These excerpts taken from the SGEN 10-K filed Mar 13, 2009.
Affiliate shall mean any corporation or other business entity controlled by, controlling, or under common control with another entity, with control meaning direct or indirect beneficial ownership of more than fifty percent (50%) of the voting stock of such corporation, or more than a fifty percent (50%) interest in the decision-making authority of such other unincorporated business entity; and a corporation in which the maximum amount of stock permitted by law to be held by another entity is beneficially owned by such other entity.
Antibodies shall mean the antibodies identified on Exhibit A and any other antibodies directed toward human and murine CD70 that are owned or controlled by CLB now or in the future.
Antibody Technology shall mean all rights to the Antibodies including, but not limited to:
(a) the patents and patent applications currently existing or filed hereafter covering the Antibodies, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; and
(b) all trade secrets and other information , including but not limited to present and future techniques, inventions, discoveries, developments, practices, methods, formulations, specifications, processes, apparatus, knowledge, know-how, skill, biological materials, design data, pharmacological, toxicological and clinical test data, sequence data, analytical and quality control data, manufacturing data and all other information and data relating to the Antibodies including, the hybridoma cell line expressing each Antibody;
provided, however, that Antibody Technology shall not include trade secrets and other information that is specifically and solely related to the Reagents Programme.
Approval shall mean all approvals, licenses, registrations and authorizations of all governmental agencies in a country necessary for the manufacture, use or sale of a Licensed Product in the applicable country.
Confidential Information shall have the meaning assigned thereto in Section 11.
First Commercial Sale shall mean, with respect to any Licensed Product, the first sale for use or consumption by the general public of such product in any country following Approval, or otherwise permitted, by the governing health authority of such country. First Commercial Sale shall not include the sale of any Licensed Product for use in clinical trials or research.
License shall have the meaning assigned thereto in Section 4.2.
Licensed Products shall mean any product incorporating the Antibodies or derived from the Antibodies or their sequences.
Net Sales shall mean the amount actually received by SGI or its Affiliates or sublicensees for the sale to an unaffiliated third party of a Licensed Product, less the following deductions for amounts actually incurred related to the sale:
In the event that a Licensed Product is sold as part of a Combination Product (as defined below), the Net Sales from the Combination Product, for the purposes of determining royalty payments, shall be determined by [***].
As used above, the term Combination Product shall mean any pharmaceutical product which comprises a Licensed Product and any other active compounds and/or ingredients.
Net Sales shall not include transfer of Licensed Products at or below cost by or on behalf of SGI in connection with research or clinical trials.
Option means the option granted by CLB to SGI pursuant to the provisions of Section 4.1 hereof to obtain the licenses under Section 4.2 hereof.
Option Period means, the period commencing as of the Effective Date and continuing for a period of [***] unless terminated earlier pursuant to the provisions of Section 4.1 below.
Phase II Clinical Trial shall mean a human clinical trial for which a primary endpoint is a preliminary determination of efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States. Any well-controlled study intended to provide the substantial evidence of efficacy necessary to support the filing of an approvable marketing applications (such as a combined Phase II Clinical Trial/ Phase III Clinical Trial, or any Phase III Clinical Trial in lieu of a Phase II Clinical Trial) (a Pivotal Study) shall automatically be deemed to have reached Phase II status. A Phase II Clinical Trial shall be deemed to have commenced when the first patient in the study has been enrolled.
Phase III Clinical Trial shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a Pivotal Study, whether or not such study is a traditional Phase III Clinical Trial. A Phase III Clinical Trial shall be deemed to have commenced when the first patient has been enrolled in a Pivotal Study.
Reagents Programme shall mean any kits or reagents for in vitro diagnostic and research use, currently and prospectively listed and offered for sale in CLBs standard Immune Reagents Product List.
2. Delivery of Antibodies and Hybridomas. CLB shall deliver to SGI 5 mg of each of the Antibodies, and hybridomas for each within [***] following the Effective Date.
3. Use of Antibodies. As of the Effective Date, CLB grants to SGI a non-exclusive, non-sublicensable, worldwide license to use the Antibodies solely for research purposes. SGI shall use the Antibodies in compliance with all applicable federal, state and local laws and regulations. No other license with regards to the Antibodies shall be granted or implied unless and until the Option is exercised by SGI.
Affiliate shall mean any corporation or other business entity controlled by,
Antibodies shall mean the antibodies identified on Exhibit A and any other antibodies directed
(a) the patents and patent
(b) all trade secrets and other information , including but not limited to present and
Approval shall mean all approvals, licenses, registrations and authorizations of all governmental
SIZE="2">Confidential Information shall have the meaning assigned thereto in Section 11.
SIZE="2">First Commercial Sale shall mean, with respect to any Licensed Product, the first sale for use or consumption by the general public of such product in any country following Approval, or otherwise permitted, by the
Net Sales shall mean the amount actually received by SGI or its Affiliates or sublicensees
FACE="Times New Roman" SIZE="2">(a) [***]
(b) [***].STYLE="margin-top:6px;margin-bottom:0px; margin-left:8%; text-indent:4%">In the event that a Licensed Product is sold as part of a Combination Product (as defined below), the Net Sales from the Combination
Product, for the purposes of determining royalty payments, shall be determined by [***].
As used above, the term
Option means the option granted by CLB to SGI pursuant to the
of efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States. Any well-controlled study intended to provide
the substantial evidence of efficacy necessary to support the filing of an approvable marketing applications (such as a combined Phase II Clinical Trial/ Phase III Clinical Trial, or any Phase III Clinical Trial in lieu of a Phase II Clinical Trial)
(a Pivotal Study) shall automatically be deemed to have reached Phase II status. A Phase II Clinical Trial shall be deemed to have commenced when the first patient in the study has been enrolled. STYLE="margin-top:6px;margin-bottom:0px; margin-left:4%; text-indent:4%">Phase III Clinical Trial shall mean a human clinical trial, the principal purpose of which is to establish safety and
efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any
other human clinical trial intended as a Pivotal Study, whether or not such study is a traditional Phase III Clinical Trial. A Phase III Clinical Trial shall be deemed to have commenced when the first patient has been enrolled in a Pivotal Study.
Reagents Programme shall mean any kits or reagents for in vitro diagnostic and research use, currently
2. Delivery of Antibodies and
SIZE="2">3. Use of Antibodies. As of the Effective Date, CLB grants to SGI a non-exclusive, non-sublicensable, worldwide license to use the Antibodies solely for research purposes. SGI shall use the Antibodies in compliance with all
FACE="Times New Roman" SIZE="2">4.1 Option Grant and Exercise. Subject to the terms of this Agreement, CLB hereby grants to SGI and its Affiliates an Option to acquire the License set forth in Section 4.2 below with respect to the
4.2 License Grant. If (i) SGI elects to exercise its Option to acquire a License with respect to the
This excerpt taken from the SGEN 10-Q filed May 8, 2007.
1.1 Abbott Agreement has the meaning set forth in Section 2.1(b).
1.2 ADC Collaboration Agreement means that certain ADC Collaboration Agreement dated April 19, 2002 by and between SGEN and GNE.
1.3 Affiliate means any corporation or other business entity controlled by, controlling, or under common control with another entity, with control meaning direct or indirect beneficial ownership of [***] of the voting stock of, or [***] interest in the income of, such corporation or other business entity. For purposes of this Agreement, with respect to GNE, the term Affiliate shall not include [***] and its successors, or any entity that controls, is controlled by or is under common control with [***], in each case that is not controlled by GNE.
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.
1.4 Allocable Overhead means [***] costs incurred by a Party that are attributable to that Partys [***]. Allocable Overhead shall not include any costs attributable to [***].
1.5 Autoimmune Disease Indication means a non-cancer disease or condition caused by an immune response against normal tissues, including multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, scleroderma and inflammatory indications.
1.6 CD40 means the CD40 cell surface receptor, which is a member of the TNF superfamily and to which CD40 ligand (CD40L or also known as CD154) binds.
1.7 Combination Product has the meaning set forth in Section 1.54.
1.8 Commercialization means the marketing, promotion, sale and/or distribution of Licensed Product in the Territory. Commercialize has a correlative meaning.
1.9 Competitive Product means any antibody-based product containing an [***] that (i) specifically [***] and (ii) is not either a [***] or a [***].
1.10 Confidential Information means all Information (whether in written, oral, electronic, visual, tangible, or other form) and materials, including biological and other tangible materials, that are disclosed by one Party to the other Party prior to the Effective Date or during the Term, provided that all information disclosed in tangible form is designated as confidential by the use of an appropriate stamp or legend and information disclosed in any other form is identified as confidential at the time of disclosure.
1.11 Controlled means, with respect to any intellectual property right or Information, that the Party owns or has a license to such intellectual property right or Information and has all the rights necessary (a) to grant to the other Party a license or sublicense to such intellectual property right as provided for herein or (b) to transfer such Information to the other Party as provided for herein (as applicable) without violating the terms of any agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such license or sublicense or to perform such transfer.
1.12 Co-Promote means the detailing or promotion of a Co-Promote Product to physicians or other authorized prescribers in the U.S. under a single trademark.
1.13 Co-Promote Product has the meaning set forth in Section 6.6(a).
1.14 Co-Promotion Notice has the meaning set forth in Section 6.6(b).
1.15 Co-Promotion Option has the meaning set forth in Section 6.6(a).
1.16 Co-Promotion Plan has the meaning set forth in Section 6.6(c).
1.17 Development means all activities that relate to (a) obtaining, maintaining or expanding Regulatory Approval of a Licensed Product, (b) studies conducted to expand the scientific or medical understanding of a Licensed Product, whether for publication in a peer-reviewed journal or not, but not necessarily for the intent of obtaining, maintaining or expanding Regulatory Approval of Licensed Product (e.g., investigator-sponsored trials) or (c) developing the ability to manufacture clinical and commercial quantities of Licensed Product. This includes: (i) research, preclinical testing, toxicology, and clinical studies of Licensed Product; (ii) preparation, submission, review, and development of data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand Regulatory Approval of Licensed Product, and outside counsel regulatory legal services related thereto; (iii) manufacturing process development and scale-up, bulk production and fill/finish work associated with the supply of Licensed Product for preclinical and clinical studies, and related quality assurance technical support activities; and (iv) post-Regulatory Approval product support for a Licensed Product (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of the safety and efficacy of a Licensed Product. Develop has a correlative meaning.
1.18 Development Costs has the meaning set forth in Section 4.7.
1.19 Development Plan has the meaning set forth in Section 4.2(a).
1.20 Diligent Efforts means, with respect to particular obligations or tasks of a Party, the carrying out of such obligations or tasks in a diligent manner consistent with (a) as to [***], [***] and (b) as to [***], [***], in each case of (a) and (b) as applicable to the
development or commercialization of a product having similar technical and regulatory hurdles and similar market potential, profit potential and strategic value, that is at a similar stage in its development or product life cycle, and is based on conditions then prevailing and with due regard to the nature of efforts and cost required and the current corporate goals and priorities of such Party, but in any event, not less than the level of effort that such Party uses to conduct its own comparable business.
1.21 Dollars or $ means the legal tender of the U.S.
1.22 Drug Approval Application means, with respect to a particular country, an application for regulatory approval required before commercial sale or use of a Licensed Product in such country. For clarity, in the U.S., a Biologics License Application and a New Drug Application (as such terms are used by the FDA) shall each be deemed to be a Drug Approval Application.
1.23 Effective Date means the date upon which all provisions of this Agreement become effective pursuant to Section 16.1.
1.24 European Union or EU means the European Union or any successor organization, including any of its member countries.
1.25 Execution Date means January 7, 2007, the date upon which this Agreement has been executed and delivered by both Parties.
1.26 Executive Officer means, in the case of SGEN, the Chief Executive Officer of SGEN or designee, and in the case of GNE, any of the following: the Vice President of Sales and Marketing, BioOncology or the Vice President, Clinical Hematology/Oncology of GNE, or their successor functionaries. In no case will any Executive Officer be a currently serving member of the JDC or JCC.
1.27 FBMC means, with respect to a given Licensed Product (or Termination Product), [***] of a Partys fully-burdened manufacturing cost (as defined by such Partys accounting policies consistently applied), which shall comprise the sum of: (a) [***] and (b) [***]. With respect to Licensed Products (or Termination Products) manufactured by a Third
Party under contract with such Party and supplied either to such Party or directly to the other Party, Section 1.27(a) shall include the net sum of (i) [***]; (ii) [***]; and (iii) to the extent not otherwise captured in the deductions for Net Sales set forth in Section 1.54, [***], and (iv) [***].
1.28 FDA means the U.S. Food and Drug Administration or any successor agency thereto.
1.29 Field means all uses.
1.30 First Commercial Sale means, with respect to a country in the Territory, the first sale to a Third Party of a Licensed Product in such country by GNE or its Affiliates or Sublicensees after the approval of the Drug Approval Application in such country, or where no Drug Approval Application is required to be approved, after compliance with such import requirements as are required to import such Licensed Product into such country for commercial sale.
1.31 FTE means the equivalent of a full-time employee of SGEN (including normal vacations, sick leave, and other similar matters). A Development FTE charged to GNE shall represent the percentage of time a full-time employee of SGEN spends working on Development activities assigned to SGEN under a Development Plan relative to total time over a given time period as recorded in the SGEN project time reporting system. For the avoidance of doubt, the time shall be recorded in a manner such that no employee of SGEN can report him/herself as more than [***] FTE in any given [***]. An FTE is measured on the basis of a total of [***].
1.32 GAAP means United States generally accepted accounting principles.
This excerpt taken from the SGEN DEF 14A filed Apr 17, 2007.
As used herein, the following definitions shall apply:
(a) Administrator means the Board, any Committees or such delegates as shall be administering the Plan in accordance with Section 4 of the Plan.
(b) Affiliate means any entity that is directly or indirectly controlled by the Company or any entity in which the Company has a significant ownership interest as determined by the Administrator.
(c) Applicable Laws means the requirements relating to the administration of stock option and stock award plans under U.S. federal and state laws, the Code, any stock exchange or quotation system on which the Company has listed or submitted for quotation the Common Stock to the extent provided under the terms of the Companys agreement with such exchange or quotation system and, with respect to Awards subject to the laws of any foreign jurisdiction where Awards are, or will be, granted under the Plan, the laws of such jurisdiction.
(d) Award means a Stock Award or Option granted in accordance with the terms of the Plan.
(e) Awardee means an Employee, Consultant or Director of the Company or any Affiliate who has been granted an Award under the Plan.
(f) Award Agreement means a Stock Award Agreement and/or Option Agreement, which may be in written or electronic format, in such form and with such terms and conditions as may be specified by the Administrator, evidencing the terms and conditions of an individual Award. Each Award Agreement is subject to the terms and conditions of the Plan.
(g) Board means the Board of Directors of the Company.
(h) Cause means (i) an action or omission of Awardee which constitutes a willful and intentional material breach of any written agreement or covenant with the Company, including without limitation, Awardees theft or other misappropriation of the Companys proprietary information; (ii) Awardees commitment of fraud, embezzlement, misappropriation of funds or breach of trust in connection with Awardees employment; or (iii) Awardees conviction of any crime which involves dishonesty or a breach of trust, or gross negligence in connection with the performance of the Awardees duties. The determination as to whether an Awardee is being terminated for Cause shall be made in good faith by the Company and shall be final and binding on the Awardee. The foregoing definition does not in any way limit the Companys ability to terminate an Awardees employment or consulting relationship at any time as provided in Section 16 below, and the term Company will be interpreted to include any Affiliate or successor thereto, if appropriate.
(i) Change in Control means any of the following, unless the Administrator provides otherwise:
i. an acquisition of the Company by another entity by means of any transaction or series of related transactions (including, without limitation, any reorganization, merger or consolidation but excluding any merger effected exclusively for the purpose of changing the domicile of the Company);
ii. a sale of all or substantially all of the assets of the Company, so long as in either i. or ii. above, the Companys stockholders of record immediately prior to such transaction will, immediately after such transaction, hold less than fifty percent (50%) of the voting power of the surviving or acquiring entity; or
iii. any other event specified by the Board or a Committee, regardless of whether at the time an Award is granted or thereafter.
(j) Code means the United States Internal Revenue Code of 1986, as amended.
(k) Committee means the compensation committee of the Board or a committee of Directors appointed by the Board in accordance with Section 4 of the Plan.
(l) Common Stock means the common stock of the Company.
(m) Company means Seattle Genetics, Inc., a Delaware corporation, or its successor.
(n) Consultant means any person engaged by the Company or any Affiliate to render services to such entity as an advisor or consultant.
(o) Conversion Award has the meaning set forth in Section 4(b)(xi) of the Plan.
(p) Director means a member of the Board.
(q) Employee means a regular, active employee of the Company or any Affiliate, including an Officer and/or Inside Director. Within the limitations of Applicable Law, the Administrator shall have the discretion to determine the effect upon an Award and upon an individuals status as an Employee in the case of (i) any individual who is classified by the Company or its Affiliate as leased from or otherwise employed by a third party or as intermittent or temporary, even if any such classification is changed retroactively as a result of an audit, litigation or otherwise, (ii) any leave of absence approved by the Company or an Affiliate, (iii) any transfer between locations of employment with the Company or an Affiliate or between the Company and any Affiliate or between any Affiliates, (iv) any change in the Awardees status from an Employee to a Consultant or Director, and (v) at the request of the Company or an Affiliate an Employee becomes employed by any partnership, joint venture or corporation not meeting the requirements of an Affiliate in which the Company or an Affiliate is a party.
(r) Exchange Act means the Securities Exchange Act of 1934, as amended.
(s) Fair Market Value of a Share on any given date means, unless otherwise required by Applicable Law, the fair market value of such Share as determined in good faith by the Administrator either through application of any reasonable valuation method or, in the absence of any method established under law, in practice or otherwise to be reasonable, then pursuant to the Administrators good faith conclusion that its valuation determination is reasonable; provided that, to the extent possible, such value shall be determined with reference to the closing price of the Companys Common Stock as quoted on the applicable date on Nasdaq or the exchange or market with the greatest volume of trading in the Common Stock as of the applicable date, or if the Shares were not trading on such date, then the closing bid on the applicable date.
The Administrator may make a good faith determination that it is reasonable to use one valuation method with respect one type of transaction arising under the Plan and a different valuation method with respect to another type of Plan transaction, provided that in each case the Administrator concludes that application of the particular method results in the most accurate measure of fair market value with respect thereto.
(t) Grant Date means, for all purposes, the date on which the Administrator makes the determination granting an Award, or such other date as is determined by the Administrator, provided that in the case of any Incentive Stock Option, the grant date shall be the later of the date on which the Administrator makes the determination granting such Incentive Stock Option or the date of commencement of the Awardees employment relationship with the Company.
(u) Incentive Stock Option means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder.
(v) Inside Director means a Director who is an Employee.
(w) Nasdaq means the Nasdaq Global Market or its successor.
(x) Nonstatutory Stock Option means an Option not intended to qualify as an Incentive Stock Option.
(y) Officer means a person who is an officer of the Company within the meaning of Section 16 of the Exchange Act and the rules and regulations promulgated thereunder.
(z) Option means a right granted under Section 8 to purchase a number of Shares at such exercise price, at such times, and on such other terms and conditions as are specified in the agreement or other documents evidencing the Option (the Option Agreement). Both Options intended to qualify as Incentive Stock Options and Nonstatutory Stock Options may be granted under the Plan.
(aa) Outside Director means a Director who is not an Employee.
(bb) Participant means the Awardee or any person (including any estate) to whom an Award has been assigned or transferred as permitted hereunder.
(cc) Plan means this Seattle Genetics, Inc. 2007 Equity Incentive Plan.
(dd) Qualifying Performance Criteria shall have the meaning set forth in Section 12(b) of the Plan.
(ee) Share means a share of the Common Stock, as adjusted in accordance with Section 13 of the Plan.
(ff) Stock Appreciation Right means a right to receive cash and/or shares of Common Stock based on a change in the Fair Market Value of a specific number of shares of Common Stock between the Grant Date and the exercise date granted under Section 11.
(gg) Stock Award means an award or issuance of Shares, Stock Units, Stock Appreciation Rights or other similar awards made under Section 11 of the Plan, the grant, issuance, retention, vesting, settlement and/or transferability of which is subject during specified periods of time to such conditions (including continued employment or performance conditions) and terms as are expressed in the agreement or other documents evidencing the Award (the Stock Award Agreement).
(hh) Stock Unit means a bookkeeping entry representing an amount equivalent to the Fair Market Value of one Share (or a fraction or multiple of such value), payable in cash, property or Shares. Stock Units represent an unfunded and unsecured obligation of the Company, except as otherwise provided for by the Administrator.
(ii) Subsidiary means any company (other than the Company) in an unbroken chain of companies beginning with the Company, provided each company in the unbroken chain (other than the Company) owns, at the time of determination, stock possessing 50% or more of the total combined voting power of all classes of stock in one of the other companies in such chain.
(jj) Termination of Employment shall mean ceasing to be an Employee, Consultant or Director, as determined in the sole discretion of the Administrator. However, for Incentive Stock Option purposes, Termination of Employment will occur when the Awardee ceases to be an employee (as determined in accordance with Section 3401(c) of the Code and the regulations promulgated thereunder) of the Company or one of its Subsidiaries. The Administrator shall determine whether any corporate transaction, such as a sale or spin-off of a division or business unit, or a joint venture, shall be deemed to result in a Termination of Employment.
(kk) Total and Permanent Disability shall have the meaning set forth in Section 22(e)(3) of the Code.