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MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT

Advertising or Marketing Agreement

MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT | Document Parties: DAEWOONG PHARMACEUTICAL CO, LTD | DNC DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY | DUSA PHARMACEUTICALS, INC You are currently viewing:
This Advertising or Marketing Agreement involves

DAEWOONG PHARMACEUTICAL CO, LTD | DNC DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY | DUSA PHARMACEUTICALS, INC

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Title: MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT
Date: 3/16/2007
Law Firm: Reed Smith LLP    

MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT, Parties: daewoong pharmaceutical co  ltd , dnc daewoong derma & plastic surgery network company , dusa pharmaceuticals  inc
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EXHIBIT 10(mm)
Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
Execution Copy
MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT
AMONG
DUSA PHARMACEUTICALS, INC.,
DAEWOONG PHARMACEUTICAL CO., LTD.,
AND
DNC DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY
DATED
January 4, 2007

 


 
EXHIBIT 10(mm)
Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
Execution Copy
      MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT (the “Agreement”) made as of the 4th day of January, 2007 (the “Effective Date” ) among DUSA PHARMACEUTICALS, INC. , a New Jersey corporation having a principal office and place of business at 25 Upton Drive, Wilmington, Massachusetts, USA 01887 (hereinafter called “ DUSA” ), and DAEWOONG PHARMACEUTICAL CO., LTD , a Korean corporation having a principal office and place of business at 163-3 Samsung-dong Gangnam-gu, Seoul, Korea, (hereinafter called “ DAEWOONG ”) and DNC DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY , a wholly-owned Korean subsidiary of DAEWOONG PHARMACEUTICAL CO., LTD having a prinicipal office and place of business at 163-3 Samsung-dong Gangnam-gu, Seoul, Korea (hereinafter called “ DNC ” and collectively with DAEWOONG hereinafter called “D&D” ).
      WHEREAS, DUSA is engaged in the development, manufacture and sale of pharmaceutical products and wishes to market certain of its products in the Territory (as such term is defined below);
      WHEREAS, D&D is a pharmaceutical company that distributes and sells pharmaceutical products in the Territory and desires to obtain an exclusive right to, distribute, promote, and sell in the Territory the Products as such term is defined manufactured by DUSA;
      WHEREAS, DUSA has agreed, subject to the terms and conditions of the Agreement, to grant D&D an exclusive right to distribute, promote, and sell such Product in the Territory and to manufacture and supply to D&D on an exclusive basis in the Territory all of D&D’s reasonable requirements of the Product;
      WHEREAS, D&D has agreed to undertake the distribution, promotion, and sale of such Products in the Territory, and will purchase the Product exclusively from DUSA in accordance with the terms and conditions of this Agreement; and
      WHEREAS, the Parties also wish to memorialize the understanding between them with respect to DUSA’s grant to D&D of a license to use the DUSA Trademarks on the DUSA labeled Products in connection with the marketing and sale of the Product in the Territory under the terms and conditions of the Agreement.
      NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS.
     For the purposes of this Agreement, capitalized terms used but not otherwise defined in this Agreement shall have the meanings set forth in this Section 1:
     1.1 “Affiliates” shall mean any Person (defined below) which directly or indirectly controls, is controlled by, or under common control with a Party to this Agreement. For purposes

 


 
Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
of the foregoing definition, the term “control” (including with correlative meaning, the terms “controlling”, “controlled by”, and “under common control with”) as used with respect to any Person, shall mean (i) in the case of corporate entities, direct or indirect ownership of at least [C.I.] of the stock or shares entitled to vote for the election of directors; and (ii) in the case of non-corporate entities, direct or indirect ownership of [C.I.] of the equity interest or the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract, or otherwise.
     1.2 “Applicable Laws” shall mean all applicable laws, statutes, rules, regulations and guidelines that may apply to the sale of the Product in the Territory or the promotion, marketing, packaging, labeling, importation, exportation, warehousing or distribution of a Product that is to be sold in the Territory or the performance of any Party’s obligations under this Agreement, and including all good manufacturing practices and all applicable standards or guidelines promulgated by the appropriate Regulatory Authority.
     1.3 “Approved Product” shall mean any Product that shall have been granted all necessary approvals by the required Regulatory Authorities to allow DUSA and/or D&D, as the case may be, the right to sell and distribute, promote, and sell the Product in any country in the Territory.
     1.4 “Batch” , with respect to any of the Product, shall mean a separate and distinct quantity of such Product processed under continuous and identical conditions and designated by a batch number.
     1.5 “Certificate of Conformance” shall mean a document, which is dated and signed by a duly authorized representative of the Quality Control or Quality Assurance Department of DUSA, certifying that a Batch of any Product meets all Specifications.
     1.6 “ Commercially Reasonable Efforts ” means the channels, methods and diligence that a Party employs with respect to other products sold by it (including its own products) of the same or similar commercial potential.
     1.7 “ Competing Products ” shall mean the products identified on Schedule A attached hereto as Competing Products.
     1.8 “ Confidential Information ” means with respect to a Party, all information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, techniques, business and financial information, projections, customer lists, and all non-public intellectual property rights, and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports)), and all business information, financial data, projections, customer lists which is disclosed by such Party to the other Parties.
     1.9 “ Domain Names and Websites ” shall mean those domain names and website agreed upon by the Parties through which the Products shall be marketed by D&D hereunder.

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
     1.10 “DUSA Trademarks” shall mean the DUSA Trademarks set forth on Schedule A hereto, as such Schedule may be amended from time to time by mutual agreement of the Parties.
     1.11 “FDA” shall mean the U.S. Food and Drug Administration, or any successor body.
     1.12 “Field” shall mean all current and future uses of the Products for dermatology indications.
     1.13 “First Approval Date” shall mean the date on which DUSA, or D&D, as the case may be, first obtains approval to market a Product from a Regulatory Authority in the Territory.
     1.14 “GMP” shall mean good manufacturing practices as required by the rules and regulations of the applicable Regulatory Authority.
     1.15 “Indemnified Party” shall have the meaning set forth in Section 14.3(a).
     1.16 “Indemnifying Party” shall have the meaning set forth in Section 14.3 (a).
     1.17 “Independent Laboratory” shall have the meaning set forth in Section 9.4.
     1.18 “Launch Date” , as to each Approved Product, shall mean that date on which marketing and distribution of such Approved Product shall commence in a given country in the Territory.
     1.19 “Launch Notice” shall have the meaning set forth in Section 7.3(a).
     1.20 “Minimum Purchase Obligations” shall have the meaning set forth in Section 7.2(a).
     1.21 “Objection Notice” shall have the meaning set forth in Section 9.4.
     1.22 “Party” means DAEWOONG, DNC, and DUSA, individually, and “Parties” means DAEWOONG, DNC and DUSA, collectively.
     1.23 “ Person ” shall mean an individual, corporation, partnership, limited liability company, firm, association, joint venture, estate, trust, governmental or administrative body or agency, or any other entity.
     1.24 “Product” shall mean the product set forth on Schedule A .
     1.25 “Product Alliance Manager” shall have the meaning set forth in Section 5.1.
     1.26 “Purchase Price Per Unit” shall have the meaning set forth on Schedule C attached hereto.

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
     1.27 “Registration” shall mean the regulatory approvals of any applicable Regulatory Authorities issued in DUSA’s name (or in either DAEWOONG’s or DNC’s name, if DUSA agrees in writing) and necessary to permit the commencement of the marketing and sale of the Product in any country in the Territory.
     1.28 “Regulatory Authority” means any and all bodies and organizations regulating the manufacture, importation, distribution, use and sale of the Product in any country in the Territory.
     1.29 “Report” shall have the meaning set forth in Section 9.4.
     1.30 “Specifications” of Product means the specifications for the Product as approved by the FDA. The Specifications may be amended from time to time by written agreement between the Parties and as specifically requested by applicable Regulatory Authorities.
     1.31 “Technical Information” shall mean the manufacturing process and any and all technical knowledge, trade secrets, analytical methodology, processes, manufacturing and toxicological information, and any and all other technical information or experience related to the manufacturing of the Product.
     1.32 “Term” shall have the meaning set forth in Section 18.1.
     1.33 “Territory” shall mean Korea, Taiwan, China, including without limitation Hong Kong, India, Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam.
     1.34 “Third Party” means any party other than DUSA, DAEWOONG, or DNC, or their respective Affiliates.
     1.35 “Third Party Loss” shall have the meaning set forth in Section 14.1.
     1.36 “Trademark Infringement Claims” shall have the meaning set forth in Section 3.3(a).
2. DISTRIBUTION, MARKETING AND PROMOTION.
     2.1 Appointment . During the Term and subject to the terms and conditions of this Agreement, DUSA hereby appoints D&D as its exclusive distributor for the Product in the Field in the Territory and D&D hereby accepts such appointment. Pursuant to this appointment, D&D shall have the exclusive right to import in finished package form, distribute, promote and sell the Product in the Field in the Territory subject to the terms and conditions of this Agreement.
     2.2 Marketing and Promotion Efforts .
          (a) D&D shall use its best efforts to vigorously distribute, sell and promote the sale of the Product in the Field within and throughout the Territory at its own expense, so as to maximize sales in each country in the Territory, beginning as soon as feasible after the date of this Agreement, using generally, [C.I.] channels and methods, exercising [C.I.] and adhering to [C.I.] that it employs with respect to [C.I.] (including its own products), provided that in the event that

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
D&D is legally prohibited from selling the Product until Registration for the Product is obtained, then D&D shall begin distribution and promotion of the Product [C.I.] after Registration for the Product is obtained.
          (b) D&D shall be deemed to have commenced the marketing of the Product in a country within the Territory [C.I.] . If D&D does not begin marketing and promotion of the Product in a country within the Territory [C.I.] after receipt of all necessary government approvals to market the Product in such country, in addition to any other remedies available to DUSA hereunder or under law or in equity, DUSA may, [C.I.] .
          (c) D&D shall provide DUSA as reasonably requested by DUSA: (1) [C.I.] for purposes of [C.I.] regarding [C.I.] in the market within the Territory, (2) a summary of [C.I.] of the Product held by D&D at [C.I.] and (3) [C.I.] report of each lot and serial number records of the Product, [C.I.] including to comply with Applicable Laws. The Parties will mutually agree on the form(s) of reports, information to be contained therein and the timing of such reports [C.I.] of the Effective Date, and such agreed upon items shall be attached to this Agreement as a Schedule D .
          (d) D&D shall, [C.I.] use [C.I.] to distribute, promote, and sell the Product for use [C.I.] as appropriate in the Territory, in compliance with Applicable Laws and good commercial practice (including, but not limited to proper shipping and storage). Without limiting the foregoing obligations, D&D shall [C.I.] consistent with good business practice, use [C.I.] to: (i) place the Product in D&D’s literature [C.I.] ; (ii) use its sales force to provide [C.I.] contact with existing and potential customers within the Territory [C.I.] ; (iii) advertise the Product in trade publications within and throughout the Territory, participate in appropriate trade shows, (iv) directly solicit orders from customers within and throughout the Territory for the Product, and (v) use [C.I.] inventory control systems by it and its sub-distributors, if any, [C.I.] sales of Product to Third Parties within or outside of the Territory.
          (e) D&D will not (and will ensure that its sub-distributors, if any, do not) enter into any sales contracts for the Product with its customers, [C.I.] that contain terms that exceed or are otherwise inconsistent with the terms of this Agreement (including but not limited to sales contracts that [C.I.] of this Agreement), without receiving DUSA’s written approval, [C.I.] before entering into such agreement.
          (f) D&D shall purchase all Product needed in pre-marketing efforts from DUSA at the Purchase Price Per Unit, except that DUSA shall [C.I.] pursuant to Section 7.3(g), [C.I.] labeled [C.I.] of the Product during the [C.I.] and [C.I.] of the Product during [C.I.] .
          (g) Prior to D&D marketing, promoting, distributing or selling a Product in the Territory, DUSA shall conduct Product related training programs for the Product for D&D’s trainers, at [C.I.] . The training program shall use training materials [C.I.] and be [C.I.] regarding the safety and efficacy of the Product in question and shall not in any way [C.I.] the Products should be marketed, promoted, distributed or sold in the Territory. Ongoing training of D&D and its personnel, sales force or sub-distributors, if any, regarding [C.I.] and all other training, [C.I.] compliance training, shall be the responsibility [C.I.] .

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
     2.3 Restrictions .
          (a) D&D undertakes and agrees that it will [C.I.] of the Territory [C.I.] for the Product [C.I.] such orders are intended [C.I.] the Territory.
          (b) Except as permitted pursuant to Section 2.5 below, during the Term of this Agreement, D&D shall [C.I.] to, market, promote, sell, offer for sale, distribute or otherwise make the Product available (nor contract [C.I.] to do any of the foregoing), except as [C.I.] to any Third Party in the Territory.
          (c) D&D warrants to DUSA that D&D [C.I.] . During the Term of this Agreement, D&D shall [C.I.] market, promote, sell, offer for sale, distribute or otherwise make available (nor contract [C.I.] to do any of the foregoing), any [C.I.] to any Person in the Territory.
     2.4 Milestone Payments .
          (a) Milestone Payments on Signing and Approval . The milestone payments to be paid herein, are being paid [C.I.] and DUSA hereby does grant to D&D the [C.I.] with DUSA [C.I.] in any, [C.I.] . Within [C.I.] of this Agreement by the Parties, D&D shall make a [C.I.] payment of [C.I.] to DUSA; provided however, (i) if [C.I.] for the Product to the [C.I.] of the [C.I.] and if the [C.I.] the Product [C.I.] and [C.I.] of the [C.I.] or (ii) if the [C.I.] or (iii) if [C.I.] the Product [C.I.] , then [C.I.] [C.I.] . In the event that the circumstance under Section 2.4(a)(ii) occurs, D&D may, [C.I.] and DUSA shall [C.I.] if (x) D&D [C.I.] (y) [C.I.] and (z) [C.I.] of written notification from [C.I.] that [C.I.] . In such case, if [C.I.] D&D shall [C.I.] to DUSA. In addition, [C.I.] of receipt by D&D, on behalf of DUSA, or DUSA, as the case may be, of [C.I.] Product for sale by the Korean Regulatory Authority, D&D shall pay a second [C.I.] milestone payment to DUSA in the amount of [C.I.] .
          (b) First Units Shipped Milestone Payment . Within [C.I.] following the total cumulative number of units of Product ordered hereunder by D&D and shipped by DUSA to D&D [C.I.] units, D&D shall make [C.I.] payment of [C.I.] to DUSA.
          (c) Second Units Shipped Milestone Payment . Within [C.I.] following the total cumulative number of units of Product ordered hereunder by D&D and shipped by DUSA to D&D [C.I.] units, D&D shall make a [C.I.] payment of [C.I.] to DUSA.
     2.5 Sub-Distributors .
          (a) D&D shall have the right to appoint [C.I.] sub-distributor to distribute, market, promote and/or sell the Product within the Territory, subject to [C.I.] and [C.I.] . The appointment of any sub-distributor shall be in writing and on such terms and conditions as [C.I.] provided such terms and conditions are not inconsistent with the terms and conditions of this Agreement. D&D shall provide DUSA with [C.I.] copies of each agreement appointing a sub-distributor hereunder.
          (b) D&D acknowledges and agrees that [C.I.] a sub-distributor hereunder shall [C.I.] of [C.I.] . D&D further agrees that it shall, [C.I.] be solely responsible:

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
               (i) for the [C.I.] sub-distributor appointed pursuant to this Section 2.5; and
               (ii) for [C.I.] or for [C.I.] to any such sub-distributors or representatives, [C.I.] ;
          (c) Sales made by such sub-distributors shall be subject to [C.I.] and such sub-distribution arrangements shall [C.I.] to DUSA in respect of such sales (that is, [C.I.] to DUSA in respect of such Product sales shall be [C.I.] ).
          (d) Each sub-distributor shall [C.I.] of D&D hereunder with respect to the activities undertaken by such sub-distributor in the distribution, marketing and sale of the Product, including without limitation [C.I.] and [C.I.] .
3. TRADEMARKS; PRODUCT MARKING.
     3.1 DUSA Trademarks .
          (a) Ownership of DUSA Trademarks . D&D shall use the DUSA Trademarks set forth on Schedule A for the Product and the Domain Names and Websites to distribute, market, promote, sell, package and label such Product during the Term in accordance with the Applicable Laws of the relevant Regulatory Authority. D&D acknowledges and agrees that [C.I.] all right, title and interest in and to each of the DUSA Trademarks and the Domain Names and Websites. During the Term: (i) D&D and its Affiliates shall [C.I.] the DUSA Trademarks or the Domain Names and Websites, and agree that [C.I.] or [C.I.] any of the DUSA Trademarks or the Domain Names and Websites by virtue of [C.I.] to D&D under this Agreement; and (ii) all use of the DUSA Trademarks or the Domain Names and Websites in the Territory during the Term, whether in combination with or apart from any Party’s corporate name, including any goodwill generated in connection therewith, [C.I.] and DUSA may [C.I.] thereof.
          (b) Use of DUSA Trademarks . Each Party shall [C.I.] during the Term not to do any act which endangers, destroys or similarly affects, in any material respect, the value of the goodwill pertaining to the DUSA Trademarks. Further, except when used in accordance with any usage guidelines agreed to by DUSA or except when a use is otherwise approved in accordance with other provisions of this Agreement, D&D shall submit to DUSA any materials bearing the DUSA Trademarks [C.I.] the use thereof.
          (c) Costs . All costs of prosecuting and maintaining the DUSA Trademarks [C.I.] .
     3.2 Other Proprietary Trademarks .
          (a) Ownership of Corporate Names . Each Party shall retain all right, title and interest in and to its corporate names, and agrees that it shall [C.I.] such other Party’s corporate names, or any registrations issued or issuing with respect thereto. Each Party expressly acknowledges and agrees that [C.I.] the limited rights of use granted under this Agreement, and that all use of the corporate names in accordance therewith, including any goodwill generated in

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
connection therewith, [C.I.] of the corporate names and the owner of such corporate names [C.I.] thereof.
          (b) Use of Corporate Names . With respect to any corporate names [C.I.] under or in connection with this Agreement, such Party agrees to conform to the customary guidelines of the [C.I.] with respect to manner of use (as provided [C.I.] of the corporate name), and to maintain the quality standards [C.I.] with respect to the goods sold and services provided in connection with such Party’s corporate names. Each Party shall use [C.I.] not to do any act which endangers, destroys or similarly affects the value of the goodwill pertaining to any other Party’s corporate names. Further, except when used in accordance with any usage guidelines [C.I.] of a corporate name or a use is otherwise [C.I.] in accordance with other provisions of this Agreement, each Party shall submit to the other Parties any materials bearing any other Party’s corporate name for [C.I.] prior to the use thereof and shall make no use of such corporate name of another Party [C.I.] . No Party shall use, or allow any of their Affiliates to use, in connection with the Product any other trademark that is similar to or substantially similar to or so nearly resembles another Party’s corporate names as to be likely to cause deception or confusion.
          (c) Cooperation . Each Party shall execute any documents required in the reasonable opinion of the other Parties to be entered as a “registered user” or recorded licensee of the other Parties’ corporate names, or to be removed as registered user or licensee thereof.
     3.3 DUSA Trademarks Infringement .
          (a) Trademark Infringement Asserted by Third Parties in the Territory . Each Party shall notify the other Parties [C.I.] of any actual or alleged infringement of any trademark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, or any such claims (hereinafter “Trademark Infringement Claims” ) [C.I.] in connection with the Product in the Territory.
               (i) Upon learning of such Trademark Infringement Claim, [C.I.] shall take [C.I.] steps to resolve the Trademark Infringement Claim with the [C.I.] provided however [C.I.] may not settle any such alleged infringement [C.I.] .
               (ii)  [C.I.] shall have the [C.I.] and [C.I.] .
          (b) DUSA Trademarks Infringement by Third Parties in the Territory . Each Party shall notify the other Parties [C.I.] of any actual or alleged infringement by a Third Party of any DUSA Trademarks in the Territory of which they become aware.
               (i) Upon learning of such infringement under this Section 3.3(b), [C.I.] shall, [C.I.] take [C.I.] steps to resolve such infringement with the [C.I.] provided however [C.I.] may not settle any such alleged infringement [C.I.] .
               (ii)  [C.I.] shall have the [C.I.] and [C.I.] .
     3.4 Product Marking . Any Product marketed and sold hereunder shall be marked with appropriate patent numbers and trademarks, as approved by DUSA.

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
     3.5 Alternative Trademarks . If one or more the DUSA Trademarks cannot be used or registered in any country within the Territory for reasons beyond DUSA’s control (e.g., due to objections by Third Parties or local trademark offices) or cannot otherwise be legally used to commercialize the Product in a country within the Territory (e.g., due to rejection by Regulatory Authorities), and if the Parties have determined that an alternative worldwide trademark is not practicable for the Product, then each Party shall have [C.I.] trademarks. [C.I.] shall then select one [C.I.] trademarks for the Product in each country in the Territory. [C.I.] will undertake the [C.I.] of conducting appropriate trademark clearance of any such selected alternative trademark for use in each such country in the Territory, and filing applications for the cleared trademark. If (a) an alternative trademark is cleared successfully for use and registration, (b) trademark applications are filed for the additional alternative trademark, and (c) such additional alternative trademark receives regulatory approval, then all terms and conditions of this Agreement shall apply, mutatis mutandis , to the use and registration of such alternative trademark [C.I.] and, thereafter the term “DUSA Trademarks” shall include such alternative trademark.
4. REGISTRATIONS.
     4.1 Approval and Maintenance .
          (a) D&D shall, [C.I.] use [C.I.] to prepare and file the documents necessary for submission to the Regulatory Authorities in each country in the Territory, if required, to seek approval for the treatment of Actinic Keratoses and/or other indications in the Field. D&D shall meet the regulatory milestones listed on Schedule E in order to retain its rights to market and sell the Product in each country of the Territory.
          (b) With regard to the application for Registration for the treatment of Actinic Keratoses, DUSA will provide D&D with copies of existing clinical and chemistry, manufacturing and controls data to support of this application. D&D shall [C.I.] for [C.I.] including but not limited to, [C.I.] and [C.I.] in connection with seeking these approvals, but DUSA shall [C.I.] . D&D shall, develop and implement documented standard operating procedures, such as, but not limited to, adverse event reporting, storage and handling, etc., required to support the Registration in all countries in the Territory.
          (c) For clarity, regulatory costs shall mean [C.I.] and [C.I.] incurred by a Party or any of its Affiliates in accordance with [C.I.] during the Term and pursuant to this Agreement in connection with the preparation of regulatory submissions for the Product, the obtaining and maintenance of Registrations, and compliance with Registrations and requirements of such Regulatory Authorities, including ICSR recordation and reporting, regulatory affairs activities, and recalls and withdrawals of the Product in the Territory. [C.I.] shall [C.I.] after the end of [C.I.] with regard to regulatory costs incurred during [C.I.] . Such report shall (i) specify [C.I.] expenses incurred [C.I.] or (ii) be accompanied by invoices or other appropriate supporting documentation for [C.I.] that individually [C.I.] as may be determined by the Parties. The Parties shall seek to resolve any questions related to [C.I.] within [C.I.] following receipt [C.I.] hereunder and [C.I.] within [C.I.] thereafter.

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Note: Certain portions of this document have been marked “ [c.i.] ” to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
     4.2 Adverse Event Reporting . D&D shall notify DUSA, in writing, of any adverse drug experience within seventy-two (72) hours of such adverse drug experience becoming known to D&D. As provided in Section 4.5, and except as required by any Applicable Laws, DUSA shall [C.I.] and [C.I.] determine whether any adverse drug experience must be reported to the applicable Regulatory Authority, and following making a determination to report, to report such events to the applicable Governmental Authority.
     4.3 Ownership of Product Registration . All Registrations and regulatory filings for the Product in the Territory, including marketing and pricing filings and authorizations, in connection with the Product, shall be filed by D&D on DUSA’s behalf, registered and owned exclusively by DUSA, unless otherwise explicitly agreed in writing by DUSA. Should any Registration be filed in the name of D&D, or any Affiliate or sub-distributor of D&D, as may be required by a Regulatory Authority, then on termination of this Agreement for

 
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