Contract
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Execution Version AMENDED AND RESTATED DEVELOPMENT AND LICENSE AGREEMENTTHIS AMENDED AND RESTATED DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”) is entered into as of February 14, 2007 (the “Execution Date”), and is effective as of February 14, 2003 (the “Effective Date”), by and between Xxx Xxxxxxxx Xxxxxxx, a Delaware corporation (“Xxx Xxxxxxxx Xxxxxxx,” and collectively with its Affiliates, “Xxxxxxxx”), and Palomar Medical Technologies, Inc., a Delaware corporation (“Palomar Medical Technologies, Inc.,” and collectively with its Affiliates, “Palomar”). Xxxxxxxx and Palomar are sometimes referred to herein individually as a “party” and collectively as the “parties.” RECITALSWHEREAS, Palomar has developed light-based systems for, among other things, the management of human hair; WHEREAS, Xxxxxxxx has specialized experience in, among other things, the development and worldwide commercialization of consumer hair management products and systems for personal use; WHEREAS, the parties entered into that certain Development and License Agreement, dated February 14, 2003 (as amended by that certain (i) Letter, dated February 14, 2003, executed by Xxxxxxxx in favor of Palomar, (ii) Letter Amendment, dated October 2, 2003, by and between the parties, (iii) Second Amendment, dated June 24, 2004, by and between the parties and (iv) Third Amendment, dated October 31, 2005, by and between the parties, as amended in full the “Original Agreement”), pursuant to which the parties entered into a collaboration for the development and commercialization of light-based, consumer products and systems for personal use for female hair management; and WHEREAS, subject to the terms and conditions set forth below, the parties now desire to amend and restate the Original Agreement to address a number of matters. NOW, THEREFORE, in consideration of the foregoing premises, the mutual promises and covenants of the parties contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows: ARTICLE I
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| Development Event | Development Completion Payment |
|---|---|
| First Development Completion Payment Date |
$2,500,000 (“First Development Completion Payment”) |
| Second Development Completion Payment Date |
$10,000,000 (“Second Development Completion Payment,” and together with the First Development Completion Payment, “Development Completion Payments”) |
| Banknorth | |
| 000 Xxxx Xxxxxx | |
| Xxxxxxxxx, XX 00000 | |
| ABA No.: 000000000 | |
| Account No.: 8241022982 | |
| Account Name: Palomar Medical Technologies, Inc. |
| If to Palomar, to: | |
| Palomar Medical Technologies, Inc. | |
| 00 Xxxxxxxxx Xxxxxx | |
| Xxxxxxxxxx, XX 00000 | |
| Attention: President & General Counsel | |
| Facsimile: (000) 000-0000 |
| with a copy to: | |
| Xxxxxxx | Procter LLP | |
| Exchange Place | |
| 00 Xxxxx Xxxxxx | |
| Xxxxxx, Xxxxxxxxxxxxx 00000 | |
| Attention: Xxxxxxxx X. Xxxx, Esq. | |
| Facsimile: (000) 000-0000 |
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| If to Xxxxxxxx, to: | |
| The Procter & Xxxxxx Company | |
| Two P&G Xxxxx | |
| Xxxxxxxxxx, XX 00000 | |
| Attn: Vice President, External Business Development | |
| Facsimile: (000) 000-0000 | |
| with copies to: | |
| Xxx Xxxxxxxx Xxxxxxx | |
| 0000 Xxxxxxxxxx Xxxxx Xxxxxxxx | |
| Xxxxxx, Xxxxxxxxxxxxx 00000 | |
| Attn: General Counsel | |
| Facsimile: (000) 000-0000 |
| Xxxxxxxxx & Xxxxxxx | |
| Xxx Xxxxx Xxxxxx | |
| Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 | |
| Attention: Xxx Xxxxxx and Xxxxx Xxxxxxx | |
| Facsimile: (000) 000-0000 | |
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or to such other address as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith. Any such communication shall be deemed to have been given (i) when delivered, if personally delivered or sent by facsimile on a business day, (ii) on the business day after dispatch, if sent by nationally-recognized overnight courier, and (iii) on the third business day following the date of mailing, if sent by mail. It is understood and agreed that this Section 14.5 is not intended to govern the day-to-day business communications necessary between the parties in performing their duties, in due course, under the terms of this Agreement. 14.6 Export Control. Notwithstanding anything else herein, neither party shall directly or indirectly export or re-export any Female Product, Joint Technology, Palomar Technology, Palomar Male Technology, Xxxxxxxx Technology or Confidential Information of the other party, or any direct product of any of the foregoing, outside the United States, without complying with all applicable U.S. and foreign export control and other laws and regulations (including providing the other party any required assurance regarding export and re-export). 14.7 Entire Agreement; Modifications. Other than the Non-Disclosure Agreement, which is addressed in Section 9.8, this Agreement sets forth and constitutes the entire agreement and understanding between the parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded hereby, including the Original Agreement (except for any rights or obligations under the Original Agreement that shall have accrued prior to the Execution Date, as those rights or obligations may be modified by the terms of this Agreement). Each party confirms that it is not relying on any representations or warranties of the other party except as specifically set forth herein. No amendment, modification, release or discharge hereof shall be binding upon the parties unless in writing and duly executed by authorized representatives of both parties. 14.8 Relationship of the Parties. It is expressly agreed that Palomar, on the one hand, and Xxxxxxxx, on the other hand, shall be independent contractors and that the relationship between the two parties shall not constitute a partnership, joint venture or agency. Neither Palomar, on the one hand, nor Xxxxxxxx, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other party to do so and no such statements, representations or commitments shall be construed so as to require either party to expend either funds or efforts or commit resources in excess of those expressly contemplated by this Agreement. All persons employed by a party shall be employees of such party and not of the other party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such party. 14.9 Equitable Relief. Each party acknowledges and agrees that the restrictions set forth in Sections 2.1(a)(iii), 5.2, 5.3, 5.4, 10.7(e)(i), 12.2(h), 12.2(i) and 12.3(n), and ARTICLE VIII and ARTICLE IX are reasonable and necessary to protect the legitimate interests of the other party and that neither party would have entered into this Agreement in the absence of such restrictions, and that any violation or threatened violation by a party of any such provision will result in irreparable injury to the other party. Each party also acknowledges and agrees that in the event of a violation or threatened violation of any such provision, the other party shall be entitled to preliminary and permanent injunctive relief, without the necessity of proving irreparable injury or actual damages and without the necessity of having to post a bond, as well as to an equitable accounting of all earnings, profits and other benefits arising from any such violation. The rights provided in the immediately preceding sentence shall be cumulative and in addition to any other rights or remedies that may be available to such other party. Nothing in this Section 14.9 is intended, or should be construed, to limit either party’s right to preliminary and permanent injunctive relief or any other remedy for a breach of any other provision of this Agreement. 14.10 Waiver. Any term or condition of this Agreement may be waived at any time by the party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. The waiver by either party hereto of any right hereunder or of the failure to perform or of a breach by the other party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise. 14.11 Counterparts. This Agreement may be executed in two (2) or more counterparts, and by different parties on separate counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 14.12 No Benefit to Third Parties. Except as otherwise expressly provided in Sections 5.3 and 5.4, the representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. 14.13 Further Assurance. Each party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other party its rights and remedies under this Agreement. 14.14 Transaction Costs. Each party shall bear its own costs, including attorneys’ fees, in connection with negotiating and entering into this Agreement. 14.15 English Language. This Agreement shall be written and executed in the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. 14.16 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section, Schedule or Exhibit shall mean references to such Article, Section, Schedule or Exhibit of this Agreement, (b) references in any section to any clause are references to such clause of such section, (c) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently varied, replaced or supplemented from time to time, as so varied, replaced or supplemented and in effect at the relevant time of reference thereto, and (d) references to Sections include subsections, which are part of the related Section (e.g., a section numbered “Section 1.1(d)” would be part of “Section 1.1" and references to “Section 1.1” would also refer to material contained in the subsection described as “Section 1.1(d)”). 14.17 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the parties and no rule of strict construction shall be applied against either party hereto. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date. |
| XXX XXXXXXXX XXXXXXX | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| By: /s/ Xxxxxxx X. Xxxxxxx | By: /s/ Xxxxxx X. Xxxxxx |
| Name: Xxxxxxx X. Xxxxxxx | Name: Xxxxxx X. Xxxxxx |
| Title: Vice President External Business Development |
Title: CEO |
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[Counterpart Signature Page to Development and License Agreement] Appendix A DefinitionsThis Appendix to the Development and License Agreement (the “Agreement”) entered into as of February 14, 2003, by and between Xxxxxxxx and Palomar provides agreed upon definitions applicable to the parties for purposes of the Agreement. The contents of this Appendix A are hereby incorporated into the Agreement and are governed by the terms and conditions of the Agreement, including the confidentiality provisions set forth therein. The following capitalized terms, whether used in the singular or the plural and correlatives thereof, shall have the following meanings as used in the Agreement: “510(k) Notification” shall mean a 510(k) Notification within the meaning of FFDCA, and the regulations promulgated thereunder, necessary to market a Female Product in the United States. ;“510(k) Product” shall mean a Female Product, the sale of which requires a 510(k) Notification but not a PMA. “Affiliate” shall mean, with respect to a Person, any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Person. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity); provided, that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests. “Amendment Date” shall mean July 1, 2006. “Applicable Law” shall mean the applicable laws, rules, regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, that may be in effect from time to time in the Territory. “Business Methods and Materials” shall mean any and all (a) Marketing Materials, business methods, marketing strategies and tactics, including (i) methods or manner of product presentation, packaging, bundling, demonstration or communication, consumer information and education strategies, tactics and materials (including, user manuals and tutorials), and (ii) methods, strategies or tactics for structuring and implementing user transactions, in each case ((i) and (ii)) that relate to or are intended to support the commercialization of a Female Product in the Consumer Field, and (b) without limitation to clause (a), adaptations or applications of business methods, materials, strategies and tactics utilized by a party in connection with products other than Female Products, in each case to or for commercialization of Female Products in the Consumer Field, except in each case ((a) and (b)) to the extent that any of the foregoing enables the Functionality of a product, process or system that uses Optical Radiation. “Calendar Quarter” shall mean each period of three consecutive calendar months ending on March 31, June 30, September 30 and December 31. “Calendar Year” shall mean each successive period of twelve months commencing on January 1 and ending on December 31. “Change of Control” shall mean, with respect to a Person, any of the following transactions with a Third Party (the “Acquiring Party”): (a) a merger or consolidation of such Person with the Acquiring Party which results in the holders of the voting securities of such Person outstanding immediately prior thereto (other than the Acquiring Party, its “affiliates” and “associates” (as such terms are used in the Exchange Act)) ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity (or, if applicable, its parent company) immediately after such merger or consolidation; (b) the sale to the Acquiring Party of all or substantially all of the business of such Person to which this Agreement relates (whether by merger, consolidation, sale of stock, sale of assets or other similar transaction); or (c) the Acquiring Party (which shall not be any trustee or other fiduciary holding securities under an employee benefit plan of such Person, or any corporation owned directly or indirectly by the stockholders of such Person, in substantially the same proportion as their ownership of stock of such Person), together with any of the Acquiring Party’s “affiliates” or “associates”, as such terms are used in the Exchange Act, becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Person or by contract or otherwise having the right to control the board of directors or equivalent governing body of such Person or the ability to cause the direction of management of such Person. “Clinical Trials” shall mean, with respect to a Female Product, the clinical trials required by the FDA for Regulatory Approval of such product in the United States, or equivalent trials required by Regulatory Authorities for Regulatory Approval of such product in a Major Market. “Commercial Assessment Period” shall mean the period commencing on the First Development Completion Payment Date and terminating on the Commercial Assessment Period Termination Date. “Commercial Assessment Period Termination Date” shall mean the first (1st) anniversary of the end of the R&D Period. “Commercially Reasonable Efforts” shall mean, with respect to the research, development, Manufacture or commercialization of Female Product(s), efforts and resources comparable to those used in the medical device industry for a product of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, its cost to develop, the competitiveness of alternative products, its proprietary position, the likelihood of regulatory approval, its profitability, and all other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis for each Female Product. “Consumable” shall mean a product, or a part or component of a product (including the container, canister, apparatus or device for holding, administering or delivering such product), which product, part or component thereof (a) is intended to be depleted by consumer use (e.g., coolants), (b) requires periodic replacement (e.g., containers for holding, delivering or administering any coolants, etc., or with respect to a Light-Based Hair Management Product, portions of such product that may be replaced depending on the design, such as the radiation source), or (c) replacement parts for any Light-Based Hair Management Product. “Consumer Field” shall mean products or systems intended for or marketed to consumers for personal use. For the avoidance of doubt, the “Consumer Field” shall exclude (i) products or systems in the Professional Field, and (ii) products or systems developed for and sold or distributed to governmental entities for treatment of medical conditions in military personnel. “Consumer Use Tests” or “CUTs” shall mean one or more tests conducted by or on behalf of Xxxxxxxx to determine consumer preferences with respect to a Female Product, including the features or function thereof. “Control” shall mean, with respect to any item of Information and Invention, Patent or other intellectual property right, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign, or grant a license, sublicense or other right to or under, such Information and Invention, Patent or other right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. “Controlled Information” shall mean the Palomar Controlled Information or Xxxxxxxx Controlled Information, as the case may be. “Core Palomar Patents” shall mean those Palomar Patents listed on Schedule A-1 hereto, and any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates, and any international or foreign equivalent of any such Patent, but excluding any continuation-in-part of any MGH Patents. “Costs” shall mean, with respect to certain activities, all costs actually incurred by a party (or any of its subcontractors) in connection with the performance of those activities during a period, and overhead calculated in accordance with the methodology exemplified on Schedule A-2 hereto. For any activity related to the research, development and/or commercialization of Female Products, “Costs” may include the costs of (a) research and development, (b) studies on clinical aspects conducted internally or externally, (c) preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain or expand Regulatory Approvals, (d) consultants necessary for the purpose of obtaining, maintaining or expanding Regulatory Approvals and handling those regulatory affairs, (e) regulatory and validation activities for Manufacturing plant and product, (f) Manufacturing Process and other process development, process improvement and scale-up and recovery costs, and (g) data management, statistical designs and studies, document preparation, and other administration expenses associated with the activities in question (including expenses associated with the clinical testing program or post-marketing studies required to maintain Regulatory Approvals). “Device Consumer Interface” shall mean, with respect to any Light-Based Hair Management Product, menus, interfaces and icon designs for the selection of options, settings and operating parameters, except to the extent that any of the foregoing enables the Functionality of a product, process or system or is otherwise required to comply with the requirements of Regulatory Authorities. “Europe” shall mean the European Union as it may be constituted from time to time. “Exclusive Field” shall mean (i) until the Male Option Termination Date (if any), the Field, and (ii) after the Male Option Termination Date (if any), the Female Field (and not the Male Field). For avoidance of doubt, if the Male Option Termination Date does not occur, then the Exclusive Field shall be the Field. “Exclusivity Period” shall mean the period commencing on the Effective Date and ending on the earliest date on which (a) Xxxxxxxx terminates such period pursuant to Section 10.2, (b) Xxxxxxxx terminates this Agreement pursuant to Section 10.4(a), 10.4(b), 10.4(c), 10.4(d) or 10.3, or (c) Palomar terminates this Agreement pursuant to Section 10.3 or 10.5. “Exploit” shall mean to make, have made, import, use, sell, or offer for sale, including to research, develop, register, modify, enhance, improve, Manufacture, have Manufactured, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose of. “Exploitation” shall mean the making, having made, importation, use, sale, offering for sale or disposition of a product or process, including the research, development, registration, modification, enhancement, improvement, Manufacture, formulation, optimization, import, export, transport, distribution, promotion or marketing of a product or process. “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto. “FDA Approval Period” shall mean a period of (a) February 14, 2007, in the case of a 510(k) Product, or (b) February 14, 2008, in the case of a PMA Product, provided that in the event that any delay in Regulatory Approval is caused by Xxxxxxxx, there shall be a corresponding extension of the FDA Approval Period. “Female Accessory Product” shall mean any apparatus, component, accessory, disposable or Consumable which is (i) designed specifically for, (ii) intended or marketed for sale or sold for use with, and (iii) physically integrated in or physically attached to, a Female Product; provided, however, that “Female Accessory Product” shall exclude any Topical. By way of example, and without limitation, a “Female Accessory Product” shall include any such apparatus, component, accessory, disposable, or Consumable comprising (i) a canister that is designed to dispense coolant and attaches to an apparatus comprising a Female Product (but not including any Topical contained therein), or (ii) a replaceable head for dispensing Optical Radiation from a Female Product. “Female Field” shall mean any product or system, which is intended or marketed for female Hair Management in the Consumer Field. “Female Product” shall mean (a) a Light-Based Hair Management Product intended for use in or marketed in the Female Field, which either (i) is developed in whole or in part by Palomar or Xxxxxxxx in connection with R&D Activities, Additional Activities, or Commercial Assessment Period Additional Activities or (ii) uses, embodies, is Manufactured using, practices an invention claimed by, comprises or is comprised of, in whole or in part, Palomar Technology, Joint Technology or Xxxxxxxx Excluded Technology, (b) all Female Accessory Products with respect thereto, (c) Female Product Topicals intended or marketed for sale or sold for use with any such Light-Based Hair Management Product for use in the Female Field, and (d) an Improvement to any of the foregoing. For the avoidance of doubt, “Female Product” shall exclude any (w) power sources, and (x) razors, blades, electric shavers or similar devices (even if any such power source, razor, blade, electric xxxxxx or similar device may be used with, or is recommended to improve the efficacy of, a Light-Based Hair Management Product), except to the extent that any such power source, razor, blade, electric xxxxxx or similar device is (1) not marketed and sold for uses independent of Light-Based Hair Management Products, (2) is physically integrated in or physically attached to a Light-Based Hair Management Product, and (3) is specifically designed for and sold for use with, a Light-Based Hair Management Product, and (y) any apparatus, component, accessory, disposable or Consumable other than Female Accessory Products covered by clause (b) above, and (z) any Topical other than Female Product Topicals covered by clause (c) above. “Female Product Topical” shall mean any Topical (a) that is (i) marketed for sale or sold for use with a Light-Based Device constituting a Female Product, and (ii) intended to be Used with such Light-Based Device; or (b) that is claimed, or the use or Manufacture of which is claimed, by a Palomar Patent or Joint Patent. “Female Product Technology” shall mean the Female Product(s), the Manufacturing Processes and any Improvements to the foregoing that, during the term of this Agreement, are Controlled by Palomar, but excluding any Information and Inventions (a) to the extent claimed by one or more claims of any Joint Patents or Palomar Excluded Third Party Patents, (b) constituting or comprising Palomar Excluded Third Party Know-How, or (c) that otherwise constitute Joint Inventions. “FFDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. as amended. “Field” shall mean the Female Field and the Male Field, collectively. “First Commercial Sale” shall mean the first sale or distribution of any Product by Xxxxxxxx or any of its sublicensees that gives rise to Net Sales under this Agreement. “First Decision Point” shall mean thirty (30) days after the later of August 31, 2006 or the date on which Palomar has completed the last R&D Activity required to be performed by Palomar pursuant to the R&D Plan. “First Development Completion Payment Date” shall mean (a) the First Decision Point, in the event that Palomar has obtained Regulatory Approval in the United States with respect to the First Female Product at least ten (10) days prior to the First Decision Point, or (b) thirty (30) days after the date on which Regulatory Approval in the United States is obtained by Palomar with respect to the First Female Product, in the event that Palomar has not obtained Regulatory Approval in the United States with respect to the First Female Product at least ten (10) days prior to the First Decision Point. “First Female Product” shall mean the Light-Based Hair Management Product intended for use in the Female Field (a) developed in whole or in part by Palomar or Xxxxxxxx pursuant to the Initial R&D Plan, and (b) comprising an apparatus for delivering Optical Radiation to areas of the skin, for which a party seeks Regulatory Approval in the United States in accordance with the terms of this Agreement. “Functionality” shall mean, with respect to a product, process or system, the operation of such product, process or system, and not the level or degree of efficacy achieved through use of such product, process or system. “GAAP”shall mean United States generally accepted accounting principles, consistently applied. “Xxxxxxxx Confidential Information” shall mean Confidential Information of Xxxxxxxx. “Xxxxxxxx Excluded Inventions” shall mean any and all Information and Inventions that are (a) first conceived, developed or reduced to practice by or on behalf of representatives, employees, agents or research partners of Xxxxxxxx (excluding Palomar), either alone or jointly (as determined under U.S. patent law) with Third Party(ies), (b) on or after the Amendment Date (but not before) and during the term of the Agreement, and (c) in connection with activities arising from, or performed pursuant to, the R&D Plan, or in the course of performing Additional Activities or Commercial Assessment Period Additional Activities, in each case to the extent such Information and Inventions consist of or constitute any (i) Topical, (ii) Device Consumer Interface, (iii) Business Methods and Materials, or (iv) Selected Topical Containers, provided, that, for clarity, it is understood and agreed that in each case ((i), (ii), (iii) and (iv)), “Xxxxxxxx Excluded Inventions” shall not include any and all Information and Inventions that are first conceived or developed in connection with activities conducted more than twelve (12) months after the latest to occur of the completion of the R&D Activities, Additional Activities or Commercial Assessment Period Additional Activities. “Xxxxxxxx Excluded Know-How” shall mean all Information and Inventions included in the Xxxxxxxx Excluded Inventions that are not generally known, plus all Specific Property Rights arising from Xxxxxxxx Excluded Inventions, but excluding any Information and Inventions to the extent claimed by a Xxxxxxxx Excluded Patent. “Xxxxxxxx Excluded Patents” shall mean any Patents to the extent (and only to the extent) one or more claims of such Patents claim any Xxxxxxxx Excluded Inventions, provided that “Xxxxxxxx Excluded Patents” shall not include claims of such Patents to the extent that any such Xxxxxxxx Excluded Invention (a) is claimed in combination with any Light-Based Device and (b) enables the Functionality of such device. “Xxxxxxxx Excluded Technology” shall mean the Xxxxxxxx Excluded Patents and the Xxxxxxxx Excluded Know-How, collectively. “Xxxxxxxx Improvement” shall mean an Improvement to a Female Product or a Manufacturing Process for a Female Product, which Improvement is first conceived, developed or reduced to practice by or on behalf of Xxxxxxxx after the date on which the Exclusivity Period or this Agreement is terminated, as applicable. “Xxxxxxxx Joint Independent Product” shall mean an Independent Product Exploited by or on behalf of Xxxxxxxx, optionally with one or more Third Parties, in the Field, which uses, embodies, is Manufactured using, practices an invention claimed by, comprises or is comprised of Joint Technology or Xxxxxxxx Excluded Technology. “Xxxxxxxx Know-How” shall mean (a) all Information and Inventions that (i) Xxxxxxxx Controls (other than pursuant to this Agreement) as of the Effective Date or at any time during the term of this Agreement that are necessary or useful for, or otherwise related to, the Exploitation of Light-Based Hair Management Products in the Female Field and that are not generally known, and (ii) that Xxxxxxxx discloses and makes available to Palomar for use in connection with the R&D Activities, Additional Activities or Commercial Assessment Period Additional Activities, plus all Specific Property Rights arising from such Information and Inventions and Controlled by Xxxxxxxx, but excluding (x) any Information and Inventions to the extent claimed by one or more of the Xxxxxxxx Patents or Joint Patents, and (y) any Joint Know-How; and (b) without limitation to clause (a), all Xxxxxxxx Excluded Know-How. “Xxxxxxxx Licensed Patents” shall mean those Xxxxxxxx Patents that (a) are Controlled (other than pursuant to this Agreement) by Xxxxxxxx and (b) claim Information and Invention(s) that are conceived prior to or during the term of the Agreement and are incorporated in Female Products (including prototypes of such products) or Manufacturing Processes for Female Products, which products or processes are developed or under development by Xxxxxxxx (by subcontract, with Palomar hereunder or with one or more Third Parties) at the time of termination of the Exclusivity Period or termination of this Agreement, as applicable and pursuant to ARTICLE X, but only with respect to such claims and no other claims of such patents; provided, however, that “Xxxxxxxx Licensed Patents” shall exclude Patent claims to the extent that they claim razors, blades, electric shavers or similar devices, products or parts thereof. “Xxxxxxxx Patents” shall mean all (a) Patents that Xxxxxxxx Controls (other than pursuant to this Agreement), as of the Effective Date or at any time during the term of this Agreement, that in each case are necessary or useful for, or otherwise related to, the Exploitation of any Light-Based Hair Management Product in the Female Field, (b) Patents that Xxxxxxxx Controls (other than pursuant to this Agreement), as of the Effective Date or at any time during the term of this Agreement, that in each case claim Information or Inventions that Xxxxxxxx discloses and makes available to Palomar for use in connection with the R&D Activities, Additional Activities or Commercial Assessment Period Additional Activities; and (c) without limitation to clauses (a) or (b), all Xxxxxxxx Excluded Patents; but excluding in the case of clauses (a) and (b) any Joint Patents. “Xxxxxxxx Prosecution Joint Patents” shall mean Joint Patents to the extent claiming (a) Business Methods and Materials, (b) Device Consumer Interfaces, (c) Selected Topical Containers or (d) Topicals, in each case ((a), (b), (c) or (d)) other than to the extent claiming any such Business Methods and Materials, Device Consumer Interfaces, Selected Topical Containers or Topicals, as applicable, in combination with any Light-Based Device with respect to which it enables Functionality. “Xxxxxxxx Regulatory Documentation” shall mean all Regulatory Documentation developed by Xxxxxxxx. “Xxxxxxxx Technology” shall mean the Xxxxxxxx Patents and the Xxxxxxxx Know-How, collectively. “Good Manufacturing Practices” shall mean the current good manufacturing practices applicable from time to time to the Manufacturing of any Female Product pursuant to Applicable Law. “Hair Management” shall mean (a) the removal of human hair shafts or changes in the associated structures, and (b) any other reduction of human hair growth, shaft diameter or pigmentation. “IDE” shall mean an investigational device exemption as defined in the regulations promulgated by the FDA for the authorization to commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory. “Improvement” shall mean any modification, variation or revision to a product, system or technology or any discovery, technology, device, process or formulation related to such product, system or technology, whether or not patented or patentable or otherwise protectable by intellectual property rights, including any enhancement in the efficiency, operation, Manufacture (including any Manufacturing Process), ingredients, preparation, presentation, formulation, means of delivery, powering or operating or packaging of such product, system or technology, any discovery or development of any new or expanded uses for such product, system or technology, or any discovery or development that improves the stability, safety or efficacy of such product, system or technology or reduces cost of operation or Manufacture. “Independent Accessory Product” shall mean any apparatus, component, accessory, disposable or Consumable which is (a) designed specifically for, (b) intended or marketed for sale or sold for use with, and (c) physically integrated in or physically attached to, an Independent Product; provided, however, that “Independent Product” shall exclude any Topical. “Independent Product” shall mean (a) any Light-Based Hair Management Product that is not a Female Product and that is intended or marketed for use in the Field, (b) Independent Accessory Products with respect thereto, (c) Independent Product Topicals for such Light-Based Hair Management Product, and (d) any Improvement to any of the foregoing. “Independent Product Topical” shall mean any Topical that is (a) marketed for sale or sold for use with a Light-Based Device constituting an Independent Product, and (b) intended to be Used with such Light-Based Device. “Information and Inventions” shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, pre-clinical and clinical trial results, Manufacturing procedures, test procedures and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable or otherwise protectable) in written, electronic or any other form now known or hereafter developed, and all Improvements, whether to the foregoing or otherwise, and other discoveries, developments and inventions (whether or not confidential, proprietary, patented or patentable or otherwise protectable). “Initial Prototypes” shall mean the six (6) Prototypes that Palomar is required pursuant to the R&D Plan to deliver to Xxxxxxxx at or near the beginning of the R&D Period. “Joint Excluded Inventions” shall mean any and all Information and Inventions that are first conceived, developed or reduced to practice jointly (as determined under U.S. patent law) by or on behalf of representatives, employees, agents or research partners of Palomar and representatives, employees, agents or research partners of Xxxxxxxx during the term of the Agreement, either together or jointly (as determined under U.S. patent law) with a Third Party(ies), on or after the Amendment Date and during the term of this Agreement to the extent constituting or comprising any (i) Topical, or (ii) Selected Topical Container. “Joint Excluded Know-How” shall mean all Information and Inventions included in the Joint Excluded Inventions that are not generally known, plus all Specific Property Rights arising from Joint Excluded Inventions, but excluding any Information and Inventions to the extent claimed by a Joint Excluded Patent. “Joint Excluded Patents” shall mean any Patents to the extent one or more claims of such Patents claim any Joint Excluded Inventions, provided that “Joint Excluded Patents” shall not include claims of such Patents to the extent that any such Joint Excluded Invention (a) is claimed in combination with any Light-Based Device and (b) enables the Functionality of such device. “Joint Excluded Technology” shall mean the Joint Excluded Patents and the Joint Excluded Know-How, collectively. “Joint Inventions” shall mean any and all Information and Inventions that are (a) first conceived, developed or reduced to practice jointly (as determined under U.S. patent law) by or on behalf of representatives, employees, agents or research partners of Palomar and representatives, employees, agents or research partners of Xxxxxxxx during the term of the Agreement, either together or jointly (as determined under U.S. patent law) with a Third Party(ies), (b) first conceived, developed or reduced to practice by or on behalf of representatives, employees, agents or research partners of Xxxxxxxx, either alone or jointly (as determined under U.S. patent law) with Third Party(ies) during the term of the Agreement in connection with activities arising from, or performed pursuant to, the R&D Plan, or in the course of performing Additional Activities or Commercial Assessment Period Additional Activities, or (c) first conceived, developed or reduced to practice by or on behalf of representatives, employees, agents or research partners of Palomar, either alone or jointly (as determined under U.S. patent law) with a Third Party(ies) during the term of the Agreement in connection with activities arising from, or performed pursuant to, the R&D Plan, or in the course of performing Additional Activities or Commercial Assessment Period Additional Activities, excluding, in each case ((a), (b) and (c)), any and all Xxxxxxxx Excluded Inventions and Palomar Excluded Inventions; provided, however, that “Joint Inventions” under clauses (b) and (c) shall exclude any and all Information and Inventions that are first conceived or developed in connection with activities conducted more than twelve (12) months after the latest to occur of the completion of the R&D Activities, Additional Activities or Commercial Assessment Period Additional Activities. “Joint Know-How” shall mean all Information and Inventions included in the Joint Inventions that are not generally known, plus all Specific Property Rights arising from Joint Inventions, but excluding any Information and Inventions to the extent claimed by a Joint Patent. “Joint Patents” shall mean any Patents to the extent one or more claims of such Patents claim any Joint Inventions. “Joint Technology” shall mean the Joint Patents and the Joint Know-How, collectively. “Launch” shall mean, with respect to a product or system, the date on which the First Commercial Sale of such product or system occurs. “Light-Based Accessory Product” shall mean any apparatus, component, accessory, disposable or Consumable which (a) is designed specifically for, (b) is intended or marketed for sale or sold for use with, and (c) is physically integrated in or physically attached to, a Light-Based Product; provided, however, that “Light-Based Accessory Product” shall exclude any Topical. “Light-Based Device” shall mean a Light-Based Hair Management Product to the extent consisting of or constituting an apparatus for delivering Optical Radiation to areas of the skin. For clarity, a “Light-Based Device” shall exclude all Topicals. “Light-Based Product” shall mean a process, product or system that achieves one or more of the following effects with the use of Optical Radiation: (i) Hair Management outside the Field, (ii) the treatment or prevention of cellulite, cosmetic anti-aging skin applications (including wrinkle reduction, improvement in skin tone, texture and elasticity, and removal of pigmented and vascular lesions), (iii) body recontouring, (iv) the removal, treatment or prevention of warts, subcutaneous fat, acne, tattoos, scars, birth marks, oily skin, odor, moles and blemishes, and (v) any other improvement of skin condition, appearance, tone or texture other than in connection with Hair Management in the Field; provided, however, that (1) as used in Sections 5.3 through 5.5 and Section 8.1(c)(iii), “Light-Based Product” shall include, without limitation, all processes, products or systems that use Optical Radiation to achieve Hair Management, and (2) as used in Sections 5.3 through 5.5, “Light-Based Product” shall include all Light-Based Accessory Products. “Light-Based Hair Management Product” shall mean (a) a process, product or system, which product or system comprises an apparatus for delivering Optical Radiation generated by such process, product or system, and which is intended or marketed for Hair Management in the Consumer Field, and (b) any (i) apparatus, component, accessory, disposable or Consumable which is (1) designed specifically for, (2) intended or marketed for sale or sold for use with, and (3) physically integrated in or physically attached to, such a process, product or system, or (ii) any Topical that is (1) marketed for sale or sold for use with such process, product or system, and (2) intended to be Used with such process, product or system. Such product or systems may include other mechanisms for Hair Management (e.g., chemical, mechanical, magnetic, acoustic, radio frequency, temperature, or electrical) to the extent that such mechanisms are designed specifically for, intended or marketed for sale or sold for use with, and physically integrated in or physically attached to such product or system. For the avoidance of doubt, “Light-Based Hair Management Products” shall exclude any (w) power sources, and (x) razors, blades, electric shavers or similar devices (even if use of any such power source, razor, blade, electric xxxxxx or similar device may be used with, or use thereof, is recommended to improve the efficacy of a Light-Based Hair Management Product), except to the extent that any such power source, razor, blade, electric xxxxxx or similar device (1) is not marketed and sold for uses independent of such product or system, (2) is physically integrated in or physically attached to such product or system, and (3) is specifically designed for and sold for use with, such product or system, and (y) any apparatus, component, accessory, disposable or Consumable other than those covered by clause (b)(i) above, and (z) any Topical other than those covered by clause (b)(ii) above. “Major Market” shall mean each of the United States, Canada, Europe and Japan. “Male Field” shall mean any product or system, which is intended or marketed for male Hair Management in the Consumer Field. “Male Option Termination Date” shall mean (i) in the event that Xxxxxxxx does not exercise the Male Option when a Male Product Opportunity is offered by Palomar to Gillette, the date on which the Male Option terminates pursuant to Section 5.1(b)(v), or (ii) in the event that Gillette exercises the Male Option pursuant to Section 5.1(b)(iv), the first date on which the Male Collaboration Agreement becomes effective. “Manufacture” and “Manufacturing” shall mean, with respect to a product or system, the manufacturing, processing, formulating, packaging, labeling, holding and quality control testing of such product or compound. “Manufacturing Process” shall mean any process or step thereof that is necessary or useful for Manufacturing any Light-Based Hair Management Product and any Improvement thereto. “Marketing Authorization” shall mean, with respect to a Female Product, a 510(k) Notification or a PMA, whichever (if any) is required by Applicable Law. “Marketing Materials” shall mean (a) material, whether in written, printed, graphic or electronic form, intended for use in marketing or promoting products, including visual aids and any other promotional support items, advertisements, brochures, displays and presentation materials, (b) product packaging materials, and (c) labels and other written, printed or graphic matter affixed to any container, packaging or wrapper utilized with a product or otherwise accompanying a product, including package inserts. “MGH” shall mean Massachusetts General Hospital. “MGH Agreements” shall mean (a) that certain License Agreement by and between Palomar and MGH, dated August 18, 1995, (b) that certain Clinical Trial Agreement by and between Palomar and MGH, dated August 18, 1995, and (c) that certain Joint Patent Agreement by and between Palomar and MGH, dated January 1, 2000, in each case as such agreement is amended as of the Effective Date and as such agreement may be amended or restated thereafter in a manner that is not inconsistent with the terms of this Agreement. “MGH Patents” shall mean (a) as of the Effective Date, all Patents in existence and to which Palomar has received or is entitled to receive a license from MGH under the MGH Agreements, and (b) all claims contained in a Patent that makes a priority claim to any of the Patents that are identified in clause (a) above, provided any such priority claim has an earliest priority date based solely on the Patents that are identified in clause (a) above. Without limitation to the foregoing, “MGH Patents” shall include the Patents listed on Schedule A-3 hereto. “MGH Valid Claim” shall mean a claim contained in a pending application for a MGH Patent or MGH Joint Patent in such country which claim was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of said application in such country. “Net Sales” shall mean, for any period, the gross amount invoiced by Gillette and its agents and (sub)licensees from or on account of the sale or distribution of Product(s) to bona fide unrelated Third Parties (the “Invoiced Sales”), less deductions actually taken, or reasonable allocations of accruals, for: (a) normal and customary trade, quantity and cash discounts and sales returns and allowances, including (i) those actually granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns and rebates; (ii) allowances and rebates paid to distributors or trade customers, or provided to or for the benefit of consumers, including consumer-oriented temporary pricing reductions (e.g., coupon value or rebates, etc.); and (iii) chargebacks; (b) freight, postage, shipping and insurance expenses to the extent that such items are actually incurred in shipping such Products to such Third Parties and included in the gross amount invoiced; (c) customs and excise duties and other duties related to the sales to the extent that such items are actually incurred and included in the gross amount invoiced; (d) sales and other taxes and duties directly related to and actually incurred for the sale or delivery of Product(s) (but not including taxes assessed against the income derived from such sale); (e) distribution expenses to the extent that such items are included in the gross amount invoiced; (f) any other similar and customary deductions that are consistent with GAAP in effect from time to time, or in the case of non-United States sales, other applicable accounting standards; and (g) any such invoiced amounts that are not collected by Gillette or its (sub)licensees. Any of the deductions listed above that involves a payment by Gillette and its agents and (sub)licensees shall be taken as a deduction in the Calendar Quarter in which the payment is accrued by such entity. Deductions pursuant to subsection (g) above shall be taken in the Calendar Quarter in which such sales are no longer recorded as a receivable. For purposes of calculating Net Sales, sales between or among The Gillette Company and its Affiliates or their agents or (sub)licensees shall be excluded from the computation of Net Sales, but sales by The Gillette Company or its Affiliates or their licensees or sublicensees to Third Parties shall be included in the computation of Net Sales. No deduction shall be made for any item of cost incurred by Gillette, its agents or (sub)licensees in preparing, manufacturing, shipping, distributing or selling Products except as expressly permitted in the foregoing paragraph. Such amounts shall be determined from the books and records of the entity that invoiced the Third Party, maintained in accordance with GAAP, or in the case of non-United States sales, other applicable accounting standards, in each case in effect from time to time consistently applied. To the extent Gillette or its agents or (sub)licensees receive consideration other than or in addition to cash with respect to the sales, promotion, or distribution of Products, Net Sales shall include the fair market value of such additional consideration. In the event that a Product is sold in any country in the form of a combination product containing one or more products, devices, components, accessories, Topicals or Consumables that are not Products (“Non-Product Components”), Net Sales of such combination product will be adjusted by multiplying actual Net Sales of such combination product in such country calculated pursuant to the first paragraph of this Section by the fraction A/(A+B), where A is the average invoice price in such country of the Product(s), if sold separately in such country, and B is the average invoice price in such country of the Non-Product Components. If, in a specific country, the Non-Product Components in the combination product are not sold separately in such country, Net Sales shall be adjusted by multiplying actual Net Sales of such combination product calculated pursuant to the first paragraph of this Section by the fraction A/C, where A is the average invoice price in such country of the Product(s)and C is the invoice price in such country of such combination product. If, in a specific country, a Product(s) is not sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such combination product calculated pursuant to the first paragraph of this Section by the fraction (C-B)/C, where B is the average invoice price in such country of the Non-Product Components in the combination product and C is the invoice price in such country of the combination product. If, in a specific country, both a Product(s) and the Non-Product Components, are not sold separately, a market price for such Product and such Non-Product Components shall be negotiated by the parties in good faith based upon the costs, overhead and profit as are then incurred for such combination product and all similar products, devices, systems, components, accessories, Topicals or Consumables then being made and marketed by Gillette and having an ascertainable market price. In the event that a Product that consists in whole or in part of a Selected Topical is sold in any country, whether sold separately or in combination with a Light-Based Device, the parties shall negotiate in good faith to determine a methodology for calculating amounts attributable to consumption of such Selected Topical other than during Use with the applicable Light-Based Device, which amounts shall be excluded from Net Sales hereunder. Notwithstanding the foregoing, the calculation of Net Sales with respect to any Specific Topical shall be subject to the condition set forth in the definition of a “Selected Topical.” “Non-Core Palomar Patents” shall mean all Palomar Patents other than Core Palomar Patents. “Non-Light-Based Product” shall mean a process, product or system that achieves one or more of the following effects without the use of Optical Radiation generated by such process, product or system: (a) Hair Management, (b) the treatment or prevention of cellulite, cosmetic anti-aging skin applications (including wrinkle reduction, improvement in skin tone, texture and elasticity, and removal of pigmented and vascular lesions), (c) body recontouring, (d) the removal, treatment or prevention of warts, subcutaneous fat, acne, tattoos, scars, birth marks, oily skin, odor, moles and blemishes, and (e) any other improvement of skin condition, appearance, tone or texture. “Optical Radiation” shall mean optical radiation that is intended to have or has a therapeutic function. “Other Independent Product” shall mean an Independent Product intended for use in or marketed in the Field (a) that is not a Gillette Joint Independent Product, and (b) that is Launched by or on behalf of Gillette, optionally with one or more Third Parties, during the Exclusivity Period or within seven (7) years after the first to occur of the termination of (i) the Exclusivity Period, or (ii) this Agreement. “Palomar Collaborator” shall mean a Third Party to which Palomar has granted a license, sublicense or other rights under certain Palomar Technology for purposes of Exploiting any product, process or system that uses Optical Radiation outside the Female Field. “Palomar Confidential Information” shall mean Confidential Information of Palomar. “Palomar Excluded Inventions” shall mean any and all Information and Inventions that are (a) first conceived, developed or reduced to practice by or on behalf of representatives, employees, agents or research partners of Palomar (excluding Gillette), either alone or jointly (as determined under U.S. patent law) with Third Party(ies), (b) on or after the Amendment Date (but not before) and during the term of the Agreement, and (c) in connection with activities arising from, or performed pursuant to, the R&D Plan, or in the course of performing Additional Activities or Commercial Assessment Period Additional Activities, in each case to the extent such Information and Inventions consist of or constitute any (i) Topical, (ii) Device Consumer Interface, (iii) Business Methods and Materials or (iv) Selected Topical Containers provided, that, for clarity, it is understood and agreed that in each case ((i), (ii), (iii) and (iv)), “Palomar Excluded Inventions” shall not include any and all Information and Inventions that are first conceived or developed in connection with activities conducted more than twelve (12) months after the latest to occur of the completion of the R&D Activities, Additional Activities or Commercial Assessment Period Additional Activities. “Palomar Excluded Know-How” shall mean all Information and Inventions included in the Palomar Excluded Inventions that are not generally known, plus all Specific Property Rights arising from Palomar Excluded Inventions, but excluding any Information and Inventions to the extent claimed by a Palomar Excluded Patent. “Palomar Excluded Patents” shall mean any Patents to the extent (and only to the extent) one or more claims of such Patents claim any Palomar Excluded Inventions, provided that “Palomar Excluded Patents” shall not include claims of such Patents to the extent that any such Palomar Excluded Invention (a) is claimed in combination with any Light-Based Device and (b) enables the Functionality of such device. “Palomar Excluded Third Party Know-How” shall mean any Information and Inventions, plus all Specific Property Rights arising therefrom, (a) not generally known, (b) first conceived, developed or reduced to practice on or after the Amendment Date (but not before) and during the term of this Agreement, (c) Controlled by Palomar other than by Palomar’s ownership thereof as a result of a license, sublicense or other right granted to Palomar by a Palomar Collaborator, (d) constituting or comprising a Topical, Device Consumer Interface, Business Methods and Materials or Selected Topical Container, and (e) not claimed by a Palomar Excluded Third Party Patent. “Palomar Excluded Third Party Patents” shall mean any Patents to the extent (and only to the extent) claiming any Information and Inventions (1) first conceived, developed or reduced to practice on or after the Amendment Date (but not before) and during the term of this Agreement, (2) Controlled by Palomar other than by Palomar’s ownership thereof as a result of a license, sublicense or other right granted to Palomar by a Palomar Collaborator, and (3) constituting or comprising a Topical, Device Consumer Interface, Business Methods and Materials or Selected Topical Container, provided that “Palomar Excluded Third Party Patents” shall not include claims of such Patents to the extent that any such Information and Inventions (a) is claimed in combination with any Light-Based Device and (b) enables the Functionality of such device. “Palomar Know-How” shall mean (a) all Information and Inventions in the Control (other than pursuant to this Agreement) of Palomar as of the Effective Date or at any time during the term of this Agreement that are necessary or useful for, or otherwise related to, the Exploitation of Light-Based Hair Management Products in the Female Field and that are not generally known, plus all Specific Property Rights arising from such Information and Inventions and Controlled by Palomar, but excluding (i) any Information and Inventions to the extent claimed by one or more of the Palomar Patents, Palomar Excluded Third Party Patents or Joint Patents, (ii) Palomar Excluded Third Party Know-How, and (iii) any Joint Know-How; and (b) without limitation to clause (a), all Palomar Excluded Know-How that are necessary or useful for, or otherwise related to, the Female Field. Palomar Know-How shall include, subject to the preceding exclusions, all clinical, safety, Manufacturing and quality control data and information Controlled by Palomar and related to the Female Product Technology. “Palomar Improvement” shall mean an Improvement to a Female Product or a Manufacturing Process for a Female Product, which Improvement is first conceived, developed or reduced to practice by or on behalf of Palomar after the date on which the Exclusivity Period or this Agreement is terminated, as applicable. For the avoidance of doubt, Palomar Improvements shall exclude any Gillette Improvements. “Palomar Male Know-How” shall mean (a) all Information and Inventions in the Control (other than pursuant to this Agreement) of Palomar as of the Effective Date or at any time during the term of this Agreement that are necessary or useful for, or otherwise related to, the Exploitation of Light-Based Hair Management Products in the Male Field and that are not generally known, plus all Specific Property Rights arising from such Information and Inventions and Controlled by Palomar, but excluding (i) any Information and Inventions to the extent claimed by one or more of the Palomar Patents, Palomar Excluded Third Party Patents or Joint Patents, (ii) Palomar Excluded Third Party Know-How, and (iii) any Joint Know-How; and (b) without limitation to clause (a), all Palomar Excluded Know-How that is necessary or useful for, or otherwise related to, the Male Field. Palomar Male Know-How shall include, subject to the preceding exclusions, all clinical, safety, Manufacturing and quality control data and information Controlled by Palomar and related to the Male Field. “Palomar Male Patents” shall mean (a) the MGH Patents, and (b) all of the Patents that Palomar Controls (other than pursuant to this Agreement), as of the Effective Date and at any time during the term of this Agreement, that in each case are necessary or useful for, or otherwise related to, the Exploitation of any Light-Based Hair Management Product in the Male Field, but excluding (i) the Joint Patents and (ii) Palomar Excluded Third Party Patents, and (c) without limitation to clause (b), all Palomar Excluded Patents that are necessary or useful for, or otherwise related to, the Male Field. The “Palomar Male Patents” shall include all Patents listed in Schedule 12.3(f), and any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates, and any international or foreign equivalent of any Patent, but excluding any continuation-in-part of any MGH Patents. “Palomar Male Technology” shall mean the Palomar Male Patents and the Palomar Male Know-How, collectively. “Palomar Patents” shall mean (a) the MGH Patents, (b) all of the Patents that Palomar Controls (other than pursuant to this Agreement), as of the Effective Date and at any time during the term of this Agreement, that in each case are necessary or useful for, or otherwise related to, the Exploitation of any Light-Based Hair Management Product in the Female Field, or that contain a claim covering any Female Product Technology, but excluding (i) the Joint Patents and (ii) Palomar Excluded Third Party Patents, and (c) without limitation to clause (b), all Palomar Excluded Patents that are necessary or useful for, or otherwise related to, the Female Field. The “Palomar Patents” shall include all Patents listed in Schedule 12.3(f), and any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates, and any international or foreign equivalent of any Patent, but excluding any continuation-in-part of any MGH Patents. “Palomar Technology” shall mean the Palomar Patents and the Palomar Know-How, collectively. “Patents” shall mean (a) all patents and patent applications and any patents issuing therefrom worldwide, (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates, term extensions (under applicable patent law or other Applicable Law), certificates of invention and the like, and any provisional applications, of any such patents or patent application, and (c) any foreign or international equivalent of any of the foregoing. “Patent Costs” shall mean the fees and expenses paid to outside legal counsel and other Third Parties (including Third Party licensors of Patents, such as MGH for the Palomar Patents), allocated in-house costs of legal counsel, and filing and maintenance expenses, incurred in connection with preparing, filing, prosecuting and maintaining Patents, including costs of patent interference, re-examination, reissue, opposition or similar proceedings relating thereto. “PCT” shall mean the Patent Cooperation Treaty, opened for signature June 19, 1970, 28 U.S.T. 7645. “Person” shall mean an individual, sole proprietorship, general partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, cooperative, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government, and the heirs, executors, administrators, legal representatives, successors and assigns of such Person as the context may require. “PMA Product” shall mean a product, the sale of which requires the filing with and approval by the FDA of a PMA. “Premarket Approval” or “PMA” shall mean a premarket approval as defined in the FFDCA, and the regulations promulgated thereunder, necessary to market a Female Product in the United States. “Product” shall mean a Female Product, Gillette Joint Independent Product, Other Independent Product, or any product or system Exploited by Palomar pursuant to any license under the Gillette Licensed Patents that is granted by Gillette to Palomar in this Agreement, as the case may be. “Product Specifications” shall mean the written specifications for the design and Manufacture of a product or system. “Professional Field” shall mean products or systems intended or marketed for sale to doctors, health care providers or other commercial service providers for use on or with patients or customers (and not for resale to any Person). “Prototypes” shall mean one or more prototypes of the Female Product Manufactured or made by or on behalf of either party during the R&D Period for the purposes of evaluating, testing or improving such product pursuant to the R&D Plan and this Agreement, which in the case of any such unit delivered by Palomar to Gillette shall have been Manufactured or made pursuant to the then-current Product Specifications. “Regulatory Approval” shall mean, on a country-by-country basis, the right with respect to a Female Product to sell or distribute such product or system for female Hair Management in the Consumer Field. In the case of the United States, sale or distribution of a Female Product may require a determination by the FDA of substantial equivalence (within the meaning of 21 C.F.R. § 807.100) following the filing with the FDA of a 510(k) Notification, or in the event that a PMA is required, the approval by the FDA of such PMA, and in the case of any other country or territory, any necessary international or foreign approvals. “Regulatory Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of the Female Product Technology in the Territory. “Regulatory Documentation” shall mean all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to any Female Product Technology, and all data contained in any of the foregoing, including all IDEs, 510K Notifications, PMA Notifications, Marketing Authorizations, advertising and promotion documents, adverse event files, complaint files and Manufacturing records. “Restricted Access Period” shall mean the period commencing on the Commencement Date and ending on the date of the later to occur of (a) three hundred and sixty five (365) days after such date, in the event that Palomar delivers to Gillette the Initial Prototypes on or before the Commencement Date, or (b) the sum of (i) the number of days after the Commencement Date until Palomar delivers to Gillette the Initial Prototypes and (ii) three hundred and sixty five (365) days, in the event that Palomar delivers to Gillette the Initial Prototypes after the Commencement Date. “R&D” shall mean research and development. “R&D Activities” shall mean those tests, studies and other activities set forth in, or required in order to obtain the information set forth in, the R&D Plan and such other tests, studies and other activities as may be specified from time to time by the R&D Committee with respect to the subject Female Product. “R&D Plan” shall have the meaning set forth in Section 1.1(a), as amended by (a) the Memorandum of Understanding signed June 19, 2006, (b) the Memorandum of Understanding signed June 21, 2006, (c) the Memorandum of Understanding signed June 22, 2006, (d) the R&D Committee minutes dated between June 22-24, 2005 and (e) the R&D Committee minutes dated August 31, 2006, in each case ((a), (b), (c), (d) and (e)) to the extent that the referenced document modifies the Initial R&D Plan. “R&D Program” shall mean the program of R&D Activities carried out by the parties pursuant to the R&D Plan. “Safety and Efficacy Standards” shall mean, with respect to a Subject Male Product, (a) a demonstrated safety performance at least as safe as the prototype Female Product presented by Palomar to Gillette on May 6 and 7, 2002, and (b) a resulting hair growth clearance period longer than the period resulting from shaving with a conventional blade device, in each case as evidenced by studies at least as stringent as those provided by Palomar to Gillette on May 6 and 7, 2002. “Second Decision Point” shall mean thirty (30) days after the Commercial Assessment Period Termination Date. “Second Development Completion Payment Date” shall mean the date of the Second Decision Point. “Selected Topical” shall mean a Female Product Topical or an Independent Product Topical that is marketed for sale or sold (a) for Use with a Light-Based Device and (b) for use on a daily basis or other periodic basis; provided, however, that Selected Topical shall not include a Female Product Topical or an Independent Product Topical that (i) is sold only with or for use with a Light-Based Device and (ii) for which Light-Based Device no other Topical is marketed for sale or sold for Use with (each such Female Product Topical and Independent Product Topical, a “Specific Topical”), and for all such Specific Topicals, the Net Sales attributable to Specific Topicals for which royalties or TTPs are paid hereunder shall be fifty percent (50%) of the actual Net Sales invoiced for Specific Topicals. “Selected Topical Containers” shall mean any containers, cartridges or applicators that hold or dispense a Topical, in each case provided any such container, cartridge or applicator (a) is not physically integrated in or physically attached to (such as any such container, cartridge or applicator that is attachable and is designed to dispense coolant) a product, process or system that uses Optical Radiation, and (b) does not enable the Functionality of a product, process or system that uses Optical Radiation. “Specific Property Rights” shall mean copyrights (including rights in computer software) and database rights but no other intellectual property rights (including Trademark rights, Patents, trade secret or other proprietary or confidentiality rights), in any part of the Territory whether registered or not registered together with the right to apply for the registration of any such rights. “Technology” shall mean, as applicable, the Gillette Technology, Palomar Technology, Palomar Male Technology or Joint Technology. “Territory” shall mean the entire world. “Third Party” shall mean any Person other than The Gillette Company, Palomar Medical Technologies, Inc. and their respective Affiliates or individuals who are their employees or agents when acting in that capacity. “Third Party Collaboration” shall mean, in the case of either Gillette or Palomar, a collaboration with a Third Party with respect to a product, system or other technology with respect to which Gillette or Palomar, as the case may be, has material co-development obligations or co-promotion rights or co-marketing rights. “Topical” shall mean any topically applied composition, including any lotion, gel, wax, gas, cream, foam, powder, spray, oil, aerosol, particles or similar composition. “Trademark” shall include any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, trade name, brand name, logo or business symbol. “TTP” shall mean a technology transfer payment. “Use” of a Topical shall mean that such Topical (i) is intended to be applied or applied in direct preparation for or during a light application session with, or (ii) enables Functionality of, a Light-Based Device. “Valid Claim” shall mean, with respect to a particular country, (a) any claim of an issued and unexpired Patent in such country that (i) has not been revoked or held permanently unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken or has been taken within the time allowed for appeal in such country, and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country; (b) a pending claim of a Patent application, other than any MGH Patents or MGH Joint Patents, applicable to such country that was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of the application, provided that such claim has not been ongoing for more than four (4) years in the case of any United States Patent application or more than seven (7) years in the case of any Patent application in any other country; and (c) for all MGH Patents and MGH Joint Patents but no other Patents, with respect to such country, an MGH Valid Claim. Terms Defined Elsewhere in this Agreement. The following terms, whether used in the singular or the plural and correlatives thereof, are defined in the applicable Sections of this Agreement. |
| Defined Term | Section | |
| “Acquiring Party” | Definition of “Change of Control” | |
| “ADR” | Section 13.2(a) | |
| “Additional Activities” | Section 1.8(a) | |
| “Additional Light-Based Hair Management Product” | Section 1.7 | |
| “Additional Product Report” | Section 1.7 | |
| “Agreement” | Preamble | |
| “Annual Exclusivity Collaboration Payment” | Section 6.1(g) | |
| “Annual Exclusivity Collaboration Period” | Section 6.1(g) | |
| “Authorized Overruns” | Section 1.8(a)(i)(2) | |
| “Commencement Date” | Section 1.1(c) | |
| “Commercial Assessment Period Additional Activities” | Section 2.2(a) | |
| “Confidential Information” | Section 9.3(a) | |
| “Cure Period” | Section 10.3 | |
| “Development Completion Payments” | Section 6.1(d)(i) | |
| “Disclosure Schedule” | Section 12.1 | |
| “Dispute” | Section 13.1 | |
| “Dispute Notice” | Section 12.3(a)(i) | |
| “Effective Date” | Preamble | |
| “Execution Date” | Preamble | |
| “Estimate” | Section 1.8(a)(2) | |
| “Evaluation Materials” | Section 5.1(b)(ii) |
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| “Exclusivity Payment Date” | Section 6.1(g) | |
| “Failure to Launch Payments” | Section 2.1(b)(ii) | |
| “Female Product Payment Rate” | Section 6.1(h) | |
| “First Development Completion Payment” | Section 6.1(d)(i) | |
| “First Press Release” | Section 9.5 | |
| “Gillette” | Preamble | |
| “Gillette Controlled Information” | Section 9.1(c) | |
| “Gillette Exclusive Licenses” | Section 8.3(a)(i) | |
| “Gillette Exclusive License Period” | Section 8.3(a)(i) | |
| “Gillette License Agreement” | Section 5.3(b)(i) | |
| “Gillette Licensee” | Section 5.3(b)(i) | |
| “Indemnification Claim Notic” | Section 11.3(a) | |
| “Indemnification Claim Notice” | Section 11.3(a) | |
| “Indemnified Party” | Section 11.3(a) | |
| “Independent Product Payment Rate” | Section 6.4 | |
| “Infringement Suit” | Section 8.5(c)(i) | |
| “Initial Gillette Specifications” | Section 5.4(a)(i)(1) | |
| “Initial R&D Plan” | Section 1.1(a) | |
| “In-License Agreement” | Section 12.3(f) | |
| “Invoiced Sales” | Definition of “Net Sales” | |
| “Launch Decision” | Section 2.3 | |
| “Licensed Palomar Patents” | Section 12.3(f) | |
| “Losses” | Section 11.1 | |
| “Male Collaboration Agreement” | Section 5.1(c) | |
| “Male Option” | Section 5.1(a) | |
| “Male Product” | Section 5.1(a) | |
| “Male Product Opportunity” | Section 5.1(b) | |
| “Merger” | Section 14.2(f) | |
| “MGH Joint Invention” | Section 8.1(c)(ii)(2) | |
| “MGH Joint Know-How” | Section 8.1(c)(ii)(2) | |
| “MGH Joint Patents” | Section 8.1(c)(ii)(2) | |
| “MGH Joint Technology” | Section 8.1(c)(ii)(2) | |
| “Neutral” | Section 13.2(a) | |
| “Non-Disclosure Agreement” | Section 9.8 | |
| “Non-Product Components” | Definition of Net Sales | |
| “Offer” | Section 10.1(b) | |
| “Offer Period” | Section 10.1(b) | |
| “Opportunity Notice” | Section 5.1(b) | |
| “Opportunity Notice Effective Date” | Section 5.1(b)(iii) | |
| “Option Exercise Notice” | Section 5.1(b)(iv) | |
| “Option Exercise Period” | Section 5.1(b)(iv) | |
| “Original Agreement” | Preamble | |
| “Overrun” | Section 1.8(a)(2) | |
| “Owned Palomar Patents” | Section 12.3(f) | |
| “Palomar” | Preamble |
|
|
| “Palomar Controlled Information” | Section 9.1(b) | |
| “Palomar Exclusive Licenses” | Section 8.4(b)(iii) | |
| “Palomar Exclusive License Period” | Section 8.4(b)(iii) | |
| “Palomar Key Personnel” | Section 1.1(d) | |
| “Palomar License Agreement” | Section 5.3(a)(i) | |
| “Palomar Licensee” | Section 5.3(a)(i) | |
| “Palomar Marks” | Section 2.1(a)(iii)(2) | |
| “Palomar Medical Technologies, Inc.” | Preamble | |
| “Palomar U.S. Regulatory Documentation” | Section 1.2(e) | |
| “Permitted Confidants” | Section 9.1(a) | |
| “Product/Service Payment Rate” | Section 6.5) | |
| “R&D Advance Payment” | Section 6.1(b) | |
| “R&D Payments” | Section 6.1(a) | |
| “R&D Committee” | Section 1.4(a) | |
| “R&D Committee Chair” | Section 1.4(c) | |
| “R&D Committee Leader” | Section 1.4(b) | |
| “R&D Leader” | Section 1.1(d) | |
| “R&D Period” | Section 1.1(c) | |
| “R&D Plan” | Section 1.1(a) | |
| “R&D Plan Subcontracted Activities” | Section 1.1(e) | |
| “SEC” | Section 9.5 | |
| “Second Development Completion Payment” | Section 6.1(d)(i) | |
| “Specific Topical” | Definition of Selected Topical | |
| “Subject Male Product” | Section 5.1(b)(1) | |
| “Supplemental R&D Plan” | Section 1.7 | |
| “Supplemental R&D Payments” | Section 1.7 | |
| “Terms and Conditions” | Section 13.2(b) | |
| “The Gillette Company” | Preamble | |
| “P&G” | Section 14.2(f) | |
| “Third Party Claim” | Section 11.1 |
Name and Title |
Responsibilities |
Percent of Time Committed to Project |
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** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. Schedule 12.1 Disclosure Schedule ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. 12.3(h) and (l) Palomar Medical Technologies, Inc. v. Lumenis, Ltd., Lumenis, Inc. ESC Medical Systems, Inc., and ESC/Sharplan Laser Industries Ltd., Trial Court, Superior Court Dept., Commonwealth of Massachusetts, Civ. Act. No. 02-4565, filed October 29, 2002. Lumenis, Inc., v. Palomar Medical Technologies, Inc. and The General Hospital Corporation, United States District Court, Northern District of California, Civ. Act. No. 02-5176, filed October 24, 2002. Palomar Medical Technologies, Inc. and The General Hospital Corporation v. Altus Medical, Inc. v. Palomar Medical Technologies, Inc. and The General Hospital Corporation, United States District Court, District of Massachusetts, Civ. Act. No. 02-10258-RWZ. ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. Schedule 12.3(f) Palomar Patents 12.3(f)(i): Owned Palomar Patents: ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. 12.3(f)(ii): Licensed Palomar Patents: ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. 12.3(f)(iii): In-License Agreements: ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. Schedule A-1 Core Palomar Patents ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. Schedule A-2 Costs ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. Schedule A-3 MGH Patents ** This material was omitted pursuant to a request for confidential treatment and was separately filed with the SEC on February 18, 2003. An aggregate of 17 pages were omitted. Such request for confidential treatment was granted on May 1, 2003. AMENDED AND RESTATEDDEVELOPMENT AND LICENSE AGREEMENTBETWEENTHE GILLETTE COMPANYANDPALOMAR MEDICAL TECHNOLOGIES, INC.ENTERED INTO AS OF FEBRUARY 14, 2007EFFECTIVE AS OF FEBRUARY 14, 2003 |
