LICENSE AND COLLABORATION AGREEMENT

Exhibit 10.45

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

LICENSE AND COLLABORATION AGREEMENT

DATED AS OF JULY 11, 2008

BY AND BETWEEN

IMMUNOMEDICS, INC.

AND

NYCOMED GmbH

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LICENSE AND COLLABORATION AGREEMENT

This License and Collaboration Agreement (this “Agreement” ), dated as of July 11, 2008 (the “Execution Date” ), is made by and between Immunomedics, Inc., a Delaware corporation ( “Immunomedics” ) headquartered at 300 American Road, Morris Plains, New Jersey 07950, USA, and Nycomed GmbH, a corporation organized under the laws of Germany ( “Licensee” ) headquartered at Byk-Gulden-Str. 2 78467 Konstanz, Germany. Immunomedics and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

W HEREAS , Immunomedics has developed and is currently further developing a pharmaceutical product known as VELTUZUMAB for the treatment of cancer and autoimmune diseases and is seeking a partner to take over responsibility for the development and commercialization of VELTUZUMAB outside of cancer;

W HEREAS , Licensee has significant experience in the development and commercialization of pharmaceutical products in the Territory; and

W HEREAS , Licensee and Immunomedics desire to establish a collaboration for the further development and commercialization of the Product in the Field in the Territory.

N OW T HEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following initially capitalized terms shall have the meanings set forth in this ARTICLE 1 or as otherwise defined elsewhere in this Agreement:

“Adverse Event” means any adverse medical occurrence in a human patient or subject who is administered the Product, whether or not considered related to the Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease associated with the use of the Product.

“Advertisement and Promotion Costs” means the Out-of-Pocket Costs paid by Licensee in the Territory (or, in the event Immunomedics exercises the Co-Promotion Option, by either Party in the U.S.), and specifically attributable to, the marketing, advertising and promotion of the Product in the Field, including (i) advertising agency fees, (ii) costs for conducting seminars, (iii) costs for exhibiting at medical conventions and participating in professional medical association meetings, (iv) costs for direct mail, internet programs and journal advertising and (v) costs for creation of Promotional and Educational Materials. For clarity, “Advertisement and Promotion Costs” shall not include any Development Costs or any costs incurred in connection with Detailing or distributing the Product.

 

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“Affiliate” means any person or entity directly or indirectly controlled by, controlling or under common control with, a Party, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) shall be presumed to exist with respect to a person or entity in the event of the possession, direct or indirect, of (a) the power to direct or cause the direction of the management and policies of such person or entity (whether through ownership of securities, by contract or otherwise), or (b) at least fifty percent (50%) of the voting securities or other comparable equity interests. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the U.S., the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case, such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct or cause the direction of the management and policies of such person or entity. For the avoidance of doubt, neither of the Parties shall be deemed to be an “Affiliate” of the other.

“ Bioequivalent Product ” means, with respect to ***in a given country *** ***, a *** that contains *** (i) that has been *** that relies in whole or in part *** and *** for the *** as determined by *** in such country and (ii) *** *** *** can be *** in such country.

“ BLA ” means a (i) biologics license application or new drug application or equivalent application that is filed with the FDA to obtain Product Approval for the Product in the Field in the U.S. or (ii) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to obtain Product Approval for the Product in the Field in such jurisdiction, including an MAA and a ***.

“ BLA Filing ” means (i) the filing of a BLA for the Product in the Field in the U.S. or (ii) the acceptance of the equivalent application by the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to obtain Product Approval for the Product in the Field in such jurisdiction, including acceptance of an MAA by the EMEA (or acceptance by the applicable Regulatory Authority in a given country in Europe to the extent mutual recognition or other national approval procedure is utilized) and acceptance of a *** by the ***.

“Change of Control” means with respect to a Party, an event in which: (i) any other person (including any legal entity) or group of persons (including any legal entities) acquires beneficial ownership of securities of such Party representing more than fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors of such Party; or (ii) such Party enters into a merger, consolidation or similar transaction with another person (or legal entity); in each case of *** to the extent *** or *** have *** are ***in ***.

“ Clinical Inventory ” means those inventories of the finished form of the Subcutaneous Formulation of the Product in clinical primary packaging presentation for use in Clinical Studies.

“Commercialize”, “Commercializing” or “Commercialization” means all activities relating to the marketing, promotion, selling or offering for sale of a product for an indication, including Pre-Marketing, advertising, educating, planning, marketing, promoting, importing, exporting, distributing and post-marketing safety surveillance reporting, and conducting Phase 4 Clinical Trials. For clarity, “Commercialization” shall not include any activities related to research or Development of the Product.

 

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“***” means with respect to a Party’s obligations under this Agreement, including to Manufacture, Develop or Commercialize the Product, the *** and the *** by such Party for a product ***, of similar *** and at a similar *** but in any event not less than, the level of *** and the *** required to carry out such obligation in a sustained manner *** with respect to such a product. Without limiting the foregoing, *** requires, with respect to such an obligation, that the Party: (i) ***, (ii) *** for carrying out such obligation, and (iii) *** with respect to such objectives.

“ Competitive Product ” means any *** with a mechanism of action *** for any use in the Field (other than the Product hereunder).

“ Control ” means, when used in reference to intellectual property, other intangible property, or materials, that a Party owns or has a license or sublicense to such intellectual property, other intangible property or materials, and has the ability to grant a license or sublicense or other right to use to such intellectual property, other intangible property or materials, as applicable, as provided for herein, without (i) requiring the consent of a Third Party or (ii) violating the terms of any agreement or other arrangement with any Third Party.

“ Co-Promote ” or “ Co-Promotion ” means those Detailing and promotional activities (including performing sales calls) with respect to the Product undertaken by Immunomedics Sales and Educational Representatives to encourage appropriate prescribing of the Product.

“Core Immunomedics Patents” means those Immunomedics Patents that specifically cover the Product in the Field or otherwise specifically provide exclusivity for the Product in the Field and which are set forth in Part A of Exhibit A , together with (a) all *** thereof, (b) all *** thereof, (c) all patents issuing on any of the foregoing, and all *** thereof, and (d) all *** and *** of any of the foregoing, as such Part A of Exhibit A may be updated in accordance with Section 10.3.4(a).

“ Detail ” means, with respect to the Product in the Field, the communication by a Sales and Educational Representative during a sales or education call (a) involving ***, (b) describing the *** which have been approved by the applicable Regulatory Authorities and *** of the Product, (c) using the Promotional and Educational Materials in an effort to increase the familiarity of *** with the Product for the *** which have been approved by the applicable Regulatory Authorities and (d) made at such *** primarily for the Product in the Field, where the *** is to place an emphasis, ***, on the Product and not simply to discuss the Product with such ***. For the avoidance of doubt, discussions at conventions or other meetings not specifically sponsored by a Party for the Product shall not constitute “Details” or “Detailing”.

“Develop” , “ Developing” or “Development” means all activities relating to research, non-clinical, preclinical and clinical testing, development of test methods, stability testing, toxicology testing, formulation development, process development, manufacturing process validation, quality assurance activities, quality control activities, qualification and validation activities, scale-up and/or analytic process development, statistical analysis and reporting,

 

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preparation and submission of applications for regulatory approval of a Product, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining all regulatory approvals for a product. For clarity, “Development” shall exclude Phase 4 Clinical Trials.

“Development Activities” means those Development activities undertaken by or on behalf of Licensee or its Affiliates with respect to the Product in the Field, including any Development activities undertaken by Immunomedics on behalf of Licensee in accordance with the Development Plan.

“Development Costs” means the costs and expenses incurred after the Execution Date by a Party or its Affiliates attributable to, or reasonably allocable to, the Development of the Product hereunder, including costs of preparing and submitting Regulatory Materials and obtaining Regulatory Approval, costs of conducting pre-clinical and clinical studies prior to Product Approval. For the avoidance of doubt, Development Costs shall not include costs or expenses related to Manufacturing, costs or expenses related to *** or costs and expenses related to the *** in the IV Formulation.

“Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

“Drug Substance” means the Product which has been *** and can be ***.

“EMEA” means the European Medicines Agency or its successor.

“FDA” means the U.S. Food and Drug Administration or its successor.

“FDA Approval” means the approval of a BLA by the FDA for the Product in the U.S.

“FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act.

“Field” means the treatment, palliation or prevention of non-cancer indications such as autoimmune and inflammatory diseases in humans using the Subcutaneous Formulation of the Product. For purposes of this Agreement, “autoimmune and inflammatory diseases” include, but are not limited to rheumatoid arthritis, ***, ***, ***, ***, ***, idiopathic thrombocytopenic purpura, ***, ***, *** and ***. For the avoidance of doubt, Field shall not include any oncology indications.

“First Commercial Sale” means, with respect to the Product, the first sale of the Product in a given country or other regulatory jurisdiction in the Territory by or on behalf of Licensee, or any of its Affiliates or sublicensees, to a Third Party, after receipt of Regulatory Approval for the Product in such country or regulatory jurisdiction.

“Good Clinical Practices” or “GCPs ” means, as applicable, (i) the then-current standards, practices and procedures promulgated or endorsed by the FDA for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, including the requirements set forth in 21 C.F.R. Parts 11, 50, 54, 56, 312, and 314 and including any related regulatory requirements imposed by the FDA, and (ii) any comparable regulatory standards, practices and procedures in jurisdictions outside of the U.S., in each case as they may

 

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be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

“Good Laboratory Practices” or “ GLPs ” means, as applicable, (i) the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and (ii) any comparable regulatory standards in jurisdictions outside the U.S., in each case as they may as they may be updated from time to time.

“Good Manufacturing Practices” or “ GMPs ” means, as applicable, (i) the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and (ii) any comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., in each case as they may be updated from time to time.

“Governmental Authority” means any multinational, federal, state, local, municipal or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal), in each case, having jurisdiction over the applicable subject matter.

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

“Immunomedics Invention” means an Invention that is discovered, made or conceived, by an employee of Immunomedics or any of its Affiliates or a person under an obligation of assignment to Immunomedics or its Affiliates.

“Immunomedics Know-How” means all (i) Immunomedics Inventions and (ii) technical information and know-how Controlled by Immunomedics (including all biological, chemical, pharmacological, toxicological, clinical, assay and related know-how and trade secrets, and all manufacturing data, the specifications of ingredients, the manufacturing processes, specifications, sourcing information, assays, quality control and testing procedures, and related know-how and trade secrets); in each case that is *** for the Manufacture, Development or Commercialization of the Product in the Field in the Territory.

“Immunomedics Manufacturing Know-How” means all Immunomedics Know-How that is *** for the Manufacture of the Product for use in the Field.

“Immunomedics Patent” means (x) all Patents covering any Immunomedics Invention and (y) the Patents Controlled by Immunomedics as of the Effective Date, in each case listed on Exhibit A , as such exhibit may be updated from time to time in accordance with Section 10.3.4, including but not limited to the Core Immunomedics Patents, and in each case (a) any *** thereof, (b) all *** thereof or any other *** to (i) any of the Patents mentioned under (x) and (y) or (ii) any *** from which the Patents mentioned under (x) and (y) ***, and (c) all patents issuing on any of the foregoing, and any *** thereof, together with all ***, or *** of any of the foregoing, and any *** thereof; in each case that are *** for the Manufacture, Development or Commercialization of the Product in the Field in the Territory.

 

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“Immunomedics Technology” means Immunomedics Patents and Immunomedics Know-How.

“IMPD” means an Investigational Medicinal Product Dossier for the Product.

“IND” means (i) an Investigational New Drug Application as defined in the FD&C Act or (ii) the equivalent application to the equivalent agency in any other regulatory jurisdiction outside the U.S., the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

“Indication” means the use of the Product for the *** of a given non-cancer disease in humans.

“Invention” means any writing, invention, discovery, improvement, technology or other know-how (in each case, ***) that is discovered, made or conceived under this Agreement during the Term.

“ITP” means idiopathic thrombocytopenic purpura.

“IV Formulation” means the formulation of the Product for intravenous administration.

“***” means an application that is filed with the *** to obtain Product Approval for the Product in the ***.

“*** Approval” means the approval of a *** by the *** for the Product in ***.

“Joint Invention” means an Invention that is discovered, made or conceived jointly by an employee of, or person under an obligation of assignment to, each of Immunomedics and Licensee or their respective Affiliates.

“Laws” means all applicable laws, statutes, rules, regulations, ordinances, guidelines and other pronouncements having the effect of law of any Governmental Authority.

“Licensee Invention” means an Invention that is discovered, made or conceived, solely or jointly with a Third Party, by an employee of Licensee or any of its Affiliates or a person under an obligation of assignment to Licensee or its Affiliates.

“Licensee Know-How” means all (i) Licensee Inventions and (ii) technical information and know-how Controlled by Licensee (including all biological, chemical, pharmacological, toxicological, clinical, assay and related know-how and trade secrets, and all manufacturing data, the specifications of ingredients, the manufacturing processes, specifications, sourcing information, assays, quality control and testing procedures, and related know-how and trade secrets); in each case that is *** for the Manufacture, Development or Commercialization of the Product in the Field or the Oncology Field in the Territory; in each case that is *** for the Manufacture, Development or Commercialization of the Product in the Field or the Oncology Field in the Territory.

 

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“Licensee Patent” means (x) all Patents covering any Licensee Invention and (y) the Patents Controlled by Licensee as of the Effective Date, in each case, (a) any ***, (b) all *** or any other patent application *** (i) any of the Patents mentioned under (x) and (y) or (ii) any patent or patent application from which the Patents mentioned under (x) and (y) ***, and (c) all patents issuing on any of the foregoing, and any ***, together with all registrations, reissues, re-examinations, renewals, supplemental protection certificates, or extensions of any of the foregoing, and any ***; in each case that are *** for the Manufacture, Development or Commercialization of the Product in the Field or the Oncology Field in the Territory.

“Licensee Technology” means Licensee Patents and Licensee Know-How.

“ Major EU Countries ” means ***, ***, ***, *** and ***.

“ Major Market Country ” means ***, ***, ***, *** and any of the ***.

“Manufacture” or “Manufacturing” means all activities related to the manufacturing of the Product, or any ingredient thereof, establishment or enhancement of manufacturing procedures including in-process and finished product testing, release of product, quality assurance activities related to manufacturing and release of product, Packaging and Labeling (whether in commercial or clinical packaging presentation) and ongoing stability tests and regulatory activities related to any of the foregoing.

“ Manufacturing Documentation ” means any and all material documentation that is *** and *** the manufacture of the Product, including *** and *** for the Product, ***for ***and***and ***, in each case, to the extent under the Control of Immunomedics or its Affiliates.

“ Marketing Authorization Application ” or “ MAA ” means an application that is filed with the EMEA under the centralized European procedure to obtain Product Approval for the Product in the EU, or an application filed with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.

“Master Cell Bank” means Immunomedics’ reference deposit or collection of vials of the *** VELTUZUMAB ***.

“MAA Approval” means the approval of a MAA by the EMEA for the Product in the EU, or Product Approval from the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.

“***” means the *** (or other applicable Regulatory Authority in *** for submitting for marketing approval for pharmaceutical products), or its successor.

“Net Sales” means the gross amount invoiced by or on behalf of Licensee or any of its Affiliates or their respective sublicensees on account of sales of the Product, less the following deductions specifically and solely related to the Product and actually allowed:

 

(a)

***;

 

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(b)

***;

 

(c)

***;

 

(d)

***; and

 

(e)

***.

For clarity, (i) Net Sales shall not be reduced by ***whether they are *** thereof) or for ***or any other ***set forth in (a) through (e) above and (ii) the ***of ***or ***with respect to the *** to a *** shall not be deducted in calculating Net Sales. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately charged to, and paid by, Third Parties shall not be deducted from the invoice price in the calculation of Net Sales. In the case of any sale of the Product for value other than in an arm ’ s length transaction exclusively for cash, such as barter or counter-trade, Net Sales shall be determined by referencing Net Sales at which substantially similar quantities of the Product are sold in an arm’s length transaction for cash.

Notwithstanding the foregoing, amounts billed by Licensee or it’s Affiliates or their respective sublicensees for the sale of Product among Licensee, its Affiliates or their respective sublicensees for resale shall not be included in the computation of Net Sales hereunder. Net Sales shall be accounted for in accordance with the generally accepted accounting principles in the U.S (the “ GAAP ”), consistently applied. For purposes of determining Net Sales, the Product shall be deemed to be sold when invoiced. Any price discounts offered by Licensee or its Affiliates or their respective sublicensees to purchasers of the Product will not exceed in the aggregate the discount levels customary in the industry for products that are comparable to the Product at a similar stage in the product life cycle. Licensee and its Affiliates and their respective sublicensees will sell the Product ***and will not sell the Product***or***that include *** to the extent required to obtain sales contracts with government entities, and in such case, the price of the Product relevant for the calculation of Net Sales will be the average price in the preceding calendar quarter of the Product *** less the average discount of all products ***.

“Oncology Field” means the treatment, palliation or prevention of the onset and/or control of cancer in humans using the IV Formulation of the Product.

“ Out-of-Pocket Costs ” means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with GAAP) by either Party.

“Packaging and Labeling” means final labeling and packaging of Product (whether in clinical or commercial packaging presentation) for use in the Field in the Territory, including insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed or graphic materials accompanying the Product, considered to be part of the finished packaged Product, and all testing and release thereof.

“Patents” means patents and patent applications and (a) any *** thereof, (b) all *** thereof or any other patent application *** to (i) any such patents or patent applications or (ii) any patent or patent application from which such patents or patent applications ***, and (c) all patents issuing on any of the foregoing, and any *** thereof, together with all ***, ***, ***, ***, ***, or *** of any of the foregoing, and any *** thereof.

 

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“Patent Term Extension” means any term extensions, supplementary protection certificates, Regulatory Exclusivity and equivalents thereof offering patent protection beyond the initial term with respect to any issued Patents.

“Phase 2 Clinical Trial” means a clinical study conducted to preliminarily evaluate the effectiveness of the pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.

“Phase 3 Clinical Trial” means one or more clinical trial(s) on a number of patients for a particular indication, which trial(s) is designed to (i) establish that a drug is safe and efficacious for such indication, (ii) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed and (iii) support approval of an application to a Regulatory Authority for the commercial sale of such drug.

“ Phase 4 Clinical Trials ” means studies that are conducted to delineate additional information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after receipt of Product Approval for a product in the indication for which such trial is being conducted.

“ Pivotal Trial ” means a clinical trial that is designed or intended to support Product Approval.

“ Pre-Marketing ” means all sales and marketing activities undertaken prior to and in preparation for the launch of the Product in a given country or other regulatory jurisdiction in the Territory. Pre-Marketing shall include advertising, education, product-related public relations, health care economic studies, sales force training and other pre-launch activities prior to the First Commercial Sale of the Product in the Field in a given country or other regulatory jurisdiction in the Territory.

“Pricing Approval” means the approval, agreement, determination or decision from a Governmental Authority establishing the price or reimbursement for the Product for sale in a given country or regulatory jurisdiction, as required by applicable Law in such country or other regulatory jurisdiction prior to the sale of the Product in the Field in such country or regulatory jurisdiction.

“Product” means VELTUZUMAB in all formulations and doses.

“Product Approval” means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which includes FDA Approval in the U.S., MAA Approval in the EMEA and *** Approval in *** (but shall not include, any Pricing Approvals).

 

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“Product Complaint” means any written, verbal or electronic expression of dissatisfaction regarding the Product in the Territory, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

“ Promotional and Educational Materials ” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than the Product labels and package inserts) for marketing, advertising and promotion of the Product in the Field in the Territory, for use (a) by a Sales and Educational Representative or (b) in advertisements, web sites or direct mail pieces.

“Quality Agreement” means an agreement between the Parties describing the required quality and other technical aspects of the Clinical Inventory and the supply of Product by Immunomedics to Licensee in accordance with ARTICLE 8.

“Regulatory Approvals” means all necessary approvals (including Product Approvals and supplements and amendments thereto and Pricing Approvals), licenses, registrations or authorizations of any Governmental Authority, necessary for the manufacture, distribution, use and sale of the Product in the Field in a given country or regulatory jurisdiction.

“Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or regulatory jurisdiction, including in the U.S., the FDA.

“ Regulatory Data ” means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), chemistry, manufacturing and control data, or similar documentation).

“Regulatory Materials” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority that are necessary in order to Develop, Manufacture, market, sell or otherwise Commercialize the Product in the Field in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, BLAs, and applications for other Product Approvals.

“Sales and Educational Representative” means an individual who is employed by or on behalf of a Party or its Affiliates and who performs Details and other promotional or educational efforts with respect to the Product in the Field.

“ Samples ” means Product packaged and distributed as a complementary trial for use with patients in the Field in the Territory and in accordance with applicable Law and free goods provided for this purpose through coupons or other mechanisms.

“***” means the current *** Clinical Trial evaluating subcutaneously administered VELTUZUMAB to patients with *** or equivalent trial or *** or equivalent trial.

 

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

“Subcutaneous Formulation” means the formulation of the Product for subcutaneous administration.

“Territory” means all countries in the world.

“Third Party” means any entity other than Immunomedics or Licensee or their respective Affiliates.

“Transition Plan” means the plan attached as Exhibit B .

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

“Valid Claim” means (a) a claim of an issued and unexpired Patent that has not been disclaimed, revoked or held to be invalid or unenforceable by a court or other authority of competent jurisdiction, from which decision no appeal can be further taken or (b) a claim included in a pending patent application whether filed before or after the Execution Date and that has not been (i) canceled, (ii) withdrawn from consideration, (iii) finally determined to be unallowable by the applicable governmental authority (from which no appeal is or can be taken), or (iv) abandoned or disclaimed.

“VELTUZUMAB” means humanized anti-CD20 antibody, also known as IMMU-106 and hA20.

Interpretation. Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “include”, “includes” and “including” are not limiting; (b) “hereof”, “hereto”, “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (c) words of one gender include the other gender; (d) references to a contract or other agreement mean such contract or other agreement as from time to time amended, modified or supplemented; (e) references to a person or entity are also to its permitted successors and assigns; (f) references to an “Article”, “Section”, “Exhibit” or “ Schedule ” refer to an Article or Section of, or an Exhibit or Schedule to, this Agreement, unless expressly stated otherwise; and (g) references to a law include any amendment or modification to such law and any rules and regulations issued thereunder, whether such amendment or modification is made, or issuance of such rules and regulations occurs, before or after the date of this Agreement.

Additional Definitions. The following terms have the meanings set forth in the corresponding Sections of this Agreement:

 

 

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ARTICLE 2

LICENSES

2.1 Grant to Licensee. Subject to the terms and conditions of this Agreement, Immunomedics hereby grants to Licensee, (i) a co-exclusive license or sublicense, as applicable, under the Immunomedics Technology and Immunomedics’ interest in Joint Collaboration Technology to Develop the Product for Commercialization in the Field in the Territory, (ii) a co-exclusive right under the Immunomedics Technology, and Immunomedics’ interest in Joint Collaboration Technology and the Immunomedics Manufacturing Know-How to Manufacture the Product in the Field in the Territory and (iii) subject to Section 7.1, an exclusive, royalty-bearing license or sublicense, as applicable, under the Immunomedics Technology and Immunomedics’ interest in Joint Collaboration Technology to Commercialize the Product in the Field in the Territory. For clarity, the license granted by Immunomedics to Licensee in the forgoing sentence is exclusive, except that with respect to the foregoing clause (i), Immunomedics retains rights to Develop the Product in the Field solely for the purpose of fulfilling its obligations under this Agreement and as more specifically set forth in ARTICLE 4, and, with respect to the foregoing clause (ii), Immunomedics retains rights to Manufacture the Product in the Field solely for the purpose of fulfilling its obligations under this Agreement and as more specifically set forth in ARTICLE 8.

2.2 Grants to Immunomedics. Subject to the terms and conditions of this Agreement, Licensee hereby grants to Immunomedics an exclusive license, or sublicense, as applicable, under the Licensee Technology, with the right to sublicense without the consent of Licensee, to Develop and Manufacture the Product for Commercialization in the Oncology Field, and to Commercialize the Product in the Territory in the Oncology Field.

 

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2.3 Right to Sublicense or Subcontract.

2.3.1 General Right of Licensee to Sublicense or Subcontract. Except as set out in Section 2.3.2 below, the rights granted to Licensee by Immunomedics pursuant to Section 2.1 shall include the right to grant sublicenses without the consent of *** of any such *** any such ***.

2.3.2 Consent Required to Sublicense. Licensee shall be required to obtain the prior written consent of Immunomedics, *** (i) *** or ***in a*** (ii) or ***or***to any ***in***. If Licensee intends to sublicense the rights or activities referenced in the foregoing clause (i) or (ii) of this Section, Licensee shall disclose to Immunomedics the identity of the potential sublicensee. Immunomedics shall within *** *** give its consent to such sublicense as applicable; provided however that Immunomedics shall have the right to withhold such consent if Immunomedics in good faith determines that the potential sublicensee is a competitor or that such sublicense would cause a material adverse effect to Immunomedics; provided further, that in the event of such a determination by Immunomedics, then Immunomedics shall demonstrate to Licensee the reasons for such determination. In the event that Immunomedics does not demonstrate the reasons for its determination to withhold consent to such proposed sublicense within the *** *** period, Immunomedics shall be deemed to have given its consent with respect to such sublicense.

2.3.3 Conditions of Sublicense. Each sublicense granted by Licensee to a permitted sublicensee pursuant to Section 2.3 shall be subject and subordinate to the terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement and shall not in any way diminish, reduce or eliminate any of Licensee’s obligations under this Agreement. Each sublicense agreement with permitted sublicensees shall include the following provisions: (i) a requirement that such sublicensee submit applicable sales or other reports consistent with the requirements set forth in Section 6.3.1, (ii) a requirement to keep books and records, and permit Immunomedics to audit (either directly or through an independent auditor) such books and records, consistent with the requirement set forth in Section 9.11, (iii) a requirement that such sublicensee comply with the confidentiality and non-use provisions of ARTICLE 13 with respect to both Parties’ Confidential Information, (iv) a requirement to comply with all other applicable terms of this Agreement, (v) a provision prohibiting such sublicensee from further sublicensing and (vi) a requirement that each sublicensee permit Immunomedics to inspect its facilities consistent with the requirements set forth in Section 4.8. Licensee shall provide Immunomedics with a copy of each such sublicense agreement within *** *** after the execution thereof.

2.3.4 Liability for Sublicensees and Subcontractors. Licensee shall ensure that each of its permitted sublicensees and subcontractors accepts and complies with all of the applicable terms and conditions of this Agreement as if such permitted sublicensees or subcontractors were a party to this Agreement. Additionally, Licensee shall ensure that each of its Affiliates to which it sublicenses any of the licenses hereunder complies with all of the applicable terms and conditions of this Agreement. Licensee shall remain fully responsible for its Affiliates’ and sublicensees’ and subcontractors’

 

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performance under this Agreement. For the avoidance of doubt, Licensee will remain directly responsible for all amounts owed to Immunomedics under this Agreement, including royalty payments for Net Sales by Licensee’s sublicensees and subcontractors. Licensee hereby expressly waives any requirement that Immunomedics exhaust any right, power or remedy, or proceed against a subcontractor or sublicensee, for any obligation or performance hereunder prior to proceeding directly against Licensee.

2.4 Additional Licensing Provisions.

2.4.1 License to Subcutaneous Formulation; License to IV Formulation. If at any time during the term of this Agreement (i) Immunomedics desires a license to the Subcutaneous Formulation to Develop, Commercialize or Manufacture the Product for use in the Oncology Field or (ii) Licensee desires a license to the IV Formulation to Develop, Commercialize or Manufacture the Product for use in the Field, the Parties shall negotiate in good faith with respect to the terms and conditions of such license. ***.

2.4.2 Negotiation Right for Immunomedics Technology. Immunomedics Technology obtained or acquired by Immunomedics from Third Parties after the Execution Date is not included in the license set forth in Section 2.1. If Immunomedics acquires or obtains such Immunomedics Technology and determines in good faith that such Immunomedics Technology has applicability to the Product in the Field in the Territory, it shall notify Licensee together with a summary of such Immunomedics Technology. The summary shall include all necessary information to evaluate the technology If Licensee desires to receive a license under any such Immunomedics Technology to Develop, Commercialize and Manufacture the Product in the Field in the Territory, then it shall provide written notice to Immunomedics within *** business days of such notice by Immunomedics and, following Immunomedics’ receipt thereof, the Parties shall negotiate in good faith *** *** terms under which such a license would be granted, including *** Notwithstanding the foregoing, Licensee shall in any event have a license to Develop, Manufacture and Commercialize the Product in the Field in the Territory, as set out in the Development Plan, the Commercialization Plan and the terms of this Agreement.

2.4.3 Negotiation Right for Licensee Technology. Licensee Technology obtained or acquired by Licensee from Third Parties after the Execution Date is not included in the license set forth in Section 2.2. If Licensee acquires or obtains such Licensee Technology and determines in good faith that such Licensee Technology has applicability to the Product in the Oncology Field in the Territory, it shall notify Immunomedics together with a summary of such Licensee Technology. The summary shall include all necessary information to evaluate the technology. If Immunomedics desires to receive a license under any such Licensee Technology to Develop, Commercialize and Manufacture the Product in the Oncology Field in the Territory, then it shall provide written notice to Licensee within *** of such notice by Licensee and, following Licensee’s receipt thereof, the Parties shall negotiate in good faith *** terms under which such a license would be granted, including ***

 

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2.4.4 Negative Covenant. Licensee covenants that it will not use or practice any of the Immunomedics Technology except for the purposes expressly permitted in the applicable license grant (and for clarity, Licensee shall not use or practice any of the Immunomedics Technology in any manner with respect to the Product in the Oncology Field or in any cancer indications).

2.4.5 No Implied Licenses; Retained Rights.

(a) Licenses Granted by Immunomedics. Except as explicitly set forth in this Agreement, Immunomedics does not grant any license, express or implied, under its intellectual property rights to Licensee, whether by implication, estoppel or otherwise. Without limiting the generality of the foregoing, Immunomedics hereby expressly retains, on behalf of itself and its Affiliates, licensees and sublicensees, all right, title and interest in and to the Immunomedics Technology, Existing Development Data, New Immunomedics Development Data and Regulatory Materials of Immunomedics with respect to (a) pharmaceutical products other than the Product, (b) all IV Formulations of the Product, (c) use of the Product for the conduct of the ITP Study and for the conduct of the Immunomedics R&D Activities, (d) all uses of the Product within the Oncology Field, (including the conduct of the ***) including developing, making, using, importing, exporting offering for sale and selling the Product for in the Oncology Field, including collaborating with, pursuing and granting licenses to Third Parties with respect to the Product in the Oncology Field, (e) research with respect to the Product, including within the Field, (f) exercising its rights and performing its obligations hereunder and (g) from and after the end of the Term, developing (including obtaining and maintaining Regulatory Approval), making, using, importing, exporting, offering for sale and selling the Product in the Field in the Territory.

2.4.6 Licenses Granted by Licensee. Except as explicitly set forth in this Agreement, Licensee does not grant any license, express or implied, under its intellectual property rights to Immunomedics, whether by implication, estoppel or otherwise. Without limiting the generality of the foregoing, Licensee hereby expressly retains, on behalf of itself and its Affiliates, licensees and sublicensees, all right, title and interest in and to the Licensee Technology, New Licensee Development Data and Regulatory Materials of Licensee with respect to all uses of the Product within the Field, including developing, making, using, importing, exporting offering for sale and selling the Product in the Field in the Territory.

2.5 Non-Competition. Licensee hereby covenants not to research, develop (including submitting any applications for regulatory approval), manufacture or commercialize, during the Term, any Competitive Product, either on its own, with or through any Affiliate, or in collaboration with a Third Party, in each case other than with respect to the Development, Manufacture and Commercialization of the Product in the Field in the Territory pursuant to this Agreement ***that ***of the ***shall not ***unless such *** hereby covenants *** or *** a *** earlier than ***after the ***, provided, however ***shall ***unless such ***. For clarity, *** acknowledges and agrees that***, is not *** a ***.

 

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ARTICLE 3

PRODUCT UPDATES; PARTY DISCUSSIONS

3.1 Product Updates.

3.1.1 General. With respect to each country in the Territory (and with respect to the Territory as a whole or any portion thereof, to the extent applicable), Licensee shall prepare and deliver to Immunomedics, at least once per *** during the Term, a written report (which written report shall contain reasonable detail with respect to the activities described therein, and at a minimum, in such detail as is reasonably necessary for Immunomedics to confirm Licensee’s compliance with its obligations under this Agreement) describing: (a) for the immediately preceding ***, (i) any and all Development Activities conducted by or on behalf of Licensee hereunder, including all Development Costs incurred in connection therewith (as well as a comparison of such costs to the Development Budget and such activities to the Development Plan), (ii) any and all regulatory activities with respect to the Product in the Field in the Territory, including the status of any Regulatory Approvals for the Product in the Field Territory and any material communications with, or submissions to, any Regulatory Authority, and (iii) any and all Commercialization activities with respect to the Product in the Field in the Territory, *** (b) for the next ***, including the *** during which such report is delivered, (i) any and all Development Activities which are in-process or anticipated to be conducted by or on behalf of Licensee hereunder, including all Development Costs anticipated to be incurred in connection therewith, (ii) any and all regulatory activities with respect to the Product in the Field in the Territory which are in-process or anticipated to be conducted by or on behalf of Licensee hereunder, including any BLAs or other material regulatory filings or submissions intended to be made, and (iii) any and all Commercialization activities with respect to the Product in the Field in the Territory which are in-process or anticipated to be conducted by or on behalf of Licensee hereunder, *** (c) a general description of the market conditions and sales information with respect to the Product in the Field in the Territory; and (d) any other material developments with relating to the Development, Manufacturing or Commercialization of the Product in the Field in the Territory. *** that Licensee (or any of its Affiliates or sublicensees) has deployed in the Territory (broken down on a country-by-country basis). The foregoing report shall be in such form as may be reasonably requested by Immunomedics from time to time.

3.1.2 Special Reports. In furtherance of the foregoing, Licensee shall on an on-going basis inform Immunomedics in writing of any decisions or activities with respect to the Product by Licensee relating to the pursuit of additional Indications in the Field, the reporting and sharing of safety and adverse event information and product branding strategies, and terms and conditions of sale, including Product pricing guidelines. Immunomedics acknowledges and agrees that Licensee, in its sole discretion, shall determine pricing guidelines and sales prices for the Product in the Field.

3.1.3 Requests from Immunomedics. Licensee shall submit in writing to Immunomedics such other reports as Immunomedics may reasonably request from time to time during the Term with respects to the Product in the Field in the Territory, including the Development, Manufacturing and Commercialization activities undertaken by Licensee for the Product in the Field in the Territory. However, Licensee shall only have the obligation***.

 

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3.2 Product Discussions. In the event that Immunomedics desires to discuss any matter related to the Product in the Field in the Territory, or the Development, Manufacture or Commercialization thereof by Licensee hereunder (including, the contents of any Development Plan or Commercialization Plan), Immunomedics shall notify Licensee thereof (including a brief description of the matters to be discussed) and the Parties shall meet within *** to discuss such matters, provided that Immunomedics has a right to call such meetings no more than ***. At any such meeting, each Party shall make available such employees who have appropriate expertise and seniority with respect to the matters to be discussed. Such meetings may be held in-person (to the extent requested by either Party), or by teleconference or videoconference or other means whereby the representatives of each of the Parties can hear each other; provided, however that to the extent that any in-person meetings are held, such in-person meetings shall alternate between offices of Immunomedics and Licensee (or such other place as the Parties may agree). In all such meetings, the Parties shall discuss in good faith the applicable matters, and Licensee shall consider in good faith all comments and positions of Immunomedics with respect to the Product in the Field in the Territory, and the Development, Manufacture or Commercialization thereof, as applicable. ***

ARTICLE 4

DEVELOPMENT

4.1 Overview of Development. In connection with the Development of the Product for use in the Field in the Territory, the Parties shall conduct the Development Activities pursuant to a comprehensive development plan (the “ Development Plan ”). Subject to the terms and conditions of this Agreement, the Parties shall collaborate with respect to the Development of the Product for use in the Field in the Territory as set forth in the Development Plan. Each Party shall conduct the Development Activities in accordance with the Development Plan as provided in this ARTICLE 4 and the terms of this Agreement.

4.2 Objectives under the Development Plan.

4.2.1 Development Activities. Licensee shall use *** to Develop the Product for Commercialization in the Field in the Territory. Without limiting the foregoing, Licensee shall carry out the Development Activities as set forth in the Development Plan.

4.2.2 Compliance. Licensee shall conduct the Development Activities in a manner consistent with sound and ethical business and scientific practices, and in compliance with all applicable Laws, GCPs and GLPs.

4.3 Development Plan and Development Budget.

 

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4.3.1 General. The Development Plan shall set forth, among other things, the following:

(a) any ***, in each case, together with all ***, with respect to the Product in the Field in the Territory;

(b) all *** and other *** of obtaining and maintaining Regulatory Approvals for the Product in the Field in each country or regulatory jurisdiction in the Territory;

(c) a detailed annual budget for all Development Costs for the activities in the applicable Development Plan (the “Development Budget” );

(d) the *** such Development Activities; and

(e) the *** for *** Regulatory Materials and for *** Regulatory Approval in the Field in the Territory.

4.3.2 Initial Development Plan. The initial Development Plan for the Product for the *** of this Agreement *** is attached to this Agreement as Schedule 4.3.2.

4.3.3 Updating and Amending Development Plan and Development Budget. On or before *** during the Term, or at Licensee’s *** request Licensee shall update and submit to Immunomedics for its review and comment the Development Plan (including the Development Budget contained herein) which shall cover the Development Activities to be conducted during the upcoming ***, and Licensee shall, on ***, review and update, as appropriate, the then-current Development Plan (including the Development Budget) to reflect any changes, reprioritizations of, or additions to the Development Plan, in each case for review and comment by Immunomedics. Licensee shall consider any comments of Immunomedics to any such Development Plan (including any updates and amendments thereto) in good faith. The Parties acknowledge that the initial Development Plan (and Development Budget) sets forth a *** for Development of the Product in the Field, and that the Parties will cooperate in seeking scientific advice from Governmental Authorities with respect to the Development of the Product in the Field. *** for its review and comment in accordance with this Section 4.3.3. The Development Plan shall not be amended with respect to any Development Activities to be undertaken by Immunomedics without the prior written consent of Immunomedics, such consent not to be unreasonably withheld. Licensee acknowledges and agrees that the ITP Study shall not be deleted, replaced, slowed down or otherwise adversely affected, except to the extent caused by safety issues with respect to the Product in ITP in the Field.

4.4 Development Costs.

4.4.1 Development Activities. Licensee shall be responsible for one hundred percent (100%) of the Development Costs (whether incurred by Licensee, Immunomedics or its respective Affiliates) for the Product in the Field.

 

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4.4.2 Payment and Reimbursement of Development Costs. If ***, incurs any Development Costs during the Term, such Development Costs, if any, shall be reimbursed by *** and *** in accordance with Section 9.9 provided, however, that *** shall reimburse *** for such Development Costs ***. The Parties acknowledge and agree that Licensee shall not be responsible for any costs or expenses incurred by Immunomedics prior to the Execution Date related to the research and development of the Product in the Field.

4.5 Records and Information.

4.5.1 General. Licensee shall maintain (and shall cause its Affiliates and sublicensees to maintain) current and accurate records of all work conducted by or on behalf of it under the Development Plan and all data and other information resulting from such work. Such records shall properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and intellectual property purposes. Licensee shall document (and shall cause its Affiliates and sublicensees to document) all preclinical studies and clinical trials to be conducted pursuant to the Development Plan in formal written study reports according to applicable national and international ( e.g. , ICH, GCP and GLP) guidelines. Licensee shall give Immunomedics an adequate opportunity, in any event not less than *** to review and comment on the drafts of reports resulting from activities conducted under the Development Plan.

4.5.2 Access to Records. Immunomedics shall have the right to review all records under the Development Plan maintained by or on behalf of Licensee (or any of its Affiliates, sublicensees or subcontractors) at reasonable times, upon written request.

4.6 Development Data.

4.6.1 Existing Development Data. Subject to the rights and licenses granted to Licensee herein, Immunomedics shall continue to be the owner of all clinical data related to the Product in the Field Controlled by Immunomedics as of the Effective Date (collectively, the “Existing Development Data” ). Within *** of this Agreement, Immunomedics shall provide Licensee with copies of all material reports of such clinical data Controlled by Immunomedics as of the Effective Date in its (or its Affiliates) possession or control.

4.6.2 New Development Data. All data (including pre-clinical, clinical, technical, chemical, safety, and scientific data and information), know-how and other results generated by or resulting from or in connection with the conduct of Development Activities hereunder, including relevant laboratory notebook information, screening data, Regulatory Data and synthesis schemes, including descriptions in any form, data and other information. (if generated by or resulting from or in connection with the Development Activities conducted by Immunomedics, the “ New Immunomedics Development Data ”; if generated by or resulting from or in connection with the Development Activities conducted by Licensee, the “ New Licensee Development Data ”, collectively the “New

 

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Development Data” ) whether generated by one or both Parties (or their respective Affiliates or sublicensees), ***, and in furtherance thereof. *** provide *** with copies of reports and summaries of all New Development Data generated at the same time that such reports and summaries become available to having generated the data (or any of its Affiliates).

4.7 Right of Reference and Use. Immunomedics hereby grants to Licensee a right of reference to all Existing Development Data and New Immunomedics Development Data solely for the purposes of performing Development Activities pursuant to this Agreement. Licensee may only use the Existing Development Data and New Immunomedics Development Data for the purpose of Developing the Product for sale in the Field in the Territory pursuant to this Agreement, provided however, that Immunomedics only grants Licensee a right of reference to Existing Development Data and New Immunomedics Development Data and generated by Immunomedics from the *** only to the extent the foregoing is related to, with respect to Phase 2 Clinical Trials or Phase 3 Clinical Trials, safety, and in addition with respect to ***, *** and *** in each case of the Product in the Oncology Field. For clarity, ***. Licensee hereby grants to Immunomedics a right of reference to all New Licensee Development Data for purposes of (i) *** under this Agreement, and (ii) *** *** and (iii) *** in any other *** or *** by or on *** or its licensee ***.

4.8 Right to Audit. Licensee shall ensure that Immunomedics’ authorized representatives and any Regulatory Authorities, to the extent permitted by applicable Law, may, during regular business hours and upon reasonable notice, (a) examine and inspect Licensee’s (and its Affiliate’s and sublicensee’s) facilities or, subject to any Third Party confidentiality restrictions and other obligations, the facilities of any subcontractor or any investigator site used by it in the performance of Development of the Product in the Field in the Territory hereunder pursuant to the Development Plan, and (b) subject to applicable Law and any Third Party confidentiality restrictions and other obligations, inspect all data, documentation and work products relating to the activities performed by Licensee (or its Affiliates or its sublicensees), the subcontractor, including, the medical records of any patient participating in any clinical study, in each case generated pursuant to the Development Activities hereunder. This right to inspect all data, documentation, and work products relating to the Product in the Field in the Territory may be exercised at any time during the Term, or such longer period as shall be required by applicable Law.

4.9 Restrictions Outside the Field. For clarity, Licensee shall have no right to research or Develop the Product for use outside the Field. In addition, notwithstanding anything to the contrary contained herein, *** Any such Development activities shall be immediately removed from the Development Plan by mutual consent after a discussion in good faith between the Parties.

 

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4.10 Immunomedics Activities.

4.10.1 General. Immunomedics shall use *** to perform the activities (the “ Immunomedics R&D Activities ”) set out in the plan attached hereto as Schedule 4.10 (the “ Immunomedics R&D Activities Plan ”). Except for costs and expenses of the ITP Study related to the treatment of ITP with the IV Formulation, Licensee shall be solely responsible for all costs and expenses incurred by Immunomedics pursuant to the Immunomedics R&D Activities Plan. The Immunomedics R&D Activities Plan shall not be amended without the prior written consent of Immunomedics, such consent not to be unreasonably withheld.

4.10.2 Finalization of ITP Study. Immunomedics shall be responsible for completion of the current clinical study with the Product for the treatment of ITP as set forth in the Development Plan (the “ ITP Study ”). Immunomedics shall ensure that the ITP Study is conducted in a manner consistent with sound and ethical business and scientific practices, and in compliance with all applicable Laws, GCPs and GLPs. Licensee shall be solely responsible for all costs and expenses of the ITP Study to the extent that such costs relate to the treatment of ITP with the Subcutaneous Formulation. Immunomedics agrees to use *** to deliver a final clinical study report to Licensee as soon as possible after completion of the ITP Study.

4.10.3 Reimbursement of Expenses. Licensee shall reimburse Immunomedics for all costs and expenses associated with Section 4.10.1 and 4.10.2 in accordance with Section 9.9 to the extent set forth in the budgets listed in the Immunomedics R&D Activities Plan and the Development Plan. Such budgets shall be increased as mutually agreed in connection with mutual agreement to modify the Immunomedics R&D Activities Plan or the Development Activities to be undertaken by Immunomedics under the Development Plan. Any changes in such budgets shall be subject to mutual agreement.

4.10.4 Access to Records. *** (or any of its Affiliates, sublicensees or subcontractors) at reasonable times, upon written request.

4.11 Development Outside the Field. Immunomedics has the right to Develop the Product for use in the Oncology Field. In the event Immunomedics Develops or has Developed the Product for use in the Oncology Field, the following terms shall apply:

4.11.1 Finalization of ***. Immunomedics shall be responsible for completion, at its sole discretion and expense, of the ***. Immunomedics shall ensure that the ***, to the extent conducted, is done so in a manner consistent with sound and ethical business and scientific practices, and in compliance with all applicable Laws, GCPs and GLPs.

4.11.2 General. Immunomedics shall maintain (and shall cause its Affiliates and sublicensees to maintain) current and accurate records of all work conducted by or on behalf of it relating to Development of the Product for use in the Oncology Field and all data and other information resulting from such work. Such records shall properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and intellectual property

 

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purposes. Immunomedics shall document (and shall cause its Affiliates and sublicensees to document) all preclinical studies and clinical trials to be conducted pursuant to the Development Plan in formal written study reports according to applicable national and international ( e.g. , ICH, GCP and GLP) guidelines.

4.11.3 Access to Records. *** at reasonable times, upon written request.

ARTICLE 5

REGULATORY

5.1 General. During the Term, responsibility for overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, all applicable Regulatory Authorities with respect to the Product in the Field in the Territory shall be allocated between the Parties as set forth in this ARTICLE 5.

5.2 Existing Regulatory Materials. Immunomedics shall continue to be the owner of all Regulatory Materials related to the Product in the Field Controlled by Immunomedics as of the Effective Date (the “Immunomedics Regulatory Materials”). Within *** of this Agreement, Immunomedics shall provide Licensee with copies of material Immunomedics Regulatory Materials in its possession. Immunomedics hereby grants to Licensee a right of reference to the Immunomedics Regulatory Materials solely for the purposes of obtaining and maintaining Regulatory Approvals for the Product in the Field in the Territory pursuant to this Agreement.

5.3 New Regulatory Materials and Regulatory Approvals.

5.3.1 General. Licensee shall use *** to obtain and maintain all Regulatory Approvals with respect to the Product in the Field in (i) the Major Market Countries *** and (ii) the other countries of the Territory where Licensee deems, upon a good faith determination, after consultation with Immunomedics, that the commercial potential of the Product in such country warrants obtaining Regulatory Approval. Without limiting the foregoing, during the Term, Licensee shall use *** to prepare and submit all additional Regulatory Materials in order to obtain and maintain all Regulatory Approvals for the Product in the Field in the Territory as set out in this Section 5.3.1 (the “Licensee Regulatory Materials ”). All such Regulatory Approvals shall be in the name of Licensee.

5.3.2 Right of Reference. Licensee hereby grants Immunomedics (and its designees) a right of reference to Licensee Regulatory Materials (as well as all Regulatory Data and Regulatory Approvals owned or otherwise Controlled by Licensee or any of its Affiliates or sublicensees) for the purposes of (i) *** under this Agreement, (ii) *** in any other *** by or on behalf of *** or its licensee and (iii) ***. Upon request of Immunomedics from time to time, Licensee shall provide Immunomedics with copies of all such Licensee Regulatory Materials.

5.4 Regulatory Coordination.

 

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5.4.1 Responsibilities of Licensee. Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, all applicable Regulatory Authorities with respect to the Product in the Field in the Territory. To the extent practicable, Immunomedics shall *** related to the Product; provided that ***to***and*** regarding ***related to the Product in the Field in the Territory.

5.4.2 Review of Correspondence. To the extent practicable, Licensee shall provide Immunomedics with drafts of any documents and other correspondence to be submitted to a Regulatory Authority pertaining to the Product in the Field in the Territory, sufficiently in advance of submission so that Immunomedics may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. All such comments shall be considered in good faith by Licensee. Licensee shall promptly provide Immunomedics with copies of any material documents or other correspondence submitted to, or received from, a Regulatory Authority pertaining to the Product.

5.4.3 Restrictions in the Oncology Field. The Parties anticipate having different Regulatory Approvals for the use of the Product in the Field and the use of the Product in the Oncology Field respectively. Notwithstanding anything to the contrary contained herein, Licensee shall have no rights with respect to any regulatory actions, communications or filings with, or submissions to, Regulatory Authorities with respect to the Product outside the Field and Licensee shall immediately notify Immunomedics of, and provide Immunomedics with, any such inquiry, communication or other correspondence from a Regulatory Authority or other person in connection with the Product outside of the Field. In addition, to the extent that any regulatory actions, communications or filings with, or submissions to, Regulatory Authorities proposed to be made by Licensee (or any of its Affiliates or sublicensees) hereunder with respect to the Product inside the Field may have a *** on the Product outside of the Field, then, *** (in which case Licensee shall consult with Immunomedics in connection therewith as promptly as reasonably practicable), Licensee shall submit (or cause to be submitted) a copy and reasonably detailed description of any such regulatory action, communication, filing or submission, as applicable, to Immunomedics for its review and approval, and Licensee shall make any changes thereto as reasonably determined by Immunomedics.

5.4.4 Filings in the Oncology the Field. The Parties shall reasonably endeavor to obtain separate Regulatory Approvals for the Product in the Field and the Product in the Oncology Field. In the event that, due to applicable legal and/or regulatory requirements, either Party cannot file for product approval (or otherwise have sole responsibility for all regulatory filings and related submissions), or to own the same in its (or its designee’s) name, for the Product in the Field with respect to Licensee, and for the Product in the Oncology Field with respect to Immunomedics, then such Party (the “ Requesting Party ”) shall send a written request to the other Party (the “ Filing Party ”) for the Filing Party do so on the Requesting Party’s (or its designee’s) behalf and in such name (including the name of Filing Party) as the Requesting Party shall designate from time to time. Upon such request, the Parties shall determine reasonable procedures for the Filing Party to file for Product Approval on behalf of the Requesting Party (or its designee). *** pursuant to this Section 5.4.4 (excluding, for the avoidance of doubt, ***and***on behalf and for the***).

 

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5.5 Assistance. Each Party shall cooperate with the other Party to provide all *** assistance and take all actions reasonably requested by the other Party that are necessary to enable such Party to comply with any regulatory requirements under applicable Laws with respect to the Product, including (i) obtaining and maintaining regulatory approvals, (ii) submitting annual reports and (iii) performing pharmacovigilance activities. Such assistance and actions shall include, among other things, notifying the other Party within *** of any information it receives from a regulatory authority which (a) raises any material concerns regarding the safety or efficacy of the Product, (b) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with the Product or (c) is reasonably likely to lead to a recall or market withdrawal of a Product.

5.6 Adverse Events. Each Party agrees to provide the other Party with respect to the Product in the Field in the Territory: (i) Serious Adverse Event information and Product Complaint information relating to the Product as compiled and prepared by such Party in the normal course of business in connection with the Development, Manufacturing or Commercialization of the Product, within time frames to allow the other Party to fulfill all of its reporting obligations under applicable Laws, if any, and (ii) upon such other Party’s reasonable request, all other Adverse Event information with respect to the Product in the Field and all other safety data and information relevant to an analysis or investigation of such Adverse Events; provided, however, that the foregoing shall not require either Party to violate any agreements with or confidentiality obligations owed to any Third Party. All such Adverse Event information provided by one Party to the other Party under this Agreement with respect to the Product in the Field shall be owned jointly by the Parties.

5.7 Pharmacovigilance and Drug Safety Data.

5.7.1 Pharmacovigilance Agreement. The Parties shall comply with applicable pharmacovigilance and drug safety requirements imposed by FDA and other Governmental Authorities. Within *** of this Agreement, the Parties will enter into a mutually agreeable pharmacovigilance agreement setting forth the Parties’ respective obligations in detail with respect to pharmacovigilance and the exchange of drug safety data. Such agreement shall ensure that the Parties will have an arrangement that ensures an adequate reporting of the complete safety profile of the Product both in the Field and in the Oncology Field. The Parties shall use *** to enter into a pharmacovigilance agreement as soon as possible, however failure to enter into such pharmacovigilance agreement within *** *** of this Agreement, in and of itself, shall not be considered a breach of the Agreement by either Party.

5.7.2 Co-operation. Immunomedics shall be responsible for the reporting of adverse events for the Product until the earlier of (i) the Parties having executed a pharmacovigilance agreement or (ii) the initiation of clinical trials by Licensee for the Product. In the event that Licensee initiates clinical trials for the Product before the Parties have executed a pharmacovigilance agreement, then Immunomedics shall be responsible,

 

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at its sole cost and expense, for collecting and reporting pharmacovigilance and other drug safety data for the Product in the Oncology Field and Licensee shall be responsible, at its sole cost and expense, for collecting and reporting pharmacovigilance and other drug safety data for the Product in the Field.

5.8 Recalls .

5.8.1 Notification. Each Party shall promptly notify the other in writing if it determines that any event, incident or circumstance has occurred which may result in the need for a permanent or limited recall, market withdrawal, field alert or other similar corrective action with respect to the Product in the Field in the Territory (a “ Recall ”).

5.8.2 Recall. Upon a notification delivered by either Party pursuant to Section 5.8.1, the Parties shall promptly meet to discuss such circumstances and to consider appropriate courses of action. Each Party shall consider in good faith the comments of the other Party. Licensee shall be primarily responsible for discussions with the applicable Governmental Authority regarding all aspects of a Recall. Licensee shall provide Immunomedics reasonable prior notice of any meetings and conferences scheduled with such Governmental Authority with respect to a Recall of a Product in the Field in the Territory. To the extent practicable, Licensee shall provide Immunomedics with drafts of any documents and other correspondence to be submitted or communicated to a Governmental Authority pertaining to a Product, sufficiently in advance of submission so that Immunomedics may review and comment on such documents or other correspondence and planned communications and have a reasonable opportunity to influence the substance of such submissions.

5.8.3 Regulatory Meetings. At all such meetings and conferences Immunomedics shall have the right to attend as an to the extent permitted by the Governmental Authority, and shall have an opportunity to influence the substance of such meeting and conferences, including as the Party having rights to the Product in the Oncology Field in the Territory. After following the procedures set forth in Sections 5.8.1 and 5.8.2, either Party may make the determination, in its sole discretion, whether to voluntarily implement any Recall and shall promptly provide the other Party with written notice of such determination.

5.8.4 Responsibility for Recall. In the event that a Recall is implemented, Licensee shall, at its cost and expense, and in consultation with Immunomedics, conduct and carry out such Recall. Licensee shall utilize a batch tracing and recall system which will enable Licensee to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers. For clarity, nothing contained herein shall grant Licensee any rights with respect to a Recall for the Product outside the Field.

5.9 Medical Inquiries for the Product. Following the Effective Date, Licensee shall be responsible for handling all medical questions or inquiries in the Territory, including all Product Complaints, with regard to the Product in the Field (including, setting up a call

 

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center in connection therewith) and Licensee shall consider in good faith input from Immunomedics in connection therewith; provided, however that upon request of Immunomedics, ***any ***to*** and ***in good faith. Immunomedics shall forward all medical questions or inquiries which it receives with respect to the Product in the Field in the Territory to Licensee in accordance with all applicable Laws. For clarity, to the extent Licensee receives any medical questions or inquiries related to the Product outside of the Field, Licensee shall not respond to such question or inquiry (other than by directing such question or inquiry to Immunomedics or its designee) and shall immediately forward such question or inquiry to Immunomedics (or its designee).

5.10 Payment and Reimbursement of Regulatory Costs. All costs (including any and all filing fees) incurred by either Party or its Affiliates in connection with performing its regulatory activities in connection with the Product in the Field in the Territory, including obligations under this Agreement in accordance with ARTICLE 5, shall be borne by Licensee. Licensee shall reimburse Immunomedics for any such costs incurred by Immunomedics (or its Affiliates) during the Term in accordance with ARTICLE 5.

ARTICLE 6

COMMERCIALIZATION

6.1 Commercialization in the Field in the Territory . Subject to Immunomedics’ Co-Promotion Option, Licensee shall be solely responsible for, and shall use *** to, Commercialize the Product in the Field in the Territory with the goal of maximizing the commercial potential of the Product in the Field in the Territory. Licensee shall be responsible for one hundred percent (100%) of the expenses (including Pre-Marketing and Detailing expenses) incurred in connection with the Commercialization of the Product in the Field in the Territory. Without limiting the foregoing, Licensee shall Commercialize the Product in the Field in the Territory in accordance with the Commercialization Plan and shall carry out the Commercialization activities assigned to it under the Commercialization Plan in accordance with the time frames set forth in the Commercialization Plan.

6.2 Accommodation for ***. Immunomedics acknowledges that Licensee does not currently ***. Accordingly, Licensee shall use *** to seek and *** to be subject to Immunomedics’ prior written consent, not to be unreasonably withheld.

6.3 Licensee’s Performance.

6.3.1 Commercialization Plan.

(a) Beginning at least *** prior to the anticipated First Commercial Sale of the Product in the Territory for use in the Field, and thereafter on an annual basis no later than ***, Licensee shall create and submit to the Immunomedics for its review and comment, an annual plan (including a budget) for the Commercialization of the Product in the Territory for use in the Field for the following calendar year. Licensee shall consider any comments of Immunomedics to any such commercialization plan and budget (including any updates and amendments thereto) in good faith. After

 

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Immunomedics has had *** to review and comment on such plan, such annual plan (including budget) shall be the “ Commercialization Plan ” for such calendar year. From time to time during a given calendar year, Licensee may propose written updates to the Commercialization Plan for review and comment by the Immunomedics, and Licensee shall consider in good faith any comments of Immunomedics thereto. Licensee shall conduct all Commercialization of the Product in the Territory in accordance with the Commercialization Plan.

(b) Each annual Commercialization Plan shall include, among other things, the following items in connection with the Commercialization of the Product in the Territory for use in the Field:

(i) ***;

(ii) ***;

(iii) ***;

(iv) a detailed budget for the Commercialization activities (including Advertisement and Promotion Costs incurred by Licensee) for the applicable period (the “Commercialization Budget” ); and

(v) ***.

6.3.2 Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization by Licensee of the Product in the Territory for use in the Field hereunder, during the Term, Licensee shall be responsible for, and each Commercialization Plan shall reflect that:

(a) Licensee shall be solely responsible for (a) receiving, accepting and filling orders for the Product in the Field in the Territory, (b) handling all returns of Product in the Field in the Territory, (c) controlling invoicing, order processing and collection of accounts receivable for the sales of Product in the Field in the Territory, (d) booking and recording sales of the Product in the Field in the Territory in its books of account and (e) distributing and managing inventory of Product in the Field in the Territory, in each case in accordance with GAAP to the extent applicable.

(b) Licensee shall launch the Product for use in the Field (i) in each Major Market Country (except that such efforts in *** are subject to the provisions of Section 6.2 no later than *** after the receipt of Regulatory Approval of the Product in such Major Market Country and (ii) subject to a good faith evaluation of the market potential in each country in the Territory other than the Major Market Countries, within *** after the receipt of Regulatory Approval of the Product in such country. Notwithstanding the foregoing clause (i), Licensee shall have no obligation to launch the Product in any Major EU Country ***Major EU Country.

 

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(c) Licensee shall Detail the Product in the Territory for use in the Field to those categories of physicians (“ Specialists ”) as set forth in the Commercialization Plan, and in connection therewith, Licensee shall assign a reasonable number of Sales and Educational Representatives for each country in the Territory to perform the Details set forth in the Commercialization Plan. Licensee shall also ensure that it assigns a reasonable number of qualified supervisors to oversee the conduct of the Sales and Educational Representatives. Licensee shall provide to Immunomedics within *** of the conclusion of each *** a detailed report setting forth the types, number and targets of Details actually performed by Licensee in each of the Major Market Countries, as well as report of the type, number and targets of Details actually performed by Licensee in each other country in the Territory, and such report shall be subject to the audit requirements set forth in Section 9.11.

6.4 Compliance. Licensee shall, in Commercializing the Product hereunder, comply with all applicable Laws, including the U.S. Foreign Corrupt Practices Act, as well as all applicable Regulatory Approvals (including any Packaging and Labeling) for the Product. In addition, Licensee shall not use in any capacity, in connection with its Commercialization (or Manufacturing or Development) of the Product hereunder, any person or entity who has been debarred pursuant to Section 306 of the FD&C Act (or similar Law outside of the U.S.), or who is subject of a conviction described in such section, and Licensee shall inform Immunomedics in writing immediately if it or any person or entity who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to the Licensee’s knowledge, is threatened, relating to the debarment of Licensee or any person or entity used in any capacity by Licensee in connection with its Commercialization (or Manufacturing or Development) of the Product hereunder.

6.5 Promotional and Educational Materials.

6.5.1 Creation of Promotional and Educational Materials. Licensee will create and develop Promotional and Educational Materials for the Product in the Field in the Territory in accordance with the Regulatory Approvals and applicable Laws and shall provide samples thereof to Immunomedics for its review and comment (and Licensee shall consider any comment thereto in good faith) prior to distributing such Promotional and Educational Materials. With respect to any promotional materials that include information concerning the indication, efficacy or safety profile of the Product, Licensee shall only use such reviewed Promotional and Educational Materials for Commercialization of the Product in the Field hereunder and shall not materially modify such Promotional and Educational Materials before submitting such revisions thereto to Immunomedics for review and comment (and Licensee shall consider any such comments in good faith). To the extent Licensee includes any Immunomedics trademarks in the Promotional and Educational Materials, Licensee shall comply with Immunomedics’ then-current guidelines for trademark usage, a copy of which shall be provided to Licensee from time to time.

 

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6.5.2 Inclusion of Logos on Packaging and Promotional and Educational Materials. To the extent required by applicable Law and subject to obtaining necessary Regulatory Authority approvals, with respect to Product to be sold by Licensee in the Territory, the Immunomedics housemark and the Licensee housemark shall be applied in the packaging on all Promotional and Educational Materials and Packaging and Labeling utilized by Licensee (including, the designation that the Product has been “licensed from Immunomedics, Inc.”). Immunomedics hereby grants to Licensee a non-exclusive, royalty-free, right and license during the Term to utilize the Immunomedics housemark (including all trademarks, names and logos) for Promotional and Educational Materials and Packaging and Labeling for the Product in the Field in the Territory. Licensee shall only use the housemark of Immunomedics with the necessary trademark designations, and Licensee shall use Immunomedics’ housemarks in a manner that does not derogate from Immunomedics’ rights in its trademarks, names and logos. Licensee will take no action that will interfere with or diminish Immunomedics’ rights in its trademarks, names and logos, and if Immunomedics reasonably believes that the use of its trademarks, names and logos by the Licensee hereunder is interfering with or diminishing its rights, Immunomedics shall notify the Licensee thereof in writing and Licensee shall promptly cease use of such trademarks, names or logos in such manner. Licensee agrees that all use of the Immunomedics’ trademarks, names and logos will inure to the benefit of Immunomedics, including all goodwill in connection therewith.

6.5.3 Licensee Ownership of Promotional and Educational Materials. During the Term, Licensee shall own all right, title and interest in and to any Promotional and Educational Materials created by Licensee hereunder relating to the Product in the Field in the Territory, but excluding trademarks, names logs and other marks owned by or on behalf of Immunomedics or its Affiliates in accordance with Section 6.5.2.

6.5.4 Use of Promotional and Educational Materials Exclusively for Products. The Promotional and Educational Materials, and any aspects of those uniquely tied to the Product, shall be used by Licensee exclusively in connection with the Commercialization of the Product in the Field (or if marketed in a portfolio of products for those products in that same portfolio) in the Territory in accordance with the terms of this Agreement, and Licensee shall not use, or allow any other person or entity to use, any such Promotional and Educational Materials except in accordance with this Agreement.

6.6 Product Trademarks.

6.6.1 General. Licensee shall Commercialize the Product in the Field in the Territory under a trademark at its discretion (the “ Product Trademark ”) and in trade dress designed by the Licensee and approved by Immunomedics (the “ Product Trade Dress ”). All uses of the Product Trademarks and Product Trade Dress to identify and/or in connection with the Commercialization of the Product in the Field in the Territory shall be approved by each of the Parties. The Product Trademarks and Product Trade Dress under which the Product is marketed or sold (other than Licensee’s corporate trademarks or trade names) shall be used by Licensee only pursuant to the terms of this Agreement to identify and in connection with the Commercialization of the Product in the Field in the Territory, and shall not be used by Licensee to identify or in connection with the marketing of any other products. Licensee shall have exclusive (even as to Immunomedics) ownership and use rights of the Product Trademarks (together with all goodwill associated

 

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therewith throughout the Territory). For clarity, Immunomedics shall not use the Product Trademarks and Product Trade Dress for Commercializing the Product in the Oncology Field (other than Immunomedics’ corporate trademarks or trade names). Licensee shall have the rights to any Internet domain names incorporating the Product Trademark or any variation or part of such Product Trademark as its URL address or any part of such address; and Immunomedics shall not establish any Internet domain name or URL incorporating such Product Trademark without the prior written consent of Licensee, such consent not to be unreasonably withheld; provided that Licensee shall be responsible for all costs incurred by Immunomedics with respect to obtaining and maintaining such Internet domain names or URLs to the extent used for the Commercialization of the Product in the Field in the Territory.

6.6.2 Maintenance of Trademark. From registration of the Product Trademark in a given country in the Territory, and thereafter during the Term, Licensee shall establish, maintain and enforce the Product Trademark in such country in the Territory, with the costs and expenses to be borne solely by Licensee.

6.6.3 Infringement. In the event that either Party becomes aware of any infringement of any Product Trademark by a Third Party in the Territory, such Party shall promptly notify the other Party and Licensee shall decide - after due consideration in good faith of any comments from Immunomedics - how to proceed with respect to such infringement, including by the institution of legal proceedings against such Third Party; provided, further, however that any reasonable costs and expenses in connection therewith shall be borne solely by Licensee.

6.6.4 No Trademark License. Except with respect to the license granted to Licensee to the Immunomedics housemark (including all trademarks, names and logos) for Promotional and Educational Materials and Packaging and Labeling pursuant to Section 6.5.2, no right or license, express or implied, is granted to Licensee to us