2
3
• | Trade-in of a first Cynosure Product in connection with the Sale of a second Cynosure Product shall be treated as follows: (i) the Net Sales attributed to the Sale of such second Cynosure Product (a) shall not include any deduction or other reduction for the trade-in given by Cynosure for such first Cynosure Product, unless Cynosure paid royalties to Palomar hereunder upon the Sale of such first Cynosure Product (e.g., there shall be no such deduction or other reduction when such first Cynosure Product is a Cynosure Other Product), and (b) shall be calculated as set forth in this definition, and such Sale of such second Cynosure Product shall be subject to the royalty obligations set forth in Section 4.4, and (ii) the Net Sales attributable to any re-Sale of such first Cynosure Product shall be calculated as set forth in this definition, and such re-Sale of such first Cynosure Product shall be subject to the royalty obligations set forth in Section 4.4. For example, without limiting the generality of the foregoing, if a customer purchases from Cynosure an Apogee 5500 System for $60,000, then under Section 4.4, Cynosure is obligated to pay Palomar a royalty of $4,500 on such Sale of the Apogee 5500 System (7.5% of $60,000). If that customer then purchases from Cynosure an Acclaim 7000 Laser System for $120,000 and is provided a credit of $20,000 in connection with a trade-in of such Apogee 5500 System that such customer previously purchased (thus paying Cynosure $100,000), then under Section 4.4, Cynosure is obligated to pay Palomar a royalty of $7,500 on such Sale of the Acclaim 7000 Laser System (7.5% of $100,000) and no amount shall be due hereunder for the $20,000 credit provided for the Apogee 5500 System. If Cynosure then re-Sells the traded-in Apogee 5500 System for $40,000, then under Section 4.4, Cynosure is obligated to pay Palomar a royalty of $3,000 on such re-Sale of the traded-in Apogee 5500 System (7.5% of $40,000). |
4
• | Installation charges, whether or not separately invoiced or identified on an invoice, shall not be deducted from the Actual Amounts. | ||
• | Charges for the standard warranty for a Licensed Product, whether or not separately invoiced or identified on an invoice, shall not be deducted from the Actual Amounts. However, charges separately identified on an invoice for an extended warranty (after deducting appropriate charges for the standard warranty) may be deducted from Actual Amounts. | ||
• | Charges for standard or basic training (often referred to as inservice training or initial training) or any training by Cynosure or Cynosure Affiliates (collectively referred to as “Standard Training”) for a Licensed Product, whether or not separately invoiced or identified on an invoice, shall not be deducted from the Actual Amounts. However, charges separately identified on an invoice for additional training by a Third Party (after deducting appropriate charges for the Standard Training, if such Third Party is to provide the Standard Training) may be deducted from Actual Amounts. | ||
• | Excluding physically separate light-based systems which are covered in the following paragraph on Bundled Packages, charges for other products, accessories, parts or items listed on an invoice along with a Licensed Product, with no separate and distinct price set forth for those other products, accessories, parts or items on the invoice in question, shall not be deducted from Actual Amounts. |
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Type of Cynosure Combination Products | Percentage of Aggregate Net | |||
Number of Cynosure Hair | Number of Cynosure | Sales To Use to Calculate | ||
Modules | Other Modules | Royalty Amount Owed | ||
None | One or more | Zero percent (0%),i.e., no royalty due | ||
One or more | None | One hundred percent (100%) | ||
Only one | One or more | Fifty percent (50%) | ||
More than one | One or more | Seventy percent (70%) |
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Bank Name: | Banknorth | |||
Bank Address: | 370 Main Street Worcester, MA 01608 Palomar Medical Technologies, Inc. Account No. 8241022982 ABA No. 211370545 |
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82 Cambridge Street
Burlington, MA 01803
Attention: CEO
Facsimile: (781) 993-2377
82 Cambridge Street
Burlington, MA 01803
Attention: General Counsel
Facsimile: (781) 993-2377
Exchange Place
53 State Street
Boston, MA 02109
Attention: Kingsley L. Taft, Esq.
Facsimile: (617) 523-1231
5 Carlisle Road
Westford, MA 01886
Attention: CEO
Facsimile: (978) 256-6556
945 Lenox Road
Richmond, MA 01254
Facsimile: (413) 698-3506
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38
Palomar Medical Technologies, Inc. | ||||
By: | /s/ Joseph P. Caruso | |||
Title: CEO | ||||
Date: 11/6/06 | ||||
Cynosure, Inc. | ||||
By: | /s/ Michael Davin | |||
Title: CEO | ||||
Date: 11/6/06 |
Cynosure Affiliates
Anderson Patents
(all validated in France, Germany, Great Britain, Italy, and Spain)
Palomar Products
Cynosure Patents
Cynosure Hair Products
Apogee Elite
Apogee 5500
Apogee Express
Apogee-40
Apogee 9300
Apogee 6200
Apogee 100
Apogee D-20
Acclaim 7000
SmartEpil
SmartEpil II
PhotoLight
PhotoSilk & PhotoSilk Plus Systems
Charm
Sure
Si
Cynosure M2 Laser
Royalty Calculation Flow Charts
[Omitted]
Royalty Payments Owed On Cynosure Combination Products
ii
Gillette Agreement
R&D Program
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-4-
-5-
-6-
-7-
-8-
-9-
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Commercialization
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CUT Supply
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License Grants
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Other Covenants of the Parties
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Payments
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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”) |
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370 Main Street
Worcester, MA 01608
ABA No.: 211370545
Account No.: 8241022982
Account Name: Palomar Medical Technologies, Inc.
-40-
Reports
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Intellectual Property Rights
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Confidentiality and Nondisclosure
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Term and Termination
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Indemnity
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Representations, Warranties and Covenants
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-82-
Dispute Resolution
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Miscellaneous
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82 Cambridge Street
Burlington, MA 01803
Attention: President & General Counsel
Facsimile: (781) 993-2300
155 Seaport Boulevard
Boston, Massachusetts 02210-2600
Attention: David A. Broadwin
Facsimile: (617) 832-7000
-88-
4800 Prudential Tower Building
Boston, Massachusetts 02199
Attn: President, Global Business Management — Grooming
Facsimile: (617) 421-8525
4800 Prudential Tower Building
Boston, Massachusetts 02199
Attn: Senior Vice President and General Counsel
Facsimile: (617) 421-7874
One Front Street
San Francisco, California 94111
Attention: Jim Snipes
Facsimile: (415) 591-6091
-89-
-90-
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THE GILLETTE COMPANY | PALOMAR MEDICAL TECHNOLOGIES, INC. | |||||||
By: | /s/ Peter Klein | By: | /s/ Joseph P. Caruso | |||||
Name: | Peter Klein | Name: | Joseph P. Caruso | |||||
Title: | Senior Vice President of Strategy and Business Development | Title: | Chief Executive Officer and President |
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-i-
-ii-
-iii-
-iv-
Manufacturing of any Female Product pursuant to Applicable Law.
of human hair growth, shaft diameter or pigmentation.
commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory.
marketed for use in the Field, and all Improvements thereto.
with, (b) approved by the FDA for use with, and (c) essential for the functionality of, a Gillette Joint Independent Product.
the beginning of the R&D Period.
excluding any Information and Inventions to the extent claimed by a Joint Patent.
occurs.
(b) approved by the FDA for use with, and (c) essential for the functionality of, a Light-Based Product.
packaging, labeling, holding and quality control testing of such product or compound.
Management Product and any Improvement thereto.
required by Applicable Law.
adjusted by multiplying actual Net Sales of such combination product in such country calculated pursuant
continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary
thereunder, necessary to market a Female Product in the United States.
service providers for use on or with patients or customers (and not for resale to any Person).
Affiliates or individuals who are their employees or agents when acting in that capacity.
trade dress, brand mark, trade name, brand name, logo or business symbol.
are defined in the applicable Sections of this Agreement.
Defined Term | Section | |
“Acquiring Party” | Section 14.2 | |
“ADR” | Section 13.2(a) | |
“Advanced CUT Female Product Costs” | Section 3.2 | |
“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) |
Defined Term | Section | |
“Commercial Assessment Period Additional Activities” | Section 2.2(a) | |
“Confidential Information” | Section 9.3(a) | |
“Cure Period” | Section 10.3 | |
“CUT Female Product” | Section 3.1(a) | |
“CUT Product Specifications” | Section 3.1(b) | |
“Delivery Date” | Section 3.1(c) | |
“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 | |
“Estimate” | Section 1.8(a)(2) | |
“Evaluation Materials” | Section 5.1(b)(ii) | |
“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 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) | |
“Female Product Payment Rate” | Section 6.1(h) | |
“Palomar” | Preamble | |
“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) | |
“Manufacturing Cost” | Section 3.2 | |
“Manufacturing Fee” | Section 3.2 |
Defined Term | Section | |
“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) | |
“Overrun” | Section 1.8(a)(2) | |
“Owned Palomar Patents” | Section 12.3(f) | |
“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) | |
“Subject Male Product” | Section 5.1(b)(1) | |
“Supplemental R&D Plan” | Section 1.7 | |
“Supplemental R&D Payments” | Section 1.7 | |
“Ten-Day Notice” | Section 3.1(a) | |
“Terms and Conditions” | Section 13.2(b) | |
“The Gillette Company” | Preamble | |
“Third Party Claim” | Section 11.1 |
Defined Term | Section | |
“Total CUT Supply” | Section 3.1(c) |
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
Percent of Time | |||||
Name and Title | Responsibilities | Committed to Project |
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
Ltd., Trial Court, Superior Court Dept., Commonwealth of Massachusetts, Civ. Act. No. 02-4565, filed October 29, 2002.
District of California, Civ. Act. No. 02-5176, filed October 24, 2002.
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
[Omitted]
[Omitted]
[Omitted]
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
** | This material has been omitted pursuant to a request for confidential treatment and has been filed separately with the SEC. An aggregate of 17 pages were omitted pursuant to a request for confidential treatment and filed separately with the SEC. |
Paul S. Weiner | Michele M. Szynal | |||
Chief Financial Officer | The Gillette Company | |||
Palomar Medical Technologies Inc | 617-421-7086 | |||
781-993-241 | michele_szynal@gillette.com | |||
ir@palmed. com |
Prudential Tower Building Boston, MA 02199-8004 Tel 617.421.7000 |
Chief Executive Officer and President
Palomar Medical Technologies, Inc.
82 Cambridge Street,
Burlington, MA 01803
which represents an offer to enter into a collaboration with Palomar Medical Technologies, Inc. for the development and commercialization of light-based, consumer products and systems for personal use for female hair management.
/s/ John E. Troy | ||
Business Development |
Director, Emerging Technology Ventures
The Gillette Company
37 A Street
Needham, MA 02492-9120
subsection (a)(ii)(2), of the Agreement shall be amended to read in its entirety as follows:
Product(s) with the goal or intent of improving its efficacy or performance in the Exclusive Field; or (B) optimizing, inducing, supporting or encouraging the use of any Light-Based Products in the Exclusive Field;
Very truly yours, | |||
PALOMAR MEDICAL TECHNOLOGIES, INC. | |||
/s/ Joseph P. Caruso | |||
Title: CEO | |||
Date: 10/2/03 |
AGREED AND ACCEPTED: | ||
THE GILLETTE COMPANY | ||
/s/ Carol S. Fischman | ||
Title: Deputy General Counsel | ||
Date: | ||
82 Cambridge Street | ||
Burlington, MA 01803 | ||
Tel. 781. 993. 2300 | ||
Fax 781. 993. 2330 | ||
www.palmed.com |
consumer products and systems for personal use for female hair management; and
Paragraph 9.9.
Activity required to be performed by Palomar pursuant to the R&D Plan.
PALOMAR MEDICAL TECHNOLOGIES, INC. | ||
/s/ Joseph P. Caruso | ||
Title: CEO | ||
THE GILLETTE COMPANY | ||
/s/ Carol S. Fischman | ||
Title: Deputy General Counsel |
consumer products and systems for personal use for female hair management; and
Palomar Medical Technologies, Inc. and filed separately with the SEC.
PALOMAR MEDICAL TECHNOLOGIES, INC. | ||
/s/ Joseph P. Caruso | ||
Title: CEO | ||
THE GILLETTE COMPANY | ||
/s/ Carol S. Fischman | ||
Title: Deputy General Counsel |
(a) | (i) | credits and allowances for price adjustment, rejection, or return of PRODUCTS previously sold or SERVICES previously performed, including reductions imposed by Medicare, Medicaid or an HMO; | |
(ii) | rebates and cash discounts to customers allowed and taken; | ||
(iii) | amounts for transportation, insurance, handling or shipping charges to customers; |
(iv) | taxes, duties and other governmental charges levied on or measured by the sale of PRODUCTS or SERVICES, whether absorbed by PALOMAR or paid by the purchaser so long as PALOMAR’S price is reduced thereby, but not franchise or income taxes of any kind whatsoever; | ||
(v) | for any revenues in which the United States government on the basis of its royalty-free license pursuant to 35 USC Sec. 202(C) to any PATENT RIGHT requires that the GROSS REVENUES of any PRODUCT or SERVICE subject to such PATENT RIGHT, be reduced by the amount of such royalty owed GENERAL pursuant to paragraph 3.1, the amount of such royalty. |
(a) | absent the licenses granted herein, would infringe a VALID CLAIM of any PATENT RIGHT, or | ||
(b) | does not infringe a VALID CLAIM of any PATENT RIGHT licensed to PALOMAR hereunder but the discovery, development, manufacture or use of which employs TECHNOLOGICAL INFORMATION. |
(a) | absent the licenses granted herein, would infringe a VALID CLAIM of any PATENT RIGHT, or | ||
(b) | does not infringe a VALID CLAIM of any PATENT RIGHT licensed to PALOMAR hereunder but the discovery, development, manufacture or use of which employs TECHNOLOGICAL INFORMATION. |
(a) | an exclusive, worldwide, royalty-bearing license in the LICENSE FIELD under GENERAL’s rights in PATENT RIGHTS to make, have made, use and sell PRODUCTS and to perform SERVICES; | ||
(b) | the right to sublicense (i) PATENT RIGHTS exclusively licensed to PALOMAR and (ii) PATENT RIGHTS non-exclusively licensed to PALOMAR to the extent such a sublicense is required for a customer to use a PRODUCT or to practice a SERVICE. |
$ | 20,000 | upon FDA allowance of the first Investigational Device Exemption with respect to a PRODUCT incorporating or combined with a ruby, alexandrite and diode laser. | ||||
$ | 35,000 | upon FDA approval (actual or deemed), by the FDA of the first 510(k) or comparable application with respect to each PRODUCT incorporating or combined with a ruby, alexandrite laser and diode laser. | ||||
$ | 75,000 | upon first issuance in the United States of a PATENT RIGHT with claims that covers a PRODUCT or SERVICE. |
(a) | Quantity of each PRODUCT sold or leased (by country) by PALOMAR, and its AFFILIATES or SUBLICENSEES; | ||
(b) | Total billings for each PRODUCT (by country); | ||
(c) | Quantities of each PRODUCT used by PALOMAR and its AFFILIATES or SUBLICENSEES; | ||
(d) | Revenues from SERVICES paid to PALOMAR and its AFFILIATES OR SUBLICENSEES; | ||
(e) | Names and addresses of all SUBLICENSEES of PALOMAR; and | ||
(f) | Total royalties payable to GENERAL. |
(a) | (i) If the amount is based on lost profits, PALOMAR shall receive an amount equal to the damages the court determines PALOMAR has suffered as a result of the infringement less the amount of any royalties that would have been due GENERAL on sales of PRODUCT lost by PALOMAR as a result of the infringement had PALOMAR made such sales; and | ||
(ii) GENERAL shall receive an amount equal to the royalties it would have received if such sales had been made by PALOMAR; or |
(b) | As to awards other than those based on lost profits, sixty (60) percent to the party initiating such proceedings and forty (40) percent to the other party, provided that in the event that GENERAL has paid for further litigation subsequent to GENERAL’s refusal to agree to a settlement, consent judgement or voluntary final disposition of a suit pursuant to paragraph 7.2, such awards shall be divided equally between the parties. |
(a) | with respect to all royalty payments, any correspondence pertaining to any PATENT RIGHT, or any notice of the use of GENERAL’s name, for GENERAL, Vice-President, Patents, Licensing and Industry Sponsored Research, and for PALOMAR, President; provided that correspondence relating to the billing of patent costs shall be copied to, for GENERAL, the Business Manager, Office of Technology Affairs, and for PALOMAR, the President. | ||
(b) | any amendment of or waiver under this Agreement, any written notice including progress reports or other communication pertaining to the Agreement: for GENERAL, the Vice-President, Patents, Licensing and Industry Sponsored Research, and for PALOMAR, the President. | ||
(c) | the above designations may be superseded from time to time by alternative designations made by: for GENERAL, the President or the Senior Vice President for Research and Technology Affairs, and for PALOMAR, the President. |
PALOMAR | THE GENERAL HOSPITAL CORPORATION | |||||||
BY | /s/ Michael H. Smotrich | BY | /s/ Marvin C. Guthrie, JD | |||||
TITLE | President | TITLE | VP Patents, Licensing and Industry Sponsored Research | |||||
DATE | August 18, 1995 | DATE | August 18, 1995 |
(i) | disclose the research results to third party commercial entities in a form or in sufficient detail suitable for use to obtain pre-marketing approval from the FDA prior to a publication of the Study; and | ||
(ii) | provide the case report forms to third party commercial entities. |
Industry Sponsored Research
Office of Technology Affairs
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1101
Charlestown, MA 02129
Palomar | THE GENERAL HOSPITAL CORPORATION (Federal Tax ID No.: 042 697 983) | |||||||||
BY: TITLE: | /s/ Michael H. Smotrich | BY: TITLE: | /s/ Marvin C. Guthrie | |||||||
Licensing And Industry | ||||||||||
Sponsored Research | ||||||||||
DATE: August 18, 1995 | DATE: August 18, 1995 | |||||||||
PRINCIPAL INVESTIGATOR | ||||||||||
/s/ R. Rox Anderson | ||||||||||
R. Rox Anderson, M.D. | ||||||||||
DATE: August 18, 1995 |
Destruction of Hair Follicles
• | Uses a longer pulse duration, to better match follicle thermal relaxation times. | ||
• | Examines response to more than one treatment, given 4 weeks apart. | ||
• | Tests the hypothesis that hair growth cycle (anagen, telogen, catagen phase) affects response. | ||
• | Provides treatment of a hair-bearing area of concern to the subject, based on response in each subject’s test sites. |
Test sites | ||||
(back or thigh) | Single treatment | 2 treatments at 1 month interval | ||
75 J/cn-L2 | 75 J/cm2 | |||
50 J/cm2 | 50 J/cm2 | |||
25 J/cm2 | 25 J/cm17 | |||
75 J/cm2 | 75 J/cm2 | |||
epilated | epilated | |||
75 J/cm2 | 75 J/cm2 | |||
2 passes | 2 passes |
hair regrowth | none | sparse | moderate | full | ||||
hypigmentation | absent | present | ||||||
hyperpigmentation | absent | present | ||||||
depigmentation | absent | present | ||||||
erythema | none | mild | moderate | violaceous | ||||
edema | none | mild | moderate | tumescent | ||||
textural change | moderate | severe | ||||||
(includes scarring) | none | |||||||
mild | ||||||||
ulceration | absent | present |
* | objective and quantitative endpoints are also included in this study |
Month 0 | Evaluation, consent and entry into study. Mapping, clipping and imaging of 10 test sites. Retin-A, hydroquinone, sun avoidance instructions | |
Month 1 | Mapping and imaging of test sites. Shave, anesthetize if necessary. Laser exposures per protocol. Wound dressing and wound care instructions. Retin-A, hydroquinone, sun avoidance for site. | |
Month 2 | Mapping and imaging of test sties. Response recording (subjective). Mapping and recording of treatment site. Laser exposures per protocol (test and treatment sites). Wound care and wound care instructions. | |
Month 3 | MAPPING, imaging AND recording of responses. | |
Month 6 | Mapping, imaging and recording of responses. | |
Month 9 | Mapping, imaging and recording of responses. Conclusion of study. Subject REMUNERATION ( $500). |
726-7900
INVESTIGATOR: | R.R. Anderson, M.D. | |
TITLE OF STUDY: | TBD | |
SPONSOR: | Palomar | |
BUDGET PERIOD: | 9/1/95–8/31/96 | |
PERSONNEL: |
Fringe | ||||||||||||||||
Name | % Effort | Salary | Benefits | Total | ||||||||||||
HMS-APPNT. | 26.04 | % | ||||||||||||||
R.R.Andemon,M-D. | 10 | % | 12,854 | $ | 3,347 | $ | 16,201 | |||||||||
Christine Dierickx, M.D. | 100 | % | 40,000 | $ | 10,416 | $ | 50,416 | |||||||||
NON-HMS APPNT. | 21.51 | % | ||||||||||||||
Senior Technician | 50 | % | 17,500 | $ | 3,764 | $ | 21,264 | |||||||||
Engineer | 50 | % | 17,500 | $ | 3,764 | $ | 21,264 | |||||||||
Secretary | 5 | % | 1,500 | $ | 323 | $ | 1,823 | |||||||||
TEMPORARYSTAFF | 11.02 | % | ||||||||||||||
Student | 100 | % | 9,000 | 992 | $ | 9,092 | ||||||||||
Total Personnel | 120,960 | |||||||||||||||
EQUIPMENT | ||||||||||||||||
CCD, digital hair count system | 8,000 | |||||||||||||||
SUPPLIES | ||||||||||||||||
Misc. optics, sources, filters and macro lens | 1,800 | |||||||||||||||
Imaging software | 1,000 | |||||||||||||||
Film purchase and developing | 1,000 | |||||||||||||||
Epliators, mv, markers and tapes | 600 | |||||||||||||||
Retin A | 2,500 | |||||||||||||||
Hydroquinone | 2,000 | |||||||||||||||
Sunscreen | 1,000 | |||||||||||||||
Anesthetic (EEMLA; l.d.xylocaine) | 1,000 | |||||||||||||||
Misc. disposables | 600 | |||||||||||||||
Misc. office supplies | 600 | |||||||||||||||
TRAVEL | 3,000 | |||||||||||||||
PATIENT CARE COSTS | ||||||||||||||||
50 patients @$500 each | 25,000 | |||||||||||||||
MISCELLANEOUS COSTS | ||||||||||||||||
Advertising and telephone expenses | 1,000 | |||||||||||||||
TOTAL DIRECT COSTS | 170,060 | |||||||||||||||
INDIRECT COSTS(28%) -TDC- | 47,617 | |||||||||||||||
TOTAL COSTS | $ | 218.788 | ||||||||||||||
Office of Technology Affairs
Building 149
Thirteenth Street — Suite 1101
Charlestown, MA 02129
617-726-2128 FAX: 617-726-1668
Vice President, Patents,
Licensing and Industry Sponsored Research
Palomar Medical Technologies, Inc.
66 Cherry Hill Drive
Beverly, MA 01915
Tel: 508-921-9300
Fax: 508-921-5801
Sincerely, | ||||
/s/ Marvin C. Guthrie | ||||
Marvin C. Guthrie | ||||
The terms of this Letter Agreement are agreed to by Palomar: | ||||
Name: | /s/ Michael H. Smotrich | |||
Title: | President | |||
Date: | August 18, 1995 |
Agreed to: | ||||||
PALOMAR | THE GENERAL HOSPITAL CORPORATION | |||||
BY: | /s/ Michael H. Smotrich | BY: | /s/ Nikki J. Zapol | |||
TITLE: | President | TITLE: | Managing Director | |||
Office of Technology Affairs | ||||||
DATE December 14, 1995 | DATE January 2, 1996 |
Agreed to: | ||||||
PALOMAR | THE GENERAL HOSPITAL CORPORATION | |||||
BY | /s/ Michael H. Smotrich | BY | /s/ Nikki J. Zapol | |||
TITLE | President | TITLE | Managing Director | |||
Office of Technology Affairs | ||||||
DATE February 14, 1997 | DATE February 18, 1997 |
Office of Technology Affairs
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1101
Charlestown, MA 02129
PALOMAR | THE GENERAL HOSPITAL CORPORATION | |||||
BY: | /s/ Michael H. Smotrich | BY: | /s/ Nikki J. Zapol | |||
TITLE: | President | TITLE: | Managing Director | |||
Office of Technology Affairs | ||||||
DATE: February 14, 1997 | DATE: February 18, 1997 |
/s/ R. Rox Anderson | ||||
DATE: February 14, 1997 | ||||
R. Rox Anderson, MD
Christine Dierickx, MD
Salvadore Gonzales, MD
INVESTIGATOR: | R.R. Anderson, M.D. | |
TITLE OF STUDY: | Dye-assisted laser injury to hair follicles | |
SPONSOR: | Palomar | |
BUDGET PERIOD: | 3/1/97-2/28/99 | |
PERSONNEL |
FRINGE | YEAR 1 | YEAR 2 | ||||||||||||||||||
NAME | % EFFORT | SALARY | BENEFITS | TOTAL | TOTAL | |||||||||||||||
HMS-APPNT | 26.20 | % | ||||||||||||||||||
R.R. Anderson, MD | A.N. | None Requested | 0 | 0 | 0 | |||||||||||||||
Christine Dierickx, MD | A.N. | None Requested | 0 | 0 | 0 | |||||||||||||||
Salvador Gonzalez, MD | 80 | % | $ | 48,000 | 12,576 | 60,576 | 62,999 | |||||||||||||
NON-HMS APPNT | 21.90 | % | ||||||||||||||||||
Senior Technician | 25 | % | $ | 9000 | 1,971 | 10,971 | 11,410 | |||||||||||||
Total Personnel | 71,547 | 74,409 | ||||||||||||||||||
EQUIPMENT | 0 | 0 | ||||||||||||||||||
SUPPLIES | ||||||||||||||||||||
Misc. Disposables | 1,000 | 1,000 | ||||||||||||||||||
Misc. Dyes | 1,000 | 1,000 | ||||||||||||||||||
Film And Film Developing | 525 | 525 | ||||||||||||||||||
Cryostat Baldes | 500 | 500 | ||||||||||||||||||
Barrier Filters For Dye Detection | 400 | 400 | ||||||||||||||||||
Office Supplies And Screening Time | 750 | 750 | ||||||||||||||||||
Total Supplies | 4,175 | 4,175 | ||||||||||||||||||
TRAVEL | 600 | 600 | ||||||||||||||||||
PATIENT CARE COSTS | ||||||||||||||||||||
Subject reimbursement (estimate) | 2,000 | 2,000 | ||||||||||||||||||
MISCELLANEOUS COSTS | ||||||||||||||||||||
Advertising and telephone expenses | 250 | 250 | ||||||||||||||||||
Histology | 1,500 | 1,500 | ||||||||||||||||||
Total Miscellaneous | 1,750 | 1,750 | ||||||||||||||||||
TOTAL DIRECT COSTS | 80,072 | 82,934 | ||||||||||||||||||
INDIRECT COSTS (25%) | 20,018 | 20,733 | ||||||||||||||||||
TOTAL COSTS | $ | 100,090 | $ | 103,665 | ||||||||||||||||
/s/ Marcia L. Smith | 2/13/97 | |||
Marcia L. Smith | ||||
Director for Proposal and Award Mgmt. |
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule A)
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule A)
Agreed to: | ||||
PALOMAR MEDICAL TECHNOLOGIES, INC. | ||||
By: Name: | /s/ Joseph P. Caruso | |||
Title: | President | |||
Date: | 11/20/00 | |||
THE GENERAL HOSPITAL CORPORATION | ||||
By: | /s/ Nikki J. Zapol | |||
Name: | Nikki J. Zapol | |||
Title: | ||||
Date: | 11/17/00 |
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule C)
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule B)
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule B)
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule A)
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule A)
Agreed to: | ||||
PALOMAR MEDICAL TECHNOLOGIES, INC. | ||||
By: Name: | /s/ Joseph P. Caruso | |||
Title: | CEO | |||
Date: | 2/18/03 | |||
THE GENERAL HOSPITAL CORPORATION | ||||
By: Name: | /s/ Frances Toneguzzo | |||
Title: | Director, Corporate Sponsored Research & Licensing | |||
Date: | 2/18/03 |
Palomar Medical Technologies, Inc. and filed separately with the SEC.
(Schedule A)
MGH Agt. No. 2006A20842
Palomar Medical Technologies, Inc. and filed separately with the SEC.
Palomar Medical Technologies, Inc. and filed separately with the SEC.
Agreed to: | ||||
PALOMAR MEDICAL TECHNOLOGIES, INC. | ||||
By: Name: | /s/ Joseph P. Caruso | |||
Title: | CEO | |||
Date: | 3/20/06 | |||
THE GENERAL HOSPITAL CORPORATION | ||||
By: | /s/ Frances Toneguzzo | |||
Name: | Frances Toneguzzo Ph.D. | |||
Title: | Director, Corporate Sponsored Research & Licensing | |||
Date: | 3/13/06 |