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EXHIBIT 10.116 LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT

Requirements Supplier Agreement

EXHIBIT 10.116 LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT | Document Parties: Senetek PLC | Triax Aesthetics, LLC You are currently viewing:
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Senetek PLC | Triax Aesthetics, LLC

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Title: EXHIBIT 10.116 LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT
Governing Law: Delaware     Date: 8/13/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

EXHIBIT 10.116 LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT, Parties: senetek plc , triax aesthetics  llc
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EXHIBIT 10.116

LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT

This License, Supply and Distribution Agreement (this “Agreement”) is made and entered into as of August 6, 2007, by and between Senetek PLC, a United Kingdom public company with its offices located at 831 Latour Court, Napa, California 94558 (“ Senetek ”), and Triax Aesthetics, LLC, a Delaware limited liability company with its offices located at 20 Commerce Drive, Cranford, New Jersey 07016( “Licensee”).

BACKGROUND

 

  A. Senetek has developed certain inventions and other proprietary intellectual property relating to the use of the Compound (as defined below) as an ingredient in topical dermatological and skin care products, and has filed patent applications claiming such use as well as a trademark application for the tradename of the Compound.

 

  B. Licensee desires to distribute, market and sell specific formulations containing the Compound in the Field in the Authorized Channel within the Territory (all as defined below).

Accordingly, in consideration of the mutual promises, covenants, and conditions set forth below, the parties agree as follows:

 

1. DEFINITIONS

When used in this Agreement, each of the following capitalized terms shall have the respective meanings set forth in this Article.

1.1 “ Affiliate ” means any corporation, partnership, proprietorship or other legal entity directly or indirectly controlled by, controlling, or under common control with another legal entity, “control” meaning, for purposes hereof, the effective power to elect at least a majority of the Board of Directors or other management body of a legal entity or to effectively direct the management of a legal entity, by the ownership of voting securities, by contract, or otherwise.

1.2 “ Agreement Date ” means the date of this Agreement first set forth above.

1.3 “ Applicable Laws ” means all laws, rules, regulations and guidelines that apply to the import, export, research and development, manufacture, marketing, distribution, or sale of the Products hereunder or the performance of either party’s obligations under this Agreement to the extent applicable and relevant to such party.

1.4 “ Anticipated Commercial Launch Date ” has the meaning specified in Section 3.10

1.5 “ Authorized Channel” means the ethical market channel, comprised of the sale of Products to (i) estheticians and dermatologists, plastic surgeons and other physicians that prescribe or dispense topical dermatological preparations, (ii) pharmacies for sale “behind the counter” and not in the health and beauty aids section, (iii) medical clinics, health maintenance organizations and other recognized prescription drug channels of trade, and (iv) distributors for resale to the channels of trade referred to in clauses (i) through (iii), and such other channels of trade, if any, as the parties may mutually agree from time to time.

 


1.6 “ Backup Manufacturer ” has the meaning specified in Section 3.3.5.

1.7 “Contract Quarter” means the three month periods beginning on the first day of the first, fourth, seventh and tenth months of a Contract Year .

1.8 “ Commercial Sale” means Licensee or its Affiliate taking a purchase order for a Product from a non- Affiliate purchaser in the Field in the Authorized Channel within the Territory .

1.9 “Compound ” means the compound described in Schedule 1.9 hereto, known as [***], in any form for use in the Field.

1.10 “ Confidential Information ” means marketing, sales, financial, scientific, and other non-public and/or proprietary information concerning the products, projects, businesses and operations of a party or its Affiliates disclosed by such party to the other party or its Affiliates or of which the other party or its Affiliates gains knowledge in performing this Agreement.

1.11 “ Contract Year ” means the twelve month period beginning on January 1, 2008 and each 12 month period thereafter.

1.12 “ Distribution Rights ” shall have the meaning specified in Section 2.1.

1.13 “ Documentation ” means the documentation relating to the Patents and the Know-How .

1.14 “ Field ” means the non-prescription topical dermatological use of Products containing the Compound in humans.

1.15 “ Final Adjudication ” means any decision by a Governmental Entity if either (a) any and all appeals in connection with the adjudication are exhausted or (b) the time for any such appeal shall have passed without such appeal having been perfected.

1.15A “ First Contract Year ” means the twelve month period commencing on January 1, 2008 and ending on December 31, 2008.

1.16 “ GAAP ” means United States generally accepted accounting principles, consistently applied.

1.17 “ Governmental Entity ” means any competent governmental agency, board, authority, commission, court or other entity having lawful jurisdiction.

1.18 “ Initial Delivery Date ” shall have the meaning specified in Section 3.3.2

1.19 “Initial Purchase Order” shall have the meaning set forth in Section 3.3.2

1.20 “Intellectual Property” means collectively the Patents , the Licensed Trademark , the Know-How and such other trademarks, tradenames, copyrights, designs and other proprietary rights related to or useful in the performance of this Agreement that Senetek or any of its Affiliates now owns, has rights to or hereafter acquires rights to specifically related to the development, manufacture or use of the Compound or the Products in the Field in the Authorized Channel in the Territory .

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


1.21 “ Know-How ” means such special knowledge, trade secrets, laboratory workbooks, manufacturing processes, recipes and formulas, testing and clinical trial data, subject photos, and all other technical or other proprietary information, whether or not patented or patentable, owned or controlled by Senetek or its Affiliates at any time prior to or during the term of this Agreement which Senetek is not prohibited from disclosing to Licensee and which is specifically related to the development, manufacture or use of the C ompound or the Products in the Field in the Authorized Channel in the Territory.

1.22 " Licensed Trademark" means all rights within the Field in the Authorized Channel within the Territory (including any registrations, applications or common law rights) to the trademark and trade name “[***]” (or, if such trade name is not in the opinion of Senetek's trademark counsel reasonably capable of being registered as a trademark in the United States Patent and Trademark Office (the " USPTO "), all such rights to such other trademark and trade name as Senetek may apply to register as a designation for the Products as provided in Section 3.2.1).

1.22A "Minimum Net Sales" shall have the meaning set forth in Section 3.9.

1.23 “Net Sales” means the aggregate amounts invoiced by Licensee or its Affiliates from sales of Products to non- Affiliates , less, without duplication, any and all (i) discounts, rebates and allowances granted by Licensee or its Affiliates and taken by such non- Affiliate customers with respect thereto, (ii) amounts actually allowed or credited by Licensee or its Affiliates for returns of such Products , (iii) amounts actually written off by Licensee or its Affiliates as uncollectible after reasonable commercial efforts to collect the same, not to exceed [***]% of gross sales, (iv) tariffs, duties, value-added taxes, sales taxes and/or use taxes directly imposed on Licensee or its Affiliates in connection with the sale of Products , and (v) packaging, freight, and insurance charges paid by Licensee or its Affiliates , to the extent consistent with and recorded in accordance with GAAP

1.24 “ Non-Performance Penalty Payment” has the meaning set forth in Section 3.10 .

1.24A “ Packaging Specifications ” means the standard packaging specifications for the Base Products as agreed to by the parties which shall be developed and set forth on Schedule 1.24A.

1.25 “ Patents ” means the patent application set forth on Schedule 1.25, any additional patent applications, divisionals, continuations and continuations in part filed by or on behalf of Senetek or its Affiliates in the Territory making claims equivalent to or no broader than the claims of the patent application set forth on Schedule 1.25, and any patents issued with respect to any of the foregoing or entitled to the benefit of the priority dates thereof. and (ii) any other patent applications and patents in the Territory that are filed by, issued to or acquired by Senetek or its Affiliates as of the Agreement Date or any time thereafter , the claims of which cover any Base Products or Additional Products .

1.26 “ Products ” means (i) the "Base Products" , meaning the two products set forth in Schedule 1.26 (comprising a lotion without SPF and a cream without SPF) in standard packaging described in the Packaging Specifications which do not exceed 3 oz. (85 g.) in Product content and which are labeled and marketed for non-prescription use in reducing the appearance of lines and wrinkles or other non-prescription "anti-aging" dermatological use ( "Anti-Aging Use" ") and (ii) the "Additional Products" , meaning (a) such larger sized Units of products having the formulations set forth in Schedule 1.26 for Anti-Aging Use or contained in packaging with specifications other than the Packaging Specifications for Anti-Aging Use and (b) such other formulations of non-prescription topical dermatological. preparations containing the Compound alone or in combination with other active ingredients, whether for Anti-Aging Use or other uses (such as skin whitening or acne rosacea), as Senetek may determine to develop and offer to Licensee from time to time and as Licensee may determine to accept as a Product for purposes of this Agreement, subject to the parties' agreement on pricing and Minimum Net Sales of such Products as set forth in Section 3.6.2).

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


1.26A “ Roll Out Program ” has the meaning set forth in Section 3.10.

1.26B "Samples" means Units of Products which Licensee distributes free of charge or at a discount from list price for promotional purposes (but excluding the Units that are the subject of the Initial Purchase Order ).

1.27 “Specifications” means (i) the specifications and Packaging Specifications for each Base Product and (ii) the specifications for any Additional Products agreed to by the parties , which shall be developed and set forth on Schedule 1.26 as provided in Section 3.1.

1.28 “ Territory ” means Canada and the United States of America, its territories and possessions including Puerto Rico and such countries of the Middle East on which the parties may agree.

1.29 “Term” means the period starting on the Agreement Date and ending (if not earlier terminated pursuant to the other terms of this Agreement) at the later of (i) expiration of the fifteenth (15 th Contract Year or (ii) expiration of the last Valid Claim covering the Products .

1.30 “Trademarks” means all rights within the Field in the Authorized Channel within the Territory (including any registrations, applications or common law rights) to any trademarks which Licensee may apply to register as a designation for the Products as provided in Section 3.2.2 and such additional common law and statutory trademarks, trade names, logos, trade dress and domain names (other than the Licensed Trademark ) as Licensee may use from time to time in connection with the distribution, marketing and sale of the Products and in conjunction with the Licensed Trademark as provided in the Agreement .

1.31 "Unit" means an individual unit of Product in its primary retail consumer packaging, whether sold separately or as part of a collection or set.

1.32 “Valid Claim” means any claim of an issued patent that is included within the Patents that has not expired or been deemed unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

 

2. LICENSE

2.1 Grant of License . Senetek hereby grants to Licensee during the Term (and such post- Term period described in Section 9.4 hereof) an exclusive, even as to Senetek, transferable (to the extent provided in Section 10.5) royalty-free license under the Intellectual Property to distribute, market, warehouse and sell the Products in the Authorized Channel in the Field in the Territory, and the right to use the Documentation and Senetek’s Confidential Information to facilitate such distribution, marketing, warehousing and sale, in each case subject to the terms of this Agreement (the “Distribution Rights”). Licensee may grant sublicenses under the Distribution Rights to its Affiliates and to distributors. For the avoidance of doubt, the parties acknowledge that as of the date hereof the application for the trademark “[***]” for the Products is presently pending before the USPTO and, as promptly as practicable after the Agreement Date, counterparts thereof (or of such other trademark application as Senetek may determine as provided in Section 3.2.1) will be filed at Senetek’s cost in each other country within the

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


Territory. Upon registration of such trademark (or such other trademark as Senetek may so determine) in the United States of America and such other countries within the Territory in which it may be registered, Licensee shall be granted an exclusive license (even as to Senetek) to the Licensed Trademark for use in the Authorized Channel in the Field in the Territory without any further action of th parties.

2.2 Exclusivity. During the Term Senetek and its Affiliates will not, in the Field in the Authorized Channel in the Territory, (i) distribute, market or sell Products or any other non-prescription topical dermatological product containing the Compound or, except as provided in Section 2.3, any other compound with respect to which Licensee would have a right of first offer pursuant to Section 2.3, owned, licensed or developed by Senetek and its Affiliates, or (ii) use the Licensed Trademark, or (iii) license, retain, authorize or contract with any third party so to do. Senetek will use its best efforts to prevent the Products and any other non-prescription topical dermatological product containing the Compound or using the Licensed Trademark from entering the Field in the Authorized Channel in the Territory. Without limiting the foregoing, Senetek and its Affiliates shall not sell or otherwise provide any Products or any other non-prescription product containing the Compound or using the Licensed Trademark to any third party outside the Territory and/or outside the Authorized Channel where Senetek has reason to believe that such Products or other products containing the Compound or using the Licensed Trademark will be sold by such third party in the Field in the Authorized Channel in the Territory. Nothing in this Agreement shall be construed to limit Senetek’s right to use or license the Intellectual Property or the Confidential Information or Documentation otherwise than in the manner exclusively licensed to Licensee in Section 2.1.

2.3 Right of First Offer. During the Term, Licensee shall have the exclusive right of first offer to obtain the right to (i) distribute, market, warehouse and sell in the Field in the Authorized Channel in the Territory products containing improved versions of the Compound, alone or in combination with other compounds, or products containing other compounds covered by any of the Valid Claims of the Patents (collectively "Improvements") and (ii) distribute, market, warehouse and sell in the Authorized Channel in the Territory products containing the Compound for approved prescription drug use in humans (collectively, "Prescription Products"), developed or otherwise acquired by Senetek or its Affiliates. At such time as Senetek determines, based on preliminary studies, that an Improvement exhibits biological activity that may make it commercially marketable or that a Prescription Product has been approved or may be approvable for marketing in the Territory, Senetek shall give written Notice thereof to Licensee, accompanied by such study and/or regulatory data as may be in Senetek's possession or control that it is permitted to disclose to Licensee, and Licensee shall have forty-five (45) days from the date that Senetek gives such Notice (the “Notice Period”) to give Notice to Senetek setting forth in reasonable detail the terms upon which Licensee would acquire the right to distribute, market, warehouse and sell products containing the Improvement in the Field in the Authorized Channel in the Territory or Prescription Products in the Authorized Channel in the Territory, as the case may be. During this Notice Period, Senetek shall not offer the Improvement or the Prescription Product to any third party in the Authorized Channel in the Territory. Senetek shall be permitted to give Notice, within fifteen (15) days after receipt of any such Notice from Licensee, either accepting or rejecting Licensee's offer and, if rejecting, may set forth Senetek's counter-offer, in which event Licensee shall be permitted to give Notice within fifteen (15) days accepting or rejecting Senetek's counter-offer and, if rejecting, may set forth a final offer, which Senetek shall accept or reject within fifteen (15) days. If Senetek elects not to accept Licensee's offer and any final offer (or if no Notice setting forth an offer or final offer is made by Licensee within the periods prescribed above) Senetek shall be free subject to the terms of this Agreement to grant such rights to others on terms no better to such other party than those last offered by Licensee.

 


2.4 No Other Right. It is expressly understood that this Agreement grants no rights to Licensee under the Intellectual Property except those express rights set forth in Sections 2.1, 2.2 and 2.3. Without limiting the foregoing, Licensee has no right pursuant to this Agreement to, and shall not, (i) manufacture or package or have manufactured or packaged any products containing the Compound that fall within the scope of a Valid Claim, (ii) distribute, market or sell or knowingly permit its customers or distributors to re-distribute, re-market or re-sell any Products that fall within the scope of a Valid Claim other than in the Field in the Authorized Channel within the Territory, (iii) distribute, market or sell products containing the Compound that fall within the scope of a Valid Claim otherwise than in accordance with the terms of this Agreement, or (iv) acquire or assert any co-ownership or other proprietary interest in any of the Intellectual Property (including without limitation the Patents) by virtue of its distribution, marketing or sale of products containing the Compound, whether alone or in combination with other active ingredients in which Licensee may have an ownership or other proprietary interest.

 

3. DEVELOPMENT, MANUFACTURE, MARKETING AND DISTRIBUTION OF PRODUCTS

3.1 Product Development and Formulation. Senetek has made available to Licensee all currently existing in vitro and in vivo pre-clinical and clinical data related to the Compound and all existing Product formulations, Product claim substantiation and Product safety testing data, and will continue to make available to Licensee all future like data related to the Products as from time to time constituted which Senetek is not prohibited from disclosing pursuant to agreements with third parties. Senetek shall be responsible for the design, development, scope and conduct of all future Product development, testing and clinical trials and for the formulation, Specifications and product claims for all Products, provided that Senetek shall not include in any Product's Specifications any compound or other ingredient other than the Compound requiring payment of royalty or other compensation to any third party without Licensee's prior, written approval. In addition, Senetek shall conduct such Product stability, preservative challenge and like testing as the parties determine is reasonably appropriate for the manufacture and storage of the Products and as required by Applicable Laws pending their distribution by Licensee. Senetek shall be solely responsible for all costs related to such Product development, testing and clinical trials and such Product stability, preservative challenge and like testing. The Specifications of each Base Product and Additional Product shall be annexed as an addendum to Schedule 1.26. Senetek shall use its best efforts to complete development of the Base Products no later than the dates set forth on Schedule 1.26.

3.2 Intellectual Property Development and Protection; Trademark

3.2.1 Senetek has made available to Licensee the patent application set forth in Schedule 1.25 and all prosecution files and records in its possession related thereto. Senetek will promptly file appropriate counterparts of such application in such other countries within the Territory as the parties shall determine and will consult with Licensee with respect to any notices from or correspondence with the USPTO or any other Governmental Entity with respect thereto and the development, filing and prosecution of any subdivisions, continuations, continuations in part or additional applications related to the Compound or any Product for use in the Field in the Territory. In addition, Senetek has made available to Licensee all applications and registrations for the Licensed Trademark and all prosecution files and records related thereto, will promptly file appropriate counterparts of such application in all other countries within the Territory and shall use commercially reasonable best efforts to prosecute such applications and will consult with Licensee with respect to any notices from or correspondence with the USPTO or any other Governmental Entity or third party with respect to the Licensed Trademark. If, in the opinion of

 


Senetek's trademark counsel, the trade name “[***]” is unlikely to be registrable with the USPTO as a statutory trademark to designate Products, Senetek shall consult with Licensee with respect to an alternate trade name that in the opinion of Senetek's trademark counsel is likely to be registrable with the USPTO as a statutory trademark to designate Products, shall use commercially reasonable best efforts to file applications for registration thereof throughout the Territory as promptly as practicable, and shall keep Licensee advised of its progress with the prosecution and maintenance of such applications and any registrations for the Licensed Trademark or the enforcement thereof. Senetek shall have sole and exclusive ownership of the Patents, the Licensed Trademark and all other Intellectual Property, Know-How and Documentation licensed to Licensee pursuant to this Agreement, and Senetek shall be solely responsible for all costs related to the foregoing, the payment of all fees required for the maintenance of all Patents, the Licensed Trademark and all other Intellectual Property, the defense of the Patents, the Licensed Trademark and all other Intellectual Property against challenge by any Governmental Entity or third party, and the prosecution of actions against any third party that may infringe any of the Patents, the Licensed Trademark or any other Intellectual Property. Senetek shall use commercially reasonable best efforts to obtain Patent and Licensed Trademark protection for the Products throughout the Territory (including, but not limited to, by the continued prosecution of any patent and trademark applications that are on file as of the Agreement Date or are filed hereafter during the Term), shall use best efforts to maintain in force all issued Patents and Licensed Trademark registrations for the Products at all times during the Term, and shall keep Licensee reasonably informed with respect to the foregoing matters and take into consideration Licensee’s reasonable suggestions with respect to such matters.

3.2.2 All Products shall be packaged and sold under Licensee's Trademark in conjunction with the Licensed Trademark, and all packaging shall bear the parties' respective principal corporate names in equal type size and prominence as follows: "Senetek/Triax". Licensee has made or will make available to Senetek all applications and registrations for the Trademark and all prosecution files and records related thereto, will promptly file appropriate counterparts of such application in all other countries within the Territory and shall use commercially reasonable best efforts to prosecute such applications and will consult with Senetek with respect to any notices from or correspondence with the USPTO or any other Governmental Entity or third party with respect to such Trademark. If, in the opinion of Licensee's trademark counsel, the Trademark is unlikely to be registrable with the USPTO as a statutory trademark to designate Products, Licensee shall consult with Senetek with respect to an alternate trade name that in the opinion of Licensee's trademark counsel is likely to be registrable with the USPTO as a statutory trademark to designate Products, shall use commercially reasonable best efforts to file applications for registration thereof throughout the Territory as promptly as practicable, and shall keep Senetek advised of its progress with the prosecution and maintenance of such applications and any registrations for such Trademark or the enforcement thereof. Licensee shall in its sole discretion select any other Trademarks to be used in the marketing of the Products under this Agreement. During the Term and at all times thereafter, Licensee and/or its designees shall solely own all rights to the Trademarks and any applications and registrations for the Trademarks. Licensee shall be solely responsible for the payment of all fees required for the maintenance of all Trademarks, the defense of the Trademarks against challenge by any Governmental Entity or third party, and the prosecution of actions against any third party that may infringe any of the Trademarks. Licensee shall use commercially reasonable efforts to maintain Trademark protection for the Products throughout the Territory (including, but not limited to, by the continued prosecution of any applications that are included in the Trademarks at any time during the Term), shall use its best efforts to maintain in force all issued Trademarks for the Products at all times during the Term, and shall keep Senetek reasonably

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


informed with respect to the foregoing matters and take into consideration Senetek's reasonable suggestions with respect to such matters. During the Term, Senetek and its Affiliates shall not use the Trademarks or any marks and names that are confusingly similar thereto, anywhere in the Territory without the prior, written consent of Licensee.

3.3 Product Manufacturing, Packaging . Except as expressly provided herein, Senetek shall be solely responsible for the manufacturing and packaging of all Products and shall manufacture, package and ship the same to Licensee free of charge. The Products shall be manufactured by a contract manufacturer appointed by Senetek. Senetek shall enter into a written agreement with the contract manufacturer which is consistent with the terms and conditions of this Section 3.3 and which expressly identifies Licensee as a third party beneficiary of Senetek’s rights under such agreement. Senetek shall provide Licensee with a true and correct copy of such agreement promptly after it is signed. All Products shall be manufactured in accordance with the Specifications therefor as in effect on the date of manufacture, shall not be adulterated or misbranded, and shall be in full compliance with all applicable cosmetic good manufacturing practices requirements (“CGMP”) and all Applicable Laws (including, but not limited to, all Applicable Laws relating to any active pharmaceutical ingredients or other drugs contained in any of the Products). Notwithstanding the foregoing, Licensee shall pay Senetek its direct expenses without mark up of manufacturing, packaging and shipping any Samples supplied to Licensee hereunder. During the period commencing on the Agreement Date and through the last day of the First Contract Year, Licensee shall pay [***]% of the total purchase price of Samples at the time of its order therefor, with the balance of all amounts payable to Senetek for Samples delivered hereunder to be paid within thirty (30) days following delivery of the Samples F.O.B. Licensee's receiving dock. Thereafter during the remainder of the Term, all amounts shall be payable to Senetek for Samples delivered hereunder within thirty (30) days following delivery of Products F.O.B. Licensee's receiving dock. Licensee shall make full payment for Samples as above provided notwithstanding that it may have any dispute or may have given any Exception Notice with respect thereto as provided in Section 3.3.4. The minimum order size for each stock keeping unit of Product shall be 5,000 Units. All shipments of Products to be delivered to Licensee under this Agreement shall be sampled and analyzed by or on behalf of Senetek to confirm that they meet the Specifications. Senetek shall deliver or cause to be delivered with each shipment of Products a certificate of analysis (or similar document) stating that the Products being delivered meet the applicable Specifications. In addition, Senetek shall provide Licensee with a Certificate of Compliance with the initial shipment of Products and thereafter annually for each Contract Year during the Term. Senetek shall cause its contract manufacturer or sub-contractor to package the Base Products in accordance with the Packaging Specifications and all other Products in accordance with packaging designs and specifications developed by Senetek in consultation with Licensee, which shall be annexed to Schedule 1.24A, and in accordance with all Applicable Laws. All Product packaging shall, to the extent that space can reasonably accommodate the same, include the following or a similar statement presented in a manner consistent with industry practice: “Sold under license from Senetek PLC” with the patent or patent application number applicable in the country of sale indicated.

3.3.1 Delivery Forecast. Except for the Initial Purchase Order provided for in Section 3.3.2 below, not later than the end of the second month of each Contract Quarter during the Term, Licensee shall deliver to Senetek a rolling forecast covering the next four (4) Contract Quarters (the “Delivery Forecast”), which shall specify Licensee’s estimated order requirements of Products (including any Samples), based on manufacturing batch sizes and multiples thereof, desired formulations, and required delivery dates and destinations for the Product. The first Contract Quarter covered by each Delivery Forecast shall be considered a firm order. Senetek shall cause its contract manufacturer to manufacture and ship Products on the delivery dates specified in any purchase order submitted hereunder to the extent the same are consistent with

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


the current Delivery Forecast, and to the extent the same are not so consistent, Senetek shall cause its contract manufacturer to use its best efforts to manufacture and ship on the delivery dates so specified, subject to its capacity and production scheduling requirements, and Licensee shall be obligated to purchase at least the quantity of each Product set forth in the first Contract Quarter of each Delivery Forecast.

3.3.2 Purchase and Sale; Acceptance. Subject to the terms hereof, during the Term, Senetek shall sell and deliver to Licensee, and Licensee shall purchase and accept, the Products pursuant to orders submitted by Licensee to Senetek in accordance with provisions hereof. All deliveries of Product shall be deemed accepted by Licensee unless Licensee shall deliver an Exception Notice to Senetek in accordance with Section 3.3.4 below. Within fifteen (15) days of the date of execution of this Agreement the parties will agree upon the number of Units of the Products pricing, payment terms and pre-launch packaging for use in the Roll Out Program (as hereinafter defined) for the Products. Licensee will thereafter submit to Senetek and Senetek will accept an initial purchase order for the number of Units of the Products with the pricing, payment terms and pre-launch packaging agreed upon by the parties with a delivery date of October 1, 2007 (the "Initial Delivery Date") for use in the Roll Out Program (as hereinafter defined) for the Products. (the "Initial Purchase Order").

3.3.3 Title and Risk of Loss. All Products to be delivered to Licensee under this Agreement shall be shipped by Senetek's contract manufacturer to Licensee fully insured against risk of loss, theft, seizure and destruction. Title and risk of loss with respect to all shipments of Product shall pass from Senetek to Licensee F.O.B. Senetek’s contract manufacturer’s shipping dock in locked containers bound for Licensee’s receiving dock (currently located in Cranford, New Jersey, USA). Licensee shall maintain at all time during the Term property casualty insurance with an insurance company or companies rated at least Best AA covering the Products (other than Samples) from the date title and risk of loss pass to Licensee through the date of resale by Licensee or its Affiliates for the full cost of replacement of such Products, including shipping and transit insurance, naming Senetek as a third party loss payee beneficiary.

3.3.4 Licensee Right of Review; Exception Notice. Licensee may conduct its own analyses on each shipment of the Product, in whatever form, delivered by or on behalf of Senetek pursuant to this Agreement. Licensee shall notify Senetek in writing within thirty (30) days after its receipt of any shipment of Product if in Licensee's opinion the same does not comply with Licensee’s order, does not meet the Specifications (including, but not limited to, any applicable release specifications), is adulterated or misbranded, or is otherwise reasonably determined by Licensee not to comply with any Applicable Laws or Applicable Permits (as defined below) (each such notice, an “Exception Notice”). Any dispute arising between Senetek and Licensee concerning the conformity of any shipment of Product which cannot be settled between the two parties within thirty (30) days following Licensee’s delivery of such notice, shall be submitted to an independent testing laboratory jointly agreed to by the parties in good faith. The laboratory’s report of its analysis shall be delivered to each party simultaneously. The decision of said laboratory shall be binding on Senetek and Licensee. To the extent that the report of analysis states that any portion of a shipment does not comply with Licensee’s order, does not meet the Specifications (including, but not limited to, any applicable release specifications), is adulterated or misbranded, or otherwise does not comply with any Applicable Laws or Applicable Permits (as defined below), (i) Senetek shall or shall cause its contract manufacturer to accept return of such Products at either Senetek’s or the contract manufacturer's shipping expense and to replace the same without payment by Licensee, (ii) Senetek shall or shall cause its contract manufacturer to pay Licensee interest on the purchase price paid for any Samples included among such

 


Products from the date of payment at the rate of [***] ([***]%) per month, and (iii) the charges of such independent testing laboratory for such analysis and report shall be paid by Senetek or Senetek's contract manufacturer. To the extent that the report of analysis does not so state, the charges of such independent testing laboratory and all other costs and expenses arising from Licensee's decision to conduct such analysis shall be paid by Licensee.

3.3.5 Backup Manufacturer. Prior to the Anticipated Commercial Launch Date of the Product, Senetek will notify Licensee in writing of at least one (1) third party manufacturer ( i.e. , in addition to the contract manufacturer for the Product appointed under this Section 3.3) that is reasonably acceptable to Licensee and that would be capable of manufacturing Products on short notice in the event of supply failure on the part of the appointed contract manufacturer (the “Backup Manufacturer”). Senetek will be responsible for ensuring the continued availability throughout the Term of such Backup Manufacturer or an alternative Backup Manufacturer to manufacture the Products on short notice.

3.3.6 Notice of Third Party Audit. Each party shall give the other party telephonic notice (with written confirmation) of any pending or threatened audit related to the Product (including, without limitation, the manufacture, production, sale, distribution, import/export or testing of the Product, in whatever form) by any Governmental Entity or other authorized person, regardless of whether such audit is of Licensee, Senetek, Senetek’s contract manufacturer or any company or other person (other than Licensee) with which Senetek or its contract manufacturer has an agreement related to the Product or any ingredient thereof or process used in connection with the manufacture thereof, including, without limitation, any suppliers of raw materials used in the manufacture of the Product, in each case which audit affects or could reasonably be expected to affect the performance of Senetek’s obligations under this Agreement or otherwise affect Licensee’s sale or distribution of the Product (each, an “Audit”); provided, however , that neither party shall be required to give such notice to the other of an Audit by any person that is conducted in the ordinary course pursuant to an agreement between Senetek and such person and not in response to any suspected violation or noncompliance. Each party shall provide any notice to the other party required under this Section 3.3.6 as soon as practicable, but in any event within five (5) business days, following the date such party first becomes aware of such Audit, and shall provide the other party with any documentation or other information provided or available to it relating to any such Audit, and shall provide the other party reasonable opportunity to review and comment upon, prior to submission, any response to such Audit. Each party shall keep the other party fully apprised of the progress and results of any Audit and shall immediately provide the other party with the results of such Audit following its conclusion.

3.3.7 Notice of Regulatory Action. Each party shall provide the other party with notification of its receipt (or the receipt by any Person with which a party has an agreement related to the Product, including, without limitation, suppliers of raw materials and contract manufacturers) of any warning, enforcement, penalty, default, non-compliance, notice of violation or any similar letters, notices, investigations, requests for information or orders from or of any Governmental Entity or other authorized person that relate to the Product. Each party shall provide any notice to the other party required under this Section 3.3.7 as soon as practicable, but in any event within twenty-four (24) hours, following the date such party first receives or becomes aware of any such regulatory action, and shall provide the other party with any documentation or other information provided or available to it relating thereto. Notwithstanding anything herein to the contrary, Senetek maintains sole responsibility for any matter pertaining to such regulatory actions to the extent such regulatory action does not relate to the labeling, trademarking

 

[***] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

 


(except in connection with the Licensed Trademark), marketing, distribution or sales of the Product. Each party shall have the right to review and comment on any responses of the other party to any such regulatory action.

3.4 Product Marketing and Promotion. Licensee shall use commercially reasonable efforts to market and promote the Products in such manner as to maximize their branding as exclusive high-end non-prescription dermatological products and their acceptance by estheticians and dermatologists, plastic surgeons and other physicians that prescribe or dispense topical dermatological preparations. During the period from the Agreement Date through the end of the First Contract Year, Licensee shall submit to Senetek for its written approval all product marketing, advertising and promotional materials and strategies, and thereafter Licensee shall have discretion to establish such changes in marketing, advertising and promotional materials and strategies as it may determine, after consultation with Senetek. In the event that during the first Contract Year, an objection or comments to the marketing, advertisng or promotional materials is not received within ten (10) business days after acknowledged receipt by Senetek, then such materials shall be deemed to be approved and Licensee shall be free to use such materials in the marketing, promotion and advertising of the Products. Licensee shall prominently display the Licensed Trademark in conjunction with the Trademarks in all advertising, marketing and promotional materials for the Products. Licensee agrees that in advertising, marketing and selling Products it shall not make any negative or disparaging claims with respect to any products licensed by Senetek to third parties without Senetek's prior approval, provided that the foregoing shall not limit Licensee’s right to make general superiority claims, in compliance with Applicable Laws, and aggressively promote and market the Products. Licensee shall be solely responsible for all of its costs of marketing and promoting the Products and all of its administrative costs related to Licensee's performance of this Agreement, except as provided in Section 3.8.1.

3.5 Product Distribution. Commencing on the first day of the First Contract Year and for the remainder of the Term, Licensee shall maintain a sales force of not less than twenty (20) sales representatives experienced in sales of topical skincare products to dermatologists, plastic surgeons and estheticians (the “Dispensing Salesforce”). Licensee shall use commercially reasonable efforts to cause the Dispensing Salesforce to distribute the Products in such manner as to maximize their penetration throughout the Authorized Channel in the Territory consistent with their branding referred to in Section 3.4. Except as provided in Section 3.8.1, Lice


 
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