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INTELLECTUAL PROPERTY LICENSE AGREEMENT

IP Intellectual Property License Assignment Agreement

INTELLECTUAL PROPERTY LICENSE AGREEMENT
 | Document Parties: MEDICIS PHARMACEUTICAL CO | Q-Med AB | Medicis Aesthetics Holdings Inc. You are currently viewing:
This IP Intellectual Property License Assignment Agreement involves

MEDICIS PHARMACEUTICAL CO | Q-Med AB | Medicis Aesthetics Holdings Inc.

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Title: INTELLECTUAL PROPERTY LICENSE AGREEMENT
Governing Law: New York     Date: 9/10/2004
Industry: Biotechnology and Drugs     Law Firm: Simpson Thacher & Bartlett LLP; Akin Gump Strauss Hauer & Feld LLP; Covington & Burling     Sector: Healthcare

INTELLECTUAL PROPERTY LICENSE AGREEMENT
, Parties: medicis pharmaceutical co , q-med ab , medicis aesthetics holdings inc.
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                                                                  EXHIBIT 10.103

 

[THE OMITTED PORTIONS INDICATED BY AN ASTERISK HAVE BEEN SEPARATELY FILED WITH

THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL

TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.]

 

                     INTELLECTUAL PROPERTY LICENSE AGREEMENT

 

            This INTELLECTUAL PROPERTY LICENSE AGREEMENT (this "AGREEMENT") is

dated this 15th day of July 2004, between Q-Med AB, a company organized under

the laws of the Kingdom of Sweden with corporate registration number 556258-6882

("Q-MED" or "LICENSOR"), and Medicis Aesthetics Holdings Inc., a corporation

organized under the laws of the State of Delaware ("MAHI" or "LICENSEE").

 

                                    RECITALS

 

            WHEREAS, Licensor desires to grant, and Licensee desires to accept,

the rights and licenses set forth herein with respect to the Licensed Rights,

Licensed Regulatory Data and certain Website Content (as each such term is

defined below); and

 

            WHEREAS, Licensee desires to grant, and Licensor desires to accept,

the rights and licenses set forth herein with respect to certain portions of the

Territory Specific Materials, Licensee Regulatory Materials (as each such term

is defined below) and certain Website Content.

 

            NOW, THEREFORE, in consideration of the premises and the

representations, warranties, covenants and agreements contained herein and for

other good and valuable consideration, the receipt and sufficiency of which is

hereby acknowledged, intending to be legally bound hereby, the Parties hereto

hereby agree as follows:

 

                                    ARTICLE I

                                   DEFINITIONS

 

       1.1 Definitions. As used in this Agreement, the following terms shall have

the meanings set forth or as referenced below:

 

            "ACCOUNT" shall have the meaning set forth in Section 8.2.

 

            "ACCOUNTING FIRM" shall have the meaning set forth in Section 8.5.

 

            "ACTION" shall mean any action, claim, suit, litigation,

arbitration, investigation, notification, audit or other proceeding brought in

law or at equity by a Governmental Authority or other Person.

 

            "ADVERTISING" shall have the meaning set forth in the Supply

Agreement.

 

            "AESTHETIC ENHANCEMENT" shall mean the alteration of the visual

appearance, visual form, visual size, or visual shape of the naked human body or

any of its components; provided that Aesthetic Enhancement shall not be deemed

to include modification of the functions, restoration of the functions,

adjustment of the functions or correction of the functions of the human body or

any of its component parts.

 

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            "AFFILIATE" of a Person shall mean, with respect to any Person, any

other Person that directly or indirectly, through one or more intermediaries,

controls, is controlled by, or is under common control with, such Person. As

used in this definition, the term "CONTROL" means the possession, directly or

indirectly, of the power to direct or cause the direction of the management and

policies of a Person, whether through ownership of voting securities, by

contract, or otherwise.

 

            "AGERUP LETTER AGREEMENT" shall mean that certain letter from Bengt

Agerup to Medicis, dated as of the Closing Date.

 

            "AGREEMENT" shall mean this Agreement, as the same may be amended or

supplemented from time to time in accordance with the terms hereof.

 

            "BUSINESS DAY" shall mean any day other than a Saturday, a Sunday or

a day on which banks in Sweden or New York are authorized or obligated by Law or

executive order to remain closed.

 

            "CANADIAN STUDY" shall have the meaning set forth in Section 2.1(c).

 

            "CANADA'S FDA" shall mean Canada's Food and Drugs Act, R.S.C. 1985,

c. F-27, as amended.

 

            "CAP" shall have the meaning set forth in Section 10.1(b).

 

            "CHANGE IN CONTROL" shall mean (a) the disposition of all or

substantially all of the outstanding shares, assets or business of a Party or

Medicis on a consolidated basis; or (b) any transaction or event (or series of

transactions or events) as a result of which any Person (other than an Affiliate

of such Party or Medicis), acting singly or as a part of a "partnership, limited

partnership, syndicate or group" (within the meaning of Section 13(d)(3) of the

United States Securities Exchange Act of 1934, as amended): (i) acquires (by

purchase, merger, consolidation or otherwise) or for the first time controls or

is able to vote (directly or through nominees, beneficial ownership, proxy or

contract) fifty percent (50%) or more of the aggregate of all outstanding equity

securities of a Party or Medicis; or (ii) acquires (by purchase, merger,

consolidation or otherwise) equity securities of a Party or Medicis with the

right to, or for the first time is otherwise able to, nominate or designate

(directly or through nominees, beneficial ownership, proxy or contract) at least

fifty percent (50%) of the nominees to the board of directors of such Party or

Medicis, in each of (a) or (b), in the event that Licensor, Licensee or Medicis,

as the case may be, was not a party to the applicable transaction and/or such

transaction was not approved by the Board of Directors of Licensor, Licensee or

Medicis, as the case may be.

 

            "CIPO" shall mean the Canadian Intellectual Property Office.

 

            "CLAIMING PARTY" shall have the meaning set forth in Section 8.5.

 

            "CLOSING" shall have the meaning set forth in Section 7.1.

 

            "CLOSING DATE" shall have the meaning set forth in Section 7.1.

 

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            "COMPETING PRODUCT" shall have the meaning set forth in Section

3.13.

 

            "COMPLAINING PARTY" shall have the meaning set forth in Section

3.10(b).

 

            "CONFIDENTIAL LICENSEE INFORMATION" shall have the meaning set forth

in Section 9.1.

 

            "CONFIDENTIAL LICENSOR INFORMATION" shall have the meaning set forth

in Section 9.2.

 

            "CONFIDENTIALITY AGREEMENT" shall have the meaning set forth in the

Supply Agreement.

 

            "CONTRACT YEAR" shall have the meaning set forth in Section 8.2.

 

            "DILIGENCE DEFAULT" shall have the meaning set forth in Section 3.1.

 

            "DISPUTED LICENSE PAYMENT" shall have the meaning set forth in

Section 8.5.

 

            "FDA" shall mean the United States Food and Drug Administration.

 

            "FDCA" shall mean the United States Federal Food, Drug, and Cosmetic

Act of 1938, as amended (21 U.S.C. ss.ss. 301 et. seq.).

 

            "FIELD" shall mean Aesthetic Enhancement.

 

            "FOOD AND DRUGS ACT" shall mean the Canadian Food and Drugs Act of

1985, as amended (R.S., c. F-27).

 

             "GOVERNMENTAL AUTHORITY" shall mean any supranational, national,

federal, state, provincial or local judicial, legislative, executive or

regulatory authority.

 

            "GUARANTEE" shall mean the guarantee dated as of the Closing Date

from Medicis to Q-Med.

 

            "HIGHEST MILESTONE" shall have the meaning set forth in Section 8.2.

 

            "IMPROVEMENTS" shall mean any replacements, improvements or

modifications, including without limitation new indications or new uses, in each

case in the Field.

 

            "INDEMNIFIED PARTY" shall have the meaning set forth in Section 10.3

herein.

 

            "INDEMNIFYING PARTY" shall have the meaning set forth in Section

10.3 herein.

 

            "JOINTLY OWNED IMPROVEMENTS" shall have the meaning set forth in

Section 2.3(c).

 

            "LABELING" shall have the meaning set forth in the Supply Agreement.

 

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            "LAUNCH" of a Licensed Product shall mean the first offer for sale

of the Licensed Product to the trade.

 

            "LAWS" shall mean all applicable laws, statutes, rules, regulations,

ordinances and other pronouncements of law of any Governmental Authority.

 

            "LIBOR RATE" shall have the meaning set forth in Section 8.2(b)

herein.

 

            "LICENSED KNOW-HOW" shall mean, except to the extent published or

otherwise known, all of Licensor's and its Affiliates' proprietary know-how,

trade secrets, unpatented inventions, technical data, formulations, technical

information and business and marketing information which Licensor or any of its

Affiliates now own or have the right to license, or hereafter acquire or obtain

the right to license during the Term, but only to the extent necessary or

reasonably useful, in the ordinary course of Licensee's business, for marketing,

using, distributing, importing, offering for sale, selling, commercializing or

otherwise disposing of the Licensed Products in the Field in the Territory,

including sales and marketing materials, medical, clinical, toxicological

testing, scientific data and injection techniques relating to the Licensed

Products; provided, that the Licensed Know-How shall not include (a) information

that Licensor is under an obligation to unrelated Third Parties not to disclose,

such as patient data and (b) the Licensed Regulatory Data.

 

            "LICENSED PATENTS" shall mean the U.S. Patent, U.S. Patent

Application and Canadian Patent Application set forth on Schedule A attached

hereto and any other patent or patent application or rights thereunder in the

Territory that covers the manufacture, use, import or sale of the Licensed

Products, together with any extensions, publications, reissues, continuations,

divisionals, continuations-in-part, reexamination certificates, substitutions or

renewals, supplemental protection certificates or certificates of inventions

thereof owned by Licensor or any of its Affiliates, or under which Licensor or

any of its Affiliates has the right to grant licenses in the Territory, as of

the date hereof or during the Term; provided, that the Licensed Patents shall

not include the Licensed Regulatory Data.

 

            * * *

 

            * * *

 

            "LICENSED RIGHTS" shall mean the Licensed Patents and the Licensed

Know-How.

 

            "LICENSEE INDEMNIFIED PERSONS" shall have the meaning set forth in

Section 10.1.

 

            * * *

 

            "LICENSEE MARKS" shall have the have the meaning set forth in

Section 3.2.

 

            "LICENSEE REGULATORY MATERIALS" shall have the have the meaning set

forth in Section 2.3(b)(ii).

 

            "LICENSEE TRADE DRESS" shall have the have the meaning set forth in

Section 3.2.

 

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            "LICENSES" shall mean the licenses granted by Licensor to Licensee

herein.

 

            "LICENSOR INDEMNIFIED PERSONS" shall have the meaning set forth in

Section 10.2.

 

            "LICENSOR MARKS" shall have the have the meaning set forth in

Section 3.2.

 

            "LICENSOR TRADE DRESS" shall have the have the meaning set forth in

Section 3.2.

 

            "LOSS" or "LOSSES" shall mean any and all damages, fines, fees,

penalties, deficiencies, losses and expenses, including reasonable legal fees

and expenses, but excluding loss of profits or other special, punitive or

consequential damages.

 

            "MACROLANE SIDE LETTER" shall mean that certain letter from Medicis

to Q-Med, dated as of the Closing Date.

 

            "MANUFACTURE" shall have the meaning set forth in the Supply

Agreement.

 

            "MEDICIS" shall mean Medicis Pharmaceutical Corporation, a Delaware

corporation.

 

            "MASTER FILES" shall have the meaning set forth in the Supply

Agreement.

 

            "MILESTONE" shall have the meaning set forth in Section 8.2.

 

            "MILESTONE PAYMENT" shall have the meaning set forth in Section 8.2.

 

            "NET REVENUES" shall mean, with respect to any Licensed Product, the

gross sales of such Licensed Product invoiced by Licensee and/or its Affiliates

to Licensee's and/or its Affiliates' customers who are not Affiliates, less, to

the extent actually paid or accrued net of payments by Licensee and/or its

Affiliates (as applicable), (a) normal and customary credits, allowances,

discounts and rebates to, and chargebacks from the account of, such customers

for spoiled, damaged, out-dated and returned Licensed Product; (b) normal and

customary freight and insurance costs incurred in transporting such Licensed

Product to and from such customers; (c) normal and customary cash, quantity and

trade discounts, rebates and other price reductions or special programs for such

Licensed Product; and (d) excise, sales, use, value-added and other direct taxes

(but not income taxes of any kind) imposed upon the sale of such Licensed

Product to such customers. For avoidance of doubt, Licensee shall calculate Net

Revenues for purposes of this Agreement according to U.S. generally accepted

accounting principles applied on a consistent basis and in a manner consistent

with Medicis' calculations of consolidated net revenues and consistent with the

numbers used to consolidate net revenues reported in Medicis' periodic reports

with the United States Securities and Exchange Commission.

 

            "NON-COMPETE PERIOD" shall have the meaning set forth in Section

3.13(b).

 

            "ONE TIME PAYMENT" shall have the meaning set forth in Section 8.1.

 

            * * *

 

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            "OTHER PARTY" shall have the meaning set forth in Section 8.5.

 

            "OUT-OF-FIELD USE" shall have the meaning set forth in Section

3.10(b).

 

            "PARTY" shall mean Licensor or Licensee and, when used in the

plural, means both Licensor and Licensee or their respective Permitted

Transferees or Third Party transferees, in each case upon the consummation of a

Transfer in accordance with the terms and conditions herein.

 

            "PATENT REQUEST" shall have the meaning set forth in Section 3.7.

 

            "PAYMENT DATE" shall have the meaning set forth in Section 8.5.

 

             "PAYMENT TERM" shall commence on the Closing Date and, unless this

Agreement is earlier terminated pursuant to Section 6.2, last until * * *.

 

            "PERMITTED TRANSFEREE" shall mean any Affiliate of the Licensor or

Medicis, as applicable, of whom the Licensor or Medicis, as applicable, directly

or indirectly, through one or more intermediaries, owns or controls more than

fifty percent (50%) of the voting securities or economic interest in such

Affiliate and such Affiliate is able to provide and at all times update a valid

Form W-8BEN in accordance with U.S. Treasury Regulation 1.1441-(e)(4)(ii), for

so long as such Affiliate continues to be a Permitted Transferee; provided, that

the Licensor or Licensee, as applicable, shall remain directly liable for the

performance by the Permitted Transferee of all obligations of the Licensor or

Licensee, as applicable, under this Agreement and no Transfer to a Permitted

Transferee hereunder shall relieve the Licensor or Licensee, as applicable, of

its obligations pursuant to this Agreement.

 

            "* * * PAYMENT" shall have the meaning set forth in Section 8.1.

 

            * * *

 

            "PMA APPLICATION" shall have the meaning set forth in the Supply

Agreement.

 

            "PMA APPROVALS" shall have the meaning set forth in the Supply

Agreement.

 

            "PERSON" shall mean any individual, firm, corporation, partnership,

limited liability company, trust, joint venture or other entity or organization.

 

            "PREVIOUS LICENSE AGREEMENT" shall mean the Amended and Restated

Intellectual Property License Agreement between Q-Med and HA North American

Sales AB, dated March 6, 2003 (as the same may be amended from time to time in

accordance with its terms).

 

            "PREVIOUS LICENSE LETTER AGREEMENT" shall mean that certain letter

from Medicis to Q-Med, dated as of the Closing Date.

 

            "PREVIOUS SUPPLY AGREEMENT" shall mean that certain Supply Agreement

dated as of March 7, 2003, between Medicis and Q-Med, as the same may be amended

from time to

 

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time in accordance with its terms.

 

            "PROMOTIONAL LABELING" shall have the meaning set forth in the

Supply Agreement.

 

            "REGULATORY APPROVALS" shall have the meaning set forth in the

Supply Agreement.

 

            "RESPONSIBLE PARTY" shall have the meaning set forth in Section

3.10(b).

 

            "RETURN PAYMENT" shall have the meaning set forth in Section 8.2.

 

            "STEERING COMMITTEE" shall have the meaning set forth in the Supply

Agreement.

 

            "SUPPLY AGREEMENT" shall mean the Supply Agreement, dated as of the

Closing, between Q-Med and MAHI (as the same may be amended from time to time in

accordance with its terms).

 

            "TERM" shall have the meaning set forth in Section 6.1.

 

            "TERRITORY" shall mean the United States, including its territories

and possessions, and Canada.

 

            "TERRITORY SPECIFIC MATERIALS" shall have the meaning set forth in

Section 2.3(b)(i).

 

            "THIRD ANNIVERSARY" shall have the meaning set forth in Section 10.1

herein.

 

            "THIRD PARTY" shall mean any Person who or which is neither a Party

nor an Affiliate of a Party.

 

            "THIRD PARTY INDEMNIFIABLE CLAIM" shall have the meaning set forth

in Section 10.4 herein.

 

            "TPD" shall mean Canada's Therapeutic Products Directorate.

 

            "TRANSACTION AGREEMENTS" shall mean this Agreement, the Supply

Agreement, the Macrolane Side Letter, the Previous License Letter Agreement, the

Guarantee and the Confidentiality Agreement.

 

            "TRANSFER" shall mean any Change in Control or Volitional Change in

Control of a Party or a transfer or assignment by a Party of its rights and

obligations under this Agreement; provided, however, that for purposes of this

Agreement the actions set forth in Section 2.1 hereof shall not be deemed to be

a Transfer.

 

            "USPTO" shall mean the United States Patent and Trademark Office.

 

            "VOLITIONAL CHANGE IN CONTROL" shall mean (a) the disposition of all

or substantially all of the outstanding shares, assets or business of a Party or

Medicis on a

 

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consolidated basis; or (b) any transaction or event (or series of transactions

or events) as a result of which any Person (other than an Affiliate of such

Party or Medicis), acting singly or as a part of a "partnership, limited

partnership, syndicate or group" (within the meaning of Section 13(d)(3) of the

United States Securities Exchange Act of 1934, as amended): (i) acquires (by

purchase, merger, consolidation or otherwise) or for the first time controls or

is able to vote (directly or through nominees, beneficial ownership, proxy or

contract) fifty percent (50%) or more of the aggregate of all outstanding equity

securities of a Party or Medicis; or (ii) acquires (by purchase, merger,

consolidation or otherwise) equity securities of a Party or Medicis with the

right to, or for the first time is otherwise able to, nominate or designate

(directly or through nominees, beneficial ownership, proxy or contract) at least

fifty percent (50%) of the nominees to the board of directors of such Party or

Medicis, in each of (a) or (b),in the event that Licensor, Licensee or Medicis,

as the case may be, was a party to the applicable transaction or of which the

Board of Directors of Licensor, Licensee or Medicis, as the case may be, shall

have approved.

 

            "WEBSITE CONTENT" shall have the meaning set forth in Section 2.5.

 

      1.2 Other Definitional Provisions.

 

      (a) The words "HEREOF", "HEREIN", "HERETO" and "HEREUNDER" and words of

similar import, when used in this Agreement, shall refer to this Agreement as a

whole and not to any particular provision of this Agreement unless otherwise

indicated.

 

      (b) The terms defined in the singular shall have a comparable meaning when

used in the plural, and vice versa.

 

      (c) The term "INCLUDING" shall mean "INCLUDING, WITHOUT LIMITATION."

 

      (d) When a reference is made in this Agreement to an Article, a Section or

Schedule, such reference shall be to an Article of, a Section of or a Schedule

to, this Agreement unless otherwise indicated.

 

                                   ARTICLE II

                             LICENSE AND RESERVATION

 

      2.1 Grant of Licenses to Licensee.

 

      (a) Grant of License to Licensed Rights. Subject to the terms and

conditions of this Agreement, Licensor grants to Licensee, effective as of the

Closing Date, a payment bearing, exclusive (even as to Licensor and its

Affiliates), nonsublicensable (except as permitted in Section 12.1) and

nonassignable (except as permitted in Section 12.1) license to the Licensed

Rights in the Field in the Territory (i) to market, use, distribute, import,

offer for sale, sell, commercialize or otherwise dispose of, but not to make or

have made, Licensed Products in the Territory, itself or to have such done on

its behalf; (ii) to market, use, distribute, offer for sale, sell, commercialize

or otherwise dispose of Licensed Products in the Territory via the Internet,

itself or to have such done on its behalf, provided that any web site owned and

operated by or on behalf of Licensee is directed solely to users in the

Territory, and provided, further, that Licensee may only ship Licensed Products

or direct promotional materials related thereto to locations within the

Territory; and (iii) to conceive, but not develop, Improvements to the Licensed

Rights

 

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<PAGE>

 

except that Licensee may develop Improvements and conduct clinical development

(or have such development done on its behalf) only to the extent expressly

provided herein and in Article VI of the Supply Agreement, provided with respect

to (iii) herein that (x) Licensor remains the sole source of development work

for Licensee unless otherwise provided herein or in Article VI of the Supply

Agreement or Licensor is unable to provide Licensee with the research and

development reasonably required by Licensee, in which case the Steering

Committee shall select a contract laboratory to provide development work under

Licensor's supervision and (y) Licensor retains ownership of all Improvements,

as set forth in Section 2.3 herein, except as expressly provided herein and in

Article VI of the Supply Agreement. For avoidance of doubt, Licensee

acknowledges and agrees that the right to develop in accordance with Section

2.1(a)(iii) shall not include a right for Licensee to modify or develop changes

to the formulation, primary packaging, or manufacturing processes for Licensed

Products. Licensee shall not use the Licensed Rights outside the Territory for

any purpose or in the Territory for any purpose other than as specifically

authorized herein.

 

      (b) Grant of License to Licensed Regulatory Data. Subject to the terms and

conditions of this Agreement, Licensor grants to Licensee, effective as of the

Closing Date, a payment bearing, exclusive (even as to Licensor and its

Affiliates), nonsublicensable (except as permitted in Section 12.1) and

nonassignable (except as permitted in Section 12.1) license in the Field in the

Territory to copy, reference and otherwise use the Licensed Regulatory Data, but

only to the extent recommended or suggested by the FDA or TPD or as necessary or

reasonably useful for the purpose of conducting clinical trials and obtaining

and maintaining Regulatory Approvals for the Licensed Products in the Field in

the Territory pursuant to this Agreement and the Supply Agreement.

 

      (c) Limited Exception to Exclusivity. Notwithstanding the exclusive rights

granted in Section 2.1(b), the Parties agree that Licensor and its Affiliates

shall have the right to complete the clinical study in Canada titled * * * in

progress as of the date hereof (the "CANADIAN STUDY"). For the avoidance of

doubt, the data, materials and other results of the Canadian Study shall be

owned by Licensor and deemed to be "Licensed Regulatory Data" for purposes of

this Agreement without any additional consideration on the part of Licensee.

 

      (d) Rights at End of Payment Term. As of the expiration of the Payment

Term, the Licenses shall be deemed fully paid up and irrevocable (except as

otherwise provided in Section 6.2) for the remainder of the Term.

 

      2.2 Reservation of Rights. Other than as expressly stated herein or in the

Previous License Agreement, Licensee shall have no other right to use or

interest in the Licensed Rights or Licensed Regulatory Data. Specifically,

Licensee shall not have any interest in any other patents, trademarks or other

intellectual property owned, licensed, developed or controlled by Licensor,

other than as expressly provided in this Agreement, the Previous License

Agreement or other valid written agreements. Licensee undertakes not to make,

market, use, import, offer for sale, sell or in any other way take any action to

commercialize the Licensed Products, Licensed Regulatory Data or Licensed Rights

outside the Territory. Each Party shall use commercially reasonable efforts to

direct to the other Party customer requests for Licensed Products received

through each Party's customer service that relate, in case of the Licensee,

requests outside the Territory and, in the case of Licensor, requests in the

Territory, in each case only to the extent

 

                                        9

 

<PAGE>

 

that such referral does not violate or conflict with any confidentiality

obligations binding on the directing Party. The Parties intend that this

Agreement shall not restrict Licensor's freedom to make, use, import, offer for

sale, sell, practice or otherwise commercialize the Licensed Products, Licensed

Regulatory Data or Licensed Rights (a) within the Field outside the Territory or

(b) outside the Field whether or not in the Territory. Except as specifically

provided herein or in Article VI of the Supply Agreement, Licensee grants no

rights of ownership, use or otherwise in Licensee's patents, trademarks,

know-how or other intellectual property.

 

      2.3 Ownership of Intellectual Property.

 

      (a) Licensor's Ownership. Licensee acknowledges and agrees that, as

between Licensee and Licensor, Licensor is the sole owner of the Licensed Rights

and Licensed Regulatory Data and any Improvements to the Licensed Rights or

Licensed Regulatory Data, including without limitation products in whole or in

part based on, utilizing or otherwise incorporating the Licensed Rights or

Licensed Regulatory Data, whether conceived, created or developed by Licensor or

Licensee, except as expressly provided herein and in Article VI of the Supply

Agreement. Licensee shall not directly or indirectly question, attack, contest,

or in any other manner impugn the validity, enforceability, registration or

Licensor's ownership of, or right to use the Licensed Rights and Licensed

Regulatory Data and any Improvements thereupon (other than the Improvements

owned by Licensee as expressly provided herein and in Article VI of the Supply

Agreement), including without limitation products in whole or in part based on,

utilizing or otherwise incorporating the Licensed Rights and Licensed Regulatory

Data, nor shall Licensee willingly become an adverse party to Licensor in any

Action contesting the validity or enforceability of, or Licensor's ownership of

or rights in, the Licensed Rights and Licensed Regulatory Data, except that

Licensee shall be permitted to be an adverse party in connection with a

defensive counterclaim, and to assert any claim or defense in any Action based

on any dispute arising out of or in connection with this Agreement, or the

breach, termination, or invalidity hereof.

 

      (b) Licensee's Ownership. Licensor acknowledges and agrees that, as

between Licensor and Licensee, Licensee shall have the right to create, develop

and acquire (itself or to have such done on its behalf) and own all right, title

and interest, and goodwill as applicable, in the following that are created,

developed or acquired by or on behalf of Licensee (and, to the extent that any

of the following constitute Improvements to the Licensed Rights or Licensed

Regulatory Data, such Improvements):

 

            (i) "TERRITORY SPECIFIC MATERIALS" which shall mean: (A) trademarks

      and trade dress for or utilized with the Licensed Products in the

      Territory (including, for the avoidance of doubt, the mark "SUBQ" or any

      mark containing the term "SUBQ"), but excluding the Licensor trademarks

      used in accordance with Section 3.2(a) e.g., NASHA or Licensor corporate

      identifier; (B) website content for the Licensed Products in the

      Territory; and (C) marketing, sales and promotional materials for the

      Licensed Products in the Territory, including Advertising and Promotional

      Labeling;

 

            (ii) * * *

 

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<PAGE>

 

            (iii) Improvements conceived by Licensee that are not in whole or in

      part based on, do not utilize or do not otherwise incorporate, the

      Licensed Rights or Licensed Regulatory Data.

 

      For avoidance of doubt, Licensee acknowledges and agrees that Licensee's

ownership of the Improvements and materials included in the Territory Specific

Materials or Licensee Regulatory Materials does not imply ownership of the

Licensed Rights or Licensed Regulatory Data or any other Improvements or

materials. Licensor shall not directly or indirectly question, attack, contest,

or in any other manner impugn the validity, enforceability, registration or

Licensee's ownership of, or right to use the Territory Specific Materials or

Licensee Regulatory Materials nor shall Licensor willingly become an adverse

party to Licensee in any Action contesting the validity or enforceability of, or

Licensee's ownership of or rights in, the Territory Specific Materials or

Licensee Regulatory Materials, except that Licensor shall be permitted to be an

adverse party in connection with a defensive counterclaim, and to assert any

claim or defense in any Action based on any dispute arising out of or in

connection with this Agreement, or the breach, termination, or invalidity

hereof.

 

      (c) Joint Ownership. The following Improvements shall be jointly owned by

the Parties: (i) Improvements to the Licensed Rights, Licensed Regulatory Data

or Licensee Regulatory Materials that the Parties' designees on the Steering

Committee mutually agree shall be jointly owned by the Parties for the purpose

of avoiding prior art status, under 35 U.S.C. ss. 102(e), and (ii) clinical data

developed by the Parties that the Parties' designees on the Steering Committee

mutually agree shall be jointly owned pursuant to Article VI of the Supply

Agreement (the "JOINTLY OWNED IMPROVEMENTS").

 

      2.4 Improvements.

 

      (a) Rights to Improvements. Notwithstanding the foregoing, any

Improvements to the Licensed Rights or Licensed Regulatory Data, including

Licensor's undivided interest in the Jointly Owned Improvements, made by or for

Licensor during the Term (other than the Improvements owned by Licensee as

expressly provided herein and in Article VI of the Supply Agreement) shall be

made available to Licensee and be deemed included within the scope of the

Licensed Rights or Licensed Regulatory Data, as applicable, without any

additional consideration on the part of Licensee. Without limiting the

generality of the foregoing and except for the Improvements owned by Licensee as

expressly provided herein and in Article VI of the Supply Agreement, Licensee

agrees not to, and not to assist any Third Party to, apply to register or

register title to any intellectual property rights in the Licensed Rights or

Licensed Regulatory Data or any Improvements thereupon, including Improvements

to Licensed Products that are, in whole or in part, based on, utilizing or

otherwise incorporating the Licensed Rights or Licensed Regulatory materials,

except for the Improvements owned by Licensee as expressly provided herein and

in Article VI of the Supply Agreement.

 

      (b) Certain Improvements Relating to * * *. If, in order to obtain * * *

for the Licensed Products, Licensor develops an Improvement to the Licensed

Products for * * * use and such Improvement has an average particle size larger

than * * *, then such Improvement will be deemed a Licensed Product under this

Agreement and the Supply Agreement notwithstanding its average particle size or

any other provision of this Agreement or the Supply Agreement to the

 

                                        11

 

<PAGE>

 

contrary, and the definition of "Licensed Product" herein and in the Supply

Agreement and Section 2.1(a) hereof shall be automatically amended as necessary

to include such Improvement, provided, however that in the event * * * are

achieved with a Licensed Product having an average particle size equal to or

less than * * *, this Section 2.4(b) shall not apply and shall be of no force or

effect. For the avoidance of doubt, nothing in this Section 2.4(b) or this

Agreement is intended to require Licensor to develop an Improvement to the

Licensed Products having an average particle size larger than * * *.

 

      (c) Grant Back License Outside the Territory. Subject to the terms and

conditions of this Agreement and to the extent that Licensee has the right to

grant license rights therein, Licensee grants to Licensor, effective as of

Closing Date, a fully paid-up, exclusive outside the Territory for all purposes,

nonsublicensable (except as permitted in Section 12.1) and nonassignable (except

as permitted in Section 12.1) license to make, market, use, distribute, import,

offer for sale, sell, commercialize or otherwise dispose of (i) all of the

Territory Specific Materials, except for the trademarks and trade dress for the

Licensed Products specified in Section 2.3(b)(i)(A) and the website content

specified in Section 2.3(b)(i)(B); (ii) all of the Licensee Regulatory Materials

except for the Regulatory Approvals and Opt Out Data; and (iii) Licensee's

undivided interest in the Jointly Owned Improvements. For the avoidance of

doubt, subject to the terms and conditions of this Agreement and to the extent

that Licensee has the right to grant license rights therein, Licensee grants to

Licensor, effective as of Closing Date, a fully paid-up, exclusive outside the

Territory for all purposes, nonsublicensable (except as permitted in Section

12.1) and nonassignable (except as permitted in Section 12.1) license to make,

market, use, distribute, import, offer for sale, sell, commercialize or

otherwise dispose of the Licensee Regulatory Materials (except for the

Regulatory Approvals and Opt Out Data), including, for the avoidance of doubt,

the regulatory and clinical data and materials generated in accordance with

Section 6.3(b)(iii) of the Supply Agreement.

 

      (d) Grant Back License Inside the Territory Outside the Field. Subject to

the terms and conditions of this Agreement and to the extent that Licensee has

the right to grant license rights therein, Licensee grants to Licensor,

effective as of Closing Date, a fully paid-up, exclusive inside the Territory

outside the Field, nonsublicensable (except as permitted in Section 12.1) and

nonassignable (except as permitted in Section 12.1) license to make, market,

use, distribute, import, offer for sale, sell, commercialize or otherwise

dispose of (i) all of the Licensee Regulatory Materials except for the

Regulatory Approvals and Opt Out Data; and (ii) Licensee's undivided interest in

the Jointly Owned Improvements. For the avoidance of doubt, subject to the terms

and conditions of this Agreement and to the extent that Licensee has the right

to grant license rights therein, Licensee grants to Licensor, effective as of

Closing Date, a fully paid-up, exclusive inside the Territory outside the Field,

nonsublicensable (except as permitted in Section 12.1) and nonassignable (except

as permitted in Section 12.1) license to make, market, use, distribute, import,

offer for sale, sell, commercialize or otherwise dispose of the Licensee

Regulatory Materials (except for the Regulatory Approvals and Opt Out Data)

including, for the avoidance of doubt, the regulatory and clinical data and

materials generated in accordance with Section 6.3(b)(iii) of the Supply

Agreement.

 

      (e) Grant Back License to the Opt Out Data. Subject to the terms and

conditions of this Agreement and to the extent that Licensee has the right to

grant license rights therein, Licensee grants to Licensor, effective as of

Closing Date, a fully paid-up, exclusive inside the

 

                                        12

 

<PAGE>

 

Territory outside the Field and outside the Territory, nonsublicensable (except

as permitted in Section 12.1) and nonassignable (except as permitted in Section

12.1) license to access and use the Opt Out Data solely for the purpose of

complying with the safety reporting requirements of the FDA, TPD, or an

equivalent regulatory body in a country outside the Territory; provided, that

the Opt Out Data shall not include data or information owned by Third Parties or

that Licensee is under an obligation at law or to Third Parties not to disclose

(e.g., protected patient identification information). For purposes of the

preceding sentence, "Third Party" shall not include contract laboratories or

other agents acting on behalf of Licensee or its Affiliates. Notwithstanding the

foregoing, with respect to data or information owned by Third Parties or that

Licensee is under an obligation to Third Parties not to disclose, Licensee shall

use commercially reasonable efforts to cause such Third Parties to provide

letters of authorization granting necessary rights of reference or permission to

disclose (e.g., to their confidential information).

 

      2.5 Website Content and URLs.

 

      (a) Cross License. To the extent a Party or an Affiliate of a Party has

the right to grant licenses to the content for its website that describes a

Licensed Product ("WEBSITE CONTENT"), such Party grants the other Party,

effective as of the Closing Date, a fully paid-up, non-exclusive,

nonsublicensable (except as permitted in Section 12.1) and nonassignable (except

as permitted in Section 12.1) license to use such Website Content in connection

with the marketing, offering for sale, and distribution of the Licensed

Products, which license shall include the right to copy, prepare derivative

works and publicly display such Website Content. The licensor of such Website

Content shall in all instances act reasonably to provide materials embodying the

Website Content to the licensee of such content and in allowing the licensee of

the Website Content to display such content as provided in all cases at the

licensee's reasonable request and sole expense. Prior to copying the Website

Content of the other Party or its Affiliates, the licensee of the Website

Content shall send the licensor an email describing the Website Content it wants

to copy, and the licensor shall, within five (5) Business Days, provide the

licensee with its commentary, updates and notes, if any, on the Website Content

identified in the licensee's email.

 

      (b) Conditions to License. The license granted to Licensee in Section

2.5(a) is subject to the conditions that (i) any website owned or operated by or

on behalf of Licensee that displays Website Content (A) is directed solely to

users in the Territory, and (B) contains a prominent disclaimer to the effect

that any Website Content is directed solely to users in the United States or

Canada; (ii) any website owned or operated by or on behalf of Licensor that

displays Website Content (A) is directed solely to users outside the Territory,

and (B) contains a translation of Licensee's Website Content into a language

other than the English language or a prominent disclaimer to the effect that any

Website Content written in the English language is not directed to users in the

United States or Canada.

 

      (c) Access to Websites. It is understood and agreed that it shall not be a

breach of this Section 2.5 if (i) users outside the Territory are able to gain

access to websites owned or operated by or on behalf of Licensee, provided that

Licensee does not take any affirmative measures to target such users and takes

commercially reasonable measures to respond only to users located within the

Territory, for example, by declining to provide additional information to users

who identify themselves as being located outside the Territory, or (ii) users in

the Territory

 

                                       13

 

<PAGE>

 

are able to gain access to websites owned or operated by or on behalf of

Licensor, provided that Licensor does not take any affirmative measures to

target such users and takes commercially reasonable measures to respond only to

users located outside the Territory, for example, by declining to provide

additional information to users who identify themselves as being located in the

Territory. Licensor and Licensee shall ensure that their respective websites

substantially comply with the applicable FDA and the applicable TPD

requirements. Licensor shall not, and shall cause its licensees not to, register

or use (i) any Licensee Mark in any URL or domain name, or (ii) any trademark

for a Licensed Product in any URL or domain name that contains the international

extension ".us" (for the United States) or ".ca" (for Canada).

 

                                    ARTICLE III

                                   OBLIGATIONS

 

      3.1 Diligence Efforts.

 

      (a) Diligence Obligations of the Parties. Licensee shall use commercially

reasonable efforts to obtain Regulatory Approvals for the Licensed Products in

the Territory, to bring Licensed Products to market, and to maximize sales of

Licensed Products in the Territory. At a minimum, it is Licensee's obligation

under this Section 3.1(a) to adopt and implement efforts to bring Licensed

Products to market and to maximize sales for each Licensed Product hereunder

that are reasonably equivalent to the sales and other efforts and sales

strategies adopted and implemented by Licensee's Affiliate pursuant to the

Previous License Agreement with regard to the launch and ongoing sales efforts

for Restylane;(TM) provided, however, that Licensee may adjust its efforts under

this Agreement to account for the differences in the products and the market

opportunities therefor. In the event the product currently marketed in Europe

under the trademark Restylane SubQ does not meet the requirements of * * *,

Licensor shall use commercially reasonable efforts to develop at least one

Licensed Product having * * *.

 

      (b) Diligence Default. In the event that Licensor believes that Licensee

has committed a material breach of its obligations under Section 3.1(a) for a

particular Licensed Product and Licensor provides Licensee with written notice

of such alleged material breach, and Licensee thereafter fails to effect a cure

of such alleged material breach within thirty (30) days of receipt of the

written notice from Licensor, Licensor may invoke the dispute resolution

procedures set forth in Article XI. If, in a final arbitral decision, the

arbitral tribunal determines that Licensee has committed a material breach of

its obligations in Section 3.1(a) with respect to a particular Licensed Product

(a "DILIGENCE DEFAULT"), Licensor shall have the exclusive remedies specified in

Sections 3.1(c) and 3.1(d).

 

      (c) Termination of Exclusive Rights. In the event a Diligence Default has

occurred, Licensor may (i) terminate the exclusive rights granted in Section 2.1

hereof for that particular Licensed Product by sending written notice of such

termination to Licensee, and (ii) obtain a duplicate PMA Approval with respect

to such Licensed Product in accordance with Section 3.1(d) only for purposes of

obtaining and maintaining approval to market and distribute such Licensed

Product in the Territory. If Licensor terminates the exclusive rights granted in

Section 2.1 hereof for a particular Licensed Product, such license with respect

to such Licensed Product shall continue in effect but shall become nonexclusive

with regard to such Licensed Product only.

 

                                       14

 

<PAGE>

 

      (d) Duplicate PMA Approvals.

 

            (i) For purposes of this Section 3.1(d), "Licensor" shall refer to

      "Licensor or its licensee." The procedure for obtaining duplicate PMA

      Approvals in the event of a Diligence Default shall be as follows:

 

            (A) Pursuant to the FDA's existing procedure, Licensor shall prepare

            and file a complete original PMA Application based upon a right of

            reference to the information in Licensee's Regulatory Approvals for

             the nonexclusive Licensed Product. Licensee shall cooperate fully to

            ensure that such PMA Application is complete, accurate and

            acceptable for filing under 21 C.F.R. ss. 814.12. Licensee shall

            promptly provide all necessary letters of authorization granting

            rights of reference, shall use commercially reasonable efforts to

            cause Third Parties to provide letters of authorization granting

            necessary rights of reference (e.g., to their Master Files) and

            otherwise shall use commercially reasonable efforts to enable

            Licensor to fully comply with and pursue the FDA requirements for

            obtaining duplicates of the original PMA Approvals in accordance

             with the terms of this Agreement. Licensee shall promptly cooperate

            with Licensor's efforts and the FDA procedures as reasonably

            requested by Licensor and as necessary to obtain such duplicate PMA

            Approvals.

 

             (B) The FDA generally refers to the foregoing procedure as licensing

            of a PMA Approval, with the owner of the original Regulatory

            Approval as the licensor and the owner of the newly issued PMA

            Approval as the licensee. These terms are not used in this Section

            3.1(d) in order to avoid confusion with this Agreement and terms

            related hereto.

 

            (ii) Upon the completion of the procedures referenced in Section

      3.1(d)(i), above: (A) Licensor shall have irrevocable ownership of its

      duplicate Regulatory Approvals for the sole purpose of marketing and

      distributing the nonexclusive Licensed Product and (B) Licensor's

      distribution (or distribution by its other licensees and/or agents) of

      such nonexclusive Licensed Products in the United States shall be

      conducted under the Regulatory Approvals that Licensor owns.

 

            (iii) As applicable, both Parties shall provide all necessary

      letters of authorization granting rights of reference, shall use

      commercially reasonable efforts to cause Third Parties to provide letters

      of authorization granting necessary rights of reference (e.g., to their

      Master Files) and otherwise shall cooperate fully in complying with the

      FDA requirements for obtaining duplicate PMA Approvals in accordance with

      the terms of this Agreement.

 

      (e) Exclusive Remedies. The remedies specified in Sections 3.1(b), 3.1(c)

and 3.1(d), shall be the exclusive remedy in the event of a Diligence Default

notwithstanding any other rights, powers, remedies and privileges that may be

available to Licensor under this Agreement (including, without limitation,

Article X hereof), the Transaction Agreements or Laws of any Governmental

Authority. If, following a Diligence Default, the exclusive license rights

granted in Section 2.1 hereof for a particular Licensed Product become

nonexclusive in accordance with

 

                                       15

 

<PAGE>

 

Section 3.1(c), Licensee shall have no further obligations under Section 3.1(a)

for that Licensed Product.

 

      3.2 Markings and Trade Dress.

 

      (a) Licensee shall use commercially reasonable efforts to substantially

comply with all patent marking and placement of corporate identifiers and

identifiers of NASHA technology on the packaging and package inserts of the

Licensed Products as required by applicable Law in the U.S. and Canada. Licensee

shall use and display on all packaging and package inserts of the Licensed

Products Licensor corporate identifiers and identifiers of NASHA technology that

are reasonably requested by Licensor and are of a size, format and location

appropriate for said packaging as reasonably determined by Licensee, provided

that such identifiers shall be displayed in a reasonably prominent manner.

Licensee shall not use or display Licensor's corporate identifiers or

identifiers of NASHA technology other than on promotional literature, packaging

and package inserts, without Licensor's express written consent, and in any

event shall not use or display Licensor's corporate identifiers or identifiers

of NASHA technology in a manner inconsistent with Licensor's use and display

thereof. It shall not be considered a breach by Licensee of this Section 3.2 if,

through inadvertence or Third Party error, such identifiers are not, or are

incorrectly, displayed on a small number of promotional literature, packages or

package inserts of the Licensed Products.

 

      (b) Licensee shall have the right to adopt, own for registration and use

for Licensed Products, in each case solely in the Territory, (i) trademarks

owned or controlled by Licensor and used to brand the Licensed Products outside

the Territory or trademarks substantially similar thereto (the "LICENSOR MARKS)

and/or the trade dress owned or controlled by Licensor and used in connection

with the Licensed Products outside the Territory, or trade dress substantially

similar thereto (the "LICENSOR TRADE DRESS"); or (ii) trademarks distinctive to

Licensee, provided such trademarks are not confusingly similar to the Licensor

Marks existing and publicly known (the "LICENSEE MARKS) and/or trade dress

distinctive to Licensee, provided such trade dress is not confusingly similar to

the Licensor Trade Dress existing and publicly known (the "LICENSEE TRADE

DRESS") and provided further that Licensee (x) shall bear its own expenses with

regard to adoption or modification of Licensee Marks and Licensee Trade Dress,

and (y) shall not adopt a Licensee Trade Dress which is incompatible with or

unduly burdensome on Licensor's packaging or other equipment. For the avoidance

of doubt, Licensee may adopt any combination of the foregoing (e.g., the

Licensee Marks with the Licensor Trade Dress or the Licensor Marks with the

Licensee Trade Dress).

 

      (c) In the event that Licensee adopts the Licensor Marks to brand and

market the Licensed Products in the Territory, the Parties agree that Licensor

shall, and shall cause its Third Party licensees to, refrain from adopting new

trademarks, or changing or modifying the existing trademarks, for any product of

Licensor that is distributed inside the Territory (either inside or outside the

Field) in a way as to make it confusingly similar to the marks adopted by

Licensee, provided that Licensor shall be free to change, modify or adapt its

trademarks used in connection with its products outside the Territory, even if

such changes, modifications or adaptations result in trademarks that are

confusingly similar to the trademarks used by Licensee in connection with

Licensed Products within the Territory.

 

                                       16

 

<PAGE>

 

      (d) In the event that Licensee elects to adopt the Licensor Trade Dress

for use in connection with the Licensed Products in the Territory, the Parties

agree that each Party shall be free to change, modify or adapt its trade dress

used in connection with its products, even if such changes, modifications or

adaptations result in trade dress that is confusingly similar to the trade dress

used by the other Party in connection with its products; provided however

Licensor shall, and shall use commercially reasonable efforts to cause its Third

Party licensees to, refrain from modifying the Licensor Trade Dress in a way

identical to Licensee's modifications of Licensor Trade Dress adopted by the

Licensee.

 

      (e) In the event that Licensee adopts the Licensee Marks or Licensee Trade

Dress to brand and market the Licensed Products in the Territory, the Parties

agree that Licensor shall, and shall cause its Third Party licensees to, refrain

from adopting new trademarks or trade dress or changing or modifying the

existing trademarks or trade dress, for any product of Licensor that is

distributed either in or outside the Territory in a way as to make it identical

or confusingly similar to the Licensee Marks or Licensee Trade Dress.

 

      3.3 Protection of Intellectual Property. Licensee shall take such action

as Licensor reasonably requests in writing, at Licensor's expense except as

otherwise determined by the Steering Committee in accordance with the Supply

Agreement, to assist Licensor in obtaining, registering and perfecting the

Licensed Rights and disclosing pertinent information and executing documents in

connection therewith.

 

      3.4 Compliance With Relevant Law. Licensor and Licensee shall each comply

in all material respects with all applicable Laws that pertain to the activities

for which Licensor and Licensee are each responsible under this Agreement.

 

      3.5 Prosecution and Maintenance of Licensed Patents. Subject to the terms

and conditions of this Agreement, Licensor shall use reasonable best efforts to

prosecute and maintain all Licensed Patents in the Territory in Licensor's name

in accordance with the applicable terms set forth herein. Except as otherwise

set forth in Section 4.2 herein with respect to Actions for the infringement,

misappropriation or impairment of or damage to the Licensed Rights, Licensor

shall be responsible for all actions and costs associated with maintaining the

enforceability and validity of the Licensed Patents, and paying maintenance fees

and/or annuities, and all other costs required to maintain the Licensed Patents.

Licensor shall use reasonable best efforts to prosecute each of the Licensed

Patents either to issuance or until administrative appeals to the Board of

Patent Appeals and Interferences or its Canadian equivalent are exhausted.

Except as provided in Section 3.7 herein with regard to patent applications

requested by Licensee, the preparation and filing of any new patent applications

shall be entirely and solely at Licensor's discretion.

 

      3.6 Correspondence Relating to Patent Prosecution. Licensor shall deliver

to Licensee, or counsel designated by Licensee, copies of all non-privileged

correspondence to and from the USPTO and CIPO relating to the Licensed Patents

in the Territory, as well as all non-privileged correspondence with the World

Intellectual Property Organization relating to any International Application

designating the United States or Canada, and all non-privileged correspondence

with any national or regional patent office containing any information that may

reasonably be material to the validity, scope or enforceability of the Licensed

Patents, relating to

 

                                        17

 

<PAGE>

 

applications corresponding to or claiming priority with or from the Licensed

Patents. Such correspondence shall be delivered promptly after the origination

or receipt of such correspondence. With respect to the Licensed Patents,

Licensee or counsel designated by Licensee shall have the right to submit

comments on such correspondence to Licensor within fifteen (15) Business Days

after Licensor sends such correspondence to Licensee or counsel designated by

Licensee. If Licensee or counsel designated by Licensee timely submits comments

to Licensor, and subject always to the best judgment of Licensor and its

counsel, Licensor shall use commercially reasonable efforts to incorporate all

reasonable comments in its further correspondence with the USPTO or CIPO,

provided incorporation of the comments would not unreasonably delay, burden or

increase the expense of the prosecution of pending patent applications.

 

      3.7 Divisional, Continuation and New Patent Applications. From time to

time Licensee may desire that Licensor file a divisional, continuation or new

application for patent in the Territory embodying an invention conceived by

Licensee and in whole or in part based on, utilizing or otherwise incorporating

the Licensed Rights. In such circumstances, Licensee shall submit to the

Steering Committee, in accordance with the Supply Agreement, a request for

patent filing detailing the invention, the effect of the invention on the

commercialization of the Licensed Products in the Territory (if any) and any

information known to Licensee regarding the novelty, non-obviousness and general

patentability of the invention (a "PATENT REQUEST"). Licensee and Licensor shall

cause their respective designees on the Steering Committee, in accordance with

the Supply Agreement, to decide whether or not to approve the Patent Request,

taking into consideration both any effect on the commercialization of the

Licensed Products in the Territory and the patentability of the invention

proposed for patenting. If the Steering Committee in accordance with the Supply

Agreement approves a Patent Request, Licensor shall use commercially reasonable

efforts to timely file a patent application based on the invention detailed

therein and to diligently prosecute such application to issuance, provided that

Licensee shall pay all reasonable costs related to any patent application filed

pursuant to a Patent Request and any patent that issues therefrom to the extent

the application and patent relate exclusively to the Territory. To the extent

the application and any patent that issues therefrom are relevant to the

worldwide market, Licensee and Licensor shall cause their respective designees

on the Steering Committee to determine the appropriate allocation of cost as

between Licensee and Licensor. Notwithstanding Licensee's payment of prosecution

and maintenance fees, any patent application embodying an invention in whole or

in part based on, utilizing or otherwise incorporating the Licensed Rights,

filed pursuant to a Patent Request, or otherwise, and any patent that issues

therefrom shall be owned in its entirety by Licensor unless the Parties'

designees on the Steering Committee mutually agree that such application or

patent shall be jointly owned for the purpose of avoiding prior art status, such

as under 35 U.S.C. ss. 102(e). For the avoidance of doubt, the Parties intend

that Licensee has the right, on its own and


 
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