, in its sole discretion, exercisable by written notice to Kolltan delivered within seven (7) Business Days after Kolltan delivers the Election Notice to MedImmune, to reject Kolltan’s election, in which case the provisions of Section 5.4.3(c) shall apply; provided, however, that if MedImmune fails to deliver such a rejection notice within such time period, the provisions of Section 5.4.3(b) shall apply; and

 

(b)           in the event Kolltan, pursuant to the Election Notice, makes an election under Section 5.4.1(c), MedImmune shall have the right, in its sole discretion, exercisable by written notice to Kolltan delivered within three (3) Business Days after Kolltan delivers the Election Notice to MedImmune, to reject Kolltan’s election, in which case Kolltan shall elect, in its sole discretion, by written notice to MedImmune delivered within three (3) Business Days after delivery of such rejection notice by MedImmune, either (i) to terminate this Agreement with respect to the Licensed Program, subject to MedImmune’s payment to Kolltan of an amount equal to the Product Acquisition Price, in which case the provisions of Section 5.4.3(a) shall apply, or (ii) to terminate all further options of MedImmune under this ARTICLE 5, subject to Kolltan’s payment of the Buyout Amount to MedImmune, in which case the provisions of Section 5.4.3(b) shall apply; provided, however, that if MedImmune fails to deliver such a rejection notice within such time period, the provisions of Section 5.4.3(d) shall apply.

 

30

 

5.4.3       Effect of Elections and Rights.

 

(a)           In the event Kolltan (i) pursuant to the Election Notice, makes an election under Section 5.4.1(a) or (ii) after receiving a rejection notice by MedImmune pursuant to Section 5.4.2(b), makes an election under clause (i) of Section 5.4.2(b), then (x) this Agreement shall terminate with respect to the Licensed Program thirty (30) days after such election is made and (y) MedImmune shall pay to Kolltan an amount equal to the Product Acquisition Price within forty-five (45) days after receipt of the corresponding invoice from Kolltan.

 

(b)           In the event Kolltan (i) pursuant to the Election Notice, makes an election under Section 5.4.1(b) that is not rejected by MedImmune pursuant to Section 5.4.2(a) or (ii) after receiving a rejection notice pursuant to Section 5.4.2(b), makes an election under clause (ii) of Section 5.4.2(b), then (x) this Agreement shall remain in effect in its entirety, including with respect to the Licensed Program (though MedImmune shall have no further rights under this ARTICLE 5 other than as set forth in this sentence), and (y) Kolltan shall pay the Buyout Amount to MedImmune within forty-five (45) days after receipt of the corresponding invoice from MedImmune.

 

(c)           In the event Kolltan, pursuant to the Election Notice, makes an election under Section 5.4.1(b) that is rejected by MedImmune pursuant to Section 5.4.2(a), then (i) the Parties shall enter into the Co-Development and Co-Commercialization Agreement in accordance with the Co-Development and Co-Commercialization Agreement Terms, as promptly as practicable after such election is made, subject to Section 5.4.3(e), and (ii) effective upon the effective date of the Co-Development and Co-Commercialization Agreement, this Agreement shall terminate with respect to the Licensed Program in accordance with Section 11.5.

 

(d)           In the event Kolltan, pursuant to the Election Notice, makes an election under Section 5.4.1(c) that is not rejected by MedImmune pursuant to Section 5.4.2(b), then (i) the Parties shall enter into the Co-Development and Co-Commercialization Agreement in accordance with the Co-Development and Co-Commercialization Agreement Terms, as promptly as practicable after such election is made, subject to Section 5.4.3(e), and (ii) effective upon the effective date of the Co-Development and Co-Commercialization Agreement, this Agreement shall terminate with respect to the Licensed Program in accordance with Section 11.5.

 

(e)           Notwithstanding anything in this Agreement to the contrary, in the event the Parties are required to enter into the Co-Development and Co-Commercialization Agreement pursuant to Section 5.4.3(c) or 5.4.3(d) but, for any reason, fail to do so within sixty (60) days after Kolltan’s delivery of the applicable Election Notice, unless the Parties otherwise mutually agree, either Party may refer the matter to the Executive Officers for attempted resolution pursuant to the provisions of Section 12.1.  In the event that the Executive Officers are not able to resolve within the Resolution Period any issues referred to them by a Party pursuant to this Section 5.4.3(e), then:

 

(i)            Kolltan shall conduct an auction, in a manner reasonably customary in the industry, for the grant to a Third Party of exclusive rights (including with respect to Kolltan and MedImmune) to the Licensed Program, including (x) license and sublicense grants as appropriate from Kolltan and MedImmune and (y) transfer by MedImmune of MedImmune Manufacturing Know-How to such Third Party or its designee as necessary to enable the Manufacture of the Licensed Antibody and Licensed Products, which transfer

 

31

 

obligation shall be analogous to the transfer obligations described in Section 3.6.3(b) and 3.6.4(b);

 

(ii)           Kolltan shall determine in good faith the Qualified Bidder that is the preferred bidder and Kolltan shall negotiate, in good faith on behalf of the Parties, the terms of an agreement (the “Auction License Agreement”) with such Qualified Bidder that, subject to the other provisions of clauses (i) through (v) of this Section 5.4.3(e), does not treat either Kolltan or MedImmune preferentially vis-à-vis the other (the “Auction License Agreement”); provided, however, that Kolltan shall (x) reasonably consult with MedImmune with respect to such actions and provide sufficient opportunity for MedImmune to review and comment upon the material terms of such Auction License Agreement, and (y) reasonably incorporate any reasonable comments provided by MedImmune with respect to any provisions of the Auction License Agreement relating to the MedImmune Manufacturing Know-How and otherwise consider in good faith any reasonable comments provided by MedImmune with respect to the Auction License Agreement; and provided, further, that the Auction License Agreement shall provide that the proceeds of any payments to be made by such Third Party with respect to the Licensed Program shall be split evenly between the Parties, subject to the provisions of clause (iv) below;

 

(iii)          upon the completion of such negotiations, Kolltan and MedImmune shall execute the Auction License Agreement with such Third Party;

 

(iv)          (x) upon execution of the Auction License Agreement, each Party shall provide the other Party with written notice of the reasonable expenses, including reasonable attorneys’ fees, incurred by such Party in connection with their activities under clauses (i) through (iii) above (along with reasonable supporting documentation as requested by the other Party), and Kolltan or MedImmune, as the case may be, shall make an appropriate reconciling payment to the other so that, after giving effect to such reconciling payment, each Party will have borne fifty percent (50%) of their collective expenses described in this clause (x), and (y) MedImmune’s share of the proceeds of any payments to be made by the applicable Third Party with respect to the Licensed Program shall be paid to Kolltan (whether directly from such Third Party or from MedImmune following its receipt thereof) until such time as Kolltan has received from MedImmune’s share of such proceeds the amount that MedImmune would have been obligated to pay Kolltan under the applicable scenario as an upfront payment under the Co-Development and Co-Commercialization Agreement (as set forth in the “Upfront payment” section of Exhibit 5.4.1(c)); and

 

(v)           effective upon the effective date of the Auction License Agreement, this Agreement shall terminate with respect to the Licensed Program in accordance with Section 11.5.

 

5.4.4       Determination of Kolltan Development Costs.  The amount payable by Kolltan or MedImmune, as applicable, under Section 5.4.3 or pursuant to the Co-Development and Co-Commercialization Agreement shall be based on Kolltan’s good faith estimate, as delivered to MedImmune together with the Election Notice or in the most recent update described in the last sentence of Section 5.4.1, of the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which the applicable payment

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

would be made under the applicable scenario (the “Estimated Kolltan Development Costs”); provided, however, that within thirty (30) days after the applicable payment is made, Kolltan shall provide written notice to MedImmune of its final determination of the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which such payment was made (the “Final Kolltan Development Costs”), together with reasonable supporting documentation.  In the event there was any underpayment or overpayment by the applicable Party based on Kolltan’s final determination, an appropriate reconciling payment shall be made within thirty (30) days after delivery of such notice.  Kolltan’s determination of the Final Kolltan Development Costs shall be subject to MedImmune’s rights as an Auditing Party under Section 6.10; provided, however, that (a) MedImmune’s right to audit the Final Kolltan Development Costs pursuant to this Section 5.4.4 shall be independent of the determination of whether MedImmune has exercised its annual right as an Auditing Party in any applicable year pursuant to Section 6.10, (b) MedImmune shall pay the full cost of such audit unless (i) the applicable payment made by Kolltan or MedImmune in accordance with Section 5.4.3 was calculated on the basis of the Kolltan Development Costs and (ii) such audit shows that the Final Kolltan Development Costs exceeded [**] percent ([**]%) of the Kolltan Development Costs as of the end of the calendar month immediately preceding the calendar month in which such payment was made, as determined by the auditors (the “Actual Kolltan Development Costs”), in which case Kolltan shall pay the full cost of such audit, and (c) if (i) the applicable payment made by Kolltan or MedImmune in accordance with Section 5.4.3 was calculated on the basis of the Kolltan Development Costs and (ii) such audit shows that the Actual Kolltan Development Costs exceeded [**] percent ([**]%) of the Estimated Kolltan Development Costs, then Kolltan shall be solely responsible for such excess costs; provided, however, that for purposes of this clause (c), Actual Kolltan Development Costs excludes any Kolltan Development Costs incurred in any calendar month after the calendar month that Kolltan projected (for purposes of the Estimated Kolltan Development Costs calculation) to be the calendar month immediately preceding the calendar month in which the applicable payment would be made under the applicable scenario under Section 5.4.3 or pursuant to the Co-Development and Co-Commercialization Agreement, to the extent such payment was actually made in a later calendar month due to (x) the actual time required for the negotiation of the Co-Development and Co-Commercialization Agreement or (y) any delay caused by MedImmune.

 

5.5          Restriction.  Prior to and during the Trigger Period and any Option Period, Kolltan shall not initiate discussions with any Third Party regarding, or consummate, any Third Party Transaction.  “Third Party Transaction” means any acquisition by a Third Party of, or the grant of any license or sublicense to a Third Party under, Kolltan’s rights to Research, Develop, Manufacture, or Commercialize the Licensed Antibody or Licensed Products; provided, however, that any transaction that does not conflict with MedImmune’s rights under Section 5.4, including any Kolltan Sale or Financing or any assignment or deemed assignment of this Agreement by Kolltan in connection with a Kolltan Sale or Financing, shall not be deemed a Third Party Transaction.

 

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ARTICLE 6
 PAYMENTS

 

6.1          Upfront Fee.  Kolltan shall pay MedImmune a non-refundable, non-creditable payment of Four Million Dollars ($4,000,000) within forty-five (45) days after the Effective Date (the “Upfront Fee”).

 

6.2          Development Milestones.

 

6.2.1       Development Milestones.  For each milestone event set forth in the following table, Kolltan shall pay the corresponding non-refundable, non-creditable amount solely for the first achievement thereof (regardless of the number of times such milestone event is achieved) by Kolltan or its Affiliates or Sublicensees:

 

	
Milestone Event
    	
 
    	
Payment Amount
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(a)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(b)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(c)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(d)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(e)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(f)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(g)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(h)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
(i)
    	
 
    	
[**]
    	
 
    	
[**]
    

 

6.2.2       Notification; Payment.  Kolltan shall notify MedImmune in writing promptly, and in no event beyond thirty (30) days, after a milestone event described in Section 6.2.1 has been achieved, and the corresponding milestone payment shall be due within forty-five (45) days after receipt of the corresponding invoice from MedImmune.

 

6.2.3       Milestones for Non-Major Indications.  Notwithstanding anything to the contrary herein, in the event that Kolltan achieves Annual Net Sales of at least [**] Dollars ($[**]) for any Licensed Product for an indication not considered to be a Major Indication, then Kolltan shall pay to MedImmune (a) the amount set forth in Section 6.2.1(b) (if such payment has not already been made) or 6.2.1(e) (if the payment set forth in Section 6.2.1(b) has already been made but the payment set forth in Section 6.2.1(e) has not already been made); provided, however, that if the payments set forth in Sections  6.2.1(b) and 6.2.1(e) have both already been made, Kolltan shall not be required to make any additional payments pursuant to this clause (a);

 

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(b) if the First Commercial Sale of such Licensed Product for such indication in the United States has occurred as of the achievement of such level of Annual Net Sales, the amount set forth Section 6.2.1(c) (if such payment has not already been made) or 6.2.1(f) (if the payment set forth in Section 6.2.1(c) has already been made but the payment set forth in Section 6.2.1(f) has not already been made); provided, however, that if the First Commercial Sale of such Licensed Product for such indication in the United States has not occurred as of the achievement of such level of Annual Net Sales , the applicable payment shall be made at such time (if any) as such First Commercial Sale occurs; and provided, further, that if the payments set forth in Sections 6.2.1(c) and 6.2.1(f) have both already been made as of the achievement of such level of Annual Net Sales, Kolltan shall not be required to make any additional payments pursuant to this clause (b); and (c) if the First Commercial Sale of such Licensed Product for such indication in the EU has occurred as of the achievement of such level of Annual Net Sales, the amount set forth Section 6.2.1(d) (if such payment has not already been made) or 6.2.1(g) (if the payment set forth in Section 6.2.1(d) has already been made but the payment set forth in Section 6.2.1(g) has not already been made); provided, however, that if the First Commercial Sale of such Licensed Product for such indication in the EU has not occurred as of the achievement of such level of Annual Net Sales, the applicable payment shall be made at such time (if any) as such First Commercial Sale occurs; and provided, further, that if the payments set forth in Sections 6.2.1(d) and 6.2.1(g) have both already been made as of the achievement of such level of Annual Net Sales, Kolltan shall not be required to make any additional payments pursuant to this clause (c).

 

6.2.4       Follow-On Products.  The foregoing provisions of this Section 6.2 (excluding subsection (a) of Section 6.2.1) shall apply, mutatis mutandis, to Follow-On Products; provided, however, that except for the payments set forth in subsections (h) and (i) of Section 6.2.1, the amounts payable by Kolltan under this Section 6.2 with respect to Follow-On Products shall be [**] percent ([**]%) of the corresponding amounts payable by Kolltan under this Section 6.2 with respect to Licensed Products.

 

6.2.5       Clarification.  For clarity, the maximum aggregate amount payable by Kolltan under this Section 6.2 is (a) with respect to Licensed Products, [**] Dollars ($[**]), and (b) with respect to Follow-On Products, [**] Dollars ($[**]).

 

6.3          Sales Milestones.

 

6.3.1       Sales Milestone Payments.  For each milestone event set forth in the following table, Kolltan shall pay the corresponding non-refundable, non-creditable amount solely for the first achievement thereof (regardless of the number of times such milestone event is achieved):

 

	
Milestone Event
    	
 
    	
Payment Amount
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(a)
    	
 
    	
Annual Net Sales of a single Licensed Product in a   single Calendar Year in excess of [**] Dollars ($[**])
    	
 
    	
[**]
    

 

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(b)
    	
 
    	
Annual Net Sales of a single Licensed Product in a   single Calendar Year in excess of [**] Dollars ($[**])
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(c)
    	
 
    	
Annual Net Sales of a single Licensed Product in a   single Calendar Year in excess of [**] Dollars ($[**])
    	
 
    	
[**]
    

 

6.3.2       Payment.  Milestone payments payable under this Section 6.3 shall be paid by Kolltan in accordance with Section 6.6.

 

6.3.3       Follow-On Products.  The foregoing provisions of this Section 6.3 shall apply, mutatis mutandis, to Follow-On Products; provided, however, that the amounts payable by Kolltan under this Section 6.3 with respect to Follow-On Products shall be [**] percent ([**]%) of the corresponding amounts payable by Kolltan under this Section 6.3 with respect to Licensed Products.

 

6.3.4       Clarification.  For clarity, the maximum aggregate amount payable by Kolltan under this Section 6.3 is (a) with respect to Licensed Products, [**] Dollars ($[**]), and (b) with respect to Follow-On Products, [**] Dollars ($[**]).

 

6.4          Royalties.

 

6.4.1       Annual Net Sales.  Subject to Sections 6.4.2 and 6.4.3, for each Licensed Product in any Calendar Year, Kolltan shall pay MedImmune royalties on Annual Net Sales of such Licensed Product in such Calendar Year at the following rates:

 

	
Annual Net Sales Level
    	
 
    	
Rate
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(a)
    	
 
    	
On that portion of Annual Net Sales of such Licensed   Product in such Calendar Year that is less than or equal to [**] Dollars   ($[**])
    	
 
    	
[**] Percent ([**]%)
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(b)
    	
 
    	
On that portion of Annual Net Sales of such Licensed   Product in such Calendar Year that is more than [**] Dollars ($[**]) but less   than or equal to [**] ($[**])
    	
 
    	
[**] Percent ([**]%)
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(c) 
    	
 
    	
On that portion of Annual Net Sales of such Licensed   Product in such Calendar Year that is greater than [**] Dollars ($[**])
    	
 
    	
[**] Percent ([**]%)
    

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

6.4.2       MRC Agreement.  In addition to the royalties described in Section 6.4.1, for each Licensed Product, Kolltan shall pay MedImmune a royalty equal to [**] percent ([**]%) of Net Sales of such Licensed Product.  Notwithstanding the foregoing, if for any sale or other transfer for consideration of any Licensed Product by Kolltan or its applicable Affiliate or Sublicensee, MedImmune or its applicable Affiliate is not required to pay royalties under the MRC Agreement, or is required to pay royalties under the MRC Agreement at a rate that is lower than [**] percent ([**]%) of Net Sales of such Licensed Product, then the royalty payable by Kolltan to MedImmune under this Section 6.4.2 with respect to such sale or other transfer for consideration shall be accordingly reduced.  MedImmune shall promptly notify Kolltan of the occurrence of any event or circumstance that would trigger a reduced royalty payment obligation under the previous sentence.

 

6.4.3       Reductions.

 

(a)           Third Party Royalty Reduction.  If Kolltan or its Affiliate or Sublicensee decides in its sole discretion to acquire a license or other rights from any Third Party (other than under any In-Licensed IP) under any Patents or Know-How controlled by such Third Party in order to Research, Develop, Manufacture, or Commercialize the Licensed Antibody or Licensed Products without infringing or misappropriating such Patents or Know-How and, pursuant to the applicable agreement with such Third Party, is required to pay royalties based on sales of a Licensed Product by Kolltan or its applicable Affiliate or Sublicensee in any Calendar Quarter, then the royalties that, but for this Section 6.4.3(a) and Section 6.4.3(b), would be payable by Kolltan to MedImmune with respect to sales of such Licensed Product in such Calendar Quarter shall be reduced by [**] percent ([**]%) of the royalties payable by Kolltan or its applicable Affiliate or Sublicensee under such Third Party agreement with respect to sales of such Licensed Product in such Calendar Quarter; provided, however, that this Section 6.4.3(a) shall not operate to reduce (i) the royalties that, but for this Section 6.4.3(a) and Section 6.4.3(b), would be payable by Kolltan to MedImmune with respect to sales of such Licensed Product in such Calendar Quarter by more than [**] percent ([**]%), or (ii) the royalties payable under Section 6.4.2.

 

(b)           Know-How Only Reduction. If, for any portion of any Calendar Quarter, any Licensed Product sold by Kolltan or its Affiliates or Sublicensees in any country is not Covered by a Valid Claim of an issued MedImmune Patent in such country, then the royalties that, but for this Section 6.4.3(b) (but after giving effect to Section 6.4.3(a)), would be payable by Kolltan to MedImmune with respect to sales of such Licensed Product in such country in such Calendar Quarter shall be reduced by [**] percent ([**]%); provided, however, that this Section 6.4.3(b) shall not operate to reduce the royalties payable under Section 6.4.2.

 

6.4.4       Payments under Certain In-License Agreements.  Each Party shall perform its obligations under Exhibit 6.4.4.

 

6.4.5       Effect of Expiration of Royalty Term.  On a Licensed Product by Licensed Product and country-by-country basis, upon expiration of the Royalty Term for a Licensed Product in a country, the rights, licenses and sublicenses granted to Kolltan hereunder with respect to such Licensed Product in such country shall continue in effect but become fully paid-

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

up, royalty-free, transferable (to the extent not transferable previously), perpetual and irrevocable.

 

6.4.6       Follow-On Products.  The foregoing provisions of this Section 6.4 (including Exhibit 6.4.4) shall apply, mutatis mutandis, to Follow-On Products; provided, however, that except with respect to the royalties payable pursuant to Section 6.4.2 and the payments described in Exhibit 6.4.4, the amounts payable by Kolltan under this Section 6.4 with respect to Follow-On Products shall be [**] percent ([**]%) of the corresponding amounts payable by Kolltan under this Section 6.4 with respect to Licensed Products.

 

6.5          Healthcare Reform Tax.  Notwithstanding anything herein to the contrary, for purposes of determining the sales milestones and royalties payable by Kolltan under Sections 6.2.4 and 6.4, Kolltan shall have the right to offset from Net Sales of Licensed Products sold in the United States that portion of the annual fee paid by Kolltan and its Affiliates and Sublicensees to the United States Government pursuant to Section 9008 of the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as may be amended) reasonably attributable to Licensed Products, as determined in accordance with an equitable method as agreed in good faith by the Parties.  This Section 6.5 shall apply, mutatis mutandis, to Follow-On Products.

 

6.6          Reports; Payments.  Within sixty (60) days after the end of each Calendar Quarter during which there are Net Sales giving rise to a payment obligation under Section 6.2.4 or 6.4, Kolltan shall submit to MedImmune a report identifying for each Licensed Product, the Net Sales of such Licensed Product for each country for such Calendar Quarter, the calculation of royalties (including gross sales and all deductions taken from gross sales), and the sales milestones and royalties payable to MedImmune.  Together with the delivery of each such report, Kolltan shall pay to MedImmune the sales milestones and royalties payable by it under Sections 6.2.4 and 6.4.  This Section 6.6 shall apply, mutatis mutandis, to Follow-On Products.

 

6.7          Methods of Payments.  All payments due under this Agreement shall be paid in Dollars by wire transfer to a bank in the United States designated in writing by MedImmune.  For the purpose of calculating any amounts due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate’s or Sublicensee’s standard conversion methodology consistent with the Accounting Standards.

 

6.8          Late Payments.  Any amount owed by a Party to the other Party under this Agreement that is not paid on or before the date such payment is due as set forth herein shall bear interest at a rate per annum equal to the lower of (i) [**], or (ii) the highest rate permitted by Applicable Law.

 

6.9          Taxes.

 

6.9.1       Withholding Taxes.  All payments due and payable by a Party (the “Paying Party”) under this Agreement will be made without any deduction or withholding, unless such deduction or withholding tax is required by Applicable Law.  If the Paying Party is so required to deduct or withhold, the Paying Party shall (a) promptly notify the other Party (the

 

38

 

“Non-Paying Party”) of such requirement; (b) remit to the relevant authorities the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against the Non-Paying Party; and (c) promptly forward to the Non-Paying Party an official receipt (or certified copy), or other documentation reasonably acceptable to the Non-Paying Party evidencing such payment to such authorities.  Notwithstanding the foregoing, if the Non-Paying Party is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, the applicable deduction or withholding tax, it may deliver to the Paying Party or the appropriate governmental authority (with the assistance of the Paying Party to the extent that this is reasonably required) the prescribed forms necessary to reduce the deduction or applicable rate of withholding or to relieve the Paying Party of its obligation to deduct or withhold tax, and the Paying Party shall apply the reduced deduction or rate of withholding, or dispense with deduction or withholding, as the case may be, provided that the Paying Party has received evidence of the Non-Paying Party’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization).

 

6.9.2       Withholding Taxes Resulting from Withholding Tax Action.  If the Paying Party (or its Affiliates or successors) is required to make a payment to the Non-Paying Party subject to a deduction or withholding of tax, then if such deduction or withholding of tax obligation arises or is increased solely as a result of the assignment or transfer of all or a portion of this Agreement by the Paying Party (or its Affiliates or successors) as a result of which payments arise or are deemed to arise in a territory other than in the United States, or there is a change in the tax residency of the Paying Party (or its Affiliates or successors), or the payments arise or are deemed to arise through a branch of the Paying Party in a territory other than the United States (a “Paying Party Withholding Tax Action”), then notwithstanding any other provision in this Agreement, the payment by the Paying Party (in respect of which such deduction and withholding of tax is required to be made) shall be increased by the amount necessary to ensure that the Non-Paying Party receives an amount equal to the same amount that it would have received had no Paying Party Withholding Tax Action occurred.

 

6.9.3       Indirect Taxes. All payments are exclusive of Indirect Taxes.  If any Indirect Taxes are chargeable in respect of any payments, the Paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the Non-Paying Party in respect of those payments.  The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If such amounts of Indirect Taxes are refunded to the Non-Paying Party by the applicable tax authority or other fiscal authority subsequent to payment, the Non-Paying Party will transfer such amount to the Paying Party within forty-five (45) days of receipt.  For purposes of this section, “Indirect Taxes” shall mean value added taxes, sales taxes, consumption taxes and other similar taxes.

 

6.10        Books and Records; Audit Rights.  Each Party (the “Audited Party”) shall keep (and, in the case of Kolltan, shall cause its Affiliates and Sublicensees to keep) complete, true and accurate books and records in accordance with the Accounting Standards in sufficient detail for the other Party (the “Auditing Party”) to determine the amount of any payments due to such Party under this Agreement. Each Auditing Party shall have the right, once annually at its own expense, to

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

have an independent, certified public accounting firm of nationally recognized standing, selected by the Auditing Party and reasonably acceptable to the Audited Party, review any such records of the Audited Party in the location(s) where such records are maintained by the Audited Party upon reasonable notice (which shall be no less than thirty (30) days’ prior written notice) and during regular business hours and under obligations of confidence, for the sole purpose of verifying the accuracy of the amounts paid under this Agreement within a two (2) year period preceding the date of the request for review.  The Audited Party shall (and, in the case of Kolltan as the Audited Party, shall cause its Affiliates and Sublicensees to) make its (and their) personnel reasonably available to answer queries reasonably required for such report. The report of such accounting firm shall be limited to a certificate stating whether any report made or invoice or payment submitted by the Audited Party during such period is accurate or inaccurate and the amounts of any discrepancy.  No other information shall be provided to the Auditing Party.  The Audited Party shall receive a copy of each such report concurrently with receipt by the Auditing Party.  Should such inspection lead to the discovery of a discrepancy to the Auditing Party’s detriment, the Audited Party shall pay the amount of the discrepancy within thirty (30) days after its receipt from the accounting firm of the certificate showing the amount of the discrepancy.  The Auditing Party shall pay the full cost of the review unless the underpayment is greater than [**] percent ([**]%) of the amount due for the applicable period, in which case the Audited Party shall pay the reasonable costs charged by such accounting firm for such review.

 

ARTICLE 7
 OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS

 

7.1          Inventorship.  Inventorship for patentable inventions made in the course of Research, Development, Manufacture or Commercialization of the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products shall be determined in accordance with the patent laws of the jurisdiction where the invention was made; provided, however, that the issue as to whether any such invention is jointly made by the Parties shall be determined in accordance with the substantive Applicable Laws of the United States, irrespective of the country in which such invention is made.

 

7.2          Ownership.  Subject to the rights and licenses granted to Kolltan under this Agreement, as between the Parties, MedImmune shall own the entire right, title and interest in and to all inventions and discoveries (and Patents claiming patentable inventions therein) first made or discovered solely by employees or consultants of MedImmune or its Affiliates or acquired solely by MedImmune or its Affiliates in the course of Research, Development or Manufacture of the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products.  Kolltan shall own the entire right, title and interest in and to all inventions and discoveries (and Patents claiming patentable inventions therein) first made or discovered solely by employees or consultants of Kolltan or its Affiliates or acquired solely by Kolltan or its Affiliates in the course of Research, Development, Manufacture or Commercialization of the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products.  Each Party shall own an undivided, one-half interest in any Joint IP and, subject to the terms and conditions of this Agreement, shall retain the right to practice under such interest without the consent of or accounting to the other.  Subject to the terms of this Agreement, the rights of the Parties as joint owners shall be determined in accordance with the substantive Applicable Laws

 

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of the United States, irrespective of the country in which any invention or discovery is made or discovered.

 

7.3          Prosecution and Maintenance of Patents.

 

7.3.1       Kolltan Rights.

 

(a)           Kolltan shall have (i) the sole right, at Kolltan’s discretion and expense, to file, prosecute, and maintain (including with respect to any interference, derivation, re-issuance, re-examination, opposition or other post-grant proceedings) any Kolltan Patents throughout the world, and (ii) the first right, at Kolltan’s discretion (subject to the remainder of this Section 7.3.1), to file, prosecute, and maintain (including with respect to any interference, derivation, re-issuance, re-examination, opposition or other post-grant proceedings) (x) any MedImmune Patents throughout the world (subject to Section 12.10 of the Dyax Agreement) and (y) any Joint Patents throughout the world.

 

(b)           Promptly after the Effective Date, MedImmune shall transfer or disclose to Kolltan, in whatever manner or form Kolltan may reasonably request, all documents, correspondence and other information and materials Controlled by MedImmune as of the Effective Date that relate to the MedImmune Patents as reasonably necessary for Kolltan to exercise its rights under clause (ii)(x) of Section 7.3.1(a).  Such transfers and disclosures shall be made (i) in any manner or form reasonably requested by Kolltan and (ii) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.

 

(c)           MedImmune shall reimburse Kolltan for the reasonable Out-of-Pocket Costs of Kolltan in the filing, prosecution and maintenance of any MedImmune Patent or Joint Patent; provided, however, that MedImmune shall have the right to assign any such Patent in any country (or, in case of a Joint Patent, to assign MedImmune’s interest in such Joint Patent in any country) to Kolltan, in which case such Patent (or Joint Patent) in such country shall thereafter be deemed a Kolltan Patent, or (in the case of a MedImmune Patent) to cause the abandonment of any such Patent in any country, at Kolltan’s election, and thereby to terminate MedImmune’s obligation to reimburse such costs incurred thereafter, upon thirty (30) days’ written notice to Kolltan.  Kolltan will provide an invoice to MedImmune for reimbursement of Out-of-Pocket Costs within 90 days of receiving an invoice from a Third Party for such Out-of-Pocket Costs.

 

(d)           The Parties shall work together in good faith to agree upon a strategy for the prosecution of any MedImmune Patents and Joint Patents, including the list of countries in which such Patents will be filed; provided, however, that (subject to Section 7.3.1(e)) Kolltan shall have the final right to make such determinations.  Kolltan shall provide MedImmune with a draft of any prosecution filing related to any MedImmune Patents or Joint Patents at least thirty (30) days in advance of submission (or, if such timing is not practicable, as far in advance of submission as practicable) and shall provide MedImmune an opportunity to provide comments on and make requests of Kolltan concerning such filing and shall consider in good faith any comments or requests regarding such filing that MedImmune may timely provide.  In

 

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addition, Kolltan shall provide to MedImmune such other information related to prosecution of any MedImmune Patents or Joint Patents as MedImmune may from time to time reasonably request to allow MedImmune to track prosecution and maintenance of such Patents and shall consider in good faith any comments that MedImmune may provide with respect to such matters.

 

(e)           Kolltan shall give MedImmune written notice reasonably, but in no event less than thirty (30) days, in advance of any decision by Kolltan not to file an application for or to abandon the prosecution of or otherwise not maintain or extend any MedImmune Patent or Joint Patent in any country.  Upon receiving such notice, MedImmune shall have the right, at its own cost, to file, prosecute, maintain and extend, as the case may be, such MedImmune Patent or Joint Patent, in MedImmune’s name, in such country; provided, however, that MedImmune shall not exercise such right without the prior written consent of Kolltan (which Kolltan may withhold in its sole discretion) if Kolltan’s decision not to file an application for or to abandon the prosecution of or otherwise not maintain or extend such MedImmune Patent or Joint Patent is made for strategic business reasons (e.g., in countries with compulsory licensing policies).  If MedImmune exercises its rights under this Section 7.3.1(e) with respect to any Joint Patent in any country, Kolltan shall (i) assign its entire right, title and interest in such Joint Patent in such country to MedImmune, (ii) use reasonable efforts to make its authorized attorneys, agents or representatives available to MedImmune and to assist MedImmune in obtaining and maintaining such patent protection, and (iii) sign or use reasonable efforts to have signed all legal documents necessary to file and prosecute such Joint Patent or to obtain or maintain such Joint Patent.

 

7.3.2       MedImmune Rights.

 

(a)           MedImmune shall have (i) the sole right, at MedImmune’s discretion and expense, to file, prosecute, and maintain (including with respect to any interference, derivation, re-issuance, re-examination, opposition or other post-grant proceedings) any MedImmune Manufacturing Patents throughout the world, and (ii) the first right, at MedImmune’s discretion (subject to the remainder of this Section 7.3.2) and expense, to file, prosecute, and maintain (including with respect to any interference, derivation, re-issuance, re-examination, opposition or other post-grant proceedings) any MedImmune Additional Patents throughout the world.

 

(b)           The Parties shall work together in good faith to agree upon a strategy for the prosecution of any MedImmune Additional Patents, including the list of countries in which such MedImmune Additional Patents will be filed; provided, however, that (subject to Section 7.3.2(c)) MedImmune shall have the final right to make such determinations. MedImmune shall provide Kolltan with a draft of any prosecution filing related to any MedImmune Additional Patents at least thirty (30) days in advance of submission (or, if such timing is not practicable, as far in advance of submission as practicable) and shall provide Kolltan an opportunity to provide comments on and make requests of MedImmune concerning such filing and shall consider in good faith any comments or requests regarding such filing that Kolltan may timely provide.  In addition, MedImmune shall provide to Kolltan such other information related to prosecution of any MedImmune Additional Patents as Kolltan may from time to time reasonably request to allow Kolltan to track prosecution and maintenance of such Patents and shall consider in good faith any comments that Kolltan may provide with respect to such matters.

 

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(c)           MedImmune shall give Kolltan written notice reasonably, but in no event less than thirty (30) days, in advance of any decision by MedImmune not to file an application for or to abandon the prosecution of or otherwise not maintain or extend any MedImmune Additional Patents in any country.  Upon receiving such notice, Kolltan shall have the right, at its own cost, to file, prosecute, maintain and extend, as the case may be, such MedImmune Additional Patents, in Kolltan’s name, in such country; provided, however, that Kolltan shall not exercise such right without the prior written consent of MedImmune (which MedImmune may withhold in its sole discretion) if MedImmune’s decision not to file an application for or to abandon the prosecution of or otherwise not maintain or extend such MedImmune Additional Patent is made for strategic business reasons (e.g., in countries with compulsory licensing policies).

 

7.4          Third Party Infringement.

 

7.4.1       Notice.  Each Party shall promptly report in writing to the other Party any known or suspected (a) infringement of any of the MedImmune Patents, MedImmune Additional Patents, Kolltan Patents or Joint Patents; (b) unauthorized use or misappropriation of any of the MedImmune Know-How, MedImmune Additional Know-How, Kolltan Know-How or Joint Know-How of which such Party becomes aware; or (c) notification under the Biologics Price Competition and Innovation Act of 2009, as amended, or any similar law, from a biosimilar applicant arising from the filing of an application for the Regulatory Approval of a product intending to show that such product is biosimilar to any Licensed Product (or, in the case of MedImmune as the notifying Party, any Follow-On Product) that is a reference product for which a claim of infringement of any of the MedImmune Patents, MedImmune Additional Patents, Kolltan Patents or Joint Patents by the manufacture or sale of such product could reasonably be asserted, and shall provide the other Party with all available evidence regarding such known or suspected infringement or unauthorized use.

 

7.4.2       Enforcement of Patents.

 

(a)           Kolltan Rights.

 

(i)            Kolltan shall have (x) the sole right, but not the obligation, to initiate a lawsuit or take other reasonable action to enforce any Kolltan Patents throughout the world and (y) the first right, but not the obligation, to initiate a lawsuit or take other reasonable action to enforce (A) any MedImmune Patents throughout the world and (B) any Joint Patents throughout the world; provided, however, that Kolltan shall not initiate any such lawsuit or take such other action with respect to any matter described in this clause (y) without first consulting with MedImmune and giving good faith consideration to any reasonable objection from MedImmune regarding Kolltan’s proposed course of action.  MedImmune shall cooperate in the prosecution of any suit under this Section 7.4.2(a)(i) as may be reasonably requested by Kolltan (including joining such suit as a plaintiff if Kolltan is unable to initiate or prosecute such action solely in its own name); provided, however, that Kolltan shall promptly reimburse all Out-of-Pocket Costs (including reasonable counsel fees and expenses) of MedImmune in connection with such cooperation.  In connection with any such proceeding, Kolltan shall not enter into any settlement admitting the invalidity of, or otherwise impairing MedImmune’s rights in, any MedImmune IP or Joint IP without the prior written consent of MedImmune.

 

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(ii)           Any recoveries resulting from an action brought by Kolltan under Section 7.4.2(a)(i) shall (x) first be applied to reimburse each Party for all Out-of-Pocket Costs incurred by such Party in connection with such proceeding (on a pro rata basis, based on each Party’s respective litigation costs, to the extent the recovery was less than all such litigation costs), and (y) second, as to any remainder after such reimbursements are made, be retained by Kolltan; provided, however, that (A) to the extent the award is based on lost profits with respect to a Licensed Product or Follow-On Product, MedImmune shall receive an amount equal to the royalty that would be payable, pursuant to Section 6.4, on the imputed amount of Net Sales of such Licensed Product or Follow-On Product, as applicable, in the country in which such infringement occurred based on the amount retained by Kolltan under this clause (y), and (B) to the extent the award reflects the amount of reasonable royalty payments due to Kolltan with respect to a Licensed Product or Follow-On Product (excluding, for clarity, any award to the extent described in clause (A) above), the amount retained by Kolltan under this clause (y) shall be deemed Net Sales hereunder (and accordingly subject to any applicable royalty obligation under Section 6.4).

 

(iii)          If Kolltan in good faith does not intend to initiate a lawsuit or take other reasonable action with respect to any matter described in clause (y) of Section 7.4.2(a)(i), then Kolltan shall notify MedImmune thereof (x) if there is no time limit for the filing of such action, within sixty (60) days following the notice of alleged infringement, or (y) if there is a time limit for the filing of such action (including those set forth in Applicable Law), at least fifteen (15) days before the time limit, and upon receipt of such notice MedImmune shall have the right, but not the obligation, to initiate such lawsuit or take such other action, after providing thirty (30) days (or five (5) days in the event there is a time limit) notice to Kolltan and giving good faith consideration to Kolltan’s reason(s) for not initiating a lawsuit or taking other action; provided, however, that MedImmune shall not initiate such a lawsuit or take such other action without the prior written consent of Kolltan (which Kolltan may withhold in its sole discretion) if Kolltan’s decision not to exercise its first right with respect thereto was made for strategic business reasons. Kolltan shall cooperate in the prosecution of any suit initiated by MedImmune to the extent permitted by the prior sentence as may be reasonably requested by MedImmune (including joining such suit as a plaintiff if MedImmune is unable to initiate or prosecute such action solely in its own name); provided, however, that MedImmune shall promptly reimburse all Out-of-Pocket Costs (including reasonable counsel fees and expenses) of Kolltan in connection with such cooperation. Subject to the proviso in the immediately preceding sentence, any recoveries resulting from such an action brought by MedImmune in accordance with this Section 7.4.2(a)(iii)shall be retained by MedImmune.

 

(b)           MedImmune Rights.

 

(i)            MedImmune shall have (x) the sole right, but not the obligation, to initiate a lawsuit or take other reasonable action to enforce any MedImmune Manufacturing Patents throughout the world and (y) the first right, but not the obligation, to initiate a lawsuit or take other reasonable action to enforce any MedImmune Additional Patents throughout the world; provided, however, that MedImmune shall not initiate any such lawsuit or take such other action with respect to any matter described in this clause (y) without first consulting with Kolltan and giving good faith consideration to any reasonable objection from Kolltan regarding MedImmune’s proposed course of action.  Kolltan shall cooperate in the

 

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prosecution of any suit under this Section 7.4.2(b)(i) as may be reasonably requested by MedImmune (including joining such suit as a plaintiff if MedImmune is unable to initiate or prosecute such action solely in its own name); provided, however, that MedImmune shall promptly reimburse all Out-of-Pocket Costs (including reasonable counsel fees and expenses) of Kolltan in connection with such cooperation.  In connection with any such proceeding, MedImmune shall not enter into any settlement admitting the invalidity of, or otherwise impairing Kolltan’s rights in, any MedImmune Additional IP without the prior written consent of Kolltan.

 

(ii)           With respect to any lawsuit initiated or other action taken by MedImmune under clause (y) of Section 7.4.2(b)(i), (w) MedImmune shall keep Kolltan reasonably informed of the status of such lawsuit or action; (x) without limiting clause (w), MedImmune shall provide Kolltan with copies of any court filings or other material documents or correspondence received from any Third Party in connection with such lawsuit or action promptly after such filings or documents or correspondence are received by MedImmune; (y) MedImmune shall consult with Kolltan with respect to such lawsuit or action and consider any comments from Kolltan with respect to such lawsuit or action in good faith; and (z) without limiting clause (y), MedImmune shall provide Kolltan with drafts of any court filings or other material documents or correspondence to be filed or delivered by MedImmune prior to the date of filing or delivery such that Kolltan has a reasonable opportunity to review and provide comments, and to the extent Kolltan provides comments thereon promptly and in sufficient time to allow MedImmune to meet applicable filing requirements, MedImmune shall consider such comments in good faith.

 

(iii)          Any recoveries resulting from an action brought by MedImmune under Section 7.4.2(b)(i) shall (x) first be applied to reimburse each Party for all Out-of-Pocket Costs incurred by such Party in connection with such proceeding (on a pro rata basis, based on each Party’s respective litigation costs, to the extent the recovery was less than all such litigation costs), and (y) second, as to any remainder after such reimbursements are made, (A) to the extent the award is based on lost profits with respect to a Licensed Product or Follow-On Product, such remainder shall be retained by Kolltan; provided, however, that if the award is based on lost profits with respect to a Licensed Product or Follow-On Product, then MedImmune shall receive an amount equal to the royalty that would be payable, pursuant to Section 6.4, on the imputed amount of Net Sales of such Licensed Product or Follow-On Product, as applicable, in the country in which such infringement occurred based on the amount retained by Kolltan under this clause (A); (B) to the extent the award reflects the amount of reasonable royalty payments due to Kolltan with respect to a Licensed Product or Follow-On Product (excluding, for clarity, any award to the extent described in clause (A) above), such remainder shall be retained by Kolltan; provided, however, that if the award is based on the amount of reasonable royalty payments due to Kolltan with respect to a Licensed Product or Follow-On Product, as applicable, then the amount retained by Kolltan under this clause (B) shall be deemed Net Sales hereunder (and accordingly subject to any applicable royalty obligation under Section 6.4); and (C) to the extent the award is not described in clauses (A) or (B) above, such remainder shall be equitably divided between MedImmune and Kolltan.

 

(iv)          If MedImmune in good faith does not intend to initiate a lawsuit or take other reasonable action with respect to any matter described in clause (y) of Section 7.4.2(b)(i), then MedImmune shall notify Kolltan thereof (x) if there is no time limit for the filing of such action, within sixty (60) days following the notice of alleged infringement, or (y) if there is a time limit for the filing of such action (including those set forth in Applicable Law), at least fifteen (15) days before the time limit, and upon receipt of such notice Kolltan shall have the right, but not the obligation, to initiate such lawsuit or take such other action, after providing thirty (30) days (or five (5) days in the event there is a time limit) notice to MedImmune and giving good faith consideration to MedImmune’s reason(s) for not initiating a lawsuit or taking other action; provided, however, that Kolltan shall not initiate such a lawsuit or take such other action without the prior written consent of MedImmune (which MedImmune may withhold in its sole discretion) if MedImmune’s decision not to exercise its first right with respect thereto was made for strategic business reasons. MedImmune shall cooperate in the prosecution of any suit initiated by Kolltan to the extent permitted by the prior sentence as may be reasonably requested by Kolltan (including joining such suit as a plaintiff if Kolltan is unable to initiate or prosecute such action solely in its own name); provided, however, that Kolltan shall promptly reimburse all Out-of-Pocket Costs (including reasonable counsel fees and expenses) of MedImmune in connection with such cooperation. Subject to the proviso in the immediately preceding sentence, any recoveries resulting from such an action brought by Kolltan in accordance with this Section 7.4.2(b)(iv)shall be retained by Kolltan.

 

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7.4.3       Conduct of Certain Actions; Costs.  The Party initiating legal action shall have the sole and exclusive right to select counsel for any suit initiated by it pursuant to Section 7.4.2 (the “Initiating Party”). Unless otherwise expressly provided herein, the Initiating Party shall bear its own Out-of-Pocket Costs incurred in any such legal action, including the fees and expenses of the counsel selected by it.  The other Party shall have the right to participate and be represented in any such legal action (in cases where such other Party has standing) by its own counsel at its own expense.

 

7.5          Patent Invalidity Claim.  Each Party shall promptly notify the other in the event of any legal action (excluding any actions covered by Section 7.3) by any Third Party with respect to the validity of a MedImmune Patent, MedImmune Additional Patent, Kolltan Patent or Joint Patent of which it becomes aware.  With respect to any such action:

 

7.5.1       Kolltan shall have (a) the sole right, but not the obligation, at its expense, to defend against any such action relating to any Kolltan Patents throughout the world, and (b) the first right, but not the obligation, at its expense, to defend against any such action relating to any MedImmune Patents throughout the world and any Joint Patents throughout the world.  If Kolltan does not defend against any such action described in clause (b) above, then MedImmune shall have the right, but not the obligation, to defend such action at MedImmune’s expense; provided, however, that MedImmune shall not defend against any such action described without the prior written consent of Kolltan (which Kolltan may withhold in its sole discretion) if Kolltan’s decision not to exercise its first right with respect thereto was made for strategic business reasons.

 

7.5.2       MedImmune shall have (a) the sole right, but not the obligation, at its expense, to defend against any such action relating to any MedImmune Manufacturing Patents throughout the world and (b) the first right, but not the obligation, at its expense, to defend against any such action relating to any MedImmune Additional Patents throughout the world.  If

 

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MedImmune does not defend against any such action described in clause (b) above, then Kolltan shall have the right, but not the obligation, to defend such action at Kolltan’s expense; provided, however, that Kolltan shall not defend against any such action described without the prior written consent of MedImmune(which MedImmune may withhold in its sole discretion) if MedImmune’s decision not to exercise its first right with respect thereto was made for strategic business reasons.  In addition, with respect to any such action described in clause(b) above, (i) MedImmune shall keep Kolltan reasonably informed of the status of such action; (ii) without limiting clause (i), MedImmune shall provide Kolltan with copies of any court filings or other material documents or correspondence received from any Third Party in connection with such action promptly after such filings or documents or correspondence are received by MedImmune; (iii) MedImmune shall consult with Kolltan with respect to such action and consider any comments from Kolltan with respect to such action in good faith; and (iv) without limiting clause (iii), MedImmune shall provide Kolltan with drafts of any court filings or other material documents or correspondence to be filed or delivered by MedImmune prior to the date of filing or delivery such that Kolltan has a reasonable opportunity to review and provide comments, and to the extent Kolltan provides comments thereon promptly and in sufficient time to allow MedImmune to meet applicable filing requirements, MedImmune shall consider such comments in good faith.

 

7.6          Patent Term Extensions.  The Parties shall cooperate with each other in obtaining patent term extensions or supplemental protection certificates or their equivalents in any country, where applicable to MedImmune Patents, MedImmune Additional Patents, Kolltan Patents and Joint Patents; provided, however, that (a) Kolltan shall have the right of final decision as to whether to seek patent term extensions or supplemental protection certificates or their equivalents in any country with respect to the MedImmune Patents, Kolltan Patents and Joint Patents, and (b) MedImmune shall have the right of final decision as to whether to seek patent term extensions or supplemental protection certificates or their equivalents in any country with respect to the MedImmune Additional Patents.

 

7.7          Patent Marking.  Kolltan shall comply with the patent marking statutes in each country in which a Licensed Product or Follow-On Product is sold by Kolltan, its Affiliates and/or its Sublicensees.

 

7.8          CREATE Act.  The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the “CREATE Act”).  MedImmune (a) without the prior written consent of Kolltan, shall not make any election under the CREATE Act with respect to the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products and (b) shall cooperate with Kolltan with respect to any actions taken by Kolltan in connection with any election made by Kolltan under the CREATE Act with respect to the Licensed Antibody, Licensed Products, Follow-On Antibodies or Follow-On Products.

 

7.9          Publications.

 

7.9.1       Publication by MedImmune.  Notwithstanding anything to the contrary in this Agreement, MedImmune may publish, present or otherwise disclose preclinical data relating to Licensed Antibody or Licensed Products, either orally or in writing, in a publication,

 

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presentation or other disclosure (a “MedImmune Publication”), only in accordance with the terms and conditions of this Section 7.9.1.

 

(a)           MedImmune shall provide a copy of any proposed MedImmune Publication to Kolltan at least thirty (30) days prior to its submission or other disclosure, and Kolltan shall have thirty (30) days from receipt of such proposed MedImmune Publication to provide comments and/or proposed changes to MedImmune.  Without limiting the remainder of this Section 7.9.1, MedImmune shall in good faith take into account any such comments and/or proposed changes.

 

(b)           Subject to the last sentence of Section 8.1 and Section 8.2, MedImmune shall not include any Confidential Information of Kolltan (other than preclinical data relating to Licensed Antibody or Licensed Products) in any MedImmune Publication without Kolltan’s prior written consent.

 

(c)           If Kolltan reasonably determines that any MedImmune Publication would entail the disclosure of any MedImmune Know-How or Joint Know-How upon which Kolltan desires to file a patent application, or if MedImmune has made the decision not to draft and file a patent application covering any MedImmune Additional Know-How disclosed in any proposed MedImmune Publication, then, at Kolltan’s request, disclosure of the proposed MedImmune Publication shall be delayed for a period not to exceed forty-five (45) days after the date of proposed submission or disclosure to enable Kolltan to draft and file a patent application covering such MedImmune Know-How, Joint Know-How or MedImmune Additional Know-How, as applicable.

 

(d)           MedImmune shall designate appropriate authors in accordance with generally recognized standards for academic publications on any MedImmune Publication.

 

7.9.2       Publication by Kolltan.  Notwithstanding anything to the contrary in this Agreement, Kolltan may publish information or data relating to the Licensed Antibody or Licensed Products in a scientific journal (a “Kolltan Publication”), only in accordance with the terms and conditions of this Section 7.9.2.

 

(a)           Prior to the Option Termination Date, (i) Kolltan shall provide to MedImmune a copy of any proposed Kolltan Publication at least thirty (30) days prior to submission, (ii) MedImmune shall have ten (10) days from receipt of such proposed Kolltan Publication to provide comments to Kolltan, and (iii) without limiting the remainder of this Section 7.9.2, Kolltan may, in its sole discretion, take into account any such comments.  From and after the Option Termination Date, Kolltan shall have no obligation to provide a copy of any proposed Kolltan Publication to MedImmune prior to submission or other disclosure.

 

(b)           Subject to the last sentence of Section 8.1 and Section 8.2, Kolltan shall not include any Confidential Information of MedImmune in any Kolltan Publication without MedImmune’s prior written consent.

 

(c)           Kolltan shall designate appropriate authors in accordance with generally recognized standards for academic publications on any Kolltan Publication.

 

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7.10        Existing Proceedings.

 

7.10.1     Prosecution by MedImmune.  Until such time as Kolltan assumes control of a particular Existing Proceeding pursuant to Section 7.10.2, MedImmune shall continue to prosecute such Existing Proceeding.  MedImmune shall provide Kolltan with a draft of any filing or document to be submitted related to any such Existing Proceeding at least thirty (30) days in advance of submission (or, if such timing is not practicable, as far in advance of submission as practicable) and shall provide Kolltan an opportunity to provide comments on and make requests of MedImmune concerning such filing or document and shall consider in good faith any comments or requests regarding such filing or document that Kolltan may timely provide.  In addition, MedImmune shall provide to Kolltan such other information related to such Existing Proceeding as Kolltan may from time to time reasonably request to allow Kolltan to track such Existing Proceeding and shall consider in good faith any comments that Kolltan may provide with respect to such matters.  MedImmune shall also work with Kolltan in good faith with respect to the strategy for the prosecution of such Existing Proceeding.

 

7.10.2     Assumption of Control by Kolltan.  MedImmune shall give Kolltan written notice reasonably, but in no event less than thirty (30) days, in advance of any decision by MedImmune not to continue to prosecute any Existing Proceeding.  Upon receiving such notice, Kolltan shall have the right, at its own cost, to continue to prosecute such Existing Proceeding.  In addition, Kolltan shall have the right, at Kolltan’s discretion and at its own cost, at any time to assume control of any Existing Proceeding by providing written notice to MedImmune.  If Kolltan exercises its rights under this Section 7.10.2, MedImmune shall transfer or disclose to Kolltan, in whatever manner or form Kolltan may reasonably request, all documents, correspondence and other information and materials Controlled by MedImmune (and not previously disclosed to Kolltan) as reasonably necessary for Kolltan to exercise its rights under this Section 7.10.2.  Such transfers and disclosures shall be made (a) in any manner or form reasonably requested by Kolltan and (b) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.  In addition, MedImmune shall (x) use reasonable efforts to make its authorized attorneys, agents or representatives available to Kolltan and to assist Kolltan in transitioning control of such Existing Proceeding to Kolltan and (y) sign or use reasonable efforts to have signed all legal documents necessary to transfer control of such Existing Proceeding to Kolltan.

 

7.10.3     Assistance.  If Kolltan assumes control of an Existing Proceeding pursuant to Section 7.10.2, MedImmune shall provide such cooperation in the prosecution of such proceeding as may be reasonably requested by Kolltan (including permitting Kolltan to continue such proceeding in MedImmune’s name if Kolltan is unable to prosecute such proceeding solely in Kolltan’s own name); provided, however, that Kolltan shall promptly reimburse all Out-of-Pocket Costs (including reasonable counsel fees and expenses) of MedImmune in connection with such cooperation.

 

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ARTICLE 8
 CONFIDENTIALITY

 

8.1          Confidentiality; Exceptions.  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party (the “Receiving Party”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Know-How in any form (whether written, oral, graphic, photographic, electronic, magnetic, or otherwise) that is disclosed to the Receiving Party by the other Party (the “Disclosing Party”) directly, or indirectly in the course of the Receiving Party’s performing its obligations or exercising its rights under this Agreement (collectively, “Confidential Information”).  Notwithstanding anything to the contrary in this Agreement, (a) any Regulatory Documentation relating to the Licensed Antibody or Licensed Products shall be deemed to be the Confidential Information of Kolltan (and not MedImmune), (b) any MedImmune Know-How, MedImmune Additional Know-How and Joint Know-How shall be deemed to be the Confidential Information of each Party and (c) subject to Section 8.3, the terms of this Agreement shall be deemed to be the Confidential Information of each Party.  Notwithstanding the foregoing, the restrictions set forth in the first sentence of this Section 8.1 shall not apply to Confidential Information of the Disclosing Party to the extent that it can be established by the Receiving Party that such Confidential Information:

 

8.1.1       was in the lawful knowledge and possession of the Receiving Party prior to the time it was disclosed to, or learned by, the Receiving Party pursuant to this Agreement, or was otherwise developed independently by the Receiving Party, as evidenced by written records kept in the ordinary course of business, or other documentary proof of actual use by the Receiving Party;

 

8.1.2       was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

8.1.3       became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; or

 

8.1.4       was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others.

 

8.2          Authorized Disclosure.  Except as expressly provided otherwise in this Agreement, a Receiving Party may use and disclose Confidential Information of the Disclosing Party as follows:

 

8.2.1       under appropriate confidentiality provisions similar to those in this Agreement, in connection with the performance of its obligations or exercise of rights expressly granted or reserved under this Agreement; provided, however, that the Receiving Party shall remain responsible for any violation of such confidentiality provisions by any Person receiving such Confidential Information;

 

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8.2.2       to the extent such disclosure is reasonably necessary in filing or prosecuting patent and copyright applications, prosecuting or defending litigation, complying with applicable governmental regulations (including the rules and regulations of any stock exchange or NASDAQ), preparing and submitting filings to Regulatory Authorities or as otherwise required by Applicable Law; provided, however, that if a Receiving Party is required by Applicable Law to make any such disclosure of a Disclosing Party’s Confidential Information (other than a disclosure to a Regulatory Authority in a filing required by Applicable Law) it will give reasonable advance notice to the Disclosing Party of such disclosure requirement and shall furnish only that portion of the Disclosing Party’s Confidential Information that the Receiving Party is legally required to furnish;

 

8.2.3       in communications with existing or bona fide prospective acquirers, merger partners, lenders, investors, licensees, sublicensees or collaborators, and consultants and advisors of the Receiving Party in connection with transactions or bona fide prospective transactions with any of the foregoing, in each case on a need to know basis and under appropriate confidentiality provisions substantially equivalent to those of this Agreement; provided, however, that the Receiving Party shall remain responsible for any violation of such confidentiality provisions by any Person receiving such Confidential Information; or

 

8.2.4       to the extent mutually agreed to in writing by the Parties.

 

8.3          Press Release; Disclosure of Agreement.

 

8.3.1       On or promptly after the Effective Date, the Parties shall issue a joint public announcement of the execution of this Agreement or each Party shall issue a separate public announcement of the execution of this Agreement; provided, however, that the content of any such public announcement (whether joint or separate) shall be mutually agreed by the Parties.  Thereafter, (a) subject to Section 7.9.1, MedImmune shall not (i) issue any other press release regarding this Agreement or the Parties’ activities hereunder without the prior written consent of Kolltan or (ii) make any other disclosures regarding this Agreement or the Parties’ activities hereunder, or any results or data arising hereunder, except for any disclosure that is reasonably necessary to comply with applicable securities exchange listing requirements or other Applicable Law; provided, however, that (x) the restrictions set forth in clauses (i) and (ii) above shall terminate at such time, if any, as this Agreement terminates pursuant to Section 5.4.3(a); and (y) if it is determined that the Parties will enter into the Co-Development and Co-Commercialization Agreement pursuant to Section 5.4.3(c) or 5.4.3(d), Kolltan shall not unreasonably withhold its consent to any press release proposed to be issued by MedImmune with respect to the Parties’ entering into the Co-Development and Co-Commercialization Agreement; and (b) subject to Section 7.9.2, Kolltan may, in its sole discretion, issue other press releases regarding its Development and Commercialization activities hereunder (including any results or data arising hereunder); provided, however, that Kolltan shall not issue any other press releases regarding the terms of this Agreement or the exercise by either Party of its rights under ARTICLE 5 without the prior written consent of MedImmune.

 

8.3.2       Each Party shall, if practicable, give the other Party a reasonable opportunity to review those portions of all filings with the United States Securities and Exchange Commission (or any stock exchange, including Nasdaq, or any similar regulatory agency in any

 

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country other than the United States) describing the terms of this Agreement (including any filings of this Agreement) prior to submission of such filings, and shall give due consideration to any reasonable comments by the non-filing Party relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.

 

8.4          Existing Confidentiality Agreement.  For the avoidance of doubt, any information disclosed by either Party to the other Party prior to the Effective Date pursuant to the Mutual Confidentiality Agreement, dated July 12, 2012, between MedImmune and Kolltan (the “Existing Confidentiality Agreement”) shall be treated as Confidential Information of the disclosing Party for all purposes under this Agreement.

 

8.5          Remedies.  In the event a Party breaches the confidentiality obligations set forth in this ARTICLE 8, the other Party shall be entitled to seek, in addition to any other right or remedy it may have, at law or in equity, a temporary injunction, without the posting of any bond or other security, enjoining or restraining the breaching Party from any violation or threatened violation of this ARTICLE 8.

 

8.6          Return of Confidential Information.  Upon the expiration or termination of this Agreement, the Receiving Party shall return to the Disclosing Party all Confidential Information of the Disclosing Party in its possession (and all copies and reproductions thereof).  In addition, the Receiving Party shall destroy: (a) any notes, reports or other documents prepared by the Receiving Party which contain Confidential Information of the Disclosing Party; and (b) any Confidential Information of the Disclosing Party (and all copies and reproductions thereof) which is in electronic form or cannot otherwise be returned to the Disclosing Party.  Alternatively, upon written request of the Disclosing Party, upon such expiration or termination, the Receiving Party shall destroy all Confidential Information of the Disclosing Party in its possession (and all copies and reproductions thereof) and any notes, reports or other documents prepared by the Receiving Party which contain Confidential Information of the Disclosing Party.  Nothing in this Section 8.6 shall require the alteration, modification, deletion or destruction of archival tapes or other electronic back-up media made in the ordinary course of business; provided that the Receiving Party shall continue to be bound by its obligations of confidentiality and other obligations under this ARTICLE 8 with respect to any Confidential Information contained in such archival tapes or other electronic back-up media.  Any requested destruction of Confidential Information shall be certified in writing to the Disclosing Party.  Notwithstanding the foregoing, (i) the Receiving Party’s legal counsel may retain one copy of the Disclosing Party’s Confidential Information solely for the purpose of determining the Receiving Party’s continuing obligations under this ARTICLE 8 and (ii) the Receiving Party may retain the Disclosing Party’s Confidential Information and its own notes, reports and other documents to the extent reasonably required (x) to comply with Applicable Law and regulatory requirements; (y) to exercise the rights and licenses of the Receiving Party expressly surviving expiration or termination of this Agreement; and (z) to perform the obligations of the Receiving Party expressly surviving expiration or termination of this Agreement.  Notwithstanding the return or destruction of the Disclosing Party’s Confidential Information, the Receiving Party shall continue to be bound by its obligations of confidentiality and other obligations under this ARTICLE 8.

 

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ARTICLE 9
 REPRESENTATIONS AND WARRANTIES

 

9.1          Representations and Warranties of Both Parties.  Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:

 

9.1.1       Such Party is duly organized, validly existing and in good standing under the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

 

9.1.2       Such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.

 

9.1.3       This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.

 

9.1.4       The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which such Party or its Affiliates is a party or by which such Party or its Affiliates is bound (including, with respect to MedImmune, any In-License Agreement), nor violate any Applicable Law.

 

9.1.5       No government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or will be necessary for, or in connection with, the transactions contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvals.

 

9.2          Representations, Warranties and Covenants of MedImmune.  MedImmune hereby represents, warrants and covenants to Kolltan that:

 

9.2.1       MedImmune is, as of the Effective Date, and at all times will be, (a) the sole and exclusive owner of all of the MedImmune IP and MedImmune Additional IP other than the In-Licensed IP and (b) the sole and exclusive licensee of the In-Licensed IP other than the In-Licensed IP under the Dyax Agreement.  MedImmune’s rights to the MedImmune IP and MedImmune Additional IP are as of the Effective Date, and at all times will be, (x) free of all liens, mortgages, encumbrances, pledges and security interests of any kind in favor of any Third Party and (y) not subject to any rights of or licenses to any Governmental Authority.

 

9.2.2       As of the Effective Date, MedImmune has obtained from each employee and agent of MedImmune or its Affiliates who has performed activities in connection with the Research, Development or Manufacture of the Licensed Antibody or Licensed Products all right,

 

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title and interest in and to any inventions and discoveries made or discovered by such employee or agent in the course of conducting such activities.

 

9.2.3       The MedImmune Patents existing as of the Effective Date are listed on Exhibit 9.2.3.  There are no MedImmune Additional Patents existing as of the Effective Date.  As of the Effective Date, all documents required to be filed and all payments required to be made in order to maintain each MedImmune Patent and each MedImmune Additional Patent have been filed or made, as the case may be, in a timely manner, and no action has been taken that would constitute waiver, abandonment or any similar relinquishment of rights with respect to any such Patent.

 

9.2.4       As of the Effective Date, (a) MedImmune has taken reasonable measures to maintain the confidentiality of the MedImmune Know-How and MedImmune Additional Know-How and has disclosed the MedImmune Know-How and MedImmune Additional Know-How to Third Parties only under confidentiality obligations similar to those set forth in ARTICLE 8, and (b) to the knowledge of MedImmune, there is no actual infringement or misappropriation or threatened infringement or misappropriation of any MedImmune IP, MedImmune Additional IP or Regulatory Documentation related to the Licensed Antibody or Licensed Products by any Person.

 

9.2.5       As of the Effective Date, to the knowledge of MedImmune, (a) none of the MedImmune Patents or MedImmune Additional Patents is invalid or unenforceable, in whole or in part, and (b) the conception, development and reduction to practice of the MedImmune IP, MedImmune Additional IP and Regulatory Documentation related to the Licensed Antibody or Licensed Products have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person.  There are not as of the Effective Date, nor have there been over the three (3) year period immediately preceding the Effective Date, any actual (or, to MedImmune’s knowledge, threatened) claims, lawsuits, arbitrations, legal or administrative or regulatory proceedings, charges, complaints or investigations by any Government Authority (except in the ordinary administrative course of the granting of patents or approvals and proceedings relating thereto) or by any Third Party relating to the MedImmune IP, MedImmune Additional IP or Regulatory Documentation related to the Licensed Antibody or Licensed Products.

 

9.2.6       As of the Effective Date, except as listed in Exhibit 9.2.6, to the knowledge of MedImmune, the exercise by Kolltan of the rights, licenses and sublicenses granted to Kolltan by MedImmune under this Agreement, including the making, using, selling, offering for sale or import of the Licensed Antibody or any Licensed Product, will not infringe any intellectual property rights of any Third Party.  For clarity, a listing on Exhibit 9.2.6 is not a statement or admission regarding infringement.

 

9.2.7       As of the Effective Date, (a) each In-License Agreement is in effect, (b) to the knowledge of MedImmune, no party to any In-License Agreement is in breach of any provisions thereof and (c) no event has occurred under any In-License Agreement that would (with or without the passage of time) permit any party thereto (other than MedImmune or its applicable Affiliate) to terminate such In-License Agreement.

 

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9.2.8       MedImmune and its Affiliates shall (a) not commit any act or permit the occurrence of any omission that would constitute a breach of any In-License Agreement or result in the termination thereof prior to the expiration thereof in accordance with the terms thereof, (b) not amend, modify or waive any rights under any In-License Agreement in such a way as to adversely affect Kolltan’s rights or obligations under this Agreement, or terminate any In-License Agreement, without Kolltan’s prior written consent, (c) promptly notify Kolltan of any breach of any In-License Agreement by any party thereto, the occurrence of which gives rise to a right of termination thereunder by any party thereto or causes automatic termination thereunder, and (d) subject to clause (b) above, use commercially reasonable efforts to enforce the terms of each In-License Agreement against each other party thereto.

 

9.2.9       This Agreement complies with any requirements or conditions set forth in any In-License Agreement with respect to the grant of a sublicense under MedImmune’s and its Affiliates rights under the In-Licensed IP.  Except as set forth on Exhibit 9.2.9, no In-License Agreement imposes, directly or indirectly, any obligation on Kolltan (as sublicensee of MedImmune’s and its Affiliates’ rights under the In-Licensed IP), or any obligation on MedImmune or its Affiliates to cause Kolltan (as sublicensee of MedImmune’s and its Affiliates’ rights under the In-Licensed IP), to take any action or refrain from taking any action.  Except as set forth on Exhibit 9.2.9, there are no restrictions on the rights of Kolltan as sublicensee of MedImmune’s and its Affiliates’ rights under the In-Licensed IP to use or disclose the In-Licensed IP, including granting further sublicenses thereunder.  Except as set forth in Exhibit 6.4.4, as between MedImmune and its Affiliates (on the one hand) and Kolltan (on the other hand), MedImmune and its Affiliates will make all payments required to be made under each In-License Agreement.

 

9.2.10     The In-Licensed IP under the MRC Agreement is not subject to any Third Party Rights (as defined in the MRC Agreement).

 

9.2.11     MedImmune or its applicable Affiliate under the Dyax Agreement (a) as of the Effective Date, has the right under its option under Clause 12 of the Dyax Agreement to obtain a MedImmune Product License (as defined in the Dyax Agreement) with respect to the Licensed Antibody and any Licensed Product to be Developed by Kolltan for any Target (as defined in the Dyax Agreement) reasonably contemplated by Kolltan’s Development activities hereunder, (b) until such time as MedImmune or its applicable Affiliate obtains a MedImmune Product License (as defined in the Dyax Agreement) with respect to the Licensed Antibody and any Licensed Product Developed or to be Developed by Kolltan for any Target (as defined in the Dyax Agreement) reasonably contemplated by Kolltan’s Development activities hereunder, shall maintain the right to do so, and (c) upon Kolltan’s written request, shall promptly take such actions as are reasonably necessary to obtain a MedImmune Product License (as defined in the Dyax Agreement) with respect to the Licensed Antibody or any Licensed Product Developed or to be Developed by Kolltan for any Target (as defined in the Dyax Agreement) reasonably contemplated by Kolltan’s Development activities hereunder.

 

9.2.12     Upon Kolltan’s written request, MedImmune or its applicable Affiliate under the Lonza Agreement shall promptly take such actions as are reasonably necessary to enter into a Product Schedule (as defined in the Lonza Agreement) with respect to the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product, so that the

 

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Exploitation (as defined in the Lonza Agreement) of the Licensed Antibody or such Licensed Product, Follow-On Antibody or Follow-On Product, as applicable, is covered by the license grants set forth in Section 6.1 of the Lonza Agreement.

 

9.2.13     As of the Effective Date, (a) the Unredacted Provisions constitute all provisions of the In-License Agreements that are relevant to the rights and obligations of Kolltan as sublicensee under the In-Licensed IP and (b) nothing in any In-License Agreement conflicts with the Unredacted Provisions thereof.

 

9.2.14     Each Third Party that conducted activities under any Research Program is subject to written confidentiality and non-use obligations with respect to any Know-How related to such Research Program that are at least as stringent as those set forth in Sections 8.1 and 8.2, and no such Third Party has any rights in or to the Licensed Antibody or the Licensed Program.  Following the Effective Date, MedImmune will not cause or permit any Third Party to conduct any activities under any Research Program without the prior written consent of Kolltan.

 

9.2.15     As of the Effective Date, MedImmune has not (a) employed or used a contractor or consultant that has employed, any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or (b) employed any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in the conduct of any activities related to the Licensed Antibody.

 

9.2.16     As of the Effective Date, MedImmune has prepared, filed and maintained all Regulatory Documentation that (a) is relevant to the Licensed Antibody and Licensed Products and (b) Applicable Law requires MedImmune to have prepared, filed and maintained, in each case in accordance with Applicable Law, and all information contained therein is true, complete and correct in all material respects.

 

9.2.17     As of the Effective Date, all activities conducted by or on behalf of MedImmune with respect to the Licensed Antibody or Licensed Products have been conducted, in all material respects, in accordance with Applicable Law, GLP, GCP and GMP, as applicable.

 

9.2.18     Without limitation of Section 9.1.4, as of the Effective Date, MedImmune has the right to grant all rights, licenses and sublicenses granted to Kolltan under this Agreement (including a sublicense under all of the In-Licensed IP as contemplated by this Agreement) and has not granted to any Third Party any rights, licenses or sublicenses that are inconsistent with the rights, licenses and sublicenses granted to Kolltan under this Agreement.

 

9.2.19     As of the Effective Date, MedImmune has disclosed or made available to Kolltan all material information, documents and materials in its possession relating to the Licensed Antibody, and all such information, documents and materials are true, complete and correct in all material respects.

 

9.3          Mutual Covenants.  Each Party hereby covenants to the other Party that:

 

9.3.1       Such Party shall comply with all Applicable Law in the performance of this Agreement and the transactions contemplated hereby.

 

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9.3.2       Such Party:

 

(a)           shall impose on each employee of such Party or its Affiliates who performs activities in connection with the Research, Development or Manufacture of the Licensed Antibody or Licensed Products the obligation to assign all right, title and interest in and to any inventions or discoveries made or discovered by such employee in the course of conducting such activities;

 

(b)           shall not (i) employ or use any contractor or consultant that employs any individual or entity debarred by the FDA (or subject to a similar sanction of EMA); or (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in each of clauses (i) and (ii) in the conduct of any activities in connection with the Research, Development, or Manufacture of the Licensed Antibody or Licensed Products.  If, at any time, (x) any individual or entity employed by such Party or any contractor or consultant used by such Party in the conduct of any activities in connection with the Research, Development or Manufacture of the Licensed Antibody or Licensed Products becomes debarred by the FDA (or subject to a similar sanction of EMA) or (y) any individual or entity employed by such Party in the conduct of any activities in connection with the Research, Development or Manufacture of the Licensed Antibody or Licensed Products becomes the subject of, or is threatened to be made the subject of, an FDA debarment investigation or proceeding (or similar proceeding of EMA), such Party shall immediately notify the other Party; and

 

(c)           shall perform all activities in connection with the Research, Development, and Manufacture of the Licensed Antibody and Licensed Products in compliance in all material respects with GLP, GCP and GMP (including those specified by the ICH), in each case as applicable;

 

provided, however, that the covenants set forth in this Section 9.3.2 shall terminate (1) upon the expiration of the Trigger Period (and any applicable Option Period), if as of such time MedImmune has not delivered an Exercise Notice, and (2) upon Kolltan’s payment of the Buyout Amount to MedImmune.

 

9.3.3       Neither Party shall grant any right, license or sublicense to any Third Party relating to any of the intellectual property rights it owns or Controls which would conflict with any of the rights, licenses or sublicenses granted or to be granted to the other Party hereunder.

 

9.4          Disclaimer.  Except as otherwise expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.  Without limiting the foregoing, except as otherwise expressly set forth in this Agreement, each Party disclaims any warranties with regards to:  (a) the success of any study or test commenced under this Agreement; (b) the safety or usefulness for any purpose of the technology or materials, including any compounds, it provides or discovers under this Agreement; or (c) the validity, enforceability, or non-infringement of any

 

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intellectual property rights or technology it provides or licenses to the other Party under this Agreement.

 

ARTICLE 10
 INDEMNIFICATION AND INSURANCE

 

10.1        Indemnification by Kolltan.  Kolltan shall defend, indemnify and hold harmless the MedImmune Indemnitees from and against any and all losses, damages, fees, expenses, settlement amounts or costs (including reasonable attorneys’ fees and witness fees) (“Losses”) relating to or in connection with a Third Party claim arising out of (a) any death, personal bodily injury or damage to real or tangible personal property alleged or proven to result, directly or indirectly, from the possession, use or consumption of, or treatment with, the Licensed Antibody or any Follow-On Antibody, Licensed Product or Follow-On Product, in each case by or on behalf of Kolltan or its Affiliates or Sublicensees, including any product liability claims; (b) the Commercialization by or on behalf of Kolltan or its Affiliates or Sublicensees of the Licensed Antibody or any Follow-On Antibody, Licensed Product or Follow-On Product; (c) any actual or alleged infringement or unauthorized use or misappropriation of any Patent or other intellectual property right of a Third Party with respect to the activities of Kolltan or its Affiliates or Sublicensees hereunder; (d) any breach by Kolltan of its representations, warranties or covenants made under this Agreement; or (e) any illegal or negligent act or omission or willful misconduct of Kolltan or its Affiliates or Sublicensees or any of their employees, contractors or agents, in performing any activities under or in connection with this Agreement; provided, however, that the foregoing indemnity shall not apply to the extent that any such Losses (i) are attributable to an illegal act by or the gross negligence or willful misconduct of any MedImmune Indemnitees, or (ii) are otherwise subject to an obligation by MedImmune to indemnify the Kolltan Indemnitees under Section 10.2, as to which Losses the provisions of Section 10.4 shall apply.

 

10.2        Indemnification by MedImmune.  MedImmune shall defend, indemnify and hold harmless the Kolltan Indemnitees from and against any and all Losses relating to or in connection with a Third Party claim arising out of (a) any activities conducted by MedImmune or its Affiliates with respect to the Licensed Antibody or Licensed Products on or prior to the Effective Date; (b) any death, personal bodily injury or damage to real or tangible personal property alleged or proven to result, directly or indirectly, from the possession, use or consumption of, or treatment with, any Licensed Antibody or Licensed Product included in or produced from the Inventory, including any product liability claims; (c) any actual or alleged infringement or unauthorized use or misappropriation of any Patent or other intellectual property right of a Third Party with respect to the activities of MedImmune or its Affiliates hereunder; (d) any breach by MedImmune of its representations, warranties or covenants made under this Agreement; or (e) any illegal or negligent act or omission or willful misconduct of MedImmune or its Affiliates or any of their employees, contractors or agents, in performing any activities under or in connection with this Agreement or the subject matter hereof, whether before or after the Effective Date; provided, however, that the foregoing indemnity shall not apply to the extent that any such Losses (i) are attributable to an illegal act by or the gross negligence or willful misconduct of any Kolltan Indemnitees, or (ii) are otherwise subject to an obligation by Kolltan to indemnify the MedImmune Indemnitees under Section 10.1, as to which Losses the provisions of Section 10.4 shall apply.

 

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10.3        Procedure.  In the event of a claim by a Third Party against any Person entitled to indemnification under this Agreement, the Party claiming indemnification (in such capacity, the “Indemnified Party”) shall promptly notify the other Party (in such capacity, the “Indemnifying Party”) in writing of the claim (it being understood that the failure by the Indemnified Party to give prompt notice of a Third Party claim as provided in this Section 10.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually prejudiced as a result of such failure to give prompt notice).  Within thirty (30) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, undertake and solely manage and control, at its sole expense and with counsel reasonably satisfactory to the Indemnified Party, the defense of the claim.  If the Indemnifying Party does not undertake such defense in accordance with the preceding sentence, the Indemnified Party shall control such defense.  The Party not controlling such defense shall cooperate with the other Party and may, at its option and expense, participate in such defense with counsel of its choice; provided, however, that if the Indemnifying Party assumes control of such defense as set forth above and the Indemnified Party in good faith concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party (or the relevant MedImmune Indemnitee or Kolltan Indemnitee seeking indemnification) have conflicting interests with respect to such action, suit, proceeding or claim, the Indemnified Party’s counsel may fully participate in such defense and the Indemnifying Party shall be responsible for the reasonable fees and expenses of one counsel to the indemnified Persons solely in connection therewith.  The Party controlling such defense shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof, shall provide the other Party copies of material documents and filings related to such action, suit, proceeding or claim and shall consider recommendations made by the other Party with respect thereto.  Except if the Indemnifying Party did not undertake defense of the claim as set forth above, or if the Indemnifying Party and the Indemnified Party (or the relevant MedImmune Indemnitee or Kolltan Indemnitee seeking indemnification) have conflicting interests with respect to such action, suit, proceeding or claim and the Indemnified Party engages separate counsel, as provided above, the Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent.  The Indemnified Party shall not settle any such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned.  The Indemnifying Party shall not settle, without the prior written consent of the Indemnified Party, any such action, suit, proceeding or claim, or consent to any judgment in respect thereof, that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party.

 

10.4        Allocation.  In the event a claim falls within the scope of the indemnity given by each Party in Section 10.1 or 10.2, as the case may be, any payments in connection with such claim shall be apportioned between the Parties in accordance with the degree of fault attributable to each Party.

 

10.5        EXCLUSION OF CONSEQUENTIAL DAMAGES.  EXCEPT WITH RESPECT TO A BREACH OF ARTICLE 8 OR THIRD PARTY CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 10, NEITHER MEDIMMUNE NOR KOLLTAN, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE FOR

 

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ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER SUCH PARTY OR ANY REPRESENTATIVE OF SUCH PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

 

10.6        Insurance.

 

10.6.1     MedImmune shall, at its own cost and expense, obtain and maintain in effect insurance at such levels sufficient to cover its obligations under this Agreement.  MedImmune shall furnish a certificate of insurance for any of the applicable policies as soon as practicable after the Effective Date and upon any renewal thereof.

 

10.6.2     Kolltan shall at its own cost and expense, obtain and maintain in effect the following insurance:

 

(a)           Property insurance written on an all-risk basis sufficient to cover the replacement value of the Inventory;

 

(b)           Commercial General Liability covering bodily injury and property damage with minimum limits of $1,000,000 each occurrence and $2,000,000 general aggregate, including Premises Liability, and Contractual Liability coverage for Kolltan’s indemnification obligations under this Agreement;

 

(c)           upon initiation by Kolltan of any human clinical trial of the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product, Products/Completed Operations Liability covering human clinical trials with minimum limits of $2,000,000 each occurrence and $2,000,000 policy aggregate;

 

(d)           Commercial Automobile Liability covering hired and non-owned vehicles with limits of at least $1,000,000 combined single limit (bodily injury and property damage);

 

(e)           Workers’ Compensation as required by Applicable Law and Employer’s Liability coverage with a limit of not less than $1,000,000; and

 

(f)            Umbrella Liability coverage with minimum limits of at least $3,000,000 each occurrence and $3,000,000 general aggregate, sitting excess of the general liability, commercial auto liability and employer’s liability programs.

 

Each of the policies in clauses (b), (c), (d) and (f) above shall name MedImmune as an Additional Insured, and all of the above policies shall be primary to any liability insurance carried by MedImmune, which insurance(s) shall be excess and non-contributory for claims and losses arising out of the performance of this Agreement.  Kolltan shall furnish a certificate of insurance for any of the required policies as soon as practicable after the Effective Date (or such later time as Kolltan obtains the applicable policy) and upon any renewal thereof.  All such insurances as required under this Section 10.6.2 shall be written with a company or companies

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

having a financial rating of not less than A- in the most current edition of Bests Key Rating Guide.

 

In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained for a period of not less than three (3) years following the termination or expiration of this Agreement.

 

MedImmune shall promptly provide to Kolltan such information as Kolltan reasonably requests to enable Kolltan to comply with its obligations under this Section 10.6.2.

 

ARTICLE 11
 TERM AND TERMINATION

 

11.1        Term; Expiration.  This Agreement shall become effective as of the Effective Date and, unless earlier terminated in accordance herewith, shall remain in effect until the expiration of the last to expire Royalty Term for any Licensed Product or Follow-On Product in any country.

 

11.2        Termination for Cause.

 

11.2.1     By Kolltan.  Kolltan may, without prejudice to any other remedies available to it under Applicable Law or in equity, terminate this Agreement (a) in its entirety, if MedImmune has materially breached or defaulted in the performance of its obligations hereunder or (b) with respect to a Program, if MedImmune has materially breached or defaulted in the performance of its obligations hereunder with respect to such Program, in either case ((a) or (b)) if such breach or default has continued for [**] days after written notice thereof describing such breach or default was provided to MedImmune by Kolltan.  Any such termination shall become effective at the end of such [**] day cure period, unless MedImmune has cured such breach or default prior to the expiration of such cure period.

 

11.2.2     By MedImmune.  MedImmune may, without prejudice to any other remedies available to it under Applicable Law or in equity, terminate this Agreement with respect to a Program if Kolltan has materially breached or defaulted in the performance of its obligations hereunder with respect to such Program and such breach or default has continued for [**] days after written notice thereof describing such breach or default was provided to Kolltan by MedImmune.  Any such termination shall become effective at the end of such [**] day cure period, unless Kolltan has cured such breach or default prior to the expiration of such cure period.

 

11.3        Termination for Insolvency Event.  Either Party may terminate this Agreement in its entirety or with respect to a Program effective upon written notice to the other Party if the other Party suffers an Insolvency Event.

 

11.4        Termination for Regulatory Reasons.  If Kolltan reasonably determines that it is not feasible for Kolltan to pursue the Development or Commercialization of Licensed Products for reasons of safety or lack of efficacy, then Kolltan may terminate this Agreement with respect to the Licensed Program upon thirty (30) days’ written notice to MedImmune.  If Kolltan reasonably determines that it is not feasible for Kolltan to pursue the Development or

 

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Commercialization of Follow-On Products for reasons of safety or lack of efficacy, then Kolltan may terminate this Agreement with respect to the Follow-On Program upon thirty (30) days’ written notice to MedImmune.

 

11.5        Termination upon Effective Date of Co-Development and Co-Commercialization Agreement or Auction License Agreement.  In the event the Parties enter into the Co-Development and Co-Commercialization Agreement pursuant to Section 5.4.3(c) or 5.4.3(d), this Agreement shall terminate with respect to the Licensed Program upon the effective date thereof.  In the event the Parties enter into the Auction License Agreement pursuant to Section 5.4.3(e), this Agreement shall terminate with respect to the Licensed Program upon the effective date thereof.

 

11.6        Other Termination.  For clarity, this Agreement may be terminated with respect to the Licensed Program pursuant to Section 5.4.3(a) in accordance with the terms thereof.

 

11.7        Effect of Termination or Expiration.

 

11.7.1     Termination by Kolltan for Cause or Insolvency.  Subject to Section 11.8, upon termination of this Agreement in its entirety or with respect to a Program by Kolltan pursuant to Section 11.2.1 or 11.3:

 

(a)           the rights of Kolltan under ARTICLE 2 (including Section 2.1), ARTICLE 3, ARTICLE 4 and ARTICLE 7 (with respect to the terminated Program, if applicable) shall remain in effect;

 

(b)           subject to clause (e) below, the rights of MedImmune under ARTICLE 7 (with respect to the terminated Program, if applicable) shall remain in effect solely to the extent related to Joint IP;

 

(c)           the obligations and covenants of MedImmune under ARTICLE 3, ARTICLE 7 and ARTICLE 9 (with respect to the terminated Program, if applicable) shall remain in effect;

 

(d)           the provisions of ARTICLE 6 (with respect to the terminated Program, if applicable) shall remain in effect;

 

(e)           the provisions of Sections 2.4, 7.1 and 7.2 and ARTICLE 10 (with respect to the terminated Program, if applicable) shall remain in effect indefinitely, and the provisions of ARTICLE 8 (with respect to the terminated Program, if applicable) shall remain in effect for a period of [**] years after such termination; and

 

(f)            in the case of any termination with respect to a Program, all rights and obligations of the Parties with respect to the other Program shall, to the extent in effect immediately prior to such termination, remain in effect.

 

11.7.2     Termination Involving MedImmune’s Payment of the Product Acquisition Price.  Subject to Section 11.8, upon termination of this Agreement with respect to the Licensed Program by Kolltan pursuant to Section 5.4.3(a):

 

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(a)           subject to clause (c) below, the rights and obligations of Kolltan under ARTICLE 7 with respect to the Licensed Program shall remain in effect solely to the extent related to any Joint IP other than Joint IP described in clauses (f) and (g) below;

 

(b)           MedImmune’s payment obligation under clause (y) of Section 5.4.3(a) shall remain in effect;

 

(c)           the rights of MedImmune under ARTICLE 7 with respect to the Licensed Program shall remain in effect, and subject to clause (d) below, the obligations of MedImmune under ARTICLE 7 with respect to the Licensed Program shall remain in effect solely to the extent related to any Joint IP other than Joint IP described in clauses (f) and (g) below;

 

(d)           the provisions of Sections 2.4, 7.1 and 7.2 with respect to the Licensed Program shall remain in effect indefinitely, and the provisions of ARTICLE 8 with respect to the Licensed Program shall remain in effect for a period of [**] years after such termination; provided, however, that from and after such termination, (i) any MedImmune Know-How, MedImmune Additional Know-How and Regulatory Documentation, in each case related to the Licensed Program (but excluding any MedImmune Know-How, MedImmune Additional Know-How and Regulatory Documentation related to the Follow-On Program), and any Regulatory Documentation and Know-How assigned to MedImmune pursuant to clause (f) below, shall be deemed to be the Confidential Information of MedImmune (and not Kolltan) and (ii) any Know-How exclusively licensed to MedImmune pursuant to clause (g) below and any Joint Know-How with respect to the Licensed Program shall be deemed to be Confidential Information of each Party;

 

(e)           the provisions of ARTICLE 10 with respect to the Licensed Program shall remain in effect; provided, however, that from and after such termination, in addition to the other grounds for indemnification set forth in Section 10.2, MedImmune shall defend, indemnify and hold harmless the Kolltan Indemnitees from and against any and all Losses relating to or in connection with a Third Party claim arising out of (i) any death, personal bodily injury or damage to real or tangible personal property alleged or proven to result, directly or indirectly, from the possession, use or consumption of, or treatment with, the Licensed Antibody or any Licensed Product, in each case by or on behalf of MedImmune or its Affiliates or sublicensees, including any product liability claims, and (ii) the Commercialization by or on behalf of MedImmune or its Affiliates or sublicensees of the Licensed Antibody or any Licensed Product;

 

(f)            Kolltan shall assign to MedImmune all of Kolltan’s right, title and interest in and to (i) any Regulatory Documentation Controlled by Kolltan or its Affiliates as of the effective date of such termination that is related to the Licensed Antibody or Licensed Products (but excluding any such Regulatory Documentation that is related to Follow-On Antibodies or Follow-On Products) and (ii) any Know-How or Patents that (x) are Controlled by Kolltan or its Affiliates as of the date of such termination and (y) solely relate to the Licensed Antibody or any Licensed Product or the Manufacture of the Licensed Antibody or any Licensed Product;

 

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(g)           Kolltan hereby grants to MedImmune, effective as of the date of such termination, an exclusive, royalty-free license, with the right to grant sublicenses, under any Know-How or Patents (other than those included in clause (f) above) that (x) are Controlled by Kolltan or its Affiliates as of the date of such termination or within three (3) months thereafter and (y) are necessary to Research, Develop, Manufacture or Commercialize the Licensed Antibody or any Licensed Product in the Field in the Territory, solely for the purpose of Researching, Developing, Manufacturing and Commercializing the Licensed Antibody and Licensed Products in the Field in the Territory;

 

(h)           Kolltan shall reasonably cooperate with MedImmune to effect an orderly transfer or disclosure, as applicable, to MedImmune of the Know-How and Regulatory Documentation described in clauses (f) and (g) above; and

 

(i)            all rights and obligations of the Parties with respect to the Follow-On Program shall, to the extent in effect immediately prior to such termination, remain in effect.

 

11.7.3     Termination by MedImmune for Cause or Insolvency or by Kolltan for Regulatory Reasons.  Subject to Section 11.8, upon termination of this Agreement in its entirety or with respect to a Program by MedImmune pursuant to Section 11.2.2 or 11.3 or by Kolltan pursuant to Section 11.4:

 

(a)           subject to clause (c) below, the rights and obligations of Kolltan under ARTICLE 7 (with respect to the terminated Program, if applicable) shall remain in effect solely to the extent related to Joint IP;

 

(b)           the rights of MedImmune under ARTICLE 7 (with respect to the terminated Program, if applicable) shall remain in effect, and subject to clause (c) below, the obligations of MedImmune under ARTICLE 7 (with respect to the terminated Program, if applicable) shall remain in effect solely to the extent related to Joint IP;

 

(c)           the provisions of Sections 2.4, 2.5, 4.3 (with respect to the non-terminated Program, if applicable), 7.1 and 7.2 and ARTICLE 10 (with respect to the terminated Program, if applicable) shall remain in effect indefinitely, and the provisions of ARTICLE 8 (with respect to the terminated Program, if applicable) shall remain in effect for a period of [**] years after such termination; provided, however, that from and after such termination, (i) any MedImmune Know-How, MedImmune Additional Know-How and Regulatory Documentation (if applicable, in each case related to the terminated Program but excluding any MedImmune Know-How, MedImmune Additional Know-How and Regulatory Documentation related to the other Program) shall be deemed to be the Confidential Information of MedImmune (and not Kolltan) and (ii) any Joint Know-How (if applicable, related to the terminated Program) shall be deemed to be the Confidential Information of each Party;

 

(d)           solely in the case of termination with respect to the Licensed Program, in the event that MedImmune, in its sole discretion, requests in writing, Kolltan shall assign to MedImmune all of Kolltan’s right, title and interest in and to (i) any Regulatory Documentation Controlled by Kolltan as of the effective date of such termination that is related to the Licensed Antibody or Licensed Products (but excluding any such Regulatory

 

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Documentation that is related to Follow-On Antibodies or Follow-On Products), (ii) all data and information to be provided to MedImmune under Section 5.1 of this Agreement, to the extent then available and not previously provided to MedImmune, and (iii) any Know-How or Patents that (x) were licensed or assigned by MedImmune or its Affiliates to Kolltan pursuant to this Agreement and (y) solely relate to the Licensed Antibody or any Licensed Product or the Manufacture of the Licensed Antibody or any Licensed Product, and Kolltan shall reasonably cooperate with MedImmune to effect an orderly transfer of such Regulatory Documentation and information to MedImmune;

 

(e)           solely in the case of termination with respect to the Licensed Program, in the event that MedImmune, in its sole discretion, requests in writing, the Parties shall enter into good faith negotiations with respect to an agreement pursuant to which Kolltan would grant to MedImmune a license under the Kolltan IP to Research, Develop, Manufacture and Commercialize the Licensed Antibody and Licensed Products, with terms regarding degree of exclusivity, royalty or other payments, access to or assignment of technical and other information or materials owned or controlled by Kolltan or its Affiliates, transfer or amendment of applicable agreements or arrangements with Third Parties and other appropriate transition matters to be negotiated in good faith;

 

(f)            Kolltan shall continue to communicate with Regulatory Authorities and complete any activities as required by Applicable Law with respect to its Development and Commercialization activities with respect to such Program hereunder; and

 

(g)           in the case of any termination with respect to a Program, all rights and obligations of the Parties with respect to the other Program shall, to the extent in effect immediately prior to such termination, remain in effect.

 

11.7.4     Termination with respect to the Licensed Program upon Effective Date of Co-Development and Co-Commercialization Agreement or Auction License Agreement.  Subject to Section 11.8, upon termination of this Agreement with respect to the Licensed Program pursuant to Section 11.5:

 

(a)           except as otherwise expressly set forth in the Co-Development and Co-Commercialization Agreement or Auction License Agreement, the provisions of Sections 2.4, 7.1 and 7.2 and ARTICLE 10 with respect to the Licensed Program shall remain in effect indefinitely, and the provisions of ARTICLE 8 with respect to the Licensed Program shall remain in effect for a period of [**] years after such termination;

 

(b)           solely in the case of termination pursuant to the second sentence of Section 11.5, the Parties’ obligations under Section 5.4.3(e)(iv)  shall remain in effect; and

 

(c)           all rights and obligations of the Parties with respect to the Follow-On Program shall, to the extent in effect immediately prior to such termination, remain in effect.

 

11.7.5     Expiration.  Subject to Section 11.8, upon expiration of this Agreement in accordance with Section 11.1:

 

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(a)           the rights, licenses and sublicenses granted to Kolltan hereunder with respect to the Licensed Antibody, Licensed Products, Follow-On Antibodies and Follow-On Products shall, to the extent in effect immediately prior to such expiration, remain in effect but (to the extent they have not already done so) become fully paid-up, royalty-free, transferable (to the extent not transferable previously), perpetual and irrevocable; and

 

(b)           the provisions of Section 2.4, ARTICLE 7 (solely with respect to the MedImmune Additional Patents and the Joint IP) and ARTICLE 10 shall, to the extent in effect immediately prior to such expiration, remain in effect indefinitely, and the provisions of ARTICLE 8 shall, to the extent in effect immediately prior to such expiration, remain in effect for a period of [**] years after such termination.

 

11.7.6     Effect of Termination on Sublicenses Granted by Kolltan.  In the event that Kolltan grants to any Third Party any sublicense under any license or sublicense granted to Kolltan under Section 2.1 (the “Sublicensed Rights”), upon any termination of this Agreement in its entirety or with respect to the applicable Program that results in the termination of Kolltan’s rights to the Sublicensed Rights, if as of such termination the applicable sublicensee is not in breach of its obligations under the applicable sublicense agreement with Kolltan, then MedImmune shall, upon the reasonable request of such sublicensee, grant such sublicensee a license or sublicense, as applicable, under the Sublicensed Rights on substantially the same terms as Kolltan had previously granted such sublicensee a sublicense under the Sublicensed Rights.

 

11.8        Accrued Rights; Surviving Provisions.

 

11.8.1     Accrued Rights.  Termination or expiration of this Agreement in its entirety or with respect to a Program for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration, including any rights of Kolltan under Section 6.4.5 and any rights of MedImmune under Section 3.5.2 or Sections 6.6 through 6.10, and any and all damages or remedies arising from any breach hereunder.  Such termination or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination of this Agreement.

 

11.8.2     Surviving Provisions.  The provisions of Sections 5.4.4, 6.6 through 6.9 (solely with respect to amounts accrued but unpaid as expiration or termination), 6.10, 9.4, 11.7 and this Section 11.8 and ARTICLE 12, and any applicable definitions in ARTICLE 1, shall survive any expiration or termination of this Agreement in its entirety or with respect to a Program for any reason, in accordance with their respective terms and conditions, and for the duration stated or, if no duration is stated, indefinitely.

 

ARTICLE 12
 MISCELLANEOUS

 

12.1        Dispute Resolution by Executive Officers.  In the event of any dispute between the Parties arising out of or in connection with this Agreement, including any dispute regarding the interpretation, effect, termination, validity, performance and/or breach of this Agreement or any amendments hereto (each, a “Dispute”), either Party may, by written notice to the other Party, refer the Dispute to the Executive Officers for attempted resolution by good faith

 

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negotiations for a period of thirty (30) days after such notice is received (or such longer time as may be agreed by the Executive Officers) (the “Resolution Period”).  In the event a Dispute is referred to the Executive Officers in accordance with the preceding sentence, (a) the Parties shall cause their respective Executive Officers to meet with each other and attempt to resolve such Dispute through good faith negotiations for the duration of the Resolution Period and (b) if the Parties are able to resolve such Dispute during the Resolution Period, upon the request of either Party, a memorandum setting forth the resolution shall be prepared and signed by the Parties.  Notwithstanding anything to the contrary in this Agreement, neither Party shall initiate any action, suit or proceeding under Section 12.2 (other than any action for a temporary restraining order, preliminary injunction or other similar interim or conservatory relief) unless the applicable Dispute has been referred to the Executive Officers under this Section 12.1 and the Resolution Period with respect to such Dispute has expired.

 

12.2        Jurisdiction and Venue.

 

12.2.1     Subject to Section 12.2.2, each Party (a) irrevocably submits to the exclusive jurisdiction of the federal and state courts located in the City of New York, State of New York (the “Court”) with respect to any Dispute, and (b) agrees not to raise any objection at any time to the laying or maintaining of the venue of any action, suit or proceeding for such purpose in any such Court, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such Court does not have any jurisdiction over such Party, and (c) agrees not to commence any action, suit or proceeding with respect to any Dispute except in such Court.  Each Party further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in the Court with respect to any matters to which it has submitted to jurisdiction in this Section 12.2.1.

 

12.2.2     Notwithstanding anything in this Agreement to the contrary, any Patent Matter shall be subject to adjudication in accordance with the laws of the country in which the applicable Patent is pending or has been issued.  The Parties agree that the venue of any such adjudication shall be (a) if the applicable Patent is pending in or has been issued by the United States, a U.S. federal district court sitting in the City of New York, State of New York, and (b) if the applicable Patent is pending in or has been issued by any other country, any competent court having jurisdiction over the subject of the Patent Matter sitting in the capital of such country (or if there is not any such competent court in the capital, a location reasonably proximate to the capital).  For any Patent Matter and any applicable court as described in the previous sentence, each Party (w) irrevocably submits to the jurisdiction of such court, (x) agrees not to raise any objection at any time to the laying or maintaining of the venue of any action, suit or proceeding relating to such Patent Matter in such court, (y) irrevocably waives any claim that any action, suit or proceeding relating to such Patent Matter in such court has been brought in an inconvenient forum, including any forum non conveniens argument, and (z) irrevocably waives the right to object, with respect to any action, suit or proceeding relating to such Patent Matter, that such court does not have any jurisdiction over such Party.

 

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12.3        Governing Law.  This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of New York without reference to conflicts of laws principles.

 

12.4        Assignment.

 

12.4.1     By MedImmune.  MedImmune may not assign this Agreement or any of its rights or obligations hereunder without the prior written consent of Kolltan, which consent shall not be unreasonably withheld or delayed.  Notwithstanding the foregoing, MedImmune may assign its rights or obligations hereunder without the prior written consent of Kolltan (but shall notify Kolltan in writing promptly after any such assignment) (a) subject to the next sentence, by way of sale of itself or the sale of the portion of its business to which this Agreement relates, through merger, sale of assets or sale of stock or ownership interest, provided that the assignee shall expressly agree to be bound by MedImmune’s obligations hereunder and that such sale is not primarily for the benefit of MedImmune’s creditors, and (b) to any of its Affiliates, provided that the assignee shall expressly agree to be bound by MedImmune’s obligations hereunder and that MedImmune shall remain responsible for its applicable Affiliate’s performance hereunder.  In the event of an acquisition of MedImmune or its assets or equity by a Third Party, such acquisition shall not provide Kolltan with rights or access to (x) any Patents or Know-How of such Third Party, or any Affiliate of such Third Party that becomes an Affiliate of MedImmune as a result of such acquisition, that exists prior to such acquisition, or (y) any Patents or Know-How of such Third Party, or any Affiliate of such Third Party that becomes an Affiliate of MedImmune as a result of such acquisition, that are filed or developed, as the case may be, after the date of such acquisition, in the case of (y) for so long as MedImmune (or, in the case of an acquisition of MedImmune’s assets by such Third Party, the applicable program of such Third Party) continues to conduct any activities related to this Agreement independently of such Third Party (or, in the case of an acquisition of MedImmune’s assets by such Third Party, any other programs of such Third Party), or such Affiliate of such Third Party, and without any sharing or transfer of relevant Know-How.

 

12.4.2     By Kolltan.

 

(a)           Kolltan may not assign this Agreement or any of its rights or obligations hereunder without the prior written consent of MedImmune, which consent shall not be unreasonably withheld or delayed.  Notwithstanding the foregoing, Kolltan may assign its rights or obligations hereunder without the prior written consent of MedImmune (but shall notify MedImmune in writing promptly after any such assignment):

 

(i)            prior to the Option Termination Date and subject to Section 12.4.2(b), by way of sale of itself or the sale of the portion of its business to which this Agreement relates (the “Triggering Sale”), through merger, sale of assets or sale of stock or ownership interest, to any Third Party that as of the time of such Triggering Sale (x) is not Commercializing a Competing Product or (y) has not enrolled the first patient in a Clinical Trial of a Competing Product, which Clinical Trial for such Competing Product is: (1) a Phase 3 Clinical Trial, if, as of the time of such Triggering Sale, Kolltan has enrolled the first patient in a Phase 3 Clinical Trial of a Licensed Product; (2) a Phase 2 Clinical Trial or Phase 3 Clinical Trial, if, as of the time of such Triggering Sale, Kolltan has enrolled the first patient in a Phase 2

 

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Clinical Trial of the Licensed Product but has not enrolled the first patient in a Phase 3 Clinical Trial of the Licensed Product; or (3) a Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial, if as of the time of such Triggering Sale, Kolltan either (A) has not enrolled the first patient in any Clinical Trial of the Licensed Product or (B) has enrolled the first patient in a Phase 1 Clinical Trial of the Licensed Product but has not enrolled the first patient in a Phase 2 Clinical Trial of the License Product or a Phase 3 Clinical Trial of the Licensed Product (a “Same or Later Stage Clinical Trial”), provided that the assignee shall expressly agree to be bound by Kolltan’s obligations hereunder and that such Triggering Sale is not primarily for the benefit of Kolltan’s creditors;

 

(ii)           on or after the Option Termination Date and subject to Section 12.4.2(b), by way of a Triggering Sale to any Third Party, provided that the assignee shall expressly agree to be bound by Kolltan’s obligations hereunder and that such Triggering Sale is not primarily for the benefit of Kolltan’s creditors; provided, however, that if, as of the time of such Triggering Sale, such Third Party (x) is Commercializing a Competing Product or (y) has enrolled the first patient in a Same or Later Stage Clinical Trial of a Competing Product, then, at such Third Party’s election, which shall be delivered by written notice to MedImmune within [**] days after the date of such Triggering Sale, such Third Party shall, as promptly as practicable but in no event more than one year following the date of such Triggering Sale, either:

 

(x)           divest all of its right, title and interest in and to any Competing Product that, as of the time of such Triggering Sale, such Third Party is Commercializing or with respect to which such Third Party has enrolled the first patient in a Same or Later Stage Clinical Trial (and any failure by such Third Party to consummate such divestment within such time period shall be deemed a material breach of Kolltan’s obligations hereunder); or

 

(y)           assign all of its rights and obligations under this Agreement with respect to the Licensed Program to a Third Party that as of the time of such assignment (1) is not Commercializing a Competing Product or (2) has not enrolled the first patient in a Same or Later Stage Clinical Trial of a Competing Product; and

 

(iii)          to any of its Affiliates, provided that the assignee shall expressly agree to be bound by Kolltan’s obligations hereunder and that Kolltan shall remain responsible for its applicable Affiliate’s performance hereunder.

 

(b)           Limitations on Reach-Through.  In the event of any acquisition of Kolltan or its assets or equity by a Third Party under Section 12.4.2(a)(i) or 12.4.2(a)(ii), such acquisition shall not provide MedImmune with rights or access to (i) any Patents or Know-How of such Third Party, or any Affiliate of such Third Party that becomes an Affiliate of Kolltan as a result of such acquisition, that exists prior to such acquisition, or (ii) any Patents or Know-How of such Third Party, or any Affiliate of such Third Party that becomes an Affiliate of Kolltan as a result of such acquisition, that are filed or developed, as the case may be, after the date of such acquisition, in the case of (ii) for so long as Kolltan (or, in the case of an acquisition of Kolltan’s assets by such Third Party, the applicable program of such Third Party) continues to conduct any activities related to this Agreement independently of such Third Party (or, in the case of an

 

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acquisition of Kolltan’s assets by such Third Party, any other programs of such Third Party), or such Affiliate of such Third Party, and without any sharing or transfer of relevant Know-How.

 

12.4.3     By Either Party.  Subject to the foregoing provisions of this Section 12.4, this Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement.  Any assignment not in accordance with this Section 12.4 shall be void.

 

12.5        Force Majeure.  Each Party shall be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by force majeure (defined below) and the nonperforming Party promptly provides notice of the prevention to the other Party.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party uses commercially reasonable efforts to remove the condition.  For purposes of this Agreement, “force majeure” shall include conditions beyond the control of the Parties, including an act of God, voluntary or involuntary compliance with any regulation, law or order of any government, war, act of terror, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe.

 

12.6        Notices.  Any notice or request required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and personally delivered or sent by facsimile transmission (receipt verified) or reputable international business courier (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below:

 

If to MedImmune,

 

addressed to:
 MedImmune, LLC
 One MedImmune Way
 Gaithersburg, MD 20878
 Attention: EVP, Research
 Facsimile: (301) 398-8268

 

with a copy to:
 MedImmune, LLC
 One MedImmune Way
 Gaithersburg, MD 20878
 Attention: Legal Department
 Facsimile: (301) 398-9263

 

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If to Kolltan,

 

addressed to:
 Bulldog Pharmaceuticals, Inc.
 Midocean Chambers, Road Town, Tortola
 British Virgin Islands
 Attention: Chief Executive Officer
 Facsimile: +1 (284) 494-4568

 

with a copy to:
 Kolltan Pharmaceuticals, Inc.
 300 George St., Suite 530
 New Haven, CT 06511
 Attention: General Counsel
 Facsimile: (203) 773-1300

 

with a copy (which shall not constitute notice) to:
 Covington & Burling LLP
 One Front Street
 San Francisco, CA 94111
 Attention:  Jim Snipes
 Facsimile:  415-955-6571

 

or to such other address for such Party as it shall have specified by like notice to the other Parties, provided that notices of a change of address shall be effective only upon receipt thereof.  The effective date of any notice shall be (a) the date of delivery, if personally delivered during the recipient’s normal business hours (and otherwise the first (1st) Business Day after the date of delivery), (b) the Business Day following verification of receipt, if sent by facsimile, and (c) the Business Day after dispatch, if sent by courier service.

 

12.7        Export Clause.  Each Party agrees that, as of the Effective Date, it will not export or re-export restricted commodities or the technical data of the other Party in any form except in compliance with Applicable Law (including obtaining any required United States and non-United States government licenses).

 

12.8        Waiver.  Neither Party may waive or release any of its rights or interests in this Agreement except in writing.  The failure of either Party to assert a right hereunder or to insist upon compliance with any term 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.

 

12.9        Severability.  If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible.  Such

 

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invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

 

12.10      Entire Agreement.  This Agreement, together with the Schedules and Exhibits hereto, set forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties as to the subject matter of this Agreement and supersedes and terminates all prior agreements and understanding between the Parties with respect to the subject matter hereof.  In particular, and without limitation, this Agreement supersedes and replaces the Existing Confidentiality Agreement and any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties as to the subject matter of this Agreement other than as set forth herein and therein.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

 

12.11      Independent Contractors.  Nothing herein shall be construed to create any relationship of employer and employee, agent and principal, partnership or joint venture between the Parties.  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.

 

12.12      Headings; Construction; Interpretation.  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.  The terms of this Agreement represent the results of negotiations between the Parties and their representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or compulsion, whether legal, economic or otherwise.  Accordingly, the terms of this Agreement shall be interpreted and construed in accordance with their usual and customary meanings, and each of the Parties hereto hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of Applicable Law to the effect that ambiguous or conflicting terms or provisions contained in this Agreement shall be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement.  Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause, Schedule or Exhibit, of or to, as the case may be, this Agreement.  Except where the context otherwise requires, (a) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein); (b) any reference to any Applicable Law refers to such Applicable Law as from time to time enacted, repealed or amended; (c) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof; and (d) the words “include,” “includes,” “including,” “exclude,” “excludes,” and “excluding,” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import.

 

72

 

12.13      Further Actions.  Each Party shall execute, acknowledge and deliver such further instruments, and do all such other acts, as may be necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.

 

12.14      Parties in Interest.  All of the terms and provisions of this Agreement shall be binding upon, and shall inure to the benefit of and be enforceable by the Parties hereto and their respective successors, heirs, administrators and permitted assigns.

 

12.15      Performance by Affiliates.  To the extent that this Agreement imposes obligations on Affiliates of a Party, such Party agrees to cause its Affiliates to perform such obligations.

 

12.16      Counterparts.  This Agreement may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies from separate computers or printers.  Facsimile signatures and signatures transmitted via portable document format (PDF) shall be treated as original signatures.

 

[Signature page to follow]

 

73

 

IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

 

	
MEDIMMUNE, LLC
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Bahija Jallal
    	
 
    
	
Name:  Bahija   Jallal
    	
 
    
	
Title: EVP
    	
 
    
	
 
    	
 
    
	
BULLDOG   PHARMACEUTICALS, INC.
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Gerald McMahon
    	
 
    
	
Name: Gerald McMahon
    	
 
    
	
Title: Director
    	
 
    

 

[Signature Page]

 

 

Exhibit 1.41

 

In-License Agreements

 

1.              MRC Agreement

 

2.              Dyax Agreement

 

3.              UT Agreement

 

4.              Lonza Agreement

 

Exhibit 1.41 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 1.42

 

In-Licensed IP

 

1.              CAT/MRC Patent Rights

 

	
Country
    	
 
    	
ApplicationStatus
    	
 
    	
AppNumber
    	
 
    	
FilDate
    	
 
    	
PatNumber
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 5 pages were omitted. [**]

 

2.              Dyax Patent Rights

 

[**]

 

3.              UTSW Patent Rights

 

	
Ctry
    	
 
    	
Status
    	
 
    	
Application
   Number
    	
 
    	
Filing Date
    	
 
    	
Patent Number
    	
 
    	
Issue Date
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 1 page was omitted. [**]

 

4.              Lonza Patent Rights

 

[**]

 

	
Territory
    	
 
    	
Appl. No.
    	
 
    	
Patent No.
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

[**]

 

[**]

 

	
Territory
    	
 
    	
Patent or Patent
   Appl. No.
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    

 

[**]

 

Exhibit 1.422 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

	
Territory
    	
 
    	
Patent or Patent
   Appl. No.
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    

 

[**]

 

a.              and (a) all patents and patent applications in any country or supranational jurisdiction corresponding to national stage counterparts to these patents and patent applications, and (b) any substitutions, divisionals, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) any other Patents licensed to MedImmune under the Lonza Agreement.

 

5.              Unpatented and technical Know-How related to subject matter disclosed in applications listed above.

 

Exhibit 1.422 - 2

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 1.96

 

Research Programs

 

Research study with external CRO, [**], titled:  In Vivo Evaluation of MEDI3379 and [**] Alone in [**] Models of [**] in [**] Mice

 

Exhibit 1.96 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 3.4.1

 

Certain Know-How to be Transferred

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 2 pages were omitted. [**]

 

Exhibit 3.4.1 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 3.6.1

 

Inventory and Materials

 

Inventory (Unformulated Drug Substance and Drug Product)

 

[**]

 

Materials

 

[**]

 

Exhibit 3.6.1 - 1

 

Exhibit 3.6.2(a)

 

Inventory Storage, Formulation, Filling and Delivery

 

1.              Form of Licensed Antibody in the Inventory.  Without limiting Section 3.6.1 or Exhibit 3.6.1, the Licensed Antibody in the Inventory includes unformulated drug substance (“UDS”) and drug product in non-labeled vials (“DP”).

 

2.              Testing as of Effective Date.  Without limiting Section 3.6.2(c), MedImmune will communicate to Kolltan the results, as of the Effective Date, of any analytical testing and stability testing of the Inventory and will indicate whether (a) as of the Effective Date, the Inventory and Materials have been stored and maintained in accordance with the applicable storage specifications set forth in Exhibit 3.6.2(a)(i), (b) as of the Effective Date, stability testing of the Inventory has been conducted, and (c) as of the date of the last stability testing of the Inventory conducted prior to the Effective Date, the Inventory conformed to the applicable product specifications set forth in Exhibit 3.6.2(c)(i).

 

3.              Storage.  MedImmune will store the Inventory and Materials at MedImmune or MedImmune’s Third Party warehouse(s) (collectively, the “Warehouses”) for up to 90 days after the Effective Date without charge.  Kolltan will notify MedImmune within 60 days after the Effective Date of Kolltan’s decision to (a) continue storage of any or all quantities of the Inventory and the Materials at the Warehouses for a fee payable to MedImmune (“Storage Fee”) and/or (b) transfer any or all quantities of the the Inventory and Materials to a warehouse designated by Kolltan with transfer fees and storage fees for that warehouse paid directly by Kolltan.  If Kolltan elects continued storage of any quantites of the Inventory and Materials by MedImmune, the Parties shall, if applicable, mutally agree on the storage terms for the Materials (to the extent they have not done so already) and MedImmune will store such quantities at the Warehouses until (x) in the case of Inventory, the applicable quantity has expired as determined by the stability study for the Inventory (“Expiration Date”) or (y) in the case of Inventory and Materials, until directed by Kolltan to transfer the applicable quantity to a warehouse designated by Kolltan.  Any Inventory remaining in storage at the Warehouses after the Expiration Date will be destroyed or transferred to a warehouse designated by Kolltan, all according to Kolltan’s reasonable written instructions.  The Storage Fee will be a pass-through, without mark-up, of the storage fee paid by MedImmune for Kolltan’s Inventory and Materials at the Warehouses.  For so long as any part of the Inventory or Materials are stored at any Warehouse, Kolltan shall have the right, at reasonable times and upon reasonable advance notice, to reasonably inspect such Warehouse to confirm MedImmune’s compliance with its obligations under Section 3.6.2.

 

Exhibit 3.6.2(a) - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

4.              Stability Studies.  MedImmune will continue to provide updates on the stability studies within [**] days after results become available under the stability study protocols, which will be provided to Kolltan.  MedImmune will charge a fee of $[**] for completion of the currently underway stability studies for Inventory.  To the extent that new stability studies for Inventory are required due to unforeseen circumstances, the Parties will discuss and agree on a reasonable fee.

 

5.              Delivery.  Kolltan will provide written instructions as to the timing and manner of delivery of Inventory and Materials out of storage.  MedImmune will deliver all Licensed Antibody in the Inventory as DP, i.e., drug product in non-labeled vialed form, unless otherwise requested by Kolltan.  MedImmune will not, and will have no obligation to, label or (subject to Section 6 below) package the Inventory.  MedImmune will prepare Inventory and Materials for shipment to Kolltan or to Kolltan’s designated Third Party.  At Kolltan’s request, MedImmune may recommend a contract manufacturer for labeling.  Kolltan will pay transfer costs to the contract manufacturer.

 

6.              Formulation and Filling.  When requested by Kolltan with no less than [**] months’ notice, MedImmune will fill DS into unlabeled vials and package them for shipment for a fee of $[**] per batch.  MedImmune will formulate UDS into DS for a fee of $[**] per batch.  At Kolltan’s request, MedImmune may recommend a contract manufacturer for filling, labeling and/or formulation and establish a plan for the transfer of the UDS and DS and the information necessary and customary in the industry to enable a Third Party to formulate UDS and fill DS for Kolltan.  Kolltan will pay for the cost of transfer to the contract manufacturer.

 

Exhibit 3.6.2(a) - 2

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 3.6.2(a)(i)

 

Inventory and Materials Storage Specifications

 

Drug Product:

Storage temperatures between [**]

Shipment temperatures between [**]

 

Unformulated Drug Substance:

Storage temperature at [**]

 

Master Cell Bank:

Stored in the [**].

 

Reference Standard

Storage temperature at less than [**]

 

Exhibit 3.6.2(a)(i) - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 3.6.2(c)(i)

 

Inventory Product Specifications

 

In-process Targets for Process Intermediates

 

	
Product   Name: MEDI3379 Unformulated Drug Substance (Process 1)
    	
Material   Number: [**]
    
	
Formulation:   [**]
    	
 
    
	
Storage   Temperature: [**]
    	
Storage   Container: 16 L Celsius Bag
    
	
Maximum   Dose: [**]
    	
Body   Mass: 40 – 150 kg
    
	
Version:   1.0
    	
 
    
			

 

	
Test
    	
 
    	
Method Number
    	
 
    	
Target Expectations
    
	
Appearance
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Total protein
    	
 
    	
[**]
    	
 
    	
[**]
    
	
pH
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Reducing gel   electrophoresis
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Non-reducing gel   electrophoresis
    	
 
    	
[**]
    	
 
    	
[**]
    
	
High performance size   exclusion chromatography (HPSEC)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Capillary isoelectric   focusing (cIEF)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
MEDI3379 bioassay
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Bioburden
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Exhibit 3.6.2(c)(i) - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

In-process Targets for Process Intermediates

 

	
Product   Name: MEDI3379 Unformulated Drug Substance (Process 1)
    	
Material   Number: [**]
    
	
Formulation:   [**]
    	
 
    
	
Storage   Temperature: [**]
    	
Storage   Container: 16 L Celsius Bag
    
	
Maximum   Dose: [**]
    	
Body   Mass: 40 – 150 kg
    
	
Version:   1.0
    	
 
    
	
 
    	
 
    	
 
    
	
Endotoxin (LAL)
    	
QC-9744
    	
[**]
    
				

 

COMMENTS:

 

[**].

 

Revision History

 

	
Version
    	
 
    	
Reason
    
	
[**]
    	
 
    	
[**]
    

 

APPROVALS

 

	
Role
    	
 
    	
Printed Name
    	
 
    	
Signature
    
	
Lot Release
    	
 
    	
[**]
    	
 
    	
[**] 02 May 12
    
	
Analytical Biochemistry
    	
 
    	
[**]
    	
 
    	
[**] 3 May 12
    
	
Quality Assurance
    	
 
    	
[**]
    	
 
    	
[**] 04 May 12
    

 

Exhibit 3.6.2(c)(i) - 2

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

 

Master Specification for Clinical Trial Material

 

Product Information

 

	
Product Name: MEDI3379 Drug   Product (Process 1)
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Formulation:  [**]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Storage Condition: [**]
    	
 
    	
Material Number: [**]
    
	
 
    	
 
    	
 
    
	
Maximum Dose: [**]
    	
 
    	
Body Weight Range: 40 – 150 kg
    
	
 
    	
 
    	
 
    
	
Nominal Fill Volume: 1.0 mL
    	
 
    	
Fill Volume: 1.3 mL
    
	
 
    	
 
    	
 
    
	
Comments: Not applicable
    	
 
    	
 
    

 

Alternate Storage Conditions

 

	
Storage   Condition: Not applicable
    	
 
    	
Material   Number: Not applicable
    
	
 
    	
 
    	
 
    
	
Storage   Condition: Not applicable
    	
 
    	
Material   Number: Not applicable
    

 

Test, Method, and Acceptance Criteria

 

	
Test
    	
 
    	
Method
    	
 
    	
Acceptance Criteria
    
	
Appearance
    	
 
    	
[**]
    	
 
    	
[**]
    
	
pH
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Total protein
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Capillary isoelectric   focusing
    	
 
    	
[**]
    	
 
    	
[**]
    
	
MEDI3379 bioassay
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Reducing gel   electrophoresis
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Non-reducing gel   electrophoresis
    	
 
    	
[**]
    	
 
    	
[**]
    
	
High performance size exclusion   chromatography
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Exhibit 3.6.2(c)(i) - 3

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

	
Test
    	
 
    	
Method
    	
 
    	
Acceptance Criteria
    
	
Endotoxin (LAL)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Sub-visible particles
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Extractable volume
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Osmolality
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Sterility
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Comments

 

[**]

 

Version History

 

	
Version
    	
 
    	
Reason
    
	
[**]
    	
 
    	
[**]
    

 

Exhibit 3.6.2(c)(i) - 4

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Justification of Specification Worksheet
 (New Specifications Only)

 

Section 1:  Material Type Abbreviations

 

	
BIVBP
    	
 
    	
= Bulk IV Bag Protectant
    
	
VIVBP
    	
 
    	
= Vialed IV Bag Protectant
    
	
BD
    	
 
    	
= Bulk Diluent
    
	
VD
    	
 
    	
= Vialed Diluent
    
	
BP
    	
 
    	
= Bulk Placebo
    
	
VP
    	
 
    	
= Vialed Placebo
    
	
DS
    	
 
    	
= Drug Substance
    
	
DP
    	
 
    	
= Drug Product
    

 

Section 2:  Material Types

 

Material Type#1

 

	
Product   Name: MEDI3379 Drug Product (Process 1)
    	
Master   Specification #: [**]
    	
Abbreviation:   DP
    
	
Formulation:   [**]
    	
 
    	
 
    
	
Storage   Condition: [**]
    	
 
    	
Material   Number: [**]
    
	
Nominal   Fill Volume: 1.0mL
    	
Target   Fill Volume: 1.3 mL
    	
 
    
					

 

Section 3:  Maximum Dosage

 

	
Maximum Dose
    	
 
    	
Applies to:
    	
 
    	
Reference
    	
 
    	
Justification
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Exhibit 3.6.2(c)(i) - 5

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Section 4:  Test, Acceptance Criteria and Justification

 

	
Text
    	
 
    	
Applies to:
    	
 
    	
Method
   Number
    	
 
    	
Acceptance Criteria
    	
 
    	
Justification
    
	
Appearance
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
pH
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Total protein
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Capillary isoelectric   focusing
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
MEDI3379 bioassay
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Reducing gel   electrophoresis
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Non-reducing gel   electrophoresis
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
High performance size   exclusion chromatography
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Endotoxin (LAL)
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Sub-visible particles
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Extractable volume
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Osmolality
    	
 
    	
DP
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Sterility
    	
 
    	
DP
    	
 
    	
Contract lab
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Section 5:  Comments

 

[**]

 

Section 6:  Approvals

 

	
Role
    	
 
    	
Name
    	
 
    	
Signature
    	
 
    	
Date
    
	
CMC Analytical   Representative
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
13 June 12
    

 

Exhibit 3.6.2(c)(i) - 6

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Justification of Specification Worksheet
 (New Specifications Only)

 

	
CMC Team Leader
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
14 June 12
    
	
MSWC Coordinator
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
15 June 12
    
	
ABC Senior Management
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
18 June 12
    

 

Exhibit 3.6.2(c)(i) - 7

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**]

 

Exhibit 3.6.2(c)(i) - 8

 

Exhibit 3.6.3(a)

 

Clinical and Research Supply Agreement Principles

 

1.             Supply Agreement - Overview

 

The Clinical and Research Supply Agreement (for purposes of this Exhibit, the “Supply Agreement”) will consist of general principles set forth in a main agreement and project addenda that will be entered into for specific manufacturing projects or for particular services (“Project Addenda”).  At this time the Parties anticipate separate Project Addenda for (1) research supply and Phase 1 & Phase 2 clinical supply, (2) Phase 3 clinical supply, and (3) special services not covered by the supply Project Addenda such as technology transfer (except for technology transfer by MedImmune upon termination as described below), process development, formulation development and the like.  Drug substance and drug product containing Licensed Antibody and Licensed Product are referred to in this Exhibit as “Product.”

 

1.1                     Manufacture.

 

MedImmune will manufacture for Kolltan those quantities of Product required by a Project Addendum.  Product will be manufactured and delivered in accordance with the Project Addendum and the Quality Agreement.  The Parties will agree on a forecasting procedure which may include a long term forecast and a binding forecast.

 

1.2                     Data Transfer.

 

MedImmune will provide to Kolltan a mutually agreed data set for each lot of Product to enable Kolltan to prepare documents required for Kolltan’s regulatory agency filings.  The foregoing sentence notwithstanding, MedImmune has no obligation under the Supply Agreement to disclose to Kolltan any MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the manufacturing process.

 

1.3                     Delivery Terms; Title and Risk of Loss.

 

Delivery terms will be FCA (Incoterms 2010) MedImmune’s facility.  Title and risk of loss or damage will pass to Kolltan upon delivery of Product to the designated carrier at MedImmune’s facility.  Kolltan will be responsible for obtaining governmental permits, consents and approvals required for export out of country of origin and for import into the destination country.

 

1.4                     Final Release of Product.

 

MedImmune will perform a manufacturer’s release of Product and will provide Kolltan with a certificate of analysis.  Kolltan will perform the final release of Product.

 

1.5                     Regulatory Matters.

 

When requested by Kolltan, MedImmune will provide to Kolltan documentation in support of GMP Manufacture of Product for filing by Kolltan with regulatory authorities in the U.S., any of the member states of the European Union, or other jurisdictions mutually agreed in writing.  If supporting such approval would require material changes or significant resources, then the Parties will first prepare a written action plan, which includes responsibilities and costs.

 

Exhibit 3.6.3(a) - 1

 

1.6                     Assistance to Kolltan.

 

MedImmune will provide reasonable assistance to Kolltan with respect to any filings related to the Product that Kolltan may wish to make to a regulatory authority; such assistance may include providing to Kolltan requested documentation with respect to the services performed under the Supply Agreement.  MedImmune further will provide reasonable assistance to Kolltan with respect to Kolltan responding to regulatory authorities.  Any additional assistance will be subject to a separate Project Addendum with a separate fee.

 

1.7                     Product Warranties; Acceptance and Rejection; Failure to Supply.

 

MedImmune will make customary warranties regarding any Product delivered to Kolltan under the Supply Agreement.  The Supply Agreement will contain procedures for acceptance and rejection of Product and procedures for dispute resolution related to rejection of Product.  The Supply Agreement will specify appropriate remedies for Kolltan if MedImmune fails to supply Product in a timely manner in accordance with the applicable warranties.

 

1.8                     Subcontractors

 

MedImmune may engage subcontractors identified on a list agreed by the Parties and attached as an exhibit to the Supply Agreement, to carry out MedImmune’s responsibilities under the Supply Agreement, provided that such subcontractors are subject to the applicable terms of the Supply Agreement and Quality Agreement.  The list of approved subcontractors may be updated from time to time by MedImmune with Kolltan’s prior written consent, which consent will not be unreasonably withheld.  MedImmune will remain responsible for the peformance by its subcontractors of its obligations under the Supply Agreement.

 

2.             Quality; Audit

 

A quality agreement will be executed at the same time as, or prior to, the execution of a Project Addendum for GMP manufacture (the “Quality Agreement”).  The Supply Agreement will include rights for Kolltan to audit and inspect MedImmune’s books, records and facilities as reasonably required to comply with regulatory requirements or confirm MedImmune’s compliance with its obligations under the Supply Agreement.

 

3.             Pricing

 

3.1.         MedImmune will supply Product to Kolltan at rates not materially different from those charged by third party contract manufacturers.

 

3.2.         Kolltan will pay invoices within 30 days after receipt.

 

4.             Compliance with Legal and Regulatory Requirements

 

4.1.         Appropriate provisions will be included in the Supply Agreement to ensure that each Party complies with all relevant local, national and international legal or regulatory requirements and other relevant requirements applicable to the manufacture, handing, transport and storage of Product.

 

5.             Document Retention

 

5.1.         Appropriate provisions will be included in the Supply Agreement with regard to maintaining appropriate documentation for patent and regulatory purposes and in full compliance with all applicable laws.

 

Exhibit 3.6.3(a) - 2

 

6.             Product Security and Waste Disposal

 

6.1.         Appropriate provisions will be included in the Supply Agreement with regard to product security and waste handling.

 

7.             Ownership of Results and Background IPR

 

7.1.         The applicable intellectual property provisions of the Agreement will be reflected as appropriate in the Supply Agreement.

 

8.             General Provisions

 

8.1.         Each Party agrees and acknowledges that the Supply Agreement will contain a number of other provisions that are standard in the biopharmaceutical manufacture industry, including with respect to insurance, indemnification, confidentiality, assignment, governing law and jurisdiction, which will not conflict or be inconsistent with the provisions of the Agreement.

 

9.             Termination

 

9.1.         Either Party shall have the right to terminate the Supply Agreement for convenience on appropriate notice (which in the case of MedImmune shall be on twelve (12) months’ notice not to be delivered prior to December 31, 2016); or for material breach of the Supply Agreement by the other Party or insolvency.

 

9.2.         The Supply Agreement shall automatically terminate:

 

9.2.1.                  upon termination of the Agreement in its entirety by MedImmune due to Kolltan’s material breach of the Agreement or insolvency; and

 

9.2.2.                  upon termination of the Agreement by Kolltan with respect to each of the Licensed Program and the Follow-On Program under Section 11.4 of the Agreement.

 

9.3.         Without limiting Section 3.6.3(b) of the Agreement (to the extent it survives termination of the Agreement, if applicable), in the event that the Supply Agreement is terminated other than (a) by MedImmune for Kolltan’s material breach of the Supply Agreement or insolvency or (b) as described in Section 9.2 of this Exhibit, MedImmune will perform such technology and knowledge transfer required to ensure continuity of supply for Kolltan.

 

Exhibit 3.6.3(a) - 3

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 5.4.1(c)

 

Co-Development and Co-Commercialization Agreement Terms

 

Capitalized terms used but not defined in this Exhibit shall have the meanings given to them in the Agreement.

 

	
Scope
    	
 
    	
The Co-Development and Co-Commercialization   Agreement shall set forth the rights and obligations of the Parties with respect   to the Development and Commercialization of the Licensed Antibody and   Licensed Products in the Field in the Territory.
    
	
 
    	
 
    	
 
    
	
Upfront payment
    	
 
    	
Within forty-five (45) days after execution of the   Co-Development and Co-Commercialization Agreement, MedImmune shall pay to   Kolltan (a) if the Co-Development and Co-Commercialization Agreement is   entered pursuant to Section 5.4.3(c) of the Agreement, an amount   equal to [**] percent ([**]%) of the Product Acquisition Price, or   (b) if the Co-Development and Co-Commercialization Agreement is entered   pursuant to Section 5.4.3(d) of the Agreement, an amount equal to   the Co-Agreement Amount (provided, however, that if the Co-Agreement Amount   is less than or equal to zero, MedImmune shall not be required to pay Kolltan   an upfront payment under this clause (b)).
    
	
 
    	
 
    	
 
    
	
License grants
    	
 
    	
Each Party shall grant the other Party a sole,   royalty-free license (which license shall be exclusive as to Third Parties   but not as to the licensor and its Affiliates), with the right to grant   sublicenses (subject to restrictions to be set forth in the Co-Development   and Co-Commercialization Agreement) under any Patents or Know-How owned or   controlled by such Party that are necessary or reasonably useful for the   Development or Commercialization of the Licensed Antibody or Licensed   Products, to Develop and Commercialize the Licensed Antibody and Licensed   Products in the Field in the Territory in accordance with the terms of the   Co-Development and Co-Commercialization Agreement.
    
	
 
    	
 
    	
 
    
	
Governance
    	
 
    	
The Parties’ activities under the Co-Development and   Co-Commercialization Agreement shall be generally overseen by a steering   committee, which shall consist of an equal number of representatives of each   Party (the “Steering Committee”). The Steering Committee shall act by   consensus; provided, however, that if the Steering Committee is unable to   reach consensus on a matter within the scope of its responsibility, the   matter shall be escalated to the Executive Officers for attempted resolution   in accordance with procedures set forth in the Co-Development and   Co-Commercialization Agreement.

 

The Parties’ Development activities under the   Co-Development and Co-Commercialization Agreement shall be specifically   overseen by a development committee, which shall consist of an equal number   of representatives of each Party (the “JDC”), and the Parties’   Commercialization activities under the Co-Development and   Co-Commercialization Agreement shall be specifically
    

 

Exhibit 5.4.1(c) - 1

 

	
 
    	
 
    	
overseen by a commercialization committee, which   shall consist of an equal number of representatives of each Party (the “JCC”).   Each of the JDC and the JCC shall act by consensus; provided, however, that   if either the JDC or the JCC is unable to reach consensus on a matter within   the scope of its responsibility, the matter shall be escalated to the   Steering Committee.
    
	
 
    	
 
    	
 
    
	
Development activities
    	
 
    	
The Steering Committee shall determine which Party   shall have primary operational responsibility for conducting Development   activities with respect to the Licensed Antibody and Licensed Products in   accordance with a Development plan and budget approved (and, as applicable,   amended) by the JDC and thereafter approved by the Steering Committee (the “Development   Plan”). To the extent feasible and based on then-existing circumstances,   the Steering Committee shall use reasonable efforts to ensure that Kolltan   shall assume primary operational responsibility whenever possible.
    
	
 
    	
 
    	
 
    
	
Development diligence
    	
 
    	
Each Party shall use Commercially Reasonable Efforts   to carry out the activities assigned to it under the Development Plan.
    
	
 
    	
 
    	
 
    
	
Development costs
    	
 
    	
Each Party shall bear 50% of the Development Costs.

 

“Development Costs” will be defined more   specifically in the Co-Development and Co-Commercialization Agreement but   generally will mean the sum of all out-of-pocket costs incurred by a Party or   its Affiliates after the effective date of the Co-Development and   Co-Commercialization Agreement that are specifically identifiable to   (i) the Development of the Licensed Antibody or Licensed Products or   (ii) the Manufacture of the Licensed Antibody or Licensed Products in   support of such Development, in each case ((i) and (ii)) in accordance   with the Development Plan (subject to any cost overruns that may be permitted   under the Co-Development and Co-Commercialization Agreement).
    
	
 
    	
 
    	
 
    
	
Commercialization activities
    	
 
    	
The Parties shall conduct Commercialization   activities with respect to Licensed Products in accordance with a   Commercialization plan approved (and, as applicable, amended) by the JCC and   thereafter approved by the Steering Committee (the “Commercialization Plan”).
    
	
 
    	
 
    	
 
    
	
Commercialization diligence
    	
 
    	
Each Party shall use Commercially Reasonable Efforts   to carry out the activities assigned to it under the Commercialization Plan.
    

 

Exhibit 5.4.1(c) - 2

 

	
Net Profits/Losses
    	
 
    	
Each Party shall be receive or bear, as applicable, fifty   percent (50%) of the Net Profits/Losses.

 

“Net Profits/Losses” will be defined more   specifically in the Co-Development and Co-Commercialization Agreement but   generally will mean Net Sales (as defined below) less Commercialization   Costs.

 

“Net Sales” will be defined more specifically   in the Co-Development and Co-Commercialization Agreement but generally will   be defined in a manner analogous to the manner in which Net Sales are defined   in the Agreement.

 

“Commercialization Costs” will be defined   more specifically in the Co-Development and Co-Commercialization Agreement   but generally will mean the sum of all out-of-pocket costs incurred by a   Party or its Affiliates after the effective date of the Co-Development and   Co-Commercialization Agreement that are specifically identifiable to   (i)(x) the Commercialization of Licensed Products or (y) the   Manufacture of Licensed Products in support of such Commercialization, in   each case ((x) and (y)) in accordance with the Commercialization Plan   (subject to any cost overruns that may be permitted under the Co-Development   and Co-Commercialization Agreement), (ii) prosecution, maintenance,   enforcement or defense of Patents, (iii) indemnification claims or other   liabilities to Third Parties not attributable to a Party’s breach, negligence   or willful misconduct or (iv) obligations to Third Parties under license   or other agreements relating to relevant Patents or Know-How, to the extent   agreed by the Parties, in each case excluding any costs to the extent   deducted under the definition of Net Sales.
    
	
 
    	
 
    	
 
    
	
Supply
    	
 
    	
If MedImmune is interested in supplying the Parties’   requirements of the Licensed Antibody and Licensed Products for their   Development and Commercialization activities under the Co-Development and   Co-Commercialization Agreement, then the Parties shall negotiate in good   faith regarding a mutually acceptable supply agreement; provided, however,   that if the Parties in good faith are unable to agree on the terms of such a   supply agreement within a reasonable period of time, then the Parties shall   negotiate in good faith with one or more Third Parties regarding a supply   agreement pursuant to which the applicable Third Party would supply the   Parties’ requirements of the Licensed Antibody and Licensed Products for   their Development and Commercialization activities under the Co-Development   and Co-Commercialization Agreement.

 

If MedImmune is not interested in supplying the   Parties’ requirements of the Licensed Antibody and Licensed Products for   their Development and Commercialization activities under the Co-Development   and Co-Commercialization Agreement, then the Parties shall mutually agree   upon a Third Party to supply such requirements.
    

 

Exhibit 5.4.1(c) - 3

 

	
Confidentiality
    	
 
    	
The Co-Development and Co-Commercialization   Agreement shall include provisions regarding protection of confidential   information, including confidential information disclosed under or in   connection with the Agreement, that are customary for similar transactions   and, to the extent applicable, consistent with the corresponding provisions   of the Agreement.
    
	
 
    	
 
    	
 
    
	
Other provisions
    	
 
    	
The Co-Development and Co-Commercialization   Agreement shall include provisions regarding (a) termination,   (b) ownership, prosecution, maintenance, enforcement and defense of   relevant Patents, (c) representations and warranties,   (d) indemnification, (e) assignment and change of control and   (f) governing law and resolution of legal disputes, in each case that   are customary for similar transactions and, to the extent applicable,   consistent with the corresponding provisions of the Agreement, and such other   provisions as may be agreed by the Parties.
    

 

Exhibit 5.4.1(c) - 4

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 6.4.4

 

Payments under Certain In-License Agreements

 

1.                                      UT Agreement.

 

1.1                               Capitalized terms used in this Section 1 but not defined in the Agreement shall have the meanings given to them in the UT Agreement.

 

1.2                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 5.1b of the UT Agreement, Kolltan shall pay Board the following milestone fees within 30 days of the applicable milestone event for each Licensed Product (as defined in the UT Agreement) that is a Licensed Product (as defined in this Agreement); provided, however that Kolltan shall not be required to make any such payment more than once for any Licensed Product (as defined in the UT Agreement):

 

	
Milestone Event
    	
 
    	
Amount
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    

 

1.3                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 5.1c of the UT Agreement, Kolltan shall pay Board the following commercial success milestone fees on or before March 1 of each year during the Term (as defined in the UT Agreement) based on the total worldwide Net Sales (as defined in the UT Agreement) of Licensed Products (as defined in this Agreement) in the previous Calendar Year:

 

	
Total Worldwide Net Sales (as defined in the UT
   Agreement) of Licensed Products (as defined in this
   Agreement) in the Previous Calendar Year
    	
 
    	
Amount
    
	
Greater than $[**] but less than or equal to $[**]
    	
 
    	
[**]
    
	
Greater than $[**] but less than or equal to $[**]
    	
 
    	
[**]
    
	
Greater than $[**] but less than or equal to $[**]
    	
 
    	
[**]
    
	
Greater than $[**] but less than or equal to $[**]
    	
 
    	
[**]
    
	
Greater than $[**]
    	
 
    	
[**]
    

 

Exhibit 6.4.4 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Notwithstanding the foregoing, if for any Calendar Year there are Net Sales (as defined in the UT Agreement) of any product other than Licensed Products (as defined in this Agreement), then promptly after the end of such Calendar Year, MedImmune shall notify Kolltan of the total amount of Net Sales (as defined in the UT Agreement) of such products for such Calendar Year, and the amount payable by Kolltan under this Section 1.3 for such Calendar Year shall be the product of (a) the total amount owed by MedImmune or its applicable Affiliate to Board under Section 5.1c of the UT Agreement for such Calendar Year and (b) a fraction, the numerator of which is the amount of Net Sales (as defined in the UT Agreement) of Licensed Products (as defined in this Agreement) for such Calendar Year and the denominator of which is the total amount of Net Sales (as defined in the UT Agreement) for such Calendar Year.

 

2.                                      Dyax Agreement.

 

2.1                               Capitalized terms used in this Section 2 but not defined in the Agreement shall have the meanings given to them in the Unredacted Provisions of the Dyax Agreement.

 

2.2                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 13.3 of the Dyax Agreement, for any Licensed Product, Kolltan shall pay Dyax a royalty of [**] percent ([**]%) of Net Sales (as defined in the Dyax Agreement after substituting, for each reference in such definition to MedImmune Products, a reference to Licensed Products) of such Licensed Product; provided, however, that Kolltan shall not be required to pay such royalty with respect to sales of any Licensed Product in any country after the tenth (10th) anniversary of the first commercial sale of such Licensed Product in such country pursuant to a Regulatory Approval in such country.

 

3.                                      Lonza Agreement.

 

3.1                               Capitalized terms used in this Section 3 but not defined in the Agreement (or in any provision of this Section 3) shall have the meanings given to them in the Unredacted Provisions of the Lonza Agreement.

 

3.2                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 6.3 of the Lonza Agreement, for any Calendar Year, if any Product or End Product that is a Licensed Product with respect to which Commencement of Phase 2 Clinical Study has occurred, is manufactured for Kolltan by MedImmune using the LB System Technology, then Kolltan shall pay to Lonza Sales a license fee for such Calendar Year in the amount of the Applicable Amount; provided, however, that Kolltan shall not be required to make such payment for any Calendar Year (a) in which Lonza Sales or any of its Affiliates manufactures for Kolltan any Product or End Product that is a Licensed Product or (b) after the

 

Exhibit 6.4.4 - 2

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Calendar Year in which the last-to-expire relevant patent (depending on which cell line is used for such Product or End Product) under the LB System Technology in Exhibit 2 to the Lonza Agreement in the country of manufacture expires.  For purposes of this Section 3.2, the “Applicable Amount” means (x) if the relevant Licensed Product is the first Product or End Product manufactured by MedImmune (or its Affiliates), regardless of whether any given Product or End Product is manufactured for MedImmune (or its Affiliates), Kolltan (or its Affiliates) or any Third Party, using the LB System Technology with respect to which Commencement of Phase 2 Clinical Study occurred, GBP [**] (£[**]), (y) if the relevant Licensed Product is the second, third or fourth Product or End Product manufactured by MedImmune (or its Affiliates), regardless of whether any given Product or End Product is manufactured for MedImmune (or its Affiliates), Kolltan (or its Affiliates) or any Third Party, using the LB System Technology with respect to which Commencement of Phase 2 Clinical Study has occurred, GBP [**] (£[**]), and (z) if the relevant Licensed Product is the [**] or later Product or End Product manufactured by MedImmune (or its Affiliates), regardless of whether any given Product or End Product is manufactured for MedImmune (or its Affiliates), Kolltan (or its Affiliates) or any Third Party, using the LB System Technology with respect to which Commencement of Phase 2 Clinical Study has occurred, [**] (£[**]).

 

3.3                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 6.5 of the Lonza Agreement, for any Product or End Product that is a Licensed Product and manufactured in any country for Kolltan by MedImmune using the LB System Technology, Kolltan shall pay to Lonza Sales a royalty of (a) if such Product or End Product was manufactured during the Royalty Patent Term of such Product or End Product in such country, [**]% of Net Sales (as defined in the Lonza Agreement) of such Product or End Product, and (b) if such Product or End Product was manufactured during the Royalty Know-How Term of such Product or End Product in such country, [**]% of Net Sales (as defined in the Lonza Agreement) of such Product or End Product.

 

3.4                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 6.7 of the Lonza Agreement, for any Calendar Year, if any Product or End Product that is (a) a Licensed Product and (b) manufactured (i) by Kolltan on its own behalf or (ii) by any Third Party other than Lonza Sales or any of its Affiliates on behalf of Kolltan, in either case ((i) or (ii)) in accordance with GMP (as defined in the Lonza Agreement) requirements and using the LB System Technology, then Kolltan shall pay to Lonza Sales a sublicense fee for such Calendar Year in the amount of the product of (x) GBP [**] (£[**]), and (y) the number of different Products and End Products described in clauses (a) and (b) above for such Calendar Year; provided, however, that Kolltan shall not be required to make such payment for any Calendar Year (A) in which Lonza Sales or any of its Affiliates manufactures for Kolltan any Product or End Product that is a Licensed Product or (B) with respect to any Product or End Product, after the Calendar Year in which the last-to-expire relevant patent (depending on which cell line is used for such Product or End Product) under the LB System

 

Exhibit 6.4.4 - 3

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Technology in Exhibit 2 to the Lonza Agreement in the country of manufacture expires.  Any Product and any End Product that have the same active ingredient shall be counted as one for purposes of calculating the fraction described in clause (y) above.

 

3.5                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 6.8 of the Lonza Agreement, for any Product or End Product that is a Licensed Product and manufactured in any country (a) by Kolltan on its own behalf or (b) by any Third Party other than Lonza Sales (as defined in the Lonza Agreement) or any of its Affiliates on behalf of Kolltan, in either case ((a) or (b)) using the LB System Technology, in lieu of the royalty described in Section 3.3 of this Exhibit, if such Product or End Product was manufactured during the Royalty Patent Term of such Product or End Product in such country, then Kolltan shall pay to Lonza Sales a royalty of [**]% of Net Sales (as defined in the Lonza Agreement) of such Product or End Product.

 

3.6                               In respect of MedImmune’s (or its applicable Affiliate’s) obligations under Section 6.9 of the Lonza Agreement, for any Product or End Product that is a Licensed Product and manufactured in any country for Kolltan by Lonza Sales or any of its Affiliates, Kolltan shall pay to Lonza Sales a royalty of (a) during the Royalty Patent Term of such Product or End Product in such country, [**]% of Net Sales (as defined in the Lonza Agreement) of such Product or End Product, and (b) during the Royalty Know-How Term of such Product or End Product in such country, [**]% of Net Sales (as defined in the Lonza Agreement) of such Product or End Product.

 

4.                                      Limitations; Cooperation.

 

4.1                               Notwithstanding the foregoing provisions of this Exhibit, if for any reason MedImmune or its applicable Affiliate is not required under the applicable provision of the applicable In-License Agreement to make any payment to the applicable licensor as a result of Kolltan’s activities under this Agreement with respect to the Licensed Program, or is required under the applicable provision of the applicable In-License Agreement to pay an amount to the applicable licensor as a result of Kolltan’s activities under this Agreement with respect to the Licensed Program that is less than the amount described in the corresponding provision of this Exhibit, then Kolltan shall not be required to make any payment, or shall be required to pay only such lesser amount, as the case may be, to the applicable licensor in respect of such provision of such In-License Agreement.  MedImmune shall promptly notify Kolltan of the existence of, and shall promptly respond to any inquiry made by Kolltan regarding, any event or circumstance that would trigger a reduced payment obligation under this Section 4.1.  Without limiting the foregoing, reasonably prior to the First Commercial Sale of the initial Licensed Product, MedImmune and Kolltan shall consult as to whether any reductions to the payment obligations described in this Exhibit apply.

 

Exhibit 6.4.4 - 4

 

4.2                               In no event shall Kolltan be required to make any payment to any licensor in respect of any provision of any In-License Agreement in an amount that is greater than the amount described in the corresponding provision of this Exhibit.

 

4.3                               As requested by Kolltan, MedImmune shall cooperate with Kolltan to determine the appropriate amount, manner and timing of any payment described in this Exhibit.

 

Exhibit 6.4.4 - 5

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 9.2.3

 

MedImmune Patents

 

MedImmune Patents

 

[**]

 

The Patents listed in Exhibit 1.42 (excluding any MedImmune Manufacturing Patents) are incorporated into this Exhibit by reference.

 

Exhibit 9.2.3 - 1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

Exhibit 9.2.6

 

Third Party Intellectual Property

 

[**]

 

Exhibit 9.2.6 - 1

 

Exhibit 9.2.9

 

Obligations and Restrictions under In-License Agreements

 

1.                                      UT Agreement.

 

1.1                               Capitalized terms used in this Section 1 but not defined in the Agreement shall have the meanings given to them in the UT Agreement.

 

1.2                               The rights granted by MedImmune to Kolltan as sublicensee under the UT Agreement are subject to the rights, conditions and limitations imposed by United States law on inventions and discoveries conceived or first actually reduced to practice during the course of research funded by a United States federal agency, as described in the first Section 3.2 of the UT Agreement.

 

1.3                               MedImmune is indirectly obligated to require Kolltan to take steps as necessary and solely as they relate to Kolltan’s activities under the Agreement to enable MedImmune to perform its obligations under the following provisions of the UT Agreement:

 

1.3.1                     first two sentences of Section 5.3;

 

1.3.2                     the reporting obligations described in Section 5.4;

 

1.3.3                     the second, third and fourth sentences of Section 5.5;

 

1.3.4                     Section 5.7;  and

 

1.3.5                     the first and third sentences of Section 7.1.

 

The Parties acknowledge and agree that (a) the Agreement includes provisions whereby Kolltan is bound to take such steps, and (b) the foregoing provisions of the UT Agreement include all the terms and conditions of the UT Agreement that are applicable to Kolltan as sublicensee under the UT Agreement.

 

2.                                      MRC Agreement

 

2.1                               Any capitalized term used in this Section 2 but not defined in the Agreement, or used in any provision of the MRC Agreement referenced in this Section 2, (a) if such capitalized term is defined in the Unredacted Provisions of the MRC Agreement, shall have the meaning given to such capitalized term in such Unredacted Provisions, or (b) if such capitalized term is defined in the MRC Agreement other than in the Unredacted Provisions, shall be construed on the basis of the plain English meaning of the words in the capitalized term itself and the portion, if any, of the definition of such capitalized term (including any definition (or portion thereof) of any other capitalized term used directly or indirectly in the definition of such capitalized term) that is not redacted.

 

Exhibit 9.2.9 - 1

 

2.2                               The rights granted by MedImmune to Kolltan as sublicensee under the MRC Agreement do not include the right to exercise or use the Technology or Patent Rights in the commercial sale of single variable domains (heavy or light) of antibodies.

 

2.3                               MedImmune is indirectly obligated to require Kolltan to take steps as necessary to enable MedImmune to perform its obligations under Clause 21 of the MRC Agreement as they apply to Kolltan’s activities under the Agreement.

 

3.                                      Dyax Agreement.

 

3.1                               Any capitalized term used in this Section 3 but not defined in the Agreement, or used in any provision of the Dyax Agreement referenced in this Section 3, (a) if such capitalized term is defined in the Unredacted Provisions of the Dyax Agreement, shall have the meaning given to such capitalized term in such Unredacted Provisions, or (b) if such capitalized term is defined in the Dyax Agreement other than in the Unredacted Provisions, shall be construed on the basis of the plain English meaning of the words in the capitalized term itself and the portion, if any, of the definition of such capitalized term (including any definition (or portion thereof) of any other capitalized term used directly or indirectly in the definition of such capitalized term) that is not redacted.

 

3.2                               Any sub-sublicenses granted by Kolltan under its sublicense from MedImmune under the Dyax Agreement must be granted pursuant to a written agreement that (a) requires the sub-sublicensee to abide by the terms of the applicable MedImmune Product License, consistent with the terms of the Agreement and this Exhibit 9.2.9, and (b) is consistent with the Unredacted Provisions of Clauses 11, 12 and 13 of the Dyax Agreement.

 

3.3                               MedImmune is indirectly obligated to require Kolltan to take steps as necessary and solely as they relate to Kolltan’s activities under the Agreement to enable MedImmune to perform its obligations under the following provisions of the Dyax Agreement:

 

3.3.1                     Clause 12.4;

 

3.3.2                     the first sentence of Clause 12.9;

 

3.3.3                     the last sentence of Clause 13.4; and

 

3.3.4                     Clause 13.6 (excluding Clause 13.6.5).

 

3.4                               As set forth in Clause 12.6 of the Dyax Agreement, Kolltan shall indemnify the Dyax Indemnitees against any liability, damage, loss or expense (including attorney’s fees and expenses of litigation) incurred by or imposed upon the Dyax Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments by or in favor of any Third Party (as defined in the Dyax

 

Exhibit 9.2.9 - 2

 

Agreement) concerning any manufacture, use or sale of any MedImmune Product by Kolltan or its sublicensee.

 

3.5                               As set forth in Clause 12.11 of the Dyax Agreement, Kolltan may assign the benefit and/or burden of its rights under any MedImmune Product License to any Affiliate (as defined in the Dyax Agreement) or Third Party (as defined in the Dyax Agreement), provided that such Affiliate (as defined in the Dyax Agreement) or Third Party (as defined in the Dyax Agreement) undertakes to Dyax to be bound by the terms of the MedImmune Product License.

 

3.6                               As set forth in Clause 12.12 of the Dyax Agreement, Dyax has the right to terminate any MedImmune Product License under which Kolltan receives a sublicense in the event that Kolltan (or its sublicensee) directly or indirectly opposes or assists any Third Party (as defined in the Dyax Agreement) to oppose the grant of letters patent or any patent application within the Dyax Patent Rights, or disputes or directly or indirectly assists any Third Party (as defined in the Dyax Agreement) to dispute the validity of any patent within the Dyax Patent Rights or any of the claims thereof.

 

4.                                      Lonza Agreement.

 

4.1                               MedImmune is indirectly obligated to require Kolltan to take steps as necessary and solely as they relate to Kolltan’s activities under the Agreement to enable MedImmune to perform its obligations under the following provisions of the Lonza Agreement:

 

4.1.1                     the reporting obligations described in Section 6.11; and

 

4.1.2                     Section 6.13.1.

 

Exhibit 9.2.9 - 3

 

AMENDMENT

To

LICENSE AND OPTION AGREEMENT

 

This Amendment (the “Amendment”) to the License and Option Agreement dated July 24, 2013 (“Agreement”) by and between MedImmune, LLC, a Delaware limited liability company, with its principal executive offices located at One MedImmune Way, Gaithersburg, MD 20878 (“MedImmune”), and Bulldog Pharmaceuticals, Inc., a company organized and existing under the laws of the British Virgin Islands, having a registered office located at Midocean Chambers, Road Town, Tortola, British Virgin Islands (“Kolltan”), as previously amended on February 10, 2014, June 25, 2014 and June 30, 2014, is entered into effective as of October 27, 2015 (the “Amendment Effective Date”).  MedImmune and Kolltan are each referred to herein by name or as a “Party” or, collectively, as “Parties.”

 

RECITALS

 

WHEREAS, MedImmune and Kolltan desire to eliminate from the Agreement certain Option Rights regarding the Licensed Antibody and the Licensed Products;

 

WHEREAS, Kolltan desires to purchase from MedImmune certain additional quantities of Licensed Antibody and Licensed Products for non-commercial clinical research purposes; and

 

WHEREAS, MedImmune is willing to supply such additional quantities of Licensed Antibody and Licensed Product to Kolltan,

 

NOW, THEREFORE, in consideration of the mutual promises and covenants hereinafter set forth, the Parties hereto agree as follows:

 

1.                                      Definitions.

 

1.1                               Capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement.

 

1.2                               The definition of Inventory set forth in Section 3.6.1 of the Agreement is hereby amended to mean any and all Drug Substance and Drug Product (each as defined below) delivered or to be delivered to Kolltan by MedImmune, regardless of whether such Drug Substance or Drug Product was existing as of the Effective Date of the Agreement.

 

1.3                               The definition of “MedImmune Manufacturing Information and Inventions” set forth in Section 1.70 of the Agreement is hereby amended as follows: Know-How (a) that is Controlled by MedImmune or its Affiliates on the Effective Date or thereafter during the Term and (b) either (i) the practice of which is necessary in order to Manufacture the Licensed Antibody, any Licensed Product, any Follow-On Antibody or any Follow-On Product in the Field in the Territory or (ii) relates to the Manufacture of the Licensed Antibody, any Licensed Product, and Follow-On Antibody or any Follow-On Product in the Field in the Territory and is expressly disclosed in the Existing IND; provided, however, that MedImmune Manufacturing Information and Inventions excludes any Joint Information and Inventions.  For avoidance of doubt, MedImmune Manufacturing Information and Inventions shall not include any Know-How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process.

 

2.                                      Deletion of Option Rights Provisions.  Article 5 (Option Rights) is hereby deleted in its entirety.  The Parties agree that all obligations with respect to Article 5, as of the Amendment Effective Date, have been met, subject to the Representations and Warranties made in Section 11 of this Amendment, and neither Party shall have any further rights or obligations pursuant thereto.  Without limitation of the foregoing, MedImmune shall retain no Option Rights under the Agreement.  The Amendment Effective Date will be the Option Termination Date for the purposes of the Agreement.

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

3.                                      Inventory Supply.

 

(a)                                 MedImmune will deliver to Kolltan:

 

i.                                          existing Inventory of [**] lots of Licensed Antiobody in formulated bulk drug substance form (“Drug Substance”) filled into the current vial configuration and fill volume (“Drug Product”); and

 

ii.                                       additional Inventory of [**] lots of Drug Substance, delivered as Drug Product, each manufactured at the [**] bioreactor scale, for delivery on or before July 31, 2017.  The pricing and payment terms for Drug Substance and Drug Product are set forth in Appendix A to this Amendment.

 

(b)                                 MedImmune may, in its sole discretion, (1) produce Drug Substance at either the Gaithersburg Pilot Facility located at One MedImmune Way, Gaithersburg, MD (“GPF”) or the Gaithersburg Pilot Facility—North located at 45 West Watkins Mill Rd, Gaithersburg, MD (“GPF-North”), (2) pool two 200L cell culture lots into one purification (Drug Substance) lot, and (3) pool more than one Drug Substance lot into one Drug Product lot.

 

(c)                                  In the event that Drug Substance manufacturing is performed at GPF-North and requires analytical comparability and stability testing activities, MedImmune and Kolltan will discuss the specific activities and associated pricing.  Such activities and costs shall correspond to standard comparability and stability testing activities.

 

(d)                                 Kolltan shall bear the responsibility for conducting any compatibility assessment between Drug Substance and Drug Product provided by MedImmune and any other Drug Substance or Drug Product.  MedImmune shall have no additional supply obligations under the Agreement beyond those set forth above.  For the avoidance of doubt, MedImmune will have no obligation to supply Drug Substance or Drug Product for commercial use to Kolltan.

 

(e)                                  MedImmune will make Drug Substance and Drug Product available to Kolltan under the terms and conditions set forth in Section 3.6.1 and 3.6.2 of the Agreement with respect to the Inventory, except as expressly set forth in this Section 3, and such Drug Substance and Drug Product shall be treated as Inventory for all other purposes under the Agreement.  MedImmune warrants that all Drug Substance and Drug Product will, as of the date of delivery to Kolltan, conform to the applicable product specifications.

 

(f)                                   With respect to Drug Substance and Drug Product supplied under this Amendment (excluding Inventory existing as of the Effective Date of the Agreement), the indemnification provided in Section 10.2(b) by MedImmune will be modified by insertion of the underlined language below:

 

“MedImmune shall defend, indemnify and hold harmless the Kolltan Indemnitees from and against any and all Losses relating to or in connection with a Third Party claim arising out of ** * (b) any death, personal bodily injury or damage to real or tangible personal property alleged or proven to result, directly or indirectly, from the gross negligence or willful misconduct of MedImmune and the possession, use or consumption of, or treatment with, any Licensed Antibody or Licensed Product included in or produced from the Inventory, including any product liability claims; ***”

 

4.                                      Deletion of Clinical and Research Supply Provision.  Section 3.6.3. (Clinical and Research Supply of Licensed Antibody and Licensed Products) is hereby deleted in its entirety.  The Parties agree that all

 

 

obligations with respect to Section 3.6.3, as of the Amendment Effective Date, have been met with no further rights and obligations outstanding.

 

5.                                      Deletion of Commercial Supply Provision.  Section 3.6.4 (Commercial Supply) is hereby deleted in its entirety.  The Parties agree that all obligations with respect to Section 3.6.4, as of the Amendment Effective Date, have been met with no further rights and obligations outstanding.

 

6.                                      Deletion of Supply of Media Provisions.  Section 3.6.5 (Supply of Media) is hereby deleted in its entirety.  The Parties agree that all obligations with respect to Section 3.6.5, as of the Amendment Effective Date, have been met with no further rights and obligations outstanding.

 

7.                                      Amendment of Prosecution and Maintenance of Patents Provision.  Section 7.3.1(c) is amended and restated in its entirety to read as follows:

 

Kolltan shall bear responsibility for all costs associated with the filing, prosecution and maintenance of any MedImmune Patent or Joint Patent.  MedImmune shall have the right to assign any such Patent in any country (or, in case of a Joint Patent, to assign MedImmune’s interest in such Joint Patent in any country) to Kolltan, in which case at Kolltan’s election, such Patent (or Joint Patent) in such country shall thereafter be deemed a Kolltan Patent, or (in the case of a MedImmune Patent) may be abandoned.

 

In addition, within ninety (90) days of the Amendment Effective Date, Kolltan will provide an invoice to MedImmune for any Out-of-Pocket Costs incurred prior to the Amendment Effective Date, for which MedImmune shall promptly reimburse Kolltan.

 

8.                                      Survival.  If Kolltan terminates the Agreement pursuant to Section 11.2.1 of the Agreement, this Amendment, and the rights and obligations of the Parties hereunder, shall survive such termination.

 

9.                                      Reference to Aareement.  Upon and after the Amendment Effective Date, each reference in the Agreement to “this Agreement”, “hereunder”, “hereof’ or words of like import referring to the Agreement shall mean and be a reference to the Agreement as modified and amended hereby.

 

10.                               Effectiveness of Amendment.  Upon execution and delivery of this Amendment by both Parties, the amendments set forth above shall be effective as of the Amendment Effective Date.  This Amendment supersedes all previous amendments and addenda to the Agreement, except as otherwise provided.  Drug Substance and Drug Product delivered pursuant to the Addendum dated June 25, 2014, will be subject to the terms and conditions of the Agreement as amended by this Amendment.  Except as specifically amended above, the Agreement is and shall continue to be in full force and effect and is hereby in all respects ratified and confirmed and shall constitute the legal, valid, binding and enforceable obligations of the Parties.

 

11.                               Representations and Warranties.  A new Section 9.5 is added to read as follows:

 

9.5 Kolltan hereby represents to MedImmune, as of the Amendment Effective Date, that it has disclosed to MedImmune all material clinical data under the Control of Kolltan with respect to the Licensed Antibody or a Licensed Product.

 

12.                               No Waiver.  The execution, delivery and effectiveness of this Amendment shall not operate as a waiver of any right, power or remedy of either Party under the Agreement, nor constitute a waiver of any provision of the Agreement.

 

13.                               Counterparts.  This Amendment may be executed in counterparts, each of which is an original, but all of which together constitute one and the same instrument.

 

The Parties have executed this Amendment to be effective as of the Amendment Effective Date.

 

 

	
BULLDOG   PHARMACEUITCALS, INC.
    	
 
    	
MEDIMMUNE, LLC
    
	
By:
    	
/s/ Gerald McMahon
    	
 
    	
By:
    	
/s/ Kripa Ram
    
	
Name:
    	
Gerald McMahon
    	
 
    	
Name:
    	
Kripa Ram
    
	
Title:
    	
Director
    	
 
    	
Title:
    	
Vice President
    
	
Date:
    	
October 27, 2015
    	
 
    	
Date:
    	
October 29, 2015
    

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Double asterisks denote omissions.

 

APPENDIX A

 

Pricing

 

A.  Prices for the Services

 

The following services will be provided by MedImmune at the prices set forth below for [**] lots of Drug Substance and thus, the total costs for this work will be calculated based on the relative number of lots of Drug Substance produced.

 

	
Activities and Services
    	
 
    	
Price (in $)
    
	
Activity 1: Pre-production activities and on-going project   management

·                  Ongoing   project management

·                  Periodic   meetings
    	
 
    	
Estimate
    [**]
    
	
 
    	
 
    	
 
    
	
Activity #2: Resins, raw materials and consumables for two runs:

·                  Purchase   of resins, raw materials and consumables

 

Note: Estimated costs. Actual raw material costs will be billed   to Kolltan
    	
 
    	
Estimate
    [**]
    
	
 
    	
 
    	
 
    
	
Activity #3: Clinical GMP Drug Substance Production

·                  Manufacture   according to cGMP standards

·                  Perform   release testing as described in IND 116023 and preparation of Certificate of   Analysis

·                  Includes   additional in-process testing of intermediates

·                  Includes   preparation of a campaign summary report

 

Note: No stability testing necessary if Manufacture using same   scale and equipment as in IND 116023
    	
 
    	
Estimate
    [**]
    
	
 
    	
 
    	
 
    
	
Activity #4: Drug Product Manufacturing

·                  Ship   material to fill finish site

·                  Perform   Drug Product fills into unlabeled vials using the fill-finish Manufacturing   process described in IND 116023

·                  Production   batch records prepared by MedImmune and approved by Kolltan

·                  Perform   release testing as described in the current IND and preparation of   Certificate of Analysis

·                  Includes   all Raw Materials and consumable needed for Manufacturing

·                  Ship   material to Kolltan-defined site
    	
 
    	
Estimate
    [**]
    
	
 
    	
 
    	
 
    
	
TOTAL
    	
 
    	
[**]Exhibit 10.25

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

THIRD AMENDED AND RESTATED LICENSE AGREEMENT

 

THIS THIRD AMENDED AND RESTATED LICENSE AGREEMENT (this “AGREEMENT”), dated as of March 14, 2013 (the “THIRD AMENDMENT EFFECTIVE DATE”), by and between YALE UNIVERSITY, a corporation organized and existing under and by virtue of a charter granted by the general assembly of the Colony and State of Connecticut and located in New Haven, Connecticut (“YALE”), and KOLLTAN PHARMACEUTICALS, INC., a corporation organized and existing under the laws of the State of Delaware, and with principal offices located at 300 George Street, New Haven, CT 06511 (“LICENSEE”) is effective as of the THIRD AMENDMENT EFFECTIVE DATE.

 

R E C I T A L S:

 

WHEREAS, in the course of research conducted under YALE auspices, Dr. Joseph Schlessinger, an employee of YALE (“SCHLESSINGER”), and the other inventors performing research under SCHLESSINGER’s immediate supervision (together with any and all people from time to time performing research under SCHLESSINGER’s immediate supervision at YALE, the “SCHLESSINGER LAB”) and Dr. Irit Lax, an employee of YALE (“LAX”), and the other inventors performing research under LAX’s immediate supervision, in the course of studying RTK biology, have produced and may continue to produce compositions of matter, know-how, methods, data and intellectual property that have and may continue to lead to the discovery and development of active substances that may induce, prevent, modify or otherwise modulate the activation of an RTK for the purpose of diagnosing, preventing or treating a disease or condition (the “INVENTIONS”);

 

WHEREAS, as of the THIRD AMENDMENT EFFECTIVE DATE, SCHLESSINGER serves on the LICENSEE Board of Directors and the LICENSEE Scientific Advisory Board, and as a paid consultant to LICENSEE;

 

WHEREAS, YALE permits its faculty such as SCHLESSINGER to engage in consulting consistent with YALE policies such as the Yale University Patent Policy, and LICENSEE acknowledges that SCHLESSINGER’s involvement with LICENSEE is subject to the Yale University Patent Policy;

 

WHEREAS, YALE wishes to have the INVENTIONS and any resulting patents commercialized to benefit the public good;

 

WHEREAS, to induce YALE to enter into this AGREEMENT, LICENSEE has represented that it has been formed for the purpose of developing and commercializing PRODUCTS IN CLASS or LICENSED METHODS and that it intends to develop the skill and expertise to seek to develop and commercialize the PRODUCTS IN CLASS or LICENSED METHODS for public use in the LICENSED TERRITORY;

 

 

WHEREAS, YALE is willing to grant a license to LICENSEE, subject to the terms and conditions of this AGREEMENT;

 

WHEREAS, YALE and LICENSEE have previously entered into an Exclusive License Agreement (the “ORIGINAL LICENSE AGREEMENT”), dated May 30, 2008 (the “ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE”);

 

WHEREAS, YALE and LICENSEE have previously entered into an Amended and Restated Exclusive License Agreement (the “AMENDED AND RESTATED LICENSE AGREEMENT”), dated November 23, 2010;

 

WHEREAS, YALE and LICENSEE have previously entered into a Second Amended and Restated Exclusive License Agreement (the “SECOND AMENDED AND RESTATED LICENSE AGREEMENT”), dated December 23, 2011(the “EFFECTIVE DATE”) and they now wish to amend and restate the SECOND AMENDED AND RESTATED LICENSE AGREEMENT in its entirety; and

 

WHEREAS, in order to minimize potential disagreements between the parties as to the genesis of unpatented know-how, materials and methods incorporated by LICENSEE into its RTK PRODUCTS during periods when SCHLESSINGER is MEANINGFULLY INVOLVED AT KOLLTAN and MEANINGFULLY INVOLVED AT YALE, the parties have agreed that certain RTK PRODUCTS developed by Kolltan during such period shall be deemed PRODUCTS IN CLASS under this AGREEMENT;

 

NOW THEREFORE, in consideration of these statements and mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which the parties hereby acknowledge, YALE and LICENSEE agree to the terms of this AGREEMENT.

 

ARTICLE 1          REPRESENTATIONS AND WARRANTIES

 

1.1.         LICENSEE represents and warrants to YALE as follows:

 

(a)           LICENSEE is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware; has all corporate power to carry on its business as presently conducted and to own and operate its properties and assets;

 

(b)           The execution, delivery and performance by LICENSEE of this AGREEMENT have been duly authorized by all necessary corporate action by LICENSEE;

 

(c)           There is no pending or, to LICENSEE’s knowledge, threatened litigation involving LICENSEE which would have any material adverse effect on this AGREEMENT or on LICENSEE’s ability to perform its obligations hereunder; and

 

(d)           There is no indenture, contract or other agreement to which LICENSEE is a party or by which LICENSEE is bound which prohibits or would prohibit the execution and delivery by LICENSEE of this AGREEMENT or the performance or observance by LICENSEE of any material term of provision of this AGREEMENT.

 

2

 

1.2.         YALE represents and warrants to LICENSEE as follows:

 

(a)           The execution, delivery and performance by YALE of this AGREEMENT have been duly authorized by all necessary requisite action on the part of YALE and YALE has all right, power and authority necessary to grant the LICENSE and to perform its obligations hereunder;

 

(b)           There is no pending or, to YALE’s knowledge, threatened patent or contract litigation involving YALE which would have any material adverse effect on this AGREEMENT or on YALE’s ability to perform its obligations hereunder;

 

(c)           There is no indenture, contract or other agreement to which YALE is a party or by which YALE is bound which prohibits or would prohibit the execution and delivery by YALE of this AGREEMENT or the performance or observance by YALE of any material term or provision of this AGREEMENT;

 

(d)

 

(i)            YALE holds all right, title and interest in and to the LICENSED PATENTS existing as of the EFFECTIVE DATE and is the sole and exclusive owner thereof, subject only to the rights, if any, of the United States government and its agencies, as specified in Section 3.5; and

 

(ii)           Except as set forth on Appendix D, YALE has adequate right, title and interest in and to the LICENSED KNOW-HOW, LICENSED MATERIALS and LICENSED METHODS existing as of the EFFECTIVE DATE sufficient to grant the LICENSE thereof to LICENSEE under this AGREEMENT and LICENSEE does not have and will not have any present or future obligations to any third party arising out of such grant; and

 

(iii)          Except as set forth on Appendix D, as of the EFFECTIVE DATE, neither YALE’s Office of Cooperative Research, SCHLESSINGER nor LAX has received written notice of, and has no reasonable knowledge of any basis for, any claim that the use by LICENSEE of TECHNOLOGY, if and to the extent such use is known to YALE’s Office of Cooperative Research, SCHLESSINGER or LAX, infringes on any patent or misappropriates any other intellectual property or ownership right of any third party; and

 

(e)

 

(i)            Except to the extent such LICENSED PATENTS have been invented or co-invented by an individual who is not SCHLESSINGER, LAX, or an employee in the SCHLESSINGER LAB or the LAX LAB, YALE will hold all right, title and interest in and to the LICENSED PATENTS that arise after the EFFECTIVE DATE and YALE will be the sole and exclusive owner thereof, subject only to the rights, if any, of the United States government and its agencies, as specified in Section 3.5; and

 

(ii)           YALE will have adequate right, title and interest in and to the LICENSED PATENTS (to the extent such LICENSED PATENTS have been invented or co-invented by an individual who is not SCHLESSINGER, LAX, or an employee in the SCHLESSINGER LAB or the LAX LAB) and LICENSED MATERIALS that arise after the EFFECTIVE DATE, in each case sufficient to grant the LICENSE thereof to LICENSEE under this AGREEMENT and, except as YALE may inform LICENSEE in writing upon the provision of any such LICENSED MATERIALS to LICENSEE, LICENSEE will not have any present or future obligations to any third party arising out of such grant with respect to such LICENSED PATENTS or LICENSED MATERIALS; and

 

3

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

(f)            YALE will promptly notify LICENSEE in writing if, after the EFFECTIVE DATE, YALE’s Office of Cooperative Research, SCHLESSINGER or LAX receives written notice of, or has reasonable knowledge of any basis for, any claim that the use by LICENSEE of TECHNOLOGY, if and to the extent such use is known to YALE’s Office of Cooperative Research, SCHLESSINGER or LAX, infringes on any patent or misappropriates any other intellectual property or ownership right of any third party relating to RTK TECHNOLOGY; and

 

(g)           So as to minimize the chances of any future disputes, YALE will use good faith reasonable efforts to segregate any work SCHLESSINGER or LAX may undertake with respect to [**]-FUNDED PATENTS, and intellectual property related thereto, from any other work SCHLESSINGER or LAX may undertake with respect to RTK TECHNOLOGY and RTK PRODUCTS; and

 

(h)           Each YALE employee who is an inventor of potentially patentable intellectual property licensed pursuant to this AGREEMENT has agreed to assign to YALE (and, in the case of such potentially patentable intellectual property existing as of the EFFECTIVE DATE, has assigned to YALE), by written instrument sufficient in form, scope and substance for such purpose, all of such inventor’s right, title and interest in and to such potentially patentable intellectual property and any resulting patents.

 

ARTICLE 2          DEFINITIONS

 

The following terms used in this AGREEMENT shall be defined as set forth below:

 

2.1.         “AFFILIATE” shall mean any entity or person that directly or indirectly controls, is controlled by or is under common control with LICENSEE.  For purposes of this definition, “control” means possession of the power to direct the management of such entity or person, whether through ownership of more than fifty percent (50%) of voting securities, by contract or otherwise.

 

2.2.         “APPROVED PRODUCT” shall mean a PRODUCT, the sale, marketing, and use of which in humans (or other animals) has been approved by the FDA, or, as to a PRODUCT sold, marketed, or used in a country other than the United States, that has been approved to the extent necessary by the comparable required government authority in such country.

 

2.3.         “CHANGE OF CONTROL” shall mean:

 

(a)           any consolidation, merger, combination, reorganization or other business combination transaction to which LICENSEE is a party and in which LICENSEE is not the surviving entity; or

 

(b)           (i) all of the outstanding shares of voting stock of LICENSEE are exchanged for or changed into other stock or securities, cash, financial vehicle and/or any other property and (ii) persons who were stockholders of LICENSEE immediately prior to such exchange or change do not hold securities entitled to at least 50% of the voting power of the entity surviving such exchange or change or the entity into whose securities for or into which the voting stock of LICENSEE is exchanged or changed; or

 

4

 

(c)           a sale or other disposition (other than by license and/or sublicense) of all or substantially all of the assets of LICENSEE for cash, securities or other property;

 

and in any such case in the preceding clause (a), (b) or (c) the surviving entity in such transaction (if LICENSEE is not the surviving entity) or LICENSEE and the entity of which LICENSEE shall have become an AFFILIATE in such transaction or the person who shall have purchased or otherwise acquired all or substantially all of LICENSEE’s assets, as the case may be, shall meet all of the following:

 

1.             immediately after such transaction, shall have cash and cash equivalent assets at least equal to $200 million, determined on a pro forma consolidated basis; and

 

2.             during the two fiscal years immediately preceding such transaction, shall have had positive cash flow, determined on a pro forma consolidated basis; and

 

3.             immediately after such transaction, the amount of its cash and cash equivalent assets shall equal at least twice its cash requirements for the 12 consecutive full calendar months immediately following such transaction, determined on a pro forma consolidated basis.

 

2.4.         “CLAIMS” is defined in Section 14.1.

 

2.5.         “CONFIDENTIAL INFORMATION” shall mean all information disclosed by one party to the other during the negotiation of or under this AGREEMENT, the SECOND AMENDED AND RESTATED LICENSE AGREEMENT, the AMENDED AND RESTATED LICENSE AGREEMENT or the ORIGINAL LICENSE AGREEMENT in any manner, whether in writing or orally, visually or in tangible form, that relates to the TECHNOLOGY or this AGREEMENT or the SECOND AMENDED AND RESTATED LICENSE AGREEMENT or the AMENDED AND RESTATED LICENSE AGREEMENT or the ORIGINAL LICENSE AGREEMENT, unless such information is subject to an exception described in Section 8.2 and shall include the terms of any sublicense or proposed sublicense and any information or reports of or about any SUBLICENSEE that LICENSEE may from time to time provide to YALE pursuant to this AGREEMENT; provided, however, that CONFIDENTIAL INFORMATION that is disclosed in tangible form shall be marked “Confidential” at the time of disclosure and CONFIDENTIAL INFORMATION that is disclosed orally or visually shall be identified as confidential within thirty (30) days after the time of disclosure and subsequently reduced to writing, marked confidential and delivered to the other party within thirty (30)  days of such disclosure.  CONFIDENTIAL INFORMATION shall include, without limitation, materials, know-how and data, technical or non-technical, inventions, methods and processes, whether or not patentable and all information provided by LICENSEE to YALE pursuant to Sections 7.3 and 9.3.  Notwithstanding anything in this Section, CONFIDENTIAL INFORMATION shall be deemed to include any scientific data, information or know-how that a reasonable scientist would believe is confidential, whether in written, oral, visual or tangible form, disclosed by LICENSEE to SCHLESSINGER or LAX, unless such information is subject to an exception described in Section 8.2.

 

5

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

2.6.         “DESIGNATED THIRD PARTY RTK PRODUCT” shall mean an RTK PRODUCT where LICENSEE acquired or in-licensed from a third party (i.e., a party other than YALE) intellectual property claiming such RTK PRODUCT and either:

 

(a)           Such RTK PRODUCT is (or another RTK PRODUCT against the same RTK and acquired or in-licensed from the same source is) the subject of an IND, or similar filing outside the United States, either at the time of such acquisition or in-license or within six (6) months thereafter (an “IND PRODUCT”); or

 

(b)           Such RTK PRODUCT is not an IND PRODUCT, and, subsequent to such acquisition or in-licensing, LICENSEE does not file a patent application listing one or more LICENSEE employees as inventors where such patent application claims the composition of matter or method of use of such RTK PRODUCT;

 

provided, however, if, in the case of (a) or (b) above, (x) prior to such acquisition or in-licensing, LICENSEE has filed a patent application listing one or more LICENSEE employees as inventors where such patent application claims the composition of matter of such RTK PRODUCT or (y) after such acquisition or in-licensing, LICENSEE conducts (or contracts with a third party to conduct on behalf of LICENSEE) pre-clinical or clinical development on such RTK PRODUCT, then (in the case of (x) or (y)), such RTK PRODUCT shall not be a DESIGNATED THIRD PARTY RTK PRODUCT.

 

2.7.         “EARNED ROYALTY” is defined in Section 6.1.

 

2.8.         “EFFECTIVE DATE” shall mean have the meaning set forth in the recitals of this AGREEMENT.

 

2.9.         “FDA” shall mean the United States Food and Drug Administration or any comparable governmental agency in any territory with regulatory authority in or for a country or group of countries other than the United States.

 

2.10.       “FEDERAL PATENT POLICY” is defined in Section 3.5.

 

2.11.       “FIRST SALE” shall mean the first sale to a third party of any PRODUCT IN CLASS in any country in which such product is an APPROVED PRODUCT, or the first sale to a third party of a service using a LICENSED METHOD.  For the avoidance of doubt, if LICENSEE is providing services to a third party in the context of a sublicense of the TECHNOLOGY or a drug development collaboration with such third party, the provision of such services shall not qualify as a FIRST SALE.

 

2.12.       “GAAP” is defined in Section 9.3

 

2.13.       “[**]-FUNDED PATENTS” shall mean any United States or foreign patent application(s) and patents(s) filed by or on behalf of YALE during the TERM that claim RTK TECHNOLOGY, where such RTK TECHNOLOGY is made, created, developed, discovered, conceived or first reduced to practice by or on behalf of SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB and such activities (i.e., the making, creation, development, discovery, conception or first reduction to practice of such RTK TECHNOLOGY)

 

6

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

are funded in whole or in part by [**] pursuant to an agreement between [**] and YALE in effect as of the EFFECTIVE DATE.  To the extent that YALE has the right with respect to such patent applications or patents to grant rights to parties other than [**], such rights held by YALE shall not be deemed to be [**]-FUNDED PATENTS and shall thus be included in the definition of LICENSED PATENTS (to the extent such rights would otherwise fall within the definition of LICENSED PATENTS).  In order to establish clarity, when any patent application that is a [**]-FUNDED PATENT publishes, YALE shall notify LICENSEE within thirty (30) days of the date of such publication.

 

2.14.       “IND” shall mean an Investigational New Drug and/or Diagnostic application filed with the FDA prior to beginning clinical trials in humans (or other animals) in the United States or in or for any country or group of countries outside the United States.

 

2.15.       “IND APPROVAL” shall mean approval of an IND filed with the FDA.

 

2.16.       “INDEMNIFIED PERSONS” is defined in Section 14.1.

 

2.17.       “INVENTIONS” is defined in the recitals to this AGREEMENT.

 

2.18.       “INSOLVENT” shall mean that that LICENSEE (i) has admitted in writing its inability to pay its debts generally when due or (ii) has commenced bankruptcy, reorganization, receivership or insolvency proceedings, or any other proceeding under any Federal, state or other law for the relief of debtors.

 

2.19.       “KOLLTAN PATENTS” shall mean:

 

(a)           the United States or foreign patent application(s) and patents(s) listed in Appendix F;

 

(b)           any United States or foreign patent application(s) and patents(s) filed by or on behalf of LICENSEE after the EFFECTIVE DATE that claim RTK TECHNOLOGY, where the RTK TECHNOLOGY claimed in such patent application(s) or patents(s) was made, created, developed, discovered, conceived or first reduced to practice by a LICENSEE employee while SCHLESSINGER is or was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN;

 

(c)           any continuations, divisionals, and continuations-in-part, and continued prosecution application(s), to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications described in clause (a) or (b);

 

(d)           any reissues, re-examinations, renewals, or extensions of patent applications or patents described in clause (a), (b) or (c), or substitutes therefor; and

 

(e)           the relevant international equivalents of any of the patents or patent applications described in clause (a), (b), (c) or (d).

 

Appendix F is incorporated into this AGREEMENT.

 

7

 

2.20.       “LAX” is defined in the recitals to this AGREEMENT.

 

2.21.       “LAX LAB” shall mean LAX, and any other individuals performing research from time to time under LAX’s immediate supervision at YALE, for so long as LICENSEE provides the RESEARCH SUPPORT described in Section 3.4(b).  .

 

2.22.       “LICENSE” is defined in Section 3.4.

 

2.23.       “LICENSED KNOW-HOW” shall mean (i) except as set forth on Appendix D, any inventions (other than LICENSED PATENTS) and any information, know-how, technical and non-technical data, processes and any drawings, plans, diagrams, specifications, and/or other documents or data forms containing such information (collectively, the “KNOW-HOW”), discovered, developed or acquired by or on behalf of SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB (including, for the avoidance of doubt, under the RESEARCH AGREEMENT), in each case prior to or after the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE, that may be used for the discovery, development, selection, improvement of, or use as, an RTK PRODUCT or LICENSED METHOD; and (ii) the VISITING SCIENTIST IP, that: (x) in the case of both (i) and (ii), is not claimed in a LICENSED PATENT and (y) in the case of (i) only, is disclosed to LICENSEE by SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB and that, with respect to such KNOW-HOW that is discovered, developed or acquired after the EFFECTIVE DATE, is discovered, developed or acquired while SCHLESSINGER is or was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN.

 

2.24.       “LICENSED MATERIALS” shall mean, except as set forth on Appendix D, tangible materials (including, but not limited to, pharmaceutical, chemical and biochemical products) (collectively, the “MATERIALS”) discovered, developed or acquired by or on behalf of SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB (including, for the avoidance of doubt, under the RESEARCH AGREEMENT) prior to or after the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE that may be used for the discovery, development, selection, improvement of or use as an RTK PRODUCT or LICENSED METHOD, that is provided to LICENSEE by SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB and that, with respect to such materials that are discovered, developed or acquired after the EFFECTIVE DATE, are discovered, developed or acquired while SCHLESSINGER is or was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN.  To the extent that any materials provided by SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB to LICENSEE after the EFFECTIVE DATE are not owned 100% by YALE, YALE shall, at the time such materials are provided to LICENSEE, notify LICENSEE of such fact in writing (with such notice identifying the source of such materials and which other party(ies) might have an ownership interest in such materials) and this definition shall only apply to the extent of YALE’s ownership interest in such materials.  It is the parties’ intention, promptly following the EFFECTIVE DATE, to enter into a material transfer agreement to establish other terms and conditions with respect to tangible materials transferred between the parties.

 

2.25.       “LICENSED METHODS” shall mean any method, procedure, service or process (collectively, the “METHODS”), discovered, developed or acquired by or on behalf of

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB, whether existing on or after the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE, the practice of which, in the absence of a license from YALE, would infringe a VALID CLAIM of a LICENSED PATENT or which uses or is derived from LICENSED KNOW-HOW, LICENSED MATERIALS, and/or the LICENSED PATENTS, in each case that is disclosed to LICENSEE by SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB and, that, with respect to such methods that are discovered, developed or acquired after the EFFECTIVE DATE, are discovered, developed or acquired while SCHLESSINGER is or was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN.  To the extent that any METHODS provided by SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB to LICENSEE after the EFFECTIVE DATE are not owned 100% by YALE, YALE shall, at the time such METHODS are provided to LICENSEE, notify LICENSEE of such fact in writing (with such notice identifying the source of such METHODS and which other party(ies) might have an ownership interest in such METHODS) and this definition shall only apply to the extent of YALE’s ownership interest in such METHODS.

 

2.26.       “LICENSED PATENTS” shall mean:

 

(a)           the United States or foreign patent application(s) and patents(s) listed in Appendix A and owned by YALE during the TERM;

 

(b)           to the full extent owned or controlled (with the ability to grant licenses or sublicenses) by YALE, any United States or foreign patent application(s) and patents(s) filed by or on behalf of YALE after the EFFECTIVE DATE that claim RTK TECHNOLOGY, (i) where such RTK TECHNOLOGY is made, created, developed, discovered, conceived or first reduced to practice by or on behalf of SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB (including, for the avoidance of doubt, under the RESEARCH AGREEMENT) and, (ii) solely with respect to United States or foreign patent application(s) and patents(s) filed after the EFFECTIVE DATE and not arising under the RESEARCH AGREEMENT, where the RTK TECHNOLOGY claimed in such patent application(s) or patents(s) was made, created, developed, discovered, conceived or first reduced to practice while SCHLESSINGER is or was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN; but in all cases excluding the [**]-FUNDED PATENTS;

 

(c)           any continuations, divisionals, and continuations-in-part, and continued prosecution application(s), to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications described in clause (a) or (b);

 

(d)           any reissues, re-examinations, renewals, or extensions of patent applications or patents described in clause (a), (b) or (c), or substitutes therefor; and

 

(e)           the relevant international equivalents of any of the patents or patent applications described in clause (a), (b), (c) or (d).

 

Appendix A is incorporated into this AGREEMENT.

 

2.27.       “LICENSED TERRITORY” shall mean Worldwide.

 

2.28.       “LMR” is defined in Section 5.2.

 

2.29.       “MEANINGFULLY INVOLVED AT KOLLTAN” shall mean a situation whereby SCHLESSINGER has an active consulting agreement with LICENSEE, or is a member of the Scientific Advisory Board of LICENSEE, or has a similar arrangement whereby

 

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SCHLESSINGER provides advice on a regular basis to LICENSEE.  For the avoidance of doubt, and without limiting the foregoing, the parties agree that SCHLESSINGER has been MEANINGFULLY INVOLVED AT KOLLTAN from the date LICENSEE was incorporated (i.e., November, 2007) through the EFFECTIVE DATE.

 

2.30.       “MEANINGFULLY INVOLVED AT YALE” shall mean a situation whereby SCHLESSINGER is serving as an employee or faculty member (including an emeritus faculty member) at YALE.

 

2.31.       “MINIMUM DIRECT COSTS” is defined in Section 7.5.

 

2.32.       “MRP” is defined in Section 6.3.

 

2.33.       “NDA” shall mean (i) a New Drug Application or Biologic License Application filed with the FDA to obtain marketing approval for a PRODUCT IN CLASS in the United States; or (ii) a foreign equivalent of (i).

 

2.34.       “NET SALES” shall mean:

 

(a)           gross invoice price from the sale, lease or other transfer or disposition, other than by sublicense, of a PRODUCT IN CLASS or LICENSED METHOD, or from services performed using a PRODUCT IN CLASS or LICENSED METHOD, by LICENSEE or any SUBLICENSEE or AFFILIATE to third parties, except as set forth in Section 2.34(b), in each case from and after the FIRST SALE of such PRODUCT IN CLASS or LICENSED METHOD, less the following deductions, provided they actually pertain to the disposition of the PRODUCTS IN CLASS or LICENSED METHODS and, in the case of the items specified in the immediately succeeding clauses (i) and (ii), are separately stated on the applicable invoice:

 

(i)                                     all discounts, credits and allowances on account of returns;

 

(ii)                                  transportation and insurance; and

 

(iii)                               duties, taxes and other governmental charges levied on the sale, transportation or delivery of PRODUCTS IN CLASS or practice of the LICENSED METHODS, but not including income taxes.

 

No deductions shall be made for any other costs or expenses, including, but not limited to, commissions to independent sales agents or those on LICENSEE’s or a SUBLICENSEE’s or AFFILIATE’s payroll or for the cost of collection.

 

(b)           “NET SALES” shall not include the gross invoice price for PRODUCTS IN CLASS or LICENSED METHODS sold to, or services performed using PRODUCTS IN CLASS or LICENSED METHODS for, any AFFILIATE unless such AFFILIATE is an end-user of any PRODUCT IN CLASS or LICENSED METHOD, in which case such consideration shall be included in NET SALES at the average selling price charged to a third party during the same quarter.

 

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2.35.       “ORIGINAL LICENSE AGREEMENT” is defined in the recitals to this AGREEMENT.

 

2.36.       “ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE” is defined in the recitals to this AGREEMENT.

 

2.37.       “PHASE 1 STUDY” shall mean a human clinical trial in any country that is intended to initially evaluate the safety of an investigational PRODUCT IN CLASS in volunteer subjects or patients that would satisfy the requirements of 21 CFR 312.21(a), or other comparable regulation imposed by the FDA or its foreign counterpart.

 

2.38.       “PHASE 2 STUDY” shall mean a human clinical trial in any country that is conducted to evaluate the effectiveness of the PRODUCT IN CLASS for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug that would satisfy the requirements of 21 CFR 312.21(b), or other comparable regulation imposed by the FDA or its foreign counterpart.

 

2.39.       “PHASE 3 STUDY” shall mean a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a PRODUCT IN CLASS as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c) or other comparable regulation imposed by the FDA or its foreign counterpart.

 

2.40.       “PIVOTAL TRIAL” shall mean a controlled clinical trial to evaluate the safety and/or efficacy of a given PRODUCT IN CLASS and/or a given LICENSED METHOD in humans. Each such clinical trial should show safety and efficacy to a statistical significance and suffice as demonstration of such PRODUCT IN CLASS’s or such LICENSED METHOD’s safety and efficacy such that the results of said trial are the basis for the filing of an NDA for such a PRODUCT IN CLASS and/or such a LICENSED METHOD.

 

2.41.       “PLAN” is defined in Section 7.1.

 

2.42.       “PRODUCT” shall mean any form of product, including but not limited to, a service, a method, a diagnostic (or the like), a drug and other type of therapeutic for human (or other) disease or condition, including, without limitation, gene therapy constructs, small molecules, proteins, peptides, peptidomimetics, antisense constructs, antibody-drug conjugates or any other natural or synthetic molecule, and assays run in reference labs for fee-for-service diagnostic tests.

 

2.43.       “PRODUCT IN CLASS” shall mean any RTK PRODUCT (i) as to which LICENSEE commenced work on, or acquired or in-licensed such product (or intellectual property claiming the composition or method of use of such product) while SCHLESSINGER was MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN; or (ii) that is claimed by a VALID CLAIM in a LICENSED PATENT.  Notwithstanding the foregoing, for purposes of this AGREEMENT, PRODUCT IN CLASS shall not include (x) an RTK PRODUCT that is owned, in-licensed (unless in-licensed (directly or indirectly) from LICENSEE) or otherwise controlled by a third party that acquires control of LICENSEE through a CHANGE OF CONTROL, where such third party owned, in-licensed

 

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(unless in-licensed (directly or indirectly) from LICENSEE) or otherwise controlled such RTK PRODUCT prior to such CHANGE OF CONTROL; (y) an RTK PRODUCT that is owned, in-licensed or otherwise controlled by a third party that acquires control of LICENSEE through a CHANGE OF CONTROL, where such third party first owned, in-licensed or otherwise controlled such RTK PRODUCT following such CHANGE OF CONTROL; or (z) a DESIGNATED THIRD PARTY RTK PRODUCT, unless in either (x), (y) or (z) such RTK PRODUCT is claimed by a VALID CLAIM in a LICENSED PATENT.

 

2.44.       “REASONABLE COMMERCIAL EFFORTS” shall mean documented efforts:

 

(a)           that are consistent with those utilized by companies of similar size and type and at a similar stage of corporate development to LICENSEE, which companies have successfully developed therapeutic or prophylactic products similar to the proposed PRODUCTS IN CLASS described in the PLAN and/or services of a type similar to LICENSED METHODS described in the PLAN; and

 

(b)           that are consistent with the interests of LICENSEE’s stockholders and the development of a PRODUCT IN CLASS and/or commercial application of LICENSED METHODS and that constitute a prudent and commercially reasonable use of LICENSEE’s capital resources; and

 

(c)           that are evidenced by a record of incurring MINIMUM DIRECT COSTS, which shall include the RESEARCH SUPPORT, and additional documented expenditures appropriate to the stage of development of one or more PRODUCTS IN CLASS and/or commercial application of LICENSED METHODS.

 

2.45.       “REDUCED EARNED ROYALTY” is defined in Section 6.1.

 

2.46.       “RESEARCH AGREEMENT” shall mean (i) the Amended and Restated Research Agreement, dated as of the EFFECTIVE DATE, by and between YALE and LICENSEE, as the same may be amended, extended, renewed or replaced from time to time and (ii) the Research Agreement between YALE and LICENSEE dated as of June 4, 2008.

 

2.47.       “RESEARCH PROGRAM” shall mean the research program that has been and will continue to be conducted under the RESEARCH AGREEMENT.

 

2.48.       “RESEARCH SUPPORT” shall mean amounts payable by LICENSEE to YALE under the RESEARCH AGREEMENT.

 

2.49.       “RTK” shall mean a tyrosine kinase receptor.

 

2.50.       “RTK PRODUCT” shall mean any PRODUCT that may induce, prevent, modify or otherwise modulate the activation of one or more RTKs for the purpose of diagnosing, preventing or treating a disease or condition in humans or non-human animals.

 

2.51.       “RTK TECHNOLOGY” shall mean all inventions and any information, know-how, technical and non-technical data, methods and processes and any drawings, plans, diagrams, specifications, and/or other documents or data form containing such information that

 

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directly relates to (i) one or more RTKs and the activity, modification and/or modulation thereof or (ii) RTK PRODUCTS (including, but not limited to, the composition, method of use or method of manufacture of RTK PRODUCTS).

 

2.52.       “SCHLESSINGER” is defined in the recitals to this AGREEMENT.

 

2.53.       “SCHLESSINGER LAB” is defined in the recitals to this AGREEMENT.

 

2.54.       “SUBLICENSEE” shall mean any third party sublicensed by LICENSEE to make, have made, use, sell, offer for sale, have sold, import or export any PRODUCT IN CLASS or to practice any LICENSED METHOD.

 

2.55.       “SUBLICENSE INCOME” shall mean consideration in any form actually received by LICENSEE or an AFFILIATE in connection with a grant to any third party or parties of a sublicense or other right, license, privilege or immunity to make, have made, use, sell, have sold, distribute, import or export PRODUCTS IN CLASS or to practice the TECHNOLOGY, but excluding consideration that may be received by LICENSEE or an AFFILIATE as a royalty (or similar consideration) on sales of such PRODUCTS IN CLASS.  SUBLICENSE INCOME shall include, without limitation, but subject to the following sentence, any license signing fee, license maintenance fee, unearned portion of any minimum royalty payment received by LICENSEE, equity interest in a person and/or entity other than LICENSEE or an AFFILIATE and any distribution or joint marketing fee.  SUBLICENSE INCOME shall not include:

 

(a)           any payments or reimbursements for past, present or future research, development, manufacturing or commercial launch activity, including, without limitation, laboratory research, clinical research and development, process development, regulatory approvals or certifications, reimbursement for payments due to YALE pursuant to Section 5.5 or Section 5.8, and commercial launch expenses, except where, and to the extent that, such payments or reimbursements are in excess of LICENSEE’s external costs and reasonably attributable internal costs incurred in undertaking such activities;

 

(b)           any consideration received for an equity interest in, extension of credit to, or other investment in, LICENSEE or an AFFILIATE; or

 

(c)           any reimbursement for patent expenses or other costs or expenses of LICENSEE or an AFFILIATE associated with creating or maintaining intellectual property protection.

 

In case an extension of credit to LICENSEE by a SUBLICENSEE, as described in clause (b) above, is forgiven in whole or in part by the SUBLICENSEE, within thirty (30) days thereafter LICENSEE shall by notice to YALE provide information in reasonable detail showing the categories and uses of such funds for purposes of determining the amount thereof, if any, that constitutes SUBLICENSE INCOME. YALE may request in writing and LICENSEE shall not unreasonably refuse to provide in writing additional information about the categories and uses of such forgiven extension of credit.

 

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2.56.       “TECHNOLOGY” shall mean LICENSED KNOW-HOW, LICENSED MATERIALS, LICENSED METHODS, and/or LICENSED PATENTS.

 

2.57.       “TERM” is defined in Section 3.7.

 

2.58.       “TERMINATION EVENT” shall mean:

 

(a)           LICENSEE fails to make any payment whatsoever due and payable pursuant to this AGREEMENT and LICENSEE shall fail to make all such payments (and to pay all interest due on such payments under Section 6.4) for thirty (30) days after receipt of written notice of such failure from YALE; or

 

(b)           LICENSEE commits a material breach of any provision of this AGREEMENT (other than as provided in the immediately preceding clause (a)) which breach (1) if capable of being cured, shall continue uncured for sixty (60) days after LICENSEE receives written notice thereof from YALE, which notice shall identify such breach in reasonable detail, or (2) is not capable of being cured; or

 

(c)           LICENSEE fails to obtain or maintain insurance as described in Article 14; or

 

(d)           LICENSEE gives notice to YALE pursuant to Section 7.4(a) or (b); or

 

(e)           the occurrence of any of the events set forth in Section 7.4(a) or (b).

 

2.59.       “TERMINATION EVENT INFORMATION NOTICE” is defined in Section 13.4(a).

 

2.60.       “TERMINATION EVENT NOTICE” is defined in Section 13.4(b).

 

2.61.       “VALID CLAIM” shall mean, as the context requires, (i) an issued and unexpired claim of a LICENSED PATENT so long as such claim shall not have been irrevocably abandoned or declared to be invalid in an unappealable decision of a court or other authority of competent jurisdiction through no fault or cause of LICENSEE or (ii) an issued and unexpired claim of a KOLLTAN PATENT so long as such claim shall not have been irrevocably abandoned or declared to be invalid in an unappealable decision of a court or other authority of competent jurisdiction.

 

2.62.       “VISITING SCIENTIST IP” shall mean any intellectual property resulting from work done by LICENSEE employees in laboratory space in the Department of Pharmacology at the Yale School of Medicine during the period from November 17, 2008 through June 22, 2009 where such intellectual property was created by such LICENSEE employees.  Such VISITING SCIENTIST IP may include inventions, discoveries, developments, technical information, trade secrets, know-how, methods, techniques, formulae, data, information, processes, intellectual property and other proprietary ideas, whether patentable or patented or not patentable or not yet patented.  Some VISITING SCIENTIST IP is described in more detail in Appendix C, which is hereby incorporated into this AGREEMENT.  YALE and LICENSEE have previously entered into (1) a Visiting Scientist Agreement, effective November 14, 2008, as amended by

 

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Amendment One to Visiting Scientist Agreement, effective January 5, 2009 and (2) a separate Visiting Scientist Agreement, effective January 5, 2009 (collectively, the “Two Visiting Scientist Agreements”).  It is understood and agreed that any VISITING SCIENTIST IP shall be governed by the terms of this AGREEMENT, in addition to the Two Visiting Scientist Agreements, however, in the case of any inconsistencies between this AGREEMENT and one or both of the Two Visiting Scientist Agreements, the provisions of this AGREEMENT shall prevail.  LICENSEE hereby acknowledges that, during the term of each of the Two Visiting Scientist Agreements, LICENSED KNOW-HOW was provided to LICENSEE pursuant to the terms of the ORIGINAL LICENSE AGREEMENT, and LICENSEE hereby acknowledges having received and made use of such LICENSED KNOW-HOW from YALE.

 

ARTICLE 3          LICENSE GRANT AND TERM

 

3.1.         Subject to all the terms and conditions of this AGREEMENT, YALE hereby grants to LICENSEE an exclusive license under all of YALE’s interest in the LICENSED PATENTS, LICENSED MATERIALS and LICENSED METHODS to make, have made, use, sell, offer for sale, have sold, import or export therapeutic and prophylactic RTK PRODUCTS in the LICENSED TERRITORY, with the right to sublicense as provided in this AGREEMENT.

 

3.2.         Subject to all the terms and conditions of this AGREEMENT, YALE hereby grants to LICENSEE a non-exclusive license under all of YALE’s interest in the LICENSED PATENTS and LICENSED METHODS and LICENSED MATERIALS to make, have made, use, sell, offer for sale, have sold, import or export diagnostic RTK PRODUCTS within the LICENSED TERRITORY, with the right to sublicense as provided in this AGREEMENT.

 

3.3.         Subject to all the terms and conditions of this AGREEMENT, YALE hereby grants to LICENSEE a non-exclusive license under all of YALE’s interest in the LICENSED KNOW-HOW to make, have made, use, sell, offer for sale, have sold, import or export any RTK PRODUCT, method, procedure, service or process in the LICENSED TERRITORY, with the right to sublicense as provided in this AGREEMENT.

 

3.4.         (a)           Collectively, the rights granted to LICENSEE under Section 3.1, Section 3.2 and Section 3.3 shall be the “LICENSE”.  The LICENSE is further subject to all the terms and conditions of this AGREEMENT, including, without limitation, YALE’s right to terminate the LICENSE if a TERMINATION EVENT has occurred and is continuing by reason of, among other things, LICENSEE’s failure to pay all amounts due to YALE pursuant to Articles 5, 6, and 10 and LICENSEE’s failure to comply with Section 7.5.

 

(b)          Part of the consideration received by YALE for the grant of the LICENSE is LICENSEE’s obligation under the RESEARCH AGREEMENT to provide RESEARCH SUPPORT in the aggregate amount of Nine Million Dollars ($9,000,000), consisting of One Million Five Hundred Thousand Dollars per year over the six-year period provided in the RESEARCH AGREEMENT.  Notwithstanding that such obligation of LICENSEE under the RESEARCH AGREEMENT forms part of the consideration for this AGREEMENT, a failure by LICENSEE to pay all or any portion of the RESEARCH SUPPORT shall not constitute a failure of consideration for this AGREEMENT or give rise to a right of YALE to terminate this AGREEMENT; provided, however, that in case of termination of the RESEARCH AGREEMENT, LICENSEE shall have paid all costs for which LICENSEE is responsible under the RESEARCH AGREEMENT and which costs were incurred by YALE and unpaid by the LICENSEE through the date of termination, including, without limitation, all non-reimbursed costs and non-cancelable commitments of YALE relating to the RESEARCH AGREEMENT, that are incurred prior to the date of termination of the RESEARCH AGREEMENT, but in the case of personnel costs, no more than salary and benefits of such personnel provided for under the RESEARCH AGREEMENT for up to one year from date of notice of termination of the RESEARCH AGREEMENT. YALE shall use reasonable best efforts to mitigate such costs and commitments, consistent with YALE’s normal policies and practices with regard to termination or transfer of, or assistance in seeking other employment for, such personnel. Expiration or termination of the RESEARCH AGREEMENT in accordance with its terms shall not be deemed a termination of this AGREEMENT.

 

3.5.         To the extent that any invention included within the LICENSED PATENTS has been funded in whole or in part by the United States government, the United States government retains certain rights in such invention as set forth in 35 U.S.C. §200-212 and all regulations

 

15

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

promulgated thereunder, as amended, and any successor statutes and regulations (the “FEDERAL PATENT POLICY”).  As a condition of the grant of the LICENSE, LICENSEE acknowledges and shall comply with all aspects of the FEDERAL PATENT POLICY applicable to the LICENSED PATENTS, including the obligation that PRODUCTS IN CLASS used or sold in the United States be manufactured substantially in the United States.  Nothing contained in this AGREEMENT obligates or shall obligate YALE to take any action that would conflict in any respect with its past, current or future obligations to the United States Government under the FEDERAL PATENT POLICY with respect to the LICENSED PATENTS.

 

3.6.         The LICENSE is expressly made subject to YALE’s reservation of the right, on behalf of itself and all other non-profit academic research institutions, to make, use and practice the TECHNOLOGY for academic research, clinical, teaching or other non-commercial purposes, and not for purposes of commercial development, use, manufacture, sale or distribution.  Nothing in this AGREEMENT shall be construed to grant by implication, estoppel or otherwise any licenses under patents of YALE other than the LICENSED KNOW-HOW, LICENSED MATERIALS, LICENSED METHODS, and LICENSED PATENTS.

 

3.7.         The term of the LICENSE (the “TERM”) shall commence on the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE and, unless terminated earlier as provided in Article 13, shall automatically expire, on a country-by-country basis, on the date that is the latest of whichever of the following is applicable:

 

(a)           the date on which the last of the VALID CLAIMS of the patents included in the LICENSED PATENTS in such country expires, lapses or is declared to be invalid by a final decision of a court or other authority of competent jurisdiction, not subject to further appeal, through no fault or cause of LICENSEE; and

 

(b)           the date that is fifteen (15) years after the last LICENSED KNOW-HOW, LICENSED MATERIALS, or LICENSED METHODS have been provided to LICENSEE by YALE under this AGREEMENT; and

 

(c)           the date that is fifteen (15) years from the date of FIRST SALE of a PRODUCT IN CLASS;

 

but in no event shall the TERM end later than the date that is thirty (30) years after the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE.

 

3.8.         YALE hereby agrees that, after the EFFECTIVE DATE and for so long as SCHLESSINGER is MEANINGFULLY INVOLVED AT YALE and MEANINGFULLY INVOLVED AT KOLLTAN, except for [**]-FUNDED PATENTS, YALE will not grant any third party (including [**]) any rights, for any therapeutic or prophylactic uses, in any patent application or patents (or, for the avoidance of doubt, related filings described in clause (c), (d) or (e) of the definition of LICENSED PATENTS) filed by or on behalf of YALE that claim RTK TECHNOLOGY made, created, developed, discovered, conceived or first reduced to practice by or on behalf of SCHLESSINGER, LAX, the SCHLESSINGER LAB or the LAX LAB (including, for the avoidance of doubt, under the RESEARCH AGREEMENT).

 

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3.9.         In the event that YALE materially breaches a representation or warranty contained in Section 1.2 with respect to the TECHNOLOGY (a “Section 1.2 Breach”), which in turn creates potential liability for LICENSEE (including, potentially, for its AFFILIATES or SUBLICENSEES) to YALE or a third party (“Section 1.2 Liability”), YALE hereby agrees it will never institute any action or suit at law or in equity against LICENSEE or its AFFILIATES or its SUBLICENSEES alleging Section 1.2 Liability with respect to the use by LICENSEE or its AFFILIATES or SUBLICENSEES of the component(s) of the TECHNOLOGY that was(were) the subject of the Section 1.2 Breach, nor institute, prosecute or in any way aid in the institution or prosecution of any claim, demand, suit, action, or cause of action for damages, costs, other compensation or injunctive relief for or on account of any Section 1.2 Liability, whether developed or undeveloped, resulting or to result, known or unknown, past, present or future, arising out of the use by LICENSEE or its AFFILIATES or its SUBLICENSEES of the component(s) of the TECHNOLOGY that was(were) the subject of the Section 1.2 Breach.  For the avoidance of doubt, the preceding sentence shall in no way limit LICENSEE’s ability to seek other remedies with respect to YALE, nor shall it in any way limit LICENSEE’s obligations to comply in good faith with all provisions of this AGREEMENT with which it is able to comply notwithstanding the Section 1.2 Breach.

 

3.10.       No earlier than twenty-seven (27) months after the EFFECTIVE DATE and no later than thirty (30) months after the EFFECTIVE DATE, YALE may, by written notice to LICENSEE, elect to deem SCHLESSINGER to no longer be MEANINGFULLY INVOLVED AT KOLLTAN and MEANINGFULLY INVOLVED AT YALE as of the third anniversary of the EFFECTIVE DATE.  Following delivery of such notice, for purposes of this AGREEMENT, SCHLESSINGER shall be deemed to be no longer MEANINGFULLY INVOLVED AT KOLLTAN and MEANINGFULLY INVOLVED AT YALE as of the third anniversary of the EFFECTIVE DATE.

 

3.11.       In the event of a CHANGE OF CONTROL, upon the occurrence of such CHANGE OF CONTROL, for purposes of this AGREEMENT, SCHLESSINGER shall be deemed to be no longer MEANINGFULLY INVOLVED AT KOLLTAN and MEANINGFULLY INVOLVED AT YALE as of the date of such occurence.

 

ARTICLE 4          SUBLICENSES

 

4.1.         Any sublicense by LICENSEE of the rights granted to it under this AGREEMENT shall comply with the provisions of Sections 4.2, 4.3 and 4.4.

 

4.2.         Subject to Section 4.5, any sublicense granted by LICENSEE shall include terms under which the SUBLICENSEE agrees with the LICENSEE, and shall include provisions in favor of LICENSEE, as sublicensor thereunder, substantially the same as are provided in Section 7.1, Section 7.2, Section 7.3, Section 7.4, Article 8, Section 9.1, Section 9.2, Section 10.6, Article 12 and Article 14 of this AGREEMENT with respect to the subject matter of such sublicense and the related definitions in this AGREEMENT.  LICENSEE will provide YALE with a copy of each sublicense agreement (and all amendments thereof) within thirty (30) days of execution of such agreement or amendment.  LICENSEE shall not be responsible for the performance of any SUBLICENSEE under any such sublicense and shall be obligated to pay

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

royalties and other amounts that arise from such sublicense and are due to YALE only as and to the extent such SUBLICENSEE pays the same to LICENSEE.

 

4.3.         LICENSEE shall pay royalties to YALE on NET SALES of SUBLICENSEES based on the same royalty rate as apply to NET SALES by LICENSEE and its AFFILIATES under Article 6, regardless of the royalty rates payable by SUBLICENSEES to LICENSEE under a sublicense agreement.  In addition, LICENSEE shall pay to YALE [**] Percent ([**]%) of any SUBLICENSE INCOME.

 

4.4.         LICENSEE agrees that it shall:

 

(a)           within thirty (30) days of execution by the parties, provide YALE with a copy of any amendments to sublicenses granted by LICENSEE under this AGREEMENT, and within thirty (30) days after termination of any sublicense, notify YALE of such termination; and

 

(b)           within thirty (30) days of receipt, provide complete copies of all reports provided to LICENSEE by SUBLICENSEES pursuant to any sublicense; provided, however, that LICENSEE may omit or redact from the copies so provided to YALE any portion of the reports of a SUBLICENSEE which portion contains information that LICENSEE would not have otherwise been required to report to YALE under Section 7.3 if such report were provided by LICENSEE directly; and

 

(c)           use commercially reasonable efforts to seek compliance in all material respects by each SUBLICENSEE with the terms of the sublicense to which such SUBLICENSEE is a party.

 

4.5.         If LICENSEE proposes to enter into a sublicense that does not include terms that require SUBLICENSEE thereunder to agree substantially as provided in Sections 7.1 and 7.2 of this AGREEMENT (and the related definitions) with respect to the subject matter of such sublicense, then LICENSEE shall submit the proposed form of such sublicense to YALE for review and approval prior to entering into such sublicense.  YALE’s review and approval of any such sublicense shall be limited to the terms of the due diligence obligations of SUBLICENSEE thereunder, provided that such sublicense otherwise complies with the requirements of Sections 4.2 and 4.3 of this AGREEMENT.  YALE shall notify LICENSEE of any objections it may have to the due diligence terms of a proposed sublicense within fifteen (15) days after LICENSEE submits such sublicense to YALE for its review and approval, and LICENSEE shall notify YALE of LICENSEE’s response to said objections within fifteen (15) days after receipt of YALE’s objections. YALE shall not unreasonably withhold its consent to any such sublicense provided that LICENSEE substantively responds to YALE’s objections.

 

ARTICLE 5          LICENSE ISSUE ROYALTY; LICENSE MAINTENANCE ROYALTY; MILESTONE ROYALTIES

 

5.1.         The parties acknowledge that LICENSEE paid to YALE, within ninety (90) days after the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE, a non-refundable license issue royalty of Fifty Thousand Dollars ($50,000.00).

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

5.2.         During the TERM, LICENSEE agrees to pay to YALE an annual license maintenance royalty (“LMR”) commencing with the first anniversary of the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE according to the following schedule:

 

	
Anniversary of the ORIGINAL LICENSE
   AGREEMENT EFFECTIVE DATE
    	
 
    	
LMR
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    

 

until LICENSEE starts to pay MRP under Section 6.3.  The parties acknowledge that, as of the EFFECTIVE DATE, LICENSEE has paid YALE the first three (3) LMR payments.

 

5.3.         LICENSEE shall pay YALE, for each therapeutic or prophylactic PRODUCT IN CLASS that is developed by LICENSEE or an AFFILIATE, a non-refundable milestone royalty of Three Million Dollars ($3,000,000.00) when LICENSEE has collected at least [**] Dollars ($[**]) in NET SALES of such PRODUCT IN CLASS, determined on an accrual basis consistent with the GAAP used in the preparation of the financial statements furnished by LICENSEE to YALE pursuant to Section 9.3, subject to Section 5.11.

 

5.4.         Notwithstanding Section 5.3, in case a CHANGE OF CONTROL shall occur, then for each therapeutic or prophylactic PRODUCT IN CLASS for which IND APPROVAL for a PHASE 1 STUDY occurs after such CHANGE OF CONTROL, in lieu of making payment in respect of such therapeutic or prophylactic PRODUCT IN CLASS of the milestone royalty provided in Section 5.3, and subject to Section 5.11, LICENSEE shall pay the following milestone royalties:

 

(a)           a non-refundable milestone royalty of [**] Dollars ($[**]) upon [**]; and

 

(b)           a non-refundable milestone royalty of [**] Dollars ($[**]) upon the [**]; and

 

(c)           a non-refundable milestone royalty of [**] Dollars ($[**]) upon the [**]; and

 

(d)           a non-refundable milestone royalty of [**] Dollars ($[**]) upon the [**]; and

 

(e)           a non-refundable milestone royalty of [**] Dollars ($[**]) upon the [**].

 

For the avoidance of doubt, each of the foregoing milestone royalties shall be payable only once for each therapeutic or prophylactic PRODUCT IN CLASS, even if such PRODUCT IN CLASS achieves a given milestone more than once.

 

5.5.         In case of a sublicense by LICENSEE with respect to a proposed or actual therapeutic or prophylactic PRODUCT IN CLASS for which, on the effective date of such sublicense, a milestone royalty under Section 5.3 shall not yet have become due and payable by LICENSEE, then from and after the date of such sublicense, LICENSEE shall pay milestone

 

19

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

royalties for such therapeutic or prophylactic PRODUCT IN CLASS in accordance with Section 5.4 and Section 5.3 shall be inapplicable to such PRODUCT IN CLASS.  In case of any such sublicense, if on the effective date of such sublicense, one or more of the milestones specified in Section 5.4 shall have been met, then, within thirty (30) days after the effective date of the sublicense for each such therapeutic or prophylactic PRODUCT IN CLASS, LICENSEE shall pay YALE the milestone royalties for all milestones specified in Section 5.4 which shall have been achieved for such PRODUCT IN CLASS prior to the effective date of such sublicense.

 

5.6.                            LICENSEE shall pay YALE, for each diagnostic PRODUCT IN CLASS that is developed by LICENSEE, a non-refundable milestone royalty of Three Hundred Thousand Dollars ($300,000.00) when LICENSEE and/or an AFFILIATE has received at least [**] Dollars ($[**]) in NET SALES of such PRODUCT IN CLASS, determined on an accrual basis consistent with the GAAP used in the preparation of the financial statement, furnished by LICENSEE to YALE pursuant to Section 9.3, subject to Section 5.11.

 

5.7.                            Notwithstanding Section 5.6, in case a CHANGE OF CONTROL shall occur, then for each diagnostic PRODUCT IN CLASS for which, after such CHANGE OF CONTROL, LICENSEE receives IND APPROVAL for the first clinical trial of such PRODUCT IN CLASS, then in lieu of making payment in respect of such PRODUCT IN CLASS of the milestone royalty provided in Section 5.6, and subject to Section 5.11, LICENSEE shall pay the following milestone royalties:

 

(a)                                 a non-refundable milestone royalty of [**] Dollars ($[**]) when [**]; and

 

(b)                                 a non-refundable milestone royalty of [**] Dollars ($[**]) when [**]; and

 

(c)                                  a non-refundable milestone royalty of [**] Dollars ($[**]) when [**].

 

For the avoidance of doubt, each of the foregoing milestone royalties shall be payable only once for each diagnostic PRODUCT IN CLASS, even if such PRODUCT IN CLASS achieves a given milestone more than once.

 

5.8.                            In case of a sublicense by LICENSEE with respect to a proposed or actual diagnostic PRODUCT IN CLASS for which, on the effective date of such sublicense, a milestone royalty under Section 5.6 shall not yet have become due and payable by LICENSEE, then from and after the date of such sublicense, LICENSEE shall pay milestone royalties for each such diagnostic PRODUCT IN CLASS in accordance with Section 5.7 and Section 5.6 shall be inapplicable to such PRODUCT IN CLASS.  In case of any such sublicense, if on the effective date of such sublicense, one or more of the milestones specified in Section 5.7 shall have been met, then, within thirty (30) days after the effective date of the sublicense for such diagnostic PRODUCT IN CLASS, LICENSEE shall pay YALE the milestone royalties for all milestones specified in Section 5.7 which shall have been achieved for such PRODUCT IN CLASS prior to the effective date of such sublicense.

 

5.9.                            In case a particular PRODUCT IN CLASS is both a therapeutic or prophylactic and a diagnostic and such therapeutic or prophylactic PRODUCT IN CLASS is or is intended to be marketed and sold separate from diagnostic PRODUCT IN CLASS and such diagnostic

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

PRODUCT IN CLASS is or is intended to be marketed and sold for a use other than determining the suitability of the use of such therapeutic or prophylactic PRODUCT IN CLASS in particular patients, then milestone royalties for both the therapeutic or prophylactic and the diagnostic PRODUCT IN CLASS under Sections 5.3, 5.4, 5.6 or 5.7 shall be due to YALE under this AGREEMENT.

 

5.10.                     None of the license issue royalty set forth in Section 5.1, the LMR set forth in Section 5.2 or the milestone royalties set forth in Sections 5.3, 5.4, 5.6 or 5.7 shall be credited against EARNED ROYALTIES payable under Article 6.  LICENSEE shall pay the amounts payable to YALE under Sections 5.3 and 5.6 within ninety (90) days after the end of LICENSEE’s fiscal year in which the applicable NET SALES threshold is met.

 

5.11.                     Notwithstanding any other provision of this AGREEMENT, for purposes of determining what constitutes a single or separate therapeutic or prophylactic and/or diagnostic PRODUCTS IN CLASS or a single or separate services using LICENSED METHODS:

 

(a)                                 any two or more therapeutic or prophylactic PRODUCTS IN CLASS or therapeutic or prophylactic LICENSED METHOD which have as an active ingredient the same molecule, chemical entity or compound as one another shall be deemed a single therapeutic PRODUCT IN CLASS or single therapeutic LICENSED METHOD, as the case may be, even if researched, developed, marketed, delivered or sold for different indications or with different formulations or under different regulatory approvals.

 

(b)                                 any two or more diagnostic PRODUCTS IN CLASS or two or more diagnostic LICENSED METHODS which have as an active ingredient the same molecule, chemical entity or compound as one another shall be deemed a single diagnostic PRODUCT IN CLASS or single service using a LICENSED METHOD, as the case may be, even if researched, developed, marketed, delivered, or sold for different indications or with different formulations or under different regulatory approvals.

 

ARTICLE 6                              EARNED ROYALTIES; MINIMUM ROYALTY PAYMENTS

 

6.1.                            During the TERM, and subject to the following sentence, as partial consideration for the LICENSE, LICENSEE shall pay to YALE an earned royalty on worldwide cumulative NET SALES of each PRODUCT IN CLASS or LICENSED METHOD developed by LICENSEE or its SUBLICENSEES or AFFILIATES equal to [**] percent ([**]%) of such NET SALES (the “EARNED ROYALTY”).  If for such a PRODUCT IN CLASS or LICENSED METHOD there is not a VALID CLAIM in either a LICENSED PATENT or a KOLLTAN PATENT, in each case claiming such PRODUCT IN CLASS or LICENSED METHOD, then the EARNED ROYALTY on such a PRODUCT IN CLASS or LICENSED METHOD shall be reduced (a “REDUCED EARNED ROYALTY”).  The REDUCED EARNED ROYALTY on worldwide cumulative NET SALES of each PRODUCT IN CLASS or LICENSED METHOD developed by LICENSEE or its SUBLICENSEES or AFFILIATES shall be equal to [**] percent ([**]%) of such NET SALES from and after the date there is no such VALID CLAIM.  Unless otherwise stated in this AGREEMENT, any reference to “EARNED ROYALTIES” shall refer to either or both EARNED ROYALTIES and REDUCED EARNED ROYALTIES, as the case may be.

 

21

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

6.2.                            LICENSEE shall pay all EARNED ROYALTIES accruing to YALE within thirty (30) days from the end of each calendar quarter (March 31, June 30, September 30 and December 31), beginning in the first calendar quarter in which NET SALES occur.

 

6.3.                            During the TERM, LICENSEE agrees to pay YALE annual Minimum Royalty Payments (“MRP”), commencing on the first anniversary of the ORIGINAL LICENSE AGREEMENT EFFECTIVE DATE to occur at least six (6) months after the date of the FIRST SALE of the first PRODUCT IN CLASS or first service using a LICENSED METHOD that results in NET SALES for such a first PRODUCT IN CLASS or LICENSED METHOD.

 

(a)                                 If the PRODUCT IN CLASS or service using a LICENSED METHOD the FIRST SALE of which gives rise to LICENSEE’s obligation to pay an MRP is a therapeutic or prophylactic PRODUCT IN CLASS or service using a LICENSED METHOD, then the MRP shall be made according to the following schedule:

 

	
Years after FIRST SALE
    	
 
    	
MRP
    
	
Year 1
    	
 
    	
[**]
    
	
Year 2
    	
 
    	
[**]
    
	
Years 3-5
    	
 
    	
[**]
    
	
Year 6 and every year   thereafter
    	
 
    	
[**]
    

 

(b)                                 If the PRODUCT IN CLASS or service using a LICENSED METHOD the FIRST SALE of which gives rise to LICENSEE’s obligation to pay an MRP is a diagnostic PRODUCT IN CLASS or service using a LICENSED METHOD, then the MRP shall be made according to the following schedule:

 

	
Years after FIRST SALE
    	
 
    	
MRP
    
	
Year 1
    	
 
    	
[**]
    
	
Year 2
    	
 
    	
[**]
    
	
Years 3-5
    	
 
    	
[**]
    
	
Year 6 and every year   thereafter
    	
 
    	
[**]
    

 

(c)                                  Once the LICENSEE has made a FIRST SALE of both a therapeutic or prophylactic PRODUCT IN CLASS or a service using a LICENSED METHOD and a diagnostic PRODUCT IN CLASS or service using a LICENSED METHOD, then thereafter MRP shall be the sum of the amounts indicated in Sections 6.3(a) and 6.3(b). If the FIRST SALE of a PRODUCT IN CLASS or service using a LICENSED METHOD is both a therapeutic or prophylactic and a diagnostic and such therapeutic or prophylactic PRODUCT IN CLASS or service using a LICENSED METHOD is, or is intended to be, marketed and sold separate from such diagnostic PRODUCT IN CLASS or service using a LICENSED METHOD, as the case may be, and such diagnostic PRODUCT IN CLASS or service using a LICENSED METHOD is, or is intended to be, marketed and sold for a use other than determining the suitability of the use of such therapeutic or prophylactic PRODUCT IN CLASS or service using a LICENSED METHOD in particular patients, then thereafter MRP shall be the sum of the amounts indicated in Sections 6.3(a) and 6.3(b).

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

(d)                                 Once the MRP commences, LICENSEE shall continue to pay the MRP for PRODUCTS IN CLASS or services using LICENSED METHODS until the end of the TERM, subject to Section 6.3(e).  YALE shall fully credit MRP paid against any EARNED ROYALTIES payable by LICENSEE in the same year.

 

(e)                                  If at any time after the MRP commences all PRODUCTS IN CLASS and services using a LICENSED METHOD for which a FIRST SALE has occurred are temporarily or permanently removed from the market and there is no longer any PRODUCT IN CLASS or service using a LICENSED METHOD subject to EARNED ROYALTY under the terms of this AGREEMENT, then the MRP due under Section 6.3 shall be suspended and LICENSEE shall resume payment of the applicable LMR under Section 5.2. The payment of LMR as so resumed shall continue until such time as marketing of any removed PRODUCT IN CLASS or service using a LICENSED METHOD has resumed or LICENSEE shall have made a FIRST SALE of another PRODUCT IN CLASS or service using a LICENSED METHOD, subject to suspension of the MRP through subsequent operation of this Section 6.3(e).  MRP that is suspended or resumed and LMR that arises by reason of this Section 6.3(e), in any such case for a period of less than 12 months, shall be prorated.

 

(f)                                   If at any time the applicable rate of EARNED ROYALTIES for all PRODUCTS IN CLASS and services using any LICENSED METHOD shall become the REDUCED EARNED ROYALTY, then the applicable MRP shall thereafter be [**] percent ([**]%) of the applicable amount from the above schedules, prorated for any period of less than 12 months.

 

6.4.                            All EARNED ROYALTIES and other payments due under this AGREEMENT shall be paid to YALE in United States Dollars.  In the event that conversion from foreign currency is required in calculating a payment under this AGREEMENT, the exchange rate used shall be the Interbank rate quoted by Citibank, N.A. at the end of the last business day of the quarter in which the royalty was earned.  If overdue, the EARNED ROYALTIES and any other payments due under this AGREEMENT shall bear interest until payment at a per annum rate equal to [**], and YALE shall be entitled to recover reasonable attorneys’ fees and costs related to the collection of overdue EARNED ROYALTIES or other overdue amounts payable by LICENSEE under this AGREEMENT, following such failure to pay.  The payment of such interest shall not foreclose YALE from exercising any other right it may have as a consequence of the failure of LICENSEE to make any payment when due.

 

ARTICLE 7                              DUE DILIGENCE

 

7.1.                            LICENSEE has designed a plan for pre-clinical and clinical development of one or more PRODUCTS IN CLASS by use of the TECHNOLOGY, which plan (i) includes a description of research and development, testing, government approval and manufacturing of PRODUCTS IN CLASS and/or LICENSED METHODS and (ii) after completion of a PIVOTAL TRIAL for a PRODUCTS IN CLASS and/or LICENSED METHODS, will additionally include a description of the plan for the marketing and sale or lease of such PRODUCTS IN CLASS and/or LICENSED METHODS (as such plan may be supplemented or modified from time to time pursuant to Section 7.3, the “PLAN”).  A copy of the PLAN as of the

 

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EFFECTIVE DATE is attached to this AGREEMENT as Appendix B and incorporated herein by reference.

 

7.2.                            LICENSEE shall use REASONABLE COMMERCIAL EFFORTS to pursue development and commercialization of PRODUCTS IN CLASS and LICENSED METHODS.  The efforts of AFFILIATES and SUBLICENSEES shall be considered LICENSEE efforts for purposes of determining whether LICENSEE is using REASONABLE COMMERCIAL EFFORTS as required by this Section 7.2.  LICENSEE shall not pursue development and commercialization of an RTK PRODUCT that is not a PRODUCT IN CLASS for the sole purpose of avoiding the payment of a royalty to YALE pursuant to Section 6.1.

 

7.3.                            No later than one hundred twenty (120) days after the end of each calendar year during the TERM, LICENSEE shall provide to YALE a written report describing LICENSEE’s, SUBLICENSEE’s, and/or AFFILIATE’s activities and progress on research and development, regulatory approvals, manufacturing, sublicensing, marketing and sales, as applicable, of one or more PRODUCTS IN CLASS or LICENSED METHODS during such year and indicating LICENSEE’s progress and problems to date in implementing the PLAN during such year.  If during the course of the year covered by such report LICENSEE, SUBLICENSEE or AFFILIATE shall have been involved in REASONABLE COMMERCIAL EFFORTS for more than one actual or proposed PRODUCT IN CLASS or LICENSED METHOD, such report for such year shall provide the information set forth above for each such actual or proposed PRODUCT IN CLASS or LICENSED METHOD.  If progress or developments differ from those anticipated in the PLAN, as supplemented by prior reports LICENSEE has provided pursuant to this Section 7.3, then in such report LICENSEE shall identify in reasonable detail the principal differences, state the reasons for the differences and set forth a modified research, development, regulatory approval, manufacturing, sublicensing, marketing and sales plan.  Such report shall also include a forecast and schedule of major events required to market the PRODUCTS IN CLASS or LICENSED METHODS under development during such year.  Such report shall also include the aggregate MINIMUM DIRECT COSTS actually incurred to the end of the most recent calendar year preceding such report.  LICENSEE shall also promptly provide any reasonable additional data that YALE by written notice to LICENSEE requests in order to evaluate LICENSEE’s exercise of REASONABLE COMMERCIAL EFFORTS during such year.  Within thirty (30) days following any assignment by LICENSEE pursuant to Section 17.6, the assignee shall provide YALE with an updated and revised copy of the PLAN.

 

7.4.                            LICENSEE shall immediately notify YALE if at any time LICENSEE (a) abandons or suspends, or determines to abandon or suspend, its research, development and marketing of the PRODUCTS IN CLASS and LICENSED METHODS, (b) fails to comply with its due diligence obligations under this Article for a period exceeding ninety (90) days, or (c) abandons or suspends, or determines to abandon or suspend, its clinical research, development or marketing of a particular PRODUCT IN CLASS or a particular LICENSED METHOD.

 

7.5.                            LICENSEE shall during the TERM incur costs (including external costs and reasonably attributable internal costs) towards research, clinical development, regulatory approvals, manufacturing, intellectual property filings or maintenance fees, or marketing of one or more PRODUCT IN CLASS and/or LICENSED METHODS (“MINIMUM DIRECT COSTS”) according to the following schedule:

 

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Period from ORIGINAL
   LICENSE AGREEMENT
   EFFECTIVE DATE to end
   of
    	
 
    	
Cumulative MINIMUM
   DIRECT COSTS
    	
 
    
	
Year 5
    	
 
    	
$
    	
15,000,000
    	
 
    
	
Year 8
    	
 
    	
$
    	
25,000,000
    	
 
    

 

In determining the amount of such costs that LICENSEE has incurred, costs of LICENSEE shall be calculated on an accrual basis, consistent with the GAAP used in the preparation of LICENSEE’s financial statements furnished to YALE pursuant to Section 9.3, and amounts paid by LICENSEE as RESEARCH SUPPORT of the RESEARCH PROGRAM and such documented costs incurred by SUBLICENSEES and/or AFFILIATES towards a PRODUCT IN CLASS or a LICENSED METHOD shall all be considered costs incurred by LICENSEE.

 

ARTICLE 8                              CONFIDENTIALITY AND PUBLICITY

 

8.1.                            Subject to the parties’ rights and obligations pursuant to this AGREEMENT, YALE and LICENSEE agree that during the TERM and for five (5) years thereafter, each of them:

 

(a)                                 will keep confidential and will cause their AFFILIATES and, in the case of LICENSEE, require its SUBLICENSEES to agree in writing with LICENSEE, to keep confidential, CONFIDENTIAL INFORMATION disclosed to it by the other party, by taking whatever action the party receiving the CONFIDENTIAL INFORMATION would take to preserve the confidentiality of its own CONFIDENTIAL INFORMATION, which in no event shall be less than reasonable care; and

 

(b)                                 will only disclose that part of the other’s CONFIDENTIAL INFORMATION to its officers, employees or agents that is necessary for those officers, employees or agents who need to know to carry out its responsibilities under this AGREEMENT; and

 

(c)                                  will not use the other party’s CONFIDENTIAL INFORMATION other than as expressly set forth in this AGREEMENT or disclose the other’s CONFIDENTIAL INFORMATION to any third parties under any circumstance without advance written permission from the other party; and

 

(d)                                 will, within sixty (60) days of termination of this AGREEMENT, return all the CONFIDENTIAL INFORMATION disclosed to it by the other party pursuant to this AGREEMENT except for one copy which may be retained by the recipient for monitoring compliance with this Article 8.

 

8.2.                            The obligations of confidentiality described above shall not pertain to that part of the CONFIDENTIAL INFORMATION that:

 

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(a)                                 was known to the recipient prior to the disclosure by the disclosing party; or

 

(b)                                 is at the time of disclosure or has become thereafter publicly known through no fault or omission attributable to the recipient; or

 

(c)                                  is rightfully given to the recipient from sources independent of the disclosing party; or

 

(d)                                 is independently developed by the receiving party without use of or reference to the CONFIDENTIAL INFORMATION of the other party; or

 

(e)                                  is required to be disclosed by law in the opinion of recipient’s attorney, but only after the disclosing party is given prompt written notice and an opportunity to seek a protective order; or

 

(f)                                   is provided under the RESEARCH AGREEMENT (which CONFIDENTIAL INFORMATION shall be governed by the provisions of the RESEARCH AGREEMENT governing confidential information).

 

8.3.                            Except as required by law, neither party may disclose the financial terms of this AGREEMENT without the prior written consent of the other party, except that LICENSEE may disclose such terms to persons who agree in writing with LICENSEE to keep such information confidential.

 

ARTICLE 9                              REPORTS, RECORDS AND INSPECTIONS

 

9.1.                            LICENSEE shall, within thirty (30) days after the calendar year in which NET SALES first occur, and within thirty (30) days after each calendar quarter (March 31, June 30, September 30 and December 31) thereafter, provide YALE with a written report detailing the NET SALES and uses, if any, made by LICENSEE, its SUBLICENSEES and AFFILIATES of LICENSED PRODUCTS and LICENSED METHODS during the preceding calendar quarter and calculating the payments due pursuant to Article 6.  NET SALES of PRODUCTS IN CLASS or LICENSED METHODS shall be deemed to have occurred as determined in accordance with the GAAP used in the preparation of the financial statement furnished by LICENSEE to YALE pursuant to Section 9.3.  Each such report shall be signed by an officer of LICENSEE (or the officer’s designee), and must include:

 

(a)                                 the number of PRODUCTS IN CLASS manufactured, sold, leased or otherwise transferred or disposed of, and the amount of LICENSED METHODS sold, by LICENSEE, SUBLICENSEES and AFFILIATES;

 

(b)                                 a calculation of NET SALES for the applicable reporting period in each country, including the gross invoice prices charged for the PRODUCTS IN CLASS and LICENSED METHODS and any permitted deductions made pursuant to Section 2.34;

 

26

 

(c)                                  a calculation of total royalties or other payment due, including any exchange rates used for conversion; and

 

(d)                                 names and addresses of all SUBLICENSEES and the type and amount of any SUBLICENSE INCOME received from each SUBLICENSEE.

 

9.2.                            LICENSEE and its SUBLICENSEES shall keep and maintain complete and accurate records and books containing an accurate accounting of all data in sufficient detail to enable verification of EARNED ROYALTIES and other payments under this AGREEMENT.  LICENSEE shall preserve such books and records for three (3) years after the calendar year to which they pertain.  Such books and records shall be open to inspection by YALE or an independent certified public accountant selected by YALE, at YALE’s expense, during normal business hours upon ten (10) days’ prior written notice, for the purpose of verifying the accuracy of the reports and computations rendered by LICENSEE.  In the event LICENSEE underpaid the amounts due to YALE with respect to the audited period by more than five percent (5%), LICENSEE shall pay the reasonable cost of such examination, together with the deficiency not previously paid, within thirty (30) days of receiving notice thereof from YALE.

 

9.3.                            LICENSEE shall deliver to YALE within one hundred fifty (150) days after the end of each fiscal year of LICENSEE during the TERM, an income statement for such fiscal year, a balance sheet of LICENSEE and statement of stockholders’ equity as of the end of such fiscal year, and a statement of cash flows for such fiscal year, such financial statements to be prepared in accordance with generally accepted accounting principles (“GAAP”), and accompanied by an audit report of independent public accountants of nationally recognized standing selected by LICENSEE.

 

ARTICLE 10                       PATENT PROTECTION

 

10.1.                     LICENSEE shall be responsible for all past, present and future costs of filing, prosecution and maintenance of all United States patent applications contained in the LICENSED PATENTS.  Any and all such United States patent applications, and resulting issued patents, shall remain the property of YALE.

 

10.2.                     LICENSEE shall be responsible for all past, present and future costs of filing, prosecution and maintenance of all foreign patent applications, and patents contained in the LICENSED PATENTS in the countries outside the United States in the LICENSED TERRITORY selected by YALE and agreed to by LICENSEE.  All such applications or patents shall remain the property of YALE.

 

10.3.                     If LICENSEE does not agree to pay the expenses of filing, prosecuting or maintaining a patent application or patent in any country outside the United States, or fails to pay the expenses of filing, prosecuting or maintaining a patent application or patent in the United States, then the LICENSE with respect to such patent application or patent shall terminate automatically with respect to that country.

 

10.4.                     The costs mentioned in Sections 10.2 and 10.3 shall include, but are not limited to, any past, present and future taxes, annuities, working fees, maintenance fees, renewal and extension charges. Payment of such costs shall be made, at YALE’s option, either directly to

 

27

 

patent counsel or by reimbursement to YALE.  In either case, LICENSEE shall make payment directly to the appropriate party within thirty (30) days of receiving its invoice.  If LICENSEE fails to make payment to YALE or patent counsel, as appropriate, within the thirty (30) day period, LICENSEE shall be charged a five percent (5%) surcharge on the invoiced amount per month or fraction thereof or such other amount (higher or lower) as may be charged by patent counsel.  Failure of LICENSEE to pay the surcharge shall be grounds for termination by YALE under Section 13.1 as and to the extent the same constitutes a TERMINATION EVENT.

 

10.5.                     All patent applications under the LICENSED PATENTS shall be prepared, prosecuted, filed and maintained by independent patent counsel chosen by YALE and reasonably acceptable to LICENSEE.  Said independent patent counsel shall be ultimately responsible to YALE.  LICENSEE shall have the right to retain, at its own expense, separate patent counsel to advise LICENSEE regarding such patent matters.  YALE shall instruct its patent counsel to keep YALE, LICENSEE and LICENSEE’s patent counsel, if any, fully informed of the progress of all patent applications and patents, and to give both YALE and LICENSEE reasonable opportunity to comment on the type and scope of useful claims and the nature of supporting disclosures and other matters in the course of patent prosecution and maintenance.  YALE will not finally abandon any patent application for which LICENSEE is bearing expenses without LICENSEE’s consent.  In making its decisions regarding patent matters YALE shall (1) give due regard to the advice of its patent counsel, (2) instruct its patent counsel to consider any advice offered by LICENSEE’s patent counsel, if any, and (3) conduct such preparation, prosecution and maintenance of patent applications and patents in a manner that is commercially reasonable and with a view to assisting LICENSEE in complying with its obligations under this AGREEMENT and to facilitate LICENSEE’s ability to commercialize PRODUCTS IN CLASS and/or LICENSED METHODS for which royalties will be payable by LICENSEE under Section 6.1.  YALE shall have no liability to LICENSEE for damages, whether direct, indirect or incidental, consequential or otherwise, allegedly arising from its good faith decisions, actions and omissions taken in compliance with this AGREEMENT in connection with such patent prosecution.

 

10.6.                     LICENSEE shall mark, and shall require SUBLICENSEES to mark, all LICENSED PRODUCTS with the numbers of all patents included in LICENSED PATENTS that cover the PRODUCTS IN CLASS.  Without limiting the foregoing, all PRODUCTS IN CLASS shall be marked in such a manner as to conform with the patent marking notices required by the law of any country where such PRODUCTS IN CLASS are made, sold, used or shipped, including, but not limited to, the applicable patent laws of that country.

 

ARTICLE 11                       INFRINGEMENT AND LITIGATION

 

11.1.                     Each party shall promptly notify the other in writing in the event that it obtains knowledge of infringing activity by third parties, or is sued or threatened with an infringement suit, in any country in the LICENSED TERRITORY as a result of activities that concern the TECHNOLOGY and shall supply the other party with documentation of the infringing activities that it possesses.

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

11.2.                     During the TERM:

 

(a)                                 LICENSEE shall have the first right and obligation to (i) defend its or its SUBLICENSEE’s use of the TECHNOLOGY against infringement or interference claims in the LICENSED TERRITORY by third parties and (ii) take action (including legal action) against third parties who may infringe the LICENSED PATENTS or otherwise misappropriate the LICENSED KNOW-HOW, LICENSED METHODS or LICENSED MATERIALS.  This right and obligation includes bringing any legal action for infringement and defending any counter claim of invalidity or action of a third party for declaratory judgment for non-infringement or non-interference.  If, in the reasonable opinion of both LICENSEE’s and YALE’s respective counsel, YALE is required to be a named party to any such suit for standing purposes, LICENSEE may join YALE as a party; provided, however, that (i) YALE shall not be the first named party in any such action, (ii) the pleadings and any public statements about the action shall state that the action is being pursued by LICENSEE and that LICENSEE has joined YALE as a party; and (iii) LICENSEE shall keep YALE reasonably apprised of all developments in any such action.  LICENSEE may settle such suits solely in its own name and solely at its own expense and through counsel of its own selection; provided, however, that no settlement shall be entered without YALE’s prior written consent.  LICENSEE shall bear the expense of such legal actions.  Except for providing reasonable assistance, at the request and expense of LICENSEE, YALE shall have no obligation regarding the legal actions described in this Section unless required to participate by law.  However, YALE shall have the right to participate in any such action through its own counsel and at its own expense.  Any recovery shall first be applied to LICENSEE’s out-of-pocket expenses and second shall be applied to YALE’s out-of-pocket expenses, including legal fees.  Thereafter, any remaining amount of such recovery by LICENSEE up to the amount of compensatory damages recovered by LICENSEE shall be retained by LICENSEE, but if related to a PRODUCT IN CLASS or LICENSED METHOD shall be deemed, to the extent so related, NET SALES of a PRODUCT IN CLASS or LICENSED METHOD, as the case may be, during the calendar quarter in which such recovery is actually paid to LICENSEE, and shall be subject to payment by LICENSEE of an EARNED ROYALTY thereon pursuant to Section 6.1.  LICENSEE shall pay YALE [**] percent ([**]%) of the amount, if any, of any such recovery by LICENSEE related to a PRODUCT IN CLASS or LICENSED METHOD which amount is in excess of (i) LICENSEE’s and YALE’s out-of-pocket expenses as aforesaid and (ii) the amount of such compensatory damages as aforesaid.  LICENSEE shall make such payment to YALE within thirty (30) days after the end of the calendar quarter in which LICENSEE actually receives the amount giving rise to such payment to YALE.

 

(b)                                 Promptly after LICENSEE (a) receives notification from YALE of infringement by a third party or (b) otherwise first becomes aware of an infringement by a third party, whichever is earlier, LICENSEE shall investigate such infringement and take other steps, including, without limitation, contacting the person believed to be infringing, to determine the nature and extent of any such infringement and, if LICENSEE determines that such infringement is occurring, notify such infringing person to cease.  If such infringement shall nonetheless continue, then LICENSEE shall proceed in a timely manner in accordance with Section 11.2(a).  If LICENSEE fails to initiate such actions to investigate and determine the nature and extent of such infringement within sixty (60) days after the earlier of such notice from YALE or the date LICENSEE first becomes aware of such infringement or if LICENSEE fails to commence a legal action under Section 11.2(a) in a timely manner, as the case may be, then YALE may by notice to LICENSEE demand that LICENSEE take such actions or commence such legal action.  If

 

29

 

LICENSEE shall fail to take such action or commence such legal action, as the case may be, within sixty (60) days after such demand by YALE, then YALE shall have the right to take such action or to initiate such legal action, as the case may be, at its own expense.  If YALE initiates such legal action YALE may use the name of LICENSEE as party plaintiff to uphold the LICENSED PATENTS.  In such case, LICENSEE shall provide reasonable assistance to YALE if requested to do so.  YALE may settle such actions solely through its own counsel.  Any recovery shall be retained by YALE.  In case YALE initiates such legal action in accordance with this Section 11.2(b), then YALE may terminate the LICENSE in the country where such legal action is taken.

 

11.3.                     In the event LICENSEE is permanently enjoined from exercising its LICENSE under this AGREEMENT pursuant to an infringement action brought by a third party, or if both LICENSEE and YALE elect not to undertake the defense or settlement of a suit alleging infringement for a period of six (6) months from notice of such suit, then either party shall have the right to terminate the LICENSE in the country where the suit was filed with respect to the allegedly infringing LICENSED PATENT following thirty (30) days’ written notice to the other party in accordance with the terms of Article 15.

 

11.4.                     If LICENSEE, AFFILIATE, and/or SUBLICENSEE challenge a VALID CLAIM of a LICENSED PATENT or challenge a claim by YALE that a product is a PRODUCT IN CLASS (each a “CHALLENGE”), then LICENSEE, AFFILIATE, and/or SUBLICENSEE shall pay or continue to pay all amounts due under this AGREEMENT during the pendency of such CHALLENGE, whether or not any of such amounts is in dispute in such CHALLENGE.

 

ARTICLE 12                       USE OF YALE’S NAME

 

LICENSEE shall not use the name “Yale” or “Yale University,” nor any variation or adaptation thereof, nor any trademark, trade name or other designation owned by YALE, nor the names of any of its trustees, officers, faculty, students, employees or agents, for any purpose without the prior written consent of YALE in each instance, except (a) that LICENSEE may disclose the terms of this AGREEMENT, the activities of the parties hereunder, and the TECHNOLOGY to its stockholders, potential investors and consultants who are subject to obligations to LICENSEE to keep such information confidential, where such confidentiality obligations are substantially similar to the obligations of LICENSEE to YALE hereunder and (b) as required by applicable law.

 

ARTICLE 13                       TERMINATION

 

13.1.                     YALE shall have the right to terminate the LICENSE upon written notice to LICENSEE in the event a TERMINATION EVENT shall have occurred and be continuing; provided, however, that any termination by reason of a TERMINATION EVENT (other than a TERMINATION EVENT described in Section 2.58(a)) shall be made in accordance with Section 13.4.

 

13.2.                     The LICENSE shall terminate automatically without any notice to LICENSEE in the event LICENSEE shall cease to carry on its business for a period of thirty (30) consecutive days or becomes INSOLVENT, or a petition in bankruptcy is filed against LICENSEE and is

 

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consented to, acquiesced in or remains undismissed for one hundred twenty (120) days, or LICENSEE makes a general assignment for the benefit of creditors, or a receiver is appointed for LICENSEE.

 

13.3.                     LICENSEE shall have the right to terminate the LICENSE upon written notice to YALE:

 

(a)                                 at any time on six (6) months’ notice to YALE, provided LICENSEE is not in breach of the AGREEMENT in any material respect and upon payment of all amounts due YALE through the effective date of termination; or

 

(b)                                 in the event YALE commits a material breach of any of the provisions of this AGREEMENT and such breach is not cured (if capable of being cured) within the sixty (60) day period after receipt of written notice thereof from LICENSEE which notice shall identify such breach in reasonable detail, or upon receipt of such notice if such breach is not capable of being cured.

 

13.4.                     Subject to Section 13.1, if YALE believes that a TERMINATION EVENT (other than a TERMINATION EVENT described in Section 2.58(a)) shall have occurred and be continuing, then such matter shall be resolved in accordance with this Section 13.4.

 

(a)                                 If YALE believes such a TERMINATION EVENT shall have occurred and be continuing and wishes to obtain additional information from LICENSEE to assess whether such a TERMINATION EVENT shall have occurred and be continuing, then YALE may so notify LICENSEE and request such information as YALE may specify in such notice to assist YALE in determining whether such a TERMINATION EVENT shall have occurred and be continuing (each a “TERMINATION EVENT INFORMATION NOTICE”).  LICENSEE shall respond to such TERMINATION EVENT INFORMATION NOTICE within thirty (30) days and in such response shall provide such information as YALE shall have requested and which LICENSEE has in its possession or may obtain without unreasonable effort or expense.

 

(b)                                 If either (1) notwithstanding LICENSEE having provided such additional information, YALE continues to believe such a TERMINATION EVENT shall have occurred and be continuing or (2) YALE believes such a TERMINATION EVENT shall have occurred and be continuing and does not wish to obtain additional information from LICENSEE under Section 13.4(a), then in either such case in the preceding clause (1) or (2) YALE may give notice to LICENSEE stating that YALE believes that such a TERMINATION EVENT shall have occurred and be continuing and setting forth in reasonable detail the basis for YALE’s belief that such a TERMINATION EVENT shall have occurred and be continuing (each a “TERMINATION EVENT NOTICE”).  Within thirty (30) days after LICENSEE receives a TERMINATION EVENT NOTICE, LICENSEE shall provide YALE such information as LICENSEE believes establishes the absence of such a TERMINATION EVENT having occurred and be continuing.

 

(c)                                  YALE shall give a TERMINATION EVENT INFORMATION NOTICE (or if YALE determines not to give a TERMINATION EVENT INFORMATION NOTICE, then a TERMINATION EVENT NOTICE) within ninety (90) days after (1) the cure period, in the

 

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case of such a notice relating to Section 2.58(b), (2) YALE first learns of the event, in the case of such a notice relating to Section 2.58(c) or 2.58(e), (3) LICENSEE’s notice to YALE, in the case of such a notice relating to Section 2.58(d), or (4) it receives LICENSEE’s annual progress report, in the case of such a notice relating to Section 7.2 or 7.5, or the due date for LICENSEE’s annual progress report, in case LICENSEE fails to provide any such report when due.  If YALE gives a TERMINATION EVENT INFORMATION NOTICE, then it shall give any TERMINATION EVENT NOTICE relating thereto within 60 days after giving such TERMINATION EVENT INFORMATION NOTICE.

 

(d)                                 Within sixty (60) days after LICENSEE receives a TERMINATION EVENT NOTICE, YALE and LICENSEE shall meet at YALE’s campus in New Haven, Connecticut to discuss and seek to resolve the matter.  If, after such meeting the parties are unable to resolve such matter, then the Managing Director of YALE’s Office of Cooperative Research, or the Managing Director’s designee, and the Chairman of the Board, the Chief Executive Officer or the President or another designee of LICENSEE shall meet at YALE’s campus in New Haven, Connecticut and seek to resolve such matter.

 

(e)                                  If, after following the procedures specified in this Section 13.4 with respect to an alleged TERMINATION EVENT of the type covered by this Section 13.4, the parties are unable to resolve the matter and YALE continues to believe that such a TERMINATION EVENT has occurred and is continuing, then YALE shall so notify LICENSEE within thirty (30) days after conclusion of the meetings provided for in Section 13.4(d).  Such notice shall specify in reasonable detail the TERMINATION EVENT(S) alleged to have occurred and be continuing.  After YALE gives such notice, the parties shall submit the dispute to JAMS or another such mutually agreed upon alternative dispute resolution provider experienced in business dispute mediation (an “ADR”) for non-binding mediation. The parties will cooperate with ADR and with one another in selecting a mediator from ADR’s panel of neutrals, and in promptly scheduling the mediation proceedings. The parties covenant that they will participate in the mediation in good faith, and that they will share ADR costs equally. All offers, promises, conduct and statements, whether oral or written, made in the course of the mediation by any of the parties, their agents, employees, experts and attorneys, and by the mediator or any ADR employees, are confidential, privileged and inadmissible for any purpose, including impeachment, in any arbitration or other proceeding involving the parties, provided that evidence that is otherwise admissible or discoverable shall not be rendered inadmissible or non-discoverable as a result of its use in the mediation. If the dispute is not resolved within ninety (90) days from the date of the submission of the dispute to mediation (or such later date as the parties may mutually agree in writing), then if such TERMINATION EVENT shall be continuing YALE shall have the right to terminate the LICENSE by giving fifteen (15) days notice to LICENSEE, which notice shall specify in reasonable detail the particular TERMINATION EVENT(S) (the “TERMINATION NOTICE”).  The mediation may continue, if the parties so agree, after YALE gives the TERMINATION NOTICE. The pendency of a mediation shall not preclude a party from seeking provisional remedies in connection with this AGREEMENT or such dispute from a court of competent jurisdiction, and the parties agree not to defend against any application for provisional relief on the ground that a mediation is pending.

 

(f)                                   Either party shall have the right to seek declaratory relief relating to this AGREEMENT in a court of competent jurisdiction.

 

32

 

13.5.                     Upon termination of the LICENSE, for any reason, all rights and licenses granted to LICENSEE under the terms of this AGREEMENT shall terminate.  In case of any termination of the LICENSE, each sublicense that LICENSEE shall have entered into in compliance with this AGREEMENT shall become a direct license by YALE to the applicable SUBLICENSEE, so long as at the time of such termination of the LICENSE such SUBLICENSEE shall be in compliance in all material respects with the terms of its sublicense; provided, however that (1) YALE shall not be liable for any breach or default under such sublicense by LICENSEE and (2) in no event shall YALE have any obligation or liability under such sublicense that it did not have to LICENSEE under this AGREEMENT prior to termination of the LICENSE.  Upon such termination, LICENSEE shall cease to manufacture or sell PRODUCTS IN CLASS and cease to practice LICENSED METHODS, except that (1) LICENSEE may complete the manufacture of quantities of PRODUCTS IN CLASS which were work-in-process on the date of such termination and (2) LICENSEE may, for up to one hundred eighty (180) days after the date of such termination, sell any inventory of PRODUCTS IN CLASS that existed on the date of such termination or which were completed as permitted by the immediately preceding clause (1).  Within sixty (60) days of the effective date of termination LICENSEE shall:

 

(a)                                 Return to YALE all materials relating to or containing the LICENSED PATENTS, LICENSED METHODS or CONFIDENTIAL INFORMATION disclosed by YALE; provided, however, that LICENSEE may retain a single file copy thereof in its records;

 

(b)                                 Provide to YALE the last report required under Section 9.1; and

 

(c)                                  Make all payments arising under this AGREEMENT up to the effective date of termination.

 

13.6.                     Termination of the LICENSE shall not affect any rights or obligations accrued prior to the effective date of such termination and specifically LICENSEE’s obligation to pay all royalties and other payments specified by Article 5 and 6 for NET SALES to the date of termination.  The parties agree that claims giving rise to indemnification may arise after the TERM or termination of the LICENSE granted herein.

 

13.7.                     The rights provided in this Article 13 shall be in addition and without prejudice to any other rights which the parties may have with respect to any default or breach of the provisions of this AGREEMENT.

 

13.8.                     Waiver by either party of one or more defaults or breaches shall not deprive such party of the right to terminate because of any subsequent default or breach.

 

13.9.                     Upon termination of the LICENSE for any reason other than breach by YALE, the TECHNOLOGY that may no longer be practiced upon termination of the LICENSE or termination of the LICENSE with respect to a particular PRODUCT IN CLASS or LICENSED METHOD that LICENSEE has chosen to abandon, as the case may be, shall be a “RETURNED TECHNOLOGY”.  LICENSEE shall permit YALE and its future licensees of the RETURNED TECHNOLOGY to utilize, reference and otherwise have the benefit of all regulatory approvals of, or clinical trials or other studies conducted by or on behalf of LICENSEE on, and all filings made by or on behalf of LICENSEE with regulatory agencies with respect to, RETURNED

 

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Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

TECHNOLOGY.  In addition, at YALE’s request and subject to Section 13.5, LICENSEE shall, at YALE’s sole cost and expense, deliver to YALE copies of records held by or on behalf of LICENSEE that are required by regulatory authorities to be maintained with respect to the sale, storage, handling, shipping and use of the RETURNED TECHNOLOGY, copies of all reimbursement approval files held by LICENSEE, and copies of all documents, data and information held by or on behalf of LICENSEE that are related to clinical trials and other studies by or on behalf of LICENSEE of RETURNED TECHNOLOGIES, all of which are collectively the “RETURNED MATERIALS”. YALE agrees that, subject to the provisions of Article 8, LICENSEE may retain one copy thereof to the extent LICENSEE is required by law to maintain such copy.  If LICENSEE so returns the RETURNED TECHNOLOGY and the RETURNED MATERIALS within six (6) months after YALE’s request, then in total consideration for the provision of the RETURNED TECHNOLOGY and the RETURNED MATERIALS, YALE shall from time to time pay to LICENSEE [**] percent ([**]%) of all revenue or other financial consideration YALE receives from any new license of the RETURNED TECHNOLOGY and the RETURNED MATERIALS, other than revenue or other consideration that is research support.  YALE shall pay such amounts to LICENSEE within ninety (90) days after YALE receives such revenue.

 

13.10.              Upon expiration of the TERM or upon termination of the LICENSE, LICENSEE shall have a non-exclusive, fully paid-up, perpetual license to LICENSED KNOW-HOW to make, have made, use, sell, have sold, import or export any PRODUCT, method, procedure, service or process in the LICENSED TERRITORY.

 

ARTICLE 14                       INDEMNIFICATION; INSURANCE; NO WARRANTIES

 

14.1.                     LICENSEE shall defend, indemnify and hold harmless YALE, its trustees, directors, officers, employees, and agents and their respective successors, heirs and permitted assigns (the “INDEMNIFIED PERSONS”) against any and all liabilities, claims, demands, damages, judgments, losses and expenses of any nature, including, without limitation, reasonable legal expenses and attorneys’ fees (collectively “CLAIMS”), (1) arising out of any theory of liability (including, without limitation, tort, warranty, or strict liability) or the death, personal injury, or illness of any person or out of damage to any property related in any way to the rights granted under this AGREEMENT; or (2) resulting from the production, manufacture, sale, use, lease, or other disposition or consumption or advertisement of the PRODUCTS IN CLASS or LICENSED METHODS by LICENSEE, its AFFILIATES, SUBLICENSEES or any other transferees; or (3) in connection with any statement, representation or warranty of LICENSEE, its AFFILIATES, SUBLICENSEES or any other transferees with respect to the LICENSED PRODUCTS or LICENSED METHODS.  Each INDEMNIFIED PERSON shall notify LICENSEE promptly after such INDEMNIFIED PERSON learns of a CLAIM or threatened CLAIM for which indemnity may be sought under this Section 14.1.  The LICENSEE shall have the right to assume the defense of any legal action for which indemnity may be sought under this Section 14.1.  LICENSEE shall not be responsible for indemnity with regard to any CLAIM that is settled without LICENSEE’s prior written consent.  Notwithstanding any provision of this AGREEMENT to the contrary, no INDEMNIFIED PERSON shall be entitled to indemnity hereunder for any CLAIM arising out of or relating to such INDEMNIFIED PERSON’s participation in any clinical trial involving any PRODUCT IN CLASS or such INDEMNIFIED PERSON’s use of a PRODUCT IN CLASS as a patient.

 

34

 

14.2.                     LICENSEE shall purchase and maintain in effect and shall require its SUBLICENSEES to purchase and maintain in effect a policy of commercial, general liability insurance to protect YALE with respect to events described in Section 14.1.  Such insurance shall:

 

(a)                                 list “YALE, its trustees, directors, officers, employees and agents” as additional insureds under the policy;

 

(b)                                 provide that such policy is primary and not excess or contributory with regard to other insurance YALE may have;

 

(c)                                  be endorsed to include product liability coverage in amounts no less than Five Million Dollars ($5,000,000.00) per incident and Five Million Dollars ($5,000,000.00) annual aggregate; and

 

(d)                                 be endorsed to include contractual liability coverage for LICENSEE’s indemnification under Section 14.1; and

 

(e)                                  by virtue of the minimum amount of insurance coverage required under Section 14.2(c), not be construed to create a limit of LICENSEE’s liability with respect to its indemnification under Section 14.1.

 

14.3.                     By signing this AGREEMENT, LICENSEE certifies that the requirements of Section 14.2 will be met on or before the earlier of (a) the date of FIRST SALE of any PRODUCT IN CLASS or LICENSED METHOD or (b) the date any PRODUCT IN CLASS, or LICENSED METHOD is tested or used on humans, and will continue to be met thereafter.  Upon YALE’s request, LICENSEE shall furnish a Certificate of Insurance and a copy of the current Insurance Policy to YALE.  LICENSEE shall give thirty (30) days’ written notice to YALE prior to any cancellation of or material change to the policy.

 

14.4.                     (a)                                 YALE MAKES NO, AND EXPRESSLY DISCLAIMS ALL, REPRESENTATIONS OR WARRANTIES THAT ANY CLAIMS OF THE LICENSED PATENTS, ISSUED OR PENDING, ARE VALID, OR THAT THE MANUFACTURE, USE, SALE OR OTHER DISPOSAL OF THE PRODUCTS IN CLASS, OR PRACTICE OF THE LICENSED METHODS, DOES NOT OR WILL NOT INFRINGE UPON ANY PATENT OR OTHER RIGHTS NOT VESTED IN YALE.

 

(b)                                 EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT, YALE MAKES NO, AND EXPRESSLY DISCLAIMS ALL, REPRESENTATIONS AND WARRANTIES WHATSOEVER WITH RESPECT TO THE LICENSED PATENTS, PRODUCTS IN CLASS AND LICENSED METHODS, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.  LICENSEE SHALL MAKE NO STATEMENTS, REPRESENTATION OR WARRANTIES WHATSOEVER TO ANY THIRD PARTIES WHICH ARE INCONSISTENT WITH SUCH DISCLAIMER BY YALE.  IN NO EVENT SHALL YALE, OR ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES, BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES OF ANY KIND, INCLUDING ECONOMIC

 

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DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER YALE SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.  IN NO EVENT SHALL YALE, OR ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES, BE LIABLE FOR DAMAGES IN EXCESS OF AMOUNTS YALE HAS RECEIVED FROM LICENSEE UNDER THIS LICENSE.

 

ARTICLE 15                       NOTICES, PAYMENTS

 

15.1.                     Any payment, notice or other communication required by this AGREEMENT (a) shall be in writing, (b) may be delivered personally or sent by reputable overnight courier with written verification of receipt or by registered or certified first class United States Mail, postage prepaid, return receipt requested, (c) shall be sent to the following addresses or to such other address as such party shall designate by written notice to the other party, and (d) shall be effective upon receipt:

 

	
FOR YALE:
    	
 
    	
FOR LICENSEE:
    	
 
    
	
Managing   Director
    	
 
    	
Chief Executive Officer
    	
 
    
	
YALE UNIVERSITY
    	
 
    	
Kolltan Pharmaceuticals, Inc.
    	
 
    
	
Office of   Cooperative Research
    	
 
    	
300 George Street
    	
 
    
	
433 Temple   Street
    	
 
    	
New Haven, Connecticut, 06511
    	
 
    
	
New Haven,   Connecticut 06511
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
With a copy to:
    	
 
    
	
 
    	
 
    	
General Counsel
    	
 
    
	
 
    	
 
    	
Kolltan Pharmaceuticals, Inc.
    	
 
    
	
 
    	
 
    	
300 George Street
    	
 
    
	
 
    	
 
    	
New Haven, Connecticut, 06511
    	
 
    

 

ARTICLE 16                       LAWS, FORUM AND REGULATIONS

 

16.1.                     Any matter arising out of or related to this AGREEMENT shall be governed by and in accordance with the substantive laws of the State of Connecticut, without regard to its conflicts of law principles, except where the federal laws of the United States are applicable and have precedence.  Any dispute arising out of or related to this AGREEMENT shall be brought in a court of competent jurisdiction in the State of Connecticut.

 

16.2.                     LICENSEE shall comply, and shall cause its AFFILIATES to comply and require its SUBLICENSEES to comply, with all foreign and United States federal, state, and local laws, regulations, rules and orders applicable to the testing, production, transportation, packaging, labeling, export, sale and use of the PRODUCTS IN CLASS and practice of the LICENSED METHODS.  In particular, LICENSEE shall be responsible for assuring compliance with all United States export laws and regulations applicable to this LICENSE and LICENSEE’s activities under this AGREEMENT.

 

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ARTICLE 17                       MISCELLANEOUS

 

17.1.                     This AGREEMENT shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns.

 

17.2.                     This AGREEMENT constitutes the entire agreement of the parties relating to the LICENSED PATENTS, PRODUCTS IN CLASS and LICENSED METHODS, and all prior representations, agreements and understandings, written or oral, are merged into it and are superseded by this AGREEMENT.  This AGREEMENT supersedes the SECOND AMENDED AND RESTATED LICENSE AGREEMENT in its entirety and, as of the THIRD AMENDMENT EFFECTIVE DATE, the SECOND AMENDED AND RESTATED LICENSE AGREEMENT shall be of no further force and effect; provided, however, that any obligations to either party accrued by the other party prior to the THIRD AMENDMENT EFFECTIVE DATE under the SECOND AMENDED AND RESTATED LICENSE AGREEMENT shall remain as such.

 

17.3.                     The provisions of this AGREEMENT shall be deemed separable.  If any part of this AGREEMENT is rendered void, invalid, or unenforceable, such determination shall not affect the validity or enforceability of the remainder of this AGREEMENT unless the part or parts which are void, invalid or unenforceable shall substantially impair the value of the entire AGREEMENT as to either party.

 

17.4.                     Articles, paragraph and section headings are inserted for convenience of reference only and do not form a part of this AGREEMENT.

 

17.5.                     No person not a party to this AGREEMENT, including any employee of any party to this AGREEMENT, shall have or acquire any rights by reason of this AGREEMENT.  Nothing contained in this AGREEMENT shall be deemed to constitute the parties partners with each other or any third party.

 

17.6.                     This AGREEMENT may not be amended or modified except by written agreement executed by each of the parties.  This AGREEMENT is personal to LICENSEE and shall not be assigned by LICENSEE without the prior written consent of YALE; provided, however, that no such consent of YALE shall be required in case of any assignment of this AGREEMENT by LICENSEE in connection with a merger, consolidation, sale or other transfer of all or substantially all of LICENSEE’s assets or any similar business combination or reorganization so long as the assignee shall expressly assume in writing LICENSEE’s obligations under this AGREEMENT; provided further, however, that in case of any such action or transaction described in the immediately preceding proviso, if the same constitutes a CHANGE OF CONTROL nothing in this Section 17.6 shall remove such transaction from Section 5.4 or 5.7.  Sublicenses shall not be deemed a sale or other transfer of assets by LICENSEE governed by this Section 17.6, but instead shall be governed by Article 4 and, in respect of milestone royalties by Sections 5.5 and 5.8.  Any attempted assignment in contravention of this Section 17.6 shall be null and void and shall constitute a material breach of this AGREEMENT.

 

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17.7.                     LICENSEE, or any SUBLICENSEE or assignee, will not create, assume or permit to exist any lien, pledge, security interest or other encumbrance on this AGREEMENT or any sublicense.

 

17.8.                     The failure of any party hereto to enforce at any time, or for any period of time, any provision of this AGREEMENT shall not be construed as a waiver of either such provision or of the right of such party thereafter to enforce each and every provision of this AGREEMENT.

 

17.9.                     This AGREEMENT may be executed in any number of counterparts and any party may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument.

 

17.10.              Neither YALE nor LICENSEE shall be liable to perform its obligations as required by this AGREEMENT, or shall be in default of its obligations under this AGREEMENT, to the extent such failure to perform or default is caused by any reason beyond such party’s control, including, without limitation, any of the following: labor disturbances or disputes of any kind, accidents, failure of any required governmental approval, civil disorders, acts of aggression, acts of God, energy or other conservation measures, failure of utilities, delays or defaults by common carrier, mechanical breakdowns, material shortages, disease, or similar occurrences.  In case of any such reason beyond a party’s control, the time for performance of such party’s obligations affected thereby shall be extended by the period of the event or circumstance constituting such reason and for a reasonable period of time thereafter.

 

17.11.              YALE has provided LICENSEE with the Yale University Patent Policy in effect as of the EFFECTIVE DATE, a copy of which is attached hereto as Appendix E.  As described in the recitals to this AGREEMENT, as of the EFFECTIVE DATE, SCHLESSINGER serves on the LICENSEE Board of Directors and the LICENSEE Scientific Advisory Board, and as a paid consultant to LICENSEE.  LICENSEE agrees that, for so long as SCHLESSINGER is an employee of YALE, LICENSEE’s rights to any INVENTIONS of SCHLESSINGER created other than in his capacity as a YALE employee shall be subject to the attached Yale University Patent Policy, and that any agreement, past or future, between SCHLESSINGER and LICENSEE regarding INVENTIONS of SCHLESSINGER shall be construed in accordance therewith.

 

[signature page follows]

 

This Space Intentionally Left Blank

 

38

 

IN WITNESS to their agreement, the parties have caused this AGREEMENT to be executed in duplicate originals by their duly authorized representatives.

 

 

	
YALE UNIVERSITY
    	
 
    	
KOLLTAN   PHARMACEUTICALS, INC.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ E. Jonathan   Soderstrom
    	
 
    	
By:
    	
/s/ Gerald McMahon
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
E. Jonathan Soderstrom,   Ph.D.
    	
 
    	
 
    	
Gerald McMahon
    
	
 
    	
Managing Director
    	
 
    	
 
    	
President and Chief   Executive Officer
    
	
 
    	
Office of Cooperative   Research
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
17 May 2013
    	
 
    	
Date:
    	
3/14/13
    

 

39

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Appendix A

 

LICENSED PATENTS

 

(Shaded Rows = International (PCT) and Foreign Applications)

 

	
M&E
   Matter
   No.
    	
 
    	
Yale
   Reference
   No.
    	
 
    	
Serial No.
    	
 
    	
Title
    	
 
    	
Filing Date
    	
 
    	
Status
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 8 pages were omitted. [**]

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Appendix B

 

THE PLAN

 

[**]

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Appendix C

 

UNPATENTED VISITING SCIENTIST IP

 

[**]

 

 

Appendix D

 

THIRD PARTY RIGHTS

 

NONE

 

 

Appendix E

 

YALE UNIVERSITY PATENT POLICY

 

	
Yale University Office of Cooperative Research
    	
 
    	
http://www.yale.edu/ocr/pfg/policies/patents.html
    

 

Yale University

 

Disclose an Invention       Licensing Opportunities       YEI        FAQs       Contact Us

 

Yale University Patent Policy

 

1.              Encouragement or Patents. In the course of teaching, research, and other intellectual and administrative activity by faculty, staff fellows, students, and other individuals in the University community, discoveries or inventions both patentable and practical occur. Encouragement of such inventions in appropriate ways is both supportive of the public interest and consistent with the advancement or knowledge for its own sake, the primary purpose of teaching and research in a university. The University Patent Policy states the procedure to be followed in the administration of inventions which result from teaching, research, and other intellectual activity performed under University auspices except as further defined in paragraph 6.

 

2.              Purpose of Patent Policy. The purposes of this University Patent Policy are (1) to help assure. In the public interest, that the patentability (or other means or explanation) and practicality of inventions will be evaluated by qualified persons, and that the income from inventions will be used to support further research or other desirable University activities; and (2) to define remuneration to the inventor or inventors (hereinafter the “Inventor”) and the University as long as the invention is productive of royalties.

 

3.              Procedure as to Inventions. The University has established a Committee on Cooperative Research, Patents, and Licensing (../../../provost/html/comm_coopresearch.html) appointed from among members of the faculty and administration. One function of the Committee is to advise the University on matters of patents policy and administration. The University has also established an Office of Cooperative Research to facilitate transfer of its inventions/discoveries in the public interest.

 

a.              Patent Applications. All inventions of the kind referred to in paragraph 1 shall be reported promptly in writing to the Provost through the Director of the Office of Cooperative Research. The Director, with the advice of the Committee on Cooperative Research, Patents, and Licensing, shall conduct an initial screening followed, when indicated, by a detailed evaluation of the invention. This may be done through an internal review, or by referral to an external organization that manages the evaluation. After the evaluation, the University may, alone or with the assistance of an external organization, make application for letters patent. At the request of the office of Cooperative Research, the Inventors shall execute assignments or other documents assigning to the University all their rights in the invention and any patent applications or resulting patents on the invention. Yale will retain title to all such patent applications and resulting patents. If the University decides that it does not wish, and has no legal obligation, to participate in the patenting or licensing of an invention, the University may release to the Inventor the University’s interest in the invention, and the Inventor shall then be free to dispose of the invention as he or she wishes.

 

b.              License Agreement.

 

i.                  If the University decides to participate in the patenting or licensing or an invention, the Office of Cooperative Research will seek to enter into appropriate licensing arrangements to commercialize the invention. The objective of the University is to assure the development of its technology in furtherance of its own educational mission and for the benefit of society in general. Therefore, as a general policy, the University will set the terms or its licenses so as to further the achievement of this objective. Exclusive licenses will be granted if it appears to the Office of Cooperative Research that this is the most effective way of ensuring development to the point that the public will benefit. Any exclusive license agreement will be so drawn as to protect against failure of the licensee to carry out effective development and marketing within a specified time period.

 

ii.               In research grants or contracts sponsored by industrial companies there will typically be a section covering patents on future inventions, if any, as in all government grants. When deemed appropriate, the sponsor may be granted a license to any inventions developed during the term of the grant or contract in accordance with the policies outlined in I) above.

 

4.              4. Division of Royalties.

 

a.              Definition. For purposes of this policy, “royalties” shall include running royalties, advances against running royalties, up-front license fees, milestone payments, shares of stock or other securities issued by the licensee or another corporation (“equity”), and any other payments received by the University under a license agreement in consideration for licensing an invention, but shall not include amounts received from a licensee or others in sponsorship of research or under other agreements for other goods, services or rights.

 

b.              Recovery of Expenses. Royalties shall be used first to offset out-of-pocket expenses incurred by the University in applying for, obtaining, and defending a patent and in developing and negotiating license agreements during the

 

1

 

life of the patent. Expenses for this purpose will include fees paid be outside legal, consulting, and licensing organizations and any other out-of-pocket costs incurred by the University. The fees paid to the external individuals or organizations for such services may be of fixed dollar amount or may be in the form of an agreed-upon fraction or the gross royalty income, if any, or in any other form directly associated with commercialization/licensing of the invention. In addition, 10% or Royalties, after reduction as provided above for out-of-pocket expenses, received in any year from an invention made on or after April 11, 1992 shall be retained by the University and applied toward the general support of the Office or Cooperative Research; provided, that if the total or such recoveries in any year exceeds the Office’s approved budget, the excess shall be allocated in a pro rata basis among those inventions from which it was recovered and shall be distributed as part of Net Royalties in accordance with subparagraph (d).

 

c.               Net Royalties. Alter recovery of expenses by the University as provided in subparagraph (b), the remaining royalties will be designated Net Royalties.

 

d.              Distribution or Net Royalties. The Net Royalties as defined above shall be divided between the Inventor(s) (as defined under the patent law) and the University as follows:

 

·        The first $100,000 of Net Royalties 
 50% to the Inventor(s) 
 50% allocated to the general support of University research, as described in paragraph 5.

 

·        Net Royalties between $100,000 and $200,000
 40% to the Inventor(s)
 60% allocated to the general support of University research, as described in paragraph 5.

 

·        Net Royalties exceeding $200,000
 30% to the Inventor(s)
 70% allocated to the general support of University research, as described in paragraph 5.

 

For purposes of applying the above Net Royalty distribution formula (i.e., whether aggregate Net Royalties are $100,000 or less, between $100,000 and $200,000, or more than $200,000), equity shall be deemed to have the per-share value agreed upon in a good-faith negotiation between the University and the licensee at the time the license agreement is executed, and the equity shall be deemed received after all cash Net Royalties received at or before the time the equity is issued. In the absence of such negotiated value, the Inventors shall receive 32% of the equity Net Royalties.

 

In its discretion, the University may either distribute equity to the Inventor(s) when it is received or arrange for the licensee to issue the Inventor’s share of equity directly to the Inventor(s).

 

As used in this document, the term “Inventor” may represent two or more individuals. These individuals will be expected to agree among themselves on the fractional distribution of the “Inventor” share of any royalties. A written agreement must be signed by all the individuals involved, and deposited for the record in the Office of Cooperative Research. (Appropriate forms are available from the Office of Cooperative Research.) If no written agreement has been deposited at the time of a distribution of Net Royalties, the Inventors’ share of such distribution shall be divided equally among the Inventors.

 

e.               Overriding Agreements with Third Parties. The foregoing provisions of this paragraph and the rest of this University Patent Policy are subject to the terms of applicable grants and contracts with third parties. See paragraph 7.

 

5.              5. General Research Support from Net Royalties. The University’s share or Net Royalties will be used in support of research, or if not specifically prohibited by the funding agency contract, will accrue to the Science Development Fund or other appropriate research fund, and will be allocated by the Provost. Before allocating funds, the Provost shall consult with the relevant subdivision of the University concerning the research to be supported.

 

6.              Inventions Not under University Auspices. Inventions by university employees usually result from teaching, research, or other intellectual activity involving University facilities or personnel. Accordingly, all inventions by University employees must be reported to the Office of Cooperative Research. When the University determines that an invention by a University employee is unrelated to the activities for which the individual is employed and has not involved the use of University facilities, then the University will make no claim to such an invention. All inventions made or conceived under circumstances involving University facilities or personnel are the property or the University.

 

An invention made by a faculty member in the course of a paid consulting engagement for a company may be assigned to the company only if it is unrelated to the activities for which the faculty member is employed by Yale and it was not made or conceived under circumstances involving University facilities or personnel. Such an invention will be considered unrelated to the activities for which the faculty member is employed by Yale if the invention arises directly out or consulting activity paid for by the company, and, for example, it is made in response to a problem posed by the company or is based on nonpublic information provided by the company to the faculty member for use in the consulting

 

2

 

engagement. It will be considered not to have involved the use of University facilities if no University facilities or resources (including but not limited to space, computers, laboratory equipment and supplies), no University-administered funds, and no University personnel other than the faculty member himself or herself, are involved in the conception or reduction to practice or the invention. All inventions made by Yale faculty members in the course of consulting, and any assignments of rights to such inventions, must be reported promptly to the Office of Cooperative Research. That Office will agree to abide by reasonable confidentiality restrictions for disclosures of inventions and assignments made in the course of consulting.

 

7.              When Arrangements with Outside Organizations Override This Policy. Arrangements with outside organizations that propose terms which are exceptions to this Policy must be submitted to the President or Provost for review by the University with he advice of the Committee on Cooperative Research, Patents, and Licensing, If approved by the University the terms shall be binding upon all members or the faculty, staff, and employees of the University conducting such research or utilizing such facilities, and will supersede the provisions of the patent policy to the extent that the terms are inconsistent therewith.

 

a.              Inventions by Staff Resulting from Performance or the Responsibilities of Their Employment. Not infrequently, in the course of carrying out assigned responsibilities of their employment, staff employees may make commercially useful inventions or develop licensable property, (i.e., the employee received salary or wages for the specific function of developing the work which ultimately has commercial value). In such cases, there is no presumption that the University will share royalty (or other) revenues with the employee. Normally, the University does not share revenues with staff except in cases where it appears that the invention or commercially valuable property has not resulted from the performance of assigned duties. In these Instances, the invention (or other commercially valuable work) will be reviewed by the Committee on Cooperative Research, Patents, and Licensing and a recommendation will be made to the Provost. In these cases, the division of royalties as specified in paragraph 4(d) of this policy may not apply and the Provost may substitute different provisions after review of the recommendations of the Committee on Cooperative Research, Patents, and Licensing.

 

9.              Governmental Rights in Certain Inventions. Current governmental regulations permit educational institutions to retain rights and title to patentable inventions which results from federally funded experimental, developmental and research work. Retention of rights by University is contingent upon the fulfilling of a number of obligations on the part of the University and of the Inventor(s) and these obligations must be discharged in order to protect the Interests of all parties. Though the University may retain rights and title to such patentable inventions, the federal government retains a royalty free license and places certain other restrictions upon the ultimate disposition or the patents(s). Details of the implementing regulations may be obtained from the Office or Cooperative Research. Incumbent upon members of the University community who apply for and receive federal finding to support research or who use federal monies in the conduct of their research is the requirement for written agreement that they will promptly disclose patentable inventions to the University and will execute all instruments necessary to protect the rights of the government and/or the University. Forms for this agreement will be provided to all faculty and will be available for other participants (i.e. collaborators, post-doctoral students, graduate students) from the appropriate departmental chairman or, at the Chairman’s option, from the Departmental Business Office.

 

10.       Revocation or Amendment. This patent policy is subject to revocation or amendment by the Corporation. In case of doubt as to the interpretation of this patent policy, a definitive interpretation will be provided by the President or Provost after receiving the advice of the Committee on Cooperative Research, Patents, and Licensing. This patent policy is effective as to all inventions/discoveries made on or after February 23, 1998.

 

Revised February, 1998

 

Copyright @ 2011, Yale University Office of Cooperative Research, New Haven, Connective, USA.

Email: OCR@yale.edu | Telephone: (203) 436-8096 | Fax: (203) 436-8086

 

3

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Appendix F

 

KOLLTAN PATENTS

 

(Shaded Rows = International (PCT) and Foreign Applications)

 

	
Jones Day
   Matter No.
    	
 
    	
Kolltan
   Reference
   No.
    	
 
    	
Serial No.
    	
 
    	
Title
    	
 
    	
Filing Date
    	
 
    	
Status
    
	
[**]
    	
 
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 2 pages were omitted. [**]

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

AMENDMENT NUMBER ONE TO THIRD AMENDED AND RESTATED LICENSE AGREEMENT

 

YALE UNIVERSITY, a corporation organized and existing under and by virtue of a charter granted by the general assembly of the Colony and State of Connecticut and located in New Haven, Connecticut (“YALE”), and KOLLTAN PHARMACEUTICALS, INC., a corporation organized and existing under the laws of the State of Delaware, and with principal offices located at 300 George Street, New Haven, CT 06511 (“LICENSEE”), have entered into that certain Third Amended and Restated License Agreement, dated March 14, 2013, as amended and/or restated from time to time (the “Agreement”), an exclusive license to YALE’s receptor tyrosine kinases (RTKs) intellectual property, which agreement YALE internally designates as contract number [**].  As set forth herein, the parties now wish to amend the Agreement.  This Amendment Number One to Third Amended and Restated License Agreement (“Amendment No. 1”), which YALE will internally designate as [**], shall be effective as of March 21, 2014 (“Effective Date”).

 

WHEREAS, an invention [**] was originally jointly owned by YALE and The Governing Council of the University of Toronto, an institution of higher education having offices located at the Innovations & Partnerships Office, 100 College Street, Toronto, ON, Canada M5G 1L5 (“TORONTO”);

 

WHEREAS, YALE has prepared a provisional patent application [**] from the invention disclosed as [**] naming inventors from YALE and from TORONTO (the “PATENT APPLICATION”), a copy of which has been provided by YALE to LICENSEE and which as of the EFFECTIVE DATE has been filed with the United States Patent and Trademark Office;

 

WHEREAS, LICENSEE and TORONTO have entered into an agreement, effective as of December 5, 2013, pursuant to which TORONTO has assigned to LICENSEE all of TORONTO’s interests in [**] and the [**] PATENTS (defined below) (the “ASSIGNMENT”); and

 

WHEREAS, [**] is, as of the effective date of the ASSIGNMENT, jointly owned by YALE and LICENSEE;

 

NOW, THEREFORE, in consideration of the premises and of the mutual covenants set forth herein, the parties agree as follows:

 

I.                                        Memorandum of Understanding

 

1.              Filing.  LICENSEE hereby agrees to pay the invoiced expenses for the [**] PATENTS pursuant to the terms of the Agreement (as amended by Amendment No. 1); provided that, upon assumption of prosecution of the [**] PATENTS pursuant to Section I.3. below, such section will govern all expenses associated with the [**] PATENTS incurred thereafter.

 

2.              Schlessinger Involvement.  The parties acknowledge that the [**] PATENTS being included as “LICENSED PATENTS” under the Agreement (as amended by Amendment No. 1) were made, created, developed, discovered, conceived or first reduced to practice while

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

SCHLESSINGER was MEANINGFULLY INVOLVED AT KOLLTAN and MEANINGFULLY INVOLVED AT YALE as defined in Section 2.26(b) under the Agreement (as amended by Amendment No. 1).

 

3.              Prosecution.  Notwithstanding Article 10 of the Agreement (as amended by Amendment No. 1), LICENSEE shall be entitled, at its sole expense, to assume prosecution of the PATENT APPLICATION and any other United States or foreign patents or patent applications claiming [**], including any continuations, divisionals, and continuations-in-part, and continued prosecution application(s), any reissues, re-examinations, renewals, or extensions, substitutes, and the relevant international equivalents (collectively, the “[**] PATENT(S)”).  Any additional patent applications claiming, using, derived from, or arising from [**] or an [**] PATENT shall be an [**] PATENT.

 

Upon request from LICENSEE, YALE will timely transfer to LICENSEE responsibility for prosecution of the [**] PATENTS.  All [**] PATENTS shall be prepared, prosecuted, filed and maintained by independent patent counsel chosen by LICENSEE and reasonably acceptable to YALE.  Said independent patent counsel shall be ultimately responsible to LICENSEE, but YALE shall also be the client of said patent counsel.  YALE shall have the right to retain, at its own expense, separate patent counsel to advise YALE regarding such patent matters.  LICENSEE shall instruct patent counsel to keep LICENSEE, YALE and YALE’s patent counsel, if such counsel should be engaged by YALE, fully informed of the progress of all [**] PATENTS, and to give both LICENSEE and YALE reasonable opportunity to comment on the type and scope of useful claims and the nature of supporting disclosures and other matters in the course of patent prosecution and maintenance.

 

In making its decisions regarding patent matters related to [**] PATENTS, LICENSEE shall (a) give due regard to the advice of its patent counsel, (b) instruct its patent counsel to consider any advice offered by YALE and YALE’s patent counsel, if such counsel should be engaged by YALE, and (c) conduct such preparation, prosecution and maintenance of [**] PATENTS in a manner that is commercially reasonable in order to commercialize PRODUCTS IN CLASS and/or LICENSED METHODS for which royalties will be payable by LICENSEE to YALE pursuant to the Agreement.  In the event of a disagreement concerning the prosecution of the [**] PATENTS, LICENSEE shall have the right to make the final decision concerning such the prosecution.  LICENSEE shall have no liability to YALE for damages, whether direct, indirect or incidental, consequential or otherwise, allegedly arising from its good faith decisions, actions and omissions taken in compliance with the Agreement in connection with such patent prosecution.

 

If LICENSEE desires to abandon any [**] PATENT, LICENSEE will provide YALE with sufficient prior written notice, and YALE may then assume prosecution of such patent; and, thereafter, (i) if the [**] PATENT remains a “LICENSED PATENT” under the Agreement,

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

then the provisions in the Agreement governing prosecution costs will apply; and (ii) if the [**] PATENT ceases to be a “LICENSED PATENT” under the Agreement, YALE’s prosecution of such patent will be at YALE’s expense, and, in the case of this clause (ii), LICENSEE will timely assign LICENSEE’s joint ownership interests in such [**] PATENTS that are being abandoned by LICENSEE to YALE.

 

4.              Joint Ownership.  YALE represents that it has not entered into any agreement with TORONTO directly relating to [**] or the [**] PATENTS.  To the extent that YALE’s consent, as a joint owner of [**] or the [**] PATENTS with TORONTO, was needed for TORONTO’s assignment of [**] or the [**] PATENTS to LICENSEE, YALE hereby consents to TORONTO’s assignment of [**] and the [**] PATENTS to LICENSEE.

 

As a result of the assignment of rights from TORONTO to LICENSEE making YALE and LICENSEE joint owners of [**] and the [**] PATENTS, YALE and LICENSEE agree that each of LICENSEE and YALE will have the right to practice and exploit [**] and any [**] PATENTS without the duty of accounting to the other party or seeking consent (for licensing, assigning, or otherwise exploiting [**] or any [**] PATENTS) from the other party by reason of the joint ownership thereof but subject to compliance with the terms and conditions of the Agreement (as amended by Amendment No. 1) or, if the Agreement has expired or terminated (entirely or with respect to [**] or a particular [**] PATENT(S)), any surviving terms of the Agreement applicable to [**] and such [**] PATENTS, as applicable; and each party hereby waives any right it may have under the laws of any jurisdiction to require any such approval or accounting, and, to the extent there are any applicable laws that prohibit such a waiver, each party will be deemed to so consent.

 

The parties acknowledge that LICENSEE has a separate ownership interest in [**] and the [**] PATENTS obtained through LICENSEE’s assignment from TORONTO, and the inclusion of [**] and the [**] PATENTS under the Agreement (as amended by Amendment No. 1) only relates to YALE’s interest in them; as such, Licensee will continue to have the right to practice and exploit [**] and [**] PATENTS even if [**] and [**] PATENTS cease to be “LICENSED PATENTS” under the Agreement (as amended by Amendment No. 1) or the Agreement (as amended by Amendment No. 1) expires or terminates.

 

II.                                   Amendments

 

1.              Definitions.  All capitalized terms used herein shall have the meaning given to such terms in the Agreement, unless otherwise specifically defined in Amendment No. 1.

 

2.              Additional LICENSED PATENTS.

 

The parties agree that the [**] PATENTS are “LICENSED PATENTS” under the Agreement (as amended by Amendment No. 1).

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

3.              Addition of the [**] PATENTS to Appendix A LICENSED PATENTS.  Appendix A of the Agreement is hereby amended to add the PATENT APPLICATION as follows:

 

	
M&E
   Matter
   No.
    	
 
    	
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   Reference
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   Issue Date
    	
 
    	
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[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

4.              Entire Agreement.  Except as explicitly amended by Amendment No. 1, all other terms and conditions of the Agreement shall remain in full force and effect and apply fully to the terms of Amendment No. 1 as if part of the Agreement.

 

Signature Page Follows

 

 

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Amendment No. 1 (including the associated Memorandum of Understanding herein).

 

 

	
YALE   UNIVERSITY
    	
KOLLTAN   PHARMACEUTICALS, INC.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   E. Jonathan Soderstrom
    	
 
    	
By:
    	
/s/ Gerald McMahon
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
E. Jonathan Soderstrom,   Ph.D.
    	
 
    	
 
    	
Gerald McMahon
    
	
 
    	
Managing Director
    	
 
    	
 
    	
President and Chief   Executive Officer
    
	
 
    	
Office of Cooperative   Research
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
10 April 2014
    	
 
    	
Date:
    	
3-24-2014
    

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

AMENDMENT NUMBER TWO TO THIRD AMENDED AND RESTATED
 LICENSE AGREEMENT

 

YALE UNIVERSITY, a corporation organized and existing under and by virtue of a charter granted by the general assembly of the Colony and State of Connecticut and located in New Haven, Connecticut (“YALE”), and KOLLTAN PHARMACEUTICALS,INC., a corporation organized and existing under the laws of the State of Delaware, and with principal offices located at 300 George Street, New Haven, CT 06511 (“LICENSEE”), have entered into that certain Third Amended and Restated License Agreement, dated March 14, 2013, as amended by that certain Amendment Number One to Third Amended and Restated License Agreement, effective March 21,2014, and as amended and/or restated from time to time (the “Agreement”), an exclusive license to YALE’s receptor tyrosine kinases (RTKs) intellectual property, which agreement YALE internally designates as contract number [**].  As set forth herein, the parties now wish to amend the AGREEMENT.  This Amendment Number Two to Third Amended and Restated License Agreement (“AMENDMENT NO. 2”), which YALE will internally designate as [**], shall be effective as of December 1, 2014 (“AMENDMENT NO. 2 EFFECTIVE DATE”).

 

WHEREAS, an invention titled [**] was developed pursuant to the RESEARCH AGREEMENT and is a “Joint Invention” under the RESEARCH AGREEMENT;

 

WHEREAS, LICENSEE has prepared a provisional patent application titled “[**]” from the invention disclosed as [**] naming inventors from YALE and LICENSEE (the “[**] PATENT APPLICATION,” described in the table II(3) below), which as of the AMENDMENT NO. 2 EFFECTIVE DATE has been filed with the United States Patent and Trademark Office;

 

WHEREAS, an invention titled “[**]” (“[**]”) was developed pursuant to the RESEARCH AGREEMENT and is a “Joint Invention” under the RESEARCH AGREEMENT;

 

WHEREAS, LICENSEE has prepared a provisional patent application titled “[**]” from the invention disclosed as [**] naming inventors from YALE and LICENSEE (the “[**] PATENT APPLICATION,” described in the table II(3) below), which as of the AMENDMENT NO. 2 EFFECTIVE DATE has been filed with the United States Patent and Trademark Office; and

 

WHEREAS, YALE and LICENSEE desire to confirm the [**] PATENT APPLICATION and the [**] PATENT APPLICATION as LICENSED PATENTS under the AGREEMENT;

 

NOW, THEREFORE, in consideration of the promises and of the mutual covenants set forth herein, the parties agree as follows:

 

I.                      Memorandum of Understanding

 

1.              Schlessinger Involvement.  The parties acknowledge that the [**] PATENT APPLICATION and the [**] PATENT APPLICATION being included as “LICENSED PATENTS” under the AGREEMENT (as amended by AMENDMENT NO. 2) claim RTK TECHNOLOGY that was made, created, developed, discovered, conceived or first reduced to practice by or on behalf of SCHLESSINGER, LAX the SCHLESSINGER LAB, or LAX LAB while

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

SCHLESSINGER·was MEANINGFULLY INVOLVED AT YALE as defined in Section 2.26(b) under the AGREEMENT (as amended by AMENDMENT NO. 2).

 

2.              Prosecution.  Notwithstanding Article 10 of the Agreement (as amended by AMENDMENT No. 2), the following prosecution provisions will govern the prosecution of the [**] PATENT APPLICATION and the [**] PATENT APPLICATION, including any continuations, divisionals, and continuations-in-part, and continued prosecution application(s), any reissues, reexaminations, renewals, or extensions, substitutes, and the relevant international equivalents of each thereof (collectively, the “AMENDMENT NO. 2 PATENT(S)”).

 

LICENSEE shall have the right to prepare, file and prosecute patent applications jointly in the name of LICENSEE and in the name of YALE claiming AMENDMENT NO. 2 PATENTS.  LICENSEE will provide YALE with a copy of any such patent applications, in a timely manner, for LAX’s and YALE’s review and comment prior to the first filing thereof and YALE and LAX shall review the same and respond to LICENSEE in a timely manner.  LICENSEE will further provide YALE with a copy of all material correspondence between the applicable patent office and LICENSEE’s patent counsel, if said counsel is not shared by the parties, concerning the prosecution of such patent application(s) in a timely manner to:

 

Yale University

Office of Cooperative Research

Attn: Director of Intellectual Property

433 Temple Street

New Haven, CT  06511

P: 203-436-4675

F: 203-436-8086

E: diane.k.morrissey@yale.edu

 

or to such other address as YALE may specify for such purpose by notice to LICENSEE, and shall reference the RESEARCH AGREEMENT ([**]).  LAX and YALE will cooperate with and provide assistance to LICENSEE in connection with such activities, including, without limitation, execution of all documents, and performance of all acts reasonably necessary, to prepare, file and prosecute such patent applications, and maintain, enforce and defend such patents.  LICENSEE shall bear all of its own expenses, including, without limitation, the fees of LICENSEE’s legal counsel, and any out-of-pocket expenses of YALE associated with the preparation, filing and prosecution of such patent applications, and the maintenance of any patents issued therefrom.

 

If LICENSEE elects not to file or thereafter prosecute specific claims and/or applications of an AMENDMENT NO.2 PATENT in any country, LICENSEE will promptly notify YALE at the address listed above, or to such other address as YALE may specify for such purpose by notice to LICENSEE, and shall reference the RESEARCH AGREEMENT ([**]).  In such event, YALE, at its expense, will have the right to file and prosecute such application, and/or maintain such patent in such country, jointly in its and LICENSEE’s names

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

3.              Joint Ownership.  As joint owners of each of [**],[**] and the AMENDMENT NO. 2 PATENTS, YALE and LICENSEE agree that each of LICENSEE and YALE will have the right to practice and exploit each of [**],[**] and the AMENDMENT NO. 2 PATENTS without the duty of accounting to the other party or seeking consent (for licensing, assigning, or otherwise exploiting [**],[**], or any AMENDMENT NO. 2 PATENT) from the other party by reason of the joint ownership thereof, but subject to compliance with the terms and conditions of the AGREEMENT (as amended by AMENDMENT NO. 2) or, if the AGREEMENT has expired or terminated (entirely or with respect to any of [**],[**], or the AMENDMENT NO. 2 PATENTS), any surviving terms of the AGREEMENT applicable to [**],[**] or such AMENDMENT NO. 2 PATENT, as applicable; and each party hereby waives any right it may have under the laws of any jurisdiction to require any such approval or accounting, and, to the extent there are any applicable laws that prohibit such a waiver, each party will be deemed to so consent.  For clarity, each of YALE and LICENSEE will continue to have the right to practice and exploit each of [**],[**] and the AMENDMENT NO. 2 PATENTS even if [**],[**] or the AMENDMENT NO. 2 PATENTS cease to be “LICENSED PATENTS” under the AGREEMENT (as amended by AMENDMENT NO. 2).

 

This Space Intentionally Left Blank: Amendments Follow

 

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

II.                 Amendments

 

1.              Definitions.  All capitalized terms used herein shall have the meaning given to such terms in the AGREEMENT, unless otherwise specifically defined in AMENDMENT NO. 2.

 

2.              Additional LICENSED PATENTS.

 

Subject to Section I(2) herein, the parties agree that the AMENDMENT NO. 2 PATENTS are “LICENSED PATENTS” under the AGREEMENT (as amended by AMENDMENT NO. 2).

 

3.              Addition of the [**] PATENT APPLICATION and the [**] PATENT APPLICATION to Appendix A LICENSED PATENTS.  Appendix A of the AGREEMENT is hereby amended to add the [**] PATENT APPLICATION and the [**] PATENT APPLICATION as follows:

 

	
JD
    Matter No.
    	
 
    	
Yale
   Reference
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    Patent No.
    	
 
    	
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4.              Entire Agreement.  Except as explicitly amended by AMENDMENT NO. 2, all other terms and conditions of the Agreement shall remain in full force and effect and apply fully to the terms of Amendment No. 2 as if part of the Agreement.

 

Signature Page Follows

 

 

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this AMENDMENT NO. 2 (including the associated Memorandum of Understanding herein).

 

	
YALE   UNIVERSITY
    	
KOLLTAN   PHARMACEUTICALS, INC.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ E.   Jonathan Soderstrom, Ph.D.
    	
 
    	
By:
    	
/s/   Gerald McMahon
    
	
 
    	
E.   Jonathan Soderstrom, Ph.D.
    	
 
    	
 
    	
Gerald   McMahon
    
	
 
    	
Managing   Director
    	
 
    	
 
    	
President   and Chief Executive Officer
    
	
 
    	
Office   of Cooperative Research
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
December 1,   2014
    	
 
    	
Date:
    	
December 5,   2014

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00280-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00280-of-00352.parquet"}]]