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CONFIDENTIAL UNIVERSITY OF PENNSYLVANIA AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

CONFIDENTIAL UNIVERSITY OF PENNSYLVANIA AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: Genovo, Inc | Targeted Genetics Corporation You are currently viewing:
This License Agreement involves

Genovo, Inc | Targeted Genetics Corporation

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Title: CONFIDENTIAL UNIVERSITY OF PENNSYLVANIA AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: Pennsylvania     Date: 5/7/2009
Industry: Biotechnology and Drugs     Law Firm: Morrison Foerster     Sector: Healthcare

CONFIDENTIAL UNIVERSITY OF PENNSYLVANIA AMENDED AND RESTATED LICENSE AGREEMENT, Parties: genovo  inc , targeted genetics corporation
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Exhibit 10.4

 

  

* Confidential Treatment has been requested for the marked portions of this exhibit pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

CONFIDENTIAL

UNIVERSITY OF PENNSYLVANIA

AMENDED AND RESTATED LICENSE AGREEMENT

This Amended and Restated License Agreement (“ Agreement ”), effective January 29, 2009 ( the “Restatement Date”) is made by and between The Trustees of the University of Pennsylvania, a Pennsylvania nonprofit corporation, with offices located at 3160 Chestnut Street, Suite 200, Philadelphia, Pennsylvania 19104-6283 (“ Penn ”) and Targeted Genetics Corporation, a corporation organized and existing under the laws of Washington (“ Targeted ”), having a place of business at 1100 Olive Way, Suite 100, Seattle, Washington 98101 and is an amendment to and restatement of the original License Agreement between Targeted and Penn (the “ Original Agreement ”) which became effective on June 1, 2002 (the “Effective Date”).

RECITALS

WHEREAS, Genovo, Inc., a corporation organized and existing under the laws of Delaware (“ Genovo ”), having a place of business at 512 Elmwood Avenue, Sharon Hill, PA 19079 and Penn are parties to the following three agreements, each dated as of June 30, 1995, and each as amended through the Effective Date (collectively sometimes called the “ Existing Agreements ”): that certain Sponsored Research Agreement, pursuant to which Genovo funded certain research at Penn relating to new strategies for gene therapy (“ Sponsored Research Agreement ”); that certain License Agreement Lung and Liver Fields pursuant to which Penn has granted certain licenses and other rights to Genovo relating to certain liver and lung fields (“ Liver/Lung License ”); and that certain License Agreement Additional Fields pursuant to which Penn has granted certain licenses and other rights to Genovo relating to certain other fields (“ Additional Fields License ”); and

WHEREAS, the Sponsored Research Agreement was terminated in accordance with that certain letter agreement between the parties dated February 27, 2001; and

WHEREAS, Penn owns and is a proprietor of certain intellectual property, including items developed under the Sponsored Research Agreement and items discovered or developed prior thereto and agreed to be subject to one or more of the Existing Agreements; and

WHEREAS, Genovo has become an Affiliate of Targeted in a transaction in which former shareholders of Genovo have become shareholders of Targeted; and


WHEREAS, Genovo and Targeted intend to pursue further research directed toward the development and improvement of gene therapy products and potential commercialization thereof in one or more applications, and Penn desires that they do so; and

WHEREAS, Penn has determined that the exploitation of such intellectual property and improvements thereto as described herein is in the best interests of Penn, is consistent with its educational and research missions and goals, and is likely to facilitate the accomplishment of the goals that originally supported the Existing Agreements and the Original Agreement;

WHEREAS, Penn and Targeted have had certain disagreements concerning interpretation of the language of the Original Agreement and after lengthy negotiation, Penn and Targeted have reached an agreement on certain amendments and modifications to the Original Agreement, including the return to Penn of certain patent dockets licensed to Targeted under the Original Agreement; and

WHEREAS, the parties now desire to amend and restate the Original Agreement in its entirety with this Agreement to reflect various matters contemplated by the parties as hereinafter set forth;

NOW, THEREFORE, in consideration of the premises and of the promises and covenants contained herein and intending to be legally bound hereby, the parties, agree as follows:

ARTICLE 1 - DEFINITIONS

For the purposes of this Agreement, in addition to the other terms defined above or elsewhere in this Agreement, the following words and phrases shall have the meanings set forth herein.

1.1 “ [*] ,” as to a product (and as to the point in time when this definition is referenced in this Agreement as to such product), means that such product [*] achieved the milestone in [*] and has since the achievement of such milestone progressed as applicable [*] set forth below:

 

 

(a)

[*] on such product with the appropriate health regulatory authority(ies) in at least one Major Nation, and Targeted, a Covered Affiliate, or their collaborators or sublicensees [*] ;

 

 

(b)

[*] clinical trials of such product have been [*] within [*] year [*] for such product [*] , and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete [*] ;

 

 

(c)

where [*] trials were [*] for such product, [*] clinical trials of such product have been [*] within [*] years after the [*] of such [*] clinical trials, and

 

  

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Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete [*] ;

 

 

(d)

[*] clinical trials of such product have been [*] within [*] years after the [*] (or [*] years after the [*] where [*] trials were [*] for such product) clinical trials for such product, and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to conduct and complete such [*] clinical trials of such product, including the [*] ;

 

 

(e)

[*] for such product has been [*] with the appropriate health regulatory authority(ies) in at least one Major Nation within [*] years after the [*] for such product, and Targeted, a Covered Affiliate, or their collaborators or sublicensees exert commercially reasonable efforts to [*] of such [*] until at least one such [*] or until all [*] (it being understood that the product will no longer be in [*] if all such [*] in all Major Nations have been [*] ); and

 

 

(f)

such product [*] in at least one Major Nation within [*] such product by the appropriate health regulatory authority(ies) in that Major Nation (including [*] in such Major Nation);

provided, however, that (1) if Targeted (or, as applicable, a Covered Affiliate, or their collaborators or sublicensees) [*] (even if, in Targeted’s or such other entity’s [*] , it is prudent for Targeted or such entity to do so), Targeted will not be considered to be exerting commercially reasonable efforts as to the conduct of such clinical trial; (2) the time periods specified in this Section as applied to a product shall be tolled during any period or periods in which Targeted (or, as applicable, a Covered Affiliate, or their collaborators or sublicensees) is, beyond its reasonable control, prevented from developing such product by government-imposed moratoriums, laws or rulings that prevent others generally from developing similar products, it being understood that if a clinical trial is halted or suspended because of [*] to Targeted’s (or such other entity’s) conduct of the trial, such action will not toll the time periods specified in this Section as applied to the product involved in such trial; and (3) if at any time or times Targeted (or, as applicable, a Covered Affiliate, or their collaborators or sublicensees) believes that it may not be able to advance a particular product through one or more of the above stages of development within any of the specific time periods specified in this Section (whether or not due to factors described in clause (2) above), Targeted may so notify Penn, together with a reasonably detailed description of the factors or reasons why Targeted believes it should nevertheless continue to be considered to have such product under [*] whereupon Penn and Targeted will over a period of at least [*] to reach agreement on extension(s) to such time period(s) as shall be reasonable in the circumstances; and

further provided, that Penn will not unreasonably withhold its consent to extensions of the forgoing timeframe requirements to the extent that Targeted can demonstrate that delays are due to the time required to enroll patients in clinical trials and conduct the protocol for such trials, so long as such enrollment and conduct of the protocol has proceeded and is proceeding continuously in accordance with the protocol (and applicable laws, regulations

 

  

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and good clinical practices) and the protocol has not been interrupted or suspended (unless such interruption or suspension is due to the action of regulatory authorities or is required to comply with applicable laws, regulations or good clinical practices, in which case, Penn would still not unreasonably withhold its consent to such an extension so long as Targeted or its sublicensees/Affiliates/collaborators are working diligently to address the issues and restart such trials).

1.2 “ Affiliate ” of an entity means and includes the entities that, directly or indirectly, own or control more than 50% of the voting interests (or equivalent control) of such entity (“ Parent ”), or more than 50% of the voting interests (or equivalent control) of which is, directly or indirectly, owned or controlled by such entity or its Parent. “ Affiliated ” refers to Affiliates. “ Covered Affiliate ” refers to an affiliate of Targeted that has agreed in writing to be bound by Targeted’s rights and obligations under this Agreement; Penn acknowledges that Genovo, by its signature agreeing to be bound by all the terms and obligations of Targeted below, is a Covered Affiliate.

1.3 “ Bankruptcy Event ” means voluntary or involuntary proceedings by or against Targeted are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for Targeted, or proceedings are instituted by or against Targeted for corporate reorganization or the dissolution of Targeted, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or Targeted makes an assignment for the benefit of creditors, or substantially all of the assets of Targeted are seized or attached and not released within sixty (60) days thereafter.

1.4 “ [*] ” includes [*] .

1.5 “ Calendar Quarter ” means each three-month period, or any portion thereof, beginning on January 1, April 1, July 1 and October 1.

1.6 “ Calendar Year ” means a period of twelve (12) months beginning on January 1 and ending on December 31.

1.7 “ [*] Field ” means the prevention, treatment or cure of [*] whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

1.8 “ Confidential Information ” means and includes all technical information, inventions, developments, discoveries, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas, whether or not patentable or copyrightable, that Penn identifies as confidential or proprietary at the time it is delivered or communicated to Targeted.

1.9 “ [*] ” means, with respect to a Penn Licensed Product: (a) the [*] filed on such Penn Licensed Product in any Major Nation; and (b) up to [*] additional [*] each of which is [*] , and for which [*] within the next [*] years for a Penn Licensed Product incorporating the

 

  

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same [*] as such Penn Licensed Product and/or [*] of up to [*] additional [*] in such Penn Licensed Product. Targeted shall designate the additional [*] and additional [*] referred to in clause (b) within [*] following the [*] on such Penn Licensed Product in any Major Nation; provided, however, that as to Penn Licensed Products covered by Group 2 Patents, Targeted may designate such additional [*] and additional [*] at an earlier time as described in Section 4.2.3. If, within such [*] following the [*] referred to in clause (a), none of Targeted or its Affiliates or licensees has actually [*] in at least one Major Nation for a Penn Licensed Product directed to a [*] that was so designated, then that [*] shall from that time forward no longer be among the [*] with respect to the Penn Licensed Product that was the subject [*] referred to in clause (a).

1.10 “ Fair Market Value ” means:

1.10.1 in the case of a Sale, the cash consideration which Targeted or its Covered Affiliate or sublicensee would realize from an unaffiliated, unrelated buyer under no obligation to buy in an arm’s length sale of an identical item sold in the same quantity and at the same time and place of the transaction; or

1.10.2 in the case of a transaction other than a Sale, the cash consideration which a willing party would realize from an unaffiliated, unrelated third party under no obligation to transact in an arm’s length transaction of the same type and at the same time and place of transaction; provided, however, that where Sales or other transactions are made in connection with patient assistance programs or other charitable purposes or to physicians or hospitals for promotional purposes, “Fair Market Value” for purposes hereof shall mean the actual consideration received, if any.

1.11 “ Federal Government Interest ” means the rights of the United States Government under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued thereunder, as such statute or regulations may be amended from time to time hereafter.

1.12 “ [*] ” means [*] .

1.13 “ [*] Letter Agreement ” means that certain letter agreement among [*] dated as of August 27, 1999, as amended through the Effective Date.

1.14 “ [*] Field ” means the prevention, treatment, or cure of [*] whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

1.15 “ Major Nation(s) ” means any one or more of Canada, France, Germany, Japan, the United Kingdom, or the United States. It is agreed for the avoidance of doubt that any filings or other actions or proceedings with or in the European Agency for the Evaluation of Medicinal Products or its successor will be considered to be with or in the health regulatory agency in at least one Major Nation.

 

  

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1.16 “ Net Sales ” means the gross sales amounts or, if such consideration is in a form other than cash or cash equivalents, the Fair Market Value, received by Targeted or its Covered Affiliates or their sublicensees from the Sale of any Penn Licensed Product(s), less qualifying costs directly attributable to such Sale borne by Targeted, its Covered Affiliate or their sublicensees. Such qualifying costs shall be limited to the following:

1.16.1 Discounts, in amounts customary in the trade, for quantity purchases, prompt payments and for wholesalers and distributors;

1.16.2 Credits or refunds, not exceeding the original invoice amount, for claims or returns;

1.16.3 Prepaid outbound packing, transportation expenses and transportation insurance premiums;

1.16.4 Sales and use taxes and other fees imposed by a governmental agency; and

1.16.5 Retroactive price reductions or rebates as required by law, all in accordance with U.S. generally accepted accounting principles consistently applied.

1.17 “ Non-Targeted Party ” means any person or entity that is not Penn, Targeted, an Affiliate of Penn, a Covered Affiliate, a sublicensee of Targeted or of a Covered Affiliate (which term refers to persons or entities to the extent acting under an express sublicense of rights of Targeted or a Covered Affiliate under this Agreement), or another collaborator or distributor of Targeted, a Covered Affiliate, or their sublicensees.

1.18 “ Penn Licensed Product(s) ” means

1.18.1 products that in the absence of this Agreement would, where and when made, used, sold, or imported, infringe at least one issued claim or pending claim of Penn Patent Rights; and

1.18.2 products that are made using a process or machine that in the absence of this Agreement would, where and when used, infringe at least one issued claim or pending claim of Penn Patent Rights.

All Penn Licensed Products intended to [*] shall be considered [*] Penn Licensed Product for purposes of Sections 4.1 and 4.3.

1.19 “ [*] ” means [*] .

 

  

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1.20 “ Penn Patent Rights ” means those patents and patent applications listed in Attachment 1 to this Agreement and all foreign counterparts thereof, as well as continuation, continuation-in-part, provided that such continuation-in-part relates directly to existing patents or patent applications and not to any new matter, divisional and re-issue applications thereof, together with any and all patents issuing thereupon or upon any foreign counterparts thereof; provided, however, that Targeted and Genovo acknowledge that the invention relating to [*] , was made at Penn following [*] . Targeted and Genovo hereby acknowledge that they have no rights in this invention relating to [*] , as defined in these applications and divisionals, continuations, re-examinations, re-issues, and any foreign counterparts thereof, and any patents issuing therefrom. Targeted and Genovo agree that they will not make or pursue any claims that this invention as so defined is or should have been part of the Penn Patent Rights.

1.20.1 “ Group 1 Patents ” means those Penn Patent Rights that are so designated in Attachment 1.

1.20.2 “ Group 2 Patents ” means those Penn Patent Rights that are so designated in Attachment 1.

1.20.3 “ Group 3 Patents ” means those Penn Patent Rights that are so Designated in Attachment 1.

1.20.4 “ Group 4 Patents ” means those Penn Patent Rights that were designated as Group 4 Patents in the Original Agreement.

1.20.5 “ Group 5 Patents ” means those Penn Patent Rights that were designated as Group 5 Patents in the Original Agreement.

1.21 “ Penn Technical Information ” means research and development information, unpatented inventions, know-how, and technical data developed by Dr. James Wilson, or other employees of Penn with a duty to assign their rights to Penn, under the Sponsored Research Agreement designated in Attachment 2 or described in the Penn Patent Rights, and not otherwise covered by Penn Patent Rights.

1.22 “ Phase I Trials ” “ Phase II Trials ” and “ Phase III Trials ” mean, respectively, human clinical trials designated by the U.S. Food and Drug Administration (FDA) as Phase I, Phase II (or Phase I/II), or Phase III trials.

1.23 “ Returned Patents ” means the Group 4 Patents, the Group 5 Patents and the portions of the Group 1, Group 2 and Group 3 Patents that were licensed to Targeted under the Original License but that are not included in the Penn Patent Rights licensed to Targeted under this Agreement.

1.24 “ Sale ” means any bona fide transaction for which consideration is received or expected for the sale, use, lease, transfer, or other disposition of Penn Licensed Product(s);

 

  

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provided, however, that the sale, lease, transfer, or other disposition of any Penn Licensed Product between Targeted, its Covered Affiliates, or their sublicensees, and another entity in such group, other than to a non-Covered-Affiliate distributor or to an end user, shall not be considered a Sale. In such cases, “Net Sales” hereunder shall be determined using the invoiced or otherwise recognized sales price by the transferee party, Covered Affiliate, or sublicensee to the non-Covered-Affiliate distributor or the end user, less the qualifying costs allowed under Section 1.16. A Sale of Penn Licensed Product(s) shall be deemed completed at the time Targeted, its Covered Affiliate or their sublicensee invoices, ships, or receives payment for such Penn Licensed Product(s), whichever occurs first. Sale shall not include any use of Penn Licensed Products in preclinical work, clinical trials, or internal research by Targeted, its Covered Affiliates, or their sublicensees or other collaborators, distributors, or contractors, or [*] .

1.25 “ Senior Officer(s) ” means, as to Targeted at any relevant time, the then-incumbent Chief Executive Officer of Targeted, and as to Penn at any relevant time, the Managing Director, Center for Technology Transfer.

1.26 “ [*] Field ” means the prevention, treatment, or cure of any disease or diseases in whole or in part through [*] , whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing). For purposes hereof, the [*] are more fully described in Attachment 3.

ARTICLE 2 - LICENSE GRANTS AND DILIGENCE

2.1 Group 1 Patents .

2.1.1 Group 1 License Grant . Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 1 Patents [*] . Such right and license shall be [*] .

2.2 Group 2 Patents .

2.2.1 Group 2 License Grant . Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 2 Patents [*] . Such right and license shall be [*] .

2.2.2 Group 2 Licenses to [*] . Penn retains the right to license [*] (“ [*] ”) non-exclusively to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 2 Patents solely [*] , and solely in conjunction with [*] proprietary [*] technology that exists as of the Effective Date, including any improvements and modifications thereof, (currently referred to as [*][*] ” and “ [*] ” technologies, including any modifications and improvements of the

 

  

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foregoing, and inclusive of subsequent improvements thereto, provided that the technology remains a [*] operably linked to some [*] proprietary [*] technology) and that is substantial and necessary to be used for such development, making, use, importation or sale of such Penn Licensed Products; provided, however, that:

 

 

(a)

[*] may be permitted to grant sublicenses under such license, provided that the sublicensee is similarly bound to use such Penn Licensed Patents solely in conjunction with such [*] proprietary [*] technology; and

 

 

(b)

Notwithstanding the foregoing in any transaction or transactions between [*] or its sublicensees on the one hand and either Targeted or [*] on the other, in any such transaction(s), rights to the Group 2 Patents will be obtained from Targeted based upon its rights under this Agreement and/or [*] based upon its sublicense from Targeted.

2.2.3 Intentionally Omitted.

2.2.4 Group 2 Specified [*] Sublicenses after Year [*] . [*] , Targeted shall make non-exclusive, commercial-use [*] under the Group 2 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*] in its discretion): (a) each such sublicense is restricted to [*] identified in such sublicense; (b) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (c) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (d) such sublicense does not permit use or application to an [*] applicable to any Penn Licensed Product that is then in [*] by Targeted, its Affiliates or their licensees. Where Targeted has [*] and [*] within [*] thereafter, Targeted shall either inform Penn [*] , together with a statement of the terms on which [*] , or else Targeted shall [*] , then Penn shall have the right to [*] , provided that [*] under clauses (a) - (d) above (reading references to [*] to refer [*] , and recognizing that Penn will [*] .

2.2.5 Group 2 Diligence outside the [*] Field . Penn shall have the right, at its option, to [*] the right and license under this Section 2.2 [*] outside of the [*] Field, if Targeted and/or its Affiliates and/or sublicensees [*] , at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 2 Patents outside of the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right (unless Targeted [*] prior to the end of such [*] period in which case no such [*] shall occur). The Parties acknowledge and agree that, as of the Restatement Date, [*] (the products developed under the agreements with [*] described in Sections 4.1.8 and 4.1.9 below) are in [*] and, therefore, diligence for the Group 2 Patents has been satisfied as of the Restatement Date.

2.3 Group 3 Patents .

 

  

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2.3.1 Group 3 License Grant . Penn hereby grants to Targeted and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold Penn Licensed Products under the Group 3 Patents in [*] .

2.3.2 Group 3 Specified [*] Sublicenses after Year [*] . [*] , Targeted shall make non-exclusive, commercial-use [*] under the Group 3 Patents available to third parties on commercially reasonable terms, provided that (unless Targeted [*] in its discretion): (a) each such sublicense is restricted to [*] identified in such sublicense; (b) such [*] is(are) not the subject of any sublicense previously granted by Targeted or its Affiliates on an exclusive basis, nor is any such exclusive sublicense with respect to such [*] then in active negotiation; (c) such sublicense does not permit use in or application to the [*] Field or in or to the [*] Field or in or to the [*] Field; and (d) such sublicense does not permit use or application to any product in an [*] applicable to any Penn Licensed Product that is then in [*] by Targeted, its Affiliates or their licensees. Where Targeted has [*] and [*] within [*] thereafter, Targeted shall either inform Penn [*] , together with a statement of the terms on which [*] , or else Targeted shall [*] under the Group 3 Patents, provided that [*] under clauses (a) – (d) above (reading references therein to [*] to refer [*] and recognizing that Penn will [*] .

2.3.3 Group 3 Diligence outside the [*] Field . Penn shall have the right, at its option, to [*] the right and license under this Section 2.3 [*] outside of the [*] Field, if Targeted and/or its Affiliates and sublicensees [*] , at any time after the [*] anniversary after the Effective Date, to have at least [*] under the Group 3 Patents [*] , or at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 3 Patents for used outside of the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right (unless Targeted [*] prior to the end of such [*] period in which case no such [*] shall occur). Targeted shall have the right, at its option and by notice to Penn given at any time, to [*] the right and license under this Section 2.3 (or with respect to one or more of the Penn Patent Rights included in Group 3) [*] from the date of such notice forward.

2.3.4 Group 3 Diligence in the [*] Field . Penn shall have the right, at its option, to [*] the right and license under this Section 2.3 [*] in the [*] Field if Targeted and its Affiliates and sublicensees [*] , at any time after the [*] anniversary after the Effective Date, to have [*] , or at any time after the [*] anniversary of the Effective Date, to have [*] at least [*] under the Group 3 Patents for use in the [*] Field, provided that Penn gives Targeted at least [*] prior notice of Penn’s intention to exercise such right. Targeted shall have the right, at its option and by notice to Penn given at any time on or before the [*] anniversary of the Effective Date, to [*] the right and license under this Section 2.3 (or with respect to one or more of the Penn Patent Rights included in Group 3) [*] in the [*] Field from the date of such notice forward.

 

  

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2.4 No Implied Diligence. Targeted’s diligence obligations with respect to this Agreement and the licenses granted hereunder are as explicitly stated in this Article 2, and no other or additional diligence or efforts obligations are implied, nor shall any be inferred.

2.5 Retained Research Rights . For all exclusive licenses granted under this Article 2: Penn retains the reserved right to use, and to permit third parties to use, the Penn Patent Rights strictly for educational and for research purposes (“Research”) and to use or commercialize the results of the Research, provided that any and all such commercialization of results, does not fall within the scope of any exclusive rights of Targeted or the Covered Affiliates hereunder, and that such limitation is incorporated into a written agreement with such third party.

2.6 Government Interest . Targeted acknowledges that in accordance with the Federal Government Interest, the United States government retains certain rights in intellectual property funded in whole or part under any contract, grant or similar agreement with a Federal agency, including but not limited to the requirement that Penn Licensed Products subject to Sale in the United States must be substantially manufactured in the United States. The license grant of this Article 2 is expressly subject to all of such rights.

2.7 Penn Technical Information . Penn, to the extent it has rights in the Penn Technical Information, hereby irrevocably grants Targeted and the Covered Affiliates a non-exclusive, royalty-free, paid-up right and license to make, use, sell, import, reproduce, disclose and otherwise exploit the same during and after the term of this Agreement, such license to Penn Technical Information shall not include the right to sublicense, except in conjunction with a sublicense of Penn Patent Rights under Article 3, and to the extent necessary to exercise the sublicense of Penn Patent Rights.

2.8 No Implied Licenses . No other rights or licenses are granted by implication hereunder. Targeted acknowledges that Penn shall have the right, in its sole discretion and without obligation to Targeted, to grant other parties licenses under the Penn Patent Rights so long as the same do not conflict with, and are not within the scope of, any of the exclusive rights or licenses granted hereunder to Targeted and the Covered Affiliates.

ARTICLE 3 - SUBLICENSES

3.1 The right to sublicense conferred upon Targeted and the Covered Affiliates under this Agreement shall be subject to the following conditions:

3.1.1 Any sublicenses shall be subject to the terms and conditions granted to Targeted and the Covered Affiliates under this Agreement.

3.1.2 No sublicensee (excluding, for this purpose, [*] under that certain [*] , among [*] , as amended, and [*] under the [*] Letter Agreement, but including, for this purpose, any sub-sublicensee of [*] under such agreement(s)) shall have the power to grant further sublicenses without the express approval of Penn, which approval shall not be

 

  

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unreasonably withheld, except that Targeted may permit a sublicensee to further sublicense its rights to a downstream sublicensee (“sub-sublicensee”) that is an Affiliate of such sublicensee; or to a third party collaborator solely for purposes of research, development or other non-commercial purposes, or as reasonably necessary, to manufacturers or distributors for the account of such sublicensees, but only on condition that any such downstream sublicense agreement (“sub-sublicense”) requires the sub-sublicensee to comply with the applicable terms of this Agreement and prohibits further sublicensing. For clarity, the sub-sublicensee shall be prohibited from further sublicensing. Except when used in this Section 3.1.2, the term sublicense includes any sub-sublicense and the term sublicensee includes any sub-sublicensee.

3.1.3 Targeted shall forward to Penn, within thirty (30) days of execution, a complete and accurate copy written in the English language of each sublicense granted hereunder, including options to sublicense and research or collaboration agreements granting any subset of rights under the Patent Rights, and including rights granted by sublicensees pursuant to 3.1.2. Penn’s receipt of such sublicense shall not constitute an approval of such sublicense or a waiver of any of Penn’s rights or Targeted’s obligations hereunder.

3.1.4 Targeted shall not grant any sublicense under any Penn Patent Rights in fields where Targeted has non-exclusive license rights hereunder unless:

 

 

(a)

with respect to Group 1 Patents, such sublicenses are (i)  [*] , (ii) are provided in connection with the grant of bona fide rights to material Targeted intellectual property or technology and (iii) the grant of rights is limited to use of Group 1 Patents in connection with such material Targeted intellectual property or technology; or

 

 

(b)

such license to Targeted hereunder was initially non-exclusive or became non-exclusive due to an election by Targeted as provided herein (rather than due to [*] ), and such sublicense is not a [*] ; or

 

 

(c)

the conditions in provision (b) apply except that the sublicense is a [*] and Targeted has obtained Penn’s prior written approval of such sublicense, which approval shall not be reasonably withheld or delayed; or

 

 

(d)

if the license to Targeted [*] , Targeted has obtained Penn’s prior written approval of such sublicense.

3.1.5 If Targeted becomes subject to a Bankruptcy Event, all payments then or thereafter due and owing to Targeted from its sublicensees shall upon notice from Penn to any such sublicensee become payable directly to Penn for the account of Targeted; provided however, that Penn shall remit to Targeted the amount by which such payments exceed the amounts owed by Targeted to Penn.

 

  

-12-

  

*Confidential Treatment Requested.


3.1.6 Notwithstanding any such sublicense, Targeted shall remain primarily liable to Penn for all of Targeted’s duties and obligations contained in this Agreement, and any act or omission of a Covered Affiliate or sublicensee of Targeted which would be a breach of this Agreement if performed by Targeted shall be deemed to be a breach by Targeted of this Agreement.

3.2 Targeted and Penn acknowledge that (i) for purposes of the [*] Letter Agreement, [*] by this Agreement, but, rather, shall only have been amended hereby, and (ii)  [*] shall not be bound by any amendment or alteration of the Existing Agreements, or any of them, to the extent the same may bear on the rights or obligations of [*] under the [*] Letter Agreement. Accordingly, Targeted and Penn agree that this Agreement is intended to be, and shall be construed to be, consistent with the [*] Letter Agreement, [*] Letter Agreement shall remain in full force and effect.

3.3. Targeted and Penn shall work together to facilitate the process for approval of sublicenses, for example, by having a pre-approved template for use with such [*] .

ARTICLE 4 - ROYALTIES AND MILESTONES

4.1 Royalties .

4.1.1 In further consideration of the licenses granted pursuant to Article 2, but subject to Section 4.1.4, Targeted shall pay to Penn a royalty in accordance with the following table for the Net Sales received by Targeted, the Covered Affiliates, or their sublicensees with respect to each particular Penn Licensed Product that has been, or that later is, in whole or in part developed by [*] under a right or sublicense granted by Targeted or a Covered Affiliate or otherwise collaboratively by [*] on the one hand and by Targeted and/or Covered Affiliates on the other:

 

For the portion of Net Sales of such Penn Licensed Product in a Calendar Year:

  

The royalty rate for
such Net Sales will be:

 

Less than or equal to [*]

  

[

*]

Greater than [*] and less than or equal to [*]

  

[

*]

Greater than [*] and less than or equal to [*]

  

[

*]

 

  

-13-

  

*Confidential Treatment Requested.


Greater than [*]

  

[

*]

4.1.2 In further consideration of the licenses granted pursuant to Article 2, but subject to Section 4.1.4, Targeted shall pay to Penn a royalty in accordance with the following table for the Net Sales received by Targeted, the Covered Affiliates, or their sublicensees with respect to each particular Penn Licensed Product to which Section 4.1.1 above is not applicable:

 

For the portion of Net Sales of such
Penn Licensed Product in a Calendar
Year:

  

The royalty rate for
such Net Sales will be:

 

Less than or equal to [*]

  

[

*]

Greater than [*] and less than or equal to [*]

  

[

*]

Greater than [*] and less than or equal to [*]

  

[

*]

Greater than [*]

  

[

*]

4.1.3 For purposes of each of Section 4.1.1 and Section 4.1.2: (i) no additional or multiple royalties shall be payable with respect to the Net Sales of any Penn Licensed Product, regardless of the number of Penn Patent Rights, or claims of Penn Patent Rights, that would in the absence of this Agreement be infringed by such Penn Licensed Product or processes or machines used to make it, even if such Penn Patent Rights include those from more than one of the patent groups defined in Section 1.20; (ii) the Net Sales thresholds in such sections will be [*] , but where the same Penn Licensed Product is [*] , or otherwise to accommodate the same to [*] , the Net Sales thereof [*] shall be [*] for purposes of Section 4.1.2; and (iii) all Net Sales of any particular Penn Licensed Product received by any of Targeted, Covered Affiliates, or their sublicensees will be [*] for purposes of Section 4.1.2.

 

 
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