Document:

ex-101seagenxgenmabxforu

Exhibit 10.1  [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Execution Copy  LICENSE AND COLLABORATION AGREEMENT  by and between  Seattle Genetics, Inc.  and  Genmab A/S  Effective as of: October 7, 2011  

 

            CONTENTS    ARTICLE 1    DEFINITIONS AND INTERPRETATION                                                                                                                          2  1.1 Definitions                                                                                                                                                                                2  1.2 Certain Rules of Interpretation in this Agreement and the Schedules                                                                            16    ARTICLE 2   LICENSES                                                                                                                                                                      17   2.1   Licenses to Genmab                                                                                                                                                              17             2.2   Genmab’s Rights to Sub                                                                                                                                                       17   2.3   Compliance with the BMS Agreement                                                                                                                                18   2.4   Licenses to SGI                                                                                                                                                                      19   2.5   SGI’s Rights to Sublicense                                                                                                                                                    19   2.6   Compliance with the Genmab In-Licenses                                                                                                                          20                           ARTICLE 3   OPT-IN TO CO-DEVELOPMENT AND CO-COMMERCIALIZATION                                                              20              3.1   Opt-In                                                                                                                                                                                       20              3.2   Joint Steering Committee                       22              3.3   Alliance Manager                                                                                                                                                                    24              3.4   Exclusivity                                                                                                                                                                                25                    ARTICLE 4   DEVELOPMENT, COMMERCIALIZATION AND MANUFACTURING OF EXCLUSIVE PRODUCTS 25  4.1 Diligence 25  4.2 Funding and Progress Reports 26  4.3 Manufacturing 26  4.4 SGI Development Support and Regulatory Assistance 26  4.5 Adverse Events 28  ARTICLE 5    CO-DEVELOPMENT OF COLLABORATION PRODUCTS 28    5.1 Establishment of Joint Development Team  28  5.2 Annual Updates to the Joint Development Plan  30  5.3 Development Activities  31  5.4 Joint Development Costs  31  5.5 Financial Representatives  31  5.6 Development Records  32  5.7 Audit                              -i-  32  

 

              5.8 Liability 33  5.9 Use of Approved Subcontractors 33  5.10 Right to Opt-Out of Co-Development and Co-Commercialization 34  5.11 Third Party Collaboration Agreements 35  ARTICLE 6    MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS 35  6.1 Commercial Supply 35  6.2 Supply Agreements 35  ARTICLE 7    REGULATORY MATTERS FOR COLLABORATION PRODUCTS 36  7.1 General 36  7.2 [ * ] of Regulatory Approvals 36  7.3 Regulatory Coordination 37  7.4 Assistance 37  7.5 Adverse Events relating to Licensed Products 37  ARTICLE 8    COMMERCIALIZATION OF COLLABORATION PRODUCTS 38  8.1 Objectives for Commercialization of Collaboration Products 38  8.2 Lead Commercialization Parties 38  8.3 Preparation of Commercialization Plan 38  8.4 Commercialization Team and Commercialization Agreement 38  8.5 Co-Promotion Agreement 39  8.6 Commercialization Activities 39  ARTICLE 9 DEVELOPMENT, COMMERCIALIZATION AND MANUFACTURING OF UNILATERAL  PRODUCTS 39  9.1 Diligence 39  9.2 Conduct 40  9.3 Funding and Progress Reports 40  9.4 Manufacturing 40  9.5 Regulatory 40  ARTICLE 10 FEES, MILESTONES AND ROYALTIES FOR EXCLUSIVE PRODUCTS AND UNILATERAL  PRODUCTS 40  10.1 FTE Fees for Exclusive Products 40  10.2 Annual Maintenance Fee 41  10.3 Royalties 41  -ii-      

 

            10.4 Royalty Offsets 43  10.5 Milestone Payments 44  10.6 Royalty Reports, Exchange Rates 45  ARTICLE 11     FINANCIAL PROVISIONS FOR COLLABORATION PRODUCTS 45  11.1 Joint Development Costs 45  11.2 Reporting and Payment of Joint Development Costs 45  11.3 Audits 46  11.4 Reporting and Payment of Commercialization Expenses and Collaboration Product Profit 46  11.5 Collaboration Product Profit Term 46  11.6 Other Research Expenses, Joint Development Costs and Commercialization Expenses 47  11.7 Utilization of Internal Resources 47  ARTICLE 12    PAYMENT TERMS; BOOKS AND RECORDS; TAX 47  12.1 Payment Terms 47  12.2 Record Keeping 48  12.3 Tax Matters 48  ARTICLE 13   CONFIDENTIALITY 48  13.1 Non-Disclosure Obligations 48  13.2 Permitted Disclosures 49  13.3 Terms of the Agreement 50  13.4 Press Releases and Other Disclosures to Third Parties 50  13.5 Publications 50  ARTICLE 14    INVENTIONS AND PATENTS 51  14.1 Ownership of Inventions 51  14.2 Patent Prosecution and Maintenance 51  14.3 Enforcement of Patents 54  14.4 Prior SGI Patent Rights 55  14.5 Prior Genmab Patent Rights 55  14.6 Product Trademarks 55  ARTICLE 15    INFRINGEMENT ACTIONS BROUGHT BY THIRD PARTIES 55  15.1 Collaboration Product 55  -iii-          

 

            15.2 Defense Costs 56  15.3 Exclusive Product, Genmab Product 56  15.4 SGI Product 56  ARTICLE 16    REPRESENTATIONS AND WARRANTIES 56  16.1 Representations and Warranties 56  16.2 Disclaimer 58  16.3 Performance by Affiliates 58  ARTICLE 17    TERM AND TERMINATION 58  17.1 Term 58  17.2 Termination by Genmab 58  17.3 Termination for Cause 59  17.4 Termination if Genmab Challenges SGI Patents 59  17.5 Termination if SGI Challenges Genmab Patents 59  17.6 Termination Upon Insolvency 59  17.7 Termination of BMS Agreement 59  17.8 Termination of [ * ] 60  17.9 Effect of Expiration and Termination 60    ARTICLE 18 INDEMNITY  61  18.1 Direct Indemnity for Non-Collaboration Products  61  18.2 Collaboration Products  61  18.3 Procedure  62  18.4 Limitations on Liability  62  ARTICLE 19 FORCE MAJEURE  62  ARTICLE 20 ASSIGNMENT  63  ARTICLE 21 SEVERABILITY  63  ARTICLE 22 INSURANCE  64  ARTICLE 23 MISCELLANEOUS  64  23.1 Notices  64  23.2 Applicable Law  65  23.3 Dispute Resolution  65  23.4 Entire Agreement  66  23.5 Independent Contractors     -iv-  66  

 

              23.6 Affiliates  66  23.7 Waiver  66  23.8 Counterparts  66    -v-     

 

            LIST OF SCHEDULES    S chedule A SGI PATENTS  S chedule B RESEARCH AND GLP GRADE SUPPLY FEE PRICING LIST  S chedule C GENMAB IN LICENSES  S chedule D SGI RESEARCH AND DEVELOPMENT SUPPORT PRIOR TO END OF PHASE I CLINICAL TRIAL  S chedule E GENMAB DEVELOPMENT PLAN AND GENMAB BUDGET  S chedule F GENMAB PATENTS  -vi-    

 

            LICENSE AND COLLABORATION AGREEMENT    This License and Collaboration Agreement is entered into as of October 7, 2011 by and between:    SEATTLE GENETICS, INC., a Delaware corporation, having its principal place of business at 21823 30th Drive S.E., Bothell,  Washington 98021 (hereinafter referred to as “SGI”)    and    GENMAB A/S, a Danish corporation with CVR no. 2102 3884, having a principal place of business at Bredgade 34, P.O. Box  9068, DK-1260 Copenhagen K, Denmark (hereinafter referred to as “Genmab”).      WITNESSETH    WHEREAS, SGI Controls (as defined below) intellectual property rights relating to certain technology useful for linking certain  proprietary cytotoxic compounds to other molecules, such as antibodies capable of directing such cytotoxic compounds to specific  tissues and/or cells;    WHEREAS, Genmab is engaged in research and development of biopharmaceutical products, including certain monoclonal antibodies  and Controls intellectual property rights relating to certain technology useful for generating monoclonal antibodies and to the  monoclonal antibodies so generated;    WHEREAS, SGI and Genmab are currently parties to the Prior Agreement (as defined below) pursuant to which they are conducting a  research and development program relating to antibodies that bind specifically to Tissue Factor (as defined below) together with SGI’s  proprietary cytotoxic compound and linker technology;    WHEREAS, pursuant to the Prior Agreement, Genmab has the right to obtain an exclusive (subject to SGI’s right to opt-in to  co-development and co-commercialization) worldwide license under SGI’s patent rights and know-how related to SGI’s proprietary  cytotoxic compound and linker technology to develop and commercialize Licensed Products (as defined below);    WHEREAS, SGI wishes to grant to Genmab such license;    WHEREAS, SGI wishes to obtain a right to opt-in to co-develop and co-commercialize with Genmab such Licensed Products; and    WHEREAS, Genmab wishes to grant to SGI such opt-in right.  -1-    

 

            NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, the Parties hereto, intending to be  legally bound, agree as follows:      ARTICLE 1 DEFINITIONS AND INTERPRETATION    1.1 Definitions For the purposes of this Agreement the following words and phrases shall have the following meanings:    1.1.1 “AAA” has the meaning set forth in Section 23.3.1.    1.1.2 “Acknowledgement” has the meaning set forth in Section 3.1.2.    1.1.3 “ADC” or “Antibody-Drug Conjugate” means an Antibody that is linked to a cytotoxic compound and that  contains, uses, is made using or is otherwise based on SGI Technology.    1.1.4 “Adverse Event” means any unfavorable and unintended medical occurrence in a human patient or subject who is  administered a Licensed Product, including any undesirable sign (including abnormal laboratory findings of clinical concern),  symptom or disease temporally associated with the use of such Licensed Product, whether or not considered related to such Licensed  Product.    1.1.5 “Affiliate” of a Party means any corporation or other business entity that, directly or indirectly, through one or more  intermediaries, controls, is controlled by, or is under common control with a Party. As used herein, the term “control” means the direct  or indirect ownership of fifty percent (50%) or more of the stock having the right to vote for directors thereof or the ability to otherwise  control the management thereof.    1.1.6 “Agreement” means this License and Collaboration Agreement, all amendments and supplements hereto and all  schedules hereto, including the following:    S chedule A - SGI Patents. {Schedule to be further updated}  S chedule B - Research and GLP Grade Supply Fee Pricing List  S chedule C - Genmab In-Licenses  S chedule D - SGI research and development support prior to end of Phase I Clinical Trial  S chedule E - Genmab Development Plan and Genmab Budget  S chedule F - Genmab Patents    1.1.7 “Alliance Manager” has the meaning set forth in Section 3.3.    1.1.8 “[ * ]” means the portion of the [ * ] costs [ * ] by a Party that are attributable to that Party’s [ * ] and [ * ], [ * ], [ * ],  or the equivalent of the foregoing to support [ * ] of a Collaboration Product, and the occupancy, facility and equipment (excluding [ * ]  for [ * ]  -2-  

 

            and [ * ]), [ * ] (to the extent not [ * ]) and its [ * ] and [ * ] necessary to support such [ * ], and, in each case, which are [ * ] to such  Party’s [ * ] based on [ * ] or [ * ] or other [ * ] consistently applied by a Party. [ * ] shall not include any [ * ] attributable to [ * ],  including, by way of example, [ * ], [ * ], [ * ], [ * ] and [ * ]. This definition of [ * ] will be further elaborated in the commercialization  agreement described in Section 8.4.    1.1.9 “Annual Maintenance Fee” has the meaning set forth in Section 10.2.    1.1.10 “Antibody” or “Antibodies” means a monoclonal antibody or a derivative thereof identifiable by [ * ] with respect  to Tissue Factor. For the purpose of the licenses granted to Genmab by SGI hereunder any Antibody when combined with [ * ] must  specifically bind to Tissue Factor.    1.1.11 “Applicable Law” means any law or statute, any rule or regulation issued by a government authority (including  courts and Regulatory Authorities), any GxP regulations or guidelines as well as and any judicial, governmental, or administrative  order, judgment, decree or ruling, in each case as applicable to the subject matter and the parties at issue.    1.1.12 “Approved Subcontractor” means a subcontractor engaged by a Party that has been approved by the JSC to  perform specific obligations of the subcontracting Party.    1.1.13 “BMS” means Bristol-Myers Squibb Company.    1.1.14 “BMS Agreement” means the License Agreement between BMS and SGI dated [ * ], as amended.    1.1.15 “Breaching Party” has the meaning set forth in Section 17.3.    1.1.16 “Calendar Quarter” means any of the three-month periods beginning on January 1, April 1, July 1 or October 1 of  any year.    1.1.17 “Change of Control” has the meaning set forth in Article 20.    1.1.18 “Claims” has the meaning set forth in Section 18.1.1.    1.1.19 “Collaboration Accounting Policies” means the accounting policies as agreed to by the Parties and approved by  the JSC to be used in determining Joint Development Costs and Collaboration Product Profit, which will be, in all material respects,  consistent with GAAP and any Applicable Laws of the United States.    1.1.20 “Collaboration Product” means an Exclusive Product as to which SGI has exercised its Opt-In Right to the extent  that neither Party subsequently issues an Opt-Out Notice pursuant to Section 5.10. For clarity, a Collaboration Product is considered a  Licensed Product.  -3-    

 

            1.1.21 “Collaboration Product Profit” means the profits or losses resulting from the Commercialization of a  Collaboration Product and shall be [ * ] to the [ * ] of the Collaboration Product [ * ] the [ * ] to the [ * ]; provided, h owever, that any  costs that would otherwise be included as a [ * ] but which, pursuant to the [ * ], are [ * ] from [ * ] to determine the [ * ] of a [ * ], shall  not also be [ * ] as a [ * ] and thereby [ * ]. Collaboration Product Profit shall also include any [ * ] by a Party from a Third Party on [ *  ] of, or in connection with [ * ] with respect to, a [ * ].    1.1.22 “Collaboration Product Trademark” has the meaning set forth in Section 14.6.    1.1.23 “Collaboration Program” means the collaborative Development, manufacturing, Regulatory Approval and  Commercialization activities undertaken pursuant to any Joint Development Plan or Commercialization Plan.    1.1.24 “Commercialization” or “Commercialize” means, with respect to a Collaboration Product, any and all activities to  establish and maintain commercial sales for such Collaboration Product that are undertaken pursuant to a Commercialization Plan.  These activities shall include: (a) the pre-launch marketing and launch activities for the Collaboration Product, (b) the marketing,  promotion, distribution, offering for sale and selling of the Collaboration Product, (c) importing and exporting the Collaboration  Product for commercial sale, and (d) manufacturing the Collaboration Product for commercial sale (except for scale-up activities prior  to First Commercial Sale, which shall be considered Development activities), including inventory build to support the launch and  making manufacturing improvements after launch; in each case in accordance with the applicable Commercialization Plan. When used  as a verb, “Commercialize” means to engage in Commercialization.    1.1.25 “Commercialization Expenses” shall mean, with respect to a Collaboration Product, (a) [ * ], (b) [ * ], (c) [ * ],  (d) [ * ], (e) [ * ], (g) [ * ], and (h) other costs as mutually agreed by the Parties, all allocated to such Collaboration Product and  calculated in accordance with the Collaboration Accounting Policies, consistently applied. This definition of Commercialization  Expenses will be further elaborated in the commercialization agreement described in Section 8.4.    1.1.26 “Commercialization Plan” means the commercialization plan for a Collaboration Product to be prepared and  approved by the JSC from time to time and the related budget to be prepared and approved by the JSC for each calendar year during  which it is anticipated that Commercialization activities will occur hereunder, to be updated as necessary during each calendar year,  setting forth, among other things, a master plan for the Commercialization of the Collaboration Product as well as each Party’s  responsibilities in connection therewith.    1.1.27 “Commercially Reasonable Efforts” means, (a) with respect to the efforts to be [ * ] by a Party to [ * ] a [ * ], the  [ * ] and [ * ] that such Party would [ * ] to [ * ] a [ * ] under [ * ], and (b) with respect to the [ * ] or [ * ] of a Licensed Product, the  level of efforts and [ * ] substantially [ * ] to those efforts and [ * ] by a Party for a [ * ] of [ * ] and at a [ * ] in  -4-    

 

            its [ * ], taking into account [ * ], [ * ], [ * ], [ * ] of [ * ], [ * ] ([ * ] taking into account the [ * ] of this Agreement), [ * ] and [ * ] and  other relevant factors. Commercially Reasonable Efforts shall be determined on a [ * ] and [ * ] basis for a particular Licensed Product.  In addition, it is anticipated that the [ * ] of [ * ] may be [ * ] for [ * ], and may [ * ], reflecting [ * ] in the [ * ] of such Licensed  Product and the market(s) involved. Without limiting the forgoing, Commercially Reasonable Efforts with respect to a Licensed  Product requires that the relevant Party: (i) [ * ] and consistently [ * ] to [ * ] for carrying out its obligations, and (ii) consistently [ * ]  and implement decisions and [ * ] for the [ * ] of [ * ] with respect to such objectives.    1.1.28 “Competing Product” means: (a) at any time during the Term (i) when SGI holds an Opt-In Right for the first  Exclusive Product or (ii) following an Opt-In Decision for such first Exclusive Product and prior to any applicable Opt-Out Date, any  product for the treatment, prevention or diagnosis of conditions and diseases in humans containing a substance (such as a small  molecule, peptide, protein, antibody, fusion protein, conjugate, [ * ] or other [ * ], as well as any [ * ] of the foregoing) that [ * ] to [ * ]  and (b) at all other times during the Term, any product for the treatment, prevention or diagnosis of conditions and diseases in humans  containing an [ * ] that [ * ] to [ * ].    1.1.29 “Competing Program” means a program intended to develop a [ * ].    1.1.30 “Confidential Information” has the meaning set forth in Section 13.1.    1.1.31 “Continuing Party” has the meaning set forth in Section 5.10.1.    1.1.32 “Control” means, with respect to any information or intellectual property right, possession by a Party or its  Affiliate of the ability to grant the right to access or use, or to grant a license or a sublicense to, or to use such information or  intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third  Party.    1.1.33 “Development” or “Develop” means, with respect to a Collaboration Product, any and all clinical drug  development activities and manufacturing activities undertaken pursuant to the relevant Joint Development Plan in order to develop a  Collaboration Product up to and including obtaining Regulatory Approval for such Collaboration Product for an indication and to  perform manufacturing scale up to enable commercial scale manufacturing prior to launch (except that inventory build shall be  considered a Commercialization activity). These activities shall include preclinical research, stability testing, toxicology testing,  formulation activities, reformulation activities, process development, manufacturing scale-up activities, development stage  manufacturing, quality assurance/quality control development, clinical studies (including Phase III Studies, Phase III-B Studies, Phase  IV Studies and other studies (e.g., pharmacovigilance programs and outcome studies) that the JSC considers necessary or economically  justifiable) and other activities to obtain the applicable Regulatory Approvals; in each case in accordance with the applicable Joint  Development Plan, as applicable. When used as a verb, “Develop” means to engage in Development.  -5-    

 

            1.1.34 “Development Support Fees” has the meaning set forth in Section 10.1.    1.1.35 “Development Support Fees Report” has the meaning set forth in Section 10.1.    1.1.36 “[ * ]” shall mean the following costs incurred by a Party or its Affiliates in the [ * ] of a [ * ], to be further  elaborated in the commercialization agreement described in Section 8.4: (a) [ * ] to be agreed upon by the Parties [ * ], (b) [ * ]  associated with [ * ], and (c) [ * ]. For the avoidance of doubt, [ * ] shall not include [ * ] or [ * ].    1.1.37 “Drug Conjugation Materials” means (a) the [ * ] or [ * ] attached to the linker [ * ] or [ * ], and (b) any related  raw materials and reagents SGI provided to Genmab pursuant to the Research Program or provides to Genmab pursuant to Section 4.4  or the Collaboration Program, in each case to the extent Controlled by SGI and included in or covered by the SGI Technology. Drug  Conjugation Materials shall also include reagents and other tangible materials to the extent included in Program Inventions assigned to  SGI pursuant to Section 14.1.2.    1.1.38 “Drug Conjugation Technology” means (a) methods that are useful in attaching the [ * ] or [ * ] to antibodies  using the linker [ * ] or [ * ], including the composition and methods of making and using such cytotoxic compound [ * ] or [ * ] and  (b) any related assays and methods SGI provided to Genmab pursuant to the Research Program or provides to Genmab pursuant to  Section 4.4 or the Collaboration Program, in each case to the extent Controlled by SGI.    1.1.39 “Drug Master File” or “DMF” means the file of information submitted to the FDA as set out in Code of Federal  Regulations, Food and Drug Administration Part 314.420.    1.1.40 “Effective Date” means the date set forth in the first line of this Agreement.    1.1.41 “Events of Force Majeure” has the meaning set forth in Article 19.    1.1.42 “Exclusive Product” means a Licensed Product as to which an Opt-In Right has not arisen or, having arisen, has  not been exercised within the Opt-In Period.    1.1.43 “FDA” means the United States Food and Drug Administration, and any successor agency thereto.    1.1.44 “Field” means monoclonal antibody targeting applications for the treatment and diagnosis of conditions and  diseases in humans. The Parties acknowledge that [ * ] is [ * ] to [ * ], including [ * ].    1.1.45 “Financial Representative” has the meaning set forth in Section 5.5.1.  -6-    

 

            1.1.46 “First Commercial Sale” means, in each country of the Territory, the first commercial sale of a Licensed Product  by a Party, their respective Affiliates or Sublicensees to a Third Party following, if required by law, Regulatory Approval and, when  Regulatory Approval is not required by law, the first commercial sale in that country, in each case for use or consumption of such  Licensed Product in such country by the general public. For the avoidance of doubt, any sale of Licensed Product by a Party for use in [  * ] shall be considered a commercial sale and shall be included in Net Sales.    1.1.47 “FTE” means the equivalent of a full-time employee of the Parties (including normal vacations, sick leave and  other similar matters) in the country where such employee is based. FTEs shall be calculated based on the time an employee of the  Parties spends working on a billable effort as recorded by such Parties’ project time reporting system. An FTE is measured on the basis  of [ * ] of [ * ] and [ * ].    1.1.48 “FTE Fees” has the meaning set forth in Section 10.1.    1.1.49 “GAAP” means generally accepted accounting principles in the United States.    1.1.50 “Genmab” has the meaning set forth in the introduction to this Agreement.    1.1.51 “Genmab ADC Know-How” means all Program Inventions Controlled by Genmab using SGI Technology to the  extent not disclosed or claimed by a Genmab Patent that are necessary for identifying, developing, making, using, offering for sale or  selling ADCs.    1.1.52 “Genmab ADC Patents” means all patent applications and patents that are Controlled by Genmab that claim  Genmab ADC Know-How as set forth in Schedule F, which shall be amended from time to time to reflect any other patents and patent  applications.    1.1.53 “Genmab Budget” shall mean the budget attached to the Genmab Development Plan under S chedule E.    1.1.54 “Genmab Development Plan” means the manufacturing and clinical development plan for an Exclusive Product  and related Genmab Budget. The initial version of the Genmab Development Plan and related Genmab Budget is set forth in  S chedule E and may be amended at Genmab ́s sole discretion prior to the beginning of the Opt-In Period.    1.1.55 “Genmab In-Licenses” means the agreements between Genmab and Third Parties as listed in S chedule C.  S chedule C may be amended from time to time pursuant to Section 2.6.1.    1.1.56 “Genmab Know-How” means all technical information, processes, formulae, data, inventions, methods, chemical  compounds, biological or physical materials, know-how and other trade secrets, in each case, that relate to (a) the composition, method  of using or method of [ * ], or (b) the composition, method of generating and making [ * ], including the [ * ], or (c) method of [ * ] and  [ * ] technology, and that are Controlled by Genmab to the extent not disclosed or claimed by a Genmab Patent, including [ * ].  -7-  

 

            1.1.57 “Genmab Patents” means:    (a) all patent applications and patents Controlled by Genmab that claim Genmab Know-How as set forth in  Schedule F, which shall be amended from time to time to reflect any other patents and patent applications;    (b) any patents and patent applications covering Program Inventions that are assigned to Genmab pursuant to  Section 14.1.2(a) and Genmab’s interest in any Joint Patents pursuant to Section 14.1.2(c);    (c)    any future patents issued from any patent applications referred to above and any future patents issued from any  continuation, continuation-in part (to the extent Controlled by Genmab), or divisional of any of the foregoing patent applications or any  patent applications from which the foregoing patents issued, in each case to the extent Controlled by Genmab; and    (d)   any reissues, reexaminations, confirmations, renewals, registrations, substitutions, extensions, or counterparts of  any of the foregoing, in each case to the extent Controlled by Genmab.    1.1.58 “Genmab Product” means a Unilateral Product as to which Genmab elects to be the Continuing Party in  accordance with Section 5.10.    1.1.59 “Genmab Technology” means the Genmab Patents (including Genmab ADC Patents) and Genmab Know-How  (including Genmab ADC Know-How).    1.1.60 “Good Clinical Practice” or “GCP” shall mean any and all laws, rules, regulations, guidelines and generally  accepted standards and requirements regarding the ethical conduct of clinical trials, including without limitation the U.S. Code of  Federal Regulations (“CFR”) Title 21, ICH GCP Guidelines E6(R1), current step 4 version, dated 10 June 1996, as amended from time  to time, national legislation implementing European Community Directive 2001/20/EC of 4 April 2001 on the approximation of the  laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the  conduct of clinical trials on medicinal products for human use, European Community Directive 2005/28/EC of 8 April 2005 laying  down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use.    1.1.61 “Good Laboratory Practice” or “GLP” shall mean any and all laws, rules, regulations, guidelines and generally  accepted standards and requirements regarding quality control for laboratories to ensure the consistency and reliability of results,  including without limitation the CFR Title 21, national legislation implementing European Community Directive 2004/9/EC of  11 February  -8-    

 

            2004 on the inspection and verification of good laboratory practice (GLP) as amended and European Community Directive  2004/10/EC of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of  the principles of good laboratory practice and the verification of their applications for tests on chemical substances as amended, OECD  Series on Principles of Good Laboratory Practice and Compliance Monitoring.    1.1.62 “Good Manufacturing Practice” or “GMP” shall mean any and all laws, rules, regulations, guidelines and  generally accepted standards and requirements regarding the quality control and manufacturing of pharmaceutical products, including  without limitation the CFR Title 21, ICH GMP Guidelines Q7, current step 4 version, dated 10 November 2000, as amended from time  to time, national legislation implementing European Community Directive 91/356/EEC of 13 June 1991 laying down the principles and  guidelines of good manufacturing practice for medicinal products for human use as amended by European Community Directives  2003/94/EC, the Rules Governing Medicinal Products in the European Community, Volume 4, including annexes.    1.1.63 “GxP” means GCP, GLP or GMP or any combination thereof, as applicable.    1.1.64 “IND” means (a) an Investigational New Drug Application, or successor application, filed with the FDA or its  equivalent in any country outside the United States where a regulatory filing is required or obtained to conduct a clinical trial; or  (b) with respect to any country where a regulatory filing is not required or obtained to conduct a clinical trial, the first enrollment of a  patient in the first trial involving the first use of a Licensed Product in humans.    1.1.65 “Indemnified Party” shall have the meaning set forth in Section 18.3.    1.1.66 “Indemnitees” shall have the meaning set forth in Section 18.1.1.    1.1.67 “Indemnitor” shall have the meaning set forth in Section 18.3.    1.1.68 “[ * ]” means all [ * ] and [ * ] by the Parties or their Affiliates for a Collaboration Product, which shall be  calculated as a [ * ] of [ * ], such [ * ] to be initially set during the calendar year of the [ * ] and any subsequent calendar year thereafter  and calculated based on that Party’s and its Affiliates’ [ * ] in a [ * ] and [ * ] in such [ * ] during the calendar year in which the [ * ]  occurs (the “[ * ]”). Such [ * ] shall also be adjusted by the Parties in the event that future [ * ] differs by [ * ] or more from the [ * ]  currently being used by the Parties. Examples of [ * ] included in the calculation of the [ * ] include, but are not limited to, [ * ] and [ *  ], [ * ] of [ * ], [ * ] and [ * ].    1.1.69 “Initiation” means, with respect to a human clinical trial, the dosing of the first patient with a Licensed Product  pursuant to the clinical protocol for the specified clinical trial.  -9-    

 

            1.1.70 “IP and Trademark Costs” means all costs relating to Joint Patents and Collaboration Product Trademarks as well  as other costs indicated to be IP and Trademark Costs herein.    1.1.71 “Joint Budget” shall mean the budget attached to the Joint Development Plan. The initial Joint Budget will be  provided by Genmab pursuant to Section 3.1.3.    1.1.72 “Joint Development Cost Report” shall have the meaning set forth in Section 11.2.1(a).    1.1.73 “Joint Development Costs” means, with respect to a Collaboration Product, the [ * ] and [ * ] costs [ * ] by a Party  from the date of the relevant [ * ] to conduct Development for a Collaboration Product calculated in accordance with the Collaboration  Accounting Policies, consistently applied. [ * ] will include [ * ] at the [ * ], [ * ] (including taxes and duties), and [ * ] required to [ * ]  related to the relevant [ * ].    1.1.74 “Joint Development Plan” means the manufacturing and clinical development plan for a Collaboration Product.  The initial Joint Development Plan will be provided by Genmab pursuant to Section 3.1.3.    1.1.75 “Joint Development Team” or “JDT” has the meaning set forth in Section 5.1.    1.1.76 “Joint Patents” has the meaning set forth in Section 14.2.4.    1.1.77 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.2.1.    1.1.78 “Lead Commercialization Party” means, with respect to a territory [ * ], the Party with responsibility for  Commercialization activities in accordance with Section 8.2.    1.1.79 “Lead Regulatory Party” means, with respect to a territory [ * ], the Party with the main responsibility for  carrying out regulatory activities in accordance with Article 7.    1.1.80 “Liabilities” has the meaning set forth in Section 18.1.1.    1.1.81 “Licensed Product” means any and all products utilizing or incorporating an ADC:    (a)  the manufacture, use, sale, offer for sale or import of which would infringe a Valid Patent Claim of any SGI  Patent, Joint Patent or Genmab Patent, if not for a Party’s ownership interest or the licenses granted in this Agreement; or    (b) which otherwise utilize, incorporate, derive from, relate to, are made using or are based on Genmab Technology  or SGI Technology.  -10-  

 

            For clarity, “Licensed Product” means an Exclusive Product, Collaboration Product and/or a Unilateral Product (i.e., a Genmab Product  or an SGI Product).    1.1.82    “[ * ]” means [ * ].    1.1.83 “Major Market Country” means any of the following: [ * ].    1.1.84 “[ * ]” means, collectively, [ * ], a [ * ], and its [ * ].    1.1.85 “[ * ]” has the meaning set forth in S chedule C.    1.1.86 “Net Sales” means, as to each Calendar Quarter, the gross invoiced sales prices charged for all Licensed Products  sold by or for a Party, including any sale of Licensed Product by a Party for use in a compassionate use or named patient program (the  “Selling Party”), its Affiliates and Sublicensees to independent Third Parties during such Calendar Quarter, after deduction (if not  already deducted in the amount invoiced) of the following items paid by the Selling Party, its Affiliates and Sublicensees during such  Calendar Quarter with respect to sales of Licensed Products, provided and to the extent that such items are incurred or allowed and do  not exceed reasonable and customary amounts in the market in which such sales occurred:    (a) trade, quantity and/or cash discounts, other distribution fees, allowances or rebates [ * ], including [ * ];    (b) credits or allowances [ * ] with respect to Licensed Products by reason of rejection, defects, recalls, returns,  rebates, retroactive price reductions [ * ];    (c) any tax, tariff, customs, duty or government charge (including any sales, value added, excise or similar tax or  government charge, but excluding any income tax) levied on the sale, transportation or delivery of a Licensed Product [ * ];    (d) any charges for freight, postage, shipping or transportation, or for insurance, [ * ]; and    (e) such other deductions in accordance with GAAP.    All of the foregoing deductions from the gross invoiced sales prices of Licensed Products shall be determined in accordance with  GAAP and shall be deemed to be a deduction from gross sales in the same period properly recorded as a sales deduction in the Parties’  financial statements. In the event that the Selling Party, its Affiliates or Sublicensees make any adjustments to such deductions after the  associated Net Sales have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled in the next report  and payment of any royalties due.    1.1.87 “Non-Continuing Party” has the meaning set forth in Section 5.10.  -11-    

 

            1.1.88 “North America” means the United States of America (and its territories and possessions, including the  Commonwealth of Puerto Rico), Canada and Mexico.    1.1.89 “Opt-In Period” has the meaning set forth in Section 3.1.4.    1.1.90 “Opt-In Right” has the meaning set forth in Section 3.1.4.    1.1.91 “Opt-In Decision” has the meaning set forth in Section 3.1.4.    1.1.92 “Opt-In Notice” has the meaning set forth in Section 3.1.5.    1.1.93 “Opt-Out Date” has the meaning set forth in Section 5.10.    1.1.94 “Opt-Out Notice” has the meaning set forth in Section 5.10.    1.1.95 “Parties” means SGI and Genmab, and “Party” means either of them.    1.1.96 “Paying Party” has the meaning set forth in Section 10.6.    1.1.97 “Phase I Clinical Trial” means a human clinical trial, the primary objective of which is to determine preliminary  safety in healthy individuals or patients. Such trial may also have secondary objectives such as, but not limited to, pharmacokinetic and  preliminary efficacy parameters and may therefore be deemed also a Phase I/II Clinical Trial.    1.1.98 “Phase II Clinical Trial” means a controlled dose human clinical trial involving a sufficient number of patients  with the disease or condition of interest to obtain sufficient efficacy and safety data of a candidate drug in the targeted patient  population to support a Phase III Clinical Trial of a candidate drug for its intended use, and to define the optimal dosing regimen, such  as trials referred to in 21 C.F.R.§312.21(b) and foreign equivalents.    1.1.99 “Phase III Clinical Trial” means a controlled, and usually multi-center, clinical trial, involving patients with the  disease or condition of interest intended to obtain sufficient efficacy and safety data to support Regulatory Approval of a candidate  drug whether or not designated as “Phase III”.    1.1.100 “Phase III-B Study” means a clinical study which provides for product support (i.e., a clinical trial which is not  required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or in seeking a  label expansion) commenced before receipt of Regulatory Approval for the indication for which such trial is being conducted.    1.1.101 “Phase IV Study” means a post-marketing study to delineate additional information about a pharmaceutical  product’s risks, benefits, and optimal use, commenced after receipt of Regulatory Approval in the indication for which such Regulatory  Approval was obtained, including a trial that would satisfy the requirements of 21 CFR 312.85.  -12-    

 

            1.1.102 “Preliminary Opt-In Notice” has the meaning set forth in Section 3.1.2.    1.1.103 “Prior Agreement” means the Research and Collaboration Agreement, effective as of [ * ], as amended, by and  between the Parties.    1.1.104 “Program Inventions” has the meaning set forth in Section 14.1.1.    1.1.105 “Program Genmab Patents” has the meaning set forth in Section [ * ].    1.1.106 “Program Support Term” has the meaning set forth in Section 4.4.2.    1.1.107 “Publication” has the meaning set forth in Section 13.5.    1.1.108 “[ * ]” means a [ * ] with an [ * ], the primary [ * ] of which is to determine [ * ] in [ * ]. Such [ * ] shall also have  [ * ] such as, but not limited to, establishing [ * ], [ * ] and [ * ]. Furthermore, such trial shall also test for preliminary evidence of [ * ]  of [ * ], in at least [ * ] with at least [ * ], [ * ] and [ * ] that is envisaged to enable the [ * ] as outlined in Genmab Development Plan.  Patients will be treated with at least [ * ] of [ * ] or until [ * ] or [ * ]. The [ * ] for the [ * ] results meeting shall include [ * ] and [ * ]  after [ * ] of [ * ] or [ * ], whichever is greater.    1.1.109 “Regulatory Approval” means final regulatory approval in a country [ * ] required to market a Licensed Product  for a disease or condition in accordance with the Applicable Laws of a given country. In the United States, its territories and  possessions, Regulatory Approval means approval of a New Drug Application (“NDA”), Biologics License Application (“BLA”) or an  equivalent by the FDA.    1.1.110 “Requesting Party” has the meaning set forth in Section 11.3.    1.1.111 “Research Program” means the research program conducted pursuant to the Prior Agreement.    1.1.112 “Responding Party” has the meaning set forth in Section 11.3.    1.1.113 “ROW” means all the countries of the world except for those in North America.    1.1.114 “Royalty Reports” has the meaning set forth in Section 10.6.1.  -13-    

 

            1.1.115 “Royalty Term” means    (a) on an Exclusive Product-by-Exclusive Product and country-by-country basis, the period commencing on the  First Commercial Sale of the relevant Exclusive Product and ending upon the later to occur of:    (i) the [ * ] anniversary of the date of First Commercial Sale of such Exclusive Product in such country; or    (ii) the expiration of the last to expire Valid Patent Claim of [ * ] that would be infringed by the manufacture,  use, sale, offer for sale or import of the Exclusive Product in such country, if not for the licenses granted hereunder; or    (b) on a Genmab Product-by-Genmab Product and country-by-country basis, the period commencing on the First  Commercial Sale of the relevant Genmab Product and ending on the later to occur of:    (i) the [ * ] anniversary of the date of the First Commercial Sale of such Genmab Product in such country; or    (ii) the expiration of the last to expire Valid Patent Claim of [ * ] that would be infringed by the manufacture,  use, sale, offer for sale or import of the Genmab Product in such country, if not for Genmab’s ownership interest or the licenses granted  hereunder; or    (c) on an SGI Product-by-SGI Product and country-by-country basis, the period commencing on the First  Commercial Sale of the relevant SGI Product and ending on the later to occur of:    (i) the [ * ] anniversary of the date of the First Commercial Sale of such SGI Product in such country; or    (ii) the expiration of the last to expire Valid Patent Claim of [ * ] that would be infringed by the manufacture,  use, sale, offer for sale or import of the SGI Product in such country if not for the assignment of the [ * ] hereunder or the licenses  granted hereunder.    1.1.116 “[ * ]” means a Party’s [ * ] specific to a Collaboration Product, including without limitation the [ * ].    1.1.117 “Serious Adverse Events” means any Adverse Event occurring at any dose in response to the administration of a  Licensed Product that: (a) results in death or threatens life; (b) results in persistent or significant disability/incapacity; (c) results in or  prolongs hospitalization; (d) results in a congenital anomaly or birth defect; or (e) is otherwise medically significant.  -14-  

 

            1.1.118 “SGI” has the meaning set forth in the introduction to this Agreement.    1.1.119 “SGI Know-How” means any and all technical information, processes, formulae, data, inventions, methods,  chemical compounds, biological or physical materials, know-how and other trade secrets, in each case that are not in the public  domain, that relate to or are useful to practice the Drug Conjugation Technology and that have been, or hereafter are, Controlled by  SGI. SGI Know-How shall include Program Inventions assigned to SGI pursuant to Section 14.1.2 to the extent not disclosed or  claimed by an SGI Patent.    1.1.120 “SGI Patents” means:  (a) any patents and patent applications listed in S chedule A to this Agreement to the extent that they claim Drug  Conjugation Materials or Drug Conjugation Technology, which shall be amended from time to time to reflect any other patents and  patent applications;    (b) any patents and patent applications covering Program Inventions that are assigned to SGI pursuant to  Section 14.1.2(b) and SGI’s interest in any Joint Patents pursuant to Section 14.1.2(c);    (c) any future patents issued from any patent applications referred to above and any future patents issued from any  continuation, continuation-in part (to the extent Controlled by SGI), or divisional of any of the foregoing patent applications or any  patent applications from which the foregoing patents issued, in each case to the extent Controlled by SGI; and    (d) any reissues, reexaminations, confirmations, renewals, registrations, substitutions, extensions, or counterparts of  any of the foregoing, in each case to the extent Controlled by SGI.    1.1.121 “SGI Product” means a Unilateral Product as to which SGI elects to be the Continuing Party in accordance with  Section 5.10.    1.1.122 “SGI Technology” means the Drug Conjugation Materials, Drug Conjugation Technology, SGI Patents and the  SGI Know-How.    1.1.123 “Sublicensee” means any person or entity that is granted a sublicense under (a) the SGI Technology by Genmab  or its Affiliates or (b) the Genmab Technology by SGI or its Affiliates in accordance with the terms of this Agreement.    1.1.124 “Supply Fees” has the meaning set forth in Section 10.1.    1.1.125 “Team Leader” has the meaning set forth in Section 5.1.    1.1.126 “Term” has the meaning set forth in Article 17.    1.1.127 “Territory” means North America and ROW.  -15-    

 

            1.1.128 “Tissue Factor” means the antigen having the NCBI Entrez Gene Symbol of F3 and an amino acid sequence  corresponding to NCBI RefSeq accession number NP-001984, [ * ].    1.1.129 “Third Party” means any person or entity other than Genmab, SGI and their respective Affiliates.    1.1.130 “Third Party Collaboration Agreement” means any agreement pursuant to which a Third Party is granted rights  to commercialize (including to develop and commercialize) one or more Collaboration Products, including development agreements,  collaboration agreements, marketing and marketing/distribution agreements, promotion agreements or other similar agreements, in  each case in accordance with the provisions of Section 5.11.    1.1.131 “Unilateral Product” has the meaning set forth in Section 5.10. For clarity, a Unilateral Product must be within  the definition of Licensed Product.    1.1.132 “Valid Patent Claim” means (a) an unexpired claim of an issued patent (including any extension thereof pursuant  to patent term extension or a supplementary protection certification) which has not been found to be unpatentable, invalid or  unenforceable by an unreversed and unappealable decision (including a decision that was not appealed within the time allotted for an  appeal) of a court or other authority in the subject country; or (b) a claim of an application for a patent that has been [ * ].    1.2 Certain Rules of Interpretation in this Agreement and the Schedules  1.2.1 Unless otherwise specified, all references to monetary amounts are to United States of America currency (U.S.  Dollars).    1.2.2 The preamble to this Agreement and the descriptive headings of Articles and Sections are inserted solely for  convenience of reference and are not intended as complete or accurate descriptions of the content of this Agreement or of such Articles  or Sections.    1.2.3 The use of words in the singular or plural, or with a particular gender, shall not limit the scope or exclude the  application of any provision of this Agreement to such person or persons or circumstances as the context otherwise permits.    1.2.4 The words “include” and “including” have the inclusive meaning of the phrases “without limitation” and “but not  limited to”.    1.2.5 Unless otherwise specified, time periods within or following which any payment is to be made or act is to be done  shall be calculated by excluding the day on which the period commences and including the day on which the period ends and by  extending the period to the next business day following if the last day of the period is not a business day in either of the jurisdictions of  the Parties to make such payment or do such act.  -16-  

 

            1.2.6 Whenever any payment is to be made or action to be taken under this Agreement is required to be made or taken on a  day other than a business day in the United States of America or Denmark, such payment shall be made or action taken on the next  business day following such day to make such payment or do such act.      ARTICLE 2   LICENSES    2.1 Licenses to Genmab  2.1.1 Exclusive Products. Subject to the terms of this Agreement (including SGI’s Opt-In Right), SGI hereby grants to  Genmab an exclusive (even as to SGI), royalty-bearing license under the SGI Technology, with the right to sublicense as permitted in  Section 2.2, to develop, have developed, make, have made, import, use, offer for sale, have sold and sell Exclusive Products within the  Field in the Territory. The license for an Exclusive Product shall continue for the Royalty Term of such Exclusive Product, unless SGI  exercises its Opt-In Right for such Exclusive Product pursuant to Section 3.1 or it is earlier terminated pursuant to Article 17.    2.1.2 Collaboration Products. Upon the date of an Opt-In Notice and subject to the terms of this Agreement, SGI hereby  grants Genmab a worldwide, co-exclusive (with SGI), royalty-free license, including the right to sublicense (as proposed by the JSC  and approved by the written consent of the Parties and in accordance with Section 5.11), under the SGI Technology to (a) perform its  obligations hereunder with respect to each Collaboration Product in accordance with the relevant Joint Development Plan, and (b) to  develop, have developed, make, have made, import, use, offer for sale, have sold and sell such Collaboration Product within the Field  in the Territory in accordance with the relevant Commercialization Plan. The license for a Collaboration Product shall continue, on a  country-by-country basis, for so long as there are Development or Commercialization activities contemplated.    2.1.3 Unilateral Products. As of the Opt-Out Date following an Opt-Out Notice from SGI and subject to the terms of this  Agreement, SGI hereby grants to Genmab an exclusive (even as to SGI), royalty-bearing license under the SGI Technology, with the  right to sublicense as permitted in Section 2.2, to develop, have developed, make, have made, import, use, offer for sale, have sold and  sell Genmab Products (i.e., a Unilateral Product for which Genmab is the Continuing Party) within the Field in the Territory. The  license for a Genmab Product shall continue for the Royalty Term of such Genmab Product, unless it is earlier terminated pursuant to  Article 17.    2.2 Genmab’s Rights to Sublicense  2.2.1 For so long as SGI holds an Opt-In Right for an Exclusive Product, Genmab may not grant a sublicense of the  license for such Exclusive Product granted to Genmab pursuant to this Agreement to a Third Party without [ * ].  -17-    

 

            2.2.2 Subject to Section 2.2.1, Genmab shall have the right to grant a sublicense of the license for an Exclusive Product or  Genmab Product granted to Genmab pursuant to this Agreement to any Affiliate or other Third Party, subject to the terms and  conditions of the BMS Agreement. Genmab shall not have the right to sublicense the SGI Technology outside the scope of the license  granted in Section 2.1.1 or 2.1.3, including no rights to develop further SGI Technology on a stand-alone basis or make or use SGI  Technology to create antibody-drug conjugates that include or are based upon any antibodies that bind specifically to an antigen other  than Tissue Factor.    2.2.3 Genmab agrees to contractually obligate any Sublicensee of an Exclusive Product or a Genmab Product to make all  payments due to SGI pursuant to this Agreement, as well as to comply with all terms of this Agreement applicable to Genmab  (including the BMS Agreement identified as applicable to Sublicensee). For the sake of clarification, such payments shall be made to  Genmab and not directly to SGI. Genmab shall also require any such Sublicensee to agree in writing to keep books and records and  permit either Genmab or SGI or both to audit the information concerning such books and records in accordance with the terms of this  Agreement (and in accordance with the terms of the BMS Agreement as applicable). If one of the Parties conducts such an audit of the  books and records of a Sublicensee without the other Party’s participation, the Party conducting the audit shall upon the other Party’s  request share the results of such audit. In addition, a sublicense to an Affiliate must provide that it will automatically terminate if the  relevant Sublicensee ceases to be an Affiliate of Genmab.    2.2.4 For sublicenses permitted hereunder granted for a Genmab Product or an Exclusive Product, Genmab shall (a) notify  SGI of each sublicense granted (both to Affiliates and Third Parties) hereunder, and (b) provide SGI with the name and address of each  Sublicensee (both Affiliates and Third Parties) and a description of the rights granted and the territory covered by each Sublicensee.  Genmab hereby notifies SGI, and SGI hereby acknowledges that as of the Effective Date Genmab has granted sublicenses to its  Affiliates, Genmab B.V., the Netherlands, and Genmab, Inc., New Jersey, USA, for the purposes of this Agreement and further that  Genmab has entered into an agreement with [ * ] related to the [ * ] of [ * ].    2.3 Compliance with the BMS Agreement  2.3.1 To the extent SGI Technology includes technology sublicensed under the BMS Agreement, Genmab, its Affiliates  and Sublicensees shall comply with all obligations, covenants and conditions of the BMS Agreement, and any amendments thereto  following written disclosure thereof to Genmab, that apply under the BMS Agreement. The Parties agree that BMS is a Third Party  beneficiary to this Agreement to the extent SGI Technology includes technology sublicensed under the BMS Agreement and limited to  those rights and obligations of this Agreement which SGI are obliged to impose on its sublicensees pursuant to the terms of the BMS  Agreement.    2.3.2 SGI will not enter into any amendment to the BMS Agreement that imposes additional monetary or other obligations  on Genmab or materially reduces the scope of the licenses granted to Genmab hereunder without the prior written consent of Genmab.  -18-  

 

            2.4 Licenses to SGI  2.4.1 Development Support for Exclusive Products. Subject to the provisions of this Agreement, Genmab hereby grants  to SGI, during the Program Support Term, a non-exclusive, royalty-free, sublicenseable license under the Genmab Patents and Genmab  Know-How in the Territory, to enable SGI solely to provide the support contemplated by Section 4.4.    2.4.2 Collaboration Products. Upon the date of SGI’s Opt-In Notice and subject to the terms of this Agreement, Genmab  shall grant to SGI a worldwide, co-exclusive (with Genmab), royalty-free license, including the right to sublicense (as proposed by the  JSC and approved by the written consent of the Parties and in accordance with Section 5.11), under the Genmab Patents and Genmab  Know-How to (a) perform its obligations hereunder with respect to each Collaboration Product in accordance with the relevant Joint  Development Plan, and (b) to develop, have developed, make, have made, import, use, offer for sale, have sold and sell such  Collaboration Product within the Field in the Territory in accordance with the relevant Commercialization Plan. The license for a  Collaboration Product shall continue, on a country-by-country basis, for so long as there are Development or Commercialization  activities contemplated.    2.4.3 Unilateral Products. As of the Opt-Out Date following an Opt-Out Notice from Genmab and subject to the terms of  this Agreement, Genmab shall grant to SGI an exclusive (even as to Genmab), royalty-bearing license under the Genmab Patents and  Genmab Know-How, with the right to sublicense as permitted in Section 2.5, to develop, have developed, make, have made, import,  use, offer for sale, have sold and sell SGI Products (i.e., a Unilateral Product for which SGI is the Continuing Party) within the Field in  the Territory. The license for an SGI Product shall continue for the Royalty Term of such SGI Product, unless it is earlier terminated  pursuant to Article 17.    2.5 SGI’s Rights to Sublicense  2.5.1 As of the Opt-Out Date following an Opt-Out Notice from Genmab, SGI shall have the right to grant a sublicense of  the license for an SGI Product granted to SGI pursuant to this Agreement to any Affiliate or other Third Party, subject to the terms and  conditions of the Genmab In-Licenses listed in S chedule C, as may be amended from time to time. SGI shall not have the right to  sublicense the Genmab Patents and Genmab Know-How outside the scope of the license granted in Section 2.4.3.    2.5.2 SGI agrees to contractually obligate any Sublicensee to make all payments due to Genmab pursuant to this  Agreement, as well as to comply with all terms of this Agreement applicable to SGI (including the Genmab In-Licenses identified as  applicable to Sublicensee), for an SGI Product. For the sake of clarification, such payments shall be made to SGI and not directly to  Genmab. SGI shall also require any such Sublicensee to agree in writing to keep books and records and permit either SGI or Genmab  or both to audit the information concerning such books and records in accordance with the terms of this Agreement (and in accordance  with the terms of any Genmab In-License as applicable). If one of the Parties  -19-    

 

            conducts such an audit of the books and records of a Sublicensee without the other Party’s participation, the Party conducting the audit  shall upon the other Party’s request share the results of such audit. In addition, a sublicense to an Affiliate must provide that it will  automatically terminate if the relevant Sublicensee ceases to be an Affiliate of SGI.    2.5.3 SGI shall for sublicenses permitted hereunder (a) notify Genmab of each sublicense granted hereunder and  (b) provide Genmab with [ * ].    2.6 Compliance with the Genmab In-Licenses  2.6.1 SGI, its Affiliates and Sublicensees shall comply with all obligations, covenants and conditions of the Genmab  In-Licenses listed in S chedule C, as amended from time to time by Genmab following written disclosure thereof to SGI. The Parties  agree that [ * ] and [ * ] are [ * ] to this [ * ] as the [ * ] are [ * ] to an [ * ] (as defined in the [ * ]).    2.6.2 Genmab will not enter into any amendment to a Genmab In-License that imposes additional monetary or other  obligations on SGI or materially reduces the scope of the licenses granted to SGI hereunder without the prior written consent of SGI.      ARTICLE 3 OPT-IN TO CO-DEVELOPMENT AND CO-COMMERCIALIZATION    3.1 Opt-In  3.1.1 As soon as reasonably practicable after the database lock of the first [ * ] of each Exclusive Product, Genmab will  begin providing SGI with all material information necessary or useful in making an Opt-In Decision as further specified in this  Section 3.1    3.1.2 [ * ] shall invite [ * ] to [ * ] meeting to be held within [ * ]. At this meeting [ * ] will present (a) all relevant [ * ] to  be included in the [ * ], (b) a package summarizing the [ * ] conducted on such Exclusive Product (including providing [ * ] with [ * ]  to the [ * ]), (c) a [ * ] and related [ * ] for such Exclusive Product (assuming for the purpose that it is a [ * ]) and a [ * ] for [ * ] in the [  * ] and [ * ] (i.e., the [ * ]), (d) a written report on the [ * ] for such [ * ], including the [ * ] with a form and content as decided by [ * ],  but no less detailed than the [ * ] that [ * ] has prepared for its internal use and (e) information relating to [ * ] within the [ * ] of [ * ]  and [ * ] to [ * ], any [ * ] listing [ * ] within the [ * ] of [ * ] and [ * ] to [ * ], and copies of [ * ] to and from the [ * ] for the [ * ]. SGI  shall provide [ * ] with [ * ] stating its preliminary decision as to whether it wishes to opt-in (“Preliminary Opt-In Notice”) within [ * ]  days [ * ] the [ * ], as such deadline may be extended in accordance with this Section 3.1.2. SGI may identify further information it [ *  ] is [ * ] to be provided by Genmab. The [ * ] shall [ * ] this [ * ] until [ * ] is [ * ], h owever, in no event should this [ * ] (including the  provision of a [ * ]) extend beyond [ * ] days after the [ * ] of the [ * ].    3.1.3 If SGI does not provide a Preliminary Opt-In Notice by the deadline (the extended deadline in Section 3.1.2 shall  apply if [ * ] has identified further information and not yet received such information), Genmab shall then be entitled to proceed with  the development of such Exclusive Product, h owever, SGI shall still be entitled to opt-in pursuant to  -20-    

 

            Section 3.1.5. If SGI subsequently provides an Opt-In Notice with respect to such Exclusive Product within the timeframe set forth in  Section 3.1.5, then the [ * ] to [ * ] the [ * ] incurred by [ * ] in the [ * ] after the [ * ] of the [ * ] and until the [ * ] as if they had been [  * ]. If SGI provides a Preliminary Opt-In Notice by the deadline (the extended deadline in Section 3.1.2 shall apply if SGI has  identified further information and not yet received such information), the Parties shall then proceed with the Development of such  Collaboration Product in accordance with the Joint Development Plan and related Joint Budget and all parts of this Agreement  pertaining to Collaboration Products shall apply subject to a final [ * ]; provided that [ * ] shall not be [ * ] to [ * ] for its [ * ] of the [ *  ] incurred in the [ * ] in the event that subsequently it does not provide an [ * ]. If [ * ] after having provided [ * ] does not provide an [  * ] with respect to such [ * ] within the [ * ] set forth in Section 3.1.5, the [ * ] acknowledge that such a [ * ] shall not be deemed an [ *  ], but that the [ * ] in question shall go back to being [ * ] an [ * ].    3.1.4 Genmab shall provide SGI with the [ * ], including the [ * ], [ * ], [ * ], [ * ] and [ * ] of [ * ] of the relevant  Exclusive Product within [ * ] days after [ * ]. Simultaneously with [ * ] submission of the [ * ], [ * ] shall notify SGI of any [ * ] or [ *  ] with any [ * ] that relates to the Exclusive Product (other than a [ * ]) and shall to the extent possible provide [ * ] with a copy of any  such agreement, provided, that, [ * ] may [ * ] from such agreement(s) any terms that are [ * ], so long as the [ * ], including, without  limitation, [ * ] relating to [ * ] by [ * ], scope of [ * ] and [ * ] terms, remain [ * ]. [ * ] shall make available suitably [ * ] to answer  questions relating to any of the matters disclosed pursuant to this Section 3.1 prior to and during the [ * ].    3.1.5 SGI shall have until [ * ] days after receipt of the [ * ] (the “Opt-In Period”) to determine whether SGI will elect to  opt-in (the “Opt-In Right”) to co-fund the development and commercialization of the Exclusive Product (the “Opt-In Decision]”).    3.1.6 If SGI exercises its Opt-In Right for an Exclusive Product, SGI shall provide written notice to Genmab of its Opt-In  Decision prior to the expiration of the Opt-In Period for such Exclusive Product (the “Opt-In Notice”). Effective as of the date of such  Opt-In Notice, (a) the Exclusive Product will be deemed to be a Collaboration Product, (b) Genmab’s license]for the relevant Exclusive  Product set forth in Section 2.1.1 will terminate and SGI will grant Genmab] a co-exclusive license with respect to the Collaboration  Product on the terms set forth in Section 2.1.2, (c) Genmab will grant SGI a co-exclusive license with respect to such Collaboration  Product on the terms set forth in Section 2.4.2, and (d) the Parties will [ * ] all Joint Development Costs, Commercialization Expenses  and Collaboration Product Profit for such Collaboration Product, subject to the applicable terms of this Agreement and oversight of the  JSC.    3.1.7 If [ * ] does not provide [ * ] with an [ * ] with respect to an Exclusive Product during the relevant [ * ], then [ * ]  shall have [ * ] to [ * ] with respect to such Exclusive Product and [ * ] shall [ * ] the [ * ] to [ * ] such Exclusive Product on its own  granted pursuant to Section 2.1.1 and shall be obligated to pay [ * ] the [ * ], [ * ] and [ * ] set forth in Article 10.  -21-  

 

            3.1.8 [ * ] agrees that the [ * ] disclosed pursuant to Section 3.1 shall be Confidential Information of [ * ] and to use such  information solely for the purpose of making the [ * ]. SGI shall return all information disclosed pursuant to Section 3.1 to Genmab  (and shall not keep any copies of such information) not later than [ * ] days after the [ * ] of the [ * ] unless [ * ] exercised its [ * ].    3.2 Joint Steering Committee. The activities of the Parties with respect to Development and Commercialization of all  Collaboration Products shall be overseen by a JSC as set forth in this Section 3.2.    3.2.1 Establishment of JSC. Promptly, but in no event later than [ * ], following the Opt-In Notice, the Parties will  establish a joint steering committee (“Joint Steering Committee” or “JSC”), which will have overall responsibility for overseeing the  Development and Commercialization undertaken pursuant to this Agreement for any and all Collaboration Products during the Term.  The JSC will be composed of [ * ] representatives from each Party. Either Party may change its representatives to the JSC upon prior  written notice to the other Party in accordance with this Agreement. It is anticipated that the membership of the JSC may change over  time in accordance with the development stage of the Collaboration Product(s). Each Party shall ensure that the representatives named  by such Party for membership on the JSC have the requisite seniority level and expertise to oversee the activities of the collaboration  during the Term. A chairman of the JSC shall be appointed for a one (1) year term. The chairmanship of the JSC shall alternate  annually between Genmab and SGI, [ * ].    3.2.2 Responsibilities. The JSC shall perform the following functions:  (a) Review and approve strategies for the Development of Collaboration Product(s), and provide direction to the  Joint Development Team as provided herein.    (b) Review and approve amendments to the Joint Development Plan and Joint Budget, including in respect of  further Development of the Collaboration Product(s) such as for any new indication or formulation.    (c) Review and approve the regulatory strategies for each Collaboration Product in the Territory, including design of  the pivotal studies that are intended to support Regulatory Approval in such territories and ensuring that such strategies are compatible.    (d) Review and discuss the goals and strategy for the manufacture of each Collaboration Product.    (e) Approve protocols for, and prioritization of, clinical trials and indications for each Collaboration Product.    (f) Review and approve the goals and strategy for the Commercialization of each Collaboration Product, including  prepare and approve an initial Commercialization Plan for each Collaboration Product.  -22-    

 

            (g) Oversee the Parties’ activities with respect to Program Genmab Patents, Joint Patents, Genmab ADC Patents,  Genmab ADC Know-How and Collaboration Product Trademarks.    (h) Establish subcommittees, as deemed necessary, and oversee such subcommittees, including the Joint  Development Team. For example, the Parties anticipate that the JSC shall form a joint commercialization team in accordance with  Section 8.4.    (i) Serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Joint  Development Team and any other subcommittee.    (j) Establish and implement out-licensing strategies to Third Parties as applicable.    (k) Approve the Collaboration Accounting Policies.    (l) Approve strategy for assigning sponsorship of clinical studies and related regulatory filings from one Party to the  other Party or a Third Party.    (m) Approve strategy for winding down activities for Dormant Product(s). Any costs related thereto shall be  considered Joint Development Costs and/or Commercialization Expenses.    (n) Perform such other functions as are specifically designated to the JSC in this Agreement or otherwise as agreed  upon by the Parties.    3.2.3 Meetings. The JSC shall meet [ * ] on such dates and at such times as agreed to by SGI and Genmab, with all  scheduled meetings to alternate between [ * ] and [ * ], or at such other locations as determined by the JSC. If one Party requests the  JSC to convene, then such meeting must be held within [ * ] of such request. Upon the determination of the JSC, any such meeting may  be conducted by conference telephone or videoconference; provided, h owever, [ * ]. Meetings shall be effective only if at least [ * ]  representatives of each Party are in attendance or participating in the meeting. Each Party may permit non-voting observers to attend  meetings of the JSC as the JSC determines. [ * ] shall be responsible for [ * ] in connection with the meetings of the JSC. The then  current Party in the chair of the JSC shall appoint its Alliance Manager to attend the meeting and record the minutes of the meeting in  writing. Such minutes shall be circulated to the other Party’s Alliance Manager no later than [ * ] following the meeting for review,  comment and approval of the other Party. If no comments are received within [ * ] of the receipt of the minutes by a Party, unless  otherwise agreed, they shall be deemed to be approved by such Party. Furthermore, if the Parties are unable to reach agreement on the  minutes within [ * ] of the applicable meeting, the sections of the minutes which have been agreed between the Parties by that date  shall be deemed approved and, in addition, each Party shall record in the same document its own version of those sections of the  minutes on which the Parties were not able to agree.  -23-    

 

            3.2.4 Decisions; Actions Without Meeting. Any approval, determination or other action of the JSC shall [ * ] of the JSC,  with each Party’s representatives [ * ]. Action that may be taken at a meeting of the JSC also may be taken without a meeting if a  written consent setting forth the action so taken is agreed in writing by all representatives to the JSC.    3.2.5 Authority. It shall be conclusively presumed that each voting member of the JSC has the authority and approval of  such member’s respective senior management in casting the vote described in Section 3.2.4 on matters as described in this Article 3.  Notwithstanding the creation of the JSC, each Party to this Agreement shall retain the rights, powers and discretion granted to it  hereunder, and the JSC shall not be delegated or vested with any such rights, powers or discretion unless such delegation or vesting is  expressly provided for herein. The JSC shall not have power to amend or modify this Agreement, to change the time any payment is  due from one Party to another, or to impose additional economic burdens on either Party beyond those specifically contemplated by  this Agreement without the prior written consent of the Party on which such burden is imposed.    3.2.6 Subcommittees. The JSC may, from time to time, establish subcommittees not already dealt with pursuant to this  Agreement. The JSC shall determine the charter, composition and other provisions relating to any such subcommittee in its discretion.    3.2.7 Disputes; Final Decision Making Authority. Any disputes or disagreements arising in the JSC that are unable to be  resolved within [ * ] after the matter is first referred to the JSC shall be referred to the [ * ] of each Party for the current dispute for  resolution. If the [ * ] are unable to resolve a matter within [ * ] after the matter is first referred to them, then the final decision on such  matters shall be made [ * ] in accordance with Sections 23.3.1 to 23.3.3.    3.2.8 Dissolution. The JSC shall continue to operate after the end of the Collaboration Program to the extent needed in  order to deal with any of the issues listed in Section 3.2.2. Following the end of the Collaboration Program, the JSC shall however not  be obliged to convene at the times set forth in Section 3.2.3, but merely when needed in order to address the issues at hand. Once the  JSC [ * ] that its responsibilities have been exhausted, then the JSC may dissolve itself.    3.3 Alliance Manager. No later than [ * ] calendar days following the Effective Date, each Party shall nominate one  (1) representative to act as a central contact for that Party (“Alliance Manager”), to whom any relevant queries and comments can be  addressed by the other Party and who will ensure that such queries and comments are further directed within his organization  appropriately and promptly to ensure efficient communication and cooperation between the Parties. Either Party may replace its  Alliance Manager at any time upon written notice to the other Party. In addition to the responsibilities of the Alliance Manager for  Development and Commercialization of Collaboration Products as described in this Article 3, during the period from the Effective  Date and until the end of the Opt-In Period the Alliance Managers shall coordinate regular meetings of cross-functional working  groups from each Party, for the purpose of facilitating consultation by SGI on Genmab’s development of Licensed Products. Each Party  shall bear its own costs associated with such coordination and participation in such regular meetings.  -24-    

 

            3.4 Exclusivity  3.4.1 Except as expressly set forth in this Agreement, the [ * ] and their Affiliates shall work [ * ] with each other to  develop and commercialize Exclusive Products (for which the [ * ] has not yet expired) and Collaboration Products solely in  accordance with the terms of this Agreement. Each Party [ * ] to [ * ] or with Affiliates or Third Parties to [ * ], [ * ], and [ * ] any [ * ]  that is not a Competing Product.    3.4.2 Except as expressly set forth in Section 3.4.3, neither Party nor any of their respective Affiliates shall, [ * ] or [ * ],  (a) [ * ], [ * ] or otherwise [ * ] to any Competing Program or (b) [ * ] any Competing Product.    3.4.3 If either Party wishes, whether directly or indirectly, to (a) [ * ] or otherwise [ * ] to any Competing Program or (b) [  * ] any Competing Product, such Party shall notify the other Party in writing [ * ] describing the proposed Competing Program and/or  Competing Product, and the Parties shall consider in good faith whether or not to [ * ] to [ * ] under which the Parties would [ * ] on  the Competing Program or [ * ] the Competing Product.    3.4.4 In the period either prior to [ * ] first [ * ] or after any relevant [ * ], [ * ] may use [ * ] to [ * ], including [ * ] in  studies designed to [ * ], [ * ], [ * ] or [ * ] an [ * ] with a [ * ] other than [ * ], provided that such studies are [ * ] in nature. At any  other time during the Term, neither Party [ * ] to [ * ] in such studies [ * ] the [ * ] of the other Party, such [ * ] not to be [ * ]. The  Parties agree that any ongoing activities initiated prior to [ * ] may be finalized according to the contemplated plan.    3.4.5 Notwithstanding anything to the contrary in this Agreement, Genmab shall be [ * ] to [ * ] and [ * ], [ * ] or with a [ *  ], a [ * ] (i.e. an [ * ] to a [ * ]) with specificity against [ * ] for [ * ] purposes. [ * ] shall ensure that any [ * ] with Third Parties  pertaining to the [ * ], [ * ] or [ * ] of such products contain provisions [ * ] the Parties to use such products to support the [ * ] and [ * ]  of Licensed Products, if appropriate. At any time during the Term, [ * ] shall be permitted to use a [ * ] (i.e. an [ * ] to a [ * ]) with [ * ]  for [ * ]. Following an [ * ] by [ * ] or if [ * ] does not exercise its [ * ] for the first Exclusive Product, [ * ] shall be permitted to [ * ],  alone or with [ * ], a [ * ] (i.e. [ * ]) with [ * ] for any purpose. Following an [ * ] by [ * ] or if [ * ] does not exercise its [ * ] for the  first Exclusive Product, [ * ] shall, [ * ] or with a [ * ], be permitted to [ * ] such [ * ] (i.e. an [ * ]) with [ * ] for any purpose after the [  * ] anniversary of the date of [ * ] in a Major Market Country of an Exclusive Product or Genmab Product.      ARTICLE 4 DEVELOPMENT, COMMERCIALIZATION AND MANUFACTURING OF EXCLUSIVE PRODUCTS    4.1 Diligence. Genmab shall use Commercially Reasonable Efforts to develop, commercialize and market one or more  Exclusive Products. Without limiting the foregoing, Genmab shall, as commercially prudent, (a) conduct [ * ], (b) diligently obtain any  necessary  -25-  

 

            approvals to market such Licensed Products [ * ], and (c) market such Exclusive Products [ * ]. Genmab shall comply with all  Applicable Laws (including GLPs, GCPs and GMPs) in the development and commercialization of such Exclusive Products, and shall  cause its Affiliates and Sublicensees to do the same.    4.2 Funding and Progress Reports. Except as expressly set forth herein, as between SGI and Genmab, Genmab shall be solely  responsible for funding all costs of the research, development and commercialization of all Exclusive Products. Genmab shall keep  SGI informed in a timely manner as to the progress of the development of each Exclusive Product. Beginning on January 30, 2012, and  [ * ] thereafter within [ * ] days following the end of each [ * ], Genmab shall provide SGI with a written report summarizing  Genmab’s significant activities performed and planned related to research and development of each Exclusive Product and status of  clinical trials and applications for Regulatory Approval necessary for marketing the Exclusive Product, including anticipated  milestones under Section 10.5.1. Such reports shall be deemed Genmab’s Confidential Information for the purposes of Article 13.    4.3 Manufacturing. Except as otherwise expressly set forth in this Agreement, Genmab shall be responsible for all  manufacturing and supply of Exclusive Products. Notwithstanding the foregoing, SGI shall upon request by Genmab provide  documents or other information that SGI has created or possesses (or which are in the possession of a potential Third Party  manufacturer contracted by SGI) that is necessary to support Genmab’s (or any of its Affiliates’, subcontractors’ or Sublicensees’)  manufacturing or testing of Drug Conjugation Materials or Exclusive Products or to support Genmab in establishing and/or procuring  Third Party arrangements for obtaining clinical and/or commercial supplies of Exclusive Products. Genmab shall [ * ] SGI for [ * ]. In  the event Genmab requests SGI to provide any assistance beyond the limited activities described above or to supply any materials  directly to Genmab, the Parties shall negotiate in good faith a separate agreement governing the terms of any such assistance or supply  by SGI, including relevant prices and other such terms as may be appropriate and customary in agreements for providing such  assistance or for supplying similar products at similar volumes.    4.4 SGI Development Support and Regulatory Assistance  4.4.1    General Support and Assistance. During the period from the Effective Date and until the end of the Opt-In Period,  SGI shall use its Reasonable Commercial Efforts to provide full and timely assistance with the matters set forth in S chedule D, which  are anticipated by the Parties to be the services needed by Genmab to ensure a timely and value-optimizing process of the development  of the Exclusive Product up and until the expiry of the Opt-In Period.  4.4.2   Delivery of Drug Conjugation Materials. For a period of [ * ] after the Effective Date (the “Program Support  Term”), SGI will (a) at Genmab’s request and expense, deliver Drug Conjugation Materials and other relevant information and SGI  Know-How to Genmab or to a subcontractor of Genmab at mutually agreed upon times and in mutually agreed upon quantities to  enable Genmab or its subcontractor to attach such materials to Antibodies to  -26-    

 

            create ADCs; and (b) at Genmab’s request, provide Genmab with the chemical structures for the Drug Conjugation Materials provided  to Genmab to enable Genmab (or any of its Affiliates, subcontractors or Sublicensees) to manufacture Drug Conjugation Materials  itself. In manufacturing and supplying Genmab with the Drug Conjugation Materials, SGI shall comply with all Applicable Laws of  the jurisdiction in which manufacturing is performed (including GLPs, GCPs and GMPs, as appropriate) as well as adhere to SGI’s  standard technical specifications and shall cause its Affiliates and subcontractors to do the same in order to ensure the quality of the  materials delivered. All Drug Conjugation Materials and other information provided by SGI to Genmab hereunder will be deemed  Confidential Information of SGI pursuant to Article 13.    4.4.3    SGI Preparation of ADCs. At the request and expense of Genmab during the Program Support Term, SGI will  prepare mutually agreed upon quantities of ADCs containing Drug Conjugation Materials using Antibodies supplied by Genmab to  SGI, and shall deliver the resulting ADCs to Genmab.    4.4.4    Payment. Genmab shall pay SGI the amounts set forth in Section 10.1 for any assistance provided by SGI pursuant  to this Section 4.4.    4.4.5    Disclosure of Drug Conjugation Technology. During the Program Support Term, SGI shall (a) disclose to Genmab  such SGI Know-How as is required and is reasonably useful to enable Genmab to use the Drug Conjugation Materials and Drug  Conjugation Technology to practice the license for an Exclusive Product on the terms, and subject to the conditions, of this Agreement  and (b) upon Genmab’s reasonable request and with adequate notice to SGI, make available to Genmab at SGI’s facilities, SGI’s  personnel to provide a reasonable amount of technical assistance and training to Genmab’s personnel. Genmab shall [ * ] to SGI for [ *  ].    4.4.6    SGI Regulatory and other Assistance. Genmab shall be solely responsible for, and shall solely own, all  applications for Regulatory Approval with respect to each Exclusive Product. Should Genmab desire to file an IND or an application  for Regulatory Approval, or equivalents of the foregoing, for an Exclusive Product, SGI agrees to provide at Genmab’s request, any  and all technical information SGI has created or possesses that is reasonably required by Genmab, including information relating to the  chemical structure of the cytotoxic compound, linker and chemistry used to create the Exclusive Product, as well as documents related  specifically to Drug Conjugation Technology that are necessary to compile the Chemistry Manufacturing and Controls section of an  application for Regulatory Approval and any other relevant information SGI has created or possesses as the Parties may mutually  agree. If SGI has a Drug Master File (DMF) with the FDA or equivalent that contains information useful to support an IND or  application for Regulatory Approval, SGI shall so notify Genmab and allow Genmab the right of reference to the contents of such  DMF. SGI shall have no obligation to provide any information contained in the DMF and may require the applicable Regulatory  Authority to maintain such information as confidential. Prior to Genmab’s Initiation of the [ * ], SGI agrees to share with Genmab  useful preclinical, clinical, CMC and regulatory experience and intelligence, that SGI is at liberty to share. The sharing of such  information can  -27-    

 

            be by exchange of documents and/or through telephone or personal meetings. Genmab shall [ * ] SGI for [ * ]. In the event SGI agrees  to provide regulatory assistance beyond the limited activities described above, the Parties shall negotiate in good faith a separate  agreement governing the terms of any such regulatory assistance by SGI, including terms as may be appropriate and customary in  agreements for similar types of regulatory assistance.    4.5 Adverse Events. Notwithstanding that Genmab shall be solely responsible for the clinical development and  commercialization of each Exclusive Product, Section 7.5 shall apply to the reporting of Adverse Events and Serious Adverse Events  relating to Exclusive Products.      ARTICLE 5 CO-DEVELOPMENT OF COLLABORATION PRODUCTS    5.1 Establishment of Joint Development Team. As soon as practicable, but in no event later than [ * ] days, after the Opt-In  Notice the Parties shall establish a joint development team (“Joint Development Team” or “JDT”), to coordinate and implement all  activities in the Joint Development Plan within the Joint Budget. One representative from each Party shall be designated as that Party’s  team leader (the “Team Leader”) to act as primary JDT contact for that Party. The JDT shall consist of [ * ] representatives of each  Party as are reasonably necessary to accomplish the goals of the JDT hereunder and each such representative may send a designate in  his or her place as appropriate for a particular meeting. Either Party may replace any or all of its representatives at any time upon  written notice to the other Party.    5.1.1 Responsibilities of the Joint Development Team. The JDT shall be responsible for:    (a) Preparing for approval by the JSC and thereafter implementing the annual updates to the Joint Development  Plan and Joint Budget.    (b) Developing an overall strategy for the Development of the Collaboration Product(s) for review and approval by  the JSC.    (c) Formulating any amendments to the Joint Development Plan (including allocation of Development activities  between the Parties) and the Joint Budget for review and approval by the JSC.    (d) Making recommendations to the JSC for further Development of the Collaboration Product(s), including  Development for new indications that are not in the then current Joint Development Plan.    (e) Making forecasts of clinical supplies requirements for Development of the Collaboration Product and reviewing  the supply of Collaboration Product.    (f) Developing a strategy for approval by the JSC for assignment of sponsorship of clinical studies and related  regulatory filings from one Party to the other Party or to a Third Party following an Opt-In Notice, Opt-Out Notice or otherwise in each  country  -28-    

 

            where clinical studies may be planned. Such strategy to include a policies and guidelines designed to enable an assignment, including  in terms of agreements (such as but not limited to agreements with clinical research organizations, clinical trial agreements, pharmacy  agreements), insurance and regulatory documents, prior to initiation of such clinical studies. In addition, developing a similar strategy  for approval by the JSC for winding down activities for Dormant Products.    (g) Exchanging information regarding the conduct of ongoing Clinical Trials and the Development of the  Collaboration Product(s) and the exercise and meeting of the Parties ́ respective rights and obligations under the Joint Development  Plan and this Agreement.    (h) Providing status updates to the JSC regarding Development activities.    (i) Overseeing and monitoring the selection of any contract manufacturers and negotiation of agreements with  same.    (j) Functioning as a forum under which SGI and Genmab would exchange information to enable the Parties to  manage the day-to-day aspects of the manufacturing and supply chain for the Collaboration Product, defending pre-approval  inspections and establishing production capability at either contract manufacturers ́ or the Parties’ sites.    (k) Discussing and facilitating technology transfer to establish process at contract manufacturers ́ sites, if necessary.    (l) Discussing and facilitating pre-approval inspection readiness of the manufacturing sites and ensuring adequate  support of the inspections.    (m) Discussing process improvements and the associated CMC regulatory strategy including new formulations and  process optimization.    (n) Liaising with the JSC regarding manufacturing.    (o) Performing such other functions as appropriate to further the purposes of this Agreement as determined by the  Parties.    The JDT may designate sub-teams as appropriate to facilitate coordination and cooperation in key areas.    5.1.2 Procedures. For a one-year period beginning on the Opt-In Date, the Team Leader of [ * ] shall serve as the  chairperson of the JDT. For each subsequent one-year period, the Team Leaders shall alternate as the chairperson of the JDT. The  Parties shall meet not less than [ * ] on such dates and at such times as agreed to by the members of the JDT. The agenda for all JDT  meetings must be established by mutual consent and the Party in the then  -29-  

 

            current chair shall send notice of such meetings, including the agenda therefore, to all JDT members; provided, h owever, that either  Party may request that specific items be included in the agenda and may request that additional meetings be scheduled as needed.  Meetings may be held telephonically or by video conference, [ * ]. [ * ] will [ * ] associated with holding and attending JDT meetings.  A quorum of at least half the JDT members appointed by each Party shall be present at or shall otherwise participate in each JDT  meeting. The Party hosting the meeting (or arranging the conference or video call) shall appoint one (1) person (who need not be a  member of the JDT) to record the minutes of the meeting in writing. Such minutes shall be circulated to the Parties promptly following  the meeting for review, comment and approval. If no comments are received within [ * ] of the receipt of the minutes by a Party, unless  otherwise agreed, they shall be deemed to be approved by such Party. If the Parties are unable to reach agreement on the minutes  within [ * ] of the applicable meeting, the sections of the minutes which have been agreed between the Parties by that date shall be  deemed approved and, in addition, each Party shall record in the same document its own version of those sections of the minutes on  which the Parties were not able to agree.    5.1.3 The JDT will [ * ], with [ * ]. In the event that the JDT members do not [ * ] with respect to a [ * ] that is [ * ] of the  JDT as [ * ], but not [ * ] after they have met and [ * ], such matter shall be referred to the JSC for resolution.    5.1.4 The JDT will cease operations and have no further function hereunder on the date on which the Parties are no longer  jointly Developing any Collaboration Product.    5.2 Annual Updates to the Joint Development Plan. On [ * ], or more frequently as necessary and agreed by the Parties,  commencing no later than [ * ] after the date of an Opt-In Notice for an Exclusive Product (thereafter, a Collaboration Product), and in  the subsequent calendar years not later than [ * ] (in order for the Parties to prepare their respective budgets for the coming [ * ]), the  JDT shall review the Joint Development Plan and the related Joint Budget in order to make annual updates to the Joint Development  Plan and Joint Budget for the then current calendar year, if any, plus the following [ * ] both to be approved by the JSC. In the event  that the JDT cannot agree on an annual update to the Joint Development Plan and Joint Budget, or the JSC does not approve an  amendment as proposed by the JDT, then the most recent version of the Joint Development Plan and Joint Budget will be deemed the  Joint Development Plan and Joint Budget for the period, until the Parties are able to reach an agreement on any update to the Joint  Development Plan and Joint Budget.    5.2.1 Content of Joint Development Plan. Each update of the Joint Development Plan for each Collaboration Product  shall contain the specific Development objectives to be achieved during the first applicable calendar year and a less detailed description  of objectives to be achieved in the second applicable calendar year, the specific activities to be performed by each of the Parties in  connection with the Development of the Collaboration Product, the timelines for performing such activities and a detailed budget for  performing such activities scheduled for the first applicable calendar year and a less detailed (i.e., “directional”) budget for performing  such activities scheduled for the second applicable calendar year. Each Joint Development Plan for each Collaboration Product shall be  consistent with the other terms and conditions of this Agreement. For purposes of clarity the allocation of regulatory activities relating  to the Development of a Collaboration Product shall be governed by Article 7.  -30-    

 

            5.3 Development Activities. Each Party shall use Commercially Reasonable Efforts to perform its obligations with respect to  the Development of each Collaboration Product in accordance with the latest Joint Development Plan and Joint Budget and all such  activities shall be conducted in accordance with all Applicable Laws, including as applicable, GCPs, GLPs and GMPs. As part of such  efforts, each Party shall commit the personnel and facilities necessary to carry out its obligations under the latest Joint Development  Plan. Neither SGI nor Genmab shall be required to undertake any activity relating to the Development of a Collaboration Product that  it believes, in good faith, may violate any Applicable Law. The Parties acknowledge and agree that neither Party guarantees the success  of the Development tasks undertaken hereunder.    5.4 Joint Development Costs  5.4.1 Unless otherwise provided in this Agreement, the Parties will share equally all Joint Development Costs for all  Collaboration Products (which have been set forth in the Joint Development Plan and Joint Budget) with respect to the Development  activities hereunder in accordance with the provisions of Article 11. The JDT shall review on a quarterly basis the Joint Development  Costs against the Joint Budget for such expenses in the applicable calendar year. If in the course of such quarterly review the JDT  determines that the actual amounts incurred for Joint Development Costs are likely to be higher than budgeted, the JDT shall refer such  estimated overrun to the JSC for review and approval and the JSC shall then review the reasons for such potential overrun and  determine whether such overrun is appropriate. The JSC may, if appropriate, amend the Joint Development Plan for a Collaboration  Product to permit such overrun or to reduce such activities such that no overrun is expected. If any costs for the Development activities  result in a budget overrun of the applicable and approved annual Joint Budget in excess of [ * ], the JSC shall have the discretion to  review such costs and designate them as Joint Development Costs. Where the JSC does not so designate excess Joint Development  Costs, any such unapproved excess Joint Development Costs shall be borne by the Party incurring them. However, if the budget  overrun is due to a delay or an advance in timing as to the planned activities, which activities are in accordance with the Joint  Development Plan, then such excess Joint Development Costs shall be shared equally by the Parties regardless of which Party has  incurred such costs.    5.4.2 The Parties agree that the mutual annual rate per FTE of either Party who performs development, consultation or  support work for Collaboration Products as set forth in the then current Joint Development Plan and to be used when calculating the  Joint Development Costs is [ * ]. Commencing upon the first (1st) anniversary of the Effective Date and upon every anniversary  thereafter, the fee will be adjusted in accordance with the [ * ].    5.5 Financial Representatives  5.5.1 Promptly, but in no event later than [ * ] days following the Opt-In Notice, each Party will appoint a representative (a  “Financial Representative”) with expertise in the areas of accounting, cost allocation, budgeting and financial reporting. Such Financial  -31-  

 

            Representatives shall work under the direction of the JSC and provide services to and consult with the JDT, in order to address the  financial, budgetary and accounting issues which arise in connection with the Joint Development Plan.    5.5.2 Each Financial Representative may be replaced at any time by the represented Party by providing written notice  thereof to the other Party. The Financial Representatives will meet at least [ * ] or as they or the JSC may agree. The Financial  Representatives shall agree upon the timing and agenda for all regular meetings. The location of regularly scheduled meetings shall  alternate between the offices of the Parties, unless otherwise agreed. The first meeting shall be held at [ * ] offices. Meetings may be  held telephonically or by video conference. One of the Financial Representatives shall record (or cause to have recorded) the minutes  of the meeting in writing. Such minutes shall be circulated to the other Financial Representative promptly following the meeting for  review, comment and approval. If no comments are received within [ * ] days of the minutes’ receipt by the other Financial  Representative, unless otherwise agreed, they shall be deemed to be approved by such Financial Representative. Following their  approval, the minutes shall be provided to each Party’s Team Leader.    5.5.3 Collaboration Accounting Policies. Promptly, but in no event later than [ * ] after the appointment of the Financial  Representatives, the Financial Representative shall prepare the Collaboration Accounting Policies based on the principles as outlined in  this Agreement for approval by the JSC. Any subsequent changes or deviations to the Collaboration Accounting Policies must be  approved by the JSC.    5.6 Development Records. All work conducted by either Party in connection with the Development of a Collaboration Product  under this Article 5 shall be completely and accurately recorded in sufficient detail and in good scientific manner. On reasonable  notice, and at reasonable intervals, each Party shall have the right to inspect and copy all such records of the other Party reflecting  Development done hereunder to the extent reasonably required to carry out its obligations and to exercise its rights hereunder. All such  records shall be jointly owned by the Parties.    5.7 Audit  5.7.1 Joint Development Cost Records. For so long as any Development activities are conducted hereunder and for a  period of [ * ] years thereafter, each Party shall keep and maintain, and shall require its Affiliates to keep and maintain, accurate and  complete cost records of activities performed by each such Party (including Joint Development Costs incurred and FTEs utilized) in  connection with its Development activities hereunder. Not more than once per calendar year, each Party shall have the right to engage  an independent certified public accounting firm of internationally recognized standing and reasonably acceptable to the other Party,  which shall have the right to examine in confidence the relevant books, records or other relevant reports, of such other Party and its  respective Affiliates as may be reasonably necessary to determine and/or verify the accuracy of the reports submitted to the JSC in  connection with the performance of a Party’s Development obligations hereunder.  -32-  

 

            5.7.2 Procedure. Such examination shall be conducted, and each Party shall make its records available, during normal  business hours, after at least [ * ] days prior written notice shall have been provided by the other Party, as applicable, and shall take  place at the facility(ies) where such records are maintained. Each such examination shall be limited to pertinent books, records and  reports for any year ending not more than [ * ] months prior to the date of request; provided, that, no Party shall be permitted to audit  the same period of time [ * ]. Before permitting such independent accounting firm to have access to such books and records, the  non-requesting Party may require such independent accounting firm and its personnel involved in such audit to sign a confidentiality  agreement (in form and substance reasonably acceptable to such Party) as to any confidential information which is to be provided to  such accounting firm or to which such accounting firm will have access while conducting the audit under this paragraph. The  accounting firm shall provide both SGI and Genmab with a written report stating whether the reports submitted by SGI or Genmab, as  applicable, are correct or incorrect and the specific details concerning any discrepancies. Such accounting firm may not reveal to the  other Party any information learned in the course of such audit other than the amount of any such discrepancies. Each Party agrees that  all such information shall be Confidential Information of the other Party and further agrees to hold in strict confidence all information  disclosed to it in accordance with Article 13.    5.7.3 Cost of Audit. The Party initiating such audit shall bear the full cost of such audit unless such audit discloses that  the actual expenses incurred in the conduct of a Party’s obligations under a Joint Development Plan, as applicable, are lower than that  reported by such Party by [ * ] percent ([ * ]%) or more, in which case the other Party shall reimburse the initiating Party for all costs  incurred by the initiating Party in connection with such audit up to a maximum amount of $[ * ]. Furthermore, the amount in excess of  the actual expenses shall be deducted from the Joint Development Costs reported by that Party and reconciled between the Parties.    5.8 Liability. In connection with conduct of the Development activities hereunder, each Party shall be responsible for, and  hereby assumes, any and all risks of personal injury or property damage attributable to the negligent acts or omissions of that Party or  its Affiliates, and their respective directors, officers, employees and agents.    5.9 Use of Approved Subcontractors. Either Party may perform some or all of its obligations under the Joint Development  Plan for a Collaboration Product through one or more Approved Subcontractors; provided, that (a) none of the rights of the other Party  hereunder are diminished or are otherwise adversely affected as a result of such subcontracting and (b) the Approved Subcontractor  undertakes in writing all obligations of confidentiality and non-use regarding both Party’s Confidential Information which are  substantially the same as those undertaken by the Parties hereunder. In the event that a Party performs one or more of its obligations  under the Joint Development Plan for a Collaboration Product through any such Approved Subcontractor, then such Party shall at all  times be responsible for the performance by such Approved Subcontractor of such Party’s obligations hereunder.  -33-    

 

            5.10 Right to Opt-Out of Co-Development and Co-Commercialization  5.10.1 Either Party shall have the right to terminate its co-funding obligation (the “Non-Continuing Party”) for one or  more Collaboration Products by providing irrevocable, written notice to the other Party (the “Continuing Party”) of such election to  terminate (the “Opt-Out Notice”). The effective date of such notice (the “Opt-Out Date”) shall be the date [ * ] days after the date of  the Opt-Out Notice.    5.10.2 Within [ * ] days after receipt of an Opt-Out Notice for a Collaboration Product, the Continuing Party shall notify  the Non-Continuing Party in writing whether or not it elects to assume sole responsibility for, and all costs and obligations of, the  continued Development and Commercialization of such Collaboration Product.    5.10.3 If the Continuing Party elects to assume sole responsibility for, and all costs and obligations of, the continued  development and commercialization of the Collaboration Product, upon the election to continue: (a) such Collaboration Product will be  deemed a “Unilateral Product”; (b) the Non-Continuing Party’s license for the relevant Collaboration Product set forth in Section 2.1.2  or 2.4.2 will terminate and the Non-Continuing Party will grant the Continuing Party an exclusive license with respect to the Unilateral  Product on the terms set forth in Section 2.1.3 or 2.4.3; (c) the Non-Continuing Party will not have any rights pursuant to Article 11,  but instead will receive prospective milestone payments for events that occur after the effective date of such termination and royalties  on Net Sales of such Unilateral Product pursuant to Article 10, and (d) promptly after the Continuing Party’s election, the Parties will  work together to transfer and assign all regulatory documents, contracts, materials and information that related to such former  Collaboration Product to the Continuing Party or its designees to the extent necessary for the Continuing Party to assume such sole  responsibility. The Non-Continuing Party will not be refunded or repaid any amounts it has paid for the Development of such former  Collaboration Product. In addition, the Non-Continuing Party will remain responsible for its share of Joint Development Costs, as  provided in Section 5.4, incurred with respect to such former Collaboration Product through [ * ] following the date of the Opt-Out  Notice, to the extent such Joint Development Costs were incurred pursuant to the Joint Development Plan and Joint Budget and/or  Commercialization Plan approved by the JSC prior to the date of the Opt-Out Notice (even if the relevant activities were included in  the less detailed portion of such Joint Development Plan and Joint Budget addressing the second applicable year) with respect to  activities that were continuing as of the date of the Opt-Out Notice. For [ * ] after the date of the Opt-Out Notice, the Non-Continuing  Party shall provide development, consultation or support work for a Unilateral Product of the Continuing Party, as reasonably requested  by the Continuing Party, and the Continuing Party shall pay for such work at the [ * ] as in force between the Parties at the Opt-Out  Date.    5.10.4 If the Continuing Party does not elect to assume sole responsibility for, subject to Section 5.10.3, all costs and  obligations of, the continued Development and Commercialization of the Collaboration Product with regards to Development activities  that are not ongoing as of the Opt-Out Date, the provisions of Section 5.11 shall apply.  -34-  

 

            5.11 Third Party Collaboration Agreements. In the event the JSC determines to engage a Third Party to collaborate with the  Parties with respect to the Development or Commercialization of a Collaboration Product, or in the event that both Parties wish to  opt-out of Development of a Collaboration Product, the JSC shall determine the strategy, timing and other matters relating to finding  such Third Party and entering into the appropriate Third Party Collaboration Agreement. At such time as the JSC determines to recruit  a Third Party, the JSC shall determine whether to designate a Party to take the lead in negotiating and entering into the applicable Third  Party Collaboration Agreement or to allocate such responsibilities between the Parties. If one Party is designated to take the lead in  negotiating the Third Party Collaboration Agreement, such Party shall provide the other Party with term sheets and agreement drafts  during the negotiations (including any proposed execution version) for review and comment and the designated Party shall not enter  into any such Third Party Collaboration Agreement (or any amendment, waiver or other modification thereof) without the written  approval of the other Party. All [ * ] received by the Parties [ * ] shall be [ * ], provided that [ * ]. If neither Party wishes to continue the  Development and Commercialization of a Collaboration Product, and the JSC decides not to license such Collaboration Product to a  Third Party or if no good faith negotiation has commenced with a Third Party within [ * ] after the date of the Opt-Out Notice, then  such Collaboration Product will be referred to as a “Dormant Product” and (a) notwithstanding anything to the contrary in  Section 17.9.3 neither Party will have any right to use, manufacture, develop, sell, have sold or otherwise exploit for any purpose such  Dormant Product and (b) all rights granted by the Parties to each other with respect to such Dormant Product shall revert to the  granting Party except as set forth in Section 17.9.3.      ARTICLE 6 MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS    6.1 Commercial Supply. As part of each Commercialization Plan for each Collaboration Product, the JSC shall determine  which Party, or Third Party(ies), shall be responsible for manufacturing the Collaboration Product and the components thereof for  commercial sale in the Territory [ * ].    6.2 Supply Agreements  6.2.1 SGI or Genmab as Supplier. In the case where either SGI or Genmab agrees to be responsible for manufacturing a  Collaboration Product (or any component thereof), the Parties shall enter into a supply agreement on customary and reasonable terms  and conditions. Each such supply agreement shall provide, among other things, for a [ * ] for such Collaboration Product (or any  component thereof) at a rate to be agreed upon by the Parties in such supply agreement, [ * ].    6.2.2 Unilateral Products; Supply Cooperation. To the extent a Party manufactured a Collaboration Product (thereafter  a Unilateral Product) or any component thereof prior to such Party’s Opt-Out Date, such Party shall, at the request of the Continuing  Party, continue to manufacture reasonable quantities of such Unilateral Product or component(s) thereof for a period not to exceed [ * ]  from the date of the Opt-Out Notice, and shall cooperate with the Continuing Party to effectuate the smooth transition of such  manufacture to the Continuing Party or to a Third Party selected by the Continuing Party. The provisions of this Section 6.2.2 are  contingent on the Continuing Party paying the Non-Continuing Party for such manufacture at the rate to be agreed between the Parties  in a separate supply agreement, which agreement shall also include other customary and reasonable terms.  -35-    

 

            6.2.3 Third Party as Supplier. In the case where the JSC elects to designate a Third Party to be responsible for  manufacturing a Collaboration Product (or any component thereof), the Parties shall enter into a supply agreement with such Third  Party on customary and reasonable terms and conditions. Each such supply agreement shall provide, among other things, for [ * ]. The  JSC shall determine the strategy, timing and other matters relating to finding such Third Party and entering into the supply agreement.  At such time as the JSC determines to recruit a Third Party, the JSC shall determine whether to designate a Party to take the lead in  negotiating and entering into the supply agreement or to allocate such responsibilities between the Parties. If one Party is designated to  take the lead in negotiating such agreement, such Party shall provide the other Party with [ * ].      ARTICLE 7 REGULATORY MATTERS FOR COLLABORATION PRODUCTS    7.1 General  7.1.1 The JSC shall be responsible for the overall regulatory strategy and for overseeing, monitoring and coordinating the  actions of the Lead Regulatory Parties, in particular the design of any pivotal clinical trial intended to support Regulatory Approval in  both the United States and the major European countries ([ * ]) shall be agreed by the JSC. [ * ] shall be [ * ] and [ * ] shall be the [ * ].  Unless otherwise agreed by the JSC, a Lead Regulatory Party shall be responsible for all regulatory actions, communications and  filings and submissions to, all applicable Regulatory Authorities with respect to a given Collaboration Product in its respective  territory. The Parties agree that if a clinical trial is necessary for one market only (i.e., a confirmatory study), then the Lead Regulatory  Party with such market in its territory shall be responsible for such clinical trial.    7.1.2 Unless otherwise agreed by the JSC, the Lead Regulatory Party for a territory shall be named “Sponsor” of the  regulatory filing as per 21 CFR 312.3 (Part B) and/or 21 CFR 312.50 or similar rules and regulations with respect to such  Collaboration Product in its respective territory. The Parties will work together to transfer and assign all regulatory documents,  contracts, materials and Information that relates to a Collaboration Product to the Lead Regulatory Party for a territory or its designees  to the extent necessary for the Lead Regulatory Party for a territory to assume such role.    7.2 [ * ] of Regulatory Approvals. Unless otherwise proposed by the JSC and agreed to by the Parties, [ * ] shall [ * ] all INDs,  BLAs and other Regulatory Approvals for a Collaboration Product [ * ]. The Lead Regulatory Party shall promptly license, transfer,  provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including  INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and  Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable  DMF that describes the Drug Conjugation Technology. Genmab may reference such section, but shall have no right, and SGI shall have  no obligation, to provide any information contained in such DMF to Genmab and may require the applicable Regulatory Authority to  maintain such information as confidential.  -36-  

 

            7.3 Regulatory Coordination  7.3.1 Responsibilities of Lead Regulatory Party. Subject to oversight by the JSC, the Lead Regulatory Party shall  oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, all applicable Regulatory  Authorities in its territory with respect to a Collaboration Product. The Lead Regulatory Party shall also be responsible for interfacing,  corresponding and meeting with the applicable Regulatory Authorities in its territory with respect to a Collaboration Product. The Lead  Regulatory Party will use its Commercially Reasonable Efforts to include [ * ] representatives of the other Party in all meetings and  material telephone discussions between representatives of the Lead Regulatory Party and such Regulatory Authority related to a  Collaboration Product.    7.3.2 Review of Correspondence. The Lead Regulatory Party shall provide the other Party with drafts of any material  documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product,  sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and  have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the  other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a  Collaboration Product.    7.4 Assistance. Each Party shall cooperate with the other Party to provide all reasonable assistance and take all actions  reasonably requested by the other Party that are reasonably necessary to enable such Party to comply with any regulatory requirements  under Applicable Law with respect to each Collaboration Product, including (a) obtaining and maintaining Regulatory Approvals,  (b) submitting annual reports, (c) performing pharmacovigilance activities and (d) sharing any relevant regulatory intelligence. Such  assistance and actions shall include, among other things, notifying the other Party within [ * ] of any information it receives from a  Regulatory Authority which (i) raises any material concerns regarding the safety or efficacy of the Collaboration Product, (ii) indicates  or suggests a potential material liability for either Party to Third Parties arising in connection with the Collaboration Product or (iii) is  reasonably likely to lead to a recall or market withdrawal of the Collaboration Product.    7.5 Adverse Events relating to Licensed Products  7.5.1 Reporting to Government Authorities. Each Party shall, and shall cause its respective Affiliates to, furnish timely  notice as required by Applicable Law (i.e., currently not later than [ * ] for deaths and immediately life-threatening Adverse Events and  not later than [ * ] for Serious Adverse Events) to all competent governmental agencies in the Territory of all Adverse Events identified  or suspected with respect to any Licensed Product administered, distributed, marketed and sold under authority of any IND or  Regulatory Approval. Each Party shall provide the other Party with all necessary assistance in complying  -37-  

 

            with all Adverse Event reporting requirements established by, or required under, any applicable IND and/or Regulatory Approval in the  Territory. Accordingly, each Party shall provide the other with timely information, in accordance with the time frames set forth below,  on any Serious Adverse Events relating to any Licensed Product to the extent that such Serious Adverse Events could affect the  Regulatory Approval for the Product, or relate to the safety, efficacy or potency of the Licensed Product.    7.5.2 Reporting to Other Party. Each Party shall, and shall cause its respective Affiliates to, furnish the other Party  written notice of all Serious Adverse Events regarding any Licensed Product reported to such Party or its Affiliates. Each Party shall  also use its [ * ] to obtain, and to furnish to the other Party hereto, such information reasonably sufficient to permit that other Party to  evaluate such Serious Adverse Events of the Licensed Product, including, but not limited to, information about the affected patients,  the circumstances surrounding the Serious Adverse Events, the consequences thereof and the sources of information. Each Party shall  retain all documents, reports, studies and other materials relating to any and all such Serious Adverse Events, as the case may be. Upon  reasonable written notice, each Party shall permit the other Party hereto to inspect, and to make copies of, all such documents, reports,  studies and other materials, subject to all Applicable Laws regarding patient confidentiality, data protection and privacy.    7.5.3 Pharmacovigilance Agreement. Without limiting the generality of the foregoing, within [ * ] after the Opt-In  Notice the Parties shall enter into a pharmacovigilance agreement detailing each Party’s pharmacovigilance responsibilities in  connection with the Collaboration Product. The first draft of this pharmacovigilance agreement will be provided by Genmab.      ARTICLE 8 COMMERCIALIZATION OF COLLABORATION PRODUCTS    8.1 Objectives for Commercialization of Collaboration Products. The Parties shall collaborate in Commercializing each  Collaboration Product in accordance with the relevant Commercialization Plan with the objective of achieving the commercial  potential of the Collaboration Product and sharing equally in (a) all Joint Development Costs and Commercialization Expenses and (b)  any Collaboration Product Profit.    8.2 Lead Commercialization Parties. Genmab shall be the Lead Commercialization Party for the ROW and SGI shall be the  Lead Commercialization Party for North America.    8.3 Preparation of Commercialization Plan. Promptly, but in no event later than [ * ] after the [ * ] of the first [ * ] with  respect to each Collaboration Product, the JSC shall prepare and approve an initial Commercialization Plan for such Collaboration  Product for the balance of the then current calendar year plus the following [ * ].    8.4 Commercialization Team and Commercialization Agreement. The JSC shall, at an appropriate (in the JSC’s discretion)  time following an Opt-In Decision but no later than [ * ] after [ * ] of the [ * ] with respect to a Collaboration Product, establish a joint  commercialization team to be responsible for the operations related to Commercialization of the  -38-    

 

            Collaboration Product. In addition, the Parties shall negotiate in good faith and enter into a separate global commercialization  agreement, at least, [ * ] prior to the anticipated commercial launch of the Collaboration Product anywhere in the Territory, which shall  be consistent with the applicable provisions of this Agreement, reflect any mechanism or structure agreed upon by the JSC pursuant to  Section 11.4 and shall include customary provisions relating to joint commercialization, including, among others, the following  matters: amendment to and updates of the Commercialization Plan, report and audit rights, promotional materials, recalls and medical  inquiries, commercialization expenses, labeling, public statements and other information concerning the Collaboration Product,  liability, indemnification, use of subcontractors and the responsibilities and powers of the joint commercialization team.    8.5 Co-Promotion Agreement. Notwithstanding the existence of a Lead Commercialization Party for a territory and in addition  to the commercialization agreement described in Section 8.4, the Parties may utilize sales representatives employed by both of the  Parties to co-promote Collaboration Products in a territory pursuant to a co-promotion agreement the terms of which shall be consistent  with the applicable provisions of this Agreement and shall include customary provisions relating to co-promotion, including, among  others, performance metrics, sales force compensation strategies, division of the applicable territory between the Parties’ respective  sales forces, sales force training and compliance with Applicable Laws. In any event, the Lead Commercialization Party in a territory  shall be entitled to employ, at least, [ * ] of such co-promotion force in such territory. The Parties shall determine whether they wish to  co-promote in a particular territory and negotiate and enter into a co-promotion agreement for such territory, at least, [ * ] prior to the  anticipated commercial launch of the Collaboration Product in such territory.    8.6 Commercialization Activities. Each Party shall use Commercially Reasonable Efforts to perform its obligations with  respect to the Commercialization of each Collaboration Product in accordance with the applicable Commercialization Plan,  commercialization agreement and, if any, co-promotion agreement, and all such activities shall be conducted in accordance with all  Applicable Laws, including GxPs. As part of such efforts, each Party shall commit the personnel and other resources necessary to carry  out its obligations under the Commercialization Plan. Neither Party shall be required to undertake any activity relating to the  Commercialization of a Collaboration Product that it believes, in good faith, may violate any Applicable Law.      ARTICLE 9 DEVELOPMENT, COMMERCIALIZATION AND MANUFACTURING OF UNILATERAL PRODUCTS    9.1 Diligence. The Continuing Party (assuming an election to continue with sole development and commercialization) shall use  Commercially Reasonable Efforts to develop, manufacture and commercialize Unilateral Products. Genmab shall have sole  responsibility for making all decisions regarding the development, manufacture and marketing of Genmab Products and SGI shall have  sole responsibility for making all decisions regarding the development, manufacture and marketing of SGI Products.  -39-    

 

            9.2 Conduct. The Continuing Party (assuming an election to continue with sole development and commercialization) shall  comply with all Applicable Laws (including GxPs to the extent applicable) in the development and commercialization of Unilateral  Products, and shall cause its Affiliates and Sublicensees to do the same.    9.3 Funding and Progress Reports. Except as expressly set forth herein, as between SGI and Genmab, Genmab shall be solely  responsible for funding all costs of the development and commercialization of Genmab Products and SGI shall be solely responsible  for funding all costs of the development and commercialization of SGI Products. The Parties shall keep each other informed in a timely  manner and no later then [ * ] in the subsequent calendar year as to the progress of the development of Unilateral Products in the  previous calendar year.    9.4 Manufacturing. Except as otherwise expressly set forth in this Agreement, Genmab shall be responsible for all  manufacturing and supply of Genmab Products and SGI shall be responsible for all manufacturing and supply of SGI Products.    9.5 Regulatory  9.5.1 Genmab shall be solely responsible for, and shall solely own, all applications for Regulatory Approval with respect  to Genmab Products and SGI shall be solely responsible for, and shall solely own, all applications for Regulatory Approval with  respect to SGI Products. If ownership of a regulatory filing for a former Collaboration Product cannot be assigned to the Continuing  Party under Section 5.10 in any country, the Non-Continuing Party shall grant to the Continuing Party a permanent, exclusive and  irrevocable right of access and reference to such regulatory filing for such former Collaboration Product in such country.    9.5.2 Should the Continuing Party desire to file an IND or an application for Regulatory Approval, or equivalents of the  foregoing, for a Genmab Product or SGI Product (as the case may be), the Non-Continuing Party will provide regulatory assistance as  described in Section 4.4, mutatis, mutandis.    ARTICLE 10 FEES, MILESTONES AND ROYALTIES FOR EXCLUSIVE PRODUCTS AND UNILATERAL PRODUCTS    10.1 FTE Fees for Exclusive Products. Genmab shall pay SGI at an annual rate of [ * ] per FTE who performs development,  consultation or support work for Exclusive Products as requested by Genmab pursuant to this Agreement (the “FTE Fees”).  Commencing upon the first (1st) anniversary of the Effective Date and upon every anniversary thereafter, the FTE Fees will be  adjusted in accordance with the [ * ]. Genmab shall also pay SGI for all Drug Conjugation Materials supplied by SGI to Genmab  hereunder for Exclusive Products at the rates set forth in S chedule B, which rates may not be increased during the Program Support  Term (the “Supply Fees”). The FTE Fees and the Supply Fees are collectively referred to herein as the “Development Support Fees”.  Within [ * ] after the end of each Calendar Quarter, SGI shall submit a report to Genmab supporting the calculation of the Development  Support Fees due for such Calendar Quarter (a “Development Support Fees Report”). Genmab shall pay all Development Support Fees  to SGI within [ * ] of receipt of each Development Support Fees Report.  -40-    

 

            10.2 Annual Maintenance Fee. Commencing upon the [ * ] of the Effective Date following the expiration of the Opt-In Period  without exercise of SGI’s Opt-In Right for the first Exclusive Product and upon every [ * ] thereafter until Genmab receives the [ * ]  for an Exclusive Product in the Territory, Genmab shall pay, within [ * ] days after having [ * ] an [ * ], an annual maintenance fee to  SGI in the sum of [ * ] by [ * ] of immediately [ * ] (the “Annual Maintenance Fee”). Notwithstanding the foregoing, the Annual  Maintenance Fee will be [ * ] by the [ * ] of any [ * ] by [ * ] under [ * ] of this Agreement during the [ * ] period preceding the date on  which the Annual Maintenance Fee is due. Annual Maintenance Fees shall not be [ * ] or [ * ] except as set forth in this Section 10.2.    10.3     Royalties  10.3.1 Royalties Payable on Net Sales of Exclusive Products with Patent Protection. In partial consideration for the  license for Exclusive Products granted to Genmab herein, during the Royalty Term and subject to Section 10.4, Genmab shall pay to  SGI royalties on the aggregate Net Sales of all Exclusive Products the manufacture, use, sale, offer for sale or import of which would,  but for the licenses granted hereunder, infringe a Valid Patent Claim described in Section 1.1.115(a)(ii) on a country-by-country basis.  Such royalties shall be paid at the following rates as set forth below:  [ * ]    10.3.2 Royalties Payable on Net Sales of Exclusive Products without Patent Protection. In partial consideration for the  license for Exclusive Products granted to Genmab herein, during the Royalty Term and subject to Section 10.4, Genmab shall pay to  SGI royalties on the aggregate Net Sales of all Exclusive Products the manufacture, use, sale, offer for sale or import of which would  not infringe a Valid Patent Claim described in Section 1.1.115(a)(ii) on a country-by-country basis. For the avoidance of doubt such  royalties shall only be paid for the [ * ] period or for the remainder of the [ * ] period as prescribed in Section 1.1.115(a)(i). Such  royalties shall be paid at the following rates as set forth below:  [ * ]    10.3.3 Royalties Payable on Net Sales of Unilateral Products with Patent Protection. In partial consideration for the  license for Unilateral Products granted to the Continuing Party herein, during the Royalty Term and subject to Section 10.4, the  Continuing Party shall pay to the Non-Continuing Party royalties on aggregate Net Sales of Unilateral Products the manufacture, use,  sale, offer for sale or import of which would (i) but for Genmab’s ownership interest or for the licenses granted hereunder, infringe a  Valid Patent Claim described in Section 1.1.115(b)(ii) with respect to a Genmab Product on a country-by-country basis or (ii) but for  the assignment of the Genmab ADC Patents hereunder or the licenses granted hereunder infringe a Valid Patent Claim described in  Section 1.1.115(c)(ii) with respect to a SGI Product on a country-by-country basis. Such royalties shall be paid at the following rates as  set forth below:    and  (a) If the Opt-Out Date is prior to or on the date of [ * ] of the [ * ] of the Unilateral Product, [ * ] percent ([ * ]%);    -41-    

 

            (b) If the Opt-Out Date is after the date of [ * ] of the [ * ] of the Unilateral Product, [ * ] percent ([ * ]%).    10.3.4 Royalties Payable on Net Sales of Unilateral Products without Patent Protection. In partial consideration for  the license for Unilateral Products granted to the Continuing Party herein, during the Royalty Term and subject to Section 10.4, the  Continuing Party shall pay to the Non-Continuing Party royalties on the aggregate Net Sales of all Unilateral Products the manufacture,  use, sale, offer for sale or import of which would not infringe a Valid Patent Claim described in Section 1.1.115(b)(ii) with respect to a  Genmab Product on a country-by country-basis or Section 1.1.115(c)(ii) with respect to a SGI Product on a country-by-country basis.  For the avoidance of doubt such royalties shall only be paid for the [ * ] year period or for the remainder of the [ * ] year period as  prescribed in Section 1.1.115(b)(i) or Section 1.1.115(c)(i), as applicable. Such royalties shall be paid at the following rates as set forth  below:                                 (a)   If the Opt-Out Date is prior to or on the date of [ * ] of the [ * ] of the Unilateral Product, [ * ] percent ([ * ]%);  and                                   (b)  If the Opt-Out Date is after the date of [ * ] of the [ * ] of the Unilateral Product, [ * ] percent ([ * ]%).    10.3.5 No Cumulative Royalties; Aggregation and Allocation of Net Sales for Determining Royalty Rate  Breakpoints.                                    (a)   In no event shall royalties under more than one of Section 10.3.1 or 10.3.2 (for Exclusive Products) or  Section 10.3.3 or 10.3.4 (for Unilateral Products) be payable for the same Licensed Product in a country; however, the [ * ] of the  applicable [ * ] shall be [ * ] but, for clarity such royalty rates shall not be cumulative.                                     (b)  All Net Sales in the Territory whether covered by Section 10.3.1 or 10.3.2 (for Exclusive Products) or  Section 10.3.3 or 10.3.4 (for Unilateral Products) shall be aggregated for purposes of determining which royalty rate set forth in  Section 10.3.1 (for Exclusive Products) or Section 10.3.3 (for Unilateral Products) is payable.    10.3.6 Acknowledgement Regarding Royalty Structure. In establishing the royalty structure of this Section 10.3, the  Parties recognize the substantial value of the various actions and investments undertaken by SGI and Genmab, respectively, prior to the  Effective Date. Such value is significant and in addition to the value of SGI’s grant to Genmab of the license for Licensed Products  pursuant to Section 2.1, and in addition to the value of Genmab’s grant to SGI of the license for Licensed Products pursuant to  Section 2.4, respectively, as it enables the rapid and effective development and commercialization of Licensed Products in the  -42-  

 

            Territory. Further, the Parties acknowledge and agree that, for their mutual convenience and after considering other alternatives, the  payments to SGI and, with respect to an SGI Product, Genmab set forth in this Agreement and the timing of payments (including the  duration of the Royalty Term) are an appropriate and mutually convenient way of compensating SGI and, with respect to an SGI  Product, Genmab.    10.4 Royalty Offsets  (a) Subject to Sections 10.4(b), (c) and (d), Genmab or, in the case of a Unilateral Product (i.e., Genmab Products and SGI  Products), the Continuing Party (i.e., Genmab or SGI) shall be solely responsible for paying all amounts, including any license fees,  milestones and royalties owed to Third Parties by either Genmab or SGI on account of developing and commercializing Exclusive  Products or Unilateral Products, including any royalties owed due to use of the SGI Technology or Genmab Technology.    (b) Notwithstanding Section 10.4(a), on a Calendar Quarter-by-Calendar Quarter and country-by-country basis, Genmab  shall be entitled to offset [ * ] percent ([ * ]%) of any [ * ] for [ * ] that are [ * ] pursuant to Section 10.3.1 or 10.3.2 for such Exclusive  Product, excluding any royalties owed under the BMS Agreement. SGI represents and warrants that all royalties owed to BMS  pursuant to the BMS Agreement are described in this Agreement. Notwithstanding anything to the contrary in this Section 10.4, in no  event shall the royalty payments due and payable to SGI pursuant to Section 10.3.1 or 10.3.2 with respect to an Exclusive Product in  any Calendar Quarter and country be reduced by more than [ * ] percent ([ * ]%) (on a tier-by-tier basis) of the royalty otherwise due to  SGI if no royalties were payable to Third Parties.    (c) Notwithstanding Section 10.4(a), on a Calendar Quarter-by-Calendar Quarter and country-by-country basis, Genmab  shall be entitled to offset [ * ] percent ([ * ]%) of any royalties payable by Genmab to Third Parties for intellectual property rights that  are necessary with respect to a Genmab Product against the royalties that would otherwise be payable to SGI pursuant to Section 10.3.3  or 10.3.4 for such Genmab Product, excluding any royalties owed under the BMS Agreement. Notwithstanding anything to the  contrary in this Section 10.4, in no event shall the royalty payments due and payable to SGI pursuant to Section 10.3.3 or 10.3.4 with  respect to a Genmab Product in any Calendar Quarter and country be reduced by more than [ * ] percentage points on any royalty tier.  For the avoidance of doubt the minimum royalty rate payable to SGI pursuant to Section 10.3.3(a) is [ * ] percent ([ * ]%), the  minimum royalty rate payable to SGI pursuant to Section 10.3.3(b) is [ * ] percent ([ * ]%), the minimum royalty rate payable to SGI  pursuant to Section 10.3.4(a) is [ * ] percent ([ * ]%) and the minimum royalty rate payable to SGI pursuant to Section 10.3.4(b) is [ * ]  hundredths percent ([ * ]%).    (d) Notwithstanding Section 10.4(a), on a Calendar Quarter-by-Calendar Quarter and country-by-country basis, SGI shall  be entitled to offset [ * ] of any royalties payable by SGI to Third Parties for intellectual property rights that are necessary with respect  to a SGI Product against the royalties that would otherwise be payable to Genmab pursuant to  -43-    

 

            Section 10.3.2 for such SGI Product, excluding any royalties owed under the Genmab In-Licenses and any other agreements disclosed  to SGI pursuant to Section 3.1 to the extent that the relevant royalty obligation was disclosed at such time. Genmab represents and  warrants that as of the Effective Date all Third Party royalties owed pursuant to the Genmab In-Licenses are described in S chedule C.  It is contemplated that Genmab will [ * ] with [ * ] for the use of [ * ] and [ * ] for [ * ]. Notwithstanding anything to the contrary in  this Section 10.4, in no event shall the royalty payments due and payable to Genmab pursuant to Section 10.3.2 with respect to an SGI  Product in any Calendar Quarter and country be reduced by more than [ * ] percentage points on any royalty tier. For the avoidance of  doubt the minimum royalty rate payable to Genmab pursuant to Section 10.3.3(a) is [ * ] percent ([ * ]%), the minimum royalty rate  payable to Genmab pursuant to Section 10.3.3(b) is [ * ] percent ([ * ]%), the minimum royalty rate payable to Genmab pursuant to  Section 10.3.4(a) is [ * ] percent ([ * ]%) and the minimum royalty rate payable to Genmab pursuant to Section 10.3.4(b) is [ * ]  percent ([ * ]%).    10.5 Milestone Payments  10.5.1 Milestone Payments by Genmab relating to Exclusive Products. As partial consideration for the licenses, rights  and privileges granted to it hereunder, Genmab shall promptly inform SGI of the achievement of any of the below milestones and pay  to SGI the following milestone payments within [ * ] of the first occurrence of each event set forth below with respect to the first  Exclusive Product to achieve such event, whether such events are achieved by Genmab, its Affiliates or Sublicensees, as follows:  [ * ]    10.5.2 If any of the milestone events in [ * ] above is achieved before the milestone event in (a) above, then payment for  the milestone event in (a) shall be deemed to become due within thirty (30) days after the achievement of either of the milestone events  in [ * ] above. For the avoidance of doubt if an Exclusive Product is replaced by a back-up candidate only such milestones not already  paid for an Exclusive Product shall become payable for the back-up candidate.    10.5.3 Milestone Payments by Continuing Party relating to Unilateral Products. As partial consideration for the  licenses, rights and privileges granted to it hereunder, the Continuing Party shall promptly inform the Non-Continuing Party of the  achievement of any of the below milestones and pay to the Non-Continuing Party the following milestone payments within [ * ] of the  first occurrence of each event set forth below with respect to the first Unilateral Product to achieve such event, whether such events are  achieved by the Continuing Party, its Affiliates or Sublicensees, as follows:  [ * ]    10.5.4 If any of the milestone events in [ * ] above is achieved before the milestone event in (a) above, then payment for  the milestone event in (a) shall be deemed to become due within [ * ] days after the achievement of either of the milestone events in [ *  ] above. No payment shall be due for any of the milestone events above that occurred before the  -44-    

 

            Opt-Out Date for the relevant Collaboration Product. For the avoidance of doubt if a Unilateral Product is replaced by a back-up  candidate only such milestones not already paid for the Unilateral Product shall become payable for the back-up candidate.    10.6 Royalty Reports, Exchange Rates  10.6.1 Royalty Reports. During the Royalty Term, any Party paying royalties hereunder (the “Paying Party”) shall furnish  to the non-Paying Party, with respect to each Calendar Quarter, a written report showing, on a consolidated basis in reasonably specific  detail and on a country-by-country basis, (a) the Net Sales of Exclusive Products or Unilateral Products sold by the Paying Party, its  Affiliates and its Sublicensees in the Territory during the corresponding Calendar Quarter including a description of the credits and  offsets deducted on a product-by-product and country-by-country basis to calculate Net Sales; (b) the royalties payable in U.S. dollars,  if any, which shall have accrued hereunder based upon such Net Sales of Exclusive Products or Unilateral Products; (c) the withholding  taxes, if any, required by law to be deducted in respect of such royalties; (d) the dates of the First Commercial Sale of each Exclusive  Product or Unilateral Product in each country in the Territory, if it has occurred during the corresponding Calendar Quarter; and (e) the  exchange rates (as determined pursuant to Section 12.1.2) used in determining the royalty amount expressed in U.S. dollars  (collectively, “Royalty Reports”).    10.6.2 Report Due Date. Royalty Reports and royalty payments shall be due on the [ * ] following the end of the  Calendar Quarter to which such Royalty Report relates. The Parties shall keep complete and accurate records in sufficient detail to  properly reflect all gross sales and Net Sales and to enable the royalties payable hereunder to be determined.    10.6.3 Exchange Rates. With respect to sales of Exclusive Products or Unilateral Products invoiced in U.S. dollars, the  gross sales, Net Sales, and royalties payable shall be expressed in U.S. dollars. With respect to sales of Exclusive Products or Unilateral  Products invoiced in a currency other than U.S. dollars, the gross sales, Net Sales and royalties payable shall be expressed in the  currency of the invoice issued by the Party making the sale together with the U.S. dollars equivalent of the royalty due, calculated as  described in Section 12.1.2.      ARTICLE 11 FINANCIAL PROVISIONS FOR COLLABORATION PRODUCTS    11.1 Joint Development Costs. Unless otherwise provided in this Agreement, during the Term, SGI and Genmab shall share  equally (50:50) all Joint Development Costs.    11.2 Reporting and Payment of Joint Development Costs  11.2.1 Reports  (a) Within [ * ] after the end of each Calendar Quarter during which any Development activities are performed  hereunder, each Party’s Financial Representative shall prepare a report showing the actual Joint Development Costs incurred or  -45-  

 

            accrued for each Collaboration Product, including but not limited to all FTEs utilized (with appropriate supporting information) during  such Calendar Quarter (the “Joint Development Cost Report”).    (b) The Joint Development Cost Reports will be in such form as the JSC may reasonably agree from time to time.    (c) Within [ * ] of the receipt of both Parties’ Joint Development Cost Reports, the JSC (or the Party appointed by  the JSC) shall provide to each Party one consolidated financial report for the Joint Development Costs consistent with Collaboration  Accounting Principles. The total costs incurred by both Parties shall, subject always to Section 5.4.1, be divided equally, with a  subsequent balancing payment by one Party to the other to the extent necessary so that each Party bears its appropriate share of such  Joint Development Costs. The Party that is due for reimbursement of Joint Development Costs in the preceding Calendar Quarter shall  invoice the other Party. Such balancing payments by one Party to reimburse the other Party’s expenditures for Joint Development Costs  for the purposes of cost sharing under this Agreement shall be paid within [ * ] following [ * ] of the [ * ]. In the event that Parties  disagree with the reported costs and any over/under spend, approval shall be required by the JSC (or its delegates) following receipt of  the report by the JSC (or its delegates). A decision by the JSC or its delegates shall be required within [ * ] following its receipt of the  consolidated report. Based on the JSC’s decision the Party due for reimbursement shall invoice the other Party and payment shall be  made within [ * ] of [ * ] of the [ * ]. Where the JSC does not so agree with the reported costs or over/under spend, any such  unapproved spend shall be borne [ * ].    11.3 Audits. Upon the written request of a Party (the “Requesting Party”) and not more than [ * ], the other Party (the  “Responding Party”) will permit an independent certified public accounting firm of nationally recognized standing, selected by the  Requesting Party and reasonably acceptable to the Responding Party, at the Requesting Party’s expense, to have access during normal  business hours to the records of the Responding Party as may be reasonably necessary to verify the accuracy of the reports provided  under Article 11, for any year ending not more than [ * ] prior to the date of such request. The provisions of Section 5.7.2 and  Section 5.7.3 shall apply with respect to such inspection and the costs of such inspection, mutatis, mutandis.  11.4 Reporting and Payment of Commercialization Expenses and Collaboration Product Profit. The Parties shall mutually  agree, through the JSC, a mechanism or structure under which they will share equally (50:50) in all Collaboration Product Profit  created by each Collaboration Product. In reaching this agreement the Parties shall also define and mutually agree, through the JSC, the  appropriate arrangements for making reports and payments between the Parties.    11.5 Collaboration Product Profit Term. Unless this Agreement is earlier terminated pursuant to Article 17, the Parties shall  share Collaboration Product Profit hereunder with respect to each Collaboration Product until each such Collaboration Product is  permanently withdrawn from, and is no longer being sold anywhere in, the Territory.  -46-    

 

            11.6 Other Research Expenses, Joint Development Costs and Commercialization Expenses. For purposes of clarity, the  Parties hereto agree and acknowledge that all expenses attributable to a Collaboration Product that are not set forth in a Joint  Development Plan or a Commercialization Plan (as each may be amended by the JSC from time to time) as Joint Development Costs  or Commercialization Expenses, or otherwise approved by the JSC pursuant to Section 5.4.1, shall be borne [ * ].    11.7 Utilization of Internal Resources. The Parties agree and acknowledge that, unless specifically agreed otherwise, it is  intended that the activities under each Joint Development Plan and each Commercialization Plan, when taken as a whole for a given  calendar year, shall be allocated and assigned to each Party such that the internal resources devoted to, and participation by the Parties  in, the Development and Commercialization activities hereunder, taken as a whole, shall be substantially equal on an ongoing basis for  such calendar year. The JSC may propose amendments to the Joint Development Plan and the Commercialization Plan for a  Collaboration Product as necessary to maintain substantial equality in resources devoted to, and participation by the Parties in, such  activities for review and approval by the JSC.      ARTICLE 12 PAYMENT TERMS; BOOKS AND RECORDS; TAX    12.1 Payment Terms  12.1.1 Currency. All payments hereunder will be in United States dollars in immediately available funds and will be  made by wire transfer to such bank account as payee may designate in writing from time to time.    12.1.2 Exchange. All amounts accruing in a currency other than United States dollars will be expressed in such currency  and converted to United States dollars using an exchange rate equal to the [ * ] of the [ * ] as [ * ] by [ * ] or, if [ * ] is not available,  another mutually agreed source of exchange rates during the applicable Calendar Quarter for which payments are being made. The  conversion calculations will be provided in any statement reporting converted amounts.    12.1.3 Late Fee. Any undisputed payments or portions thereof due hereunder which are not paid on the date such  payments are due under this Agreement will bear interest at a [ * ] to the [ * ] of (a) [ * ] on the first day of each Calendar Quarter in  which such payments are overdue, plus [ * ], or (b) the [ * ], calculated on the number of days such payment is delinquent,  compounded [ * ].    12.1.4 Legal Restrictions. If at any time legal restrictions prevent the prompt remittance of any monies owed with respect  to a Licensed Product in any jurisdiction, payment shall be made through such lawful means or methods as the Parties shall reasonably  determine.  -47-  

 

            12.2 Record Keeping. In accordance with GAAP consistently applied, each Party and its Affiliates will maintain, and will use  Commercially Reasonable Efforts to cause its permitted Sublicensees, contractors and agents to maintain, books of account and  accurate records relating to each Licensed Product and all amounts payable or receivable under this Agreement, in sufficient detail to  permit the other Party to confirm the correctness of such items. All books of account and records will be maintained for a period not  less than relevant time permitted for audit of such accounts and records pursuant to this Agreement and for any applicable tax period.    12.3 Tax Matters. Except as otherwise provided below, all amounts due from any paying Party to any receiving Party under  this Agreement are gross amounts. The paying Party shall be entitled to deduct the amount of any withholding taxes payable or  required to be withheld by it, its Affiliates, licensees, or Sublicensees (as applicable) to the extent such paying Party, its Affiliates,  licensees, or Sublicensees (as applicable) actually pay such withheld amounts to the appropriate governmental authority on behalf of  the receiving Party. The paying Party shall use Commercially Reasonable Efforts to minimize any such taxes, levies or charges  required to be withheld on behalf of the receiving Party. The paying Party promptly shall deliver to the receiving Party proof of  payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental  authority with respect thereto, and shall cooperate with the receiving Party in seeking any related tax credits that may be available to  the receiving Party with respect thereto.    12.4 This Article 12 shall be applicable to all Licensed Products.      ARTICLE 13   CONFIDENTIALITY    13.1 Non-Disclosure Obligations. Except as otherwise provided in this Article 13, during the Term and for a period of [ * ]  thereafter, each Party shall maintain in confidence, and use only for purposes as expressly authorized and contemplated by this  Agreement, all confidential or proprietary information, data, documents or other materials supplied by the other Party under this  Agreement and marked or otherwise identified as “Confidential”. Confidential Information of SGI shall include SGI Know-How, Drug  Conjugation Technology, SGI’s interest in any Program Inventions, whether or not marked “Confidential.” Confidential Information of  Genmab shall include Genmab Technology, the contents, terms and conditions of Genmab’s In-Licenses, and Genmab’s interest in any  Program Inventions, whether or not marked “Confidential”. Notwithstanding anything to the contrary in this Article 13 or this  Agreement, Confidential Information of SGI related to drug and linker manufacturing, including release assay information, shall be  maintained in confidence indefinitely unless publicly disclosed by SGI or permitted to be disclosed by SGI pursuant to Section 13.2(b).  Confidential Information of a Party may also include information relating to such Party’s research programs, development, marketing  and other business practices and finances. For purposes of this Agreement, information and data described above together with all  information and data designated as Genmab Confidential Information or Seattle Genetics Confidential Information under the Prior  Agreement shall be hereinafter referred to as “Confidential Information.” Each Party shall use at least the same standard of care as it  uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants and clinical  investigators only make use  -48-  

 

            of the other Party’s Confidential Information for purposes as expressly authorized and contemplated by this Agreement and do not  disclose or make any unauthorized use of such Confidential Information.    13.2 Permitted Disclosures. Notwithstanding the foregoing, but subject to the last sentence of this Section 13.2, the provisions  of Section 13.1 shall not apply to information, documents or materials that the receiving Party can conclusively establish:  (a) Have become published or otherwise entered the public domain other than by breach of this Agreement by the  receiving Party or its Affiliates.    (b) Are permitted to be disclosed by prior written consent of the other Party.    (c) Have become known to the receiving Party by a Third Party, that is not breaching any duty of confidentiality by  disclosing the same and provided such Confidential Information was not obtained by such Third Party directly or indirectly from the  other Party under this Agreement or the Prior Agreement on a confidential basis.    (d) Prior to disclosure under this Agreement, was already in the possession of the receiving Party, its Affiliates or  Sublicensees, as demonstrated by written records provided such Confidential Information was not obtained directly or indirectly from  the other Party under this Agreement or the Prior Agreement.    (e) Is independently developed by or for the receiving Party by its employees or contractors without making use of the  other Party’s Confidential Information under this Agreement or the Prior Agreement.    (f) Are required to be disclosed by the receiving Party to comply with any Applicable Law, or are reasonably necessary to  authorizations to conduct clinical trials with, and to seek Regulatory Approval of, Licensed Product(s), provided that the receiving  Party shall wherever possible provide prior written notice of such disclosure to the other Party and take reasonable and lawful actions  to avoid or minimize the degree of disclosure. The Parties agree that nothing in this Section 13.2(f) is intended to require a Party to not  comply with any Applicable Law.    (g) Subject to Section 14.2.1 and 14.2.2, are required solely to the extent reasonably necessary in a patent application  claiming Program Inventions made hereunder to be filed with the United States Patent and Trademark Office and/or any similar foreign  agency, provided that the Party filing the patent shall provide at least thirty (30) days prior written notice of such disclosure to the other  Party and take reasonable and lawful actions to avoid or minimize the degree of disclosure.    (h) Are disclosed to a Sublicensee as permitted hereunder, provided that such Sublicensee is then subject to obligations of  confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein.  -49-    

 

            (i) Are disclosed to a bona fide collaborator or manufacturing, development or sales contractor or partner or to another  Third Party for purposes as expressly authorized and contemplated by this Agreement, but only to the extent directly relevant to the  collaboration, partnership or contract and provided that such collaborator, partner or contractor is then subject to obligations of  confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein.    Notwithstanding the disclosures permitted under subsections (f)-(i), if the information, documents or materials covered by such  subsection is otherwise protected by obligations of confidentiality, then the confidentiality obligations of Section 13.1 shall still apply.    13.3 Terms of the Agreement. Genmab and SGI shall not disclose any terms or conditions of this Agreement to any Third  Party without the prior consent of the other Party, except as required by Applicable Law or to comply with rules of a securities  exchange or regulatory authority, in which case the disclosing Party shall provide notice to the other Party and take reasonable and  lawful actions to avoid or minimize the degree of such disclosures. Notwithstanding the foregoing, each Party may disclose the terms  and conditions of this Agreement, without such consent, to advisors, existing and potential investors, licensees, assignees and/or  acquirers on a need-to-know basis under circumstances that reasonably ensure the confidentiality thereof.    13.4 Press Releases and Other Disclosures to Third Parties. Neither SGI nor Genmab will, without the prior consent of the  other, issue any press release or make any other public announcement or furnish any statement to any person or entity (other than either  Parties’ respective Affiliates) concerning the existence of this Agreement, its terms and the transactions contemplated hereby, except  for (a) disclosures made in compliance with Sections 13.2 and 13.3, and (b) disclosures made to attorneys, consultants, and accountants  retained to represent the Parties in connection with the transactions contemplated hereby.    13.5 Publications. Neither Party may publish, present or announce results of ADCs or Collaboration Products developed  hereunder either orally or in writing (a “Publication”) without complying with the provisions of this Section 13.5. The other Party shall  have [ * ] from receipt of a proposed Publication to provide comments and/or proposed changes to the publishing Party. The publishing  Party shall take into account the comments and/or proposed changes made by the other Party on any Publication and shall agree to  designate employees or others acting on behalf of the other Party as co-authors on any Publication describing results to which such  persons have contributed in accordance with standards applicable to authorship of scientific publications. If the other Party reasonably  determines that the Publication would entail the public disclosure of such Party’s Confidential Information and/or of a patentable  invention upon which a patent application should be filed prior to any such disclosure, submission of the concerned Publication to  Third Parties shall be delayed for such period as may be reasonably necessary for deleting any such Confidential Information of the  other Party (if the other Party has requested deletion thereof from the proposed Publication), and/or the drafting and filing of a patent  application covering such invention, provided such additional period shall not exceed [ * ] from the date the publishing Party first  provided the proposed Publication to the other Party. For clarity,  -50-  

 

            Section 13.2(f), but not this Section 13.5, is intended to apply to any announcements required by either Party under Applicable Law,  including but not limited to notifications to the relevant stock exchanges.      ARTICLE 14 INVENTIONS AND PATENTS    14.1 Ownership of Inventions  14.1.1     Disclosure of Inventions. Each Party shall promptly disclose to the other Party the making, conception or  reduction to practice of any inventions directly arising out of activities conducted under this Agreement (“Program Inventions”).  Program Inventions shall also comprise inventions relating to ADCs and uses thereof described in the Genmab ADC Patents filed prior  to the Effective Date of this Agreement and as listed in S chedule F.                           14.1.2   Ownership of Program Inventions. All right, title and interest in all Program Inventions that are discovered,  made or conceived as part of the activities conducted pursuant to this Agreement shall be owned as follows:    (a) Genmab shall own all Program Inventions that (i) are invented solely by one or more employees, agents or  consultants of Genmab and [ * ] (ii) are invented solely or jointly by employees, agents or consultants of Genmab and/or SGI and [ * ].  To the extent that any such Program Inventions [ * ] shall have been invented by SGI employees and/or are owned by SGI, SGI hereby  assigns all of its right, title and interest therein to Genmab. An “Improvement Invention to Genmab Material” (as defined in the Prior  Agreement) shall be deemed a Program Invention owned by Genmab.    (b) SGI shall own all Program Inventions that (i) are invented solely by one or more employees, agents or  consultants of SGI and [ * ] or (ii) are invented solely or jointly by employees, agents or consultants of Genmab and/or SGI and [ * ].  To the extent that any Program Inventions [ * ] shall have been invented by Genmab and are owned by Genmab, Genmab hereby  assigns all of its right, title and interest therein to SGI. An “Improvement Invention to Seattle Genetics Material/Technology” (as  defined in the Prior Agreement) shall be deemed a Program Invention owned by SGI.    (c) Except as set forth in Sections 14.1.2(a) and 14.1.2(b), Genmab and SGI shall jointly own all other Program  Inventions.    (d) Inventorship, for purposes of this Agreement, shall be determined in accordance with U.S. laws of inventorship.    14.2 Patent Prosecution and Maintenance                         14.2.1     SGI shall be responsible for and shall control the preparation, filing, prosecution, grant, maintenance and defense  of all SGI Patents including SGI Program Inventions but excluding SGI’s share in Joint Patents. SGI shall, at its sole expense, prepare,  file, prosecute and maintain such SGI Patents in good faith consistent with its customary patent policy and its reasonable business  judgment, and shall consider in good faith the interests of Genmab in so doing.  -51-  

 

                                 14.2.2   Genmab shall be responsible for and shall control the preparation, filing, prosecution, grant, maintenance and  defense of all Genmab Patents, but excluding Genmab’s share in Joint Patents and further excluding Program Genmab Patents, but only  to the extent required in this Sections 14.2.3 to 14.2.5. Genmab shall, at its sole expense, prepare, file, prosecute and maintain such  Genmab Patents in good faith consistent with its customary patent policy and its reasonable business judgment, and shall consider in  good faith the interests of SGI in so doing.                        14.2.3   Subject to the oversight of the JSC under Section 3.2.2(g), Section 14.3 and Section 14.2.4 in the event SGI  exercises its Opt-In Right, each Party shall be responsible for and shall control the preparation, filing, prosecution, grant, maintenance  and defense, of any patents and patent applications claiming Program Inventions owned solely by it in accordance with Section 14.1.2  and shall, at its sole expense, prepare, file, prosecute and maintain such patent rights in good faith consistent with its customary patent  policy and its reasonable business judgment.                       14.2.4   If SGI exercises its Opt-In Right, the Parties agree that all Genmab ADC Patents shall continue to be owned by  Genmab, but shall be prepared, filed, prosecuted and maintained by [ * ] at the shared cost of both Parties. Following any Opt-Out   Notice by Genmab and provided that SGI elects to continue with the Development and Commercialization of the Collaboration      Product (thereafter an SGI Product), then such Genmab ADC Patents shall be assigned to SGI and subject to any obligations pursuant     to the Genmab In-Licenses with respect to such Genmab ADC Patents. SGI may at its sole expense, prepare, file, prosecute and   maintain such patent rights in good faith consistent with its customary patent policy and its reasonable business judgment. Following   any Opt-Out Notice by SGI and provided that Genmab elects to continue with the Development and Commercialization of the  Collaboration Product (thereafter a Genmab Product), then Genmab shall, at its sole expense, prepare, file, prosecute and maintain such  patent rights in good faith consistent with its customary patent policy and its reasonable business judgment.                       14.2.5   In case of a Genmab ADC Patent assigned to SGI pursuant to Section 14.2.4, if SGI decides not to continue  prosecuting any such patent right in whole or in part, then SGI shall promptly so notify Genmab (which notice shall be at least [ * ]  before any relevant deadline for such patent right). Thereafter, Genmab shall have the right to prosecute or maintain such patent right at  its sole expense. If Genmab elects to prosecute or maintain such patent right, [ * ]. Such patent shall [ * ].                       14.2.6   Patents and patent applications claiming Program Inventions owned jointly by both Parties in accordance with    Section 14.1.2(c) (“Joint Patents”) shall be prepared, filed, prosecuted and maintained by [ * ]. The cost [ * ] shall be borne equally by    the Parties in case of a Collaboration Product and shall be deemed IP and Trademark Costs.  -52-  

 

                             14.2.7    If either Party decides not to continue prosecuting any Joint Patents or not to maintain any Joint Patent, then such  Party shall promptly so notify the other Party (which notice shall be at least [ * ] before any relevant deadline for such Joint Patent).  Thereafter, the other Party shall have the right to prosecute or maintain such Joint Patent, at such Party’s sole expense. If the other     Party elects to prosecute or maintain such Joint Patent, such Party can request that the Joint Patent be transferred to the sole ownership   of such Party at such Party’s cost. Such Joint Patent that is only being prosecuted or maintained by one Party [ * ].                      14.2.8    The Parties shall at all times fully cooperate with each other in order to reasonably implement the foregoing  provisions of this Section14.2 and to handle any further activities under the Joint Patents outside the scope of this Agreement,      including without limitation licenses to Third Parties. Such cooperation may include each Party’s execution of necessary legal  documents, coordinating, filing and/or prosecution of applications to avoid potential issues during prosecution (including novelty,  enablement, estoppel and double patenting, execution of amendments and documents for reliance on the CREATE Act, if needed), and  the assistance of each Party’s relevant personnel. Without limiting the foregoing, it is understood that even if a Party is permitted to  reference the other Party’s technology in a patent application pursuant to this Agreement, the filing Party [ * ]. If the non-filing Party  determines [ * ] the Parties shall cooperate in accordance with this Section 14.2.8 to determine a strategy that would protect each    Party’s interests, including, without limitation, delaying the filing or co-owning such patent application, as the case may be. Except as  otherwise expressly authorized in this Agreement, Genmab shall not disclose and/or claim in any patent application, patent or   publication any [ * ] without SGI’s prior written consent. Except as otherwise expressly authorized in this Agreement, SGI shall not  disclose and/or claim in any patent application, patent or publication any [ * ] without Genmab’s prior written consent.                      14.2.9     Common Interest Disclosures. With regard to any information or opinions disclosed pursuant to this Agreement   by one Party to the other regarding intellectual property and/or technology owned by Third Parties, SGI or Genmab (or their respective  Affiliates), SGI and Genmab agree that they have a common legal interest in coordinating prosecution of their respective patent  applications, as set forth in this Article 14, and in determining whether, and to what extent, Third Party intellectual property rights may  affect the conduct of the development, manufacturing, marketing and/or sale of Licensed Products, and have a further common legal  interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual  property rights relating to the development, manufacturing, marketing and/or sale of Licensed Products. Accordingly, SGI and Genmab  agree that all such information and opinions obtained by SGI and Genmab from each other will be used solely for purposes of the  Parties’ common legal interests with respect to the conduct of the Agreement. All information and opinions will be treated as protected  by the attorney-client privilege, the work product privilege, and any other privilege or immunity that may otherwise be applicable. By  sharing any such information and opinions, neither Party intends to waive or limit any privilege or immunity that may apply to the   shared information and opinions. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party  without such other Party’s prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party    be deemed to apply against any other Party.  -53-    

 

            14.3 Enforcement of Patents             14.3.1  [ * ] shall have the [ * ] to determine the appropriate course of action to enforce the [ * ] or otherwise abate the  infringement thereof, to take (or refrain from taking) appropriate action to enforce such [ * ] to control any litigation or other  enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the [ * ]  shall in good faith [ * ]. All monies recovered upon the final judgment or settlement of any such suit to enforce any such [ * ] with  respect to the [ * ] shall be allocated first to [ * ], second to [ * ], and finally any remaining amounts shall be [ * ]. [ * ] shall fully  cooperate with [ * ] in any such action [ * ], to enforce the [ * ].               14.3.2   If [ * ] fails to exercise its rights under Section 14.3.1 to take any action to enforce the [ * ] or control any litigation       with respect to such [ * ] within a period of [ * ] days [ * ] after the Parties receive reasonable notice of the infringement of the [ * ],    then [ * ] shall have the [ * ] to bring and control any such action by counsel of its own choice, [ * ], to enter into or permit, the   settlement of any such litigation or other enforcement action with respect to the [ * ]. In such case, all monies recovered upon the final  judgment or settlement of any such suit to enforce any [ * ] shall be [ * ] allocated first to [ * ], second to [ * ], and finally any     remaining amounts shall be [ * ]. In such a case, [ * ] shall cooperate fully with [ * ], in its efforts to enforce the [ * ]. In no event may [  *] without [ * ] prior written consent.              14.3.3   [ * ] shall have the [ * ], to determine the appropriate course of action to enforce [ * ], or otherwise to abate the  infringement thereof, to take (or refrain from taking) appropriate action to enforce the [ * ], to control any litigation or other    enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the [ *     ]. All monies recovered upon the final judgment or settlement of any such suit to enforce any [ * ] shall be [ * ]. [ * ] shall fully   cooperate with [ * ], in any action to enforce the [ * ]. In the case of a [ * ] rights under this Section 14.3.3 shall be [ * ]. In the case of    an [ * ], if [ * ] fails to exercise its rights under this  -54-    

 

            Section 14.3.3 to take any action to enforce the [ * ] or control any litigation with respect to the [ * ] within a period of [ * ] days [ * ]  after the Parties receive reasonable notice of the infringement of the [ * ], then [ * ] shall have the [ * ] to bring and control any such  action by counsel of its own choice, [ * ] and permit, the settlement of any such litigation or other enforcement action with respect to     the [ * ]. In such case, all monies recovered upon the final judgment or settlement of any such suit to enforce any [ * ] shall be [ * ],  allocated first to [ * ], second to [ * ], and finally any remaining amounts shall be [ * ]. In such a case, [ * ] shall cooperate fully with [  *  ], in its efforts to enforce the [ * ]. In no event may [ * ] without [ * ] prior written consent.                       14.3.4   [ * ] shall have the [ * ], to determine the appropriate course of action to enforce [ * ], or otherwise to abate the  infringement thereof, to take (or refrain from taking) appropriate action to enforce such [ * ], to control any litigation or other  enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to such [   *]. All monies recovered upon the final judgment or settlement of any such suit to enforce such Genmab Patents shall be [ * ]. [ * ]     shall fully cooperate with [ * ], in any action to enforce the [ * ]. In the case of [ * ], if [ * ] fails to exercise its rights under this       Section 14.3.3 to take any action to enforce such [ * ] or control any litigation with respect to [ * ] within a period of [ * ] days [ * ]     after the Parties receive reasonable notice of the infringement of such [ * ], then [ * ] shall have the right to bring and control any such  action by counsel of its own choice, [ * ], to permit the settlement of any such litigation or other enforcement action with respect to     such [ * ]. In such case, all monies recovered upon the final judgment or settlement of any such suit to enforce such [ * ] shall be [ * ]  allocated first to [ * ], second to [ * ], and finally any remaining amounts shall be [ * ]. In such a case, [ * ] shall cooperate fully with [     * ], in its efforts to enforce such [ * ]. In no event may [ * ] without [ * ] prior written consent.                      14.3.5   In the event either Party becomes aware of [ * ], it shall promptly notify the other Party and the Parties shall  determine a mutually agreeable course of action. In no event shall [ * ] without [ * ] prior written consent.               14.4  Prior SGI Patent Rights. Notwithstanding anything to the contrary in this Agreement, with respect to any [ * ] that are  subject to the [ * ], the rights and obligations of the Parties under Section 14.2 and 14.3 shall be [ * ].                14.5  Prior Genmab Patent Rights. Notwithstanding anything to the contrary in this Agreement, with respect to any [ * ], the  rights and obligations of the Parties under Section 14.2 and 14.3 shall be [ * ].                14.6  Product Trademarks. The Parties’ shall propose and through the JSC select the trademark, trade dress, logos and slogans  under which each Collaboration Product shall be exclusively marketed (each a “Collaboration Product Trademark”). The Parties shall  register the Collaboration Product Trademark and shall take all such actions as are required to continue and maintain in full force and  effect the trademarks and the registrations thereof as well as enforce such trademarks and registrations. The Parties shall jointly own     the trademarks which are specifically directed to Collaboration Products and each Party shall execute all documents and take all actions  as are reasonably requested by the other Party to effectuate such joint ownership in such trademarks unless such joint ownership would  not be practicable in any such jurisdiction, in which case the Lead Commercialization Party shall have sole ownership. Collaboration  Product Trademarks shall be used only pursuant to the terms of this Agreement and any applicable co-promotion agreement to identify,  and in connection with the marketing of, Collaboration Products and shall not be used by either Party to identify, or in connection with  the marketing of, any other products. In case a Party Opts-Out it shall be obliged to assign its title to and interest in the Collaboration  Product Trademarks to the Continuing Party free of charge, provided the Continuing Party pays the costs of assignment.      ARTICLE 15 INFRINGEMENT ACTIONS BROUGHT BY THIRD PARTIES    15.1 Collaboration Product. If [ * ], is sued by [ * ] for infringement of [ * ] in connection with activities relating to the  manufacture, use, handling, storage, Development, Commercialization or other disposition of a [ * ] shall promptly notify [ * ] within [  * ] days of its receipt of notice of such suit. The notice shall set forth [ * ]. The Parties shall then meet to discuss [ * ], provided, that  (a) if such infringement relates primarily to [ * ], then [ * ] shall have the first right to control such suit in close consultation with [ * ]  and (b) if such infringement  -55-    

 

            relates primarily to [ * ], then [ * ] shall have the first right to control such suit in close consultation with [ * ]. In no event may [ * ]  without the express written consent of [ * ]. To the extent a claim is subject to [ * ] the procedure in [ * ] must be followed. Each Party  will [ * ] for its activities which are outside the scope of this Agreement.    15.2 Defense Costs. If the alleged infringement relates to [ * ], all reasonable costs associated with the defense of the action  will [ * ], and any payment due [ * ] as damages or in settlement [ * ] will be [ * ]. Any settlement that requires [ * ] will require prior  written approval of [ * ].    15.3 Exclusive Product, Genmab Product. If [ * ], is sued by [ * ] claiming infringement of a Third Party’s patent in  connection with activities relating to the manufacture, use, handling, storage, development, commercialization or other disposition of [  * ] shall be [ * ] for the defense [ * ]. To the extent such claimed infringement or any part thereof relates to [ * ] shall have the first right  to control the defense against such claims of infringement [ * ], provided that [ * ] shall be [ * ]. For clarity, [ * ] shall have the right to  control the defense against any claims of infringement not related to [ * ]. If [ * ] chooses not to defend against claims of infringement  related to [ * ], then [ * ] shall have the right to control such defense on its own.    15.4 SGI Product. If [ * ], is sued by [ * ] claiming infringement of a Third Party’s patent in connection with activities relating  to the manufacture, use, handling, storage, development, commercialization or other disposition of [ * ] shall be [ * ] for the defense [ *  ]. To the extent such claimed infringement or any part thereof relates to [ * ] shall have the first right to control the defense against such  claims of infringement [ * ], provided that [ * ] shall be entitled to participate in such defense. For clarity, [ * ] shall have the right to  control the defense against any claims of infringement not relating to [ * ]. If [ * ] chooses not to defend against claims of infringement  related to the [ * ], then [ * ] shall have the right to control such defense on its own.      ARTICLE 16 REPRESENTATIONS AND WARRANTIES    16.1 Representations and Warranties  16.1.1 This Agreement has been duly executed and delivered by each Party and constitutes the valid and binding  obligation of each Party, enforceable against such Party in accordance with its terms, except as enforceability may be limited by  bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium or other laws relating to or affecting creditors’ rights  generally and by general equitable principals. The execution, delivery and performance of this Agreement has been duly authorized by  all necessary action on the part of each Party, its officers and directors.    16.1.2 The execution, delivery and performance of the Agreement by each Party does not conflict with any agreement,  instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any  court, governmental body or administrative or other agency having jurisdiction over it.  -56-  

 

            16.1.3 SGI represents and warrants that as of the Effective Date:  (a) it has the right to grant the licenses granted herein;    (b) the SGI Technology licensed hereunder is free and clear of any security interests, claims, encumbrances or  charges of any kind;    (c) it has not assigned and/or granted licenses, nor shall it assign and/or grant licenses, to the SGI Technology or a  Licensed Product to any Third Party that would restrict or impair the rights granted to Genmab hereunder;    (d) to its [ * ], without [ * ], [ * ] of any Third Parties would be [ * ] by [ * ] the Drug Conjugation Materials and  Drug Conjugation Technology licensed hereunder, furthermore, to its [ * ], [ * ], [ * ] of any Third Party exist with [ * ] after [ * ] with  claims covering Antibody-Drug Conjugates that incorporate such Drug Conjugation Materials and Drug Conjugation Technology for  the treatment of cancer;    (e) to its [ * ], no Third Party has [ * ] the SGI Technology using an antibody drug conjugate that binds to Tissue  Factor;    (f) it shall not invoke any dominant patent or patent application owned or controlled by, or licensed to, it or its  Affiliates to in any way [ * ] the rights and/or licenses granted hereunder; and    (g) the SGI Technology licensed hereunder constitutes all of SGI’s intellectual property rights necessary or useful to  develop, have developed, make, have made, import, use, offer for sale, have sold or sell the Drug Conjugation Materials and Drug  Conjugation Technology as contemplated to be used in a Licensed Product.    16.1.4 Genmab represents and warrants that as of the Effective Date:  (a) it has the right to grant the licenses granted herein;    (b) the Genmab Technology licensed hereunder is free and clear of any security interests, claims, encumbrances or  charges of any kind;    (c) it has not assigned and/or granted licenses, nor shall it assign and/or grant licenses, to the Genmab Technology  with regard to a Licensed Product to any Third Party that would restrict or impair the rights granted to SGI hereunder;    (d) apart from the information previously disclosed in writing to SGI, it has [ * ] of any [ * ] of any [ * ] by the [ * ]  from [ * ] to [ * ]; furthermore, to [ * ] no [ * ] of any [ * ] with [ * ] after [ * ] with [ * ] (i) the [ * ] denoted [ * ] or [ * ] or (ii) a [ * ]  the [ * ] denoted [ * ] or [ * ] for the treatment of [ * ];    (e) to its [ * ], no Third Party has [ * ] the Genmab Technology using an antibody that binds to Tissue Factor;  -57-  

 

            (f) it has notified SGI in writing of all [ * ];    (g) it shall not invoke any dominant patent or patent application owned or controlled by, or licensed to, it or its  Affiliates to in any way restrict the rights and/or licenses granted hereunder; and    (h) the Genmab Technology licensed hereunder constitutes all of Genmab’s intellectual property rights necessary or  useful to develop, have developed, make, have made, import, use, offer for sale, have sold or sell an Antibody as contemplated to be  used in a Licensed Product.    16.2 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE KNOW-HOW, CONFIDENTIAL  INFORMATION AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY ARE PROVIDED “AS IS” AND  EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND EXPRESS OR IMPLIED,  INCLUDING BY OPERATION OF LAW OR BY STATUTE OR OTHERWISE, INCLUDING WITHOUT LIMITATION THE  WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT  OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OF DEALING, USAGE OR  TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.    16.2.1 EXCEPT AS MAY BE OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NONE OF THE  PARTIES MAKE ANY REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR  BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, REGARDING THE ANTIBODIES, DRUG CONJUGATION  MATERIALS OR ANY ADCS, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, NON-INFRINGEMENT  OR FITNESS FOR A PARTICULAR USE OR PURPOSE.    16.3 Performance by Affiliates. The Parties recognize that each may perform some or all of its obligations under this  Agreement through Affiliates, provided, h owever, that each Party shall remain responsible and be a guarantor of the performance by its  Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.      ARTICLE 17 TERM AND TERMINATION    17.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and be valid and in force until  terminated pursuant to the Articles 17 or 19.    17.2 Termination by Genmab. Genmab shall have the right, at any time after the first anniversary of the Effective Date other  than the period (a) following an Opt-In Decision and prior to any applicable Opt-Out Date or (b) during which SGI is developing or  commercializing an SGI Product, to terminate this Agreement in its entirety by providing not less than [ * ] days’ prior written notice  to SGI of such termination. For clarity, as regards termination without cause following an Opt-In Decision and prior to any applicable  Opt-Out Date, Section 5.10 will apply where a Party wishes to cease collaborating with the other Party.  -58-    

 

            17.3 Termination for Cause. Either Party may terminate this Agreement for breach by the other Party (the “Breaching Party”)  of any material provision of the Agreement or in the case of a license, a breach of a [ * ] related to such license, including diligence  obligations, if, in the event that the breach is by its nature capable of being cured, the Breaching Party has not cured such breach within  [ * ] after notice thereof (or in the event any breach is incapable of being cured in such time period, if the Breaching Party commences  a cure within such [ * ] period and diligently pursues the cure to completion).    17.4 Termination if Genmab Challenges SGI Patents. SGI may terminate this Agreement for cause at any time after [ * ]  written notice to Genmab of its intent to so terminate if Genmab, its Affiliates or Sublicensees, challenges the validity, enforceability,  patentability or scope of a claim of any SGI Patent. Any such termination shall not become effective if Genmab has [ * ], provided such  [ * ].    17.5 Termination if SGI Challenges Genmab Patents. Genmab may terminate this Agreement for cause at any time after [ * ]  written notice to SGI of its intent to so terminate if SGI, its Affiliates or Sublicensees, challenges the validity, enforceability,  patentability or scope of a claim of any Genmab Patent. Any such termination shall not become effective if SGI has [ * ], provided such  [ * ].    17.6 Termination Upon Insolvency. Either Party may terminate this Agreement if, at any time, (a) the other Party shall file in  any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or  for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, (b) such other Party  proposes a written agreement of composition or extension of its debts, (c) [ * ], (d) such other Party shall propose or be a party to any  dissolution or liquidation, or (e) such other Party shall make an assignment for the benefit of its creditors. Notwithstanding the  foregoing, the Parties intend for this Agreement and the licenses granted herein to come within Section 365(a) of the United States  Bankruptcy Code, and notwithstanding the bankruptcy or insolvency of SGI, this Agreement and the licenses granted herein shall  remain in full force and effect so long as Genmab shall remain in material compliance with the terms and conditions hereof.    17.7 Termination of BMS Agreement. All rights and obligations under the BMS Agreement sublicensed under this Agreement  shall terminate upon forty-five (45) days prior written notice by SGI if Genmab performs any action that would constitute a breach of  any material provision of the BMS Agreement and fails to cure such breach within such forty-five (45) day period (or in the event any  breach is incapable of being cured in such time period, if Genmab commences a cure within such forty-five (45) day period and  diligently pursues the cure to completion); provided, h owever, that such cure period may be extended by mutual written consent of the  Parties. All rights and obligations under the BMS Agreement shall automatically terminate if Genmab fails to maintain the insurance  required under the BMS Agreement. SGI shall maintain the BMS Agreement for the term of this Agreement.  -59-    

 

            17.8 Termination of [ * ]. All [ * ] and [ * ] under a [ * ] under this Agreement shall terminate upon [ * ] prior written notice by  [ * ] if [ * ] performs any action that would [ * ] a [ * ] of any [ * ] of such [ * ] and [ * ] to [ * ] such [ * ] within such [ * ] period (or in  the event any [ * ] is [ * ] of [ * ] in such [ * ], if [ * ] a [ * ] within such [ * ]and [ * ] the [ * ] to [ * ]); provided, h owever, that such [ *  ] may be [ * ] by [ * ] of the Parties. [ * ] shall [ * ] that the [ * ] for [ * ] with [ * ] is [ * ] for the [ * ] of this [ * ].    17.9 Effect of Expiration and Termination  17.9.1 Except where explicitly provided within this Agreement, termination of this Agreement for any reason, or  expiration of this Agreement, will not affect any: (a) obligations, including payment of any royalties or other sums which have accrued  as of the date of termination or expiration, and (b) rights and obligations which, from the context thereof, are intended to survive  termination or expiration of this Agreement, including provisions of Articles 1, 13, 14, 15, 18 (as to actions arising during the term of  this Agreement or in the course of a Party practicing any licenses retained by such Party thereafter), 22 and 23, Sections 5.7, 11.3 and  17.9 and any payment obligations pursuant to Article 10 and 11 incurred prior to termination.    17.9.2 Upon termination of this Agreement for any reason, all licenses granted by one Party to the other hereunder,  including all licenses for Exclusive Products, Collaboration Products and Unilateral Products, and all sublicenses granted to Affiliates  or Third Parties by a Party hereunder will immediately terminate.    17.9.3 Upon any termination of this Agreement by Genmab pursuant to Section 17.2 or by SGI pursuant to Sections 17.3,  17.4, 17.6 or 17.7, or in the case of a Dormant Product (provided that at the time of the Collaboration Product becoming a Dormant  Product no Licensed Products are in development or are being commercialized by either Party), Genmab shall to the extent necessary  grant to [ * ] license in the Territory under the [ * ] to make, have made, use, sell, offer to sell and import [ * ]. For the avoidance of  doubt [ * ] shall not [ * ].    17.9.4 Upon the expiration of the Royalty Term:  (a) SGI shall grant, and shall by this provision be deemed to have granted, to Genmab a royalty-free, perpetual,  worldwide, nonexclusive license to use the Joint Patents and SGI Technology to make, use, sell, offer for sale and import Exclusive  Products or Genmab Products, as applicable, with no further obligation to SGI; and    (b) Genmab shall grant, and shall by this provision be deemed to have granted, to SGI a royalty-free, perpetual,  worldwide, nonexclusive license to use the Joint Patents and Genmab Technology to make, use, sell, offer for sale and import SGI  Products, with no further obligation to Genmab.  -60-    

 

            17.9.5 In the event that a Party is commercializing Licensed Products under this Agreement, and in accordance with the  foregoing provisions of this Article a license is terminated then such Party shall be entitled to, and the licenses shall be deemed to  survive to the extent necessary for such Party to wind down the activities in an orderly manner, including the right to sell off inventory,  but in no event for a period longer than [ * ] from the effective date of termination.      ARTICLE 18   INDEMNITY    18.1 Direct Indemnity for Non-Collaboration Products  18.1.1 With respect to Genmab Products, SGI Products and Exclusive Products, each Party shall defend, indemnify and  hold harmless the other Party, its Affiliates and their respective directors, officers, employees and agents (collectively, the  “Indemnitees”) from and against all liabilities, losses, damages, and expenses, including reasonable attorneys’ fees and costs,  (collectively, the “Liabilities”) resulting from all Third Party claims, suits, actions, terminations or demands (collectively, the  “Claims”) that are incurred, relate to or arise out of (a) the [ * ] of any [ * ] of this Agreement by the indemnifying Party, including a [ *  ] of any representation or warranty made by such Party in this Agreement, or (b) the [ * ] of the indemnifying Party in connection with  the performance of its obligations hereunder.    18.1.2 Genmab shall defend, indemnify and hold harmless the SGI Indemnitees from and against all Liabilities resulting  from all Claims that are incurred, relate to or arise out of the development, manufacture or commercialization of Exclusive Products or  Genmab Products by SGI for Genmab or by Genmab, its Affiliates or Sublicensees, including any failure to test for or provide  adequate warnings of adverse side effects, or any manufacturing defect in any Exclusive Product or Genmab Product; except to the  extent such Liabilities must be indemnified by SGI pursuant to Sections 18.1.1.    18.1.3 SGI shall defend, indemnify and hold harmless the Genmab Indemnitees from and against all Liabilities resulting  from all Claims that are incurred, relate to or arise out of the development, manufacture or commercialization of SGI Products by  Genmab for SGI or by SGI, its Affiliates or Sublicensees, including any failure to test for or provide adequate warnings of adverse side  effects, or any manufacturing defect in any SGI Product; except to the extent such Liabilities must be indemnified by Genmab pursuant  to Sections 18.1.1    18.2 Collaboration Products  18.2.1 Each Party hereby agrees to indemnify, defend, and hold harmless the other Party’ Indemnitees from and against  any and all Liabilities, incurred as a result of any Claims relating to the manufacture, use, handling, storage, Development,  Commercialization or other disposition of any Collaboration Product by the indemnifying Party, its Affiliates, employees, agents or  Sublicensees, but only to the extent such Claims result from: (a) the [ * ] of the indemnifying Party, its Affiliates, employees, agents or  Sublicensees; or (b) any [ * ] by the indemnifying Party of any [ * ] of this Agreement, including a [ * ] of any representation or  warranty made by such Party in this Agreement; except, in each case, to the comparative extent of any such Claim resulting from the [  * ] of the Indemnitees.  -61-    

 

            18.2.2 Except for those Claims subject to Section 18.2.1, the Parties shall share equally any Liabilities in connection with:  (a) any Claim brought against either Party by a Third Party resulting directly or indirectly from the manufacture, use, handling, storage,  Development, Commercialization or other disposition of any given Collaboration Product (in the same manner as the Parties share  Product Profit); and (b) the defense or settlement of claims of infringement of Third Party patent rights in accordance with the  procedures set forth in Article 15.    18.2.3 If either Party receives notice of a Claim with respect to any Collaboration Product, such Party shall inform the  other Party in writing as soon as reasonably practicable. The Parties shall confer through the JSC how to respond to the Claim and how  to handle the Claim in an efficient manner. In the absence of such an agreement, each Party shall have the right to take such action as it  deems appropriate, subject to Section 18.3.    18.3 Procedure. A Party (the “Indemnified Party”) that intends to claim indemnification under this Article 18 shall promptly  provide notice to the other Party (the “Indemnitor”) of any Liability or action in respect of which the Indemnified Party intends to  claim such indemnification, which notice shall include a reasonable identification of the alleged facts giving rise to such Liability, and  the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor so desires, jointly with any other Indemnitor  similarly noticed, to assume the defense thereof with counsel selected by the Indemnitor. However, notwithstanding the foregoing, the  Indemnified Party shall have the right to retain its own counsel, [ * ], unless the [ * ], in which case [ * ]. The Indemnified Party cannot  settle any Liability for which it intends to claim indemnification by the Indemnitor without the prior consent of the Indemnitor. Any  settlement of a Liability for which any Indemnified Party seeks to be indemnified, defended or held harmless under this Article 18 that  could adversely affect the Indemnified Party shall be subject to prior consent of such Indemnified Party, provided that such consent  shall not be withheld unreasonably.    18.4 Limitations on Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR TO ANY  THIRD PARTY FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING  FROM THIS AGREEMENT OR FOR ANY AMOUNTS REPRESENTING LOSS OF PROFITS OR LOSS OF BUSINESS,  WHETHER THE BASIS OF THE LIABILITY IS BREACH OF CONTRACT, TORT, STATUTES, OR ANY OTHER LEGAL  THEORY, AND WHETHER SUCH FIRST PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR  NOT.      ARTICLE 19    FORCE MAJEURE    19.1 No Party (or any of its Affiliates) shall be held liable or responsible to the other Party (or any of its Affiliates), or be  deemed to have defaulted under or breached the Agreement, for failure or delay by such Party in fulfilling or performing any term of  the Agreement when  -62-  

 

            such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party (or any of its Affiliates),  including fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, acts of God,  earthquakes, or omissions or delays in acting by any governmental authority (collectively, “Events of Force Majeure”); provided,  h owever, that the affected Party shall promptly advise the other Party of the existence of such Event of Force Majeure and shall exert  all Commercially Reasonable Efforts to eliminate, cure or overcome any such Event of Force Majeure and to resume performance of  its obligations promptly. Notwithstanding the foregoing, to the extent that an Event of Force Majeure continues for a period in excess  of [ * ], the affected Party shall promptly notify in writing the other Party of such continued Event of Force Majeure and within [ * ] of  the other Party’s receipt of such notice, the Parties shall negotiate in good faith either (a) a resolution of the Event of Force Majeure, if  possible, (b) an extension by mutual agreement of the time period to resolve, eliminate, cure or overcome such Event of Force Majeure,  (c) an amendment of this Agreement to the extent reasonably possible, or (d) an early termination of this Agreement. If a solution  under subsection (a)-(d) has not been reached after four (4) months of the other Party’s receipt of such notice, then the Party not  affected shall be entitled to give notice to the affected Party to terminate this Agreement, specifying the date (which shall not be less  than [ * ] after the date on which the notice of termination is given) on which termination will take effect. Such a termination notice  shall be irrevocable, except with the consent of both Parties, and upon termination the provisions of Section 17.9 shall apply.      ARTICLE 20   ASSIGNMENT    20.1   This Agreement may not be assigned or otherwise transferred, nor, except as expressly provided hereunder, may any right  or obligations hereunder be assigned or transferred to any Third Party by either Party without the consent of the other Party, such  consent not to be unreasonably withheld; provided, h owever, that [ * ]. Any permitted assignee shall assume all rights and obligations  of its assignor under this Agreement; provided, h owever, that [ * ] shall not be [ * ]. Any attempted assignment of this Agreement not  in accordance with this Article 20 shall be void and of no effect.      ARTICLE 21   SEVERABILITY    21.1   Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations,  treaty or decision of any government agency or executive body thereof of any country or community or association of countries.  Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid  provisions for such invalid provisions, that in their economic effect, are sufficiently similar to the invalid provisions that it can be  reasonably assumed that the Parties would have entered into this Agreement based on such valid provisions. In case such alternative  provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this  Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably  assumed that the Parties would not have entered into this Agreement without the invalid provisions.  -63-  

 

            ARTICLE 22   INSURANCE    22.1   During the Term and thereafter for the period of time required below, each Party shall maintain on an ongoing basis  comprehensive general liability insurance in the minimum amount of [ * ] Dollars ($[ * ]) per occurrence and [ * ] Dollars ($[ * ])  annual aggregate combined single limit for bodily injury and property damage liability. Commencing not later than [ * ] days prior to  the first use in humans of any Collaboration Product, Exclusive Product or Genmab Product and thereafter for the period of time  required below, Genmab shall obtain and maintain on an ongoing basis products liability insurance (including contractual liability  coverage on Genmab’s indemnification obligation under this Agreement) in the amount of at least [ * ] Dollars ($[ * ]) per and in an  annual aggregate combined single limit for bodily injury and property damage liability. Commencing not later than [ * ] days prior to  the first use in humans of any Collaboration Product or SGI Product, and thereafter for the period of time required below, SGI shall  obtain and maintain on an ongoing basis products liability insurance (including contractual liability coverage on SGI’s indemnification  obligations under this Agreement) in the amount of at least [ * ] Dollars ($[ * ]) per occurrence and in an annual aggregate combined  single limit for bodily injury and property damage liability. All of such insurance coverage shall be maintained with an insurance  company or companies having an A.M. Best rating of “A-” or better and an aggregate deductible not to exceed [ * ] Dollars ($[ * ]) per  occurrence. Upon the Effective Date and not later than [ * ] prior to the first use in humans of the first Collaboration Product, Exclusive  Product, Genmab Product or SGI Product, as the case may be, each Party shall provide to other Party a certificate(s) evidencing all  required coverage hereunder. Each Party shall maintain such insurance coverage without interruption during the Term and for a period  of at least [ * ] thereafter. Each Party’s insurance shall name [ * ] on the products liability insurance required hereunder. Each Party  shall provide the other Party at least forty [ * ]’ prior written notice of any cancellation or material change in the insurance policy. The  cost of insurance required by this Article 22 with respect to the Collaboration Product shall be treated as a Joint Development Cost or  an “other cost” for the purposes of calculating Commercialization Expenses, as applicable.      ARTICLE 23   MISCELLANEOUS    23.1 Notices. Any consent, notice or report required or permitted to be given or made under this Agreement by one of the  Parties hereto to the other shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery, first  class air mail or courier), first class air mail or courier, postage prepaid (where applicable), addressed to such other Party at its address  indicated below, or to such other address as the addressee shall have last furnished in writing to the address or in accordance with this  Section 23.1 and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee. Notices shall be  deemed to have been received (a) on the date delivered if delivered personally; (b) on the date received if sent by certified or registered  mail, return receipt requested, postage prepaid; (c) on the first business day after the date sent if sent by recognized overnight courier  (or two-day courier, if next-day service is unavailable); or (d) on the date transmitted if sent via facsimile (with confirmation of receipt  generated by the transmitting machine).  -64-    

 

            If to SGI:  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    Invoices to SGI: [ * ]    If to Genmab:  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    With a copy to:  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    Invoices to Genmab: [ * ]    23.2 Applicable Law. The Agreement shall be governed by and construed in accordance with the laws of the [ * ], without  regard to the conflict of law principles thereof that may dictate application of the laws of any other [ * ], or the [ * ] as applicable.    23.3 Dispute Resolution. The Parties agree that they shall seek to resolve any dispute or disagreement that arises between  Genmab on the one hand and SGI on the other in respect of this Agreement that is not resolved by the JSC pursuant to the procedure  set forth in Section 3.2.7.    23.3.1 Any dispute not resolved by the procedure set forth in Section 3.2.7 shall be submitted by the Parties for resolution  by [ * ] in [ * ] except as otherwise provided herein. The Parties shall [ * ] within [ * ] of [ * ]. The [ * ] shall be [ * ]. If [ * ], the [ * ]  shall [ * ] within [ * ] of [ * ]. The [ * ] shall [ * ]. Nothing in this Agreement shall be deemed as preventing either Party from seeking  injunctive relief (or any other equitable or provisional remedy). If the issues in dispute involve [ * ], any [ * ] shall [ * ].  -65-    

 

            23.3.2 In the event of a dispute regarding any payments owing under this Agreement, all undisputed amounts shall be paid  promptly when due and the balance, if any, promptly after resolution of the dispute with interest in accordance with Section 12.1.3.    23.3.3 Notwithstanding the foregoing, any disputes relating to inventorship or the validity, enforceability or scope of any  patent or trademark rights (except for a dispute relating to the remedy under Section 17.4 or 17.5) shall be submitted for resolution by a  court of competent jurisdiction.    23.4 Entire Agreement. This Agreement and the Prior Agreement contains the entire understanding of the Parties with respect  to the specific subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made,  including the Prior Agreement, are expressly superseded by this Agreement. This Agreement may be amended, or any term hereof  modified, only by a written instrument duly executed by both Parties hereto.    23.5 Independent Contractors. SGI and Genmab each acknowledge that they shall be independent contractors and that the  relationship between the two Parties shall not constitute a partnership, joint venture, agency or any type of fiduciary relationship.  Neither SGI nor Genmab shall have the authority to make any statements, representations or commitments of any kind, or to take any  action, which shall be binding on the other Party, without the prior consent of the other Party to do so.    23.6 Affiliates. Each Party shall cause its respective Affiliates to comply fully with the provisions of this Agreement to the  extent such provisions specifically relate to, or are intended to specifically relate to, such Affiliates, as though such Affiliates were  expressly named as joint obligors hereunder.    23.7 Waiver. The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party  shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar  nature or otherwise.    23.8 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original,  but all of which together shall constitute one and the same instrument.  -66-    

 

            IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.    SEATTLE GENETICS, INC.    By: /s/ Clay B. Siegall  Name: Clay B. Siegall  Title: President & CEO    GENMAB A/S    By: /s/ Jan van de Winkel  Name: Jan van de Winkel  Title: President & CEO  

 

            S chedule A    SGI PATENTS    [ * ]                                                                                                         S chedule A  1  

 

            S chedule B    Research and GLP Grade Supply Fee Pricing List    [ * ]                                                                                                             S chedule B  1  

 

            S chedule C    GENMAB IN-LICENSES    [ * ]                                                                                                           S chedule C  1  

 

            S chedule D    SGI RESEARCH AND DEVELOPMENT SUPPORT PRIOR TO END OF PHASE I CLINICAL TRIAL    [ * ]    {2 pages omitted}                                                                          S chedule D  1    

 

            S chedule E    GENMAB DEVELOPMENT PLAN AND GENMAB BUDGET    [ * ]                                                                                                                              S chedule E  1    

 

            S chedule F    GENMAB PATENTS    [ * ]    {9 pages omitted}                                                                                                       S chedule F  1ex-102xseagenxabbottxfor

1/4  Exhibit 10.2 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED  BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. SEVENTH AMENDMENT  TO DEVELOPMENT AND SUPPLY AGREEMENT  Effective as of date of the last signature below, Abbott Laboratories, an Illinois corporation having a principal place of business at  100 Abbott Park Road, Abbott Park, Illinois 60064-3500 (“Abbott”), and Seattle Genetics, Inc., a Delaware corporation having a principal  place of business at 21823 – 30th Drive Southeast in Bothell, Washington 98021 (“Seattle Genetics”) (individually the “Party” or  collectively the “Parties”) agree to the following terms and conditions (this “Seventh Amendment”) as set forth below.  WHEREAS, the Parties entered into a Development and Supply Agreement with an Effective Date of February 23, 2004 for the  manufacture of a chimeric anti-CD30 AC10 monoclonal antibody known as cAC10 Bulk Drug Substance (the “Original Agreement”),  which also constitutes the antibody component of SGN-35 and the Parties subsequently entered into six amendments to the Original  agreement (the “First Amendment”, “Second Amendment”, “Third Amendment”, “Fourth Amendment”, “Fifth Amendment” and “Sixth  Amendment”, respectively. Collectively the Original Agreement, the First Amendment, the Second Amendment, the Third Amendment,  the Fourth Amendment, the Fifth Amendment and the Sixth Amendment are hereinafter referred to as the “Agreement”); and  WHEREAS, the Parties desire to further amend the Agreement as herein provided as of the date hereof.  NOW, THEREFORE, in consideration of the mutual covenants and agreements contained here and for other good and valuable  consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:  1. I ncorporation of the Agreement. All capitalized terms which are used but not otherwise defined herein shall have the same meanings as set forth in the Agreement, and the Agreement, to the extent not inconsistent with this Seventh Amendment, is incorporated  herein by this reference as though the same was set forth in its entirety. To the extent any terms and provisions of the Agreement are  inconsistent with the amendments set forth in Paragraphs 2 and 3 below, such terms and provisions shall be deemed superseded hereby.  Except as specifically set forth herein, the Agreement shall remain in full force and effect and its provisions shall be binding on the parties.  2. P rocess Development Work. The Parties agree that Abbott shall perform the activities set forth in Stage 13a of Attachment 1  hereto pursuant to the terms and conditions of the Agreement.  3. P ayment Schedule. As compensation for the activities to be performed by Abbott pursuant to Attachment 1 hereto, Seattle Genetics shall pay to Abbott the price established for each project stage on the dates set forth in Attachment 2. Billings associated with this  Seventh Amendment may be combined on the same invoice with other, regular Payment Schedule charges.  4. P roject References. All references to the Project set forth in the Agreement, with the exception of the Payment Schedule and Facility Reservation Fee for the Project, shall also be deemed to apply to the activities performed by Abbott, pursuant to this Seventh  Amendment.  

 

    2/4       6. E ffectuation. The amendment to the Agreement contemplated by this Seventh Amendment shall be deemed effective as of the last  date written below upon the full execution of this Seventh Amendment and without any further action required by the parties hereto. There  are no conditions precedent or subsequent to the effectiveness of this Seventh Amendment. All terms and conditions set forth in  Agreement that are not amended hereby shall remain in full force and effect. Any term of this Seventh Amendment may be amended with  the written consent of both parties. From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as  amended by this Seventh Amendment.  7. C ounterparts. This Seventh Amendment may be executed in two or more counterparts, each of which shall be deemed to be an  original, but all of which together shall constitute one and the same instrument. One or more counterparts of this Seventh Amendment may  be delivered by facsimile, with the intention that delivery by such means shall have the same effect as delivery of an original counterpart  thereof.  8. E ntire Agreement. This Seventh Amendment and exhibits hereto are the product of both of the Parties hereto, and together with  the Agreement and exhibits thereto constitute the entire agreement between such parties pertaining to the subject matter hereof, and merge  all prior negotiations and drafts of the Parties with regard to the transactions contemplated herein.  IN WITNESS WHEREOF, the parties have executed Second Amendment of the dates set forth below.    ABBOTT LABORATORIES SEATTLE GENETICS, INC.    By:   /s/ Keith Kentala By: /s/ Clay B. Siegall     Name: Keith Kentala Name: Clay. B. Siegall  Title: General Manager, Commercial Operations Title: President & CEO  Date: 01/02/2013 Date: 12/19/12  

 

    3/4       STAGE 13A: REFERENCE STANDARD GENERATION AND STABILITY  [ * ].    Table 1: Reference Standard Testing – Qualification and Stability (i.e. Re-evaluation) Testing      Time point (Months)   S torage Temperature  [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]  [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]  [ * ]     Seattle Genetics Deliverables:     [ * ]     Abbot Deliverables:     [ * ]     Price:     Reference standard generation & year [ * ] testing:  Stability testing – years [ * ] through [ * ]    $[ * ]  $[ * ]  Total   $[ * ]    

 

    4/4       PAYMENT SCHEDULE    [ * ]  2012  S tage Activities Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Year                 13A Reference Std  Gen and  Testing [ * ] [ * ]  13A Reference Std  Gen and  Testing [ * ] [ * ]  Total [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]    2013    S tage  13A      13A                    2014    S tage  13A      13A                    2015    S tage  13A      13A                    2016    S tage  13A      13A          Activities  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec  Year  Reference Std  Gen and  Testing                          [ * ]         [ * ]  Reference Std                            Gen and                            Testing                      [ * ]    [ * ]  Total  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    Activities  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec  Year  Reference Std  Gen and  Testing                          [ * ]         [ * ]  Reference Std                            Gen and                            Testing                      [ * ]    [ * ]  Total  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    Activities  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec  Year  Reference Std  Gen and  Testing                          [ * ]         [ * ]  Reference Std                            Gen and                            Testing                      [ * ]    [ * ]  Total  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]    Activities  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec  Year  Reference Std  Gen and  Testing                           [ * ]         [ * ]  Reference Std                            Gen and                            Testing                      [ * ]    [ * ]  Total  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]  [ * ]

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